SUBCHAPTER 610 - IMPORT PROCEDURES

611 - SCOPE

These procedures in this section cover imported merchandise. Your personal safety during any import procedures outlined in this subchapter is important. For more information concerning personal safety, see IOM 510.01.

612 - DIVISION OF AUTHORITY

These procedures in this section cover imported merchandise. Your personal safety during any import procedures outlined in this subchapter is important. For more information concerning personal safety, see IOM 510.01.

FDA determines if an article is in compliance with the Acts enforced by FDA. It also determines whether or not the article can be brought into compliance with the appropriate statute and authorizes reconditioning for that purpose.

Supervision over the reconditioning is exercised by either FDA or Customs as mutually arranged. At ports in reasonably close proximity to an FDA office, supervision is ordinarily exercised by FDA. At remote ports supervision may be exercised by Customs.

The refusal of admission, exportation, or destruction of merchandise is carried out under the direction of Customs. However, at some ports the actual supervision of the destruction of violative merchandise may be conducted by FDA pursuant to a local FDA/Customs agreement.

613 - ENTRIES

These procedures in this section cover imported merchandise. Your personal safety during any import procedures outlined in this subchapter is important. For more information concerning personal safety, see IOM 510.01.

FDA determines if an article is in compliance with the Acts enforced by FDA. It also determines whether or not the article can be brought into compliance with the appropriate statute and authorizes reconditioning for that purpose.

Supervision over the reconditioning is exercised by either FDA or Customs as mutually arranged. At ports in reasonably close proximity to an FDA office, supervision is ordinarily exercised by FDA. At remote ports supervision may be exercised by Customs.

The refusal of admission, exportation, or destruction of merchandise is carried out under the direction of Customs. However, at some ports the actual supervision of the destruction of violative merchandise may be conducted by FDA pursuant to a local FDA/Customs agreement.null

613.01 - Formal Entries

These procedures in this section cover imported merchandise. Your personal safety during any import procedures outlined in this subchapter is important. For more information concerning personal safety, see IOM 510.01.

FDA determines if an article is in compliance with the Acts enforced by FDA. It also determines whether or not the article can be brought into compliance with the appropriate statute and authorizes reconditioning for that purpose.

Supervision over the reconditioning is exercised by either FDA or Customs as mutually arranged. At ports in reasonably close proximity to an FDA office, supervision is ordinarily exercised by FDA. At remote ports supervision may be exercised by Customs.

The refusal of admission, exportation, or destruction of merchandise is carried out under the direction of Customs. However, at some ports the actual supervision of the destruction of violative merchandise may be conducted by FDA pursuant to a local FDA/Customs agreement.null

All articles offered for entry into the U.S. and subject to the Acts enforced by FDA, with a value greater than $2000 (current), are considered formal entries. They are subject to bond requirements, which include a condition for the redelivery of the merchandise, or any part of it, upon demand by Customs at any time, as prescribed for in the Custom's regulations in force on the date of entry. (See section 801(b) of the FD&C Act [21 U.S.C. 381(b)], 19 CFR Part 113). The bond is filed with Customs which, in case of default, takes appropriate action to effect the collection of liquidated damages provided for in the bond after consultation with FDA. (See 19 CFR Section 113.62(k) and 21 CFR Section 1.97).

Notification of the Customs entry is generally accomplished by electronic submission through the Customs Automated Commercial System (ACS). Non-electronic entries are submitted directly to FDA. Electronic entries received by FDA may be reviewed on screen (OSR) to determine if further action is needed, or if full documentation must be submitted. For entries requiring further review, FDA will be provided the appropriate Customs Entry documents (CF 3461/3461ALT, or other Customs entry forms), which also document interstate commerce, along with a copy of the invoice, etc. If an entry is not filed electronically, these documents will be submitted to FDA at the time Customs entry is made, in accordance with local port operations.

613.02 - Informal Entries

These procedures in this section cover imported merchandise. Your personal safety during any import procedures outlined in this subchapter is important. For more information concerning personal safety, see IOM 510.01.

FDA determines if an article is in compliance with the Acts enforced by FDA. It also determines whether or not the article can be brought into compliance with the appropriate statute and authorizes reconditioning for that purpose.

Supervision over the reconditioning is exercised by either FDA or Customs as mutually arranged. At ports in reasonably close proximity to an FDA office, supervision is ordinarily exercised by FDA. At remote ports supervision may be exercised by Customs.

The refusal of admission, exportation, or destruction of merchandise is carried out under the direction of Customs. However, at some ports the actual supervision of the destruction of violative merchandise may be conducted by FDA pursuant to a local FDA/Customs agreement.null

All articles offered for entry into the U.S. and subject to the Acts enforced by FDA, with a value greater than $2000 (current), are considered formal entries. They are subject to bond requirements, which include a condition for the redelivery of the merchandise, or any part of it, upon demand by Customs at any time, as prescribed for in the Custom's regulations in force on the date of entry. (See section 801(b) of the FD&C Act [21 U.S.C. 381(b)], 19 CFR Part 113). The bond is filed with Customs which, in case of default, takes appropriate action to effect the collection of liquidated damages provided for in the bond after consultation with FDA. (See 19 CFR Section 113.62(k) and 21 CFR Section 1.97).

Notification of the Customs entry is generally accomplished by electronic submission through the Customs Automated Commercial System (ACS). Non-electronic entries are submitted directly to FDA. Electronic entries received by FDA may be reviewed on screen (OSR) to determine if further action is needed, or if full documentation must be submitted. For entries requiring further review, FDA will be provided the appropriate Customs Entry documents (CF 3461/3461ALT, or other Customs entry forms), which also document interstate commerce, along with a copy of the invoice, etc. If an entry is not filed electronically, these documents will be submitted to FDA at the time Customs entry is made, in accordance with local port operations.

Normally, informal entries (value less than $2000 currently) do not require posting a redelivery bond. All informal entries of articles subject to FDA jurisdiction, entered electronically, are forwarded to FDA through the Customs/FDA ACS interface. Informal entries not filed electronically are processed as paper entries. When an informal entry is sampled, Customs may be requested to convert it into a formal consumption entry.

613.03 - Mail/Personal Baggage

These procedures in this section cover imported merchandise. Your personal safety during any import procedures outlined in this subchapter is important. For more information concerning personal safety, see IOM 510.01.

FDA determines if an article is in compliance with the Acts enforced by FDA. It also determines whether or not the article can be brought into compliance with the appropriate statute and authorizes reconditioning for that purpose.

Supervision over the reconditioning is exercised by either FDA or Customs as mutually arranged. At ports in reasonably close proximity to an FDA office, supervision is ordinarily exercised by FDA. At remote ports supervision may be exercised by Customs.

The refusal of admission, exportation, or destruction of merchandise is carried out under the direction of Customs. However, at some ports the actual supervision of the destruction of violative merchandise may be conducted by FDA pursuant to a local FDA/Customs agreement.null

All articles offered for entry into the U.S. and subject to the Acts enforced by FDA, with a value greater than $2000 (current), are considered formal entries. They are subject to bond requirements, which include a condition for the redelivery of the merchandise, or any part of it, upon demand by Customs at any time, as prescribed for in the Custom's regulations in force on the date of entry. (See section 801(b) of the FD&C Act [21 U.S.C. 381(b)], 19 CFR Part 113). The bond is filed with Customs which, in case of default, takes appropriate action to effect the collection of liquidated damages provided for in the bond after consultation with FDA. (See 19 CFR Section 113.62(k) and 21 CFR Section 1.97).

Notification of the Customs entry is generally accomplished by electronic submission through the Customs Automated Commercial System (ACS). Non-electronic entries are submitted directly to FDA. Electronic entries received by FDA may be reviewed on screen (OSR) to determine if further action is needed, or if full documentation must be submitted. For entries requiring further review, FDA will be provided the appropriate Customs Entry documents (CF 3461/3461ALT, or other Customs entry forms), which also document interstate commerce, along with a copy of the invoice, etc. If an entry is not filed electronically, these documents will be submitted to FDA at the time Customs entry is made, in accordance with local port operations.

Normally, informal entries (value less than $2000 currently) do not require posting a redelivery bond. All informal entries of articles subject to FDA jurisdiction, entered electronically, are forwarded to FDA through the Customs/FDA ACS interface. Informal entries not filed electronically are processed as paper entries. When an informal entry is sampled, Customs may be requested to convert it into a formal consumption entry.

In the case of imports by mail or personal baggage, FDA districts should arrange for coverage with their local Customs International Mail Office or border crossing office. This should include agreements designating who is responsible for coverage, when (how often), etc. Customs is responsible for examination of personal baggage. If an article subject to FDA review is encountered, the Customs officer will determine if it should be brought to the attention of the local FDA office. Personal importations meeting the criteria of a formal entry will be processed in accordance with normal non-electronic entries. Generally, since most personal importations are small in size and value, guidance has been developed for evaluating these importations. (See RPM Chapter "Coverage of Personal Importations".)

"Section 321 entries" for Customs are those entries with a value of $200 or less. Generally, this form of entry applies to articles which pass free of duty and tax, as defined in 19 C.F.R. 101.1(o), and imported by one person. Customs and FDA may conduct periodic "blitzes" to determine the volume and type of FDA-regulated merchandise admitted under "Section 321 entries." The use of the 321 entry process should not apply to multiple shipments covered by a single order or contract, sent separately for the express purpose of securing free entry and avoiding compliance with pertinent law or regulation.

613.04 - Entry Processing

These procedures in this section cover imported merchandise. Your personal safety during any import procedures outlined in this subchapter is important. For more information concerning personal safety, see IOM 510.01.

FDA determines if an article is in compliance with the Acts enforced by FDA. It also determines whether or not the article can be brought into compliance with the appropriate statute and authorizes reconditioning for that purpose.

Supervision over the reconditioning is exercised by either FDA or Customs as mutually arranged. At ports in reasonably close proximity to an FDA office, supervision is ordinarily exercised by FDA. At remote ports supervision may be exercised by Customs.

The refusal of admission, exportation, or destruction of merchandise is carried out under the direction of Customs. However, at some ports the actual supervision of the destruction of violative merchandise may be conducted by FDA pursuant to a local FDA/Customs agreement.null

All articles offered for entry into the U.S. and subject to the Acts enforced by FDA, with a value greater than $2000 (current), are considered formal entries. They are subject to bond requirements, which include a condition for the redelivery of the merchandise, or any part of it, upon demand by Customs at any time, as prescribed for in the Custom's regulations in force on the date of entry. (See section 801(b) of the FD&C Act [21 U.S.C. 381(b)], 19 CFR Part 113). The bond is filed with Customs which, in case of default, takes appropriate action to effect the collection of liquidated damages provided for in the bond after consultation with FDA. (See 19 CFR Section 113.62(k) and 21 CFR Section 1.97).

Notification of the Customs entry is generally accomplished by electronic submission through the Customs Automated Commercial System (ACS). Non-electronic entries are submitted directly to FDA. Electronic entries received by FDA may be reviewed on screen (OSR) to determine if further action is needed, or if full documentation must be submitted. For entries requiring further review, FDA will be provided the appropriate Customs Entry documents (CF 3461/3461ALT, or other Customs entry forms), which also document interstate commerce, along with a copy of the invoice, etc. If an entry is not filed electronically, these documents will be submitted to FDA at the time Customs entry is made, in accordance with local port operations.

Normally, informal entries (value less than $2000 currently) do not require posting a redelivery bond. All informal entries of articles subject to FDA jurisdiction, entered electronically, are forwarded to FDA through the Customs/FDA ACS interface. Informal entries not filed electronically are processed as paper entries. When an informal entry is sampled, Customs may be requested to convert it into a formal consumption entry.

In the case of imports by mail or personal baggage, FDA districts should arrange for coverage with their local Customs International Mail Office or border crossing office. This should include agreements designating who is responsible for coverage, when (how often), etc. Customs is responsible for examination of personal baggage. If an article subject to FDA review is encountered, the Customs officer will determine if it should be brought to the attention of the local FDA office. Personal importations meeting the criteria of a formal entry will be processed in accordance with normal non-electronic entries. Generally, since most personal importations are small in size and value, guidance has been developed for evaluating these importations. (See RPM Chapter "Coverage of Personal Importations".)

"Section 321 entries" for Customs are those entries with a value of $200 or less. Generally, this form of entry applies to articles which pass free of duty and tax, as defined in 19 C.F.R. 101.1(o), and imported by one person. Customs and FDA may conduct periodic "blitzes" to determine the volume and type of FDA-regulated merchandise admitted under "Section 321 entries." The use of the 321 entry process should not apply to multiple shipments covered by a single order or contract, sent separately for the express purpose of securing free entry and avoiding compliance with pertinent law or regulation.

FDA district offices generally receive notification of all formal and informal entries subject to FDA's jurisdiction at ports of entry located in its territory. However, through the use of Custom's Automated Commercial System and FDA's Operational and Administrative System for Import Support (ACS/OASIS) some electronic entries may be forwarded to off-site districts for processing during certain periods of time, i.e., late night coverage of air carrier hubs. The means of receiving notification for non-ABI/OASIS entries can be arranged through local Customs/FDA District agreements.

The most satisfactory and efficient means of getting notification is through FDA's OASIS system. Electronic entries processed through this system are electronically screened against criteria established by FDA for coverage. Automated Broker Interface (ABI) filers using the Customs ACS for cargo release are required to provide FDA information on entries subject to its jurisdiction submitted through ACS.

Customs' ACS uses guides established by each Federal agency to identify which commodities are subject to their jurisdiction. These guides are known as Other Government Agency (OGA) flags. FDA flags are identified as FD0, FD1 and FD2. FD0 indicates the article, even though subject to FDA regulation, may be released without further presentation of entry information to FDA. For entries flagged FD1, the commodity may or may not be subject to FDA regulation. The filer may, based on information received from the importer regarding the intended use of the commodity, specify the entry is not subject to FDA regulation and "Disclaim" the entry. Otherwise, FDA required information must be submitted. FDA review of "Disclaimed" entries is performed periodically to confirm the accuracy of the declaration. Entries covered by an FD2 flag must include FDA required information.

Electronic entries for Customs review includes all mandatory Customs entry required information, i.e., entry number, entry date, importer identification, port of entry, vessel/voyage information, filer identification, Harmonized Tariff System (HTS) code for product description, information on foreign shipper, country of origin, quantity, value, etc. Through the screening process in ACS, Customs determines if the article is subject to FDA examination (see OGA flag identifications above).

FDA's electronic screening of the Customs ABI/ACS entry requires the filer to provide the following information.

1. FDA product code. (FDA's product code is not the same as the HTS codes used for Customs screening purposes.)

2. The "Manufacturer's Identification" (MID) code (a Customs designation) of the foreign manufacturer. The MID consists, at a minimum, of the 2 letter identification of the foreign country, the name of the foreign firm, generally made up of the first three letters of the first and second names of the firm, where applicable. Up to 4 numbers, if present in the address, and the first three letters of the city where the firm is located. This code is subsequently transmitted to FDA's screen as the un-coded identified firm.

3. The MID information of the foreign shipper, including city and country. (Which may or may not be the same as the foreign manufacturer.) and

4. The country of origin. (Which may be different from the country of origin identified for Customs purposes.)

FDA has also established Affirmation of Compliance (AofC) codes which are designed to provide FDA reviewers with information concerning the imported article (example: medical device listing number). Use of the AofC is voluntary, and may or may not provide for a more expeditious screening of the entry.

In OASIS, the FDA forms identified as: "Notice of Sampling," "Release Notice," "Notice of Detention and Hearing," and "Notice of Refusal of Admission," are no longer issued as specific forms. OASIS generates a "Notice of FDA Action" providing information on the actions taken regarding a particular entry line. The notice identifies the specific line(s) of the entry, where appropriate, with the description of the sample collected or intended for sampling, specific line(s) identified as detained, and/or the specific line(s) identified as released, refused, etc. As the status changes for a particular line, a new "Notice of FDA Action" is issued to advise the appropriate individuals of the changes. The use of the designation "Product Collected by FDA," "Detained," "Released," "Refused," etc., or similar wording on the "Notice of FDA Action," meet the requirements of the wording of the law and regulation when applied to "giving notice thereof to the owner or consignee." See Exhibit 610-C.

OASIS notices are designed to be mailed to the addressees. A copy of each notice is produced with the filer, importer of record, and consignee on the addressee line. (If the same firm acts in one or more of those functions, only one copy is produced for the firm.) Notices are official documents which provide FDA decisions on entries. The distribution of the notices is made by FDA, not the filer, to ensure proper notification to the parties involved (i.e., FAX, express pick-up services, postal service, etc.). The intention is for FDA to distribute to the responsible firm without an intermediary.

614 - SAMPLING

These procedures in this section cover imported merchandise. Your personal safety during any import procedures outlined in this subchapter is important. For more information concerning personal safety, see IOM 510.01.

FDA determines if an article is in compliance with the Acts enforced by FDA. It also determines whether or not the article can be brought into compliance with the appropriate statute and authorizes reconditioning for that purpose.

Supervision over the reconditioning is exercised by either FDA or Customs as mutually arranged. At ports in reasonably close proximity to an FDA office, supervision is ordinarily exercised by FDA. At remote ports supervision may be exercised by Customs.

The refusal of admission, exportation, or destruction of merchandise is carried out under the direction of Customs. However, at some ports the actual supervision of the destruction of violative merchandise may be conducted by FDA pursuant to a local FDA/Customs agreement.null

All articles offered for entry into the U.S. and subject to the Acts enforced by FDA, with a value greater than $2000 (current), are considered formal entries. They are subject to bond requirements, which include a condition for the redelivery of the merchandise, or any part of it, upon demand by Customs at any time, as prescribed for in the Custom's regulations in force on the date of entry. (See section 801(b) of the FD&C Act [21 U.S.C. 381(b)], 19 CFR Part 113). The bond is filed with Customs which, in case of default, takes appropriate action to effect the collection of liquidated damages provided for in the bond after consultation with FDA. (See 19 CFR Section 113.62(k) and 21 CFR Section 1.97).

Notification of the Customs entry is generally accomplished by electronic submission through the Customs Automated Commercial System (ACS). Non-electronic entries are submitted directly to FDA. Electronic entries received by FDA may be reviewed on screen (OSR) to determine if further action is needed, or if full documentation must be submitted. For entries requiring further review, FDA will be provided the appropriate Customs Entry documents (CF 3461/3461ALT, or other Customs entry forms), which also document interstate commerce, along with a copy of the invoice, etc. If an entry is not filed electronically, these documents will be submitted to FDA at the time Customs entry is made, in accordance with local port operations.

Normally, informal entries (value less than $2000 currently) do not require posting a redelivery bond. All informal entries of articles subject to FDA jurisdiction, entered electronically, are forwarded to FDA through the Customs/FDA ACS interface. Informal entries not filed electronically are processed as paper entries. When an informal entry is sampled, Customs may be requested to convert it into a formal consumption entry.

In the case of imports by mail or personal baggage, FDA districts should arrange for coverage with their local Customs International Mail Office or border crossing office. This should include agreements designating who is responsible for coverage, when (how often), etc. Customs is responsible for examination of personal baggage. If an article subject to FDA review is encountered, the Customs officer will determine if it should be brought to the attention of the local FDA office. Personal importations meeting the criteria of a formal entry will be processed in accordance with normal non-electronic entries. Generally, since most personal importations are small in size and value, guidance has been developed for evaluating these importations. (See RPM Chapter "Coverage of Personal Importations".)

"Section 321 entries" for Customs are those entries with a value of $200 or less. Generally, this form of entry applies to articles which pass free of duty and tax, as defined in 19 C.F.R. 101.1(o), and imported by one person. Customs and FDA may conduct periodic "blitzes" to determine the volume and type of FDA-regulated merchandise admitted under "Section 321 entries." The use of the 321 entry process should not apply to multiple shipments covered by a single order or contract, sent separately for the express purpose of securing free entry and avoiding compliance with pertinent law or regulation.

FDA district offices generally receive notification of all formal and informal entries subject to FDA's jurisdiction at ports of entry located in its territory. However, through the use of Custom's Automated Commercial System and FDA's Operational and Administrative System for Import Support (ACS/OASIS) some electronic entries may be forwarded to off-site districts for processing during certain periods of time, i.e., late night coverage of air carrier hubs. The means of receiving notification for non-ABI/OASIS entries can be arranged through local Customs/FDA District agreements.

The most satisfactory and efficient means of getting notification is through FDA's OASIS system. Electronic entries processed through this system are electronically screened against criteria established by FDA for coverage. Automated Broker Interface (ABI) filers using the Customs ACS for cargo release are required to provide FDA information on entries subject to its jurisdiction submitted through ACS.

Customs' ACS uses guides established by each Federal agency to identify which commodities are subject to their jurisdiction. These guides are known as Other Government Agency (OGA) flags. FDA flags are identified as FD0, FD1 and FD2. FD0 indicates the article, even though subject to FDA regulation, may be released without further presentation of entry information to FDA. For entries flagged FD1, the commodity may or may not be subject to FDA regulation. The filer may, based on information received from the importer regarding the intended use of the commodity, specify the entry is not subject to FDA regulation and "Disclaim" the entry. Otherwise, FDA required information must be submitted. FDA review of "Disclaimed" entries is performed periodically to confirm the accuracy of the declaration. Entries covered by an FD2 flag must include FDA required information.

Electronic entries for Customs review includes all mandatory Customs entry required information, i.e., entry number, entry date, importer identification, port of entry, vessel/voyage information, filer identification, Harmonized Tariff System (HTS) code for product description, information on foreign shipper, country of origin, quantity, value, etc. Through the screening process in ACS, Customs determines if the article is subject to FDA examination (see OGA flag identifications above).

FDA's electronic screening of the Customs ABI/ACS entry requires the filer to provide the following information.

1. FDA product code. (FDA's product code is not the same as the HTS codes used for Customs screening purposes.)

2. The "Manufacturer's Identification" (MID) code (a Customs designation) of the foreign manufacturer. The MID consists, at a minimum, of the 2 letter identification of the foreign country, the name of the foreign firm, generally made up of the first three letters of the first and second names of the firm, where applicable. Up to 4 numbers, if present in the address, and the first three letters of the city where the firm is located. This code is subsequently transmitted to FDA's screen as the un-coded identified firm.

3. The MID information of the foreign shipper, including city and country. (Which may or may not be the same as the foreign manufacturer.) and

4. The country of origin. (Which may be different from the country of origin identified for Customs purposes.)

FDA has also established Affirmation of Compliance (AofC) codes which are designed to provide FDA reviewers with information concerning the imported article (example: medical device listing number). Use of the AofC is voluntary, and may or may not provide for a more expeditious screening of the entry.

In OASIS, the FDA forms identified as: "Notice of Sampling," "Release Notice," "Notice of Detention and Hearing," and "Notice of Refusal of Admission," are no longer issued as specific forms. OASIS generates a "Notice of FDA Action" providing information on the actions taken regarding a particular entry line. The notice identifies the specific line(s) of the entry, where appropriate, with the description of the sample collected or intended for sampling, specific line(s) identified as detained, and/or the specific line(s) identified as released, refused, etc. As the status changes for a particular line, a new "Notice of FDA Action" is issued to advise the appropriate individuals of the changes. The use of the designation "Product Collected by FDA," "Detained," "Released," "Refused," etc., or similar wording on the "Notice of FDA Action," meet the requirements of the wording of the law and regulation when applied to "giving notice thereof to the owner or consignee." See Exhibit 610-C.

OASIS notices are designed to be mailed to the addressees. A copy of each notice is produced with the filer, importer of record, and consignee on the addressee line. (If the same firm acts in one or more of those functions, only one copy is produced for the firm.) Notices are official documents which provide FDA decisions on entries. The distribution of the notices is made by FDA, not the filer, to ensure proper notification to the parties involved (i.e., FAX, express pick-up services, postal service, etc.). The intention is for FDA to distribute to the responsible firm without an intermediary.null

614.01 - Ports Covered by FDA

These procedures in this section cover imported merchandise. Your personal safety during any import procedures outlined in this subchapter is important. For more information concerning personal safety, see IOM 510.01.

FDA determines if an article is in compliance with the Acts enforced by FDA. It also determines whether or not the article can be brought into compliance with the appropriate statute and authorizes reconditioning for that purpose.

Supervision over the reconditioning is exercised by either FDA or Customs as mutually arranged. At ports in reasonably close proximity to an FDA office, supervision is ordinarily exercised by FDA. At remote ports supervision may be exercised by Customs.

The refusal of admission, exportation, or destruction of merchandise is carried out under the direction of Customs. However, at some ports the actual supervision of the destruction of violative merchandise may be conducted by FDA pursuant to a local FDA/Customs agreement.null

All articles offered for entry into the U.S. and subject to the Acts enforced by FDA, with a value greater than $2000 (current), are considered formal entries. They are subject to bond requirements, which include a condition for the redelivery of the merchandise, or any part of it, upon demand by Customs at any time, as prescribed for in the Custom's regulations in force on the date of entry. (See section 801(b) of the FD&C Act [21 U.S.C. 381(b)], 19 CFR Part 113). The bond is filed with Customs which, in case of default, takes appropriate action to effect the collection of liquidated damages provided for in the bond after consultation with FDA. (See 19 CFR Section 113.62(k) and 21 CFR Section 1.97).

Notification of the Customs entry is generally accomplished by electronic submission through the Customs Automated Commercial System (ACS). Non-electronic entries are submitted directly to FDA. Electronic entries received by FDA may be reviewed on screen (OSR) to determine if further action is needed, or if full documentation must be submitted. For entries requiring further review, FDA will be provided the appropriate Customs Entry documents (CF 3461/3461ALT, or other Customs entry forms), which also document interstate commerce, along with a copy of the invoice, etc. If an entry is not filed electronically, these documents will be submitted to FDA at the time Customs entry is made, in accordance with local port operations.

Normally, informal entries (value less than $2000 currently) do not require posting a redelivery bond. All informal entries of articles subject to FDA jurisdiction, entered electronically, are forwarded to FDA through the Customs/FDA ACS interface. Informal entries not filed electronically are processed as paper entries. When an informal entry is sampled, Customs may be requested to convert it into a formal consumption entry.

In the case of imports by mail or personal baggage, FDA districts should arrange for coverage with their local Customs International Mail Office or border crossing office. This should include agreements designating who is responsible for coverage, when (how often), etc. Customs is responsible for examination of personal baggage. If an article subject to FDA review is encountered, the Customs officer will determine if it should be brought to the attention of the local FDA office. Personal importations meeting the criteria of a formal entry will be processed in accordance with normal non-electronic entries. Generally, since most personal importations are small in size and value, guidance has been developed for evaluating these importations. (See RPM Chapter "Coverage of Personal Importations".)

"Section 321 entries" for Customs are those entries with a value of $200 or less. Generally, this form of entry applies to articles which pass free of duty and tax, as defined in 19 C.F.R. 101.1(o), and imported by one person. Customs and FDA may conduct periodic "blitzes" to determine the volume and type of FDA-regulated merchandise admitted under "Section 321 entries." The use of the 321 entry process should not apply to multiple shipments covered by a single order or contract, sent separately for the express purpose of securing free entry and avoiding compliance with pertinent law or regulation.

FDA district offices generally receive notification of all formal and informal entries subject to FDA's jurisdiction at ports of entry located in its territory. However, through the use of Custom's Automated Commercial System and FDA's Operational and Administrative System for Import Support (ACS/OASIS) some electronic entries may be forwarded to off-site districts for processing during certain periods of time, i.e., late night coverage of air carrier hubs. The means of receiving notification for non-ABI/OASIS entries can be arranged through local Customs/FDA District agreements.

The most satisfactory and efficient means of getting notification is through FDA's OASIS system. Electronic entries processed through this system are electronically screened against criteria established by FDA for coverage. Automated Broker Interface (ABI) filers using the Customs ACS for cargo release are required to provide FDA information on entries subject to its jurisdiction submitted through ACS.

Customs' ACS uses guides established by each Federal agency to identify which commodities are subject to their jurisdiction. These guides are known as Other Government Agency (OGA) flags. FDA flags are identified as FD0, FD1 and FD2. FD0 indicates the article, even though subject to FDA regulation, may be released without further presentation of entry information to FDA. For entries flagged FD1, the commodity may or may not be subject to FDA regulation. The filer may, based on information received from the importer regarding the intended use of the commodity, specify the entry is not subject to FDA regulation and "Disclaim" the entry. Otherwise, FDA required information must be submitted. FDA review of "Disclaimed" entries is performed periodically to confirm the accuracy of the declaration. Entries covered by an FD2 flag must include FDA required information.

Electronic entries for Customs review includes all mandatory Customs entry required information, i.e., entry number, entry date, importer identification, port of entry, vessel/voyage information, filer identification, Harmonized Tariff System (HTS) code for product description, information on foreign shipper, country of origin, quantity, value, etc. Through the screening process in ACS, Customs determines if the article is subject to FDA examination (see OGA flag identifications above).

FDA's electronic screening of the Customs ABI/ACS entry requires the filer to provide the following information.

1. FDA product code. (FDA's product code is not the same as the HTS codes used for Customs screening purposes.)

2. The "Manufacturer's Identification" (MID) code (a Customs designation) of the foreign manufacturer. The MID consists, at a minimum, of the 2 letter identification of the foreign country, the name of the foreign firm, generally made up of the first three letters of the first and second names of the firm, where applicable. Up to 4 numbers, if present in the address, and the first three letters of the city where the firm is located. This code is subsequently transmitted to FDA's screen as the un-coded identified firm.

3. The MID information of the foreign shipper, including city and country. (Which may or may not be the same as the foreign manufacturer.) and

4. The country of origin. (Which may be different from the country of origin identified for Customs purposes.)

FDA has also established Affirmation of Compliance (AofC) codes which are designed to provide FDA reviewers with information concerning the imported article (example: medical device listing number). Use of the AofC is voluntary, and may or may not provide for a more expeditious screening of the entry.

In OASIS, the FDA forms identified as: "Notice of Sampling," "Release Notice," "Notice of Detention and Hearing," and "Notice of Refusal of Admission," are no longer issued as specific forms. OASIS generates a "Notice of FDA Action" providing information on the actions taken regarding a particular entry line. The notice identifies the specific line(s) of the entry, where appropriate, with the description of the sample collected or intended for sampling, specific line(s) identified as detained, and/or the specific line(s) identified as released, refused, etc. As the status changes for a particular line, a new "Notice of FDA Action" is issued to advise the appropriate individuals of the changes. The use of the designation "Product Collected by FDA," "Detained," "Released," "Refused," etc., or similar wording on the "Notice of FDA Action," meet the requirements of the wording of the law and regulation when applied to "giving notice thereof to the owner or consignee." See Exhibit 610-C.

OASIS notices are designed to be mailed to the addressees. A copy of each notice is produced with the filer, importer of record, and consignee on the addressee line. (If the same firm acts in one or more of those functions, only one copy is produced for the firm.) Notices are official documents which provide FDA decisions on entries. The distribution of the notices is made by FDA, not the filer, to ensure proper notification to the parties involved (i.e., FAX, express pick-up services, postal service, etc.). The intention is for FDA to distribute to the responsible firm without an intermediary.null

For electronic entry submissions, if the filer receives a message indicating FDA review, the filer will provide appropriate entry information to the FDA office having jurisdiction over the port of entry. For those entries submitted by paper, all appropriate entry documents should be included with the package sent to the local FDA office.

After evaluating the entry, if FDA decides to collect a sample, the appropriate individuals/firms will be provided with a Notice for Sampling and advised:

1. if the entry is to be held intact for FDA examination or sampling;
2. only those designated items need be held; etc.

614.02 - Ports not Covered by FDA

These procedures in this section cover imported merchandise. Your personal safety during any import procedures outlined in this subchapter is important. For more information concerning personal safety, see IOM 510.01.

FDA determines if an article is in compliance with the Acts enforced by FDA. It also determines whether or not the article can be brought into compliance with the appropriate statute and authorizes reconditioning for that purpose.

Supervision over the reconditioning is exercised by either FDA or Customs as mutually arranged. At ports in reasonably close proximity to an FDA office, supervision is ordinarily exercised by FDA. At remote ports supervision may be exercised by Customs.

The refusal of admission, exportation, or destruction of merchandise is carried out under the direction of Customs. However, at some ports the actual supervision of the destruction of violative merchandise may be conducted by FDA pursuant to a local FDA/Customs agreement.null

All articles offered for entry into the U.S. and subject to the Acts enforced by FDA, with a value greater than $2000 (current), are considered formal entries. They are subject to bond requirements, which include a condition for the redelivery of the merchandise, or any part of it, upon demand by Customs at any time, as prescribed for in the Custom's regulations in force on the date of entry. (See section 801(b) of the FD&C Act [21 U.S.C. 381(b)], 19 CFR Part 113). The bond is filed with Customs which, in case of default, takes appropriate action to effect the collection of liquidated damages provided for in the bond after consultation with FDA. (See 19 CFR Section 113.62(k) and 21 CFR Section 1.97).

Notification of the Customs entry is generally accomplished by electronic submission through the Customs Automated Commercial System (ACS). Non-electronic entries are submitted directly to FDA. Electronic entries received by FDA may be reviewed on screen (OSR) to determine if further action is needed, or if full documentation must be submitted. For entries requiring further review, FDA will be provided the appropriate Customs Entry documents (CF 3461/3461ALT, or other Customs entry forms), which also document interstate commerce, along with a copy of the invoice, etc. If an entry is not filed electronically, these documents will be submitted to FDA at the time Customs entry is made, in accordance with local port operations.

Normally, informal entries (value less than $2000 currently) do not require posting a redelivery bond. All informal entries of articles subject to FDA jurisdiction, entered electronically, are forwarded to FDA through the Customs/FDA ACS interface. Informal entries not filed electronically are processed as paper entries. When an informal entry is sampled, Customs may be requested to convert it into a formal consumption entry.

In the case of imports by mail or personal baggage, FDA districts should arrange for coverage with their local Customs International Mail Office or border crossing office. This should include agreements designating who is responsible for coverage, when (how often), etc. Customs is responsible for examination of personal baggage. If an article subject to FDA review is encountered, the Customs officer will determine if it should be brought to the attention of the local FDA office. Personal importations meeting the criteria of a formal entry will be processed in accordance with normal non-electronic entries. Generally, since most personal importations are small in size and value, guidance has been developed for evaluating these importations. (See RPM Chapter "Coverage of Personal Importations".)

"Section 321 entries" for Customs are those entries with a value of $200 or less. Generally, this form of entry applies to articles which pass free of duty and tax, as defined in 19 C.F.R. 101.1(o), and imported by one person. Customs and FDA may conduct periodic "blitzes" to determine the volume and type of FDA-regulated merchandise admitted under "Section 321 entries." The use of the 321 entry process should not apply to multiple shipments covered by a single order or contract, sent separately for the express purpose of securing free entry and avoiding compliance with pertinent law or regulation.

FDA district offices generally receive notification of all formal and informal entries subject to FDA's jurisdiction at ports of entry located in its territory. However, through the use of Custom's Automated Commercial System and FDA's Operational and Administrative System for Import Support (ACS/OASIS) some electronic entries may be forwarded to off-site districts for processing during certain periods of time, i.e., late night coverage of air carrier hubs. The means of receiving notification for non-ABI/OASIS entries can be arranged through local Customs/FDA District agreements.

The most satisfactory and efficient means of getting notification is through FDA's OASIS system. Electronic entries processed through this system are electronically screened against criteria established by FDA for coverage. Automated Broker Interface (ABI) filers using the Customs ACS for cargo release are required to provide FDA information on entries subject to its jurisdiction submitted through ACS.

Customs' ACS uses guides established by each Federal agency to identify which commodities are subject to their jurisdiction. These guides are known as Other Government Agency (OGA) flags. FDA flags are identified as FD0, FD1 and FD2. FD0 indicates the article, even though subject to FDA regulation, may be released without further presentation of entry information to FDA. For entries flagged FD1, the commodity may or may not be subject to FDA regulation. The filer may, based on information received from the importer regarding the intended use of the commodity, specify the entry is not subject to FDA regulation and "Disclaim" the entry. Otherwise, FDA required information must be submitted. FDA review of "Disclaimed" entries is performed periodically to confirm the accuracy of the declaration. Entries covered by an FD2 flag must include FDA required information.

Electronic entries for Customs review includes all mandatory Customs entry required information, i.e., entry number, entry date, importer identification, port of entry, vessel/voyage information, filer identification, Harmonized Tariff System (HTS) code for product description, information on foreign shipper, country of origin, quantity, value, etc. Through the screening process in ACS, Customs determines if the article is subject to FDA examination (see OGA flag identifications above).

FDA's electronic screening of the Customs ABI/ACS entry requires the filer to provide the following information.

1. FDA product code. (FDA's product code is not the same as the HTS codes used for Customs screening purposes.)

2. The "Manufacturer's Identification" (MID) code (a Customs designation) of the foreign manufacturer. The MID consists, at a minimum, of the 2 letter identification of the foreign country, the name of the foreign firm, generally made up of the first three letters of the first and second names of the firm, where applicable. Up to 4 numbers, if present in the address, and the first three letters of the city where the firm is located. This code is subsequently transmitted to FDA's screen as the un-coded identified firm.

3. The MID information of the foreign shipper, including city and country. (Which may or may not be the same as the foreign manufacturer.) and

4. The country of origin. (Which may be different from the country of origin identified for Customs purposes.)

FDA has also established Affirmation of Compliance (AofC) codes which are designed to provide FDA reviewers with information concerning the imported article (example: medical device listing number). Use of the AofC is voluntary, and may or may not provide for a more expeditious screening of the entry.

In OASIS, the FDA forms identified as: "Notice of Sampling," "Release Notice," "Notice of Detention and Hearing," and "Notice of Refusal of Admission," are no longer issued as specific forms. OASIS generates a "Notice of FDA Action" providing information on the actions taken regarding a particular entry line. The notice identifies the specific line(s) of the entry, where appropriate, with the description of the sample collected or intended for sampling, specific line(s) identified as detained, and/or the specific line(s) identified as released, refused, etc. As the status changes for a particular line, a new "Notice of FDA Action" is issued to advise the appropriate individuals of the changes. The use of the designation "Product Collected by FDA," "Detained," "Released," "Refused," etc., or similar wording on the "Notice of FDA Action," meet the requirements of the wording of the law and regulation when applied to "giving notice thereof to the owner or consignee." See Exhibit 610-C.

OASIS notices are designed to be mailed to the addressees. A copy of each notice is produced with the filer, importer of record, and consignee on the addressee line. (If the same firm acts in one or more of those functions, only one copy is produced for the firm.) Notices are official documents which provide FDA decisions on entries. The distribution of the notices is made by FDA, not the filer, to ensure proper notification to the parties involved (i.e., FAX, express pick-up services, postal service, etc.). The intention is for FDA to distribute to the responsible firm without an intermediary.null

For electronic entry submissions, if the filer receives a message indicating FDA review, the filer will provide appropriate entry information to the FDA office having jurisdiction over the port of entry. For those entries submitted by paper, all appropriate entry documents should be included with the package sent to the local FDA office.

After evaluating the entry, if FDA decides to collect a sample, the appropriate individuals/firms will be provided with a Notice for Sampling and advised:

1. if the entry is to be held intact for FDA examination or sampling;
2. only those designated items need be held; etc.

For those ports where Customs does not maintain its ACS electronic entry process, and FDA does not generally cover the port under its normal operating schedule, the responsible FDA district office will coordinate coverage with the responsible Customs Port manager to assure FDA notification. If FDA decides to examine or sample articles being entered through such a port, Customs, the importer, and broker will notified.

Generally, for these entries, examination and/or sampling can take place at the point of destination. Under certain conditions, however, FDA may ask Customs to collect a sample at the point of entry for forwarding to the FDA servicing laboratory. Appropriate information on the entry, sample requirement, and requirements for holding the entry will be provided to the Customs officials and importer by the responsible district.

614.03 - Entry Sampling

These procedures in this section cover imported merchandise. Your personal safety during any import procedures outlined in this subchapter is important. For more information concerning personal safety, see IOM 510.01.

FDA determines if an article is in compliance with the Acts enforced by FDA. It also determines whether or not the article can be brought into compliance with the appropriate statute and authorizes reconditioning for that purpose.

Supervision over the reconditioning is exercised by either FDA or Customs as mutually arranged. At ports in reasonably close proximity to an FDA office, supervision is ordinarily exercised by FDA. At remote ports supervision may be exercised by Customs.

The refusal of admission, exportation, or destruction of merchandise is carried out under the direction of Customs. However, at some ports the actual supervision of the destruction of violative merchandise may be conducted by FDA pursuant to a local FDA/Customs agreement.null

All articles offered for entry into the U.S. and subject to the Acts enforced by FDA, with a value greater than $2000 (current), are considered formal entries. They are subject to bond requirements, which include a condition for the redelivery of the merchandise, or any part of it, upon demand by Customs at any time, as prescribed for in the Custom's regulations in force on the date of entry. (See section 801(b) of the FD&C Act [21 U.S.C. 381(b)], 19 CFR Part 113). The bond is filed with Customs which, in case of default, takes appropriate action to effect the collection of liquidated damages provided for in the bond after consultation with FDA. (See 19 CFR Section 113.62(k) and 21 CFR Section 1.97).

Notification of the Customs entry is generally accomplished by electronic submission through the Customs Automated Commercial System (ACS). Non-electronic entries are submitted directly to FDA. Electronic entries received by FDA may be reviewed on screen (OSR) to determine if further action is needed, or if full documentation must be submitted. For entries requiring further review, FDA will be provided the appropriate Customs Entry documents (CF 3461/3461ALT, or other Customs entry forms), which also document interstate commerce, along with a copy of the invoice, etc. If an entry is not filed electronically, these documents will be submitted to FDA at the time Customs entry is made, in accordance with local port operations.

Normally, informal entries (value less than $2000 currently) do not require posting a redelivery bond. All informal entries of articles subject to FDA jurisdiction, entered electronically, are forwarded to FDA through the Customs/FDA ACS interface. Informal entries not filed electronically are processed as paper entries. When an informal entry is sampled, Customs may be requested to convert it into a formal consumption entry.

In the case of imports by mail or personal baggage, FDA districts should arrange for coverage with their local Customs International Mail Office or border crossing office. This should include agreements designating who is responsible for coverage, when (how often), etc. Customs is responsible for examination of personal baggage. If an article subject to FDA review is encountered, the Customs officer will determine if it should be brought to the attention of the local FDA office. Personal importations meeting the criteria of a formal entry will be processed in accordance with normal non-electronic entries. Generally, since most personal importations are small in size and value, guidance has been developed for evaluating these importations. (See RPM Chapter "Coverage of Personal Importations".)

"Section 321 entries" for Customs are those entries with a value of $200 or less. Generally, this form of entry applies to articles which pass free of duty and tax, as defined in 19 C.F.R. 101.1(o), and imported by one person. Customs and FDA may conduct periodic "blitzes" to determine the volume and type of FDA-regulated merchandise admitted under "Section 321 entries." The use of the 321 entry process should not apply to multiple shipments covered by a single order or contract, sent separately for the express purpose of securing free entry and avoiding compliance with pertinent law or regulation.

FDA district offices generally receive notification of all formal and informal entries subject to FDA's jurisdiction at ports of entry located in its territory. However, through the use of Custom's Automated Commercial System and FDA's Operational and Administrative System for Import Support (ACS/OASIS) some electronic entries may be forwarded to off-site districts for processing during certain periods of time, i.e., late night coverage of air carrier hubs. The means of receiving notification for non-ABI/OASIS entries can be arranged through local Customs/FDA District agreements.

The most satisfactory and efficient means of getting notification is through FDA's OASIS system. Electronic entries processed through this system are electronically screened against criteria established by FDA for coverage. Automated Broker Interface (ABI) filers using the Customs ACS for cargo release are required to provide FDA information on entries subject to its jurisdiction submitted through ACS.

Customs' ACS uses guides established by each Federal agency to identify which commodities are subject to their jurisdiction. These guides are known as Other Government Agency (OGA) flags. FDA flags are identified as FD0, FD1 and FD2. FD0 indicates the article, even though subject to FDA regulation, may be released without further presentation of entry information to FDA. For entries flagged FD1, the commodity may or may not be subject to FDA regulation. The filer may, based on information received from the importer regarding the intended use of the commodity, specify the entry is not subject to FDA regulation and "Disclaim" the entry. Otherwise, FDA required information must be submitted. FDA review of "Disclaimed" entries is performed periodically to confirm the accuracy of the declaration. Entries covered by an FD2 flag must include FDA required information.

Electronic entries for Customs review includes all mandatory Customs entry required information, i.e., entry number, entry date, importer identification, port of entry, vessel/voyage information, filer identification, Harmonized Tariff System (HTS) code for product description, information on foreign shipper, country of origin, quantity, value, etc. Through the screening process in ACS, Customs determines if the article is subject to FDA examination (see OGA flag identifications above).

FDA's electronic screening of the Customs ABI/ACS entry requires the filer to provide the following information.

1. FDA product code. (FDA's product code is not the same as the HTS codes used for Customs screening purposes.)

2. The "Manufacturer's Identification" (MID) code (a Customs designation) of the foreign manufacturer. The MID consists, at a minimum, of the 2 letter identification of the foreign country, the name of the foreign firm, generally made up of the first three letters of the first and second names of the firm, where applicable. Up to 4 numbers, if present in the address, and the first three letters of the city where the firm is located. This code is subsequently transmitted to FDA's screen as the un-coded identified firm.

3. The MID information of the foreign shipper, including city and country. (Which may or may not be the same as the foreign manufacturer.) and

4. The country of origin. (Which may be different from the country of origin identified for Customs purposes.)

FDA has also established Affirmation of Compliance (AofC) codes which are designed to provide FDA reviewers with information concerning the imported article (example: medical device listing number). Use of the AofC is voluntary, and may or may not provide for a more expeditious screening of the entry.

In OASIS, the FDA forms identified as: "Notice of Sampling," "Release Notice," "Notice of Detention and Hearing," and "Notice of Refusal of Admission," are no longer issued as specific forms. OASIS generates a "Notice of FDA Action" providing information on the actions taken regarding a particular entry line. The notice identifies the specific line(s) of the entry, where appropriate, with the description of the sample collected or intended for sampling, specific line(s) identified as detained, and/or the specific line(s) identified as released, refused, etc. As the status changes for a particular line, a new "Notice of FDA Action" is issued to advise the appropriate individuals of the changes. The use of the designation "Product Collected by FDA," "Detained," "Released," "Refused," etc., or similar wording on the "Notice of FDA Action," meet the requirements of the wording of the law and regulation when applied to "giving notice thereof to the owner or consignee." See Exhibit 610-C.

OASIS notices are designed to be mailed to the addressees. A copy of each notice is produced with the filer, importer of record, and consignee on the addressee line. (If the same firm acts in one or more of those functions, only one copy is produced for the firm.) Notices are official documents which provide FDA decisions on entries. The distribution of the notices is made by FDA, not the filer, to ensure proper notification to the parties involved (i.e., FAX, express pick-up services, postal service, etc.). The intention is for FDA to distribute to the responsible firm without an intermediary.null

For electronic entry submissions, if the filer receives a message indicating FDA review, the filer will provide appropriate entry information to the FDA office having jurisdiction over the port of entry. For those entries submitted by paper, all appropriate entry documents should be included with the package sent to the local FDA office.

After evaluating the entry, if FDA decides to collect a sample, the appropriate individuals/firms will be provided with a Notice for Sampling and advised:

1. if the entry is to be held intact for FDA examination or sampling;
2. only those designated items need be held; etc.

For those ports where Customs does not maintain its ACS electronic entry process, and FDA does not generally cover the port under its normal operating schedule, the responsible FDA district office will coordinate coverage with the responsible Customs Port manager to assure FDA notification. If FDA decides to examine or sample articles being entered through such a port, Customs, the importer, and broker will notified.

Generally, for these entries, examination and/or sampling can take place at the point of destination. Under certain conditions, however, FDA may ask Customs to collect a sample at the point of entry for forwarding to the FDA servicing laboratory. Appropriate information on the entry, sample requirement, and requirements for holding the entry will be provided to the Customs officials and importer by the responsible district.

If no examination or sample is requested, FDA will notify Customs and the filer (who is responsible for notifying the importer, or other designated parties). This electronic notification is called a "May Proceed Notice," and indicates the shipment may proceed without further FDA examination. In the ACS/OASIS process, this may occur as a result of the initial FDA/OASIS screening, or after the district performs an "On-Screen-Review". (NOTE: Since the article is allowed entry without FDA examination, should the article, at a later time, be found in violation of the law, the Agency is not prevented from taking legal action because the article was allowed admission by FDA without examination at the time of importation. (See section 304(d) of the FD&C Act [21 USC 334(d)]).

If an examination or sample is requested, FDA notifies Customs, broker or filer, importer, or other designated parties, either through the electronic entry system or other form of notification, (Notice of FDA Action) to hold the entry, and will identify the specific product(s) to be sampled, etc.

614.04 - Notice Of Sampling

These procedures in this section cover imported merchandise. Your personal safety during any import procedures outlined in this subchapter is important. For more information concerning personal safety, see IOM 510.01.

FDA determines if an article is in compliance with the Acts enforced by FDA. It also determines whether or not the article can be brought into compliance with the appropriate statute and authorizes reconditioning for that purpose.

Supervision over the reconditioning is exercised by either FDA or Customs as mutually arranged. At ports in reasonably close proximity to an FDA office, supervision is ordinarily exercised by FDA. At remote ports supervision may be exercised by Customs.

The refusal of admission, exportation, or destruction of merchandise is carried out under the direction of Customs. However, at some ports the actual supervision of the destruction of violative merchandise may be conducted by FDA pursuant to a local FDA/Customs agreement.null

All articles offered for entry into the U.S. and subject to the Acts enforced by FDA, with a value greater than $2000 (current), are considered formal entries. They are subject to bond requirements, which include a condition for the redelivery of the merchandise, or any part of it, upon demand by Customs at any time, as prescribed for in the Custom's regulations in force on the date of entry. (See section 801(b) of the FD&C Act [21 U.S.C. 381(b)], 19 CFR Part 113). The bond is filed with Customs which, in case of default, takes appropriate action to effect the collection of liquidated damages provided for in the bond after consultation with FDA. (See 19 CFR Section 113.62(k) and 21 CFR Section 1.97).

Notification of the Customs entry is generally accomplished by electronic submission through the Customs Automated Commercial System (ACS). Non-electronic entries are submitted directly to FDA. Electronic entries received by FDA may be reviewed on screen (OSR) to determine if further action is needed, or if full documentation must be submitted. For entries requiring further review, FDA will be provided the appropriate Customs Entry documents (CF 3461/3461ALT, or other Customs entry forms), which also document interstate commerce, along with a copy of the invoice, etc. If an entry is not filed electronically, these documents will be submitted to FDA at the time Customs entry is made, in accordance with local port operations.

Normally, informal entries (value less than $2000 currently) do not require posting a redelivery bond. All informal entries of articles subject to FDA jurisdiction, entered electronically, are forwarded to FDA through the Customs/FDA ACS interface. Informal entries not filed electronically are processed as paper entries. When an informal entry is sampled, Customs may be requested to convert it into a formal consumption entry.

In the case of imports by mail or personal baggage, FDA districts should arrange for coverage with their local Customs International Mail Office or border crossing office. This should include agreements designating who is responsible for coverage, when (how often), etc. Customs is responsible for examination of personal baggage. If an article subject to FDA review is encountered, the Customs officer will determine if it should be brought to the attention of the local FDA office. Personal importations meeting the criteria of a formal entry will be processed in accordance with normal non-electronic entries. Generally, since most personal importations are small in size and value, guidance has been developed for evaluating these importations. (See RPM Chapter "Coverage of Personal Importations".)

"Section 321 entries" for Customs are those entries with a value of $200 or less. Generally, this form of entry applies to articles which pass free of duty and tax, as defined in 19 C.F.R. 101.1(o), and imported by one person. Customs and FDA may conduct periodic "blitzes" to determine the volume and type of FDA-regulated merchandise admitted under "Section 321 entries." The use of the 321 entry process should not apply to multiple shipments covered by a single order or contract, sent separately for the express purpose of securing free entry and avoiding compliance with pertinent law or regulation.

FDA district offices generally receive notification of all formal and informal entries subject to FDA's jurisdiction at ports of entry located in its territory. However, through the use of Custom's Automated Commercial System and FDA's Operational and Administrative System for Import Support (ACS/OASIS) some electronic entries may be forwarded to off-site districts for processing during certain periods of time, i.e., late night coverage of air carrier hubs. The means of receiving notification for non-ABI/OASIS entries can be arranged through local Customs/FDA District agreements.

The most satisfactory and efficient means of getting notification is through FDA's OASIS system. Electronic entries processed through this system are electronically screened against criteria established by FDA for coverage. Automated Broker Interface (ABI) filers using the Customs ACS for cargo release are required to provide FDA information on entries subject to its jurisdiction submitted through ACS.

Customs' ACS uses guides established by each Federal agency to identify which commodities are subject to their jurisdiction. These guides are known as Other Government Agency (OGA) flags. FDA flags are identified as FD0, FD1 and FD2. FD0 indicates the article, even though subject to FDA regulation, may be released without further presentation of entry information to FDA. For entries flagged FD1, the commodity may or may not be subject to FDA regulation. The filer may, based on information received from the importer regarding the intended use of the commodity, specify the entry is not subject to FDA regulation and "Disclaim" the entry. Otherwise, FDA required information must be submitted. FDA review of "Disclaimed" entries is performed periodically to confirm the accuracy of the declaration. Entries covered by an FD2 flag must include FDA required information.

Electronic entries for Customs review includes all mandatory Customs entry required information, i.e., entry number, entry date, importer identification, port of entry, vessel/voyage information, filer identification, Harmonized Tariff System (HTS) code for product description, information on foreign shipper, country of origin, quantity, value, etc. Through the screening process in ACS, Customs determines if the article is subject to FDA examination (see OGA flag identifications above).

FDA's electronic screening of the Customs ABI/ACS entry requires the filer to provide the following information.

1. FDA product code. (FDA's product code is not the same as the HTS codes used for Customs screening purposes.)

2. The "Manufacturer's Identification" (MID) code (a Customs designation) of the foreign manufacturer. The MID consists, at a minimum, of the 2 letter identification of the foreign country, the name of the foreign firm, generally made up of the first three letters of the first and second names of the firm, where applicable. Up to 4 numbers, if present in the address, and the first three letters of the city where the firm is located. This code is subsequently transmitted to FDA's screen as the un-coded identified firm.

3. The MID information of the foreign shipper, including city and country. (Which may or may not be the same as the foreign manufacturer.) and

4. The country of origin. (Which may be different from the country of origin identified for Customs purposes.)

FDA has also established Affirmation of Compliance (AofC) codes which are designed to provide FDA reviewers with information concerning the imported article (example: medical device listing number). Use of the AofC is voluntary, and may or may not provide for a more expeditious screening of the entry.

In OASIS, the FDA forms identified as: "Notice of Sampling," "Release Notice," "Notice of Detention and Hearing," and "Notice of Refusal of Admission," are no longer issued as specific forms. OASIS generates a "Notice of FDA Action" providing information on the actions taken regarding a particular entry line. The notice identifies the specific line(s) of the entry, where appropriate, with the description of the sample collected or intended for sampling, specific line(s) identified as detained, and/or the specific line(s) identified as released, refused, etc. As the status changes for a particular line, a new "Notice of FDA Action" is issued to advise the appropriate individuals of the changes. The use of the designation "Product Collected by FDA," "Detained," "Released," "Refused," etc., or similar wording on the "Notice of FDA Action," meet the requirements of the wording of the law and regulation when applied to "giving notice thereof to the owner or consignee." See Exhibit 610-C.

OASIS notices are designed to be mailed to the addressees. A copy of each notice is produced with the filer, importer of record, and consignee on the addressee line. (If the same firm acts in one or more of those functions, only one copy is produced for the firm.) Notices are official documents which provide FDA decisions on entries. The distribution of the notices is made by FDA, not the filer, to ensure proper notification to the parties involved (i.e., FAX, express pick-up services, postal service, etc.). The intention is for FDA to distribute to the responsible firm without an intermediary.null

For electronic entry submissions, if the filer receives a message indicating FDA review, the filer will provide appropriate entry information to the FDA office having jurisdiction over the port of entry. For those entries submitted by paper, all appropriate entry documents should be included with the package sent to the local FDA office.

After evaluating the entry, if FDA decides to collect a sample, the appropriate individuals/firms will be provided with a Notice for Sampling and advised:

1. if the entry is to be held intact for FDA examination or sampling;
2. only those designated items need be held; etc.

For those ports where Customs does not maintain its ACS electronic entry process, and FDA does not generally cover the port under its normal operating schedule, the responsible FDA district office will coordinate coverage with the responsible Customs Port manager to assure FDA notification. If FDA decides to examine or sample articles being entered through such a port, Customs, the importer, and broker will notified.

Generally, for these entries, examination and/or sampling can take place at the point of destination. Under certain conditions, however, FDA may ask Customs to collect a sample at the point of entry for forwarding to the FDA servicing laboratory. Appropriate information on the entry, sample requirement, and requirements for holding the entry will be provided to the Customs officials and importer by the responsible district.

If no examination or sample is requested, FDA will notify Customs and the filer (who is responsible for notifying the importer, or other designated parties). This electronic notification is called a "May Proceed Notice," and indicates the shipment may proceed without further FDA examination. In the ACS/OASIS process, this may occur as a result of the initial FDA/OASIS screening, or after the district performs an "On-Screen-Review". (NOTE: Since the article is allowed entry without FDA examination, should the article, at a later time, be found in violation of the law, the Agency is not prevented from taking legal action because the article was allowed admission by FDA without examination at the time of importation. (See section 304(d) of the FD&C Act [21 USC 334(d)]).

If an examination or sample is requested, FDA notifies Customs, broker or filer, importer, or other designated parties, either through the electronic entry system or other form of notification, (Notice of FDA Action) to hold the entry, and will identify the specific product(s) to be sampled, etc.

When a sample is collected by FDA, a Notice of FDA Action is issued to the importer of record, consignee, and filer. If Customs collects the sample for FDA, the district will enter the entry information into OASIS and issue the Notice of FDA Action

For those entries where specific lines (items) of an entry are not sampled or examined, the Notice of FDA Action will be amended to indicate which lines (items) "May Proceed." (See RPM chapter "Notice of Sampling" for detailed guidance.)

614.05 - Payment For Samples

These procedures in this section cover imported merchandise. Your personal safety during any import procedures outlined in this subchapter is important. For more information concerning personal safety, see IOM 510.01.

FDA determines if an article is in compliance with the Acts enforced by FDA. It also determines whether or not the article can be brought into compliance with the appropriate statute and authorizes reconditioning for that purpose.

Supervision over the reconditioning is exercised by either FDA or Customs as mutually arranged. At ports in reasonably close proximity to an FDA office, supervision is ordinarily exercised by FDA. At remote ports supervision may be exercised by Customs.

The refusal of admission, exportation, or destruction of merchandise is carried out under the direction of Customs. However, at some ports the actual supervision of the destruction of violative merchandise may be conducted by FDA pursuant to a local FDA/Customs agreement.null

All articles offered for entry into the U.S. and subject to the Acts enforced by FDA, with a value greater than $2000 (current), are considered formal entries. They are subject to bond requirements, which include a condition for the redelivery of the merchandise, or any part of it, upon demand by Customs at any time, as prescribed for in the Custom's regulations in force on the date of entry. (See section 801(b) of the FD&C Act [21 U.S.C. 381(b)], 19 CFR Part 113). The bond is filed with Customs which, in case of default, takes appropriate action to effect the collection of liquidated damages provided for in the bond after consultation with FDA. (See 19 CFR Section 113.62(k) and 21 CFR Section 1.97).

Notification of the Customs entry is generally accomplished by electronic submission through the Customs Automated Commercial System (ACS). Non-electronic entries are submitted directly to FDA. Electronic entries received by FDA may be reviewed on screen (OSR) to determine if further action is needed, or if full documentation must be submitted. For entries requiring further review, FDA will be provided the appropriate Customs Entry documents (CF 3461/3461ALT, or other Customs entry forms), which also document interstate commerce, along with a copy of the invoice, etc. If an entry is not filed electronically, these documents will be submitted to FDA at the time Customs entry is made, in accordance with local port operations.

Normally, informal entries (value less than $2000 currently) do not require posting a redelivery bond. All informal entries of articles subject to FDA jurisdiction, entered electronically, are forwarded to FDA through the Customs/FDA ACS interface. Informal entries not filed electronically are processed as paper entries. When an informal entry is sampled, Customs may be requested to convert it into a formal consumption entry.

In the case of imports by mail or personal baggage, FDA districts should arrange for coverage with their local Customs International Mail Office or border crossing office. This should include agreements designating who is responsible for coverage, when (how often), etc. Customs is responsible for examination of personal baggage. If an article subject to FDA review is encountered, the Customs officer will determine if it should be brought to the attention of the local FDA office. Personal importations meeting the criteria of a formal entry will be processed in accordance with normal non-electronic entries. Generally, since most personal importations are small in size and value, guidance has been developed for evaluating these importations. (See RPM Chapter "Coverage of Personal Importations".)

"Section 321 entries" for Customs are those entries with a value of $200 or less. Generally, this form of entry applies to articles which pass free of duty and tax, as defined in 19 C.F.R. 101.1(o), and imported by one person. Customs and FDA may conduct periodic "blitzes" to determine the volume and type of FDA-regulated merchandise admitted under "Section 321 entries." The use of the 321 entry process should not apply to multiple shipments covered by a single order or contract, sent separately for the express purpose of securing free entry and avoiding compliance with pertinent law or regulation.

FDA district offices generally receive notification of all formal and informal entries subject to FDA's jurisdiction at ports of entry located in its territory. However, through the use of Custom's Automated Commercial System and FDA's Operational and Administrative System for Import Support (ACS/OASIS) some electronic entries may be forwarded to off-site districts for processing during certain periods of time, i.e., late night coverage of air carrier hubs. The means of receiving notification for non-ABI/OASIS entries can be arranged through local Customs/FDA District agreements.

The most satisfactory and efficient means of getting notification is through FDA's OASIS system. Electronic entries processed through this system are electronically screened against criteria established by FDA for coverage. Automated Broker Interface (ABI) filers using the Customs ACS for cargo release are required to provide FDA information on entries subject to its jurisdiction submitted through ACS.

Customs' ACS uses guides established by each Federal agency to identify which commodities are subject to their jurisdiction. These guides are known as Other Government Agency (OGA) flags. FDA flags are identified as FD0, FD1 and FD2. FD0 indicates the article, even though subject to FDA regulation, may be released without further presentation of entry information to FDA. For entries flagged FD1, the commodity may or may not be subject to FDA regulation. The filer may, based on information received from the importer regarding the intended use of the commodity, specify the entry is not subject to FDA regulation and "Disclaim" the entry. Otherwise, FDA required information must be submitted. FDA review of "Disclaimed" entries is performed periodically to confirm the accuracy of the declaration. Entries covered by an FD2 flag must include FDA required information.

Electronic entries for Customs review includes all mandatory Customs entry required information, i.e., entry number, entry date, importer identification, port of entry, vessel/voyage information, filer identification, Harmonized Tariff System (HTS) code for product description, information on foreign shipper, country of origin, quantity, value, etc. Through the screening process in ACS, Customs determines if the article is subject to FDA examination (see OGA flag identifications above).

FDA's electronic screening of the Customs ABI/ACS entry requires the filer to provide the following information.

1. FDA product code. (FDA's product code is not the same as the HTS codes used for Customs screening purposes.)

2. The "Manufacturer's Identification" (MID) code (a Customs designation) of the foreign manufacturer. The MID consists, at a minimum, of the 2 letter identification of the foreign country, the name of the foreign firm, generally made up of the first three letters of the first and second names of the firm, where applicable. Up to 4 numbers, if present in the address, and the first three letters of the city where the firm is located. This code is subsequently transmitted to FDA's screen as the un-coded identified firm.

3. The MID information of the foreign shipper, including city and country. (Which may or may not be the same as the foreign manufacturer.) and

4. The country of origin. (Which may be different from the country of origin identified for Customs purposes.)

FDA has also established Affirmation of Compliance (AofC) codes which are designed to provide FDA reviewers with information concerning the imported article (example: medical device listing number). Use of the AofC is voluntary, and may or may not provide for a more expeditious screening of the entry.

In OASIS, the FDA forms identified as: "Notice of Sampling," "Release Notice," "Notice of Detention and Hearing," and "Notice of Refusal of Admission," are no longer issued as specific forms. OASIS generates a "Notice of FDA Action" providing information on the actions taken regarding a particular entry line. The notice identifies the specific line(s) of the entry, where appropriate, with the description of the sample collected or intended for sampling, specific line(s) identified as detained, and/or the specific line(s) identified as released, refused, etc. As the status changes for a particular line, a new "Notice of FDA Action" is issued to advise the appropriate individuals of the changes. The use of the designation "Product Collected by FDA," "Detained," "Released," "Refused," etc., or similar wording on the "Notice of FDA Action," meet the requirements of the wording of the law and regulation when applied to "giving notice thereof to the owner or consignee." See Exhibit 610-C.

OASIS notices are designed to be mailed to the addressees. A copy of each notice is produced with the filer, importer of record, and consignee on the addressee line. (If the same firm acts in one or more of those functions, only one copy is produced for the firm.) Notices are official documents which provide FDA decisions on entries. The distribution of the notices is made by FDA, not the filer, to ensure proper notification to the parties involved (i.e., FAX, express pick-up services, postal service, etc.). The intention is for FDA to distribute to the responsible firm without an intermediary.null

For electronic entry submissions, if the filer receives a message indicating FDA review, the filer will provide appropriate entry information to the FDA office having jurisdiction over the port of entry. For those entries submitted by paper, all appropriate entry documents should be included with the package sent to the local FDA office.

After evaluating the entry, if FDA decides to collect a sample, the appropriate individuals/firms will be provided with a Notice for Sampling and advised:

1. if the entry is to be held intact for FDA examination or sampling;
2. only those designated items need be held; etc.

For those ports where Customs does not maintain its ACS electronic entry process, and FDA does not generally cover the port under its normal operating schedule, the responsible FDA district office will coordinate coverage with the responsible Customs Port manager to assure FDA notification. If FDA decides to examine or sample articles being entered through such a port, Customs, the importer, and broker will notified.

Generally, for these entries, examination and/or sampling can take place at the point of destination. Under certain conditions, however, FDA may ask Customs to collect a sample at the point of entry for forwarding to the FDA servicing laboratory. Appropriate information on the entry, sample requirement, and requirements for holding the entry will be provided to the Customs officials and importer by the responsible district.

If no examination or sample is requested, FDA will notify Customs and the filer (who is responsible for notifying the importer, or other designated parties). This electronic notification is called a "May Proceed Notice," and indicates the shipment may proceed without further FDA examination. In the ACS/OASIS process, this may occur as a result of the initial FDA/OASIS screening, or after the district performs an "On-Screen-Review". (NOTE: Since the article is allowed entry without FDA examination, should the article, at a later time, be found in violation of the law, the Agency is not prevented from taking legal action because the article was allowed admission by FDA without examination at the time of importation. (See section 304(d) of the FD&C Act [21 USC 334(d)]).

If an examination or sample is requested, FDA notifies Customs, broker or filer, importer, or other designated parties, either through the electronic entry system or other form of notification, (Notice of FDA Action) to hold the entry, and will identify the specific product(s) to be sampled, etc.

When a sample is collected by FDA, a Notice of FDA Action is issued to the importer of record, consignee, and filer. If Customs collects the sample for FDA, the district will enter the entry information into OASIS and issue the Notice of FDA Action

For those entries where specific lines (items) of an entry are not sampled or examined, the Notice of FDA Action will be amended to indicate which lines (items) "May Proceed." (See RPM chapter "Notice of Sampling" for detailed guidance.)

The FDA will pay for all physical samples found in compliance or collected as an audit of private laboratory reports of analysis submitted to FDA in response to detention (See 21 CFR 1.91). (NOTE: This does not apply in the case of an audit sample collected to document reconditioning). See IOM 416.02 for guidance on sample costs.

Billing for reimbursement should be made to the FDA district office in whose territory the shipment was offered for import. FDA will not pay for a sample if the article is initially found to be in violation, even though it is subsequently released. For this reason, do not pay for samples at the time of collection.

Samples taken in connection with the supervision of a reconditioning are not paid for by FDA.

615 - PROCEDURE WHEN PRODUCTS CANNOT BE SAMPLED OR EXAMINED

These procedures in this section cover imported merchandise. Your personal safety during any import procedures outlined in this subchapter is important. For more information concerning personal safety, see IOM 510.01.

FDA determines if an article is in compliance with the Acts enforced by FDA. It also determines whether or not the article can be brought into compliance with the appropriate statute and authorizes reconditioning for that purpose.

Supervision over the reconditioning is exercised by either FDA or Customs as mutually arranged. At ports in reasonably close proximity to an FDA office, supervision is ordinarily exercised by FDA. At remote ports supervision may be exercised by Customs.

The refusal of admission, exportation, or destruction of merchandise is carried out under the direction of Customs. However, at some ports the actual supervision of the destruction of violative merchandise may be conducted by FDA pursuant to a local FDA/Customs agreement.null

All articles offered for entry into the U.S. and subject to the Acts enforced by FDA, with a value greater than $2000 (current), are considered formal entries. They are subject to bond requirements, which include a condition for the redelivery of the merchandise, or any part of it, upon demand by Customs at any time, as prescribed for in the Custom's regulations in force on the date of entry. (See section 801(b) of the FD&C Act [21 U.S.C. 381(b)], 19 CFR Part 113). The bond is filed with Customs which, in case of default, takes appropriate action to effect the collection of liquidated damages provided for in the bond after consultation with FDA. (See 19 CFR Section 113.62(k) and 21 CFR Section 1.97).

Notification of the Customs entry is generally accomplished by electronic submission through the Customs Automated Commercial System (ACS). Non-electronic entries are submitted directly to FDA. Electronic entries received by FDA may be reviewed on screen (OSR) to determine if further action is needed, or if full documentation must be submitted. For entries requiring further review, FDA will be provided the appropriate Customs Entry documents (CF 3461/3461ALT, or other Customs entry forms), which also document interstate commerce, along with a copy of the invoice, etc. If an entry is not filed electronically, these documents will be submitted to FDA at the time Customs entry is made, in accordance with local port operations.

Normally, informal entries (value less than $2000 currently) do not require posting a redelivery bond. All informal entries of articles subject to FDA jurisdiction, entered electronically, are forwarded to FDA through the Customs/FDA ACS interface. Informal entries not filed electronically are processed as paper entries. When an informal entry is sampled, Customs may be requested to convert it into a formal consumption entry.

In the case of imports by mail or personal baggage, FDA districts should arrange for coverage with their local Customs International Mail Office or border crossing office. This should include agreements designating who is responsible for coverage, when (how often), etc. Customs is responsible for examination of personal baggage. If an article subject to FDA review is encountered, the Customs officer will determine if it should be brought to the attention of the local FDA office. Personal importations meeting the criteria of a formal entry will be processed in accordance with normal non-electronic entries. Generally, since most personal importations are small in size and value, guidance has been developed for evaluating these importations. (See RPM Chapter "Coverage of Personal Importations".)

"Section 321 entries" for Customs are those entries with a value of $200 or less. Generally, this form of entry applies to articles which pass free of duty and tax, as defined in 19 C.F.R. 101.1(o), and imported by one person. Customs and FDA may conduct periodic "blitzes" to determine the volume and type of FDA-regulated merchandise admitted under "Section 321 entries." The use of the 321 entry process should not apply to multiple shipments covered by a single order or contract, sent separately for the express purpose of securing free entry and avoiding compliance with pertinent law or regulation.

FDA district offices generally receive notification of all formal and informal entries subject to FDA's jurisdiction at ports of entry located in its territory. However, through the use of Custom's Automated Commercial System and FDA's Operational and Administrative System for Import Support (ACS/OASIS) some electronic entries may be forwarded to off-site districts for processing during certain periods of time, i.e., late night coverage of air carrier hubs. The means of receiving notification for non-ABI/OASIS entries can be arranged through local Customs/FDA District agreements.

The most satisfactory and efficient means of getting notification is through FDA's OASIS system. Electronic entries processed through this system are electronically screened against criteria established by FDA for coverage. Automated Broker Interface (ABI) filers using the Customs ACS for cargo release are required to provide FDA information on entries subject to its jurisdiction submitted through ACS.

Customs' ACS uses guides established by each Federal agency to identify which commodities are subject to their jurisdiction. These guides are known as Other Government Agency (OGA) flags. FDA flags are identified as FD0, FD1 and FD2. FD0 indicates the article, even though subject to FDA regulation, may be released without further presentation of entry information to FDA. For entries flagged FD1, the commodity may or may not be subject to FDA regulation. The filer may, based on information received from the importer regarding the intended use of the commodity, specify the entry is not subject to FDA regulation and "Disclaim" the entry. Otherwise, FDA required information must be submitted. FDA review of "Disclaimed" entries is performed periodically to confirm the accuracy of the declaration. Entries covered by an FD2 flag must include FDA required information.

Electronic entries for Customs review includes all mandatory Customs entry required information, i.e., entry number, entry date, importer identification, port of entry, vessel/voyage information, filer identification, Harmonized Tariff System (HTS) code for product description, information on foreign shipper, country of origin, quantity, value, etc. Through the screening process in ACS, Customs determines if the article is subject to FDA examination (see OGA flag identifications above).

FDA's electronic screening of the Customs ABI/ACS entry requires the filer to provide the following information.

1. FDA product code. (FDA's product code is not the same as the HTS codes used for Customs screening purposes.)

2. The "Manufacturer's Identification" (MID) code (a Customs designation) of the foreign manufacturer. The MID consists, at a minimum, of the 2 letter identification of the foreign country, the name of the foreign firm, generally made up of the first three letters of the first and second names of the firm, where applicable. Up to 4 numbers, if present in the address, and the first three letters of the city where the firm is located. This code is subsequently transmitted to FDA's screen as the un-coded identified firm.

3. The MID information of the foreign shipper, including city and country. (Which may or may not be the same as the foreign manufacturer.) and

4. The country of origin. (Which may be different from the country of origin identified for Customs purposes.)

FDA has also established Affirmation of Compliance (AofC) codes which are designed to provide FDA reviewers with information concerning the imported article (example: medical device listing number). Use of the AofC is voluntary, and may or may not provide for a more expeditious screening of the entry.

In OASIS, the FDA forms identified as: "Notice of Sampling," "Release Notice," "Notice of Detention and Hearing," and "Notice of Refusal of Admission," are no longer issued as specific forms. OASIS generates a "Notice of FDA Action" providing information on the actions taken regarding a particular entry line. The notice identifies the specific line(s) of the entry, where appropriate, with the description of the sample collected or intended for sampling, specific line(s) identified as detained, and/or the specific line(s) identified as released, refused, etc. As the status changes for a particular line, a new "Notice of FDA Action" is issued to advise the appropriate individuals of the changes. The use of the designation "Product Collected by FDA," "Detained," "Released," "Refused," etc., or similar wording on the "Notice of FDA Action," meet the requirements of the wording of the law and regulation when applied to "giving notice thereof to the owner or consignee." See Exhibit 610-C.

OASIS notices are designed to be mailed to the addressees. A copy of each notice is produced with the filer, importer of record, and consignee on the addressee line. (If the same firm acts in one or more of those functions, only one copy is produced for the firm.) Notices are official documents which provide FDA decisions on entries. The distribution of the notices is made by FDA, not the filer, to ensure proper notification to the parties involved (i.e., FAX, express pick-up services, postal service, etc.). The intention is for FDA to distribute to the responsible firm without an intermediary.null

For electronic entry submissions, if the filer receives a message indicating FDA review, the filer will provide appropriate entry information to the FDA office having jurisdiction over the port of entry. For those entries submitted by paper, all appropriate entry documents should be included with the package sent to the local FDA office.

After evaluating the entry, if FDA decides to collect a sample, the appropriate individuals/firms will be provided with a Notice for Sampling and advised:

1. if the entry is to be held intact for FDA examination or sampling;
2. only those designated items need be held; etc.

For those ports where Customs does not maintain its ACS electronic entry process, and FDA does not generally cover the port under its normal operating schedule, the responsible FDA district office will coordinate coverage with the responsible Customs Port manager to assure FDA notification. If FDA decides to examine or sample articles being entered through such a port, Customs, the importer, and broker will notified.

Generally, for these entries, examination and/or sampling can take place at the point of destination. Under certain conditions, however, FDA may ask Customs to collect a sample at the point of entry for forwarding to the FDA servicing laboratory. Appropriate information on the entry, sample requirement, and requirements for holding the entry will be provided to the Customs officials and importer by the responsible district.

If no examination or sample is requested, FDA will notify Customs and the filer (who is responsible for notifying the importer, or other designated parties). This electronic notification is called a "May Proceed Notice," and indicates the shipment may proceed without further FDA examination. In the ACS/OASIS process, this may occur as a result of the initial FDA/OASIS screening, or after the district performs an "On-Screen-Review". (NOTE: Since the article is allowed entry without FDA examination, should the article, at a later time, be found in violation of the law, the Agency is not prevented from taking legal action because the article was allowed admission by FDA without examination at the time of importation. (See section 304(d) of the FD&C Act [21 USC 334(d)]).

If an examination or sample is requested, FDA notifies Customs, broker or filer, importer, or other designated parties, either through the electronic entry system or other form of notification, (Notice of FDA Action) to hold the entry, and will identify the specific product(s) to be sampled, etc.

When a sample is collected by FDA, a Notice of FDA Action is issued to the importer of record, consignee, and filer. If Customs collects the sample for FDA, the district will enter the entry information into OASIS and issue the Notice of FDA Action

For those entries where specific lines (items) of an entry are not sampled or examined, the Notice of FDA Action will be amended to indicate which lines (items) "May Proceed." (See RPM chapter "Notice of Sampling" for detailed guidance.)

The FDA will pay for all physical samples found in compliance or collected as an audit of private laboratory reports of analysis submitted to FDA in response to detention (See 21 CFR 1.91). (NOTE: This does not apply in the case of an audit sample collected to document reconditioning). See IOM 416.02 for guidance on sample costs.

Billing for reimbursement should be made to the FDA district office in whose territory the shipment was offered for import. FDA will not pay for a sample if the article is initially found to be in violation, even though it is subsequently released. For this reason, do not pay for samples at the time of collection.

Samples taken in connection with the supervision of a reconditioning are not paid for by FDA.

If the entry is still under control of the district inspection operations, and the sample collection can not be completed, the district may annotate the notice to the filer and importer no product was collected, and return the entry to the flier designating the entry "May Proceed." If the designated product was part of a multi-line entry where other products were collected, the notice issued for the other items sampled will be appropriately updated with the release of the product not sampled.

In the OASIS system, when a notice is issued for the collection or examination of a product, and neither operation is accomplished, the filer will be advised through a revised Notice indicating the article is given a "May Proceed" status. The system will print a status of "May Proceeded" in the Line Summary and also print a detail section "Lines Which May Proceed."

In OASIS, the following are definitions used to describe "May Proceed" or "Release" actions:

May Proceed: "Product may proceed without FDA examination. FDA has made no determination the product complies with all provisions of the Food, Drug, and Cosmetic Act, or other related acts. This message does not preclude action should the products later be found violative." (No compliance decision has been made.)

Release: "The product is released after FDA examination. This message does not constitute assurance the product complies with all provisions of the Food, Drug and Cosmetic Act, or other related Acts, and does not preclude action should the product later be found violative." (A compliance decision has been made.)

Districts will follow the appropriate guidance under each of the above procedures, according to their import operations.

616 - PROCEDURE WHEN NO VIOLATION IS FOUND

These procedures in this section cover imported merchandise. Your personal safety during any import procedures outlined in this subchapter is important. For more information concerning personal safety, see IOM 510.01.

FDA determines if an article is in compliance with the Acts enforced by FDA. It also determines whether or not the article can be brought into compliance with the appropriate statute and authorizes reconditioning for that purpose.

Supervision over the reconditioning is exercised by either FDA or Customs as mutually arranged. At ports in reasonably close proximity to an FDA office, supervision is ordinarily exercised by FDA. At remote ports supervision may be exercised by Customs.

The refusal of admission, exportation, or destruction of merchandise is carried out under the direction of Customs. However, at some ports the actual supervision of the destruction of violative merchandise may be conducted by FDA pursuant to a local FDA/Customs agreement.null

All articles offered for entry into the U.S. and subject to the Acts enforced by FDA, with a value greater than $2000 (current), are considered formal entries. They are subject to bond requirements, which include a condition for the redelivery of the merchandise, or any part of it, upon demand by Customs at any time, as prescribed for in the Custom's regulations in force on the date of entry. (See section 801(b) of the FD&C Act [21 U.S.C. 381(b)], 19 CFR Part 113). The bond is filed with Customs which, in case of default, takes appropriate action to effect the collection of liquidated damages provided for in the bond after consultation with FDA. (See 19 CFR Section 113.62(k) and 21 CFR Section 1.97).

Notification of the Customs entry is generally accomplished by electronic submission through the Customs Automated Commercial System (ACS). Non-electronic entries are submitted directly to FDA. Electronic entries received by FDA may be reviewed on screen (OSR) to determine if further action is needed, or if full documentation must be submitted. For entries requiring further review, FDA will be provided the appropriate Customs Entry documents (CF 3461/3461ALT, or other Customs entry forms), which also document interstate commerce, along with a copy of the invoice, etc. If an entry is not filed electronically, these documents will be submitted to FDA at the time Customs entry is made, in accordance with local port operations.

Normally, informal entries (value less than $2000 currently) do not require posting a redelivery bond. All informal entries of articles subject to FDA jurisdiction, entered electronically, are forwarded to FDA through the Customs/FDA ACS interface. Informal entries not filed electronically are processed as paper entries. When an informal entry is sampled, Customs may be requested to convert it into a formal consumption entry.

In the case of imports by mail or personal baggage, FDA districts should arrange for coverage with their local Customs International Mail Office or border crossing office. This should include agreements designating who is responsible for coverage, when (how often), etc. Customs is responsible for examination of personal baggage. If an article subject to FDA review is encountered, the Customs officer will determine if it should be brought to the attention of the local FDA office. Personal importations meeting the criteria of a formal entry will be processed in accordance with normal non-electronic entries. Generally, since most personal importations are small in size and value, guidance has been developed for evaluating these importations. (See RPM Chapter "Coverage of Personal Importations".)

"Section 321 entries" for Customs are those entries with a value of $200 or less. Generally, this form of entry applies to articles which pass free of duty and tax, as defined in 19 C.F.R. 101.1(o), and imported by one person. Customs and FDA may conduct periodic "blitzes" to determine the volume and type of FDA-regulated merchandise admitted under "Section 321 entries." The use of the 321 entry process should not apply to multiple shipments covered by a single order or contract, sent separately for the express purpose of securing free entry and avoiding compliance with pertinent law or regulation.

FDA district offices generally receive notification of all formal and informal entries subject to FDA's jurisdiction at ports of entry located in its territory. However, through the use of Custom's Automated Commercial System and FDA's Operational and Administrative System for Import Support (ACS/OASIS) some electronic entries may be forwarded to off-site districts for processing during certain periods of time, i.e., late night coverage of air carrier hubs. The means of receiving notification for non-ABI/OASIS entries can be arranged through local Customs/FDA District agreements.

The most satisfactory and efficient means of getting notification is through FDA's OASIS system. Electronic entries processed through this system are electronically screened against criteria established by FDA for coverage. Automated Broker Interface (ABI) filers using the Customs ACS for cargo release are required to provide FDA information on entries subject to its jurisdiction submitted through ACS.

Customs' ACS uses guides established by each Federal agency to identify which commodities are subject to their jurisdiction. These guides are known as Other Government Agency (OGA) flags. FDA flags are identified as FD0, FD1 and FD2. FD0 indicates the article, even though subject to FDA regulation, may be released without further presentation of entry information to FDA. For entries flagged FD1, the commodity may or may not be subject to FDA regulation. The filer may, based on information received from the importer regarding the intended use of the commodity, specify the entry is not subject to FDA regulation and "Disclaim" the entry. Otherwise, FDA required information must be submitted. FDA review of "Disclaimed" entries is performed periodically to confirm the accuracy of the declaration. Entries covered by an FD2 flag must include FDA required information.

Electronic entries for Customs review includes all mandatory Customs entry required information, i.e., entry number, entry date, importer identification, port of entry, vessel/voyage information, filer identification, Harmonized Tariff System (HTS) code for product description, information on foreign shipper, country of origin, quantity, value, etc. Through the screening process in ACS, Customs determines if the article is subject to FDA examination (see OGA flag identifications above).

FDA's electronic screening of the Customs ABI/ACS entry requires the filer to provide the following information.

1. FDA product code. (FDA's product code is not the same as the HTS codes used for Customs screening purposes.)

2. The "Manufacturer's Identification" (MID) code (a Customs designation) of the foreign manufacturer. The MID consists, at a minimum, of the 2 letter identification of the foreign country, the name of the foreign firm, generally made up of the first three letters of the first and second names of the firm, where applicable. Up to 4 numbers, if present in the address, and the first three letters of the city where the firm is located. This code is subsequently transmitted to FDA's screen as the un-coded identified firm.

3. The MID information of the foreign shipper, including city and country. (Which may or may not be the same as the foreign manufacturer.) and

4. The country of origin. (Which may be different from the country of origin identified for Customs purposes.)

FDA has also established Affirmation of Compliance (AofC) codes which are designed to provide FDA reviewers with information concerning the imported article (example: medical device listing number). Use of the AofC is voluntary, and may or may not provide for a more expeditious screening of the entry.

In OASIS, the FDA forms identified as: "Notice of Sampling," "Release Notice," "Notice of Detention and Hearing," and "Notice of Refusal of Admission," are no longer issued as specific forms. OASIS generates a "Notice of FDA Action" providing information on the actions taken regarding a particular entry line. The notice identifies the specific line(s) of the entry, where appropriate, with the description of the sample collected or intended for sampling, specific line(s) identified as detained, and/or the specific line(s) identified as released, refused, etc. As the status changes for a particular line, a new "Notice of FDA Action" is issued to advise the appropriate individuals of the changes. The use of the designation "Product Collected by FDA," "Detained," "Released," "Refused," etc., or similar wording on the "Notice of FDA Action," meet the requirements of the wording of the law and regulation when applied to "giving notice thereof to the owner or consignee." See Exhibit 610-C.

OASIS notices are designed to be mailed to the addressees. A copy of each notice is produced with the filer, importer of record, and consignee on the addressee line. (If the same firm acts in one or more of those functions, only one copy is produced for the firm.) Notices are official documents which provide FDA decisions on entries. The distribution of the notices is made by FDA, not the filer, to ensure proper notification to the parties involved (i.e., FAX, express pick-up services, postal service, etc.). The intention is for FDA to distribute to the responsible firm without an intermediary.null

For electronic entry submissions, if the filer receives a message indicating FDA review, the filer will provide appropriate entry information to the FDA office having jurisdiction over the port of entry. For those entries submitted by paper, all appropriate entry documents should be included with the package sent to the local FDA office.

After evaluating the entry, if FDA decides to collect a sample, the appropriate individuals/firms will be provided with a Notice for Sampling and advised:

1. if the entry is to be held intact for FDA examination or sampling;
2. only those designated items need be held; etc.

For those ports where Customs does not maintain its ACS electronic entry process, and FDA does not generally cover the port under its normal operating schedule, the responsible FDA district office will coordinate coverage with the responsible Customs Port manager to assure FDA notification. If FDA decides to examine or sample articles being entered through such a port, Customs, the importer, and broker will notified.

Generally, for these entries, examination and/or sampling can take place at the point of destination. Under certain conditions, however, FDA may ask Customs to collect a sample at the point of entry for forwarding to the FDA servicing laboratory. Appropriate information on the entry, sample requirement, and requirements for holding the entry will be provided to the Customs officials and importer by the responsible district.

If no examination or sample is requested, FDA will notify Customs and the filer (who is responsible for notifying the importer, or other designated parties). This electronic notification is called a "May Proceed Notice," and indicates the shipment may proceed without further FDA examination. In the ACS/OASIS process, this may occur as a result of the initial FDA/OASIS screening, or after the district performs an "On-Screen-Review". (NOTE: Since the article is allowed entry without FDA examination, should the article, at a later time, be found in violation of the law, the Agency is not prevented from taking legal action because the article was allowed admission by FDA without examination at the time of importation. (See section 304(d) of the FD&C Act [21 USC 334(d)]).

If an examination or sample is requested, FDA notifies Customs, broker or filer, importer, or other designated parties, either through the electronic entry system or other form of notification, (Notice of FDA Action) to hold the entry, and will identify the specific product(s) to be sampled, etc.

When a sample is collected by FDA, a Notice of FDA Action is issued to the importer of record, consignee, and filer. If Customs collects the sample for FDA, the district will enter the entry information into OASIS and issue the Notice of FDA Action

For those entries where specific lines (items) of an entry are not sampled or examined, the Notice of FDA Action will be amended to indicate which lines (items) "May Proceed." (See RPM chapter "Notice of Sampling" for detailed guidance.)

The FDA will pay for all physical samples found in compliance or collected as an audit of private laboratory reports of analysis submitted to FDA in response to detention (See 21 CFR 1.91). (NOTE: This does not apply in the case of an audit sample collected to document reconditioning). See IOM 416.02 for guidance on sample costs.

Billing for reimbursement should be made to the FDA district office in whose territory the shipment was offered for import. FDA will not pay for a sample if the article is initially found to be in violation, even though it is subsequently released. For this reason, do not pay for samples at the time of collection.

Samples taken in connection with the supervision of a reconditioning are not paid for by FDA.

If the entry is still under control of the district inspection operations, and the sample collection can not be completed, the district may annotate the notice to the filer and importer no product was collected, and return the entry to the flier designating the entry "May Proceed." If the designated product was part of a multi-line entry where other products were collected, the notice issued for the other items sampled will be appropriately updated with the release of the product not sampled.

In the OASIS system, when a notice is issued for the collection or examination of a product, and neither operation is accomplished, the filer will be advised through a revised Notice indicating the article is given a "May Proceed" status. The system will print a status of "May Proceeded" in the Line Summary and also print a detail section "Lines Which May Proceed."

In OASIS, the following are definitions used to describe "May Proceed" or "Release" actions:

May Proceed: "Product may proceed without FDA examination. FDA has made no determination the product complies with all provisions of the Food, Drug, and Cosmetic Act, or other related acts. This message does not preclude action should the products later be found violative." (No compliance decision has been made.)

Release: "The product is released after FDA examination. This message does not constitute assurance the product complies with all provisions of the Food, Drug and Cosmetic Act, or other related Acts, and does not preclude action should the product later be found violative." (A compliance decision has been made.)

Districts will follow the appropriate guidance under each of the above procedures, according to their import operations.

If the shipment is found in compliance after examination, the importer of record, consignee (where applicable), filer, and Customs are notified with a Notice of Release. The shipment may be admitted. (See RPM chapter "Release Notices" for detailed guidance).

617 - PROCEDURE WHEN VIOLATION IS FOUND

These procedures in this section cover imported merchandise. Your personal safety during any import procedures outlined in this subchapter is important. For more information concerning personal safety, see IOM 510.01.

FDA determines if an article is in compliance with the Acts enforced by FDA. It also determines whether or not the article can be brought into compliance with the appropriate statute and authorizes reconditioning for that purpose.

Supervision over the reconditioning is exercised by either FDA or Customs as mutually arranged. At ports in reasonably close proximity to an FDA office, supervision is ordinarily exercised by FDA. At remote ports supervision may be exercised by Customs.

The refusal of admission, exportation, or destruction of merchandise is carried out under the direction of Customs. However, at some ports the actual supervision of the destruction of violative merchandise may be conducted by FDA pursuant to a local FDA/Customs agreement.null

All articles offered for entry into the U.S. and subject to the Acts enforced by FDA, with a value greater than $2000 (current), are considered formal entries. They are subject to bond requirements, which include a condition for the redelivery of the merchandise, or any part of it, upon demand by Customs at any time, as prescribed for in the Custom's regulations in force on the date of entry. (See section 801(b) of the FD&C Act [21 U.S.C. 381(b)], 19 CFR Part 113). The bond is filed with Customs which, in case of default, takes appropriate action to effect the collection of liquidated damages provided for in the bond after consultation with FDA. (See 19 CFR Section 113.62(k) and 21 CFR Section 1.97).

Notification of the Customs entry is generally accomplished by electronic submission through the Customs Automated Commercial System (ACS). Non-electronic entries are submitted directly to FDA. Electronic entries received by FDA may be reviewed on screen (OSR) to determine if further action is needed, or if full documentation must be submitted. For entries requiring further review, FDA will be provided the appropriate Customs Entry documents (CF 3461/3461ALT, or other Customs entry forms), which also document interstate commerce, along with a copy of the invoice, etc. If an entry is not filed electronically, these documents will be submitted to FDA at the time Customs entry is made, in accordance with local port operations.

Normally, informal entries (value less than $2000 currently) do not require posting a redelivery bond. All informal entries of articles subject to FDA jurisdiction, entered electronically, are forwarded to FDA through the Customs/FDA ACS interface. Informal entries not filed electronically are processed as paper entries. When an informal entry is sampled, Customs may be requested to convert it into a formal consumption entry.

In the case of imports by mail or personal baggage, FDA districts should arrange for coverage with their local Customs International Mail Office or border crossing office. This should include agreements designating who is responsible for coverage, when (how often), etc. Customs is responsible for examination of personal baggage. If an article subject to FDA review is encountered, the Customs officer will determine if it should be brought to the attention of the local FDA office. Personal importations meeting the criteria of a formal entry will be processed in accordance with normal non-electronic entries. Generally, since most personal importations are small in size and value, guidance has been developed for evaluating these importations. (See RPM Chapter "Coverage of Personal Importations".)

"Section 321 entries" for Customs are those entries with a value of $200 or less. Generally, this form of entry applies to articles which pass free of duty and tax, as defined in 19 C.F.R. 101.1(o), and imported by one person. Customs and FDA may conduct periodic "blitzes" to determine the volume and type of FDA-regulated merchandise admitted under "Section 321 entries." The use of the 321 entry process should not apply to multiple shipments covered by a single order or contract, sent separately for the express purpose of securing free entry and avoiding compliance with pertinent law or regulation.

FDA district offices generally receive notification of all formal and informal entries subject to FDA's jurisdiction at ports of entry located in its territory. However, through the use of Custom's Automated Commercial System and FDA's Operational and Administrative System for Import Support (ACS/OASIS) some electronic entries may be forwarded to off-site districts for processing during certain periods of time, i.e., late night coverage of air carrier hubs. The means of receiving notification for non-ABI/OASIS entries can be arranged through local Customs/FDA District agreements.

The most satisfactory and efficient means of getting notification is through FDA's OASIS system. Electronic entries processed through this system are electronically screened against criteria established by FDA for coverage. Automated Broker Interface (ABI) filers using the Customs ACS for cargo release are required to provide FDA information on entries subject to its jurisdiction submitted through ACS.

Customs' ACS uses guides established by each Federal agency to identify which commodities are subject to their jurisdiction. These guides are known as Other Government Agency (OGA) flags. FDA flags are identified as FD0, FD1 and FD2. FD0 indicates the article, even though subject to FDA regulation, may be released without further presentation of entry information to FDA. For entries flagged FD1, the commodity may or may not be subject to FDA regulation. The filer may, based on information received from the importer regarding the intended use of the commodity, specify the entry is not subject to FDA regulation and "Disclaim" the entry. Otherwise, FDA required information must be submitted. FDA review of "Disclaimed" entries is performed periodically to confirm the accuracy of the declaration. Entries covered by an FD2 flag must include FDA required information.

Electronic entries for Customs review includes all mandatory Customs entry required information, i.e., entry number, entry date, importer identification, port of entry, vessel/voyage information, filer identification, Harmonized Tariff System (HTS) code for product description, information on foreign shipper, country of origin, quantity, value, etc. Through the screening process in ACS, Customs determines if the article is subject to FDA examination (see OGA flag identifications above).

FDA's electronic screening of the Customs ABI/ACS entry requires the filer to provide the following information.

1. FDA product code. (FDA's product code is not the same as the HTS codes used for Customs screening purposes.)

2. The "Manufacturer's Identification" (MID) code (a Customs designation) of the foreign manufacturer. The MID consists, at a minimum, of the 2 letter identification of the foreign country, the name of the foreign firm, generally made up of the first three letters of the first and second names of the firm, where applicable. Up to 4 numbers, if present in the address, and the first three letters of the city where the firm is located. This code is subsequently transmitted to FDA's screen as the un-coded identified firm.

3. The MID information of the foreign shipper, including city and country. (Which may or may not be the same as the foreign manufacturer.) and

4. The country of origin. (Which may be different from the country of origin identified for Customs purposes.)

FDA has also established Affirmation of Compliance (AofC) codes which are designed to provide FDA reviewers with information concerning the imported article (example: medical device listing number). Use of the AofC is voluntary, and may or may not provide for a more expeditious screening of the entry.

In OASIS, the FDA forms identified as: "Notice of Sampling," "Release Notice," "Notice of Detention and Hearing," and "Notice of Refusal of Admission," are no longer issued as specific forms. OASIS generates a "Notice of FDA Action" providing information on the actions taken regarding a particular entry line. The notice identifies the specific line(s) of the entry, where appropriate, with the description of the sample collected or intended for sampling, specific line(s) identified as detained, and/or the specific line(s) identified as released, refused, etc. As the status changes for a particular line, a new "Notice of FDA Action" is issued to advise the appropriate individuals of the changes. The use of the designation "Product Collected by FDA," "Detained," "Released," "Refused," etc., or similar wording on the "Notice of FDA Action," meet the requirements of the wording of the law and regulation when applied to "giving notice thereof to the owner or consignee." See Exhibit 610-C.

OASIS notices are designed to be mailed to the addressees. A copy of each notice is produced with the filer, importer of record, and consignee on the addressee line. (If the same firm acts in one or more of those functions, only one copy is produced for the firm.) Notices are official documents which provide FDA decisions on entries. The distribution of the notices is made by FDA, not the filer, to ensure proper notification to the parties involved (i.e., FAX, express pick-up services, postal service, etc.). The intention is for FDA to distribute to the responsible firm without an intermediary.null

For electronic entry submissions, if the filer receives a message indicating FDA review, the filer will provide appropriate entry information to the FDA office having jurisdiction over the port of entry. For those entries submitted by paper, all appropriate entry documents should be included with the package sent to the local FDA office.

After evaluating the entry, if FDA decides to collect a sample, the appropriate individuals/firms will be provided with a Notice for Sampling and advised:

1. if the entry is to be held intact for FDA examination or sampling;
2. only those designated items need be held; etc.

For those ports where Customs does not maintain its ACS electronic entry process, and FDA does not generally cover the port under its normal operating schedule, the responsible FDA district office will coordinate coverage with the responsible Customs Port manager to assure FDA notification. If FDA decides to examine or sample articles being entered through such a port, Customs, the importer, and broker will notified.

Generally, for these entries, examination and/or sampling can take place at the point of destination. Under certain conditions, however, FDA may ask Customs to collect a sample at the point of entry for forwarding to the FDA servicing laboratory. Appropriate information on the entry, sample requirement, and requirements for holding the entry will be provided to the Customs officials and importer by the responsible district.

If no examination or sample is requested, FDA will notify Customs and the filer (who is responsible for notifying the importer, or other designated parties). This electronic notification is called a "May Proceed Notice," and indicates the shipment may proceed without further FDA examination. In the ACS/OASIS process, this may occur as a result of the initial FDA/OASIS screening, or after the district performs an "On-Screen-Review". (NOTE: Since the article is allowed entry without FDA examination, should the article, at a later time, be found in violation of the law, the Agency is not prevented from taking legal action because the article was allowed admission by FDA without examination at the time of importation. (See section 304(d) of the FD&C Act [21 USC 334(d)]).

If an examination or sample is requested, FDA notifies Customs, broker or filer, importer, or other designated parties, either through the electronic entry system or other form of notification, (Notice of FDA Action) to hold the entry, and will identify the specific product(s) to be sampled, etc.

When a sample is collected by FDA, a Notice of FDA Action is issued to the importer of record, consignee, and filer. If Customs collects the sample for FDA, the district will enter the entry information into OASIS and issue the Notice of FDA Action

For those entries where specific lines (items) of an entry are not sampled or examined, the Notice of FDA Action will be amended to indicate which lines (items) "May Proceed." (See RPM chapter "Notice of Sampling" for detailed guidance.)

The FDA will pay for all physical samples found in compliance or collected as an audit of private laboratory reports of analysis submitted to FDA in response to detention (See 21 CFR 1.91). (NOTE: This does not apply in the case of an audit sample collected to document reconditioning). See IOM 416.02 for guidance on sample costs.

Billing for reimbursement should be made to the FDA district office in whose territory the shipment was offered for import. FDA will not pay for a sample if the article is initially found to be in violation, even though it is subsequently released. For this reason, do not pay for samples at the time of collection.

Samples taken in connection with the supervision of a reconditioning are not paid for by FDA.

If the entry is still under control of the district inspection operations, and the sample collection can not be completed, the district may annotate the notice to the filer and importer no product was collected, and return the entry to the flier designating the entry "May Proceed." If the designated product was part of a multi-line entry where other products were collected, the notice issued for the other items sampled will be appropriately updated with the release of the product not sampled.

In the OASIS system, when a notice is issued for the collection or examination of a product, and neither operation is accomplished, the filer will be advised through a revised Notice indicating the article is given a "May Proceed" status. The system will print a status of "May Proceeded" in the Line Summary and also print a detail section "Lines Which May Proceed."

In OASIS, the following are definitions used to describe "May Proceed" or "Release" actions:

May Proceed: "Product may proceed without FDA examination. FDA has made no determination the product complies with all provisions of the Food, Drug, and Cosmetic Act, or other related acts. This message does not preclude action should the products later be found violative." (No compliance decision has been made.)

Release: "The product is released after FDA examination. This message does not constitute assurance the product complies with all provisions of the Food, Drug and Cosmetic Act, or other related Acts, and does not preclude action should the product later be found violative." (A compliance decision has been made.)

Districts will follow the appropriate guidance under each of the above procedures, according to their import operations.

If the shipment is found in compliance after examination, the importer of record, consignee (where applicable), filer, and Customs are notified with a Notice of Release. The shipment may be admitted. (See RPM chapter "Release Notices" for detailed guidance).null

617.01 - "Notice of Detention & Hearing"

These procedures in this section cover imported merchandise. Your personal safety during any import procedures outlined in this subchapter is important. For more information concerning personal safety, see IOM 510.01.

FDA determines if an article is in compliance with the Acts enforced by FDA. It also determines whether or not the article can be brought into compliance with the appropriate statute and authorizes reconditioning for that purpose.

Supervision over the reconditioning is exercised by either FDA or Customs as mutually arranged. At ports in reasonably close proximity to an FDA office, supervision is ordinarily exercised by FDA. At remote ports supervision may be exercised by Customs.

The refusal of admission, exportation, or destruction of merchandise is carried out under the direction of Customs. However, at some ports the actual supervision of the destruction of violative merchandise may be conducted by FDA pursuant to a local FDA/Customs agreement.null

All articles offered for entry into the U.S. and subject to the Acts enforced by FDA, with a value greater than $2000 (current), are considered formal entries. They are subject to bond requirements, which include a condition for the redelivery of the merchandise, or any part of it, upon demand by Customs at any time, as prescribed for in the Custom's regulations in force on the date of entry. (See section 801(b) of the FD&C Act [21 U.S.C. 381(b)], 19 CFR Part 113). The bond is filed with Customs which, in case of default, takes appropriate action to effect the collection of liquidated damages provided for in the bond after consultation with FDA. (See 19 CFR Section 113.62(k) and 21 CFR Section 1.97).

Notification of the Customs entry is generally accomplished by electronic submission through the Customs Automated Commercial System (ACS). Non-electronic entries are submitted directly to FDA. Electronic entries received by FDA may be reviewed on screen (OSR) to determine if further action is needed, or if full documentation must be submitted. For entries requiring further review, FDA will be provided the appropriate Customs Entry documents (CF 3461/3461ALT, or other Customs entry forms), which also document interstate commerce, along with a copy of the invoice, etc. If an entry is not filed electronically, these documents will be submitted to FDA at the time Customs entry is made, in accordance with local port operations.

Normally, informal entries (value less than $2000 currently) do not require posting a redelivery bond. All informal entries of articles subject to FDA jurisdiction, entered electronically, are forwarded to FDA through the Customs/FDA ACS interface. Informal entries not filed electronically are processed as paper entries. When an informal entry is sampled, Customs may be requested to convert it into a formal consumption entry.

In the case of imports by mail or personal baggage, FDA districts should arrange for coverage with their local Customs International Mail Office or border crossing office. This should include agreements designating who is responsible for coverage, when (how often), etc. Customs is responsible for examination of personal baggage. If an article subject to FDA review is encountered, the Customs officer will determine if it should be brought to the attention of the local FDA office. Personal importations meeting the criteria of a formal entry will be processed in accordance with normal non-electronic entries. Generally, since most personal importations are small in size and value, guidance has been developed for evaluating these importations. (See RPM Chapter "Coverage of Personal Importations".)

"Section 321 entries" for Customs are those entries with a value of $200 or less. Generally, this form of entry applies to articles which pass free of duty and tax, as defined in 19 C.F.R. 101.1(o), and imported by one person. Customs and FDA may conduct periodic "blitzes" to determine the volume and type of FDA-regulated merchandise admitted under "Section 321 entries." The use of the 321 entry process should not apply to multiple shipments covered by a single order or contract, sent separately for the express purpose of securing free entry and avoiding compliance with pertinent law or regulation.

FDA district offices generally receive notification of all formal and informal entries subject to FDA's jurisdiction at ports of entry located in its territory. However, through the use of Custom's Automated Commercial System and FDA's Operational and Administrative System for Import Support (ACS/OASIS) some electronic entries may be forwarded to off-site districts for processing during certain periods of time, i.e., late night coverage of air carrier hubs. The means of receiving notification for non-ABI/OASIS entries can be arranged through local Customs/FDA District agreements.

The most satisfactory and efficient means of getting notification is through FDA's OASIS system. Electronic entries processed through this system are electronically screened against criteria established by FDA for coverage. Automated Broker Interface (ABI) filers using the Customs ACS for cargo release are required to provide FDA information on entries subject to its jurisdiction submitted through ACS.

Customs' ACS uses guides established by each Federal agency to identify which commodities are subject to their jurisdiction. These guides are known as Other Government Agency (OGA) flags. FDA flags are identified as FD0, FD1 and FD2. FD0 indicates the article, even though subject to FDA regulation, may be released without further presentation of entry information to FDA. For entries flagged FD1, the commodity may or may not be subject to FDA regulation. The filer may, based on information received from the importer regarding the intended use of the commodity, specify the entry is not subject to FDA regulation and "Disclaim" the entry. Otherwise, FDA required information must be submitted. FDA review of "Disclaimed" entries is performed periodically to confirm the accuracy of the declaration. Entries covered by an FD2 flag must include FDA required information.

Electronic entries for Customs review includes all mandatory Customs entry required information, i.e., entry number, entry date, importer identification, port of entry, vessel/voyage information, filer identification, Harmonized Tariff System (HTS) code for product description, information on foreign shipper, country of origin, quantity, value, etc. Through the screening process in ACS, Customs determines if the article is subject to FDA examination (see OGA flag identifications above).

FDA's electronic screening of the Customs ABI/ACS entry requires the filer to provide the following information.

1. FDA product code. (FDA's product code is not the same as the HTS codes used for Customs screening purposes.)

2. The "Manufacturer's Identification" (MID) code (a Customs designation) of the foreign manufacturer. The MID consists, at a minimum, of the 2 letter identification of the foreign country, the name of the foreign firm, generally made up of the first three letters of the first and second names of the firm, where applicable. Up to 4 numbers, if present in the address, and the first three letters of the city where the firm is located. This code is subsequently transmitted to FDA's screen as the un-coded identified firm.

3. The MID information of the foreign shipper, including city and country. (Which may or may not be the same as the foreign manufacturer.) and

4. The country of origin. (Which may be different from the country of origin identified for Customs purposes.)

FDA has also established Affirmation of Compliance (AofC) codes which are designed to provide FDA reviewers with information concerning the imported article (example: medical device listing number). Use of the AofC is voluntary, and may or may not provide for a more expeditious screening of the entry.

In OASIS, the FDA forms identified as: "Notice of Sampling," "Release Notice," "Notice of Detention and Hearing," and "Notice of Refusal of Admission," are no longer issued as specific forms. OASIS generates a "Notice of FDA Action" providing information on the actions taken regarding a particular entry line. The notice identifies the specific line(s) of the entry, where appropriate, with the description of the sample collected or intended for sampling, specific line(s) identified as detained, and/or the specific line(s) identified as released, refused, etc. As the status changes for a particular line, a new "Notice of FDA Action" is issued to advise the appropriate individuals of the changes. The use of the designation "Product Collected by FDA," "Detained," "Released," "Refused," etc., or similar wording on the "Notice of FDA Action," meet the requirements of the wording of the law and regulation when applied to "giving notice thereof to the owner or consignee." See Exhibit 610-C.

OASIS notices are designed to be mailed to the addressees. A copy of each notice is produced with the filer, importer of record, and consignee on the addressee line. (If the same firm acts in one or more of those functions, only one copy is produced for the firm.) Notices are official documents which provide FDA decisions on entries. The distribution of the notices is made by FDA, not the filer, to ensure proper notification to the parties involved (i.e., FAX, express pick-up services, postal service, etc.). The intention is for FDA to distribute to the responsible firm without an intermediary.null

For electronic entry submissions, if the filer receives a message indicating FDA review, the filer will provide appropriate entry information to the FDA office having jurisdiction over the port of entry. For those entries submitted by paper, all appropriate entry documents should be included with the package sent to the local FDA office.

After evaluating the entry, if FDA decides to collect a sample, the appropriate individuals/firms will be provided with a Notice for Sampling and advised:

1. if the entry is to be held intact for FDA examination or sampling;
2. only those designated items need be held; etc.

For those ports where Customs does not maintain its ACS electronic entry process, and FDA does not generally cover the port under its normal operating schedule, the responsible FDA district office will coordinate coverage with the responsible Customs Port manager to assure FDA notification. If FDA decides to examine or sample articles being entered through such a port, Customs, the importer, and broker will notified.

Generally, for these entries, examination and/or sampling can take place at the point of destination. Under certain conditions, however, FDA may ask Customs to collect a sample at the point of entry for forwarding to the FDA servicing laboratory. Appropriate information on the entry, sample requirement, and requirements for holding the entry will be provided to the Customs officials and importer by the responsible district.

If no examination or sample is requested, FDA will notify Customs and the filer (who is responsible for notifying the importer, or other designated parties). This electronic notification is called a "May Proceed Notice," and indicates the shipment may proceed without further FDA examination. In the ACS/OASIS process, this may occur as a result of the initial FDA/OASIS screening, or after the district performs an "On-Screen-Review". (NOTE: Since the article is allowed entry without FDA examination, should the article, at a later time, be found in violation of the law, the Agency is not prevented from taking legal action because the article was allowed admission by FDA without examination at the time of importation. (See section 304(d) of the FD&C Act [21 USC 334(d)]).

If an examination or sample is requested, FDA notifies Customs, broker or filer, importer, or other designated parties, either through the electronic entry system or other form of notification, (Notice of FDA Action) to hold the entry, and will identify the specific product(s) to be sampled, etc.

When a sample is collected by FDA, a Notice of FDA Action is issued to the importer of record, consignee, and filer. If Customs collects the sample for FDA, the district will enter the entry information into OASIS and issue the Notice of FDA Action

For those entries where specific lines (items) of an entry are not sampled or examined, the Notice of FDA Action will be amended to indicate which lines (items) "May Proceed." (See RPM chapter "Notice of Sampling" for detailed guidance.)

The FDA will pay for all physical samples found in compliance or collected as an audit of private laboratory reports of analysis submitted to FDA in response to detention (See 21 CFR 1.91). (NOTE: This does not apply in the case of an audit sample collected to document reconditioning). See IOM 416.02 for guidance on sample costs.

Billing for reimbursement should be made to the FDA district office in whose territory the shipment was offered for import. FDA will not pay for a sample if the article is initially found to be in violation, even though it is subsequently released. For this reason, do not pay for samples at the time of collection.

Samples taken in connection with the supervision of a reconditioning are not paid for by FDA.

If the entry is still under control of the district inspection operations, and the sample collection can not be completed, the district may annotate the notice to the filer and importer no product was collected, and return the entry to the flier designating the entry "May Proceed." If the designated product was part of a multi-line entry where other products were collected, the notice issued for the other items sampled will be appropriately updated with the release of the product not sampled.

In the OASIS system, when a notice is issued for the collection or examination of a product, and neither operation is accomplished, the filer will be advised through a revised Notice indicating the article is given a "May Proceed" status. The system will print a status of "May Proceeded" in the Line Summary and also print a detail section "Lines Which May Proceed."

In OASIS, the following are definitions used to describe "May Proceed" or "Release" actions:

May Proceed: "Product may proceed without FDA examination. FDA has made no determination the product complies with all provisions of the Food, Drug, and Cosmetic Act, or other related acts. This message does not preclude action should the products later be found violative." (No compliance decision has been made.)

Release: "The product is released after FDA examination. This message does not constitute assurance the product complies with all provisions of the Food, Drug and Cosmetic Act, or other related Acts, and does not preclude action should the product later be found violative." (A compliance decision has been made.)

Districts will follow the appropriate guidance under each of the above procedures, according to their import operations.

If the shipment is found in compliance after examination, the importer of record, consignee (where applicable), filer, and Customs are notified with a Notice of Release. The shipment may be admitted. (See RPM chapter "Release Notices" for detailed guidance).null

If examination of the sample or other evidence indicates the article appears to be in violation, and detention is the course of action chosen by the district, the filer, owner and consignee, where applicable, are advised of such action by "Notice of Detention and Hearing." The Notice will specify the nature of the violation charged and designate a site for the owner or consignee (or authorized representative) to appear at a hearing. These hearings are informal meetings with the district, designed to provide the respondents an opportunity to present evidence supporting admissibility of the article. Ordinarily the respondents are allowed 10 working days to appear. However, if for some compelling reason the district determines ten (10) working days are insufficient, this time period may be extended. On the OASIS generated "Notice of FDA Action", this date is identified under the caption "Respond By". A copy of this Notice is also sent to Customs. (See RPM chapter "Notice of Detention and Hearing".)

617.02 - Response To "Notice of Detention & Hearing"

These procedures in this section cover imported merchandise. Your personal safety during any import procedures outlined in this subchapter is important. For more information concerning personal safety, see IOM 510.01.

FDA determines if an article is in compliance with the Acts enforced by FDA. It also determines whether or not the article can be brought into compliance with the appropriate statute and authorizes reconditioning for that purpose.

Supervision over the reconditioning is exercised by either FDA or Customs as mutually arranged. At ports in reasonably close proximity to an FDA office, supervision is ordinarily exercised by FDA. At remote ports supervision may be exercised by Customs.

The refusal of admission, exportation, or destruction of merchandise is carried out under the direction of Customs. However, at some ports the actual supervision of the destruction of violative merchandise may be conducted by FDA pursuant to a local FDA/Customs agreement.null

All articles offered for entry into the U.S. and subject to the Acts enforced by FDA, with a value greater than $2000 (current), are considered formal entries. They are subject to bond requirements, which include a condition for the redelivery of the merchandise, or any part of it, upon demand by Customs at any time, as prescribed for in the Custom's regulations in force on the date of entry. (See section 801(b) of the FD&C Act [21 U.S.C. 381(b)], 19 CFR Part 113). The bond is filed with Customs which, in case of default, takes appropriate action to effect the collection of liquidated damages provided for in the bond after consultation with FDA. (See 19 CFR Section 113.62(k) and 21 CFR Section 1.97).

Notification of the Customs entry is generally accomplished by electronic submission through the Customs Automated Commercial System (ACS). Non-electronic entries are submitted directly to FDA. Electronic entries received by FDA may be reviewed on screen (OSR) to determine if further action is needed, or if full documentation must be submitted. For entries requiring further review, FDA will be provided the appropriate Customs Entry documents (CF 3461/3461ALT, or other Customs entry forms), which also document interstate commerce, along with a copy of the invoice, etc. If an entry is not filed electronically, these documents will be submitted to FDA at the time Customs entry is made, in accordance with local port operations.

Normally, informal entries (value less than $2000 currently) do not require posting a redelivery bond. All informal entries of articles subject to FDA jurisdiction, entered electronically, are forwarded to FDA through the Customs/FDA ACS interface. Informal entries not filed electronically are processed as paper entries. When an informal entry is sampled, Customs may be requested to convert it into a formal consumption entry.

In the case of imports by mail or personal baggage, FDA districts should arrange for coverage with their local Customs International Mail Office or border crossing office. This should include agreements designating who is responsible for coverage, when (how often), etc. Customs is responsible for examination of personal baggage. If an article subject to FDA review is encountered, the Customs officer will determine if it should be brought to the attention of the local FDA office. Personal importations meeting the criteria of a formal entry will be processed in accordance with normal non-electronic entries. Generally, since most personal importations are small in size and value, guidance has been developed for evaluating these importations. (See RPM Chapter "Coverage of Personal Importations".)

"Section 321 entries" for Customs are those entries with a value of $200 or less. Generally, this form of entry applies to articles which pass free of duty and tax, as defined in 19 C.F.R. 101.1(o), and imported by one person. Customs and FDA may conduct periodic "blitzes" to determine the volume and type of FDA-regulated merchandise admitted under "Section 321 entries." The use of the 321 entry process should not apply to multiple shipments covered by a single order or contract, sent separately for the express purpose of securing free entry and avoiding compliance with pertinent law or regulation.

FDA district offices generally receive notification of all formal and informal entries subject to FDA's jurisdiction at ports of entry located in its territory. However, through the use of Custom's Automated Commercial System and FDA's Operational and Administrative System for Import Support (ACS/OASIS) some electronic entries may be forwarded to off-site districts for processing during certain periods of time, i.e., late night coverage of air carrier hubs. The means of receiving notification for non-ABI/OASIS entries can be arranged through local Customs/FDA District agreements.

The most satisfactory and efficient means of getting notification is through FDA's OASIS system. Electronic entries processed through this system are electronically screened against criteria established by FDA for coverage. Automated Broker Interface (ABI) filers using the Customs ACS for cargo release are required to provide FDA information on entries subject to its jurisdiction submitted through ACS.

Customs' ACS uses guides established by each Federal agency to identify which commodities are subject to their jurisdiction. These guides are known as Other Government Agency (OGA) flags. FDA flags are identified as FD0, FD1 and FD2. FD0 indicates the article, even though subject to FDA regulation, may be released without further presentation of entry information to FDA. For entries flagged FD1, the commodity may or may not be subject to FDA regulation. The filer may, based on information received from the importer regarding the intended use of the commodity, specify the entry is not subject to FDA regulation and "Disclaim" the entry. Otherwise, FDA required information must be submitted. FDA review of "Disclaimed" entries is performed periodically to confirm the accuracy of the declaration. Entries covered by an FD2 flag must include FDA required information.

Electronic entries for Customs review includes all mandatory Customs entry required information, i.e., entry number, entry date, importer identification, port of entry, vessel/voyage information, filer identification, Harmonized Tariff System (HTS) code for product description, information on foreign shipper, country of origin, quantity, value, etc. Through the screening process in ACS, Customs determines if the article is subject to FDA examination (see OGA flag identifications above).

FDA's electronic screening of the Customs ABI/ACS entry requires the filer to provide the following information.

1. FDA product code. (FDA's product code is not the same as the HTS codes used for Customs screening purposes.)

2. The "Manufacturer's Identification" (MID) code (a Customs designation) of the foreign manufacturer. The MID consists, at a minimum, of the 2 letter identification of the foreign country, the name of the foreign firm, generally made up of the first three letters of the first and second names of the firm, where applicable. Up to 4 numbers, if present in the address, and the first three letters of the city where the firm is located. This code is subsequently transmitted to FDA's screen as the un-coded identified firm.

3. The MID information of the foreign shipper, including city and country. (Which may or may not be the same as the foreign manufacturer.) and

4. The country of origin. (Which may be different from the country of origin identified for Customs purposes.)

FDA has also established Affirmation of Compliance (AofC) codes which are designed to provide FDA reviewers with information concerning the imported article (example: medical device listing number). Use of the AofC is voluntary, and may or may not provide for a more expeditious screening of the entry.

In OASIS, the FDA forms identified as: "Notice of Sampling," "Release Notice," "Notice of Detention and Hearing," and "Notice of Refusal of Admission," are no longer issued as specific forms. OASIS generates a "Notice of FDA Action" providing information on the actions taken regarding a particular entry line. The notice identifies the specific line(s) of the entry, where appropriate, with the description of the sample collected or intended for sampling, specific line(s) identified as detained, and/or the specific line(s) identified as released, refused, etc. As the status changes for a particular line, a new "Notice of FDA Action" is issued to advise the appropriate individuals of the changes. The use of the designation "Product Collected by FDA," "Detained," "Released," "Refused," etc., or similar wording on the "Notice of FDA Action," meet the requirements of the wording of the law and regulation when applied to "giving notice thereof to the owner or consignee." See Exhibit 610-C.

OASIS notices are designed to be mailed to the addressees. A copy of each notice is produced with the filer, importer of record, and consignee on the addressee line. (If the same firm acts in one or more of those functions, only one copy is produced for the firm.) Notices are official documents which provide FDA decisions on entries. The distribution of the notices is made by FDA, not the filer, to ensure proper notification to the parties involved (i.e., FAX, express pick-up services, postal service, etc.). The intention is for FDA to distribute to the responsible firm without an intermediary.null

For electronic entry submissions, if the filer receives a message indicating FDA review, the filer will provide appropriate entry information to the FDA office having jurisdiction over the port of entry. For those entries submitted by paper, all appropriate entry documents should be included with the package sent to the local FDA office.

After evaluating the entry, if FDA decides to collect a sample, the appropriate individuals/firms will be provided with a Notice for Sampling and advised:

1. if the entry is to be held intact for FDA examination or sampling;
2. only those designated items need be held; etc.

For those ports where Customs does not maintain its ACS electronic entry process, and FDA does not generally cover the port under its normal operating schedule, the responsible FDA district office will coordinate coverage with the responsible Customs Port manager to assure FDA notification. If FDA decides to examine or sample articles being entered through such a port, Customs, the importer, and broker will notified.

Generally, for these entries, examination and/or sampling can take place at the point of destination. Under certain conditions, however, FDA may ask Customs to collect a sample at the point of entry for forwarding to the FDA servicing laboratory. Appropriate information on the entry, sample requirement, and requirements for holding the entry will be provided to the Customs officials and importer by the responsible district.

If no examination or sample is requested, FDA will notify Customs and the filer (who is responsible for notifying the importer, or other designated parties). This electronic notification is called a "May Proceed Notice," and indicates the shipment may proceed without further FDA examination. In the ACS/OASIS process, this may occur as a result of the initial FDA/OASIS screening, or after the district performs an "On-Screen-Review". (NOTE: Since the article is allowed entry without FDA examination, should the article, at a later time, be found in violation of the law, the Agency is not prevented from taking legal action because the article was allowed admission by FDA without examination at the time of importation. (See section 304(d) of the FD&C Act [21 USC 334(d)]).

If an examination or sample is requested, FDA notifies Customs, broker or filer, importer, or other designated parties, either through the electronic entry system or other form of notification, (Notice of FDA Action) to hold the entry, and will identify the specific product(s) to be sampled, etc.

When a sample is collected by FDA, a Notice of FDA Action is issued to the importer of record, consignee, and filer. If Customs collects the sample for FDA, the district will enter the entry information into OASIS and issue the Notice of FDA Action

For those entries where specific lines (items) of an entry are not sampled or examined, the Notice of FDA Action will be amended to indicate which lines (items) "May Proceed." (See RPM chapter "Notice of Sampling" for detailed guidance.)

The FDA will pay for all physical samples found in compliance or collected as an audit of private laboratory reports of analysis submitted to FDA in response to detention (See 21 CFR 1.91). (NOTE: This does not apply in the case of an audit sample collected to document reconditioning). See IOM 416.02 for guidance on sample costs.

Billing for reimbursement should be made to the FDA district office in whose territory the shipment was offered for import. FDA will not pay for a sample if the article is initially found to be in violation, even though it is subsequently released. For this reason, do not pay for samples at the time of collection.

Samples taken in connection with the supervision of a reconditioning are not paid for by FDA.

If the entry is still under control of the district inspection operations, and the sample collection can not be completed, the district may annotate the notice to the filer and importer no product was collected, and return the entry to the flier designating the entry "May Proceed." If the designated product was part of a multi-line entry where other products were collected, the notice issued for the other items sampled will be appropriately updated with the release of the product not sampled.

In the OASIS system, when a notice is issued for the collection or examination of a product, and neither operation is accomplished, the filer will be advised through a revised Notice indicating the article is given a "May Proceed" status. The system will print a status of "May Proceeded" in the Line Summary and also print a detail section "Lines Which May Proceed."

In OASIS, the following are definitions used to describe "May Proceed" or "Release" actions:

May Proceed: "Product may proceed without FDA examination. FDA has made no determination the product complies with all provisions of the Food, Drug, and Cosmetic Act, or other related acts. This message does not preclude action should the products later be found violative." (No compliance decision has been made.)

Release: "The product is released after FDA examination. This message does not constitute assurance the product complies with all provisions of the Food, Drug and Cosmetic Act, or other related Acts, and does not preclude action should the product later be found violative." (A compliance decision has been made.)

Districts will follow the appropriate guidance under each of the above procedures, according to their import operations.

If the shipment is found in compliance after examination, the importer of record, consignee (where applicable), filer, and Customs are notified with a Notice of Release. The shipment may be admitted. (See RPM chapter "Release Notices" for detailed guidance).null

If examination of the sample or other evidence indicates the article appears to be in violation, and detention is the course of action chosen by the district, the filer, owner and consignee, where applicable, are advised of such action by "Notice of Detention and Hearing." The Notice will specify the nature of the violation charged and designate a site for the owner or consignee (or authorized representative) to appear at a hearing. These hearings are informal meetings with the district, designed to provide the respondents an opportunity to present evidence supporting admissibility of the article. Ordinarily the respondents are allowed 10 working days to appear. However, if for some compelling reason the district determines ten (10) working days are insufficient, this time period may be extended. On the OASIS generated "Notice of FDA Action", this date is identified under the caption "Respond By". A copy of this Notice is also sent to Customs. (See RPM chapter "Notice of Detention and Hearing".)

Response to the Notice of Detention and Hearing may be made personally, by representative or by mail. The importer may present evidence supporting the admissibility of the article, request refusal of admission, propose an effective manner of reconditioning, or a method to remove the product from the authority of the Act.

617.03 - Request for Authorization to Relabel or Perform Other Acts

These procedures in this section cover imported merchandise. Your personal safety during any import procedures outlined in this subchapter is important. For more information concerning personal safety, see IOM 510.01.

FDA determines if an article is in compliance with the Acts enforced by FDA. It also determines whether or not the article can be brought into compliance with the appropriate statute and authorizes reconditioning for that purpose.

Supervision over the reconditioning is exercised by either FDA or Customs as mutually arranged. At ports in reasonably close proximity to an FDA office, supervision is ordinarily exercised by FDA. At remote ports supervision may be exercised by Customs.

The refusal of admission, exportation, or destruction of merchandise is carried out under the direction of Customs. However, at some ports the actual supervision of the destruction of violative merchandise may be conducted by FDA pursuant to a local FDA/Customs agreement.null

All articles offered for entry into the U.S. and subject to the Acts enforced by FDA, with a value greater than $2000 (current), are considered formal entries. They are subject to bond requirements, which include a condition for the redelivery of the merchandise, or any part of it, upon demand by Customs at any time, as prescribed for in the Custom's regulations in force on the date of entry. (See section 801(b) of the FD&C Act [21 U.S.C. 381(b)], 19 CFR Part 113). The bond is filed with Customs which, in case of default, takes appropriate action to effect the collection of liquidated damages provided for in the bond after consultation with FDA. (See 19 CFR Section 113.62(k) and 21 CFR Section 1.97).

Notification of the Customs entry is generally accomplished by electronic submission through the Customs Automated Commercial System (ACS). Non-electronic entries are submitted directly to FDA. Electronic entries received by FDA may be reviewed on screen (OSR) to determine if further action is needed, or if full documentation must be submitted. For entries requiring further review, FDA will be provided the appropriate Customs Entry documents (CF 3461/3461ALT, or other Customs entry forms), which also document interstate commerce, along with a copy of the invoice, etc. If an entry is not filed electronically, these documents will be submitted to FDA at the time Customs entry is made, in accordance with local port operations.

Normally, informal entries (value less than $2000 currently) do not require posting a redelivery bond. All informal entries of articles subject to FDA jurisdiction, entered electronically, are forwarded to FDA through the Customs/FDA ACS interface. Informal entries not filed electronically are processed as paper entries. When an informal entry is sampled, Customs may be requested to convert it into a formal consumption entry.

In the case of imports by mail or personal baggage, FDA districts should arrange for coverage with their local Customs International Mail Office or border crossing office. This should include agreements designating who is responsible for coverage, when (how often), etc. Customs is responsible for examination of personal baggage. If an article subject to FDA review is encountered, the Customs officer will determine if it should be brought to the attention of the local FDA office. Personal importations meeting the criteria of a formal entry will be processed in accordance with normal non-electronic entries. Generally, since most personal importations are small in size and value, guidance has been developed for evaluating these importations. (See RPM Chapter "Coverage of Personal Importations".)

"Section 321 entries" for Customs are those entries with a value of $200 or less. Generally, this form of entry applies to articles which pass free of duty and tax, as defined in 19 C.F.R. 101.1(o), and imported by one person. Customs and FDA may conduct periodic "blitzes" to determine the volume and type of FDA-regulated merchandise admitted under "Section 321 entries." The use of the 321 entry process should not apply to multiple shipments covered by a single order or contract, sent separately for the express purpose of securing free entry and avoiding compliance with pertinent law or regulation.

FDA district offices generally receive notification of all formal and informal entries subject to FDA's jurisdiction at ports of entry located in its territory. However, through the use of Custom's Automated Commercial System and FDA's Operational and Administrative System for Import Support (ACS/OASIS) some electronic entries may be forwarded to off-site districts for processing during certain periods of time, i.e., late night coverage of air carrier hubs. The means of receiving notification for non-ABI/OASIS entries can be arranged through local Customs/FDA District agreements.

The most satisfactory and efficient means of getting notification is through FDA's OASIS system. Electronic entries processed through this system are electronically screened against criteria established by FDA for coverage. Automated Broker Interface (ABI) filers using the Customs ACS for cargo release are required to provide FDA information on entries subject to its jurisdiction submitted through ACS.

Customs' ACS uses guides established by each Federal agency to identify which commodities are subject to their jurisdiction. These guides are known as Other Government Agency (OGA) flags. FDA flags are identified as FD0, FD1 and FD2. FD0 indicates the article, even though subject to FDA regulation, may be released without further presentation of entry information to FDA. For entries flagged FD1, the commodity may or may not be subject to FDA regulation. The filer may, based on information received from the importer regarding the intended use of the commodity, specify the entry is not subject to FDA regulation and "Disclaim" the entry. Otherwise, FDA required information must be submitted. FDA review of "Disclaimed" entries is performed periodically to confirm the accuracy of the declaration. Entries covered by an FD2 flag must include FDA required information.

Electronic entries for Customs review includes all mandatory Customs entry required information, i.e., entry number, entry date, importer identification, port of entry, vessel/voyage information, filer identification, Harmonized Tariff System (HTS) code for product description, information on foreign shipper, country of origin, quantity, value, etc. Through the screening process in ACS, Customs determines if the article is subject to FDA examination (see OGA flag identifications above).

FDA's electronic screening of the Customs ABI/ACS entry requires the filer to provide the following information.

1. FDA product code. (FDA's product code is not the same as the HTS codes used for Customs screening purposes.)

2. The "Manufacturer's Identification" (MID) code (a Customs designation) of the foreign manufacturer. The MID consists, at a minimum, of the 2 letter identification of the foreign country, the name of the foreign firm, generally made up of the first three letters of the first and second names of the firm, where applicable. Up to 4 numbers, if present in the address, and the first three letters of the city where the firm is located. This code is subsequently transmitted to FDA's screen as the un-coded identified firm.

3. The MID information of the foreign shipper, including city and country. (Which may or may not be the same as the foreign manufacturer.) and

4. The country of origin. (Which may be different from the country of origin identified for Customs purposes.)

FDA has also established Affirmation of Compliance (AofC) codes which are designed to provide FDA reviewers with information concerning the imported article (example: medical device listing number). Use of the AofC is voluntary, and may or may not provide for a more expeditious screening of the entry.

In OASIS, the FDA forms identified as: "Notice of Sampling," "Release Notice," "Notice of Detention and Hearing," and "Notice of Refusal of Admission," are no longer issued as specific forms. OASIS generates a "Notice of FDA Action" providing information on the actions taken regarding a particular entry line. The notice identifies the specific line(s) of the entry, where appropriate, with the description of the sample collected or intended for sampling, specific line(s) identified as detained, and/or the specific line(s) identified as released, refused, etc. As the status changes for a particular line, a new "Notice of FDA Action" is issued to advise the appropriate individuals of the changes. The use of the designation "Product Collected by FDA," "Detained," "Released," "Refused," etc., or similar wording on the "Notice of FDA Action," meet the requirements of the wording of the law and regulation when applied to "giving notice thereof to the owner or consignee." See Exhibit 610-C.

OASIS notices are designed to be mailed to the addressees. A copy of each notice is produced with the filer, importer of record, and consignee on the addressee line. (If the same firm acts in one or more of those functions, only one copy is produced for the firm.) Notices are official documents which provide FDA decisions on entries. The distribution of the notices is made by FDA, not the filer, to ensure proper notification to the parties involved (i.e., FAX, express pick-up services, postal service, etc.). The intention is for FDA to distribute to the responsible firm without an intermediary.null

For electronic entry submissions, if the filer receives a message indicating FDA review, the filer will provide appropriate entry information to the FDA office having jurisdiction over the port of entry. For those entries submitted by paper, all appropriate entry documents should be included with the package sent to the local FDA office.

After evaluating the entry, if FDA decides to collect a sample, the appropriate individuals/firms will be provided with a Notice for Sampling and advised:

1. if the entry is to be held intact for FDA examination or sampling;
2. only those designated items need be held; etc.

For those ports where Customs does not maintain its ACS electronic entry process, and FDA does not generally cover the port under its normal operating schedule, the responsible FDA district office will coordinate coverage with the responsible Customs Port manager to assure FDA notification. If FDA decides to examine or sample articles being entered through such a port, Customs, the importer, and broker will notified.

Generally, for these entries, examination and/or sampling can take place at the point of destination. Under certain conditions, however, FDA may ask Customs to collect a sample at the point of entry for forwarding to the FDA servicing laboratory. Appropriate information on the entry, sample requirement, and requirements for holding the entry will be provided to the Customs officials and importer by the responsible district.

If no examination or sample is requested, FDA will notify Customs and the filer (who is responsible for notifying the importer, or other designated parties). This electronic notification is called a "May Proceed Notice," and indicates the shipment may proceed without further FDA examination. In the ACS/OASIS process, this may occur as a result of the initial FDA/OASIS screening, or after the district performs an "On-Screen-Review". (NOTE: Since the article is allowed entry without FDA examination, should the article, at a later time, be found in violation of the law, the Agency is not prevented from taking legal action because the article was allowed admission by FDA without examination at the time of importation. (See section 304(d) of the FD&C Act [21 USC 334(d)]).

If an examination or sample is requested, FDA notifies Customs, broker or filer, importer, or other designated parties, either through the electronic entry system or other form of notification, (Notice of FDA Action) to hold the entry, and will identify the specific product(s) to be sampled, etc.

When a sample is collected by FDA, a Notice of FDA Action is issued to the importer of record, consignee, and filer. If Customs collects the sample for FDA, the district will enter the entry information into OASIS and issue the Notice of FDA Action

For those entries where specific lines (items) of an entry are not sampled or examined, the Notice of FDA Action will be amended to indicate which lines (items) "May Proceed." (See RPM chapter "Notice of Sampling" for detailed guidance.)

The FDA will pay for all physical samples found in compliance or collected as an audit of private laboratory reports of analysis submitted to FDA in response to detention (See 21 CFR 1.91). (NOTE: This does not apply in the case of an audit sample collected to document reconditioning). See IOM 416.02 for guidance on sample costs.

Billing for reimbursement should be made to the FDA district office in whose territory the shipment was offered for import. FDA will not pay for a sample if the article is initially found to be in violation, even though it is subsequently released. For this reason, do not pay for samples at the time of collection.

Samples taken in connection with the supervision of a reconditioning are not paid for by FDA.

If the entry is still under control of the district inspection operations, and the sample collection can not be completed, the district may annotate the notice to the filer and importer no product was collected, and return the entry to the flier designating the entry "May Proceed." If the designated product was part of a multi-line entry where other products were collected, the notice issued for the other items sampled will be appropriately updated with the release of the product not sampled.

In the OASIS system, when a notice is issued for the collection or examination of a product, and neither operation is accomplished, the filer will be advised through a revised Notice indicating the article is given a "May Proceed" status. The system will print a status of "May Proceeded" in the Line Summary and also print a detail section "Lines Which May Proceed."

In OASIS, the following are definitions used to describe "May Proceed" or "Release" actions:

May Proceed: "Product may proceed without FDA examination. FDA has made no determination the product complies with all provisions of the Food, Drug, and Cosmetic Act, or other related acts. This message does not preclude action should the products later be found violative." (No compliance decision has been made.)

Release: "The product is released after FDA examination. This message does not constitute assurance the product complies with all provisions of the Food, Drug and Cosmetic Act, or other related Acts, and does not preclude action should the product later be found violative." (A compliance decision has been made.)

Districts will follow the appropriate guidance under each of the above procedures, according to their import operations.

If the shipment is found in compliance after examination, the importer of record, consignee (where applicable), filer, and Customs are notified with a Notice of Release. The shipment may be admitted. (See RPM chapter "Release Notices" for detailed guidance).null

If examination of the sample or other evidence indicates the article appears to be in violation, and detention is the course of action chosen by the district, the filer, owner and consignee, where applicable, are advised of such action by "Notice of Detention and Hearing." The Notice will specify the nature of the violation charged and designate a site for the owner or consignee (or authorized representative) to appear at a hearing. These hearings are informal meetings with the district, designed to provide the respondents an opportunity to present evidence supporting admissibility of the article. Ordinarily the respondents are allowed 10 working days to appear. However, if for some compelling reason the district determines ten (10) working days are insufficient, this time period may be extended. On the OASIS generated "Notice of FDA Action", this date is identified under the caption "Respond By". A copy of this Notice is also sent to Customs. (See RPM chapter "Notice of Detention and Hearing".)

Response to the Notice of Detention and Hearing may be made personally, by representative or by mail. The importer may present evidence supporting the admissibility of the article, request refusal of admission, propose an effective manner of reconditioning, or a method to remove the product from the authority of the Act.

FDA may authorize relabeling or other remedial action upon the timely submission of an "Application for Authorization to Relabel or To Perform Other Action," (FD Form 766 - See Exhibit 610-A). Application may also be made by letter and the execution of a good and sufficient bond by the owner or consignee (See section 801(b) of the FD&C Act [21 U.S.C. 381(b)]). The redelivery bond on file with the District Director of Customs for the particular importation applies to any re-labeling or other action authorized, and a new bond will not have to be filed.

After review of the application, FDA will notify the importer of its approval or disapproval. If approved the original application will be returned outlining the conditions to be fulfilled and the time limit within which to fulfill them will be noted. Notification to other parties will be made where appropriate. A copy will be retained in the district files. (See RPM chapter "Response to Notice of Detention and Hearing", and RPM chapter "Reconditioning" for detailed guidance).

617.04 - Inspection After Completion of Authorization to Bring Article Into Compliance

These procedures in this section cover imported merchandise. Your personal safety during any import procedures outlined in this subchapter is important. For more information concerning personal safety, see IOM 510.01.

FDA determines if an article is in compliance with the Acts enforced by FDA. It also determines whether or not the article can be brought into compliance with the appropriate statute and authorizes reconditioning for that purpose.

Supervision over the reconditioning is exercised by either FDA or Customs as mutually arranged. At ports in reasonably close proximity to an FDA office, supervision is ordinarily exercised by FDA. At remote ports supervision may be exercised by Customs.

The refusal of admission, exportation, or destruction of merchandise is carried out under the direction of Customs. However, at some ports the actual supervision of the destruction of violative merchandise may be conducted by FDA pursuant to a local FDA/Customs agreement.null

All articles offered for entry into the U.S. and subject to the Acts enforced by FDA, with a value greater than $2000 (current), are considered formal entries. They are subject to bond requirements, which include a condition for the redelivery of the merchandise, or any part of it, upon demand by Customs at any time, as prescribed for in the Custom's regulations in force on the date of entry. (See section 801(b) of the FD&C Act [21 U.S.C. 381(b)], 19 CFR Part 113). The bond is filed with Customs which, in case of default, takes appropriate action to effect the collection of liquidated damages provided for in the bond after consultation with FDA. (See 19 CFR Section 113.62(k) and 21 CFR Section 1.97).

Notification of the Customs entry is generally accomplished by electronic submission through the Customs Automated Commercial System (ACS). Non-electronic entries are submitted directly to FDA. Electronic entries received by FDA may be reviewed on screen (OSR) to determine if further action is needed, or if full documentation must be submitted. For entries requiring further review, FDA will be provided the appropriate Customs Entry documents (CF 3461/3461ALT, or other Customs entry forms), which also document interstate commerce, along with a copy of the invoice, etc. If an entry is not filed electronically, these documents will be submitted to FDA at the time Customs entry is made, in accordance with local port operations.

Normally, informal entries (value less than $2000 currently) do not require posting a redelivery bond. All informal entries of articles subject to FDA jurisdiction, entered electronically, are forwarded to FDA through the Customs/FDA ACS interface. Informal entries not filed electronically are processed as paper entries. When an informal entry is sampled, Customs may be requested to convert it into a formal consumption entry.

In the case of imports by mail or personal baggage, FDA districts should arrange for coverage with their local Customs International Mail Office or border crossing office. This should include agreements designating who is responsible for coverage, when (how often), etc. Customs is responsible for examination of personal baggage. If an article subject to FDA review is encountered, the Customs officer will determine if it should be brought to the attention of the local FDA office. Personal importations meeting the criteria of a formal entry will be processed in accordance with normal non-electronic entries. Generally, since most personal importations are small in size and value, guidance has been developed for evaluating these importations. (See RPM Chapter "Coverage of Personal Importations".)

"Section 321 entries" for Customs are those entries with a value of $200 or less. Generally, this form of entry applies to articles which pass free of duty and tax, as defined in 19 C.F.R. 101.1(o), and imported by one person. Customs and FDA may conduct periodic "blitzes" to determine the volume and type of FDA-regulated merchandise admitted under "Section 321 entries." The use of the 321 entry process should not apply to multiple shipments covered by a single order or contract, sent separately for the express purpose of securing free entry and avoiding compliance with pertinent law or regulation.

FDA district offices generally receive notification of all formal and informal entries subject to FDA's jurisdiction at ports of entry located in its territory. However, through the use of Custom's Automated Commercial System and FDA's Operational and Administrative System for Import Support (ACS/OASIS) some electronic entries may be forwarded to off-site districts for processing during certain periods of time, i.e., late night coverage of air carrier hubs. The means of receiving notification for non-ABI/OASIS entries can be arranged through local Customs/FDA District agreements.

The most satisfactory and efficient means of getting notification is through FDA's OASIS system. Electronic entries processed through this system are electronically screened against criteria established by FDA for coverage. Automated Broker Interface (ABI) filers using the Customs ACS for cargo release are required to provide FDA information on entries subject to its jurisdiction submitted through ACS.

Customs' ACS uses guides established by each Federal agency to identify which commodities are subject to their jurisdiction. These guides are known as Other Government Agency (OGA) flags. FDA flags are identified as FD0, FD1 and FD2. FD0 indicates the article, even though subject to FDA regulation, may be released without further presentation of entry information to FDA. For entries flagged FD1, the commodity may or may not be subject to FDA regulation. The filer may, based on information received from the importer regarding the intended use of the commodity, specify the entry is not subject to FDA regulation and "Disclaim" the entry. Otherwise, FDA required information must be submitted. FDA review of "Disclaimed" entries is performed periodically to confirm the accuracy of the declaration. Entries covered by an FD2 flag must include FDA required information.

Electronic entries for Customs review includes all mandatory Customs entry required information, i.e., entry number, entry date, importer identification, port of entry, vessel/voyage information, filer identification, Harmonized Tariff System (HTS) code for product description, information on foreign shipper, country of origin, quantity, value, etc. Through the screening process in ACS, Customs determines if the article is subject to FDA examination (see OGA flag identifications above).

FDA's electronic screening of the Customs ABI/ACS entry requires the filer to provide the following information.

1. FDA product code. (FDA's product code is not the same as the HTS codes used for Customs screening purposes.)

2. The "Manufacturer's Identification" (MID) code (a Customs designation) of the foreign manufacturer. The MID consists, at a minimum, of the 2 letter identification of the foreign country, the name of the foreign firm, generally made up of the first three letters of the first and second names of the firm, where applicable. Up to 4 numbers, if present in the address, and the first three letters of the city where the firm is located. This code is subsequently transmitted to FDA's screen as the un-coded identified firm.

3. The MID information of the foreign shipper, including city and country. (Which may or may not be the same as the foreign manufacturer.) and

4. The country of origin. (Which may be different from the country of origin identified for Customs purposes.)

FDA has also established Affirmation of Compliance (AofC) codes which are designed to provide FDA reviewers with information concerning the imported article (example: medical device listing number). Use of the AofC is voluntary, and may or may not provide for a more expeditious screening of the entry.

In OASIS, the FDA forms identified as: "Notice of Sampling," "Release Notice," "Notice of Detention and Hearing," and "Notice of Refusal of Admission," are no longer issued as specific forms. OASIS generates a "Notice of FDA Action" providing information on the actions taken regarding a particular entry line. The notice identifies the specific line(s) of the entry, where appropriate, with the description of the sample collected or intended for sampling, specific line(s) identified as detained, and/or the specific line(s) identified as released, refused, etc. As the status changes for a particular line, a new "Notice of FDA Action" is issued to advise the appropriate individuals of the changes. The use of the designation "Product Collected by FDA," "Detained," "Released," "Refused," etc., or similar wording on the "Notice of FDA Action," meet the requirements of the wording of the law and regulation when applied to "giving notice thereof to the owner or consignee." See Exhibit 610-C.

OASIS notices are designed to be mailed to the addressees. A copy of each notice is produced with the filer, importer of record, and consignee on the addressee line. (If the same firm acts in one or more of those functions, only one copy is produced for the firm.) Notices are official documents which provide FDA decisions on entries. The distribution of the notices is made by FDA, not the filer, to ensure proper notification to the parties involved (i.e., FAX, express pick-up services, postal service, etc.). The intention is for FDA to distribute to the responsible firm without an intermediary.null

For electronic entry submissions, if the filer receives a message indicating FDA review, the filer will provide appropriate entry information to the FDA office having jurisdiction over the port of entry. For those entries submitted by paper, all appropriate entry documents should be included with the package sent to the local FDA office.

After evaluating the entry, if FDA decides to collect a sample, the appropriate individuals/firms will be provided with a Notice for Sampling and advised:

1. if the entry is to be held intact for FDA examination or sampling;
2. only those designated items need be held; etc.

For those ports where Customs does not maintain its ACS electronic entry process, and FDA does not generally cover the port under its normal operating schedule, the responsible FDA district office will coordinate coverage with the responsible Customs Port manager to assure FDA notification. If FDA decides to examine or sample articles being entered through such a port, Customs, the importer, and broker will notified.

Generally, for these entries, examination and/or sampling can take place at the point of destination. Under certain conditions, however, FDA may ask Customs to collect a sample at the point of entry for forwarding to the FDA servicing laboratory. Appropriate information on the entry, sample requirement, and requirements for holding the entry will be provided to the Customs officials and importer by the responsible district.

If no examination or sample is requested, FDA will notify Customs and the filer (who is responsible for notifying the importer, or other designated parties). This electronic notification is called a "May Proceed Notice," and indicates the shipment may proceed without further FDA examination. In the ACS/OASIS process, this may occur as a result of the initial FDA/OASIS screening, or after the district performs an "On-Screen-Review". (NOTE: Since the article is allowed entry without FDA examination, should the article, at a later time, be found in violation of the law, the Agency is not prevented from taking legal action because the article was allowed admission by FDA without examination at the time of importation. (See section 304(d) of the FD&C Act [21 USC 334(d)]).

If an examination or sample is requested, FDA notifies Customs, broker or filer, importer, or other designated parties, either through the electronic entry system or other form of notification, (Notice of FDA Action) to hold the entry, and will identify the specific product(s) to be sampled, etc.

When a sample is collected by FDA, a Notice of FDA Action is issued to the importer of record, consignee, and filer. If Customs collects the sample for FDA, the district will enter the entry information into OASIS and issue the Notice of FDA Action

For those entries where specific lines (items) of an entry are not sampled or examined, the Notice of FDA Action will be amended to indicate which lines (items) "May Proceed." (See RPM chapter "Notice of Sampling" for detailed guidance.)

The FDA will pay for all physical samples found in compliance or collected as an audit of private laboratory reports of analysis submitted to FDA in response to detention (See 21 CFR 1.91). (NOTE: This does not apply in the case of an audit sample collected to document reconditioning). See IOM 416.02 for guidance on sample costs.

Billing for reimbursement should be made to the FDA district office in whose territory the shipment was offered for import. FDA will not pay for a sample if the article is initially found to be in violation, even though it is subsequently released. For this reason, do not pay for samples at the time of collection.

Samples taken in connection with the supervision of a reconditioning are not paid for by FDA.

If the entry is still under control of the district inspection operations, and the sample collection can not be completed, the district may annotate the notice to the filer and importer no product was collected, and return the entry to the flier designating the entry "May Proceed." If the designated product was part of a multi-line entry where other products were collected, the notice issued for the other items sampled will be appropriately updated with the release of the product not sampled.

In the OASIS system, when a notice is issued for the collection or examination of a product, and neither operation is accomplished, the filer will be advised through a revised Notice indicating the article is given a "May Proceed" status. The system will print a status of "May Proceeded" in the Line Summary and also print a detail section "Lines Which May Proceed."

In OASIS, the following are definitions used to describe "May Proceed" or "Release" actions:

May Proceed: "Product may proceed without FDA examination. FDA has made no determination the product complies with all provisions of the Food, Drug, and Cosmetic Act, or other related acts. This message does not preclude action should the products later be found violative." (No compliance decision has been made.)

Release: "The product is released after FDA examination. This message does not constitute assurance the product complies with all provisions of the Food, Drug and Cosmetic Act, or other related Acts, and does not preclude action should the product later be found violative." (A compliance decision has been made.)

Districts will follow the appropriate guidance under each of the above procedures, according to their import operations.

If the shipment is found in compliance after examination, the importer of record, consignee (where applicable), filer, and Customs are notified with a Notice of Release. The shipment may be admitted. (See RPM chapter "Release Notices" for detailed guidance).null

If examination of the sample or other evidence indicates the article appears to be in violation, and detention is the course of action chosen by the district, the filer, owner and consignee, where applicable, are advised of such action by "Notice of Detention and Hearing." The Notice will specify the nature of the violation charged and designate a site for the owner or consignee (or authorized representative) to appear at a hearing. These hearings are informal meetings with the district, designed to provide the respondents an opportunity to present evidence supporting admissibility of the article. Ordinarily the respondents are allowed 10 working days to appear. However, if for some compelling reason the district determines ten (10) working days are insufficient, this time period may be extended. On the OASIS generated "Notice of FDA Action", this date is identified under the caption "Respond By". A copy of this Notice is also sent to Customs. (See RPM chapter "Notice of Detention and Hearing".)

Response to the Notice of Detention and Hearing may be made personally, by representative or by mail. The importer may present evidence supporting the admissibility of the article, request refusal of admission, propose an effective manner of reconditioning, or a method to remove the product from the authority of the Act.

FDA may authorize relabeling or other remedial action upon the timely submission of an "Application for Authorization to Relabel or To Perform Other Action," (FD Form 766 - See Exhibit 610-A). Application may also be made by letter and the execution of a good and sufficient bond by the owner or consignee (See section 801(b) of the FD&C Act [21 U.S.C. 381(b)]). The redelivery bond on file with the District Director of Customs for the particular importation applies to any re-labeling or other action authorized, and a new bond will not have to be filed.

After review of the application, FDA will notify the importer of its approval or disapproval. If approved the original application will be returned outlining the conditions to be fulfilled and the time limit within which to fulfill them will be noted. Notification to other parties will be made where appropriate. A copy will be retained in the district files. (See RPM chapter "Response to Notice of Detention and Hearing", and RPM chapter "Reconditioning" for detailed guidance).

After the re-labeling or reconditioning operation has been completed, the applicant will submit the "Importer's Certificate" (the reverse side of Form FDA 766, Exhibit 610-A) or advise the district reconditioning is complete. At this point, FDA may conduct a follow-up inspection and/or sampling to determine compliance with the terms of the authorization, or it may accept the statement from the importer with no further follow-up. The follow-up inspection and/or sampling may be made by FDA or Customs, depending on agreements between the district and the local Customs. The "Report of Inspector" (reverse side of FDA 766, Exhibit 610-A), or other appropriately completed summary of reconditioning, should be forwarded to the appropriate FDA office.

617.05 - Procedure When Conditions of Authorization Have Been Fulfilled

If the conditions of the authorization have been fulfilled, the district will notify the owner or consignee by Notice of Release. This notice is usually identified as "Originally Detained and Now Released." A copy is also sent to Customs and filer. Where there is a non-admissible portion (rejects), they must be destroyed or re-exported under FDA or Customs supervision. A Notice of Refusal of Admission should be issued for the rejected portion. FDA may include in its approval of the reconditioning a provision for the non-admissible portions (rejects) of the reconditioning to be destroyed and not exported.

617.06 - Procedure When Conditions of Reconditioning Have Not Been Fulfilled

If the conditions of the authorization have been fulfilled, the district will notify the owner or consignee by Notice of Release. This notice is usually identified as "Originally Detained and Now Released." A copy is also sent to Customs and filer. Where there is a non-admissible portion (rejects), they must be destroyed or re-exported under FDA or Customs supervision. A Notice of Refusal of Admission should be issued for the rejected portion. FDA may include in its approval of the reconditioning a provision for the non-admissible portions (rejects) of the reconditioning to be destroyed and not exported.

If the initial attempt at reconditioning is unsuccessful, a second attempt should not be considered unless a revised method of restoration shows reasonable assurance of success.

If the conditions of the authorization have not been fulfilled, a "Notice of Refusal of Admission" is issued to the importer, consignee, where applicable, to the filer, and to Customs.

617.07 - Procedure after hearing - "Notice of Release"

If the conditions of the authorization have been fulfilled, the district will notify the owner or consignee by Notice of Release. This notice is usually identified as "Originally Detained and Now Released." A copy is also sent to Customs and filer. Where there is a non-admissible portion (rejects), they must be destroyed or re-exported under FDA or Customs supervision. A Notice of Refusal of Admission should be issued for the rejected portion. FDA may include in its approval of the reconditioning a provision for the non-admissible portions (rejects) of the reconditioning to be destroyed and not exported.

If the initial attempt at reconditioning is unsuccessful, a second attempt should not be considered unless a revised method of restoration shows reasonable assurance of success.

If the conditions of the authorization have not been fulfilled, a "Notice of Refusal of Admission" is issued to the importer, consignee, where applicable, to the filer, and to Customs.

If, after presentation of testimony, the district determines the article should be released, the importer of record and consignee are issued a "Notice of Release". The Notice will declare the detained goods may be admitted. The Notice will also be identified "Originally Detained and Now Released" and, where appropriate, explain the reason for the change of action. A copy of the Notice is sent to Customs, and all parties receiving the Notice of Sampling/Notice of Detention. (See RPM chapter "Release Notices" for detailed guidance.)

617.08 - Procedure after hearing -

If the conditions of the authorization have been fulfilled, the district will notify the owner or consignee by Notice of Release. This notice is usually identified as "Originally Detained and Now Released." A copy is also sent to Customs and filer. Where there is a non-admissible portion (rejects), they must be destroyed or re-exported under FDA or Customs supervision. A Notice of Refusal of Admission should be issued for the rejected portion. FDA may include in its approval of the reconditioning a provision for the non-admissible portions (rejects) of the reconditioning to be destroyed and not exported.

If the initial attempt at reconditioning is unsuccessful, a second attempt should not be considered unless a revised method of restoration shows reasonable assurance of success.

If the conditions of the authorization have not been fulfilled, a "Notice of Refusal of Admission" is issued to the importer, consignee, where applicable, to the filer, and to Customs.

If, after presentation of testimony, the district determines the article should be released, the importer of record and consignee are issued a "Notice of Release". The Notice will declare the detained goods may be admitted. The Notice will also be identified "Originally Detained and Now Released" and, where appropriate, explain the reason for the change of action. A copy of the Notice is sent to Customs, and all parties receiving the Notice of Sampling/Notice of Detention. (See RPM chapter "Release Notices" for detailed guidance.)

When the importer requests the district issue a notice of refusal of admission, or the district decides the shipment still appears to be in violation, the importer, owner, and consignee where applicable, are issued a "Notice of Refusal of Admission." On this Notice, the charge(s) is stated exactly as shown on the original (or amended) Notice of Detention and Hearing. A copy of the Notice is also sent to Customs. (See RPM chapter "Notice of Refusal of Admission" for detailed guidance.)

The Notice of Refusal provides for the exportation or destruction of the shipment, under Customs supervision, within 90 days of the date of the notice, or within such additional time as specified by Customs Regulation. Under OASIS, the Notice will also contain language which includes reference to the requirement for redelivery, and contain all the above required information concerning the product and charge(s). The FDA file remains open until the district receives notification indicating the merchandise Was either destroyed or exported.

FDA is responsible for the protection of the U.S. public regarding foods, drugs, cosmetics, etc. until the violative article is either destroyed or exported.

617.09 - Payment of Costs of Supervision of Relabeling and/or Other Action

If the conditions of the authorization have been fulfilled, the district will notify the owner or consignee by Notice of Release. This notice is usually identified as "Originally Detained and Now Released." A copy is also sent to Customs and filer. Where there is a non-admissible portion (rejects), they must be destroyed or re-exported under FDA or Customs supervision. A Notice of Refusal of Admission should be issued for the rejected portion. FDA may include in its approval of the reconditioning a provision for the non-admissible portions (rejects) of the reconditioning to be destroyed and not exported.

If the initial attempt at reconditioning is unsuccessful, a second attempt should not be considered unless a revised method of restoration shows reasonable assurance of success.

If the conditions of the authorization have not been fulfilled, a "Notice of Refusal of Admission" is issued to the importer, consignee, where applicable, to the filer, and to Customs.

If, after presentation of testimony, the district determines the article should be released, the importer of record and consignee are issued a "Notice of Release". The Notice will declare the detained goods may be admitted. The Notice will also be identified "Originally Detained and Now Released" and, where appropriate, explain the reason for the change of action. A copy of the Notice is sent to Customs, and all parties receiving the Notice of Sampling/Notice of Detention. (See RPM chapter "Release Notices" for detailed guidance.)

When the importer requests the district issue a notice of refusal of admission, or the district decides the shipment still appears to be in violation, the importer, owner, and consignee where applicable, are issued a "Notice of Refusal of Admission." On this Notice, the charge(s) is stated exactly as shown on the original (or amended) Notice of Detention and Hearing. A copy of the Notice is also sent to Customs. (See RPM chapter "Notice of Refusal of Admission" for detailed guidance.)

The Notice of Refusal provides for the exportation or destruction of the shipment, under Customs supervision, within 90 days of the date of the notice, or within such additional time as specified by Customs Regulation. Under OASIS, the Notice will also contain language which includes reference to the requirement for redelivery, and contain all the above required information concerning the product and charge(s). The FDA file remains open until the district receives notification indicating the merchandise Was either destroyed or exported.

FDA is responsible for the protection of the U.S. public regarding foods, drugs, cosmetics, etc. until the violative article is either destroyed or exported.

After completion of the authorized relabeling or other action, FDA will submit a detailed statement of expenses incurred, including travel, per diem or subsistence, and supervisory charges, on an FDA 790 (See Exhibit 610-B, Charges for Supervision) of officers of employees of the FDA regarding the supervision of the authorized relabeling or other action to Customs National Finance Center. The expenses shall be computed on the following basis:

• Inspector's time
• Analyst's time
• Per diem allowance
• Travel other than by auto - actual cost of such travel
• Travel by auto (mileage, toll fees, etc.)
• Administrative support

Future enhancements to FDA import system may result in electronic processing of the supervisory charges submitted to Customs, in which case the FDA 790 will no longer be used. (See RPM chapter "Supervisory Charges" for detailed guidance.)

Customs, upon receipt of the charges for supervision, will send a notice for payment to the identified importer of record. The expenses shall include charges of supervision of destruction of the article or rejects. The remittance by the owner or consignee shall be to Customs. Payment of supervisory charges should not be accepted by FDA district offices.

617.10 - Exportation of Merchandise Refused Admission

If the conditions of the authorization have been fulfilled, the district will notify the owner or consignee by Notice of Release. This notice is usually identified as "Originally Detained and Now Released." A copy is also sent to Customs and filer. Where there is a non-admissible portion (rejects), they must be destroyed or re-exported under FDA or Customs supervision. A Notice of Refusal of Admission should be issued for the rejected portion. FDA may include in its approval of the reconditioning a provision for the non-admissible portions (rejects) of the reconditioning to be destroyed and not exported.

If the initial attempt at reconditioning is unsuccessful, a second attempt should not be considered unless a revised method of restoration shows reasonable assurance of success.

If the conditions of the authorization have not been fulfilled, a "Notice of Refusal of Admission" is issued to the importer, consignee, where applicable, to the filer, and to Customs.

If, after presentation of testimony, the district determines the article should be released, the importer of record and consignee are issued a "Notice of Release". The Notice will declare the detained goods may be admitted. The Notice will also be identified "Originally Detained and Now Released" and, where appropriate, explain the reason for the change of action. A copy of the Notice is sent to Customs, and all parties receiving the Notice of Sampling/Notice of Detention. (See RPM chapter "Release Notices" for detailed guidance.)

When the importer requests the district issue a notice of refusal of admission, or the district decides the shipment still appears to be in violation, the importer, owner, and consignee where applicable, are issued a "Notice of Refusal of Admission." On this Notice, the charge(s) is stated exactly as shown on the original (or amended) Notice of Detention and Hearing. A copy of the Notice is also sent to Customs. (See RPM chapter "Notice of Refusal of Admission" for detailed guidance.)

The Notice of Refusal provides for the exportation or destruction of the shipment, under Customs supervision, within 90 days of the date of the notice, or within such additional time as specified by Customs Regulation. Under OASIS, the Notice will also contain language which includes reference to the requirement for redelivery, and contain all the above required information concerning the product and charge(s). The FDA file remains open until the district receives notification indicating the merchandise Was either destroyed or exported.

FDA is responsible for the protection of the U.S. public regarding foods, drugs, cosmetics, etc. until the violative article is either destroyed or exported.

After completion of the authorized relabeling or other action, FDA will submit a detailed statement of expenses incurred, including travel, per diem or subsistence, and supervisory charges, on an FDA 790 (See Exhibit 610-B, Charges for Supervision) of officers of employees of the FDA regarding the supervision of the authorized relabeling or other action to Customs National Finance Center. The expenses shall be computed on the following basis:

• Inspector's time
• Analyst's time
• Per diem allowance
• Travel other than by auto - actual cost of such travel
• Travel by auto (mileage, toll fees, etc.)
• Administrative support

Future enhancements to FDA import system may result in electronic processing of the supervisory charges submitted to Customs, in which case the FDA 790 will no longer be used. (See RPM chapter "Supervisory Charges" for detailed guidance.)

Customs, upon receipt of the charges for supervision, will send a notice for payment to the identified importer of record. The expenses shall include charges of supervision of destruction of the article or rejects. The remittance by the owner or consignee shall be to Customs. Payment of supervisory charges should not be accepted by FDA district offices.Exportation of refused merchandise is done under Customs supervision. However, if after a reasonable time, FDA has not received notification of exportation or destruction, the district should investigate the status of disposition. Districts should also consider, under certain conditions, verifying the refused goods have been held intact pending exportation or destruction, or that re-export actually occurred. Guidance on refusals to be verified may change, based on the reason for detention.

617.11 - Bond Action

If the conditions of the authorization have been fulfilled, the district will notify the owner or consignee by Notice of Release. This notice is usually identified as "Originally Detained and Now Released." A copy is also sent to Customs and filer. Where there is a non-admissible portion (rejects), they must be destroyed or re-exported under FDA or Customs supervision. A Notice of Refusal of Admission should be issued for the rejected portion. FDA may include in its approval of the reconditioning a provision for the non-admissible portions (rejects) of the reconditioning to be destroyed and not exported.

If the initial attempt at reconditioning is unsuccessful, a second attempt should not be considered unless a revised method of restoration shows reasonable assurance of success.

If the conditions of the authorization have not been fulfilled, a "Notice of Refusal of Admission" is issued to the importer, consignee, where applicable, to the filer, and to Customs.

If, after presentation of testimony, the district determines the article should be released, the importer of record and consignee are issued a "Notice of Release". The Notice will declare the detained goods may be admitted. The Notice will also be identified "Originally Detained and Now Released" and, where appropriate, explain the reason for the change of action. A copy of the Notice is sent to Customs, and all parties receiving the Notice of Sampling/Notice of Detention. (See RPM chapter "Release Notices" for detailed guidance.)

When the importer requests the district issue a notice of refusal of admission, or the district decides the shipment still appears to be in violation, the importer, owner, and consignee where applicable, are issued a "Notice of Refusal of Admission." On this Notice, the charge(s) is stated exactly as shown on the original (or amended) Notice of Detention and Hearing. A copy of the Notice is also sent to Customs. (See RPM chapter "Notice of Refusal of Admission" for detailed guidance.)

The Notice of Refusal provides for the exportation or destruction of the shipment, under Customs supervision, within 90 days of the date of the notice, or within such additional time as specified by Customs Regulation. Under OASIS, the Notice will also contain language which includes reference to the requirement for redelivery, and contain all the above required information concerning the product and charge(s). The FDA file remains open until the district receives notification indicating the merchandise Was either destroyed or exported.

FDA is responsible for the protection of the U.S. public regarding foods, drugs, cosmetics, etc. until the violative article is either destroyed or exported.

After completion of the authorized relabeling or other action, FDA will submit a detailed statement of expenses incurred, including travel, per diem or subsistence, and supervisory charges, on an FDA 790 (See Exhibit 610-B, Charges for Supervision) of officers of employees of the FDA regarding the supervision of the authorized relabeling or other action to Customs National Finance Center. The expenses shall be computed on the following basis:

• Inspector's time
• Analyst's time
• Per diem allowance
• Travel other than by auto - actual cost of such travel
• Travel by auto (mileage, toll fees, etc.)
• Administrative support

Future enhancements to FDA import system may result in electronic processing of the supervisory charges submitted to Customs, in which case the FDA 790 will no longer be used. (See RPM chapter "Supervisory Charges" for detailed guidance.)

Customs, upon receipt of the charges for supervision, will send a notice for payment to the identified importer of record. The expenses shall include charges of supervision of destruction of the article or rejects. The remittance by the owner or consignee shall be to Customs. Payment of supervisory charges should not be accepted by FDA district offices.Exportation of refused merchandise is done under Customs supervision. However, if after a reasonable time, FDA has not received notification of exportation or destruction, the district should investigate the status of disposition. Districts should also consider, under certain conditions, verifying the refused goods have been held intact pending exportation or destruction, or that re-export actually occurred. Guidance on refusals to be verified may change, based on the reason for detention.

Under the provisions of the FD&C Act (section 801(b) of the FD&C Act [21 U.S.C. 381(b)]) and Customs regulations (19 CFR 113.62) a bond is required for all conditionally released articles offered for importation. This bond provides relief to the government on the default of the conditions of the bond and the payment of liquidated damages in the amount specified in Customs notice of assessment of liquidated damages for failure to redeliver such merchandise.

Bond actions are taken when an entry is distributed prior to FDA release and can not be redelivered, or when an article has been detained and refused and the article is not destroyed or exported in accordance with the requirements of the law.

If district has evidence the entry, or any portion of an entry subject to FDA jurisdiction, was disposed of in violation of the terms of the appropriate Act, or its regulations, or of the terms of the bond, (see 19 CFR Section 113.62(k)) they should immediately contact the appropriate Customs office.

The district, upon receiving evidence the refused article was not exported or destroyed should immediately investigate the matter. Send a detailed statement showing the importer's liability under the redelivery bond or other applicable customs bond to the responsible Customs office. If the facts warrant, and the article was under detention, and the Notice of Refusal of Admission has not been issued, immediately issue a Notice of Refusal to the owner or consignee, with a copy to Customs.

Upon the receipt of an application for relief (appeal for Mitigation or Cancellation of Assessed Liquidated Damages) Customs may agree to mitigate the amount of damages. However, in cases involving FDA merchandise, Customs does not usually mitigate unless FDA is in full agreement with the action [see 21 CFR section 1.97(b)]. It is FDA's policy to always seek 100% penalty. (See RPM chapter "Bond Actions" for detailed guidance.)

Page Top Previous Page | Document TOC | Chapter TOC | Next Page