Contents

SUBCHAPTER 950 - SURVEILLANCE

950 - SURVEILLANCE PROCEDURES

Instructions for planned surveillance activities are found in your Compliance Program Guidance Manual. During your inspectional, investigational, and other activities, be alert to anything which may be new or unusual or interesting from FDA's viewpoint such as:

1. New firms;
2. New products;
3. New production and distribution practices;
4. New equipment and industrial processes;
5. Seasonal practices;
6. Industry trends;
7. Recent or on-going construction and plans for future expansion;
8. Proposed products;
9. New ideas the firm is contemplating;
10. New products in the development stage;
11. Activities about a firm's competitor;
12. Plans for consolidation, mergers, diversification, etc.;
13. Equipment failures or malfunction possibly affecting other firms, faulty design of equipment, incompatibility of ingredients, faulty process design, equipment manufacturers' recommendations which violate proper manufacturing precautions, health fraud (quackery), etc.
14. Health Fraud (Quackery) is defined as "the deceptive promotion, advertisement, distribution or sale of articles, intended for human or animal use, which are represented as effective to diagnose, prevent, cure, treat or mitigate disease, or provide a beneficial effect on health, but which have not been scientifically proven safe and effective for such purposes." See CPG: Chapter 1.

Use the FDA-457, Product/Establishment Surveillance Report, to report any of the items listed above. Include any other ideas/observations you may consider worthy of reporting. FDA must keep abreast of new ideas, trends, or contemplated changes in the industries we regulate as well as problems with possible broad impact.

951 - FDA 457 PREPARATION

Report product or establishment surveillance on the FDA 457, Product/Establishment Surveillance Report, and submit it to your supervisor. See IOM Exhibit 960-A. Prospective new establishments must be verified for appropriateness before inclusion in the active FEI. See Field Management Directive (FMD) 130.

Complete blocks 1 through 18 and 22 through 26 of the FDA 457 for product surveillance or blocks 1,6, 8 through 10, and 18 through 26 of the FDA 457 for establishment surveillance. Your supervisor or reviewing official will complete blocks 27 through 30. For a human drug firm or product which has not actually entered the market, enter the information in the REMARKS Section.

The following number designations correspond to identically numbered blocks on the FDA 457.

1. "HOME DISTRICT" - Enter the name of the home district of the new firm or firm producing the product reported. See IOM 702 for definition of home district.
2. "REPORTING UNIT SYMBOL" - Enter your district symbol here, e.g., " ATL-DO", "BOS-DO", "LOS-DO", etc. If units other than field units report on the form, their mailing symbol goes here.
3. "CENTRAL FILE NO." - Enter the central file number if readily available. Otherwise, leave blank.
4. " J.D./T.A." - Leave blank.
5. "COUNTY" - Leave blank.
6. "DATE" - Enter date you prepare the FDA 457.
7. "PRODUCT CODE" - Enter the 7-character Product Code from the Data Codes Manual.
8. "OPERATION" - Enter operation code from the Data Codes Manual. For surveillance it is 13.
9. "PROGRAM ASSIGNMENT CODE" - Enter the Program/Assignment Code (PAC) from the Data Codes Manual.
10. "HOURS" - Enter the time spent on this operation, including time for preparing the report, through FACTS. Report time to the nearest 1/4 hour in fractions, not decimals. Do not report travel time.
11. " IDENTIFICATION" - Enter the generic name of the product and quote enough of the label to properly identify the item, including the firm name and address.
12. "MANUFACTURER CONTROL CODES" - Enter all codes, lot numbers, batch codes, etc., found on the containers, labels, wrappers, packages, cases, etc. and indicate whether the number is located on the label, containers, case, etc.
13. "AMOUNT ON HAND" - List lot size (amount of the products) on hand or available. If count cannot be made, make an estimate and so indicate.
14. "DATE LOT RECEIVED" - Determine & enter the date the dealer received the lot(s).
15. "ESTIMATED VALUE" - This is the invoice value of the amount on hand at the time you observed it. Estimate, if not readily available.
16. "SAMPLE NO(s)" - Enter sample number(s) of any relevant samples collected. If no samples are collected, enter "None".
17. "DEALER" - List name and complete address including the ZIP code of dealer who owns or has custody of the product.
18. "DISTRIBUTOR MANUFACTURER SHIPPER OTHER" - Check applicable box or boxes and list name, complete address, ZIP code and telephone number, including area code.
19. "ESTABLISHMENT TYPES/INDUSTRY CODES" - Enter up to three establishment types with up to six industry codes each for the establishment.
20. "ESTABLISHMENT SIZE" - Enter gross dollar value of the annual production of all FDA regulated products made or manipulated in the establishment.
21. "INFORMATION OBTAINED BY" - Check the applicable box to indicate how the FEI information was obtained.
22. "REMARKS" - Enter explanatory information here.
23. "REPORT PREPARED BY" - Type or print your name and title.
24. "EMPL NO." - Enter your employee number.
25. "PC" - Enter your Position Classification code.
26. "SIGNATURE" - Enter usual signature.
27. "REPORTING UNIT ACTION" - Your supervisor or reviewing official completes this section by checking the applicable box.
28. "NAME OF REVIEWING OFFICIAL" - Typed or printed name of person reviewing the report.
29. "TITLE" - Title of reviewing official.
30. "DATE REVIEWED" - The reviewing official enters date report was reviewed.

Complete reverse side of the FDA 457 by checking the appropriate box(s).

952 - FDA 457 ROUTING

Submit all FDA 457's to your supervisor for review, assignment, or routing as indicated:

1. Human Drug Surveillance - Submit a copy of the FDA 457 to the Center For Drug Evaluation & Research (HFD-323).
2. Veterinary Drug Surveillance - Submit a copy of the FDA 457 to the Center for Veterinary Medicine, (HFV-236).
3. Device Surveillance - Submit a copy of the FDA 457 to the Office of Medical Devices (HFZ-331).
4. Foods Surveillance - Submit a copy of the FDA 457 to the home district.
5. Other Products - Submit a copy of the FDA 457 to the home district.

SUBCHAPTER 960 - INVESTIGATIONAL RESEARCH

961 - RESEARCH ASSIGNMENTS

"Investigational Research" is investigation to discover and interpret facts, or to revise accepted theories and practices in the light of new facts, to improve investigational operations.

Investigational Research may be proposed by you, or assigned by your supervisor, and must be submitted for approval on the FDA 1609, Research Project Record. To formally propose research, complete this form and submit the original and two copies to your supervisor. After branch approval, original is retained by the branch research coordinator; one copy to the researcher; and one copy to HFC-132. Approval authority, except for research under the Science Advisor Research Associate Program (SARAP), is at the branch director level. SARAP projects are considered on a competitive basis and approved at headquarters. Investigational personnel are eligible to compete for SARAP approvals. Instructions and conditions for SARAP proposals are provided in the "ORO Research Programs" booklet.

Numerical and alpha listings of active laboratory and investigational research projects will be computer generated at headquarters and supplied to the districts on a semi-annual basis. To prevent duplications, check these listings (in possession of the science branch research coordinator) prior to proposing projects.

962 - JOINT RESEARCH PROJECTS

Project proposals involving significant analytical requirements must be approved in advance by the appropriate laboratory. Whenever investigational research requires analysis of samples, consider submitting a joint investigational/laboratory project proposal and final report. In these instances, request your supervisor to assist in arranging such joint projects.

When proposed research projects involve engineering assistance beyond that which is available within the district, request this through your supervisor from the Domestic Operations Branch/Division of Field Investigations (HFC-130). DFI Engineers may be available to assist on a specific short term basis, and to work with field investigators on joint projects, or may initiate investigational research independently.

963 - RESEARCH PROJECT IDENTIFICATION CODE

964 - RESEARCH PROJECT PROGRESS REPORTS

You must submit semi-annual progress reports for each ongoing research project. Each researcher shall initiate this form for each active project in April and October to reach DFI (HFC-130) by April 15th and October 15th respectively.

965 - TERMINATION OF RESEARCH PROJECTS

Report project termination on FDA 1609 and FDA 1609a. Enter a summary of the completed project on the FDA 1609, including actions taken and publication, if any. If a paper has been prepared for publication, include the abstract.

The complete project report, with supporting data, may be on plain-paper continuation sheets to the FDA 1609, or may be a separate memorandum attached to the FDA 1609. Submit FDA 1609a to accompany a termination FDA 1609, to summarize the concluding semi-annual period of work on the project and to report final time expenditures. The minimum number of termination forms and project report copies is original plus two. After branch action, original is retained by the branch research coordinator; one copy by researcher; and one copy by HFC-130.

966 - PRIORITY

967 - DATA REPORTING

Investigational research time is reported into FACTS under the Miscellaneous Operations Accomplishment Hours screen (available under navigate on the tool bar), using a distinctive Program/Assignment Code (PAC), reporting as Operation 01, Research.

If laboratory personnel are working on investigational research projects, follow laboratory procedures for reporting time, while using the Investigational Research Project Identification Code.