I. AGENCY Food and Drug Administration (FDA)

REPORT PREPARED BY Barbara J. Schulman

TITLE Consumer Safety Officer/Freedom of Information (FOI) Staff

ADDRESS 5600 Fishers Lane (HFI-35), Rockville, MD 20857

PHONE NUMBER (301) 827-6500

ELECTRONIC ADDRESS FOR REPORT ON THE WORLD WIDE WEB: www.fda.gov/foi/foia2.htm

ADDRESS FOR PAPER COPIES OF REPORT:

Food and Drug Administration
Freedom of Information Staff
5600 Fishers Lane, HFI-35, Room 12A-16
Rockville, MD 20857

II. HOW TO MAKE A FOIA REQUEST: refer to: www.fda.gov/opacom/backgrounders/foiahand.html Select "Handbook for Requesting Information and Records from FDA"

A. Names, addresses, and telephone numbers of all individual agency components and offices that process FOIA requests:

Refer to attachment

B. Brief description of agency's response time range(s):

FY 98 response time ranged from a median of 22 days for simple requests to 51 days for complex requests. The median processing time for single track requests was 30 days.

C. Brief description of why some requests are not granted:

Some requests were not granted because documents requested were protected by an exemption and release would have caused harm to the interest protected by the exemption.

III. DEFINITIONS OF TERMS AND ACRONYMS USED IN REPORT:

A. Agency-specific acronyms or other terms:

N/A

B. Basic terms:

1. FOIA/PA request -- Freedom of Information Act/Privacy Act request. A FOIA request is generally a request for access to records concerning a third party, an organization, or a particular topic of interest. A Privacy Act request is a request for records concerning oneself: such requests are also treated as FOIA requests.

2. Initial Request -- a request to a federal agency for access to records under the Freedom of Information Act.

3. Appeal -- a request to a federal agency asking that it review at a higher administrative level a full denial or partial denial of access to records under the Freedom of Information Act, or any other FOIA determination such as a matter pertaining to fees.

4. Processed Request or Appeal -- a request or appeal for which an agency has taken a final action on the request or the appeal in all respects.

5. Multi-track processing -- a system in which simple requests requiring relatively minimal review are placed in one processing track and more voluminous and complex requests are placed in one or more other tracks. Requests in each track are processed on a first-in/first-out basis. A requester who has an urgent need for records may request expedited processing (see below).

6. Expedited processing -- an agency will process a FOIA request on an expedited basis when a requester has shown an exceptional need or urgency for the records which warrants prioritization of his or her request over other requests that were made earlier.

7. Simple request -- a FOIA request that an agency using multi-track processing places in its fastest (nonexpedited) track based on the volume and/or simplicity of records requested.

8. Complex requests -- a FOIA request that an agency using multi-track processing places in a slower track based on the volume and/or complexity of records requested.

9. Grant -- an agency decision to disclose all records in full in response to a FOIA request.

10. Partial grant -- an agency decision to disclose a record in part in response to a FOIA request, deleting information determined to be exempt under one or more of the FOIA's exemptions; or a decision to disclose some records in their entireties, but to withhold others in whole or in part.

11. Denial -- an agency decision not to release any part of a record or records in response to a FOIA request because all the information in the requested records is determined by the agency to be exempt under one or more of the FOIA's exemptions, or for some procedural reason.

12. Time limits -- the time period in the Freedom of Information Act for an agency to respond to a FOIA request (ordinarily 20 working days from proper receipt of a "perfected" FOIA request).

13. Exemption 3 statute -- a separate federal statute prohibiting the disclosure of a certain type of information and authorizing its withholding under FOIA subsection (b)(3).

14. Median number -- the middle, not average, number. For example, of 3, 7 and 14, the median number is 7.

IV. EXEMPTION 3 STATUTES:

A. List of Exemption 3 statutes relied on by the agency during report year:

National Defense Authorization Act (41 U.S.C. 253b(m))

1. Brief description of type(s) of information withheld under each statute:
Contractor Proposals

2. Has a court upheld the use of each statute? If so, cite example:
No

V. INITIAL FOIA/PA ACCESS REQUESTS:

A. Numbers of initial requests:

1. Number of requests pending at close of preceding fiscal year: 16,704
2. Number of requests received during reporting fiscal year: 36,140
3. Number of requests processed during reporting fiscal year: 39,025
4. Number of requests pending at close of reporting fiscal year: 13,819

B. Disposition of Initial Requests:

1. Number granted in full 32,082
2. Number granted in part 8
3. Number of full and partial denials 213

a. Number of times each FOIA exemption was used:

Exemption 1	0
Exemption 2	0
Exemption 3	3
Exemption 4	126
Exemption 5	9
Exemption 6	7
Exemption 7(A)	64
Exemption 7(B)	0
Exemption 7(C)	10
Exemption 7(D)	9
Exemption 7(E)	0
Exemption 7(F)	0
Exemption 8	0
Exemption 9	0

4. Other reasons for non-disclosure (total) 6722

a. no records 2085
b. referrals 83
c. request withdrawn 2953
d. fee-related reason 30
e. records not reasonably described 9
f. not a proper FOIA request for some other reason 1203
g. not an agency record 3
h. duplicate request 181
i. other (specify) 175 (e.g., information that was requested is available on the Internet)

VI. APPEALS OF INITIAL DENIALS OF FOIA/PA REQUESTS:

A. Number of Appeals: _______

(Appeal authority for FDA denials is the Deputy Assistant Secretary for Public Affairs (Media), Department of Health and Human Services (HHS). Information about FDA appeals will be included in the Annual FOIA Report for HHS.)

1. Number of appeals received during the fiscal year _______
2. Number of appeals processed during the fiscal year ______

B. Disposition of Appeals: ______

1. Number completely upheld _______
2. Number partially reversed ________
3. Number completely reversed ______

a. Number of times each FOIA exemption used

Exemption 1
Exemption 2
Exemption 3
Exemption 4
Exemption 5
Exemption 6
Exemption 7(A)
Exemption 7(B)
Exemption 7(C)
Exemption 7(D)
Exemption 7(E)
Exemption 7(F)
Exemption 8
Exemption 9

4. Other reasons for non-disclosure (total) _______

a. no records
b. referrals
c. request withdrawn
d. fee-related reason
e. records not reasonably described
f. not a proper FOIA request for some other reason
g. not an agency record
h. duplicate request
i. other (specify)

VII. COMPLIANCE WITH TIME LIMITS/STATUS OF PENDING REQUESTS:

A. Median Processing Time for Requests Processed During the Year

1. Simple Requests (if multiple tracks used):

a. number of requests processed 13,503
b. median number of days to process 22

2. Complex Requests:

a. number of requests processed 576
b. median number of days to process 51

3. Requests Accorded Expedited Processing:

a. number of requests processed 1
b. median number of days to process 11

4. Single Track

a. number of requests processed 24,945
b. median number of days to process 30

B. Status of Pending Requests

1. Number of requests pending as of the end of the fiscal year covered in this report 13,819
2. Median number of days that such requests were pending as of that date 194

VIII. COMPARISONS WITH PREVIOUS YEAR(S) (Optional)

IX. COSTS/FOIA STAFFING:

A. Staffing levels:

1. Number of full-time FOIA personnel 68
2. Number of personnel with part-time or occasional FOIA duties (in total work-years) 45.31 work years
3. Total number of personnel (in work years) 113.31 work years

B. Total costs (including staff and all resources):

1. FOIA processing (including appeals) $8,157,218
2. Litigation-related activities (estimated) $5,000
3. Total costs $8,162,218
4. Comparison with previous year(s) (including percentage of change)

There was a 17% increase in the total costs for FOI activities for FY98 compared to the nine month reporting period for 1997 (The nine month report was a result of the transition from a calendar year report to a fiscal year report). While there was a 16% decrease in the number of FOI requests received, the increase in costs is attributed to the cost incurred implementing the Electronic FOI Act of 1996.

X. FEES:

A. Total amount of fees collected by agency for processing requests: $821,960
B. Percentage of total costs: 10%

XI. FOIA REGULATIONS:

FDA's FOIA regulations are contained in 21 CFR Part 20 and may be viewed on the Internet in FDA's Electronic Reading Room at: www.fda.gov/opacom/backgrounders/foiahand.html. Scroll to "Obtaining Information from FDA" and click on the site, 21 CFR Part 20.

*Address all FOIA correspondence to the Freedom of Information Staff at address given above.

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