FISCAL YEAR (FY) 2000
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.htmADDRESS 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" III. DEFINITIONS OF TERMS AND ACRONYMS USED IN REPORT:
- Names, addresses, and telephone numbers of all individual agency components and offices that process FOIA requests:
Refer to attachment
- Brief description of agency's response time range(s):
FY 00 response time ranged from a median of 11 days for simple requests to 65.5 days for complex requests. The median processing time for single track requests was 26.5 days.
- 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.
- Agency-specific acronyms or other terms:
N/A
- Basic terms:
- 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.
- Initial Request -- a request to a federal agency for access to records under the Freedom of Information Act.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
- Grant -- an agency decision to disclose all records in full in response to a FOIA request.
- 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.
- 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.
- 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).
- 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).
- Median number -- the middle, not average, number. For example, of 3, 7 and 14, the median number is 7.
IV. EXEMPTION 3 STATUTES:
- List of Exemption 3 statutes relied on by the agency during report year:
None
- Brief description of type(s) of information withheld under each statute:
- Has a court upheld the use of each statute? If so, cite example:
V. INITIAL FOIA/PA ACCESS REQUESTS:
A. Numbers of initial requests:
1. Number of requests pending at close of  preceding fiscal year: 12,655 2. Number of requests received during reporting  fiscal year: 25,011 3. Number of requests processed during reporting  fiscal year: 24,040 4. Number of requests pending at close of  reporting fiscal year: 13,626
B. Disposition of Initial Requests:
1. Number granted in full 18,354 2. Number granted in part 147 3. Number of full and partial denials 231 VI. APPEALS OF INITIAL DENIALS OF FOIA/PA REQUESTS: a. Number of times each FOIA exemption was used: Exemption 1 0 Exemption 2 2 Exemption 3 0 Exemption 4 87 Exemption 5 9 Exemption 6 7 Exemption 7(A) 128 Exemption 7(B) 0 Exemption 7(C) 13 Exemption 7(D) 11 Exemption 7(E) 2 Exemption 7(F) 0 Exemption 8 0 Exemption 9 0 4. Other reasons for non-disclosure  (total) 5,455 a. no records 2,435 b. referrals 49 c. request withdrawn 1883 d. fee-related reason 104 e. records not reasonably described 2 f. not a proper FOIA request for some other reason 403 g. not an agency record 2 h. duplicate request 296 i. other (specify) 281 (e.g., information that was requested is available on the Internet)
- Number of Appeals:
1. Number of appeals received during the fiscal year 2. Number of appeals processed during the fiscal year B. Disposition 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.) VII. COMPLIANCE WITH TIME LIMITS/STATUS OF PENDING REQUESTS: 1. Number completely upheld 2. Number partially reversed 3. Number completely reversed
- 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) A. Median Processing Time for Requests Processed During the Year 1. Simple Requests (if multiple tracks used): a. number of requests processed 12,671 b. median number of days to process 11 2. Complex Requests: a. number of requests processed 896 b. median number of days to process 65.5 3. Requests Accorded Expedited Processing: a. number of requests processed 1 b. median number of days to process 3 4. Single Track a. number of requests processed 10,472 b. median number of days to process 26.5 B. Status of Pending Requests Number of requests pending as of the end of the fiscal year covered in this report 13,626 Median number of days that such requests were pending as of that date 188 VIII. COMPARISONS WITH PREVIOUS YEAR(S) (Optional) IX. COSTS/FOIA STAFFING: A. Staffing levels: 1. Number of full-time FOIA personnel 75 2. Number of personnel with part-time or occasional FOIA duties (in total work-years) 16.72 work years 3. Total number of personnel (in work years) 91.72 work years B. Total costs (including staff and all resources): 1. FOIA processing (including appeals) $6,576,036 2. Litigation-related activities (estimated) $150,000 3. Total costs $6,726,036 4. Comparison with previous year(s) (including percentage of change). There was an 8% decrease in the total costs for FOI activities for FY00 compared to FY99. There was a 10% decrease in the number of FOI requests received. X. FEES: A.Total amount of fees collected by agency for processing requests: $703,142 B. Percentage of total costs: 10.5% 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.
FDA HEADQUARTERS COMPONENT FREEDOM OF INFORMATION/PRIVACY ACT OFFICERS AND CONTACTS
*Address all FOIA correspondence to the Freedom of Information Staff at address given above.
Office of Chief Counsel |
Office of Administrative Law Judge |
Office of the Ombudsman |
Office of Women's Health |
Office of Internal Affairs |
Office of Special Health Issues |
Office of Tobacco Programs |
Office of Equal Opportunity |
Office of Policy |
Office of International and Constituent Relations |
Office of Science |
Office of Orphan Products Development |
Office of the Commissioner and Executive Secretariat |
Office of Executive Operations |
Office of Information Resources Management |
Office of Financial Management |
Office of Facilities & Central Services |
Division of Information Services and Policy |
Division of Management Programs |
Dockets Management Branch |
Committee Management |
Office of Human Resources and |
Division of Contracts and Procurement |
Office of Regulatory Affairs |
Office of Criminal Investigations |
Center for Drug Evaluation
and Research |
Office of Consumer Affairs |
Office of International Affairs |
Office Public Affairs |
Center for Biologics Evaluation and Research |
Office of Planning |
Center for Food Safety and
Applied Nutrition |
National Center for
Toxicological Research |
Center for Veterinary Medicine |
Office of Legislation |
Center for Devices and
Radiological Health |
FDA DISTRICT FREEDOM OF INFORMATION/
PRIVACY ACT OFFICERS AND CONTACTS
November 2000
Food and Drug Administration Staff
Freedom of Information Staff
5600 Fishers Lane, HFI-35, Rm 12A-16
Rockville, MD 20857
Telephone (301) 827-6500
Fax (301) 443-1726
Confirm Fax Received (301) 443-2414
*Address all FOIA correspondence to the Freedom of Information Staff.
DISTRICT OFFICES * |
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NEW YORK DISTRICT 158-15 Liberty Avenue Jamaica, New York 11423 (718) 340-7000 |
PHILADELPHIA DISTRICT U.S. Customhouse 2nd and Chestnut Streets, Room 900 Philadelphia, Pennsylvania 19106 (215) 597-4390 |
SAN FRANCISCO DISTRICT 1431 Harbor Bay Parkway Alameda, California 94502-7070 (510) 337-6700 |
SAN JUAN DISTRICT 466 Fernandez Juncos Avenue Puerto de Tierra San Juan, Puerto Rico 00901-3223 (787) 729-6894 |
SEATTLE DISTRICT 2201 23rd Drive, S.E. Bothell, Washington 98041-3012 (425) 486-8788 |
ST. LOUIS BRANCH 12 Sunnen Drive, Suite 122 St. Louis, Missouri 63143 (314) 645-1167 |
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