Regulatory Information
Freedom of Information Annual Report 2005
I. AGENCY Food and Drug Administration (FDA)
REPORT PREPARED BY Garfield Daley
TITLE FOI Specialist/Division of Freedom of Information (DFOI)
ADDRESS 5600 Fishers Lane (HFI-35), Rockville, MD 20857
PHONE NUMBER (301) 827-6500
ELECTRONIC ADDRESS FOR REPORT ON THE WORLD WIDE WEB:
http://www.fda.gov/RegulatoryInformation/FOI/FOIAAnnualReports/default.htm
ADDRESS FOR PAPER COPIES OF REPORT:
Food and Drug Administration
Division of Freedom of Information
5600 Fishers Lane, HFI-35, Room 6B-05
Rockville, MD 20857
II. HOW TO MAKE A FOIA REQUEST: refer to: http://www.fda.gov/RegulatoryInformation/FOI/HowtoMakeaFOIARequest/default.htm "Handbook for Requesting Information and Records from FDA"
- 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 05 response time ranged from a median of 26 days for simple requests to 390 days for complex requests. The median processing time for single track requests was 86 days. There were two (2) expedited requests processed for FY 05. - 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:
- 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:
A. List of Exemption 3 statutes relied on by the agency during report year:
a. Ethics in Government Act (5 U.S.C. 107(a)(2) Appendix 4)
b. Public Health and Bioterrorism Preparedness and Response Act of 2002, Section 415 (a)(4) (5 U.S.C 55 (b)(3).1. Brief description of type(s) of information withheld under each statute:
a. Confidential Financial Disclosure Reports
b. Food Registration Documents2. Has a court upheld the use of each statute? If so, cite example:
a. Yes. Meyerhoff v. EPA, 958 F.2nd 1498 (9th Cir 1992)
b. No
V. INITIAL FOIA/PA ACCESS REQUESTS:
A. Numbers of initial requests:
- Number of requests pending at close of preceding fiscal year: 16,671
- Number of requests received during reporting fiscal year: 19,233
- Number of requests processed during reporting fiscal year: 18,535
- Number of requests pending at close of reporting fiscal year: 17,369
B. Disposition of Initial Requests:
- Number granted in full 14,235
- Number granted in part 39
- Number of full denials 37
Exemption 1 | 0 |
---|---|
Exemption 2 | 4 |
Exemption 3 | 5 |
Exemption 4 | 44 |
Exemption 5 | 8 |
Exemption 6 | 17 |
Exemption 7(A) | 20 |
Exemption 7(B) | 0 |
Exemption 7(C) | 5 |
Exemption 7(D) | 2 |
Exemption 7(E) | 1 |
Exemption 7(F) | 0 |
Exemption 8 | 0 |
Exemption 9 | 0 |
4. Other reasons for non-disclosure (total) 4,224
a. no records 1109
b. referrals 35
c. request withdrawn 1916
d. fee-related reason 454
e. records not reasonably described 0
f. not a proper FOIA request for some other reason 191
g. not an agency record 0
h. duplicate request 249
i. other (specify) 270
(e.g., information that was requested is available on the Internet)
VI. APPEALS OF INITIAL DENIALS OF FOIA/PA REQUESTS:
- 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 N/A
2. Number of appeals processed during the fiscal year N/A
B. Disposition of Appeals:
- Number completely upheld N/A
- Number partially reversed N/A
- Number completely reversed N/A
Exemption 1 | N/A |
---|---|
Exemption 2 | N/A |
Exemption 3 | N/A |
Exemption 4 | N/A |
Exemption 5 | N/A |
Exemption 6 | N/A |
Exemption 7(A) | N/A |
Exemption 7(B) | N/A |
Exemption 7(C) | N/A |
Exemption 7(D) | N/A |
Exemption 7(E) | N/A |
Exemption 7(F) | N/A |
Exemption 8 | N/A |
Exemption 9 | N/A |
4. Other reasons for non-disclosure (total) N/A
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 15,539
b. median number of days to process 26
2. Complex Requests:
a. number of requests processed 1,987
b. median number of days to process 390
3. Requests Accorded Expedited Processing:
a. number of requests processed 2
b. median number of days to process 52
4. Single Track
a. number of requests processed 1,007
b. median number of days to process 86
B. Status of Pending Requests
1. Number of requests pending as of the end of the fiscal year covered in this report 17,369
2. Median number of days that such requests were pending as of that date 261
VIII. COMPARISONS WITH PREVIOUS YEAR(S) (Optional)
IX. COSTS/FOIA STAFFING:
A. Staffing levels:
1. Number of full-time FOIA personnel 71
2. Number of personnel with part-time or occasional FOIA duties (in total work-years) 14.90 work years
3. Total number of personnel (in work years) 85.90 work years
B. Total costs (including staff and all resources):
1. FOIA processing (including appeals) $11,133,436
2. Litigation-related activities (estimated) $487,314
3. Total costs $11,620,750
4. Comparison with previous year(s) (including percentage of change)
There was a 9% increase in the total costs for FOI activities for FY05 compared to FY04. There was a 3.0% decrease in the number of FOI requests received.
X. FEES:
- Total amount of fees collected by agency for processing requests: $392,145
- Percentage of total costs: 3.3%
XI. FOIA REGULATIONS:
FDA's FOIA regulations are contained in 21 CFR Part 20 and may be viewed on the Internet in FDA's Reference Materials at: http://www.fda.gov/RegulatoryInformation/FOI/ReferenceMaterials/default.htm click on the site, 21 CFR Part 20.
FDA HEADQUARTERS COMPONENT FREEDOM OF INFORMATION/PRIVACY ACT OFFICERS AND CONTACTS
Food and Drug Administration Staff
Division of Freedom of Information (DFOI)
5600 Fishers Lane, Parklawn (PKLN) Building
HFI-35, Room 6-30
Rockville, MD 20857
Telephone (301) 827-6500
Fax (301) 443-1726
Confirm Fax Received (301) 443-2414
*Address all FOIA correspondence to the Division of Freedom of Information at address given above.
Component FOIA Offices* |
Office of Chief Counsel (301) 827-1187 Pkln, Room 6-05 |
Advisory Committee Oversight & Management Staff (301) 827-1220 Pkln, Room 15A-12 |
Office of the Ombudsman (301) 827-3390 Pkln, Room 13B-03 |
Office of Women's Health (301) 827-0350 Pkln, Room 16-65 |
Office of Internal Affairs One Church Street, Church Building Room 700 Rockville, MD 20850 (301) 827-0243 |
Office of External Relations (301) 827-4402 Pkln, Room 14-89 |
Office of Special Health Issues (301) 827-4460 Pkln, Room 9-49 |
Office of Equal Opportunity (301) 827-4840 Pkln, Room 8-72 |
Office of Policy (301) 827-3360 Pkln, Room 14-101 |
Office of Science (301) 827-3038, Pkln, Room 17-51 |
Office of Orphan Products Development (301) 827-3666 Pkln, Room 6A-55 |
Office of the Commissioner and Executive Secretariat (301) 827-4550 Pkln, Room 16-70 |
Office of Executive Operations (301) 827-4450 Pkln, Room 11-101 |
Office of the Chief Information Officer/Strategy & Planning Staff (301) 827-0964 Pkln, Room 16B-42 |
Office of Financial Management (301) 827-5001 Pkln, Room 11-61 |
Office of Real Property 5630 Fishers Lane, Room 1011 Rockville, MD 20857 (301) 827-7056 |
Paperwork Reduction Act & Records Management Branch (301) 827-1481 Pkln, Room 4B-41 |
Ethics & Integrity Staff (301) 827-5511 Pkln, Room 4-72 |
Division of Dockets Management 5630 Fishers Lane, Room 1061 Rockville, MD 20857 (301) 827-6860 |
Office of Aquisitions and Grant Services 5630 Fishers Lane, Room 2112 Rockville, MD 20857 (301) 827-7009 |
Office of Crisis Management
|
Office of Regulatory Affairs 15800 Crabbs Branch Way, Suite 126 Rockville, MD 20850 (240) 632-6860 |
Office of Criminal Investigations 7500 Standish Place, MPN #2, Room 250N Rockville, MD 20855 (301) 294-4030 |
Center for Drug Evaluation and Research (CDER) 15400 Calhoun Drive, Room 2100 Rockville, MD 20855 (240) 453-6666 |
Office of International Programs (301) 827-3363 Pkln, Room 15A-55 |
Office of Combination Products 15800 Crabbs Branch Way Room 200 Rockville, MD 20855 (301) 427-1934 |
Office Public Affairs (301) 827-6242 Pkln, Room 15-05 |
Center for Biologics Evaluation and Research (CBER) 11400 Rockville Pike, Rockwall Building, Room 601 Rockville, MD 20857 (301) 827-2000 |
Office of Planning (301) 827-5292 Pkln, Room 14-101 |
Center for Food Safety and Applied Nutrition (CFSAN) 5100 Paint Branch Pkwy Room 4B-023 College Park, MD 20740-3835 (301) 436-1590 |
National Center for Toxicological Research 3900 NCTR Road Jefferson, Arkansas 72079 (870) 543-7130 |
Center for Veterinary Medicine (CVM) 7519 Standish Place, MPN Bldg. #4 Room 3502 Rockville, MD 20855 (301) 827-3792 |
Office of Legislation (301) 827-0096 Pkln, Room 15-47 |
Center for Devices and Radiological Health (CDRH) 2094 Gaither Road, Oak Grove Building #8, Room 106 Rockville, MD 20850 (301) 827-9844 |
District Offices |
Atlanta District 60 Eighth Street, N.E. Atlanta, GA 30309 (404) 253-1200 |
Baltimore District 6000 Metro Drive Suite 101 Baltimore, MD 21215 (410) 779-5454 |
Buffalo District 300 Pearl Street Suite100 Buffalo, NY 14202 (716) 551-4461 |
Chicago District 550 West Jackson Blvd. Suite 1500 Chicago, IL 60661 (312) 353-5863 |
Cincinnati District 6751 Steger Drive Cincinnati, OH 45237 (513) 679-2700 |
Dallas District 4040 N. Central Expressway Suite 300 Dallas, TX 75204 (214) 253-5200 |
Denver District P.O. Box 25087 DFC Bldg. 20 West 6th Avenue & Kipling Street Denver, CO 80225 (303) 236-3000 |
Detroit District 300 River Place Suite 5900 Detroit, MI 48207 (313) 393-8100 |
Florida District 555 Winderley Place Suite 200 Maitland, FL 32751 (407) 475-4700 |
Kansas City District 11630 West 80th Street Lenexa, KS 66285 (913) 752-2100 |
Los Angeles District 19701 Fairchild Irvine, CA 92612 (949) 608-2900 |
Minneapolis District 212 Third Avenue South Minneapolis, MN 55401 (612) 334-4100 |
Nashville Branch 297 Plus Park Blvd., Nashville, TN 37217 (615) 781-5388 |
New England District One Montvale Avenue Stoneham, MA 02180 (781) 596-7700 |
New Jersey District Waterview Corporate Center 10 Waterview Blvd., 3rd floor Parsippany, NJ 07054 (973) 526-6000 |
New Orleans District 6600 Plaza Drive Suite 400 New Orleans, LA 70127 (504) 253-4500 |
New York District 158-15 Liberty Avenue Jamaica, NY 11423 (718) 340-7000 |
Philadelphia District U.S. Customshouse 2nd & Chestnut Streets Room 900 Philadelphia, PA 19106 (215) 597-4390 |
San Francisco District 1431 Harbor Bay Parkway Alameda, CA 94502 (510) 337-6700 |
San Juan District 466 Fernandez Juncos Avenue Puerto De Tierra San Juan, Puerto Rico 00901 (787) 474-9500 |
Seattle District 22201 23rd Drive S.E. Bothel, WA 98021 (425) 486-8788 |
St. Louis Resident Post 12 Sunnen Drive St. Louis, MO 63143 (314) 645-1167 |