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U.S. Department of Health and Human Services

Regulatory Information

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Freedom of Information Annual Report 1998

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: http://www.fda.gov/RegulatoryInformation/FOI/FOIAAnnualReports/default.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: http://www.fda.gov/RegulatoryInformation/FOI/HowtoMakeaFOIARequest/default.htm. 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 10
Exemption 20
Exemption 33
Exemption 4126
Exemption 59
Exemption 67
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 80
Exemption 90

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 Reference Materials at: http://www.fda.gov/RegulatoryInformation/FOI/ReferenceMaterials/default.htm. Scroll to, 21 CFR Part 20.

FDA HEADQUARTERS COMPONENT FREEDOM OF INFORMATION/PRIVACY ACT OFFICERS AND CONTACTS

 

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 at address given above.

 

Component FOIA Officers and Contacts*
Office of Chief Counsel
(301) 827-1137 Pkln, Room 6-57
Office of the Special Assistant for Investigations
(301) 443-5742 Pkln, Room 15-44
Office of the Chief Mediator and Ombudsman
(301) 827-3390 Pkln, Room 14-105
Office of Women's Health
(301) 827-0350 Pkln, Room 15-61
Office of Internal Affairs
(301) 827-0273 Church Bldg., Rm. 700
Office of Special Health Issues
(301) 827-4460 Pkln, Room 9-49
Office of the Equal Employment Opportunity and Civil Rights
(301) 827-4840 Pkln, Room 8-72
Office of the Deputy Commissioner for Policy
(301) 827-0565 Pkln, Room 14-101
Office of the Deputy Commissioner for Operations
(301) 827-3320 Pkln, Room 14-71
Office of Orphan Products Development
(301) 827-0983 Pkln, Room 8-73
Commissioner's Office
(301) 827-4435 Pkln, Room 16-70
Office of External Affairs
(301) 827-3364 Pkln, Room 14C-03
Office of the Deputy Commissioner for Management and Systems
(301) 827-3389 Pkln, Room 14-82
Office of Information Resources Management
(301) 827-4280 Pkln, Room 16B-30

Component FOIA Officers and Contacts*
Office of Financial Management
(301) 827-5004 Pkln, Room 11-61
Office of Facilities & Central Services
(301) 827-7027 Room N-135, MPN2
Information Collection & Dissemination Branch
(301) 827-4274 Pkln, Room 16B-19
Division of Management Systems & Policy
(301) 827-5503 Pkln, Room 4-72
Dockets Management Branch
(301) 827-6860 5630 Fishers Ln., Room 1061
Committee Management Branch (FDA Advisory Committee)
(301) 827-5496 Pkln, Rm. 4B-17
Organization Planning Branch
(301) 827-4812 Pkln, Room 4-72
Office of Human Resources Management
(301) 827-4810 Pkln, Bldg., Room 4B-03
Office of Contracts and Grants
(301) 827-6890 5630 Fishers Ln.,Rm. 2035
Office of Regulatory Affairs
(301) 827-0420 Twinbrook Bldg. 5 Ste 517
Office of Criminal Investigations
(301) 294-4052 MPN #2 Room 250
Center for Drug Evaluation and Research
(301) 827-4565 or (301) 827-4583 Pkln Room 12B-05
Office of the Associate Commissioner for Consumer Affairs
(301) 827-4396 Pkln, Room 16-75
Office of International Affairs
(301) 827-4480 Pkln, Room 15A-16
Office of the Associate Commissioner for Public Affairs
(301) 827-6242 Pkln, Room 15-05
Center for Biologics Evaluation and Research
(301) 827-2000 Rockwall Bldg. Room 615
Office of the Associate Commissioner for Planning and Evaluation
(301) 827-5297 Pkln, Room 10-61
Center for Food Safety and Applied Nutrition
(202) 205-5309 FB8 Room 6848
National Center for Toxicological Research
(870) 543-7130 Jefferson, Arkansas 72079
Center for Veterinary Medicine
(301) 827-6510 MPN Bldg. #2, Rm 400
Office of the Associate Commissioner for Legislative Affairs
(301) 827-0099 Pkln, Room 15-55
Office of the Associate Commissioner for Health Affairs
(301) 827-6599 Pkln, Room 15-26
Center for Devices and Radiological Health
(301) 594-4774 x128 Oak Grove Bldg. Rm. 108

 


FDA DISTRICT FREEDOM OF INFORMATION/ PRIVACY ACT OFFICERS AND CONTACTS

December 1998

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 *
ATLANTA DISTRICT
60 Eighth Street, N.E.
Atlanta, Georgia 30309
(404) 347-4001
BALTIMORE DISTRICT
900 Madison Avenue
Baltimore, Maryland 21201
(410) 962-4099
BUFFALO DISTRICT
599 Delaware Avenue
Buffalo, New York 14202
(716) 551-4461
CHICAGO DISTRICT
300 S. Riverside Plaza, Suite 550
Chicago, Illinois 60606
(312) 353-5863
CINCINNATI DISTRICT
6751 Steger Dr
Cincinnati, Ohio 45237-3097
(513) 684-3501
DALLAS DISTRICT
3310 Live Oak Street
Dallas, Texas 75204
(214) 655-5317
DENVER DISTRICT
P.O. Box 25087
DFC Building 20
West 6th Avenue & Kipling Street
Denver, Colorado 80225-0087
(303) 236-3000
DETROIT DISTRICT
1560 E. Jefferson Avenue
Detroit, Michigan 48207
(313) 226-6260
FLORIDA DISTRICT
555 Winderley Pl., Ste 200
Maitland, Florida 32751
(407) 475-4700
KANSAS CITY DISTRICT
11510 W. 80th Street
P.O. Box 15905
Lenexa, Kansas 66285
(913) 752-2100
LOS ANGELES DISTRICT
19900 MacArthur Boulevard, Suite 300
Irvine, California 92612
(714) 798-7639
MINNEAPOLIS DISTRICT
240 Hennepin Avenue
Minneapolis, Minnesota 55401
(612) 334-4100
NASHVILLE DISTRICT
297 Plus Park Boulevard
Nashville, Tennessee 37217
(615) 781-5388
NEW ENGLAND
One Montvale Avenue
Stoneham, Massachusetts 02180-3542
(781) 279-1675
NEW JERSEY DISTRICT
Waterview Corporate Center
10 Waterview Boulevard, 3rd Floor
Parsippany, New Jersey 07054
(973) 526-6000
NEW ORLEANS DISTRICT
4298 Elysian Fields Avenue
New Orleans, Louisiana 70122-3848
(504) 589-7166
NEW YORK DISTRICT
850 Third Avenue
Brooklyn, New York 11232
(718) 965-5300
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
P.O. Box 3012
Bothell, Washington 98041-3012
(425) 486-8788
ST. LOUIS BRANCH
12 Sunnen Drive, Suite 122
St. Louis, Missouri 63143
(314) 645-1167