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U.S. Department of Health and Human Services

Regulatory Information

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Freedom of Information Annual Report 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: 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"
 

  1. 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.

    III. DEFINITIONS OF TERMS AND ACRONYMS USED IN REPORT:
  1. Agency-specific acronyms or other terms:

       N/A

 

  • 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:

  1. List of Exemption 3 statutes relied on by the agency during report year:
     None


  

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


 

  2. 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
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)


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

  1. 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
  1. 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 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 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 Administrative Law Judge
(301) 827-7120 Pkln, Room 9-57
Office of the Ombudsman
(301) 827-3390 Pkln, Room 14B-03
Office of Women's Health
(301) 827-0350 Pkln, Room 15-61
Office of Internal Affairs
(301) 827-0243 Church Bldg., Rm. 700
Office of Special Health Issues
(301) 827-4460 Pkln, Room 9-49
Office of Tobacco Programs
(301) 827-0841 Pkln, Room 12A-55
Office of Equal Opportunity
(301) 827-4840 Pkln, Room 8-72
Office of Policy
(301) 827-0565 Pkln, Room 14-101
Office of International and Constituent Relations
(301) 827-3360, Pkln, Room 14C-03
Office of Science
(301) 827-3038, Pkln, Room 17-35
Office of Orphan Products Development
(301) 827-0983 Pkln, Room 8-73
Office of the Commissioner and Executive Secretariat
(301) 827-4435 Pkln, Room 16-70
Office of Executive Operations
(301) 827-3365 Pkln, Room 14C-03
Office of Information Resources Management
(301) 827-4655 Pkln, Room 16B-45
Office of Financial Management
(301) 827-5004 Pkln, Room 11-61
Office of Facilities & Central Services
(301) 827-7056
5630 Fishers Lane, Room 1041
Division of Information Services and Policy
(301) 827-1481 Pkln, Room 16B-26
Division of Management Programs
(301) 827-4810 Pkln, Room 4-72
Dockets Management Branch
(301) 827-6860
5630 Fishers Ln., Room 1061
Committee Management
(FDA Advisory Committee)
(301) 827-5496 Pkln, Rm. 4B-17
Office of Human Resources and
Management Services
(301) 827-4810 Pkln, Room 4B-03
Division of Contracts and Procurement
(301) 827-6890
5630 Fishers Ln., Room. 2035
Office of Regulatory Affairs
(301) 827-0420
1350 Piccard, 4th Floor
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 Consumer Affairs
(301) 827-4406 Pkln, Room 16-75
Office of International Affairs
(301) 827-4480 Pkln, Room 15A-16
Office Public Affairs
(301) 827-6242 Pkln, Room 15-05
Center for Biologics Evaluation and Research
(301) 827-2000
Rockwall Bldg., Room 601
Office of Planning
(301) 827-5292 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, Room 400
Office of Legislation
(301) 827-0099 Pkln, Room 15-55
Center for Devices and Radiological Health
(301) 594-4774 x128
Oak Grove Bldg. 4, Rm. 108

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 *

ATLANTA DISTRICT

60 Eighth Street, N.E.

Atlanta, Georgia 30309

(404) 253-1275

BALTIMORE DISTRICT

900 Madison Avenue

Baltimore, Maryland 21201

(410) 962-4099

BUFFALO DISTRICT

300 Pearl Street Suite 100

Buffalo, New York 14202

(716) 551-4461

CHICAGO DISTRICT

300 S. Riverside Plaza, Suite 550 South

Chicago, Illinois 60606

(312) 353-5863

CINCINNATI DISTRICT

6751 Steger Dr

Cincinnati, Ohio 45237-3097

(513) 679-2700

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., Suite 200

Maitland, Florida 32751

(407) 475-4700

KANSAS CITY DISTRICT

11630 W. 80th Street

P.O. Box 15905

Lenexa, Kansas 66285

(913) 752-2100

LOS ANGELES DISTRICT

19900 MacArthur Boulevard, Suite 300

Irvine, California 92612

(949) 798-7666

MINNEAPOLIS DISTRICT

240 Hennepin Avenue

Minneapolis, Minnesota 55401

(612) 334-4100

NASHVILLE BRANCH

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

6600 Plaza Drive, Suite 400

New Orleans, Louisiana 70127

(504) 253-4500

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