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U.S. Department of Health and Human Services

Regulatory Information

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Freedom of Information Annual Report 2001

I. AGENCY Food and Drug Administration (FDA)

REPORT PREPARED BY Barbara J. Schulman

TITLE Consumer Safety Officer/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 12A-16
Rockville, MD 20857

 

II. HOW TO MAKE A FOIA REQUEST: refer to: http://www.fda.gov/RegulatoryInformation/FOI/HowtoMakeaFOIARequest/default.htm

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

    Refer to attachment                                                                                                                                       

  2. Brief description of agency’s response time range(s):
FY 01 response time ranged from a median of 14 days for simple requests to 332 days for complex requests. The median processing time for single track requests was 30 days. 
  1. 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                                                                                                                                                               

  2. 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).

 

7. 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.

 

8. 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.

 

9. 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.

 

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

 

11. 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.

 

12. 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.

 

13. 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).

 

14. 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).

 

15. 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:

a. Ethics in Government Act (5 U.S. C. 107(a)(2) Appendix 4)                                              

                              

 

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

    a. Confidential Financial Disclosure Reports                                                                               

  2. 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)    

                                                     

V. INITIAL FOIA/PA ACCESS REQUESTS:

A. Numbers of initial requests:

1. Number of requests pending at close of preceding fiscal year:   13,626                  

2. Number of requests received during reporting fiscal year:   22,248                          

3. Number of requests processed during reporting fiscal year:   22,721                       

4. Number of requests pending at close of reporting fiscal year:   13,153                    

B. Disposition of Initial Requests:

1. Number granted in full   17,899     

2. Number granted in part   92     

3. Number of full denials   62   

a. Number of times each FOIA exemption was used:

Exemption 1           0          

Exemption 2           0          

Exemption 3           2          

Exemption 4          83         

Exemption 5           0          

Exemption 6          10         

Exemption 7(A)     104        

Exemption 7(B)       0         

Exemption 7(C)      16        

Exemption 7(D)       6       

Exemption 7(E)       0       

Exemption 7(F)       0      

Exemption 8           0       

Exemption 9           0       

4. Other reasons for non-disclosure (total)   4,668  

a. no records   1964  

b. referrals   63    

c. request withdrawn     1969   

d. fee-related reason     24     

e. records not reasonably described   0   

f. not a proper FOIA request for some other reason   276   

g. not an agency record    0   

h. duplicate request   131  

i. other (specify)   241    

(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    N/A    

2. Number of appeals processed during the fiscal year   N/A    

B. Disposition of Appeals:

  1. Number completely upheld   N/A    

     
  2. Number partially reversed  N/A    

     
  3. Number completely reversed     N/A   

    a. Number of times each FOIA exemption used

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    N/A  

b. referrals    N/A  

c. request withdrawn    N/A  

d. fee-related reason    N/A  

e. records not reasonably described    N/A  

f. not a proper FOIA request for some other reason    N/A  

g. not an agency record    N/A  

h. duplicate request    N/A  

i. other (specify)    N/A  

 

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   8,145  

b. median number of days to process   14  

 

2. Complex Requests:

a. number of requests processed   977  

b. median number of days to process   332  

 

3. Requests Accorded Expedited Processing:

a. number of requests processed   2  

b. median number of days to process   5  

 

4. Single Track

a. number of requests processed   13,597  

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   13,153                              

2.  Median number of days that such requests were pending as of that date  146    

                              

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) 18.697 work years                

3. Total number of personnel (in work years)  89.697 work years       

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

1. FOIA processing (including appeals)   $8,165,088  

2. Litigation-related activities (estimated)   $59,488  

3. Total costs   $8,224,576  

4. Comparison with previous year(s) (including percentage of change)

 

There was an 18% increase in the total costs for FOI activities for FY01 compared to FY00, largely due to the 2001 salary increase, fringe benefits increase, and increase in some components reporting higher grade levels for part-time hours. There was a 11% decrease in the number of FOI requests received.

X. FEES:

A. Total amount of fees collected by agency for processing requests:  583,624                           

B. Percentage of total costs:   7%       

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
Division of Freedom of Information (DFOI)
5600 Fishers Lane, Parklawn (PKLN) Building
HFI-35, Room 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 Division of Freedom of Information at address given above.

 

 

 

 

Component FOIA Offices*

Office of Chief Counsel
(301) 827-1137 Pkln, Room 6-57
Advisory Committee Oversight & Management Staff (301) 827-1220 Pkln, Room 14-72
Office of the Ombudsman
(301) 827-3390 Pkln, Room 14B-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 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 17-35
Office of Orphan Products Development
(301) 827-0990 Pkln, Room 15A-08
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
5630 Fishers Lane, Room 1041
Rockville, MD 20857
(301) 827-7056
Division of Information Services and Policy
(301) 827-1481 Pkln, Room 16B-26
Division of Management Programs
(301) 827-4810 Pkln, Room 4B-03
Dockets Management Branch
5630 Fishers Lane, Room 1061
Rockville, MD 20857
(301) 827-6860
Committee Management
(FDA Advisory Committee)
(301) 827-5496 Pkln, Room 4B-07
Office of Human Resources and Management Services
(301) 827-4129 Pkln, Room 7-59
Division of Contracts and Procurement
5630 Fishers Lane, Room 2035
Rockville, MD 20857
(301) 827-6890
Office of Regulatory Affairs
1350 Piccard, 4th Floor
Rockville, MD 20850
(301) 827-0420
Office of Criminal Investigations
7500 Standish Place, MPN #2, Room 250 Rockville, MD 20855
(301) 294-4052
Center for Drug Evaluation and Research (CDER)
12720 Twinbrook Parkway, (TW-3)
Rockville, MD 20852
(301) 827-4565 or (301) 827-4583
Office of Consumer Affairs
(301) 827-4406 Pkln, Room 16-85
Office of International Programs
(301) 827-4553 Pkln, Room 15A-55
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) 436-2430
National Center for Toxicological Research
3900 NCTR Road Jefferson, Arkansas 72079 (870) 543-7130
Center for Veterinary Medicine (CVM) 7500 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 #4, Room 108
Rockville, MD 20850
(301) 594-4774

 

 


 

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 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 Division of Freedom of Information at address given above.

 

 

 

 

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
300 South Riverside Plaza
Suite 550 South
Chicago, IL 60606
(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
1560 East Jefferson Avenue
Detroit, MI 48207
(313) 226-6260
Florida District
555 Winderley Place Suite 200
Maitland, FL 32751
(407) 475-4700
Kansas City District
11630 West 80th Street
P.O. Box 15905
Lenexa, KS 66285
(913) 752-2100
Los Angeles District
19900 MacArthur Blvd.
Suite 300 Irvine, CA 92612
(949) 798-7700
Minneapolis District
240 Hennepin Avenue
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) 729-6894
Seattle District
2201 23rd Drive S.E.
Bothel, WA 98041
(425) 486-8788
St. Louis Branch
12 Sunnen Drive, Suite 122
St. Louis, MO 63143
(314) 645-1167