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U.S. Department of Health and Human Services

Regulatory Information

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Freedom of Information Annual Report 2003

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

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                                                                                                                    
  2. Brief description of agency's response time range(s):

    FY 03 response time ranged from a median of 19 days for simple requests                   
     to 363 days for complex requests. The median processing time for single                     
    track requests was 44 days. Of 26 requests for expedited processing, 2 were               
    granted with a median processing time of 16 days.                                                          

     
  3. 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).
  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:

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:   14,097                  
  2. .Number of requests received during reporting fiscal year:   18,094                 
  3. Number of requests processed during reporting fiscal year:   15,656                 
  4. Number of requests pending at close of reporting fiscal year:   16,535                 
     

B. Disposition of Initial Requests:

  1. Number granted in full  11,560           
  2. Number granted in part     45                
  3. Number of full denials    37                
     
a. Number of times each FOIA exemption was used:
Exemption 1      0    
Exemption 2      2    
Exemption 3      0    
Exemption 4     42    
Exemption 5     6    
Exemption 6     10    
Exemption 7(A)     27    
Exemption 7(B)     1     
Exemption 7(C)     9    
Exemption 7(D)     7    
Exemption 7(E)     0    
Exemption 7(F)     0    
Exemption 8     0    
Exemption 9     0    

4. Other reasons for non-disclosure (total)   4,014  

a. no records   1397  
b. referrals   39   
c. request withdrawn     1936   
d. fee-related reason     12     
e. records not reasonably described   0   
f. not a proper FOIA request for some other reason   235   
g. not an agency record    1   
h. duplicate request   125  
i. other (specify)   269    
(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
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   10,021     
b. median number of days to process   19     

2. Complex Requests:

a. number of requests processed  1,011     
b. median number of days to process   363     

3. Requests Accorded Expedited Processing:

a.number of requests processed   2   
b. median number of days to process   16     

4. Single Track

a. number of requests processed   4,622     
b. median number of days to process   44     

B. Status of Pending Requests

1. Number of requests pending as of the end of the fiscal year covered in this report   16,535     

2. Median number of days that such requests were pending as of that date   216   

  

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)   16.264 work years   

3. Total number of personnel (in work years)   91.264 work years    

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

1. FOIA processing (including appeals) $9,775,335

2. Litigation-related activities (estimated) $69,280

3. Total costs $9,844,615

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

There was a 7.28% increase in the total costs for FOI activities for FY03 compared to FY02. There was a 8.57 % decrease in the number of FOI requests received.

X. FEES:

  1. Total amount of fees collected by agency for processing requests:     $388,737                           
  2. Percentage of total costs:     3.4%        

                   

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 6-05

 
Advisory Committee Oversight & Management Staff
(301) 827-1220 Pkln, Room 15A-12

 
Office of the Ombudsman
(301) 827-3390 Pkln, Room 4B-44

 
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 14-72

 
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 16-70

 
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 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

 
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 Human Resources and Management Services
(301) 827-4120 Pkln, Room 7-57

 
Division of Contracts and Procurement
5630 Fishers Lane, Room 2035
Rockville, MD 20857
(301) 827-7009

 
Office of Regulatory Affairs
1350 Piccard, 4 th Floor
Rockville, MD 20850
(301) 827-0420

 
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) 827-4480 Pkln, Room 15A-55

 
Office of Combination Products
15800 Crabbs Branch Way
Room 200
Rockville, MD 20855
(301) 827-9229

 
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) 827-3793 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

 

 

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