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U.S. Department of Health and Human Services

Regulatory Information

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Freedom of Information Annual Report 2007

I. AGENCY   Food and Drug Administration (FDA)                                                         

REPORT PREPARED BY    Frederick J. Sadler                                                   

TITLE   Director, Division of Freedom of Information, Office of Management Programs, U.S. Food and Drug Administration (FDA) 

ADDRESS  5600 Fishers Lane (HFI-35), Rockville, MD 20857                                        

PHONE NUMBER   (301) 827-6567                                                                                 

ELECTRONIC ADDRESS FOR REPORT ON THE WORLD WIDE WEB:

Copies of the annual reports of a number of individual HHS Operating Divisions can be found by contacting the responsible component shown in Section II below, or by locating a FOIA link at the following Web sites:

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:  Please see the FDA Handbook for Requesting Information and Records from FDA at: http://www.fda.gov/RegulatoryInformation/FOI/HowtoMakeaFOIARequest/default.htm

A. Names, addresses, and telephone numbers of all individual agency components and offices that process FOIA requests: Attached, at the close of this report.

B. Brief description of agency's response time range(s): As indicated below.

C. Brief description of why some requests are not granted: Documents requested were protected by a statutory 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:

HHS - U.S. Department of Health and Human Services
OPDIVs - Operating Divisions of HHS
OS - Office of the Secretary
OASPA - Office of the Assistant Secretary for Public Affairs, HHS
AoA - Administration on Aging
ACF - Administration for Children and Families
AHRQ - Agency for Healthcare Research and Quality
ATSDR - Agency for Toxic Substances and Disease Registry
CDC - Centers for Disease Control and Prevention
FDA - Food and Drug Administration
HRSA - Health Resources and Services Administration
IHS - Indian Health Service
NIH - National Institutes of Health
OPHS - Office of Public Health and Science
PHS - Public Health Service
PRO - Professional Review Organization
PSC - Program Support Center
SAMHSA - Substance Abuse and Mental Health Services Administration

B. Basic terms (from FOIA Update, Summer 1997):

FOIA/PA request - Freedom of Information/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. (All requests for access to records, regardless of which law is cited by the requester, are included in this report).

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 final action on the request or 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 (non-expedited) track based on the volume and/or simplicity of the records requested.

Complex request - A FOIA request, which 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 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 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 FOIA exemptions or for some procedural reason (such as because no record is located in response to a FOIA request).

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).

Perfected request - A FOIA request for records which adequately describes the records sought, which has been received by the FOIA office of the agency component in possession of the records, and for which there is no remaining question about the payment of applicable fees.

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 number, not the average. For example, of 3, 7, and 14, the median number is 7.

Average number - The number obtained by dividing the sum of a group of numbers by the quantity of numbers in the group. For example, of 3, 7, and 14, the average number is eight.

IV. EXEMPTION 3 STATUTES:

A. List of Exemption 3 statutes relied on by the agency during report year:

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:

1) Ethics in Government Act (P.L. 95-521, as amended).
- Confidential, financial disclosure reports.
- upheld under Meyerhoff v. EPA, 958 F.2nd 1498 (9th Cir 1992).

2) Public Health Security and Bioterrorism Preparedness and Response Act, 2002 (P.L. 107-188).
- Food Registration Documents.
- The statute has not been litigated.

V. INITIAL FOIA/PA ACCESS REQUESTS (Include all requests, 3rd or 1st party):

A. Numbers of initial requests (line 1 + line 2 - line 3 = line 4):

1. Number of requests pending at close of preceding fiscal year  19,328 
2. Number of requests received during reporting fiscal year          12,320 
3. Number of requests processed during reporting fiscal year      14,190  
4. Number of requests pending at close of reporting fiscal year    17,458 

B. Disposition of Initial Requests:

1. Number granted in full    10,365 
2. Number granted in part         49 
3. Number of full denials           52 
 

a. Number of times each FOIA exemption was used:
Exemption 1   0
Exemption 2   4
Exemption 3   2
Exemption 4   56
Exemption 5   15    
Exemption 6   22    
Exemption 7(A)        30
Exemption 7(B)        0
Exemption 7(C)        7
Exemption 7(D)        4
Exemption 7(E)        4
Exemption 7(F)        0    
Exemption 8   0
Exemption 9   0

4. Other reasons for non-disclosure (total)

a. No records  675  
b. Referrals  11   
c. Request withdrawn  1,858   
d. Fee-related reason  96   
e. Records not reasonably described  1   
f. Not a proper FOIA request for some other reason  174   
g. Not an agency record   2   
h. Duplicate request   282   
i. Other (specify)   625   

In the main, the "Other" category represents requests for records that were posted on the Agency's Internet Web site; or requests from regulated industry for copies of their own inspection reports. The agency proactively releases unredacted copies of Establishment Inspection Reports (EIRs) to the subject of the inspection, without requiring submission of a FOIA request, as both an educational tool and a method of achieving transparency.

VI. APPEALS OF INITIAL DENIALS OF FOIA/PA REQUESTS: (include all access requests whether first or third party):

A. Number of Appeals:   N/A   

Appeals to denials issued by the FDA are filed with the FOI officer for the Public Health Service, HHS, and processed within that office, after consultation with FDA.

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 (counting each exemption used once per appeal)
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   11,336  
b. Median number of days to process   146  

2. Complex Requests:

a. Number of requests processed   2,850     
b. Median number of days to process   653   

3. Requests Accorded Expedited Processing:

a. Number of requests processed   4   
b. Median number of days to process   84   

B. Status of Pending Requests (if multiple tracks are being used, report for each track as well as totals). 

1. Number of requests pending as of the end of the fiscal year covered in this report (from Line V.A.4)   17,458   
2. Median number of days that such requests were pending as of that date.   311   
   (Medians vary greatly from OPDIV to OPDIV.)

VIII. COMPARISONS WITH PREVIOUS YEAR(S) (Optional)

IX. COSTS/FOIA STAFFING:

A. Staffing levels:

1. Number of full-time FOIA personnel   69  
2. Number of personnel with part-time or occasional FOIA duties (in total work-years)   24.61  
3. Total number of personnel (in work years)   93.61  

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

1. FOIA processing (including appeals) $14,588,882.47
2. Litigation-related activities (estimated) $99,500.00
3. Total costs $14,688,382.47
4. Comparison with previous year(s) (including percentage of change) (optional)

X. FEES:

A. Total amount of fees collected by agency for processing requests:  $410,218.17 

B. Percentage of total costs:   3.5 %  

XI. FOIA REGULATIONS:

The Food and Drug Administration's implementing regulations are found in 21 CFR Part 20, and may be viewed on the Internet in the Agency's Electronic Reading Room at: http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr20_04.html.

XII. Report on FOIA Executive Order Implementation

Please refer to the DHHS Annual Report:www.hhs.gov/foia/reports/07anlrpt.html.

 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 6B-05
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) 827-1181 Pkln, Room 6-89

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

 
Office of the Ombudsman
(301) 827-3390 Pkln, Room 14-72

 
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) 827-4835 Pkln, Room 8-72

 
Office of Policy
(301) 827-3360 Pkln, Room 14-101

 
Office of Science
(301) 827-3038, Pkln, Room 14C-06

 
Office of Orphan Products Development
(301) 827-3666 Pkln, Room 6A-55

 
Office of the Commissioner and Executive Secretariat
(301) 827-4433 Pkln, Room 16-70

 
Office of Executive Operations
(301) 827-3394 Pkln, Room 11-101

 
Office of the Chief Information Officer
(301) 827-4655 Pkln, Room 16B-45

 
Office of Financial Management
(301) 827-5045 Pkln, Room 11-68

 
Office of Real Property
5630 Fishers Lane, Room 2030
Rockville, MD 20857
(301) 827-7056

 
Paperwork Reduction Act & Records Management Branch
(301) 827-1476 Pkln, Room 6A08

 
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 2035
Rockville, MD 20857
(301) 827-7009

 
Office of Crisis Management
(301) 796-8240 or 1-866-300-4374 Pkln, Room 12A-55
 
Office of Regulatory Affairs
15800 Crabbs Branch Way, Suite 130
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 Policy, Europe, Trade & Harmonization Staff
(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, Bldg. 50, Room 707
Jefferson, Arkansas 72079
(870) 543-7130

 
Center for Veterinary Medicine (CVM)
7519 Standish Place,
MPN Bldg. #4 Room 3502
Rockville, MD 20855
(240) 276-9131

 
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
(240) 276-0684

 

 

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

 
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
297 Plus Park Blvd.
Nashville, TN 37217
(615) 366-7809

 
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
15 Sunnen Drive
St. Louis, MO 63143
(314) 645-1167