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`FOIA Annual Reports > Freedom of Information Annual Report 2007
`
`Home Regulatory Information Freedom of Information FOIA Annual Reports
`Regulatory Information
`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.htm1
`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.htm2
`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
`
`https://www.fda.gov/RegulatoryInformation/FOI/FOIAAnnualReports/ucm148025.htm
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`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):
`
`https://www.fda.gov/RegulatoryInformation/FOI/FOIAAnnualReports/ucm148025.htm
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`A. Number of Appeals: N/A
`
` N/A
`
` 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
` N/A
`7(A)
`Exemption
`7(B)
`Exemption
`7(C)
`Exemption
`7(D)
`Exemption
`7(E)
`Exemption
` N/A
`7(F)
`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
`
` N/A
`
` N/A
`
`B. Percentage of total costs: 3.5 %
`https://www.fda.gov/RegulatoryInformation/FOI/FOIAAnnualReports/ucm148025.htm
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`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.html3.
`XII. Report on FOIA Executive Order Implementation
`Please refer to the DHHS Annual Report:www.hhs.gov/foia/reports/07anlrpt.html4.
` 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
`
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`5630 Fishers Lane, Room 2030
`Rockville, MD 20857
`(301) 827-7056
`
`FOIA Annual Reports > Freedom of Information Annual Report 2007
`
`
`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
`
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`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
`
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`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
`
`
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`U.S. Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`Ph. 1-888-INFO-FDA (1-888-463-6332)
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`2. http://www.fda.gov/RegulatoryInformation/FOI/HowtoMakeaFOIARequest/default.htm
`3. http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr20_04.html
`4. http://www.hhs.gov/foia/reports/07anlrpt.html
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