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U.S. Department of Health and Human Services

Regulatory Information

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Freedom of Information Annual Report 2009

I. AGENCY: Food and Drug Administration (FDA)

REPORT PREPARED BY: Frederick J. Sadler

TITLE: Director, Division of Freedom of Information, OPILS, OSS, OM

ADDRESS: 5600 Fishers Lane, Rockville, MD 20857

PHONE NUMBER:(301) 827-6567



1.   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, HHS
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
Office of the Inspector General
OPHS - Office of Public Health and Science
PHS - Public Health Service
PRO - Professional Review Organization
Program Support Center
SAMHSA - Substance Abuse and Mental Health Services Administration

2.   Basic terms (from FOIA UPDATE, Summer 1997):

  1. Administrative Appeal – a request to a federal agency asking that it review at a higher administrative level a FOIA determination   made by the agency at the initial request level
  2. 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 8. 
  3. Backlog – the number of requests or administrative appeals that are pending at an agency at the end of the fiscal year that are  beyond the statutory time period for a response.
  4. Component – for agencies that process requests on a decentralized basis, a “component” is an entity, also sometimes referred  to as an Office, Division, Bureau, Center, or Directorate, within the agency that processes FOIA requests. The FOIA now requires  that agencies include in their annual report data for both the agency overall and for each principal component of the agency.
  5. Consultation – the procedure whereby the agency responding to a FOIA request first forwards a record to another agency for its     review because that agency has an interest in the document.  Once the agency in receipt of the consultation finishes its review      of the record,  it responds back to the agency that forwarded it.  That Agency, in turn, will then respond to the FOIA requester
  6. Exemption 3 Statute – a federal statute that exempts information from disclosure and which the agency relies on to withhold   information  under subsection (b)(3) of the FOIA. 
  7. FOIA Request – a FOIA request is generally a request to a federal agency for access to records concerning another person (i.e.,     “third-party” request), or concerning an organization, or a particular topic of interest. FOIA requests also include requests made by requesters seeking records concerning themselves (i.e., “first-party” requests) when those requesters are not subject to the Privacy Act, such as non-U.S. citizens. Moreover, because all first-party requesters should be afforded the benefit of both the access provisions of the FOIA as well as those of the Privacy Act, FOIA requests also include any first-party requests where an agency determines that it must search beyond its Privacy Act “systems of records” or where a Privacy Act exemption applies, and the agency looks to FOIA to afford the greatest possible access. All requests which require the agency to utilize the FOIA in responding to the requester are included in this Report. Additionally, a FOIA request includes records referred to the agency for processing and direct response to the requester. It does not, however, include records for which the agency has received a consultation from another agency. (Consultations are reported separately in Section XII of this Report.)
  8. Full Grant - an agency decision to disclose all records in full in response to a FOIA request.
  9. Full Denial - an agency decision not to release any records in response to a FOIA request because the records are exempt in their entireties under one or more of the FOIA exemptions, or because of a procedural reason, such as when no records could be located
  10. Median Number - the middle, not average, number.  For example, of 3, 7, and 14, the median number is 7.
  11. 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 granted expedited processing are placed in yet another track. Requests in each track are processed on a first in/first out basis.
  12. i. Expedited Processing – an agency will process a FOIA request on an expedited basis when a requester satisfies the requirements for expedited processing as set forth in the statute and in agency regulations.

    ii. Simple Request – a FOIA request that an agency using multi-track processing places in its fastest (non-expedited) track based on the low volume and/or simplicity of the records requested. 

    iii. Complex Request – a FOIA request that an agency using multi-track processing places in a slower track based on the high volume and/or complexity of the records requested.

  13. Partial Grant/Partial Denial – in response to a FOIA request, an agency decision to disclose portions of the records and to withhold other portions that are exempt under the FOIA, or to otherwise deny a portion of the request for a procedural reason.
  14. Pending Request or Pending Administrative Appeal– a request or administrative appeal for which an agency has not taken final action in all respects.
  15. Perfected Request – a request for records which reasonably describes such records and is made in accordance with published rules stating the time, place, fees (if any) and procedures to be followed.
  16. Processed Request or Processed Administrative Appeal– a request or administrative appeal for which an agency has taken final action in all respects.
  17. Range in Number of Days – the lowest and highest number of days to process requests or administrative appeals.
  18. Time Limits – the time period in the statute for an agency to respond to a FOIA request (ordinarily twenty working days from receipt  of a perfected FOIA request).

3. Concise descriptions of the nine FOIA exemptions:

a. Exemption 1: classified national defense and foreign relations information

b. Exemption 2: internal agency rules and practices

c. Exemption 3: information that is prohibited from disclosure by another federal law

d. Exemption 4: trade secrets and other confidential business  information

e. Exemption 5: inter-agency or intra-agency communications that are protected by legal privileges

f.  Exemption 6: information involving matters of personal privacy

g. Exemption 7: records or information compiled for law enforcement purposes, to the extent that the production of those records 

(A) could reasonably be expected to interfere with enforcement proceedings,
(B) would deprive a person of a right to a fair trial or an impartial adjudication, 
(C) could reasonably be expected to constitute an unwarranted invasion of personal privacy,
(D) could reasonably be expected to disclose the identity of a confidential source, 
(E) would disclose techniques and procedures for law enforcement investigations or prosecutions, or would disclose guidelines for law enforcement investigations or prosecutions, or
(F) could reasonably be expected to endanger the life or physical safety of any individual

h. Exemption 8: information relating to the supervision of financial institutions

i.  Exemption 9: geological information on wells:

IV.     EXEMPTION 3 STATUTES (See chart)

V.      FOIA Requests 

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

1. Number of requests pending as of start of fiscal year:  6,568

2. Number of requests received in fiscal year: 10,337

3. Number of requests processed in fiscal year: 12,087

4. Number of requests pending as of end of fiscal year:  4,818

B. (1)  Disposition of FOIA Requests: (See chart)

1. Number of full grants:  8,592

2. Number of partial grants:  135 

3. Number of full denials based on Exemptions: 111

4. Number of Full Denials Based on Reasons Other than Exemptions

a. No records:  934
b. Referrals:  36
c. Request withdrawn: 1,158
d. Fee-related reason:  228
e. Records not reasonably described:  14
f. Improper FOIA request for some other reason: 129  
g. Not an agency record:  3
h. Duplicate request:  216
i. Other (specify):  531

B. (2)  Disposition of FOIA Requests – Other (See chart)

B. (3)  Disposition of FOIA Requests - Number of times exemptions applied  (See chart)                      

Exemption 1:  0
Exemption 2:  4
Exemption 3:  48
Exemption 4:  126
Exemption 5:  15
Exemption 6:  32
Exemption 7(A): 111  
Exemption 7(B):  0
Exemption 7(C):  12
Exemption 7(D):  1
Exemption 7(E):  3
Exemption 7(F):  0
Exemption 8: 0
Exemption 9: 0


 A.  Received, Processed and Pending Administrative Appeals 

1.  Number of  appeals pending as of start of Fiscal Year

2.   Number of appeals received in Fiscal Year

3.   Number of appeals processed in Fiscal Year

4.   Number appeals pending as of end of Fiscal Year

 B.  Disposition of Administrative Appeals – All Processed Appeals 

1.   Number affirmed on appeal: 
2.  Number partially affirmed and partially reversed/remanded on appeal:

3.   Number completely reversed/remanded on appeal: 

4.  Number of appeals closed for other reasons: 

C.(1) Reasons for denial on Appeal – Number of Times Exemptions applied

Exemption 1:
Exemption 2:
Exemption 3:
Exemption 4:
Exemption 5:
Exemption 6:
Exemption 7

Exemption 7(A):
Exemption 7(B):
Exemption 7(C):
Exemption 7(D):
Exemption 7(E):
Exemption 7(F):
Exemption 8:
Exemption 9:

C. (2)  Reasons for denial on Appeal – Reasons other than exemptions

a. No Records:
b.  Referrals: 
c.  Request withdrawn: 
d.  Fee-related reason: 
e.  Records not reasonably described: 
f.  Improper request for other reason: 
g.  Not an agency record: 
h.  Duplicate request:   
i.  Request in litigation: 
j.  Appeal based solely on denial of request for expedited processing:
k. Other

C.(3)  Reasons for denial on Appeal 
Administrative closures, records previously released to appellant

C. (4)  Response time for administrative appeals

a.  Median number of days: 
b.  Average number of days: 
c.  Lowest Number of days: 
d. Highest number of days: 

C. (5)  Ten Oldest Pending Appeals 


A. Processed Requests - Response Time for All Processed Perfected
Requests (See chart)
B. Processed Requests - Response Time for Perfected Requests in Which
Information Was Granted (See chart)
C. Processed Requests - Response Time in Day Increments (See chart)
D. Pending Requests - All Pending Perfected Requests (See chart)
E. Pending Requests - Ten Oldest Pending Perfected Requests (See chart)


A. Requests for Expedited Processing: 2 (See chart)
B. Requests for Fee Waiver: 300 (See chart)


A. Personnel: Total 124.4
B. Costs: Total: $21,465,408


A. Total: $388,084.10




A. Backlogs of FOIA Requests and Administrative Appeals (See chart)
Requests: 4,818

Appeals: Not applicable to FDA
B. Consultations on FOIA Requests - Received, Processed, and Pending Consultations (See chart)
Received and Pending at Start of Fiscal Year: 0
Received During Fiscal Year: 13
Received and Processed: 13
Received and Pending: 0
C. Consultations on FOIA Requests - Ten Oldest Consultations Received from Other Agencies and Pending at Your Agency (See chart)
Total: 0
D. Comparison of Numbers of Requests from Previous and Current Annual Report - Requests Received, Processed, and Backlogged (See chart)
Received from Last Year's Report: 9,432
Received from Current Year's Report: 10,337
Processed from Last Year's Report: 20,348
Processed from Current Year's Report: 12,087
Number of Backlogged Requests from Previous Year: 6,568
Number of Backlogged Requests from Current Year: 4,818
E. Comparison of Numbers of Administrative Appeals from Previous and Current Annual Report - Appeals Received, Processed, and Backlogged - Not applicable to FDA.
Received from Current Year's Report:
Processed from Last Year's Report:
Processed from Current Year's Report:
Comparison of Numbers of Backlogged Administrative Appeals from Previous Year
Comparison of Numbers of Backlogged Administrative Appeals from Current Year