FISCAL YEAR (FY) 2000

I. AGENCY Food and Drug Administration (FDA)				 

REPORT PREPARED BY  Barbara J. Schulman					 

TITLE Consumer Safety Officer/Freedom of Information (FOI) Staff 	 

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

PHONE NUMBER  (301) 827-6500						 

ELECTRONIC ADDRESS FOR REPORT ON THE WORLD WIDE WEB:

www.fda.gov/foi/foia2.htm 						

ADDRESS FOR PAPER COPIES OF REPORT:
Food and Drug Administration
Freedom of Information Staff
5600 Fishers Lane, HFI-35, Room 12A-16
Rockville, MD 20857
									 
II. HOW TO MAKE A FOIA REQUEST: 
refer to: www.fda.gov/opacom/backgrounders/foiahand.html
Select "Handbook for Requesting Information 
and Records from FDA"


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


	Refer to attachment					 
								 
								 

Brief description of agency's response time range(s):
FY 00 response  time ranged from a median of 11 days for		 
simple requests to 65.5 days for complex requests.  The median 		
processing time for single track requests was 26.5 days.		
						


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:



Agency-specific acronyms or other terms:


	N/A						
							
							

Basic terms:

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.

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 a final action 
on the request or the 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
(nonexpedited) track based on the volume and/or 
simplicity of records requested.

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.

Grant -- an agency decision to disclose all records
in full in 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's 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 the FOIA's 
exemptions, or for some procedural reason.

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).

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

IV. EXEMPTION 3 STATUTES:

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


None							
							 
							 

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

							
							 
Has a court upheld the use of each statute? 
If so, cite example:

							
							
							

V. INITIAL FOIA/PA ACCESS REQUESTS:
	A. Numbers of initial requests:

1. Number of requests pending at close of 
   preceding; fiscal year: 12,655	

2. Number of requests received during reporting
   fiscal; year: 	  25,011	 

3. Number of requests processed during reporting
   fiscal; year:	  24,040	 

4. Number of requests pending at close of 
   reporting; fiscal year:  13,626	


	B. Disposition of Initial Requests:


1. Number granted in full	18,354		
 
2. Number granted in part	147		 

3. Number of full and partial denials 	231	


a. Number of times each FOIA exemption was 
   used:

Exemption 1		0	
Exemption 2		2	
Exemption 3		0	
Exemption 4		87	
Exemption 5		9	
Exemption 6		7	
Exemption 7(A)		128	
Exemption 7(B)		0	
Exemption 7(C)		13	
Exemption 7(D)		11	
Exemption 7(E)		2	
Exemption 7(F)		0	
Exemption 8		0	
Exemption 9		0	
4. Other reasons for non-disclosure
   (total)	5,455		

a. no records 	2,435				
b. referrals 		49			
c. request withdrawn	1883			
d. fee-related reason	104			
e. records not reasonably described	2	
f. not a proper FOIA request for some other
   reason	403	
g. not an agency record	 2			
h. duplicate request	296			
i. other (specify)	281			 
   (e.g., information that was requested is available 
   on the Internet)	


VI. APPEALS OF INITIAL DENIALS OF FOIA/PA REQUESTS:

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 		 

		 2. Number of appeals processed during the fiscal year		


	B. Disposition of Appeals:
1. Number completely upheld			

2. Number partially reversed			

3. Number completely reversed			


Number of times each FOIA exemption used

Exemption 1			
Exemption 2			
Exemption 3			
Exemption 4			
Exemption 5			
Exemption 6			
Exemption 7(A)			
Exemption 7(B)			
Exemption 7(C)			
Exemption 7(D)			
Exemption 7(E)			
Exemption 7(F)			
Exemption 8			
Exemption 9			


4. Other reasons for non-disclosure (total)			


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	12,671		 
          b. median number of days to process	 11		 

     2. Complex Requests: 
          
          a. number of requests processed	896		 
          b. median number of days to process	 65.5		

     3. Requests Accorded Expedited Processing:

          a. number of requests processed	1		
          b. median number of days to process	3		

     4. Single Track

          a. number of requests processed	10,472		
          b. median number of days to process	 26.5		

 B. Status of Pending Requests

     Number of requests pending as of the end of the fiscal year covered in 
     this report  13,626					

     Median number of days that such requests were pending 
     as of that date 188					

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)		16.72 work years	

          3. Total number of personnel (in work years) 	91.72 work years

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

          1. FOIA processing (including appeals)	 $6,576,036	

          2. Litigation-related activities (estimated) $150,000		

	  3. Total costs	$6,726,036			

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

             There was an 8% decrease in the total costs for 
             FOI activities for FY00 compared to FY99. 
             There was a 10% decrease in the number of FOI requests received.

X. FEES:	

      A.Total amount of fees collected by agency for processing requests: 
      	$703,142						

      B. Percentage of total costs:	10.5%			

XI. FOIA REGULATIONS:

     FDA's FOIA regulations are contained in 21 CFR Part 20 and may be viewed 
     on the Internet in FDA's Electronic Reading Room at:
     www.fda.gov/opacom/backgrounders/foiahand.html. Scroll to "Obtaining 
     Information from FDA" and click on the site, 21 CFR Part 20.

FDA HEADQUARTERS COMPONENT FREEDOM OF INFORMATION/PRIVACY ACT OFFICERS AND CONTACTS