[Federal Register: June 23, 2003 (Volume 68, Number 120)]
[Page 37162-37163]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 1999P-1656]

Posting Warning Letter Responses on FDA's Web Site; Notice of 
Pilot Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) plans to implement a 6-
month pilot program in which we (FDA) will post on our Internet Web 
site certain responses to warning letters. The pilot program is part of 
our ongoing efforts to keep the public informed regarding agency 
activities and to make information publicly available. During this 
pilot, we will post copies of certain responses to warning letters if 
the recipient requests that the response be posted on our Web site and 
submits the response in an appropriate electronic format. We will 
review the responses and redact certain information to ensure that the 
responses comply with protections available under the Freedom of 
Information Act (FOIA).

DATES: The pilot program will begin on September 22, 2003.

FOR FURTHER INFORMATION CONTACT: Philip L. Chao, Office of Policy and 
Planning, Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857, 301-827-0587.


I. Background

    FDA traditionally receives many requests under FOIA (5 U.S.C. 552) 
for warning letters issued to FDA-regulated entities. In compliance 
with the Electronic Freedom of Information Act Amendments of 1996 
(EFOIA), we post on our Web site warning letters that are, or are 
likely to be, frequently requested documents under FOIA. Updated 
information regarding a specific issue discussed in a warning letter, 
however, may not be available on the Web site. In a citizen petition 
dated May 26, 1999, we were asked to draft regulatory procedures that 
would require us to promptly post, to the extent permitted under FOIA, 
agency records related to any previously posted warning letters. The 
petition requested that this policy extend to agency memoranda or 
letters that relate, refer, or pertain to any resolution of any of the 
issues in the warning letters and, where applicable, updates to the 
firm profile. We declined to post all materials related to warning 
letters on our Internet Web site, but decided to initiate a 6-month 
pilot program in which we will post certain responses to warning 

II. Pilot Program Description

    The pilot program is part of our ongoing efforts to keep the public 
informed regarding agency activities and to make information available 
in a manner that is accessible and fair. Accordingly, we plan to test, 
for 6 months, a pilot program that provides warning letter recipients 
the opportunity to have their responses to warning letters posted on 
our Web site. For purposes of this pilot only, we consider warning 
letter recipients to be the addressee and any other individuals or 
entities specifically named in a warning letter.
    When the pilot program begins, responses submitted to us: (1) With 
request that the response be posted, and (2) in the format described in 
the following paragraphs, will be considered for the pilot program. 
After 180 days, we will evaluate the pilot and determine whether the 
program should become permanent. However, if we experience undue burden 
in dealing with the process, find that the process is too resource-
intensive, or determine that misleading information is being conveyed 
to the public as a result of the pilot, we may discontinue the program.
    We will post a warning letter recipient's response on our Web site 
if the recipient: (1) Requests that the response be posted, and (2) 
submits to us a copy of the response in a word processing format on a 
disk or CD-ROM. (The disk or CD-ROM should be submitted to the FDA 
office that issued the warning letter and should be submitted with the 
response.) We will review the response and redact certain information 
to ensure that the response complies with protections available under 
FOIA. For purposes of this pilot program only, we consider a warning 
letter recipient to be the addressee and any other individual or entity 
specifically named in a warning letter. If a warning letter recipient 
wishes to participate in this pilot, the recipient should submit a copy 
of the response on a computer disk in a word processing format. We will 
electronically redact and also convert the document to a format that is 
consistent with 29 U.S.C. 794d. Warning letter recipients submitting a 
response should clearly identify the warning letter to which they are 
responding by noting the date of the warning letter and the 
company(ies) or individual(s) involved.
    We reserve the right not to post responses in some cases, such as 
when a response would likely mislead the public concerning the safety 
or efficacy of a company's product(s). During this pilot program, we 
also intend to place a disclaimer on our Web site stipulating the 

    Note: The Food and Drug Administration cannot assure the 
accuracy of information submitted to the agency without a complete 
review of the submitted materials and resolution of the issues 
discussed therein. To make certain information available to the 
public, the agency has undertaken a pilot program to post responses 
to warning letters before evaluating the documents and resolving the 
issues. The responses are redacted to the extent permitted by the 
Freedom of Information Act.

[[Page 37163]]

    We believe the disclaimer allows us to properly inform the public 
about the information contained on our Web site. We reserve the right 
to change the language in the disclaimer should we consider it 
appropriate to do so.
    Once we have had sufficient opportunity to assess our experience in 
implementing the pilot program, we will decide whether to make the 
program permanent.

    Dated: June 16, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-15732 Filed 6-20-03; 8:45 am]