[Federal Register Volume 68, Number 120 (Monday, June 23, 2003)]
[Notices]
[Pages 37162-37163]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-15732]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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.
SUPPLEMENTARY INFORMATION:
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
letters.
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
following:
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]
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