[Federal Register Volume 67, Number 132 (Wednesday, July 10, 2002)]
[Notices]
[Pages 45742-45743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-17275]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0209]


Request for Comment on First Amendment Issues

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to 
September 13, 2002, the comment period for original comments and is 
extending to October 28, 2002, the comment period for responses to 
those comments relating to FDA's Request for Comment on First Amendment 
Issues published in the Federal Register of May 16, 2002 (67 FR 34942). 
The agency is taking this action in response to requests for an 
extension.

DATES: Submit written or electronic comments on the Request for Comment 
on First Amendment Issues by September 13, 2002, and submit written or 
electronic responses to those comments by October 28, 2002.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.

[[Page 45743]]

1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Catherine Lorraine, Office of Policy, 
Planning, and Legislation (HF-11), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-3360.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 16, 2002 (67 
FR 34942), FDA published a document entitled ``Request for Comment on 
First Amendment Issues.'' In this document FDA asked the public to 
comment on a number of questions to help ensure that the agency's 
regulations, guidances, policies, and practices continue to comply with 
the governing First Amendment case law. Recent case law has emphasized 
the need for not imposing unnecessary restrictions on speech. The 
document also stated the agency's wish to learn what empirical evidence 
exists concerning, among other things, the effect of commercial speech 
on the public health.
    The agency received three letters requesting that the agency extend 
the comment period for 60 days until September 30, 2002, for the 
submission of comments and until November 13, 2002, for the submission 
of responses to the comments. The three requests cited the need for 
additional time because of the complexity and importance of the subject 
matter to be commented on. The requests also stated an extension was 
needed to enable consultation with a variety of individuals, including 
social science and other experts, as well as business partners. One 
request pointed out that summer vacation schedules would make this 
consultation even more difficult. FDA has determined that it is 
appropriate to grant these requests. However, FDA believes that an 
additional 45 days will be sufficient time to allow for the 
consultations discussed and the preparation of comments.
    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments on the document requesting 
comment on First Amendment issues by September 13, 2002, and responses 
to comments by October 28, 2002. Three copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Comments and responses to comments may be seen in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: July 3, 2002.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 02-17275 Filed 7-9-02; 8:45 am]
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