[Federal Register Volume 73, Number 151 (Tuesday, August 5, 2008)]
[Notices]
[Pages 45455-45456]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-18002]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0417]
Draft Guidance for the Public and the Food and Drug
Administration Staff on Convening Advisory Committee Meetings;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance document entitled ``Guidance for the
Public and FDA Staff on Convening Advisory Committee Meetings.'' This
draft guidance is intended to provide guidance on when FDA should
consider referring a matter to an advisory committee. Elsewhere in this
issue of the Federal Register, FDA is announcing the availability of
four guidances intended to improve FDA's advisory committee procedures.
DATES: Although you can comment on any guidance at any time (see Sec.
10.115(g)(5) (21 CFR 10.115(g)(5))), to ensure that the agency
considers your comment on this draft guidance before it begins work on
the final version of the guidance, submit written or electronic
comments on the draft guidance by October 6, 2008.
ADDRESSES: Submit written requests for single copies of the guidance
to the Office of Policy (HF-11), Office of the Commissioner, Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one
self-addressed adhesive label to assist that office in processing your
requests. Submit phone requests to 800-835-4709 or 301-827-1800. Submit
written comments on the guidance to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov . See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Jill Hartzler Warner, Office of Policy
and Planning (HF-11), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-3370.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance entitled
``Guidance for the Public and FDA Staff on Convening Advisory Committee
Meetings,'' dated July 2008. Advisory committees provide FDA with
independent, expert advice on a range of complex scientific and
technical issues related to the products it regulates. These issues
typically focus on a specific food or medical product, a class of foods
or medical products, the development and implementation of a specific
regulatory program, or the development and implementation of a
regulatory policy. Advisory committee meetings also facilitate public
discussion of important topics and provide a means for the public to
provide comments to the agency.
To enhance the transparency of FDA's advisory committee program,
the agency is publishing this draft guidance to provide its current
thinking on when to bring a matter to an advisory committee. In some
instances, FDA refers a matter to an advisory committee because it is
required to do so by law. In others, FDA convenes an advisory committee
meeting at its own discretion. Regardless, FDA recognizes that advisory
committee meetings demand significant resource commitments by advisory
committee members, sponsors, and other public participants, as well as
for FDA itself, and should be used for important matters. The draft
guidance is intended to clarify how the agency identifies which matters
should be referred.
In developing this draft guidance, FDA has been mindful of the
legal requirements of the Federal Advisory Committee Act (FACA), other
relevant statutes, regulations, guidance, and policies, and the goals
of FDA's of advisory committee program.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (Sec. 10.115). The draft guidance
represents the agency's current thinking on when FDA convenes an
advisory committee meeting. It does not create or confer any rights for
or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
[[Page 45456]]
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/ohrms/dockets/default.htm or http://www.regulations.gov.
Dated: August 1, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-18002 Filed 8-4-08; 8:45 am]
BILLING CODE 4160-01-S