[Federal Register: August 5, 2008 (Volume 73, Number 151)]
[Notices]
[Page 45456-45457]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05au08-63]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0196] (formerly Docket No. 2007D-0449)
Guidance for Food and Drug Administration Advisory Committee
Members and Food and Drug Administration Staff: Voting Procedures for
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 guidance document for FDA advisory committee members
and FDA staff entitled ``Voting Procedures for Advisory Committee
Meetings.'' This document is intended to provide guidance on advisory
committee voting procedures that should be used when votes are taken
during advisory committee meetings. It does not define when votes
should be taken. Elsewhere in this issue of the Federal Register, FDA
is announcing the availability of three additional guidances and one
draft guidance, intended to improve FDA's advisory committee
procedures.
DATES: The guidance is effective August 5, 2008. Submit written or
electronic comments on agency guidances at any time.
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 telephone requests to 800-835-4709 or 301-827-1800.
See the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
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.
FOR FURTHER INFORMATION CONTACT: Jill Hartzler Warner, Office of
Policy, Planning, and Preparedness (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 guidance for FDA advisory
committee members and FDA staff entitled ``Voting Procedures for
Advisory Committee Meetings,'' dated August 2008. FDA's advisory
committees provide independent and expert advice on scientific,
technical, and policy matters related to the development and evaluation
of products regulated by FDA. Advisory committees are a valuable
resource to FDA, and they make an important contribution to the
agency's decisionmaking processes. Although advisory committees provide
recommendations to FDA, the agency makes the final decisions.
Advisory committees typically communicate advice or recommendations
to the agency in two ways. First, FDA learns from the discussion and
exchange that occurs among advisory committee members, and from
individual recommendations and suggestions made during the discussion
of any advisory committee meeting. Second, advisory committees often
vote on a question or series of questions posed to the committee during
a committee meeting.
Votes can be an effective means of communicating with FDA because
they provide feedback on discrete questions. These questions are
generally scientific in nature and can involve a range of subjects,
including evaluation of postmarket safety data or premarket assessment
of a product's risk/benefit profile. Because all members vote on the
same question, the results help FDA gauge a committee's collective view
on complex, multi-faceted issues. This view helps inform the agency's
own deliberations on scientific and regulatory matters.
This guidance recommends adopting uniform voting procedures to help
maximize the integrity and meaning of voting results. In developing
these recommendations, FDA was mindful of the legal requirements of the
Federal Advisory Committee Act, other relevant statutes (e.g., the
Federal Food, Drug, and Cosmetic Act), regulations (e.g., 21 CFR part
14), guidance, policies, and the goals of FDA's of advisory committee
program.
FDA issued a draft of this guidance on November 19, 2007 (72 FR
65046), and gave interested persons an opportunity to comment on the
agency's proposal. FDA carefully evaluated the comments submitted to
that docket and considered them in preparation of the guidance.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). This guidance document represents
the agency's current thinking on uniform procedures that should be used
for the voting process when votes are taken during advisory committee
meetings. 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.
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
[[Page 45457]]
accepted by FDA only through FDMS at http://www.regulations.gov.
Electronic Access:
Persons with access to the Internet may obtain the document at:
http://www.regulations.gov.
Dated: August 1, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-18001 Filed 8-4-08; 8:45 am]
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