[Federal Register Volume 73, Number 151 (Tuesday, August 5, 2008)]
[Notices]
[Pages 45456-45457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-18001]


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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draft guidance, intended to improve FDA's advisory committee 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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