
[Federal Register Volume 75, Number 237 (Friday, December 10, 2010)]
[Notices]
[Pages 76992-76993]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31022]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-D-0072] (formerly Docket No. 2005D-0042)


Guidance for the Public, FDA Advisory Committee Members, and FDA 
Staff: The Open Public Hearing at FDA 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 entitled ``Guidance for the Public, FDA 
Advisory Committee Members, and FDA Staff: The Open Public Hearing at 
FDA Advisory Committee Meetings.'' We are issuing the guidance to 
provide information on how the public may participate at the open 
public hearing (OPH) portion of FDA advisory committee meetings. The 
guidance also provides recommendations regarding financial disclosure 
by persons participating in the OPH portion of advisory committee 
meetings.

DATES: Submit electronic or written comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Office of Special Medical Programs, Office of the Commissioner, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 
5103, Silver Spring, MD 20993. Send one self-addressed adhesive label 
to assist that office in processing your request. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance. Submit 
electronic comments on the guidance to http://www.regulations.gov. 
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.

FOR FURTHER INFORMATION CONTACT: Michael Ortwerth, Office of Special 
Medical Programs, Office of the Commissioner, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5103, Silver 
Spring, MD 20993, e-mail: Michael.Ortwerth@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the February 15, 2005, issue of the Federal Register (70 FR 
7747), FDA issued a notice announcing the availability of a draft 
guidance entitled ``The Open Public Hearing; FDA Advisory Committee 
Meetings.'' The guidance is intended for members of the public who 
choose to participate in the OPH portion of an FDA advisory committee 
meeting.
    FDA issues guidance documents for FDA staff, applicants and 
sponsors of regulated products, and the public that describe the 
agency's current thinking on a regulatory matter, including its 
interpretation of, and policies regarding, statutes and regulations. 
FDA's advisory committees provide independent expert advice and 
recommendations to the agency on scientific, technical, and policy 
matters related to FDA-regulated products. Although advisory committees 
provide recommendations to FDA, FDA makes the final decisions on any 
matters considered by an advisory committee (21 CFR 14.5). Under 21 CFR 
14.25(a), every meeting of an FDA advisory committee includes an OPH 
session during which interested persons may present relevant 
information or views orally or in writing. The hearing session is 
conducted in accordance with the procedures set forth in 21 CFR 14.29.
    FDA encourages participation from all public stakeholders in our 
decisionmaking processes. We issued the draft guidance to answer 
questions about how the public may participate at an OPH session. 
Participants may include, but are not limited to, general members of 
the public, individuals or spokespersons from the regulated industry, 
consumer advocacy groups, and professional organizations, societies, 
and associations. The guidance provides information on such matters as 
how to submit a request to speak at an OPH session, logistical 
procedures, and disclosure of financial relationships relevant to the 
meeting topic.
    We received two comments on the draft guidance. In response to the 
comments and at our own initiative, we have revised the guidance in 
several respects, including with regard to how the OPH session is 
conducted and instructions regarding financial disclosure.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's thinking on participation in the OPH portion of FDA 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

[[Page 76993]]

requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments 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.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
http://www.fda.gov/oc/advisory/default.htm.

    Dated: December 6, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-31022 Filed 12-9-10; 8:45 am]
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