[Federal Register Volume 75, Number 237 (Friday, December 10, 2010)]
[Notices]
[Pages 76992-76993]
From the Federal Register Online via the Government Publishing 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: [email protected].
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7747), FDA issued a notice announcing the availability of a draft
guidance entitled ``The Open Public Hearing; FDA Advisory Committee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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