[Federal Register Volume 79, Number 61 (Monday, March 31, 2014)]
[Notices]
[Pages 18032-18033]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-06997]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2002-D-0094]
Guidance for the Public, Food and Drug Administration Advisory
Committee Members, and Food and Drug Administration Staff: Public
Availability of Advisory Committee Members' Financial Interest
Information and Waivers; 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 for the public, FDA advisory committee
members, and
[[Page 18033]]
FDA staff, entitled ``Guidance for the Public, Food and Drug
Administration Advisory Committee Members, and Food and Drug
Administration Staff: Public Availability of Advisory Committee
Members' Financial Interest Information and Waivers.'' We are issuing
the guidance to help the public, FDA advisory committee members, and
FDA staff to understand and implement FDA procedures regarding public
availability of information regarding certain financial interests and
waivers granted by FDA to permit individuals to participate in an
advisory committee meeting. This guidance replaces the guidance of the
same title dated March 2012.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of this guidance
to Advisory Committee Oversight and Management Staff, Office of Special
Medical Programs, Office of Medical Products and Tobacco, 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 requests. See the SUPPLEMENTARY INFORMATION
section for electronic access to the guidance document.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments 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, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993, 301-796-8220, email:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for the public,
FDA advisory committee members, and FDA staff, entitled ``Guidance for
the Public, Food and Drug Administration Advisory Committee Members,
and Food and Drug Administration Staff: Public Availability of Advisory
Committee Members' Financial Interest Information and Waivers.''
FDA's advisory committees provide independent expert advice and
recommendations to the Agency on scientific, technical, and policy
matters related to FDA-regulated products. In March 2012, FDA published
a guidance for the public, FDA advisory committee members, and FDA
staff concerning the implementation of Agency-wide procedures regarding
disclosure of financial interest information that apply to all special
Government employees and regular Government employees invited to
participate in FDA advisory committee meetings subject to the Federal
Advisory Committee Act.
Effective October 1, 2012, the Food and Drug Administration Safety
and Innovation Act amended the statutory provision related to this
guidance. The amendments were relatively minor. FDA is revising the
March 2012 guidance to reflect these amendments and to make other non-
substantive editorial changes.
This level 2 guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance represents
the Agency's thinking on the public availability of waivers relating to
the disclosure of conflicts of interest for advisory committee members
participating in 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 requirements of the applicable statutes and regulations.
II. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of 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, and will be posted to the docket at http://www.regulations.gov.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/RegulatoryInformation/Guidances/ucm122045.htm
or http://www.regulations.gov.
Dated: March 25, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-06997 Filed 3-28-14; 8:45 am]
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