[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]
BILLING CODE 4160-01-P