[Federal Register Volume 72, Number 210 (Wednesday, October 31, 2007)]
[Notices]
[Pages 61657-61658]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-5408]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2002D-0049 (formerly Docket No. 02D-0049)]


Draft Guidance for the Public, Food and Drug Administration 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availability of a draft guidance document for the public, FDA advisory 
committee members, and FDA staff entitled ``Guidance for the Public, 
FDA Advisory Committee Members, and FDA Staff: Public Availability of 
Advisory Committee Members' Financial Interest Information and 
Waivers.'' This guidance is intended 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. The draft 
guidance announced in this notice supersedes FDA's ``Draft Guidance on 
Disclosure of Conflicts of Interest for Special Government Employees 
Participating in FDA Product Specific Advisory Committees,'' dated 
January 2002.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115 (g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by December 31, 2007.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Policy (HF-11), Office of the Commissioner, 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.
    Submit written comments on the draft guidance to the Division of 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 either http://www.fda.gov/dockets/ecomments or http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Jill Hartzler Warner, Office of Policy 
and Planning (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 draft guidance entitled 
``Guidance for the Public, FDA Advisory Committee Members, and FDA 
Staff: Public Availability of Advisory Committee Members' Financial 
Interest Information and Waivers,'' dated October 2007. 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. FDA implements a rigorous process for 
soliciting and vetting candidates for advisory committee meetings to 
minimize any potential for financial conflicts of interest. The agency 
is authorized by statute to grant waivers to allow individuals with 
potentially conflicting financial

[[Page 61658]]

interests to participate in meetings where we conclude, after close 
scrutiny, that certain criteria are met. (See 18 U.S.C. 208(b)(1) and 
(b)(3) and section 712(c)(2)(B) of the Federal Food, Drug, and Cosmetic 
Act (the act) (added by the Food and Drug Administration Amendments Act 
of 2007 (Public Law No. 110-85), section 701 (effective October 1, 
2007).)
    In the  Federal Register of January 12, 2002 (67 FR 6545), FDA 
issued ``Draft Guidance on Disclosure of Conflicts of Interest for 
Special Government Employees Participating in FDA Product Specific 
Advisory Committees,'' and requested comments on the draft guidance 
(Docket No. 02D-0049). The draft guidance was limited in application to 
special government employees (SGEs) participating in advisory committee 
meetings at which particular matters relating to particular products 
were discussed.
    FDA has recently undertaken an internal assessment of its advisory 
committee process. As a result of this review, and based on the 
comments submitted to the docket for the January 2002 draft guidance, 
FDA is revising this draft guidance to broaden its applicability, bring 
as much transparency as possible to FDA's waiver process, and increase 
the consistency and clarity of the process. The draft guidance proposes 
revised procedures, consistent with section 712(c)(3) of the act, to 
make publicly available relevant information regarding financial 
interests and waivers granted by the agency for SGEs and regular 
Government employees invited to participate in FDA advisory committee 
meetings.
    The draft guidance also includes a template for disclosing to the 
public the disqualifying financial interests for which waivers are 
sought and a template for all waivers that FDA grants. The guidance 
further describes FDA's process for making these documents available on 
its Web site in advance of each advisory committee meeting.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance 
represents the agency's current thinking on public availability of 
information regarding advisory committee members' financial interests 
and waivers granted by FDA to permit participation in 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.

    Dated: October 24, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-5408 Filed 10-29-07; 8:45 am]
BILLING CODE 4160-01-S