[Federal Register Volume 73, Number 151 (Tuesday, August 5, 2008)]
[Notices]
[Pages 45459-45460]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-17999]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2002-D-0094] (formerly Docket No. 2002D-0049)


Guidance for the Public, FDA Advisory Committee Members, and FDA 
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 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 
guidance announced in this notice finalizes the draft guidance of the 
same title dated October 2007 and FDA's ``Draft Guidance on Disclosure 
of Conflicts of Interest for Special Government Employees Participating 
in FDA Product Specific Advisory Committees'' dated January 2002. 
Elsewhere in this issue of the Federal Register, FDA is announcing the 
availability of three additional guidances, and one draft guidance, 
intended to improve FDA's advisory committee procedures.

DATES:  The guidance is effective August 5, 2008. Submit written or 
electronic comments on agency guidances at any time.

ADDRESSES:  Submit written requests for single copies of the 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 phone requests to 800-835-4709 or 301-827-1800. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.
    Submit written comments on the guidance to the Division of Dockets

[[Page 45460]]

Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Jill Hartzler Warner, Office of 
Policy, Planning, and Preparedness (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 document entitled 
``Guidance for the Public, FDA Advisory Committee Members, and FDA 
Staff: Public Availability of Advisory Committee Members' Financial 
Interest Information and Waivers,'' dated August 2008. 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 interests to participate in meetings 
where we conclude, after close scrutiny, that certain criteria are met. 
See 18 U.S.C. 208(b)(1), (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 January 2002, 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. 2002D-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 has revised the 2002 draft guidance to broaden its applicability, 
to bring as much transparency as possible to FDA's waiver process, and 
to increase the consistency and clarity of the process. The guidance 
revises 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 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.
    In the Federal Register of October 31, 2007 (72 FR 61657), FDA 
announced the availability of the draft guidance of the same title 
dated October 2007. FDA received one comment on the draft guidance 
generally supporting the guidance. Editorial changes were made to 
improve clarity.
    This guidance document is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance document 
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, at any time, 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/opacom/morechoices/industry/guidedc.htm or http://www.regulations.gov.

    Dated: July 31, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-17999 Filed 8-4-08; 8:45 am]
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