[Federal Register: August 5, 2008 (Volume 73, Number 151)]
[Notices]
[Page 45459-45460]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05au08-66]
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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guidance announced in this notice finalizes the draft guidance of the
same title dated October 2007 and FDA's ``Draft Guidance on Disclosure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availability of three additional guidances, and one draft guidance,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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov.
III. Electronic Access
Persons with access to the Internet may obtain the document at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/opacom/morechoices/industry/guidedc.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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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