[Federal Register: October 31, 2007 (Volume 72, Number 210)]
[Notices]
[Page 61657-61658]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31oc07-85]
-----------------------------------------------------------------------
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Draft Guidance for the Public, Food and Drug Administration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.
-----------------------------------------------------------------------
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availability of a draft guidance document for the public, FDA advisory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 The draft
guidance announced in this notice supersedes FDA's ``Draft Guidance on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this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Policy (HF-11), Office of the Commissioner,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Submit written comments on the draft guidance to the Division of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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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