[Federal Register: March 23, 2007 (Volume 72, Number 56)]
[Notices]
[Page 13805-13806]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23mr07-93]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0101]
Draft Guidance for the Public, FDA Advisory Committee Members,
and FDA Staff on Procedures for Determining Conflict of Interest and
Eligibility for Participation in FDA Advisory Committees; 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 document for the public, FDA advisory committee
members, and FDA staff entitled ``Guidance for the Public, FDA Advisory
Committee Members, and FDA Staff: Procedures for Determining Conflict
of Interest and Eligibility for Participation in FDA Advisory
Committees'' dated March 2007. This draft guidance describes the
factors and analyses that should be used in considering whether an
advisory committee member has a potential conflict of interest and
whether participation in a meeting is appropriate. This guidance is
intended to help the public, FDA advisory committee members, and FDA
staff to understand and implement FDA policy in applying the applicable
statutory and regulatory requirements. This draft guidance, when
finalized, will replace the guidance document entitled ``FDA Waiver
Criteria 2000.''
DATES: Submit written or electronic comments on the draft guidance by
May 21, 2007. General comments on agency guidance documents are welcome
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. 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written comments on the draft guidance to the Division of Dockets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 http://www.fda.gov/dockets/ecomments.
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 document, entitled
``Guidance for the Public, FDA Advisory Committee Members, and FDA
Staff; Procedures for Determining Conflict of Interest and Eligibility
for Participation in FDA Advisory Committees,'' dated March 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 is committed to strictly adhering to the laws and regulations
governing the process for selecting advisory committee members. FDA for
many years has screened, prior to each meeting, all advisory committee
members who are special government employees or regular government
employees, to determine whether the potential for a financial conflict
of interest exists. The agency may grant a waiver to allow an
individual to
[[Page 13806]]
participate in a meeting when statutory criteria are met; for example,
when the need for the individual's services outweighs the potential for
a conflict of interest created by the financial interest involved. FDA
administers several laws and regulations that govern conflict of
interest determinations; these laws are not entirely consistent and set
out different standards. FDA's Waiver Criteria 2000 guidance, which
this draft guidance would replace, attempted to comprehensively address
the complex set of variables that can be applied in reaching a
determination about an individual advisory committee participant.
However, because of its complexity and discretionary elements, FDA
staff found it difficult to achieve consistent results that the public
could readily understand. As part of FDA's recent internal assessment
of its advisory committee process, the agency has targeted its
assessment of potential conflicts of interest and granting of waivers
as an area that needs improvement. This draft guidance will implement a
more stringent approach for considering eligibility for participation
in FDA advisory committee meetings. The purpose of this draft guidance
is to simplify and streamline the process by which FDA considers
meeting participation, increase the transparency, clarity, and
consistency of the process, and enhance public trust in this important
function.
We welcome comments on the draft guidance and specifically seek
comment on (1) whether the draft approach, due to its stringency, could
unduly restrict eligibility of needed experts for advisory committee
meetings, (2) whether the $50,000 figure generally employed as the
maximum amount for disqualifying financial interests, after applying
certain exemptions, is appropriate or, alternatively, whether a
different figure (higher or lower) should be used, and (3) whether and
what additional examples should be provided for the steps described in
this draft guidance for determining conflicts of interest and
eligibility for participating in an 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 procedures for considering
conflict of interest and eligibility for participation in FDA advisory
committees. 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.
III. Electronic Access
Persons with access to the Internet may obtain the document at:
http://www.fda.gov/opacom/morechoices/industry/guidedc.htm
Dated: March 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-1459 Filed 3-21-07; 1:43 pm]
BILLING CODE 4160-01-S