[Federal Register Volume 73, Number 151 (Tuesday, August 5, 2008)]
[Notices]
[Pages 45458-45459]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-17998]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0424] (formerly Docket No. 2007D-0101)
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 guidance 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 August 2008. This 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 guidance finalizes the
draft guidance of the same title dated March 2007 and replaces the
guidance document entitled ``FDA Waiver Criteria 2000.'' 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of three additional guidances, and one draft guidance, intended to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: This guidance is effective for advisory committee meetings
scheduled on or after December 3, 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
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; Procedures for Determining Conflict of Interest and Eligibility
for Participation in FDA Advisory Committees,'' 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 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 potential 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
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. The applicable laws have recently changed with
the enactment of the Food and Drug Administration Amendments Act
(FDAAA). Title VII of FDAAA added section 712 of the Federal Food,
Drug, and Cosmectic Act (the act), which became effective October 1,
2007, replaced the conflict of interest provisions in section 505(n)(4)
of the act, and introduced new requirements. In addition, the agency
must apply 18 U.S.C. section 208, which contains different standards
for assessing conflicts of interest. FDA's Waiver Criteria 2000
guidance, which this guidance replaces, 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 guidance implements a more
stringent approach for considering eligibility for participation in FDA
advisory committee meetings. The purpose of this 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.
In the Federal Register of March 23, 2007 (72 FR 13805), FDA
announced the availability of the draft guidance of the same title
dated March 2007. FDA received a number of comments on the draft
guidance and those comments were considered as the guidance was
[[Page 45459]]
finalized. In addition, changes necessitated by the enactment of FDAAA
were incorporated into the final guidance. A summary of changes
includes the following:
FDA is choosing to limit the waivers the agency grants and
harmonize our implementation of the various statutory provisions by
applying a generally stricter test for granting waivers than would be
required in some cases. FDA will ensure that all waivers meet the
standard established by section 712(c)(2)(B) of the act that the waiver
is ``necessary to afford the advisory committee essential expertise.''
The guidance incorporates a progressively more stringent
cap on the numbers of waivers issued per fiscal year in accordance with
FDAAA.
Advisory committee members will be considered for meeting
participation under a rigorous policy regarding the value of their
personal financial interests and those of their immediate family that
potentially could be affected by the meeting deliberations. If an
individual or his spouse or minor child has disqualifying financial
interests whose combined value exceeds $50,000, she generally would not
participate in the meeting, regardless of the need for her expertise.
Financial interests imputed to the member (e.g., the financial
interests of a university that employs the member) are not subject to
the $50,000 maximum.
FDA will not issue a waiver in certain circumstances where
the agency has determined that the conflict of interest is significant.
Waivers may be voting or non-voting at the discretion of
the agency.
Past financial interests that are outside of the scope of
18 U.S.C. 208 and section 712 of the act are not addressed in this
guidance.
New section 712 of the act harmonizes with 18 U.S.C. 208
those exempted interests considered too remote or inconsequential to
affect the integrity of the services of advisory committee members;
therefore, the guidance incorporates such exemptions.
The guidance removes references to administrative steps
(e.g., submission of internal memoranda) that staff should follow;
internal staff instructions will be developed separately.
In addition, editorial changes were made to improve clarity.
This guidance is effective for advisory committee meetings
scheduled on or after (see DATES). FDA staff begin planning and
preparing for advisory committee meetings well in advance of the
meeting date, in order to initiate and complete conflict of interest
screening, among other things, for potential advisory committee
participants. Accordingly, while staff will begin using the guidance
directly, its impact on advisory committee meetings will not be fully
apparent until 120 days after publication.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The 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, 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 Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through FDMS only.
III. Electronic Access
Persons with access to the Internet may obtain the document at:
http://www.fda.gov/ohrms/dockets/default.htm
Dated: July 31, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-17998 Filed 8-4-08; 8:45 am]
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