[Federal Register Volume 73, Number 151 (Tuesday, August 5, 2008)]
[Pages 45458-45459]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-17998]



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.


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draft guidance of the same title dated March 2007 and replaces the 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of three additional guidances, and one draft guidance, intended to 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.


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 
     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 
     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: 

    Dated: July 31, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-17998 Filed 8-4-08; 8:45 am]