[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Draft Guidance for the Public, FDA Advisory Committee Members, 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 This draft guidance describes the 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 This draft guidance, when 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DATES:  Submit written or electronic comments on the draft guidance by 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written comments on the draft guidance to the Division of Dockets 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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]

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