[Federal Register Volume 77, Number 47 (Friday, March 9, 2012)]
[Notices]
[Pages 14404-14405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-5776]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2002-D-0094; (formerly Docket No. 02D-0049)]


Guidance for the Public, Food and Drug Administration (FDA) 
Advisory Committee Members, and FDA Staff: Public Availability of 
Advisory Committee Members' Financial Interest Information and Waivers; 
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 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.'' We are issuing the guidance to help the public, FDA advisory 
committee members, and FDA staff to understand the public availability 
of information regarding certain financial interests and waivers 
granted by FDA to permit individuals to participate in an advisory 
committee meeting. The guidance provides additional transparency to 
FDA's advisory committee process beyond current guidance. This guidance 
finalizes the draft guidance of the same title dated March 2010 and 
replaces the guidance of the same title dated August 2008.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this guidance 
to Advisory Committee Oversight and Management Staff, Office of Special 
Medical Programs, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 32, rm. 5103, Silver Spring, MD 20993. Send one self-
addressed adhesive label to assist that office in processing your 
request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. 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.

FOR FURTHER INFORMATION CONTACT: Michael Ortwerth, Office of the 
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 32, rm. 5104, Silver Spring, MD 20993, email: 
<a href="/cdn-cgi/l/email-protection#f0bd99939891959cdebf82848795828498b0969491de989883de979f86"><span class="__cf_email__" data-cfemail="da97b3b9b2bbbfb6f495a8aeadbfa8aeb29abcbebbf4b2b2a9f4bdb5ac">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: 

I. The Guidance

    FDA is announcing the availability of a guidance entitled, 
``Guidance for the Public, FDA Advisory Committee Members, and FDA 
Staff: Public Availability of Advisory Committee Members' Financial 
Interest Information and Waivers.'' FDA issues guidance documents for 
FDA staff, applicants and sponsors, and the public that describe the 
Agency's current views on a subject.
    In January 2002, 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 (formerly Docket No. 02D-0049, now Docket No. FDA-
2002-D-0094, 67 FR 6545, February 12, 2002). 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. In October 
2007, after an internal assessment of FDA's advisory committee process, 
FDA published a revised draft guidance for public comment (72 FR 61657, 
October 31, 2007). The Agency reviewed the submitted comments on the 
January 2002 draft guidance, the October 2007 draft guidance, and the 
results of the internal assessment of FDA's advisory committee process 
and issued guidance that expanded public availability of relevant 
information to include regular Government employees and SGEs, brought 
additional transparency to FDA's waiver process, and increased the 
consistency and clarity of the process (73 FR 45459, August 5, 2008) 
(www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm125647.pdf).
    In the Federal Register of April 22, 2010 (75 FR 21000), FDA issued 
for public comment ``Draft Guidance for the Public, FDA Advisory 
Committee Members, and FDA Staff: Public Availability of Advisory 
Committee Members' Financial Interest Information and Waivers,'' dated 
March 2010. The Agency explained that it tentatively concluded it is 
appropriate for additional information to be disclosed for individuals 
receiving a waiver of conflict of interest prior to participating in an 
FDA advisory committee meeting. Specifically, FDA proposed disclosure 
of the name of the company or institution associated with the financial 
interest. The Agency based its draft guidance on the expectation that: 
(1) This information would help the public understand the nature of the 
potential conflict and FDA's decision-making and that (2) individuals 
invited as advisory committee members would agree to the inclusion of 
this level of detail as a routine part of required disclosures. FDA 
specifically requested comments on whether disclosing the name of the 
company or institution associated with the financial interest would: 
(1) Increase the transparency of FDA's decisions regarding advisory 
committee member participation and (2) not significantly deter current 
and potential advisory committee members from service on those 
committees. The draft guidance also included a template for disclosing 
to the public the financial interests for which waivers are granted, a 
template for public disclosure of waivers that FDA grants, and FDA's 
process for making these documents available on its Web site.
    We received several comments on the draft guidance. No commenter 
indicated that the proposed policies would deter participation and most 
noted that it would increase transparency.
    FDA is issuing the draft guidance with minor revisions to improve 
clarity.
    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 the public availability of financial 
interest information and waivers relating to the disclosure of 
conflicts of interest for advisory committee members participating in 
FDA 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) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. Identify 
comments with the

[[Page 14405]]

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/AdvisoryCommittees/default.htm.

    Dated: February 28, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-5776 Filed 3-8-12; 8:45 am]
BILLING CODE 4160-01-P


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