[Federal Register Volume 77, Number 47 (Friday, March 9, 2012)]
[Notices]
[Pages 14404-14405]
From the Federal Register Online via the Government Printing 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finalizes the draft guidance of the same title dated March 2010 and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:
Michael.Ortwerth@fda.hhs.gov.
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