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, 14404-14405 [2012-5776]
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Federal Register / Vol. 77, No. 47 / Friday, March 9, 2012 / Notices
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: March 5, 2012.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2012–5674 Filed 3–8–12; 8:45 am]
BILLING CODE 4160–01–P
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.
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finalizes the draft guidance of the same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.
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
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16:21 Mar 08, 2012
Jkt 226001
Submit electronic comments on the
guidance to https://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
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
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
E:\FR\FM\09MRN1.SGM
09MRN1
Federal Register / Vol. 77, No. 47 / Friday, March 9, 2012 / Notices
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 https://
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Preparation for International
Cooperation on Cosmetics
Regulations; Public Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of meeting.
The Food and Drug
Administration (FDA) is announcing a
public meeting entitled ‘‘International
Cooperation on Cosmetics Regulations
(ICCR)–Preparation for ICCR–6 Meeting
in Rockville, Maryland’’ to provide
information and receive comments on
the International Cooperation on
Cosmetics Regulations (ICCR) as well as
the upcoming meetings in Rockville,
MD. The topics to be discussed are the
topics for discussion at the forthcoming
ICCR Steering Committee meeting. The
purpose of the meeting is to solicit
public input prior to the next steering
committee and expert working group
meetings in Rockville, MD on July10 to
13, 2012.
Date and Time: The meeting will be
held on May 15, 2012, from 2 to 4 p.m.
Location: The meeting will be held in
the Washington Theater Room at the
Hilton Washington DC/Rockville Hotel
& Executive Meeting Center, 1750
Rockville Pike, Rockville, MD 20852.
Contact Person: All participants must
register with Kimberly Franklin, Office
of the Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, by
email: Kimberly.Franklin@fda.hhs.gov
or FAX: 301–595–7937.
Registration and Requests for Oral
Presentations: Send registration
information (including: Name, title, firm
name, address, telephone, and fax
number), written material and requests
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:21 Mar 08, 2012
Jkt 226001
to make oral presentation, to the contact
person by May 9, 2012.
If you need special accommodations
due to a disability, please contact
Kimberly Franklin (see Contact Person)
at least 7 days in advance.
Interested persons may present data,
information, or views orally or in
writing, on issues pending at the public
meeting. Time allotted for oral
presentations may be limited to 10
minutes. Those desiring to make oral
presentations should notify the contact
person by May 9, 2012, and submit a
brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses,
telephone number, FAX and email of
the proposed participants, and an
indication of the approximate time
requested to make their presentation.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD. A transcript will
also be available in either hardcopy or
on CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to Division of
Freedom of Information (ELEM–1029),
Food and Drug Administration, 12420
Parklawn Dr., Element Bldg. Rockville,
MD 20857.
SUPPLEMENTARY INFORMATION: The
purpose of the multilateral framework
on the ICCR is to pave the way for the
removal of regulatory obstacles to
international trade while maintaining
global consumer protection.
ICCR is a voluntary international
group of cosmetics regulatory
authorities from the: United States,
Japan, the European Union, and Canada.
These regulatory authority members
will enter into constructive dialogue
with their relevant cosmetics’ industry
trade associations. Currently, the ICCR
members are: Health Canada; the
European Directorate General for
Enterprise and Industry; the Ministry of
Health, Labor and Welfare of Japan; and
the U.S. Food and Drug Administration.
All decisions made by consensus will be
compatible with the laws, policies,
rules, regulations, and directives of the
respective administrations and
governments. Members will implement
and/or promote actions or documents
within their own jurisdictions and seek
convergence of regulatory policies and
practices. Successful implementation
will require input from stakeholders.
Interested persons may present data,
information, or views orally or in
PO 00000
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14405
writing, on issues pending at the public
meeting. Time allotted for oral
presentations may be limited to 10
minutes. Those desiring to make oral
presentations should notify the contact
person by April 22, 2011, and submit a
brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses,
telephone number, fax, and email of
proposed participants, and an
indication of the approximate time
requested to make their presentation.
The agenda for the public meeting
will be made available on the Internet
at https://www.fda.gov/Cosmetics/
InternationalActivities/
ConferencesMeetingsWorkshops/
InternationalCooperationon
CosmeticsRegulationsICCR/default.htm.
Dated: March 6, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–5744 Filed 3–8–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Ancillary Studies
for ISC Consortium.
Date: March 29, 2012.
Time: 2 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892, (Telephone
Conference Call).
Contact Person: Maria E. Davila-Bloom,
Ph.D., Scientific Review Officer, Review
Branch, DEA, NIDDK, National Institutes of
Health, Room 758, 6707 Democracy
Boulevard, Bethesda, MD 20892–5452, (301)
E:\FR\FM\09MRN1.SGM
09MRN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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
https://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
