Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers; Availability, 21000-21001 [2010-9313]
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Federal Register / Vol. 75, No. 77 / Thursday, April 22, 2010 / Notices
A.12–1—ESTIMATES OF ANNUAL BURDEN HOURS
Number of
respondents
Type of respondents
Frequency of
response
Health care professionals who complete the survey .......................................
330
1
Totals ........................................................................................................
330
330
There are no Capital Costs, Operating
Costs, and/or Maintenance Costs to
report.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) Evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and (4) Minimize the burden
of the collection of information on those
who are to respond, including the use
of appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
srobinson on DSKHWCL6B1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Susan McMullen,
RN, Director, Office of Patient Outreach
and Recruitment, Center for Cancer
Research, NCI, Bloch Building 82, Room
101, MSC 8200, 9030 Old Georgetown
Road, Bethesda, Maryland 20892 or by
e-mailing your request, including your
address to: mcmulles@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Dated: April 15, 2010.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2010–9259 Filed 4–21–10; 8:45 am]
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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)
Draft Guidance for the Public, Food
and Drug Administration Advisory
Committee Members, and Food and
Drug Administration 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 draft 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.’’ This draft
guidance is intended to help the public,
FDA advisory committee members, and
FDA staff to understand and implement
FDA procedures regarding public
availability of information regarding
certain financial interests and waivers
granted by FDA to permit individuals to
participate in an advisory committee
meeting. The draft guidance would
provide even greater transparency to
FDA’s advisory committee process than
current guidance. The draft guidance
announced in this notice, when
finalized, would replace guidance of the
same title dated August 2008.
DATES: Although you may comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by June 21, 2010.
ADDRESSES: Submit written requests for
single copies of the guidance to Office
of Special Medical Programs, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, rm. 5103,
PO 00000
Frm 00024
Fmt 4703
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Average Time
per response
(minutes/hour)
Annual burden
hours
5/60
(0.083)
27.5
27.5
Silver Spring, MD 20993. Send one selfaddressed 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 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 https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Michael Ortwerth, Office of Special
Medical Programs, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 5103, Silver Spring,
MD 20993, 301–796–8220.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft 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’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 implements a
rigorous process for soliciting and
vetting candidates for advisory
committee meetings to minimize any
potential for financial conflicts of
interest. The agency is authorized by
statute to grant waivers to allow
individuals with potentially conflicting
financial interests to participate in
meetings where we conclude, after close
scrutiny, that certain criteria are met.
(See 18 U.S.C. 208(b)(1) and (b)(3),
section 712(c)(2)(B) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 379d-1) (added by the Food and
Drug Administration Amendments Act
of 2007, Public Law No. 110–85), and
section 701 (21 U.S.C. 371) (effective
October 1, 2007)).
In January 2002, FDA issued the
‘‘Draft Guidance on Disclosure of
Conflicts of Interest for Special
E:\FR\FM\22APN1.SGM
22APN1
srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 77 / Thursday, April 22, 2010 / Notices
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). 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 August 2008, after an internal
assessment of FDA’s advisory
committee process and based on the
comments submitted to the docket for
the January 2002 draft guidance and a
revised draft guidance published for
public comment in October 2007, the
agency issued guidance that expanded
public availability of relevant
information, brought additional
transparency to FDA’s waiver process,
and increased the consistency and
clarity of the process (www.fda.gov/
downloads/RegulatoryInformation/
Guidances/ucm125647.pdf).
FDA is now making available for
public comment revisions to the August
2008 guidance that provide even greater
transparency. The agency has
tentatively concluded that it is
appropriate to request that individuals
receiving a waiver of conflict of interest
to participate in an FDA advisory
committee meeting disclose the name of
the company or institution when
identifying the ‘‘nature’’ of the
disqualifying financial interest.
In determining how much
information to publicly disclose, FDA
needs to provide enough detail so the
public can understand the nature of the
potential conflict and FDA’s
decisionmaking regarding participation,
while not disclosing so much detail that
the agency would be unable to attract
essential expertise to its advisory
committees. Under the August 2008
guidance, the nature of the financial
interest was identified only as sponsor,
competitor, or other affected firm. This
approach was informed, in part, by a
survey in 2001 of active advisory
committee members that asked whether
members would decline to participate
based on varying levels of disclosure.
FDA is now proposing to disclose
more detail than it did under its August
2008 guidance. Specifically, the agency
proposes to disclose the name of the
company or institution associated with
the financial interest. New information
indicates that this additional detail
would not be a deterrent to current and
potential advisory committee members.
For example, the agency notes that
academic institutions, peer-reviewed
journals, and scientific symposia,
VerDate Nov<24>2008
18:25 Apr 21, 2010
Jkt 220001
among other entities/venues, have in
recent years developed more rigorous
policies for disclosure of potential
conflicts of interest with the work that
is being presented or discussed. (See
‘‘Conflict of Interest in Medical
Research, Education, and Practice,
Committee on Conflict of Interest in
Medical Research, Education, and
Practice, Board on Health Sciences
Policy,’’ Institute of Medicine of the
National Academies (see p. 62 at https://
books.nap.edu/
openbook.php?record_id=12598). While
policies differ among organizations,
many provide for disclosure of the name
of the company or entity constituting
the potential conflict of interest. (See
‘‘Uniform Format for Disclosure of
Competing Interests in ICMJE Journals’’
that describes a disclosure policy and
format that includes identification of the
entity that is the source of the financial
interest; adopted by all International
Committee of Medical Journal Editors
(ICMJE) journals (accessed at https://
content.nejm.org/cgi/content/full/361/
19/1896)). In addition, FDA informally
polled several active advisory
committee members. While not a
representative sample, the survey
indicated that disclosing the names of
companies would not adversely affect
FDA’s ability to attract and retain expert
advisors. Accordingly, we have
tentatively concluded that the public
now expects this level of detail to help
them understand the nature of a
potential conflict and that individuals
would accept this level of detail as a
routine part of required disclosures.
To help us in issuing a final guidance,
FDA is requesting 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 includes a
template for disclosing to the public the
financial interests for which waivers are
granted and a template for disclosing to
the public all waivers that FDA grants.
The draft guidance further describes
FDA’s process for making these
documents available on its Web site in
advance of each advisory committee
meeting.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on public availability of information
regarding advisory committee members’
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
21001
financial interests and waivers granted
by FDA to permit participation in
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) 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.
II. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/
RegulatoryInformation/Guidances/
ucm122045.htm or https://
www.regulations.gov.
Dated: April 19, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–9313 Filed 4–21–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Health Center Program
AGENCY: Health Resources and Services
Administration, HHS.
ACTION: Notice of Noncompetitive
Replacement Awards to Cornerstone
Care, Inc.
SUMMARY: The Health Resources and
Services Administration (HRSA) will be
transferring Health Center Program
(section 330 of the Public Health Service
Act) New Access Point (NAP), Increased
Demand for Service (IDS), and Capital
Improvement Program (CIP) funds
originally awarded to Community
Medical Services to Cornerstone Care,
Inc. to ensure the provision of critical
primary health care services to
underserved populations in Fayette
County, Pennsylvania.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\22APN1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 77 (Thursday, April 22, 2010)]
[Notices]
[Pages 21000-21001]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-9313]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2002-D-0094] (formerly Docket No. 02D-0049)
Draft Guidance for the Public, Food and Drug Administration
Advisory Committee Members, and Food and Drug Administration 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 draft 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.'' This
draft guidance is intended to help the public, FDA advisory committee
members, and FDA staff to understand and implement FDA procedures
regarding public availability of information regarding certain
financial interests and waivers granted by FDA to permit individuals to
participate in an advisory committee meeting. The draft guidance would
provide even greater transparency to FDA's advisory committee process
than current guidance. The draft guidance announced in this notice,
when finalized, would replace guidance of the same title dated August
2008.
DATES: Although you may comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by June 21, 2010.
ADDRESSES: Submit written requests for single copies of the guidance to
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 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 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 https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Michael Ortwerth, Office of Special
Medical Programs, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 5103, Silver Spring, MD 20993, 301-796-8220.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft 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'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 implements a rigorous process for soliciting and vetting
candidates for advisory committee meetings to minimize any potential
for financial conflicts of interest. The agency is authorized by
statute to grant waivers to allow individuals with potentially
conflicting financial interests to participate in meetings where we
conclude, after close scrutiny, that certain criteria are met. (See 18
U.S.C. 208(b)(1) and (b)(3), section 712(c)(2)(B) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 379d-1) (added by the Food
and Drug Administration Amendments Act of 2007, Public Law No. 110-85),
and section 701 (21 U.S.C. 371) (effective October 1, 2007)).
In January 2002, FDA issued the ``Draft Guidance on Disclosure of
Conflicts of Interest for Special
[[Page 21001]]
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). 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 August 2008, after an internal assessment of FDA's advisory
committee process and based on the comments submitted to the docket for
the January 2002 draft guidance and a revised draft guidance published
for public comment in October 2007, the agency issued guidance that
expanded public availability of relevant information, brought
additional transparency to FDA's waiver process, and increased the
consistency and clarity of the process (www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm125647.pdf).
FDA is now making available for public comment revisions to the
August 2008 guidance that provide even greater transparency. The agency
has tentatively concluded that it is appropriate to request that
individuals receiving a waiver of conflict of interest to participate
in an FDA advisory committee meeting disclose the name of the company
or institution when identifying the ``nature'' of the disqualifying
financial interest.
In determining how much information to publicly disclose, FDA needs
to provide enough detail so the public can understand the nature of the
potential conflict and FDA's decisionmaking regarding participation,
while not disclosing so much detail that the agency would be unable to
attract essential expertise to its advisory committees. Under the
August 2008 guidance, the nature of the financial interest was
identified only as sponsor, competitor, or other affected firm. This
approach was informed, in part, by a survey in 2001 of active advisory
committee members that asked whether members would decline to
participate based on varying levels of disclosure.
FDA is now proposing to disclose more detail than it did under its
August 2008 guidance. Specifically, the agency proposes to disclose the
name of the company or institution associated with the financial
interest. New information indicates that this additional detail would
not be a deterrent to current and potential advisory committee members.
For example, the agency notes that academic institutions, peer-reviewed
journals, and scientific symposia, among other entities/venues, have in
recent years developed more rigorous policies for disclosure of
potential conflicts of interest with the work that is being presented
or discussed. (See ``Conflict of Interest in Medical Research,
Education, and Practice, Committee on Conflict of Interest in Medical
Research, Education, and Practice, Board on Health Sciences Policy,''
Institute of Medicine of the National Academies (see p. 62 at https://books.nap.edu/openbook.php?record_id=12598). While policies differ
among organizations, many provide for disclosure of the name of the
company or entity constituting the potential conflict of interest. (See
``Uniform Format for Disclosure of Competing Interests in ICMJE
Journals'' that describes a disclosure policy and format that includes
identification of the entity that is the source of the financial
interest; adopted by all International Committee of Medical Journal
Editors (ICMJE) journals (accessed at https://content.nejm.org/cgi/content/full/361/19/1896)). In addition, FDA informally polled several
active advisory committee members. While not a representative sample,
the survey indicated that disclosing the names of companies would not
adversely affect FDA's ability to attract and retain expert advisors.
Accordingly, we have tentatively concluded that the public now expects
this level of detail to help them understand the nature of a potential
conflict and that individuals would accept this level of detail as a
routine part of required disclosures.
To help us in issuing a final guidance, FDA is requesting 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 includes a template for disclosing to the
public the financial interests for which waivers are granted and a
template for disclosing to the public all waivers that FDA grants. The
draft guidance further describes FDA's process for making these
documents available on its Web site in advance of each advisory
committee meeting.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on public
availability of information regarding advisory committee members'
financial interests and waivers granted by FDA to permit participation
in 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) 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.
II. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/RegulatoryInformation/Guidances/ucm122045.htm
or https://www.regulations.gov.
Dated: April 19, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-9313 Filed 4-21-10; 8:45 am]
BILLING CODE 4160-01-S
