Draft Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA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, 13805-13806 [07-1459]
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Federal Register / Vol. 72, No. 56 / Friday, March 23, 2007 / Notices
speak in their assigned order. If
registered presenters are not given an
opportunity to speak because of time
restrictions, we will accept and present
their written testimony to the TAG
members. Time permitting, comments
from other participants (individuals
who are not registered presenters) may
be heard after the scheduled
testimonies.
If there are individuals who cannot
attend the meeting but wish to submit
comments/statements regarding issues
related to the EMTALA TAG, we will
accept and present their written
comments/statements at the meeting if
their comments/statements are received
by postal mail or e-mail at the address
listed in the ADDRESSES section of this
notice by April 19, 2007.
sroberts on PROD1PC70 with NOTICES
III. Registration Instructions
The Center for Medicare Management
of CMS is coordinating meeting
registration. While there is no
registration fee, all individuals must
register to attend due to limited seating.
As specified in the DATES section of this
notice, individuals who wish to attend
the meeting but do not plan to present
testimony must register by April 26,
2007. Individuals who would like both
to attend and to present testimony on
issues relating to the EMTALA TAG
must register by April 12, 2007 and
must state specifically in their
registration request that they wish to
present testimony for EMTALA TAG
consideration. A copy of the presenter’s
written testimony must be received by
CMS at the address specified in the
ADDRESSES section of this notice by
April 19, 2007.
You may register by e-mail to
Marianne Myers at
Marianne.Myers@cms.hhs.gov, by fax to
the attention of Marianne Myers at (410)
786–0681, or by telephone at (410) 786–
5962. All registration requests must
include your name, name of the
organization (if applicable), address,
telephone and fax numbers, e-mail
address (if available). Individuals will
receive a registration confirmation with
instructions for your arrival at the
Hubert Humphrey Building. If seating
capacity has been reached, registrants
will be notified that the meeting has
reached capacity. All registrants are
asked to arrive at the Hubert Humphrey
Building no later than 20 minutes before
the scheduled starting time of each
meeting session they wish to attend.
IV. Security Information
Since this meeting will be held in a
Federal government building, Federal
security measures are applicable. As
noted above, in planning your arrival
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16:41 Mar 22, 2007
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time, we recommend allowing
additional time to clear security. In
order to gain access to the building,
participants must bring a governmentissued photo identification such as a
driver’s license or a passport and a copy
of your registration information for the
meeting. Access may be denied to
persons without proper identification.
All persons entering the building
must pass through a metal detector. In
addition, all items brought to CMS,
whether personal or for the purpose of
demonstration or to support a
presentation, are subject to inspection.
We cannot assume responsibility for
coordinating the receipt, transfer,
transport, storage, set-up, safety, or
timely arrival of any personal
belongings or items used for
demonstration or to support a
presentation.
Authority: Section 945 of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA).
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: March 16, 2007.
Leslie V. Norwalk,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. E7–5329 Filed 3–22–07; 8:45 am]
BILLING CODE 4120–01–P
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.
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
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
13805
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 selfaddressed 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 https://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
E:\FR\FM\23MRN1.SGM
23MRN1
13806
Federal Register / Vol. 72, No. 56 / Friday, March 23, 2007 / Notices
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: https://
www.fda.gov/opacom/morechoices/
industry/guidedc.htm
sroberts on PROD1PC70 with NOTICES
Proposed Project: The National Health
Service Corps (NHSC) Scholarship
Program In-School Worksheets (OMB
No. 0915–0250): Extension
Dated: March 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07–1459 Filed 3–21–07; 1:43 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
Number of
respondents
Instrument
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, call the
HRSA Reports Clearance Officer on
(301) 443–1129.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Responses
per respondent
The National Health Service Corps
(NHSC) Scholarship program provides
scholarships to students in health
professions in return for service in a
federally-designated Health Professional
Shortage Area (HPSA). If awarded an
NHSC scholarship, the program requires
the schools and the awardees to review
and complete data collection
worksheets for each year that the
student is an NHSC Scholar. The forms
provide information on the following:
Verification of enrollment status;
current curriculum; current contact
information; and verification of
accuracy of student data. The
worksheets require minimal burden and
provide the program with information
that is required to determine if scholars
are maintaining their status of eligibility
as required by Federal statute.
The annual estimate of burden is as
follows:
Hours per
response
(minutes)
Total responses
Total burden
hours
Scholar Worksheet ...............................................................
School Verification Worksheet .............................................
School Contact Information .................................................
800
300
550
1
1
1
800
300
550
10
10
10
134
50
92
Total ..............................................................................
1,650
........................
1,650
........................
276
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17:56 Mar 22, 2007
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23MRN1
]]>Agencies
[Federal Register Volume 72, Number 56 (Friday, March 23, 2007)]
[Notices]
[Pages 13805-13806]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-1459]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://
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:
https://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]
BILLING CODE 4160-01-S
