Proposed Collection; Comment Request; Survey of Health Care Professionals' Awareness and Perceptions of the National Cancer Institute's Intramural Clinical Trials (NCI), 20999-21000 [2010-9259]
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Federal Register / Vol. 75, No. 77 / Thursday, April 22, 2010 / Notices
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Sandra L. Kusumoto,
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Licensing.
[FR Doc. 2010–9231 Filed 4–21–10; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Survey of Health Care
Professionals’ Awareness and
Perceptions of the National Cancer
Institute’s Intramural Clinical Trials
(NCI)
SUMMARY: In compliance with the
requirement of section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Cancer Institute (NCI), the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection: Title: The
Survey of Health Care Professionals’
Awareness and Perceptions of the
National Cancer Institute’s Intramural
Clinical Trials (NCI) Type of
Information Collection Request: New.
Need and Use of Information Collection:
To assess respondents’ awareness and
knowledge of NCI and measure
awareness of NCI clinical trials at the
NIH Clinical Center in Bethesda, Md.
The survey will be disseminated
electronically to members of the
American Medical Association (AMA)
with a certain primary specialties.
Frequency of Response: Yearly.
Affected Public: Individual adults. Type
of Respondents: Health care providers
(AMA members who have allowed the
use of their e-mail address).
The annual reporting burden is
estimated at 28 hours (see Table below).
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21000
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]
BILLING CODE 4140–01–P
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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
Sfmt 4703
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
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Agencies
[Federal Register Volume 75, Number 77 (Thursday, April 22, 2010)]
[Notices]
[Pages 20999-21000]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-9259]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; Survey of Health Care
Professionals' Awareness and Perceptions of the National Cancer
Institute's Intramural Clinical Trials (NCI)
SUMMARY: In compliance with the requirement of section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Cancer Institute
(NCI), the National Institutes of Health (NIH) will publish periodic
summaries of proposed projects to be submitted to the Office of
Management and Budget (OMB) for review and approval.
Proposed Collection: Title: The Survey of Health Care
Professionals' Awareness and Perceptions of the National Cancer
Institute's Intramural Clinical Trials (NCI) Type of Information
Collection Request: New. Need and Use of Information Collection: To
assess respondents' awareness and knowledge of NCI and measure
awareness of NCI clinical trials at the NIH Clinical Center in
Bethesda, Md. The survey will be disseminated electronically to members
of the American Medical Association (AMA) with a certain primary
specialties.
Frequency of Response: Yearly. Affected Public: Individual adults.
Type of Respondents: Health care providers (AMA members who have
allowed the use of their e-mail address).
The annual reporting burden is estimated at 28 hours (see Table
below).
[[Page 21000]]
A.12-1--Estimates of Annual Burden Hours
----------------------------------------------------------------------------------------------------------------
Average Time
Type of respondents Number of Frequency of per response Annual burden
respondents response (minutes/hour) hours
----------------------------------------------------------------------------------------------------------------
Health care professionals who complete the 330 1 5/60 27.5
survey......................................... (0.083)
---------------------------------------------------------------
Totals...................................... 330 330 .............. 27.5
----------------------------------------------------------------------------------------------------------------
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.
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]
BILLING CODE 4140-01-P