Proposed Collection: Comment Request: Drug Accountability Report Form and Investigator Registration Procedure in the Conduct of Investigational Trials for the Treatment of Cancer (NCI), 58401-58402 [2012-23243]
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Federal Register / Vol. 77, No. 183 / Thursday, September 20, 2012 / Notices
indication of nosocomial pneumonia
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Procedure: Interested persons may
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orally or in writing, on issues pending
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submissions may be made to the contact
person on or before November 13, 2012.
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November 2, 2012. Time allotted for
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speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by November 5, 2012.
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Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
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: Drug
Accountability Report Form and
Investigator Registration Procedure in
the Conduct of Investigational Trials for
the Treatment of Cancer (NCI) (OMB No.
0925–0613). Type of Information
Collection Request: Revision. Need and
Use of Information Collection: The U.S.
Food and Drug Administration (FDA)
holds the National Cancer Institute
(NCI) responsible, as a sponsor of
investigational drug trials, for the
collection of information about the
clinical investigators who participate in
these trials and to assure the FDA that
systems for accountability are being
maintained by investigators in its
clinical trials program. The information
collected is used to identify qualified
investigators and to facilitate the
submission and distribution of
important information relative to the
investigational drug and the response of
the patient to that drug. Investigators are
physicians who specialize in the
treatment of patients with cancer. Data
obtained from the Drug Accountability
Record is used to track the dispensing
of investigational anticancer agents from
receipt from the NCI to dispensing or
administration to patients. NCI and/or
its auditors use this information for
compliance purposes. Frequency of
Response: Up to 16 times per year.
Affected Public: Private sector including
businesses, other for-profit
organizations, and non-profit
institutions. Type of Respondents:
Investigators, pharmacists, nurses,
pharmacy technicians, and data
managers. The annualized respondents’
burden for record keeping is estimated
to require 14,223 hours (see Table 1).
There are no capital costs, operating
costs, or maintenance costs.
Dated: September 13, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–23185 Filed 9–19–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection: Comment
Request: Drug Accountability Report
Form and Investigator Registration
Procedure in the Conduct of
Investigational Trials for the Treatment
of Cancer (NCI)
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
SUMMARY:
TABLE 1—ESTIMATES OF ANNUAL BURDEN
Investigators and Designee for Investigator Registration and DARF.
mstockstill on DSK4VPTVN1PROD with NOTICES
Form
Statement of Investigator .................
20,112
1
15/60
5,028
Supplemental Investigator ................
Financial Disclosure .........................
Drug Accountability Record Form
(DARF and DARF-Oral).
20,112
20,112
3,907
1
1
16
10/60
5/60
4/60
3,352
1,676
4,167
...........................................................
........................
........................
........................
14,223
Totals .........................................
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Number of
respondents
Fmt 4703
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Frequency of
response
Average time
per response
(hours)
Type of
respondents
E:\FR\FM\20SEN1.SGM
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Total hour
burden
58402
Federal Register / Vol. 77, No. 183 / Thursday, September 20, 2012 / Notices
Request for Comments
Written comments and/or suggestions
from the public and affected agencies
are invited to address one or more of the
following points: (1) 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) 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)
The quality, utility, and clarity of the
information 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 Charles, Hall, RPh,
M.S., Chief, Pharmaceutical
Management Branch, Cancer Therapy
Evaluation Program, National Cancer
Institute, Executive Plaza North, Room
7149, 9000 Rockville Pike, Bethesda,
Maryland 20891. Or call non-toll-free
number 301–496–5725 or email your
request, include your address to:
hallch@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: September 14, 2012.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2012–23243 Filed 9–19–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
mstockstill on DSK4VPTVN1PROD with NOTICES
National Human Genome Research
Institute; 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
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Jkt 226001
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 Human
Genome Research Institute Special Emphasis
Panel; R25 DAP Sept. 2012.
Date: October 25, 2012.
Time: 1 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Human Genome Research
Institute, 5635 Fishers Lane, 3rd Floor
Conference Room, Rockville, MD 20852
(Telephone Conference Call).
Contact Person: Keith McKenney, Ph.D.,
Scientific Review Officer, NHGRI, 5635
Fishers Lane, Suite 4076, Bethesda, MD
20814, 301–594–4280,
mckenneyk@mail.nih.gov.
Name of Committee: National Human
Genome Research Institute Special Emphasis
Panel; Genomic Resources.
Date: October 29, 2012.
Time: 10 a.m. to 1 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Human Genome Research
Institute, 5635 Fishers Lane, 4th floor
Conference Room, Rockville, MD 20852
(Telephone Conference Call).
Contact Person: Keith McKenney, Ph.D.,
Scientific Review Officer, NHGRI, 5635
Fishers Lane, Suite 4076, Bethesda, MD
20814, 301–594–4280,
mckenneyk@mail.nih.gov.
Name of Committee: National Human
Genome Research Institute Initial Review
Group; Genome Research Review Committee,
GNOM–G (CEGS plus regular load).
Date: November 1–2, 2012.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Human Genome Research
Institute, 5635 Fishers Lane, Terrace Suite 9
& 10, Rockville, MD 20852.
Contact Person: Ken D. Nakamura, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Human Genome Research
Institute, National Institutes of Health,
Bethesda, MD 20892, 301–402–0838.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.172, Human Genome
Research, National Institutes of Health, HHS)
Dated: September 14, 2012.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–23128 Filed 9–19–12; 8:45 am]
BILLING CODE 4140–01–P
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Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Complementary &
Alternative Medicine; Notice of Closed
Meeting
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 meeting.
The meeting 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 Center for
Complementary and Alternative Medicine
Special Emphasis Panel; Clinical Research of
Complementary Medical Care.
Date: October 22, 2012.
Time: 1:30 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892.
Contact Person: Hungyi Shau, Ph.D.,
Scientific Review Officer, National Center
For Complementary and Alternative
Medicine, National Institutes of Health, 6707
Democracy Boulevard, Suite 401, Bethesda,
MD 20892, 301–402–1030,
Hungyi.Shau@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.213, Research and Training
in Complementary and Alternative Medicine,
National Institutes of Health, HHS)
Dated: September 13, 2012.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–23129 Filed 9–19–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the Board
of Scientific Counselors, NHLBI.
The meeting will be closed to the
public as indicated below in accordance
E:\FR\FM\20SEN1.SGM
20SEN1
]]>Agencies
[Federal Register Volume 77, Number 183 (Thursday, September 20, 2012)]
[Notices]
[Pages 58401-58402]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23243]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection: Comment Request: Drug Accountability Report
Form and Investigator Registration Procedure in the Conduct of
Investigational Trials for the Treatment of Cancer (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: Drug Accountability Report Form and
Investigator Registration Procedure in the Conduct of Investigational
Trials for the Treatment of Cancer (NCI) (OMB No. 0925-0613). Type of
Information Collection Request: Revision. Need and Use of Information
Collection: The U.S. Food and Drug Administration (FDA) holds the
National Cancer Institute (NCI) responsible, as a sponsor of
investigational drug trials, for the collection of information about
the clinical investigators who participate in these trials and to
assure the FDA that systems for accountability are being maintained by
investigators in its clinical trials program. The information collected
is used to identify qualified investigators and to facilitate the
submission and distribution of important information relative to the
investigational drug and the response of the patient to that drug.
Investigators are physicians who specialize in the treatment of
patients with cancer. Data obtained from the Drug Accountability Record
is used to track the dispensing of investigational anticancer agents
from receipt from the NCI to dispensing or administration to patients.
NCI and/or its auditors use this information for compliance purposes.
Frequency of Response: Up to 16 times per year. Affected Public:
Private sector including businesses, other for-profit organizations,
and non-profit institutions. Type of Respondents: Investigators,
pharmacists, nurses, pharmacy technicians, and data managers. The
annualized respondents' burden for record keeping is estimated to
require 14,223 hours (see Table 1). There are no capital costs,
operating costs, or maintenance costs.
Table 1--Estimates of Annual Burden
----------------------------------------------------------------------------------------------------------------
Average time
Type of respondents Form Number of Frequency of per response Total hour
respondents response (hours) burden
----------------------------------------------------------------------------------------------------------------
Investigators and Designee for Statement of 20,112 1 15/60 5,028
Investigator Registration and Investigator.
DARF.
Supplemental 20,112 1 10/60 3,352
Investigator.
Financial 20,112 1 5/60 1,676
Disclosure.
Drug 3,907 16 4/60 4,167
Accountability
Record Form
(DARF and DARF-
Oral).
---------------------------------------------------------------
Totals.................... ................ .............. .............. .............. 14,223
----------------------------------------------------------------------------------------------------------------
[[Page 58402]]
Request for Comments
Written comments and/or suggestions from the public and affected
agencies are invited to address one or more of the following points:
(1) 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) 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) The quality, utility, and clarity of the information
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 Charles, Hall, RPh, M.S., Chief, Pharmaceutical
Management Branch, Cancer Therapy Evaluation Program, National Cancer
Institute, Executive Plaza North, Room 7149, 9000 Rockville Pike,
Bethesda, Maryland 20891. Or call non-toll-free number 301-496-5725 or
email your request, include your address to: hallch@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: September 14, 2012.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2012-23243 Filed 9-19-12; 8:45 am]
BILLING CODE 4140-01-P
