Proposed Collection; 60-Day Comment Request; Drug Accountability Report Form and Investigator Registration Procedure in the Conduct of Investigational Trials for the Treatment of Cancer (NCI), 71815-71816 [2015-29246]
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Federal Register / Vol. 80, No. 221 / Tuesday, November 17, 2015 / Notices
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
mstockstill on DSK4VPTVN1PROD with NOTICES
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: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Topics in Digestive Disease.
Date: November 23, 2015.
Time: 2:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Aiping Zhao, MD.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Rm 2188
MSC7818, Bethesda, MD 20892–7818, (301)
435–0682, zhaoa2@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Oncology 2—Translational Clinical
Applications.
Date: November 24, 2015.
Time: 11:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Sharon K. Gubanich,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6195D,
MSC 7804, Bethesda, MD 20892, (301) 408–
9512, gubanics@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
VerDate Sep<11>2014
18:14 Nov 16, 2015
Jkt 238001
Dated: November 10, 2015.
Natasha Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–29243 Filed 11–16–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day 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
Cancer Therapy Evaluation Program
(CTEP)/Division of Cancer Therapy and
Diagnostics (DCTD), 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.
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 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.
To Submit Comments and for Further
Information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact, Charles Hall, RPh, M.S.,
SUMMARY:
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
71815
Chief, Pharmaceutical Management
Branch, Cancer Therapy Evaluation
Program, National Cancer Institute, 9609
Medical Center Drive, RM 5W240, MSC
9725, Bethesda, Maryland 20892. Or call
non-toll-free number (240) 276–6575, or
email your request, include your
address to: hallch@mail.nih.gov.
Comment 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.
Proposed Collection: Title: Drug
Accountability Report Form and
Investigator Registration Procedure in
the Conduct of Investigational Trials for
the Treatment of Cancer, 0925–0613,
Expiration Date 03/31/2016, Revision,
National Cancer Institute (NCI),
National Institutes of Health (NIH).
Need and Use of Information
Collection: Revision. 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. The frequency of
Response is up to 16 times per year. The
affected public is private sector
including businesses, other for-profit
organizations, and non-profit
institutions. The type of respondents are
investigators, pharmacists, nurses,
pharmacy technicians, and data
managers.
OMB approval is requested for 3
years. There are no capital costs,
operating costs or maintenance costs.
The total estimated annualized burden
hours are 22,645 hours.
Estimated Annualized Burden Hours
E:\FR\FM\17NON1.SGM
17NON1
71816
Federal Register / Vol. 80, No. 221 / Tuesday, November 17, 2015 / Notices
TABLE 1—ESTIMATES OF ANNUAL BURDEN
Number of
respondents
Type of respondents
Form
Investigators and Designee for Investigator Registration and DARF.
Statement of Investigator (Attachments 3A, 3B or 10).
NCI/DCTD/CTEP Supplemental Investigator (Attachment 4).
Financial Disclosure Forms (Attachment 5A or 5B).
NCI/DCTD/CTEP Drug Accountability Record Form (DARF and
DARF-Oral) (Attachments 1 & 2).
Dated: November 9, 2015.
Karla Bailey,
Project Clearance Liaison, National Cancer
Institute, NIH.
[FR Doc. 2015–29246 Filed 11–16–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases: Notice of Closed
Meetings
mstockstill on DSK4VPTVN1PROD with NOTICES
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
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID SBIR Phase II
Clinical Trial Implementation Cooperative
Agreement (U44).
Date: December 9, 2015.
Time: 9:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Room
4C100, 5601 Fishers Lane, Rockville, MD
20892.
Contact Person: Zhuqing (Charlie) Li,
Ph.D., Scientific Review Officer, Scientific
Review Program, Division of Extramural
Activities, Room # 3G41B, National Institutes
of Health/NIAID, 5601 Fishers Lane,
MSC9823, Bethesda, MD 20892–9823, (240)
669–5068, zhuqing.li@nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
VerDate Sep<11>2014
18:14 Nov 16, 2015
Jkt 238001
15/60
5,571
22,283
1
10/60
3,721
22,283
1
5/60
1,849
3,288
16
4/60
3,525
Dated: November 9, 2015.
Natasha Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–29247 Filed 11–16–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2); 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 purpose of this
meeting is to evaluate requests for
preclinical development resources for
potential new therapeutics for the
treatment of cancer. The outcome of the
evaluation will provide information to
internal NCI committees that will
Fmt 4703
Sfmt 9990
Total hour
burden
1
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Frm 00047
Average time
per response
(in hours)
22,283
Emphasis Panel; NIAID Resource-Related
Research Projects (R24) and NIAID
Investigator Initiated Program Project
Applications (P01).
Date: January 12–13, 2016.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Room
3F100, 5601 Fishers Lane, Rockville, MD
20892 (Telephone Conference Call).
Contact Person: Quirijn Vos, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
Room 3G31A, National Institutes of Health/
NIAID, 5601 Fishers Lane, MSC 9823,
Bethesda, MD 20892–9823, (240) 669–5059,
qvos@niaid.nih.gov.
PO 00000
Frequency of
response
decide whether NCI should support
requests and make available contract
resources for development of the
potential therapeutic to improve the
treatment of various forms of cancer.
The research proposals and the
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the
proposed research projects, the
disclosure of which would constitute a
clearly unwarranted invasion of
personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Dec 2015
Cycle 21 NExT SEP Committee Meeting.
Date: December 16, 2015.
Time: 8:30 a.m. to 4:30 p.m.
Agenda: To evaluate the NCI Experimental
Therapeutics Program Portfolio.
Place: National Institutes of Health, 9000
Rockville Pike, Campus Building 31,
Conference Room 6C6, Bethesda, MD 20892.
Contact Person: Barbara Mroczkowski,
Ph.D., Executive Secretary, Discovery
Experimental Therapeutics Program National
Cancer Institute, NIH, 31 Center Drive, Room
3A44, Bethesda, MD 20817, (301) 496–4291,
mroczkoskib@mail.nih.gov.
Toby Hecht, Ph.D., Executive Secretary,
Development Experimental Therapeutics
Program, National Cancer Institute, NIH,
9609 Medical Center Drive, Room 3W110,
Rockville, MD 20850, (240) 276–5683
toby.hecht2@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: November 10, 2015.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–29245 Filed 11–16–15; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\17NON1.SGM
17NON1
]]>Agencies
[Federal Register Volume 80, Number 221 (Tuesday, November 17, 2015)]
[Notices]
[Pages 71815-71816]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29246]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day 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 Cancer Therapy Evaluation
Program (CTEP)/Division of Cancer Therapy and Diagnostics (DCTD), 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.
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 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.
To Submit Comments and for Further Information: To obtain a copy of
the data collection plans and instruments, submit comments in writing,
or request more information on the proposed project, contact, Charles
Hall, RPh, M.S., Chief, Pharmaceutical Management Branch, Cancer
Therapy Evaluation Program, National Cancer Institute, 9609 Medical
Center Drive, RM 5W240, MSC 9725, Bethesda, Maryland 20892. Or call
non-toll-free number (240) 276-6575, or email your request, include
your address to: hallch@mail.nih.gov.
Comment 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.
Proposed Collection: Title: Drug Accountability Report Form and
Investigator Registration Procedure in the Conduct of Investigational
Trials for the Treatment of Cancer, 0925-0613, Expiration Date 03/31/
2016, Revision, National Cancer Institute (NCI), National Institutes of
Health (NIH).
Need and Use of Information Collection: Revision. 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. The frequency of Response is
up to 16 times per year. The affected public is private sector
including businesses, other for-profit organizations, and non-profit
institutions. The type of respondents are investigators, pharmacists,
nurses, pharmacy technicians, and data managers.
OMB approval is requested for 3 years. There are no capital costs,
operating costs or maintenance costs. The total estimated annualized
burden hours are 22,645 hours.
Estimated Annualized Burden Hours
[[Page 71816]]
Table 1--Estimates of Annual Burden
----------------------------------------------------------------------------------------------------------------
Average time
Type of respondents Form Number of Frequency of per response Total hour
respondents response (in hours) burden
----------------------------------------------------------------------------------------------------------------
Investigators and Designee for Statement of 22,283 1 15/60 5,571
Investigator Registration and Investigator
DARF. (Attachments
3A, 3B or 10).
NCI/DCTD/CTEP 22,283 1 10/60 3,721
Supplemental
Investigator
(Attachment 4).
Financial 22,283 1 5/60 1,849
Disclosure
Forms
(Attachment 5A
or 5B).
NCI/DCTD/CTEP 3,288 16 4/60 3,525
Drug
Accountability
Record Form
(DARF and DARF-
Oral)
(Attachments 1
& 2).
----------------------------------------------------------------------------------------------------------------
Dated: November 9, 2015.
Karla Bailey,
Project Clearance Liaison, National Cancer Institute, NIH.
[FR Doc. 2015-29246 Filed 11-16-15; 8:45 am]
BILLING CODE 4140-01-P
