Submission for OMB Review; 30-Day Comment Request; The Clinical Trials Reporting Program (CTRP) Database (NCI), 44318-44319 [2019-18202]
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Federal Register / Vol. 84, No. 164 / Friday, August 23, 2019 / Notices
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Dated: August 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–18199 Filed 8–22–19; 8:45 am]
Dated: August 19, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
Dated: August 19, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Submission for OMB Review; 30-Day
Comment Request; The Clinical Trials
Reporting Program (CTRP) Database
(NCI)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
jbell on DSK3GLQ082PROD with NOTICES
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, 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.
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, 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: Cardiovascular and
Respiratory Sciences Integrated Review
Group; Lung Cellular, Molecular, and
Immunobiology Study Section.
Date: September 24–25, 2019.
Time: 8:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bahia Resort Hotel, 998 West
Mission Drive, San Diego, CA 92109.
Contact Person: George M. Barnas, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2180,
MSC 7818, Bethesda, MD 20892, 301–435–
0696, barnasg@csr.nih.gov.
Name of Committee: Brain Disorders and
Clinical Neuroscience Integrated Review
Group; Pathophysiological Basis of Mental
Disorders and Addictions Study Section.
Date: September 25–26, 2019.
Time: 10:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Name of Committee: Healthcare Delivery
and Methodologies Integrated Review Group;
Health Services Organization and Delivery
Study Section.
Date: September 23–24, 2019.
Time: 8:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: New Orleans Marriott, 555 Canal
Street, New Orleans, LA 70130.
Contact Person: Jacinta Bronte-Tinkew,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3164,
MSC 7770, Bethesda, MD 20892, (301) 806–
0009, brontetinkewjm@csr.nih.gov.
Name of Committee: Integrative,
Functional and Cognitive Neuroscience
Integrated Review Group; Somatosensory and
Pain Systems Study Section.
Date: September 24–25, 2019.
Time: 8:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
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AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30 days of the date of this
publication.
SUMMARY:
Written comments and/or
suggestions regarding the item(s)
contained in this notice, especially
regarding the estimated public burden
and associated response time, should be
directed to the: Office of Management
and Budget, Office of Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: NIH
Desk Officer.
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: Gisele Sarosy, MD,
Coordinating Center for Clinical Trials
(CCCT), National Cancer Institute, 9609
Medical Center Drive, 6W134,
Rockville, MD 20852 or call non-tollfree number 240–276–6172 or Email
ADDRESSES:
E:\FR\FM\23AUN1.SGM
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44319
Federal Register / Vol. 84, No. 164 / Friday, August 23, 2019 / Notices
your request, including your address to:
gisele.sarosy@nih.gov.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on June 3, 2019, page 25550
(Vol. 84, No. 106 FR 25550) and allowed
60 days for public comment. No public
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment. The
National Cancer Institute (NCI),
National Institutes of Health, may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
all NCI-supported clinical research. This
resource allows the NCI to consolidate
reporting, aggregate information and
reduce redundant submissions.
Information is submitted by clinical
research administrators as designees of
clinical investigators who conduct NCIsupported clinical research. The
designees can electronically access the
CTRP website to complete the initial
trial registration. Subsequent to
registration, four amendments and four
study subject accrual updates occur per
trial annually.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The estimated
annualized burden hours are 18,000.
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below.
Proposed Collection: The Clinical
Trials Reporting Program (CTRP)
Database (NCI), 0925–0600, Expiration
Date 08/31/2019—REVISION, National
Cancer Institute (NCI), National
Institutes of Health (NIH).
Need and Use of Information
Collection: The Clinical Trials Reporting
Program (CTRP) is an electronic
resource that serves as a single,
definitive source of information about
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Average
time per
response
(in hours)
Total annual
burden hours
Type of respondents
Initial Registration .............................
Amendment .......................................
Update ..............................................
Accrual Updates ...............................
Clinical Trials ....................................
3,000
1,500
1,500
3,000
1
4
4
4
1
1
1
15/60
3,000
6,000
6,000
3,000
Total ...........................................
...........................................................
........................
27,000
........................
18,000
Diane Kreinbrink,
Project Clearance Liaison, National Cancer
Institute, National Institutes of Health.
[FR Doc. 2019–18202 Filed 8–22–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Advancing
Translational Sciences; Notice of
Closed Meeting
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Number of
respondents
Form name
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, 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.
Emphasis Panel; CTSA Collaborative
Innovation Awards Review Meeting.
Date: September 25, 2019.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, One
Democracy Plaza, 6701 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: M. Lourdes Ponce, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Center for Advancing
Translational, Sciences (NCATS), National
Institutes Of Health, 6701 Democracy Blvd.,
Democracy 1, Room 1073, Bethesda, MD
20892, 301–435–0810, lourdes.ponce@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.350, B—Cooperative
Agreements; 93.859, Biomedical Research
and Research Training, National Institutes of
Health, HHS)
Dated: August 19, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–18178 Filed 8–22–19; 8:45 am]
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Name of Committee: National Center for
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DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
[Docket No. FWS–HQ–IA–2019–0057;
FXIA16710900000–190–FF09A30000]
Foreign Endangered Species; Receipt
of Permit Applications
Fish and Wildlife Service,
Interior.
ACTION: Notice of receipt of permit
applications; request for comments.
AGENCY:
We, the U.S. Fish and
Wildlife Service, invite the public to
comment on applications to conduct
certain activities with foreign species
that are listed as endangered under the
Endangered Species Act (ESA). With
some exceptions, the ESA prohibits
activities with listed species unless
Federal authorization is issued that
allows such activities. The ESA also
requires that we invite public comment
before issuing permits for any activity
otherwise prohibited by the ESA with
respect to any endangered species.
DATES: We must receive comments by
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ADDRESSES:
Obtaining Documents: The
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SUMMARY:
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]]>Agencies
[Federal Register Volume 84, Number 164 (Friday, August 23, 2019)]
[Notices]
[Pages 44318-44319]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18202]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request; The Clinical
Trials Reporting Program (CTRP) Database (NCI)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has submitted to the Office of
Management and Budget (OMB) a request for review and approval of the
information collection listed below.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 30 days of the date of
this publication.
ADDRESSES: Written comments and/or suggestions regarding the item(s)
contained in this notice, especially regarding the estimated public
burden and associated response time, should be directed to the: Office
of Management and Budget, Office of Regulatory Affairs,
[email protected] or by fax to 202-395-6974, Attention: NIH
Desk Officer.
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: Gisele Sarosy, MD, Coordinating Center for
Clinical Trials (CCCT), National Cancer Institute, 9609 Medical Center
Drive, 6W134, Rockville, MD 20852 or call non-toll-free number 240-276-
6172 or Email
[[Page 44319]]
your request, including your address to: [email protected].
SUPPLEMENTARY INFORMATION: This proposed information collection was
previously published in the Federal Register on June 3, 2019, page
25550 (Vol. 84, No. 106 FR 25550) and allowed 60 days for public
comment. No public comments were received. The purpose of this notice
is to allow an additional 30 days for public comment. The National
Cancer Institute (NCI), National Institutes of Health, may not conduct
or sponsor, and the respondent is not required to respond to, an
information collection that has been extended, revised, or implemented
on or after October 1, 1995, unless it displays a currently valid OMB
control number.
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction
Act of 1995, the National Institutes of Health (NIH) has submitted to
the Office of Management and Budget (OMB) a request for review and
approval of the information collection listed below.
Proposed Collection: The Clinical Trials Reporting Program (CTRP)
Database (NCI), 0925-0600, Expiration Date 08/31/2019--REVISION,
National Cancer Institute (NCI), National Institutes of Health (NIH).
Need and Use of Information Collection: The Clinical Trials
Reporting Program (CTRP) is an electronic resource that serves as a
single, definitive source of information about all NCI-supported
clinical research. This resource allows the NCI to consolidate
reporting, aggregate information and reduce redundant submissions.
Information is submitted by clinical research administrators as
designees of clinical investigators who conduct NCI-supported clinical
research. The designees can electronically access the CTRP website to
complete the initial trial registration. Subsequent to registration,
four amendments and four study subject accrual updates occur per trial
annually.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The estimated annualized burden
hours are 18,000.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average time
Form name Type of Number of responses per per response Total annual
respondents respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
Initial Registration.......... Clinical Trials. 3,000 1 1 3,000
Amendment..................... 1,500 4 1 6,000
Update........................ 1,500 4 1 6,000
Accrual Updates............... 3,000 4 15/60 3,000
---------------------------------------------------------------
Total..................... ................ .............. 27,000 .............. 18,000
----------------------------------------------------------------------------------------------------------------
Diane Kreinbrink,
Project Clearance Liaison, National Cancer Institute, National
Institutes of Health.
[FR Doc. 2019-18202 Filed 8-22-19; 8:45 am]
BILLING CODE 4140-01-P
