Proposed Collection; 60-Day Comment Request; The Clinical Trials Reporting Program (CTRP) Database (NCI), 25550 [2019-11459]
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25550
Federal Register / Vol. 84, No. 106 / Monday, June 3, 2019 / Notices
Dated: May 20, 2019.
Holli Richmond,
Executive Director, President’s Council on
Sports, Fitness, and Nutrition, Office of the
Assistant Secretary for Health, U.S.
Department of Health and Human Services.
BILLING CODE 4150–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; The Clinical Trials Reporting
Program (CTRP) Database (NCI)
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide
opportunity for public comment on
proposed data collection projects, the
National Cancer Institute (NCI) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
SUMMARY:
Comments regarding this
information collection are best assured
of having their full effect if received
DATES:
Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: 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)
Ways to enhance the quality, utility, and
clarity of the information to be
SUPPLEMENTARY INFORMATION:
National Institutes of Health,
HHS.
ACTION:
To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
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
your request, including your address to:
gisele.sarosy@nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2019–11476 Filed 5–31–19; 8:45 am]
AGENCY:
collected; and (4) Ways to 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.
Proposed Collection Title: The
Clinical Trials Reporting Program
(CTRP) Database, 0925–0600, Expiration
Date 08/31/2019—EXTENSION,
National Cancer Institute (NCI),
National Institutes of Health (NIH).
Need and Use of Information
Collection: The Clinical Trials Reporting
Program (CTRP) Database 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.
within 60 days of the date of this
publication.
ESTIMATED ANNUALIZED BURDEN HOURS
Average time
per response
(in 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 ...........................................................................
...........................
9,000
27,000
........................
18,000
Patricia M. Busche,
Project Clearance Liaison, National Cancer
Institute, National Institutes of Health.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2019–11459 Filed 5–31–19; 8:45 am]
National Institutes of Health
BILLING CODE 4140–01–P
jbell on DSK3GLQ082PROD with NOTICES
Number of
respondents
Number of
responses per
respondent
Form name
Submission for OMB Review; 30-Day
Comment Request; Generic Clearance
for Application Information for
Fellowships, Internships, Training
Programs, and Specialty Positions,
National Cancer Institute (NCI)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
SUMMARY:
VerDate Sep<11>2014
16:26 May 31, 2019
Jkt 247001
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
Total annual
burden hours
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below.
Comments regarding this
information collection are best assured
of having their full effect if received
within 30-days of the date of this
publication.
DATES:
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
ADDRESSES:
E:\FR\FM\03JNN1.SGM
03JNN1
]]>Agencies
[Federal Register Volume 84, Number 106 (Monday, June 3, 2019)]
[Notices]
[Page 25550]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11459]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; The Clinical Trials
Reporting Program (CTRP) Database (NCI)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995 to provide opportunity for public comment on proposed data
collection projects, the National Cancer Institute (NCI) will publish
periodic summaries of proposed projects to be submitted to the Office
of Management and Budget (OMB) for review and approval.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 60 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, submit comments in writing, or
request more information on the proposed project, 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 your request,
including your address to: [email protected]. Formal requests for
additional plans and instruments must be requested in writing.
SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: 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) Ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) Ways
to 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.
Proposed Collection Title: The Clinical Trials Reporting Program
(CTRP) Database, 0925-0600, Expiration Date 08/31/2019--EXTENSION,
National Cancer Institute (NCI), National Institutes of Health (NIH).
Need and Use of Information Collection: The Clinical Trials
Reporting Program (CTRP) Database 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 respondents Number of responses per per response Total annual
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...................................... ....................................... 9,000 27,000 .............. 18,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Patricia M. Busche,
Project Clearance Liaison, National Cancer Institute, National
Institutes of Health.
[FR Doc. 2019-11459 Filed 5-31-19; 8:45 am]
BILLING CODE 4140-01-P
