Proposed Collection; 60-Day Comment Request; Information Program on Clinical Trials: Maintaining a Registry and Results Databank (National Library of Medicine), 63884-63885 [2019-24996]
Download as PDF
<![CDATA[
63884
Federal Register / Vol. 84, No. 223 / Tuesday, November 19, 2019 / Notices
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Ai-Ping Zou, MD, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4118,
MSC 7814, Bethesda, MD 20892, 301–408–
9497, zouai@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
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)
Dated: November 12, 2019.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–24997 Filed 11–18–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Information Program on
Clinical Trials: Maintaining a Registry
and Results Databank (National Library
of Medicine)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
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 Library of Medicine (NLM), 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.
SUMMARY:
0586, Expiration Date: 02/29/2020,
EXTENSION, National Library of
Medicine (NLM), National Institutes of
Health (NIH).
Need and Use of Information
Collection: The National Institutes of
Health operates ClinicalTrials.gov,
which was established as a clinical trial
registry under section 113 of the Food
and Drug Administration Modernization
Act of 1997 (Pub. L. 105–115) and was
expanded to include a results data bank
by Title VIII of the Food and Drug
Administration Amendments Act of
2007 (FDAAA) and by the Clinical
Trials Registration and Results
Information Submission regulations at
42 CFR part 11. ClinicalTrials.gov
collects registration and results
information for clinical trials and other
types of clinical studies (e.g.,
observational studies and patient
registries) with the objectives of
enhancing patient enrollment and
providing a mechanism for tracking
subsequent progress of clinical studies
to the benefit of public health. It is
widely used by patients, physicians,
and medical researchers; in particular
those involved in clinical research.
While many clinical studies are
registered and submit results
information voluntarily, 42 CFR part 11
requires the registration of certain
applicable clinical trials of drug,
biological, and device products and the
submission of results information for
completed applicable clinical trials of
drug, biological, and device products
whether or not they are approved,
licensed, or cleared by the Food and
Drug Administration.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
1,072,306.
Comments regarding this
information collection are best assured
of having their full effect if received
with 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: David Sharlip, Office of
Administrative and Management
Analysis Services, National Library of
Medicine, Building 38A, Room B2N12,
8600 Rockville Pike, Bethesda, MD
20894, or call non-toll-free number (301)
827–6361, or Email your request,
including your address to: sharlipd@
mail.nih.gov. 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: Information
Program on Clinical Trials: Maintaining
a Registry and Results Databank, 0925–
DATES:
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
khammond on DSKJM1Z7X2PROD with NOTICES
Submission type
Registration—attachment 2:
Initial .........................................................................................................
Updates ....................................................................................................
Triggered, voluntary ..................................................................................
Initial, non-regulated, NIH Policy ..............................................................
Updates, non-regulated, NIH Policy .........................................................
Initial, voluntary and non-regulated ..........................................................
Updates, voluntary and non-regulated .....................................................
Results Information Submission—attachment 5:
Initial .........................................................................................................
Updates ....................................................................................................
Triggered, voluntary—also attachment 2 .................................................
Initial, non-regulated, NIH Policy ..............................................................
Updates, non-regulated, NIH Policy .........................................................
VerDate Sep<11>2014
16:47 Nov 18, 2019
Jkt 250001
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average time
per response
(in hours)
Total annual
burden hours
7,400
7,400
88
657
657
11,244
11,244
1
8
1
1
8
1
8
8
2
8
8
2
8
2
59,200
118,400
704
5,256
10,512
89,952
179,904
7,400
7,400
30
657
657
1
2
1
1
2
40
10
45
40
10
296,000
148,000
1,350
26,280
13,140
E:\FR\FM\19NON1.SGM
19NON1
63885
Federal Register / Vol. 84, No. 223 / Tuesday, November 19, 2019 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Submission type
Average time
per response
(in hours)
Total annual
burden hours
Initial, voluntary and non-regulated ..........................................................
Updates, voluntary and non-regulated .....................................................
Other:
Certification to delay results—attachment 6 .............................................
Extension request—attachment 7 ............................................................
Initial, expanded access—attachment 3 ...................................................
Updates, expanded access—attachment 3 ..............................................
2,000
2,000
1
2
40
10
80,000
40,000
5,150
250
213
213
1
1
1
2
30/60
2
2
15/60
2,575
500
426
107
Total ...................................................................................................
........................
210,037
........................
1,072,306
Dated: November 4, 2019.
David H. Sharlip,
Project Clearance Liaison, National Library
of Medicine, National Institutes of Health.
[FR Doc. 2019–24996 Filed 11–18–19; 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
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
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 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
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; DEC2019
Cycle 33 NExT SEP Committee Meeting.
Date: December 11, 2019.
Time: 9:00 a.m. to 3:00 p.m.
Agenda: To evaluate the NCI Experimental
Therapeutics Program Portfolio.
VerDate Sep<11>2014
16:47 Nov 18, 2019
Jkt 250001
Place: National Institutes of Health, 9000
Rockville Pike, Building 35A, Room 35,
Bethesda, MD 20892.
Contact Persons: 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 13, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–24998 Filed 11–18–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Neurodegeneration and
Neuropathology.
Date: December 12, 2019.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Peter B. Guthrie, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4142,
MSC 7850, Bethesda, MD 20892, (301) 435–
1239, guthriep@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Neuropharmacology.
Date: December 12, 2019.
Time: 2:30 p.m. to 5:00 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: Richard D. Crosland,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4190,
MSC 7850, Bethesda, MD 20892, 301–694–
7084, crosland@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Neuroimmunology,
Neuroinflammation and Brain Tumor.
Date: December 17, 2019.
Time: 11:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Nataliya Gordiyenko,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5202,
MSC 7846, Bethesda, MD 20892,
301.435.1265, gordiyenkon@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–18–
669: Specific Pathogen Free Macaque
Colonies.
E:\FR\FM\19NON1.SGM
19NON1
]]>Agencies
[Federal Register Volume 84, Number 223 (Tuesday, November 19, 2019)]
[Notices]
[Pages 63884-63885]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24996]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; Information Program
on Clinical Trials: Maintaining a Registry and Results Databank
(National Library of Medicine)
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 Library of Medicine (NLM), 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.
DATES: Comments regarding this information collection are best assured
of having their full effect if received with 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: David
Sharlip, Office of Administrative and Management Analysis Services,
National Library of Medicine, Building 38A, Room B2N12, 8600 Rockville
Pike, Bethesda, MD 20894, or call non-toll-free number (301) 827-6361,
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: Information Program on Clinical Trials:
Maintaining a Registry and Results Databank, 0925-0586, Expiration
Date: 02/29/2020, EXTENSION, National Library of Medicine (NLM),
National Institutes of Health (NIH).
Need and Use of Information Collection: The National Institutes of
Health operates ClinicalTrials.gov, which was established as a clinical
trial registry under section 113 of the Food and Drug Administration
Modernization Act of 1997 (Pub. L. 105-115) and was expanded to include
a results data bank by Title VIII of the Food and Drug Administration
Amendments Act of 2007 (FDAAA) and by the Clinical Trials Registration
and Results Information Submission regulations at 42 CFR part 11.
ClinicalTrials.gov collects registration and results information for
clinical trials and other types of clinical studies (e.g.,
observational studies and patient registries) with the objectives of
enhancing patient enrollment and providing a mechanism for tracking
subsequent progress of clinical studies to the benefit of public
health. It is widely used by patients, physicians, and medical
researchers; in particular those involved in clinical research. While
many clinical studies are registered and submit results information
voluntarily, 42 CFR part 11 requires the registration of certain
applicable clinical trials of drug, biological, and device products and
the submission of results information for completed applicable clinical
trials of drug, biological, and device products whether or not they are
approved, licensed, or cleared by the Food and Drug Administration.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 1,072,306.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average time
Submission type Number of responses per per response Total annual
respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
Registration--attachment 2:
Initial..................................... 7,400 1 8 59,200
Updates..................................... 7,400 8 2 118,400
Triggered, voluntary........................ 88 1 8 704
Initial, non-regulated, NIH Policy.......... 657 1 8 5,256
Updates, non-regulated, NIH Policy.......... 657 8 2 10,512
Initial, voluntary and non-regulated........ 11,244 1 8 89,952
Updates, voluntary and non-regulated........ 11,244 8 2 179,904
Results Information Submission--attachment 5:
Initial..................................... 7,400 1 40 296,000
Updates..................................... 7,400 2 10 148,000
Triggered, voluntary--also attachment 2..... 30 1 45 1,350
Initial, non-regulated, NIH Policy.......... 657 1 40 26,280
Updates, non-regulated, NIH Policy.......... 657 2 10 13,140
[[Page 63885]]
Initial, voluntary and non-regulated........ 2,000 1 40 80,000
Updates, voluntary and non-regulated........ 2,000 2 10 40,000
Other:
Certification to delay results--attachment 6 5,150 1 30/60 2,575
Extension request--attachment 7............. 250 1 2 500
Initial, expanded access--attachment 3...... 213 1 2 426
Updates, expanded access--attachment 3...... 213 2 15/60 107
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total................................... .............. 210,037 .............. 1,072,306
----------------------------------------------------------------------------------------------------------------
Dated: November 4, 2019.
David H. Sharlip,
Project Clearance Liaison, National Library of Medicine, National
Institutes of Health.
[FR Doc. 2019-24996 Filed 11-18-19; 8:45 am]
BILLING CODE 4140-01-P
