Submission for OMB Review; 30-Day Comment Request; Information Program on Clinical Trials: Maintaining a Registry and Results Databank (National Library of Medicine), 4332-4333 [2020-01157]
Download as PDF
<![CDATA[
4332
Federal Register / Vol. 85, No. 16 / Friday, January 24, 2020 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent
License: Antibody-Based Therapeutics
and Chimeric Antigen Receptors
Targeting Glypican-2
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Cancer Institute
(NCI), National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant of
an exclusive, sublicensable patent
license to Stanford University,
(‘‘Stanford’’), a non-profit university
located in California, in its rights to the
inventions and patents listed in the
SUPPLEMENTARY INFORMATION section of
this notice.
DATES: Only written comments and/or
applications for a license which are
received by the NCI Technology
Transfer Center February 10, 2020 will
be considered.
ADDRESSES: Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
exclusive patent license should be
directed to: Rose M. Freel, Ph.D., Senior
Licensing and Patenting Manager, NCI
Technology Transfer Center, 8490
Progress Drive, Suite 400, Frederick MD
21701 (for business mail), Telephone:
(301) 624–8775; Facsimile: (301) 631–
3027; Email: rose.freel@nih.gov.
SUPPLEMENTARY INFORMATION: The
following and all continuing U.S. and
foreign patents/patent applications
thereof are the intellectual properties to
be licensed under the prospective
agreement to Stanford: United States
Provisional Patent Application No. 62/
844,695, filed May 7, 2019 and entitled
‘‘CHIMERIC ANTIGEN RECEPTORS
TARGETING GLYCIPAN–2’’ [HHS
Reference No. E–064–2019/0–US–01].
The patent rights in these inventions
have been assigned to the Government
of the United States of America,
Stanford University, and Children’s
Hospital of Philadelphia. The
prospective patent license will be for
the purpose of consolidating the patent
rights to Stanford, one of the co-owners
of said rights, for commercial
development and marketing.
Consolidation of these co-owned rights
is intended to expedite development of
the invention, consistent with the goals
of the Bayh-Dole Act codified as 35
U.S.C. 200–212.
The prospective patent license will be
worldwide, exclusive, and may be
lotter on DSKBCFDHB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:03 Jan 23, 2020
Jkt 250001
limited to those fields of use
commensurate in scope with the patent
rights. It will be sublicensable, and any
sublicenses granted by Stanford will be
subject to the provisions of 37 CFR part
401 and 404.
The invention pertains to novel
antibody binders and chimeric antigen
receptors (CARs) that target glypican-2
(GPC–2), a cell surface heparin sulfate
proteoglycan with very restricted
expression in normal tissue but with
expression on many hard-to-treat
pediatric and adult solid tumors such as
glioblastoma, small cell lung cancer,
uterine carcinoma, neuroblastoma, and
medulloblastoma. Based on current
available data, the intended use for the
invention is as a therapeutic for the
treatment of GPC–2 expressing solid
tumors.
This notice is made pursuant to 35
U.S.C. 209 and 37 CFR part 404. The
prospective exclusive patent license
will include terms for the sharing of
royalty income with NCI from
commercial sublicenses of the patent
rights and may be granted unless within
fifteen (15) days from the date of this
published notice the NCI receives
written evidence and argument that
establishes that the grant of the license
would not be consistent with the
requirements of 35 U.S.C. 209 and 37
CFR part 404.
Complete applications for a license
that are timely filed in response to this
notice will be treated as objections to
the grant of the contemplated exclusive
patent license. In response to this
Notice, the public may file comments or
objections. Comments and objections,
other than those in the form of a license
application, will not be treated
confidentially, and may be made
publicly available.
License applications submitted in
response to this Notice will be
presumed to contain business
confidential information and any release
of information from these license
applications will be made only as
required and upon a request under the
Freedom of Information Act, 5 U.S.C.
§ 552.
Dated: January 15, 2020.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2020–01154 Filed 1–23–20; 8:45 am]
BILLING CODE 4140–01–P
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-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
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,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH.
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: 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-tollfree number (301) 827–6361, or Email
your request, including your address to:
sharlipd@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on November 19, 2019, pages
63884–5 (84 FR 63884) 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 Library of Medicine (NLM),
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
SUMMARY:
E:\FR\FM\24JAN1.SGM
24JAN1
4333
Federal Register / Vol. 85, No. 16 / Friday, January 24, 2020 / Notices
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: 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
widely used by patients, physicians,
and medical researchers; in particular
those involved in clinical research.
While many clinical studies are
registered and results information
submitted voluntarily, 42 CFR part 11
requires the registration and submission
of results information for certain
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.
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
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
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 .........................................................
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 ..............................................
Total ...................................................................................................
Dated: January 21, 2020.
David H. Sharlip,
Project Clearance Liaison, National Library
of Medicine, National Institutes of Health.
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
lotter on DSKBCFDHB2PROD with NOTICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
VerDate Sep<11>2014
17:03 Jan 23, 2020
Jkt 250001
Frm 00065
Fmt 4703
Sfmt 4703
Total annual
burden hours
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
2,000
2,000
1
2
1
1
2
1
2
40
10
45
40
10
40
10
296,000
148,000
1,350
26,280
13,140
80,000
40,000
5,150
250
213
213
1
1
1
2
30/60
2
2
15/60
2,575
500
426
107
64,660
210,037
........................
1,072,306
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; RFA–DK–19–505:
Limited Competition for the Accelerating
Medicines Partnership (AMP) in Type 2
Diabetes Knowledge Portal (UM1 Clinical
Trial Not Allowed).
Date: March 12, 2020.
PO 00000
Average time
per response
(in hours)
7,400
7,400
88
657
657
11,244
11,244
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.
[FR Doc. 2020–01157 Filed 1–23–20; 8:45 am]
Number of
responses per
respondent
Time: 11:00 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Dianne Camp, Ph.D.,
Scientific Review Officer, Review Branch,
Division of Extramural Activities, NIDDK,
National Institutes of Health, Room 7013,
6707 Democracy Boulevard, Bethesda, MD
20892–2542, (301) 594–7682, campd@
extra.niddk.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
E:\FR\FM\24JAN1.SGM
24JAN1
]]>Agencies
[Federal Register Volume 85, Number 16 (Friday, January 24, 2020)]
[Notices]
[Pages 4332-4333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01157]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-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 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: Desk
Officer for NIH.
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: 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].
SUPPLEMENTARY INFORMATION: This proposed information collection was
previously published in the Federal Register on November 19, 2019,
pages 63884-5 (84 FR 63884) 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 Library of
Medicine (NLM), 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
[[Page 4333]]
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: 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 results information submitted
voluntarily, 42 CFR part 11 requires the registration and submission of
results information for certain 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
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
---------------------------------------------------------------
Total................................... 64,660 210,037 .............. 1,072,306
----------------------------------------------------------------------------------------------------------------
Dated: January 21, 2020.
David H. Sharlip,
Project Clearance Liaison, National Library of Medicine, National
Institutes of Health.
[FR Doc. 2020-01157 Filed 1-23-20; 8:45 am]
BILLING CODE 4140-01-P
