30-day FRN

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: [email protected].
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

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SUMMARY:

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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

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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,
[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-tollfree 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
SUMMARY:

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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

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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.

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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.

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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)

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