30-day FRN

23737

Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices
Estimates of annualized total hour
burden are summarized in Table A.12–
1.4 Below.
Number of
respondents

Type of respondent

Number of
responses per
respondent

Participants ......................................................................................................
Non-Participants ..............................................................................................

4580
3030

1
1

Totals ........................................................................................................

7610

2

Average time
per response
(in hours)

Total annual
burden hour

90/60
15/60

7,653
729
8,382

(Note: reported and calculated numbers differ slightly due to rounding.)
Dated: April 18, 2016.
Valery Gheen,
NHLBI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2016–09313 Filed 4–21–16; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: The Development of AntiCD70 Chimeric Antigen Receptors
(CARs) for the Treatment of Chronic
Myelogenous Leukemia
AGENCY:

National Institutes of Health,

HHS.
ACTION:

Notice.

This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR part 404,
that the National Cancer Institute,
National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant of
an exclusive patent license to Dedalus
Pharma, LLC (‘‘Dedalus’’) located in
Maryland, USA.

mstockstill on DSK4VPTVN1PROD with NOTICES

SUMMARY:

Intellectual Property
United States Provisional Patent
Application No. 62/088,882, filed
December 8, 2014, entitled ‘‘Anti-CD70
Chimeric Antigen Receptors’’ [HHS
Reference No. E–021–2015/0–US–01];
and PCT Application No. PCT/US2015/
025047 filed April 9, 2015 entitled
‘‘Anti-CD70 Chimeric Antigen
Receptors’’ [HHS Reference No. E–021–
2015/0–PCT–02].
The patent rights in these inventions
have been assigned to the government of
the United States of America.
The patent rights in these inventions
have been assigned to the government of
the United States of America. The
prospective exclusive license territory
may be worldwide and the field of use
may be limited to the development and
commercialization of CD70 chimeric
antigen receptor (CAR)-based
autologous peripheral blood T cell

VerDate Sep<11>2014

20:03 Apr 21, 2016

Jkt 238001

therapy products as set forth in the
Licensed Patent Rights for the treatment
of chronic myelogenous leukemia in
humans.
DATES: Only written comments and/or
applications for a license which are
received by the Technology Transfer
Center at the National Cancer Institute
on or before May 9, 2016 will be
considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
exclusive license should be directed to:
Andrew Burke, Ph.D., Licensing and
Patenting Manager, Technology Transfer
Center, National Cancer Institute, 9609
Medical Center Drive, MSC 9702,
Rockville, MD 20852; Telephone: (240)
276–5484; Email: andy.burke@nih.gov.
SUPPLEMENTARY INFORMATION: The
present invention describes chimeric
antigen receptors (CARs) targeting
CD70. CARs are hybrid proteins
comprised of extracellular antigen
binding domains and intracellular
signaling domains designed to activate
the cytotoxic functions of CARtransduced T cells upon antigen
stimulation.
CD70 is a co-stimulatory molecule
that provides proliferative and survival
cues to competent cells upon binding to
its cognate receptor, CD27. Its
expression is primarily restricted to
activated lymphoid cells; however,
recent research has demonstrated that
several cancers, including renal cell
carcinoma, glioblastoma, non-Hodgkin’s
lymphoma, and chronic myelogenous
leukemia also express CD70 under
certain circumstances. Due to its limited
expression in normal tissues, CARs
targeting CD70 may be useful in
adoptive cell therapy protocols for the
treatment of select cancers.
The prospective exclusive license will
be royalty bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR part 404. The
prospective exclusive license may be
granted unless within fifteen (15) days
from the date of this published notice,
the NCI receives written evidence and

PO 00000

Frm 00064

Fmt 4703

Sfmt 4703

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 in
an appropriate field of use that are
timely filed in response to this notice
will be treated as objections to the grant
of the contemplated exclusive license.
Comments and objections submitted to
this notice will not be made available
for public inspection and, to the extent
permitted by law, will not be released
under the Freedom of Information Act,
5 U.S.C. 552.
Dated: April 18, 2016.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2016–09324 Filed 4–21–16; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; The Agricultural
Health Study: A Prospective Cohort
Study of Cancer and Other Diseases
Among Men and Women in Agriculture
(NIEHS)
Under the provisions of
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. This proposed information
collection was previously published in
the Federal Register on November 27,
2015, Pages 74115–74116, 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 Institute of Environmental
Health Sciences (NIEHS), National
Institutes of Health, may not conduct or
sponsor, and the respondent is not
required to respond to, an information

SUMMARY:

E:\FR\FM\22APN1.SGM

22APN1

23738

Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices

collection that has been extended,
revised, or implemented on or after
October 1, 1995, unless it displays a
currently valid OMB control number.
Direct Comments to OMB: 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.
DATES: Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments or request more
information on the proposed project
contact: Dale Sandler, Ph.D., Chief,
Epidemiology Branch, National Institute
of Environmental Health Sciences, NIH,
111 T.W. Alexander Drive, P.O. Box
12233, MD A3–05, Research Triangle
Park, NC 27709, or call non-toll-free
number 919–541–4668, or email your
request, including your address to:
sandler@niehs.nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.

from occupational and environmental
exposures in the agricultural
environment. Secondary objectives
include evaluating biological markers
that may be associated with agricultural
exposures and risk of certain types of
cancer. Phase IV questionnaire data are
collected by using self-administered
computer assisted web survey (CAWI);
self-administered paper-and-pen (Paper/
pen); or an interviewer administered
computer assisted telephone interview
(CATI) and in-person interview (CAPI)
systems for telephone screeners and
home visit interviews, respectively.
Some respondents are also asked to
participate in the collection of
biospecimens and environmental
samples, including blood, urine, buccal
cells (loose cells from the respondent’s
mouth), and vacuum dust. The findings
will provide valuable information
concerning the potential link between
agricultural exposures and cancer and
other chronic diseases among
Agricultural Health Study cohort
members, and this information may be
generalized to the entire agricultural
community.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
11,440.

Proposed Collection: The Agricultural
Health Study: A Prospective Cohort
Study of Cancer and Other Diseases
Among Men and Women in Agriculture,
0925–0406 (Expiration Date 9/30/2016,
REVISION), National Institute of
Environmental Health Sciences
(NIEHS), National Institutes of Health
(NIH).
Need and Use of Information
Collection: The purpose of this
information collection is to request new
components as part of the ongoing
Study of Biomarkers of Exposures and
Effects in Agriculture (BEEA), as well as
continue and complete phase IV (2013–
2016) of the Agricultural Health Study
(AHS) and continue buccal cell
collection. Phase IV will continue to
update the occupational and
environmental exposure information as
well as medical history information for
licensed pesticide applicators and their
spouses enrolled in the AHS. The new
BEEA components are a control
respondent group, and a smartphone
application (app), along with new
sample collection (buccal cell and air
monitoring samples). The new
components will use similar procedures
to ones already employed on the BEEA
study, as well as other NCI studies. The
primary objectives of the study are to
determine the health effects resulting

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent
Private and Commercial Applicators and Spouses.
Private and Commercial Applicators and Spouses.
Private and Commercial Applicators and Spouses.
Private Applicators ................
Private Applicators ................
Private Applicators ................
Private Applicators ................
Private Applicators ................
Private Applicators ................
Private Applicators ................
Private Applicators ................

mstockstill on DSK4VPTVN1PROD with NOTICES

Private Applicators ................
Private Applicators ................
Private Applicators ................
Private Applicators ................
Private Applicators ................
Private Applicators ................
Private Applicators ................

VerDate Sep<11>2014

19:18 Apr 21, 2016

Number of
respondents

Form name

Number of
responses per
respondent

Average time
per response
(in hours)

Total annual
burden hours

IA/NC Scripts for Verbal Consent for Buccal

100

1

3/60

5

IA/NC Written Consent for Buccal ...............

100

1

5/60

8

Buccal Follow-up Scripts (as needed): Reminder, Missing Consent, or Damaged/
Missing Sample.
BEEA CATI Screening Script for RSG,
REG or AMG Eligibility.
IA/NC BEEA Consent for RSG Home Visit
or REG Home Visit or AMG Home Visit.
IA/NC BEEA RSG Pre-Visit Show Card ......
IA/NC BEEA RSG Paper/Pen Dust Questionnaire.
BEEA RSG Pre-Home Visit Script ...............
BEEA RSG Home Visit CAPI, Blood,
Buccal cell, Urine & Dust.
IA/NC BEEA REG Pre-Visit Show Card ......
IA/NC BEEA REG Paper/Pen Dust Questionnaire.
BEEA REG Pre-Home Visit Script ...............
BEEA REG Home Visit CAPI, Blood,
Buccal cell, Urine & Dust.
IA/NC BEEA REG Post-Exposure Scheduling Script.
IA/NC BEEA AMG Pre-Visit Show Card ......
IA/NC BEEA AMG Paper/Pen Dust Questionnaire.
BEEA AMG Pre-Home Visit Script ..............
BEEA AMG Home Visit CAPI, Blood, Urine,
Buccal cell & Dust.

30

1

2/60

1

480

1

20/60

160

196

1

5/60

16

160
160

1
1

5/60
10/60

13
27

160
160

1
1

2/60
90/60

5
240

20
20

3
3

5/60
10/60

5
10

20
20

3
3

2/60
90/60

2
90

20

1

2/60

1

16
16

2
2

5/60
10/60

3
5

16
16

2
2

2/60
90/60

1
48

Jkt 238001

PO 00000

Frm 00065

Fmt 4703

Sfmt 4703

E:\FR\FM\22APN1.SGM

22APN1

23739

Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Form name

Private Applicators ................
Private Applicators ................
Controls .................................
Controls .................................
Controls .................................
Controls .................................
Controls .................................
Controls .................................

IA/NC BEEA Consent for AMG Farm Visit ..
BEEA Pre-Farm Visit Script .........................
BEEA CATI Control Eligibility Script ............
IA/NC BEEA Control Home Visit Consent ...
IA/NC BEEA Pre-Visit Show Card ...............
IA/NC BEEA Paper/Pen Dust Questionnaire
BEEA REG Pre-Visit Script ..........................
BEEA Control Home Visit CAPI, Blood,
Buccal cell, Urine, & Dust.
‘Life in a Day’ Smartphone App Consent
and Setup.
‘Life in a Day’ Smartphone Application ........
Phase IV Follow-up CAWI, CATI, or Paper/
pen.
Phase IV Follow-up CAWI, CATI, or Paper/
pen.
Phase IV Follow-up CAWI, CATI, or Paper/
pen.

Private Applicators ................
Private Applicators ................
Private Applicators ................
Spouses ................................
Proxy .....................................
Total ...............................

.......................................................................

Dated: April 18, 2016.
Jane M. Lambert,
Project Clearance Liaison, NIEHS.
[FR Doc. 2016–09296 Filed 4–21–16; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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.

mstockstill on DSK4VPTVN1PROD with NOTICES

Number of
respondents

Type of respondent

Name of Committee: National Cancer
Institute Initial Review Group; Subcommittee
F—Institutional Training and Education.
Date: June 14, 2016.
Time: 12:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W030, Rockville, MD 20850, (Telephone
Conference Call).

VerDate Sep<11>2014

19:18 Apr 21, 2016

Jkt 238001

5/60
2/60
20/60
5/60
5/60
10/60
2/60
90/60

1
1
72
6
6
11
2
101

78

1

20/60

26

78
13,855

30
1

10/60
25/60

390
5,773

10,201

1

25/60

4,250

635

1

15/60

159

27,139

29,641

........................

11,438

[FR Doc. 2016–09315 Filed 4–21–16; 8:45 am]

Frm 00066

Fmt 4703

Sfmt 4703

Total annual
burden hours

1
2
1
1
1
1
1
1

Dated: April 18, 2016.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.

PO 00000

Average time
per response
(in hours)

16
16
215
67
67
67
67
67

Contact Person: Timothy C. Meeker, M.D.,
Scientific Review Officer, Resources and
Training Review Branch, Division of
Extramural Activities, National Cancer
Institute, 9609 Medical Center Drive, Room
7W624, Bethesda, MD 20892–9750, 240–276–
6464, meekert@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel,
Comprehensive Partnerships to Advance
Cancer Health Equity (CPACHE) (U54).
Date: June 15–16, 2016.
Time: 8:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Hotel Bethesda, 8120
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Yisong Wang, Ph.D.,
Scientific Review Officer, Special Review
Branch, Division of Extramural Activities,
National Cancer Institute, 9609 Medical
Center Drive, Room 7W240, Bethesda, MD
20892–9750, 240–276–7157, yisong.wang@
mail.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)

BILLING CODE 4140–01–P

Number of
responses per
respondent

DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
[1651–0123]

Agency Information Collection
Activities: Regulations Relating to
Recordation and Enforcement of
Trademarks and Copyrights
U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: 30-Day notice and request for
comments; Extension of an existing
collection of information.
AGENCY:

U.S. Customs and Border
Protection (CBP) of the Department of
Homeland Security will be submitting
the following information collection
request to the Office of Management and
Budget (OMB) for review and approval
in accordance with the Paperwork
Reduction Act: Regulations Relating to
Recordation and Enforcement of
Trademarks and Copyrights (Part 133 of
the CBP Regulations). This is a proposed
extension of an information collection
that was previously approved. CBP is
proposing that this information
collection be extended with no change
to the burden hours or to the
information collected. This document is
published to obtain comments from the
public and affected agencies.
DATES: Written comments should be
received on or before May 23, 2016 to
be assured of consideration.
ADDRESSES: Interested persons are
invited to submit written comments on
this proposed information collection to
SUMMARY:

E:\FR\FM\22APN1.SGM

22APN1