30-day FRN

30-day FRN2017-10205.pdf

Application Process for Clinical Research Training and Medical Education at the Clinical Center and its impact on Course and Training Program Enrollment and Effectiveness

30-day FRN

OMB: 0925-0698

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23010

Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices

Estimated Total Annual Burden
Hours: 15,114.
In compliance with the requirements
of the Paperwork Reduction Act of 1995
(Pub. L. 104–13, 44 U.S.C. Chap 35), the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW.,
Washington, DC 20201. Attn: ACF
Reports Clearance Officer. Email
address: [email protected]. All
requests should be identified by the title
of the information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.

Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2017–10150 Filed 5–18–17; 8:45 am]
BILLING CODE 4184–40–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Community Services Block
Grant (CSBG) Model State Plan
(Revision).
OMB No.: 0970–0382.
Description: Section 676 of the
Community Services Block Grant
(CSBG) Act requires States, including
the District of Columbia and the
Commonwealth of Puerto Rico, and U.S.
territories applying for CSBG funds to
submit an application and plan (Model
State Plan). The CSBG State Plan
submitted by States must meet statutory
requirements prior to being funded with
CSBG funds. Applicants have the option
to submit a detailed plan annually or
biannually. Entities that submit a
biannual plan must provide an

abbreviated plan the following year if
substantial changes to the initial plan
will occur.
In 2015, the Model State Plan was
substantially revised by automating the
form, streamlining the information, and
incorporating accountability measures
that include customer satisfaction
information from eligible entities that
receive a proportional share of CSBG
funding through State CSBG lead
agencies along with technical
assistance, monitoring, and other
programmatic support.
In fall 2015, the Office of Community
Services (OCS) used the American
Customer Satisfaction Index (ACSI) to
obtain feedback from CSBG eligible
entities about services provided by the
state CSBG Lead Agencies, as detailed
in the new State Accountability
Measures. OCS also obtained feedback
from state CSBG Lead Agencies on
services provided by the federal agency,
as outlined in the new Federal
Accountability Measures. Both OCS and
state CSBG Directors received their state
survey results in February 2016.
To support ongoing implementation
of state accountability measures related
to customer satisfaction from eligible
entities, OCS plans to survey eligible
entities using the ACSI survey
instrument. No changes are planned
from the content of the 2015 survey.
Respondents: CSBG eligible entities.

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ANNUAL BURDEN ESTIMATES
Instrument

Number of
respondents

Number of
responses per
respondent

Average
burden hours
per response

Total burden
hours

ACSI CSBG Eligible Entity Survey ..................................................................

1035

1

.5

517.5

Estimated Total Annual Burden
Hours: 517.5.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 330
C Street SW., Washington, DC 20201.
Attention Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: [email protected].
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office

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of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
[email protected], Attn:
Desk Officer for the Administration for
Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2017–10209 Filed 5–18–17; 8:45 am]
BILLING CODE 4184–27–P

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request: Application
Process for Clinical Research Training
and Medical Education at the NIH
Clinical Center and Its Impact on
Course and Training Program
Enrollment and Effectiveness (Clinical
Center)
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

SUMMARY:

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23011

Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices
collection listed below. This proposed
information collection was previously
published in the Federal Register on
March 9, 2017, 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.
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.
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: Dr. Robert M.
Lembo, Deputy Director, Office of
Clinical Research Training and Medical
Education, NIH Clinical Center,
ADDRESSES:

application process is to allow the
Office of Clinical Research Training and
Medical Education (OCRTME) at the
NIH Clinical Center to evaluate
applicants’ qualifications to determine
applicants’ eligibility for courses and
training programs managed by the
Office. Applicants must provide the
required information requested in the
respective applications to be considered
a candidate for participation.
Information submitted by candidates for
training programs is reviewed initially
by OCRTME administrative staff to
establish eligibility for participation.
Eligible candidates are then referred to
the designated training program
director/administrator or training
program selection committee for review
and decisions regarding acceptance for
participation. A secondary objective of
the application process is to track
enrollment in courses and training
programs over time.

Building 10, Room 1N252, MSC–1158,
Bethesda, Maryland, 20892 or call nontoll-free number (301) 594–4193 or
Email your request, including your
address to: [email protected].
SUPPLEMENTARY INFORMATION: The NIH
Clinical Center (CC), 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
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: Application
Process for Clinical Research Training
and Medical Education at the NIH
Clinical Center, Revision OMB #0925–
0698, Expiration date May 31, 2017,
National Institutes of Health Clinical
Center (CC), National Institutes of
Health (NIH).
Need and Use of Information
Collection: The primary objective of the

OMB approval is requested for 3
years. There is no cost to respondents
other than their time. There are capital,
operating, and/or maintenance costs of
$64,448. The total estimated annualized
burden hours are 4,148.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)

Number of
responses per
respondent

Total annual
burden hours

Form name

Pre-Doctoral (MD, DDS, DVM, PhD) Students, Post-Doctoral Students, Physicians/Surgeons, Other Health Care Practitioners/Technicians.

MRSP ...................................

140

1

20/60

47

IPPCR ...................................
NIH-Duke ..............................
PCP ......................................
PhD Summer Course ...........
Sabbatical .............................
GME ......................................

6700
16
800
70
10
2500

1
1
1
1
1
1

20/60
20/60
20/60
20/60
20/60
20/60

2233
5
267
23
3
833

CEP ......................................
REP ......................................
Bioethics ...............................
Clinical Research Course .....

300
90
262
1560

1
1
1
1

20/60
20/60
20/60
20/60

100
30
87
520

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

12,448

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

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

4148

Pre-Doctoral (MD, DDS, DVM, PhD) Students, Post-Doctoral Students, Physicians/Surgeons, Other Health Care Practitioners/Technicians.

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

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Number of
respondents
per year

Type of respondents

Dated: May 9, 2017.
Laura M. Lee,
Project Clearance Liaison, NIH Clinical
Center, National Institutes of Health.
[FR Doc. 2017–10205 Filed 5–18–17; 8:45 am]
BILLING CODE 4140–01–P

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Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent
License: Chimeric L1/L2 Protein and
Virus-Like Particles Based Human
Papillomavirus Vaccines
National Institutes of Health,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:

The National Cancer Institute,
an institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an exclusive patent license to
practice the inventions embodied in the
U.S. Patents and Patent Applications
listed in the Supplementary Information
section of this notice to PathoVax, LLC
located in Baltimore, MD.
DATES: Only written comments and/or
applications for a license which are
received by the National Cancer
Institute’s Technology Transfer Center
on or before June 5, 2017 will be
considered.
SUMMARY:

Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
exclusive license should be directed to:
Kevin W. Chang, Ph.D., Senior
Technology Transfer Manager, NCI
Technology Transfer Center, 9609
Medical Center Drive, RM 1E530 MSC
9702, Bethesda, MD 20892–9702 (for
business mail), Rockville, MD 20850–
9702 Telephone: (240)-276–6910;
Facsimile: (240)-276–5504 Email:
[email protected].
SUPPLEMENTARY INFORMATION:
ADDRESSES:

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Intellectual Property
United States Provisional Patent
Application No. 60/649,249 filed
February 1, 2005 and entitled,
‘‘Papillomavirus L2 N-terminal Peptides
For The Induction Of Broadly Crossneutralizing Antibodies’’ [HHS
Reference No. E–103–2005/0–US–01];
United States Provisional Patent
Application No. 60/697,655 filed July 7,
2005 and entitled, ‘‘Papillomavirus L2
N-terminal Peptides For The Induction
Of Broadly Cross-neutralizing
Antibodies’’ [HHS Reference No. E–
103–2005/1–US–01]; United States
Provisional Patent Application No. 60/
752,268 filed December 21, 2005 and
entitled, ‘‘Papillomavirus L2 N-terminal
Peptides For The Induction Of Broadly

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Cross-neutralizing Antibodies’’ [HHS
Reference No. E–103–2005/2–US–01];
International PCT Application No. PCT/
US2006/003601 filed February 1, 2006,
and entitled, ‘‘Papillomavirus L2 Nterminal Peptides For The Induction Of
Broadly Cross-neutralizing Antibodies’’
[HHS Reference No. E–103–2005/3–
PCT–01]; United States Patent No.
8,404,244, issued March 26, 2013 and
entitled, ‘‘Papillomavirus L2 N-terminal
Peptides For The Induction Of Broadly
Cross-neutralizing Antibodies’’ [HHS
Ref. No. E–103–2005/3–US–02]; United
States Patent No. 9,388,221 issued July
12, 2016 and entitled, ‘‘Papillomavirus
L2 N-terminal Peptides For The
Induction Of Broadly Cross-neutralizing
Antibodies’’ [HHS Ref. No. E–103–2005/
3–US–10]; Canadian Patent Application
No. 2,596,698 filed February 1, 2006
and entitled, ‘‘Papillomavirus L2 Nterminal Peptides For The Induction Of
Broadly Cross-neutralizing Antibodies’’
[HHS Ref. No. E–103–2005/3–CA–03];
Australian Patent No. 2006210792
issued November 8, 2012 and entitled,
‘‘Papillomavirus L2 N-terminal Peptides
For The Induction Of Broadly Crossneutralizing Antibodies’’ [HHS Ref. No.
E–103–2005/3–AU–04]; Japanese Patent
No. 5224821 issued March 22, 2013 and
entitled, ‘‘Papillomavirus L2 N-terminal
Peptides For The Induction Of Broadly
Cross-neutralizing Antibodies’’ [HHS
Ref. No. E–103–2005/3–JP–05];
Brazilian Patent Application No.
PI0607097–3 filed February 1, 2006 and
entitled, ‘‘Papillomavirus L2 N-terminal
Peptides For The Induction Of Broadly
Cross-neutralizing Antibodies’’ [HHS
Ref. No. E–103–2005/3–BR–06]; Chinese
Patent No. 200680011079.1 issued
March 27, 2013 and entitled,
‘‘Papillomavirus L2 N-terminal Peptides
For The Induction Of Broadly Crossneutralizing Antibodies’’ [HHS Ref. No.
E–103–2005/3–CN–07]; Indian Patent
No. 263255 issued October 16, 2014 and
entitled, ‘‘Papillomavirus L2 N-terminal
Peptides For The Induction Of Broadly
Cross-neutralizing Antibodies’’ [HHS
Ref. No. E–103–2005/3–IN–08];
European Patent No. 1853307 issued
December 14, 2016 and entitled,
‘‘Papillomavirus L2 N-terminal Peptides
For The Induction Of Broadly Crossneutralizing Antibodies’’ [HHS Ref. No.
E–103–2005/3–EP–09]; German Patent
No. 1853307 issued December 14, 2016
and entitled, ‘‘Papillomavirus L2 Nterminal Peptides For The Induction Of
Broadly Cross-neutralizing Antibodies’’
[HHS Ref. No. E–103–2005/3–DE–11];
French Patent No. 1853307 issued

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December 14, 2016 and entitled,
‘‘Papillomavirus L2 N-terminal Peptides
For The Induction Of Broadly Crossneutralizing Antibodies’’ [HHS Ref. No.
E–103–2005/3–FR–12]; and United
Kingdom Patent No. 1853307 issued
December 14, 2016 and entitled,
‘‘Papillomavirus L2 N-terminal Peptides
For The Induction Of Broadly Crossneutralizing Antibodies’’ [HHS Ref. No.
E–103–2005/3–GB–13]. The patent
rights in these inventions have been
assigned and/or exclusively licensed 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 use
of Licensed Patent Rights for the
following: ‘‘Use of Human
Papillomavirus Virus (HPV) L1/L2
chimeric proteins and Virus Like
Particles (VLPs) for the prevention and/
or treatment of cutaneous, mucosal HPV
infections and diseases.’’
The subject technologies are
papillomavirus L2 capsid protein based
vaccines against HPV. The L2 protein is
the minor papillomavirus capsid protein
for papillomaviruses. It is known that
antibodies to this protein can neutralize
homologous infection. Furthermore, L2
proteins can induce cross-neutralizing
antibodies. Specifically, epitopes at the
N-terminus of L2 shared by cutaneous
and mucosal types of papillomavirus
types and by types that infect divergent
species are broadly cross-neutralizing.
These epitopes at the N-terminus of L2
can be used to elicit cross-neutralizing
antibodies against different types of
HPV.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive license will
be royalty bearing, and the prospective
exclusive license may be granted unless
within fifteen (15) days from the date of
this published notice, the National
Cancer Institute 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 in
the prospective field of use that are filed
in response to this notice will be treated
as objections to the grant of the
contemplated Exclusive Patent License
Agreement. 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.

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