30-day FRN

30-day FRN2017-26495.pdf

Generic Submission for Formative Research, Pre-testing, Stakeholder Measures and Advocate Forms at NCI

30-day FRN

OMB: 0925-0641

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Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices

NIH. The ODP fulfills this mission by
providing leadership for the
development, coordination, and
implementation of prevention research
in collaboration with NIH Institutes,
Centers, and Offices and other partners.
The first ODP strategic plan was
released in February 2014 and charted
new directions and, at the same time,
built upon and expanded existing
programs. The Office has made
considerable progress on the priorities
identified in the initial plan, and the
ODP remains committed to playing an
integral role in advancing trans-NIH
prevention-related activities. Input
received from this Request for
Information will inform the
development of the final FY 2019–2023
Strategic Plan, which will outline
activities coordinated by the ODP to
assess, facilitate, and stimulate research
in disease prevention, and disseminate
the results of this research to improve
public health.
The ODP is seeking input on the
following strategic priorities:
• Strategic Priority I: Systematically
monitor NIH investments in prevention
research and the progress and results of
that research.
• Strategic Priority II: Identify
prevention research areas for investment
or expanded effort by the NIH.
• Strategic Priority III: Promote the
use of the best available methods in
prevention research and support the
development of better methods.
• Strategic Priority IV: Promote
collaborative prevention research
projects and facilitate coordination of
such projects across the NIH and with
other public and private entities.
• Strategic Priority V: Advance the
understanding of prevention research,
increase the availability of prevention
research resources and programs, and
enhance ODP’s stakeholder engagement.
The ODP is also seeking input on the
following questions:
• What new strategic priorities
should the ODP consider adding to its
plan?
• What opportunities or challenges in
disease prevention research and
methods could the ODP help to address?
• Who should the ODP partner with
to address pressing needs in disease
prevention research and methods?
• What areas transcend disease
prevention research that the ODP
should consider as it develops its new
plan?
The definition of prevention research
used by the ODP to guide its work and
decision-making encompasses research
designed to yield results directly
applicable to identifying and assessing
risk, developing interventions for

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preventing or ameliorating high-risk
behaviors and exposures, the occurrence
of a disease, disorder, or injury, or the
progression of detectable but
asymptomatic disease. Prevention
research also includes research studies
to develop and evaluate disease
prevention, health promotion
recommendations, and public health
programs. The ODP definition of
prevention includes the following
categories of research:
• Identification of modifiable risk and
protective factors for diseases/disorders/
injuries
• Studies on assessment of risk,
including genetic susceptibility
• Development of methods for
screening and identification of markers
for those at risk for onset or progression
of asymptomatic diseases/disorders, or
those at risk for adverse, high-risk
behaviors/injuries
• Development and evaluation of
interventions to promote health for
groups of individuals without
recognized signs or symptoms of the
target condition
• Translation of proven effective
prevention interventions into practice
• Effectiveness studies that examine
factors related to the organization,
management, financing, and adoption of
prevention services and practices
• Methodological and statistical
procedures for assessing risk and
measuring the effects of preventive
interventions.
Responses to this RFI are voluntary
and may be submitted anonymously.
Please do not include any personally
identifiable or other information that
you do not wish to make public.
Proprietary, classified, confidential, or
sensitive information should not be
included in responses. Comments
submitted will be compiled for
discussion and incorporated into the
strategic plan as appropriate. Any
personal identifiers (personal names,
email addresses, etc.) will be removed
when responses are compiled.
This RFI is for informational and
planning purposes only and is not a
solicitation for applications or an
obligation on the part of the United
States (U.S.) Government to provide
support for any ideas identified in
response to it. Please note that the U.S.
Government will not pay for the
preparation of any information
submitted or for use of that information.
Dated: December 1, 2017.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2017–26453 Filed 12–7–17; 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; A Generic
Submission for Formative Research,
Pre-testing, Stakeholder Measures and
Advocate Forms at NCI (National
Cancer Institute)
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.
SUMMARY:

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: Amy Williams,
Director of the Office of Advocacy
Relations (OAR), NCI, NIH, 31 Center
Drive, Bldg. 31, Room 10A28, MSC
2580, Bethesda, MD 20892, call nontoll-free number 240–781–3406, or
email your request, including your
address, to [email protected].
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on October 2, 2017, page 45870
(82 FR 45870) and allowed 60 days for
public comment. No public comments
were received. The National Cancer
Institute (NCI), 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
ADDRESSES:

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Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices
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 Title: A Generic
Submission for Formative Research, Pretesting, Stakeholder Measures and
Advocate Forms at NCI, 0925- 0641.
Extension. National Cancer Institute
(NCI), National Institutes of Health
(NIH).
Need and Use of Information
Collection: This is a request for OMB to
approve the extension of the generic
collection titled, ‘‘A Generic Submission
for Formative Research, Pre-testing,
Stakeholder Measures and Advocate
Forms at NCI’’ for an additional three
years of data collection. The Office of
Advocacy Relations (OAR) disseminates
cancer-related information to a variety
of stakeholders, seeks input and

allowing NCI to: (1) Understand
characteristics (attitudes, beliefs, and
behaviors) of the intended target
audience and use this information in the
development of effective strategies,
concepts, activities; (2) use a feedback
loop to help refine, revise, and enhance
OAR’s efforts—ensuring that they have
the greatest relevance, utility,
appropriateness, and impact for/to
target audiences; and (3) expend limited
program resource dollars wisely and
effectively. The anticipated respondents
will consist of: Adult cancer research
advocates; members of the public;
health care professionals; and
organizational representatives.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
45.

feedback, and facilitates collaboration to
advance NCI’s authorized programs. It is
beneficial for NCI, through the OAR, to
pretest strategies, concepts, activities
and materials while they are under
development. Additionally,
administrative forms are a necessary
part of collecting demographic
information and areas of interest for
advocates. Since OAR is responsible for
matching advocates to NCI programs
and initiatives across the cancer
continuum, it is necessary to measure
the satisfaction of both internal and
external stakeholders with this
collaboration. This customer satisfaction
research helps ensure the relevance,
utility, and appropriateness of the many
initiatives and products that OAR and
NCI produce. The OAR will use a
variety of qualitative (interviews)
methodology to conduct this research,

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Type of respondent

Average time
per response
(in hours)

Total annual
burden hour

Individual In-Depth Interviews .........................................................................
Profile Completion ...........................................................................................

40
50

1
1

30/60
30/60

20
25

Total ..........................................................................................................

90

90

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

45

Dated: December 2, 2017.
Karla Bailey,
Project Clearance Liaison, National Cancer
Institute, National Institutes of Health.
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent
License: N-Acetyl Mannosamine as a
Therapeutic Agent
AGENCY:

National Institutes of Health,

HHS.
ACTION:

Notice.

The National Human Genome
Research 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 Patents
and Patent Applications listed in the
SUPPLEMENTARY INFORMATION section of
this notice to Leadiant Biosciences, Inc,
located in Gaithersburg, Maryland,
USA.
SUMMARY:

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Only written comments and/or
applications for a license which are
received by the National Human
Genome Research Institute’s Technology
Transfer Office on or before December
26, 2017 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive license should
be directed to: Eggerton Campbell,
Ph.D., Senior Licensing and Patenting
Manager, Technology Transfer Office
(TTO), National Human Genome
Research Institute (NHGRI), National
Institutes of Health (NIH), 5635 Fishers
Lane, Suite 3058, MSC 9307, Bethesda,
MD 20892–9307. Telephone: 301–402–
1648. Fax: 301–402–9722. email:
[email protected].
SUPPLEMENTARY INFORMATION:
DATES:

[FR Doc. 2017–26495 Filed 12–7–17; 8:45 am]

sradovich on DSK3GMQ082PROD with NOTICES

Number of
responses per
respondent

Intellectual Property
U.S. Provisional Patent Application
No.: 60/932,451, [HHS Ref. No.: E–217–
2007/0–US–01], Filed May 31, 2007;
PCT Patent Application No.: PCT/
US2008/006895, [HHS Ref. No.: E–217–
2007/0–PCT–02], Filed: May 30, 2008;
CA Patent Application 2680842, [HHS
Ref. No.: E–217–2007/0–CA–03], Filed:
May 30, 2008; EP Patent Application
No.: 08767999.9, [HHS Ref. No.: E–217–

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2007/0–EP–04], Filed: September 14,
2009; IL Patent Application No.:
200872, [HHS Ref. No.: E–217–2007/0–
IL–05], Filed: May 30, 2008; JP Patent
Application No.: 2010–510363, [HHS
Ref. No.: E–217–2007/0–JP–06, Filed:
May 30, 2008; U.S. Patent Application
No.: 12/530,433, [HHS Ref. No.: E–217–
2007/0–US–07], Filed: Sept 8, 2009;
U.S. Patent Application No.: 13/
791,576, [HHS Ref. No.: E–217–2007/0–
US–08], Filed: March 8, 2013; JP Patent
Application No.: 2014–208695, [HHS
Ref. No.: E–217–2007/0–JP–09], Filed:
May 30, 2008; U.S. Patent Application
No.: 14/754,304, [HHS Ref. No.: E–217–
2007/0–US–10], Filed: June 29, 2015;
CA Patent Application No.: 2903133,
[HHS Ref. No.: E–217–2007/0–CA–11],
Filed: May 30, 2008; IL Patent
Application No.: 245026, [HHS Ref. No.:
E–217–2007/0–IL–12], Filed: March 8,
2013; JP Patent Application No.: 2016–
159061, [HHS Ref. No.: E–217–2007/0–
JP–13], Filed: August 15, 2016; EP
Patent Application No.: 16196935.7,
[HHS Ref. No.: E–217–2007/0–EP–14],
Filed: March 8, 2013; U.S. Patent
Application No.: 15/702,529, [HHS Ref.
No.: E–217–2007/0–US–08], Filed:
September 12, 2017; and all continuing
applications and foreign counterparts.

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