30-day FRN

20080

Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Notices

The proposed Rural Quality draft
measures reflect a reduced number of
required measures and improvements to
the number of optional measures
including the following: 24 total
measures (previously 43), which
includes 16 required measures
applicable to all awardees in addition to
improved optional measure choices for
8 total optional measures (previously 4).
Proposed revisions specifically include
the following: (1) Alignment of clinical
measures to current National Quality
Forum endorsement recommendations
and (2) broadened orientation of
measures for improved applicability
across variety of rural quality
improvement project topic areas.
With the continuing shift in the
healthcare environment towards

provision of value-based care and
utilization of reimbursement strategies
through Centers for Medicare and
Medicaid quality reporting programs,
the latest competitive cohort also aligns
with this shift. An increased number of
sophisticated applicants leveraging
increasingly intricate reporting
methodologies for quality data
collection, utilization, and analysis has
resulted in an estimate of burden hours
more in line with the realities of the
health care landscape.
Likely Respondents: The respondents
would be award recipients of the Small
Health Care Provider Quality
Improvement Program.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,

disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents

Form name

Small Health Care Provider Quality Improvement Program
Performance Improvement Measurement System
(PIMS) Measurement .......................................................

Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2018–09674 Filed 5–4–18; 8:45 am]
BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Rural Health Opioid Program
Grant Performance Measures, OMB
No. 0906–xxxx—NEW
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:

In compliance with the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. HRSA published
the 60-day notice on December 15, 2017,
FR Doc. 2017–27013. HRSA received
one comment. Comments submitted
during the first public review of this ICR
will be provided to OMB. OMB will
accept further comments from the

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SUMMARY:

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32
32

Number of
responses per
respondent

1
........................

public during the review and approval
period.
DATES: Comments on this ICR should be
received no later than June 6, 2018.
ADDRESSES: Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
[email protected] or by
fax to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
[email protected] or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Rural Health Opioid Program Grant
Performance Measures
OMB No. 0906–xxxx—NEW
Abstract: The Rural Health Opioid
Program aims to promote rural health
care services outreach by expanding the
delivery of opioid related health care
services to rural communities. The
program will work to reduce the
morbidity and mortality related to
opioid overdoses in rural communities
through the development of broad
community consortiums to prepare
individuals with opioid-use disorder to
start treatment, implement care
coordination practices to organize
patient care activities, and support

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Average
burden per
response
(in hours)

Total
responses

32
32

22
........................

Total
burden
hours

704
704

individuals in recovery through the
enhancement of behavioral counselling
and peer support activities.
Need and Proposed Use of the
Information: For this program,
performance measures were drafted to
provide data to the program and to
enable HRSA to provide aggregate
program data required by Congress
under the Government Performance and
Results Act of 1993. These measures
cover the principal topic areas of
interest to the Federal Office of Rural
Health Policy (FORHP), including: (a)
Target population demographics; (b)
referrals to substance abuse treatment;
(c) substance abuse treatment process
and outcomes; (d) education of health
care providers and community
members; and (e) rates of fatal and nonfatal opioid-related overdose. All
measures will speak to FORHP’s
progress toward meeting the goals set.
Likely Respondents: The respondents
would be recipients of the Rural Health
Opioid Program grant funding.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and

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20081

Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Notices
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search

data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden

hours estimated for this ICR are
summarized in the table below.

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents

Form name

Average
burden per
response
(in hours)

Total
responses

Total
burden
hours

Rural Health Opioid Program Grant Performance Measures ...................................................................................

10

1

10

11

110

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

10

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

10

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

110

Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)

Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2018–09668 Filed 5–4–18; 8:45 am]
BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious 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.
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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.

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Number of
responses per
respondent

Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel PHS, 2017–1 NIAID Topic 43
(Adjuvant Development).
Date: May 30, 2018.
Time: 10:30 a.m. to 12:30 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892
(Telephone Conference Call).
Contact Person: Thomas F. Conway, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
Room 3G51, National Institutes of Health,
NIAID, 5601 Fishers Lane, MSC 9823,
Bethesda, MD 20892–9823, 240–507–9685,
[email protected].
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,

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Transfer and Development, 31 Center
Drive Room 4A29, MSC2479, Bethesda,
MD 20892–2479; Telephone: +1–301–
Dated: May 2, 2018.
435–4507; Fax: +1–301–594–3080;
Natasha M. Copeland,
Email: [email protected].
Program Analyst, Office of Federal Advisory
SUPPLEMENTARY INFORMATION: The
Committee Policy.
following represents the intellectual
[FR Doc. 2018–09659 Filed 5–4–18; 8:45 am]
property to be licensed under the
BILLING CODE 4140–01–P
prospective agreement:
U.S. Provisional Patent Application
No. 61/488,671, filed May 20, 2011; PCT
DEPARTMENT OF HEALTH AND
Application. No. PCT/US2012/028926,
HUMAN SERVICES
filed March 13, 2012; U.S. Patent No.
9,068,003, issued June 30, 2015; U.S.
National Institutes of Health
Patent No. 9,896,511, issued February
Prospective Grant of Exclusive Patent
20, 2018; and U.S. Patent Application
License: Antibodies Against TL1A, a
No. 15/872,592, filed January 16, 2018,
TNF-Family Cytokine, for the
‘‘Antibodies Against TL1A, a TNFTreatment and Diagnosis of Crohn’s
Family Cytokine, for the Treatment and
Disease, Ulcerative Colitis, Asthma,
Diagnosis of Autoimmune Inflammatory
Psoriasis and Biliary Cirrhosis
Diseases’’, NIH Reference No. E–073–
2011/0,1,2.
AGENCY: National Institutes of Health,
With respect to persons who have an
HHS.
obligation to assign their right, title and
ACTION: Notice.
interest to the Government of the United
SUMMARY: The National Heart, Lung, and States of America, the patent rights in
these inventions have been assigned to
Blood Institute (‘‘NHLBI’’), an institute
the Government of the United States of
of the National Institutes of Health; an
agency within the Department of Health America.
The prospective exclusive license
and Human Services, is contemplating
territory may be worldwide and the
the grant of an exclusive patent license
field of use may be limited to the use
to commercialize the invention(s)
of Licensed Patent Rights for the
embodied in the intellectual property
following: ‘‘Development and
estate stated in the Summary
commercialization of antibodies against
Information section of this notice to
TL1A for the treatment and diagnosis of
Precision IBD, Inc., located in San
Crohn’s Disease, Ulcerative Colitis,
Diego, California, and incorporated
Asthma, Psoriasis and Biliary Cirrhosis’’
under the laws of Delaware.
The subject technology is based on
DATES: Only written comments and/or
the use of antibodies against TL1A, a
applications for a license which are
TNF-Family cytokine, for the treatment
received by the NHLBI Office of
and diagnosis of autoimmune
Technology Transfer and Development
inflammatory diseases. Autoimmune
on or before May 22, 2018 will be
inflammatory diseases occur in greater
considered.
than five percent of the U.S. population.
Treatments generally include
ADDRESSES: Requests for copies of the
immunosuppressants or antipatent application, inquiries, and
inflammatory drugs, which can have
comments relating to the contemplated
serious side effects. Recently, more
exclusive license should be directed to:
specific immunomodulatory therapies
Cristina Thalhammer-Reyero, Ph.D.,
such as TNF-alpha antagonists have
MBA, Senior Licensing and Patenting
been developed. In experiments with
Manager, NHLBI Office of Technology

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