83_FR_20168 83 FR 20080 - 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

83 FR 20080 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 83, Issue 88 (May 7, 2018)

Page Range20080-20081
FR Document2018-09668

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 public during the review and approval period.

Federal Register, Volume 83 Issue 88 (Monday, May 7, 2018)
[Federal Register Volume 83, Number 88 (Monday, May 7, 2018)]
[Notices]
[Pages 20080-20081]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-09668]


-----------------------------------------------------------------------

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

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: 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 
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 OIRA_submission@omb.eop.gov 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 paperwork@hrsa.gov 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 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 non-fatal 
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

[[Page 20081]]

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                    Average burden
            Form name                Number of     responses per       Total       per response    Total burden
                                    respondents     respondent       responses      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
Rural Health Opioid Program                   10               1              10              11             110
 Grant Performance Measures.....
                                 -------------------------------------------------------------------------------
    Total.......................              10  ..............              10  ..............             110
----------------------------------------------------------------------------------------------------------------


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



                                               20080                                Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Notices

                                                  The proposed Rural Quality draft                           provision of value-based care and                             disclose or provide the information
                                               measures reflect a reduced number of                          utilization of reimbursement strategies                       requested. This includes the time
                                               required measures and improvements to                         through Centers for Medicare and                              needed to review instructions; to
                                               the number of optional measures                               Medicaid quality reporting programs,                          develop, acquire, install and utilize
                                               including the following: 24 total                             the latest competitive cohort also aligns                     technology and systems for the purpose
                                               measures (previously 43), which                               with this shift. An increased number of                       of collecting, validating and verifying
                                               includes 16 required measures                                 sophisticated applicants leveraging                           information, processing and
                                               applicable to all awardees in addition to                     increasingly intricate reporting                              maintaining information, and disclosing
                                               improved optional measure choices for                         methodologies for quality data                                and providing information; to train
                                               8 total optional measures (previously 4).                     collection, utilization, and analysis has                     personnel and to be able to respond to
                                               Proposed revisions specifically include                       resulted in an estimate of burden hours
                                                                                                                                                                           a collection of information; to search
                                               the following: (1) Alignment of clinical                      more in line with the realities of the
                                               measures to current National Quality                                                                                        data sources; to complete and review
                                                                                                             health care landscape.
                                               Forum endorsement recommendations                               Likely Respondents: The respondents                         the collection of information; and to
                                               and (2) broadened orientation of                              would be award recipients of the Small                        transmit or otherwise disclose the
                                               measures for improved applicability                           Health Care Provider Quality                                  information. The total annual burden
                                               across variety of rural quality                               Improvement Program.                                          hours estimated for this ICR are
                                               improvement project topic areas.                                Burden Statement: Burden in this                            summarized in the table below.
                                                  With the continuing shift in the                           context means the time expended by
                                               healthcare environment towards                                persons to generate, maintain, retain,

                                                                                                      TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
                                                                                                                                                                                             Average
                                                                                                                                                  Number of                                                         Total
                                                                                                                              Number of                                       Total        burden per
                                                                             Form name                                                          responses per                                                      burden
                                                                                                                             respondents                                   responses        response
                                                                                                                                                  respondent                                                        hours
                                                                                                                                                                                            (in hours)

                                               Small Health Care Provider Quality Improvement Program
                                                Performance Improvement Measurement System
                                                (PIMS) Measurement .......................................................                 32                         1            32                       22              704
                                                                                                                                           32   ........................           32   ........................            704



                                               Amy P. McNulty,                                               public during the review and approval                         individuals in recovery through the
                                               Acting Director, Division of the Executive                    period.                                                       enhancement of behavioral counselling
                                               Secretariat.                                                  DATES: Comments on this ICR should be                         and peer support activities.
                                               [FR Doc. 2018–09674 Filed 5–4–18; 8:45 am]                    received no later than June 6, 2018.                             Need and Proposed Use of the
                                               BILLING CODE 4165–15–P                                                                                                      Information: For this program,
                                                                                                             ADDRESSES: Submit your comments,
                                                                                                                                                                           performance measures were drafted to
                                                                                                             including the ICR Title, to the desk
                                                                                                                                                                           provide data to the program and to
                                                                                                             officer for HRSA, either by email to
                                               DEPARTMENT OF HEALTH AND                                                                                                    enable HRSA to provide aggregate
                                                                                                             OIRA_submission@omb.eop.gov or by
                                               HUMAN SERVICES                                                                                                              program data required by Congress
                                                                                                             fax to (202) 395–5806.
                                                                                                                                                                           under the Government Performance and
                                               Health Resources and Services                                 FOR FURTHER INFORMATION CONTACT: To                           Results Act of 1993. These measures
                                               Administration                                                request a copy of the clearance requests                      cover the principal topic areas of
                                                                                                             submitted to OMB for review, email Lisa                       interest to the Federal Office of Rural
                                               Agency Information Collection                                 Wright-Solomon, the HRSA Information                          Health Policy (FORHP), including: (a)
                                               Activities: Submission to OMB for                             Collection Clearance Officer at                               Target population demographics; (b)
                                               Review and Approval; Public Comment                           paperwork@hrsa.gov or call (301) 443–                         referrals to substance abuse treatment;
                                               Request; Rural Health Opioid Program                          1984.                                                         (c) substance abuse treatment process
                                               Grant Performance Measures, OMB                               SUPPLEMENTARY INFORMATION:                                    and outcomes; (d) education of health
                                               No. 0906–xxxx—NEW                                               Information Collection Request Title:                       care providers and community
                                               AGENCY: Health Resources and Services                         Rural Health Opioid Program Grant                             members; and (e) rates of fatal and non-
                                               Administration (HRSA), Department of                          Performance Measures                                          fatal opioid-related overdose. All
                                               Health and Human Services.                                      OMB No. 0906–xxxx—NEW                                       measures will speak to FORHP’s
                                               ACTION: Notice.                                                 Abstract: The Rural Health Opioid                           progress toward meeting the goals set.
                                                                                                             Program aims to promote rural health                             Likely Respondents: The respondents
                                               SUMMARY:   In compliance with the                             care services outreach by expanding the                       would be recipients of the Rural Health
                                               Paperwork Reduction Act of 1995,                              delivery of opioid related health care                        Opioid Program grant funding.
                                               HRSA has submitted an Information                             services to rural communities. The                               Burden Statement: Burden in this
                                               Collection Request (ICR) to the Office of                     program will work to reduce the                               context means the time expended by
                                               Management and Budget (OMB) for                               morbidity and mortality related to                            persons to generate, maintain, retain,
daltland on DSKBBV9HB2PROD with NOTICES




                                               review and approval. HRSA published                           opioid overdoses in rural communities                         disclose or provide the information
                                               the 60-day notice on December 15, 2017,                       through the development of broad                              requested. This includes the time
                                               FR Doc. 2017–27013. HRSA received                             community consortiums to prepare                              needed to review instructions; to
                                               one comment. Comments submitted                               individuals with opioid-use disorder to                       develop, acquire, install and utilize
                                               during the first public review of this ICR                    start treatment, implement care                               technology and systems for the purpose
                                               will be provided to OMB. OMB will                             coordination practices to organize                            of collecting, validating and verifying
                                               accept further comments from the                              patient care activities, and support                          information, processing and


                                          VerDate Sep<11>2014     17:38 May 04, 2018     Jkt 244001    PO 00000     Frm 00049   Fmt 4703   Sfmt 4703     E:\FR\FM\07MYN1.SGM      07MYN1


                                                                                            Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Notices                                                                     20081

                                               maintaining information, and disclosing                                    data sources; to complete and review                           hours estimated for this ICR are
                                               and providing information; to train                                        the collection of information; and to                          summarized in the table below.
                                               personnel and to be able to respond to                                     transmit or otherwise disclose the
                                               a collection of information; to search                                     information. The total annual burden

                                                                                                                 TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
                                                                                                                                                                                                           Average
                                                                                                                                                                Number of                                                         Total
                                                                                                                                             Number of                                      Total        burden per
                                                                                   Form name                                                                  responses per                                                      burden
                                                                                                                                            respondents                                  responses        response
                                                                                                                                                                respondent                                                        hours
                                                                                                                                                                                                          (in hours)

                                               Rural Health Opioid Program Grant Performance Meas-
                                                 ures ...................................................................................                10                         1            10                      11               110

                                                     Total ..............................................................................                10   ........................           10   ........................            110



                                               Amy P. McNulty,                                                            Microbiology and Infectious Diseases        Transfer and Development, 31 Center
                                               Acting Director, Division of the Executive                                 Research, National Institutes of Health, HHS)
                                                                                                                                                                      Drive Room 4A29, MSC2479, Bethesda,
                                               Secretariat.                                                                  Dated: May 2, 2018.                      MD 20892–2479; Telephone: +1–301–
                                               [FR Doc. 2018–09668 Filed 5–4–18; 8:45 am]                                 Natasha M. Copeland,                        435–4507; Fax: +1–301–594–3080;
                                               BILLING CODE 4165–15–P                                                     Program Analyst, Office of Federal Advisory Email: thalhamc@mail.nih.gov.
                                                                                                                          Committee Policy.                           SUPPLEMENTARY INFORMATION: The
                                                                                                                          [FR Doc. 2018–09659 Filed 5–4–18; 8:45 am]  following represents the intellectual
                                               DEPARTMENT OF HEALTH AND                                                   BILLING CODE 4140–01–P                      property to be licensed under the
                                               HUMAN SERVICES                                                                                                         prospective agreement:
                                                                                                                                                                         U.S. Provisional Patent Application
                                               National Institutes of Health                                              DEPARTMENT OF HEALTH AND                    No. 61/488,671, filed May 20, 2011; PCT
                                                                                                                          HUMAN SERVICES                              Application. No. PCT/US2012/028926,
                                               National Institute of Allergy and                                                                                      filed March 13, 2012; U.S. Patent No.
                                               Infectious Diseases; Notice of Closed                                      National Institutes of Health               9,068,003, issued June 30, 2015; U.S.
                                               Meeting                                                                                                                Patent No. 9,896,511, issued February
                                                 Pursuant to section 10(d) of the                                         Prospective Grant of Exclusive Patent       20, 2018; and U.S. Patent Application
                                               Federal Advisory Committee Act, as                                         License: Antibodies Against TL1A, a         No. 15/872,592, filed January 16, 2018,
                                               amended, notice is hereby given of the                                     TNF-Family Cytokine, for the                ‘‘Antibodies Against TL1A, a TNF-
                                               following meeting.                                                         Treatment and Diagnosis of Crohn’s          Family Cytokine, for the Treatment and
                                                 The meeting will be closed to the                                        Disease, Ulcerative Colitis, Asthma,        Diagnosis of Autoimmune Inflammatory
                                               public in accordance with the                                              Psoriasis and Biliary Cirrhosis             Diseases’’, NIH Reference No. E–073–
                                               provisions set forth in sections                                           AGENCY: National Institutes of Health,
                                                                                                                                                                      2011/0,1,2.
                                               552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,                                                                                With respect to persons who have an
                                                                                                                          HHS.
                                               as amended. The contract proposals and                                                                                 obligation to assign their right, title and
                                                                                                                          ACTION: Notice.
                                               the discussions could disclose                                                                                         interest to the Government of the United
                                               confidential trade secrets or commercial                                   SUMMARY: The National Heart, Lung, and States of America, the patent rights in
                                               property such as patentable material,                                      Blood Institute (‘‘NHLBI’’), an institute   these inventions have been assigned to
                                               and personal information concerning                                        of the National Institutes of Health; an    the Government of the United States of
                                               individuals associated with the contract                                   agency within the Department of Health America.
                                               proposals, the disclosure of which                                         and Human Services, is contemplating           The prospective exclusive license
                                               would constitute a clearly unwarranted                                     the grant of an exclusive patent license    territory may be worldwide and the
                                               invasion of personal privacy.                                              to commercialize the invention(s)           field of use may be limited to the use
                                                                                                                          embodied in the intellectual property       of Licensed Patent Rights for the
                                                 Name of Committee: National Institute of                                                                             following: ‘‘Development and
                                               Allergy and Infectious Diseases Special                                    estate stated in the Summary
                                                                                                                          Information section of this notice to       commercialization of antibodies against
                                               Emphasis Panel PHS, 2017–1 NIAID Topic 43
                                               (Adjuvant Development).                                                    Precision IBD, Inc., located in San         TL1A for the treatment and diagnosis of
                                                 Date: May 30, 2018.                                                      Diego, California, and incorporated         Crohn’s Disease, Ulcerative Colitis,
                                                 Time: 10:30 a.m. to 12:30 p.m.                                           under the laws of Delaware.                 Asthma, Psoriasis and Biliary Cirrhosis’’
                                                 Agenda: To review and evaluate contract                                                                                 The subject technology is based on
                                                                                                                          DATES: Only written comments and/or         the use of antibodies against TL1A, a
                                               proposals.
                                                 Place: National Institutes of Health, 5601                               applications for a license which are        TNF-Family cytokine, for the treatment
                                               Fishers Lane, Rockville, MD 20892                                          received by the NHLBI Office of             and diagnosis of autoimmune
                                               (Telephone Conference Call).                                               Technology Transfer and Development         inflammatory diseases. Autoimmune
                                                 Contact Person: Thomas F. Conway, Ph.D.,                                 on or before May 22, 2018 will be           inflammatory diseases occur in greater
                                               Scientific Review Officer, Scientific Review                               considered.                                 than five percent of the U.S. population.
daltland on DSKBBV9HB2PROD with NOTICES




                                               Program, Division of Extramural Activities,
                                               Room 3G51, National Institutes of Health,                                  ADDRESSES: Requests for copies of the       Treatments generally include
                                               NIAID, 5601 Fishers Lane, MSC 9823,                                        patent application, inquiries, and          immunosuppressants or anti-
                                               Bethesda, MD 20892–9823, 240–507–9685,                                     comments relating to the contemplated       inflammatory drugs, which can have
                                               thomas.conway@nih.gov.                                                     exclusive license should be directed to:    serious side effects. Recently, more
                                               (Catalogue of Federal Domestic Assistance                                  Cristina Thalhammer-Reyero, Ph.D.,          specific immunomodulatory therapies
                                               Program Nos. 93.855, Allergy, Immunology,                                  MBA, Senior Licensing and Patenting         such as TNF-alpha antagonists have
                                               and Transplantation Research; 93.856,                                      Manager, NHLBI Office of Technology         been developed. In experiments with


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Document Created: 2018-05-05 02:48:03
Document Modified: 2018-05-05 02:48:03
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesComments on this ICR should be received no later than June 6, 2018.
ContactTo 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.
FR Citation83 FR 20080 

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