82_FR_59865 82 FR 59625 - Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Rural Health Opioid Program Grant Performance Measures, OMB No. 0906-xxxx-New

82 FR 59625 - Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: 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 82, Issue 240 (December 15, 2017)

Page Range59625-59626
FR Document2017-27013

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

Federal Register, Volume 82 Issue 240 (Friday, December 15, 2017)
[Federal Register Volume 82, Number 240 (Friday, December 15, 2017)]
[Notices]
[Pages 59625-59626]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-27013]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request; Information Collection Request Title: 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 requirement for opportunity for public 
comment on proposed data collection projects of the Paperwork Reduction 
Act of 1995, HRSA announces plans to submit an Information Collection 
Request (ICR), described below, to the Office of Management and Budget 
(OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the 
public regarding the burden estimate, below, or any other aspect of the 
ICR.

DATES: Comments on this ICR should be received no later than February 
13, 2018.

ADDRESSES: Submit your comments to [email protected] or mail the HRSA 
Information Collection Clearance Officer, Room 14N39, 5600 Fishers 
Lane, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
draft instruments, email [email protected] or call Lisa Wright-
Solomon, the HRSA Information Collection Clearance Officer at (301) 
443-1984.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the information request collection title 
for reference.
    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 (GPRA) 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 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.....
                                 -------------------------------------------------------------------------------
                                              10  ..............              10  ..............             110
----------------------------------------------------------------------------------------------------------------

    HRSA specifically requests comments on: (1) The necessity and 
utility of the proposed information collection for the proper 
performance of the agency's functions; (2) the accuracy of the 
estimated burden; (3) ways to enhance the quality, utility, and clarity 
of the information to be collected; and (4) the use of automated 
collection techniques

[[Page 59626]]

or other forms of information technology to minimize the information 
collection burden.

Amy McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2017-27013 Filed 12-14-17; 8:45 am]
 BILLING CODE 4165-15-P



                                                                                         Federal Register / Vol. 82, No. 240 / Friday, December 15, 2017 / Notices                                                                                     59625

                                                                                                                                                                                                                                                  OMB control
                                                                                  21 CFR part; guidance; or FDA form                                                                                  Topic                                          No.

                                                801 and 809 .........................................................................................................   Labeling ............................................................       0910–0485
                                                ‘‘Recommendations: Clinical Laboratory Improvement Amendments of 1988                                                   CLIA waiver ......................................................          0910–0598
                                                   (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices’’.
                                                807, subparts A through D ...................................................................................           Registration and listing .....................................              0910–0625
                                                ‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission                                               Q-submissions ..................................................            0910–0756
                                                   Program and Meetings with Food and Drug Administration Staff’’.
                                                ‘‘De Novo Classification Process (Evaluation of Automatic Class III Designa-                                            De Novo classification process ........................                     0910–0844
                                                   tion)’’.



                                                  Dated: December 11, 2017.                                                    Information Collection Clearance                                  enable HRSA to provide aggregate
                                                Leslie Kux,                                                                    Officer, Room 14N39, 5600 Fishers                                 program data required by Congress
                                                Associate Commissioner for Policy.                                             Lane, Rockville, MD 20857.                                        under the Government Performance and
                                                [FR Doc. 2017–26987 Filed 12–14–17; 8:45 am]                                   FOR FURTHER INFORMATION CONTACT: To                               Results Act (GPRA) of 1993. These
                                                BILLING CODE 4164–01–P                                                         request more information on the                                   measures cover the principal topic areas
                                                                                                                               proposed project or to obtain a copy of                           of interest to the Federal Office of Rural
                                                                                                                               the data collection plans and draft                               Health Policy (FORHP), including: (a)
                                                DEPARTMENT OF HEALTH AND                                                       instruments, email paperwork@hrsa.gov                             Target population demographics; (b)
                                                HUMAN SERVICES                                                                 or call Lisa Wright-Solomon, the HRSA                             referrals to substance abuse treatment;
                                                                                                                               Information Collection Clearance Officer                          (c) substance abuse treatment process
                                                Health Resources and Services                                                  at (301) 443–1984.                                                and outcomes; (d) education of health
                                                Administration                                                                                                                                   care providers and community
                                                                                                                               SUPPLEMENTARY INFORMATION: When
                                                                                                                               submitting comments or requesting                                 members; and (e) rates of fatal and non-
                                                Agency Information Collection                                                                                                                    fatal opioid-related overdose. All
                                                Activities: Proposed Collection: Public                                        information, please include the
                                                                                                                               information request collection title for                          measures will speak to FORHP’s
                                                Comment Request; Information                                                                                                                     progress toward meeting the goals set.
                                                Collection Request Title: Rural Health                                         reference.
                                                                                                                                  Information Collection Request Title:                             Likely Respondents: The respondents
                                                Opioid Program Grant Performance                                                                                                                 would be recipients of the Rural Health
                                                Measures, OMB No. 0906–xxxx–New                                                Rural Health Opioid Program Grant
                                                                                                                               Performance Measures.                                             Opioid Program grant funding.
                                                AGENCY: Health Resources and Services                                             OMB No. 0906–xxxx–New.                                            Burden Statement: Burden in this
                                                Administration (HRSA), Department of                                              Abstract: The Rural Health Opioid                              context means the time expended by
                                                Health and Human Services.                                                     Program aims to promote rural health                              persons to generate, maintain, retain,
                                                ACTION: Notice                                                                 care services outreach by expanding the                           disclose or provide the information
                                                                                                                               delivery of opioid related health care                            requested. This includes the time
                                                SUMMARY:   In compliance with the                                              services to rural communities. The                                needed to review instructions; to
                                                requirement for opportunity for public                                         program will work to reduce the                                   develop, acquire, install and utilize
                                                comment on proposed data collection                                            morbidity and mortality related to                                technology and systems for the purpose
                                                projects of the Paperwork Reduction Act                                        opioid overdoses in rural communities                             of collecting, validating and verifying
                                                of 1995, HRSA announces plans to                                               through the development of broad                                  information, processing and
                                                submit an Information Collection                                               community consortiums to prepare                                  maintaining information, and disclosing
                                                Request (ICR), described below, to the                                         individuals with opioid-use disorder to                           and providing information; to train
                                                Office of Management and Budget                                                start treatment, implement care                                   personnel and to be able to respond to
                                                (OMB). Prior to submitting the ICR to                                          coordination practices to organize                                a collection of information; to search
                                                OMB, HRSA seeks comments from the                                              patient care activities, and support                              data sources; to complete and review
                                                public regarding the burden estimate,                                          individuals in recovery through the                               the collection of information; and to
                                                below, or any other aspect of the ICR.                                         enhancement of behavioral counselling                             transmit or otherwise disclose the
                                                DATES: Comments on this ICR should be                                          and peer support activities.                                      information. The total annual burden
                                                received no later than February 13,                                               Need and Proposed Use of the                                   hours estimated for this ICR are
                                                2018.                                                                          Information: For this program,                                    summarized in the table below.
                                                ADDRESSES: Submit your comments to                                             performance measures were drafted to                                 Total Estimated Annualized Burden
                                                paperwork@hrsa.gov or mail the HRSA                                            provide data to the program and to                                Hours:

                                                                                                                                                                                                                            Average
                                                                                                                                                                      Number of
                                                                                                                                                   Number of                                       Total                  burden per              Total burden
                                                                                      Form name                                                                     responses per
                                                                                                                                                  respondents                                   responses                  response                  hours
                                                                                                                                                                      respondent                                           (in hours)

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



                                                  HRSA specifically requests comments                                          proper performance of the agency’s                                the quality, utility, and clarity of the
                                                on: (1) The necessity and utility of the                                       functions; (2) the accuracy of the                                information to be collected; and (4) the
                                                proposed information collection for the                                        estimated burden; (3) ways to enhance                             use of automated collection techniques



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                                                59626                       Federal Register / Vol. 82, No. 240 / Friday, December 15, 2017 / Notices

                                                or other forms of information                           DEPARTMENT OF HEALTH AND                                be recorded by knowingly requesting
                                                technology to minimize the information                  HUMAN SERVICES                                          biological testing of a mixture of
                                                collection burden.                                                                                              compounds that he falsely claimed to
                                                                                                        Office of the Secretary                                 be a single compound
                                                Amy McNulty,                                                                                                  • In Manuscript 1, Respondent falsified
                                                Acting Director, Division of the Executive              Findings of Research Misconduct                         and/or fabricated the results on page
                                                Secretariat.                                                                                                    S26 of the Supporting Information by
                                                                                                        AGENCY:   Office of the Secretary, HHS.
                                                [FR Doc. 2017–27013 Filed 12–14–17; 8:45 am]                                                                    modifying the HPLC trace through
                                                                                                        ACTION:   Notice.
                                                BILLING CODE 4165–15–P                                                                                          peak erasure to make the preparation
                                                                                                        SUMMARY:    Findings of research                        of C35deOAmB appear more pure
                                                                                                        misconduct have been made on the part                   than in the actual results of
                                                DEPARTMENT OF HEALTH AND                                of Matthew Endo, former graduate                        experimentation
                                                HUMAN SERVICES                                          student, Department of Chemistry,                     • In Manuscript 1, Respondent falsified
                                                                                                        University of Illinois at Urbana-                       and/or fabricated the results of
                                                Determination Concerning a Petition                     Champaign. The questioned research                      Surface Plasmon Resonance data on
                                                To Add a Class of Employees to the                      was supported by National Institute of                  page S7 of the Supporting Information
                                                Special Exposure Cohort                                 General Medical Sciences (NIGMS),                       to make the error bars smaller than
                                                                                                        National Institutes of Health (NIH),                    the actual results of experimentation
                                                AGENCY: National Institute for                          grant R01 GM080436. The                               • In Manuscript 1, Respondent falsified
                                                Occupational Safety and Health                          administrative actions, including three                 and/or fabricated the results of a
                                                (NIOSH), Centers for Disease Control                    (3) years of supervision, which are                     WST08 Cell Proliferation Assay on
                                                and Prevention, Department of Health                    implemented beginning on November                       page S32 of the Supporting
                                                and Human Services (HHS).                               16, 2017, are detailed below.                           Information by falsely claiming to run
                                                                                                        FOR FURTHER INFORMATION CONTACT:
                                                                                                                                                                the reaction in triplicate when it was
                                                ACTION:   Notice.                                                                                               only performed in duplicate
                                                                                                        Wanda K. Jones, Dr.P.H., Interim
                                                                                                        Director, Office of Research Integrity,               • In correspondence with his advisor,
                                                SUMMARY:  HHS gives notice of a                                                                                 Respondent falsified and/or fabricated
                                                determination concerning a petition to                  1101 Wootton Parkway, Suite 750,
                                                                                                        Rockville, MD 20852, (240) 453–8200.                    the results of the preparation of
                                                add a class of employees from the                                                                               putative C2deoAmB where
                                                Carborundum Company, in Niagara                         SUPPLEMENTARY INFORMATION: Notice is
                                                                                                                                                                Respondent modified and relabeled a
                                                Falls, New York, to the Special                         hereby given that the Office of Research                HPLC trace and relabeled an NMR
                                                Exposure Cohort (SEC) under the Energy                  Integrity (ORI) has taken final action in               spectrum to falsely claim
                                                Employees Occupational Illness                          the following case:                                     characterization, purity, and
                                                Compensation Program Act of 2000                           Matthew Endo, University of Illinois                 identification of sample that was sent
                                                (EEOICPA).                                              at Urbana-Champaign: Based on the                       for biological assay
                                                                                                        Respondent’s admission, an assessment
                                                                                                        conducted by University of Illinois at                  Mr. Endo entered into a Voluntary
                                                FOR FURTHER INFORMATION CONTACT:
                                                                                                        Urbana-Champaign (UIUC), and analysis                 Settlement Agreement and voluntarily
                                                Stuart L. Hinnefeld, Director, Division                                                                       agreed for a period of three (3) years,
                                                of Compensation Analysis and Support,                   conducted by ORI in its oversight
                                                                                                        review, ORI found that Mr. Matthew                    beginning on November 16, 2017:
                                                National Institute for Occupational                                                                             (1) To have his research supervised;
                                                Safety and Health (NIOSH), 1090                         Endo, a former graduate student,
                                                                                                        Department of Chemistry, UIUC,                        Respondent agreed to ensure that prior
                                                Tusculum Avenue, MS C–46,                                                                                     to the submission of an application for
                                                Cincinnati, OH 45226–1938, Telephone                    engaged in research misconduct in
                                                                                                        research supported by National Institute              PHS support for a research project on
                                                1–877–222–7570. Information requests                                                                          which Respondent’s participation is
                                                                                                        of General Medical Sciences (NIGMS),
                                                can also be submitted by email to                                                                             proposed and prior to Respondent’s
                                                                                                        National Institutes of Health (NIH),
                                                DCAS@CDC.GOV.                                                                                                 participation in any capacity on PHS-
                                                                                                        grant R01 GM080436.
                                                SUPPLEMENTARY INFORMATION:                                 ORI found that Respondent engaged                  supported research, the institution
                                                                                                        in research misconduct by intentionally,              employing him must submit a plan for
                                                   Authority: [42 U.S.C.7384q].                                                                               supervision of Respondent’s duties to
                                                                                                        knowingly, or recklessly causing false
                                                                                                        data to be recorded, falsifying and/or                ORI for approval; the plan for
                                                  On November 16, 2017, the Acting
                                                                                                        fabricating data and related images by                supervision must be designed to ensure
                                                Secretary of HHS determined that the                                                                          the scientific integrity of Respondent’s
                                                following class of employees does not                   alteration and/or reuse and/or relabeling
                                                                                                        of experimental data, and reporting                   research contribution; Respondent
                                                meet the statutory criteria for addition                                                                      agreed that he will not participate in
                                                to the SEC as authorized under                          falsified and/or fabricated data in one
                                                                                                        (1) manuscript subsequently submitted                 any PHS-supported research until a plan
                                                EEOICPA:                                                                                                      for supervision is submitted and
                                                                                                        for publication:
                                                   All employees who worked in any area of              • ‘‘Amphotericin primarily kills human                approved by ORI;
                                                the Carborundum Company facility on                        cells by binding and extracting                      (2) that any institution employing him
                                                Buffalo Avenue, Niagara Falls, New York,                   cholesterol.’’ Submitted for                       must submit in conjunction with each
                                                from January 1, 1943, through December 31,                 publication to the Proceedings of the              application for PHS funds, or report,
                                                                                                                                                              manuscript, or abstract involving PHS
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                                                1976.                                                      National Academy of Sciences
                                                                                                           [withdrawn prior to peer review]                   supported research in which
                                                John Howard,                                                                                                  Respondent is involved, a certification
                                                Director, National Institute for Occupational              (hereafter referred to as ‘‘Manuscript
                                                                                                           1’’)                                               to ORI that the data provided by
                                                Safety and Health.                                                                                            Respondent are based on actual
                                                [FR Doc. 2017–27039 Filed 12–14–17; 8:45 am]              Specifically, ORI found that:                       experiments or are otherwise
                                                BILLING CODE 4163–19–P                                  • In Manuscript 1, Respondent caused                  legitimately derived and that the data,
                                                                                                          falsified and/or fabricated results to              procedures, and methodology are


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Document Created: 2017-12-15 03:37:46
Document Modified: 2017-12-15 03:37:46
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 February 13, 2018.
ContactTo request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email [email protected] or call Lisa Wright- Solomon, the HRSA Information Collection Clearance Officer at (301) 443-1984.
FR Citation82 FR 59625 

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