80_FR_42643 80 FR 42506 - Agency Information Collection Activities: Proposed Collection: Public Comment Request

80 FR 42506 - Agency Information Collection Activities: Proposed Collection: Public Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 80, Issue 137 (July 17, 2015)

Page Range42506-42507
FR Document2015-17552

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (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 80 Issue 137 (Friday, July 17, 2015)
[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)]
[Notices]
[Pages 42506-42507]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-17552]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice.

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

SUMMARY: In compliance with the requirement for opportunity for public 
comment on proposed data collection projects (Section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995), the Health Resources and Services 
Administration (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 Information Collection Request must be received 
no later than September 15, 2015.

ADDRESSES: Submit your comments to [email protected] or mail the HRSA 
Information Collection Clearance Officer, Room 10C-03, Parklawn 
Building, 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 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: Bureau of Health Workforce 
(BHW) Uniform Data System (UDS).
    OMB No. 0915-XXXX--NEW.
    Abstract: The UDS is the Bureau of Primary Health Care's (BPHC's) 
annual reporting system for HRSA-supported health centers. The UDS is a 
program performance reporting system that tracks a variety of 
information, including patient demographics, services provided, 
staffing, clinical indicators, utilization rates, costs, and revenues. 
BHW proposes that HRSA Nurse Managed Health Clinic (NMHC) grantees and 
Interprofessional Collaborative Practice (IPCP) program cooperative 
agreement awardees also submit data into the UDS.

[[Page 42507]]

    This request is to expand the UDS data reporting resource to the 
BHW NMHC grantees and IPCP program cooperative agreement awardees. 
Calendar year data would be submitted annually to enable BHW to track 
clinical practice and patient outcome data. The data collection is 
limited to NMHC and IPCP grantees and cooperative agreement awardees 
because of the similarities these care models share with health 
centers; therefore, the use of the pre-existing infrastructure will 
enable HRSA to populate the data set with additional sources, making 
the resource more robust.
    Need and Proposed Use of the Information: HRSA collects UDS data 
which are used to ensure compliance with legislative and regulatory 
requirements, improve grantee and cooperative agreement awardee 
performance and operations, and report overall program accomplishments. 
BHW proposes to collect core data elements that include patient 
demographics, healthcare services, clinical indicators and outcomes, 
provider utilization, and costs. BHW will use the patient and provider-
level data to determine the impact of healthcare services on patient 
outcomes. The data will also enable BHW to establish or expand targeted 
programs and identify effective services and interventions to improve 
the health of underserved communities and vulnerable populations. In 
addition, the UDS data are useful to BHW grantees and cooperative 
agreement awardees for performance and operations improvement, patient 
forecasts, identification of trends/patterns, implication of access 
barriers, and cost analysis to support long-term sustainability.
    Likely Respondents: The respondents will be HRSA BHW Nurse Managed 
Health Clinic (NMHC) grantees and Interprofessional Collaborative 
Practice (IPCP) program cooperative agreement awardees.
    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 Information Collection Request are summarized in the table below.

----------------------------------------------------------------------------------------------------------------
                                                                                      Average
   Total estimated annualized        Number of       Number of         Total        burden per     Total burden
        hours: Form name            respondents    responses per     responses     response  (in       hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
Universal Report................              81               1              81             170          13,770
Grant Report....................              81               1              81              22           1,782
                                 -------------------------------------------------------------------------------
    Total.......................             162  ..............  ..............  ..............          15,552
----------------------------------------------------------------------------------------------------------------

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

Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015-17552 Filed 7-16-15; 8:45 am]
 BILLING CODE 4165-15-P



                                                42506                            Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Notices

                                                   Name of Committee: Vaccines and                       the meeting. Background material is                   DEPARTMENT OF HEALTH AND
                                                Related Biological Products Advisory                     available at http://www.fda.gov/                      HUMAN SERVICES
                                                Committee.                                               AdvisoryCommittees/Calendar/
                                                   General Function of the Committee:                    default.htm. Scroll down to the                       Health Resources and Services
                                                To provide advice and                                    appropriate advisory committee meeting                Administration
                                                recommendations to the Agency on                         link.
                                                FDA’s regulatory issues.                                                                                       Agency Information Collection
                                                   Date and Time: The meeting will be                       Procedure: Interested persons may                  Activities: Proposed Collection: Public
                                                held on September 15, 2015, from 8:30                    present data, information, or views,                  Comment Request
                                                a.m. to 2:30 p.m.                                        orally or in writing, on issues pending
                                                                                                         before the committee. Written                         AGENCY: Health Resources and Services
                                                   Location: FDA White Oak Campus,
                                                                                                         submissions may be made to the contact                Administration, HHS.
                                                10903 New Hampshire Ave., Building
                                                31 Conference Center, the Great Room                     person on or before September 8, 2015.                ACTION: Notice.
                                                (Rm. 1503), Silver Spring, MD 20993.                     Oral presentations from the public will               SUMMARY:    In compliance with the
                                                Answers to commonly asked questions                      be scheduled between approximately                    requirement for opportunity for public
                                                including information regarding special                  12:15 p.m. to 1:15 p.m. on September                  comment on proposed data collection
                                                accommodations due to a disability,                      15, 2015. Those individuals interested                projects (Section 3506(c)(2)(A) of the
                                                visitor parking, and transportation may                  in making formal oral presentations                   Paperwork Reduction Act of 1995), the
                                                be accessed at: http://www.fda.gov/                      should notify the contact person and                  Health Resources and Services
                                                AdvisoryCommittees/                                      submit a brief statement of the general               Administration (HRSA) announces
                                                AboutAdvisoryCommittees/                                 nature of the evidence or arguments                   plans to submit an Information
                                                ucm408555.htm.                                           they wish to present, the names and                   Collection Request (ICR), described
                                                   For those unable to attend in person,                 addresses of proposed participants, and               below, to the Office of Management and
                                                the meeting will also be webcast and                     an indication of the approximate time                 Budget (OMB). Prior to submitting the
                                                will be available at the following link
                                                                                                         requested to make their presentation on               ICR to OMB, HRSA seeks comments
                                                https://collaboration.fda.gov/
                                                                                                         or before August 31, 2015. Time allotted              from the public regarding the burden
                                                cbervrbpac0915/.
                                                   Contact Person: Sujata Vijh or Denise                 for each presentation may be limited. If              estimate, below, or any other aspect of
                                                Royster, Center for Biologics Evaluation                 the number of registrants requesting to               the ICR.
                                                and Research, Food and Drug                              speak is greater than can be reasonably               DATES: Comments on this Information
                                                Administration, 10903 New Hampshire                      accommodated during the scheduled                     Collection Request must be received no
                                                Ave., Bldg. 71, Rm. 6128, Silver Spring,                 open public hearing session, FDA may                  later than September 15, 2015.
                                                MD 20993–0002, 240–402–7107 or 240–                      conduct a lottery to determine the                    ADDRESSES: Submit your comments to
                                                402–8158, or FDA Advisory Committee                      speakers for the scheduled open public                paperwork@hrsa.gov or mail the HRSA
                                                Information Line, 1–800–741–8138                         hearing session. The contact person will              Information Collection Clearance
                                                (301–443–0572 in the Washington, DC                      notify interested persons regarding their             Officer, Room 10C–03, Parklawn
                                                area). A notice in the Federal Register                  request to speak by September 1, 2015.                Building, 5600 Fishers Lane, Rockville,
                                                about last minute modifications that                        Persons attending FDA’s advisory                   MD 20857.
                                                impact a previously announced                            committee meetings are advised that the               FOR FURTHER INFORMATION CONTACT: To
                                                advisory committee meeting cannot                        Agency is not responsible for providing               request more information on the
                                                always be published quickly enough to                    access to electrical outlets.                         proposed project or to obtain a copy of
                                                provide timely notice. Therefore, you                                                                          the data collection plans and draft
                                                should always check the Agency’s Web                        FDA welcomes the attendance of the                 instruments, email paperwork@hrsa.gov
                                                site at http://www.fda.gov/                              public at its advisory committee                      or call the HRSA Information Collection
                                                AdvisoryCommittees/default.htm and                       meetings and will make every effort to                Clearance Officer at (301) 443–1984.
                                                scroll down to the appropriate advisory                  accommodate persons with physical                     SUPPLEMENTARY INFORMATION: When
                                                committee meeting link, or call the                      disabilities or special needs. If you                 submitting comments or requesting
                                                advisory committee information line to                   require special accommodations due to                 information, please include the
                                                learn about possible modifications                       a disability, please contact Sujata Vijh at           information request collection title for
                                                before coming to the meeting.                            least 7 days in advance of the meeting.               reference.
                                                   Agenda: On September 15, 2015, from                      FDA is committed to the orderly                       Information Collection Request Title:
                                                8:30 a.m. to 2:30 p.m., the committee                    conduct of its advisory committee                     Bureau of Health Workforce (BHW)
                                                will meet in open session to discuss and                 meetings. Please visit our Web site at                Uniform Data System (UDS).
                                                make recommendations on the safety                       http://www.fda.gov/                                      OMB No. 0915–XXXX—NEW.
                                                and immunogenicity of Seasonal                                                                                    Abstract: The UDS is the Bureau of
                                                                                                         AdvisoryCommittees/
                                                Trivalent Influenza Vaccine, Surface                                                                           Primary Health Care’s (BPHC’s) annual
                                                                                                         AboutAdvisoryCommittees/
                                                Antigen, Inactivated, Adjuvanted with                                                                          reporting system for HRSA-supported
                                                                                                         ucm111462.htm for procedures on
                                                MF59 (FLUAD) manufactured by                                                                                   health centers. The UDS is a program
                                                                                                         public conduct during advisory                        performance reporting system that
                                                Novartis.
                                                   FDA intends to make background                        committee meetings.                                   tracks a variety of information,
                                                material available to the public no later                   Notice of this meeting is given under              including patient demographics,
                                                than 2 business days before the meeting.                 the Federal Advisory Committee Act (5                 services provided, staffing, clinical
srobinson on DSK5SPTVN1PROD with NOTICES




                                                If FDA is unable to post the background                  U.S.C. app. 2).                                       indicators, utilization rates, costs, and
                                                material on its Web site prior to the                      Dated: July 10, 2015.                               revenues. BHW proposes that HRSA
                                                meeting, the background material will                                                                          Nurse Managed Health Clinic (NMHC)
                                                                                                         Leslie Kux,
                                                be made publicly available at the                                                                              grantees and Interprofessional
                                                location of the advisory committee                       Associate Commissioner for Policy.                    Collaborative Practice (IPCP) program
                                                meeting, and the background material                     [FR Doc. 2015–17559 Filed 7–16–15; 8:45 am]           cooperative agreement awardees also
                                                will be posted on FDA’s Web site after                   BILLING CODE 4164–01–P                                submit data into the UDS.


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                                                                                            Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Notices                                                                                    42507

                                                  This request is to expand the UDS                                        proposes to collect core data elements                             Interprofessional Collaborative Practice
                                                data reporting resource to the BHW                                         that include patient demographics,                                 (IPCP) program cooperative agreement
                                                NMHC grantees and IPCP program                                             healthcare services, clinical indicators                           awardees.
                                                cooperative agreement awardees.                                            and outcomes, provider utilization, and                               Burden Statement: Burden in this
                                                Calendar year data would be submitted                                      costs. BHW will use the patient and                                context means the time expended by
                                                annually to enable BHW to track clinical                                   provider-level data to determine the                               persons to generate, maintain, retain,
                                                practice and patient outcome data. The                                     impact of healthcare services on patient                           disclose or provide the information
                                                data collection is limited to NMHC and                                     outcomes. The data will also enable                                requested. This includes the time
                                                IPCP grantees and cooperative                                              BHW to establish or expand targeted                                needed to review instructions; to
                                                agreement awardees because of the                                          programs and identify effective services                           develop, acquire, install and utilize
                                                similarities these care models share                                       and interventions to improve the health                            technology and systems for the purpose
                                                with health centers; therefore, the use of                                 of underserved communities and                                     of collecting, validating and verifying
                                                the pre-existing infrastructure will                                       vulnerable populations. In addition, the                           information, processing and
                                                enable HRSA to populate the data set                                       UDS data are useful to BHW grantees                                maintaining information, and disclosing
                                                with additional sources, making the                                        and cooperative agreement awardees for                             and providing information; to train
                                                resource more robust.                                                      performance and operations                                         personnel and to be able to respond to
                                                  Need and Proposed Use of the                                             improvement, patient forecasts,                                    a collection of information; to search
                                                Information: HRSA collects UDS data                                        identification of trends/patterns,                                 data sources; to complete and review
                                                which are used to ensure compliance                                        implication of access barriers, and cost                           the collection of information; and to
                                                with legislative and regulatory                                            analysis to support long-term                                      transmit or otherwise disclose the
                                                requirements, improve grantee and                                          sustainability.                                                    information. The total annual burden
                                                cooperative agreement awardee                                                Likely Respondents: The respondents                              hours estimated for this Information
                                                performance and operations, and report                                     will be HRSA BHW Nurse Managed                                     Collection Request are summarized in
                                                overall program accomplishments. BHW                                       Health Clinic (NMHC) grantees and                                  the table below.

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

                                                Universal Report ..................................................................                      81                         1                        81                        170            13,770
                                                Grant Report ........................................................................                    81                         1                        81                         22             1,782

                                                      Total ..............................................................................               162   ........................   ........................   ........................         15,552



                                                  HRSA specifically requests comments                                      SUMMARY:   In compliance with Section                                Abstract: This program is authorized
                                                on (1) the necessity and utility of the                                    3507(a)(1)(D) of the Paperwork                                     by the Public Health Improvement Act
                                                proposed information collection for the                                    Reduction Act of 1995, the Health                                  Title IV—Cardiac Arrest Survival Act of
                                                proper performance of the agency’s                                         Resources and Services Administration                              2000, Subtitle B—Rural Access to
                                                functions, (2) the accuracy of the                                         (HRSA) has submitted an Information                                Emergency Devices, Section 413, (42
                                                estimated burden, (3) ways to enhance                                      Collection Request (ICR) to the Office of                          U.S.C. 254c (Note) and the Consolidated
                                                the quality, utility, and clarity of the                                   Management and Budget (OMB) for                                    and Further Continuing Appropriations
                                                information to be collected, and (4) the                                   review and approval. Comments                                      Act (Pub. L. 113–235). The purpose of
                                                use of automated collection techniques                                     submitted during the first public review                           this grant program is to: (1) Purchase
                                                or other forms of information                                              of this ICR will be provided to OMB.                               automated external defibrillators (AEDs)
                                                technology to minimize the information                                     OMB will accept further comments from                              that have been approved, or cleared for
                                                collection burden.                                                         the public during the review and                                   marketing, by the Food and Drug
                                                                                                                           approval period.                                                   Administration; (2) provide defibrillator
                                                Jackie Painter,
                                                                                                                           DATES: Comments on this ICR should be                              and basic life support training in AED
                                                Director, Division of the Executive Secretariat.                                                                                              usage through the American Heart
                                                [FR Doc. 2015–17552 Filed 7–16–15; 8:45 am]
                                                                                                                           received no later than August 17, 2015.
                                                                                                                                                                                              Association, the American Red Cross, or
                                                                                                                           ADDRESSES: Submit your comments,
                                                BILLING CODE 4165–15–P                                                                                                                        other nationally recognized training
                                                                                                                           including the Information Collection                               courses; and (3) place the AEDs in rural
                                                                                                                           Request Title, to the desk officer for                             communities with local organizations.
                                                DEPARTMENT OF HEALTH AND                                                   HRSA, either by email to OIRA_
                                                HUMAN SERVICES                                                             submission@omb.eop.gov or by fax to                                  Need and Proposed Use of the
                                                                                                                           202–395–5806.                                                      Information: For this program,
                                                Health Resources and Services                                                                                                                 performance measures were drafted to
                                                                                                                           FOR FURTHER INFORMATION CONTACT: To                                provide data useful to the program and
                                                Administration                                                             request a copy of the clearance requests                           to enable HRSA to provide aggregate
                                                Agency Information Collection                                              submitted to OMB for review, email the                             program data required by Congress
                                                Activities: Submission to OMB for                                          HRSA Information Collection Clearance                              under the Government Performance and
srobinson on DSK5SPTVN1PROD with NOTICES




                                                Review and Approval; Public Comment                                        Officer at paperwork@hrsa.gov or call                              Results Act (GPRA) of 1993 (Pub. L.
                                                Request                                                                    (301) 443–1984.                                                    103–62). These measures cover the
                                                                                                                           SUPPLEMENTARY INFORMATION:                                         principal topic areas of interest to the
                                                AGENCY:Health Resources and Services                                         Information Collection Request Title:                            Federal Office of Rural Health Policy,
                                                Administration, HHS.                                                       Rural Access to Emergency Devices                                  including: (a) The number of counties
                                                                                                                           Grant Program OMB No. 0915–xxxx—                                   served by the program; (b) the number
                                                ACTION:      Notice.
                                                                                                                           NEW.                                                               of AEDs purchased and placed and the


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Document Created: 2018-02-23 09:20:55
Document Modified: 2018-02-23 09:20:55
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 Information Collection Request must be received no later than September 15, 2015.
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 the HRSA Information Collection Clearance Officer at (301) 443-1984.
FR Citation80 FR 42506 

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