83_FR_53042 83 FR 52840 - Agency Information Collection Activities: Proposed Collection: Public Comment Request: Information Collection Request Title: Bureau of Health Workforce Performance Data Collection, OMB No. 0915-0061-Revision

83 FR 52840 - Agency Information Collection Activities: Proposed Collection: Public Comment Request: Information Collection Request Title: Bureau of Health Workforce Performance Data Collection, OMB No. 0915-0061-Revision

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 83, Issue 202 (October 18, 2018)

Page Range52840-52841
FR Document2018-22708

In compliance with the requirement for opportunity for public

Federal Register, Volume 83 Issue 202 (Thursday, October 18, 2018)
[Federal Register Volume 83, Number 202 (Thursday, October 18, 2018)]
[Notices]
[Pages 52840-52841]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-22708]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES



Health Resources and Services Administration




Agency Information Collection Activities: Proposed Collection: 

Public Comment Request: Information Collection Request Title: Bureau of 

Health Workforce Performance Data Collection, OMB No. 0915-0061--

Revision



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

of Health and Human Services (HHS).



ACTION: Notice.



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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 December 

17, 2018.



ADDRESSES: Submit your comments to paperwork@hrsa.gov 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 paperwork@hrsa.gov 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: Bureau of Health Workforce 

Performance Data Collection, OMB No. 0915-0061--Revision.

    Abstract: Over 40 Bureau of Health Workforce (BHW) programs award 

grants to health professions schools and training programs across the 

United States to develop, expand, and enhance training, and to 

strengthen the distribution of the health workforce. These programs are 

governed by the Public Health Service Act (42 U.S.C. 201 et seq.), 

specifically Titles III, VII, and VIII. Performance information about 

these health professions programs is



[[Page 52841]]



collected in the HRSA Performance Report for Grants and Cooperative 

Agreements. Specific performance measurement requirements for each 

program may be found on the HRSA website at https://bhw.hrsa.gov/grants/reportonyourgrant. Data collection activities consist of two 

reports, an annual progress and annual performance report that are 

submitted by awardees to comply with statutory and programmatic 

requirements for performance measurement and evaluation (including 

specific Title III, VII and VIII requirements), as well as the 

Government Performance and Results Act of 1993 (GPRA) and the GPRA 

Modernization Act of 2010 requirements. The performance measures were 

last revised in 2016 to ensure they addressed programmatic changes, met 

evolving program management needs, and responded to emerging workforce 

concerns. As these changes successfully enabled BHW to demonstrate 

accurate outputs and outcomes associated with the health professions 

programs, BHW will continue with its current performance management 

strategy and make only minor changes that reflect new HHS and HRSA 

priorities with the addition of a question asking awardees how many 

trainees received training in telehealth, substance use treatment, and/

or medication-assisted treatment.

    Need and Proposed Use of the Information: The purpose of the 

proposed data collection is to continue analysis and reporting of 

awardee training activities and educational programs, identify intended 

practice locations, and report outcomes of funded initiatives. Data 

collected from these grant programs will also provide a description of 

the program activities of approximately 1,500 reporting grantees to 

inform policymakers on the barriers, opportunities, and outcomes 

involved in health care workforce development. The proposed measures 

focus on five key outcomes: (1) Increasing the workforce supply of 

well-educated practitioners in needed professions; (2) increasing the 

number of practitioners that practice in underserved and rural areas; 

(3) enhancing the quality of education; (4) increasing the recruitment, 

training, and placement of under-represented groups in the health 

workforce; and (5) supporting educational infrastructure to increase 

the capacity to train more health professionals in high demand areas.

    Likely Respondents: Respondents are awardees of BHW health 

professions grant programs.

    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

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

Direct Financial Support Program             500               1             500             3.1           1,550

Infrastructure Program..........             100               1             100             4.5             450

Multipurpose or Hybrid Program..             900               1             900             4.3           3,870

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

                                           1,500  ..............           1,500  ..............           5,870

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



    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.



Amy P. McNulty,

Acting Director, Division of the Executive Secretariat.

[FR Doc. 2018-22708 Filed 10-17-18; 8:45 am]

BILLING CODE 4165-15-P





                                               52840                       Federal Register / Vol. 83, No. 202 / Thursday, October 18, 2018 / Notices

                                               begins. The approval phase starts with                  verified the applicant’s claim that the               DEPARTMENT OF HEALTH AND
                                               the initial submission of an application                biologics license application (BLA) for               HUMAN SERVICES
                                               to market the human biological product                  AFSTYLA (BLA 125591) was initially
                                               and continues until FDA grants                          submitted on May 29, 2015.                            Health Resources and Services
                                               permission to market the biological                                                                           Administration
                                                                                                         3. The date the application was
                                               product. Although only a portion of a
                                                                                                       approved: May 25, 2016. FDA has                       Agency Information Collection
                                               regulatory review period may count
                                               toward the actual amount of extension                   verified the applicant’s claim that BLA               Activities: Proposed Collection: Public
                                               that the Director of USPTO may award                    125591 was approved on May 25, 2016.                  Comment Request: Information
                                               (for example, half the testing phase must                 This determination of the regulatory                Collection Request Title: Bureau of
                                               be subtracted as well as any time that                  review period establishes the maximum                 Health Workforce Performance Data
                                               may have occurred before the patent                     potential length of a patent extension.               Collection, OMB No. 0915–0061—
                                               was issued), FDA’s determination of the                 However, the USPTO applies several                    Revision
                                               length of a regulatory review period for                statutory limitations in its calculations             AGENCY: Health Resources and Services
                                               a human biological product will include                 of the actual period for patent extension.            Administration (HRSA), Department of
                                               all of the testing phase and approval                   In its application for patent extension,              Health and Human Services (HHS).
                                               phase as specified in 35 U.S.C.                         this applicant seeks 1,047 days of patent
                                               156(g)(1)(B).                                                                                                 ACTION: Notice.
                                                                                                       term extension.
                                                  FDA has approved for marketing the
                                                                                                                                                             SUMMARY:   In compliance with the
                                               human biologic product AFSTYLA                          III. Petitions                                        requirement for opportunity for public
                                               (Antihemophilic Factor (Recombinant),
                                                                                                          Anyone with knowledge that any of                  comment on proposed data collection
                                               Single Chain). AFSTYLA is indicated in
                                                                                                       the dates as published are incorrect may              projects of the Paperwork Reduction Act
                                               children and adults with hemophilia A
                                                                                                       submit either electronic or written                   of 1995, HRSA announces plans to
                                               (congenital Factor VIII deficiency) for:
                                                                                                       comments and, under 21 CFR 60.24, ask                 submit an Information Collection
                                               (1) On-demand treatment and control of
                                                                                                                                                             Request (ICR), described below, to the
                                               bleeding episodes, (2) routine                          for a redetermination (see DATES).
                                                                                                                                                             Office of Management and Budget
                                               prophylaxis to reduce the frequency of                  Furthermore, as specified in § 60.30 (21
                                                                                                                                                             (OMB). Prior to submitting the ICR to
                                               bleeding episodes, and (3) perioperative                CFR 60.30), any interested person may
                                                                                                                                                             OMB, HRSA seeks comments from the
                                               management of bleeding. Subsequent to                   petition FDA for a determination
                                               this approval, the USPTO received a                                                                           public regarding the burden estimate,
                                                                                                       regarding whether the applicant for                   below, or any other aspect of the ICR.
                                               patent term restoration application for                 extension acted with due diligence
                                               AFSTYLA (U.S. Patent No. 7,041,635)                                                                           DATES: Comments on this ICR should be
                                                                                                       during the regulatory review period. To
                                               from SK Chemicals Co, LTD., and the                                                                           received no later than December 17,
                                                                                                       meet its burden, the petition must
                                               USPTO requested FDA’s assistance in                                                                           2018.
                                                                                                       comply with all the requirements of
                                               determining this patent’s eligibility for               § 60.30, including but not limited to:                ADDRESSES:    Submit your comments to
                                               patent term restoration. In a letter dated                                                                    paperwork@hrsa.gov or mail the HRSA
                                                                                                       Must be timely (see DATES), must be
                                               August 1, 2017, FDA advised the                                                                               Information Collection Clearance
                                                                                                       filed in accordance with § 10.20, must
                                               USPTO that this human biological                                                                              Officer, Room 14N39, 5600 Fishers
                                               product had undergone a regulatory                      contain sufficient facts to merit an FDA
                                                                                                       investigation, and must certify that a                Lane, Rockville, MD 20857.
                                               review period and that the approval of                                                                        FOR FURTHER INFORMATION CONTACT: To
                                               AFSTYLA represented the first                           true and complete copy of the petition
                                                                                                       has been served upon the patent                       request more information on the
                                               permitted commercial marketing or use                                                                         proposed project or to obtain a copy of
                                               of the product. Thereafter, the USPTO                   applicant. (See H. Rept. 857, part 1, 98th
                                                                                                       Cong., 2d sess., pp. 41–42, 1984.)                    the data collection plans and draft
                                               requested that FDA determine the                                                                              instruments, email paperwork@hrsa.gov
                                               product’s regulatory review period.                     Petitions should be in the format
                                                                                                       specified in 21 CFR 10.30.                            or call Lisa Wright-Solomon, the HRSA
                                               II. Determination of Regulatory Review                                                                        Information Collection Clearance Officer
                                               Period                                                     Submit petitions electronically to                 at (301) 443–1984.
                                                                                                       https://www.regulations.gov at Docket                 SUPPLEMENTARY INFORMATION: When
                                                  FDA has determined that the
                                                                                                       No. FDA–2013–S–0610. Submit written                   submitting comments or requesting
                                               applicable regulatory review period for
                                                                                                       petitions (two copies are required) to the            information, please include the
                                               AFSTYLA is 1,734 days. Of this time,
                                                                                                       Dockets Management Staff (HFA–305),                   information request collection title for
                                               1,371 days occurred during the testing
                                               phase of the regulatory review period,                  Food and Drug Administration, 5630                    reference.
                                               while 363 days occurred during the                      Fishers Lane, Rm. 1061, Rockville, MD                    Information Collection Request Title:
                                               approval phase. These periods of time                   20852.                                                Bureau of Health Workforce
                                               were derived from the following dates:                    Dated: October 12, 2018.                            Performance Data Collection, OMB No.
                                                  1. The date an exemption under                       Leslie Kux,                                           0915–0061—Revision.
                                               section 505(i) of the Federal Food, Drug,                                                                        Abstract: Over 40 Bureau of Health
                                                                                                       Associate Commissioner for Policy.
                                               and Cosmetic Act (21 U.S.C. 355(i))                                                                           Workforce (BHW) programs award
                                                                                                       [FR Doc. 2018–22696 Filed 10–17–18; 8:45 am]          grants to health professions schools and
                                               became effective: August 28, 2011. FDA
                                               has verified the applicant’s claim that                 BILLING CODE 4164–01–P                                training programs across the United
                                                                                                                                                             States to develop, expand, and enhance
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                                               the date the investigational new drug
                                               application became effective was on                                                                           training, and to strengthen the
                                               August 28, 2011.                                                                                              distribution of the health workforce.
                                                  2. The date the application was                                                                            These programs are governed by the
                                               initially submitted with respect to the                                                                       Public Health Service Act (42 U.S.C. 201
                                               human biological product under section                                                                        et seq.), specifically Titles III, VII, and
                                               351 of the Public Health Service Act (42                                                                      VIII. Performance information about
                                               U.S.C. 262): May 29, 2015. FDA has                                                                            these health professions programs is


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                                                                                Federal Register / Vol. 83, No. 202 / Thursday, October 18, 2018 / Notices                                                                  52841

                                               collected in the HRSA Performance                                  management strategy and make only                             recruitment, training, and placement of
                                               Report for Grants and Cooperative                                  minor changes that reflect new HHS and                        under-represented groups in the health
                                               Agreements. Specific performance                                   HRSA priorities with the addition of a                        workforce; and (5) supporting
                                               measurement requirements for each                                  question asking awardees how many                             educational infrastructure to increase
                                               program may be found on the HRSA                                   trainees received training in telehealth,                     the capacity to train more health
                                               website at https://bhw.hrsa.gov/grants/                            substance use treatment, and/or                               professionals in high demand areas.
                                               reportonyourgrant. Data collection                                 medication-assisted treatment.                                   Likely Respondents: Respondents are
                                               activities consist of two reports, an                                 Need and Proposed Use of the                               awardees of BHW health professions
                                               annual progress and annual                                         Information: The purpose of the                               grant programs.
                                               performance report that are submitted                              proposed data collection is to continue                          Burden Statement: Burden in this
                                               by awardees to comply with statutory                               analysis and reporting of awardee                             context means the time expended by
                                               and programmatic requirements for                                  training activities and educational                           persons to generate, maintain, retain,
                                               performance measurement and                                        programs, identify intended practice                          disclose or provide the information
                                               evaluation (including specific Title III,                          locations, and report outcomes of                             requested. This includes the time
                                               VII and VIII requirements), as well as                             funded initiatives. Data collected from                       needed to review instructions; to
                                               the Government Performance and                                     these grant programs will also provide                        develop, acquire, install and utilize
                                               Results Act of 1993 (GPRA) and the                                 a description of the program activities of                    technology and systems for the purpose
                                               GPRA Modernization Act of 2010                                     approximately 1,500 reporting grantees                        of collecting, validating and verifying
                                               requirements. The performance                                      to inform policymakers on the barriers,                       information, processing and
                                               measures were last revised in 2016 to                              opportunities, and outcomes involved                          maintaining information, and disclosing
                                               ensure they addressed programmatic                                 in health care workforce development.                         and providing information; to train
                                               changes, met evolving program                                      The proposed measures focus on five                           personnel and to be able to respond to
                                               management needs, and responded to                                 key outcomes: (1) Increasing the                              a collection of information; to search
                                               emerging workforce concerns. As these                              workforce supply of well-educated                             data sources; to complete and review
                                               changes successfully enabled BHW to                                practitioners in needed professions; (2)                      the collection of information; and to
                                               demonstrate accurate outputs and                                   increasing the number of practitioners                        transmit or otherwise disclose the
                                               outcomes associated with the health                                that practice in underserved and rural                        information. The total annual burden
                                               professions programs, BHW will                                     areas; (3) enhancing the quality of                           hours estimated for this ICR are
                                               continue with its current performance                              education; (4) increasing the                                 summarized in the table below.

                                                                                                           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)

                                               Direct Financial Support Program .......................................                        500                        1            500                       3.1          1,550
                                               Infrastructure Program .........................................................                100                        1            100                       4.5            450
                                               Multipurpose or Hybrid Program ..........................................                       900                        1            900                       4.3          3,870

                                                                                                                                          1,500      ........................         1,500    ........................       5,870



                                                 HRSA specifically requests comments                              DEPARTMENT OF HEALTH AND                                      SW, Washington, DC 20201; Telephone:
                                               on (1) the necessity and utility of the                            HUMAN SERVICES                                                202–205–2882.
                                               proposed information collection for the                                                                                          SUPPLEMENTARY INFORMATION:
                                               proper performance of the agency’s                                 Office of the Secretary
                                                                                                                                                                                  National Security Presidential
                                               functions; (2) the accuracy of the                                                                                               Memorandum: Support for National
                                                                                                                  Posting of the National Security
                                               estimated burden; (3) ways to enhance                                                                                            Biodefense.
                                                                                                                  Presidential Memorandum 14,
                                               the quality, utility, and clarity of the                                                                                           Memorandum for: The Vice President;
                                                                                                                  ‘‘Support for National Biodefense’’
                                               information to be collected; and (4) the                                                                                         The Secretary of State; The Secretary of
                                               use of automated collection techniques                             ACTION:     Notice.                                           the Treasury; The Secretary of Defense;
                                               or other forms of information                                                                                                    The Attorney General; The Secretary of
                                               technology to minimize the information                             SUMMARY:   National Security Presidential                     the Interior; The Secretary of
                                               collection burden.                                                 Memorandum 14 directs                                         Agriculture; The Secretary of
                                                                                                                  implementation of the National                                Commerce; The Secretary of Labor; The
                                               Amy P. McNulty,                                                    Biodefense Strategy. The Secretary is                         Secretary of Health and Human
                                               Acting Director, Division of the Executive                         authorized and directed to publish the                        Services; The Secretary of
                                               Secretariat.                                                       Memorandum in the Federal Register.                           Transportation; The Secretary of Energy;
                                               [FR Doc. 2018–22708 Filed 10–17–18; 8:45 am]                       DATES: National Security Presidential                         The Secretary of Veterans Affairs; The
                                                                                                                  Memorandum 14 was signed on                                   Secretary of Homeland Security;
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                                               BILLING CODE 4165–15–P
                                                                                                                  September 18, 2018.                                           Assistant to the President and Chief of
                                                                                                                  FOR FURTHER INFORMATION CONTACT:                              Staff; Administrator of the
                                                                                                                  Robert P. Kadlec, MD, MTM&H, MS,                              Environmental Protection Agency;
                                                                                                                  Assistant Secretary for Preparedness                          Director of the Office of Management
                                                                                                                  and Response, Office of the Secretary,                        and Budget; The Representative of the
                                                                                                                  Department of Health and Human                                United States to the United Nations;
                                                                                                                  Services, 200 Independence Avenue                             Director of National Intelligence;


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Document Created: 2018-10-18 03:06:09
Document Modified: 2018-10-18 03:06:09
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 December
ContactTo request more information on the
FR Citation83 FR 52840 

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