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)
Health Resources and Services Administration
Federal Register Volume 83, Issue 202 (October 18, 2018)
| Page Range | 52840-52841 | |
| FR Document | 2018-22708 |
[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
khammond on DSK30JT082PROD with NOTICES
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;
khammond on DSK30JT082PROD with NOTICES
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
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on this ICR should be received no later than December | |
| Contact | To request more information on the | |
| FR Citation | 83 FR 52840 |
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