Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Small Rural Hospital Transition Project (SRHT), OMB No. 0906-0026-Extension, 29217-29218 [2019-13195]

Download as PDF 29217 Federal Register / Vol. 84, No. 120 / Friday, June 21, 2019 / Notices To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202– 395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0342. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, PRAStaff@ fda.hhs.gov. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Substances Generally Recognized as Safe (GRAS): Notification Procedure— 21 CFR Part 170, Subpart E and 21 CFR Part 570, Subpart E OMB Control Number 0910–0342— Extension The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that all food additives (as defined by section 201(s) (21 U.S.C. 321(s)) be approved by FDA before they are marketed. Section 409 of the FD&C Act (21 U.S.C. 349) establishes a premarket approval requirement for ‘‘food additives.’’ Section 201(s) of the FD&C Act provides an exclusion to the definition of food additive and thus from the premarket approval requirement, for uses of substances that are GRAS by qualified experts. The GRAS provision of section 201(s) of the FD&C Act is implemented in (part 170) 21 CFR part 170 and (part 570) 21 CFR part 570 for human food and animal food, respectively. Part 170, subpart E and part 570, subpart E provide a standard format for the submission of a notice. This collection utilizes a voluntary administrative procedure for notifying FDA about a conclusion that a substance is GRAS under the conditions of its intended use in human food or animal food. The information submitted to us in a GRAS notice is necessary to allow us to administer efficiently the FD&C Act’s various provisions that apply to the use of substances added to food, specifically with regard to whether a substance is GRAS under the conditions of its intended use or is a food additive subject to premarket review. We use the information collected through the GRAS notification procedures to complete our evaluation within specific timelines. Description of Respondents: The respondents to this collection of information are manufacturers of substances used in human food and animal food and feed. In the Federal Register of March 12, 2019 (84 FR 8876), we published a 60day notice requesting public comment on the proposed collection of information. No comments were received. We estimate the burden of the information collection as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity; 21 CFR section GRAS notification procedure for human food; 170.210– 170.280 (part 170, subpart E) .......................................... GRAS notification procedure for animal food and animal feed; 570.210–570.280 (part 570, subpart E) .................. Total .............................................................................. 1 There Number of responses per respondent Average burden per response Total hours 100 1 100 170 17,000 25 1 25 170 4,250 ........................ ........................ 75 ........................ 21,250 are no capital costs or operating and maintenance costs associated with this collection of information. Our estimated burden reflects an overall increase of 8,500 hours, which corresponds to an increase in GRAS submissions for human food from 50 to 100 we have received over the last 2 years. Dated: June 17, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–13220 Filed 6–20–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. FOR FURTHER INFORMATION CONTACT: 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 18:30 Jun 20, 2019 Jkt 247001 Comments on this Information Collection Request must be received no later than August 20, 2019. DATES: ADDRESSES: SUMMARY: VerDate Sep<11>2014 (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. Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Small Rural Hospital Transition Project (SRHT), OMB No. 0906–0026—Extension AGENCY: jspears on DSK30JT082PROD with NOTICES Total annual responses PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 14N136B, 5600 Fishers Lane, Rockville, Maryland 20857. 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. When submitting comments or requesting information, please include the SUPPLEMENTARY INFORMATION: E:\FR\FM\21JNN1.SGM 21JNN1 29218 Federal Register / Vol. 84, No. 120 / Friday, June 21, 2019 / Notices information request collection title for reference. Information Collection Request Title: Small Rural Hospital Transition Project (SRHT), OMB No. 0906–0026— Extension. Abstract: Under Section 330A of the Public Health Service Act (42 U.S.C. 254c), the Federal Office of Rural Health Policy (FORHP) funds grant programs supporting expanding access to, coordinating, restraining the cost of, and improving the quality of essential health care services in rural and frontier communities. Small rural hospitals are facing many challenges in the new health care environment including the concurrent need to better measure and account for quality of care in all settings, improve transitions of care as patients move from one care setting to another, the evolution of new payment approaches such as value-based purchasing, and new approaches to care delivery such as accountable care organizations (ACO) and patientcentered medical homes. Success in this new environment will require bridging the gaps between the current system and the newly emerging system of healthcare delivery and payment. Because little is known about how these new models might impact rural communities, there is a need to help hospitals understand and consider those factors that would make them logical participants in health care systems that focus on quality, rather than the quantity of care provided to patients. The Small Rural Hospital Transition (SRHT), also funded by Section 330A, assists small rural hospitals facing these challenges. The purpose of the project is to provide on-site technical assistance to nine small rural hospitals residing in persistent poverty counties. Technical assistance is provided in the areas of: (1) Conducting financial assessments, (2) creating a quality-focused environment, (3) aligning services to community need, and (4) to the extent that financial and quality core areas have been stabilized, providing assistance to help recipients of technical assistance consider factors that would make them logical participants in health care systems that focus on value (e.g., ACOs, shared savings programs, and primary care medical homes). Need and Proposed Use of the Information: This information collection request consists of two forms: The SRHT Online Application and the Assessment. The application form is designed to solicit information that will be scored and ranked to aid in the selection of nine small rural hospitals to receive onsite technical assistance. The assessment determines applicant capacity in specific key areas leading to performance excellence across the organization (e.g., leadership, strategic planning, operations, and processes). Likely Respondents: The likely respondents are small rural hospitals located in a rural community. Hospitals must be (1) rural, as defined by FORHP and reside in a persistent poverty county or (2) reside in the rural census tract of a metro county (non-rural county) that is also a persistent poverty county and have 49 staffed beds or less as reported on the hospital’s most recently filed Medicare Cost Report. Hospitals may be for-profit or not-forprofit. 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 respondents Form name Number of responses per respondent Average burden per response (in hours) Total responses Total SRHT Online Application ..................................................... Assessment: Performance Excellence for Rural Hospitals 30 30 1 1 30 30 .50 .25 15.0 7.5 Total .............................................................................. * 30 ........................ 60 ........................ 22.5 jspears on DSK30JT082PROD with NOTICES * The same individuals complete the SRHT Online Application and the Assessment for a total of 30 respondents. 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. Maria G. Button, Director, Division of the Executive Secretariat. [FR Doc. 2019–13195 Filed 6–20–19; 8:45 am] BILLING CODE 4165–15–P VerDate Sep<11>2014 18:30 Jun 20, 2019 Jkt 247001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Solicitation of Nominations for Membership To Serve on the Advisory Committee on Organ Transplantation Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Request for nominations. AGENCY: HRSA is seeking nominations of qualified candidates to be considered for appointment as members of the Advisory Committee on Organ Transplantation (ACOT). ACOT shall: SUMMARY: PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 (1) Advise the Secretary, acting through the HRSA Administrator, on all aspects of organ donation, procurement, allocation, and transplantation, and on such other matters that the Secretary determines; (2) advise the Secretary on federal efforts to maximize the number of deceased donor organs made available for transplantation and to support the safety of living organ donation; (3) at the request of the Secretary, review significant proposed Organ Procurement and Transplantation Network (OPTN) policies submitted for the Secretary’s approval to recommend whether they should be made enforceable; and (4) provide expert input to the Secretary on the latest advances in the science of E:\FR\FM\21JNN1.SGM 21JNN1

Agencies

[Federal Register Volume 84, Number 120 (Friday, June 21, 2019)]
[Notices]
[Pages 29217-29218]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13195]


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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: Small 
Rural Hospital Transition Project (SRHT), OMB No. 0906-0026--Extension

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

ACTION: Notice.

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

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

DATES: Comments on this Information Collection Request must be received 
no later than August 20, 2019.

ADDRESSES: Submit your comments to [email protected] or mail the HRSA 
Information Collection Clearance Officer, Room 14N136B, 5600 Fishers 
Lane, Rockville, Maryland 20857.

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

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the

[[Page 29218]]

information request collection title for reference.
    Information Collection Request Title: Small Rural Hospital 
Transition Project (SRHT), OMB No. 0906-0026--Extension.
    Abstract: Under Section 330A of the Public Health Service Act (42 
U.S.C. 254c), the Federal Office of Rural Health Policy (FORHP) funds 
grant programs supporting expanding access to, coordinating, 
restraining the cost of, and improving the quality of essential health 
care services in rural and frontier communities. Small rural hospitals 
are facing many challenges in the new health care environment including 
the concurrent need to better measure and account for quality of care 
in all settings, improve transitions of care as patients move from one 
care setting to another, the evolution of new payment approaches such 
as value-based purchasing, and new approaches to care delivery such as 
accountable care organizations (ACO) and patient-centered medical 
homes. Success in this new environment will require bridging the gaps 
between the current system and the newly emerging system of healthcare 
delivery and payment. Because little is known about how these new 
models might impact rural communities, there is a need to help 
hospitals understand and consider those factors that would make them 
logical participants in health care systems that focus on quality, 
rather than the quantity of care provided to patients. The Small Rural 
Hospital Transition (SRHT), also funded by Section 330A, assists small 
rural hospitals facing these challenges. The purpose of the project is 
to provide on-site technical assistance to nine small rural hospitals 
residing in persistent poverty counties. Technical assistance is 
provided in the areas of: (1) Conducting financial assessments, (2) 
creating a quality-focused environment, (3) aligning services to 
community need, and (4) to the extent that financial and quality core 
areas have been stabilized, providing assistance to help recipients of 
technical assistance consider factors that would make them logical 
participants in health care systems that focus on value (e.g., ACOs, 
shared savings programs, and primary care medical homes).
    Need and Proposed Use of the Information: This information 
collection request consists of two forms: The SRHT Online Application 
and the Assessment. The application form is designed to solicit 
information that will be scored and ranked to aid in the selection of 
nine small rural hospitals to receive on-site technical assistance. The 
assessment determines applicant capacity in specific key areas leading 
to performance excellence across the organization (e.g., leadership, 
strategic planning, operations, and processes).
    Likely Respondents: The likely respondents are small rural 
hospitals located in a rural community. Hospitals must be (1) rural, as 
defined by FORHP and reside in a persistent poverty county or (2) 
reside in the rural census tract of a metro county (non-rural county) 
that is also a persistent poverty county and have 49 staffed beds or 
less as reported on the hospital's most recently filed Medicare Cost 
Report. Hospitals may be for-profit or not-for-profit.
    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
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of         Total        burden per
            Form name               respondents    responses per     responses     response (in        Total
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
SRHT Online Application.........              30               1              30             .50            15.0
Assessment: Performance                       30               1              30             .25             7.5
 Excellence for Rural Hospitals.
                                 -------------------------------------------------------------------------------
    Total.......................            * 30  ..............              60  ..............            22.5
----------------------------------------------------------------------------------------------------------------
* The same individuals complete the SRHT Online Application and the Assessment for a total of 30 respondents.

    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.

Maria G. Button,
Director, Division of the Executive Secretariat.
[FR Doc. 2019-13195 Filed 6-20-19; 8:45 am]
BILLING CODE 4165-15-P