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]
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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
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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
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]]>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]
-----------------------------------------------------------------------
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
