Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: SHIP COVID-19 Testing and Mitigation Program Data Collection-New, Emergency, 52914-52915 [2021-20601]
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Federal Register / Vol. 86, No. 182 / Thursday, September 23, 2021 / Notices
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diseases, and the donor (and product/
source material) test results for relevant
disease agents are negative or
nonreactive. To prevent transmission of
disease when manufacturing ACTPs, it
is necessary to determine that donors
are healthy and free from relevant
disease agents. Transmission of relevant
disease agents by an ACTP may be the
result of the presence of relevant disease
agents in the donated cells/tissues
(either within the cells/tissues, within
other accompanying cells/tissues, or in
the extracellular components of the
product).
The CGMP requirements for new
animal drugs are found in Title 21 parts
210 and 211 of the Code of Federal
Regulations (21 CFR parts 210 and 211).
These regulations are broad in scope,
and FDA recognizes that they do not
specifically or fully address some
aspects of the manufacture of ACTPs,
including donor eligibility
determinations. This guidance offers
FDA’s recommendations for
determining that a donor is free from
relevant disease agents and is an eligible
source of cells, tissues, or both, used in
the manufacture of allogeneic or
xenogeneic ACTPs. We encourage
sponsors and manufacturers of ACTPs
to contact CVM early in the product
development process to discuss
considerations specific to approval of a
new animal drug product.
This level 1 draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the current
thinking of FDA on donor eligibility for
animal cells, tissues, and cell- and
tissue-based products. It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 514 have
VerDate Sep<11>2014
17:19 Sep 22, 2021
Jkt 253001
been approved under OMB control
number 0910–0032.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/animal-veterinary/
guidance-regulations/guidanceindustry, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: September 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–20517 Filed 9–22–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
[OMB No. 0906–XXXX]
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: SHIP COVID–
19 Testing and Mitigation Program
Data Collection—New, Emergency
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
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 October 4, 2021.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or by mail to the
HRSA Information Collection Clearance
Officer, Room 14N136B, 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
SUMMARY:
PO 00000
Frm 00043
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instruments, email paperwork@hrsa.gov
or call Samantha Miller, the HRSA
Information Collection Clearance Officer
at (301) 443–9094.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
for reference.
Information Collection Request Title:
SHIP COVID–19 Testing and Mitigation
Program Data Collection, OMB No.
0906–XXXX—New, Emergency.
Abstract: The American Rescue Plan
Act of 2021 (Pub. L. 117–2) provided
one-time funding for awards that will be
carried out under Section 711 of the
Social Security Act (42 U.S.C.
912(b)(5)). The Small Rural Hospital
Improvement Program (SHIP) is
requesting approval of an emergency
ICR. State grantees will improve health
care in rural areas by using the funding
to provide support to eligible rural
hospitals to increase COVID–19 testing
efforts, expand access to testing in rural
communities, and expand the range of
mitigation activities.
Need and Proposed Use of the
Information: The terms and conditions
for this program specify that, ‘‘hospitals
will be required to report on the number
of tests provided and categories in
which the funding is spent.’’ The data
will allow HRSA to ensure SHIP
COVID–19 recipients are meeting the
terms and conditions of their funding,
while providing HRSA with information
on the effectiveness of funds distributed
through this program.
Likely Respondents: The respondents
will be hospital staff and designated
representatives.
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.
E:\FR\FM\23SEN1.SGM
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52915
Federal Register / Vol. 86, No. 182 / Thursday, September 23, 2021 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
SHIP COVID–19 Testing and
Mitigation Data Reporting.
Total ...................................
Number of responses per
respondent
1,540: Number of unique organizations funded through the
program.
6: Reported on a quarterly
basis during the 18 month
program or the end of the
public health emergency
(whichever is first).
9,240
.25
1,540 ........................................
...................................................
9,240
........................
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, Executive Secretariat.
Total
responses
Contact Person: Karen Nieves-Lugo,
M.P.H., Ph.D., Scientific Review Officer,
Office of Extramural Research Activities,
National Institute on Minority Health and
Health Disparities, National Institutes of
Health, Gateway Building, 7201 Wisconsin
Avenue, Bethesda, MD 20892, (301) 480–
4727, karen.nieveslugo@nih.gov.
Dated: September 17, 2021.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–20583 Filed 9–22–21; 8:45 am]
BILLING CODE 4140–01–P
[FR Doc. 2021–20601 Filed 9–22–21; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4165–15–P
National Institute on Minority Health
and Health Disparities; Notice of
Closed Meeting
lotter on DSK11XQN23PROD with NOTICES1
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Minority Health and Health Disparities
Special Emphasis Panel; Impact of Structural
Racism and Discrimination on Minority
Health and Health Disparities.
Date: November 15–17, 2021.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Gateway Plaza, 7201 Wisconsin Avenue,
Bethesda, MD 20817 (Virtual Meeting).
17:19 Sep 22, 2021
Jkt 253001
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Exploratory Data Science
Methods and Algorithm Development, EarlyStage Development of Data Science
Technologies, and Enhancement or
Sustainment of Data Science Tools for
Infectious and Immune-Mediated Diseases
(R21, U01, U24).
Date: October 26–28, 2021.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
PO 00000
Frm 00044
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2,310: Total hours spent on responses for all funded organizations over a 2-year period.
2,310.
Health, 5601 Fishers Lane, Room 3G42,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Sandip Bhattacharyya,
Ph.D., Scientific Review Officer, Scientific
Review Program, Division of Extramural
Activities, National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G42,
Rockville, MD 20852, 240–292–0189,
sandip.bhattacharyya@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: September 17, 2021.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
BILLING CODE 4140–01–P
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
National Institutes of Health
Total burden hours
[FR Doc. 2021–20585 Filed 9–22–21; 8:45 am]
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Sep<11>2014
Average
burden per
response
(in hours)
Number of respondents
Form name
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of
meetings of the Board of Scientific
Counselors, National Institute of
Neurological Disorders and Stroke.
The meetings will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
NATIONAL INSTITUTE OF
NEUROLOGICAL DISORDERS AND
STROKE, including consideration of
personnel qualifications and
performance, and the competence of
individual investigators, the disclosure
of which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: Board of Scientific
Counselors, National Institute of
Neurological Disorders and Stroke.
E:\FR\FM\23SEN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 182 (Thursday, September 23, 2021)]
[Notices]
[Pages 52914-52915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20601]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
[OMB No. 0906-XXXX]
Agency Information Collection Activities: Proposed Collection:
Public Comment Request Information Collection Request Title: SHIP
COVID-19 Testing and Mitigation Program Data Collection--New, Emergency
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 ICR should be received no later than October 4,
2021.
ADDRESSES: Submit your comments to [email protected] or by mail to the
HRSA Information Collection Clearance Officer, Room 14N136B, 5600
Fishers Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email [email protected] or call Samantha Miller,
the HRSA Information Collection Clearance Officer at (301) 443-9094.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the ICR title for reference.
Information Collection Request Title: SHIP COVID-19 Testing and
Mitigation Program Data Collection, OMB No. 0906-XXXX--New, Emergency.
Abstract: The American Rescue Plan Act of 2021 (Pub. L. 117-2)
provided one-time funding for awards that will be carried out under
Section 711 of the Social Security Act (42 U.S.C. 912(b)(5)). The Small
Rural Hospital Improvement Program (SHIP) is requesting approval of an
emergency ICR. State grantees will improve health care in rural areas
by using the funding to provide support to eligible rural hospitals to
increase COVID-19 testing efforts, expand access to testing in rural
communities, and expand the range of mitigation activities.
Need and Proposed Use of the Information: The terms and conditions
for this program specify that, ``hospitals will be required to report
on the number of tests provided and categories in which the funding is
spent.'' The data will allow HRSA to ensure SHIP COVID-19 recipients
are meeting the terms and conditions of their funding, while providing
HRSA with information on the effectiveness of funds distributed through
this program.
Likely Respondents: The respondents will be hospital staff and
designated representatives.
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.
[[Page 52915]]
Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
SHIP COVID-19 Testing and 1,540: Number of 6: Reported on a 9,240 .25 2,310: Total
Mitigation Data Reporting. unique quarterly basis hours spent on
organizations during the 18 responses for
funded through month program all funded
the program. or the end of organizations
the public over a 2-year
health period.
emergency
(whichever is
first).
----------------------------------------------------------------------------------
Total.................... 1,540........... ................ 9,240 .............. 2,310.
----------------------------------------------------------------------------------------------------------------
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, Executive Secretariat.
[FR Doc. 2021-20601 Filed 9-22-21; 8:45 am]
BILLING CODE 4165-15-P
