Agency Information Collection Activities: Coronavirus 2019 (COVID-19) Data Report, OMB No. 0906-xxxx-Emergency, 32041-32042 [2020-11586]
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Federal Register / Vol. 85, No. 103 / Thursday, May 28, 2020 / Notices
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Ryan Newkirk, Center for Food Safety
and Applied Nutrition (HFS–005), Food
and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240–402–
3712, ryan.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of February 14, 2020
(85 FR 8599), we published a notice
announcing the availability of a
supplemental draft guidance for
industry entitled ‘‘Mitigation Strategies
to Protect Food Against Intentional
Adulteration: Draft Guidance for
Industry.’’ This multichapter
supplemental draft guidance for
industry is intended to help food
facilities required to comply, develop,
and implement some of the components
of a food defense plan, and meet other
requirements under 21 CFR part 121.
The Agency has received a request for
an extension of the comment period for
120 days. The request conveyed concern
that the current comment period does
not allow sufficient time to develop a
comprehensive response.
FDA has considered the request and
is extending the comment period for the
notice of availability for 60 days, until
August 14, 2020. The Agency believes
that a 60-day extension allows adequate
time for interested persons to submit
comments.
Dated: May 21, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–11455 Filed 5–27–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Coronavirus 2019 (COVID–
19) Data Report, OMB No. 0906-xxxx—
Emergency
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. OMB will accept
comments from the public during the
review and approval period. OMB may
act on HRSA’s ICR only after the 10-day
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:32 May 27, 2020
Jkt 250001
comment period for this notice has
closed.
DATES: Comments on this ICR should be
received no later than June 8, 2020.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 10 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Coronavirus 2019 (COVID–19) Data
Report, OMB No. 0906-xxxx ¥
Emergency
Abstract: HRSA’s Ryan White HIV/
AIDS Program (RWHAP) funds and
coordinates with cities, states, and local
clinics/community-based organizations
to deliver efficient and effective HIV
care, treatment, and support to low
income people with HIV. Nearly twothirds of clients (patients) live at or
below 100 percent of the federal poverty
level and approximately three-quarters
of RWHAP clients are racial/ethnic
minorities. Since 1990, the RWHAP has
developed a comprehensive system of
safety net providers who deliver high
quality direct health care and support
services to over half a million people
with HIV—more than 50 percent of all
people with diagnosed HIV in the
United States.
FY 2020 Coronavirus Aid, Relief, and
Economic Security Act
On March 27, 2020, the President
signed into law the Coronavirus Aid,
Relief, and Economic Security Act
(CARES Act). The CARES Act
appropriated $90 million to HRSA’s
RWHAP to prevent, prepare for, and
respond to coronavirus disease 2019
(COVID–19). This funding supports 581
RWHAP recipients across the country,
including city/county health
departments, state health departments,
health clinics, community-based
organizations, and AIDS Education and
Training Centers in their efforts to help
prevent or minimize the impact of
COVID–19 on RWHAP clients. The
award provides RWHAP recipients the
flexibility to meet evolving COVID–19
needs in their respective communities,
including extending operational hours,
increasing staffing hours, purchasing
additional equipment, enhancing
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
32041
workforce training and capacity
development, and providing critical
services to people with HIV during this
pandemic, such as home-delivered
meals, emergency housing, and
transportation.
HRSA’s HIV/AIDS Bureau identified a
new data collection need to support
HRSA’s requirement to monitor and
report quarterly to the Secretary of HHS
the COVID–19 activities conducted with
the CARES Act funding. HRSA is
proposing to create a new COVID–19
Data Report (CDR) module that will
provide monthly reporting on the types
of services provided and number of
people served for the treatment or
prevention of COVID–19 among
RWHAP clients (and immediate
household members in limited
circumstances). This module will be
required for all providers (regardless of
whether they are recipients or
subrecipients) who receive CARES Act
RWHAP funding.
Need and Proposed Use of the
Information: HRSA proposes that
service providers who receive CARES
Act RWHAP funding report aggregate
information on the number of clients
and immediate household members
tested for COVID–19, the number of
clients newly diagnosed (or presumed
positive) with COVID–19, the
cumulative number of clients with
COVID–19, the number of clients who
received services in each RWHAP
service category (identified in Policy
Clarification Notice 16–02 RWHAP
Services: Eligible Individuals and
Allowable Uses of Funds), and the types
of services provided using telehealth
technology in the CDR. The information
obtained in this module will assist
HRSA in understanding how CARES
Act RWHAP funding is being used to
support RWHAP clients and immediate
household members and ensure that
HRSA is compliant with federal
reporting requirements.
Likely Respondents: All RWHAP
providers (regardless of whether they
are recipients or subrecipients) who
receive CARES Act RWHAP funding.
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
E:\FR\FM\28MYN1.SGM
28MYN1
32042
Federal Register / Vol. 85, No. 103 / Thursday, May 28, 2020 / Notices
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
COVID–19 Data Report (CVD) ........................................
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020–11586 Filed 5–27–20; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
jbell on DSKJLSW7X2PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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: Center for Scientific
Review Special Emphasis Panel; Small
Business: Non-HIV Anti-viral Therapeutics.
Date: June 23–24, 2020.
Time: 9:00 a.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Bidyottam Mittra, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, Bethesda, MD 20894, (301) 435–4057,
bidyottam.mittra@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; The BloodBrain Barrier, Neurovascular System and
CNS Therapeutics.
Date: June 23, 2020.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
VerDate Sep<11>2014
16:32 May 27, 2020
Jkt 250001
2045
2045
Number of
responses per
respondent
12
........................
Contact Person: Linda MacArthur, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4187,
Bethesda, MD 20892, 301–537–9986,
macarthurlh@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Dermatology, Rheumatology and
Inflammation.
Date: June 23, 2020.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Rajiv Kumar, Ph.D., Chief,
MOSS IRG, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 4216, MSC 7802 Bethesda, MD
20892, 301–435–1212, kumarra@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Digestive Sciences.
Date: June 24, 2020.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Ganesan Ramesh, Ph.D.,
Center for Scientific Review, National
Institutes of Health, 6701 Rockledge Drive,
Room 2182 MSC 7818, Bethesda, MD 20892,
301–827–5467, ganesan.ramesh@nih.gov.
Name of Committee: Genes, Genomes, and
Genetics Integrated Review Group;
Therapeutic Approaches to Genetic Diseases
Study Section.
Date: June 24–25, 2020.
Time: 9:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Methode Bacanamwo,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2200,
Bethesda, MD 20892, 301–827–7088,
methode.bacanamwo@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
Average burden
per response
(in hours)
Total
responses
24,540
24,540
Total burden
hours
2
............................
49,080
49,080
Dated: May 21, 2020.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–11381 Filed 5–27–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
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: Allergy, Immunology,
and Transplantation Research Committee
Allergy, Immunology, and Transplantation
Research Committee (AITC) October Council.
Date: June 25–26, 2020.
Time: 9:00 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
Health, 5601 Fishers Lane, Room 3G31B,
Rockville, MD 20892, (Telephone Conference
Call).
Contact Person: James T. Snyder, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institutes of Health, National
Institute of Allergy and Infectious Diseases,
5601 Fishers Lane, Room 3G31B, Bethesda,
MD 20892–9834, (240) 669–5060,
james.snyder@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
E:\FR\FM\28MYN1.SGM
28MYN1
]]>Agencies
[Federal Register Volume 85, Number 103 (Thursday, May 28, 2020)]
[Notices]
[Pages 32041-32042]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11586]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Coronavirus 2019
(COVID-19) Data Report, OMB No. 0906-xxxx--Emergency
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with of the Paperwork Reduction Act of 1995,
HRSA has submitted an Information Collection Request (ICR) to the
Office of Management and Budget (OMB) for review and approval. OMB will
accept comments from the public during the review and approval period.
OMB may act on HRSA's ICR only after the 10-day comment period for this
notice has closed.
DATES: Comments on this ICR should be received no later than June 8,
2020.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 10 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by using the search function.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email Lisa Wright-Solomon, the
HRSA Information Collection Clearance Officer at [email protected] or
call (301) 443-1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Coronavirus 2019 (COVID-19)
Data Report, OMB No. 0906-xxxx - Emergency
Abstract: HRSA's Ryan White HIV/AIDS Program (RWHAP) funds and
coordinates with cities, states, and local clinics/community-based
organizations to deliver efficient and effective HIV care, treatment,
and support to low income people with HIV. Nearly two-thirds of clients
(patients) live at or below 100 percent of the federal poverty level
and approximately three-quarters of RWHAP clients are racial/ethnic
minorities. Since 1990, the RWHAP has developed a comprehensive system
of safety net providers who deliver high quality direct health care and
support services to over half a million people with HIV--more than 50
percent of all people with diagnosed HIV in the United States.
FY 2020 Coronavirus Aid, Relief, and Economic Security Act
On March 27, 2020, the President signed into law the Coronavirus
Aid, Relief, and Economic Security Act (CARES Act). The CARES Act
appropriated $90 million to HRSA's RWHAP to prevent, prepare for, and
respond to coronavirus disease 2019 (COVID-19). This funding supports
581 RWHAP recipients across the country, including city/county health
departments, state health departments, health clinics, community-based
organizations, and AIDS Education and Training Centers in their efforts
to help prevent or minimize the impact of COVID-19 on RWHAP clients.
The award provides RWHAP recipients the flexibility to meet evolving
COVID-19 needs in their respective communities, including extending
operational hours, increasing staffing hours, purchasing additional
equipment, enhancing workforce training and capacity development, and
providing critical services to people with HIV during this pandemic,
such as home-delivered meals, emergency housing, and transportation.
HRSA's HIV/AIDS Bureau identified a new data collection need to
support HRSA's requirement to monitor and report quarterly to the
Secretary of HHS the COVID-19 activities conducted with the CARES Act
funding. HRSA is proposing to create a new COVID-19 Data Report (CDR)
module that will provide monthly reporting on the types of services
provided and number of people served for the treatment or prevention of
COVID-19 among RWHAP clients (and immediate household members in
limited circumstances). This module will be required for all providers
(regardless of whether they are recipients or subrecipients) who
receive CARES Act RWHAP funding.
Need and Proposed Use of the Information: HRSA proposes that
service providers who receive CARES Act RWHAP funding report aggregate
information on the number of clients and immediate household members
tested for COVID-19, the number of clients newly diagnosed (or presumed
positive) with COVID-19, the cumulative number of clients with COVID-
19, the number of clients who received services in each RWHAP service
category (identified in Policy Clarification Notice 16-02 RWHAP
Services: Eligible Individuals and Allowable Uses of Funds), and the
types of services provided using telehealth technology in the CDR. The
information obtained in this module will assist HRSA in understanding
how CARES Act RWHAP funding is being used to support RWHAP clients and
immediate household members and ensure that HRSA is compliant with
federal reporting requirements.
Likely Respondents: All RWHAP providers (regardless of whether they
are recipients or subrecipients) who receive CARES Act RWHAP funding.
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
[[Page 32042]]
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
----------------------------------------------------------------------------------------------------------------
COVID-19 Data Report (CVD).... 2045 12 24,540 2 49,080
2045 .............. 24,540 ................ 49,080
----------------------------------------------------------------------------------------------------------------
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020-11586 Filed 5-27-20; 8:45 am]
BILLING CODE 4165-15-P
