Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Coronavirus 2019 (COVID-19) Data Report OMB No. 0906-0053-Extension

Cited as:85 FR 73060
Court:Health Resources And Services Administration
Publication Date:16 Nov 2020
Record Number:2020-25219
73060
Federal Register / Vol. 85, No. 221 / Monday, November 16, 2020 / Notices
T
ABLE
1—E
STIMATED
A
NNUAL
R
EPORTING
B
URDEN
—Continued
21 CFR section Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden
per response
(in hours) Total hours
314.107(e)—notification of court actions or written con-
sent to approval. 247 2 494 0.5 (30 minutes) .. 247
SUBPART G, H, I
314.420—drug master files [FDA 3938]—original
amendments. 36 27.2 981 61 ........................ 59,841
DMFs—technical, administrative, REMS) ...................... 2,946 11.4 33,590 8 .......................... 268,720
DMFs—annual reports ................................................... 2,946 3.33 9,834 4 .......................... 39,336
314.550—Promotional material and subpart H applica-
tions. 55 11.6 640 120 ...................... 76,800
Total ........................................................................ ........................ ........................ ........................ ............................. 4,118,933.5
Our estimated burden for the
information collection reflects a
decrease. We attribute this adjustment
to improved operational efficiencies
with regard to Agency data systems and
digital submission processes.
Dated: November 10, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–25239 Filed 11–13–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Information Collection
Request Title: Coronavirus 2019
(COVID–19) Data Report OMB No.
0906–0053—Extension
AGENCY
: Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
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. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30 day
comment period for this notice has
closed.
DATES
: Comments on this ICR should be
received no later than December 16,
2020.
ADDRESSES
: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or 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 Data Report OMB No.
0906–0053—Extension.
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 (CARES) 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 Parts A, B, C, D and F
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. The COVID–19
Data Report (CDR) module will collect
information 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 (e.g.,
recipients or subrecipients) who receive
CARES Act RWHAP funding.
A 60-day notice published in the
Federal Register on September 1, 2020,
vol. 85, No. 170; pp. 54390–54391.
There were no public comments.
Need and Proposed Use of the
Information: HRSA proposes that
service providers who receive CARES
Act RWHAP funding report aggregate
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Federal Register / Vol. 85, No. 221 / Monday, November 16, 2020 / Notices
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 (e.g., 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
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.
T
OTAL
E
STIMATED
A
NNUALIZED
B
URDEN
—H
OURS
Form name Number of
respondents
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
CDR Module ........................................................................ 2,045 12 24,540 3.2 78,528
Total .............................................................................. 2,045 ........................ 24,540 ........................ 78,528
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. 2020–25219 Filed 11–13–20; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the National Vaccine
Advisory Committee
AGENCY
: Office of Infectious Disease and
HIV/AIDS Policy, Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION
: Notice.
SUMMARY
: As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that the National Vaccine Advisory
Committee (NVAC) will hold a virtual
meeting. The meeting will be open to
the public and public comment will be
heard during the meeting.
DATES
: The meeting will be held
December 4, 2020. The confirmed
meeting times and agenda will be
posted on the NVAC website at http://
www.hhs.gov/nvpo/nvac/meetings/
index.html as soon as they become
available.
ADDRESSES
: Instructions regarding
attending this meeting will be posted
online at: http://www.hhs.gov/nvpo/
nvac/meetings/index.html at least one
week prior to the meeting. Pre-
registration is required for those who
wish to attend the meeting or participate
in public comment. Please register at
http://www.hhs.gov/nvpo/nvac/
meetings/index.html.
FOR FURTHER INFORMATION CONTACT
: Ann
Aikin, Acting Designated Federal
Officer, at the Office of Infectious
Disease and HIV/AIDS Policy, U.S.
Department of Health and Human
Services, Mary E. Switzer Building,
Room L618, 330 C Street SW,
Washington, DC 20024. Email: nvac@
hhs.gov. Phone: 202–695–9742.
SUPPLEMENTARY INFORMATION
: Pursuant
to Section 2101 of the Public Health
Service Act (42 U.S.C. 300aa–1), the
Secretary of HHS was mandated to
establish the National Vaccine Program
to achieve optimal prevention of human
infectious diseases through
immunization and to achieve optimal
prevention against adverse reactions to
vaccines. The NVAC was established to
provide advice and make
recommendations to the Director of the
National Vaccine Program on matters
related to the Program’s responsibilities.
The Assistant Secretary for Health
serves as Director of the National
Vaccine Program.
During this NVAC meeting, NVAC
will hear presentations to support the
recent charge from Admiral Brett P.
Giroir, MD, the Assistant Secretary for
Health and Director of the National
Vaccine Program, and respond to the
following question: The FDA standards
for approval and licensure of vaccines
for COVID–19 addresses safety and
effectiveness and encourages inclusion
of minorities, the elderly, pregnant
women, and people with medical
comorbidities in clinical trials. In
particular, for COVID–19 vaccines, I am
interested in the approach the nation
should take in regard to vaccination of
children, given that there will be
relatively little data on children from
some of the early clinical trials? As
context, the case fatality rate for
children under age 18 is .02%. What is
the appropriate approach, and timing,
of generating the needed data and
proceeding to potential childhood
vaccination as we move forward? The
NVAC will also review a draft report of
the response to the full charge. Please
note that agenda items are subject to
change, as priorities dictate. Information
on the final meeting agenda will be
posted prior to the meeting on the
NVAC website: http://www.hhs.gov/
nvpo/nvac/index.html.
Members of the public will have the
opportunity to provide comment at the
NVAC meeting during the public
comment period designated on the
agenda. Public comments made during
the meeting will be limited to three
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