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, 73060-73061 [2020-25219]

Download as PDF 73060 Federal Register / Vol. 85, No. 221 / Monday, November 16, 2020 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN—Continued Number of respondents 21 CFR section 314.107(e)—notification of court actions or written consent to approval. Number of responses per respondent 247 Average burden per response (in hours) Total annual responses Total hours 2 494 0.5 (30 minutes) .. 247 36 27.2 981 61 ........................ 59,841 2,946 2,946 55 11.4 3.33 11.6 33,590 9,834 640 8 .......................... 4 .......................... 120 ...................... 268,720 39,336 76,800 ........................ ........................ ........................ ............................. 4,118,933.5 SUBPART G, H, I 314.420—drug master files [FDA 3938]—original amendments. DMFs—technical, administrative, REMS) ...................... DMFs—annual reports ................................................... 314.550—Promotional material and subpart H applications. Total ........................................................................ 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 Health Resources and Services Administration (HRSA), Department of Health and Human Services. AGENCY: ACTION: Notice. 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. jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 20:13 Nov 13, 2020 Jkt 253001 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 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. DATES: 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’’ PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 (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 E:\FR\FM\16NON1.SGM 16NON1 73061 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. TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS Number of respondents Form name Average burden per response (in hours) Total responses 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 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. AGENCY: ACTION: Notice. 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. SUMMARY: jbell on DSKJLSW7X2PROD with NOTICES Number of responses per respondent VerDate Sep<11>2014 20:13 Nov 13, 2020 Jkt 253001 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. Preregistration 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 DATES: PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 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 E:\FR\FM\16NON1.SGM 16NON1

Agencies

[Federal Register Volume 85, Number 221 (Monday, November 16, 2020)]
[Notices]
[Pages 73060-73061]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25219]


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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 [email protected] 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

[[Page 73061]]

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.

                                    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)
----------------------------------------------------------------------------------------------------------------
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