Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Health Center Program: COVID-19 Data Collection Tools, OMB No. 0906-0062-Revision, 21756-21757 [2021-08454]

Download as PDF 21756 Federal Register / Vol. 86, No. 77 / Friday, April 23, 2021 / Notices TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Activity; 21 CFR Section Number of respondents Number of disclosures per respondent Total annual disclosures Average burden per disclosure Total hours Nutrient labeling; 107.10(a) and 107.20 .............................. 5 13 65 8 520 1 There are no capital costs or operating and maintenance costs associated with the information collection. We estimate compliance with our infant formula labeling requirements in 21 CFR 107.10(a) and 107.20 requires 520 hours annually. Dated: April 15, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–08470 Filed 4–22–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Health Center Program: COVID–19 Data Collection Tools, OMB No. 0906–0062—Revision 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 June 22, 2021. ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail 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 paperwork@hrsa.gov or call Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at (301) 443–1984. khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:15 Apr 22, 2021 Jkt 253001 When submitting comments or requesting information, please include the information request collection title for reference. Information Collection Request Title: Health Center Program: COVID–19 Data Collection Tools, OMB No. 0906–0062— Revision. Abstract: This information collection request was previously approved by OMB on June 11, 2020, as an emergency clearance (OMB No.: 0906–0062). HRSA is currently undertaking the standard Paperwork Reduction Act process for normal OMB approval. During the COVID–19 public health emergency, HRSA-supported health centers and Federally Qualified Health Center Look-Alikes (look-alikes) have played a key role in providing testing and care for those affected by the virus. HRSA awarded billions of dollars in new funding to support health center awardees and look-alikes in the detection, prevention, diagnosis, and treatment of COVID–19. This funding has enabled health centers to maintain or increase their staffing levels, conduct training, provide COVID–19 treatment, and administer millions of tests for both existing and new patients. In addition, HRSA, in collaboration with Centers for Disease Control and Prevention, launched the Health Center COVID–19 Vaccine program as part of a White House initiative focused on health equity. This occurred in February 2021 to directly allocate COVID–19 vaccines to HRSA-supported health centers. This ICR to support the implementation of COVID–19 relief funding and response activities includes forms previously submitted in the emergency information collection request clearance: (1) Health Center COVID–19 Data Collection Survey Tool, (2) Addendum to COVID–19 Data Collection Survey Tool, and (3) the Health Center COVID–19 Vaccine Program Readiness Assessment Tool. This revised information collection request includes two newly added forms: (1) Primary Care Association (PCA) COVID–19 Data Collection Survey Tool 1 and (2) the Health Center SUPPLEMENTARY INFORMATION: 1 The bi-weekly COVID–19 PCA Survey Tool (comprised of six questions) is currently approved PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 COVID–19 Vaccine Program Conditions of Participation Agreement. Need and Proposed Use of the Information: HRSA uses the data collected to optimize COVID–19 testing and vaccination; track health center capacity and the impact of COVID–19 on operations, patients, and staff; and better understand training and technical assistance, funding, and other health center resource needs. The data allow HRSA to assess health center capacity prior to program enrollment, supporting successful vaccine allocation strategies while providing HRSA with information on the effectiveness of vaccine distribution through this program. In addition, the data inform HRSA in resource allocation and technical assistance to health centers. The readiness assessment supports HRSA’s analysis of health center ability to successfully participate in the Health Center COVID–19 Vaccine Program. These data are critical to determine health center capacity to implement the vaccination program as well as comply with program requirements. These data are used to assess program readiness including: • Ability to safely store the vaccine • Availability of trained and credentialed staff and other staff capacity • Reporting capacity • Sufficient Personal Protective Equipment • Plan for vaccine transport The health center weekly survey and addendum support HRSA’s ability to monitor progress towards the development and delivery of COVID–19 prevention, preparedness, and/or response activities and ensure appropriate vaccine administration as well as better understand training and technical assistance, funding, and other health center resource needs. The Conditions of Participation Agreement governs all COVID–19 vaccination activities at all health center sites that receive COVID–19 vaccine through the HRSA Health Center under the HHS Secretary’s Public Health Emergency Authority to waive the requirements of the Paperwork Reduction Act during the Public Health Emergency for reporting on a voluntary basis. E:\FR\FM\23APN1.SGM 23APN1 21757 Federal Register / Vol. 86, No. 77 / Friday, April 23, 2021 / Notices COVID–19 Vaccine Program. Health Centers that sign the agreement agree to adhere to each of the stated requirements. The PCA weekly survey increases information sharing between health centers, PCAs, and HRSA in order to better support COVID–19 emergency response efforts inclusive of testing and vaccination activities. Data collected from the survey tool is used to track and monitor issues/challenges to program implementation and assess the need for the delivery/dissemination of targeted training and technical assistance. Likely Respondents: HRSA-supported health centers, look-alikes, and PCAs. 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 Condition of Participation Agreement (one-time completion for vaccine program participants only). Readiness Assessment Tool (one-time completion for vaccine program participants only). 1,467 (Total health centers, including lookalikes, in 2019). 1,467 (Total health centers, including lookalikes, in 2019). 1,389 (Total health centers in 2019). Health Center COVID–19 Data Collection Survey Tool (weekly completion of existing 20 questions). Addendum to COVID–19 Data Collection Survey Tool (weekly completion for vaccine program participants only). PCA COVID–19 Data Collection Survey Tool (biweekly completion of existing six questions). Total ............................................................... 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. 2021–08454 Filed 4–22–21; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health khammond on DSKJM1Z7X2PROD with NOTICES Number of responses to form per respondent Form name Eunice Kennedy Shriver National Institute of Child Health and Human Development; 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. VerDate Sep<11>2014 18:15 Apr 22, 2021 Jkt 253001 Total responses Total burden hours 1 1,467 .25 366.75 1 1,467 .50 733.5 48 66,672 1.00 66,672 1,389 (Total health centers in 2019). 48 66,672 .50 33,336 52 .................................. 6 312 .75 234 5,764 ............................. ........................ 136,590 ........................ 101,342.25 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 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 clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Child Health and Human Development Initial Review Group Obstetrics and Maternal-Fetal Biology Subcommittee. Date: June 25, 2021. Time: 10:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: NICHD/NIH, 6710B Rockledge Drive, Bethesda, MD 20892 (Video-Assisted Meeting). Contact Person: Luis E. Dettin, Ph.D., Scientific Review Officer, Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6710B Rockledge Drive, Room 2131B, Bethesda, MD 20892, 301–827–8231, luis.dettin@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; PO 00000 Average burden per response (in hours) Frm 00075 Fmt 4703 Sfmt 4703 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) Dated: April 20, 2021. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–08475 Filed 4–22–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute of Diabetes and Digestive and Kidney 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 E:\FR\FM\23APN1.SGM 23APN1

Agencies

[Federal Register Volume 86, Number 77 (Friday, April 23, 2021)]
[Notices]
[Pages 21756-21757]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08454]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request Information Collection Request Title: Health 
Center Program: COVID-19 Data Collection Tools, OMB No. 0906-0062--
Revision

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 June 22, 
2021.

ADDRESSES: Submit your comments to [email protected] or mail 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 Lisa Wright-
Solomon, the HRSA Information Collection Clearance Officer at (301) 
443-1984.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the information request collection title 
for reference.
    Information Collection Request Title: Health Center Program: COVID-
19 Data Collection Tools, OMB No. 0906-0062--Revision.
    Abstract: This information collection request was previously 
approved by OMB on June 11, 2020, as an emergency clearance (OMB No.: 
0906-0062). HRSA is currently undertaking the standard Paperwork 
Reduction Act process for normal OMB approval.
    During the COVID-19 public health emergency, HRSA-supported health 
centers and Federally Qualified Health Center Look-Alikes (look-alikes) 
have played a key role in providing testing and care for those affected 
by the virus. HRSA awarded billions of dollars in new funding to 
support health center awardees and look-alikes in the detection, 
prevention, diagnosis, and treatment of COVID-19. This funding has 
enabled health centers to maintain or increase their staffing levels, 
conduct training, provide COVID-19 treatment, and administer millions 
of tests for both existing and new patients. In addition, HRSA, in 
collaboration with Centers for Disease Control and Prevention, launched 
the Health Center COVID-19 Vaccine program as part of a White House 
initiative focused on health equity. This occurred in February 2021 to 
directly allocate COVID-19 vaccines to HRSA-supported health centers.
    This ICR to support the implementation of COVID-19 relief funding 
and response activities includes forms previously submitted in the 
emergency information collection request clearance: (1) Health Center 
COVID-19 Data Collection Survey Tool, (2) Addendum to COVID-19 Data 
Collection Survey Tool, and (3) the Health Center COVID-19 Vaccine 
Program Readiness Assessment Tool. This revised information collection 
request includes two newly added forms: (1) Primary Care Association 
(PCA) COVID-19 Data Collection Survey Tool \1\ and (2) the Health 
Center COVID-19 Vaccine Program Conditions of Participation Agreement.
---------------------------------------------------------------------------

    \1\ The bi-weekly COVID-19 PCA Survey Tool (comprised of six 
questions) is currently approved under the HHS Secretary's Public 
Health Emergency Authority to waive the requirements of the 
Paperwork Reduction Act during the Public Health Emergency for 
reporting on a voluntary basis.
---------------------------------------------------------------------------

    Need and Proposed Use of the Information: HRSA uses the data 
collected to optimize COVID-19 testing and vaccination; track health 
center capacity and the impact of COVID-19 on operations, patients, and 
staff; and better understand training and technical assistance, 
funding, and other health center resource needs. The data allow HRSA to 
assess health center capacity prior to program enrollment, supporting 
successful vaccine allocation strategies while providing HRSA with 
information on the effectiveness of vaccine distribution through this 
program. In addition, the data inform HRSA in resource allocation and 
technical assistance to health centers.
    The readiness assessment supports HRSA's analysis of health center 
ability to successfully participate in the Health Center COVID-19 
Vaccine Program. These data are critical to determine health center 
capacity to implement the vaccination program as well as comply with 
program requirements. These data are used to assess program readiness 
including:

 Ability to safely store the vaccine
 Availability of trained and credentialed staff and other staff 
capacity
 Reporting capacity
 Sufficient Personal Protective Equipment
 Plan for vaccine transport

    The health center weekly survey and addendum support HRSA's ability 
to monitor progress towards the development and delivery of COVID-19 
prevention, preparedness, and/or response activities and ensure 
appropriate vaccine administration as well as better understand 
training and technical assistance, funding, and other health center 
resource needs.
    The Conditions of Participation Agreement governs all COVID-19 
vaccination activities at all health center sites that receive COVID-19 
vaccine through the HRSA Health Center

[[Page 21757]]

COVID-19 Vaccine Program. Health Centers that sign the agreement agree 
to adhere to each of the stated requirements.
    The PCA weekly survey increases information sharing between health 
centers, PCAs, and HRSA in order to better support COVID-19 emergency 
response efforts inclusive of testing and vaccination activities. Data 
collected from the survey tool is used to track and monitor issues/
challenges to program implementation and assess the need for the 
delivery/dissemination of targeted training and technical assistance.
    Likely Respondents: HRSA-supported health centers, look-alikes, and 
PCAs.
    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
                                    Number of      responses to        Total      Average burden   Total burden
           Form name               respondents       form per        responses     per response        hours
                                                    respondent                      (in hours)
----------------------------------------------------------------------------------------------------------------
Condition of Participation      1,467 (Total                   1           1,467             .25          366.75
 Agreement (one-time             health centers,
 completion for vaccine          including look-
 program participants only).     alikes, in
                                 2019).
Readiness Assessment Tool (one- 1,467 (Total                   1           1,467             .50           733.5
 time completion for vaccine     health centers,
 program participants only).     including look-
                                 alikes, in
                                 2019).
Health Center COVID-19 Data     1,389 (Total                  48          66,672            1.00          66,672
 Collection Survey Tool          health centers
 (weekly completion of           in 2019).
 existing 20 questions).
Addendum to COVID-19 Data       1,389 (Total                  48          66,672             .50          33,336
 Collection Survey Tool          health centers
 (weekly completion for          in 2019).
 vaccine program participants
 only).
PCA COVID-19 Data Collection    52..............               6             312             .75             234
 Survey Tool (bi-weekly
 completion of existing six
 questions).
                               ---------------------------------------------------------------------------------
    Total.....................  5,764...........  ..............         136,590  ..............      101,342.25
----------------------------------------------------------------------------------------------------------------

    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. 2021-08454 Filed 4-22-21; 8:45 am]
BILLING CODE 4165-15-P