2021-16591. 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 September 3, 2021.

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 more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email [e-mail] or call Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at [phone].

SUPPLEMENTARY INFORMATION:

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 has 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 the Centers for Disease Control and Prevention, launched the Health Center COVID-19 Vaccine program as part of an Administration 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 also 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.

A 60-day notice published in the Federal Register on April 23, 2021, vol. 86, No. 77; pp. 21756-57. There were no public comments.

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 PPE
• 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 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

Form name	Number of respondents	Number of responses to form per respondent	Total responses	Average burden per response (in hours)	Total burden hours
Condition of Participation Agreement (one-time completion for vaccine program participants only)	1,467 (Total health centers, including look-alikes, in 2019)	1	1,467	.25	366.75
Readiness Assessment Tool (one-time completion for vaccine program participants only)	1,467 (Total health centers, including look-alikes, in 2019)	1	1,467	.50	733.50
Health Center COVID-19 Data Collection Survey Tool (weekly completion of existing 20 questions)	1,389 (Total health centers in 2019)	48	66,672	1.00	66,672.00
Addendum to COVID-19 Data Collection Survey Tool (weekly completion for vaccine program participants only)	1,389 (Total health centers in 2019)	48	66,672	.50	33,336.00
PCA COVID-19 Data Collection Survey Tool (bi-weekly completion of existing six questions)	52	6	312	.75	234.00
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.

Footnotes

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.