Signed Memo from HRSA Acting Administrator

DEPARTMENT OF HEALTH & HUMAN SERVICES

Health Resources and Services
Administration

Rockville, MD 20857

TO:

Sharon Block, Associate Administrator
Office of Information and Regulatory Affairs

FROM:

Diana Espinosa, Acting Administrator

DATE:

February 16, 2021

SUBJECT:

Expedited Review of the Health Center COVID-19 Vaccine Program Readiness
Assessment and the COVID-19 Data Collection Survey Tool with Addendum for
the Health Center COVID-19 Vaccine Program

ISSUE
The Health Resources and Services Administration (HRSA) is requesting an expedited review of:
(1) The Health Center COVID-19 Vaccine Program Readiness Assessment, and (2) The COVID-19
Data Collection Survey Tool, with Addendum questions for health centers participating in the
Vaccine Program. These data collection tools were developed by HRSA to support implementation
of the Health Center COVID-19 Vaccine Program and improve HRSA’s ability to provide resources
and technical assistance to health centers and strengthen the federal response to the COVID-19
pandemic. These data collection tools are essential for HRSA’s ability to assess: (1) the readiness
and interest of HRSA-funded health centers preliminarily identified by the Centers for Disease
Control and Prevention (CDC) and HRSA to receive a direct allocation of a limited supply of
COVID-19 vaccines, and (2) progress in vaccine administration and equitable access to vaccine.
BACKGROUND
President Biden announced the Administration's goal of administering 100 million shots in 100
days and ensuring that vaccines are administered equitably. Through collaboration between
HRSA and CDC, the Health Center COVID-19 Vaccine Program will directly allocate a limited
supply of COVID-19 vaccines to select HRSA-funded health centers starting the week of
February 15, 2021.
The Health Center COVID-19 Vaccine Program Readiness Assessment Tool is necessary to
document and assess health center COVID-19 vaccine administration capacity (e.g. capacity to
safely store the vaccine, availability of trained and credentialed staff and sufficient PPE to
administer vaccine in a timely manner, and reporting capacity, including to state and/or local
departments of health). The tool also includes an assessment of health center capacity to manage
inventory and distribution of vaccines, as well as ability to meet program expectations. This tool
serves as the designated mechanism for health centers to propose sites for vaccine delivery.
Currently, HRSA-funded health centers and Health Center Program look-alikes voluntarily

Sharon Block, Associate Administrator
Page 2
complete the weekly COVID-19 Data Collection Survey Tool. 1 HRSA uses this tool to collect
key information regarding COVID-19 activities to assist in tracking health center capacity and
the impact of the COVID-19 public health emergency on health center operations, patients, and
staff, as well as to better understand training and technical assistance, funding, and other health
center resource needs. HRSA requires a mechanism to capture data on vaccine doses administered
by health centers participating in the Health Center COVID-19 Vaccine Program. As a result we
are adding an Addendum to the Survey Tool to capture this additional information.
Given the critical need to provide vaccines in a timely and equitable manner, and that no existing
data collection system currently captures the information contained in the proposed Readiness
Assessment Tool and Addendum to COVID-19 Data Collection Survey Tool, HRSA needs to
move expeditiously to establish a mechanism to assess health center readiness for this initiative
and implement it.
HRSA proposes mandatory data collection from health centers participating in the vaccine
allocation program via three instruments: (1) the new Readiness Assessment Tool, (2) the
existing COVID-19 Data Collection Survey Tool, and (3) the new Addendum to COVID-19
Data Collection Survey Tool.
DISCUSSION
Health Center COVID-19 Vaccine Program Readiness Assessment Tool
Health centers who wish to participate in the vaccine program will be required to complete the
Health Center COVID-19 Vaccine Program Readiness Assessment Tool. This one-time
assessment is comprised of a total of 10 questions, including 9 yes or no questions and 1 multiple
choice question, with 3 questions possibly requiring a written response. Health centers will
securely complete the Readiness Assessment Tool in the Health Center COVID-19 Vaccine
Program Online Community.
The Readiness Assessment Tool will be open in the Health Center COVID-19 Vaccine Program
Online Community on Monday, February 15, 2021. Information provided via the Readiness
Assessment tool will support HRSA assessment of the health center's capacity to administer
vaccines and meet program expectations, inform the development of training and technical
assistance resources for health centers, and support the establishment of a federal vaccine
program account.
COVID-19 Data Collection Survey Tool and Addendum
Health centers selected for program participation will also be required to complete the weekly
COVID-19 Data Collection Survey Tool (currently comprised of 20 questions) as well as
additional questions in the survey addendum through the Health Center COVID-19 Vaccine
Program Online Community (https://hrsa.force.com/HRSABPHC/s/health-center-survey) to
support secure data collection.
The weekly survey is currently approved under the HHS Secretary’s Public Health Emergency Authority to waive
the requirements of the Paperwork Reduction during the Public Health Emergency for reporting on a voluntary basis.
1

Sharon Block, Associate Administrator
Page 3
Approval of the Readiness Assessment Tool and the COVID-19 Data Collection Survey Tool
and Addendum is urgent and time-sensitive to ensure that HRSA and CDC, in coordination with
the jurisdictions, can effectively analyze future vaccine allocation, distribution, and uptake data
to determine vaccine allocations to health centers and expand participation in this White House
initiative.
Because of the urgent nature of the COVID-19 pandemic response and the need to support a lifesaving vaccination rollout through this White House initiative, it is critical for HRSA to obtain
health center capacity and implementation data as quickly as possible through these mechanisms.
The data will 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. It will also inform HRSA in
resource allocation and technical assistance to health centers.
These data collection instruments will provide HRSA with critical and timely data on health
center capacity for program participation.
Thank you for consideration of this expedited approval.

Digitally signed by Diana
Diana
Espinosa -S
Date: 2021.02.16
Espinosa
-S
18:42:47 -05'00'
________________________
Diana Espinosa

Attachments:
PRA Emergency Clearance Package