Supporting Statement A

^{SUPPORTING STATEMENT} A

COVID-19 Data Report

OMB Control No. 0915-0053

Extension Request

Terms of Clearance: None

1. Justification

1. Circumstances Making the Collection of Information Necessary

The Health Resources and Services Administration (HRSA) is requesting continued approval from the Office of Management and Budget (OMB) for continuation of a data collection module which received OMB approval under emergency review on June 11, 2020 with an expiration date of December 31, 2020. This module supports the HRSA HIV/AIDS Bureau (HAB) requirement to monitor and report on funds distributed under the fiscal year (FY) 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act.¹ Signed into law on March 27, 2020, the CARES Act appropriated $90 million to the HRSA HAB Ryan White HIV/AIDS Program (RWHAP) to prevent, prepare for, and respond to coronavirus disease 2019 (COVID-19). This additional funding was awarded to eligible RWHAP recipients on April 15, 2020, with an initial data reporting requirement due 30 days later.

This data reporting module – the COVID-19 Data Report (CDR) – collects information on CARES Act funded activities. The CDR collects monthly, aggregate data on the number of people served for treatment or prevention of COVID-19 among RWHAP clients (and immediate household members in limited circumstances) and the allowable RWHAP services provided.² Completion of the CDR is required for all providers (regardless of whether they are recipients or subrecipients) who receive CARES Act RWHAP funding. The information obtained by the CDR assists HRSA HAB in understanding how CARES Act RWHAP funding is being used to support RWHAP clients and immediate household members and ensure that HRSA HAB is compliant with federal reporting requirements.³

The CDR allows HAB to meet time-sensitive federal reporting requirements as outlined in the CARES Act legislation.³ The original data reporting deadline for RWHAP recipients was May 15, 2020 (30 days after issuance of the notice of award). Due to the time required to build the new module in the Bureau Reporting System (BRS), however, this deadline was extended to June 15, 2020. Not all recipients receiving CARES Act RWHAP funding have submitted a provider report due to not having executed local procurements for RWHAP COVID-19 funding, however, the initial and subsequent submissions of CDR data have occurred without issue, allowing HRSA to meet the deadline to submit a quarterly report to the U.S. Department of Health and Human Services and to Congress.

2. Purpose and Use of Information Collection

The CDR is designed to collect information from RWHAP-funded providers who use CARES Act RWHAP funding to provide RWHAP core medical or support services to RWHAP-eligible clients and immediate household members. These data are critical to meet HRSA HAB’s requirements to monitor and report on how federal funding is being used and to measure the effectiveness of the RWHAP in addressing the COVID-19 pandemic. Specifically, these data are being used to assess the following:

• Whether program funds are being spent for their intended purposes;

• How program funds are being used to provide RWHAP core medical and support services;

• How many individuals are receiving services;

• The numbers of individuals who were tested for COVID-19 and/or diagnosed with COVID-19 (both new and cumulative cases);

• How services are distributed across geographic areas and types of organizations; and

• What types of services are provided using telehealth technology

3. Use of Improved Information Technology and Burden Reduction

The CDR module is housed in the Electronic Handbooks (EHB), an existing website for RWHAP recipients to enter other data required for RWHAP-funded agencies, such as the Grantee Contract Management System (GCMS), RWHAP Services Report (RSR), and the Allocations and Expenditures Reports, which are easily accessible. The integration of the CDR module into the existing EHB streamlines users’ access and technology knowledge. The EHB also allows for some information to pre-populate, particularly organization details, so that users can easily update or change their data.

4. Efforts to Identify Duplication and Use of Similar Information

Data required to evaluate and monitor the CARES Act RWHAP funding, such as client services, funding allocations, and expenditures are not available elsewhere; the CARES Act was signed into law for the first time on March 27, 2020.

5. Impact on Small Businesses or Other Small Entities

This information collection includes small entities; however, this activity does not impose a significant impact on such entities. The information being requested has been held to the absolute minimum required for the intended use of the data. Smaller organizations typically provide fewer RWHAP services than larger agencies; and as such, these entities will not be required to complete as many questions on the CDR.

6. Consequences of Collecting the Information Less Frequently

Without monthly reporting on the use of grant funds, expenditures, and services, HRSA HAB would not be able to carry out its responsibility to oversee compliance with the intent of Congressional appropriations in a timely manner. Monthly reporting is necessary to determine whether the administration of CARES Act funding is responding to the needs of RWHAP clients and whether this funding is being spent on its intended purpose.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

The data is collected in a manner fully consistent with the guidelines in 5 CFR 1320.5(b).

8. Comments in Response to the Federal Register Notice/Outside Consultation

Section 8A: A 60-day Federal Register Notice was published in the Federal Register on September 1, 2020, vol. 85, No. 170; pp. 54390-54391 (Attachment A). There were no public comments.

Section 8B: HRSA consulted with the following subject matter experts in 2020 for creation and maintenance of the CDR. There were no major problems that could not be resolved during consultation. To date, no public comments have been received.

Shelita Merchant, PhD, MPH

Chief - Data Management and Analysis Branch

HIV/AIDS Bureau

Health Resources and Services Administration

5600 Fishers Lane, Rm 09N176D

Rockville, MD 20857

Phone: 301-443-0214

Email: [email protected]

Role: Advise on content and questionnaire design

Stacy Cohen, MPH

Acting Chief - Data Management and Analysis Branch

HIV/AIDS Bureau

Health Resources and Services Administration

5600 Fishers Lane, Rm 09N160

Rockville, MD 20857

Phone: 301-443-3259

Email: [email protected]

Role: Advise on content, questionnaire design, and data structure

Greg Manus

Mathematical Statistician - Data Management and Analysis Branch

HIV/AIDS Bureau

Health Resources and Services Administration

5600 Fishers Lane, Rm 09N130A

Rockville, MD 20857

Phone: 301-443-0737

Email: [email protected]

Role: Advise on content, questionnaire design, and data structure

Preston Garnes, MPH

Statistician - Data Management and Analysis Branch

HIV/AIDS Bureau

Health Resources and Services Administration

5600 Fishers Lane, Rm 09N180B

Rockville, MD 20857

Phone: 301-443-5261

Email: [email protected]

Role: Advise on content, questionnaire design, and data structure

Robert Mills, PhD

Health Statistician - Data Management and Analysis Branch

HIV/AIDS Bureau

Health Resources and Services Administration

5600 Fishers Lane, Rm 09N190B

Rockville, MD 20857

Phone: 301-443-3899

Email: [email protected]

Role: Advise on content, questionnaire design, and data structure

Chi-Chung (Alex) Chan

Information Specialist - Office of Information Technology

Office of Operations

Health Resources and Services Administration

5600 Fishers Lane, Rm 12W01C

Rockville, MD 20857

Phone: 301-443-0558

Email: [email protected]

Role: Advise on content, questionnaire design, and data structure

Antigone Dempsey, MEd

Division Director - Division of Policy and Data

HIV/AIDS Bureau

Health Resources and Services Administration

5600 Fishers Lane, Rm 09N150

Rockville, MD 20857

Phone: 301-443-0360

Email: [email protected]

Role: Review and validate content and design

Tracy Matthews, CAPT, USPHS

Deputy Division Director - Division of Policy and Data

HIV/AIDS Bureau

Health Resources and Services Administration

5600 Fishers Lane, Rm 09N152

Rockville, MD 20857

Phone: 301-443-7804

Email: [email protected]

Role: Review and validate content and design

Laura Cheever, MD, ScM

Associate Administrator

HIV/AIDS Bureau

Health Resources and Services Administration

5600 Fishers Lane, Rm 09W37

Rockville, MD 20857

Phone: 301-443-1993

Email: [email protected]

Role: Review and validate content and design

Heather Hauck, MSW

Chief - Data Management and Analysis Branch

HIV/AIDS Bureau

Health Resources and Services Administration

5600 Fishers Lane, Rm 09W29

Rockville, MD 20857

Phone: 301-443-3613

Email: [email protected]

Role: Review and validate content and design

9. Explanation of any Payment/Gift to Respondents

Respondents will not receive any payments or gifts.

10. Assurance of Confidentiality Provided to Respondents

The CDR module does not require any information that could identify individual clients. Aggregate data on the number of clients and immediate household members who received services will be collected, but client names or other personally identifiable information will not be collected.

11. Justification for Sensitive Questions

The CDR does not collect confidential or protected information. There are no questions of a sensitive nature.

12. Estimates of Annualized Hour and Cost Burden

12A: Estimated Annualized Burden Hours

The CDR is a data module that is limited to only a subset of RWHAP providers (i.e., providers who use CARES Act RWHAP funding to provide services to RWHAP-eligible clients and immediate household members). Some RWHAP-funded providers will not accept or use CARES Act funding; and thus, will not be required to complete the CDR. As HRSA HAB does not know the exact number of providers who will be required to complete the CDR at this time, estimates of annualized burden are based on all RWHAP providers in calendar year 2018 (the most recent data available) and may be overestimated. More accurate counts of funded providers will be collected and reported once they are available. Between August 26, 2020 and September 17, 2020, six RWHAP Part C and D recipients were surveyed to report the amount of time they estimated it would take to complete their CDR submission. Extrapolating this time against the RWHAP providers in calendar year 2018, burden estimates for respondents are presented in in Table 1: Estimated Annualized Burden Hours. The total estimated burden for CDR respondents is 78,528 hours per year. These estimates take into account prior experience in collecting, maintaining, and reporting data using the RWHAP data systems.

Table 1: Estimated Annualized Burden Hours

	Number of Respondents	Number of Responses per Respondent	Total Responses	Average Burden per Response (hours)	Total Burden Hours
CDR Module	2,045	12	24,540	3.2	78,528

12B: Estimated Annualized Burden Costs

Table 2: Estimated Annualized Cost

Type of Respondent	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
Providers	78,528	$30.33	$2,381,754

13. Estimates of other Total Annual Cost Burden to Respondents or Recordkeepers/Capital Costs

HRSA has contracted with REI Solutions for the development of the CDR module, system maintenance, and data collection ($560,236.00). Contract support for technical assistance is provided by WRMA/CSR for $18,130.03. Additionally, government personnel will require 15% of 1 FTE at a GS-13 level, Step 5 ($17,453) to provide data analysis and reporting.

14. Annualized Cost to Federal Government

The total cost of this data collection is $595,819.03. This includes the cost of contract support for technical assistance and government personnel required to provide analysis and reporting.

15. Explanation for Program Changes or Adjustments

There is an adjustment of the burden estimate submitted in the emergency clearance request. The information provided in sections 12A and 12B are reflective of six RWHAP Part C clinics who tracked their time completing their September 2020 CDR data submission.

16. Plans for Tabulation, Publication, and Project Time Schedule

After OMB emergency approval was obtained, the CDR opened for data collection on the 1st of each month, beginning on June 1, 2020. Respondents have until the 15th of each month to complete the module (with an allowable extension for 15 additional days). The first submission for the CDR was due June 15, 2020, and then on a monthly basis thereafter. Because CARES Act funding can be used retroactively from January 20, 2020, the first data submission included 3 distinct reports that collect information on 3 different time periods:

• 1/20/2020 – 3/31/2020 (pre-award)

• 4/1-4/30/2020

• 5/1-5/31/2020

Data from the CDR module is extracted within two weeks of the end of the reporting period to allow for analysis of the use of CARES Act funding to support RWHAP clients and household members. There are no plans to publish, tabulate or manipulate collected data, outside of the quarterly report to the U.S. Department of Health and Human Services and to Congress.

17. Reason(s) Display of OMB Expiration Date is Inappropriate

The OMB number and Expiration date will be displayed on every page of every form/instrument.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

1 FY 2020 Coronavirus Aid, Relief, and Economic Security Act, P.L. 116-136 (CARES Act).

2 Allowable RWHAP service categories are described in Policy Clarification Notice 16-02 Ryan White HIV/AIDS Program Services: Eligible Individuals and Allowable Uses of Funds.

3 The 2020 CARES Act states “Not later than 10 days after the end of each calendar quarter, any Recipient that is an entity receiving more than $150,000 total in funds under the Coronavirus Aid, Relief, and Economics Security Act (P.L. 116-136)…shall submit to the Secretary and the [Pandemic Response Accountability] Committee a report. This report shall contain…a detailed list of all projects or activities for which large covered funds were expended or obligated, including: the name and description of the project or activity…”