2019-06767. Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Assessing Care and Health Outcomes Among Ryan White HIV/AIDS Program (RWHAP) Clients Who Do Not Receive RWHAP-...

AGENCY:

Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).

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 7, 2019.

ADDRESSES:

Submit your comments to [e-mail] or mail the HRSA Information Collection Clearance Officer, Room 14N39, 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 [e-mail] or call Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at [phone].

SUPPLEMENTARY INFORMATION:

When submitting comments or requesting information, please include the information request collection title for reference.

Information Collection Request Title: Assessing Care and Health Outcomes Among Ryan White HIV/AIDS Program Clients Who Do Not Receive RWHAP-Funded Outpatient Ambulatory Health Services, OMB No. 0906-xxxx-New.

Abstract: RWHAP is administered by HRSA's HIV/ADS Bureau. RWHAP funds and coordinates with cities, states, and local clinics and community-based organizations to deliver HIV care, treatment, and support to low-income people living with HIV (PLWH). Nearly two-thirds of RWHAP clients live at or below 100 percent of the federal poverty level and about three-quarters are racial or ethnic minorities. Since 1990, the RWHAP has developed a comprehensive system of nearly 2,000 safety net provider organizations that deliver high quality health care and support services to more than 500,000 PLWH, more than 50 percent of all diagnosed PLWH in the United States. Recipients and subrecipients funded to provide direct services must submit client-level data annually to HRSA as part of their RWHAP Services Report (RSR). The RSR (0906-0039) contains a single record for each RWHAP-eligible client who received a service during the calendar year. Providers report demographic and service use data for all their clients. However, they report clinical data (including lab results) only for those who received RWHAP-funded OAHS.

HRSA is embarking on a 24-month study called Assessing Care and Health Outcomes Among RWHAP Clients Who Do Not Receive RWHAP-Funded OAHS. The purpose of the study is to learn about the quality of care and health outcomes among the one-third of clients for whom HRSA does not collect clinical information—that is, for the 164,000 clients who do not receive directly funded OAHS under the RWHAP. HRSA will use the findings to (1) assess HIV care and health outcomes among its non-OAHS clients, (2) determine if and where these clients receive OAHS, (3) identify any unmet HIV care and treatment needs faced by this population, and (4) develop strategies to better coordinate services between RWHAP-funded and nonfunded providers. To meet these objectives, HRSA proposes to conduct 30 site visits. Each site visit will include one RWHAP-funded provider that is not directly funded to deliver OAHS and, if necessary for accessing the medical records of their non-OAHS clients, up to two non-RWHAP medical providers. During each site visit, HRSA will collect qualitative and quantitative information via (1) semistructured interviews with program managers, clinicians, and frontline service providers, as well as with non-OAHS clients and (2) medical chart reviews for clients who do not receive directly funded OAHS under the RWHAP.

Need and Proposed Use of the Information: The interviews with provider staff and clients will provide qualitative information on HIV-related medical service use, process, and health outcomes; barriers to care; unmet needs; provider referral relationships; and opportunities to improve care and outcomes among clients who do not receive directly funded OAHS under the RWHAP. The medical chart reviews will provide quantitative information on medical visits, prescription medications, and clinical outcomes for a representative sample of non-OAHS clients. HRSA will use the data to estimate three main outcomes for the study population: (1) Retention in care, (2) initiation of antiretroviral therapy, and (3) viral suppression. This information will supplement data available from the RSR on OAHS clients and enable HRSA for the first time to measure the quality of care and health outcomes for its entire client population, an important step toward ending the HIV epidemic in the United States.

Likely Respondents: HRSA plans to conduct individual interviews with two groups of informants: (1) Program managers, case managers or other frontline service providers, and medical directors or clinicians; and (2) RWHAP clients. HRSA also plans to review and abstract key data elements from non-OAHS client medical records from providers.

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 per respondent	Total responses	Average burden per response (in hours)	Total burden hours
Program manager	30	1	30	1.00	30
Case manager	30	1	30	1.00	30
Medical director	40	1	40	1.00	40
Client	120	1	120	0.50	60
Chart abstraction	30	50	1,500	0.08	120
	250		1,720		280

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.

Amy P. McNulty,

Acting Director, Division of the Executive Secretariat.