07-3219. Agency Information Collection Activities Under Emergency Review for the Office of Management and Budget (OMB)

The Health Resources and Services Administration (HRSA) has submitted the following request (see below) for emergency OMB review under the Paperwork Reduction Act (44 U.S.C. Chapter 35). OMB approval has been requested within 20 days of publication of this notice. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, call the HRSA Reports Clearance Officer on [phone].

Written comments and recommendations should be sent within 14 days of publication of this notice to the desk officer for HRSA, either by e-mail to [e-mail] or by fax to 202-395-6974. Please direct all correspondence “to the attention of the desk officer for HRSA.”

Proposed Project: Ryan White HIV/AIDS Program Core Medical Services Waiver Application Requirements (NEW)

Title XXVI of the Public Health Service (PHS) Act, as amended by the Ryan White HIV/AIDS Treatment Modernization Act of 2006 (Ryan White HIV/AIDS Program) requires that grantees expend 75 percent of Parts A, B, and C funds on core medical services, including antiretroviral drugs, for individuals with HIV/AIDS identified and eligible under the legislation, effective Fiscal Year (FY) 2007. In order for grantees under Parts A, B, and C to be exempted from the 75 percent core medical services requirement, they must request and receive a waiver from HRSA, as required in the Act. HRSA has developed a process for waiver request submission, review, and notification. The core medical services waiver uniform standard and waiver request process will apply to Ryan White HIV/AIDS Program grant awards under Parts A, B, and C of Title XXVI of the PHS Act beginning FY 2008. Core medical services waivers will be effective for a one-year period consistent with the grant award period.

Grantees must submit a waiver request with the annual grant application containing the following certifications and documentations which will be utilized by HRSA in making determinations regarding waiver requests. The waiver must include:

1. Certification from the Part B state grantee that there are no current or anticipated ADAP services waiting lists in the state for the year in which such waiver request is made. This certification must also specify that there are no waiting lists for a particular core class of antiretroviral therapeutics established by the Secretary, e.g., fusion inhibitors;

2. Certification that all core medical services listed in the statute (Part A section 2604(c)(3), Part B section 2612(b)(3), and Part C section 2651(c)(3)), regardless of whether such services are funded by the Ryan White HIV/AIDS Program, are available within 30 days for all identified and eligible individuals with HIV/AIDS in the service area;

3. Evidence that a public process was conducted to seek public input on availability of core medical services;

4. Evidence that receipt of the core medical services waiver is consistent with the grantee's Ryan White HIV/AIDS Program application (e.g., “Description of Priority Setting and Resource Allocation Processes” and “Unmet Need Estimate and Assessment” sections of the application for Parts A, “Needs Assessment and Unmet Need” section of the application under Part B, and “Description of the Local HIV Service Delivery System,” and “Current and Projected Sources of Funding” sections of the application under Part C).

The estimated annual burden is as follows:

Application	Number of respondents	Responses per respondent	Total responses	Hours per response	Total burden hours
Waiver Request	20	1	20	6.5	130
Total	20		20		130

Dated: June 27, 2007.

Alexandra Huttinger,

Acting Director, Division of Policy Review and Coordination.