Health Resources and Services Administration July 2014 – Federal Register Recent Federal Regulation Documents
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National Vaccine Injury Compensation Program; List of Petitions Received
The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Availability of Interpretive Rule: Implementation of the Exclusion of Orphan Drugs for Certain Covered Entities Under the 340B Program
HHS is announcing the availability of an interpretive rule providing HHS's interpretation of section 340B(e) of the Public Health Service Act (PHSA), entitled ``Implementation of the Exclusion of Orphan Drugs for Certain Covered Entities Under the 340B Program.'' The interpretive rule states that section 340B(e) of the PHSA excludes drugs with an orphan designation only when those drugs are transferred, prescribed, sold, or otherwise used for the rare condition or disease for which the drug was designated under section 526 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Clarifications Regarding the Ryan White HIV/AIDS Program and Reconciliation of Advanced Premium Tax Credits Under the Affordable Care Act; Request for Comment
HRSA's HIV/AIDS Bureau (HAB) recently released HAB Policy Clarification Notice 14-01, which requires RWHAP grantees and subgrantees that use program funds to purchase health insurance in the Marketplace to establish appropriate mechanisms to vigorously pursue any excess premium tax credit a client receives from the Internal Revenue Service (IRS) upon submission of the client's tax return. HRSA now seeks public comment on the operational feasibility for RWHAP grantees and subgrantees to implement a complementary policy that would allow RWHAP grantees and subgrantees to use RWHAP funds to pay the IRS any additional income tax liability a client may owe to the IRS solely based on reconciliation of the premium tax credit. In addition to general comments about the feasibility of implementing such a policy, HRSA would like feedback on the following issues related to this policy: Could this proposed policy be easily implemented by a grantee? What challenges would grantees and subgrantees face in implementing this proposed policy? Will grantees be able to conduct fiscal monitoring of this proposed policy? If so, what level of effort would be required?
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Ryan White HIV/AIDS Program, AIDS Education and Training Centers, Graduate Medical Education Grant Under the Ryan White HIV/AIDS Program
HRSA will be issuing non-competitive awards under the Ryan White HIV/AIDS Program, AETC/GME Program. Approximately $450,000 will be made available in the form of a grant to current grantees (listed in chart below) during the budget period of July 1, 2014, through June 30, 2015. This will: (1) Continue the current cohort and provide support for one additional cohort of graduate medical residents; (2) continue to provide workforce development that is integral to the national interest through meeting National HIV/AIDS Strategy goals, and that enhances the implementation of the Affordable Care Act; and (3) provide a more robust program evaluation that will yield sufficient data; and aid HRSA/HAB in future decisions regarding the replication and the viability of a subsequent GME competition. The scope of work does not change.
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