Department of Health and Human Services May 20, 2011 – Federal Register Recent Federal Regulation Documents

This Federal Register notice announces the non-competitive extension with funds of the Enhancing Linkages to HIV Care and Treatment in Jail Settings Initiative, Demonstration Sites (hereafter referred to as the SPNS Enhancing Linkages Initiative) in order to complete linkages to HIV medical care and support services for HIV positive individuals returning from jail settings to the community, follow-up data collection, analysis and dissemination of findings and lessons learned. The findings generated by this Initiative are capable of impacting service delivery systems and increasing linkages to critical HIV care and support services if the model programs can be adapted in jails and HIV service delivery settings across the United States, as well as to demonstrate that HIV testing and linkage to care in jail settings, and transitioning individuals to HIV care and treatment in the community is feasible and effective.

The ``Veterans Health Care Act of 1992,'' enacted section 340B of the Public Health Service Act (PHSA) ``Limitation on Prices of Drugs Purchased by Covered Entities.'' Section 340B implemented a drug pricing program by which manufacturers who participate in Medicaid are required to sell covered outpatient drugs to particular covered entities listed in the statute and must agree to charge a price that will not exceed the amount determined under a statutory formula. The manufacturer's obligation to sell at no greater than the ceiling price extends only to covered outpatient drugs and does not apply to inpatient drugs. Covered entities are required to ensure that drugs purchased under 340B are used only for outpatients. The Patient Protection and Affordable Care Act expanded the types of covered entities eligible to participate in the 340B Drug Pricing Program (340B Program) under the PHSA to include certain free standing cancer hospitals, rural referral centers, sole community hospitals, critical access hospitals, and children's hospitals. Of these entities, children's hospitals were already eligible to participate in the 340B drug pricing program under the Deficit Reduction Act of 2005. The Health Care and Education Reconciliation Act (HCERA) (the Patient Protection and Affordable Care Act and HCERA collectively hereinafter will be referred to as the ``Affordable Care Act''), as amended by the Medicare and Medicaid Extenders Act of 2010, contained a provision that limits the types of drugs that free standing cancer hospitals, rural referral centers, sole community hospitals and critical access hospitals could obtain through the 340B Program. Under the changes made by the Affordable Care Act, orphan drugs, when used for the rare condition or disease for which that orphan drug was designated under the Federal Food, Drug, and Cosmetic Act (FFDCA), are excluded from the definition of covered outpatient drug for the specified newly-eligible covered entity types for purposes of the 340B Program. This regulatory action details how these exclusions will be implemented under the 340B Program.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of April 25, 2011 (76 FR 22906). The document announced the availability of the guidance entitled ``Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Documents: Topical Oxygen Chamber for Extremities.'' The document published inadvertently with outdated information in the ADDRESSES, FOR FURTHER INFORMATION CONTACT, and Electronic Access sections. This document corrects those errors.

This notice announces a request for applications for organizations to participate in the Pioneer Accountable Care Organization Model for a period beginning in 2011 and ending December 2016.