Department of Health and Human Services 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Adoption of FDA Food Code by Local, State and Tribal Governments'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

This notice fulfills the Secretary's obligation under section 1153(i) of the Social Security Act (the Act) to provide at least 6 months' advance notice of the expiration dates of contracts with out- of-State Quality Improvement Organizations (QIOs) before renewing any of those QIOs' contracts. It also specifies the period of time in which in-State QIOs may submit a proposal for those contracts.

The final rule with comment period in this document revises the Medicare hospital outpatient prospective payment system (OPPS) to implement applicable statutory requirements and changes arising from our continuing experience with this system and to implement certain provisions of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (Affordable Care Act). In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These changes are applicable to services furnished on or after January 1, 2011. In addition, this final rule with comment period updates the revised Medicare ambulatory surgical center (ASC) payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system and to implement certain provisions of the Affordable Care Act. In this final rule with comment period, we set forth the applicable relative payment weights and amounts for services furnished in ASCs, specific HCPCS codes to which these changes apply, and other pertinent ratesetting information for the CY 2011 ASC payment system. These changes are applicable to services furnished on or after January 1, 2011. In this document, we also are including two final rules that implement provisions of the Affordable Care Act relating to payments to hospitals for direct graduate medical education (GME) and indirect medical education (IME) costs; and new limitations on certain physician referrals to hospitals in which they have an ownership or investment interest. In the interim final rule with comment period that is included in this document, we are changing the effective date for otherwise eligible hospitals and critical access hospitals that have been reclassified from urban to rural under section 1886(d)(8)(E) of the Social Security Act and 42 CFR 412.103 to receive reasonable cost payments for anesthesia services and related care furnished by nonphysician anesthetists from cost reporting periods beginning on or after October 1, 2010, to December 2, 2010.

The Food and Drug Administration (FDA) is announcing an amendment to the notice of a meeting of the Oncologic Drugs Advisory Committee. This meeting was announced in the Federal Register of October 19, 2010 (75 FR 64314). The amendment is being made to reflect changes in the Date and Time, Agenda, and Procedure portions of the document. We also are postponing a session regarding biologics license application (BLA) 125377, with the proposed trade name Yervoy (ipilimumab), manufactured by Bristol-Myers Squibb Co. The proposed indication (use) for this product is for the treatment of advanced melanoma in patients who have received prior therapy. This portion of the meeting has been postponed due to the need to complete the review of additional data submitted by the applicant. Future meeting dates may be announced in the Federal Register.

As stipulated by the Federal Advisory Committee Act, as amended (5 U.S.C. App), the U.S. Department of Health and Human Services is hereby announcing renewal of the charter for the Advisory Committee on Blood Safety and Availability (ACBSA).

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Administration on Aging is announcing the availability of supplemental grant funds for the support of the Senior Medicare Program (SMP). The goal of this supplemental is a program expansion for one award to include direct Medicare fraud prevention intervention activities in high risk areas. Funding Opportunity Title/Program Name: National Hispanic SMP (NHSMP). Announcement Type: Proposed program expansion. Funding Opportunity Number: Program Announcement No. HHS-2011-AoA- MP-1102. Statutory Authority: HIPAA of 1996 (Pub. L. 104-191). Catalog of Federal Domestic Assistance (CFDA) Number: 93.048 Discretionary Projects.

The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for ACCUTANE (isotretinoin) Capsules held by Hoffmann-La Roche Inc., 340 Kingsland St., Nutley, NJ 07110- 1199. Hoffmann-La Roche Inc. notified the Agency in writing that the drug product was no longer marketed and requested that the approval of the application be withdrawn.