Department of Health and Human Services August 27, 2010 – Federal Register Recent Federal Regulation Documents

This notice announces a listening session to receive comments regarding implementation of section 10332 of the Patient Protection and Affordable Care Act (the Affordable Care Act), which amended section 1874 of the Social Security Act: Availability of Medicare Data for Performance Measurement. The purpose of the listening session is to solicit input from potential stakeholders on key components of the design of the program. We are soliciting input on the types of organizations that may be interested in receiving data as qualified entities under this provision; the criteria such organizations will have to meet for participation; procedures for CMS to approve interested organizations for participation; provider communities and geographic areas that might be served by these entities; data elements required, and the sources and types of other data that these organizations might match to Medicare claims; challenges in calculating performance measures from the data, and issues related to the identification, selection, and reporting of the performance measures.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the John E. Fogarty International Center, the National Institutes of Health has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on May 27, 2010 (volume 75, number 102, page 29763) and allowed 60 days for public comment. One comment was received from a member of the public. The purpose of this notice is to allow an additional 30 days for public comment.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (DHHS) is hereby giving notice that the President's Council on Fitness, Sports and Nutrition (PCFSN) will hold a meeting. The meeting will be open to the public.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist clinical trial sponsors and investigators in the development of antimicrobial drugs for the treatment of acute bacterial skin and skin structure infections (ABSSSI), impetigo, and minor cutaneous abscesses. FDA's thinking in this area has evolved in recent years, and this draft guidance, when finalized, will inform sponsors of the changes in the definitions of ABSSSI and the recommendations for clinical drug development.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) from Peptech Animal Health Pty, Ltd. to Dechra, Ltd. and for an abbreviated new animal drug application (ANADA) from Church & Dwight Co., Inc., to Pegasus Laboratories, Inc. In addition, FDA is removing those portions of the regulations that reflect approval of two other NADAs transferred from Church & Dwight Co., Inc., to Pegasus Laboratories, Inc., for which voluntary withdrawal of approval was requested after the change of sponsorship. In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these two NADAs.