Department of Health and Human Services December 2009 – Federal Register Recent Federal Regulation Documents

The Office of the President's Council on Physical Fitness and Sports (PCPFS) announces the opportunity for non-Federal public and private sector entities to co-sponsor and administer a series of financially self-sustaining activities related to the President's Challenge Physical Activity and Fitness Awards Program (President's Challenge). Potential co-sponsors must have a demonstrated interest in and be capable of managing the day to day operations associated with the program and be willing to participate substantively in the co- sponsored activity.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for an abbreviated new animal drug application (ANADA) for isoflurane, USP, from Nicholas Piramal India Ltd. UK, to Piramal Healthcare Ltd.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 5: Disintegration Test General Chapter.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Disintegration Test General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. In the Federal Register of February 21, 2008 (73 FR 9575), FDA made available a guidance on the Q4B process entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.''

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 8: Sterility Test General Chapter.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Sterility Test General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. In the Federal Register of February 21, 2008 (73 FR 9575), FDA made available a guidance on the Q4B process entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.''

The NTP invites public comment on the recommendation from an expert panel on the listing status for formaldehyde in the 12th RoC and the scientific justification for the recommendation. The recommendation and scientific justification for formaldehyde are available electronically in Part B of the Expert Panel Report (https:// ntp.niehs.nih.gov/go/29682 Formaldehyde, Expert Panel Report Part B) or in printed text from the RoC Center (see FOR FURTHER INFORMATION CONTACT below). The RoC Center convened a ten-member expert panel of scientists, plus four technical scientific experts, from the public and private sectors on November 2-4, 2009, in Research Triangle Park, NC. The panel was asked (1) to apply the RoC listing criteria to the relevant scientific evidence and make a recommendation regarding listing status (i.e., known to be a human carcinogen, reasonably anticipated to be a human carcinogen, or not to list) for formaldehyde in the 12th RoC and (2) to provide the scientific justification for their recommendation.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Timeframe for Submission of Tobacco Health Documents.'' This document provides written guidance to tobacco product manufacturers and importers on enforcement of the requirement to submit certain documents to FDA under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).

This Notice advises the public that the Indian Health Service (IHS) proposes to expand the geographic boundaries of the Service Delivery Area (SDA) for the Cowlitz Indian Tribe. The Cowlitz SDA currently is comprised of Clark, Cowlitz, King, Lewis, Pierce, Skamania, and Thurston in the State of Washington. These counties were designated as the Tribe's SDA in 67 FR 46329. It is proposed that Columbia County, Oregon, and Wahkiakum and Kittitas Counties, Washington be added to the existing SDA.

This notice announces a meeting of the Advisory Panel on Medicare Education (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare program. This meeting is open to the public.

This notice announces a listening session to discuss the Physician Quality Reporting Initiative (PQRI). The purpose of the listening session is to solicit input from participating stakeholders on