Department of Health and Human Services December 17, 2007 – Federal Register Recent Federal Regulation Documents

HRSA will be providing temporary critical HIV medical care and treatment services through Chase Brexton Health Services to avoid a disruption of HIV clinical care to homeless populations in the Baltimore, Maryland, area.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides the results of the ICH Q4B evaluation of the Test for Particulate Contamination: Subvisible Particles General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The draft guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The draft guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing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. This is the third annex to the core Q4B guidance, which was made available in draft in the Federal Register of August 8, 2006 (71 FR 45059).

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods,'' dated December 2007. The guidance document provides to blood establishments and FDA staff revised recommendations for the collection of Platelets by automated methods (plateletpheresis). The guidance is intended to help blood establishments ensure donor safety and the safety, purity, and potency of Platelets collected by an automated blood cell separator device. For the purpose of this document, Platelets collected by automated methods will be referred to by the product name ``Platelets, Pheresis.'' The document contains recommendations for appropriate criteria for a biologics license application or supplement for manufacturing Platelets, Pheresis. The guidance announced in this notice finalizes the draft guidance of the same title dated September 2005, and supersedes the guidance entitled ``Revised Guideline for the Collection of Platelets, Pheresis,'' dated October 1988.

This notice announces the date and location of the Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation (HHS/ASPE) Expert Meeting on Disease Management Outcomes Measurement. The objective of the meeting is to convene a panel of experts from government, academia, and private industry to discuss measurement of the impact of disease management on health outcomes and costs of care, with a focus on potential for public sector programs.