Department of Health and Human Services February 17, 2009 – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Services published a notice in the Federal Register of January 14, 2009 (Vol. 74, No. 9, pages 2076-2078) soliciting comments on the draft strategic National Vaccine Plan. Comments were requested no later than 5 p.m. on January 30, 2009. Because many stakeholders responded that they did not have adequate time to coordinate comments from their respective constituencies, the National Vaccine Program Office (NVPO) is extending the period for public comments.

The Food and Drug Administration (FDA) is announcing the availability of the source code and supporting technical documentation for the Phonetic Orthographic Computer Analysis (POCA) software program. POCA is an analytic tool designed to help identify drug and biologic names and medical terminology that are phonetically and orthographically similar to one another. POCA is one analytic tool that FDA uses to review proposed proprietary drug and biologic names.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``S9 Nonclinical Evaluation for Anticancer Pharmaceuticals.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use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 The draft guidance provides recommendations for nonclinical studies for the development of pharmaceuticals, including both drugs and biotechnology-derived products, intended to treat patients with advanced cancer. The recommendations describe the type and timing of nonclinical studies to support an investigational new drug application (IND) and the submission of a new drug application (NDA) or biologics license application (BLA). The draft guidance is intended to provide information on internationally accepted recommendations for nonclinical studies to facilitate the development of anticancer pharmaceuticals.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 6: Uniformity of Dosage Units General Chapter.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use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 The draft guidance provides the results of the ICH Q4B evaluation of the Uniformity of Dosage Units General Chapter harmonized text from each of the three pharmacopoeias (United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 draft guidance is the sixth annex to the core Q4B guidance, which was made available in the Federal Register of February 21, 2008 (73 FR 9575).