Department of Health and Human Services February 2009 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 269
Solicitation of Written Comments on Draft Strategic National Vaccine Plan; Extension of Period for Public Comments
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.
Phonetic Orthographic Computer Analysis Software Program for Review of Proprietary Drug and Biologic Names; Availability
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.
International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Dissolution Test General Chapter; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 7: Dissolution Test General Chapter.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use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 The draft guidance provides the results of the ICH Q4B evaluation of the Dissolution Test General Chapter harmonized text from each of the three pharmacopoeias (United States,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 The draft guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The draft guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing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 seventh annex to the core Q4B guidance, which was made available in the Federal Register of February 21, 2008 (73 FR 9575).
International Conference on Harmonisation; Draft Guidance on S9 Nonclinical Evaluation for Anticancer Pharmaceuticals; Availability
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.
International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Sterility Test General Chapter; Availability
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 8: Sterility Test 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 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 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 eighth annex to the core Q4B guidance, which was made available in the Federal Register of February 21, 2008 (73 FR 9575).
International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Uniformity of Dosage Units General Chapter; Availability
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).
Medicare Program; Medicare Evidence Development & Coverage Advisory Committee; Cancellation of the March 18, 2009 Meeting and Announcement of the June 17, 2009 Meeting
This notice announces the cancellation of the March 18, 2009 public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') that was published in the January 16, 2009 Federal Register (74 FR 3051 through 3053). This notice also announces a public meeting on Wednesday, June 17, 2009. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will focus on the use of Bayesian statistics to interpret evidence in making coverage decisions. The meeting will introduce Bayesian concepts, contrast Bayesian approaches with frequentist approaches, and provide some examples of using Bayesian techniques for meta-analyses. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Oral Dosage Form New Animal Drugs; Tiamulin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The supplemental NADA provides for removal of a 250-pound weight restriction and the addition of a reproductive caution statement to labeling of tiamulin concentrate solution used in drinking water for the treatment of certain bacterial respiratory and enteric diseases in swine.
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