Department of Health and Human Services February 21, 2012 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October Through December 2011
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from October through December 2011, relating to the Medicare and Medicaid programs and other programs administered by CMS.
Draft Guidance for Industry on Drug Interaction Studies-Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations; Availability
The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled ``Drug Interaction StudiesStudy Design, Data Analysis, Implications for Dosing, and Labeling Recommendations.'' The revised draft guidance is intended to provide recommendations for sponsors of new drug applications (NDAs) and biologics license applications (BLAs) for therapeutic biologics regarding in vitro and in vivo studies of drug metabolism, drug transport, and drug-drug, or drug-therapeutic protein interactions.
Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information '' dated February 2012. The guidance provides certain Investigational New Drug Application (IND) sponsors with recommendations in connection with the submission of INDs for early clinical trials with live biotherapeutic products (LBPs). The guidance announced in this notice finalizes the draft guidance of the same title dated September 2010.
Draft Guidance for Industry on Providing Submissions in Electronic Format-Standardized Study Data; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Providing Submissions in Electronic FormatStandardized Study Data.'' This draft guidance establishes FDA's recommendation that sponsors and applicants submit nonclinical and clinical study data in a standardized electronic format. The draft guidance recognizes that standardized study data promotes the efficient review of this information. The purpose of this draft guidance is to promote the use of data standards for study data, and increase the number of standardized study data submissions to the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health.
International Conference on Harmonisation; Guidance on E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``E7 Studies in Support of Special Populations: Geriatrics; Questions and Answers.'' 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 questions and answers (Q&A) guidance addresses special considerations for the design and conduct of clinical trials of drugs likely to have significant use in the elderly. The Q&As are intended to provide guidance on the use of geriatric data to adequately characterize and represent the safety and efficacy of a drug for a marketing application, including data collected postmarketing.
Determination That REQUIP XL (Ropinerole Hydrochloride) Extended-Release Tablets, 3 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that REQUIP XL (ropinerole hydrochloride) extended-release tablets, 3 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for ropinerole hydrochloride extended- release tablets, 3 mg, if all other legal and regulatory requirements are met.
Health Claim; Phytosterols and Risk of Coronary Heart Disease
The Food and Drug Administration (FDA) is extending the period of time that it intends to exercise enforcement discretion concerning the use of the health claim for phytosterols and risk of coronary heart disease (CHD), in a manner that is consistent with FDA's February 14, 2003, letter of enforcement discretion to Cargill Health and Food Technologies, until publication of a final rule.
Tribal Consultation Meetings Regarding Requirements Applicable to Title IV-B Child and Family Services Plan
The title IV-B regulations regarding the title IV-B plan and fiscal requirements are outdated due to statutory changes over the last 15 years. The Children's Bureau (CB) is deciding whether to revise the regulations accordingly. Per the ACF Tribal Consultation Policy (76 FR 55678, published September 8, 2011), we request comments from Indian Tribes that operate a title IV-B, subpart 1 and/or title IV-B, subpart 2 program and any other interested party. We provide further information on these statutory changes below, under SUPPLEMENTARY INFORMATION.
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