Department of Health and Human Services December 17, 2012 – Federal Register Recent Federal Regulation Documents
Results 1 - 21 of 21
Office of the Assistant Secretary for Planning and Evaluation; Meeting of the Advisory Council on Alzheimer's Research, Care, and Services
This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). Notice of these meetings is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). The Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. Representatives of the three federal subgroups (Research, Clinical Care, Long-Term Services and Supports) will provide updates on the implementation of the National Plan to Address Alzheimer's Disease. The Advisory Council will hear a presentation on work underway by the Department of Veterans Affairs to support Veterans with Alzheimer's disease and their caregivers. The subcommittee chairs will present recommendations for adoption by the Advisory Council as formal recommendations to the Secretary of HHS and Congress.
Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition)
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Questions and Answers Regarding Food Facility Registration (Fifth Edition).'' The guidance provides updated information pertaining to registration of human and animal food facilities under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA) on January 4, 2011.
Small Entity Compliance Guide: What You Need To Know About Registration of Food Facilities; Availability
The Food and Drug Administration (FDA) is announcing the availability of an updated guidance for industry entitled ``What You Need To Know About Registration of Food FacilitiesSmall Entity Compliance Guide.'' FDA has prepared this guidance to restate the legal requirements pertaining to registration of food facilities in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). Previously, this guidance restated the legal requirements of FDA's food facility registration regulation. This document also served as FDA's Small Entity Compliance Guide for FDA's food facility registration regulation in accordance with the Small Business Regulatory Enforcement Fairness Act. FDA is revising this document to provide guidance intended to help any entity comply with the requirements pertaining to registration of food facilities in the FD&C Act, including the amendments made by FSMA. This document continues to serve as FDA's Small Entity Compliance Guide for FDA's food facility registration regulation. Further, this guidance is intended to set forth in plain language the requirements for registration of food facilities and help small businesses understand the requirements.
Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability
The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products,'' which explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.
Compliance Policy Guide; Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs; Notice To Extend Expiration Date
The Food and Drug Administration (FDA) is extending the expiration date of compliance policy guide (CPG) Sec. 400.210 entitled ``Radiofrequency Identification (RFID) Feasibility Studies and Pilot Programs for Drugs'' to December 31, 2014.
Notice of Intent To Prepare an Environmental Impact Statement, Public Scoping Meeting, and Request for Comments; 2015-2025 Facilities Master Plan for Edward R. Roybal Campus in Atlanta, GA
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) announces its intent to prepare an Environmental Impact Statement (EIS) for the proposed 2015-2025 Facilities Master Plan for HHS/CDC's Edward R. Roybal Campus located at 1600 Clifton Road NE., in Atlanta, Georgia. This announcement follows the requirements of the National Environmental Policy Act of 1969 (NEPA) as implemented by the Council on Environmental Quality (CEQ) Regulations (40 CFR Part 1500-1508); and, the Department of Health and Human Services (HHS) General Administration Manual Part 30 Environmental Procedures, dated February 25, 2000.
Agency Information Collection Activities; Proposed Collection; Comment Request; Information To Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed revision of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information to accompany humanitarian device exemption (HDE) applications and the collection of information regarding the annual distribution number (ADN).
Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products.'' The purpose of this document is to provide guidance to industry on enrichment strategies that can be used in clinical trials intended to support effectiveness and safety claims in new drug applications (NDAs) and biologics license applications (BLAs). This document defines several types of enrichment strategies, provides examples of various potential clinical trial designs, and discusses potential regulatory considerations when using enrichment strategies in clinical trials.
Ag-Mark, Incorporated, et al.; Proposal To Withdraw Approval of New Animal Drug Applications; Opportunity for a Hearing
The Food and Drug Administration (FDA) is announcing an opportunity to request a hearing on the Agency's proposal to withdraw approval of 19 new animal drug applications (NADAs) and 1 abbreviated new animal drug application (ANADA) from multiple sponsors. The basis for the proposal is that the sponsors have repeatedly failed to file required periodic reports for these applications.
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