Department of Health and Human Services June 29, 2016 – Federal Register Recent Federal Regulation Documents
Results 1 - 8 of 8
National Institutes of Health, Precision Medicine Initiative® (PMI) Cohort Program; Notice of Meeting
Pursuant to the NIH Reform Act of 2006 (42 U.S.C. 281(d)(4)), notice is hereby given that the National Institutes of Health (NIH), Precision Medicine Initiative[supreg] (PMI) Cohort Program will host two (2) teleconferences to enable public discussion of its proposal to align the authority and responsibility for the execution of PMI Cohort Program by establishing this program within the NIH Office of the Director, and reporting to the NIH Director.
Gifts to the Food and Drug Administration: Evaluation and Acceptance: Draft Guidance for the Public and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for the public and FDA staff entitled ``Gifts to FDA: Evaluation and Acceptance.'' The Secretary of the Department of Health and Human Services (HHS) has the authority to accept conditional or unconditional gifts on behalf of the United States. The Secretary has delegated this gift authority to the Commissioner of Food and Drugs. This guidance provides the process and principles we will use in implementing this authority.
Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in Food and Drug Administration Advisory Committees; Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees; Guidance for the Public, FDA Advisory Committee Members, and FDA Staff.'' This draft guidance addresses FDA's process, under Government-wide Federal regulations, for evaluating whether an advisory committee member has an appearance issue that raises concerns about the member's participation in an advisory committee meeting and describes FDA's process for determining whether to authorize a member with an appearance issue to participate in the advisory committee meeting. This draft guidance is not final nor is it in effect at this time. FDA is also requesting comment on whether FDA should request that each advisory committee member who has an appearance issue and who has received an authorization from FDA to participate in an advisory committee meeting voluntarily publicly disclose the authorization.
Medical Devices; General and Plastic Surgery Devices; Classification of the Electrosurgical Device for Over-the-Counter Aesthetic Use
The Food and Drug Administration (FDA) is classifying the electrosurgical device for over-the-counter aesthetic use into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the electrosurgical device for over-the-counter aesthetic use's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Microbiology Devices Panel of the Medical Devices
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to the Agency on FDA's regulatory issues. At least one portion of the meeting will be closed to the public.
Agency Information Collection Activities; Proposed Collection; Public Comment Request; Senior Medicare Patrol (SMP) Program National Beneficiary Survey
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on ACL's intention to collect information from the public related to the Senior Medicare Patrol (SMP) Program. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
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