Department of Health and Human Services February 29, 2016 – Federal Register Recent Federal Regulation Documents
Results 1 - 17 of 17
Issuance of Final Publication
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), announces the availability of the following publication: NIOSH Criteria for a Recommended Standard: Occupational Exposure to Heat and Hot Environments [2016-106].
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food and Drug Administration's Research and Evaluation Survey for the Public Education Campaign on Tobacco Among LGBT (RESPECT)
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Food and Drug Administration's Research and Evaluation Survey for the Public Education Campaign on Tobacco among LGBT (RESPECT)'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Draft Food and Drug Administration Tribal Consultation Policy; Availability; Request for Comments
The Food and Drug Administration (FDA or we) is announcing the availability of the draft FDA Tribal Consultation Policy. We are also announcing the establishment of a docket to receive comments on the draft FDA Tribal Consultation Policy. The purpose of the FDA Tribal Consultation Policy, when finalized, is to establish clear policies to further the government-to-government relationship between FDA and American Indian and Alaskan Native Tribes (hereafter, Indian Tribes) and facilitate tribal consultation with FDA. The draft FDA Tribal Consultation Policy provides background on FDA's mission and organizational structure and sets out principles and guidelines for the tribal consultation process.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Additive Petitions and Investigational Food Additive Exemptions
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Requirements for Transactions With First Responders Under Section 582 of the Federal Food, Drug, and Cosmetic Act-Compliance Policy; Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic ActCompliance Policy.'' This guidance describes FDA's compliance policy regarding certain requirements in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) for trading partners engaged in transactions with first responders. This compliance policy is in effect until further notice by FDA.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Reporting; Electronic Submissions
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products and Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products and Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Medical Devices-Quality Systems Survival: Success Strategies for Production and Process Controls/Corrective and Preventative Action; Public Workshop
The Food and Drug Administration (FDA), Office of Regulatory Affairs, Southwest Regional Office, in co-sponsorship with the FDA Medical Device Industry Coalition, Inc. (FMDIC), is announcing a public workshop entitled ``Medical DevicesQuality Systems Survival: Success Strategies for Production and Process Controls/Corrective and Preventative Action''. The public workshop is intended to seek input from representatives of medical device manufacturers and other stakeholders, on best practices, what has worked for them and what FDA can do to inspire quality efforts. This event will also focus on various topics of interest for those industry representatives who are responsible to insure compliance with FDA regulations.
Agency Information Collection Activities; Proposed Collection; Comment Request; National Direct-to-Consumer Advertising Survey
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled, ``National Direct-to- Consumer Advertising Survey.'' The objective of this research is to survey the public about their experiences with and attitudes toward direct-to-consumer (DTC) advertising of prescription drugs.
Basic Health Program; Federal Funding Methodology for Program Years 2017 and 2018
This document provides the methodology and data sources necessary to determine Federal payment amounts made in program years 2017 and 2018 to states that elect to establish a Basic Health Program under the Affordable Care Act to offer health benefits coverage to low- income individuals otherwise eligible to purchase coverage through Affordable Insurance Exchanges (hereinafter referred to as the Exchanges).
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