Department of Health and Human Services September 19, 2017 – Federal Register Recent Federal Regulation Documents
Results 1 - 20 of 20
Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry entitled ``Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.'' This guidance is intended to assist persons making tobacco product establishment registration and product listing submissions to FDA.
Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access; Public Meeting; Request for Comments; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the public meeting on ``Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access'' for which the notice of public meeting appeared in the Federal Register of June 22, 2017. In the notice of public meeting, FDA requested comments concerning administration of the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to help ensure that the intended balance between encouraging innovation in drug development and accelerating the availability to the public of lower cost alternatives to innovator drugs is maintained. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study on Warning Statements for Cigarette Graphic Health Warnings
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.
Flavor Developer and Manufacturer Site Tours Program
The Food and Drug Administration (FDA), Center for Tobacco Products (CTP), is announcing an invitation for participation in its voluntary Flavor Developer and Manufacturer Site Tours Program. This program is intended to give CTP staff an opportunity to visit companies that develop and/or manufacture flavors (including flavor mixtures) that are sold to tobacco product manufacturers in order to gain a better understanding of the development, testing, and production of flavors and flavor mixtures used in the manufacturing of tobacco products. The site tours in this program are not intended as regulatory inspections. The purpose of this notice is to invite parties interested in participating in the Flavor Developer and Manufacturer Site Tours Program to submit requests to CTP.
Agency Information Collection Activities; Proposed Collection; Comment Request; Establishing and Maintaining Lists of United States Manufacturers/Processors With Interest in Exporting Center for Food Safety and Applied Nutrition-Regulated Products to China
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions found in the guidance entitled ``Establishing and Maintaining a List of U.S. Milk and Milk Product, Seafood, Infant Formula, and Formula for Young Children Manufacturers/Processors with Interest in Exporting to China: Guidance for Industry.''
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the ``Leveraging the Emerging Field of Disaster Citizen Science to Enhance Community Resilience to Improve Disaster Response'' project. This project will include individual and group interviews of citizen scientists and their partners and will field a nationally representative survey of local health departments to understand experiences and perceptions of citizen science for disaster preparedness.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
