Department of Health and Human Services September 13, 2019 – Federal Register Recent Federal Regulation Documents
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Drug Vial Size Report
This notice announces the issuance of the August 2, 2019 single-source funding opportunity titled ``Drug Vial Size Report'' available solely to the Health and Medicine Division of the National Academies of Sciences, Engineering, and Medicine [the Academies] to conduct a study on the Federal healthcare costs, safety, and quality concerns associated with discarded drugs that results from weight-based dosing of medicines contained in single dose vials as stated in Senate report 114-274.
The Special 510(k) Program; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``The Special 510(k) Program.'' FDA established the Special 510(k) Program to facilitate the submission, review, and clearance of changes to a manufacturer's own legally marketed predicate device. This guidance provides the framework that FDA uses when considering whether a premarket notification (510(k)) is appropriate for review as a Special 510(k).
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services (HHS), is publishing the following summary of a proposed collection for public comment.
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