Department of Health and Human Services November 10, 2020 – Federal Register Recent Federal Regulation Documents
Results 1 - 8 of 8
Special Considerations, Incentives, and Programs To Support the Approval of New Animal Drugs for Minor Uses and for Minor Species; Draft Guidance for Industry; Availability; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of July 15, 2020. In that notice, FDA requested comments on draft guidance for industry (GFI) #61 entitled ``Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species.'' FDA 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: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 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 the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Regulatory Considerations for Microneedling Products; 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 ``Regulatory Considerations for Microneedling Products.'' This guidance is being issued to assist industry in understanding when a microneedling product is a device as defined in the Federal Food, Drug, and Cosmetic Act (FD&C Act). This document also provides information on the regulatory pathway to market for microneedling devices for aesthetic use.
Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017; Revised Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a revised final guidance for industry entitled ``Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017,'' which supersedes the now withdrawn final guidance issued in May 2018 (May 2018 guidance). This revised final guidance concerns FDA's implementation of the Prescription Drug User Fee Amendments of 2017. In particular, this revised final guidance removes section VI.B. contained in the May 2018 guidance, regarding the ``same product as another product'' prescription drug program fee exception for certain prescription drug products under the Federal Food, Drug, and Cosmetic Act.
Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Enhancing the Diversity of Clinical Trial PopulationsEligibility Criteria, Enrollment Practices, and Trial Designs.'' This guidance recommends approaches that sponsors of clinical trials intended to support a new drug application or a biologics license application can take to increase enrollment of underrepresented populations in their clinical trials. This guidance is being issued, in part, to satisfy the mandates of the FDA Reauthorization Act of 2017 (FDARA). This guidance finalizes the draft guidance of the same title issued on June 7, 2019.
Acquisition Regulations; Buy Indian Act; Procedures for Contracting
The United States Department of Health and Human Services (HHS) is proposing to issue regulations guiding implementation of the Buy Indian Act, which provides IHS with authority to set-aside procurement contracts for Indian-owned and controlled businesses.
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