Department of Health and Human Services August 11, 2023 – Federal Register Recent Federal Regulation Documents
Results 1 - 15 of 15
Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle
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 of existing FDA regulations concerning FDA-regulated human food, including dietary supplements, and cosmetics manufactured from, processed with, or otherwise containing material derived from cattle.
Postmarketing Approaches To Obtain Data on Under-Represented Populations in Clinical Trials; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Postmarketing Approaches to Obtain Data on Under-Represented Populations in Clinical Trials.'' The purpose of this draft guidance is to describe FDA requirements and provide recommendations for obtaining safety and effectiveness information on drug and biological products, when appropriate, in the postmarketing setting in historically under- represented patient populations in clinical trials.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Reports of Corrections and Removals
The Food and Drug Administration (FDA, Agency, or we) 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.
Determination That ANJESO (Meloxicam) Solution, 30 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that ANJESO (meloxicam) solution, 30 milligrams (mg)/ milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for meloxicam solution, 30 mg/mL, if all other legal and regulatory requirements are met.
Classification Categories for Certain Supplements Under the Biosimilar User Fee Amendments of 2022; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Classification Categories for Certain Supplements Under BsUFA III.'' This draft guidance provides recommendations for applicants and FDA review staff on classification categories A, B, C, D, E, and F for original and resubmitted prior approval supplements submitted to approved applications under the Public Health Service Act (PHS Act). The commitment letter associated with the Biosimilar User Fee Amendments of 2022 (BsUFA III) sets forth these supplement classification categories and their associated review performance goals. This draft guidance is intended to help applicants identify the appropriate classification category and review goal date of the supplement being submitted.
Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.'' This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar or interchangeable biosimilar products regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). This draft guidance for industry revises and replaces the draft guidance of the same name issued in June 2018.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug and Animal Generic Drug User Fee Submissions
The Food and Drug Administration (FDA or we) 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; Vercise Genus Deep Brain Stimulation System
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VERCISE GENUS DEEP BRAIN STIMULATION SYSTEM (VERCISE GENUS DBS SYSTEM) and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Prospective Grant of an Exclusive Patent License: Manufacture, Distribution, Sale and Use of T-Cell-Based Immunotherapies for Solid Tumors
The Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Cancer Institute, both institutes of the National Institutes of Health, Department of Health and Human Services, are contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to EnZeta Immunotherapies, Inc. of the State of Delaware.
Agency Information Collection Activities: Submission for OMB Review; 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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.
Proposed Information Collection Activity; Formative Data Collections for ACF Research and Evaluation (Office of Management and Budget #0970-0356)
The Administration for Children and Families (ACF) proposes to extend data collection under the existing overarching generic clearance for Formative Data Collections for ACF Research and Evaluation (Office of Management and Budget (OMB) #0970-0356). There are no changes proposed.
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