Department of Health and Human Services October 22, 2021 – Federal Register Recent Federal Regulation Documents

Advisory Committee on Immunization Practices (ACIP)
Document Number: 2021-23222
Type: Notice
Date: 2021-10-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. Time will be available for public comment. The meeting will be webcast live via the World Wide Web; for more information on ACIP please visit the ACIP website: http:/ /www.cdc.gov/vaccines/acip/index.html.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-23107
Type: Notice
Date: 2021-10-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Prospective Grant of Exclusive Patent Commercialization License: CD28H Domain-Containing Chimeric Antigen Receptors and Methods of Use
Document Number: 2021-23092
Type: Notice
Date: 2021-10-22
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Ankarys Therapeutics Inc., located at 110 Cumberland Street, Suite 520, M5R 3V5, Toronto, Ontario, Canada, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2021-23091
Type: Notice
Date: 2021-10-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-23090
Type: Notice
Date: 2021-10-22
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2021-23089
Type: Notice
Date: 2021-10-22
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation
Document Number: 2021-23086
Type: Notice
Date: 2021-10-22
Agency: Food and Drug Administration, Department of Health and Human Services
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 this notice. This notice solicits comments on the collection of information contained in the Public Health Service (PHS) guideline entitled ``PHS Guideline on Infectious Disease Issues in Xenotransplantation.''
Determination That ROBAXIN and ROBAXIN-750 (Methocarbamol), Oral Tablets, 500 Milligrams and 750 Milligrams, and Other Drug Products, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2021-23084
Type: Notice
Date: 2021-10-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2021-23082
Type: Notice
Date: 2021-10-22
Agency: Department of Health and Human Services, National Institutes of Health
Data Standards for Drug and Biological Product Submissions Containing Real-World Data; Draft Guidance for Industry; Availability
Document Number: 2021-23081
Type: Notice
Date: 2021-10-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Data Standards for Drug and Biological Product Submissions Containing Real- World Data.'' This guidance provides recommendations to sponsors to help support compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) when submitting study data derived from real-world data (RWD) sources in applicable regulatory submissions using standards specified in the Data Standards Catalog (Catalog). FDA is publishing this draft guidance as part of a series of guidance documents under its program to evaluate the use of real-world evidence (RWE) in regulatory decision making.
Fresenius USA, Inc., et al.; Withdrawal of Approval of 216 Abbreviated New Drug Applications
Document Number: 2021-23075
Type: Notice
Date: 2021-10-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 216 abbreviated new drug applications (ANDAs) from multiple holders of those ANDAs. The basis for the withdrawal is that these ANDA holders have repeatedly failed to submit required annual reports for those ANDAs.
Determination of Regulatory Review Period for Purposes of Patent Extension; NUBEQA
Document Number: 2021-23074
Type: Notice
Date: 2021-10-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for NUBEQA 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 human drug product.
National Eye Institute; Notice of Closed Meetings
Document Number: 2021-23045
Type: Notice
Date: 2021-10-22
Agency: Department of Health and Human Services, National Institutes of Health