Department of Health and Human Services November 1, 2021 – Federal Register Recent Federal Regulation Documents
Results 1 - 17 of 17
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.
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water
The Food and Drug Administration (FDA, Agency, or we) 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 procedure by which both domestic and foreign bottled water manufacturers that sell bottled water in the United States maintain records of microbiological testing and corrective measures, in addition to existing recordkeeping requirements.
Agency Information Collection Activities; Proposed Collection; Comment Request; Text Analysis of Proprietary Drug Name Interpretations
The Food and Drug Administration (FDA, Agency, or we) 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed study entitled ``Text Analysis of Proprietary Drug Name Interpretations.''
Allergan Sales, LLC, et al.; Withdrawal of Approval of 18 New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 18 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Submission for OMB Review; Data Collection for the Integrating Financial Capability and Employment Services Project (New Collection)
The Office of Planning, Research, and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing a data collection activity as part of the Integrating Financial Capability and Employment Services Project. The objective of this project is to better understand financial capability interventions offered in the context of delivering employment and training services for low-income adults. This descriptive study intends to use this information to build more evidence about the extent, forms, and practices of incorporating financial capability interventions into organizations delivering employment and training services for low-income adult populations, and to help establish a basis for future research and evaluation in this area. This project will focus on organizations delivering employment and training services that also offer financial capability services to low-income adults.
Determination of Regulatory Review Period for Purposes of Patent Extension; ENHERTU
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ENHERTU and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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 biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; VYONDYS 53
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VYONDYS 53 and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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.
Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act.'' This draft guidance addresses the process through which registrants of drug establishments should submit to FDA reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Determination of Regulatory Review Period for Purposes of Patent Extension; SPINRAZA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SPINRAZA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claims that human drug product.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Family-to-Family Health Information Center Feedback Surveys, OMB #: 0906-0040, Extension
In compliance with the requirement for opportunity for public comment on proposed data collection of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).
World Trade Center Health Program Scientific/Technical Advisory Committee (WTCHP STAC)
In accordance with the Federal Advisory Committee Act, CDC announces the following virtual meeting for the World Trade Center Health Program Scientific/Technical Advisory Committee (WTCHP STAC). A notice of this WTCHP STAC meeting has also been posted on the committee website at: https://www.cdc.gov/wtc/stac_meeting.html.
Submission for OMB Review; ACF-901-American Rescue Plan (ARP) Stabilization Grants Provider-Level Data (New Collection)
The Office of Child Care, Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new collection, ACF-901American Rescue Plan (ARP) Stabilization Grants Provider-Level Data. The data collection will provide numbers and characteristics of child care providers receiving ARP Act stabilization grant awards.
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