Department of Health and Human Services – Federal Register Recent Federal Regulation Documents

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Meeting of the COVID-19 Health Equity Task Force
Document Number: 2021-12320
Type: Notice
Date: 2021-06-11
Agency: Department of Health and Human Services
As required by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the COVID-19 Health Equity Task Force (Task Force) will hold a virtual meeting on June 25, 2021. The purpose of this meeting is to consider interim recommendations addressing the inequities and the impact of long-COVID or Post-Acute Sequelae of SARS-CoV-2 infection (PASC), and access to personal protection equipment, testing, and therapeutics that are related to this pandemic. This meeting is open to the public and will be live-streamed at www.hhs.gov/live. Information about the meeting will be posted on the HHS Office of Minority Health website: www.minorityhealth.hhs.gov/healthequitytaskforce/ prior to the meeting.
Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available as Over-the-Counter; Guidance for Industry; Availability
Document Number: 2021-12297
Type: Notice
Date: 2021-06-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a final guidance for industry (GFI) #263 entitled ``Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to Be Available as Over-the-Counter.'' This guidance document provides information to sponsors of medically important antimicrobial new animal drug products who are interested in changing the approved marketing status of these products from over-the-counter (OTC) to by veterinary prescription (Rx) consistent with FDA's recommendation that the use of such drugs in animals be limited to uses that include veterinary oversight to mitigate development of antimicrobial resistance. It also establishes timelines for stakeholders wishing to comply voluntarily with this guidance.
Determination of Regulatory Review Period for Purposes of Patent Extension; BRAVECTO; Correction
Document Number: 2021-12284
Type: Notice
Date: 2021-06-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) published a notice in the Federal Register of February 12, 2018. After review of a timely request for reconsideration by the applicant of the determination of the regulatory review period of the animal drug, BRAVECTO, in that notice, FDA has determined that a revision of the SUPPLEMENTARY INFORMATION section is warranted. This document presents the revised regulatory review period.
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2021-12266
Type: Notice
Date: 2021-06-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Study of Disclosures to Healthcare Providers Regarding Data That Do Not Support Unapproved Use of an Approved Prescription Drug
Document Number: 2021-12265
Type: Notice
Date: 2021-06-11
Agency: Food and Drug Administration, Department of Health and Human Services
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 (PRA).
Agency Information Collection Activities; Proposed Collection; Comment Request; Accelerated Approval Disclosures on Direct-to-Consumer Prescription Drug Websites
Document Number: 2021-12264
Type: Notice
Date: 2021-06-11
Agency: Food and Drug Administration, Department of Health and Human Services
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 the proposed study entitled ``Accelerated Approval Disclosures on Direct-to-Consumer Prescription Drug websites.''
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Under the Federal Import Milk Act
Document Number: 2021-12263
Type: Notice
Date: 2021-06-11
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices
Document Number: 2021-12259
Type: Notice
Date: 2021-06-11
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications
Document Number: 2021-12256
Type: Notice
Date: 2021-06-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) 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.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2021-12235
Type: Notice
Date: 2021-06-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice of Closed Meeting
Document Number: 2021-12234
Type: Notice
Date: 2021-06-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2021-12233
Type: Notice
Date: 2021-06-11
Agency: Department of Health and Human Services, National Institutes of Health
Milk and Cream Products and Yogurt Products; Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt
Document Number: 2021-12220
Type: Rule
Date: 2021-06-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is issuing a final rule to revoke the standards of identity for lowfat yogurt and nonfat yogurt and amend the standard of identity for yogurt in numerous respects. This action is in response, in part, to a citizen petition submitted by the National Yogurt Association (NYA). The final rule modernizes the yogurt standard to allow for technological advances while preserving the basic nature and essential characteristics of yogurt and promoting honesty and fair dealing in the interest of consumers.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice for Finished Pharmaceuticals, Including Medical Gases, and Active Pharmaceutical Ingredients
Document Number: 2021-12214
Type: Notice
Date: 2021-06-10
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-12211
Type: Notice
Date: 2021-06-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Program Evaluation of CDC's Core State Injury Prevention Program. The proposed project is intended to assess both recipient-level and program-level outcomes associated with the NCIPC's Core SIPP funded state injury prevention program.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2021-12210
Type: Notice
Date: 2021-06-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled The National Survey of Family Growth (NSFG), designed to provide nationally representative, scientifically credible data on factors related to birth and pregnancy rates, family formation and dissolution patterns, and reproductive health.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-12208
Type: Notice
Date: 2021-06-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Determination of Regulatory Review Period for Purposes of Patent Extension; EVENITY
Document Number: 2021-12199
Type: Notice
Date: 2021-06-10
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 EVENITY 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.
Electronic Study Data Submission; Data Standards; Support and Requirement Begin for Study Data Tabulation Model Version 1.8 With Standard for Exchange of Nonclinical Data Implementation Guide-Animal Rule Version 1.0; Correction
Document Number: 2021-12198
Type: Notice
Date: 2021-06-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a document that appeared in the Federal Register on March 11, 2020. The document announced that FDA will begin supporting the Clinical Data Interchange Standards Consortium (CDISC) for Study Data Tabulation Model version 1.8 (SDTM v1.8), and CDISC Standard for Exchange of Nonclinical Data Implementation GuideAnimal Rule version 1.0 (SENDIG- AR v1.0) on March 15, 2020, and that these new standards will be required in submissions to FDA effective March 15, 2022. The document omitted the 36-month implementation period for certain investigational new drugs applications (INDs) as required by the guidance for industry entitled ``Providing Regulatory Submissions in Electronic Format Standardized Study Data'' which is referenced in that document. This document corrects that error.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Investigational Use
Document Number: 2021-12197
Type: Notice
Date: 2021-06-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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; SPRAVATO
Document Number: 2021-12193
Type: Notice
Date: 2021-06-10
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 SPRAVATO 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; OPTIMIZER
Document Number: 2021-12192
Type: Notice
Date: 2021-06-10
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 OPTIMIZER 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 medical device.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry and Food and Drug Administration Staff-Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Principle
Document Number: 2021-12191
Type: Notice
Date: 2021-06-10
Agency: Food and Drug Administration, Department of Health and Human Services
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; SARCLISA
Document Number: 2021-12189
Type: Notice
Date: 2021-06-10
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 SARCLISA 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; National Agriculture and Food Defense Strategy Survey
Document Number: 2021-12188
Type: Notice
Date: 2021-06-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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.
Government-Owned Inventions; Availability for Licensing
Document Number: 2021-12182
Type: Notice
Date: 2021-06-10
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
Document Number: 2021-12181
Type: Notice
Date: 2021-06-10
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
Document Number: 2021-12179
Type: Notice
Date: 2021-06-10
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Advisory Committee; Medical Imaging Drugs Advisory Committee; Renewal
Document Number: 2021-12174
Type: Notice
Date: 2021-06-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of the Medical Imaging Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Medical Imaging Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the May 18, 2023, expiration date.
Determination of Regulatory Review Period for Purposes of Patent Extension; MAYZENT
Document Number: 2021-12171
Type: Notice
Date: 2021-06-10
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 MAYZENT 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; XPOVIO
Document Number: 2021-12167
Type: Notice
Date: 2021-06-10
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 XPOVIO 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.
Core Patient-Reported Outcomes in Cancer Clinical Trials; Draft Guidance for Industry; Availability
Document Number: 2021-12166
Type: Notice
Date: 2021-06-10
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 ``Core Patient-Reported Outcomes in Cancer Clinical Trials.'' This draft guidance provides recommendations to sponsors regarding the collection of a core set of patient-reported clinical outcomes in cancer clinical trials and related considerations for instrument selection and trial design. This guidance focuses on patient-reported outcome (PRO) measures and is specific to registration trials for anti-cancer therapies intended to demonstrate an effect on survival, tumor response, or delay in the progression of a malignancy. The draft guidance recommendations supplement previous guidance on use of PRO measures in clinical trials by providing additional considerations specific to the cancer clinical trial setting. The draft guidance is intended to facilitate generation of high-quality data on a core set of patient-reported symptom and functional impacts that are important contributors to a patient's health-related quality of life.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2021-12156
Type: Notice
Date: 2021-06-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Bureau of Primary Health Care-Program Management Resource Compendium, 0906-XXXX, New
Document Number: 2021-12150
Type: Notice
Date: 2021-06-10
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; WAKIX
Document Number: 2021-12148
Type: Notice
Date: 2021-06-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined the regulatory review period for WAKIX 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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-12144
Type: Notice
Date: 2021-06-10
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2021-12142
Type: Notice
Date: 2021-06-10
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2021-12141
Type: Notice
Date: 2021-06-10
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2021-12140
Type: Notice
Date: 2021-06-10
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2021-12139
Type: Notice
Date: 2021-06-10
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2021-12138
Type: Notice
Date: 2021-06-10
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request; 30-Day Public Comment Request
Document Number: 2021-12113
Type: Notice
Date: 2021-06-10
Agency: Department of Health and Human Services
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2021-12094
Type: Notice
Date: 2021-06-09
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2021-12093
Type: Notice
Date: 2021-06-09
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2021-12092
Type: Notice
Date: 2021-06-09
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung and Blood Institute; Notice of Closed Meeting
Document Number: 2021-12091
Type: Notice
Date: 2021-06-09
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Evaluation of the Family Unification Program-Extension (OMB #0970-0514)
Document Number: 2021-12074
Type: Notice
Date: 2021-06-09
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) requests an extension to continue data collection for the Evaluation of the Family Unification Program (FUP) (OMB #0970- 0514). Information collection activities requested include interviews, focus group discussions, program data, and administrative data collection.
Proposed Information Collection Activity; “State SNAP Agency NDNH Matching Program Performance Report” (OMB No.: 0970-0464)
Document Number: 2021-12057
Type: Notice
Date: 2021-06-09
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF) is requesting the federal Office of Management and Budget (OMB) approve the ``State SNAP Agency NDNH Matching Program Performance Report,'' with minor revisions, for an additional three years. State agencies administering their Supplemental Nutrition Assistance Program (SNAP) provide the annual performance report to OCSE in accordance with the computer matching agreement between state SNAP agencies and OCSE. The current OMB approval expires on February 28, 2022.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2021-12033
Type: Notice
Date: 2021-06-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2021-12030
Type: Notice
Date: 2021-06-09
Agency: Department of Health and Human Services, National Institutes of Health