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

Results 51 - 100 of 245
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and ROBAXIN-750 (Methocarbamol), Oral Tablets, 500 Milligrams and 750 Milligrams, and Other Drug Products, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-22992
Type: Notice
Date: 2021-10-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2021-22990
Type: Notice
Date: 2021-10-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2021-22966
Type: Notice
Date: 2021-10-21
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2021-22965
Type: Notice
Date: 2021-10-21
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-22964
Type: Notice
Date: 2021-10-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2021-22956
Type: Notice
Date: 2021-10-21
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-22955
Type: Notice
Date: 2021-10-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-22954
Type: Notice
Date: 2021-10-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-22953
Type: Notice
Date: 2021-10-21
Agency: Department of Health and Human Services, National Institutes of Health
Nominations to the Presidential Advisory Council on HIV/AIDS; Solicitation of Nominations for Appointment to Presidential Advisory Council on HIV/AIDS (PACHA)
Document Number: 2021-22950
Type: Notice
Date: 2021-10-21
Agency: Department of Health and Human Services
The Office of the Assistant Secretary for Health (OASH) is seeking nominations for membership on the Presidential Advisory Council on HIV/AIDS (referred to as PACHA and/or the Council). The PACHA is a federal advisory committee within the U.S. Department of Health and Human Services (HHS). Management support for the activities of this Council is the responsibility of the OASH. The qualified individuals will be nominated to the Secretary of Health and Human Services for consideration for appointment as members of the PACHA. Members of the Council, including the Chair and or Co-Chairs, are appointed by the Secretary. Members are invited to serve on the Council for up to four- year terms. The Council was established to provide advice, information, and recommendations to the Secretary regarding programs and policies intended to promote effective prevention and care of HIV infection and AIDS. The functions of the Council are solely advisory in nature.
Agency Generic Information Collection Request; 30-Day Public Comment Request
Document Number: 2021-22946
Type: Notice
Date: 2021-10-21
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 Eye Institute; Notice of Closed Meeting
Document Number: 2021-22919
Type: Notice
Date: 2021-10-21
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2021-22918
Type: Notice
Date: 2021-10-21
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.
Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Program of All-Inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021; Extension of Timeline To Finalize a Rulemaking
Document Number: 2021-22908
Type: Proposed Rule
Date: 2021-10-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Social Security Act (the Act) requires us to publish a Medicare final rule no later than 3 years after the publication date of the proposed rule. This document announces an extension of the timeline for publication of a Medicare final rule in accordance with the Act, which allows us to extend the timeline for publication of the ``Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Program of All- inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021'' final rule under exceptional circumstances.
Proposed Collection; 60-Day Comment Request; Collection of Customer Service, Demographic, and Smoking/Tobacco Use Information From the National Cancer Institute's (NCI) Cancer Information Service (CIS)
Document Number: 2021-22875
Type: Notice
Date: 2021-10-20
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirements of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; COVID-19 Provider Relief Fund (PRF) Reporting Activities, OMB No. 0906-XXXX-New
Document Number: 2021-22831
Type: Notice
Date: 2021-10-20
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30 day comment period for this notice has closed.
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2021-22828
Type: Notice
Date: 2021-10-20
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-22827
Type: Notice
Date: 2021-10-20
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2022 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Changes to Medicaid Provider Enrollment; and Changes to the Medicare Shared Savings Program; Corrections
Document Number: 2021-22724
Type: Rule
Date: 2021-10-20
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical and typographical errors in the final rule that appeared in the August 13, 2021, issue of the Federal Register titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2022 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Changes to Medicaid Provider Enrollment; and Changes to the Medicare Shared Savings Program.''
Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2021-22612
Type: Notice
Date: 2021-10-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products.'' The FDA Reauthorization Act of 2017 (FDARA) directed FDA to update and finalize the draft guidance entitled ``Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products,'' issued on November 7, 2013. Therefore, FDA is issuing this updated draft guidance, which supersedes the November 7, 2013, draft guidance. This updated draft guidance is intended to describe hearing aids, personal sound amplification products (PSAPs), their respective intended uses, and the regulatory requirements that apply to these products. This draft guidance is not final nor is it in effect at this time.
New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
Document Number: 2021-22604
Type: Rule
Date: 2021-10-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditional new animal drug applications (cNADAs) during January, February, and March 2021. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy and readability of the regulations.
Department of Health and Human Services Proposed Repeal of HHS Rules on Guidance, Enforcement, and Adjudication Procedures
Document Number: 2021-22503
Type: Proposed Rule
Date: 2021-10-20
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS or the Department) is proposing to repeal two final rules: ``Department of Health and Human Services Good Guidance Practices,'' published in the Federal Register of December 7, 2020; and ``Department of Health and Human Services Transparency and Fairness in Civil Administrative Enforcement Actions,'' published in the Federal Register of January 14, 2021.
Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids
Document Number: 2021-22473
Type: Proposed Rule
Date: 2021-10-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or the Agency) is proposing to establish a regulatory category for over-the-counter (OTC) hearing aids and to make related amendments to update the regulatory framework for hearing aids. Specifically, we propose to define OTC hearing aids and establish applicable requirements; amend existing rules for consistency with a new OTC category; repeal the conditions for sale applicable to hearing aids; amend the existing labeling requirements for hearing aids; and update regulations relating to decisions on applications for exemption from Federal preemption that would become obsolete as a result of changes to the hearing aid requirements. This action, if finalized, would more clearly define prescription hearing aids; however, it would not change the classification of existing device types. In creating a regulatory category for OTC hearing aids and amending existing rules, we intend to provide reasonable assurance of safety and effectiveness for these devices as well as foster access to, and innovation in, hearing aid technology, thereby protecting and promoting the public health.
Performance Review Board Members
Document Number: 2021-22748
Type: Notice
Date: 2021-10-19
Agency: Department of Health and Human Services
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Rural Health Care Services Outreach Program Performance Improvement and Measurement Systems (PIMS) Measures, OMB No. 0906-0009-Revision
Document Number: 2021-22737
Type: Notice
Date: 2021-10-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: National Health Service Corps Scholar/Students to Service Travel Worksheet, OMB No. 0915-0278-Extension
Document Number: 2021-22735
Type: Notice
Date: 2021-10-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30 day comment period for this notice has closed.
National Institute of Nursing Research; Notice of Closed Meeting
Document Number: 2021-22719
Type: Notice
Date: 2021-10-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Meeting
Document Number: 2021-22718
Type: Notice
Date: 2021-10-19
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Amended Notice of Meeting
Document Number: 2021-22717
Type: Notice
Date: 2021-10-19
Agency: Department of Health and Human Services, National Institutes of Health
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-22698
Type: Notice
Date: 2021-10-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-22697
Type: Notice
Date: 2021-10-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-22696
Type: Notice
Date: 2021-10-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-22695
Type: Notice
Date: 2021-10-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Meeting for the Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC)
Document Number: 2021-22693
Type: Notice
Date: 2021-10-19
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Secretary of Health and Human Services (Secretary) announces a meeting of the Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC). The ISUDCC is open to the public and members of the public can attend the meeting via telephone or webcast only, and not in person. Agenda with call-in information will be posted on the SAMHSA website prior to the meeting at: https://www.samhsa.gov/ about-us/advisory-councils/meetings. The meeting will include information on support for the mission and work of the Committee, federal advances to address challenges in substance use disorder (SUD); non-federal advances to address challenges in SUD. Committee Name: Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC). Date/Time/Type: December 9, 2021 from 1:00 p.m. EST-5:00 p.m. EST.
Submission for OMB Review; Cost Study of Trauma-Specific Evidence-Based Programs Used in the Regional Partnership Grants Program (0970-0557)
Document Number: 2021-22677
Type: Notice
Date: 2021-10-19
Agency: Department of Health and Human Services, Administration for Children and Families
The Children's Bureau (CB), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting an extension with minor changes to the approved information collection: The Cost Study of Trauma-Specific Evidence-Based Programs used in the Regional Partnership Grants (RPG) Program. This data collection request was previously approved and scheduled for spring 2021 but was delayed due to the COVID-19 pandemic. Data collection is now feasible but will extend beyond the current expiration date of November 30, 2021, so an extension is needed. Additionally, since approval, minor changes were made to the instruments to include a question in the time log to ask about virtual service delivery since the COVID-19 pandemic resulted in grantees offering virtual services.
Paternity Establishment Percentage Performance Relief
Document Number: 2021-22553
Type: Proposed Rule
Date: 2021-10-19
Agency: Department of Health and Human Services, Administration for Children and Families
Due to the impact of the COVID-19 public health emergency on state child support program operations, the Office of Child Support Enforcement (OCSE) proposes to modify the Paternity Establishment Percentage (PEP) from the 90 percent performance threshold to 50 percent for Federal Fiscal Years (FFY) 2020 and 2021 in order for a state to avoid a financial penalty. OCSE also proposes to provide that adverse findings of data reliability audits of a state's paternity establishment data will not result in a financial penalty.
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2021-22649
Type: Notice
Date: 2021-10-18
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.
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2021-22647
Type: Notice
Date: 2021-10-18
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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-22644
Type: Notice
Date: 2021-10-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2021-22643
Type: Notice
Date: 2021-10-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Meeting
Document Number: 2021-22641
Type: Notice
Date: 2021-10-18
Agency: Department of Health and Human Services, National Institutes of Health