Department of Health and Human Services 2020 – Federal Register Recent Federal Regulation Documents

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Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-28982
Type: Notice
Date: 2020-12-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Requirement for Negative Pre-Departure COVID-19 Test Result for All Airline Passengers Arriving Into the United States From the United Kingdom
Document Number: 2020-28981
Type: Notice
Date: 2020-12-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), a component of the U.S. Department of Health and Human Services (HHS), announces an Agency Order requiring negative pre-departure COVID-19 test results for all airline passengers arriving into the United States from the United Kingdom (UK). This Order is issued to preserve human life; prevent the further introduction, transmission, and spread of the virus that causes COVID-19 into the United States, including new virus variants; preserve the health and safety of airline crew members, passengers, airport personnel, and communities; and preserve hospital, healthcare, and emergency response resources within the United States.
Updates to the Bright Futures Periodicity Schedule
Document Number: 2020-28971
Type: Notice
Date: 2020-12-31
Agency: Department of Health and Human Services, Health Resources and Service Administration
Effective December 28, 2020, HRSA accepted a recommended update to the Bright Futures Periodicity Schedule, a HRSA-supported guideline for infants, children and adolescents, for purposes of health insurance coverage without cost sharing under the Public Health Service (PHS) Act. The update includes screening for Hepatitis C Virus Infection for individuals ages 18 to 21. Please see https:// mchb.hrsa.gov/maternal-child-health-topics/child-health/brigh t- futures.html for additional information.
Reimbursement Rates for Calendar Year 2021
Document Number: 2020-28950
Type: Notice
Date: 2020-12-31
Agency: Department of Health and Human Services, Indian Health Service
Notice is provided that the Director of the Indian Health Service has approved the rates for inpatient and outpatient medical care provided by IHS facilities for Calendar Year 2021.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-28936
Type: Notice
Date: 2020-12-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2020-28935
Type: Notice
Date: 2020-12-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Meeting
Document Number: 2020-28934
Type: Notice
Date: 2020-12-31
Agency: Department of Health and Human Services, National Institutes of Health
Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final Monograph Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; Availability
Document Number: 2020-28929
Type: Notice
Date: 2020-12-31
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 final guidance for industry entitled ``Consumer Antiseptic Rub Final Rule Questions and Answers.'' We are issuing this guidance in accordance with the Small Business Regulatory Enforcement Fairness Act to help small businesses understand and comply with the Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final Monograph (Consumer Antiseptic Rub FR). In the Consumer Antiseptic Rub FR, FDA established that 28 active ingredients used in nonprescription (also known as over-the-counter (OTC)) consumer antiseptic products intended for use without water (consumer antiseptic rubs) are not eligible for evaluation under FDA's OTC Drug Review, which was used to evaluate the safety and effectiveness of OTC drug products marketed in the United States on or before May 1972. The Consumer Antiseptic Rub FR also established that three active ingredients used in consumer antiseptic rubs are eligible for evaluation under the OTC Drug Review and granted requests to temporarily defer further rulemaking on these three eligible ingredients to allow for the development and submission of new safety and effectiveness data.
Submission for OMB Review; Generic Clearance for the Comprehensive Child Welfare Information System (CCWIS) Review and Technical Assistance Process (New Collection)
Document Number: 2020-28925
Type: Notice
Date: 2020-12-31
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 proposing to establish a generic clearance to collect information to assess regulatory requirements of title IV-E agencies' Comprehensive Child Welfare Information System (CCWIS) and ensure that the CCWIS is utilized for purposes consistent with the efficient, economical, and effective administration of the title IV-B and IV-E plans. The information collected is intended to be used for review and technical assistance processes.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2020-28921
Type: Notice
Date: 2020-12-31
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Meeting of the National Advisory Council on Nurse Education and Practice
Document Number: 2020-28920
Type: Notice
Date: 2020-12-31
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act, this notice announces that the National Advisory Council on Nurse Education and Practice (NACNEP) will hold public meetings for the 2021 calendar year (CY). Information about NACNEP, agendas, and materials for these meetings can be found on the NACNEP website at https://www.hrsa.gov/ advisory-committees/nursing/.
Meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry
Document Number: 2020-28919
Type: Notice
Date: 2020-12-31
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD) will hold public meetings for the 2021 calendar year (CY). Information about ACTPCMD, agendas, and materials for these meetings can be found on the ACTPCMD website at https://www.hrsa.gov/advisory-committees/primarycare-dentist/ index.html.
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
Document Number: 2020-28903
Type: Notice
Date: 2020-12-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Meeting
Document Number: 2020-28902
Type: Notice
Date: 2020-12-31
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Secure Electronic Prior Authorization For Medicare Part D
Document Number: 2020-28877
Type: Rule
Date: 2020-12-31
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule names a new transaction standard for the Medicare Prescription Drug Benefit program's (Part D) e-prescribing program as required by the ``Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act'' or the ``SUPPORT Act.'' Under the SUPPORT Act, the Secretary is required to adopt standards for the Part D e-prescribing program to ensure secure electronic prior authorization request and response transmissions. In this final rule, we amend the Part D e- prescribing regulations to require Part D plan sponsors' support of version 2017071 of the National Council for Prescription Drug Programs (NCPDP) SCRIPT standard for use in certain electronic Prior Authorization (ePA) transactions with prescribers regarding Part D- covered drugs to Part D-eligible individuals.
Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements
Document Number: 2020-28567
Type: Rule
Date: 2020-12-31
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule will advance CMS' efforts to support state flexibility to enter into innovative value-based purchasing arrangements (VBPs) with manufacturers, and to provide manufacturers with regulatory support to enter into VBPs with payers, including Medicaid. To ensure that the regulatory framework is sufficient to support such arrangements and to promote transparency, flexibility, and innovation in drug pricing without undue administrative burden, we are finalizing new regulatory policies and clarifying certain already established policies to assist manufacturers and states in participating in VBPs in a manner that is consistent with the law and maintains the integrity of the Medicaid Drug Rebate Program (MDRP). This final rule also revises regulations regarding: Authorized generic sales when manufacturers calculate average manufacturer price (AMP) for the brand name drug; pharmacy benefit managers (PBM) accumulator programs and their impact on AMP and best price when manufacturer- sponsored assistance is not passed through to the patient; state and manufacturer reporting requirements to the MDRP; new Medicaid Drug Utilization Review (DUR) provisions designed to reduce opioid related fraud, misuse and abuse; the definitions of CMS-authorized supplemental rebate agreement, line extension, new formulation, oral solid dosage form, single source drug, multiple source drug, innovator multiple source drug for purposes of the MDRP; payments for prescription drugs under the Medicaid program; and coordination of benefits (COB) and third party liability (TPL) rules related to the special treatment of certain types of care and payment in Medicaid and Children's Health Insurance Program (CHIP).
Proposed Information Collection Activity; OPRE Data Collection for Supporting Youth To Be Successful in Life (SYSIL) (New Collection)
Document Number: 2020-28886
Type: Notice
Date: 2020-12-30
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) is requesting approval from the Office of Management and Budget (OMB) for a new data collection. The Supporting Youth to be Successful in Life study (SYSIL) will build evidence on how to end homelessness among youth and young adults with experience in the child welfare system by continuing work with an organization who conducted foundational work as part of the Youth At-Risk of Homelessness project (OMB Control Number: 0970-0445). SYSIL will provide important information to the field by designing and conducting a federally led evaluation of a comprehensive service model for youth at risk of homelessness.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2020-28851
Type: Notice
Date: 2020-12-30
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.
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2020-28842
Type: Notice
Date: 2020-12-30
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2020-28841
Type: Notice
Date: 2020-12-30
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2020-28840
Type: Notice
Date: 2020-12-30
Agency: Department of Health and Human Services, National Institutes of Health
Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee
Document Number: 2020-28833
Type: Notice
Date: 2020-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC) in the Center for Devices and Radiological Health. Nominations will be accepted for current and upcoming vacancies effective with this notice. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
Product Labeling for Laparoscopic Power Morcellators; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2020-28816
Type: Notice
Date: 2020-12-30
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 final guidance entitled ``Product Labeling for Laparoscopic Power Morcellators.'' This guidance updates recommended ``Contraindications'' and ``Warnings'' information to be included in product labeling to reflect the state of the science and available technology regarding use of laparoscopic power morcellators (LPMs). These labeling recommendations are intended to enhance, but not replace, the physician-patient discussion of the benefits and risks of use of LPMs that uniquely pertain to individual patients.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2020-28795
Type: Notice
Date: 2020-12-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Implementation of Executive Order on Access to Affordable Life-Saving Medications
Document Number: 2020-28483
Type: Rule
Date: 2020-12-23
Agency: Department of Health and Human Services
This final rule implements an Executive Order requiring entities funded under section 330(e) of the Public Health Service Act (PHS Act or the Act), whether by receiving a federal award or a subaward, and that also participate in the 340B Drug Pricing Program (340B Program) must establish practices to provide access to insulin and injectable epinephrine to low-income health center patients at the price the health center purchased these two drugs through the 340B Program. The Executive Order supports the improved access to these life-saving medications by low-income individuals who do not have access to affordable insulin and injectable epinephrine due to either lack of insurance or high cost sharing requirements.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meetings
Document Number: 2020-28399
Type: Notice
Date: 2020-12-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
Document Number: 2020-28398
Type: Notice
Date: 2020-12-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Meeting
Document Number: 2020-28397
Type: Notice
Date: 2020-12-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Meeting
Document Number: 2020-28396
Type: Notice
Date: 2020-12-23
Agency: Department of Health and Human Services, National Institutes of Health
Solicitation of Nominations for Appointment to the Advisory Committee on Breast Cancer in Young Women (ACBCYW)
Document Number: 2020-28380
Type: Notice
Date: 2020-12-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the ACBCYW. The ACBCYW consists of 15 experts in fields associated with breast cancer, disease prevention, early detection, diagnosis, public health, social marketing, genetic screening and counseling, treatment, rehabilitation, palliative care, and survivorship in young women, or in related disciplines with a specific focus on young women.
Advisory Board on Radiation and Worker Health (ABRWH), Subcommittee on Dose Reconstruction Review (SDRR), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2020-28379
Type: Notice
Date: 2020-12-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Subcommittee for Dose Reconstruction Review Subcommittee (SDRR) of the Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcomed to listen to the meeting by joining the audio conference (information below). The audio conference line has 150 ports for callers.
Advisory Board on Radiation and Worker Health (ABRWH), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2020-28378
Type: Notice
Date: 2020-12-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board). This meeting is open to the public, limited only by the space available. The audio conference line has 150 ports for callers. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the teleconference (information below).
Advisory Board on Radiation and Worker Health (ABRWH), Subcommittee for Procedure Reviews (SPR), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2020-28377
Type: Notice
Date: 2020-12-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Subcommittee for Procedure Reviews (SPR) of the Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcomed to listen to the meeting by joining the audio conference (information below). The audio conference line has 150 ports for callers.
Extension of Designation of Scarce Materials or Threatened Materials Subject to COVID-19 Hoarding Prevention Measures; Correction of Extension Date
Document Number: 2020-28374
Type: Notice
Date: 2020-12-23
Agency: Department of Health and Human Services, Office of the Secretary
This document updates the July 30, 2020, Federal Register Notice entitled ``Extension of Designation of Scarce Materials or Threatened Materials Subject to COVID-19 Hoarding Prevention Measures,'' by revising the last sentence in the ``Summary'' section.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2020-28369
Type: Notice
Date: 2020-12-23
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 (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.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2020-28360
Type: Notice
Date: 2020-12-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings
Document Number: 2020-28358
Type: Notice
Date: 2020-12-23
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2020-28357
Type: Notice
Date: 2020-12-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2020-28356
Type: Notice
Date: 2020-12-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2020-28355
Type: Notice
Date: 2020-12-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Meeting
Document Number: 2020-28354
Type: Notice
Date: 2020-12-23
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Feed Directive
Document Number: 2020-28353
Type: Notice
Date: 2020-12-23
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 the notice. This notice solicits comments on veterinary feed directive regulation.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2020-28351
Type: Notice
Date: 2020-12-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2020-28350
Type: Notice
Date: 2020-12-23
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Drugs
Document Number: 2020-28349
Type: Notice
Date: 2020-12-23
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.
Hospira, Inc., et al.; Withdrawal of Approval of 27 New Drug Applications
Document Number: 2020-28346
Type: Notice
Date: 2020-12-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 27 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.
Endo Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for OPANA (Oxymorphone Hydrochloride) Extended-Release Tablets
Document Number: 2020-28283
Type: Notice
Date: 2020-12-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of the new drug application (NDA) for OPANA (oxymorphone hydrochloride) extended-release (ER) tablets (NDA 201655), held by Endo Pharmaceuticals, Inc., 1400 Atwater Dr., Malvern, PA 19355 (Endo). Endo requested that the approval of this application be withdrawn and has waived its opportunity for a hearing.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2020-28276
Type: Notice
Date: 2020-12-23
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2020-28224
Type: Notice
Date: 2020-12-23
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 (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; Annual Statistical Report on Children in Foster Homes and Children in Families Receiving Payment in Excess of the Poverty Income Level From a State Program Funded Under Part A of Title IV of the Social Security Act
Document Number: 2020-28252
Type: Notice
Date: 2020-12-22
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Family Assistance (OFA), Administration for Children and Families, is requesting a 3-year extension of the form ACF-4125: Annual Statistical Report on Children in Foster Homes and Children in Families Receiving Payment in Excess of the Poverty Income Level from a State Program Funded Under Part A of Title IV of the Social Security Act (OMB #0970-0004, expiration 3/21/2021). There are no changes requested to the form.
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