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

Results 151 - 200 of 245
Termination of Listing of Color Additives Exempt From Certification; Lead Acetate
Document Number: 2021-21892
Type: Rule
Date: 2021-10-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is responding to objections and a public hearing request that we received from Combe Inc., on the final rule entitled ``Termination of Listing of Color Additives Exempt From Certification; Lead Acetate,'' which published on October 31, 2018. The final rule amended the color additive regulations to no longer provide for the safe use of lead acetate in cosmetics intended for coloring hair on the scalp. After reviewing the objections, we have concluded that the objections do not raise issues of material fact that justify a hearing. Therefore, the stay of the effectiveness for the repeal and delisting of the color additive regulation is now lifted, and we are amending the color additive regulations to no longer provide for the safe use of lead acetate in cosmetics intended for coloring hair on the scalp.
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2021-22037
Type: Notice
Date: 2021-10-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. Members will participate via teleconference. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Revised Draft Guidance for Industry; Availability
Document Number: 2021-21970
Type: Notice
Date: 2021-10-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled ``Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act'' (``revised draft guidance''). This revised draft guidance, when finalized, will describe how FDA intends to apply certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to human drug products compounded by State- licensed pharmacies that are not outsourcing facilities and distributed for use within a hospital or health system. First, it addresses the requirement that compounding be based on the receipt of a valid prescription order for an identified individual patient. Second, it addresses the provision concerning compounded drug products that are essentially copies of a commercially available drug product. This draft guidance revises the draft guidance issued in 2016 entitled, ``Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act'' (``draft guidance''). FDA is revising the draft guidance to address stakeholder feedback and provide further clarification on policies regarding hospital and health system compounding. This revised draft guidance is not final nor is it in effect at this time.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-21965
Type: Notice
Date: 2021-10-07
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-21963
Type: Notice
Date: 2021-10-07
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Request for comments on the draft Department Strategic Plan for FY 2022-2026
Document Number: 2021-21939
Type: Notice
Date: 2021-10-07
Agency: Department of Health and Human Services, Office of the Secretary
The Department of Health and Human Services (HHS) is seeking public comment on its draft Strategic Plan for Fiscal Years 2022-2026 through the Department of Health and Human Services website at www.hhs.gov/about/draft-strategic-plan/index.html.
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 2021-21903
Type: Notice
Date: 2021-10-07
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meetings
Document Number: 2021-21899
Type: Notice
Date: 2021-10-07
Agency: Department of Health and Human Services, National Institutes of Health
Request for Public Comments on the Development of the 2021-2022 IACC Strategic Plan for Autism Spectrum Disorder (ASD)
Document Number: 2021-21883
Type: Notice
Date: 2021-10-07
Agency: Department of Health and Human Services, National Institutes of Health
On behalf of the Interagency Autism Coordinating Committee (IACC), the National Institute of Mental Health (NIMH) Office of Autism Research Coordination (OARC) is seeking public comments to assist the IACC in identifying priorities for the 2021-2022 update of the IACC Strategic Plan for Autism Spectrum Disorder (ASD) as required by the Autism Collaboration, Accountability, Research, Education and Support (CARES) Act of 2019. The IACC is requesting public comments on research, services, and policy issues related to the seven topics addressed by the IACC Strategic Plan: Screening and Diagnosis, Biology, Risk Factors, Treatments and Interventions, Services, Lifespan Issues, and Infrastructure and Surveillance. The IACC is also requesting information on two additional issues related to autism described in two supplemental questions that are included in this Request for Public Comment.
Ensuring Access to Equitable, Affordable, Client-Centered, Quality Family Planning Services
Document Number: 2021-21542
Type: Rule
Date: 2021-10-07
Agency: Department of Health and Human Services
The Office of Population Affairs (OPA) in the Office of the Assistant Secretary for Health issues this final rule to revise the regulations that govern the Title X family planning program (authorized by Title X of the Public Health Service Act) by readopting the 2000 regulations, with several revisions to ensure access to equitable, affordable, client-centered, quality family planning services for clients, especially low-income clients. The effect of this 2021 final rule is to revoke the requirements of the 2019 regulations, including removing restrictions on nondirective options counseling and referrals for abortion services and eliminating requirements for strict physical and financial separation between abortion-related activities and Title X project activities, thereby reversing the negative public health consequences of the 2019 regulations. OPA also makes several revisions to the 2000 regulations to increase access to equitable, affordable, client-centered, quality family planning services.
Requirements Related to Surprise Billing; Part II
Document Number: 2021-21441
Type: Rule
Date: 2021-10-07
Agency: Employee Benefits Security Administration, Department of Labor, Department of Health and Human Services, Internal Revenue Service, Department of Treasury, Department of the Treasury, Office of Personnel Management
This document sets forth interim final rules implementing certain provisions of the No Surprises Act, which was enacted as part of the Consolidated Appropriations Act, 2021. These interim final rules implement provisions of the No Surprises Act that provide for a Federal independent dispute resolution (IDR) (Federal IDR) process to permit group health plans and health insurance issuers offering group or individual health insurance coverage and nonparticipating providers, facilities, and providers of air ambulance services to determine the out-of-network rate for items and services that are emergency services, nonemergency services furnished by nonparticipating providers at participating facilities, and air ambulance services furnished by nonparticipating providers of air ambulance services, under certain circumstances. The Department of Health and Human Services (HHS), the Department of Labor (DOL), and the Department of the Treasury (collectively, the Departments) are issuing these interim final rules with largely parallel provisions that apply to group health plans and health insurance issuers offering group or individual health insurance coverage and certified IDR entities, providers, facilities, and providers of air ambulance services. In addition to the interim final rules issued jointly by the Departments, this document also includes interim final rules issued by the Office of Personnel Management (OPM) to clarify how certain No Surprises Act provisions apply to health benefits plans offered by carriers under the Federal Employees Health Benefits (FEHB) Act. In addition to the interim final rules issued jointly by the Departments and OPM, this document includes interim final rules issued by HHS that address good faith estimates of health care items and services for uninsured or self-pay individuals and the associated patient-provider dispute resolution process. The HHS-only interim final rules apply to selected dispute resolution (SDR) entities, providers, facilities, and providers of air ambulance services.
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 2021-21855
Type: Notice
Date: 2021-10-06
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of an Exclusive Patent License: Development and Commercialization of T Cell Therapies for Mesothelin-Expressing Cancers
Document Number: 2021-21846
Type: Notice
Date: 2021-10-06
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Ares Immunotherapy, Inc. (``Ares''), a Delaware corporation.
Prospective Grant of an Exclusive Patent License: Personalized Tumor Vaccine and Use Thereof for Cancer Immunotherapy
Document Number: 2021-21845
Type: Notice
Date: 2021-10-06
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the (U.S.) Patents and Patent Applications listed in the Supplementary Information section of this notice to NE1 Inc, located at 515 Madison Avenue, 8th Fl. Suite 8096, New York, NY 10022.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-21839
Type: Notice
Date: 2021-10-06
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-21836
Type: Notice
Date: 2021-10-06
Agency: Department of Health and Human Services, National Institutes of Health
Issuance of Priority Review Voucher; Rare Pediatric Disease Product; Withdrawal
Document Number: 2021-21823
Type: Notice
Date: 2021-10-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing the notice that published in the Federal Register of September 30, 2021, that announced the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Register notice was published in error and is being withdrawn.
Lead Exposure and Prevention Advisory Committee
Document Number: 2021-21807
Type: Notice
Date: 2021-10-06
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 Lead Exposure and Prevention Advisory Committee (LEPAC). This meeting is open to the public by teleconference but advance registration by November 19, 2021 is needed to receive the information to join the meeting. The registration link is https://www.zoomgov.com/webinar/register/WN_qeMSB7npRJ23PTV6t 1KMtQ.
Healthcare Infection Control Practices Advisory Committee (HICPAC)
Document Number: 2021-21806
Type: Notice
Date: 2021-10-06
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 Healthcare Infection Control Practices Advisory Committee (HICPAC). This virtual meeting is open to the public, limited only by audio and web conference lines (300 audio and web conference lines are available). Registration is required. To register for this web conference, please go to: www.cdc.gov/hicpac. All registered participants will receive the meeting link and instructions shortly before the meeting.
Guidance Documents Related to Coronavirus Disease 2019; Availability
Document Number: 2021-21798
Type: Notice
Date: 2021-10-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of FDA guidance documents related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE). This notice of availability (NOA) is pursuant to the process that FDA announced, in the Federal Register of March 25, 2020, for making available to the public COVID-19-related guidances. The guidances identified in this notice address issues related to the COVID-19 PHE and have been issued in accordance with the process announced in the March 25, 2020, notice. The guidances have been implemented without prior comment, but they remain subject to comment in accordance with the Agency's good guidance practices. FDA is also announcing the withdrawal of two FDA guidance documents related to the COVID-19 PHE.
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 2021-21793
Type: Notice
Date: 2021-10-06
Agency: Department of Health and Human Services, National Institutes of Health
Listing of Color Additives Exempt From Certification; Silver Nitrate
Document Number: 2021-21755
Type: Rule
Date: 2021-10-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of silver nitrate as a color additive in professional-use only cosmetics to color eyebrows and eyelashes. This action is in response to a color additive petition (CAP) filed by GW Cosmetics GmbH.
Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs; Guidance for Industry; Availability
Document Number: 2021-21689
Type: Notice
Date: 2021-10-06
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 (GFI) #268 entitled ``Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs.'' The guidance describes FDA's current thinking with respect to assisting sponsors in incorporating complex adaptive and other novel investigation designs into proposed clinical investigation protocols and applications for new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Biomarkers and Surrogate Endpoints in Clinical Studies To Support Effectiveness of New Animal Drugs; Guidance for Industry; Availability
Document Number: 2021-21688
Type: Notice
Date: 2021-10-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry (GFI) #267 entitled ``Biomarkers and Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs.'' The guidance describes FDA's current thinking with respect to incorporating biomarkers and surrogate endpoints into proposed clinical investigational protocols and applications for new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Use of Real-World Data and Real-World Evidence To Support Effectiveness of New Animal Drugs; Guidance for Industry; Availability
Document Number: 2021-21687
Type: Notice
Date: 2021-10-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry (GFI) #266 entitled ``Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs.'' The guidance describes FDA's current thinking with respect to assisting sponsors in incorporating real-world data and real-world evidence (including ongoing surveillance activities, observational studies, and registry data) into proposed clinical investigation protocols and applications for new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Use of Data From Foreign Investigational Studies To Support Effectiveness of New Animal Drugs; Guidance for Industry; Availability
Document Number: 2021-21686
Type: Notice
Date: 2021-10-06
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 #265 entitled ``Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs.'' The guidance describes FDA's current thinking with respect to assisting sponsors in incorporating data from foreign countries into proposed clinical investigational protocols and applications for new animal drugs under the Federal Food, Drug, and Cosmetic Act.
Flexibility for Head Start Designation Renewals in Certain Emergencies
Document Number: 2021-19786
Type: Rule
Date: 2021-10-06
Agency: Department of Health and Human Services, Administration for Children and Families
This rule adopts as final the provision to the Head Start Program Performance Standards (HSPPS) to establish parameters by which ACF may make designation renewal determinations during a federally declared major disaster, emergency, or public health emergency (PHE) and in the absence of all normally required data.
Best Practices for Development and Application of Disease Progression Models; Public Workshop
Document Number: 2021-21758
Type: Notice
Date: 2021-10-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research, are announcing a public workshop entitled ``Best Practices for Development and Application of Disease Progression Models.'' The purpose of this public workshop is to discuss the best practices for developing disease progression models and their application to support drug development decisions, share experiences and case studies that highlight the opportunities and limitations in the development and application of disease progression models including models for natural history of disease and clinical trial simulations, and discuss the knowledge gaps and research needed to advance the development and use of disease progression models.
National Institute of General Medical Sciences: Notice of Closed Meeting
Document Number: 2021-21731
Type: Notice
Date: 2021-10-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2021-21730
Type: Notice
Date: 2021-10-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences: Notice of Closed Meeting
Document Number: 2021-21729
Type: Notice
Date: 2021-10-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2021-21728
Type: Notice
Date: 2021-10-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2021-21727
Type: Notice
Date: 2021-10-05
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-21726
Type: Notice
Date: 2021-10-05
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Cancellation of Meeting
Document Number: 2021-21723
Type: Notice
Date: 2021-10-05
Agency: Department of Health and Human Services, National Institutes of Health
S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals; International Council for Harmonisation; Draft Guidance for Industry; Availability
Document Number: 2021-21692
Type: Notice
Date: 2021-10-05
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 ``S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals''. The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance expands the testing scheme for assessing human carcinogenic risk of small molecule pharmaceuticals by introducing an additional approach that is not described in the original S1B Guideline. The draft guidance is intended to offer an integrative approach that provides specific weight of evidence (WoE) criteria that inform whether or not a 2-year rat study adds value in completing a human carcinogenicity risk assessment. The Addendum also adds a plasma exposure ratio-based approach for setting the high dose in the rasH2-Tg mouse model, while all other aspects of the recommendations for high dose selection in S1C(R2) Guideline would still apply.
Medical Device De Novo Classification Process
Document Number: 2021-21677
Type: Rule
Date: 2021-10-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a final rule to establish requirements for the medical device De Novo classification process under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This final rule establishes procedures and criteria related to requests for De Novo classification (``De Novo request'') and provides a pathway to obtain marketing authorization as a class I or class II device and for certain combination products. These requirements are intended to ensure the most appropriate classification of devices consistent with the protection of the public health and the statutory scheme for device regulation. They are also intended to limit the unnecessary expenditure of FDA and industry resources that may occur if devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness are subject to premarket approval. The final rule implements the De Novo classification process under the FD&C Act, as enacted by the Food and Drug Administration Modernization Act of 1997 (FDAMA) and modified by the Food and Drug Administration Safety and Innovation Act (FDASIA) and the 21st Century Cures Act (Cures Act).
National Cancer Institute; Notice of Meeting
Document Number: 2021-21666
Type: Notice
Date: 2021-10-05
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-21665
Type: Notice
Date: 2021-10-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2021-21664
Type: Notice
Date: 2021-10-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2021-21606
Type: Notice
Date: 2021-10-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2021-21605
Type: Notice
Date: 2021-10-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meetings
Document Number: 2021-21604
Type: Notice
Date: 2021-10-05
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2021-21603
Type: Notice
Date: 2021-10-05
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2021-21602
Type: Notice
Date: 2021-10-05
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2021-21600
Type: Notice
Date: 2021-10-05
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2021-21599
Type: Notice
Date: 2021-10-05
Agency: Department of Health and Human Services, National Institutes of Health
Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children
Document Number: 2021-21582
Type: Notice
Date: 2021-10-05
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Public Health Service Act and the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC or Committee) has scheduled a public meeting. Information about ACHDNC and the agenda for this meeting can be found on ACHDNC website at https:// www.hrsa.gov/advisory-committees/heritable-disorders/index.ht ml.
Meeting of the National Advisory Committee on Rural Health and Human Services
Document Number: 2021-21581
Type: Notice
Date: 2021-10-05
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act, this notice announces the Secretary's National Advisory Committee on Rural Health and Human Services (NACRHHS) has scheduled a public meeting. Information about NACRHHS and the agenda for this meeting can be found on the NACRHHS website at https://www.hrsa.gov/advisory-committees/rural-health/index.h tml.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-21580
Type: Notice
Date: 2021-10-05
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.