Department of Health and Human Services October 5, 2021 – Federal Register Recent Federal Regulation Documents

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.
Premarket Tobacco Product Applications and Recordkeeping Requirements
Document Number: 2021-21011
Type: Rule
Date: 2021-10-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, us, or we) is issuing a final rule that sets forth requirements for premarket tobacco product applications (PMTAs) and requires manufacturers to maintain records establishing that their tobacco products are legally marketed. The rule will help ensure that PMTAs contain sufficient information for FDA to determine whether a marketing granted order should be issued for a new tobacco product. The rule codifies the general procedures FDA will follow when evaluating PMTAs and creates postmarket reporting requirements for applicants that receive marketing granted orders. The rule also requires tobacco product manufacturers to keep records establishing that their tobacco products are legally marketed, such as documents showing that a tobacco product is not required to undergo premarket review or has received premarket authorization.
Applications for Premarket Review of New Tobacco Products; Draft Guidance for Industry; Withdrawal
Document Number: 2021-21010
Type: Notice
Date: 2021-10-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the withdrawal of a draft guidance for industry entitled ``Applications for Premarket Review of New Tobacco Products.'' We are withdrawing this guidance because the topics discussed in the draft guidance are addressed in the final rule entitled ``Premarket Tobacco Product Applications and Recordkeeping Requirements.''
Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports
Document Number: 2021-21009
Type: Rule
Date: 2021-10-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is issuing this final rule to provide additional information on the content and format of reports intended to demonstrate the substantial equivalence of a tobacco product (SE Reports). The final rule also establishes the general procedures FDA intends to follow when evaluating SE Reports, including procedures that address communications with the applicant and the confidentiality of data in an SE Report. The final rule will provide applicants with more certainty and clarity related to preparing and submitting SE Reports.