Department of Health and Human Services October 24, 2022 – Federal Register Recent Federal Regulation Documents

Announcement of Solicitation of Written Comments on Proposed Healthy People 2030 Objectives
Document Number: 2022-22983
Type: Notice
Date: 2022-10-24
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services (HHS) solicits written comments on an additional objective proposed to be added to Healthy People 2030, and written comments from the public proposing additional new core, developmental, or research objectives to be included in Healthy People 2030. Public comment informed the development of Healthy People 2030. HHS will provide opportunities for public input periodically throughout the decade to ensure Healthy People 2030 reflects current public health priorities and public input. The updated set of Healthy People 2030 objectives will be incorporated on https://health.gov/healthypeople. This updated set will reflect further review and deliberation by federal Healthy People topic area workgroups, the Federal Interagency Workgroup on Healthy People 2030, and other federal subject matter experts.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2022-23068
Type: Notice
Date: 2022-10-24
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: 2022-23011
Type: Notice
Date: 2022-10-24
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.
Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH); Notice of Charter Renewal
Document Number: 2022-23007
Type: Notice
Date: 2022-10-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through February 3, 2023.
In Vitro Permeation Test Studies for Topical Products Submitted in Abbreviated New Drug Applications; Draft Guidance for Industry; Availability
Document Number: 2022-23018
Type: Notice
Date: 2022-10-24
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 ``In Vitro Permeation Test Studies for Topical Products Submitted in ANDAs.'' This draft guidance document provides recommendations for in vitro permeation test (IVPT) studies for locally acting liquid-based and/or other semisolid topical products. This draft guidance is intended to assist applicants who are submitting abbreviated new drug applications (ANDAs) for such products by providing recommendations for IVPT studies, which can be used to support a demonstration that two topical products are bioequivalent.
In Vitro Release Test Studies for Topical Products Submitted in Abbreviated New Drug Applications; Draft Guidance for Industry; Availability
Document Number: 2022-23017
Type: Notice
Date: 2022-10-24
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 ``In Vitro Release Test Studies for Topical Products Submitted in ANDAs.'' This draft guidance provides recommendations for in vitro release test (IVRT) studies for locally acting liquid-based and/or other semisolid topical products. This draft guidance is intended to assist applicants who are submitting abbreviated new drug applications (ANDAs) for such products, by providing recommendations for IVRT studies, which can be used to support a demonstration that two topical products are bioequivalent.
Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in Abbreviated New Drug Applications; Draft Guidance for Industry, Availability
Document Number: 2022-23016
Type: Notice
Date: 2022-10-24
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 ``Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs.'' This draft guidance is intended to assist applicants who submit abbreviated new drug applications (ANDAs) for liquid-based and/or other semisolid products applied to the skin, including integumentary and mucosal (e.g., vaginal) membranes (referred to as ``topical products''). This draft guidance document provides recommendations for physicochemical and structural (collectively, ``Q3'') characterizations that can be used to identify the dosage form of a proposed generic (test) topical product, and to describe properties of the drug product that may be critical to its performance (to support a demonstration of bioequivalence (BE)).
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Document Number: 2022-23015
Type: Notice
Date: 2022-10-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances for developing topical products applied to the skin, as well as integumentary and mucosal (e.g., vaginal) membranes. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.
Proposed Information Collection Activity; Temporary Assistance for Needy Families (TANF) Financial Report, ACF-196T
Document Number: 2022-23013
Type: Notice
Date: 2022-10-24
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) is requesting a 3-year extension of the Temporary Assistance for Needy Families (TANF) Financial Report, Form ACF-196T (Office of Management and Budget (OMB) #0970-0345, expiration April 30, 2023). ACF is proposing minor updates to the form to remove a reporting line-item reference that was associated with an expired program expenditure and minor edits to the instructions and formatting to better the presentation of the document.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2022-23001
Type: Notice
Date: 2022-10-24
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Annual Summary Reporting Requirements Under the Right to Try Act
Document Number: 2022-23035
Type: Notice
Date: 2022-10-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Miles Laboratories Inc.; Proposal To Withdraw Approval of an Abbreviated New Drug Application for Alcohol and Dextrose Injection; 5 Milliliters/100 Milliliters, 5 Grams/100 Milliliters; Opportunity for a Hearing
Document Number: 2022-23034
Type: Notice
Date: 2022-10-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of an abbreviated new drug application (ANDA) for Alcohol and Dextrose Injection, 5 milliliters (mL)/100 mL, 5 grams (g)/100 mL, and is announcing an opportunity for the ANDA holder to request a hearing on this proposal: Miles Laboratories Inc., P.O. Box 1986, 4th and Parker St., Berkeley, CA 94701, is the last holder of record. The bases for the proposal are that the ANDA holder has repeatedly failed to file required annual reports for this ANDA and that the Agency has scientific data and experience to show that the drug product under this ANDA is unsafe for use under the conditions of use for which the product was approved.
Nonprescription Drug Product With an Additional Condition for Nonprescription Use; Extension of Comment Period
Document Number: 2022-23033
Type: Proposed Rule
Date: 2022-10-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the proposed rule that appeared in the Federal Register of June 28, 2022. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Topical Dermatologic Corticosteroids: In Vivo Bioequivalence; Draft Guidance for Industry; Availability
Document Number: 2022-23032
Type: Notice
Date: 2022-10-24
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 ``Topical Dermatologic Corticosteroids: In Vivo Bioequivalence.'' This draft guidance is intended to assist applicants who submit abbreviated new drug applications (ANDAs) for topical dermatologic corticosteroid products of all potency groups (referred to in this notice as topical corticosteroids). The draft guidance describes recommendations for an in vivo pharmacodynamic approach to demonstrate the bioequivalence of topical corticosteroids. When finalized, this guidance will replace FDA's 1995 guidance for industry of the same name. Revising this guidance will provide clarity for potential ANDA applicants on the appropriate pilot and pivotal studies and other recommendations for pharmacodynamic approach to assess the bioequivalence of topical dermatologic corticosteroids. These recommendations have evolved since the original guidance was issued in 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mammography Quality Standards Act Requirements
Document Number: 2022-23028
Type: Notice
Date: 2022-10-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2022-23066
Type: Notice
Date: 2022-10-24
Agency: Department of Health and Human Services, National Institutes of Health
Human Gene Therapy for Neurodegenerative Diseases; Guidance for Industry; Availability
Document Number: 2022-23057
Type: Notice
Date: 2022-10-24
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 ``Human Gene Therapy for Neurodegenerative Diseases; Guidance for Industry.'' Neurodegenerative diseases are a heterogeneous group of disorders characterized by progressive degeneration of the structure and function of the central nervous system or peripheral nervous system. The guidance document provides recommendations to sponsors developing human gene therapy (GT) products for neurodegenerative diseases affecting adult and pediatric patients. The guidance focuses on considerations for product development, preclinical testing, and clinical trial design. The guidance announced in this notice finalizes the draft guidance of the same title dated January 2021.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2022-23054
Type: Notice
Date: 2022-10-24
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
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