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

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Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-20847
Type: Notice
Date: 2021-09-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on an existing information collection project titled the CDC Worksite Health Scorecard. The collection is an organizational assessment and planning tool designed to help employers identify gaps in their health promotion programs and prioritize high-impact strategies for health promotion at their worksites.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-20846
Type: Notice
Date: 2021-09-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled National Healthcare Safety Network (NHSN). NHSN is the nation's most widely used healthcare- associated infection tracking system, providing facilities, states, regions, and the nation with data needed to identify problem areas, measure progress of prevention efforts, and ultimately eliminate healthcare-associated infections.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-20845
Type: Notice
Date: 2021-09-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Annual Submission of the Ingredients Added to, and the Quantity of Nicotine Contained in, Smokeless Tobacco Manufactured, Imported, or Packaged in the U.S. This Extension permits CDC to collect a list of ingredients added to tobacco in the manufacture of smokeless tobacco products, and a specification of the quantity of nicotine contained in each product. CDC's Office of Smoking and Health (OSH) has been delegated with the responsibility for implementing the required information collection by HHS.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-20844
Type: Notice
Date: 2021-09-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a continuing information collection project titled List of Ingredients Added to Tobacco in the Manufacture of Cigarette Products. The proposed collection allows CDC's Office of Smoking and Health (OSH) to collect information about the ingredients used in cigarette products, a responsibility that has been delegated to CDC by HHS.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-20843
Type: Notice
Date: 2021-09-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Understanding Health System Approaches to Chronic Pain Management. The proposed study is designed to evaluate the effects of evidence-based guidelines related to chronic pain management and opioid prescribing.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-20842
Type: Notice
Date: 2021-09-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2021-20838
Type: Notice
Date: 2021-09-27
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: 2021-20837
Type: Notice
Date: 2021-09-27
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: 2021-20835
Type: Notice
Date: 2021-09-27
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: 2021-20831
Type: Notice
Date: 2021-09-27
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.
Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use; Over the Counter Monograph Proposed Order; Availability
Document Number: 2021-20780
Type: Notice
Date: 2021-09-27
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 an over-the-counter (OTC) monograph proposed order (order ID OTC000008) entitled ``Amending Over-the- Counter (OTC) Monograph M020: Sunscreen Drug Products for OTC Human Use.'' FDA is issuing this proposed order to amend and revise the deemed final administrative order concerning nonprescription sunscreen drug products (Deemed Final Order) established by the enactment of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). This proposed order, if finalized, would replace the Deemed Final Order in its entirety with new conditions under which nonprescription sunscreen drug products would be determined to be generally recognized as safe and effective (GRASE) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). It also sets forth certain characteristics that would establish that a sunscreen drug product is not GRASE.
Patient Protection and Affordable Care Act; Updating Payment Parameters, Section 1332 Waiver Implementing Regulations, and Improving Health Insurance Markets for 2022 and Beyond
Document Number: 2021-20509
Type: Rule
Date: 2021-09-27
Agency: Department of Health and Human Services, Department of the Treasury
This final rule sets forth revised 2022 user fee rates for issuers offering qualified health plans (QHPs) through federally- facilitated Exchanges and State-based Exchanges on the Federal platform; repeals separate billing requirements related to the collection of separate payments for the portion of QHP premiums attributable to coverage for certain abortion services; expands the annual open enrollment period and Navigator duties; implements a new monthly special enrollment period for qualified individuals or enrollees, or the dependents of a qualified individual or enrollee, who are eligible for advance payments of the premium tax credit (APTC) and whose household income does not exceed 150 percent of the Federal poverty level, available during periods of time during which APTC benefits are available such that certain applicable taxpayers' applicable percentage is set at zero, such as during tax years 2021 and 2022 under the section 9661 of the American Rescue Plan Act of 2021; repeals the recent establishment of a Direct Enrollment option for Exchanges; and modifies regulations and policies related to section 1332 waivers.
Medicare Program; Town Hall Meeting on the FY 2023 Applications for New Medical Services and Technologies Add-On Payments
Document Number: 2021-20811
Type: Notice
Date: 2021-09-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a Town Hall Meeting in accordance with the Social Security Act (the Act) to discuss fiscal year (FY) 2023 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). The United States is responding to an outbreak of respiratory disease caused by the virus ``SARS-CoV-2'' and the disease it causes ``coronavirus disease 2019'' (abbreviated ``COVID-19''). Due to the COVID-19 pandemic, the Town Hall Meeting will be held virtually rather than as an in-person meeting. Interested parties are invited to this meeting to present their comments, recommendations, and data regarding whether the FY 2023 new medical services and technologies applications meet the substantial clinical improvement criterion.
Notice of Diabetes Mellitus Interagency Coordinating Committee Meeting
Document Number: 2021-20802
Type: Notice
Date: 2021-09-24
Agency: Department of Health and Human Services, National Institutes of Health
The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on November 8, 2021. The topic for this meeting will be ``Evolving Concepts in the Assessment and Management of Hypoglycemia.'' The meeting is open to the public.
Proposed Information Collection Activity; Mother and Infant Home Visiting Program Evaluation (MIHOPE): Long-Term Follow-Up, Kindergarten Data Collection (MIHOPE-K) (OMB #0970-0402)
Document Number: 2021-20798
Type: Notice
Date: 2021-09-24
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), in partnership with the Health Resources and Services Administration (HRSA), both of the U.S. Department of Health and Human Services (HHS), is proposing to extend data collection activity as part of the kindergarten phase of the Mother and Infant Home Visiting Program Evaluation Long-Term Follow-Up project (MIHOPE-K). The purpose of MIHOPE-K is to conduct a follow-up study that assesses the long-term impact of the Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Program when the participating children are in kindergarten. This Federal Register notice is seeking to extend data collection for the kindergarten follow-up. The original Federal Register notices for the MIHOPE-K data collection were titled under MIHOPE-Long-Term Follow-Up (MIHOPE-LT).
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-20789
Type: Notice
Date: 2021-09-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-20788
Type: Notice
Date: 2021-09-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2021-20787
Type: Notice
Date: 2021-09-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2021-20786
Type: Notice
Date: 2021-09-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2021-20785
Type: Notice
Date: 2021-09-24
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-20784
Type: Notice
Date: 2021-09-24
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Meeting
Document Number: 2021-20783
Type: Notice
Date: 2021-09-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2021-20768
Type: Notice
Date: 2021-09-24
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-20767
Type: Notice
Date: 2021-09-24
Agency: Department of Health and Human Services, National Institutes of Health
Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
Document Number: 2021-20754
Type: Notice
Date: 2021-09-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Gravity Diagnostics, LLC (Gravity) for the Gravity Diagnostics COVID-19 Assay, Materials and Machines Corporation of America (DBA MatmaCorp, Inc.) (Matmacorp) for the MatMaCorp COVID-19 2SF Test, and Guardant Health Inc. (Guardant) for the Guardant-19. FDA revoked Gravity's Authorization on July 21, 2021, Matmacorp's Authorization on August 3, 2021, and Guardant's Authorization on August 6, 2021, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document.
Notice of Meeting for the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC)
Document Number: 2021-20741
Type: Notice
Date: 2021-09-24
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Secretary of Health and Human Services announces a meeting of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The ISMICC is open to the public and can be accessed via telephone or webcast only, and not in person. Agenda with call-in information and the draft report to Congress will be posted on SAMHSA's website prior to the meeting at: https://www.samhsa.gov/about-us/advisory-councils/ meetings. The meeting will address feedback from the ISMICC members regarding the final report to Congress and include information on federal efforts related to serious mental illness (SMI) and serious emotional disturbance (SED).
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2021-20740
Type: Notice
Date: 2021-09-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2021-20733
Type: Notice
Date: 2021-09-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cardiovascular and Renal Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-20727
Type: Notice
Date: 2021-09-24
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 OMB Review; Comment Request
Document Number: 2021-20722
Type: Notice
Date: 2021-09-24
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 (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.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Advanced Nursing Education Program Specific Form OMB No. 0915-0375-Revision
Document Number: 2021-20653
Type: Notice
Date: 2021-09-24
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Bureau of Health Workforce Performance Data Collection, OMB No. 0915-0061-Revision
Document Number: 2021-20650
Type: Notice
Date: 2021-09-24
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Meeting of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment
Document Number: 2021-20646
Type: Notice
Date: 2021-09-24
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 Secretary's Centers for Disease Control and Prevention (CDC)/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHAC) has scheduled a public meeting. Information about CHAC and the agenda for this meeting can be found on the CHAC website at https://www.cdc.gov/maso/facm/facmCHACHSPT.html and the meeting website at https://www.chacfall2021.org/.
OIG Modernization Initiative To Improve Its Publicly Available Resources-Request for Information
Document Number: 2021-20558
Type: Notice
Date: 2021-09-24
Agency: Department of Health and Human Services, Office of Inspector General
This request for information seeks input from the public on OIG resources and how OIG could enhance the usefulness and timeliness of such resources and improve their accessibility and usability.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-20608
Type: Notice
Date: 2021-09-23
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-20607
Type: Notice
Date: 2021-09-23
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: SHIP COVID-19 Testing and Mitigation Program Data Collection-New, Emergency
Document Number: 2021-20601
Type: Notice
Date: 2021-09-23
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-20585
Type: Notice
Date: 2021-09-23
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2021-20584
Type: Notice
Date: 2021-09-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Minority Health and Health Disparities; Notice of Closed Meeting
Document Number: 2021-20583
Type: Notice
Date: 2021-09-23
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2021-20582
Type: Notice
Date: 2021-09-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2021-20581
Type: Notice
Date: 2021-09-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2021-20580
Type: Notice
Date: 2021-09-23
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; National Survey of Early Care and Education COVID-19 Follow-Up
Document Number: 2021-20573
Type: Notice
Date: 2021-09-23
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), plans to request from the Office of Management and Budget (OMB) an extension to complete data collection for a two-wave COVID-19 Follow-up data collection currently underway as part of the National Survey of Early Care and Education (NSECE). The objective of the NSECE COVID-19 Follow-up is to document the nation's current supply of early care and education services (that is, home-based providers, center-based providers, and the center-based provider workforce). There are no changes proposed.
Submission for OMB Review; Early Head Start Family and Child Experiences Survey 2022 (Baby FACES 2022)
Document Number: 2021-20572
Type: Notice
Date: 2021-09-23
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval to continue to collect descriptive information for the Early Head Start Family and Child Experiences Survey 2022 (Baby FACES 2022). This information collection is to provide nationally representative data on Early Head Start (EHS) programs, centers, classrooms, staff, and families to guide program planning, technical assistance, and research. This data collection will complete the previously approved second round of data collection originally planned to take place in 2020 (OMB 0970-0354). The work began in early 2020 but had to be postponed after only 3 weeks due to the COVID-19 pandemic. No changes are proposed to the currently approved information collection materials.
Proposed Information Collection Activity; Understanding the Value of Centralized Services Study (New Collection)
Document Number: 2021-20556
Type: Notice
Date: 2021-09-23
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS) is proposing a new data collection activity as part of the Understanding the Value of Centralized Services study. The objective of this descriptive study is to understand the advantages, disadvantages, and costs of centralizing social services for individuals and families with low incomes.
Proposed Information Collection Activity; Unaccompanied Children (UC) Program Budget Workbook Template (New Collection)
Document Number: 2021-20547
Type: Notice
Date: 2021-09-23
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families' (ACF) Office of Refugee Resettlement (ORR) is requesting clearance for the proposed new collection titled ``UC Program Budget Workbook'' to streamline budget details and justifications of applicants to funding opportunities.
Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products; Draft Guidance for Industry; Availability
Document Number: 2021-20517
Type: Notice
Date: 2021-09-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency or we) is announcing the availability of a draft guidance for industry #254 entitled ``Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products.'' FDA's Center for Veterinary Medicine (CVM) is issuing this guidance for sponsors, firms, individuals, and establishments that participate in the manufacture of, or perform any aspect of, the donor eligibility determination for animal cells, tissues, and cell- and tissue-based products (ACTPs), which meet the definition of new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Donor eligibility is a critical component of current good manufacturing practices (CGMPs) when manufacturing ACTPs. A donor should be considered eligible to donate ACTPs only if screening of the donor shows that the donor is free from risk factors for, and clinical evidence of, infection with relevant disease agents and diseases, and the donor (and product/source material) test results for relevant disease agents are negative or nonreactive.
Good Manufacturing Practices for Animal Cells, Tissues, and Cell- and Tissue-Based Products; Draft Guidance for Industry; Availability
Document Number: 2021-20514
Type: Notice
Date: 2021-09-23
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 draft guidance for industry #253 entitled ``Good Manufacturing Practices for Animal Cells, Tissues, and Cell- and Tissue-Based Products.'' FDA's Center for Veterinary Medicine (CVM) is issuing this guidance to provide establishments that manufacture animal cells, tissues, and cell- and tissue-based products (ACTPs) meeting the definition of new animal drugs with recommendations for meeting requirements for current good manufacturing practices (CGMPs). All new animal drugs, including ACTPs, are required to be manufactured in accordance with CGMPS to ensure that such drugs meet the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as to safety, and have the identity, strength, quality, and purity characteristics, which they purport to or are represented to possess. This guidance also provides FDA's recommendations for those aspects of manufacturing specific to ACTPs in accordance with existing CGMP regulations, as applicable, and with the FD&C Act. In this guidance, we specifically address the methods, facilities, and controls used for manufacturing ACTPs.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Bureau of Primary Health Care-Program Management Resource Compendium, 0906-XXXX, New
Document Number: 2021-20524
Type: Notice
Date: 2021-09-22
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with 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.