Department of Health and Human Services March 2023 – Federal Register Recent Federal Regulation Documents
Results 201 - 250 of 339
Rescission of the Requirements for Negative Pre-Departure COVID-19 Test Result or Documentation of Recovery From COVID-19 for Aircraft Passengers Traveling to the United States From the People's Republic of China
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the rescission of the Order requiring negative pre-departure COVID-19 test result or documentation of recovery from COVID-19 for aircraft passengers traveling to the United States from the People's Republic of China, including the Special Administrative Regions of Hong Kong and Macau.
Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Abbott Diagnostics Scarborough, Inc. (Abbott) for the BinaxNOW COVID-19 Ag 2 Card, and Standard BioTools, Inc. (Standard) for the Advanta Dx SARS-CoV-2 RT-PCR Assay and Advanta Dx COVID-19 EASE Assay. FDA revoked these Authorizations 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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Custom Device Reporting
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 information collection associated with annual reporting for custom devices.
Proposed Collection; 60-Day Comment Request; Office of Minority Health Research Coordination (OMHRC) Research Training and Mentor Programs Applications (National Institute of Diabetes and Digestive and Kidney Diseases)
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Guidance Documents Related to Coronavirus Disease 2019 (COVID-19)
On February 9, 2023, the Secretary of Health and Human Services (HHS) renewed the Coronavirus Disease 2019 (COVID-19) public health emergency declaration issued under section 319 of the Public Health Service Act (PHS Act) (``PHE declaration''), effective February 11, 2023. The declaration is expected to expire at the end of the day on May 11, 2023. The Food and Drug Administration (FDA, Agency, or we) has issued guidance documents to address the circumstances of the public health emergency and, more generally, COVID-19. Many of those guidance documents are tied to the duration of the PHE declaration. This notice is intended to provide clarity to stakeholders with respect to the guidance documents that will no longer be effective with the expiration of the PHE declaration and the guidances that FDA is revising to continue in effect after the expiration of the PHE declaration.
Authorization of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for use during the COVID-19 pandemic. FDA has issued one Authorization for the drug product KINERET (anakinra) as requested by Swedish Orphan Biovitrum AB (Sobi). The Authorization contains, among other things, conditions on the emergency use of the authorized product. The Authorization follows the February 4, 2020, determination by the Secretary of Health and Human Services (HHS) that there is a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves a novel (new) coronavirus. The virus, now named SARS-CoV- 2, causes the illness COVID-19. On the basis of such determination, the Secretary of HHS declared on March 27, 2020, that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to the FD&C Act, subject to the terms of any authorization issued under that section. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.
Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Antimicrobial 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.
Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications.'' This guidance focuses on specific recommendations pertinent to pH-dependent drug-drug interaction (DDI) assessment and describes the current recommendations of FDA regarding when clinical DDI studies with acid-reducing agents (ARAs) are needed, design of the clinical studies, interpretation of study results, and options for managing pH-dependent DDIs in patients. This guidance finalizes the draft guidance of the same title issued on December 1, 2020.
Gastrointestinal Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Gastrointestinal 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.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled STD Surveillance Network (SSuN). This information collection request is designed to strengthen national and local surveillance capacity for incident, new and emerging sexually transmitted diseases (STDs) by collecting relevant risk, demographic, and clinical information on patients at risk for STDs attending STD-related healthcare facilities, and providing more accurate estimates of the burden of disease, incidence of STDs, trends and impact of STDs at the population level.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Standardized National Hypothesis Generating Questionnaire (NHGQ). This questionnaire collects exposure information from ill people involved in a suspected multistate foodborne outbreak, and aids public health investigators in identifying the potential source of infection.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Reducing Fatigue Among Taxi Drivers. The goal of this project is to evaluate two interventions, a training and a wrist-device that provide personalized daily fatigue scores, designed to enable taxi drivers to reduce their fatigue levels. This research study involves two parts: development of a fatigue management eLearning training tool designed for drivers-for-hire (e.g., taxi drivers; ride sourcing drivers); and an evaluation of the effectiveness of this training alone and paired with the wrist-device that provides personalized daily fatigue scores.
Agency Information Collection Activities: Proposed Collection; Comment Request
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
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; Comment Request
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.
Authorization of Emergency Use of an In Vitro Diagnostic Device in Response to an Outbreak of Mpox; Availability
The Food and Drug Administration (FDA or Agency) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) in response to an outbreak of mpox. FDA has issued an Authorization for an in vitro diagnostic device as requested by Cepheid. The Authorization contains, among other things, conditions on the emergency use of the authorized product. The Authorization follows the August 9, 2022, determination by the Secretary of Health and Human Services (HHS) that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad, and that involves monkeypox virus. On the basis of such determination, the Secretary of HHS declared, on September 7, 2022, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of infection with the monkeypox virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus, pursuant to the FD&C Act, subject to terms of any authorization issued under that section. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.
Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability
The Food and Drug Administration (FDA or Agency) is announcing the issuance of Emergency Use Authorizations (EUAs) (the Authorizations) for certain medical devices related to the Coronavirus Disease 2019 (COVID-19) public health emergency. FDA has issued the Authorizations listed in this document under the Federal Food, Drug, and Cosmetic Act (FD&C Act). These Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorizations follow the February 4, 2020, determination by the Secretary of Health and Human Services (HHS) that there is a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves the virus that causes COVID-19, and the subsequent declarations on February 4, 2020, March 2, 2020, and March 24, 2020, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19, personal respiratory protective devices, and medical devices, including alternative products used as medical devices, respectively, subject to the terms of any authorization issued under the FD&C Act. These Authorizations, which include an explanation of the reasons for issuance, are listed in this document, and can be accessed on FDA's website from the links indicated.
Submission for OMB Review; National Communication System for Runaway and Homeless Youth, Currently Operated by the National Runaway Safeline (NRS) Data Collection (New Collection)
The Family and Youth Services Bureau's (FYSB) Runaway and Homeless Youth Division has a legislative requirement to fund a National Communication System, which is currently operated by the National Runaway Safeline (NRS). The NRS provides information, referral services, crisis intervention, and prevention resources to vulnerable youth at risk of running away and/or becoming homeless and their families or legal guardians at no cost. When necessary, the NRS refers runaway and homeless youth to shelters, counseling, medical assistance, and other vital services. The NRS collects information from all contacts with youth and adults connecting with the NRS (i.e., parents, family members, legal guardians, service providers) on a voluntary basis to inform crisis services and develop an annual report on the information collected during calls, chats, emails, and forum posts from young people who reached out to the NRS's crisis services.
Proposed Information Collection Activity; Office of Refugee Resettlement Unaccompanied Refugee Minors Program Application and Withdrawal of Application or Declination of Placement Form (OMB #0970-0550)
The Office of Refugee Resettlement (ORR) is requesting a three-year extension with revisions of the Unaccompanied Refugee Minors (URM) Program Application and Withdrawal of Application or Declination of Placement Form (OMB #0970-0550, expiration 08/31/2023). Proposed revisions include additional instructions, a small number of new questions, dropping a few questions, and rephrasing existing questions.
Proposed Requirements for Tobacco Products Manufacturing Practice; Tobacco Products Scientific Advisory Committee; Notice of Meeting; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Tobacco Products Scientific Advisory Committee (TPSAC). The general function of the committee is to provide advice and recommendations to FDA on regulatory issues related to tobacco products. This meeting will be held to discuss and provide an opportunity for recommendations on the Requirements for Tobacco Product Manufacturing Practice (TPMP) proposed rule. The meeting will be open to the public.
Proposed Requirements for Tobacco Product Manufacturing Practice; Public Hearing; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public oral hearing entitled ``Proposed Requirements for Tobacco Product Manufacturing Practice.'' The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to prescribe current good manufacturing practice (cGMP) or hazard analysis and critical control point methodology (HACCP) regulations related to the manufacture, preproduction design validation, packing, and storage of tobacco products to protect public health and ensure compliance with the FD&C Act. In accordance with this provision, FDA is proposing requirements for tobacco product manufacturing practice (TPMP) elsewhere in this issue of the Federal Register. The FD&C Act further requires FDA to afford an opportunity for an oral hearing on the proposed regulation. We are holding this public oral hearing to carry out this statutory mandate and obtain information and views on the proposed TPMP requirements.
Requirements for Tobacco Product Manufacturing Practice
The Food and Drug Administration (FDA, we, or Agency) is proposing to establish tobacco product manufacturing practice requirements for manufacturers of finished and bulk tobacco products. This proposed rule, if finalized, would set forth the requirements with which finished and bulk tobacco product manufacturers must comply in the manufacture, preproduction design validation, packing, and storage of finished and bulk tobacco products, to assure that the public health is protected and that tobacco products are in compliance with chapter IX of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Mammography Quality Standards Act
The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule to update the mammography regulations that were issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). We are issuing updates to modernize the regulations by incorporating current science and mammography best practices. These updates are intended to improve the delivery of mammography services by strengthening the communication of healthcare information; allowing for more informed decision making by patients and providers (by requiring facilities to provide them with additional health information); helping to ensure the availability of qualified mammography personnel; bolstering the medical outcomes audit to provide feedback to improve mammography interpretations; modernizing technological aspects of the standards; and adding additional tools to deal with noncompliant facilities.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: HRSA Grantee Customer Satisfaction Survey
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.
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Name and Address
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July, August, and September 2022. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy and readability of the regulations.
Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Babson Diagnostics, Inc., for the Babson Diagnostics aC19G1, and Twist Bioscience Corporation for the SARS-CoV-2 NGS Assay. FDA revoked these Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by each Authorization holder. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document.
Proposed Information Collection Activity; Generic for Administration for Children and Families Program Monitoring Activities (Office of Management and Budget)
The Administration for Children and Families (ACF) intends to request from the Office of Management and Budget (OMB) an extension of approval for an umbrella generic clearance for information collections related to ACF program office monitoring activities. ACF programs promote the economic and social well-being of families, children, individuals, and communities. The Generic for ACF Program Monitoring Activities allows ACF program offices to collect standardized information from recipients that receive federal funds to ensure oversight, evaluation, support purposes, and stewardship of federal funds. There are no changes proposed to the terms of the generic. Burden estimates have been updated.
Freedom of Information Act Predisclosure Notice
This notice informs submitters who reported COVID-19 data in 2020 for the High-Impact Area Distribution that HRSA received a Freedom of Information Act (FOIA) request for data reported to HHS that was used in determining COVID-19 High-Impact Area Distribution payments under the Provider Relief Fund. Specifically, the request seeks certain information pertaining to providers who did not receive COVID-19 High- Impact Area Distribution payments. This notice seeks input from these providers so that HRSA can respond to the FOIA request.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; State Plan for Independent Living Instrument and Instructions OMB Control Number 0985-0044
The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-day notice collects comments on the information collection requirements related to the State Plan for Independent Living Instrument and Instructions.
Supplemental Evidence and Data Request on Genitourinary Syndrome of Menopause
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Genitourinary Syndrome of Menopause, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Ryan White HIV/AIDS Program: Expenditures Forms, OMB No. 0915-xxxx-New
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.
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