Department of Health and Human Services 2023 – Federal Register Recent Federal Regulation Documents
Results 651 - 700 of 3,523
Request for Information; Potential Changes to its Evidence-Based Practices Resource Center; Notice of Correction
The Substance Abuse and Mental Health Services Administration published a document in the Federal Register of September 7, 2023, announcing a Notice of request for information (RFI). The document contained incorrect date in the DATES section.
Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids
The Administration for Strategic Preparedness and Response is issuing this screening framework guidance, which sets forth baseline standards for the gene and genome synthesis industry, as well as best practices for all entities involved in the provision, use, and transfer of synthetic nucleic acids, regarding screening orders and recipients and maintaining records. In addition, this guidance seeks to encourage best practices to address biosecurity concerns associated with the potential misuse of synthetic nucleic acids in order to bypass existing regulatory controls and commit unlawful acts.
Biomedical Advanced Research and Development Authority Industry Day 2023
The Biomedical Advanced Research and Development Authority (BARDA) annually hosts BARDA Industry Day (BID), a two-day conference with industry and our government partners to share BARDA's goals and objectives, increase awareness of U.S. government medical countermeasure (MCM) priorities, and facilitate collaboration between public and private sectors within the health security space. This year, BARDA plans to discuss implementation efforts for our 2022-2026 Strategic Plan, which focuses on strengthening the health security of the nation, embracing lessons learned from the COVID-19 pandemic, incorporating new avenues of promising research and development, and addressing the imperative for MCMs that are safe, effective, and widely accessible.
Kerry Ingredients and Flavours Ltd.; Filing of Food Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Kerry Ingredients and Flavours Ltd., proposing that the food additive regulations be amended to provide for the safe use of vitamin D3 as a nutrient supplement in powdered drink mixes added to water or carbonated water, excluding drinks or drink mixes that are specially formulated or processed for infants.
Kerry Inc.; Filing of Food Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Kerry, Inc., proposing that the food additive regulations be amended to provide for the safe use of sodium alginate as a stabilizer and thickener in plant protein products at a level not to exceed 3 percent.
Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Recall Regulations
The Food and Drug Administration (FDA, Agency, or we) 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 FDA Recall Regulations.
Quality Considerations for Topical Ophthalmic Drug Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Quality Considerations for Topical Ophthalmic Drug Products.'' This draft guidance discusses certain quality considerations for ophthalmic drug products (i.e., solutions, suspensions, emulsions, gels, ointments, and creams) intended for topical delivery in and around the eye. Specifically, this draft guidance discusses approaches to evaluating visible particulate matter, extractables and leachables, and impurities and degradation products; use of in vitro drug release/dissolution testing as an optional quality control strategy for certain ophthalmic dosage forms; recommendations for design and delivery and dispensing features of container closure systems; and recommendations for stability studies. The draft guidance applies to ophthalmic drug products approved under new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs), as well as to over-the-counter (OTC) monograph drugs.
Prior Notice of Imported Food Questions and Answers (Edition 4): Guidance for Industry; Availability
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled ``Prior Notice of Imported Food Questions and Answers (Edition 4): Guidance for Industry.'' The guidance document updates the current version of the guidance by including three additional questions. One question relates to any effect systems recognition or equivalency determinations have on prior notice requirements. The other two questions relate to FDA's notice to a submitter or transmitter of prior notice of an FDA refusal for inadequate prior notice or hold, if the food article is from a foreign facility that is not registered and addresses the timeframe for making requests for FDA review of such refusal or hold. FDA is also making other technical editorial changes. The guidance announced in this notice finalizes the draft guidance of the same title dated September 13, 2022.
Proposed Information Collection Activity; Tribal Child Support Enforcement Direct Funding Request: (Office of Management and Budget #0970-0218)
The Office of Child Support Services (OCSS), Administration for Children and Families (ACF) is requesting proposed revisions to an approved information collection the Tribal Child Support Enforcement Direct Funding Requests(Office of Management and Budget (OMB) #0970- 0218, expiration March 31, 2026). We are proposing a new requirement for tribes or tribal organizations to provide that charging fees and recovering costs will not be permitted.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Importation of Prescription Drugs
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.
Submission for Office of Management and Budget Review; Evaluation of Resources To Support the Identification and Care of Children With Prenatal Substance or Alcohol Exposure in the Child Welfare System (Office of Management and Budget #0970-0608)
The Children's Bureau (CB), Administration for Children and Families (ACF), U.S. Department of Health and Human Services, is proposing to collect data for an evaluation of a set of resources that are being developed to support the identification and care of children with prenatal substance or alcohol exposure in the child welfare system.
Mandatory Guidelines for Federal Workplace Drug Testing Programs
The Department of Health and Human Services (``HHS'' or ``Department'') has revised the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG) which published in the Federal Register of October 25, 2019.
Mandatory Guidelines for Federal Workplace Drug Testing Programs
The Department of Health and Human Services (``HHS'' or ``Department'') has revised the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG), which published in the Federal Register of January 23, 2017.
Meeting of the Advisory Committee on Infant and Maternal Mortality
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Infant and Maternal Mortality (ACIMM) has scheduled a public meeting. Information about ACIMM and the agenda for this meeting can be found on the ACIMM website at https://www.hrsa.gov/advisory- committees/infant-mortality/.
Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
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 the collections of information in the regulations for in vivo radiopharmaceuticals used for diagnosis and monitoring.
Supplemental Evidence and Data Request on Documentation Burden
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 Documentation Burden, 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; Comment Request; Cattle Materials Prohibited From Use in Animal Food or Feed
The Food and Drug Administration (FDA, Agency, or we) 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 the reporting and recordkeeping requirements for cattle materials prohibited from use in animal food or feed.
Determination That CYTOXAN (Cyclophosphamide) for Injection (Sterile Dry Powder Excipient-Free Formulation), 500 Milligrams/Vial, 1 Gram/Vial, and 2 Grams/Vial, and CYTOXAN (Cyclophosphamide) for Injection (Sterile Dry Powder With Sodium Chloride Formulation), 500 Milligrams/Vial, 1 Gram/Vial, and 2 Grams/Vial, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or the Agency) has determined that the sterile dry powder excipient-free formulation of CYTOXAN (cyclophosphamide) for Injection, 500 milligrams (mg)/vial, 1 gram (g)/vial, and 2 g/vial, and the sterile dry powder with sodium chloride formulation of CYTOXAN (cyclophosphamide) for Injection, 500 mg/vial, 1 g/vial, and 2 g/vial, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to the sterile dry powder excipient- free formulation or the sterile dry powder with sodium chloride formulation of these drug products, and it will allow FDA to continue to approve ANDAs that refer to these formulations of CYTOXAN as long as they meet relevant legal and regulatory requirements.
Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children
In accordance with 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 to be held on Thursday, November 2, 2023, and Friday, November 3, 2023. Information about the ACHDNC and the agenda for this meeting can be found on the ACHDNC website at https://www.hrsa.gov/advisory- committees/heritable-disorders/.
Determination That MEKINIST (Trametinib Dimethyl Sulfoxide) Tablets, 1 Milligram, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or the Agency) has determined that MEKINIST (trametinib dimethyl sulfoxide) tablets, 1 milligram (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for trametinib dimethyl sulfoxide tablets, 1 mg, if all other legal and regulatory requirements are met.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers
The Food and Drug Administration (FDA, we, or us) 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.
Request for Nominations for Voting Members for the Digital Health Advisory Committee
The Food and Drug Administration (FDA or Agency) is requesting nominations for voting members, excluding consumer and industry representatives, to serve on the Digital Health Advisory Committee (the Committee) in the Center for Devices and Radiological Health. Nominations will be accepted for current vacancies effective with this notice. FDA seeks to include the views of members of all gender groups, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
Request for Nominations of Individuals and Industry Organizations for the Digital Health Advisory Committee
The Food and Drug Administration (FDA or Agency) is requesting nominations for temporary nonvoting industry representatives to be included in a pool of individuals to serve on the Digital Health Advisory Committee. FDA is also requesting that industry organizations interested in participating in the selection of a pool of nonvoting industry representatives to serve as temporary nonvoting members on the Digital Health Advisory Committee (the Committee) in the Center for Devices and Radiological Health notify FDA in writing. Nominees recommended to serve as a temporary nonvoting industry representative may either be self-nominated or nominated by an industry organization. This position may be filled by representatives of different medical device areas based on areas of expertise relevant to the topics being considered by the Committee. Nominations will be accepted for current vacancies effective with this notice. FDA seeks to include the views of members of all gender groups, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore encourages nominations of appropriately qualified candidates from these groups.
Request for Nominations of Individuals and Consumer Organizations for the Digital Health Advisory Committee
The Food and Drug Administration (FDA or Agency) is requesting nominations for a voting consumer representative to serve on the Digital Health Advisory Committee. FDA is also requesting that any consumer organizations interested in participating in the selection of a voting consumer representative to serve on the Digital Health Advisory Committee notify FDA in writing. Nominees recommended to serve as a voting consumer representative may either be self-nominated or may be nominated by a consumer organization. Nominations will be accepted for the current vacancy effective with this notice. FDA seeks to include the views of members of all gender groups, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore encourages nominations of appropriately qualified candidates from these groups.
Advisory Committee; Digital Health Committee; Establishment
Under the Federal Advisory Committee Act, the Food and Drug Administration (FDA or Agency) is announcing the establishment of the Digital Health Advisory Committee. The Commissioner of Food and Drugs (Commissioner) has determined that it is in the public interest to establish such a committee. Duration of this committee is 2 years from the date the Charter is filed, unless the Commissioner formally determines that renewal is in the public interest.
Agency Information Collection Activities; Proposed Collection; Comment Request; Adherence Potential and Patient Preference in Prescription Drug Promotion
The Food and Drug Administration (FDA, Agency, or we) 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed study entitled ``Adherence Potential and Patient Preference in Prescription Drug Promotion.''
Meeting of the Advisory Commission on Childhood Vaccines
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Commission on Childhood Vaccines (ACCV) will hold public meetings for the 2024 calendar year (CY). Information about ACCV, agendas, and materials for these meetings can be found on the ACCV website at https://www.hrsa.gov/advisory- committees/vaccines/.
Medicare Program; Medicare Secondary Payer and Certain Civil Money Penalties
This final rule will specify how and when CMS must calculate and impose civil money penalties (CMPs) when group health plan (GHP) and non-group health plan (NGHP) responsible reporting entities (RREs) fail to meet their Medicare Secondary Payer (MSP) reporting obligations by failing to register and report as required by MSP reporting requirements. This final rule will also establish CMP amounts and circumstances under which CMPs will and will not be imposed.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Healthcare Infection Control Practices Advisory Committee (HICPAC)
In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Healthcare Infection Control Practices Advisory Committee (HICPAC). This is a virtual meeting. The public is welcomed to listen to the meeting live via webcast on the World Wide Web. The webcast link can be found on the HICPAC website at www.cdc.gov/hicpac/meeting.html. Time will be available for public comment.
Submission for Office of Management and Budget Review; Generic for Administration for Children and Families Program Monitoring Activities (Office of Management and Budget #: 0970-0558)
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.
Second Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications
On March 1, 2023 the Drug Enforcement Administration (DEA), in concert with the Department of Health and Human Services (HHS), promulgated two notices of proposed rulemakings (NPRMs) soliciting comments on proposals to allow for prescribing of controlled medications pursuant to the practice of telemedicine in instances where the prescribing practitioner has never conducted an in-person medical evaluation of the patient. On May 10, 2023, following initial review of the comments received, DEA, jointly with HHS, issued a temporary rule (First Temporary Rule) extending certain exceptions granted to existing DEA regulations in March 2020 as a result of the COVID-19 Public Health Emergency (COVID-19 PHE). These exceptions were granted in order to avoid lapses in care for patients. In particular, with respect to practitioner-patient relationships formed after the May 11, 2023, expiration of the COVID-19 PHE, the First Temporary Rule extended the temporary exceptions until November 11, 2023. In this second temporary rule, as DEA and HHS continue to consider revisions to the proposed rules set forth in the March 1, 2023 NPRMs and in light of Telemedicine Listening Sessions that DEA hosted on September 12 and 13, 2023, DEA and HHS are further extending such exceptions to existing DEA regulations for new practitioner-patient relationships through December 31, 2024.
Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of Mpox; Availability
The Food and Drug Administration (FDA) is announcing the revocations of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Life Technologies Corp. (a part of Thermo Fisher Scientific Inc.), for the TaqPath Monkeypox/Orthopox Virus DNA Kit, and Becton, Dickinson and Co., for the VIASURE Monkeypox virus Real Time PCR Reagents for BD MAX System. FDA revoked these Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by these Authorization holders. The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document.
Food and Drug Administration Information Technology Strategy; Request for Comments; Correction
The Food and Drug Administration (FDA or Agency) is correcting a notice entitled ``Food and Drug Administration Information Technology Strategy; Request for Comments'' that appeared in the Federal Register of September 19, 2023. The document announced the availability of an information technology (IT) strategic plan entitled the ``FDA Information Technology Strategy'' and a request for comment on this IT Strategy. The document was published with an incorrect set of fiscal year information. This document corrects that error.
Public Health Service Policies on Research Misconduct
In this Notice of Proposed Rulemaking (NPRM), the Department of Health and Human Services (HHS), Office of the Secretary, Office of the Assistant Secretary for Health (OASH), Office of Research Integrity (ORI) proposes to revise the Public Health Service (PHS) Policies on Research Misconduct. The proposed revisions are based on the experience ORI and institutions have gained with the regulation since it was released in 2005. This NPRM seeks comment from individuals, institutional officials, organizations, institutions, research funding agencies, and other members of the public on the proposed revisions and how to improve the clarity of substantive and non-substantive.
Annual Civil Monetary Penalties Inflation Adjustment
The Department of Health and Human Services (HHS) is updating its regulations to reflect required annual inflation-related increases to the civil monetary penalty (CMP) amounts in its regulations, under the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 and adds references to new penalty authorities.
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 or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comments on a proposed information collection titled Surveillance of HIV-related service barriers among Individuals with Early or Late HIV Diagnoses (SHIELD), which collects information from people who were recently diagnosed with HIV at early (Stage 0) or late diagnosis (Stage 3) to understand barriers to HIV prevention and testing services to contributing to transmission.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
