Department of Health and Human Services 2024 – Federal Register Recent Federal Regulation Documents

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcomed to listen to the meeting by joining the teleconference (information below). The audio conference line has 150 ports for callers.

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 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.

HRSA is inviting public comment on the draft Health Center Program Policy Guidance Regarding Services to Support Transitions in Care for Justice-Involved Individuals Reentering the Community. The purpose of the draft Policy Information Notice (PIN) is to propose Health Center Program policy guidance for all health centers that apply for and receive federal award funds under the Health Center Program, as authorized by section 330 of the Public Health Service (PHS) Act (including sections 330(e), (g), (h), and (i)), as well as section 330 subrecipient organizations and Health Center Program look-alikes, to clarify the conditions under which they may provide certain health services as part of the Health Center Program scope of project to certain incarcerated/detained individuals. This draft PIN establishes policy guidance that identifies a set of health services that a health center may provide, the locations at which such services may be provided, the target population for such services (specifically, incarcerated/detained individuals who are scheduled for release from a carceral setting within 90 days), and other pertinent circumstances under which the health center may, on its own behalf and subject to all section 330 requirements, provide such services to justice-involved individuals reentering the community to support their care transition from the carceral setting to the community within the scope of their Health Center Program project.

The Food and Drug Administration (FDA) 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.

The Food and Drug Administration (FDA, Agency, or we) has determined that VISTARIL (hydroxyzine pamoate) Oral Suspension, 25 milligrams (mg)/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for VISTARIL (hydroxyzine pamoate) Oral Suspension, 25 mg/5 mL, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA, Agency, 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.

The Administration for Children and Families (ACF) proposes to extend data collection under the existing overarching Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (Office of Management and Budget (OMB) #0970-0401). There are no changes to the proposed types of information collection or uses of data, but ACF is requesting an increase to the estimated number responses per respondent.

Findings of research misconduct have been made against Gian- Stefano Brigidi, Ph.D. (Respondent), who was a Postdoctoral Fellow, Department of Neurobiology, University of California San Diego (UCSD), and was an Assistant Professor, Department of Neurobiology, University of Utah (UU). Respondent engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Institute of Mental Health (NIMH), National Institutes of Health (NIH), grant F32 MH110141, National Human Genome Research Institute (NHGRI), NIH, grant T32 HG000044, National Institute of Neurological Disorders and Stroke (NINDS), NIH, grant P30 NS047101, and National Library of Medicine (NLM), NIH, grant T15 LM011271. The research was included in grant applications submitted for PHS funds, specifically R01 NS131809-01, R01 NS133405-01, DP2 NS127276-01, and R01 NS111162-01A1 submitted to NINDS, NIH, and R21 MH121860-01, R21 MH121860-01A1, F32 MH110141-01, F32 MH110141-01A1, and F32 MH110141- 01AS1 submitted to NIMH, NIH. The administrative actions, including supervision for a period of five (5) years, were implemented beginning on March 24, 2024, and are detailed below.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of the Agency's annual compilation of notices of updates to the Agency's Susceptibility Test Interpretive Criteria web page. The Agency established the Susceptibility Test Interpretive Criteria web page on December 13, 2017, and since establishment has provided updates to both the format of the web pages and the susceptibility test interpretive criteria identified and recognized by FDA on the web pages. FDA is publishing this notice in accordance with procedures established by the 21st Century Cures Act (Cures Act).

The Food and Drug Administration (FDA or the Agency) is announcing the following public meeting entitled "Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments." The topic to be discussed is the financial transparency and efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.

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.

The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group (IRG) Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will be closed to the public.

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 Assisted Reproductive Technology (ART) Program Reporting System. This study is designed to collect information on ART cycles to publish information on pregnancy success rates as required under Section 2(a) of the Federal Clinic Success Rate and Certification Act (FCSRCA).

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 DFWED National Hypothesis Generation and Investigation Module. The proposed data collection will define a core set of standardized data elements and forms used for outbreak investigations and surveillance activities for a variety of enteric illnesses.

The Food and Drug Administration (FDA or the Agency) is requesting nominations for voting members, excluding consumer and industry representatives, to serve on the Patient Engagement Advisory Committee (the Committee) in the Center for Devices and Radiological Health. Nominations will be accepted for upcoming 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.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Robert Lance Shuffert for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Shuffert was convicted of one felony count under Federal law for, with the intent to defraud and mislead, causing a drug to be misbranded while it was held for sale after shipment in interstate commerce. The factual basis supporting Mr. Shuffert's conviction, as described below, is conduct relating to the importation into the United States of any drug or controlled substance. Mr. Shuffert was given notice of the proposed debarment and an opportunity to request a hearing to show why he should not be debarred. As of March 4, 2024 (30 days after receipt of the notice), Mr. Shuffert had not responded. Mr. Shuffert's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the renewal of the charter of the Advisory Board on Radiation and Worker Health (ABRWH).

This proposed rule would update the hospice wage index, payment rates, and aggregate cap amount for Fiscal Year (FY) 2025. This rule proposes changes to the Hospice Quality Reporting Program. This rule also proposes to adopt the most recent Office of Management and Budget statistical area delineations, which would change the hospice wage index. This rule proposes to clarify current policy related to the "election statement" and the "notice of election", as well as to add clarifying language regarding hospice certification. Finally, this rulemaking solicits comments regarding potential implementation of a separate payment mechanism to account for high intensity palliative care 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 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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Data Integrity for In Vivo Bioavailability and Bioequivalence Studies." The purpose of this guidance is to provide recommendations to applicants and testing site management on achieving and maintaining data integrity for the clinical and bioanalytical portions of bioavailability (BA) and bioequivalence (BE) studies submitted in support of investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and the bioanalytical portion of clinical pharmacologic studies supporting Center for Drug Evaluation and Research-regulated biologic license applications (BLAs) as well as amendments and supplements to these applications. In addition, the recommendations in this guidance apply to the bioanalytical portion of nonclinical studies. FDA also encourages applicants and testing sites to consider these recommendations when conducting other studies, including in vitro and pharmacology and toxicology studies.

This rulemaking proposes to update the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital. This rulemaking also proposes to revise the patient-level adjustment factors, the Emergency Department adjustment, and the payment amount for electroconvulsive therapy. These proposed changes would be effective for IPF discharges occurring during the fiscal year beginning October 1, 2024 through September 30, 2025 (FY 2025). In addition, this proposed rule seeks to adopt a new quality measure and modify reporting requirements under the IPF Quality Reporting Program beginning with the FY 2027 payment determination. Furthermore, this proposed rule solicits comments through Requests for Information (RFIs) regarding potential future revisions to the IPF PPS facility-level adjustments and regarding the development of a standardized IPF Patient Assessment Instrument.

In compliance with the Paperwork Reduction Act of 1995, HRSA 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.

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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Draft Guidance on Oxymetazoline Hydrochloride." The draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for oxymetazoline hydrochloride ophthalmic solution.

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.

In compliance with the Paperwork Reduction Act of 1995, HRSA 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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies." This guidance provides instructions for the electronic submission of expedited individual case safety reports (ICSRs) from investigational new drug (IND)-exempt bioavailability (BA)/bioequivalence (BE) studies to the FDA Adverse Event Reporting System (FAERS). This guidance finalizes the draft guidance entitled "Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies" issued on August 3, 2022.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is seeking nominations for membership on the Communications and Public Engagement Workgroup (CPEW) of the Advisory Committee to the Director, CDC. The CPEW consists of approximately 15 members who are experts in fields associated with communications, including public relations, health communication, risk communication, communication research, and marketing; community and partner engagement; public health science and practice, including implementation; and behavioral science/behavior change campaigns.

Notice is hereby given that the Indian Health Service (IHS) has updated the geographic boundaries of the purchased/referred care delivery area (PRCDA) for the Mississippi Band of Choctaw Indians to include the counties of Carroll and Jackson in the State of Mississippi and the county of Lauderdale in the State of Tennessee. The PRCDA for the Mississippi Band of Choctaw Indians now comprises the Mississippi counties of Attala, Carroll, Jackson, Jasper, Jones, Kemper, Leake, Neshoba, Newton, Noxubee, Scott, and Winston, and the Tennessee county of Lauderdale. The sole purpose of this expansion is to authorize additional Mississippi Band of Choctaw Indians members and beneficiaries to receive purchased/referred care (PRC) services.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting conducted as a webcast on April 18, 2024. This virtual meeting will be open to the public. Registration is required for the public to attend the meeting, provide comment, and/or distribute material(s) to ACMH members. Any individual who wishes to participate in the virtual meeting should register using the Zoom registration link provided below by 5:00 p.m. EDT on April 12, 2024. Instructions regarding participating in the call and providing written or verbal public comments will be provided after meeting registration occurs. Information about the meeting will be posted on the HHS Office of Minority Health (OMH) website: www.minorityhealth.hhs.gov. Information about ACMH activities can be found on the OMH website under the heading About OMH, Committees and Working Groups.

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.

The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data from Eligible Afghan Arrivals (EAAs) in need of direct legal services through Immigration Legal Services for Afghan Arrivals (ILSAA) to determine eligibility.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Providing Regulatory Submissions in Electronic Format: IND Safety Reports." This guidance finalizes the draft guidance of the same name published on October 30, 2019, and describes the electronic format sponsors will be required to use when they electronically submit investigational new drug application (IND) safety reports to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) for serious and unexpected suspected adverse reactions, as required by FDA regulations. FDA is establishing the electronic format requirements described in this guidance under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The requirements in the guidance will be effective 24 months after the date of publication (April 1, 2026). Certain sponsors will be required to submit the specified IND safety reports electronically to FDA using the FDA Adverse Event Reporting System (FAERS) as structured data elements, which will provide sponsors with a reporting format that is consistent with the International Council for Harmonisation (ICH) E2B format guidelines and reporting requirements to other regulatory agencies.

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. Information about ACHDNC and the agenda for this meeting can be found on the ACHDNC website at https://www.hrsa.gov/advisory- committees/heritable-disorders/.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is seeking nominations for membership on the Mine Safety and Health Research Advisory Committee (MSHRAC). MSHRAC consists of 10 experts in fields associated with mine safety and health research.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Animal Studies for Dental Bone Grafting Material DevicesPremarket Notification (510(k)) Submissions." This draft guidance document provides animal study design recommendations and animal study information to include to support a 510(k) submission for dental bone grafting material devices. This draft guidance may help manufacturers comply with some special controls for dental bone grafting material devices. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of these submissions. This draft guidance is not final nor is it for implementation at this time.

The Food and Drug Administration (FDA or the Agency) is announcing the over-the-counter (OTC) monograph drug facility (MDF) fee rates under the OTC monograph drug user fee program (OMUFA) for fiscal year (FY) 2024. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters of OTC monograph order requests (OMORs). This notice publishes the OMUFA facility fee rates for FY 2024.

This rule proposes updates to the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2025. As required by statute, this proposed rule includes the classification and weighting factors for the IRF prospective payment system's case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2025. We are proposing updates to the Office of Management and Budget (OMB) market area delineations for the IRF prospective payment system (PPS) wage index and proposing to apply a 3-year phase-out of the rural adjustment. This rule also includes proposals for the IRF Quality Reporting Program (QRP).

The Family and Youth Services Bureau's Runaway and Homeless Youth (RHY) Program is requesting a 3-year extension of the Runaway and Homeless YouthHomeless Management Information System (RHY-HMIS) data collection efforts (OMB #0970-0573, expiration 07/31/2024). There are no changes requested to the data elements.

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 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.

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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Handling and Retention of BA and BE Testing Samples.'' This guidance is intended to provide recommendations for applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs), including supplemental applications, and contract research organizations (CROs), regarding the procedures for handling reserve samples from relevant bioavailability (BA) and bioequivalence (BE) studies, and recommendations regarding responsibilities of each party involved in the study pertaining to reserve samples. Additionally, this guidance describes the conditions under which the Agency generally does not intend to take enforcement action against an applicant or CRO that retains less than the quantity of reserve samples specified in the regulation.

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 information collection requirements for a voluntary survey for the Department of Health and Human Services (HHS), the U.S. Department of Agriculture (USDA), and the Department of Homeland Security (DHS), which will inform the FDA Food Safety Modernization Act (FSMA), National Agriculture and Food Defense Strategy (NAFDS) Report to Congress. The proposed survey will be used to determine what food defense activities, if any, State, local, territorial, and/or tribal (SLTT) agencies have completed to date. The information will be compared to the initial baseline data previously collected by State(s).

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish a 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 collection of information extension solicits comments on the information collection requirements relating to the State Plan of Assistive Technology (OMB Control Number 0985-0048).

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.

The Food and Drug Administration (FDA or Agency) is announcing that it is withdrawing approval of the indications for the treatment of adult patients with advanced ovarian cancer for poly (ADP-ribose) polymerase (PARP) inhibitors under three new drug applications (NDAs) from multiple applicants. The applicants Clovis Oncology, Inc. (Clovis), AstraZeneca Pharmaceuticals LP (AZ), and GlaxoSmithKline, LLC (GSK) have each voluntarily requested that the Agency withdraw approval of the indications for the treatment of adult patients with advanced ovarian cancer for their respective PARP inhibitors and waived their opportunities for hearings. Applicant and indication details are further discussed in SUPPLEMENTARY INFORMATION.

The Food and Drug Administration's (FDA or Agency) Center for Biologics Evaluation and Research (CBER) is announcing support for the Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Nonclinical Data Implementation GuideAnimal Rule Version 1.0 (SENDIG-AR v1.0) on March 26, 2024, and this standard will be required in submissions to CBER for studies that start after March 15, 2027. The Agency will update the FDA Data Standards Catalog (Catalog) to reflect this change.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Phillip Leonowens for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Leonowens was convicted of one felony count under Federal law for conspiracy to smuggle goods into the United States. The factual basis supporting Mr. Leonowens' conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Leonowens was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of December 31, 2023 (30 days after receipt of the notice), Mr. Leonowens had not responded. Mr. Leonowens's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

The Food and Drug Administration (FDA, Agency, or we) has determined that ISUPREL (isoproterenol hydrochloride) injection, 0.2 milligrams (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for ISUPREL (isoproterenol hydrochloride) injection, 0.2 mg/mL, if all other legal and regulatory requirements are met.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that an in-person meeting is scheduled to be held for the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). The meeting will be open to the public as well as streamed live on hhs.gov/live. A pre-registered public comment and innovation spotlight session will be held during the meeting. Pre-registration is required for members of the public who wish to present their comments or innovations live during the meeting. Individuals who wish to send in their written public comment should send an email to CARB@hhs.gov. Registration information is available on the website https:// www.hhs.gov/paccarb and must be completed by May 16, 2024, to attend the May 21-22, 2024, public meeting or by May 14, 2024, to provide live comments at the meeting. Additional information about registering for the meeting and providing public comment can be obtained at https:// www.hhs.gov/ paccarb on the Upcoming Meetings page.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

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 the Paperwork Reduction Act of 1995. This 30-day notice collects comments on the information collection requirements related to the ACL Program Performance Report Generic Information Collection, OMB 0985-NEW.

The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Martin Valdes, M.D., from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Valdes was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product under the FD&C Act. Dr. Valdes was given notice of the proposed permanent debarment and an opportunity to request a hearing to show why he should not be debarred. As of January 7, 2023 (30 days after receipt of the notice), Dr. Valdes had not responded. Dr. Valdes's failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of his right to a hearing concerning this action.

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 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.

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 Generic Clearance for the Collection of Minimal Data Necessary for Case Data During an Emergency Response. This information collection will allow CDC to collect the minimum data necessary for confirmed, probable, and suspected cases of any disease or condition that is the subject of an emergency response.

This final notice announces our decision to approve the Utilization Review Accreditation Commission (URAC) for continued recognition as a national accrediting organization that accredits suppliers of home infusion therapy (HIT) services that wish to participate in the Medicare or Medicaid programs.

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) concerning a proposed authorization to conduct the generic solution for solicitation for awards for HRSA-funded programs that provide one-time funding, including pilot programs. 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.

The Food and Drug Administration (FDA or we) is amending its regulations relating to the procedures for determining that a premarket notification for a food contact substance (FCN) is no longer effective. The final rule provides additional reasons that could form the basis for FDA to determine that an FCN is no longer effective. The final rule also ensures that manufacturers or suppliers have the opportunity to provide input before we determine that an FCN is no longer effective. We are making these changes to allow FDA to respond better to new information on the safety and use of food contact substances (FCSs), as well as manufacturers' business decisions, and also improve the efficiency of the premarket notification program.

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Life Technologies Corp. (a legal entity of Thermo Fisher Scientific, Inc.), for the TaqPath COVID-19 Pooling Kit; Bio-Rad Laboratories, Inc., for the Reliance SARS-CoV-2 RT-PCR Assay Kit; Revvity, Inc., (on behalf of Revvity Omics (a Revvity, Inc. company that was a rebranding of PerkinElmer Genomics)), for the PerkinElmer SARS-CoV-2 RT-qPCR Reagent Kit; bioM[eacute]rieux SA for the VIDAS SARS-CoV-2 IgM kit; bioM[eacute]rieux SA for the VIDAS SARS- CoV-2 IgG kit; and Luminex Corp. for the xMAP SARS-CoV-2 Multi-Antigen IgG Assay. FDA revoked the Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products.'' FDA is issuing this draft guidance as part of a series of guidance documents under its Real-World Evidence (RWE) Program and to satisfy, in part, a mandate under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to issue guidance about the use of RWE in regulatory decision-making. The draft guidance provides recommendations to sponsors who are considering submitting a non- interventional study, also referred to as an observational study, to FDA to contribute to a demonstration of substantial evidence of effectiveness and/or evidence of safety of a drug. This draft guidance was developed in response to stakeholders' growing interest in the potential use of non-interventional studies to contribute to a demonstration of the effectiveness or safety of a drug.

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 reporting, recordkeeping, and third-party disclosure burden associated with the veterinary feed directive 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 the reporting and recordkeeping requirements of our regulations implementing the Federal Import Milk Act (FIMA).

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.