Department of Health and Human Services October 2, 2023 – Federal Register Recent Federal Regulation Documents
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Human Prescription Drug and Biological Products-Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers-“Dose Banding”; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Human Prescription Drug and Biological ProductsLabeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers`Dose Banding.' '' The guidance is intended to assist applicants in incorporating dose banding information, based on dosing information of a previously approved drug product that is based on weight or body surface area (BSA), into the proposed labeling of injectable drug products that are the subject of certain marketing applications submitted to FDA. This guidance finalizes the draft guidance of the same title issued on July 21, 2022.
Proposed Information Collection Activity; Home-Based Child Care Toolkit for Nurturing School-Age Children Study (New Collection)
The Administration for Children and Families (ACF) Office of Planning, Research, and Evaluation (OPRE) at the U.S. Department of Health and Human Services (HHS) is proposing to collect information to examine a toolkit of new measures designed to assess and strengthen the quality of child care, the Home-Based Child Care Toolkit for Nurturing School-Age Children (HBCC-NSAC Toolkit). This study aims to build evidence about the English version of the HBCC-NSAC Toolkit for use by/ with providers caring for children in a residential setting (i.e., home-based child care [HBCC]).
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).
Solicitation of Nominations for Appointment to the Advisory Committee on Breast Cancer in Young Women (ACBCYW)
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the ACBCYW. The ACBCYW consists of 15 experts in fields associated with breast cancer, disease prevention, early detection, diagnosis, public health, social marketing, genetic screening and counseling, treatment, rehabilitation, palliative care, and survivorship in young women, or in related disciplines with a specific focus on young women.
Advisory Committee to the Director, Centers for Disease Control and Prevention
In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Committee to the Director, Centers for Disease Control and Prevention (ACD, CDC). This is a hybrid meeting, accessible both in person and virtually (webcast live via the World Wide Web). It is open to the public and limited only by the space available. Time will be available for public comment.
Advisory Committee on Immunization Practices (ACIP); Amended Notice of Meeting
The Centers for Disease Control and Prevention (CDC), announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public.
Support for Clinical Trials Advancing Rare Disease Therapeutics Pilot Program; Program Announcement
The Food and Drug Administration's (FDA or Agency) Center for Biologics Evaluation and Research's (CBER) Office of Therapeutic Products (OTP) and Center for Drug Evaluation and Research's (CDER) Office of New Drugs are announcing the opportunity for a limited number of development programs to participate in the Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program, with the goal of further accelerating the pace of development of certain CBER- and CDER-regulated products (novel drug and biological products) that are intended to treat a rare disease. Because each Center has identified specific needs concerning regulated products for rare diseases, the eligibility criteria for the pilot differ between CBER and CDER. This pilot would augment the currently available formal meetings between FDA and sponsors by addressing issues related to the development of individual products through more rapid, ad-hoc communication mechanisms. Sponsors, if selected for the pilot, would receive more frequent advice related to such specific issues through additional interactions to facilitate novel drug and biological product program development and generate high quality and reliable data intended to support a Biologics License Application (BLA) or New Drug Application (NDA). This notice outlines the eligibility criteria, what to submit in a request to participate in the pilot, selection criteria, process, and FDA-Sponsor interactions expected to occur for programs participating in the pilot.
Strengthening Temporary Assistance for Needy Families (TANF) as a Safety Net and Work Program
ACF proposes to amend the Temporary Assistance for Needy Families (TANF) program regulations to strengthen the safety net and reduce administrative burden. This NPRM encompasses a package of reforms to ensure TANF programs are designed and funds are used in accordance with the statute. In addition, the package includes provisions that are more technical in nature and are designed to reduce administrative burden and increase program effectiveness.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
On Monday, September 25, 2023, the Centers for Medicare & Medicaid Services (CMS) published a notice document entitled, ``Agency Information Collection Activities: Submission for OMB Review; Comment Request.'' That notice invited public comments on five separate information collection requests, under Document Identifiers: CMS-R-26, CMS-R- 185, CMS-116, CMS-2746 and CMS-10261. Through the publication of this document, we are withdrawing the portion of the notice requesting public comment on the information collection request titled, ``Clinical Laboratory Improvement Amendments (CLIA) Regulations.'' Form number: CMS-R-26 (OMB control number: 0938-0612). We are also withdrawing the portion of the notice requesting public comment on the information collection request titled, ``Granting and Withdrawal of Deeming Authority to Private Nonprofit Accreditation Organizations and CLIA Exemption Under State Laboratory Programs.'' Form number: CMS-R-185 (OMB control number 0938-0686).
Proposed Information Collection Activity; Application Requirements for the Low Income Home Energy Assistance Program (LIHEAP) Model Plan Application (Office of Management and Budget #0970-0075)
The Office of Community Services (OCS), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting to extend the currently approved Low Income Home Energy Assistance Program (LIHEAP) Model Plan Application (OMB #0970-0075, expiration 12/31/2023) through August 31, 2024, and then making significant revisions to the FY 2025 application to be effective September 1, 2024. This notice outlines the proposed revisions for FY 2025.
Proposed Collection; 60-Day Comment Request; ABCD Study® Audience Feedback Teams (National Institute on Drug Abuse)
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 Institute on Drug Abuse (NIDA) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Medicare and Medicaid Programs; Application From the Center for Improvement in Healthcare Quality for Initial CMS Approval of Its Psychiatric Hospital
This notice announces our decision to approve the Center for Improvement in Healthcare Quality (CIHQ) as a national accrediting organization (AO) for psychiatric hospitals that wish to participate in the Medicare or Medicaid programs.
Charter Renewal for the Advisory Committee on Infant and Maternal Mortality
In accordance with the Federal Advisory Committee Act, the Department of Health and Human Services is giving notice that the Advisory Committee on Infant and Maternal Mortality (ACIMM or Committee) is renewed. The effective date of the charter renewal is September 30, 2023.
Meeting Date for Ground Ambulance and Patient Billing (GAPB) Advisory Committee-October 31 and November 1, 2023
This notice announces that the date for the third public meeting of the Ground Ambulance and Patient Billing (GAPB) Advisory Committee is October 31, 2023 and November 1, 2023. The GAPB Advisory Committee will make recommendations with respect to the disclosure of charges and fees for ground ambulance services and insurance coverage, consumer protection and enforcement authorities of the Departments of Labor, Health and Human Services, and the Treasury (the Departments) and relevant States, and the prevention of balance billing to consumers. The recommendations shall address options, best practices, and identified standards to prevent instances of balance billing; steps that can be taken by State legislatures, State insurance regulators, State attorneys general, and other State officials as appropriate, consistent with current legal authorities regarding consumer protection; and legislative options for Congress to prevent balance billing.
Regional Pediatric Pandemic Network
HRSA provided additional award funds to the two Regional Pediatric Pandemic Network (RPPN) Program recipients in Maryland and Ohio with periods of performance ending in fiscal year 2024.
Guidelines for the Use of Doxycycline Post-Exposure Prophylaxis for Bacterial Sexually Transmitted Infection (STI) Prevention; Request for Comment and Informational Presentation
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the opening of a docket to obtain comment on proposed guidelines for the use of doxycycline post-exposure prophylaxis (PEP) for prevention of bacterial sexually transmitted infections (STI). The proposed guidelines for bacterial STI prevention include post-exposure prophylaxis with doxycycline (doxycycline PEP) because it has demonstrated benefit in reducing chlamydia, gonorrhea, and syphilis infections and represents a new approach to addressing STI prevention in populations at increased risk for these infections. Doxycycline PEP, when offered, should be implemented in the context of a comprehensive sexual health approach including risk reduction counseling, STI screening and treatment, recommended vaccination, and linkage to HIV pre-exposure prophylaxis (PrEP), HIV care, or other services, as appropriate. The purpose of the proposed guidelines is to provide updated clinical guidance for healthcare providers to inform the use of doxycycline PEP for preventing bacterial STI infections. CDC has made available a pre- recorded informational presentation to provide information about the studies considered when developing the proposed guideline, explain the public comment process, and provide an overview of important monitoring for antibiotic use and antibiotic resistance that the agency will be considering to address potential risks.
Announcement of the Intent To Award Three Supplements to Community Services Block Grant Award Recipients
OCS announces the intent to award a supplement in the amount of up to $3.6 million ($1.2 million per year for 3 fiscal years at $400,000 per individual award) to three Community Services Block Grant (CSBG) award recipients under Notice of Funding Opportunity (NOFO): Regional Performance and Innovation Consortia (RPIC) (HHS-2019-ACF-OCS- ET-1582, HHS-2019-ACF-OCS-ET-1586, and HHS-2019-ACF-OCS-ET-1587). The purpose of the RPIC awards is to support robust regional training and technical (T/TA) strategies for the CSBG Networkstates, territories, directly-funded tribes and tribal organizations, and CSBG-eligible entities, and state associations within the 10 ACF regions. The RPICs are designed to assist in meeting high organizational standards in the areas of consumer input and involvement, community engagement, community assessment, organizational leadership, board governance, strategic planning, human resource management, financial operations and oversight, and data and analysis. In addition, the RPICs identify, promote, and support multiyear T/TA efforts to ensure high-quality programs and services and impactful outcomes for individuals, families, and communities.
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