Department of Health and Human Services 2023 – Federal Register Recent Federal Regulation Documents

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.

The Food and Drug Administration (FDA) is issuing an order, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), withdrawing its January 25, 2023, order debarring Mark Moffett from providing services in any capacity to a person with an approved or pending drug product application. FDA is issuing this order because the U.S. Court of Appeals for the First Circuit vacated Mr. Moffett's convictions and sentence.

The Food and Drug Administration (FDA or the Agency) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to the Agency on pediatric regulatory issues. At least one portion of the meeting will be closed to the public. FDA is establishing a docket for public comment on this document.

The Food and Drug Administration (FDA or Agency), in collaboration with the Clinical Trials Transformation Initiative (CTTI), is requesting applications from patient advocates interested in participating on the Patient Engagement Collaborative (PEC). The PEC is an ongoing, collaborative forum coordinated through the FDA's Patient Affairs Staff, Office of Clinical Policy and Programs (OCPP), Office of the Commissioner at FDA, and is hosted by CTTI. Through the PEC, the patient community and FDA Staff are able to discuss an array of topics related to increasing meaningful patient engagement with diverse populations in medical product development and regulatory discussions at FDA. The activities of the PEC may include, but are not limited to, providing diverse perspectives on topics such as systematic patient engagement, transparency, and communication; providing considerations for implementing new strategies to enhance patient engagement at FDA; and proposing new models of collaboration in which patient, caregiver and patient advocate perspectives are incorporated into general medical product development and regulatory processes.

The Administration for Children and Families (ACF) is requesting a 3-year extension of the form ACF-123: Guidance for the Tribal Temporary Assistance for Needy Families (TANF) Program (Office of Management and Budget (OMB) #0970-0157, expiration date: August 31, 2023). There are minor clarifying changes requested to the guidance.

The Food and Drug Administration (FDA) is amending its regulations to reflect a change in the name of Division of Dockets Management to Dockets Management Staff and information regarding copies. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.

This is a notice of proposed rulemaking (NPRM) to repromulgate and revise certain regulatory provisions of the HHS, Uniform Administrative Rule Requirements, Cost Principles, and Audit Requirements for HHS Awards, previously set forth in a final rule published in the Federal Register.

The Administration for Community Living (ACL) announces the intent to award a single-source supplemental to the current cooperative agreement held by the National Council on Aging (NCOA) for the National Center for Benefits Outreach and Enrollment (NCBOE). The purpose of the NCBOE is to provide technical assistance to states, Area Agencies on Aging, Aging and Disability Resource Centers and service providers who conduct outreach and low-income benefits enrollment assistance, particularly to older individuals with greatest economic need for federal and state programs. The administrative supplement for FY 2023 will be for $1,932,521, bringing the total award for FY 2023 to $13,432,521.

The Administration for Community Living (ACL) announces the intent to award a single-source supplement to the current cooperative agreement held by the National Council on Aging for the Strengthening the Direct Care Workforce: A Technical Assistance and Capacity Building Initiative. The administrative supplement for FY 2023 will be in the amount of $1,974,846, bringing the total award for FY 2023 to $3,269,466. The supplement will provide sufficient resources to enable the grantee and their partners to increase funding for technical assistance (TA) to state aging and disability partnerships to collaborate with workforce entities to strengthen the Direct Care Workforce (DCW). The funding will enable the grantee to support additional states, including at more robust levels than originally planned. The funding will also enable additional work to strengthen the self-direction workforce by identifying gaps in knowledge and highlighting best practices to support and sustain those who self- direct, for dissemination via the DCW resource hub to a national audience.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.''

CDC has modified its structure. This notice announces the reorganization of the Office of Readiness and Response (ORR). ORR reorganized to improve rapid response to disease outbreaks and public health emergencies within the United States and around the world. It is critical for CDC's internal emergency response structure and readiness capabilities align with the changing public health landscape in order to best protect populations that are at increased risk of death, disability, and disease before, during, and after responses.

CDC has modified its structure. This notice announces the reorganization of the Office of Communications (OC). OC has established the Office of Emergency Risk Communications by realigning the Emergency Risk Communications Branch formerly of the Center for Preparedness and Response, Division of Emergency Operations. Additionally, OC retitled and updated mission and functional statements updates to some organizational entities.

CDC has modified its structure. This notice announces the reorganization of the Office of Public Health Data, Surveillance, and Technology (OPHDST).

CDC has modified its structure. This notice announces the reorganization of the Office of Safety, Security and Asset Management (OSSAM). OSSAM realigned internal emergency management functions with related functions such as public health emergency response functions to a single leader.

CDC has modified its structure. This notice announces the reorganization of the Office of Financial Resources (OFR). OFR established an activity in the Office of the Director, established two branches, and renamed existing branches within the Office of Acquisition Services.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Nonprescription Drugs Advisory Committee (the 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.

CDC has modified its structure. This notice announces the reorganization of the Global Health Center (GHC). GHC reorganized to ensure optimal strategic planning and implementation of CDC's global health work to protect the United States and achieve global public health impact.

CDC has modified its structure. This notice announces the reorganization of the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID). NCEZID reorganized to improve collaboration between science and public health programs within NCEZID as well as with our partners across and outside the agency, which will increase our public health impact.

The CFPB, an independent agency, HHS, and the Treasury (collectively, the agencies), are soliciting comments from the public and interested parties on medical credit cards, loans, and other financial products used to pay for health care. The agencies seek to understand the prevalence, nature, and impact of these products, including disparities across different demographic groups. The agencies also seek to understand the effects these products may have on patients and on the health care system. In particular, the agencies seek comment on whether these products may allow health care providers to operate outside of a broad range of patient and consumer protections. The agencies also seek comment on whether these products may contribute to health care cost inflation, displace hospitals' provision of financial assistance, lead patients to pay inaccurate or inflated medical bills, increase the amount patients must pay due to financing costs, or otherwise harm patients' mental, physical, and financial well-being, including through downstream credit reporting and debt collection practices. In line with the agencies' work to lower health care costs and reduce the burden of medical debt, the agencies also seek comment on policy options to protect consumers from harm.

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

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.

This document sets forth proposed rules that would amend the definition of short-term, limited-duration insurance, which is excluded from the definition of individual health insurance coverage under the Public Health Service Act. This document also sets forth proposed amendments to the requirements for hospital indemnity or other fixed indemnity insurance to be considered an excepted benefit in the group and individual health insurance markets. This document further sets forth proposed amendments to clarify the tax treatment of certain benefit payments in fixed amounts received under employer-provided accident and health plans. Finally, this document solicits comments regarding coverage only for a specified disease or illness that qualifies as excepted benefits, and comments regarding level-funded plan arrangements.

The Food and Drug Administration (FDA or Agency) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of individuals on its advisory committee regardless of their gender identification, religious affiliation, racial and ethnic identification, or disability status and, therefore, encourages nominations of appropriately qualified candidates from all groups.

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.

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.

Notice is given for the August 29, 2023, virtual meeting of SAMHSA's Tribal Technical Advisory Committee (TTAC). TTAC meetings are exclusively between federal officials and elected officials of Tribal governments (or their designated employees) to exchange views, information, or advice related to the management or implementation of SAMHSA programs. The public may attend but are not allowed to participate in the meeting. Immediately following the TTAC meeting, SAMHSA will host American Indian and Alaska Native (AI/AN) Federally Recognized Tribes for a virtual Tribal Consultation session on the BEHAVIORAL HEALTH AND SUBSTANCE USE DISORDER RESOURCES FOR NATIVE AMERICANS PROGRAM.

The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), proposes to amend its foreign quarantine regulation to provide additional clarity and safeguards to address the public health risk of dog-maintained rabies virus variant (DMRVV) associated with the importation of dogs into the United States. The United States has been DMRVV-free since 2007, and reintroduction poses significant risk to human and animal health. The close relationship between dogs and people means there is a direct public health risk to individuals that interact with inadequately vaccinated dogs imported from countries at high risk of DMRVV (high- risk countries). The notice of proposed rulemaking (NPRM) also addresses the importation of cats because both dogs and cats are included in the current regulation. Cats are not required to have proof of rabies vaccination and CDC is not proposing new substantive changes relating to the importation of cats.

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.

HRSA is seeking nominations of qualified candidates to be considered for appointment as members of the Advisory Committee on Organ Transplantation (ACOT or Committee). ACOT provides advice and recommendations to the Secretary of HHS (Secretary) on proposed Organ Procurement and Transplantation Network policies and such other matters as the Secretary determines. The Secretary also may seek the advice of the Committee on other proposed policies.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled National Wastewater Surveillance System for COVID-19 and other infectious disease targets of public health concern. The proposed information collection project aims to collect pathogen and public health target concentration in wastewater, wastewater target variant sequencing data, sewershed spatial files, and associated sewershed-level case data from participating jurisdictions in the United States to inform infectious disease prevention and control efforts.

Pursuant to the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) announces the following advisory committee meeting. This meeting is open to the public. The public is welcome to attend in person or virtually by following the instructions posted on the website: https://ncvhs.hhs.gov/meetings/full-committee- meeting-14/. Name: National Committee on Vital and Health Statistics (NCVHS) Meeting.

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 Administration for Community Living (ACL) 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 Proposed Revision and solicits comments on the information collection requirements related to the ``SHIP-SMP Survey of One-on-One Assistance''.

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 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 Office of Child Support Services (OCSS), Administration for Children and Families (ACF), is requesting the Federal Office of Management and Budget (OMB) to extend approval of the Information Comparison with Insurance Data, with minor changes, for an additional three years. The current OMB approval (OMB No.: 0970-0342) expires January 31, 2024.

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is seeking nominations for membership on the Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC). The BSC, NCIPC consists of up to 18 experts in pertinent disciplines involved in injury and violence prevention.

This final rule amends the civil money penalty (CMP) regulations of the Department of Health and Human Services (HHS) Office of Inspector General (OIG) to: incorporate new CMP authority for information blocking; incorporate new authorities for CMPs, assessments, and exclusions related to HHS grants, contracts, other agreements; and increase the maximum penalties for certain CMP violations.

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.

This is the first of two notices planned for the coming months informing the public of the availability of the complete lists of all geographic areas, population groups, and facilities designated as primary medical care, dental health, and mental health professional shortage areas (HPSAs). This notice includes the lists of HPSAs in a designated status as of April 28, 2023. The lists are available on the shortage area topic page on HRSA's data.hrsa.gov website and includes HPSAs which are proposed for withdrawal but currently remain designated. HRSA is extending the transition time communicated in the notice published on July 7, 2022, for jurisdictions and facilities to prepare for potential loss of HPSA designations. HPSA designations that are currently proposed for withdrawal will remain in this status until they are re-evaluated in preparation for the publication of the January 2, 2024, HPSA Federal Register notice. If these HPSAs do not meet the requirements for designation by the data pull scheduled for November 15, 2023, they will be withdrawn with the publication of a second Federal Register notice planned for January 2, 2024.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cardiovascular and Renal Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Office of Head Start (OHS), Administration for Children and Families (ACF), U.S. Department of Health and Human Services, requests public comment on an extension with changes to recordkeeping requirements for ACF Head Start grant recipients. A Final Rule published on January 6, 2023, added a recordkeeping requirement that Head Start grant recipients update their program policies and procedures to include an evidence-based COVID-19 mitigation policy. OHS requested and received emergency approval from OMB to implement the updated recordkeeping requirement as required in the Final Rule. Approval was for 6 months. Subsequently, a final rule was published on June 26, 2023, which removed all previously approved vaccination recordkeeping requirements and the requirement to maintain a testing protocol. This request is to remove these requirements from the information collection and extend approval of the remaining recordkeeping requirement under this OMB number for an additional 3 years.

The Office of Child Support Services (OCSS), Administration for Children and Families (ACF), is requesting the federal Office of Management and Budget (OMB) to extend approval of the Multistate Financial Institution (MSFIDM) Data Match with Federally Assisted State Transmitted (FAST) Levy, without changes, for an additional three years. The current OMB approval (OMB No.: 0970-0169) expires January 31, 2024.

This proposed rule would update and revise the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year 2024. This rule also proposes to update the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. This rule also includes requests for information regarding potential changes to the low-volume payment adjustment under the ESRD PPS. In addition, this proposed rule would update requirements for the ESRD Quality Incentive Program and the ESRD Treatment Choices Model.

The Department of Health and Human Services (HHS or Department) is issuing this request for information (RFI) to receive input from the public on the Draft HHS 2023 Framework to Support and Accelerate Smoking Cessation to guide the Department's efforts to sustain and strengthen existing programs and drive further progress toward smoking cessation, with an emphasis on serving populations and communities disproportionately impacted by smoking-related morbidity and mortality.

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) 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 Office of Child Support Services (OCSS), Administration for Children and Families (ACF), United States Department of Health and Human Services, is requesting a three-year extension of the Voluntary Acknowledgment of Paternity and Required Data Elements for Paternity Establishment Affidavits (OMB #0970-0171, expiration 1/31/2024). No changes are proposed.

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 inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. to achieve expeditious commercialization of results of federally-funded research and development.

Pursuant to the Federal Advisory Committee Act, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP, the full meeting agenda, and instructions for linking to public access will be posted on the SACHRP website at https://www.dhhs.gov/ohrp/sachrp-committee/meetings/ index.html.

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 Children's Bureau, Administration for Children and Families (ACF), United States Department of Health and Human Services, is proposing to collect data for a new descriptive study, Judicial, Court, and Attorney Measures of Performance (JCAMP): Feedback and Implementation. This expands on earlier work around technical assistance, as approved under Office of Management and Budget #: 0970- 0593.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' This draft guidance describes FDA's interpretation of, and policies concerning, the statutory prohibition on wholesaling for certain compounded drugs. This draft guidance also describes examples of how FDA intends to apply the statutory wholesaling provision.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug application (NDA) for OXANDRIN (oxandrolone) tablets, 2.5 milligrams (mg) and 10 mg, held by Gemini Laboratories, LLC (Gemini). Gemini voluntarily requested withdrawal of this application and waived its opportunity for a hearing. In addition, FDA is withdrawing approval of four abbreviated new drug applications (ANDAs) for oxandrolone tablets from multiple ANDA holders. Upsher-Smith Laboratories, LLC (Upsher- Smith), Par Pharmaceutical, Inc. (Par), and Sandoz Inc. (Sandoz) voluntarily requested withdrawal of their respective applications and waived their opportunity for a hearing.

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 we) is extending the comment period for the color additive petition for which we published a notice of filing in the Federal Register on May 3, 2023. In the notice, FDA requested comments on a filed color additive petition submitted by Environmental Defense Fund, et al., proposing that FDA repeal the color additive regulation providing for the use of titanium dioxide in foods. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

The Centers for Disease Control and Prevention (CDC) announces an amendment to the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public.

This notice with comment period provides information to the public on the process we will use to provide transitional coverage for emerging technologies (TCET) through the national coverage determination (NCD) process under the Social Security Act (the Act). It also solicits public comment on the proposed TCET pathway.

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 Expanding PrEP in Communities of Color (EPICC). The purpose of this study is to implement and evaluate the effectiveness of a clinic- based intervention that utilizes evidence-based education and support tools increase provider knowledge and improve PrEP adherence.

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 Nonpharmacologic Treatment for Maternal Mental Health Conditions, 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.

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 ``Chronic Q fever in the United States: Enhanced Clinical Surveillance''. This enhanced medical surveillance for chronic Q fever will collect specific clinical data not otherwise collected during routine public health surveillance to allow for better characterization of the clinical presentation and risk factors of chronic Q fever in the United States.

The Agency for Toxic Substances and Disease Registry (ATSDR), 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 APPLETREE Performance Measures. ATSDR will use this data collection to manage the next five-year cooperative agreement program under Notice of Funding Opportunity (NOFO) No. CDC-RFA-TS-23-0001.

HRSA published a document in the Federal Register of August 31, 2021, amending the Statement of Organization, Functions, and Delegations of Authority. The document contained an incorrect administrative code under RE; Office of Intergovernmental and External Affairs. Delete administrative code RE10 and replace with REX for the Seattle Regional Office.

HRSA is providing additional award funds to the current ITCP State awards recipients in fiscal year 2023 to build state and local capacity and implement the infant-toddler court approach in additional sites.

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 draft guidance for industry entitled ``Psychedelic Drugs: Considerations for Clinical Investigations.'' Because interest in the therapeutic potential of psychedelic drugs has been increasing and designing clinical trials to evaluate these compounds presents unique challenges, FDA has developed this draft guidance to present foundational aspects for sponsors to consider. This draft guidance provides general considerations for sponsors developing psychedelic drugs for treatment of medical conditions (e.g., psychiatric disorders, substance use disorders) and discusses considerations for clinical investigations using psychedelic drugs.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of an immediate in effect guidance entitled ``Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding when Conventional Platelets Are Not Available or Their Use Is Not Practical.'' FDA is issuing this guidance to provide a notice of exceptions and alternatives to certain requirements in the biologics regulations regarding blood and blood components. This notice is being issued to respond to a public health need and address the urgent and immediate need for platelets for the treatment of active bleeding when conventional platelets are not available, or their use is not practical. In addition, the guidance document provides recommendations to blood establishments for the manufacture and labeling of cold-stored platelets (CSP).