Department of Health and Human Services 2022 – Federal Register Recent Federal Regulation Documents

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) reapprove the proposed information collection project ``Consumer Assessment of Healthcare Providers and Systems (CAHPS) Home and Community Based Services (HCBS) Survey Database.'' This proposed information collection was previously published in the Federal Register on August 19, 2022, and allowed 60 days for public comment. AHRQ did not receive any substantive comments during this period. The purpose of this notice is to allow an additional 30 days for public comment.

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award $62,000,000 (total costs) for up to one year to Vibrant Emotional Health for the 988 National Suicide Prevention Lifeline Expansion for Behavioral Health Crisis Response (Lifeline Expansion). These funds will allow Vibrant Emotional Health to ensure effective and continuous operations of the national Lifeline backup, chat/text, Spanish and LGBTQI+ youth crisis center networks, administrative and leadership support to ensure training, evaluation, personnel, and committee oversight and implementation, and continued development of the Lifeline unified platform and information technology integration for local and national crisis centers.

In accordance with the Federal Advisory Committee Act (FACA) and the Public Health Service (PHS) Act, HHS is hereby giving notice that the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) has been renewed. The effective date of the charter renewal is November 10, 2022.

The Food and Drug Administration (FDA, Agency, or we) has determined the regulatory review period for PREVYMIS, new drug application (NDA) 209939, and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

This notice acknowledges the receipt of an application from a hospital that has requested a waiver of statutory requirements to enter into an agreement with an organ procurement organization (OPO) other than its designated organ procurement organization. This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled ``Referencing the Definition of `Device' in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents.'' FDA is issuing this guidance to promote clarity regarding references to the terms ``device'' and ``counterfeit device'' in guidance, regulatory documents, communications, and other public documents.

The Food and Drug Administration (FDA or the Agency) is extending the comment period for two proposed rules that appeared in the Federal Register of September 28, 2022. In the proposed rule entitled ``Protection of Human Subjects and Institutional Review Boards,'' FDA requested comments on proposed changes to its regulations regarding obtaining and documenting informed consent from research participants, and institutional review board membership and functions, including continuing review (Docket No. FDA-2021-N-0286). In the proposed rule entitled ``Institutional Review Boards; Cooperative Research,'' FDA requested comment on a change to its regulations that would require any institution located in the United States participating in FDA-regulated cooperative research to rely on approval by a single institutional review board (IRB) for that portion of the research that is conducted in the United States, with some exceptions (Docket No. FDA-2019-N-2175). The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

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 we) is amending the color additive regulations to provide for the expanded safe use of spirulina (Arthrospira platensis) extract as a color additive in alcoholic beverages with less than 20 percent alcohol-by-volume content, non-alcoholic beverages, condiments and sauces, dips, dairy product alternatives (identified as non-dairy yogurt alternatives, non-dairy frozen desserts, and non-dairy puddings), salad dressings, and seasoning mixes (unheated). This action is in response to a color additive petition (CAP) filed by GNT USA, Inc. (GNT).

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TISSUEBLUE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for NEXLETOL and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for XCOPRI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The meeting of the Oncologic Drugs Advisory Committee scheduled for November 22, 2022, is canceled. This meeting was announced in the Federal Register of September 22, 2022. The meeting is no longer needed.

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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial; Guidance for Industry.'' The guidance document provides recommendations to sponsors interested in studying multiple versions of a cellular or gene therapy product in an early phase clinical trial for a single disease. Sponsors have expressed interest in gathering preliminary evidence of safety and activity using multiple versions of a cellular or gene therapy product in a single clinical trial, where each version of the product is distinct and is generally submitted to FDA in a separate investigational new drug application (IND). The guidance provides recommendations for conducting such studies, including how to organize and structure the INDs, submit new information, and report adverse events. The guidance announced in this notice finalizes the draft guidance of the same title dated September 2021.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide an opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) 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, 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 Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ANGELMED GUARDIAN SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

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 Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $935,000, with an expected total funding of approximately $4,675,000 over a five- year period, to Public Health Accreditation Board (PHAB).

This final rule sets forth routine updates to the Medicare home health payment rates for calendar year (CY) 2023 in accordance with existing statutory and regulatory requirements. This final rule also finalizes a methodology for determining the impact of the difference between assumed versus actual behavior change on estimated aggregate expenditures for home health payments as result of the change in the unit of payment to 30 days and the implementation of the Patient Driven Groupings Model (PDGM) case-mix adjustment methodology and finalizes a corresponding permanent prospective adjustment to the CY 2023 home health payment rate. This rule finalizes the reassignment of certain diagnosis codes under the PDGM case-mix groups, and establishes a permanent mitigation policy to smooth the impact of year-to-year changes in home health payments related to changes in the home health wage index. This rule also finalizes recalibration of the PDGM case-mix weights and updates the low utilization payment adjustment (LUPA) thresholds, functional impairment levels, comorbidity adjustment subgroups for CY 2023, and the fixed-dollar loss ratio (FDL) used for outlier payments. Additionally, this rule discusses comments received on the future collection of data regarding the use of telecommunications technology during a 30-day home health period of care on home health claims. This rule also finalizes changes to the Home Health Quality Reporting Program (HH QRP) requirements; changes to the expanded Home Health Value-Based Purchasing (HHVBP) Model; and updates to the home infusion therapy services payment rates for CY 2023.

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 Templates for Extramural Data Management Plans. The aim of this collection is to provide contract and cooperative agreement applicants and awardees with templates for the creation of data management plans (DMPs).

CDC has redelegated the authority under the Federal Food, Drug, and Cosmetic (FD&C) Act to create and issue amended emergency use instructions (EUI) to inform healthcare providers or individuals to whom an eligible product, as defined under the FD&C Act, is to be administered, concerning the product's approved, licensed, or cleared conditions of use that deviate from approved labeling, standard clinical practice, and/or standard medical modality (e.g., individual prescription within the patient-clinician relationship). This notice announces the redelegation of the above-mentioned authority, without the authority to redelegate, from the Director, CDC, to the Director, National Center for Immunizations and Respiratory Diseases (NCIRD).

The Office of the Assistant Secretary for Health published a notice in the Federal Register on September 16, 2022, concerning a meeting of the Tick-Borne Disease Working Group (TBDWG) that was scheduled to occur on December 7, 2022. This notice is being amended to announce that the meeting has been rescheduled to November 21, 2022. This will be the final TBDWG meeting.

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute (Cleveland Clinic) for the Cleveland Clinic SARS-CoV-2 Assay and SelfCheck COVID-19 TaqPath Multiplex PCR. FDA revoked these Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document.

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 Administration for Children and Families (ACF) is requesting a revision of the approved ACF Uniform Project Description (UPD) (Office of Management and Budget (OMB) # 0970-0139, expiration March 31, 2025).

As required by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the President's Advisory Commission on Asian Americans, Native Hawaiians, and Pacific Islanders will hold a virtual, two-day meeting on December 5 and December 6, 2022.

This notice seeks comments on two draft recommendations to update the HRSA-Supported Women's Preventive Services Guidelines (``Guidelines'') relating to Screening for Diabetes in Pregnancy and Screening for Type 2 Diabetes after Pregnancy. The existing Guidelines address Screening for Gestational Diabetes Mellitus (GDM) and Screening for Diabetes Mellitus after Pregnancy. These draft recommendations have been developed through a cooperative agreement, known as the Women's Preventive Services Initiative (WPSI), with the American College of Obstetricians and Gynecologists (ACOG), through which they convene health professionals to develop draft recommendations. Under applicable law, non-grandfathered group health plans and health insurance issuers offering non-grandfathered group and individual health insurance coverage must include coverage, without cost sharing, for certain preventive services, including those provided for in the HRSA-supported Guidelines. The Departments of Labor, Health and Human Services, and the Treasury have previously issued regulations, which describe how group health plans and health insurance issuers apply the coverage requirements.

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 revision 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 provisions associated with FDA's Federal-State Food Regulatory Program Standards.

This notice seeks public comment on a proposed update to the Periodicity Schedule of the Bright Futures Recommendations for Pediatric Preventive Health Care (``Bright Futures Periodicity Schedule''), as part of the HRSA-supported preventive service guidelines for infants, children, and adolescents. Please see https:// mchb.hrsa.gov/maternal-child-health-topics/child-health/brigh t- futures.html for additional information. Specifically, the proposed update to the Bright Futures Periodicity Schedule is to extend the upper age range for the existing universal Human Immunodeficiency Virus (HIV) screening recommendation. In the Bright Futures Periodicity Schedule, a ``dot'' with an ``arrow'' indicates a ``range during which a service may be provided.'' In the current Bright Futures Periodicity Schedule, the age range recommended for which adolescents may be provided universal screening for HIV is between the 15-year visit and 18-year visit. The proposed update to the Bright Futures Periodicity Schedule would indicate that the recommended age range for which adolescents may be provided universal screening for HIV is between the 15-year visit and 21-year visit. The proposed update also includes an accompanying footnote to provide updated information from the American Academy of Pediatrics (AAP) about more frequent screening for youth assessed as at high risk of HIV infection.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers.'' Since 2017, FDA has received many questions concerning implementation of the regulatory requirements of the expanded access program. In addition, FDA developed recommendations for fulfilling the new requirements for expanded access submissions promulgated in the 21st Century Cures Act (Cures Act) (2016) and the FDA Reauthorization Act of 2017 (FDARA). FDA is providing this guidance in a question-and- answer format, addressing the most recent frequently asked questions and sharing recommendations to fulfill the new statutory requirements. This guidance revises the guidance of the same title issued in June 2016 and updated in October 2017.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program.'' This guidance provides stakeholders with information regarding FDA's implementation of the Over-the-Counter Monograph Drug User Fee Program authorized under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled ``Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/ Ps): Small Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entity establishments that manufacture HCT/Ps better understand the comprehensive regulatory framework for HCT/Ps set forth in the regulations and comply with certain HCT/P- related final rules. The SECG announced in this notice supersedes the SECG of the same title dated August 2007.

Pursuant to the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) announces the following advisory committee meeting and related Request for Comment (RFC). The meeting is open to the public. The public is welcome to obtain the link to attend this meeting by following the instructions posted on the Committee website: https://ncvhs.hhs.gov/ meetings/standards-subcommittee-hearing/. Name: National Committee on Vital and Health Statistics (NCVHS) Standards Subcommittee Meeting.

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).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials.'' The purpose of this draft guidance is to outline the most appropriate methods for measuring and recording growth and evaluating pubertal development for drugs or biological products in development for pediatric use when such an assessment is necessary to support safety. This draft guidance is intended to encourage a consistent approach to collecting interpretable and accurate growth and pubertal development data. This draft guidance does not address use of growth or pubertal development data to support primary evidence of efficacy in growth disorders and does not address evaluation of nutritional status.

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 in the guidance for industry entitled ``Special Protocol Assessment'' (Revision 1).

The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) authorizes AHRQ, on behalf of the Secretary of HHS, to list as a patient safety organization (PSO) an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ accepted a notification of proposed voluntary relinquishment from the SimCore PSO, LLC, PSO number P0189, of its status as a PSO, and has delisted the PSO accordingly.

The Administration for Children and Families at HHS is requesting an extension to continue data collection for an evaluation of the initiative, Community Collaborations to Strengthen and Preserve Families (also referred to as Child Welfare Community Collaborations [CWCC]). The cross-site process evaluation will provide insight to ACF about the various factors that promote or impede the implementation of child welfare community collaborations.

The Food and Drug Administration (FDA or Agency) is announcing the opportunity for a limited number of applicants to participate in a Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program, to facilitate the expedited CMC development of products under an investigational new drug (IND) application, where warranted, based upon the anticipated clinical benefit of earlier patient access to the products. FDA is implementing this pilot program to facilitate CMC readiness for selected Center for Biologics Evaluation and Research (CBER)- and Center for Drug Evaluation and Research (CDER)-regulated products with accelerated clinical development timelines. To accelerate CMC development and facilitate CMC readiness, the pilot features increased communication between FDA and sponsors and explores the use of science- and risk-based regulatory approaches, such as those described in FDA guidance, as applicable. This notice outlines the eligibility criteria and process for submitting a request to participate in the pilot.

This notice announces the dates and times of the virtual Healthcare Common Procedure Coding System (HCPCS) public meetings to be held November 29, 2022 through December 1, 2022 to discuss our preliminary coding, Medicare benefit category, and payment determinations for new revisions to the HCPCS Level II code set, as well as how to register for those meetings.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). This is a hybrid meeting, accessible both in person and virtually. It is open to the public, limited only by the space available and the number of audio conference lines and internet conference accesses. Time will be available for public comment. The public is also welcome to submit written comments in advance of the meeting, to the contact person listed in the addresses section below.

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 or Agency) is announcing the availability of a draft guidance for industry entitled ``Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention.'' The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of Clostridioides difficile infection (CDI), reduction of recurrence, or prevention of CDI.

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 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 or we) is correcting a notification that appeared in the Federal Register of July 11, 2022. The notification contained errors in the subject heading and list of petitioners. This document corrects the errors.

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 is a new information collection request soliciting comments on the information collection requirements relating to the Office of Healthcare Information and Counseling (OHIC) Profiles project at ACL.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Quantitative Brain Amyloid PET Imaging in Patients with Alzheimer's Disease.'' The purpose of the public workshop is to evaluate the role of quantitative positron emission tomography (PET) measures of amyloid deposition in the brain in clinical trials and clinical use in patients with suspected or confirmed Alzheimer's disease.

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.

In compliance with of the Paperwork Reduction Act of 1995, HRSA has 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 Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services, is requesting expedited review of an information collection request from the Office of Management and Budget (OMB). This information collection will allow the ORR Unaccompanied Children (UC) Program to enhance monitoring efforts at care provider facilities that are not licensed by the state. A separate notice will be published inviting public comments on the proposed collection.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) re-approve the proposed information collection project ``The Systematic Review Data Repository (SRDR) Platform''. This proposed information collection was previously published in the Federal Register on August 12, 2022 and allowed 60 days for public comment. AHRQ did not receive substantive comments during public review period. The purpose of this notice is to allow an additional 30 days for public comment.

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award $47 million (total costs) for up to one year to Vibrant Emotional Health for the 988 Suicide and Crisis Lifeline Access Improvement Project. Funding for this program is from the Bipartisan Safer Communities Act, [Pub. L. 117-159, Division B, Title II]. Under this cooperative agreement, Vibrant Emotional Health will expand access to the local and national Lifeline backup centers, language services, system evaluation and data reporting, and access to specialized care for populations to be known at higher risk for suicide by: (1) expanding options for connection and support for individuals at higher risk of suicide, which includes but is not limited to LGBTQI+, American Indian/Alaska Native, rural individuals, individuals with mental illness and substance use disorders, Black/African-American youth and older men; (2) expanding current language access services to include Spanish chat and text, and videophone for those deaf and hard of hearing; and (3) improve access and capacity utilization of the nationwide backup system while maximizing state and territory response. Funding Opportunity Title: 988 Suicide and Crisis Lifeline Access Improvement Project. Assistance Listing Number: 93.243. Authority: Section 520E-3 of the Public Health Service Act, as amended. Justification: Eligibility for this award is limited to the Mental Health Association of New York City, Inc. (DBA Vibrant Emotional Health). Vibrant Emotional Health is the current Lifeline system administrator and this award expand options for connection and support for individuals at higher risk of suicide, expand current language access services to include Spanish chat and text services, work to activate videophone for those deaf and hard of hearing, and improve access and capacity utilization of the nationwide backup system while maximizing state and territory response. Since 2005, Vibrant Emotional Health has provided oversight and management of the NSPL and its local call centers, backup centers, Spanish network, and chat/text functions with a network of over 200 centers in all fifty states. In FY 2021, SAMHSA issued a competitive Notice of Funding Opportunity for the NSPL, which was awarded to Vibrant Emotional Health for a 5-year project period (September 30, 2021, to September 29, 2026). Vibrant Emotional Health has the infrastructure, experience, and national reach to work with the backup centers, language services, and chat/text organizations to address the increased contact volumes expected in 2023. With the transition to 988 accomplished, greater services, such as expanding access to the local and national Lifeline backup centers, language services, system evaluation and data reporting, and access to specialized care for populations to be known at higher risk for suicide, are required for the 988 projected contacts in 2023 and beyond. It would not be possible for any other organization to establish the relationships or technical systems with crisis centers that Vibrant Emotional Health has built over the last 15 years to accomplish the goals by December 2023. Any significant modification to the current 988 network, technology platform and/or administration would significantly delay operational outcomes and run the risk of significant numbers of unanswered calls, chats, and texts of individuals in crisis. Since the transition to 988, the Lifeline, under Vibrant's network administration and HHS funding, has seen call answer rates significantly improve and far greater numbers of individuals served in crisis. The impact of having administration disruption and splitting of network oversight significantly increases public safety risk now more than ever as 988 is quickly becoming transitioned to a greater utilized public service and an entry way into more centralized behavioral health crisis care. Oversight of the expanded back up, language services, and chat/text centers would be fragmented and run the risk of both inefficiencies and adverse outcomes, as well as coordination, quality monitoring, and rapid response could be compromised. Vibrant has extensive engagement, including direct contractual obligations, with the Department of Veterans Affairs (VA), Veterans Crisis Line (VCL) that helps ensure call connectivity between Vibrant and VCL, backup services, and engagement across the Lifeline local crisis centers on Veteran identification, care, and linkage to VA. and is uniquely qualified to carry-out the requirements of this funding opportunity.

The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting expedited review of an information collection request from the Office of Management and Budget (OMB) and inviting public comments on the proposed collection. This request will allow the Unaccompanied Children (UC) Program to expand specific policy and procedural protections to category 2 sponsors, children who wish to challenge placement in restrictive settings, and children seeking access to legal counsel.

To reflect organizational changes within the Center for Medicare and Medicaid Innovation (CMMI).

This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through February 3, 2023.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``In Vitro Release Test Studies for Topical Products Submitted in ANDAs.'' This draft guidance provides recommendations for in vitro release test (IVRT) studies for locally acting liquid-based and/or other semisolid topical products. This draft guidance is intended to assist applicants who are submitting abbreviated new drug applications (ANDAs) for such products, by providing recommendations for IVRT studies, which can be used to support a demonstration that two topical products are bioequivalent.

The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances for developing topical products applied to the skin, as well as integumentary and mucosal (e.g., vaginal) membranes. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.

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's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of an abbreviated new drug application (ANDA) for Alcohol and Dextrose Injection, 5 milliliters (mL)/100 mL, 5 grams (g)/100 mL, and is announcing an opportunity for the ANDA holder to request a hearing on this proposal: Miles Laboratories Inc., P.O. Box 1986, 4th and Parker St., Berkeley, CA 94701, is the last holder of record. The bases for the proposal are that the ANDA holder has repeatedly failed to file required annual reports for this ANDA and that the Agency has scientific data and experience to show that the drug product under this ANDA is unsafe for use under the conditions of use for which the product was approved.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Topical Dermatologic Corticosteroids: In Vivo Bioequivalence.'' This draft guidance is intended to assist applicants who submit abbreviated new drug applications (ANDAs) for topical dermatologic corticosteroid products of all potency groups (referred to in this notice as topical corticosteroids). The draft guidance describes recommendations for an in vivo pharmacodynamic approach to demonstrate the bioequivalence of topical corticosteroids. When finalized, this guidance will replace FDA's 1995 guidance for industry of the same name. Revising this guidance will provide clarity for potential ANDA applicants on the appropriate pilot and pivotal studies and other recommendations for pharmacodynamic approach to assess the bioequivalence of topical dermatologic corticosteroids. These recommendations have evolved since the original guidance was issued in 1995.