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

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 2022 Ebola Airport Entry Questionnaires. The purpose of this information collection is to determine the public health risk posed by travelers from areas affected by the 2022 outbreak of Ebola originating in Uganda.

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 Community Health Workers for COVID Response and Resilient Communities (CCR) National Evaluation. This data collection will assess the activities implemented by the 68 recipients of the CDC-RFA-DP21- 2109 CCR NOFO (CCR award recipients).

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.

The Food and Drug Administration (FDA or the Agency) is extending the period before FDA intends to begin enforcing the statutory 5 percent limit on distribution of compounded human drug products out of the State in which they are compounded in States that have not entered into a standard memorandum of understanding (MOU) with FDA addressing certain distributions of compounded human drug products. FDA is extending the period, which was scheduled to end on October 27, 2022, until the effective date of a final rule regarding certain distributions of compounded human drug products and publication of an updated standard MOU.

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 Research Integrity (ORI) announces the opportunity for non-federal public and private sector entities to co- sponsor ORI conferences, workshops, symposia, meetings, roundtables, or other such events (collectively, ``Events''). ORI co-sponsors a limited number of events with non-federal entities each year. Potential co- sponsors must have demonstrated interest and experience in the responsible conduct of research or handling allegations of research misconduct. Potential co-sponsors must be willing to participate substantively in the co-sponsored event.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Multiple Endpoints in Clinical Trials.'' This guidance provides sponsors and review staff with the Agency's thinking about the problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in clinical trials for human drugs, including drugs subject to licensing as biological products. This guidance finalizes the draft guidance of the same title issued on January 13, 2017.

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 notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting administrative supplements to the 54 grant recipients funded under the FY 2022 Cooperative Agreements for States and Territories to Build Local 988 Capacity (988 State and Territory Grants) Notice of Funding Opportunity (NOFO) SM-22-015, which have a project end date of April 2024. This supplemental funding is within scope and is expected to increase and/or expand original workforce capacity, ease of access to services, contact demand, including coverage area, through phone, chat, and text, and contact answer rates for 988 crisis care. The 988 State and Territory Cooperative Agreement grant recipients are eligible to apply for awards from $458,333 to $2,000,000 for a total funding of $50,000,000 from the Bipartisan Safer Communities Act (BSCA). The supplements will support 988 response and workforce expansion by improving 988 collaborations, infrastructure, hiring and retention, communications and marketing, and evaluation activities. These awards will help improve 988 and 911 coordination, especially in cases of emergency intervention due to suicidal behavior, improve state/ territory infrastructure to answer 988 Lifeline chat and text request initiated within their state or territory, align communications and marketing of the 988 Lifeline in conjunction with SAMHSA and HHS's 988 communications and marketing strategy, help streamline access to mobile crisis and crisis response teams for all 988 crisis centers, assist the development and expansion of human resource systems to increase the pace of 988 recruitment and hiring, conduct root cause analyses on identified critical incidents contacting through the 988 system, support continuity of care throughout the larger crisis response system and improve follow up and referral outcomes to decrease suicide and ensure individuals are connected to post-contact care. This is not a formal request for application. Assistance will only be provided to the 54 recipients funded in FY 2022 under the 988 State and Territory Cooperative Agreement NOFO SM-22-015 based on the receipt of a satisfactory application and associated budget that is approved by a review group. Funding Opportunity Title: FY 2022 Cooperative Agreements for States and Territories to Build Local 988 Capacity NOFO SM 22-015. Assistance Listing Number: 93.243. Authority: Section 520E-3 of the Public Health Services (PHS) Act [290bb-36c], as amended. Justification: SAMHSA is limiting eligibility for this supplemental funding to the 988 State and Territory grant recipients, which were funded in FY 2022 under the Cooperative Agreements for States and Territories to Build Local 988 Capacity, SM-22-015. These recipients provide leadership and oversee the current 988 and state- and territory-wide local crisis service systems. In addition, the recipients have the required active relationships with and can quickly provide fiscal resources directly to local and statewide Lifeline crisis centers for 988 response; thereby reducing burden on the nationwide network of Lifeline crisis centers, ensuring all those needing 988 services have awareness and access to localized care. Due to the requirements of the FY 2022 Cooperative Agreements for States and Territories to Build Local 988 Capacity, recipients are the only entities that can utilize these funds to successfully complete the required activities to improve 988 Lifeline crisis center workforce response and meet defined state and territory key performance indicators. Contact: James Wright, LPC, Chief of Crisis Center Operations, Substance Abuse and Mental Health Services Administration, 5600 Fishers Lane, Rockville, MD 20857, telephone 240-276-1615; email: james.wright@samhsa.hhs.gov.

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 Strategies for Integrating Behavioral Health and Primary Care, 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.

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 ``Online Submission Form for Supplemental Evidence and Data for Systematic Reviews for the Evidence-based Practice Center Program.'' This proposed information collection was previously published in the Federal Register on July 19, 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.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry #253 entitled ``Current Good Manufacturing Practice for Animal Cells, Tissues, and Cell- and Tissue-Based Products.'' FDA's Center for Veterinary Medicine (CVM) is issuing this guidance to provide establishments that manufacture animal cells, tissues, and cell- and tissue-based products (ACTPs) with recommendations for meeting requirements for current good manufacturing practice (CGMP). All new animal drugs, including ACTPs, are required to be manufactured in accordance with CGMP to ensure that such drugs meet the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as to safety, and have the identity, strength, quality, and purity characteristics, which they purport to or are represented to possess. This guidance also provides FDA's recommendations for those aspects of manufacturing specific to ACTPs in accordance with existing CGMP regulations, as applicable, and with the FD&C Act. In this guidance, we specifically address the methods, facilities, and controls used for manufacturing ACTPs.

The seventh iteration of the Prescription Drug User Amendments (PDUFA VII), included as part of the FDA User Fee Reauthorization Act of 2022, highlights the goal of facilitating and advancing the use of complex adaptive, Bayesian, and other novel clinical trial designs. The Food and Drug Administration (FDA or Agency) is announcing the continuation of the paired meeting program established under the sixth iteration of PDUFA that affords sponsors, who are selected, the opportunity to meet with Agency staff to discuss the use of complex innovative trial design (CID) approaches in medical product development. Meetings under the program will be conducted by FDA's Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) during fiscal years 2023 to 2027. For each sponsor whose meeting request is granted, two meetings will be held between the sponsor and CDER or CBER that will provide an opportunity for medical product developers to discuss their CID proposals. To promote innovation in this area, trial designs developed through the paired meeting program may be presented by FDA (e.g., in a guidance or public workshop) as case studies, including trial designs for drugs that have not yet been approved by FDA.

The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) is proposing to collect qualitative data to examine innovative and promising consumer education strategies that Child Care and Development Fund (CCDF) Lead Agencies are using to help families search for and select child care and early education (CCEE). This information collection aims to present an internally valid description of the experiences of up to six, purposively selected case study sites, not to promote statistical generalization to different sites or service populations.

The Administration for Children and Families (ACF) is requesting a 3-year extension of the ACF-Tribal Maternal, Infant, and Early Childhood Home Visiting (Tribal MIECHV) Program Form 2: Grantee Performance Measures (Office of Management and Budget (OMB) #0970-0500; Expiration date Feb 28, 2023). There are no changes requested to the form.

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) is announcing an amendment to the notice of meeting of the Pulmonary-Allergy Drugs Advisory Committee. This meeting was announced in the Federal Register of September 8, 2022. The amendment is being made to reflect changes in the DATES, ADDRESSES, and SUPPLEMENTARY INFORMATION portions of the document. The meeting was rescheduled to allow time for FDA to review new information submitted to the application. There are no other changes.