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

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``In Vitro Release Test Studies for Topical Products Submitted in ANDAs.'' This draft guidance provides recommendations for in vitro release test (IVRT) studies for locally acting liquid-based and/or other semisolid topical products. This draft guidance is intended to assist applicants who are submitting abbreviated new drug applications (ANDAs) for such products, by providing recommendations for IVRT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

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.