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

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.