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 efforts 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 revision of the information collection project titled National Health and Nutrition Examination Survey (NHANES). NHANES produces descriptive statistics, which measure the health and nutrition status of the general population.

The Grants and Acquisitions Management Division (GAM) in the Office of the Assistant Secretary for Health (OASH), in conjunction with the grant making program offices it supports, announces the opportunity for non-federal public and private sector entities to co- sponsor OASH-supported grants workshops (OASH Grants Workshops). Potential co-sponsors must have a demonstrated interest and experience in building capacity among potential grant applicants and grant recipients. Potential co-sponsors must be willing to participate substantively in the co-sponsored activity. Expressions of interest for co-sponsorships of OASH Grants Workshops are received throughout the year at the email address below. OASH intends to co-sponsor a limited number of workshops with other entities each year. Expressions of interest are being received for OASH Grants Workshops that will take place in the next fiscal year (October 2022 through September 2023) or beyond. Expressions of interest for co-sponsorships should be sent by email to OASH_Grants@HHS.GOV with ``Co-sponsorship for OASH-supported Grants Workshops'' in the subject field or by mail to Duane Barlow, Grants Branch Chief, OASH, Grants and Acquisitions Management Division, at 1101 Wootton Parkway, Plaza Level, Rockville, MD 20852.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Animal Drug User Fee Act.'' The purpose of the public meeting is to discuss the proposed recommendations for the reauthorization of the Animal Drug User Fee Act (ADUFA V) for fiscal years 2024 through 2028.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Cargill, Inc., proposing that the food additive regulations be amended to provide for the safe use of hydrogen peroxide (CAS Reg. No. 7722-84-1) as an antimicrobial agent, oxidizing and reducing agent, and bleaching agent, and to remove sulfur dioxide.

The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. 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.

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: ``Medical Expenditure Panel SurveyInsurance Component.'' This proposed information collection was previously published in the Federal Register on September 6th, 2022 and allowed 60 days for public comment. AHRQ received no substantive comments from members of the public during this period. The purpose of this notice is to allow an additional 30 days for public comment.

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, the Agency, or we) is announcing the availability of a document entitled ``Draft Amended Environmental Assessment for Production of AquAdvantage Salmon at the Bay Fortune and Rollo Bay Facilities on Prince Edward Island, Canada.'' This draft amended environmental assessment (EA) has been prepared by FDA in support of the approved new animal drug application (NADA 141- 454) concerning AquAdvantage Salmon (AAS), in response to an order by the U.S. District Court, Northern District of California.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is modifying an existing system of records maintained by the Administration for Children & Families (ACF), Office of Child Support Enforcement (OCSE): System No. 09-80-0389, ``OCSE Data Center General Support System, HHS/ACF/OCSE.''

Findings of research misconduct have been made against Romina Mizrahi, M.D., Ph.D. (Respondent), who was a Clinician Scientist, Positron Emission Tomography Centre, Centre for Addiction and Mental Health (CAMH), and an Associate Professor, Department of Psychology, University of Toronto (UT). Respondent engaged in research misconduct in research reported in a grant application submitted for U.S. Public Health Service (PHS) funds, specifically National Institute of Mental Health (NIMH), National Institutes of Health (NIH), grant application R01 MH118495-01. The administrative actions, including supervision for a period of one (1) year, were implemented beginning on November 3, 2022, and are detailed below.

The Food and Drug Administration (FDA, the Agency, or we) is announcing our preliminary assessment that certain types of naloxone hydrochloride (``naloxone'') drug products may be approvable as safe and effective for nonprescription use. It is our preliminary opinion at this time that naloxone nasal spray up to 4 milligrams (mg), and naloxone autoinjector for intramuscular (IM) or subcutaneous (SC) use up to 2 mg, have the potential to be safe and effective for use as directed in nonprescription drug labeling without the supervision of a healthcare practitioner. We believe the prescription requirement for these naloxone products might not be necessary for the protection of the public health. However, we need additional data such as product- specific data on the nonprescription user interface design, including packaging and labeling, to make a conclusive determination in this respect. The Federal Food, Drug, and Cosmetic Act (FD&C Act) does not permit the simultaneous marketing of the same drug with the same active ingredient as both a prescription and nonprescription product, absent a clinically meaningful difference between them. Therefore, if and when FDA has sufficient data to support approval of a nonprescription naloxone product (e.g., through submission and approval of an application for a nonprescription naloxone product or a supplemental application to switch an FDA-approved naloxone product from prescription to nonprescription status), currently marketed naloxone products labeled as ``Rx only'' with no clinically meaningful difference from the approved nonprescription products will be considered misbranded.

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 the National Death Index (NDI). The goal of NDI and the services it provides allows NCHS to collect mortality data to support epidemiological research and to furnish mortality information to approved public health and medical investigators.

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 new proposed information collection project titled TRANSCEND: Transgender status-neutral community-to-clinic models to end the HIV epidemic. This project is designed to collect standardized program evaluation data from the clinics and community- based organizations who receive federal funds for HIV prevention and care activities.

In accordance with the Federal Advisory Committee Act, this notice announces that the Secretary's Advisory Council on Blood Stem Cell Transplantation (ACBSCT) has scheduled public meetings. Information about ACBSCT and the agenda for these meetings can be found on the ACBSCT website at https://bloodstemcell.hrsa.gov/about/advisory- council.