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

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.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring David Elias Mendoza for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Mendoza engaged in a pattern of importing or offering for import misbranded drugs (i.e., in an amount, frequency, or dosage that is inconsistent with his personal or household use) that are not designated in an authorized electronic data interchange system as products regulated by FDA. Mr. Mendoza was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of March 28, 2022 (30 days after receipt of the notice), Mr. Mendoza had not responded. Mr. Mendoza's failure to respond and request a hearing within the timeframe prescribed by regulation constitutes a waiver of his right to a hearing and any contentions concerning this matter.

The Food and Drug Administration (FDA or the Agency) 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 the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Library of Medicine (NLM), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The Department of Health and Human Services' (HHS) Office of Infectious Disease and HIV/AIDS Policy (OIDP) in the Office of the Assistant Secretary for Health (OASH) announces the draft targets for updating the Healthcare-Associated Infections (HAI) National Action Plan, Phase 1, Acute Care Hospitals, for public comment. The HHS Core Group of the HAI National Action Plan reviewed data pre-pandemic and between 2020 and 2021 and developed potential 5-year targets based on assumptions that current HAI rates should return to pre-pandemic baseline rates within 2 years or within 3 years when determining these 5-year targets. The HHS HAI NAP Core Group recommends 5-year targets assuming a return to pre-pandemic baseline rates within 3 years based on two fundamentals: (1) pandemic-related challenges will likely persist in upcoming years, and (2) the pandemic has caused major strains on the health care system which make a 3-year timeline to achieve pre-pandemic Standardized Infection Ratio (SIR) the most appropriate choice. The draft targets are below.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation. The draft guidance updates the ICH guidance for industry ``Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin'' issued in September 1998 to reflect advances in scientific knowledge and regulatory expectations. The draft guidance is intended to describe risk-based principles and mitigation strategies to assure the viral safety of biotechnology products, including the data necessary to submit in a marketing application.

This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April through June 2022, relating to the Medicare and Medicaid programs and other programs administered by CMS.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for PREVYMIS IV Solution, new drug application (NDA) 209940, 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 that would otherwise require the hospital to enter into an agreement with its designated organ procurement organization (OPO). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.