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

The Food and Drug Administration (FDA or we) is classifying the interoperable automated glycemic controller into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the interoperable automated glycemic controller's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.

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 and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on an information collection titled, Aggregate Reports for Tuberculosis Program Evaluation. The goal of the study is to allow CDC to collect and monitor indicators for key program activities, such as finding tuberculosis infections in recent contacts of cases and in other high- risk persons likely to be infected, and providing therapy for latent tuberculosis infection, in an effort to eliminate tuberculosis in the United States.

The Food and Drug Administration (FDA, Agency, or we) has determined that MPI DMSA KIDNEY REAGENT (Technetium Tc-99m Succimer Kit), Injectable, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for Technetium Tc-99m Succimer Kit, Injectable, if all other legal and regulatory requirements are met.

Pursuant to the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) announces the following advisory committee meeting. This meeting is open to the public. The public is welcome to obtain the link to attend this meeting by following the instructions posted on the Committee website: https://ncvhs.hhs.gov/ meetings/full-committee-meeting-10/. Name: National Committee on Vital and Health Statistics (NCVHS), Meeting of the full Committee.

The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a final guidance for industry entitled ``Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions.'' This guidance states Agency policy regarding enforcement of certain requirements related to supply-chain programs for contract manufacturers/processors, the intentional adulteration regulation, and supplier approval and verification requirements in the Current Good Manufacturing Practice and Preventive Controls Regulations and the Foreign Supplier Verification Programs (FSVP) Regulation.

The Principal Deputy Administrator of the Administration for Community Living (ACL) seeks nominations for individuals to serve on the Family Caregiving Advisory Council.

Findings of research misconduct have been made against Terry Magnuson, Ph.D. (Respondent), Kay M. & Van L. Weatherspoon Eminent Distinguished Professor, Department of Genetics, School of Medicine (SOM), University of North Carolina at Chapel Hill (UNC). Respondent engaged in research misconduct in research included in one (1) grant application for U.S. Public Health Service (PHS) funds, specifically National Cancer Institute (NCI), National Institutes of Health (NIH), grant application R01 CA267946-01A1. The administrative actions, including supervision from February 25, 2022-January 5, 2024, are detailed below.

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 Postpartum Care for Women Up to One Year After Pregnancy, 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.

The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) authorizes AHRQ, on behalf of the Secretary of HHS, to list as a patient safety organization (PSO) an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ accepted a notification of proposed voluntary relinquishment from the QCMetrix PSO, PSO number P0166, of its status as a PSO, and has delisted the PSO accordingly.

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 announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Online Application Order Form for Products from the Healthcare Cost and Utilization Project (HCUP).'' This proposed information collection was previously published in the Federal Register on January 3rd, 2021 and allowed 60 days for public comment. During the 60 days, no substantive comments from members of the public were received by AHRQ. The purpose of this notice is to allow an additional 30 days for public comment.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance entitled ``Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.'' This revised draft guidance addresses the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA). Specifically, this revised draft guidance covers the statutory verification system requirements that include the quarantine and investigation of a product determined to be suspect and the quarantine and disposition of a product determined to be illegitimate. The revised draft guidance also addresses the statutory requirement for notification to the Agency of a product that has been cleared by a manufacturer, repackager, wholesale distributor, or dispenser (also referred to as ``trading partners'') after a suspect product investigation because it is determined that the product is not an illegitimate product. Finally, the revised draft guidance addresses the statutory requirement for responding to requests for verification and processing saleable returns.

The Office of the Assistant Secretary for Health published a document in the Federal Register of March 2, 2022, announcing the request for comments for the Vaccines Federal Implementation Plan. The document includes a weblink where the Vaccines Federal Implementation Plan can be found: https://www.hhs.gov/vaccines/vaccines-national- strategic-plan/vaccines-federal-implementation-plan/ index.html#:~:text=The%20Vaccines%20Federal%20Implementation% 20Plan%20ou tlines%20specific%20actions%20that%20federal,National%20Strat egic%20Plan %202021%2D2025.&text=The%20public%20comment%20period%20for,2% 2C%202022%2 0at%209%20a.m.

The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to solicit comments on changes to FDA's previously proposed quality metrics reporting program (QM Reporting Program). This notice describes considerations for refining the QM Reporting Program based on lessons learned from two pilot programs with industry that were announced in the Federal Register in June 2018, a Site Visit Program and a Quality Metrics Feedback Program, as well as stakeholder feedback on FDA's 2016 revised draft guidance for industry entitled ``Submission of Quality Metrics Data.'' FDA is interested in responses to the questions listed in section III of this document, in addition to any general comments on the proposed direction for the program. This notice is not intended to communicate our regulatory expectations for reporting quality metrics data to FDA but is instead intended to seek input from industry to inform the future regulatory approach.

The Department of Health and Human Services (HHS or Department), through the National Institutes of Health (NIH), proposes to update the existing regulation for NIH Loan Repayment Programs (LRPs) to reflect the consolidation of NIH LRPs into two programs, the Intramural Loan Repayment Program (for NIH researchers) and the Extramural Loan Repayment Program (for non-NIH researchers); the direct authority of the NIH Director to administer the NIH LRPs (formerly the duty of the Secretary, HHS); and the increase in the annual loan repayment amount from a maximum of $35,000 to a maximum of $50,000.