Department of Health and Human Services September 5, 2024 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Control of Nitrosamine Impurities in Human Drugs." This guidance recommends steps manufacturers of active pharmaceutical ingredients (APIs) and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in pharmaceutical products. The guidance describes two general structural classes of nitrosamine impurities: small-molecule nitrosamine impurities (i.e., nitrosamine impurities that do not share structural similarity to the API), and nitrosamine drug substance-related impurities (NDSRIs), which share structural similarity to the API and are generally unique to each API. The potential root causes of small-molecule nitrosamine impurities and NDSRI formation, detection of nitrosamine impurities, and recommendations for risk assessments, testing, and implementation of controls and other appropriate strategies to prevent or reduce the presence of small-molecule nitrosamine impurities and NDSRIs are provided. This guidance revises the final guidance of the same name issued on February 24, 2021.

The Administration for Children and Families (ACF) Office of Child Care plans to submit revisions to an approved generic information collection (GenIC) under the umbrella generic: Generic Clearance for Financial Reports used for ACF Non-Discretionary Grant Programs (0970- 0510). The request revises ACF-696T, the annual financial report for tribal CCDF grant programs to submit financial claims. This specific form collects financial data for Tribal CCDF programs. The proposed revisions to the ACF-696T will provide reporting instructions to Tribal Lead Agencies who are approved under a temporary opportunity to retroactively request the use CCDF funds, including most COVID- relief funds, for construction and/or major renovation with the intent of offsetting increased costs of materials, labor, and other related project costs.

The Food and Drug Administration (FDA or we) is classifying the heparin and direct oral factor Xa inhibitor drug test system 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 heparin and direct oral factor Xa inhibitor drug test system'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 Food and Drug Administration (FDA) is amending the food additive regulations to update the organism Pichia pastoris which has been renamed as Komagataella pastoris. Additionally, the food additive regulation is being updated to include language to clarify that the yeast is non-viable in the market formulation. This action is being taken to improve the accuracy of the regulations.

The Food and Drug Administration (FDA or we) is classifying the radiofrequency toothbrush 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 radiofrequency toothbrush'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 Food and Drug Administration (FDA or we) 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.

The Food and Drug Administration (FDA, the Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish 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 notice solicits comments on the information collections related to requirements for drug establishment registration and drug listing, including registrant reporting under the Federal Food, Drug, and Cosmetic Act (FD&C Act) with respect to listed drugs and certain guidances.