Department of Health and Human Services March 14, 2018 – Federal Register Recent Federal Regulation Documents

In accordance with the requirements of the Privacy Act of 1974, as amended, HHS is altering an existing department-wide system of records, ``Records About Restricted Dataset Requesters,'' System Number 09-90-1401. This system of records covers records about individuals within and outside HHS who request restricted datasets and software products from HHS (e.g., for health-related scientific research and study purposes), when HHS maintains the requester records in a system from which they are retrieved directly by an individual requester's name or other personal identifier. The system of records currently covers records maintained by three HHS Operating Divisions. It is being altered to include records maintained by a fourth Operating Division, the National Institutes of Health (NIH), and to include three revised and five new routine uses, some of which will apply to all records in the system and some of which will apply to only NIH's records. The alterations affect the System Locations, Legal Authorities, Purposes, Retention, System Manager, and Routine Uses sections of the System of Records Notice (SORN).

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.

The Food and Drug Administration (FDA) is withdrawing approval of four abbreviated new drug applications (ANDAs) from two applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance entitled ``M7(R1): Assessment and Control of Deoxyribonucleic Acid (DNA) Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.'' This guidance updates and replaces the May 2015 guidance for industry ``M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.'' This guidance finalizes the draft guidance ``M7(R1) Addendum to ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk,'' issued September 28, 2015 (80 FR 58261). The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. This M7(R1) document provides guidance on acceptable intakes (AIs), or permissible daily exposures (PDEs), derived for some chemicals that are considered to be mutagens and carcinogens and, are also commonly used in the synthesis of pharmaceuticals or are, useful examples to illustrate the principles for deriving compound-specific intakes described in ICH M7. This document is intended to provide guidance for new drug substances and new drug products during their clinical development and subsequent applications for marketing.

The Food and Drug Administration (FDA or Agency) is publishing an order granting a petition requesting exemption from premarket notification requirements for over-the-counter (OTC) denture repair kits (Product Code EBO). These devices consist of material, such as a resin monomer system of powder and liquid glues, which is intended to be applied permanently to a denture to mend cracks or breaks. This order exempts OTC denture repair kits, class II devices, from premarket notification (510(k)). This exemption from 510(k) is immediately in effect for OTC denture repair kits. FDA is publishing this order in accordance with the section of the Federal Food, Drug, and Cosmetic Act (FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).

The Graduate Psychology Education (GPE) Program is authorized by section 756 of the Public Health Service Act and administered by HRSA. The program provides financial support to organizations and institutions that train doctoral-level psychologists. This notice seeks public comment to inform and guide policy and planning associated with the GPE Program.