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

ACF is seeking public suggestions, in particular from state and tribal title IV-E agencies and Indian tribes and tribal consortiums and other stakeholders, for streamlining the Adoption and Foster Care Analysis and Reporting System (AFCARS) data elements and removing any undue burden related to reporting AFCARS.

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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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.

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 a proposed information collection project titled ''Using Qualitative Methods to Understand Issues in HIV Prevention, Care and Treatment in the United States.'' CDC's goal for this generic information collection mechanism is to conduct qualitative studies to quickly identify barriers and facilitators to HIV prevention, care and treatment in specific regions with high HIV burden in the US.

The Food and Drug Administration (FDA) 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 Centers for Disease Control and Prevention CDC is seeking nominations for membership on the BSC, NCIPC. The BSC, NCIPC consists of 18 experts in fields associated with surveillance, basic epidemiologic research, intervention research, and implementation, dissemination, and evaluation of promising and evidence-based strategies for the prevention of injury and violence. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based on expertise in the fields of knowledgeable in the pertinent disciplines involved in injury and violence prevention, including, but not limited to, epidemiologists, statisticians, trauma surgeons, rehabilitation medicine specialists, behavioral scientists, health economists, program evaluation specialists, political science, law, criminology and specialists in various aspects of injury management. Federal employees will not be considered for membership. Members may be invited to serve for four- year terms.

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS) announces the availability of the Final Revised Environmental Assessment (EA) and a Finding of No Significant Impact (FONSI) for the CDC Lawrenceville Campus Proposed Improvements 2015-2025.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry #240 entitled ``Proprietary Names for New Animal Drugs.'' This draft guidance provides recommendations to help new animal drug sponsors develop proprietary names for new animal drugs that do not contribute to medication errors, negatively impact safe use of the drug, or misbrand the drug. This draft guidance proposes a framework for evaluating proposed proprietary names before submitting them for review by the Center for Veterinary Medicine (CVM or we). It also explains how new animal drug sponsors can request that CVM evaluate a proposed proprietary name.

The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (animal use) proposing that the food additive regulations be amended to provide for the safe use of L-selenomethionine as a dietary source of selenium in feed for poultry, swine, and ruminants.

The Food and Drug Administration is correcting a notice entitled ``Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments'' that appeared in the Federal Register of February 22, 2018. The document was published with the incorrect docket number. This document corrects that error.

The Food and Drug Administration (FDA or Agency) has determined that DORYX MPC (doxycycline hyclate), delayed-release tablets, 60 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for DORYX MPC (doxycycline hyclate), delayed-release tablets, 60 mg, if all other legal and regulatory requirements are met.