Department of Health and Human Services August 2, 2017 – Federal Register Recent Federal Regulation Documents

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 Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases.'' The purpose of the guidance is to assist sponsors in the development of new antibacterial drugs to treat serious bacterial diseases in patients with an unmet medical need, including patients who have a serious bacterial disease for which effective antibacterial drugs are limited or lacking. This guidance finalizes the draft guidance of the same name issued July 2, 2013.

The National Cancer Institute (NCI) in collaboration with the NCI Molecular Analysis for Therapy Choice (MATCH) trial leadership (NCT 02465060) invites applications for Clinical Laboratory Improvements Program (CLIA) certified/accredited laboratories that test tumor specimens from patients utilizing Next Generation Sequencing (NGS) assays to participate in the NCI MATCH trial. The NCI MATCH trial has implemented a new process for identifying patients for arms with rare variant eligibility criteria. Laboratories will contact any of the approximately 1100 sites that have activated NCI MATCH if a specimen sent from one of these sites has a rare variant that would potentially make the patient eligible for one of the treatment arms open in this initiative.

The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2018 rates for the establishment and re-inspection fees related to entities that compound human drugs and elect to register as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The FD&C Act authorizes FDA to assess and collect an annual establishment fee from outsourcing facilities, as well as a re-inspection fee for each re-inspection of an outsourcing facility. This document establishes the FY 2018 rates for the small business establishment fee ($5,364), the non-small business establishment fee ($17,364), and the re-inspection fee ($16,093) for outsourcing facilities; provides information on how the fees for FY 2018 were determined; and describes the payment procedures outsourcing facilities should follow. These fee rates are effective October 1, 2017, and will remain in effect through September 30, 2018.

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for fiscal year (FY) 2018 generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2013 (AGDUFA II), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, and for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. This notice establishes the fee rates for FY 2018.

The Office for Human Research Protections (OHRP), a program office in the Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), is seeking nominations of qualified candidates to be considered for appointment as members of the Secretary's Advisory Committee on Human Research Protections (SACHRP). SACHRP provides advice and recommendations to the Secretary, HHS (Secretary), through the Assistant Secretary for Health, on matters pertaining to the continuance and improvement of functions within the authority of HHS directed toward protections for human subjects in research. SACHRP was established by the Secretary on October 1, 2002. OHRP is seeking nominations of qualified candidates to fill four positions on the Committee membership that will be vacated during the 2018 calendar year.