Department of Health and Human Services March 16, 2020 – 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 ``Slowly Progressive, Low-Prevalence Rare Diseases With Substrate Deposition That Results From Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies.'' This document provides guidance to sponsors on the evidence necessary to demonstrate the effectiveness of investigational new drugs or new drug uses intended for slowly progressive, low-prevalence rare diseases that are associated with substrate deposition and are caused by single enzyme defects. This guidance applies only to those low-prevalence rare diseases with a well-characterized pathophysiology and in which changes in substrate deposition can be readily measured in relevant tissue or tissues. This guidance incorporates the comments received for and finalizes the draft guidance of the same name issued on July 27, 2018.

The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice entitled ``Drug Products Labeled as Homeopathic; Draft Guidance for Food and Drug Administration Staff and Industry'' that appeared in the Federal Register of October 25, 2019. The Agency is taking this action to allow interested persons additional time to submit comments.

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 School Health Profiles Test- Retest Reliability Study. CDC is requesting a one-year approval to conduct the School Health Profiles Test-Retest Reliability Study, a study to test the reliability of the data collected through the School Health Profiles questionnaires administered by state and local agencies to principals and lead health education teachers in public secondary schools containing at least one of grades 6 through 12 in the United States.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Competitive Generic Therapies.'' This guidance provides a description of the process that applicants should follow to request designation of a drug as a competitive generic therapy (CGT) and the criteria for designating a drug as a CGT. In addition, this guidance includes information on the actions that FDA may take to expedite the development and review of an abbreviated new drug application (ANDA) for a drug designated as a CGT. Further, this guidance provides information on how FDA implements the statutory provision for a 180-day exclusivity period for certain first approved applicants that submit ANDAs for drugs designated as a CGT. This guidance finalizes the draft guidance of the same title dated February 19, 2019.