Department of Health and Human Services March 24, 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products; Guidance for Industry'' dated March 2015. The guidance document provides investigational new drug application (IND) sponsors and applicants for a biologics license application (BLA) or a supplement to a BLA (BLA supplement), with recommendations on considerations when assessing whether to submit an Environmental Assessment (EA) for gene therapies, vectored vaccines, and related recombinant viral or microbial products (GTVVs). The guidance also contains recommendations as to what information should be included in an EA and what you can expect once an EA is filed. The guidance announced in this notice finalizes the draft guidance of the same title dated June 2014.

The Food and Drug Administration (FDA or we) is announcing the establishment of a docket to obtain comments that will inform our development of FDA Food Safety Modernization Act (FSMA) implementation work plans. FDA is also announcing a public meeting entitled ``FDA Food Safety Modernization Act: Focus on Implementation Strategy for Prevention-Oriented Food Safety Standards.'' At the public meeting, we will share our current thinking on our operational strategy for implementation work plans. We will also provide interested persons an opportunity to provide input on this operational strategy and the risk- based industry oversight framework that is at the core of FSMA.

The Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on Promotion of the National Amyotrophic Lateral Sclerosis (ALS) Registry to Non-referral Centers.

This document corrects a notice that was published in the Federal Register on March 4, 2015 (Volume 80, Number 42, Page 11677). The time and date should read as follows: