Department of Health and Human Services August 26, 2013 – Federal Register Recent Federal Regulation Documents

The National Institutes of Health (NIH) is providing guidance to Public Health Service (PHS) awardee institutions on implementation of the revised International Guiding Principles for Biomedical Research Involving Animals (``Guiding Principles''). The NIH is seeking input from the public on any concerns they may have regarding the revised Guiding Principles.

The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on our proposed collection of certain information. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice invites comments on the procedure by which a manufacturer or distributor of dietary supplements or of a new dietary ingredient is to submit information to us upon which it has based its conclusion that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe.

The Food and Drug Administration (FDA) is announcing the availability on the Agency Web site of revised final versions of the following four documents that support making regulatory submissions in electronic format using the electronic Common Technical Document (eCTD) specifications: ``The eCTD Backbone Files Specification for Module 1,'' version 2.2 (which includes the U.S. regional document type definition (DTD), version 3.2); ``The Comprehensive Table of Contents Headings and Hierarchy,'' version 2.2; ``Specifications for eCTD Validation Criteria,'' version 3.0; and ``Example Submissions using eCTD Backbone Files Specification for Module 1,'' version 1.2. Technical files that support these documents are also available on the Agency Web site. A complete summary of the revisions made is included in the updated documents. FDA estimates it will be able to receive submissions utilizing Module 1 Specifications 2.2 by June 2014, and will give 30 days' advance notice to industry.