Department of Health and Human Services March 31, 2015 – Federal Register Recent Federal Regulation Documents

Pursuant to 42 U.S.C. 5106a, the Children's Bureau (CB) announces the opportunity for public comment on the policy interpretation of section 106(b)(2)(B)(x) articulated in question 2.1A.4 #8 of the Child Welfare Policy Manual (CWPM), which concerns the public disclosure of findings or information about a case of child abuse or neglect which results in a child fatality or near fatality.

The Administration for Community Living (ACL) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. 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 solicits comments on the information collection requirements relating to the Help America Vote Act (HAVA), Public Law 107-252, title II, subtitle D, section 291, Payments for Protection and Advocacy Systems (P&As Narrative Annual Report).

The Food and Drug Administration (FDA) is announcing a request for additional comments on the chemistry, manufacturing, and control (CMC) information that a sponsor of an investigational new drug application (IND) should provide in its IND in order to meet regulatory requirements when commercially available foods or dietary supplements containing live biotherapeutic products (LBPs) are used as investigational new drugs in early phase clinical trials. The request for additional comments on the CMC information is related to the guidance entitled, ``Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry,'' dated February 2012 (February 2012 guidance).

The Food and Drug Administration (FDA or Agency) is announcing support for the World Health Organization (WHO) Drug Dictionary (available at https://www.who-umc.org/), which is maintained and updated by the Uppsala Monitoring Centre. FDA is encouraging sponsors and applicants to use WHO Drug Dictionary codes in investigational study data provided in regulatory submissions to the Center for Drug Evaluation and Research and to the Center for Biologics Evaluation and Research. The WHO Drug Dictionary contains unique codes for identifying drug names and evaluating medicinal product information, including active ingredients and therapeutic uses. Typically, WHO Drug Dictionary is used to code concomitant medications used by subjects during the course of a clinical trial. WHO Drug Dictionary will be listed in the FDA Data Standards Catalog posted to FDA's Study Data Standards Resources Web site at https://www.fda.gov/forindustry/datastandards/ studydatastandards/default.htm

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Development and Submission of Near Infrared Analytical Procedures.'' This draft guidance provides recommendations to applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding the development and submission of near infrared (NIR) analytical procedures used during the manufacture and analysis of pharmaceuticals. This draft guidance only pertains to the development and validation of NIR analytical procedures and does not provide recommendations concerning the set up and qualification of NIR instruments or their maintenance and calibration.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry #226 entitled ``Target Animal Safety Data Presentation and Statistical Analysis.'' The purpose of this document is to provide recommendations to industry regarding the presentation and statistical analyses of target animal safety (TAS) data submitted to the Center for Veterinary Medicine (CVM) as part of a study report to support approval of a new animal drug. These recommendations apply to TAS data generated from both TAS and field effectiveness studies conducted in companion animals (e.g., dogs, cats, and horses) and food animals (e.g., swine, ruminants, fish, and poultry).