Department of Health and Human Services March 19, 2012 – Federal Register Recent Federal Regulation Documents

The National Institutes of Health (NIH) will hold a public meeting on Thursday, April 19, 2012, from 6:30-9:30 p.m. at Roxbury Community College, Main Stage, 1234 Columbus Avenue, Boston, MA 02120. The purpose of the meeting is to solicit public comments regarding the Draft Supplementary Risk Assessment for the National Emerging Infectious Diseases Laboratories. Comments provided during the meeting, as well as those received during the public comment period, will be considered in NIH's preparation of the Final Supplementary Risk Assessment for the National Emerging Infectious Diseases Laboratories. Individuals wishing to provide oral comments at the meeting must sign- in prior to the start of the meeting. Sign-in will begin at 5:30 p.m. In order to ensure everyone has the opportunity to speak, comments must be limited to no longer than three minutes. An agenda, slides for the meeting, and the draft supplementary risk assessment will be available at: https://nihblueribbonpanel-bumc-neidl.od.nih.gov/meetings.asp. This public meeting is part of the 67-day public comment period initiated with the publication of a Notice of Availability in the Federal Register on February 24, 2012. The 67-day comment period began on February 24, 2012 and will end on May 1, 2012. Written comments can also be sent to: National Institutes of Health, ATTN: NEIDL Risk Assessment, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892, or emailed to NIH_BRP@od.nih.gov. For further information concerning this meeting, please contact Office of Biotechnology Activities, National Institutes of Health, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892; telephone: 301-496- 9838; email: BRP_NIH@od.nih.gov. Requests for reasonable accommodations or translation services should be made to BRP_ NIH@od.nih.gov no later than April 12, 2012.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The NADA provides for the veterinary prescription use of pergolide mesylate tablets in horses for the control of clinical signs associated with Pituitary Pars Intermedia Dysfunction (Equine Cushing's Disease).

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens.'' This document was developed to support the reclassification of nucleic acid-based in vitro diagnostic devices for the detection of M. tuberculosis complex in respiratory specimens from class III into class II. These devices are intended to be used as an aid in the diagnosis of pulmonary tuberculosis. This draft guidance document describes a means by which in vitro diagnostic devices for the detection of M. tuberculosis complex in respiratory specimens may comply with the requirement of special controls for class II devices.

The Food and Drug Administration (FDA) is issuing this final rule to amend the regulations to reflect organizational change in the Agency and to make other conforming changes. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.

The Food and Drug Administration (FDA) has determined that CITANEST (prilocaine hydrochloride (HCl)) Injection, 1%, 2%, and 3%, and CITANEST PLAIN (prilocaine HCl) Injection, 4%, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for prilocaine HCl injection, 1%, 2%, and 3%, and prilocaine HCl injection, 4%, if all legal and regulatory requirements are met.