The Federal Register

New Animal Drugs; Change of Sponsor's Name

Wed, Dec 26 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the [[Page 72921]]
animal drug regulations to reflect a change of sponsor's name from Altana, Inc., to Nycomed US, Inc.

Agency Emergency Processing Under the Office of Management and Budget Review; Certification to Accompany Drug,

Wed, Dec 26 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of December 12, 2007 (72 FR 70599). The document announced that a proposed collection of information had been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995. The document was published with an error. This document corrects that error.

DSM Nutritional Products, Inc.; Filing of Color Additive Petition; Correction

Wed, Dec 26 2007 11:00:00 GMT

The Food and Drug Administration is correcting a notice that appeared in the Federal Register of December 4, 2007 (72 FR 68166). The document announced that DSM Nutritional Products, Inc., has filed a petition proposing that the color additive regulations be amended to provide for the safe use of astaxanthin dimethyldisuccinate as a color additive in the feed of salmonid fish to enhance the color of their flesh.

Clinical Trial Design for Community-Acquired Pneumonia; Public Workshop

Wed, Dec 26 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing a public workshop, cosponsored with the Infectious Diseases Society of America (IDSA), regarding scientific issues in clinical trial design for communityacquired pneumonia. This public workshop is intended to provide information for and to gain perspective from health care providers, academia, and industry on various aspects of antimicrobial drug development for communityacquired pneumonia, including diagnosis of communityacquired pneumonia, effect of antimicrobial treatment for communityacquired pneumonia, endpoints for trials of community acquired pneumonia, and statistical issues in analysis of results of trials in communityacquired pneumonia. The input from this public workshop will help in developing topics for further discussion.

Date and Time: The public workshop will be held on January 17, 2008, from 8 a.m. to 6 p.m. and on January 18, 2008, from 8 a.m. to 5 p.m.

Location: The public workshop will be held at the Crowne Plaza H

Maximizing the Public Health Benefit of Adverse Event Collection Throughout a Product's Marketed Life Cycle; Public

Wed, Dec 26 2007 11:00:00 GMT

The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) are announcing a public workshop entitled ``Maximizing the Public Health Benefit of Adverse Event Collection Throughout a Product's Marketed Life Cycle.'' The purpose of the public workshop is to solicit information and views from interested persons on research approaches and methods associated with the best ways to assess the public health benefit of collecting and reporting all adverse events (AEs). The input from this workshop will be used to publish a request for information to determine the types of outside organizations that would be interested in, and have the capability to conduct, the research described in this paragraph, followed by a request for proposal (RFP).