Department of Health and Human Services September 7, 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) has determined the regulatory review period for EFFIENT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration's (FDA or agency) Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) are announcing a public meeting to solicit comments and concerns of industry, other government agencies, and interested parties on the regulatory and scientific challenges as addressed in the draft document entitled ``Guidance for Industry: Animal ModelsEssential Elements to Address Efficacy Under the Animal Rule'' dated January 2009 (Draft Guidance), and as related to the development of medical countermeasures under the ``Animal Rule'' with respect to chemical, biological, radiological, or nuclear (CBRN) threats. Comments on these issues will be considered in connection with the development of a final version of the Draft Guidance.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of Federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Bar Code Label RequirementsQuestions and Answers (Question 12 Update)'' dated August 2010. This draft guidance provides you, manufacturers of a licensed vaccine, with advice concerning compliance with the bar code label requirements. In this guidance, FDA is proposing to amend our response to question 12 (Q12) in the ``Bar Code Label Requirements Questions and Answers'' guidance dated October 2006 (Bar Code Guidance), to provide recommendations to manufacturers of licensed vaccines in connection with the use of alternative coding technologies. When this guidance is finalized, we intend to incorporate the revised response to Q12 into the Bar Code Guidance, but otherwise continue with our recommendations for bar code label requirements as currently provided in the Bar Code Guidance.

The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) is announcing an invitation to participate in a pilot evaluation program for CBER's eSubmitter Program (eSubmitter). CBER's eSubmitter has been customized as an automated biologics license application (BLA) and BLA supplement (BLS) submission system for blood and blood components. Participation in the pilot program is open to blood establishments that collect Whole Blood and blood components. The pilot program is intended to provide industry and CBER regulatory review staff the opportunity to evaluate the eSubmitter system and determine if it facilitates the BLA/BLS submission process. The purpose of this notice is to invite blood establishments that collect Whole Blood and blood components to submit a request to CBER if they are interested in participating in this pilot program.