Department of Health and Human Services September 17, 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products'' dated September 2009. The guidance document provides recommendations to manufacturers, sponsors, and clinical investigators involved in the transplantation of allogeneic pancreatic islet cell products for clinical investigations of the treatment of type 1 diabetes mellitus. The guidance identifies the types of data and information obtained during investigational new drug studies that may be helpful in establishing the safety, purity, and potency of a biological product in a biologics license application (BLA). The guidance announced in this notice finalizes the draft guidance of the same title, dated May 2008.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Microbiological Data for Systemic Antibacterial Drug Products Development, Analysis, and Presentation.'' The draft guidance informs industry of FDA's current thinking regarding the types of microbiological studies, assessments, and clinical trials needed to support an investigational new drug application (IND) and a new drug application (NDA) for a systemic antibacterial drug product. Recommendations in this guidance cover microbiological considerations in the three major areas of conducting general nonclinical studies; conducting animal and human studies and clinical trials; and establishing and updating in vitro susceptibility test methods, quality control (QC) parameters, and interpretive criteria. This guidance also recommends the content and format for presentation of microbiological data for antibacterial drug products in the Microbiology subsection of labeling.

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires a 60-day advance opportunity for public comment on the proposed information collection project, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review.