FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: AGENCY INFORMATION COLLECTION ACTIVITIES; SUBMISSION FOR OFFICE OF MANAGEMENT AND BUDGET REVIEW; COMMENT REQUEST; BIOLOGICAL PRODUCTS: REPORTING OF BIOLOGICAL PRODUCT DEVIATIONS AND HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCT DEVIATIONS IN MANUFACTURING

WASHINGTON, Sept. 16 -- Food and Drug Administration has issued a notice called: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing.

The notice was published in the Federal Register on Sept. 16 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act o...