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FDA is announcing the availability of a document entitled “Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion” dated September 2012. The guidance document provides blood establishments with recommendations for pre-storage leukocyte reduction of Whole Blood and blood components intended for transfusion, including recommendations for validation and quality control monitoring of the leukocyte reduction process. The guidance also provides information to assist licensed blood establishments for submitting biologics license application supplements to include leukocytes reduced components.
The guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents FDA's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirement of the applicable statutes and regulations.
The guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 607 and Form FDA 2830 have been approved under OMB control number 0910-0052; the collections of information in 21 CFR 606.100(b), 606.100(c), 606.121, and 606.122 have been approved under OMB control number 0910-0116; the collections of information in 21 CFR 211.192 and 211.198 have been approved under OMB control number 0910-0139; and the collections of information in 21 CFR 601.12 and 610.60 and Form FDA 356h have been approved under OMB control number 0910-0338.
Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see
Persons with access to the Internet may obtain the guidance at either