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FDA proposes requirements for human blood and blood components intended for transfusion or further manufacturing use
The Food and Drug Administration (FDA) proposes to revise and update the regulations applicable to blood and blood components, including Source Plasma and Source Leukocytes, to add donor requirements that are consistent with current practices in the blood industry, and to more closely align the regulations with current FDA recommendations. FDA is taking this action to help ensure the safety of the national blood supply and to help protect donor health by requiring establishments to evaluate donors for factors that may adversely affect the safety, purity, and potency of blood and blood components, or the health of a donor during the donation process.
Through the years, FDA has issued a number of guidance documents containing recommendations intended to assure a safe, pure, and potent blood supply. The Notice of Proposed Rulemaking discusses the recommendations contained in current guidance that fall under the proposed regulation, including donor eligibility and screening for HIV and certain other transfusion-transmitted infections. FDA believe the proposed rule will more explicitly describe donor eligibility standards and will clarify the relationship between the regulations and the applicable recommendations.
The proposed rule, among other things, provides for the establishment of minimum criteria for the assessment of donor eligibility, and the suitability of the donation of blood and blood components. The rule is expected to have a minor net impact on blood establishments because it is already usual and customary business practice in the blood industry to assess donors for eligibility, and donations for suitability. FDA believes the primary impact of the rule will be the one-time review of current SOPs that the proposed rule would require each blood collecting establishment to conduct.
Written or electronic comments on the proposed rule, identified by Docket No. 2006N- 0221, may be submitted to the agency until February 6, 2008 through any of the following methods:
Electronic Submissions Submit electronic comments in the following ways: Federal eRulemaking Portal: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. Follow the instructions for submitting comments.
Agency Web site: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Follow the instructions for submitting comments on the agency Web site.
Written Submissions: Submit written submissions in the following ways: FAX: 301-827-6870. Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
HIV/AIDS Program Director
Food and Drug Administration