Important note: Information in this article was accurate in 2007. The state of the art may have changed since the publication date.
 |
Food and Drug Administration - December 14, 2007
Richard Klein, HIV/AIDS Program Director
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:
Submit electronic comments in the following ways:
Federal eRulemaking Portal: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingF R.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=leavingF R.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
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 Administratio
5630 Fishers Lane, rm. 1061
Rockville, MD 20852.
Richard Klein
HIV/AIDS Program Director
Food and Drug Administration
071214
FD071202
SOURCE: Food and Drug Administration (FDA).
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Boehringer Ingelheim, Bridgestone/Firestone Charitable Trust, Bristol-Myers Squibb Company, Elton John AIDS Foundation, the National Library of Medicine, Roche and Trimeris, and donations from users like you. Always watch for outdated information. This article first appeared in 2007. This material is designed to support, not replace, the relationship that exists between you and your doctor.
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ©1980, 2007. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .