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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Withdrawal of "Guidance for Industry: Supplemental Testing and the Notification of Consignees of Donor Test Results for Antibody to Hepatitis C Virus (Anti-HCV)"

FDA hereby withdraws its "Guidance for Industry: Supplemental Testing and the Notification of Consignees of Donor Test Results for Antibody to Hepatitis C Virus (Anti-HCV)," published in the Federal Register on March 20, 1998.

In order to address public comments that were received relating to this March 1998 guidance, FDA will, in the near future, issue a comprehensive guidance on quarantine and disposition of units from prior collections from donors with repeatedly reactive screening tests for hepatitis C and supplemental testing, and the notification of consignees and blood recipients of donor test results for antibody to HCV.

This comprehensive guidance will replace the March 1998 guidance and supersede the HCV sections of FDA's July 19, 1996 guidance entitled: "Recommendations for Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human T-Lymphotropic Virus Type I (HTLV-I)."

Withdrawal of the March 20,1998 guidance removes FDA's recommendation that blood establishments should begin notification of consignees within six months of the date of publication of guidance (i.e. by September 20, 1998) concerning results of donations tested prior to the date of implementation of the guidance.

Date: 09/08/1998

 

Contact FDA

(800) 835-4709
(301) 827-1800
Manufacturers Assistance and Technical Training Branch (CBER)

Division of Manufacturers Assistance and Training

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-41

Rockville, MD 20852-1448