Application of Nucleic Acid Testing to Blood Borne Pathogens and Emerging Technologies; Public Workshop

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

The Food and Drug Administration (FDA) is announcing a public workshop entitled “Application of Nucleic Acid Testing to Blood Borne Pathogens and Emerging Technologies.” The purpose of the public workshop is to focus on issues surrounding the implementation of nucleic acid testing (NAT) to screen blood and plasma donors.

Date and Time: The 2-day public workshop will be held on December 4 and 5, 2001, from 8:30 a.m. to 5 p.m.

Location: The public workshop will be held at the Lister Hill Center, National Institutes of Health, Bldg. 38A, 8600 Rockville Pike, Bethesda, MD.

Contact: Joseph Wilczek, Center for Biologics Evaluation and Research (HFM-305), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6129, FAX 301-827-2843, e-mail: wilczek@cber.fda.gov.

Registration: Preregistration is not required. However, early registration is recommended because there are only 175 seats at the site. Registration at the site will be done on a space available basis on the days of the workshop, beginning at 7:30 a.m. Mail, e-mail, or fax your registration information (including name, title, firm name, address, telephone and fax number, and e-mail address) to the contact person on or before November 23, 2001. A registration form is available on the Internet at http://www.fda.gov/cber/scireg.htm . There is no registration fee. If you need special accommodations due to a disability, please contact Joseph Wilczek (address above) at least 7 days in advance.

Transcripts: Transcripts of the public workshop may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15-working days after the meeting at a cost of 10 cents per page. The public workshop transcript will also be available on the Internet at http://www.fda.gov/cber/minutes/workshop-min.htm .

SUPPLEMENTARY INFORMATION:

FDA is sponsoring a public workshop on issues surrounding the implementation of NAT for blood borne pathogens. These issues for testing blood and plasma donors include screening for human immunodeficiency virus, hepatitis C virus, hepatitis B virus, and testing manufacturing pools for hepatitis A virus and parvovirus B-19. The goals of the public workshop are to examine: (1) International developments and regulatory issues regarding the implementation of minipool and single unit NAT; (2) standardization and quality assurance of NAT methods; (3) industry experience with minipool NAT for donor screening and in-process plasma pools; (4) potential replacement of current viral marker tests by NAT; and (5) emerging issues in nucleic acid testing, including new pathogens and new screening technologies. Another goal of the workshop is to evaluate future directions in NAT for blood borne pathogens. The public workshop agenda is posted on the Internet at http://www.fda.gov/cber/scireg.htm .