Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is announcing the availability of a document entitled “Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection” dated May 2003. The guidance provides our revisions to the guidance of the same title dated October 2002 in which FDA provided its recommendations for assessing donor suitability and product safety for donors with proven recent West Nile Virus (WNV) infections or with illness potentially due to WNV. The guidance is intended to recommend deferral of donors infected or potentially infected with WNV, and to recommend quarantine of blood and blood products previously collected from such donors. These measures are intended to reduce the possibility of WNV transmission by blood and blood products and are for immediate implementation. This guidance supersedes the guidance of the same title dated October 2002.
Submit written or electronic comments on agency guidances at any time.
Submit written or electronic requests for single copies of this guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling the CBER Voice Information System at 1-800-835-4709 or 301-827-1800 or by fax by calling the FAX Information System at 1-888-CBER-FAX or 301-827-3844. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.
Submit written comments on the guidance document to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Nathaniel L. Geary, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6210.End Further Info End Preamble Start Supplemental Information
FDA is announcing the availability of a document entitled “Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection” dated May 2003. The guidance document provides information related to the possible risk of WNV transmission by blood or blood products. The presence of WNV in blood components and transfusion transmission from blood components has been documented. FDA developed this guidance in consultation with other Public Health Service agencies of the Department of Health and Human Services. The guidance supersedes the guidance of the same title dated October 2002.
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). This guidance document represents the agency's current thinking on this topic. Start Printed Page 25898 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 requirements of the applicable statutes and regulations.
The agency is soliciting public comment, and is recommending the implementation of the guidance by June 1, 2003, because of public health concerns related to the possible risk of transfusion transmitted WNV.
Interested persons may, at any time, submit written or electronic comments to the Dockets Management Branch (see ADDRESSES) regarding this guidance document. Two copies of mailed comments are to be submitted, except individuals may submit one copy. Comments should be identified with the docket number found in the brackets in the heading of this document. A copy of the document and received comments are available for public examination in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
III. Electronic AccessStart Signature
Dated: May 6, 2003.
Assistant Commissioner for Policy.
[FR Doc. 03-11980 Filed 5-13-03; 8:45 am]
BILLING CODE 4160-01-S