E6-13234. Draft Guidance for Industry on an Amendment Involving Donor Deferral for Transfusion in France Since 1980 to “Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) ...

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled “Guidance for Industry: Amendment (Donor Deferral for Transfusion in France Since 1980) to ‘Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products,’” dated August 2006. The draft guidance document, when finalized, is intended to amend FDA's “Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products” dated January 2002. This draft guidance, which is a level I guidance document, would add to the January 2002 guidance a donor deferral recommendation for donors who have received a transfusion of blood or blood components in France since 1980. After we review comments received on this draft guidance, we intend to incorporate this donor deferral recommendation and reissue the revised January 2002 guidance as a level II guidance document for immediate implementation.

DATES:

Submit written or electronic comments on the draft guidance by October 13, 2006 to ensure their adequate consideration in preparation of the revisions to the 2002 guidance. General comments on agency guidance documents are welcome at any time.

ADDRESSES:

Submit written requests for single copies of the draft guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug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, suite 200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/​dockets/​ecomments.

FOR FURTHER INFORMATION CONTACT:

Brenda R. Friend, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft document entitled “Guidance for Industry: Amendment (Donor Deferral for Transfusion in France Since 1980) to ‘Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products’” dated August 2006 (Draft Guidance). The Draft Guidance is intended to amend FDA's “Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products” (CJD/vCJD Guidance), dated January 2002, by adding a donor deferral recommendation for donors who have received a transfusion of blood or blood components in France since 1980. After we review comments received on this Draft Guidance, we intend to incorporate this donor deferral recommendation and reissue the revised CJD/vCJD Guidance as a level II guidance document in accordance with § 10.115(g)(4)(i) (21 CFR 10.115(g)(4)(i)).

Since the original publication of the CJD/vCJD Guidance, we have learned of additional information warranting revision to the CJD/vCJD Guidance to address a possible increased risk of vCJD transmission from individuals who have received a transfusion of blood or blood components in France. This revision is based on:

• The likelihood of exposure to the Bovine Spongiform Encephalopathy (BSE) agent in that country and
• The recent documentation of three presumptive cases of transfusion-transmitted vCJD infection in the United Kingdom (U.K.).

Because an unknown but possibly significant number of blood donors might have already been infected in France during peak significant years of the BSE outbreak in Europe, FDA believes that it would be a prudent preventive measure to indefinitely defer all donors (including Source Plasma donors) who received transfusions of blood or blood components in France since 1980.

The Draft Guidance is being issued consistent with FDA's good guidance practices regulation (§ 10.115). The Draft Guidance, when finalized, will represent FDA's current thinking on this topic. 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 requirement of the applicable statutes and regulations.

II. Comments

The Draft Guidance is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding the Draft Guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in the brackets in the heading of this document. A copy of the Draft Guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet may obtain the Draft Guidance at either http://www.fda.gov/​cber/​guidelines.htm or http://www.fda.gov/​ohrms/​dockets/​default.htm.

Dated: August 1, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.