[Federal Register Volume 71, Number 156 (Monday, August 14, 2006)]
[Notices]
[Pages 46484-46485]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-13234]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1997D-0318] (formerly Docket No. 97D-0318)


Draft Guidance for Industry on an Amendment Involving Donor 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) and Variant 
Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products''; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 The draft guidance document, when 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 This draft 
guidance, which is a level I guidance document, would add to the 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 After we review comments received on this draft guidance, 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DATES:  Submit written or electronic comments on the draft guidance by 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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

[[Page 46485]]

incorporate this donor deferral recommendation and reissue the revised 
CJD/vCJD Guidance as a level II guidance document in accordance with 
Sec.  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 (Sec.  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.
[FR Doc. E6-13234 Filed 8-11-06; 8:45 am]
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