Document ID: FDA-1997-D-0008-0004
Agency: fda
Document Type: Notice
Title: Guidance For Industry: Revised Preventive Measures to Reduce Possible Risk of Transmission of Creutzfeldt-Jakob Disease, etc.
Posted Date: 2010-05-27T04:00Z

[Federal Register: May 27, 2010 (Volume 75, Number 102)]
[Notices]               
[Page 29768-29769]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27my10-66]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1997-D-0008] (formerly Docket No. 1997D-0318)

 
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 document entitled ``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 May 2010. The guidance 
announced in this notice provides blood collecting establishments and 
manufacturers of plasma derivatives with comprehensive FDA 
recommendations intended to minimize the possible risk of transmission 
of CJD and vCJD from blood and blood products. This guidance document 
amends the January 2002 guidance document of the same title by: 
Incorporating donor deferral recommendations for donors who have 
received a transfusion of blood or blood components in France since 
1980, providing updated scientific information on CJD and vCJD, 
revising labeling recommendations for Whole Blood and blood components 
intended for transfusion, and recognizing AABB's full Donor History 
Questionnaire Version 1.3 as an acceptable mechanism for collection of 
donor history information. The guidance announced in this notice 
supersedes the guidance document entitled ``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 (2002 
guidance), and the draft guidance document entitled ``Draft Guidance 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 (2006 draft guidance).

DATES: Submit electronic or written comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Office of Communication, Outreach and Development (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 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 guidance document.
    Submit electronic or written comments on the guidance. Submit 
electronic comments to http://www.regulations.gov. Submit written 
comments to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Denise S[aacute]nchez, 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 document entitled 
``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 May 2010. This guidance amends the 2002 FDA guidance of the same 
title by incorporating donor deferral recommendations as to donors in 
France (as announced in the 2006 draft guidance), providing updated 
scientific information on CJD and vCJD, revising labeling 
recommendations for Whole Blood and blood components intended for 
transfusion, and recognizing the use of AABB's full Donor History 
Questionnaire Version 1.3 as an acceptable mechanism that is consistent 
with FDA requirements and recommendations for collecting donor history 
information.
    In the Federal Register of January 16, 2002 (67 FR 2226), FDA 
announced the availability of a guidance entitled ``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 (the 2002 guidance). The 2002 guidance finalized 
recommendations to all blood collecting establishments and 
manufacturers of plasma derivatives for deferral of donors with 
possible exposure to the CJD and vCJD agents. In the Federal Register 
of August 14, 2006 (71 FR 46484), FDA announced the availability of a 
draft guidance entitled ``Draft 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''' (the 
2006 draft guidance). The 2006 draft guidance was intended to amend the 
2002 guidance by adding a donor deferral recommendation for donors who 
have received a transfusion of blood or blood components in France 
since 1980. Specifically, in the 2006 draft guidance, we stated that we 
intended to incorporate the new donor deferral recommendation after 
receiving comments on the draft guidance and reissue the revised 2002 
guidance as a level 2 guidance document for immediate implementation 
(71 FR 46484, August 14, 2006). Upon further consideration, however, we 
believe it appropriate to issue the guidance announced in this notice 
as a level 1 guidance document.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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

[[Page 29769]]

requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR 601.12 have been approved under 
OMB control number 0910-0338; the collections of information in 21 CFR 
606.100 have been approved under OMB control number 0910-0116; and the 
collections of information in 21 CFR Part 600.14 and 606.171 have been 
approved under OMB control number 0910-0458.

III. Comments

    Interested persons may, at any time, submit to the Division of 
Dockets Management (see ADDRESSES) electronic or written comments 
regarding the 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 brackets in the heading of this document. A copy of the 
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.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http:/
/www.regulations.gov.

    Dated: May 18, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-12696 Filed 5-26-10; 8:45 am]
BILLING CODE 4160-01-S