[Federal Register Volume 75, Number 102 (Thursday, May 27, 2010)]
[Notices]
[Pages 29768-29769]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-12696]
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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guidance), and the draft guidance document entitled ``Draft Guidance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