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Draft Guidance for Industry on an Amendment Involving Donor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 The draft guidance document, when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 This draft
guidance, which is a level I guidance document, would add to the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 After we review comments received on this draft guidance,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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers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