
[Federal Register Volume 77, Number 112 (Monday, June 11, 2012)]
[Notices]
[Page 34390]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14034]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0307]


Draft Guidance for Industry: Amendment to ``Guidance for 
Industry: Revised Preventive Measures To Reduce the Possible Risk of 
Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob 
Disease 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 (revisions to labeling recommendations for potential risk of 
vCJD) 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 June 2012. The draft guidance document proposes 
amendments to the labeling recommendations for plasma-derived products, 
including albumin and products containing plasma-derived albumin, in 
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 May 2010 (2010 CJD/vCJD 
guidance). When finalized, the revised labeling recommendations will be 
incorporated into the 2010 CJD/vCJD guidance, but FDA will otherwise 
continue with its recommendations in the 2010 CJD/vCJD guidance as 
currently provided.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that FDA considers your comment on this draft 
guidance before it begins work on the final version of the guidance, 
submit either electronic or written comments on the draft guidance by 
September 10, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Outreach and Development (HFM-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 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 electronic comments on the draft guidance 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: Tami Belouin, 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 (revisions to labeling 
recommendations for potential risk of vCJD) 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 April 2012. The 
draft guidance document proposes amendments to labeling recommendations 
in the 2010 CJD/vCJD guidance for plasma-derived products, including 
albumin and products containing plasma-derived albumin, to reflect 
current knowledge of vCJD transmission through blood. When finalized, 
the revised labeling recommendations will be incorporated into the 2010 
CJD/vCJD guidance.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 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 requirements 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) either 
electronic or written comments regarding this document. It is only 
necessary to send one set of comments. Identify comments with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen 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/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: April 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14034 Filed 6-8-12; 8:45 am]
BILLING CODE 4160-01-P


