Document ID: FDA-2012-D-0307-0007
Agency: fda
Document Type: Notice
Title: Revised Preventive Measures To Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob
Disease by Blood and Blood Products; Guidance for Industry; Availability
Posted Date: 2016-01-14T05:00Z

[Federal Register Volume 81, Number 9 (Thursday, January 14, 2016)]
[Notices]
[Pages 1957-1958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00536]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Revised Preventive Measures To Reduce the Possible Risk of 
Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob 
Disease by Blood and Blood Products; Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a document entitled ``Revised Preventive Measures 
to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob 
Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood 
Products; Guidance for Industry.'' The guidance document provides blood 
collecting establishments and manufacturers of plasma derivatives with 
comprehensive recommendations intended to minimize the possible risk of 
transmission of Creutzfeldt-Jakob Disease (CJD) and Variant 
Creutzfeldt-Jakob Disease (vCJD) from blood and blood products. The 
guidance amends 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 
guidance) by finalizing and incorporating the recommendations from the 
draft document entitled ``Draft Guidance for Industry: Amendment to 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''' dated June 
2012 (2012 draft guidance).

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

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2012-D-0307 for Revised Preventive Measures to Reduce the Possible 
Risk of Transmission of Creutzfeldt-Jakob Disease and Variant 
Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for 
Industry. Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at http://www.regulations.gov or at the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access

[[Page 1958]]

the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to the 
Office of Communication, Outreach, and Development, Center for 
Biologics Evaluation and Research (CBER), Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. 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 240-402-8010. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Tami Belouin, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled ``Revised 
Preventive Measures to Reduce the Possible Risk of Transmission of 
Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by 
Blood and Blood Products; Guidance for Industry.'' The guidance 
document provides blood collecting establishments and manufacturers of 
plasma derivatives with comprehensive recommendations intended to 
minimize the possible risk of transmission of CJD and vCJD from blood 
and blood products. The guidance is the latest in a series of guidances 
addressing the risk of CJD and vCJD transmission by blood and blood 
products.
    The guidance amends the 2010 guidance (May 27, 2010; 75 FR 29768) 
and finalizes the 2012 draft guidance (June 11, 2012; 77 FR 34390) by 
providing revised labeling recommendations for plasma-derived products, 
including albumin and products containing plasma-derived albumin. The 
guidance also provides manufacturers of plasma-derived products with 
recommendations on how to report the labeling changes to FDA under 21 
CFR 601.12. Additional changes to the guidance include adding 
information in the background section relevant to the new labeling 
recommendations; providing updated information on the global vCJD and 
Bovine Spongiform Encephalopathy epidemics; clarifying the reentry 
criteria for a donor with a family history of CJD; clarifying the 
requirements related to biological product deviation reporting; and, 
updating, adding, and removing certain footnotes and references. FDA 
received four comments on the 2012 draft guidance, and those comments 
were considered in the finalization of the draft guidance.
    This guidance does not address potential changes to the geographic 
exposure based deferrals for risk of vCJD. FDA discussed such potential 
changes with its Transmissible Spongiform Encephalopathies Advisory 
Committee in June 2015 and intends to address revised recommendations 
for geographic donor deferrals in future guidance documents.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on Revised Preventive Measures to Reduce the 
Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant 
Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for 
Industry. It does not establish any rights for any person and is not 
binding on FDA or the public. You can use an alternative approach if it 
satisfies the 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 600.14 and 606.171 have been 
approved under OMB control number 0910-0458.

III. 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: January 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-00536 Filed 1-13-16; 8:45 am]
 BILLING CODE 4164-01-P