Document ID: FDA-2012-D-0307-0031
Agency: fda
Document Type: Notice
Title: Recommendations To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob Disease by Blood and Blood Components;  Draft Guidance for Industry; Availability
Posted Date: 2020-01-31T05:00Z

[Federal Register Volume 85, Number 21 (Friday, January 31, 2020)]
[Notices]
[Pages 5668-5670]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01815]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Recommendations To Reduce the Possible Risk of Transmission of 
Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob Disease by 
Blood and Blood Components; Draft Guidance for Industry; Availability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the availability of a draft guidance entitled ``Recommendations to 
Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease 
and Variant Creutzfeldt Jakob Disease by Blood and Blood Components.'' 
The draft guidance provides blood establishments that collect blood and 
blood components with revised recommendations intended to reduce the 
possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and 
variant Creutzfeldt-Jakob disease (vCJD) by blood and blood components. 
The recommendations in the draft guidance apply to the collection of 
Whole Blood and blood components intended for transfusion or for use in 
further manufacturing, including Source Plasma. The draft guidance 
replaces the document entitled ``Amendment to `Revised Preventive 
Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-
Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood 
Products,' '' Draft Guidance for Industry, dated December 2017, and 
when finalized, will supersede the 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,'' dated May 2010 and 
updated January 2016.

DATES: Submit either electronic or written comments on the draft 
guidance by March 31, 2020 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

[[Page 5669]]

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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 ``Recommendations to Reduce the Possible Risk of 
Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob 
Disease by Blood and Blood Components.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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 the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft 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 draft 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 draft 
guidance document.

FOR FURTHER INFORMATION CONTACT: Sana F. Hussain, 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 draft guidance entitled 
``Recommendations to Reduce the Possible Risk of Transmission of 
Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob Disease by 
Blood and Blood Components.'' The draft guidance provides blood 
establishments that collect blood and blood components with revised 
recommendations intended to reduce the possible risk of transmission of 
CJD and vCJD by blood and blood components. The recommendations in the 
draft guidance apply to the collection of Whole Blood and blood 
components intended for transfusion or for use in further 
manufacturing, including Source Plasma. FDA is revising or removing our 
current recommendations to screen blood donors for: (1) Geographic risk 
of possible exposure to bovine spongiform encephalopathy, including 
time spent on U.S. military bases in Europe; (2) receipt of a blood 
transfusion in certain vCJD risk countries; (3) risk factors for 
iatrogenic CJD (i.e., a history of taking human cadaveric pituitary-
derived growth hormone; (4) having blood relatives with CJD; and (5) a 
history of injecting bovine insulin.
    In the Federal Register of December 22, 2017 (82 FR 60747), FDA 
announced the availability of the draft document entitled ``Amendment 
to `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 December 2017 (December 
2017 draft guidance). FDA received several comments on the December 
2017 draft guidance. Based on those comments, FDA is announcing a 
revised draft guidance. The draft guidance announced in this notice 
replaces the December 2017 draft guidance, and, when finalized, will 
supersede the 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,'' dated May 2010 and updated January 2016.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on 
recommendations to reduce the possible risk of transmission of CJD and 
vCJD by blood and blood components. It does not establish any rights 
for any person and is not binding on FDA or the public. You can use an 
alternative

[[Page 5670]]

approach if it satisfies the requirements of the applicable statutes 
and regulations.

II. Paperwork Reduction Act of 1995

    This draft 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. 3501-3521). The 
collections of information in 21 CFR 601.12 and Form FDA 356h have been 
approved under OMB control number 0910-0338; the collections of 
information in 21 CFR parts 610 and 630 have been approved under OMB 
control numbers 0910-0116.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances or 
https://www.regulations.gov.

    Dated: January 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01815 Filed 1-30-20; 8:45 am]
 BILLING CODE 4164-01-P