Document ID: FDA-2012-D-0307-0063
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; Guidance for Industry; Availability;
Posted Date: 2020-06-17T04:00Z

[Federal Register Volume 85, Number 117 (Wednesday, June 17, 2020)]
[Notices]
[Pages 36593-36594]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13055]

-----------------------------------------------------------------------

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; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final 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 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 guidance apply to the collection of Whole Blood 
and blood components intended for transfusion or for use in further 
manufacturing, including Source Plasma. The guidance finalizes the 
draft guidance of the same title dated January 2020, and supersedes the 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: The announcement of the guidance is published in the Federal 
Register on June 17, 2020.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

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

[[Page 36594]]

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 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: 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 guidance entitled 
``Recommendations to Reduce the Possible Risk of Transmission of 
Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob Disease by 
Blood and Blood Components.'' This document was posted on FDA's website 
on April 2, 2020 (see section III for electronic access to the 
guidance). The 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 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 prior 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 January 31, 2020 (85 FR 5668), FDA 
announced the availability of the draft guidance of the same title 
dated January 2020. FDA received several comments on the draft guidance 
and those comments were considered as the guidance was finalized. Based 
on these comments, editorial changes were made to improve clarity. The 
guidance announced in this notice finalizes the draft guidance dated 
January 2020, and supersedes 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 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 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 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. 3501-3521). 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 number 0910-0116.

III. Electronic Access

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

    Dated: June 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13055 Filed 6-16-20; 8:45 am]
BILLING CODE 4164-01-P