[Federal Register Volume 87, Number 100 (Tuesday, May 24, 2022)]
[Notices]
[Pages 31563-31565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-11119]


=======================================================================
-----------------------------------------------------------------------

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, Agency, or we) 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 document provides blood 
establishments that collect blood and blood components with 
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 removes the recommendations to defer 
indefinitely blood donors for geographic risk of possible exposure to 
bovine spongiform encephalopathy for time spent in the United Kingdom 
(U.K.) from 1980 to 1996 and for time spent in France and Ireland from 
1980 to 2001, and receipt of a blood transfusion in the U.K., France, 
and Ireland from 1980 to the present. The guidance also provides 
recommendations for requalification of individuals previously deferred 
for these geographic risk factors, provided they meet all other 
eligibility requirements. The guidance announced in this notice 
supersedes the guidance

[[Page 31564]]

of the same title dated April 2020 and updated August 2020 (2020 
guidance).

DATES: The Agency is soliciting public comment, but is implementing 
this guidance immediately, because the Agency has determined that prior 
public participation is not feasible or appropriate. The announcement 
of the guidance is published in the Federal Register on May 24, 2022.

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, 240-402-7500.
     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, 240-402-7500.
    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: 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 
``Recommendations to Reduce the Possible Risk of Transmission of 
Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by 
Blood and Blood Components.'' The guidance document provides blood 
establishments that collect blood and blood components with 
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 removes the recommendations in the 2020 
guidance to defer indefinitely blood donors for: (1) Geographic risk of 
possible exposure to bovine spongiform encephalopathy for time spent in 
the U.K. from 1980 to 1996 and for time spent in France and Ireland 
from 1980 to 2001, and (2) receipt of a blood transfusion in the U.K., 
France, and Ireland from 1980 to present. The guidance also provides 
recommendations for requalification of individuals previously deferred 
for these geographic risk factors, provided they meet all other 
eligibility requirements. The guidance announced in this notice 
supersedes the final guidance of the same title dated April 2020 and 
updated August 2020. In the Federal Register of June 17, 2020 (85 FR 
36593), FDA announced the availability of the final guidance of the 
same title dated April 2020. The guidance was updated in August 2020.
    The recommendations on reducing the possible risk of transmission 
of CJD are unchanged from the 2020 guidance. The guidance changes the 
geographic deferral recommendations for vCJD risk based on new 
information in the risk assessments published by U.K.'s Advisory 
Committee on the Safety of Blood, Tissues and Organs and

[[Page 31565]]

Medicines and Healthcare Products Regulatory Agency. These risk 
assessment models, which FDA has independently evaluated, demonstrate 
that, in the U.K., the current risk of vCJD transmission by blood and 
blood components would expose transfusion recipients to no or minimal 
additional risk of vCJD in the future, and, for blood components that 
are leukocyte reduced, the possible risk is even further reduced. FDA 
has determined that the recommendations will simplify the donor 
screening process and increase the number of eligible donors while 
maintaining the safety of blood and blood components.
    FDA is issuing this guidance for immediate implementation in 
accordance with Sec.  10.115(g)(2) (21 CFR 10.115(g)(2)) without 
initially seeking prior comment, because the Agency has determined that 
prior public participation is not feasible or appropriate (see Sec.  
10.115(g)(2) and section 701(h)(1)(C)(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 371(h)(1)(C)(i))). Specifically, we are not 
seeking prior comment because the revised recommendations present a 
less burdensome policy for reducing the risk of transmission of CJD and 
vCJD by blood and blood components that is consistent with public 
health, and we expect that the revised recommendations will increase 
the availability of blood and blood components while maintaining the 
safety of blood and blood components.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (Sec.  10.115). The guidance represents the 
current thinking of FDA on ``Recommendations to Reduce the Possible 
Risk of Transmission of Creutzfeldt-Jakob Disease and Variant 
Creutzfeldt-Jakob Disease 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

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. 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 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 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or 
https://www.regulations.gov.

    Dated: May 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-11119 Filed 5-23-22; 8:45 am]
BILLING CODE 4164-01-P