[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]
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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; 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, 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]
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