[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]
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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 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draft guidance of the same title dated January 2020, and supersedes the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