[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Blood and Blood Components; Draft Guidance for Industry; Availability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the availability of a draft guidance entitled ``Recommendations to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The draft guidance provides blood establishments that collect blood and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The recommendations in the draft guidance apply to the collection of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 The draft guidance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Products,' '' Draft Guidance for Industry, dated December 2017, and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DATES: Submit either electronic or written comments on the draft
guidance by March 31, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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]
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