82 FR 60747 - 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of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry;” Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 245 (December 22, 2017)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a 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of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry;' Draft Guidance for Industry.'' The draft guidance document provides blood collection establishments with revised recommendations intended to reduce the possible risk of transmission of variant Creutzfeldt-Jakob Disease (vCJD) by blood and blood products by revising and removing certain recommended deferrals for geographic risk of bovine spongiform encephalopathy (BSE) exposure and recommending deferral for individuals with a history of blood transfusion in Ireland from 1980 to the present. The recommendations apply to the collection of Whole Blood and blood components intended for transfusion or for use in further manufacturing into injectable and non-injectable products, including recovered plasma, Source Leukocytes and Source Plasma. The draft guidance, when finalized, will amend the document entitled ``Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and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'' updated January 2016 (``2016 vCJD Guidance'') by incorporating into an updated final guidance any new recommendations adopted. All other recommendations in the 2016 vCJD Guidance will remain unchanged.

[Federal Register Volume 82, Number 245 (Friday, December 22, 2017)]
[Notices]
[Pages 60747-60749]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-27569]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0307]


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; Guidance for 
Industry;'' Draft Guidance for Industry; Availability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 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; Guidance for Industry;' Draft Guidance for 
Industry.'' The draft guidance document provides blood collection 
establishments with revised recommendations intended to reduce the 
possible risk of transmission of variant Creutzfeldt-Jakob Disease 
(vCJD) by blood and blood products by revising and removing certain 
recommended deferrals for geographic risk of bovine spongiform 
encephalopathy (BSE) exposure and recommending deferral for individuals 
with a history of blood transfusion in Ireland from 1980 to the 
present. The recommendations apply to the collection of Whole Blood and 
blood components intended for transfusion or for use in further 
manufacturing into injectable and non-injectable products, including 
recovered plasma, Source Leukocytes and Source Plasma.
    The draft guidance, when finalized, will amend 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'' updated 
January 2016 (``2016 vCJD Guidance'') by incorporating into an updated 
final guidance any new recommendations adopted. All other 
recommendations in the 2016 vCJD Guidance will remain unchanged.

DATES: Submit either electronic or written comments on the draft 
guidance by March 22, 2018 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:

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

[[Page 60748]]

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 ``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; 
Guidance for Industry;' Draft Guidance for Industry.'' 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.thefederalregister.org/fdsys/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: Melissa Segal, 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 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; Guidance for Industry;' 
Draft Guidance for Industry.'' The draft guidance provides blood 
collection establishments with revised recommendations intended to 
reduce the possible risk of transmission of vCJD by blood and blood 
products. The draft guidance, when finalized, will amend FDA's current 
recommendations by revising and removing certain recommended deferrals 
for geographic risk of BSE exposure; and recommending deferral for 
individuals with a history of blood transfusion in Ireland from 1980 to 
the present. The draft guidance also includes recommendations for blood 
collection establishments to update their donor history questionnaires 
(DHQ), including full-length and abbreviated DHQs and accompanying 
materials, and processes to incorporate the recommendations provided in 
the guidance, and recommendations for licensed establishments on how to 
report such changes to FDA. The recommendations apply to the collection 
of Whole Blood and blood components intended for transfusion or for use 
in further manufacturing into injectable and non-injectable products, 
including recovered plasma, Source Leukocytes and Source Plasma. While 
this draft guidance specifically provides revised recommendations to 
address vCJD risk, we may address Creutzfeldt-Jakob Disease (CJD) risk 
in future guidance documents.
    The revised donor deferral recommendations are based on the results 
of an FDA quantitative risk assessment model. The model was developed 
to rank the risk of vCJD in different countries, to evaluate risk 
reduction and donor loss resulting from the current donor deferral 
policy compared with alternative policies, and to evaluate the 
potential additional reduction in risk afforded by leukocyte reduction 
of red blood cells. The model estimated that the United Kingdom, 
Ireland, and France, the three countries with the highest vCJD risks, 
contributed 95 percent of the total vCJD risk in the United States. The 
model also predicted that a revised policy of deferring donors only for 
time spent in these three countries would maintain a level of blood 
safety similar to that resulting from current policy, assuming 
approximately 71.3 to 95 percent of red blood cells currently 
transfused in the United States are leukocyte reduced. Based on its 
value in reducing the risk of transfusion-transmitted vCJD and its 
other medical benefits, FDA continues to consider potential rulemaking 
that would require leukocyte reduction of red blood cells and platelets 
intended for transfusion. The draft guidance, when finalized, will 
amend the 2016 vCJD Guidance.
    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 ``Revised 
Preventive Measures to Reduce the Possible Risk of Transmission of 
Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by 
Blood and Blood Products.'' 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

[[Page 60749]]

regulations. This guidance is not subject to Executive Order 12866.

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. 3501-3520). The 
collections of information in 21 CFR 601.12 and Form FDA 356h have been 
approved under OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: December 18, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27569 Filed 12-21-17; 8:45 am]
BILLING CODE 4164-01-P