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of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry;” Draft Guidance for Industry; Availability, 60747-60749 [2017-27569]
Download as PDF
60747
Federal Register / Vol. 82, No. 245 / Friday, December 22, 2017 / Notices
coaching funders or providers, ECE
center directors, coaches, teachers, and
FCC providers.
ANNUAL BURDEN ESTIMATES
Total number
of respondents
Instrument
sradovich on DSK3GMQ082PROD with NOTICES
State coaching informant interview protocol ........................
ECE setting eligibility screener ............................................
Center director survey .........................................................
Coach survey .......................................................................
Teacher/FCC provider survey ..............................................
Center director semi-structured interview protocol ..............
Coach semi-structured interview protocol ...........................
Teacher/FCC provider semi-structured interview protocol ..
Coach supervisor semi-structured interview protocol ..........
Estimated Total Annual Burden
Hours: 157.
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research,
and Evaluation, 330 C Street SW,
Washington, DC 20201, Attn: OPRE
Reports Clearance Officer. Email
address: OPREinfocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on (a) whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Mary Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2017–27578 Filed 12–21–17; 8:45 am]
BILLING CODE 4184–22–P
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Jkt 244001
Annual
number of
respondents
45
173
60
90
172
12
12
12
12
23
87
30
45
86
6
6
6
6
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.
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
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1
1
1
1
1
1
1
1
1
Average
burden hours
per response
1
0.25
0.5
0.5
0.58
1.5
1
1
0.5
Annual burden
hours
23
22
15
23
50
9
6
6
3
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.
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:
DATES:
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
E:\FR\FM\22DEN1.SGM
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Federal Register / Vol. 82, No. 245 / Friday, December 22, 2017 / Notices
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
sradovich on DSK3GMQ082PROD with NOTICES
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.gpo.gov/
VerDate Sep<11>2014
16:59 Dec 21, 2017
Jkt 244001
fdsys/pkg/FR-2015-09-18/pdf/201523389.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
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
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 noninjectable 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
E:\FR\FM\22DEN1.SGM
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Federal Register / Vol. 82, No. 245 / Friday, December 22, 2017 / Notices
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/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–6395]
Request for Nominations of Members
for the Clinical Trials Transformation
Initiative/Food and Drug
Administration Patient Engagement
Collaborative
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency), in
collaboration with the Clinical Trials
Transformation Initiative (CTTI), is
requesting nominations of patient
advocates interested in participating on
the Patient Engagement Collaborative
(PEC). The PEC will be an ongoing,
collaborative forum coordinated through
the Patient Affairs Staff, Office of
Medical Products and Tobacco (OMPT),
Office of the Commissioner, and will be
hosted by CTTI. Through the PEC, the
patient community and regulators will
be able to discuss an array of topics
regarding increasing meaningful patient
engagement in medical product
development and regulatory discussions
at FDA. The activities of the PEC may
include, but are not limited to,
providing diverse perspectives on topics
such as systematic patient engagement,
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:59 Dec 21, 2017
Jkt 244001
60749
transparency, and communication;
providing considerations for
implementing new strategies to enhance
patient engagement at FDA; and
proposing new models of collaboration
in which patients and patient advocates
are partners in certain aspects of the
medical product development and FDA
review process.
DATES: Nominations received by 11:59
p.m. Eastern Time on or before January
29, 2018, will be given first
consideration for membership on the
PEC. Nominations received after the
submission deadline will be retained for
future consideration.
ADDRESSES: All nominations should be
submitted to the FDA’s Patient Affairs
Staff in the OMPT. Email nominations
are preferred and should be submitted
to PatientEngagementCollaborative@
fda.hhs.gov. Though not required, it is
appreciated if all nomination materials
are compiled into a single PDF file and
attached to the submission email.
Nominations may also be submitted by
mail or delivery service to Patient
Affairs Staff, Office of Medical Products
and Tobacco, Office of the
Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 1316, Silver Spring,
MD 20993. Only complete applications,
as described in section ‘‘IV. Nomination
Process’’ of this document, will be
considered.
FOR FURTHER INFORMATION CONTACT:
Andrea Furia-Helms, Office of Medical
Products and Tobacco, Office of the
Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 1316, Silver Spring,
MD 20993, 301–796–8455,
PatientEngagementCollaborative@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
at FDA. The PEC will be a joint
endeavor between the CTTI and FDA.
The activities of the PEC may inform
relevant FDA and CTTI activities. The
PEC is not intended to advise or
otherwise direct the activities of either
organization, and membership will not
constitute employment by either
organization.
The Food and Drug Administration
Safety and Innovation Act (Pub. L. 112–
144), section 1137, entitled ‘‘Patient
Participation in Medical Product
Discussions,’’ added section 569C to the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360bbb–8c). This provision
directs the Secretary of Health and
Human Services to develop and
implement strategies to solicit the views
of patients during the medical product
development process and consider the
perspectives of patients during
regulatory discussions. On November 4,
2014, FDA issued a Federal Register
notice establishing a docket (FDA–
2014–N–1698) for public commenters to
submit information related to FDA’s
implementation of this provision (79 FR
65410). Upon review of the comments
received, one common theme, among
others, included establishing an external
group to provide input on patient
engagement strategies across FDA’s
Centers.
Recent legislation in both section
3001 of the 21st Century Cures Act and
section 605 of the Food and Drug
Administration Reauthorization Act of
2017 supports tools for fostering patient
participation in the regulatory process.
The purpose of this notice is to
announce that the nomination process
for the PEC is now open, and to invite
and encourage nominations by the
submission deadline for appropriately
qualified individuals. Self-nominations
are accepted.
I. Background and Purpose
The CTTI is a public-private
partnership co-founded by FDA and
Duke University whose mission is to
develop and drive adoption of practices
that will increase the quality and
efficiency of clinical trials. FDA and
CTTI have long involved patients and
considered patient perspectives in their
work. Furthering the engagement of
patients as valued partners across the
medical product research and
development continuum requires an
open forum for patients and regulators
to discuss and exchange ideas.
The PEC will be an ongoing,
collaborative forum in which the patient
community and regulators will discuss
an array of topics regarding increasing
patient engagement in medical product
development and regulatory discussions
II. Criteria for Membership
The PEC will include up to 16 diverse
representatives of the patient
community. Selected members will
include the following: (1) Patients who
have personal disease experience; (2)
caregivers who support patients, such as
a parent, child, partner, other family
member, or friend, and who have
personal disease experience through
this caregiver role; and (3)
representatives from patient groups
who, through their role in the patient
group, have direct or indirect disease
experience. Please note that for
purposes of this activity, the term
‘‘caregiver’’ is not intended to include
individuals who are engaged in
caregiving as health care professionals;
and the term ‘‘patient group’’ is used
herein to encompass patient advocacy
PO 00000
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E:\FR\FM\22DEN1.SGM
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Agencies
[Federal Register Volume 82, Number 245 (Friday, December 22, 2017)]
[Notices]
[Pages 60747-60749]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27569]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.gpo.gov/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