Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus; Guidance for Industry; Availability, 3002-3004 [2017-00200]
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Federal Register / Vol. 82, No. 6 / Tuesday, January 10, 2017 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–2175]
Recommendations for Assessment of
Blood Donor Eligibility, Donor Deferral
and Blood Product Management in
Response to Ebola Virus; 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
document entitled ‘‘Recommendations
for Assessment of Blood Donor
Eligibility, Donor Deferral and Blood
Product Management in Response to
Ebola Virus; Guidance for Industry.’’
The guidance document notifies blood
establishments that FDA has determined
Ebola virus to be a transfusiontransmitted infection (TTI) and provides
blood establishments that collect blood
and blood components for transfusion
or further manufacture, including
Source Plasma, with FDA
recommendations for assessing blood
donor eligibility, donor deferral, and
blood product management in the event
that an outbreak of Ebola virus disease
(EVD) with widespread transmission is
declared in at least one country. The
guidance document applies to Ebola
virus (species Zaire ebolavirus). The
recommendations apply to routine
collection of blood and blood
components for transfusion or further
manufacture, including Source Plasma.
The guidance announced in this notice
finalizes the draft guidance of the same
title dated December 2015.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
pmangrum on DSK3GDR082PROD with NOTICES
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
VerDate Sep<11>2014
19:05 Jan 09, 2017
Jkt 241001
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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2014–D–2175 for ‘‘Recommendations
for Assessment of Blood Donor
Eligibility, Donor Deferral and Blood
Product Management in Response to
Ebola Virus; 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
Division of Dockets Management
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
PO 00000
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both copies to the Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
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:
Jessica T. Walker, 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
for Assessment of Blood Donor
Eligibility, Donor Deferral and Blood
Product Management in Response to
Ebola Virus; Guidance for Industry.’’
The guidance document notifies blood
establishments that FDA has determined
Ebola virus to be a TTI under 21 CFR
E:\FR\FM\10JAN1.SGM
10JAN1
pmangrum on DSK3GDR082PROD with NOTICES
Federal Register / Vol. 82, No. 6 / Tuesday, January 10, 2017 / Notices
630.3(l) because of the severity of the
disease and the risk of transmission by
blood and blood products. The guidance
also provides blood establishments that
collect blood and blood components for
transfusion or further manufacture,
including Source Plasma, with FDA
recommendations for assessing blood
donor eligibility, donor deferral, and
blood product management in the event
that an outbreak of EVD with
widespread transmission occurs in at
least one country.
Ebola virus is a member of the family
Filoviridae that can cause severe
hemorrhagic fever in humans and nonhuman primates with historically high
morbidity and mortality rates of up to
90 percent. However, in the 2014
outbreak in West Africa, the mortality
rate was markedly lower. In humans,
EVD is typically characterized at onset
by fever, severe headache, muscle pain,
and weakness, followed by diarrhea,
vomiting, abdominal pain, and
sometimes diffuse hemorrhage (bleeding
or bruising). In previous outbreaks of
EVD, symptoms generally appeared
within 21 days and most often within 4
to 10 days following infection; however,
based on mathematical models,
symptom onset later than 21 days is
estimated as possible in 0.1 to 12
percent of cases. Although viremia in
survivors typically resolves within 21
days of disease onset, infectious virus
and viral ribonucleic acid (RNA) has
been detected in other body components
or fluids (e.g., aqueous humor, semen,
and vaginal fluids) for longer periods.
For instance, infectious virus and viral
RNA have been detected in semen up to
82 and 272 days post-EVD onset,
respectively, and a case of sexual
transmission of Ebola virus was
reported in which the patient was
exposed to Ebola virus through sexual
contact with a survivor 179 days after
likely disease onset.
Transmission of Ebola virus from
human to human occurs by direct
contact with body fluids (such as blood,
urine, stool, saliva, semen, vaginal
fluids, or vomit) of symptomatic
infected individuals. Therefore, blood
and blood products from symptomatic
individuals, if they were to donate,
would have the potential of transmitting
Ebola virus to recipients.
Under 21 CFR 630.10(a) and (f)(1), a
donor must be in good health and have
a normal temperature at the time of
donation. Standard procedures that are
in place to assure that the donor feels
healthy at the time of donation serve as
an effective safeguard against collecting
blood or blood components from a
donor who seeks to donate after the
onset of clinical symptoms of EVD. FDA
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Jkt 241001
is providing guidance to reduce the
risks of collecting blood and blood
components from potentially Ebola
virus-infected persons during the
asymptomatic incubation period before
the onset of clinical symptoms, as well
as from individuals with a history of
Ebola virus infection or disease.
The guidance recommends blood
establishments update their donor
educational materials to instruct donors
with a history of Ebola virus infection
or disease to not donate blood or blood
components. In the event that one or
more countries is classified by Centers
for Disease Control and Prevention
(CDC) as having widespread
transmission of Ebola virus, blood
establishments must update their donor
history questionnaire (DHQ), including
the full-length and abbreviated DHQ
and accompanying materials, to assess
donors for a history of Ebola virus
infection or disease and travel to, or
residence in, an area endemic for Ebola
virus. The guidance recommends
indefinite deferral of a donor with a
history of Ebola virus infection or
disease and for a donor who has been
a resident of or has travelled to a
country with widespread transmission
of EVD, FDA recommends that
establishments defer a donor for 8
weeks from the time of the donor’s
departure from that country. The
guidance document provides additional
recommendations for blood
establishments in the event that one or
more countries are classified by CDC as
having widespread transmission of
Ebola virus. For a donor who has had
close contact with a person confirmed to
have EVD or a person under
investigation for Ebola virus infection or
disease in whom diagnosis is pending,
FDA recommends that establishments
defer a donor for 8 weeks after the last
contact. In addition, FDA recommends
that establishments defer a donor for 8
weeks after the last sexual contact with
a person known to have recovered from
EVD, regardless of the time since the
person’s recovery. FDA also
recommends that establishments defer
for a period of 8 weeks after exposure
a donor who has been notified by a
Federal, State, or local public health
authority that he or she may have been
exposed to a person with EVD.
The guidance includes FDA
recommendations on retrieval and
quarantine of blood and blood
components from a donor later
determined to have Ebola virus
infection or disease or risk factors for
Ebola virus infection or disease,
notification of consignees, and reporting
a biological product deviation to FDA.
The guidance also addresses
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3003
convalescent plasma intended for
transfusion.
In the Federal Register of December 3,
2015 (80 FR 75681), FDA announced the
availability of the draft guidance of the
same title dated December 2015. FDA
received comments on the draft
guidance and those comments were
considered as the guidance was
finalized. A summary of changes made
in the final guidance includes: (1)
Notifying blood establishments that
FDA has determined Ebola virus to be
a TTI under § 630.30(l); (2) providing a
recommendation that the donor
educational materials instruct donors
with a history of EVD to self-defer; (3)
adding a recommended timeframe for
when blood establishments should
discontinue donor questioning after
CDC declares there is no longer
widespread transmission of Ebola virus;
and (4) clarifying certain
recommendations on product retrieval,
quarantine, and notification of
consignees of blood and blood
components from donors at risk of Ebola
virus infection or disease. In addition,
editorial changes were made to improve
clarity. The guidance announced in this
notice finalizes the draft guidance of the
same title dated December 2015.
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
for assessment of blood donor
eligibility, donor deferral, and blood
product management in response to
Ebola virus. 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–
3520). The collections of information in
21 CFR part 312 have been approved
under OMB control number 0910–0014;
the collections of information in 21 CFR
600.14 and 606.171 have been approved
under OMB control number 0910–0458;
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 606.160 have
been approved under OMB control
numbers 0910–0116 and 0910–0795;
and the collections of information in 21
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Federal Register / Vol. 82, No. 6 / Tuesday, January 10, 2017 / Notices
CFR 630.10 and 630.40 have been
approved under OMB control number
0910–0795.
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
Dated: January 3, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–00200 Filed 1–9–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–4646]
Annual Reporting by Prescription Drug
Wholesale Distributors and Third-Party
Logistics Providers: Questions and
Answers; 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
guidance for industry entitled ‘‘Annual
Reporting by Prescription Drug
Wholesale Distributors and Third-Party
Logistics Providers: Questions and
Answers.’’ This draft addresses
questions about and clarifies FDA’s
expectations for annual reporting to
FDA by prescription drug wholesale
distributors (wholesale distributors) and
third-party logistics providers (3PLs) as
required under the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) as
amended by the Drug Supply Chain
Security Act (DSCSA).
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by March 13,
2017.
pmangrum on DSK3GDR082PROD with NOTICES
SUMMARY:
ADDRESSES:
You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
VerDate Sep<11>2014
19:05 Jan 09, 2017
Jkt 241001
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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2016–D–4646 for ‘‘Annual Reporting by
Prescription Drug Wholesale
Distributors and Third-Party Logistics
Providers: Questions and Answers; Draft
Guidance for Industry; Availability.’’
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
Division of Dockets Management
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
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
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 Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002; or 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 that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Office of Compliance, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–3130,
WDD3PLRequirements@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 204 of the DSCSA (Title II of
Pub. L. 113–54) amended section 503(e)
E:\FR\FM\10JAN1.SGM
10JAN1
]]>Agencies
[Federal Register Volume 82, Number 6 (Tuesday, January 10, 2017)]
[Notices]
[Pages 3002-3004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00200]
[[Page 3002]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-2175]
Recommendations for Assessment of Blood Donor Eligibility, Donor
Deferral and Blood Product Management in Response to Ebola Virus;
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 document entitled ``Recommendations for
Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product
Management in Response to Ebola Virus; Guidance for Industry.'' The
guidance document notifies blood establishments that FDA has determined
Ebola virus to be a transfusion-transmitted infection (TTI) and
provides blood establishments that collect blood and blood components
for transfusion or further manufacture, including Source Plasma, with
FDA recommendations for assessing blood donor eligibility, donor
deferral, and blood product management in the event that an outbreak of
Ebola virus disease (EVD) with widespread transmission is declared in
at least one country. The guidance document applies to Ebola virus
(species Zaire ebolavirus). The recommendations apply to routine
collection of blood and blood components for transfusion or further
manufacture, including Source Plasma. The guidance announced in this
notice finalizes the draft guidance of the same title dated December
2015.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2014-D-2175 for ``Recommendations for Assessment of Blood Donor
Eligibility, Donor Deferral and Blood Product Management in Response to
Ebola Virus; 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 Division of Dockets Management 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 Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
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: Jessica T. Walker, 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 for Assessment of Blood Donor Eligibility, Donor
Deferral and Blood Product Management in Response to Ebola Virus;
Guidance for Industry.'' The guidance document notifies blood
establishments that FDA has determined Ebola virus to be a TTI under 21
CFR
[[Page 3003]]
630.3(l) because of the severity of the disease and the risk of
transmission by blood and blood products. The guidance also provides
blood establishments that collect blood and blood components for
transfusion or further manufacture, including Source Plasma, with FDA
recommendations for assessing blood donor eligibility, donor deferral,
and blood product management in the event that an outbreak of EVD with
widespread transmission occurs in at least one country.
Ebola virus is a member of the family Filoviridae that can cause
severe hemorrhagic fever in humans and non-human primates with
historically high morbidity and mortality rates of up to 90 percent.
However, in the 2014 outbreak in West Africa, the mortality rate was
markedly lower. In humans, EVD is typically characterized at onset by
fever, severe headache, muscle pain, and weakness, followed by
diarrhea, vomiting, abdominal pain, and sometimes diffuse hemorrhage
(bleeding or bruising). In previous outbreaks of EVD, symptoms
generally appeared within 21 days and most often within 4 to 10 days
following infection; however, based on mathematical models, symptom
onset later than 21 days is estimated as possible in 0.1 to 12 percent
of cases. Although viremia in survivors typically resolves within 21
days of disease onset, infectious virus and viral ribonucleic acid
(RNA) has been detected in other body components or fluids (e.g.,
aqueous humor, semen, and vaginal fluids) for longer periods. For
instance, infectious virus and viral RNA have been detected in semen up
to 82 and 272 days post-EVD onset, respectively, and a case of sexual
transmission of Ebola virus was reported in which the patient was
exposed to Ebola virus through sexual contact with a survivor 179 days
after likely disease onset.
Transmission of Ebola virus from human to human occurs by direct
contact with body fluids (such as blood, urine, stool, saliva, semen,
vaginal fluids, or vomit) of symptomatic infected individuals.
Therefore, blood and blood products from symptomatic individuals, if
they were to donate, would have the potential of transmitting Ebola
virus to recipients.
Under 21 CFR 630.10(a) and (f)(1), a donor must be in good health
and have a normal temperature at the time of donation. Standard
procedures that are in place to assure that the donor feels healthy at
the time of donation serve as an effective safeguard against collecting
blood or blood components from a donor who seeks to donate after the
onset of clinical symptoms of EVD. FDA is providing guidance to reduce
the risks of collecting blood and blood components from potentially
Ebola virus-infected persons during the asymptomatic incubation period
before the onset of clinical symptoms, as well as from individuals with
a history of Ebola virus infection or disease.
The guidance recommends blood establishments update their donor
educational materials to instruct donors with a history of Ebola virus
infection or disease to not donate blood or blood components. In the
event that one or more countries is classified by Centers for Disease
Control and Prevention (CDC) as having widespread transmission of Ebola
virus, blood establishments must update their donor history
questionnaire (DHQ), including the full-length and abbreviated DHQ and
accompanying materials, to assess donors for a history of Ebola virus
infection or disease and travel to, or residence in, an area endemic
for Ebola virus. The guidance recommends indefinite deferral of a donor
with a history of Ebola virus infection or disease and for a donor who
has been a resident of or has travelled to a country with widespread
transmission of EVD, FDA recommends that establishments defer a donor
for 8 weeks from the time of the donor's departure from that country.
The guidance document provides additional recommendations for blood
establishments in the event that one or more countries are classified
by CDC as having widespread transmission of Ebola virus. For a donor
who has had close contact with a person confirmed to have EVD or a
person under investigation for Ebola virus infection or disease in whom
diagnosis is pending, FDA recommends that establishments defer a donor
for 8 weeks after the last contact. In addition, FDA recommends that
establishments defer a donor for 8 weeks after the last sexual contact
with a person known to have recovered from EVD, regardless of the time
since the person's recovery. FDA also recommends that establishments
defer for a period of 8 weeks after exposure a donor who has been
notified by a Federal, State, or local public health authority that he
or she may have been exposed to a person with EVD.
The guidance includes FDA recommendations on retrieval and
quarantine of blood and blood components from a donor later determined
to have Ebola virus infection or disease or risk factors for Ebola
virus infection or disease, notification of consignees, and reporting a
biological product deviation to FDA. The guidance also addresses
convalescent plasma intended for transfusion.
In the Federal Register of December 3, 2015 (80 FR 75681), FDA
announced the availability of the draft guidance of the same title
dated December 2015. FDA received comments on the draft guidance and
those comments were considered as the guidance was finalized. A summary
of changes made in the final guidance includes: (1) Notifying blood
establishments that FDA has determined Ebola virus to be a TTI under
Sec. 630.30(l); (2) providing a recommendation that the donor
educational materials instruct donors with a history of EVD to self-
defer; (3) adding a recommended timeframe for when blood establishments
should discontinue donor questioning after CDC declares there is no
longer widespread transmission of Ebola virus; and (4) clarifying
certain recommendations on product retrieval, quarantine, and
notification of consignees of blood and blood components from donors at
risk of Ebola virus infection or disease. In addition, editorial
changes were made to improve clarity. The guidance announced in this
notice finalizes the draft guidance of the same title dated December
2015.
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 for assessment of blood
donor eligibility, donor deferral, and blood product management in
response to Ebola virus. 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. 3501-3520). The
collections of information in 21 CFR part 312 have been approved under
OMB control number 0910-0014; the collections of information in 21 CFR
600.14 and 606.171 have been approved under OMB control number 0910-
0458; 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 606.160 have been approved under OMB control
numbers 0910-0116 and 0910-0795; and the collections of information in
21
[[Page 3004]]
CFR 630.10 and 630.40 have been approved under OMB control number 0910-
0795.
III. Electronic Access
Persons with access to the Internet may obtain the guidance at
either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
Dated: January 3, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00200 Filed 1-9-17; 8:45 am]
BILLING CODE 4164-01-P
