[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]



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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.

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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notice finalizes the draft guidance of the same title dated December 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: http://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

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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

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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 http://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