80 FR 75681 - Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 232 (December 3, 2015)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry.'' The draft guidance document provides blood establishments that collect blood and blood components for transfusion or further manufacture, including Source Plasma, with FDA recommendations for assessing blood donor suitability, 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 The draft guidance document applies primarily to Ebola virus (species Zaire ebolavirus), but recommendations are expected to apply to other viruses of the Ebolavirus genus such as Sudan virus, Bundibugyo virus, and Ta[iuml] Forest virus. The recommendations would apply to routine collection of blood and blood components for transfusion or further manufacture, including Source Plasma.

[Federal Register Volume 80, Number 232 (Thursday, December 3, 2015)]
[Notices]
[Pages 75681-75683]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-30589]


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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 Suitability, Donor 
Deferral and Blood Product Management in Response to Ebola Virus; Draft 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

[[Page 75682]]


ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft document entitled ``Recommendations for 
Assessment of Blood Donor Suitability, Donor Deferral and Blood Product 
Management in Response to Ebola Virus; Draft Guidance for Industry.'' 
The draft guidance document provides blood establishments that collect 
blood and blood components for transfusion or further manufacture, 
including Source Plasma, with FDA recommendations for assessing blood 
donor suitability, 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 draft guidance 
document applies primarily to Ebola virus (species Zaire ebolavirus), 
but recommendations are expected to apply to other viruses of the 
Ebolavirus genus such as Sudan virus, Bundibugyo virus, and Ta[iuml] 
Forest virus. The recommendations would apply to routine collection of 
blood and blood components for transfusion or further manufacture, 
including Source Plasma.

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 2, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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 
Suitability, Donor Deferral and Blood Product Management in Response to 
Ebola Virus; Draft Guidance for Industry.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://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 http://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 http://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.

FOR FURTHER INFORMATION CONTACT: Paul E. Levine, Jr., 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 
``Recommendations for Assessment of Blood Donor Suitability, Donor 
Deferral and Blood Product Management in Response to Ebola Virus; Draft 
Guidance for Industry.'' The draft guidance document provides blood 
establishments that collect blood and blood components for transfusion 
or further manufacture, including Source Plasma, with FDA 
recommendations for assessing blood donor suitability, donor deferral, 
and blood product management in the event that an outbreak of EVD with 
widespread transmission is declared 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 has 
been 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 4-10 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. In addition, there have been isolated reports of apparently 
asymptomatic Ebola virus infection in

[[Page 75683]]

individuals who had contact with Ebola patients.
    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.
    Current regulations 21 CFR 640.3(b) and 21 CFR 640.63(b)(3) require 
that a donor be in good health with 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. 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 draft guidance permits blood establishments to 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 designated as having widespread 
transmission of Ebola virus, the draft guidance includes 
recommendations to blood establishments to update their donor history 
questionnaire (DHQ), including the full-length and abbreviated DHQ and 
accompanying materials, to assess prospective donors for risk of Ebola 
virus infection or disease. The draft guidance also includes 
recommendations to blood establishments to defer indefinitely a blood 
donor with a history of Ebola virus infection or disease, until more 
data regarding the persistence of Ebola virus in survivors becomes 
available. For a donor who in the past 8 weeks has been a resident of 
or has travelled to a country with widespread transmission of Ebola 
virus disease, FDA recommends that establishments defer the donor for 8 
weeks from the time of the donor's departure from that country. For a 
donor who has had close contact with a person confirmed or 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 close contact that could have resulted in direct contact 
with body fluids, or 8 weeks after the last sexual contact with a 
person known to have recovered from Ebola virus disease. In addition, 
FDA 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 Ebola virus disease.
    The draft 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, for notification of consignees, and for 
reporting a biological product deviation to FDA. The draft guidance 
also addresses convalescent plasma intended for transfusion.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on 
``Recommendations for Assessment of Blood Donor Suitability, Donor 
Deferral and Blood Product Management in Response to Ebola Virus; Draft 
Guidance for Industry.'' 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

    The 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 have been approved under 
OMB control number 0910-0338; the collections of information in 21 CFR 
606.160(b)(1)(i), 640.3(a) and 640.63(b)(3) have been approved under 
OMB control number 0910-0116; the collection of information in 21 CFR 
606.171 has been approved under OMB control number 0910-0458.

III. Electronic Access

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

    Dated: November 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-30589 Filed 12-2-15; 8:45 am]
BILLING CODE 4164-01-P