[Federal Register Volume 81, Number 148 (Tuesday, August 2, 2016)]
[Notices]
[Pages 50708-50710]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18183]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2071]


Determining Donor Eligibility for Autologous Donors of Blood and 
Blood Components Intended Solely for Autologous Use--Compliance Policy; 
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 or we) is 
announcing the availability of a document titled ``Determining Donor 
Eligibility for Autologous Donors of Blood and Blood Components 
Intended Solely for Autologous Use--Compliance Policy; Guidance for 
Industry.'' This guidance addresses the regulatory requirements for 
determining donor

[[Page 50709]]

eligibility that apply to establishments that collect blood and blood 
components (blood establishments) intended solely for autologous use. 
On May 22, 2015, in order to better assure the safety of the nation's 
blood supply and to help protect donor health, FDA finalized its 
revision of the applicable requirements for blood establishments to 
test donors for infectious disease, and to determine that donors are 
eligible to donate and that donations are suitable for transfusion or 
further manufacture (``Requirements for Blood and Blood Components 
Intended for Transfusion or for Further Manufacturing Use'' (donor 
eligibility rule)). The donor eligibility rule includes requirements 
related to current good manufacturing practice, donation testing, donor 
eligibility, and donation suitability. It became effective on May 23, 
2016.
    FDA has developed this guidance in response to questions from blood 
establishments concerning the applicability of the donor eligibility 
rule to autologous donations. The guidance explains the conditions 
under which FDA does not intend to take regulatory action for a blood 
establishment's failure to comply with certain donor eligibility 
determination requirements in collecting blood and blood components 
intended solely for autologous use.

DATES: The Agency is soliciting public comment, but is implementing 
this guidance immediately because the Agency has determined that prior 
public participation is not feasible or appropriate. 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: 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-2016-D-2071 for ``Determining Donor Eligibility for Autologous 
Donors of Blood and Blood Components Intended Solely for Autologous 
Use--Compliance Policy; 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.
    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: Jonathan McKnight, 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 
``Requirements for Determining Donor Eligibility for Autologous Donors 
of Blood and Blood Components Intended Solely for Autologous Use--
Compliance Policy; Guidance for Industry.'' We are implementing this 
guidance without prior public comment because we have determined that 
prior public participation is not feasible or appropriate (Sec.  
10.115(g)(2)). Although this guidance document is immediately in 
effect, it remains subject to comment in accordance with FDA's good 
guidance practices regulation.
    This guidance addresses the regulatory requirements for determining 
donor eligibility that apply to blood establishments that collect blood 
and blood components intended solely for autologous use described in 
the final

[[Page 50710]]

rule entitled, ``Requirements for Blood and Blood Components Intended 
for Transfusion or for Further Manufacturing Use,'' 80 FR 29842 (donor 
eligibility rule)) that became effective on May 23, 2016.
    A small proportion of collections of blood and blood components are 
intended for autologous transfusion. In those instances, the autologous 
donor presents with a physician's prescription for the collection of 
the donor's blood for the donor's own upcoming medical (e.g., surgical) 
procedure. If the donor ultimately does not need the blood, blood 
establishments may, in some instances, use these donations for 
allogeneic (i.e. intended for transfusion to a recipient other than the 
donor) transfusions. This is referred to as ``cross-over.''
    Blood establishments have requested clarification on certain 
requirements of the donor eligibility rule and the applicability of 
certain sections of the donor eligibility rule to the collection of 
blood and blood components intended for autologous use. To address 
these questions, FDA has developed this guidance to clarify the 
Agency's policy with respect to the requirements for autologous donors 
of blood and blood components intended solely for autologous use, 
(i.e., not subject to cross-over). Specifically, the guidance describes 
FDA's policy with respect to the following: The requirements in 21 CFR 
630.10 related to screening autologous donors for relevant transfusion-
transmitted infections; the requirement in 21 CFR 630.15(a)(1)(ii) that 
the responsible physician examine the autologous donor to permit more 
frequent collections; and, the requirement in 21 CFR 630.20(a) that the 
responsible physician determine and document that the autologous 
donor's health permits the collection of blood and blood components 
intended for autologous use.
    Autologous donors have long been permitted to donate blood for 
their own use even if they do not meet certain donor eligibility 
criteria that apply to allogeneic donors because autologous donors are 
not exposed to new transfusion-transmitted infections in receiving 
their own blood. For example, FDA does not require testing of 
autologous donations for Relevant Transfusion-Transmitted Infection 
(RTTI) unless the donations are used for allogeneic transfusion or 
shipped to another establishment (21 CFR 610.40(d)). Consistent with 
this approach to testing autologous donations, FDA does not believe it 
is necessary to assess autologous donors for risks for RTTI as required 
in certain provisions in Sec.  630.10 if the donation is intended 
solely for autologous use.
    Sections 630.15(a) and 630.20(a) describe conditions for which a 
responsible physician must examine and determine and document that the 
autologous donor's health permits a collection procedure. Autologous 
donors are under the care of the physician who prescribes the 
autologous donation. In light of the medical oversight provided by the 
autologous donor's physician, FDA believes blood establishments can 
appropriately protect autologous donors' health by following standard 
operating procedures that are approved by the responsible physician of 
the blood establishment and that define criteria for when the 
autologous donation may proceed and the conditions under which the 
responsible physician must be consulted.
    The guidance explains the conditions under which FDA does not 
intend to take regulatory action for a blood establishment's failure to 
comply with the donor eligibility determination requirements in 
collecting blood and blood components intended solely for autologous 
use.
    The guidance represents the current thinking of the FDA on this 
topic. 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 part 630 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 http://www.regulations.gov.

    Dated: July 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18183 Filed 8-1-16; 8:45 am]
 BILLING CODE 4164-01-P