[Federal Register Volume 83, Number 186 (Tuesday, September 25, 2018)]
[Notices]
[Pages 48446-48447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20776]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3197]


Further Testing of Donations That Are Reactive on a Licensed 
Donor Screening Test for Antibodies to Hepatitis C Virus; Draft 
Guidance for Industry; Availability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 draft document entitled ``Further Testing of 
Donations that are Reactive on a Licensed Donor Screening Test for 
Antibodies to Hepatitis C Virus; Draft Guidance for Industry.'' The 
draft guidance document provides blood establishments that collect 
Whole Blood and blood components, including Source Plasma, with 
recommendations for further testing of donations that are reactive on a 
licensed donor screening test for antibodies to hepatitis C virus 
(anti-HCV). The draft guidance also provides guidance to blood 
establishments on how to report the implementation of these 
recommendations. The draft guidance, when finalized, will update the 
recommendations related to the use of an appropriate multiantigen 
supplemental test contained in ``Guidance for Industry: `Lookback' for 
Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, 
Further Testing, Product Disposition, and Notification of Transfusion 
Recipients Based on Donor Test Results Indicating Infection with HCV'' 
dated December 2010.

DATES: Submit either electronic or written comments on the draft 
guidance by December 24, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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 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-2018-D-3197 for ``Further Testing of Donations that are Reactive on 
a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus; 
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: Stephen Ripley, 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 
``Further Testing of Donations that are Reactive on a Licensed Donor 
Screening Test for Antibodies to Hepatitis C Virus; Draft Guidance for 
Industry.'' The draft guidance provides blood establishments that 
collect Whole Blood and blood components, including Source Plasma, with 
recommendations for further testing of donations that are reactive on a 
licensed donor screening test for anti-

[[Page 48447]]

HCV, as required under Sec.  610.40(e) (21 CFR 610.40(e)). The draft 
guidance also provides guidance to blood establishments on how to 
report the implementation of these recommendations.
    In accordance with Sec.  610.40(e), each donation, including 
autologous donations, found to be reactive by a donor screening test 
must be further tested using a licensed, approved, or cleared 
supplemental test, when available. If no such supplemental test is 
available, blood establishments must perform one or more licensed, 
approved, or cleared tests as adequate and appropriate to provide 
additional information concerning the reactive donor's infection status 
(Sec.  610.40(e)). The draft guidance provides recommendations for 
adequate and appropriate testing under Sec.  610.40(e), with the 
licensed HCV NAT (nucleic acid test) and anti-HCV donor screening tests 
that are currently available, to provide additional information 
concerning the anti-HCV reactive donor's infection status. The draft 
guidance, when finalized, will update the recommendations related to 
the use of an appropriate multiantigen supplemental test contained in 
``Guidance for Industry: `Lookback' for Hepatitis C Virus (HCV): 
Product Quarantine, Consignee Notification, Further Testing, Product 
Disposition, and Notification of Transfusion Recipients Based on Donor 
Test Results Indicating Infection with HCV'' dated December 2010.
    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 further 
testing of donations that are reactive on a licensed donor screening 
test for antibodies to HCV. 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. 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 part 601 have been approved under 
OMB control number 0910-0338; and the collections of information in 21 
CFR part 610 and 21 CFR 630.40 have been approved under OMB control 
number 0910-0116.

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: September 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20776 Filed 9-24-18; 8:45 am]
 BILLING CODE 4164-01-P