Document ID: FDA-2018-D-3197-0016
Agency: fda
Document Type: Notice
Title: Further Testing of Donations That Are Reactive on a Licensed Donor
Screening Test for Antibodies to Hepatitis C Virus; Guidance for
Industry; Availability
Posted Date: 2019-10-03T04:00Z

[Federal Register Volume 84, Number 192 (Thursday, October 3, 2019)]
[Notices]
[Pages 52885-52886]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21506]

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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; 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 final guidance entitled ``Further Testing of 
Donations that are Reactive on a Licensed Donor Screening Test for 
Antibodies to Hepatitis C Virus; Guidance for Industry.'' The 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 
guidance also provides guidance to blood establishments on how to 
report the implementation of these recommendations. The guidance 
updates 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. The guidance announced in this notice 
finalizes the draft guidance of the same title dated September 2018.

DATES: The announcement of the guidance is published in the Federal 
Register on October 3, 2019.

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; 
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 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: 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 document entitled ``Further 
Testing of Donations that are Reactive on a

[[Page 52886]]

Licensed Donor Screening Test for Antibodies to Hepatitis C Virus; 
Guidance for Industry.'' The 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 anti-HCV, as 
required under Sec.  610.40(e) (21 CFR 610.40(e)). The 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 guidance provides recommendations for adequate 
and appropriate testing under Sec.  610.40(e), using a licensed HCV NAT 
(nucleic acid test) labeled with the supplemental indication and 
licensed anti-HCV donor screening tests or approved or cleared anti-HCV 
diagnostic tests that are currently available, to provide additional 
information concerning the donor's infection status. The guidance 
updates 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 (available at: https://www.fda.gov/media/124265/download).
    In the Federal Register of September 25, 2018, (83 FR 48446), FDA 
announced the availability of the draft guidance of the same title 
dated September 2018. FDA received a few comments on the draft guidance 
and those comments were considered as the guidance was finalized. In 
addition, editorial changes were made to improve clarity. The guidance 
announced in this notice finalizes the draft guidance dated September 
2018.
    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 further testing of donations that are 
reactive on a licensed donor screening test for antibodies to hepatitis 
C 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. 
This guidance is not subject to Executive Order 12866.

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 601 have been approved under 
OMB control number 0910-0338; and the collections of information in 21 
CFR part 610 and 21 CFR part 630 have been approved under OMB control 
number 0910-0116.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances or 
https://www.regulations.gov.

    Dated: September 27, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21506 Filed 10-2-19; 8:45 am]
BILLING CODE 4164-01-P