[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]
[[Page 48446]]
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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Donor Screening Test for Antibodies to Hepatitis C Virus; Draft
Guidance for Industry; Availability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Antibodies to Hepatitis C Virus; Draft Guidance for Industry.''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draft guidance document provides blood establishments that collect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 The draft guidance also provides guidance to blood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 The draft guidance, when finalized, will update the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DATES: Submit either electronic or written comments on the draft
guidance by December 24, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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