[Federal Register Volume 82, Number 233 (Wednesday, December 6, 2017)]
[Notices]
[Pages 57601-57603]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26226]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0137]
Use of Serological Tests to Reduce the Risk of Transmission of
Trypanosoma cruzi Infection in Blood and Blood Components; 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 document entitled ``Use of Serological Tests to
Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood
and Blood Components; Guidance for Industry.'' The guidance document
provides recommendations to blood collection establishments regarding
the use of serological tests to reduce the risk of transmission of
Trypanosoma cruzi (T. cruzi) infection in blood and blood components.
The recommendations apply to the collection of blood and blood
components, except Source Plasma, for transfusion or for use in
manufacturing a product, including donations intended as a component
of, or used to manufacture, a medical device. The guidance announced in
this notice supersedes the guidance entitled ``Guidance for Industry:
Use of Serological Tests to Reduce the Risk of Transmission of
Trypanosoma cruzi Infection in Whole Blood and Blood Components
Intended for Transfusion'' dated December 2010 (2010 Chagas Guidance)
and finalizes the draft guidance entitled ``Amendment to `Guidance for
Industry: Use of Serological Tests to Reduce the Risk of Transmission
of Trypanosoma cruzi Infection in Whole Blood and Blood Components
Intended for Transfusion'; Draft Guidance for Industry'' dated November
2016 (2016 Draft Chagas Guidance). The guidance incorporates
recommendations for blood donor testing, deferral, and donor reentry
from the 2016 Draft Chagas Guidance.
DATES: The announcement of the guidance is published in the Federal
Register on December 6, 2017.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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
[[Page 57602]]
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-2009-D-0137 for ``Use of Serological Tests to Reduce the Risk of
Transmission of Trypanosoma cruzi Infection in Blood and Blood
Components; 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: Tami Belouin, 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 ``Use of
Serological Tests to Reduce the Risk of Transmission of Trypanosoma
cruzi Infection in Blood and Blood Components; Guidance for Industry.''
The guidance document addresses the use of serological tests to reduce
the risk of transmission of T. cruzi infection in blood and blood
components. The recommendations apply to the collection of blood and
blood components, except Source Plasma, for transfusion or for use in
manufacturing a product, including donations intended as a component
of, or used to manufacture, a medical device. The guidance incorporates
recommendations for blood donor testing, deferral, notification, and
donor reentry from the 2016 Draft Chagas Guidance. The 2016 Draft
Chagas Guidance amended the 2010 Chagas Guidance by (1) expanding the
scope of the guidance to include the collection of blood and blood
components for use in manufacturing a product, including donations
intended as a component of, or used to manufacture, a medical device;
(2) removing the recommendation to ask donors about a history of Chagas
disease; and (3) providing a recommendation for a reentry algorithm for
certain donors deferred on the basis of screening test results for
antibodies to T. cruzi or on the basis of answering ``yes'' to the
Chagas screening question. The 2016 Draft Chagas Guidance also provided
notice that FDA had licensed a supplemental test for antibodies to T.
cruzi. and further testing of donations found repeatedly reactive to a
screening test for T. cruzi is therefore required under 21 CFR
610.40(e).
In the Federal Register of December 6, 2010 (75 FR 75810), FDA
announced the availability of the guidance entitled ``Guidance for
Industry: Use of Serological Tests to Reduce the Risk of Transmission
of Trypanosoma cruzi Infection in Whole Blood and Blood Components
Intended for Transfusion'' dated December 2010. In the Federal Register
of November, 10, 2016 (81 FR 79034), FDA announced the availability of
the draft guidance entitled ``Amendment to 'Guidance for Industry: Use
of Serological Tests to Reduce the Risk of Transmission of Trypanosoma
cruzi Infection in Whole Blood and Blood Components Intended for
Transfusion'; Draft Guidance for Industry'' dated November 2016. FDA
received two comments on the 2016 Draft Chagas Guidance and those
comments were considered as the guidance was finalized. The guidance
announced in this notice supersedes the 2010 Chagas Guidance and
finalizes the 2016 Draft Chagas Guidance.
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 ``Use of Serological Tests to Reduce the
Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood
Components.'' 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.
[[Page 57603]]
II. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The
guidance refers to the following collections of information: (1)
Establishments notify consignees of all previously collected in-date
blood and blood components from a donor that tests repeatedly reactive
by a licensed test for T. cruzi antibody to quarantine and return the
blood and blood components to the establishments or to destroy them;
(2) establishments notify consignees of all previously distributed
blood and blood components collected from such a donor during the
lookback period; and (3) if such blood components were transfused,
consignees notify the recipient's physician of record of a possible
increased risk of T. cruzi infection. These collections of information
have been approved under OMB control number 0910-0681.
This guidance also refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by OMB under the PRA. 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 parts
606, 610, and 630 have been approved under OMB control numbers 0910-
0116 and 0910-0795.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
Dated: November 30, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26226 Filed 12-5-17; 8:45 am]
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