[Federal Register Volume 85, Number 25 (Thursday, February 6, 2020)]
[Notices]
[Pages 6957-6959]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02373]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-3324]
Use of Serological Tests To Reduce the Risk of Transfusion-
Transmitted Human T-Lymphotropic Virus Types I and II; 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 ``Use of Serological
Tests to Reduce the Risk of Transfusion-Transmitted Human T-
Lymphotropic Virus Types I and II (HTLV-I/II).'' The guidance document
provides blood collection establishments with recommendations regarding
the use of
[[Page 6958]]
serological tests to reduce the risk of HTLV-I/II transmission by blood
and blood components. The guidance announced in this notice finalizes
the draft guidance entitled ``Recommendations for Requalification of
Blood Donors Deferred Because of Reactive Test Results for Antibodies
to Human T-Lymphotropic Virus Types I and II (anti-HTLV-I/II)'' dated
September 2018. The guidance also consolidates FDA's other previously
issued recommendations on HTLV-I/II into one document. Therefore, the
guidance also supersedes the recommendations specific to HTLV-1
contained in the memorandum to blood establishments entitled
``Recommendations for the Quarantine and Disposition of Units from
Prior Collections from Donors with Repeatedly Reactive Screening Tests
for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human T-
Lymphotropic Virus Type I (HTLV-I)'' dated July 1996. In addition, the
guidance supersedes the memorandum to blood establishments entitled
``HTLV-I Antibody Testing, Memorandum'' dated November 1988; the
memorandum to blood establishments entitled ``HTLV-I Antibody Testing,
Memorandum'' dated July 1989; and the document entitled ``Guidance for
Industry: Donor Screening for Antibodies to HTLV-II'' dated August
1997.
DATES: The announcement of the guidance is published in the Federal
Register on February 6, 2020.
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 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-3324 for ``Use of Serological Tests to Reduce the Risk of
Transfusion Transmitted Human T-Lymphotropic Virus Types I and II
(HTLV-I/II).'' 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.govinfo.gov/content/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: Melissa Segal, 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 Transfusion-Transmitted Human
T-Lymphotropic Virus Types I and II (HTLV-I/II).'' The guidance
document provides blood collection establishments with recommendations
regarding the use of serological tests to reduce the risk of HTLV-I/II
transmission by blood and blood components.
In the Federal Register of September 25, 2018 (83 FR 48448), FDA
announced the availability of the draft guidance entitled
``Recommendations for Requalification of Blood Donors Deferred Because
of Reactive Test Results for Antibodies to Human T-Lymphotropic Virus
Types I and II (anti-HTLV-I/II)'' dated September 2018. FDA received a
few comments on the draft guidance and those comments
[[Page 6959]]
were considered as the guidance was finalized.
The guidance announced in this notice finalizes the draft guidance
entitled ``Recommendations for Requalification of Blood Donors Deferred
Because of Reactive Test Results for Antibodies to Human T-Lymphotropic
Virus Types I and II (anti-HTLV-I/II)'' dated September 2018. The
guidance also consolidates FDA's other previously issued
recommendations on HTLV-I/II into one document. Therefore, the guidance
also supersedes the recommendations specific to HTLV-1 contained in the
memorandum to blood establishments, entitled ``Recommendations for the
Quarantine and Disposition of Units from Prior Collections from Donors
with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV),
Hepatitis C Virus (HCV), and Human T-Lymphotropic Virus Type I (HTLV-
I)'' dated July 1996. In addition, the guidance supersedes the
memorandum to blood establishments entitled ``HTLV-I Antibody Testing,
Memorandum'' dated November 1988; the memorandum to blood
establishments entitled ``HTLV-I Antibody Testing, Memorandum'' dated
July 1989; and the document entitled ``Guidance for Industry: Donor
Screening for Antibodies to HTLV-II'' dated August 1997.
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 the use of serological tests to reduce the
risk of transfusion-transmitted human T-lymphotropic virus types I and
II. 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. 3501-3521). The
collections of information in 21 CFR part 601 and Form FDA 356h have
been approved under OMB control number 0910-0338, and the collections
of information in 21 CFR parts 610 and 606 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: February 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-02373 Filed 2-5-20; 8:45 am]
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