Document ID: FDA-2018-D-3324-0016
Agency: fda
Document Type: Notice
Title: Use of Serological Tests To Reduce the Risk of Transfusion-Transmitted
Human T-Lymphotropic Virus Types I and II; Guidance for Industry;
Availability
Posted Date: 2020-02-06T05:00Z

[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]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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the draft guidance entitled ``Recommendations for Requalification of 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]
 BILLING CODE 4164-01-P