[Federal Register Volume 85, Number 201 (Friday, October 16, 2020)]
[Notices]
[Pages 65817-65819]
[FR Doc No: 2020-22926]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-1876]

Testing for Biotin Interference in In Vitro Diagnostic Devices;
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 ``Testing for Biotin Interference in In Vitro
Diagnostic Devices; Guidance for Industry.'' The guidance provides
FDA's recommendations on the testing for interference by biotin on the
performance of in vitro diagnostic devices (IVDs). The guidance is
intended to help device developers and clinicians understand how FDA
recommends biotin interference testing be performed, and how the
results of the testing should be communicated to end users, including
clinical laboratories and clinicians. The guidance announced in this
notice finalizes the draft guidance of the same title dated June 2019.

DATES: The announcement of the guidance is published in the Federal
Register on October 16, 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-2019-D-1876 for ``Testing for Biotin Interference in In Vitro
Diagnostic Devices; 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,<PHONE_NUMBER>.
     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,<PHONE_NUMBER>.
    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 or the
Office of Policy, Guidance and Policy Development, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5431, 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<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Shruti Modi, 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 ``Testing
for Biotin Interference in In Vitro Diagnostic Devices; Guidance for
Industry.'' The guidance provides FDA's recommendations on the testing
for interference by biotin on the performance of IVDs. The guidance is
intended to help device developers and clinicians understand how FDA
recommends biotin interference testing be performed, and how the
results of the testing should be communicated to end users, including
clinical laboratories and clinicians. The recommendations apply to
IVDs, including devices that are licensed under section 351 of the
Public Health Service Act (42 U.S.C. 262) and used in donor screening,
that use biotin technology.
    Biotin, also known as vitamin B7, is a water-soluble vitamin often
found in multivitamins, prenatal vitamins, and dietary supplements
marketed for hair, skin, and nail growth. FDA has become aware of
potential biotin interference with IVDs that use biotin/avidin
interactions as part of the device technology. Biotin levels in samples
from patients who consume more than the recommended daily intake of
biotin can cause falsely high or falsely low results, depending on the
test principle.
    In the Federal Register of June 10, 2019 (84 FR 27781), FDA
announced the availability of the draft guidance of the same title. FDA
received a few

comments on the draft guidance and those comments were considered as
the guidance was finalized. We considered comments on the recommended
level of biotin concentration for evaluation. We decline to recommend
evaluating a concentration level below 3,500 nanograms per milliliter.
We believe this level is appropriate for minimizing the risk to
patients from incorrect test results. Further, this level is consistent
with best practices among the industry to test at three times the
highest concentration levels observed, as recommended in the FDA-
recognized standard published by the Clinical Laboratory Standards
Institute. Other comments recommended FDA clarify or expand upon the
necessity of mitigation strategies to address biotin interference other
than labeling. We decline to recommend other specific mitigation
strategies, but note that other mitigation strategies such as customer
information letters and technical mitigations may be considered when
the risk of potentially incorrect results from biotin interference
could significantly affect patient or public health. Finally, we
considered comments regarding additional types of information to be
communicated to end-users, but we declined to provide more specific
recommendations because manufacturers may not have sufficient data to
provide more specific information in the labeling. In addition,
editorial edits were made to improve clarity. The guidance announced in
this notice finalizes the draft guidance of the same title dated June
2019.
    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 testing for biotin interference in in vitro
diagnostic devices. 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

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 809 have been approved under OMB control
number 0910-0485.

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,
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products, or https://www.regulations.gov.

    Dated: October 9, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22926 Filed 10-15-20; 8:45 am]
BILLING CODE 4164-01-P