[Federal Register Volume 85, Number 201 (Friday, October 16, 2020)]
[Notices]
[Pages 65817-65819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

[[Page 65818]]

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notice finalizes the draft guidance of the same title dated June 2019.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, 240-402-7500.
     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, 240-402-7500.
    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 240-402-8010. 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

[[Page 65819]]

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