Notice2021-13580
Agency Information Collection Activities; Proposed Collection; Comment Request; Class II Special Controls for Human Immunodeficiency Virus Serological Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests
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Published
June 25, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on class II special controls for human immunodeficiency virus (HIV) serological diagnostic and supplemental tests and HIV nucleic acid (NAT) diagnostic and supplemental tests.
Full Text
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<title>Federal Register, Volume 86 Issue 120 (Friday, June 25, 2021)</title>
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[Federal Register Volume 86, Number 120 (Friday, June 25, 2021)]
[Notices]
[Pages 33708-33710]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-13580]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0386]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Class II Special Controls for Human Immunodeficiency
Virus Serological Diagnostic and Supplemental Tests and Human
Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on class II special controls for human
immunodeficiency
[[Page 33709]]
virus (HIV) serological diagnostic and supplemental tests and HIV
nucleic acid (NAT) diagnostic and supplemental tests.
DATES: Submit either electronic or written comments on the collection
of information by August 24, 2021.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 24, 2021. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 24, 2021. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2021-N-0386 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Class II Special Controls for
Human Immunodeficiency Virus Serological Diagnostic and Supplemental
Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and
Supplemental Tests.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#055557445671646363456361642b6d6d762b626a73"><span class="__cf_email__" data-cfemail="b0e0e2f1e3c4d1d6d6f0d6d4d19ed8d8c39ed7dfc6">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Class II Special Controls for Human Immunodeficiency Virus Serological
Diagnostic and Supplemental Tests and Human Immunodeficiency Virus
Nucleic Acid Diagnostic and Supplemental Tests
OMB Control Number 0910-NEW
In the Federal Register of February 21, 2020 (85 FR 10110), we
published a proposed order to reclassify certain HIV serological
diagnostic and supplemental tests and HIV NAT diagnostic and
supplemental tests from class III (premarket approval) into class II
(special controls) (the proposed order). In the proposed order, FDA
proposed special controls that the Agency believes are necessary to
provide a
[[Page 33710]]
reasonable assurance of safety and effectiveness for these devices. The
proposed special controls would require the submission of a log of all
complaints annually for a period of 5 years following FDA clearance of
a traditional premarket notification (510(k)) submission for a device
within the scope of the proposed order.
Currently, manufacturers of HIV serological diagnostic and
supplemental tests and HIV NAT diagnostic and supplemental tests are
subject to FDA regulations in part 820 (21 CFR part 820), which govern
the methods used in, and the facilities and controls used for, the
design, manufacture, packaging, labeling, storage, installation, and
servicing of all finished devices intended for human use. Manufacturers
are required to maintain complaint files and to review and evaluate
complaints for these devices under Sec. 820.198 (21 CFR 820.198).
Complaints required to be reported in the annual logs under the
proposed special controls, such as certain complaints involving
unusually high invalid rates or issues with users conducting the test,
may not meet the definition of a medical device report required to be
reported to FDA under 21 CFR part 803 (medical device reporting;
currently approved under OMB control number 0910-0437), but could
potentially affect the safety and efficacy of these devices. If the
proposed order is finalized, we intend to review the information in the
complaint logs in a timely manner and engage with manufacturers as
necessary. The submission of the complaint log would provide us with
earlier notification of concerns and enable us to determine whether
they have been adequately addressed. The Agency usually would not
evaluate this kind of complaint information until an FDA inspection,
which typically occurs less frequently than annually. We believe
implementing these specific reporting measures as part of the special
controls would be necessary to provide a reasonable assurance of safety
and effectiveness for HIV diagnostic and supplemental tests subject to
the proposed order.
Description of Respondents: The respondents to the information
collection are manufacturers of HIV diagnostic and supplemental test
devices that would be subject to the proposed order, if finalized.
Finalizing the proposed order would add classification regulations
for these devices in 21 CFR part 866 (Immunology and Microbiology
Devices) at 21 CFR 866.3956 for the HIV serological diagnostic and
supplemental tests, and 21 CFR 866.3957 for the HIV NAT diagnostic and
supplemental tests, and establish special controls necessary to provide
reasonable assurance of their safety and effectiveness. As described
above, the special controls would require the submission of a log of
all complaints annually for a period of 5 years following FDA clearance
of a traditional 510(k) submission for one of these devices.
We estimate the reporting burden hours associated with the proposed
order, if finalized, to be approximately 30 reporting burden hours.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1
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Number of
21 CFR citation, activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Proposed 21 CFR 866.3956(b)(1)(iii) and 866.3957(b)(1)(iii), 10 1 10 3 30
Submission of log to FDA..........................................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimate of the average burden per response on our
experience with other types of annual report submissions. We base our
estimate of the number of affected respondents on the expected number
of manufacturers that would be submitting a 510(k) for a new device or
changes to an existing device that would require a 510(k).
As noted above, manufacturers of the devices subject to the
proposed order must already maintain complaint files and review and
evaluate complaints under Sec. 820.198. If the proposed order is
finalized as proposed, we estimate it would take a manufacturer
approximately 3 hours annually to review their existing records,
prepare the complaint log, and submit it to FDA. Although respondents
may submit the information electronically through the FDA Electronic
Submission Gateway, on paper, or electronic media (e.g., CD, DVD) to
the Center for Biologics Evaluation and Research's Document Control
Center, we assume that all manufacturers will submit their logs
electronically.
Dated: June 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13580 Filed 6-24-21; 8:45 am]
BILLING CODE 4164-01-P
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