Notice2022-03437
Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 17, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 87 Issue 33 (Thursday, February 17, 2022)</title>
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[Federal Register Volume 87, Number 33 (Thursday, February 17, 2022)]
[Notices]
[Pages 9057-9058]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-03437]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0386]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by March 21, 2022.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0437. Also include the FDA docket
number found in brackets in the heading of this document.
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#0e5e5c4f5d7a6f68684e686a6f2066667d20696178"><span class="__cf_email__" data-cfemail="5b0b091a082f3a3d3d1b3d3f3a75333328753c342d">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Medical Device Reporting--21 CFR Part 803
OMB Control Number 0910-0437--Revision
In the Federal Register of February 21, 2020 (85 FR 10110), we
published a proposed order to reclassify certain human immunodeficiency
virus (HIV) serological diagnostic and supplemental tests and HIV
nucleic acid (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 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
[[Page 9058]]
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)
(approved under OMB control number 0910-0073).
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 effectiveness of these devices. 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.
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 are
requesting approval to revise the scope of the information collections
included in OMB control number 0910-0437 (medical device reporting) to
include the information collection associated with this special control
provision.
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.
In the Federal Register of June 25, 2021 (86 FR 33708), we
published a 60-day notice requesting public comment on the new
reporting provisions of the proposed order. One comment was received,
however it was not responsive to the four information collection topics
solicited, nor did it suggest FDA revise its burden estimate.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section; 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: February 10, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03437 Filed 2-16-22; 8:45 am]
BILLING CODE 4164-01-P
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