Document ID: FDA-2021-N-0386-0002
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2022-02-17T05:00Z

[Federal Register Volume 87, Number 33 (Thursday, February 17, 2022)]
[Notices]
[Pages 9057-9058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.reginfo.gov/public/do/PRAMain. 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, 
[email protected].

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