Document ID: FDA-2021-N-0386-0001
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2021-06-25T04:00Z

[Federal Register Volume 86, Number 120 (Friday, June 25, 2021)]
[Notices]
[Pages 33708-33710]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     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-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 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.

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, 
PRAStaff@fda.hhs.gov.

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