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, 33708-33710 [2021-13580]
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33708
Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices
DEPARTMENT OF DEFENSE
GENERAL SERVICES
ADMINISTRATION
Submission for OMB Review;
Construction Wage Rate
Requirements—Price Adjustment
(Actual Method)
Department of Defense (DOD),
General Services Administration (GSA),
and National Aeronautics and Space
Administration (NASA).
ACTION: Notice.
Under the provisions of the
Paperwork Reduction Act, the
Regulatory Secretariat Division has
submitted to the Office of Management
and Budget (OMB) a request to review
and approve a revision and extension of
a previously approved information
collection requirement regarding
construction wage rate requirements—
price adjustment (Actual Method).
DATES: Submit comments on or before
July 26, 2021.
ADDRESSES: Written comments and
recommendations for this information
collection should be sent within 30 days
of publication of this notice to
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.
Additionally, submit a copy to GSA
through https://www.regulations.gov and
follow the instructions on the site. This
website provides the ability to type
short comments directly into the
comment field or attach a file for
lengthier comments.
Instructions: All items submitted
must cite OMB Control No. 9000–0154,
Construction Wage Rate Requirements—
Price Adjustment (Actual Method).
Comments received generally will be
posted without change to https://
www.regulations.gov, including any
personal and/or business confidential
information provided. To confirm
receipt of your comment(s), please
check www.regulations.gov,
approximately two-to-three days after
submission to verify posting. If there are
difficulties submitting comments,
contact the GSA Regulatory Secretariat
Division at 202–501–4755 or
GSARegSec@gsa.gov.
FOR FURTHER INFORMATION CONTACT:
Zenaida Delgado, Procurement Analyst,
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Jkt 253001
Centers for Disease Control and
Prevention
B. Need and Uses
AGENCY:
18:38 Jun 24, 2021
SUPPLEMENTARY INFORMATION:
9000–0154, Construction Wage Rate
Requirements—Price Adjustment
(Actual Method).
[OMB Control No. 9000–0154; Docket No.
2021–0053; Sequence No. 7]
VerDate Sep<11>2014
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
A. OMB Control Number, Title, and
Any Associated Form(s)
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
SUMMARY:
at telephone 202–969–7207, or
zenaida.delgado@gsa.gov.
This clearance covers the information
that contractors must submit to comply
with the following Federal Acquisition
Regulation (FAR) requirements:
• 52.222–32, Construction Wage Rate
Requirements—Price Adjustment
(Actual Method). This clause requires
contractors to submit at the exercise of
each option to extend the term of the
contract, a statement of the amount
claimed for incorporation of the most
current Department of Labor wage
determination, and any relevant
supporting data, including payroll
records, that the contracting officer may
reasonably require.
Contracting officers use the
information to establish the contract’s
construction requirements price
adjustment to reflect the contractor’s
actual increase or decrease in wages and
fringe benefits.
Respondents: 506.
Total Annual Responses: 506.
Total Burden Hours: 20,240.
D. Public Comment
A 60-day notice was published in the
Federal Register at 86 FR 20699, on
April 21, 2021. No comments were
received.
Obtaining Copies: Requesters may
obtain a copy of the information
collection documents from the GSA
Regulatory Secretariat Division, by
calling 202–501–4755 or emailing
GSARegSec@gsa.gov. Please cite OMB
Control No. 9000–0154, Construction
Wage Rate Requirements—Price
Adjustment (Actual Method).
William Clark,
Director, Office of Governmentwide
Acquisition Policy, Office of Acquisition
Policy, Office of Governmentwide Policy.
[FR Doc. 2021–13628 Filed 6–24–21; 8:45 am]
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Notice is hereby given that I have
delegated the authority to designate
chairs and invite members to serve on
the Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel to the Centers for
Disease Control and Prevention Director
(CDC) and the Agency for Toxic
Substances and Disease Registry
(ATSDR) Administrator. This authority
may be redelegated by the CDC Director,
or the ATSDR Administrator.
This delegation became effective upon
date of signature. In addition, I hereby
affirm and ratify any actions taken by
you or your subordinates that involved
the exercise of the authorities delegated
herein, or substantially similar
authorities vested in me by prior annual
HHS appropriations acts, prior to the
effective date of the delegation.
Dated: June 15, 2021.
Xavier Becerra,
Secretary.
[FR Doc. 2021–13605 Filed 6–24–21; 8:45 am]
BILLING CODE 4160–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
C. Annual Burden
PO 00000
Delegation of Authority
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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.
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
SUMMARY:
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Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices
virus (HIV) serological diagnostic and
supplemental tests and HIV nucleic acid
(NAT) diagnostic and supplemental
tests.
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.
DATES:
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’’).
lotter on DSK11XQN23PROD with NOTICES1
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
VerDate Sep<11>2014
18:38 Jun 24, 2021
Jkt 253001
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-201509-18/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.
PO 00000
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33709
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
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Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices
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 § 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
21 CFR citation, activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Proposed
21
CFR
866.3956(b)(1)(iii)
and
866.3957(b)(1)(iii), Submission of log to FDA .................
10
1
10
3
30
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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 § 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.
VerDate Sep<11>2014
18:38 Jun 24, 2021
Jkt 253001
Dated: June 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–13580 Filed 6–24–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–1802]
Cancer Clinical Trial Eligibility Criteria:
Approach to Available Therapy in NonCurative Settings; Draft Guidance for
Sponsors; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for sponsors entitled ‘‘Cancer
Clinical Trial Eligibility Criteria:
SUMMARY:
PO 00000
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Approach to Available Therapy in NonCurative Settings.’’ The draft guidance
provides recommendations to sponsors
of clinical trials of investigational
cancer drugs regarding the inclusion of
patients who have not previously
received available therapy (commonly
referred to as existing treatment options)
for their cancer in the non-curative
setting. The draft guidance is intended
to facilitate increased clinical trial
options for patients with non-curable
cancers by recognizing that, with
appropriate informed consent, it may be
reasonable for patients to be eligible for
inclusion in trials of investigational
cancer drugs, regardless of whether they
have received available therapy, in the
non-curative setting.
Submit either electronic or
written comments on the draft guidance
by August 24, 2021 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
DATES:
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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,
[email protected].
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
