Notice2023-07524
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Corrections and Removals
Primary source
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Published
April 11, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, 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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with reports of removals and corrections for medical and radiation emitting products regulated by FDA's Center for Devices and Radiological Health.
Full Text
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<title>Federal Register, Volume 88 Issue 69 (Tuesday, April 11, 2023)</title>
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[Federal Register Volume 88, Number 69 (Tuesday, April 11, 2023)]
[Notices]
[Pages 21677-21679]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-07524]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-1006]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices; Reports of Corrections and Removals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, 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,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
associated with reports of removals and corrections for medical and
radiation emitting products regulated by FDA's Center for Devices and
Radiological Health.
DATES: Either electronic or written comments on the collection of
information must be submitted by June 12, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. 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 June 12, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received 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
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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-2023-N-1006 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Devices; Reports of
Corrections and Removals.'' 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: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
<a href="/cdn-cgi/l/email-protection#49191b081a3d282f2f092f2d286721213a672e263f"><span class="__cf_email__" data-cfemail="39696b786a4d585f5f795f5d581751514a175e564f">[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, including
each proposed extension of an existing 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.
Medical Devices; Reports of Corrections and Removals--21 CFR Part 806
OMB Control Number 0910-0359--Revision
This information collection supports implementation of provisions
of section 519(g) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360i(g)) requiring device manufacturers and importers to report
promptly to FDA certain actions concerning device corrections and
removals and to maintain associated records. Applicable regulations are
found in 21 CFR part 806 and set forth definitions, prescribe format
and required content elements for reporting, and identify actions that
are exempt from the reporting requirements. The information collected
is used by FDA to identify marketed devices that have serious problems
and to ensure that defective devices are removed from the market. The
information also helps ensure that FDA has current and complete
information regarding these corrections and removals to determine
whether recall action is adequate.
Reports of corrections and removals may be submitted to FDA via
mail, email, or using FDA's Electronic Submission Gateway (ESG). To
assist respondents with submitting reports of corrections or removals,
we developed a fillable PDF electronic submission template entitled,
``Device Correction/Removal Report for Industry,'' that transmits
required data to FDA's Recall Enterprise System. Instructions for the
fillable template are provided in pop-up text boxes that appear over
each data field. We expect that use of the fillable template will
expedite processing of the reports of corrections or removals submitted
to FDA.
We estimate the burden of the information collection as follows:
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Table 1--Estimated Annual Reporting Burden
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Total
Number of Number of Total annual Average operating and
21 CFR part; collection activity respondents responses per responses burden per Total hours maintenance
respondent response costs
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Electronic process setup................................ 517 1 517 3.08 1,592 $25,850
806; Submission of corrections and removals............. 1,033 1 1,033 10 10,330 ..............
4.102(c)(1)(iii)); Submitting correction or removal 20 1 20 10 200 ..............
reports................................................
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Total............................................... .............. .............. .............. .............. .............. 25,850
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For respondents who submit corrections and removals using the ESG,
the operating and maintenance costs associated with this information
collection are approximately $50 per year to purchase a digital
verification certificate (certificate must be valid for 1 to 3 years).
This burden may be reduced if the respondent has already purchased a
verification certificate for other electronic submissions to FDA. This
burden may also be reduced if respondents utilize the new PDF template
and submit it to the Agency using email, mitigating the need for a
digital verification certificate.
Table 2--Estimated Annual Recordkeeping Burden \1\ \2\
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Number of Average burden
21 CFR part; collection Number of records per Total annual per Total hours
activity recordkeepers recordkeeper records recordkeeping
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806; Records of corrections 93 1 93 10.............. 930
and removals.
4.105(b); recordkeeping by 279 1 279 0.5 (30 minutes) 140
device-led combination
products.
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Total..................... .............. .............. .............. ................ 1,070
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1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Figures have been rounded.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate. We estimate that 50 percent of submitters will use the ESG to
submit the required information. Our estimate of the reporting and
recordkeeping burden is based on Agency records and our experience with
this program, as well as similar programs that utilize FDA's ESG. For
the purposes of estimating the burden, we assume that all respondents
who submit corrections and removals using the electronic process will
establish a new WebTrader account and purchase a digital verification
certificate.
Dated: April 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07524 Filed 4-10-23; 8:45 am]
BILLING CODE 4164-01-P
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