Notice2023-17264
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Reports of Corrections and Removals
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
August 11, 2023
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 88 Issue 154 (Friday, August 11, 2023)</title>
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[Federal Register Volume 88, Number 154 (Friday, August 11, 2023)]
[Notices]
[Pages 54621-54622]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-17264]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-1006]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 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 September 11, 2023.
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 0910-0359. 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#550507140621343333153331347b3d3d267b323a23"><span class="__cf_email__" data-cfemail="f2a2a0b3a186939494b2949693dc9a9a81dc959d84">[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.
[[Page 54622]]
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.
In the Federal Register of April 11, 2023 (88 FR 21677), we
published a 60-day notice soliciting comment on the proposed collection
of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
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Number of Total operating
21 CFR part; collection activity Number of responses per Total annual Average burden Total hours and maintenance
respondents respondent responses per 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 (including any sharing of information with
other constituent part applicants as required under
4.103)..............................................
Total............................................ .............. .............. .............. .............. 12,122 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
21 CFR part; collection activity Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
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806; Records of corrections and removals.... 93 1 93 10........................................ 930
4.105(b); recordkeeping by device-led 279 1 279 0.5 (30 minutes).......................... 140
combination products.
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, however we have revised the collection to include the new
electronic reporting instrument ``Device Correction/Removal Report for
Industry.'' 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: August 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17264 Filed 8-10-23; 8:45 am]
BILLING CODE 4164-01-P
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