Notice2024-21904
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Recall Authority
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
September 25, 2024
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 89 Issue 186 (Wednesday, September 25, 2024)</title>
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[Federal Register Volume 89, Number 186 (Wednesday, September 25, 2024)]
[Notices]
[Pages 78313-78315]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-21904]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2381]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Device Recall
Authority
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 October 25, 2024.
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
[[Page 78314]]
by using the search function. The OMB control number for this
information collection is 0910-0432. Also include the FDA docket number
found in brackets in the heading of this document.
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#a1f1f3e0f2d5c0c7c7e1c7c5c08fc9c9d28fc6ced7"><span class="__cf_email__" data-cfemail="247476657750454242644240450a4c4c570a434b52">[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.
Medical Device Recall Authority
OMB Control Number 0910-0432--Extension
This collection of information helps to implement section 518(e) of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360h(e))
and regulations in part 810 (21 CFR part 810) which set forth mandatory
medical device recall authority provisions. Section 518(e) of the FD&C
Act provides FDA with the authority to issue an order requiring an
appropriate person, including manufacturers, importers, distributors,
and retailers of a device, if FDA finds that there is reasonable
probability that the device intended for human use would cause serious,
adverse health consequences or death, to: (1) Immediately cease
distribution of such device and (2) immediately notify health
professionals and device-user facilities of the order and to instruct
such professionals and facilities to cease use of such device.
The person named in the order will have an opportunity for a
regulatory hearing or to provide a written request to FDA asking that
the order be modified, vacated, or amended. FDA may later amend the
order to require a mandatory recall of the device. FDA currently allows
for these requests, along with other reports and records concerning
mandatory recalls, to be submitted to the Agency using electronic
methods including email and FDA's eSubmitter program (<a href="https://www.fda.gov/industry/fda-esubmitter">https://www.fda.gov/industry/fda-esubmitter</a>).
FDA issued part 810 to implement the provisions of section 518 of
the FD&C Act. The information collected under the mandatory recall
authority provisions is used by FDA to implement mandatory recalls.
Description of Respondents: Respondents for this collection of
information are firms, including medical device manufacturers,
importers, distributors, and retailers, that have been issued a cease
distribution and notification order or mandatory recall order in
accordance with the provisions under part 810, during the timeframe(s)
specified in the order.
In the Federal Register of June 5, 2024 (89 FR 48174), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Total Average
Collection activity--21 CFR section Number of responses per annual burden per Total
respondents respondent responses response hours
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Submission of information to FDA about device 2 1 2 8 16
distribution and remedial actions to be taken,
as specified in the order--810.10(d)...........
Submission of a written request for regulatory 1 1 1 8 8
hearing--810.11(a).............................
Submission of a written request to FDA asking 1 1 1 8 8
that the order be modified or vacated--810.12(a-
b).............................................
Submission of a strategy for compliance with 2 1 2 16 32
cease distribution and notification or
mandatory recall order--810.14.................
Submission of periodic status reports to FDA to 2 12 24 40 960
enable the Agency to assess progress in
compliance with the order--810.16(a-b).........
Submission of a written request to FDA to 2 1 2 8 16
certify compliance with and terminate the
order--810.17(a)...............................
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Total Hours................................. ........... .............. .......... ........... 1,040
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Total Average burden
Collection activity--21 CFR section Number of records per annual per Total
recordkeepers recordkeeper records recordkeeping hours
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Documentation of communications to 2 1 2 8 16
appropriate person(s)--810.15(b)......
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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Number of
Number of disclosures Total Average Total
Collection activity--21 CFR section respondents per annual burden per hours
respondent responses disclosure
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Communications to appropriate person(s) concerning 2 1 2 12 24
a cease distribution and notification or mandatory
recall order--810.15(a)-(c).......................
Follow up communications to appropriate person(s) 2 1 2 4 8
who fail to respond to the initial communication--
810.15(d).........................................
[[Page 78315]]
Notifications provided by recipients of 10 1 10 1 10
communications to appropriate consignees--
810.15(e).........................................
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Total.......................................... ........... ........... .......... ........... 42
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The burden per response, burden per recordkeeping, and burden per
disclosure estimates are based on FDA's recent experience with
voluntary recalls under 21 CFR part 7. Based on an analysis of cease
distribution and notification and mandatory recall order activity over
the last 3 years, FDA expects no more than two of such actions per year
as a conservative estimate.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: September 19, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21904 Filed 9-24-24; 8:45 am]
BILLING CODE 4164-01-P
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