Notice2024-12346
Agency Information Collection Activities; Proposed Collection; 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
June 5, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) 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 the information collection provisions related to Medical Device Recall Authority.
Full Text
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<title>Federal Register, Volume 89 Issue 109 (Wednesday, June 5, 2024)</title>
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[Federal Register Volume 89, Number 109 (Wednesday, June 5, 2024)]
[Notices]
[Pages 48174-48176]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-12346]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2381]
Agency Information Collection Activities; Proposed Collection;
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 or Agency) 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 the information collection provisions
related to Medical Device Recall Authority.
DATES: Either electronic or written comments on the collection of
information must be submitted by August 5, 2024.
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
[[Page 48175]]
August 5, 2024. 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 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-2024-N-2381 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Device Recall
Authority.'' 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: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
<a href="/cdn-cgi/l/email-protection#025250435176636464426466632c6a6a712c656d74"><span class="__cf_email__" data-cfemail="3f6f6d7e6c4b5e59597f595b5e1157574c11585049">[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 Device Recall Authority--21 CFR Part 810
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
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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.
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 2 12 24 40 960
to 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 Average burden
Collection activity--21 CFR section Number of records per Total 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 Average
Collection activity--21 CFR section Number of disclosures Total annual burden per Total
respondents per respondent disclosures disclosure hours
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Communications to appropriate person(s) 2 1 2 12 24
concerning a cease distribution and
notification or mandatory recall order--
810.15(a)-(c).............................
Follow up communications to appropriate 2 1 2 4 8
person(s) who fail to respond to the
initial communication--810.15(d)..........
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: May 31, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-12346 Filed 6-4-24; 8:45 am]
BILLING CODE 4164-01-P
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