Notice2021-16635
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
August 4, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the 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 86 Issue 147 (Wednesday, August 4, 2021)</title>
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[Federal Register Volume 86, Number 147 (Wednesday, August 4, 2021)]
[Notices]
[Pages 41973-41974]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-16635]
[[Page 41973]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0405]
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, the 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 3, 2021.
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 0910-0432. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#28787a697b5c494e4e684e4c490640405b064f475e"><span class="__cf_email__" data-cfemail="035351425077626565436567622d6b6b702d646c75">[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--21 CFR Part 810
OMB Control Number 0910-0432--Extension
This collection of information implements section 518(e) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360h(e)) and
part 810 (21 CFR part 810), 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.
FDA will then provide the person named in the cease distribution
and notification order with the opportunity for an informal hearing on
whether the order should be amended to require a mandatory recall of
the device. If, after providing the opportunity for an informal
hearing, FDA determines that such an order is necessary, the Agency may
amend the order to require a mandatory recall.
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 will be used by FDA to implement mandatory
recalls.
In the Federal Register of April 5, 2021 (86 FR 17610), 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
Activity; 21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Collections Specified in the 2 1 2 8 16
Order--810.10(d)...............
Request for Regulatory Hearing-- 1 1 1 8 8
810.11(a)......................
Written Request for Review-- 1 1 1 8 8
810.12(a) and (b)..............
Mandatory Recall Strategy-- 2 1 2 16 32
810.14.........................
Periodic Status Reports-- 2 12 24 40 960
810.16(a) and (b)..............
Termination Request--810.17(a).. 2 1 2 8 16
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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
Activity; 21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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Documentation of Notifications to Recipients--810.15(b)............ 2 1 2 8 16
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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
Activity; 21 CFR section Number of disclosures Total annual Average burden Total hours
respondents per respondent disclosures per disclosure
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Notification to Recipients-- 2 1 2 12 24
810.15(a) through (c)..........
Notification to Recipients; 2 1 2 4 8
Follow-up--810.15(d)...........
Notification of Consignees by 10 1 10 1 10
Recipients--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.
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The burden estimates are based on FDA's experience with voluntary
recalls under 21 CFR part 7. FDA expects no more than two mandatory
recalls per year, as most recalls are done voluntarily.
Section 810.10(d)--Collections Specified in the Order--
(Reporting)--FDA may require the person named in the cease distribution
and notification order to submit certain information to the Agency,
e.g., distribution information, progress reports.
Section 810.11(a)--Request for Regulatory Hearing--(Reporting)--A
request for regulatory hearing regarding the cease distribution and
notification order must be submitted in writing to FDA.
Section 810.12(a) and (b)--Written Request for Review--
(Reporting)--In lieu of requesting a regulatory hearing under Sec.
810.11, the person named in the cease distribution and notification
order may submit a written request to FDA asking that the order be
modified or vacated. A written request for review of a cease
distribution and notification order shall identify each ground upon
which the requestor relies in asking that the order be modified or
vacated, address an appropriate cease distribution and notification
strategy, and address whether the order should be amended to require a
recall of the device that was the subject of the order and the actions
required by such a recall order.
Section 810.14--Mandatory Recall Strategy--(Reporting)--The person
named in the cease distribution and notification order or a mandatory
recall order must develop and submit a strategy to FDA for complying
with the order that is appropriate for the individual circumstances.
Section 810.15(a) through (c)--Notifications to Recipients--(Third-
Party Disclosure)--The person named in a cease distribution and
notification order or a mandatory recall order must promptly notify
each health professional, user facility, consignee, or individual of
the order.
Section 810.15(b)--Documentation of Notifications to Recipients--
(Recordkeeping)--Telephone calls or other personal contacts may be made
in addition to, but not as a substitute for, the verified written
communication, and shall be documented in an appropriate manner.
Section 810.15(d)--Notification to Recipients; Followup--(Third-
Party Disclosure)--The person named in the cease distribution and
notification order or mandatory recall order shall ensure that followup
communications are sent to all who fail to respond to the initial
communication.
Section 810.15(e)--Notification of Consignees by Recipients--
(Third-Party Disclosure)--Health professionals, device user facilities,
and consignees should immediately notify their consignees of the order.
Section 810.16(a) and (b)--Periodic Status Reports--(Reporting)--
The person named in a cease distribution and notification order or a
mandatory recall order must submit periodic status reports to FDA to
enable the Agency to assess the person's progress in complying with the
order. The frequency of such reports and the Agency official to whom
such reports must be submitted will be specified in the order.
Section 810.17(a)--Termination Request--(Reporting)--The person
named in a cease distribution and notification order or a mandatory
recall order may request termination of the order by submitting a
written request to FDA. The person submitting a request must certify
that he or she has complied in full with all the requirements of the
order and shall include a copy of the most current status report
submitted to the Agency.
Based on a review of the information collection since our last
request for OMB approval, we have made no changes to the burden
estimate.
Dated: July 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16635 Filed 8-3-21; 8:45 am]
BILLING CODE 4164-01-P
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