Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Recall Authority, 41973-41974 [2021-16635]
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41973
Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Notices
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.
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:
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration,
HHS.
ACTION:
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:
Notice.
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, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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 https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review-Open for Public Comments’’ or
SUMMARY:
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
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity; 21 CFR section
Total annual
responses
Average
burden per
response
Total hours
Collections Specified in the Order—810.10(d) .....................................................
Request for Regulatory Hearing—810.11(a) ........................................................
Written Request for Review—810.12(a) and (b) ..................................................
Mandatory Recall Strategy—810.14 .....................................................................
Periodic Status Reports—810.16(a) and (b) ........................................................
Termination Request—810.17(a) ..........................................................................
2
1
1
2
2
2
1
1
1
1
12
1
2
1
1
2
24
2
8
8
8
16
40
8
16
8
8
32
960
16
Total Hours ....................................................................................................
........................
........................
........................
........................
1,040
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity; 21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total
hours
Documentation of Notifications to Recipients—810.15(b) ....................................
2
1
2
8
16
Average
burden per
disclosure
Total
hours
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
lotter on DSK11XQN23PROD with NOTICES1
Number of
disclosures
per
respondent
Number of
respondents
Activity; 21 CFR section
Total
annual
disclosures
Notification to Recipients—810.15(a) through (c) .................................................
Notification to Recipients; Follow-up—810.15(d) ..................................................
Notification of Consignees by Recipients—810.15(e) ..........................................
2
2
10
1
1
1
2
2
10
12
4
1
24
8
10
Total ...............................................................................................................
........................
........................
........................
........................
42
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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41974
Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Notices
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 § 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—(ThirdParty 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
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16:45 Aug 03, 2021
Jkt 253001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: Health Center
Program: COVID–19 Data Collection
Tools, OMB No. 0906–0062—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
SUMMARY:
PO 00000
Frm 00038
Fmt 4703
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Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than September 3,
2021.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Health Center Program: COVID–19 Data
Collection Tools, OMB No. 0906–0062—
Revision.
Abstract: This information collection
request was previously approved by
OMB on June 11, 2020, as an emergency
clearance (OMB No.: 0906–0062). HRSA
is currently undertaking the standard
Paperwork Reduction Act process for
normal OMB approval.
During the COVID–19 public health
emergency, HRSA-supported health
centers and Federally Qualified Health
Center Look-Alikes (look-alikes) have
played a key role in providing testing
and care for those affected by the virus.
HRSA has awarded billions of dollars in
new funding to support health center
awardees and look-alikes in the
detection, prevention, diagnosis, and
treatment of COVID–19. This funding
has enabled health centers to maintain
or increase their staffing levels, conduct
training, provide COVID–19 treatment,
and administer millions of tests for both
existing and new patients. In addition,
HRSA, in collaboration with the Centers
for Disease Control and Prevention,
launched the Health Center COVID–19
Vaccine program as part of an
Administration initiative focused on
health equity. This occurred in February
2021 to directly allocate COVID–19
vaccines to HRSA-supported health
centers.
This ICR to support the
implementation of COVID–19 relief
funding and response activities includes
forms previously submitted in the
emergency information collection
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]]>Agencies
[Federal Register Volume 86, Number 147 (Wednesday, August 4, 2021)]
[Notices]
[Pages 41973-41974]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16635]
[[Page 41973]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://www.reginfo.gov/public/do/PRAMain. 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,
[email protected].
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
----------------------------------------------------------------------------------------------------------------
Number of
Activity; 21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
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
-------------------------------------------------------------------------------
Total Hours................. .............. .............. .............. .............. 1,040
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity; 21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Documentation of Notifications to Recipients--810.15(b)............ 2 1 2 8 16
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
----------------------------------------------------------------------------------------------------------------
Number of
Activity; 21 CFR section Number of disclosures Total annual Average burden Total hours
respondents per respondent disclosures per disclosure
----------------------------------------------------------------------------------------------------------------
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)..........
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 42
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 41974]]
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
