Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Reporting, 40593-40595 [2021-16034]
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Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices
pulverized roots of cynanchum
auriculatum, in addition to aegeline, in
its OxyElite Pro ‘‘Advanced Formula’’
supplement. The cynanchum
auriculatum-containing product was
called OxyElite Pro ‘‘Advanced
Formula.’’ On or about June 15, 2013,
Mr. Geissler’s coconspirator instructed a
Chinese chemical seller to have two
metric tons of ground cynanchum
auriculatum root powder, rather than an
extract, shipped internationally to
laboratories in California for inclusion
in USP Labs’ products, using the false
name ‘‘cynanchum auriculatum root
extract.’’ USP Labs then used the
substance in its OxyElite Pro
‘‘Advanced Formula’’ supplement
which it shipped to retailers and
wholesalers using false labels. When
there was a liver-injury outbreak, USP
Labs put out a misleading press release
stating that the ingredients in OxyElite
Pro had been studied and showed ‘‘no
negative liver issues,’’ but USP Labs
knew that a study had shown ‘‘liver
issues’’ related to cynanchum
auriculatum. Mr. Geissler did, with
intent to defraud and mislead, cause the
shipment of misbranded OxyElite Pro
‘‘Advanced Formula’’ to be shipped in
interstate commerce. The conspirators
collected millions in revenue.
As a result of this conviction FDA
sent Mr. Geissler, by certified mail on
March 4, 2021, a notice proposing to
debar him for a period of 5 years from
importing articles of food or offering
such articles for import into the United
States. The proposal was based on a
finding under section 306(b)(1)(C) of the
FD&C Act that Mr. Geissler’s felony
conviction of conspiracy to introduce
misbranded food into interstate
commerce with an intent to defraud and
mislead in violation of 18 U.S.C. 371 (21
U.S.C. 331(a) and 21 U.S.C. 333(a)(2)),
constitutes conduct relating to the
importation of an article of food into the
United States because the offense
involved a conspiracy with others to
import a variety of chemicals with false
labeling in order to either use those
chemicals in dietary supplements which
would themselves also contain false
labeling or to determine whether those
chemicals could be used in new dietary
supplements.
The proposal was also based on a
determination, after consideration of the
relevant factors set forth in section
306(c)(3) of the FD&C Act, that Mr.
Geissler should be subject to a 5-year
period of debarment. The proposal also
offered Mr. Geissler an opportunity to
request a hearing, providing him 30
days from the date of receipt of the letter
in which to file the request, and advised
Mr. Geissler that failure to request a
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17:16 Jul 27, 2021
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hearing constituted a waiver of the
opportunity for a hearing and of any
contentions concerning this action. Mr.
Geissler failed to respond within the
timeframe prescribed by regulation and
has, therefore, waived his opportunity
for a hearing and waived any
contentions concerning his debarment
(21 CFR part 12).
II. Findings and Order
Therefore, the Assistant
Commissioner, Office of Human and
Animal Food Operations, under section
306(b)(1)(C) of the FD&C Act, under
authority delegated to the Assistant
Commissioner, finds that Mr. Jacobo
Geissler has been convicted of a felony
count under Federal law for conduct
relating to the importation into the
United States of an article of food and
that he is subject to a 5-year period of
debarment.
As a result of the foregoing finding,
Mr. Geissler is debarred for a period of
5 years from importing articles of food
or offering such articles for import into
the United States, effective July 28,
2021. Pursuant to section 301(cc) of the
FD&C Act (21 U.S.C. 331(cc)), the
importing or offering for import into the
United States of an article of food by,
with the assistance of, or at the direction
of Jacobo Geissler is a prohibited act.
Any application by Mr. Geissler for
termination of debarment under section
306(d)(1) of the FD&C Act should be
identified with Docket No. FDA–2020–
N–2169 and sent to the Dockets
Management Staff (ADDRESSSES). The
public availability of information in
these submissions is governed by 21
CFR 10.20.
Publicly available submissions will be
placed in the docket and will be
viewable at https://www.regulations.gov
or at the Dockets Management Staff (see
ADDRESSES) between 9 a.m. and 4 p.m.,
Monday through Friday, 240–402–7500.
Dated: July 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–16045 Filed 7–27–21; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
40593
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–6730]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Device
Reporting
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Food and Drug
Administration (FDA) 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 August 27,
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 0910–0437. Also include
the FDA docket number found in
brackets in the heading of this
document.
SUMMARY:
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, 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:
Medical Device Reporting—21 CFR Part
803
OMB Control Number 0910–0437—
Extension
This information collection supports
FDA regulations and FDA’s Medical
Device Reporting program. Section
519(a), (b), and (c) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360i(a), (b), and (c)) requires user
facilities, manufacturers, importers, and
distributors of medical devices to report
adverse events involving medical
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Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices
devices to FDA. These provisions are
codified in part 803 (21 CFR part 803),
Medical Device Reporting. As amended
most recently by the FDA
Reauthorization Act of 2017 (FDARA)
(Pub. L. 115–52), medical device
manufacturers and importers must
submit medical device reports (MDRs)
using FDA’s electronic submission
system. User facilities, however, may
elect to submit reports using paperbased Form FDA 3500A—MedWatch—
Mandatory Reporting (approved under
OMB control number 0910–0291). The
regulations also establish recordkeeping
requirements and provide for certain
exemptions, variances, or alternative
forms of reporting. Exemptions and/or
variances from individual reporting
must be requested in writing and must
receive Agency approval. Additionally,
the regulations permit user facilities to
submit paper-based annual reports, for
which we have developed Form FDA
3419 entitled ‘‘Medical Device
Reporting Annual User Facility Report.’’
This information collection also
includes the use of existing formats
such as Form FDA 3500A 1—
MedWatch—Mandatory Reporting to
allow manufacturers to summarize in a
single report multiple events with
shared characteristics for device
associated reportable malfunction
events. For example, the Voluntary
Malfunction Summary Reporting
Program (VMSRP) 2 provides
recommendations for manufacturers of
certain devices to submit a single report
that summarizes multiple device
associated reportable malfunction
events on a quarterly basis. The VMSRP
was established under section
519(a)(1)(B)(ii) of the FD&C Act and
reflects goals for streamlining
malfunction reporting as outlined in the
Medical Device User Fee Amendments
(MDUFA) IV ‘‘Commitment Letter’’ for
2018 through 2022 agreed to by FDA
and industry and submitted to Congress.
The Commitment Letter was finalized
with the passage of FDARA on August
18, 2017, and, as passed, is entitled
‘‘MDUFA Performance Goals And
Procedures, Fiscal Years 2018 Through
2022.’’ 3
The information that is obtained from
this information collection will be used
to evaluate risks associated with
medical devices and enable FDA to take
appropriate measures to protect the
public health. Complete, accurate, and
timely adverse event information is
necessary for the identification of
emerging device problems so the
Agency can protect the public health
under section 519 of the FD&C Act. FDA
makes the releasable information
available to the public for downloading
on its website. Respondents are
manufacturers and importers of medical
devices and device user facilities.4
In the Federal Register of April 29,
2021 (86 FR 22671), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received. Upon our own review,
however, we have updated submission
figures from our VMSRP program and
supplemental reports under § 803.56 (21
CFR 803.56) to reflect an increase in
submissions. Since publication of our
60-day notice, therefore, we have
modified our estimated burden for
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Total annual
responses
Activity/21 CFR section
FDA form No.
Exemptions/Variances—803.19 ................
........................
6
135.8
815
User Facility Reporting—803.30 and
803.32.
User Facility Annual Reporting—803.33 ...
Importer Reporting, Death and Serious Injury—803.40 and 803.42.
Manufacturer Reporting—803.50, 803.52
and 803.53.
Voluntary Malfunction Summary Reporting
Program.
Supplemental Reports—803.56 ................
........................
271
17.2
4,661
3,419
........................
93
112
2
440.25
186
49,308
........................
1,799
809.83
1,456,884
........................
67
695.15
46,575
........................
1,291
438
565,458
Total ....................................................
........................
........................
........................
........................
1 There
Average
burden per
response
0.10 (6 minutes).
0.35 (21 minutes).
1 .....................
0.10 (6 minutes).
0.10 (6 minutes).
0.10 (6 minutes).
0.10 (6 minutes).
........................
Total hours 2
82
1,631
186
4,931
145,688
4,658
56,546
213,722
are no capital costs or operating and maintenance costs associated with this collection of information.
has been rounded.
khammond on DSKJM1Z7X2PROD with NOTICES
2 Number
The number of respondents to the
information collection is based on
MDRs received by FDA recently. The
annual frequency per response and total
annual responses shown are based on
the number of MDRs reported during
the same period. Based on the scope and
conditions of the VMSRP and our
experience with MDR reporting, FDA
estimates that approximately 10 percent
of malfunction reports would continue
to be submitted as individual reports.
Approximately 62 percent of the
manufacturer reports received under
§§ 803.50, 803.52 and 803.53 are
malfunction reports (903,268 of the
1,456,884 total annual responses
received in 2020).
Supplemental Reports—§ 803.56. We
have increased our estimate, of the
number of supplemental reports to
reflect a corresponding increase of
annual submissions, as reflected in table
1, row 7.
Voluntary Malfunction Summary
Reporting Program. The VMSRP
includes the same respondent pool as
individual manufacturer reporting.
Based on a current review of Agency
data, we have increased our estimate to
1 Form FDA 3500A is approved under OMB
control number 0910–0291.
2 In the Federal Register of August 17, 2018 (83
FR 40973), FDA issued a notification permitting
manufacturers to report certain device malfunction
MDRs in summary form on a quarterly basis.
3 Available at: https://www.fda.gov/downloads/
ForIndustry/UserFees/MedicalDeviceUserFee/
UCM535548.pdf.
4 Device user facility means a hospital,
ambulatory surgical facility, nursing home,
outpatient diagnostic facility, or outpatient
treatment facility as defined in § 803.3 (21 CFR
803.3), which is not a physician’s office (also
defined in § 803.3).
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Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices
reflect an increase in annual
submissions, as reflected in table 1, row
6.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity/21 CFR section
Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total hours
MDR Procedures—803.17 ...................................................
MDR Files—803.18 ..............................................................
1,799
1,799
1
1
1,799
1,799
3.3
1.5
5,937
2,699
Total ..............................................................................
........................
........................
........................
........................
8,636
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The number of respondents in table 2
is based on the MDRs reported to FDA’s
internal databases recently. We believe
that the majority of respondents
(manufacturers, user facilities, and
importers) have already established
written procedures and MDR files to
document complaints and information
to meet the MDR requirements as part
of their internal quality control system.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Activity/21 CFR section
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Importer Reporting, Death and Serious Injury—803.40 and
803.42.
112
25
2,800
1 There
Average
burden per
disclosure
0.35 (21 minutes).
Total hours 2
980
are no capital costs or operating and maintenance costs associated with this collection of information.
has been rounded.
2 Number
The number of respondents for each
CFR section in table 3 was identified
from the MDRs reported to FDA’s
internal databases during the period
recently.
Since the publication of the 60 day
notice we have adjusted our burden
estimate. Our estimated burden for the
information collection reflects an
increase of 155,360 total burden hours
and a corresponding increase of
1,566,458 total annual responses. This
increase corresponds with data obtained
from our database.
Dated: July 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–16034 Filed 7–27–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
khammond on DSKJM1Z7X2PROD with NOTICES
[Docket No. FDA–2021–N–0706]
Animal Drug User Fee Rates and
Payment Procedures for Fiscal Year
2022
AGENCY:
ACTION:
SUPPLEMENTARY INFORMATION:
Food and Drug Administration,
HHS.
17:16 Jul 27, 2021
I. Background
Section 740 of the FD&C Act (21
U.S.C. 379j–12) establishes four
Notice.
VerDate Sep<11>2014
The Food and Drug
Administration (FDA or Agency) is
announcing the fee rates and payment
procedures for fiscal year (FY) 2022
animal drug user fees. The Federal
Food, Drug, and Cosmetic Act (FD&C
Act), as amended by the Animal Drug
User Fee Amendments of 2018 (ADUFA
IV), authorizes FDA to collect user fees
for certain animal drug applications and
supplemental animal drug applications,
for certain animal drug products, for
certain establishments where such
products are made, and for certain
sponsors of such animal drug
applications and/or investigational
animal drug submissions. This notice
establishes the fee rates for FY 2022.
FOR FURTHER INFORMATION CONTACT: Visit
FDA’s website at https://www.fda.gov/
ForIndustry/UserFees/
AnimalDrugUserFeeActADUFA/
default.htm or contact Lisa Kable,
Center for Veterinary Medicine (HFV–
10), Food and Drug Administration,
7500 Standish Pl., Rockville, MD 20855,
240–402–6888, Lisa.Kable@fda.hhs.gov.
For general questions, you may also
email FDA’s Center for Veterinary
Medicine (CVM) at: cvmadufa@
fda.hhs.gov.
SUMMARY:
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different types of user fees: (1) Fees for
certain types of animal drug
applications and supplemental animal
drug applications; (2) annual fees for
certain animal drug products; (3) annual
fees for certain establishments where
such products are made; and (4) annual
fees for certain sponsors of animal drug
applications and/or investigational
animal drug submissions (21 U.S.C.
379j–12(a)). When certain conditions are
met, FDA will waive or reduce fees (21
U.S.C. 379j–12(d)).
For FYs 2019 through 2023, the FD&C
Act establishes aggregate yearly base
revenue amounts for each fiscal year (21
U.S.C. 379j–12(b)(1)). Base revenue
amounts are subject to adjustment for
inflation and workload (21 U.S.C. 379j–
12(c)(2) and (3)). Beginning with FY
2021, the annual fee revenue amounts
are also subject to adjustment to reduce
workload-based increases by the amount
of certain excess collections or to
account for certain collection shortfalls
(21 U.S.C. 379j–12(c)(3) and (g)(5)). Fees
for applications, establishments,
products, and sponsors are to be
established each year by FDA so that the
percentages of the total revenue that are
derived from each type of user fee will
be as follows: (1) Revenue from
application fees shall be 20 percent of
total fee revenue; (2) revenue from
product fees shall be 27 percent of total
fee revenue; (3) revenue from
establishment fees shall be 26 percent of
E:\FR\FM\28JYN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40593-40595]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16034]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-6730]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Device
Reporting
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) 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 August 27, 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 0910-0437. 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 Reporting--21 CFR Part 803
OMB Control Number 0910-0437--Extension
This information collection supports FDA regulations and FDA's
Medical Device Reporting program. Section 519(a), (b), and (c) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360i(a),
(b), and (c)) requires user facilities, manufacturers, importers, and
distributors of medical devices to report adverse events involving
medical
[[Page 40594]]
devices to FDA. These provisions are codified in part 803 (21 CFR part
803), Medical Device Reporting. As amended most recently by the FDA
Reauthorization Act of 2017 (FDARA) (Pub. L. 115-52), medical device
manufacturers and importers must submit medical device reports (MDRs)
using FDA's electronic submission system. User facilities, however, may
elect to submit reports using paper-based Form FDA 3500A--MedWatch--
Mandatory Reporting (approved under OMB control number 0910-0291). The
regulations also establish recordkeeping requirements and provide for
certain exemptions, variances, or alternative forms of reporting.
Exemptions and/or variances from individual reporting must be requested
in writing and must receive Agency approval. Additionally, the
regulations permit user facilities to submit paper-based annual
reports, for which we have developed Form FDA 3419 entitled ``Medical
Device Reporting Annual User Facility Report.''
This information collection also includes the use of existing
formats such as Form FDA 3500A \1\--MedWatch--Mandatory Reporting to
allow manufacturers to summarize in a single report multiple events
with shared characteristics for device associated reportable
malfunction events. For example, the Voluntary Malfunction Summary
Reporting Program (VMSRP) \2\ provides recommendations for
manufacturers of certain devices to submit a single report that
summarizes multiple device associated reportable malfunction events on
a quarterly basis. The VMSRP was established under section
519(a)(1)(B)(ii) of the FD&C Act and reflects goals for streamlining
malfunction reporting as outlined in the Medical Device User Fee
Amendments (MDUFA) IV ``Commitment Letter'' for 2018 through 2022
agreed to by FDA and industry and submitted to Congress. The Commitment
Letter was finalized with the passage of FDARA on August 18, 2017, and,
as passed, is entitled ``MDUFA Performance Goals And Procedures, Fiscal
Years 2018 Through 2022.'' \3\
---------------------------------------------------------------------------
\1\ Form FDA 3500A is approved under OMB control number 0910-
0291.
\2\ In the Federal Register of August 17, 2018 (83 FR 40973),
FDA issued a notification permitting manufacturers to report certain
device malfunction MDRs in summary form on a quarterly basis.
\3\ Available at: https://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM535548.pdf.
---------------------------------------------------------------------------
The information that is obtained from this information collection
will be used to evaluate risks associated with medical devices and
enable FDA to take appropriate measures to protect the public health.
Complete, accurate, and timely adverse event information is necessary
for the identification of emerging device problems so the Agency can
protect the public health under section 519 of the FD&C Act. FDA makes
the releasable information available to the public for downloading on
its website. Respondents are manufacturers and importers of medical
devices and device user facilities.\4\
---------------------------------------------------------------------------
\4\ Device user facility means a hospital, ambulatory surgical
facility, nursing home, outpatient diagnostic facility, or
outpatient treatment facility as defined in Sec. 803.3 (21 CFR
803.3), which is not a physician's office (also defined in Sec.
803.3).
---------------------------------------------------------------------------
In the Federal Register of April 29, 2021 (86 FR 22671), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received. Upon our own
review, however, we have updated submission figures from our VMSRP
program and supplemental reports under Sec. 803.56 (21 CFR 803.56) to
reflect an increase in submissions. Since publication of our 60-day
notice, therefore, we have modified our estimated burden for collection
of information as follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR section FDA form No. Number of responses per Total annual Average burden per Total hours \2\
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exemptions/Variances--803.19........ .............. 6 135.8 815 0.10 (6 minutes).......... 82
User Facility Reporting--803.30 and .............. 271 17.2 4,661 0.35 (21 minutes)......... 1,631
803.32.
User Facility Annual Reporting-- 3,419 93 2 186 1......................... 186
803.33.
Importer Reporting, Death and .............. 112 440.25 49,308 0.10 (6 minutes).......... 4,931
Serious Injury--803.40 and 803.42.
Manufacturer Reporting--803.50, .............. 1,799 809.83 1,456,884 0.10 (6 minutes).......... 145,688
803.52 and 803.53.
Voluntary Malfunction Summary .............. 67 695.15 46,575 0.10 (6 minutes).......... 4,658
Reporting Program.
Supplemental Reports--803.56........ .............. 1,291 438 565,458 0.10 (6 minutes).......... 56,546
---------------------------------------------------------------------------------------------------
Total........................... .............. .............. .............. .............. .......................... 213,722
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Number has been rounded.
The number of respondents to the information collection is based on
MDRs received by FDA recently. The annual frequency per response and
total annual responses shown are based on the number of MDRs reported
during the same period. Based on the scope and conditions of the VMSRP
and our experience with MDR reporting, FDA estimates that approximately
10 percent of malfunction reports would continue to be submitted as
individual reports. Approximately 62 percent of the manufacturer
reports received under Sec. Sec. 803.50, 803.52 and 803.53 are
malfunction reports (903,268 of the 1,456,884 total annual responses
received in 2020).
Supplemental Reports--Sec. 803.56. We have increased our estimate,
of the number of supplemental reports to reflect a corresponding
increase of annual submissions, as reflected in table 1, row 7.
Voluntary Malfunction Summary Reporting Program. The VMSRP includes
the same respondent pool as individual manufacturer reporting. Based on
a current review of Agency data, we have increased our estimate to
[[Page 40595]]
reflect an increase in annual submissions, as reflected in table 1, row
6.
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
----------------------------------------------------------------------------------------------------------------
MDR Procedures--803.17.......... 1,799 1 1,799 3.3 5,937
MDR Files--803.18............... 1,799 1 1,799 1.5 2,699
---------------------------------------------------------------
Total....................... .............. .............. .............. .............. 8,636
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The number of respondents in table 2 is based on the MDRs reported
to FDA's internal databases recently. We believe that the majority of
respondents (manufacturers, user facilities, and importers) have
already established written procedures and MDR files to document
complaints and information to meet the MDR requirements as part of
their internal quality control system.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR section Number of disclosures per Total annual Average burden per disclosure Total hours \2\
respondents respondent disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Importer Reporting, Death and Serious Injury-- 112 25 2,800 0.35 (21 minutes)................... 980
803.40 and 803.42.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Number has been rounded.
The number of respondents for each CFR section in table 3 was
identified from the MDRs reported to FDA's internal databases during
the period recently.
Since the publication of the 60 day notice we have adjusted our
burden estimate. Our estimated burden for the information collection
reflects an increase of 155,360 total burden hours and a corresponding
increase of 1,566,458 total annual responses. This increase corresponds
with data obtained from our database.
Dated: July 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16034 Filed 7-27-21; 8:45 am]
BILLING CODE 4164-01-P
