Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Reporting: Manufacturer, Importer, User Facility, and Distributor Reporting, 26278-26280 [2015-10995]
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26278
Federal Register / Vol. 80, No. 88 / Thursday, May 7, 2015 / Notices
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the
human drug product OSENI (alogliptin
benzoate and pioglitazone
hydrochloride). OSENI is indicated as
an adjunct to diet and exercise to
improve glycemic control in adults with
type 2 diabetes mellitus. Subsequent to
this approval, the USPTO received a
patent term restoration application for
OSENI (U.S. Patent No. 6,329,404) from
Takeda Pharmaceutical Company
Limited, and the USPTO requested
FDA’s assistance in determining this
patent’s eligibility for patent term
restoration. In a letter dated May 2,
2014, FDA advised the USPTO that this
human drug product had undergone a
regulatory review period and that the
approval of OSENI represented the first
permitted commercial marketing or use
of the product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
FDA has determined that the
applicable regulatory review period for
OSENI is 2,482 days. Of this time, 895
days occurred during the testing phase
of the regulatory review period, while
1,587 days occurred during the approval
phase. These periods of time were
derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 355(i)) became effective: April
12, 2006. The applicant claims April 13,
2006, as the date the investigational new
drug application (IND) became effective.
However, FDA records indicate that the
IND effective date was April 12, 2006,
which was 30 days after FDA receipt of
the IND.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: September 22,
2008. FDA has verified the applicant’s
claim that the new drug application
(NDA) for OSENI (NDA 22–426) was
submitted on September 22, 2008.
3. The date the application was
approved: January 25, 2013. FDA has
verified the applicant’s claim that NDA
22–426 was approved on January 25,
2013.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,826 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
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18:07 May 06, 2015
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Management (see ADDRESSES) either
electronic or written comments and ask
for a redetermination by July 6, 2015.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
November 3, 2015. To meet its burden,
the petition must contain sufficient facts
to merit an FDA investigation. (See H.
Rept. 857, part 1, 98th Cong., 2d sess.,
pp. 41–42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments and written or electronic
petitions. It is only necessary to send
one set of comments. Identify comments
with the docket number found in
brackets in the heading of this
document. If you submit a written
petition, two copies are required. A
petition submitted electronically must
be submitted to https://
www.regulations.gov, Docket No. FDA–
2013–S–0610.
Comments and petitions that have not
been made publicly available on
https://www.regulations.gov may be
viewed in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: May 1, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–11002 Filed 5–6–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0110]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Device
Reporting: Manufacturer, Importer,
User Facility, and Distributor Reporting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
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
SUMMARY:
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Sfmt 4703
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
medical device reporting (MDR);
manufacturer, importer, user facility,
and distributor reporting.
DATES: Submit either electronic or
written comments on the collection of
information by July 6, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), 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
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Federal Register / Vol. 80, No. 88 / Thursday, May 7, 2015 / Notices
of automated collection techniques,
when appropriate, and other forms of
information technology.
mstockstill on DSK4VPTVN1PROD with NOTICES
Medical Device Reporting:
Manufacturer, Importer, User Facility,
and Distributor Reporting (21 CFR part
803) OMB Control Number 0910–
0437—Extension
Section 519(a)(1) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360i(a)(1)) requires every
manufacturer or importer to report
whenever the manufacturer or importer
receives or otherwise becomes aware of
information that reasonably suggests
that one of its marketed devices may
have caused or contributed to a death or
serious injury or has malfunctioned and
that such device or a similar device
marketed by the manufacturer or
importer would be likely to cause or
contribute to a death or serious injury if
the malfunction were to recur.
Section 519(b)(1)(A) of the FD&C Act
requires whenever a device user facility
receives or otherwise becomes aware of
information that reasonably suggests
that a device has or may have caused or
contributed to the death or serious
illness, of a patient of the facility, the
facility shall, as soon as practicable but
not later than 10 working days after
becoming aware of the information,
report the information to the Secretary
of HHS and, if the identity of the
manufacturer is known, to the
manufacturer of the device.
Section 519(b)(1)(B) of the FD&C Act
requires whenever a device user facility
receives or otherwise becomes aware of
information that reasonably suggests
that a device has or may have caused or
contributed to the serious illness of, or
serious injury to, a patient of the
facility, shall, as soon as practicable but
not later than 10 working days after
becoming aware of the information,
report the information to the
manufacturer of the device or to the
Secretary of HHS if the identity of the
manufacturer is not known.
Complete, accurate, and timely
adverse event information is necessary
for the identification of emerging device
problems. Information from these
reports will be used to evaluate risks
associated with medical devices which
will enable FDA to take appropriate
regulatory measures in protection of the
public health under section 519 of the
FD&C Act. Thus FDA is requesting
approval for these information
collection requirements which are being
implemented under part 803.
Respondents to this collection of
information are businesses or other forprofit and nonprofit organizations
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18:07 May 06, 2015
Jkt 235001
including user facilities, manufacturers,
and importers of medical devices.
Part 803 requires user facilities to
report to the device manufacturer and to
FDA in case of a death, incidents where
a medical device caused or contributed
to a death or serious injury.
Additionally, user facilities are required
to annually submit the number and
summary of advents reported during the
calendar year using Form FDA 3419.
Manufacturers of medical devices are
required to report to FDA when they
become aware of information indicating
that one of their devices may have
caused or contributed to death or
serious injury or has malfunctioned in
such a way, that should the malfunction
recur, it would be likely to cause or
contribute to a death or serious injury.
Device importers report deaths and
serious injuries to the manufacturers
and FDA. Importers report malfunctions
only to the manufacturers, unless they
are unknown, then the reports are sent
to FDA.
The number of respondents for each
CFR section in table 1 is based upon the
number of respondents entered into
FDA’s internal databases. FDA
estimates, based on its experience and
interaction with the medical device
community, that all reporting CFR
sections are expected to take 1 hour to
complete, with the exception of
§ 803.19. Section 803.19 is expected to
take approximately 3 hours to complete,
but is only required for reporting the
summarized data quarterly to FDA. By
summarizing events, the total time used
to report for this section is reduced
because the respondents do not submit
a full report for each event they report
in a quarterly summary report.
The Agency believes that the majority
of manufacturers, user facilities, and
importers have already established
written procedures to document
complaints and information to meet the
MDR requirements as part of their
internal quality control system. There
are an estimated 30,000 medical device
distributors. Although they do not
submit MDR reports, they must
maintain records of complaints under
§ 803.18(d).
The Agency has estimated that on
average 220 user facilities, importers,
and manufacturers would annually be
required to establish new procedures, or
revise existing procedures, in order to
comply with this provision.
Therefore, FDA estimates the onetime burden to respondents for
establishing or revising procedures
under § 803.17 to be 2,200 hours (220
respondents × 10 hours). For those
entities, a one-time burden of 10 hours
is estimated for establishing written
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26279
MDR procedures. The remaining
manufacturers, user facilities, and
importers, not required to revise their
written procedures to comply with this
provision, are excluded from the burden
because the recordkeeping activities
needed to comply with this provision
are considered ‘‘usual and customary’’
under 5 CFR 1320.3(b)(2).
Under § 803.18, 30,000 respondents
represent distributors, importers, and
other respondents to this information
collection. FDA estimates that it should
take them approximately 1.5 hours to
complete the recordkeeping requirement
for this section. Total hours for this
section equal 45,000 hours.
Reporting Requirements
Part 803 requires user facilities to
report incidents where a medical device
caused or contributed a death or serious
injury to the device manufacturer and to
FDA in the case of a death.
Manufacturers of medical devices are
required to report to FDA when they
become aware of information indicating
that one of their devices may have
caused or contributed to death or
serious injury or has malfunctioned in
such a way that, should the malfunction
recur, it would be likely to cause or
contribute to a death or serious injury.
Device importers report deaths and
serious injuries to the manufacturers
and FDA. Importers report malfunctions
only to the manufacturers (see thirdparty disclosure burden table), unless
the manufacturers are unknown, then
the reports are sent to FDA.
FDA estimates, based on its
experience and interaction with the
medical device community, that all
reporting CFR sections are expected to
take 1 hour to complete with the
exception of § 803.19. Section 803.19 is
expected to take approximately 3 hours
to complete, but is only required to
report the summarized data quarterly to
FDA. By summarizing events, the total
time used to report for this section is
reduced because the respondents do not
submit a full report for each event they
report in a quarterly summary report.
Recordkeeping Requirements
The Agency believes that the majority
of manufacturers, user facilities, and
importers have already established
written procedures to document
complaints and information to meet the
MDR requirements as part of their
internal quality control system. There
are an estimated 30,000 medical device
distributors. Although they do not
submit MDR reports, they must
maintain records of complaints under
§ 803.18(d). We estimate that it will take
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07MYN1
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Federal Register / Vol. 80, No. 88 / Thursday, May 7, 2015 / Notices
each respondent 1.5 hours annually to
maintain the records.
The Agency has estimated that on
average, 220 user facilities, importers,
and manufacturers would annually be
required, under § 803.17, to establish
new procedures, or revise existing
procedures, in order to comply with this
provision. We estimate that it will take
each respondent 10 hours annually to
establish new procedures, or revise
existing procedures.
Importers report malfunctions only to
the manufacturers, unless they are
unknown, then the reports are sent to
FDA. We estimate that it will take
respondents 1 hour annually to report
the information.
FDA estimates the burden of this
collection of information as follows:
Third-Party Disclosure Burden
Under §§ 803.40 and 803.42, device
importers report deaths and serious
injuries to the manufacturers and FDA.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
Total annual
responses
CFR section
FDA form No.
Exemptions—803.19 ................................
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,
through 803.53 .....................................
Supplemental Reports—803.56 ...............
........................
57
4
228
3
684
........................
3419
544
195
9
1
4,896
195
1
1
4,896
195
........................
1
1
1
1
1
........................
........................
1,239
124
243
302
301,077
37,448
1
1
301,077
37,448
Total ..................................................
........................
........................
........................
........................
........................
344,301
1 There
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
records per
recordkeeper
Number of
recordkeepers
21 CFR section
Average
burden per
record
Total annual
records
Total hours
MDR Procedures—803.17 .................................................
MDR Files—803.18 ............................................................
220
30,000
1
1
220
30,000
10
1.5
2,200
45,000
Total ............................................................................
........................
........................
........................
..........................
47,200
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
21 CFR section
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Importer Reporting, Malfunctions—803.40 and 803.42 .......
1
25
25
1
25
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–10995 Filed 5–6–15; 8:45 am]
mstockstill on DSK4VPTVN1PROD with NOTICES
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Joint Meeting of the Bone,
Reproductive, and Urologic Drugs
Advisory Committee, and the Drug
Safety and Risk Management Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of two public advisory
committees of the Food and Drug
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18:57 May 06, 2015
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Administration (FDA). The meeting will
be open to the public.
Name of Committees: Bone,
Reproductive, and Urologic Drugs
Advisory Committee, and the Drug
Safety and Risk Management Advisory
Committee.
General Function of the Committees:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on June 4, 2015, from 8 a.m. to 5
p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
E:\FR\FM\07MYN1.SGM
07MYN1
]]>Agencies
[Federal Register Volume 80, Number 88 (Thursday, May 7, 2015)]
[Notices]
[Pages 26278-26280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10995]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0110]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Reporting: Manufacturer, Importer, User
Facility, and Distributor Reporting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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 medical device reporting
(MDR); manufacturer, importer, user facility, and distributor
reporting.
DATES: Submit either electronic or written comments on the collection
of information by July 6, 2015.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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
[[Page 26279]]
of automated collection techniques, when appropriate, and other forms
of information technology.
Medical Device Reporting: Manufacturer, Importer, User Facility, and
Distributor Reporting (21 CFR part 803) OMB Control Number 0910-0437--
Extension
Section 519(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360i(a)(1)) requires every manufacturer or importer to
report whenever the manufacturer or importer receives or otherwise
becomes aware of information that reasonably suggests that one of its
marketed devices may have caused or contributed to a death or serious
injury or has malfunctioned and that such device or a similar device
marketed by the manufacturer or importer would be likely to cause or
contribute to a death or serious injury if the malfunction were to
recur.
Section 519(b)(1)(A) of the FD&C Act requires whenever a device
user facility receives or otherwise becomes aware of information that
reasonably suggests that a device has or may have caused or contributed
to the death or serious illness, of a patient of the facility, the
facility shall, as soon as practicable but not later than 10 working
days after becoming aware of the information, report the information to
the Secretary of HHS and, if the identity of the manufacturer is known,
to the manufacturer of the device.
Section 519(b)(1)(B) of the FD&C Act requires whenever a device
user facility receives or otherwise becomes aware of information that
reasonably suggests that a device has or may have caused or contributed
to the serious illness of, or serious injury to, a patient of the
facility, shall, as soon as practicable but not later than 10 working
days after becoming aware of the information, report the information to
the manufacturer of the device or to the Secretary of HHS if the
identity of the manufacturer is not known.
Complete, accurate, and timely adverse event information is
necessary for the identification of emerging device problems.
Information from these reports will be used to evaluate risks
associated with medical devices which will enable FDA to take
appropriate regulatory measures in protection of the public health
under section 519 of the FD&C Act. Thus FDA is requesting approval for
these information collection requirements which are being implemented
under part 803.
Respondents to this collection of information are businesses or
other for-profit and nonprofit organizations including user facilities,
manufacturers, and importers of medical devices.
Part 803 requires user facilities to report to the device
manufacturer and to FDA in case of a death, incidents where a medical
device caused or contributed to a death or serious injury.
Additionally, user facilities are required to annually submit the
number and summary of advents reported during the calendar year using
Form FDA 3419. Manufacturers of medical devices are required to report
to FDA when they become aware of information indicating that one of
their devices may have caused or contributed to death or serious injury
or has malfunctioned in such a way, that should the malfunction recur,
it would be likely to cause or contribute to a death or serious injury.
Device importers report deaths and serious injuries to the
manufacturers and FDA. Importers report malfunctions only to the
manufacturers, unless they are unknown, then the reports are sent to
FDA.
The number of respondents for each CFR section in table 1 is based
upon the number of respondents entered into FDA's internal databases.
FDA estimates, based on its experience and interaction with the medical
device community, that all reporting CFR sections are expected to take
1 hour to complete, with the exception of Sec. 803.19. Section 803.19
is expected to take approximately 3 hours to complete, but is only
required for reporting the summarized data quarterly to FDA. By
summarizing events, the total time used to report for this section is
reduced because the respondents do not submit a full report for each
event they report in a quarterly summary report.
The Agency believes that the majority of manufacturers, user
facilities, and importers have already established written procedures
to document complaints and information to meet the MDR requirements as
part of their internal quality control system. There are an estimated
30,000 medical device distributors. Although they do not submit MDR
reports, they must maintain records of complaints under Sec.
803.18(d).
The Agency has estimated that on average 220 user facilities,
importers, and manufacturers would annually be required to establish
new procedures, or revise existing procedures, in order to comply with
this provision.
Therefore, FDA estimates the one-time burden to respondents for
establishing or revising procedures under Sec. 803.17 to be 2,200
hours (220 respondents x 10 hours). For those entities, a one-time
burden of 10 hours is estimated for establishing written MDR
procedures. The remaining manufacturers, user facilities, and
importers, not required to revise their written procedures to comply
with this provision, are excluded from the burden because the
recordkeeping activities needed to comply with this provision are
considered ``usual and customary'' under 5 CFR 1320.3(b)(2).
Under Sec. 803.18, 30,000 respondents represent distributors,
importers, and other respondents to this information collection. FDA
estimates that it should take them approximately 1.5 hours to complete
the recordkeeping requirement for this section. Total hours for this
section equal 45,000 hours.
Reporting Requirements
Part 803 requires user facilities to report incidents where a
medical device caused or contributed a death or serious injury to the
device manufacturer and to FDA in the case of a death. Manufacturers of
medical devices are required to report to FDA when they become aware of
information indicating that one of their devices may have caused or
contributed to death or serious injury or has malfunctioned in such a
way that, should the malfunction recur, it would be likely to cause or
contribute to a death or serious injury. Device importers report deaths
and serious injuries to the manufacturers and FDA. Importers report
malfunctions only to the manufacturers (see third-party disclosure
burden table), unless the manufacturers are unknown, then the reports
are sent to FDA.
FDA estimates, based on its experience and interaction with the
medical device community, that all reporting CFR sections are expected
to take 1 hour to complete with the exception of Sec. 803.19. Section
803.19 is expected to take approximately 3 hours to complete, but is
only required to report the summarized data quarterly to FDA. By
summarizing events, the total time used to report for this section is
reduced because the respondents do not submit a full report for each
event they report in a quarterly summary report.
Recordkeeping Requirements
The Agency believes that the majority of manufacturers, user
facilities, and importers have already established written procedures
to document complaints and information to meet the MDR requirements as
part of their internal quality control system. There are an estimated
30,000 medical device distributors. Although they do not submit MDR
reports, they must maintain records of complaints under Sec.
803.18(d). We estimate that it will take
[[Page 26280]]
each respondent 1.5 hours annually to maintain the records.
The Agency has estimated that on average, 220 user facilities,
importers, and manufacturers would annually be required, under Sec.
803.17, to establish new procedures, or revise existing procedures, in
order to comply with this provision. We estimate that it will take each
respondent 10 hours annually to establish new procedures, or revise
existing procedures.
Third-Party Disclosure Burden
Under Sec. Sec. 803.40 and 803.42, device importers report deaths
and serious injuries to the manufacturers and FDA. Importers report
malfunctions only to the manufacturers, unless they are unknown, then
the reports are sent to FDA. We estimate that it will take respondents
1 hour annually to report the information.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average
CFR section FDA form No. Number of responses per Total annual burden per Total hours
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exemptions--803.19...................................... .............. 57 4 228 3 684
User Facility Reporting--803.30 and 803.32.............. .............. 544 9 4,896 1 4,896
User Facility Annual Reporting--803.33.................. 3419 195 1 195 1 195
Importer Reporting, Death and Serious Injury--803.40 and .............. 1 1 1 1 1
803.42.................................................
Manufacturer Reporting--803.50, through 803.53.......... .............. 1,239 243 301,077 1 301,077
Supplemental Reports--803.56............................ .............. 124 302 37,448 1 37,448
-----------------------------------------------------------------------------------------------
Total............................................... .............. .............. .............. .............. .............. 344,301
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
21 CFR section Number of records per Total annual Average burden Total hours
recordkeepers recordkeeper records per record
----------------------------------------------------------------------------------------------------------------
MDR Procedures--803.17......... 220 1 220 10 2,200
MDR Files--803.18.............. 30,000 1 30,000 1.5 45,000
--------------------------------------------------------------------------------
Total...................... .............. .............. .............. ............... 47,200
----------------------------------------------------------------------------------------------------------------
\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
21 CFR section Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Importer Reporting, Malfunctions--803.40 and 803.42................ 1 25 25 1 25
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-10995 Filed 5-6-15; 8:45 am]
BILLING CODE 4164-01-P
