Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Reporting: Manufacturer, Importer, User Facility, and Distributor Reporting, 8260-8262 [2012-3344]
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References
EPA. 2009. Endocrine Disruptor Screening
Program Test Guidelines. OPPTS 890.1300:
Estrogen Receptor Transcriptional Activation
(Human Cell Line (HeLa-9903)). Washington,
DC: U.S. Environmental Protection Agency.
Available: https://www.regulations.gov/
#!documentDetail;D=EPA-HQ-OPPT-20090576-0006.
ICCVAM. 2011. ICCVAM Test Method
Evaluation Report: The LUMI–CELL® ER
(BG1Luc ER TA) Test Method: An In Vitro
Assay for Identifying Human Estrogen
Receptor Agonist and Antagonist Activity of
Chemicals. Research Triangle Park, NC:
National Institute of Environmental Health
Sciences. Available: https://
iccvam.niehs.nih.gov/methods/endocrine/
ERTA-TMER.htm.
ICCVAM. 2006. Addendum to ICCVAM
Evaluation of In Vitro Test Methods for
Detecting Potential Endocrine Disruptors.
Research Triangle Park, NC: National
Institute of Environmental Health Sciences.
Available: https://iccvam.niehs.nih.gov/docs/
endo_docs/EDAddendFinal.pdf.
ICCVAM. 2003a. ICCVAM Evaluation of In
Vitro Test Methods For Detecting Potential
Endocrine Disruptors: Estrogen Receptor and
Androgen Receptor Binding and
Transcriptional Activation Assays. NIH
Publication No. 03–4503. Research Triangle
Park, NC: National Institute of Environmental
Health Sciences. Available: https://
iccvam.niehs.nih.gov/methods/endocrine/
end_TMER.htm.
ICCVAM. 2002a. Background Review
Document. Current Status of Test Methods
for Detecting Endocrine Disruptors: In Vitro
Estrogen Receptor Transcriptional Activation
Assays. NIH Publication No. 03–4505.
Research Triangle Park, NC: National
Institute of Environmental Health Sciences.
Available: https://iccvam.niehs.nih.gov/
methods/endocrine/end_bckgnd.htm#ERTA.
ICCVAM. 2002b. Background Review
Document. Current Status of Test Methods
for Detecting Endocrine Disruptors: In Vitro
Androgen Receptor Binding Assays. NIH
Publication No. 03–4506. Research Triangle
Park, NC: National Institute of Environmental
Health Sciences. Available: https://
iccvam.niehs.nih.gov/methods/endocrine/
end_bckgnd.htm#ARBnd.
ICCVAM. 2002c. Background Review
Document: Current Status of Test Methods
for Detecting Endocrine Disruptors: In Vitro
Estrogen Receptor Binding Assays. NIH
Publication No. 03–4504. Research Triangle
Park, NC: National Institute of Environmental
Health Sciences. Available: https://
iccvam.niehs.nih.gov/methods/endocrine/
end_bckgnd.htm#ERBnd.
ICCVAM. 2002d. Background Review
Document. Current Status of Test Methods
for Detecting Endocrine Disruptors: In Vitro
Androgen Receptor Transcriptional
Activation Assays. NIH Publication No. 03–
4507. Research Triangle Park, NC: National
Institute of Environmental Health Sciences.
Available: https://iccvam.niehs.nih.gov/
methods/endocrine/end_bckgnd.htm#ARTA.
ICCVAM. 2002e. Expert Panel Evaluation
of the Validation Status of In Vitro Test
Methods for Detecting Endocrine Disruptors:
Estrogen Receptor and Androgen Receptor
VerDate Mar<15>2010
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Jkt 226001
Binding and Transcriptional Activation
Assays. Expert Panel Final Report. Research
Triangle Park, NC: National Institute of
Environmental Health Sciences. Available:
https://iccvam.niehs.nih.gov/methods/
endocrine/end_EPrpt.htm.
OECD. 2009. Test No 455: The Stably
Transfected Human Estrogen Receptor-alpha
Transcriptional Activation Assay for
Detection of Estrogenic Agonist-Activity of
Chemicals. In: OECD Guidelines for the
Testing of Chemicals, Section 4: Health
Effects. Paris: OECD Publishing. Available:
https://www.oecd-ilibrary.org/environment/
oecd-guidelines-for-the-testing-of-chemicalssection-4-health-effects_20745788.
Rogers JM, Denison MS. 2000.
Recombinant cell bioassays for endocrine
disruptors: Development of a stably
transfected human ovarian cell line for the
detection of estrogenic and anti-estrogenic
chemicals. In Vitro Mol Toxicol 13(1):67–82.
Dated: February 7, 2012.
John R. Bucher,
Associate Director, National Toxicology
Program.
[FR Doc. 2012–3437 Filed 2–13–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier CMS–10421]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Correction
In notice document 2012–2821
appearing on pages 6123–6124 in the
issue of February 7, 2012, make the
following correction:
On page 6124, in the first column, in
the last line, ‘‘April 9, 2012’’ should
read ‘‘April 3, 2012’’.
[FR Doc. C1–2012–2821 Filed 2–13–12; 8:45 am]
BILLING CODE 1505–01–D
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
SUMMARY:
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
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 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 April 16, 2012.
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:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@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
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
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Federal Register / Vol. 77, No. 30 / Tuesday, February 14, 2012 / Notices
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Medical Device 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: (A) May have caused or
contributed to a death or serious injury,
or (B) 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 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: (i) 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 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 (21 CFR
part 803).
Respondents to this collection of
information are businesses or other forprofit and nonprofit organizations
including user facilities, manufacturers,
and importers of medical devices.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section/ form FDA No.
803.19
803.30
803.33
803.40
803.50
803.56
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
..................................................................................
and .32 .....................................................................
Form FDA 3419 .......................................................
and .42 .....................................................................
and .52 .....................................................................
..................................................................................
57
393
393
73
1,601
1,200
4
2
1
37
104
63
228
777
393
2,682
166,271
76,186
3
1
1
1
1
1
684
777
393
2,682
166,271
76,186
Total ..............................................................................
........................
........................
........................
........................
246,993
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
recordkeepers
21 CFR section
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
803.17 ..............................................................
803.18 (c) & (d) ................................................
220
30,000
1
1
220
30,000
10
1.5
2,200
45,000
Total ..........................................................
............................
............................
............................
............................
47,200
mstockstill on DSK4VPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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
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21:57 Feb 13, 2012
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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 of this document
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Sfmt 4703
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
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Federal Register / Vol. 77, No. 30 / Tuesday, February 14, 2012 / Notices
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 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 § 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.
Dated: February 9, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–3344 Filed 2–13–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
[Docket No. FDA–2012–D–0081]
Draft Guidance on Investigational New
Drug Applications for Positron
Emission Tomography Drugs;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Mar<15>2010
21:57 Feb 13, 2012
Jkt 226001
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance entitled
‘‘Investigational New Drug Applications
for Positron Emission Tomography
(PET) Drugs.’’ The draft guidance is
intended to assist manufacturers of PET
drugs in submitting investigational new
drug applications (INDs).
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by May 14, 2012.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave. Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Kyong (Kaye) Kang, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2352,
Silver Spring, MD 20993, 301–796–
2050.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
FDA is announcing the availability of
a draft guidance entitled
‘‘Investigational New Drug Applications
for Positron Emission Tomography
(PET) drugs.’’ The draft guidance
summarizes the IND process for PET
drugs, makes recommendations for how
to submit an IND, provides advice on
expanded access options for
investigational PET drugs, and describes
the process for requesting permission to
charge for an investigational PET drug.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on the submission of INDs for PET
drugs. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
PO 00000
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Fmt 4703
Sfmt 4703
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. 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. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). INDs and
requests to charge for a drug under an
IND are submitted to FDA under part
312 (21 CFR part 312). NDAs and
ANDAs are submitted to FDA under
§§ 314.50 and 314.94 (21 CFR 314.50
and 3.14.94). The collections of
information in part 312 and in §§ 314.50
and 314.94 have been approved under
OMB control numbers 0910–0014,
0910–0653, 0910–0651, and 0910–0001.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: February 8, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–3319 Filed 2–13–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0805]
Dermatologic and Ophthalmic Drugs
Advisory Committee; Amendment of
Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug Administration
(FDA) is announcing an amendment to
the notice of the meeting of the
Dermatologic and Ophthalmic Drugs
E:\FR\FM\14FEN1.SGM
14FEN1
]]>Agencies
[Federal Register Volume 77, Number 30 (Tuesday, February 14, 2012)]
[Notices]
[Pages 8260-8262]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3344]
-----------------------------------------------------------------------
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 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 April 16, 2012.
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: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@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 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
[[Page 8261]]
assumptions used; (3) ways to enhance the quality, utility, and clarity
of the information to be collected; and (4) ways to minimize the burden
of the collection of information on respondents, including through the
use of automated collection techniques, when appropriate, and other
forms of information technology.
Medical Device 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: (A) May have caused or contributed to a death or
serious injury, or (B) 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 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: (i) 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 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 (21 CFR 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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section/ form FDA No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
803.19.......................... 57 4 228 3 684
803.30 and .32.................. 393 2 777 1 777
803.33 Form FDA 3419............ 393 1 393 1 393
803.40 and .42.................. 73 37 2,682 1 2,682
803.50 and .52.................. 1,601 104 166,271 1 166,271
803.56.......................... 1,200 63 76,186 1 76,186
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 246,993
----------------------------------------------------------------------------------------------------------------
\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
21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.17........................................................ 220 1 220 10 2,200
803.18 (c) & (d).............................................. 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.
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 of this
document 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
[[Page 8262]]
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.
Dated: February 9, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-3344 Filed 2-13-12; 8:45 am]
BILLING CODE 4160-01-P
