Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Reporting: Manufacturer, Importer, User Facility, and Distributor Reporting, 33746-33748 [2012-13832]
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Federal Register / Vol. 77, No. 110 / Thursday, June 7, 2012 / Notices
year. The NEW program report provides
information on the activities and
accomplishments of grantees’ NEW
programs. The NEW program report and
instructions specify the program data
that NEW grantees report annually.
Respondents
Federally recognized Indian Tribes
and Tribal organizations that are NEW
program grantees.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
NEW program plan guidance ..........................................................................
NEW program report .......................................................................................
srobinson on DSK4SPTVN1PROD with NOTICES
Estimated Total Annual Burden
Hours: 1,474.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012–13812 Filed 6–6–12; 8:45 am]
BILLING CODE 4184–01–P
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26
48
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0110]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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
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: Fax written comments on the
collection of information by July 9,
2012.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0437. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1
1
Average
burden hours
per response
29
15
Total burden
hours
754
720
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
E:\FR\FM\07JNN1.SGM
07JNN1
srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 110 / Thursday, June 7, 2012 / Notices
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.
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 § 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
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17:48 Jun 06, 2012
Jkt 226001
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
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.
In the Federal Register of February
14, 2012 (77 FR 8260), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
Subsequent to publication of the 60day notice, FDA performed an
additional inspection of the data and
consulted with the MDR program staff.
Per this extra review, FDA has updated
the estimated burden hours to more
accurately reflect the burden.
Reporting Requirements
21 CFR 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
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
33747
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 21 CFR 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
21 CFR 803.18(d). We estimate that it
will take 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 21 CFR 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 21 CFR 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:
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07JNN1
33748
Federal Register / Vol. 77, No. 110 / Thursday, June 7, 2012 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Annual
frequency of
response
Number of
respondents
Total
annual
responses
Hours per
response
Total
hours
CFR Section
FDA Form No.
Exemptions—803.19 ................................
User Facility Reporting—803.30 and
803.32 ...................................................
User Facility Annual Reporting—803.33
........................
57
4
228
3
684
........................
FDA Form
3419
544
195
9
1
4,896
195
1
1
4,896
195
Importer Reporting, Death and Serious
Injury—803.40 and 803.42 ...................
Manufacturer
Reporting—803.50,
through 803.53 .....................................
Supplemental Reports—803.56 ...............
........................
1
1
1
1
1
........................
........................
1,239
124
243
302
301,077
37,448
1
1
301,077
37,448
Total ..................................................
........................
........................
........................
........................
........................
344,301
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN
Number of
recordkeepers
Annual
frequency of
recordkeeping
Total
annual records
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
21 CFR Section
Hours per
recordkeeper
Total
hours
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN
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
Dated: June 1, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–13832 Filed 6–6–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0178]
International Conference on
Harmonisation; Guidance on S2(R1)
Genotoxicity Testing and Data
Interpretation for Pharmaceuticals
Intended for Human Use; Availability
AGENCY:
Food and Drug Administration,
HHS.
srobinson on DSK4SPTVN1PROD with NOTICES
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance entitled
‘‘S2(R1) Genotoxicity Testing and Data
Interpretation for Pharmaceuticals
Intended for Human Use’’ (ICH S2(R1)).
This guidance was prepared under the
auspices of the International Conference
SUMMARY:
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17:48 Jun 06, 2012
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on Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use (ICH).
The ICH S2(R1) combines and replaces
two ICH guidances, ‘‘S2A Specific
Aspects for Regulatory Genotoxicity
Tests for Pharmaceuticals’’ and ‘‘S2B
Genotoxicity: A Standard Battery for
Genotoxicity Testing of
Pharmaceuticals.’’ ICH S2(R1) provides
guidance to drug sponsors on which
tests should be performed to assess
potential genotoxicity of
pharmaceuticals. It also provides
guidance on testing conditions, data
interpretation, and followup strategies if
a positive response is seen in in vitro
assays. This guidance is intended to
provide drug sponsors with
recommendations to ensure that drugs
are appropriately tested for potential to
cause genetic damage and to ensure
efficient development of new drugs.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002, or the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
the office in processing your requests.
The guidance may also be obtained by
mail by calling CBER at 1–800–835–
4709 or 301–827–1800. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
Submit electronic comments on the
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:
Regarding the Guidance
David Jacobson-Kram, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6488,
E:\FR\FM\07JNN1.SGM
07JNN1
]]>Agencies
[Federal Register Volume 77, Number 110 (Thursday, June 7, 2012)]
[Notices]
[Pages 33746-33748]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-13832]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0110]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 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: Fax written comments on the collection of information by July 9,
2012.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0437.
Also include the FDA 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: 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: 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
[[Page 33747]]
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.
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 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.
In the Federal Register of February 14, 2012 (77 FR 8260), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
Subsequent to publication of the 60-day notice, FDA performed an
additional inspection of the data and consulted with the MDR program
staff. Per this extra review, FDA has updated the estimated burden
hours to more accurately reflect the burden.
Reporting Requirements
21 CFR 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 21 CFR 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 21 CFR
803.18(d). We estimate that it will take 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 21 CFR
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 21 CFR 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:
[[Page 33748]]
Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
CFR Section FDA Form No. Number of frequency of Total annual Hours per Total hours
respondents response 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.................. FDA Form 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 2--Estimated Annual Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section Number of frequency of Total annual Hours per Total hours
recordkeepers recordkeeping records recordkeeper
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Table 3--Estimated Annual Third-Party Disclosure Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: June 1, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-13832 Filed 6-6-12; 8:45 am]
BILLING CODE 4160-01-P
