Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Reporting: Manufacturer Reporting, Importer Reporting, User Facility Reporting, and Distributor Reporting, 76318-76319 [E5-7726]
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76318
Federal Register / Vol. 70, No. 246 / Friday, December 23, 2005 / Notices
(Catalog of Federal Domestic Assistance
Program No. 93.733, Medicare—Hospital
Insurance Program; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: December 16, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. E5–7757 Filed 12–22–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0484]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Device
Reporting: Manufacturer Reporting,
Importer Reporting, User Facility
Reporting, 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: Manufacturer
Reporting, Importer Reporting, User
Facility Reporting, and Distributor
Reporting.
Submit written or electronic
comments on the collection of
information by February 21, 2006.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. 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:
Denver Presley, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1472.
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
DATES:
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
of automated collection techniques,
when appropriate, and other forms of
information technology.
Medical Device Reporting:
Manufacturer Reporting, Importer
Reporting, User Facility Reporting, and
Distributor Reporting—21 CFR Part 803
(OMB Control Number 0910–0437)
Section 519(a), (b), and (c) of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360i(a), (b), and (c))
requires user facilities, manufacturers,
and importers of medical devices to
report adverse events involving medical
devices to FDA. On December 11, 1995
(60 FR 63578 at 63597), FDA issued part
803 (21 CFR part 803) that implemented
section 519 of the act. The regulation
was amended to conform to the changes
reflected in the FDA Modernization Act
of 1997.
Information from these reports will be
used to evaluate risks associated with
medical devices and to enable FDA to
take appropriate regulatory measures to
protect the public health.
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
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
55
4
220
3
660
803.30
700
5
3,500
1
3,500
803.33, FDA Form 3419
700
1
700
1
700
803.40
40
17
680
1
680
803.50
wwhite on PROD1PC61 with NOTICES
803.19
1,465
57
83,505
1
83,505
700
5
3,500
1
3,500
803.55, FDA Form 3417
Total
1 There
92,545
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 70, No. 246 / Friday, December 23, 2005 / Notices
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR Section
No. of
Recordkeepers
803.17
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Record
Total Hours
220
220
3.3
726
30,000
803.18(c) and (d)
1
1
30,000
1.5
45,000
Total
wwhite on PROD1PC61 with NOTICES
1 There
45,726
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 the case of a death, incidents
where a medical device caused or
contributed to a death or serious injury.
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
medical device reporting (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
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16:55 Dec 22, 2005
Jkt 208001
revise existing procedures, in order to
comply with this provision.
Therefore, FDA estimates the onetime burden to respondents for
establishing or revising procedures 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).
The annual burden for recordkeeping
to respondents follows. Under § 803.17,
FDA estimates 220 respondents will
spend approximately 3.3 hours to
complete the requirements for this
section. The number of respondents was
estimated by consolidating the total of
all new reporting entities together. The
3.3 hours was estimated by FDA, as this
section deals with a respondent creating
new MDR procedures and is a one-time
function. The ‘‘total hours’’ for this
section equals approximately 726 hours.
Under § 803.18, 30,000 respondents
represent distributors, importers, and
other respondents to this information
collection. FDA estimates that it should
take them approximately 11⁄2 hours to
complete the recordkeeping requirement
for this section. Total hours for this
section equal 45,000 hours.
Dated: December 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5–7726 Filed 12–22–05; 8:45 am]
BILLING CODE 4160–01–S
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[USCG–2005–23285]
Collection of Information Under
Review by Office of Management and
Budget: OMB Control Number 1625–
0048
Coast Guard, DHS.
Request for comments.
AGENCY:
ACTION:
SUMMARY: In compliance with the
Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to seek the
approval of OMB for the renewal of an
Information Collection Request (ICR).
The ICR is 1625–0048, Vessel Reporting
Requirements. Before submitting the
ICRs to OMB, the Coast Guard is
inviting comments on them as described
below.
DATES: Comments must reach the Coast
Guard on or before February 21, 2006.
ADDRESSES: To make sure that your
comments and related material do not
enter the docket [USCG–2005–23285]
more than once, please submit them by
only one of the following means:
(1) By mail to the Docket Management
Facility, U.S. Department of
Transportation (DOT), room PL–401,
400 Seventh Street SW., Washington,
DC 20590–0001.
(2) By delivery to room PL–401 on the
Plaza level of the Nassif Building, 400
Seventh Street SW., Washington, DC,
between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
The telephone number is 202–366–
9329.
(3) By fax to the Docket Management
Facility at 202–493–2251.
(4) Electronically through the Web
Site for the Docket Management System
at https://dms.dot.gov.
The Docket Management Facility
maintains the public docket for this
notice. Comments and material received
from the public, as well as documents
mentioned in this notice as being
available in the docket, will become part
of this docket and will be available for
inspection or copying at room PL–401
E:\FR\FM\23DEN1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 246 (Friday, December 23, 2005)]
[Notices]
[Pages 76318-76319]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-7726]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0484]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Reporting: Manufacturer Reporting,
Importer Reporting, User Facility Reporting, 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:
Manufacturer Reporting, Importer Reporting, User Facility Reporting,
and Distributor Reporting.
DATES: Submit written or electronic comments on the collection of
information by February 21, 2006.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments. 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: Denver Presley, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1472.
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 of automated collection techniques, when
appropriate, and other forms of information technology.
Medical Device Reporting: Manufacturer Reporting, Importer Reporting,
User Facility Reporting, and Distributor Reporting--21 CFR Part 803
(OMB Control Number 0910-0437)
Section 519(a), (b), and (c) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 360i(a), (b), and (c)) requires user
facilities, manufacturers, and importers of medical devices to report
adverse events involving medical devices to FDA. On December 11, 1995
(60 FR 63578 at 63597), FDA issued part 803 (21 CFR part 803) that
implemented section 519 of the act. The regulation was amended to
conform to the changes reflected in the FDA Modernization Act of 1997.
Information from these reports will be used to evaluate risks
associated with medical devices and to enable FDA to take appropriate
regulatory measures to protect the public health.
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\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
803.19 55 4 220 3 660
--------------------------------------
--------------------------------------
--------------------------------------
---------------------------------------------------------
--------------------------------------
--------------------------------------
Total 92,545
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 76319]]
Table 2.--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
----------------------------------------------------------------------------------------------------------------
803.17 220 1 220 3.3 726
---------------====================
-----------------------------------
Total 45,726
----------------------------------------------------------------------------------------------------------------
\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 the case of a death, incidents where a
medical device caused or contributed to a death or serious injury.
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 medical device
reporting (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 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).
The annual burden for recordkeeping to respondents follows. Under
Sec. 803.17, FDA estimates 220 respondents will spend approximately
3.3 hours to complete the requirements for this section. The number of
respondents was estimated by consolidating the total of all new
reporting entities together. The 3.3 hours was estimated by FDA, as
this section deals with a respondent creating new MDR procedures and is
a one-time function. The ``total hours'' for this section equals
approximately 726 hours.
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\1/2\ hours to
complete the recordkeeping requirement for this section. Total hours
for this section equal 45,000 hours.
Dated: December 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5-7726 Filed 12-22-05; 8:45 am]
BILLING CODE 4160-01-S
