Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Reporting: Manufacturer, Importer, User Facility, and Distributor Reporting, 8547-8549 [E9-4057]
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8547
Federal Register / Vol. 74, No. 36 / Wednesday, February 25, 2009 / Notices
431,148. (For policy questions regarding
this collection contact: Christine
Dobrzycki at 410–786–3389. For all
other issues call 410–786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web Site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office at (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on March 27, 2009.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS Desk
Officer, New Executive Office Building,
Room 10235, Washington, DC 20503,
Fax Number: (202) 395–6974.
Dated: February 12, 2009.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E9–3937 Filed 2–24–09; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Child Care Quarterly Case
Record Report—ACF–801.
OMB No.: 0970–0167.
Description: Section 658K of the Child
Care and Development Block Grant Act
of 1990 (Pub. L. 101–508, 42 U.S.C.
9858) requires that States and
Territories submit monthly case-level
data on the children and families
receiving direct services under the Child
Care and Development Fund. The
implementing regulations for the
statutorily required reporting are at 45
CFR 98.70. Case level reports, submitted
quarterly or monthly (at grantee option),
include monthly sample or full
population case level data. The data
elements to be included in these reports
are represented in the ACF–801. ACF
uses disaggregate data to determine
program and participant characteristics
as well as costs and levels of child care
services provided. This provides ACF
with the information necessary to make
reports to Congress, address national
child care needs, offer technical
assistance to grantees, meet performance
measures, and conduct research.
Consistent with the statute and
regulations, ACF requests extension of
the ACF–801. With this extension, ACF
is proposing several changes and
clarifications to the reporting
requirements and instructions.
Respondents: States, the District of
Columbia, and Territories including
Puerto Rico, Guam, the Virgin Islands,
American Samoa, and the Northern
Mariana Islands.
ANNUAL BURDEN ESTIMATES
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ACF–801 ..........................................................................................
Estimated Total Annual Burden
Hours: 4,480
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Administration, Office of Information
Services, 370 L’Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. E-mail address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
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Jkt 217001
Number of
responses per
respondent
Number of
respondents
Instrument
56
Dated: February 17, 2009.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E9–3834 Filed 2–24–09; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0075]
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
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
Average
burden hours
per response
4
Total burden
hours
20
4,480
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 written or electronic
comments on the collection of
information by April 27, 2009.
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:
Denver Presley, Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
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8548
Federal Register / Vol. 74, No. 36 / Wednesday, February 25, 2009 / Notices
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)
SUPPLEMENTARY INFORMATION:
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 (the 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 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 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 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
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 BURDEN1
21 CFR Section
FDA Form No.
No. of
Respondents
803.19
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
57
4
228
3.0
684
393
2
777
1.0
777
393
1
393
1
393
803.40 and .42
73
37
2,682
1.0
2,682
803.50 and .52
1,601
104
166,271
1.0
166,271
803.56
1,200
63
76,186
1.0
76,186
803.30 and .32
803.33
3419
Total
1 There
246,537
246,993
are no capital or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN
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21 CFR Section
No. of
Recordkeepers
803.17
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Record
220
1
220
10
2,200
30,000
803.18 (a) through (d)
1
30,000
1.5
45,000
Total
1 There
Total Hours
47,200
are no capital or operating and maintenance costs associated with this collection of information.
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18:09 Feb 24, 2009
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Federal Register / Vol. 74, No. 36 / Wednesday, February 25, 2009 / Notices
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 FDA Form 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
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
VerDate Nov<24>2008
18:09 Feb 24, 2009
Jkt 217001
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 19, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–4057 Filed 2–24–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0050]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Importer’s Entry
Notice
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
FDA’s need to collect additional
information in the Importer’s Entry
Notice.
DATES: Submit written or electronic
comments on the collection of
information by April 27, 2009.
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
PO 00000
Frm 00054
Fmt 4703
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8549
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth G. Berbakos, Office of
Information Management (HFA–710),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–796–3792.
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.
Importer’s Entry Notice (OMB Control
Number 0910–0046–Extension)
In order to make an admissibility
decision for each entry, FDA needs four
additional pieces of information that are
not available in the U.S. Customs and
Border Protection’s (CBP’s) data set.
These data elements are the FDA
Product Code, FDA country of
production, FDA manufacturer/shipper,
and ultimate consignee. It is the
‘‘automated’’ collection of these four
data elements for which OMB approval
is requested. FDA construes this request
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]]>Agencies
[Federal Register Volume 74, Number 36 (Wednesday, February 25, 2009)]
[Notices]
[Pages 8547-8549]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-4057]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0075]
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 written or electronic comments on the collection of
information by April 27, 2009.
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: Denver Presley, Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3793.
[[Page 8548]]
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, 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 (the
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 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 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 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 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section FDA Form No. Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.19 ................. 57 4 228 3.0 684
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.30 and .32 ................. 393 2 777 1.0 777
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.33 3419 393 1 393 1 393
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.40 and .42 ................. 73 37 2,682 1.0 2,682
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.50 and .52 ................. 1,601 104 166,271 1.0 166,271
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.56 ................. 1,200 63 76,186 1.0 76,186
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total ................. ................. .................... 246,537 ................. 246,993
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.17 220 1 220 10 2,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.18 (a) through (d) 30,000 1 30,000 1.5 45,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 47,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with this collection of information.
[[Page 8549]]
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
FDA Form 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.
Dated: February 19, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-4057 Filed 2-24-09; 8:45 am]
BILLING CODE 4160-01-S
