Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device Tracking, 6729-6731 [E8-2078]
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6729
Federal Register / Vol. 73, No. 24 / Tuesday, February 5, 2008 / Notices
information from students and health
care professionals who are interested in
becoming involved in CDRH activities.
The process will reduce the time and
cost of submitting written
documentation to the agency and lessen
the likelihood of applications being
misrouted within the agency mail
system. It will assist the agency in
promoting and protecting the public
health by encouraging outside persons
to share their expertise with CDRH.
In the Federal Register of November
9, 2007 (72 FR 63614), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimate of the burden for this
collection of information is as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
5 U.S.C. Section/
FDA Form No.
No. of
Respondents
1104, 1302, 3301, 3304, 3320, 3361,
3393, 3394/
Form No. 3608
1 There
250
Dated: January 30, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–2068 Filed 2–4–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2008–N–0048] (formerly
Docket No. 2007N–0182)
Hours per
Response
250
Food and Drug Administration,
HHS.
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Information Program on Clinical Trials
for Serious and Life-Threatening
Diseases: Maintaining a Databank’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
SUPPLEMENTARY INFORMATION: In the
Federal Register of October 19, 2007 (72
FR 59295), the agency announced that
the proposed information collection had
been submitted to OMB for review and
VerDate Aug<31>2005
15:34 Feb 04, 2008
Jkt 214001
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0459. The
approval expires on January 31, 2011. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
BILLING CODE 4160–01–S
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Information Program on Clinical Trials
for Serious and Life-Threatening
Diseases: Maintaining a Databank
rmajette on PROD1PC64 with NOTICES
1
Dated: January 30, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–2076 Filed 2–4–08; 8:45 am]
Food and Drug Administration
ACTION:
Total Annual
Responses
Total Hours
1
250
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA based these estimates on the
number of inquiries that have been
received concerning the program and
the number of requests for application
forms over the past 3 years.
AGENCY:
Annual Frequency
per Response
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0050]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Devices;
Device Tracking
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
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
information collection requirements for
the tracking of medical devices.
DATES: Submit written or electronic
comments on the collection of
information by April 7, 2008.
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 the Chief
Information Officer (HFA–250), Food
and Drug Administration,5600 Fishers
Lane, Rockville, MD 20857, 301 827–
1472.
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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\05FEN1.SGM
05FEN1
6730
Federal Register / Vol. 73, No. 24 / Tuesday, February 5, 2008 / Notices
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 Devices; Device Tracking—21
CFR Part 821 (OMB Control Number
0910–0442)—Extension
Section 211 of the Food and Drug
Administration Modernization Act
(FDAMA) (Public Law 105–115) became
effective on February 19, 1998. FDAMA
amended the previous medical device
tracking provisions under Section
519(e)(1) and (2) of the Federal Food,
Drug, and Cosmetic Act (the act) 21
U.S.C. 360i(e)(1) and (2) and were added
by the Safe Medical Devices Act of 1990
(SMDA) (Public Law 101–629). Unlike
the tracking provisions under SMDA
which required tracking of any medical
device meeting certain criteria, FDAMA
allows FDA discretion in applying
tracking provisions to medical devices
meeting certain criteria, and provides
that tracking requirements for medical
devices can be imposed only after FDA
issues an order. In the Federal Register
of February 8, 2002 (67 FR 5943), FDA
issued a final rule which conformed
existing tracking regulations to changes
in tracking provisions effected by
FDAMA under part 821 (21 CFR part
821).
Section 519(e)(1) of the act, as
amended by FDAMA, provides that
FDA may require by order, that a
manufacturer adopt a method for
tracking a class II or III medical device,
if the device meets one of the three
following criteria: (1) The failure of the
device would be reasonably likely to
have serious adverse health
consequences, (2) the device is intended
to be implanted in the human body for
more than 1 year (referred to as a
‘‘tracked implant’’), or (3) the device is
life-sustaining or life-supporting
(referred to as a ‘‘tracked l/s-l/s device’’)
and is used outside a device user
facility.
Tracked device information is
collected to facilitate identifying the
current location of medical devices and
patients possessing those devices, to the
extent that patients permit the
collection of identifying information.
Manufacturers and FDA (where
necessary), use the data to: (1) Expedite
the recall of distributed medical devices
that are dangerous or defective and (2)
facilitate the timely notification of
patients or licensed practitioners of the
risks associated with the medical
device.
In addition, the regulations include
provisions for: (1) Exemptions and
variances; (2) system and content
requirements for tracking; (3)
obligations of persons other than device
manufacturers, e.g., distributors; records
and inspection requirements; (4)
confidentiality; and (5) record retention
requirements.
Respondents for this collection of
information are medical device
manufacturers, importers, and
distributors of tracked implants or
tracked l/s-l/s devices used outside a
device user facility. Distributors include
multiple and final distributors,
including hospitals.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
Annual Frequency of
Response
Total Annual
Responses
Hours per
Response
Total Hours
821.2 and 821.30(e)
4
1
4
12
48
821.25(a)
1
1
1
76
76
821.25(d)
22
1
22
2
44
17,000
72
1,222,725
0.1666
203,706
1
1
1
28
28
17,000
15
259,186
0.1666
43,180
821.30(a) and (b)
821.30(c)(2)
821.30(d)
Total
1 There
247,082
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED AVERAGE ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
Annual Frequency
of Recordkeeping
Total Annual
Records
Hours per
Record
Total Hours
229
46,260
10,593,433
0.2899
3,071,036
821.25(c)
229
1
229
63.0
14,430
821.25(c)(3)
rmajette on PROD1PC64 with NOTICES
821.25(b)
229
1,124
257,454
0.2899
74,636
TOTAL
1 There
3,160,102
are no capital costs or operating and maintenance costs associated with this collection of information.
The annual hourly reporting burden
for respondents involved with medical
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15:34 Feb 04, 2008
Jkt 214001
device tracking is estimated to be
247,082 hours, and the annual
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Fmt 4703
Sfmt 4703
recordkeeping burden for these
respondents is estimated to be 3,160,102
E:\FR\FM\05FEN1.SGM
05FEN1
Federal Register / Vol. 73, No. 24 / Tuesday, February 5, 2008 / Notices
hours. These figures have been rounded
up. The burden estimates cited in tables
1 and 2 of this document are based
primarily upon the data and methods
provided in FDA’s assessment for fiscal
year (FY) 1999 entitled ‘‘A Cost
Assessment of Medical Device
Tracking.’’ Using implantation
procedures from the National Center for
Health Statistics, FDA applied a 2percent annual growth rate to estimate
the number of procedures for tracked
implant devices for FY1997 through
FY2006. This assessment also used unit
shipment data in combination with
various growth rates to estimate annual
sales distribution for the tracked l/s-l/s
devices over the same time period. In
addition, the assessment also estimated
the burden on industry for developing
and maintaining tracking systems for
these medical devices for FY1997
through FY2006.
For the annual recordkeeping burden,
the number of respondent medical
device manufacturers subject to device
tracking is estimated to be 229 and is
based on data from FDA’s
manufacturers database. FDA issued
tracking orders to 20 additional medical
device manufacturers during the time
period for FY2002 through FY2004.
Under § 821.25(c), the additional
medical device manufacturers
collectively bear a one-time
recordkeeping burden of 10,560 hours to
develop a medical device tracking
system. FDA’s estimate of 17,000
medical device distributor respondents
contained in this assessment, are
derived from Dun & Bradstreet sources
on medical equipment wholesalers,
retailers, home care dealers, and rental
companies. Health Forum, an American
Hospital Association Company,
provided statistics on hospitals.
Please note that on January 15, 2008,
the FDA Web site transitioned to the
Federal Dockets Management System
(FDMS). FDMS is a Government-wide,
electronic docket management system.
Electronic submissions will be accepted
by FDA through FDMS only.
Dated: January 30, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–2078 Filed 2–4–08; 8:45 am]
rmajette on PROD1PC64 with NOTICES
BILLING CODE 4160–01–S
VerDate Aug<31>2005
15:34 Feb 04, 2008
Jkt 214001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2008N–0016]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Additional Listing
Information for Medical Device
Registration and Listing
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 public
comments on the reporting and
recordkeeping burden associated with
the paperwork requirements under
§ 807.31 (21 CFR 807.31), which
requires device establishments to retain
and, upon FDA’s specific request,
submit certain additional listing
information.
DATES: Submit written or electronic
comments on the collection of
information by April 7, 2008.
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 the Chief
Information Officer (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
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
6731
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.
Additional Listing Information for
Medical Device Registration and
Listing—21 CFR 80.31; (OMB Control
Number 0910–0387)—Extension
The Food and Drug Administration
Amendments Act of 2007 (the 2007
Amendments), enacted September 27,
2007, requires that device establishment
registrations and listings under 21
U.S.C. 360(p) (including the submission
of updated information), be submitted to
the Secretary of Health and Human
Services (the Secretary) by electronic
means, unless the Secretary grants a
request for waiver of the requirement
because the use of electronic means is
not reasonable for the person requesting
the waiver. See section 224 of the 2007
Amendments. The 2007 Amendments
provides for an October 1, 2007,
effective date by which FDA expects
approximately 30,000 establishments to
begin registering. FDA is seeking OMB
approval for the information collected
by electronic means. Registration by
electronic means for device
establishments will mean replacement
of FDA Forms 2891 and 2891a,
‘‘Registration of Device Establishment’’
and FDA Form 2892 ‘‘Medical Device
Listing,’’ with electronic versions.
However, for OMB approval of the
extension request for this collection of
E:\FR\FM\05FEN1.SGM
05FEN1
]]>Agencies
[Federal Register Volume 73, Number 24 (Tuesday, February 5, 2008)]
[Notices]
[Pages 6729-6731]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-2078]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0050]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices; Device Tracking
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 information collection
requirements for the tracking of medical devices.
DATES: Submit written or electronic comments on the collection of
information by April 7, 2008.
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 the
Chief Information Officer (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
[[Page 6730]]
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 Devices; Device Tracking--21 CFR Part 821 (OMB Control Number
0910-0442)--Extension
Section 211 of the Food and Drug Administration Modernization Act
(FDAMA) (Public Law 105-115) became effective on February 19, 1998.
FDAMA amended the previous medical device tracking provisions under
Section 519(e)(1) and (2) of the Federal Food, Drug, and Cosmetic Act
(the act) 21 U.S.C. 360i(e)(1) and (2) and were added by the Safe
Medical Devices Act of 1990 (SMDA) (Public Law 101-629). Unlike the
tracking provisions under SMDA which required tracking of any medical
device meeting certain criteria, FDAMA allows FDA discretion in
applying tracking provisions to medical devices meeting certain
criteria, and provides that tracking requirements for medical devices
can be imposed only after FDA issues an order. In the Federal Register
of February 8, 2002 (67 FR 5943), FDA issued a final rule which
conformed existing tracking regulations to changes in tracking
provisions effected by FDAMA under part 821 (21 CFR part 821).
Section 519(e)(1) of the act, as amended by FDAMA, provides that
FDA may require by order, that a manufacturer adopt a method for
tracking a class II or III medical device, if the device meets one of
the three following criteria: (1) The failure of the device would be
reasonably likely to have serious adverse health consequences, (2) the
device is intended to be implanted in the human body for more than 1
year (referred to as a ``tracked implant''), or (3) the device is life-
sustaining or life-supporting (referred to as a ``tracked l/s-l/s
device'') and is used outside a device user facility.
Tracked device information is collected to facilitate identifying
the current location of medical devices and patients possessing those
devices, to the extent that patients permit the collection of
identifying information. Manufacturers and FDA (where necessary), use
the data to: (1) Expedite the recall of distributed medical devices
that are dangerous or defective and (2) facilitate the timely
notification of patients or licensed practitioners of the risks
associated with the medical device.
In addition, the regulations include provisions for: (1) Exemptions
and variances; (2) system and content requirements for tracking; (3)
obligations of persons other than device manufacturers, e.g.,
distributors; records and inspection requirements; (4) confidentiality;
and (5) record retention requirements.
Respondents for this collection of information are medical device
manufacturers, importers, and distributors of tracked implants or
tracked l/s-l/s devices used outside a device user facility.
Distributors include multiple and final distributors, including
hospitals.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency of Total Annual Hours per
21 CFR Section Respondents Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
821.2 and 4 1 4 12 48
821.30(e)
----------------------------------------------------------------------------------------------------------------
821.25(a) 1 1 1 76 76
----------------------------------------------------------------------------------------------------------------
821.25(d) 22 1 22 2 44
----------------------------------------------------------------------------------------------------------------
821.30(a) and 17,000 72 1,222,725 0.1666 203,706
(b)
----------------------------------------------------------------------------------------------------------------
821.30(c)(2) 1 1 1 28 28
----------------------------------------------------------------------------------------------------------------
821.30(d) 17,000 15 259,186 0.1666 43,180
----------------------------------------------------------------------------------------------------------------
Total ................. .................... ................. ................. 247,082
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2.--Estimated Average Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers of Recordkeeping Records Hours per Record Total Hours
----------------------------------------------------------------------------------------------------------------
821.25(b) 229 46,260 10,593,433 0.2899 3,071,036
----------------------------------------------------------------------------------------------------------------
821.25(c) 229 1 229 63.0 14,430
----------------------------------------------------------------------------------------------------------------
821.25(c)(3) 229 1,124 257,454 0.2899 74,636
----------------------------------------------------------------------------------------------------------------
Total ................. ................. ................. ................. 3,160,102
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The annual hourly reporting burden for respondents involved with
medical device tracking is estimated to be 247,082 hours, and the
annual recordkeeping burden for these respondents is estimated to be
3,160,102
[[Page 6731]]
hours. These figures have been rounded up. The burden estimates cited
in tables 1 and 2 of this document are based primarily upon the data
and methods provided in FDA's assessment for fiscal year (FY) 1999
entitled ``A Cost Assessment of Medical Device Tracking.'' Using
implantation procedures from the National Center for Health Statistics,
FDA applied a 2-percent annual growth rate to estimate the number of
procedures for tracked implant devices for FY1997 through FY2006. This
assessment also used unit shipment data in combination with various
growth rates to estimate annual sales distribution for the tracked l/s-
l/s devices over the same time period. In addition, the assessment also
estimated the burden on industry for developing and maintaining
tracking systems for these medical devices for FY1997 through FY2006.
For the annual recordkeeping burden, the number of respondent
medical device manufacturers subject to device tracking is estimated to
be 229 and is based on data from FDA's manufacturers database. FDA
issued tracking orders to 20 additional medical device manufacturers
during the time period for FY2002 through FY2004. Under Sec.
821.25(c), the additional medical device manufacturers collectively
bear a one-time recordkeeping burden of 10,560 hours to develop a
medical device tracking system. FDA's estimate of 17,000 medical device
distributor respondents contained in this assessment, are derived from
Dun & Bradstreet sources on medical equipment wholesalers, retailers,
home care dealers, and rental companies. Health Forum, an American
Hospital Association Company, provided statistics on hospitals.
Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through FDMS only.
Dated: January 30, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-2078 Filed 2-4-08; 8:45 am]
BILLING CODE 4160-01-S
