Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Device Tracking, 21631-21632 [E8-8682]
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Federal Register / Vol. 73, No. 78 / Tuesday, April 22, 2008 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2008–N–0050]
[Docket No. FDA–2006–D–0302] (formerly
Docket No. 2006D–0419)
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Voluntary National Retail Food
Regulatory Program Standards
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Voluntary National Retail Food
Regulatory Program Standards’’ 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.
In the
Federal Register of January 15, 2008 (73
FR 2500), the agency announced that
the proposed information collection had
been submitted to OMB for review and
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 0910–0621. The
approval expires on March 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.
SUPPLEMENTARY INFORMATION:
Dated: April 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–8680 Filed 4–21–08; 8:45 am]
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BILLING CODE 4160–01–S
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Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices;
Device Tracking
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 May 22,
2008.
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:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0442. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Medical Devices; Device Tracking—
(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 (e)(2) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 360i(e)(1) and (e)(2)) and were
added by the Safe Medical Devices Act
of 1990 (SMDA) (Public Law 101–629).
Unlike the tracking provisions under
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
21631
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.
In the Federal Register of February 5,
2008 (73 FR 6729), FDA published a 60day notice requesting public comment
on the information collection
provisions. No comments were received.
E:\FR\FM\22APN1.SGM
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21632
Federal Register / Vol. 73, No. 78 / Tuesday, April 22, 2008 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
CFR Sections
No. of
Respondents
Annual Frequency per
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 ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
CFR Sections
Annual Frequency
per
Recordkeeping
Total Annual
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
sroberts on PROD1PC70 with NOTICES
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 in 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
hours. These numbers have been
rounded up. The burden estimates cited
in tables 1 and 2 of this notice 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 FY 1997 through FY
2006. 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 FY 1997
through FY 2006.
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
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16:25 Apr 21, 2008
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tracking orders to 20 additional medical
device manufacturers during the time
period for FY 2002 through FY 2004.
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.
Dated: April 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–8682 Filed 4–21–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Joint Meeting of the Anesthetic and
Life Support Drugs Advisory
Committee and the Drug Safety and
Risk Management Advisory
Committee; Amendment of Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug Administration
(FDA) is announcing an amendment to
the notice of meeting of the Anesthetic
and Life Support Drugs Advisory
Committee and the Drug Safety and Risk
Management Advisory Committee. This
meeting was announced in the Federal
Register of March 27, 2008 (73 FR
16314). The amendment is being made
to reflect changes in the introductory
paragraph and to add a portion entitled
‘‘Closed Committee Deliberations.’’
There are no other changes.
FOR FURTHER INFORMATION CONTACT:
Teresa Watkins, Center for Drug
Evaluation and Research (HFD–21),
Food and Drug Administration, 5600
Fishers Lane, (for express delivery, 5630
Fishers Lane, rm. 1093), Rockville, MD
20857, 301–827–7001, FAX: 301–827–
6776, e-mail:
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22APN1
]]>Agencies
[Federal Register Volume 73, Number 78 (Tuesday, April 22, 2008)]
[Notices]
[Pages 21631-21632]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-8682]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0050]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Devices;
Device Tracking
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 May 22,
2008.
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: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments
should be identified with the OMB control number 0910-0442. Also
include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Medical Devices; Device Tracking--(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 (e)(2) of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 360i(e)(1) and (e)(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.
In the Federal Register of February 5, 2008 (73 FR 6729), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
[[Page 21632]]
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Total Annual Hours per
CFR Sections 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 Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual Frequency
CFR Sections No. of per Total Annual Hours per Record Total Hours
Recordkeepers Recordkeeping Records
----------------------------------------------------------------------------------------------------------------
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 in
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 hours. These numbers have been rounded up. The burden
estimates cited in tables 1 and 2 of this notice 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 FY 1997 through FY
2006. 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 FY 1997
through FY 2006.
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 FY 2002 through FY 2004. 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.
Dated: April 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-8682 Filed 4-21-08; 8:45 am]
BILLING CODE 4160-01-S
