Agency Information Collection Activities; Submission for Office of Management and Budget Review; Medical Devices; Device Tracking, 10648-10650 [05-4161]
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10648
Federal Register / Vol. 70, No. 42 / Friday, March 4, 2005 / Notices
In 2001, when preparing the earlier
package for approval of the information
collection requirements in part 806,
FDA reviewed the reports of corrections
and removals submitted in the previous
3 years under part 7 (21 CFR part 7) (the
agency’s recall provisions). FDA has
determined that estimates of the
reporting burden in §§ 806.10 and
806.20 should be revised to reflect a
reduction of 29 percent for reports and
records submitted under part 7 due to
a decrease in recall actions. The time
needed to collect information has been
reduced by 4 hours per record due to
the implementation of a computerized
program for information collection
requirements in part 806.
Dated: February 25, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–4159 Filed 3–3–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N–0401]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Customer/Partner
Service Surveys
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 April 4,
2005.
OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. 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: Fumie Yokota, Desk Officer
for FDA, FAX: 202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
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.
ADDRESSES:
Customer/Partner Service Surveys—
(OMB Control Number 0910–0360)—
Extension
Under section 903 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
393), FDA is authorized to conduct
research and public information
programs about regulated products and
responsibilities of the agency. Executive
Order 12862, entitled ‘‘Setting Customer
Service Standard,’’ directs Federal
agencies that ‘‘provide significant
services directly to the public’’ to
‘‘survey customers to determine the
kind and quality of services they want
and their level of satisfaction with
existing services.’’ FDA is seeking OMB
clearance to conduct a series of surveys
to implement Executive Order 12862.
Participation in the surveys is
voluntary. This request covers
customer/partner service surveys of
regulated entities, such as the following:
Food processors; cosmetic drug, biologic
and medical device manufacturers;
consumers; and health professionals.
The request also covers ‘‘partner’’ (State
and local governments) customer
service surveys.
FDA will use the information from
these surveys to identify strengths and
weaknesses in service to customers/
partners and to make improvements.
The surveys will measure timeliness,
appropriateness and accuracy of
information, courtesy, and problem
resolution in the context of individual
programs.
FDA projects that approximately 15
customer/partner service surveys will be
conducted per year, with a sample of
between 50 and 6,000 customers,
requiring an average of 18 minutes for
review and completion for each survey.
Some of these surveys will be repeats of
earlier surveys, for purposes of
monitoring customer/partner service
and developing long-term data.
In the Federal Register of September
16, 2004 (69 FR 55823), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Type of Survey
No. of Respondents
Mail/telephone/fax/web-based
1There
Annual Frequency per
Response
15,000
Total Annual
Responses
1
15,000
Hours per Respondent
.30
Total Hours
4,500
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 25, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–4160 Filed 3–3–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N–0498]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Medical Devices; Device Tracking
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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Notice.
Frm 00058
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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 April 4,
2005.
OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. To ensure that comments on
ADDRESSES:
E:\FR\FM\04MRN1.SGM
04MRN1
10649
Federal Register / Vol. 70, No. 42 / Friday, March 4, 2005 / Notices
the information collection are received,
OMB recommends that comments be
faxed to the Office of Information and
Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX:
202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
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—
21 CFR Part 821 (OMB Control Number
0910–0442)—Extension
Section 211 of the Food and Drug
Administration Modernization Act of
1997 (FDAMA) (Public Law 105–115)
became effective on February 19, 1998.
It amended the previous medical device
tracking provisions in 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) that were added by
the Safe Medical Devices Act of 1990
(SMDA) (Public Law 101–629). Unlike
the tracking provisions under SMDA,
possessing the devices, to the extent that
patients permit the collection of
identifying information. Manufacturers
and, as necessary, FDA use the data to
expedite the recall of distributed
devices that are dangerous or defective,
and to facilitate the timely notification
of patients or licensed practitioners of
the risks associated with the devices.
Respondents to this collection of
information are 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.
The regulations include requirements
for exemptions and variances; system
and content requirements of tracking;
obligations of persons other than device
manufacturers, e.g., distributors; records
and inspection requirements;
confidentiality; and record retention
requirements.
In the Federal Register of November
30, 2004 (69 FR 69604), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
which required tracking for any device
meeting certain criteria, FDAMA allows
FDA discretion in applying tracking
requirements to devices that meet
certain criteria and provides that
tracking requirements 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 to
conform existing tracking regulations to
changes in tracking provisions effected
by FDAMA (part 821 (21 CFR part 821)).
Current section 519(e)(1) of the act, as
amended by FDAMA, provides that
FDA may by order require a
manufacturer to adopt a method of
tracking a class II or class III device, if
the device meets one of three 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 lifesupporting (referred to as a ‘‘tracked l/
s-l/s device’’) and is used outside a
device user facility.
Tracking information is collected to
facilitate identifying the current location
of tracked devices and patients
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
821.2 (also 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
1
1
1
17,000
15
259,186
821.30(a) and (b)
821.30(c)(2)
821.30(d)
0.1666
28
0.1666
Total
1 There
203,706
28
43,180
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
21 CFR Section
Annual Frequency
per
Recordkeeping
Total Annual
Records
821.25(b)
229
46,260
10,593,433
821.25(c)
229
1
229
821.25(c)(3)
229
1,124
Hours per
Recordkeeper
0.2899
257,454
63.0
0.2899
Total
1 There
Total Hours
3,071,036
14,430
74,636
3,160,102
are no capital costs or operating and maintenance costs associated with this collection of information.
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E:\FR\FM\04MRN1.SGM
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10650
Federal Register / Vol. 70, No. 42 / Friday, March 4, 2005 / Notices
The annual reporting burden hours to
respondents for medical device tracking
is estimated to be 247,082 hours, and
recordkeeping burdens for respondents
is estimated to be 3,160,102 hours.
These numbers have been rounded up.
The estimates cited in tables 1 and 2 of
this document are based primarily upon
the data and methods provided in FDA’s
1999 assessment 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 from 1997–2006. The
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.
Additionally, the assessment estimates
the industry burden for developing and
maintaining tracking systems for these
devices from 1997–2006.
For the annual recordkeeping burden,
the number of manufacturers subject to
device tracking (229) is based on data
from FDA’s manufacturers database.
FDA issued tracking orders to 20
additional manufacturers during the
time period 2002–2004. Under
§ 821.25(c), the additional
manufacturers collectively bear a onetime burden of 10,560 hours to develop
a device tracking system. FDA’s
estimate of 17,000 distributor
respondents contained in the
assessment is derived from Dun &
Bradstreet sources on medical
equipment wholesalers, retailers, home
care dealers, and rental companies.
Health Forum, an American Hospital
Association Co., provided statistics on
hospitals.
Dated: February 25, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–4161 Filed 3–3–05; 8:45 am]
BILLING CODE 4160–01–S
VerDate jul<14>2003
19:07 Mar 03, 2005
Jkt 205001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
5100 Paint Branch Pkwy., College Park,
MD 20740, 301–436–1903.
SUPPLEMENTARY INFORMATION:
I. Background
The Department of Health and Human
[Docket No. 2005N–0065]
Services Healthy People 2010 is a
Risk Assessment of the Public Health
comprehensive set of disease prevention
Impact from Foodborne Listeria
and health promotion objectives for the
Monocytogenes in Smoked Finfish;
Nation to achieve over the first decade
of the new century. Created by scientists
and Evaluation of Food Code
both inside and outside of Government,
Provisions That Address Preventive
Controls for Listeria Monocytogenes in it identifies a wide range of public
health priorities and specific,
Retail and Foodservice
measurable objectives. One of these
Establishments; Request for
objectives calls on Federal food safety
Comments and for Scientific Data and
agencies to reduce foodborne listeriosis
Information
(Ref. 1). In support of this goal, in 2003,
AGENCY: Food and Drug Administration, FDA issued an assessment of the
HHS.
relative risk to the public health from
ACTION: Notice; request for comments
foodborne L. monocytogenes among
and for scientific data and information.
selected categories of RTE foods
(Listeria risk assessment) (Ref. 2). The
SUMMARY: The Food and Drug
Listeria risk assessment formed the basis
Administration (FDA) is requesting
of the 2003 FDA/CDC Listeria Action
comments and scientific data and
Plan (Ref. 3), which identifies
information that would assist the agency prevention and control activities that
in its plans to conduct a risk assessment FDA and CDC will take to reduce the
for Listeria monocytogenes in smoked
incidence of foodborne listeriosis in the
finfish (smoked finfish risk assessment), United States. The smoked finfish risk
and evaluate the provisions of the 2001
assessment and the evaluation of the
Food Code that address preventive
Food Code (Ref. 4) provisions for
controls for L. monocytogenes in retail
preventive controls for L.
and foodservice establishments. The
monocytogenes in retail and foodservice
purpose of the smoked finfish risk
establishments are two of these
assessment is to ascertain the impact on prevention and control activities that
public health from the reduction and/or support the agency’s commitment to
prevention of L. monocytogenes growth
fulfilling the Listeria Action Plan.
and recontamination during the
Smoked Finfish Risk Assessment: The
manufacturing and/or processing of hot- 2003 Listeria risk assessment used data
and cold-smoked finfish. The smoked
on food contamination at retail, the
finfish risk assessment and the
ability of the food to support growth,
evaluation of the Food Code provisions
and the impact of home storage time
for preventive controls for L.
and temperature to estimate the
monocytogenes in retail and foodservice likelihood of a type of food to cause
establishments support the agency’s
listeriosis. The Listeria risk assessment
commitment to the Listeria Action Plan
determined that smoked seafood has a
(revised 2003) that FDA and the Centers relatively high rate of contamination
for Disease Control and Prevention
and a high predicted per serving relative
(CDC) developed to reduce L.
risk, yet a lower per annum risk because
monocytogenes illnesses associated with it is generally consumed only
occasionally in small quantities and/or
the consumption of ready-to-eat (RTE)
eaten by a relatively small portion of the
foods.
population.
DATES: Submit comments and scientific
As a followup to the Listeria risk
data and information by May 3, 2005.
assessment, the smoked finfish risk
ADDRESSES: Submit written comments
assessment model will evaluate the
and scientific data and information to
sources of contamination, how
the Division of Dockets Management
individual steps in manufacturing and/
(HFA–305), Food and Drug
or processing contribute to
Administration, 5630 Fishers Lane, rm.
contamination, and the effectiveness of
1061, Rockville, MD 20852. Submit
various preventative strategies. The
electronic comments, data, and
objectives of the smoked finfish risk
information to https://www.fda.gov/
assessment are to evaluate the impact on
dockets/ecomments.
public health from the reduction/
prevention of the following: (1) L.
FOR FURTHER INFORMATION CONTACT:
Sherri B. Dennis, Center for Food Safety monocytogenes growth during the
manufacturing and/or processing of
and Applied Nutrition (HFS–06), Food
smoked finfish, (2) L. monocytogenes
and Drug Administration, rm. 2B–023,
PO 00000
Frm 00060
Fmt 4703
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E:\FR\FM\04MRN1.SGM
04MRN1
]]>Agencies
[Federal Register Volume 70, Number 42 (Friday, March 4, 2005)]
[Notices]
[Pages 10648-10650]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-4161]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0498]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 April
4, 2005.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on
[[Page 10649]]
the information collection are received, OMB recommends that comments
be faxed to the Office of Information and Regulatory Affairs, OMB,
Attn: Fumie Yokota, Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1223.
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--21 CFR Part 821 (OMB Control
Number 0910-0442)--Extension
Section 211 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Public Law 105-115) became effective on February 19,
1998. It amended the previous medical device tracking provisions in
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) that were added by the
Safe Medical Devices Act of 1990 (SMDA) (Public Law 101-629). Unlike
the tracking provisions under SMDA, which required tracking for any
device meeting certain criteria, FDAMA allows FDA discretion in
applying tracking requirements to devices that meet certain criteria
and provides that tracking requirements 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 to conform existing tracking regulations
to changes in tracking provisions effected by FDAMA (part 821 (21 CFR
part 821)).
Current section 519(e)(1) of the act, as amended by FDAMA, provides
that FDA may by order require a manufacturer to adopt a method of
tracking a class II or class III device, if the device meets one of
three 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.
Tracking information is collected to facilitate identifying the
current location of tracked devices and patients possessing the
devices, to the extent that patients permit the collection of
identifying information. Manufacturers and, as necessary, FDA use the
data to expedite the recall of distributed devices that are dangerous
or defective, and to facilitate the timely notification of patients or
licensed practitioners of the risks associated with the devices.
Respondents to this collection of information are 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.
The regulations include requirements for exemptions and variances;
system and content requirements of tracking; obligations of persons
other than device manufacturers, e.g., distributors; records and
inspection requirements; confidentiality; and record retention
requirements.
In the Federal Register of November 30, 2004 (69 FR 69604), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
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
----------------------------------------------------------------------------------------------------------------
821.2 (also 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
21 CFR Section No. of per Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Recordkeeper
----------------------------------------------------------------------------------------------------------------
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.
[[Page 10650]]
The annual reporting burden hours to respondents for medical device
tracking is estimated to be 247,082 hours, and recordkeeping burdens
for respondents is estimated to be 3,160,102 hours. These numbers have
been rounded up. The estimates cited in tables 1 and 2 of this document
are based primarily upon the data and methods provided in FDA's 1999
assessment 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 from 1997-2006. The
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. Additionally, the assessment
estimates the industry burden for developing and maintaining tracking
systems for these devices from 1997-2006.
For the annual recordkeeping burden, the number of manufacturers
subject to device tracking (229) is based on data from FDA's
manufacturers database. FDA issued tracking orders to 20 additional
manufacturers during the time period 2002-2004. Under Sec. 821.25(c),
the additional manufacturers collectively bear a one-time burden of
10,560 hours to develop a device tracking system. FDA's estimate of
17,000 distributor respondents contained in the assessment is derived
from Dun & Bradstreet sources on medical equipment wholesalers,
retailers, home care dealers, and rental companies. Health Forum, an
American Hospital Association Co., provided statistics on hospitals.
Dated: February 25, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-4161 Filed 3-3-05; 8:45 am]
BILLING CODE 4160-01-S
