[Federal Register: November 30, 2004 (Volume 69, Number 229)]
[Notices]
[Page 69604-69606]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30no04-57]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0498]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices; Device Tracking
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of
information 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 tracking of medical devices.
DATES: Submit written or electronic comments on the collection of
information by January 31, 2005.
ADDRESSES: Submit electronic comments on the collection of information
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments on
the collection of information to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1223.
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
[[Page 69605]]
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. 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.
FDA estimates the burden of this collection of information as
follows:
TABLE 1.--ESTIMATED ANNUAL REPORTING BURDEN\1\
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Annual Frequency per Total Annual Hours per
21 CFR Section No. of Respondents Response Responses Response Total Hours
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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), (b) 17,000 72 1,222,725 0.1666 203,706
821.30(c)(2) 1 1 1 28 28
821.30(d) 17,000 15 259,186 0.1666 43,180
Total .................... .................... .............. .............. 247,082
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.--ESTIMATED ANNUAL RECORDKEEPING BURDEN\1\
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Annual Frequency Total Annual Hours per
21 CFR Section No. of Recordkeepers per Recordkeeping Records Recordkeeper Total Hours
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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
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
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 FDAs 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 Company, provided statistics on
hospitals.
[[Page 69606]]
Dated: November 19, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-26331 Filed 11-29-04; 8:45 am]
BILLING CODE 4160-01-S