[Federal Register: March 4, 2005 (Volume 70, Number 42)]
[Notices]               
[Page 10648-10650]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04mr05-71]                         

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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.

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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.

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\
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                        No. of        Annual Frequency     Total Annual         Hours per
 21 CFR Section      Respondents        per Response        Responses           Response          Total Hours
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821.2 (also                       4                  1                  4             12                      48
 821.30(e))
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821.25(a)                         1                  1                  1             76                      76
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821.25(d)                        22                  1                 22              2                      44
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821.30(a) and                17,000                 72          1,222,725              0.1666            203,706
 (b)
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821.30(c)(2)                      1                  1                  1             28                      28
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821.30(d)                    17,000                 15            259,186              0.1666             43,180
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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
 21 CFR Section         No. of              per            Total Annual         Hours per         Total Hours
                    Recordkeepers      Recordkeeping         Records          Recordkeeper
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821.25(b)                       229             46,260         10,593,433              0.2899          3,071,036
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821.25(c)                       229                  1                229             63.0                14,430
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821.25(c)(3)                    229              1,124            257,454              0.2899             74,636
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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.


[[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