[Federal Register: November 30, 2004 (Volume 69, Number 229)]
[Page 69604-69606]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


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 

    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 
    FDA estimates the burden of this collection of information as 

                                 TABLE 1.--ESTIMATED ANNUAL REPORTING BURDEN\1\
                                            Annual Frequency per   Total Annual      Hours per
   21 CFR Section      No. of Respondents         Response           Responses       Response       Total Hours
821.2 (also                              4                     1               4              12              48
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
\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   Total Annual      Hours per
     21 CFR Section      No. of Recordkeepers  per Recordkeeping      Records      Recordkeeper     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 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 

[[Page 69606]]

    Dated: November 19, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-26331 Filed 11-29-04; 8:45 am]