[Federal Register Volume 73, Number 24 (Tuesday, February 5, 2008)]
[Notices]
[Pages 6729-6731]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-2078]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0050]


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 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 the tracking of medical devices.

DATES:  Submit written or electronic comments on the collection of 
information by April 7, 2008.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://www.regulations.gov. 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: 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: 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

[[Page 6730]]

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 
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. 
FDAMA amended the previous medical device tracking provisions under 
Section 519(e)(1) and (2) of the Federal Food, Drug, and Cosmetic Act 
(the act) 21 U.S.C. 360i(e)(1) and (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.
    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 of     Total Annual        Hours per
21 CFR Section     Respondents           Response            Responses           Response         Total Hours
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821.2 and                       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 Average Annual Recordkeeping Burden\1\
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                         No. of        Annual Frequency     Total Annual
  21 CFR Section     Recordkeepers     of Recordkeeping       Records       Hours per  Record     Total Hours
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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.

    The annual hourly reporting burden for respondents involved with 
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

[[Page 6731]]

hours. These figures have been rounded up. The burden estimates cited 
in tables 1 and 2 of this document 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 FY1997 through FY2006. 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 FY1997 through FY2006.
    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 FY2002 through FY2004. 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.
    Please note that on January 15, 2008, the FDA Web site transitioned 
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will 
be accepted by FDA through FDMS only.

    Dated: January 30, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-2078 Filed 2-4-08; 8:45 am]
BILLING CODE 4160-01-S