Document ID: FDA-2008-N-0050-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Device Tracking
Posted Date: 2008-04-22T04:00Z

[Federal Register: April 22, 2008 (Volume 73, Number 78)]
[Notices]               
[Page 21631-21632]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22ap08-56]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 May 22, 
2008.

ADDRESSES:  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: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments 
should be identified with the OMB control number 0910-0442. Also 
include the FDA 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: 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--(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 (e)(2) of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 360i(e)(1) and (e)(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.
    In the Federal Register of February 5, 2008 (73 FR 6729), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

[[Page 21632]]

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                      No. of       Annual Frequency per     Total Annual        Hours per
 CFR Sections      Respondents            Response           Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
821.2 and                       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
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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
   CFR Sections          No. of              per            Total Annual    Hours per  Record     Total Hours
                     Recordkeepers      Recordkeeping         Records
----------------------------------------------------------------------------------------------------------------
821.25(b)                        229             46,260         10,593,433             0.2899          3,071,036
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Total              .................  .................  .................  .................          3,160,102
----------------------------------------------------------------------------------------------------------------
\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 in 
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 hours. These numbers have been rounded up. The burden 
estimates cited in tables 1 and 2 of this notice 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 FY 1997 through FY 
2006. 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 FY 1997 
through FY 2006.
    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 FY 2002 through FY 2004. 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.

    Dated: April 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-8682 Filed 4-21-08; 8:45 am]

BILLING CODE 4160-01-S