[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
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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 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
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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 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