[Federal Register: February 5, 2008 (Volume 73, Number 24)]
[Notices]
[Page 6729-6731]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05fe08-70]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency of Total Annual Hours per
21 CFR Section 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
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers of Recordkeeping Records Hours per Record 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 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