[Federal Register Volume 79, Number 80 (Friday, April 25, 2014)]
[Notices]
[Pages 22991-22993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-09467]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0555]
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 either electronic or written comments on the collection
of information by June 24, 2014.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of
[[Page 22992]]
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, [email protected].
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 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) (Pub. L. 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
FD&C Act) (21 U.S.C. 360i(e)(1) and (e)(2)) that were added by the Safe
Medical Devices Act of 1990 (SMDA) (Pub. L. 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 that
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 FD&C 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; (4) records and inspection requirements; (5)
confidentiality; and (6) 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.
The annual hourly burden for respondents involved with medical
device tracking is estimated to be 615,380 hours per year. The burden
estimates cited in tables 1, 2, and 3 of this document are based on the
number of device tracking orders issued in the last 3 years.
This regulation also refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by Office of Management and Budget under the PRA
(44 U.S.C. 3501-3520). The collections of information found in
Sec. Sec. 821.2(b), 821.25(e), and 821.30(e) have been approved under
OMB control number 0910-0183.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity/21 CFR Part Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Discontinuation of business-- 1 1 1 1 1
821.1(d).......................
Exemption or variance--821.2 and 1 1 1 1 1
821.30(e)......................
Notification of failure to 1 1 1 1 1
comply--821.25(d)..............
Multiple distributor data-- 1 1 1 1 1
821.30(c)(2)...................
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Total....................... .............. .............. .............. .............. 4
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 22993]]
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
Activity/21 CFR Part Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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Tracking information--821.25(a). 12 1 12 76 912
Record of tracking data-- 12 46,260 555,120 1 555,120
821.25(b)......................
Standard operating procedures-- 12 1 12 63 756
821.25(c) \2\..................
Manufacturer data audit-- 12 1,124 13,488 1 13,488
821.25(c)(3)...................
Multiple distributor data and 22,000 1 22,000 1 22,000
distributor tracking records--
821.30(c)(2) and (d)...........
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Total....................... .............. .............. .............. .............. 592,276
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ One-time burden.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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Number of
Activity/21 CFR Part Number of disclosures Total annual Average burden Total hours
respondents per respondent disclosures per disclosure
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Acquisition of tracked devices 22,000 1 22,000 1 22,000
and final distributor data--
821.30(a) and (b)..............
Multiple distributor data and 1,100 1 1,100 1 1,100
distributor tracking records--
821.30(c)(2) and (d)...........
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Total....................... .............. .............. .............. .............. 23,100
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: April 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09467 Filed 4-24-14; 8:45 am]
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