[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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