[Federal Register Volume 79, Number 200 (Thursday, October 16, 2014)]
[Notices]
[Pages 62161-62163]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-24599]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0555]


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 
November 17, 2014.

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: 202-395-7285, or emailed to [email protected]. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

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--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

[[Page 62162]]

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 to 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 the 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.
    In the Federal Register of April 25, 2014 (79 FR 22991), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although one comment was received, it was 
not responsive to the four collection of information topics solicited 
and therefore will not be discussed in this document.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
      Activity/21 CFR part           Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       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.


                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                     Number of                        Average
      Activity/21 CFR part           Number of      records per    Total annual     burden 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)...........
                                 -------------------------------------------------------------------------------
    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
                                     Number of      disclosures    Total annual       Average
      Activity/21 CFR part          respondents         per         disclosures     burden per      Total hours
                                                    respondent                      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)...........
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          23,100
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.



[[Page 62163]]

    Dated: October 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-24599 Filed 10-15-14; 8:45 am]
BILLING CODE 4164-01-P