83 FR 2163 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Device Tracking

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 10 (January 16, 2018)

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.

[Federal Register Volume 83, Number 10 (Tuesday, January 16, 2018)]
[Notices]
[Pages 2163-2165]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-00568]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5569]


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.

-----------------------------------------------------------------------

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 
February 15, 2018.

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: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[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 
of 1997 (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 (2) of the Federal Food, Drug, and Cosmetic 
Act (FD&C Act) (21 U.S.C. 360i(e)(1) and (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)

[[Page 2164]]

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 through 3 are based on the number of device 
tracking orders issued in the last 3 years, an average of 12 tracking 
orders annually. FDA estimates that approximately 22,000 respondents 
may be subject to tracking reporting requirements.
    Under Sec.  821.25(a), device manufacturers subject to FDA tracking 
orders must adopt a tracking method that can provide certain device, 
patient, and distributor information to FDA within 3 to 10 working 
days. Assuming one occurrence per year, FDA estimates it would take a 
firm 20 hours to provide FDA with location data for all tracked devices 
and 56 hours to identify all patients and/or multiple distributors 
possessing tracked devices.
    Under Sec.  821.25(d) manufacturers must notify FDA of distributor 
noncompliance with reporting requirements. Based on the number of 
audits manufacturers conduct annually, FDA estimates it would receive 
no more than one notice in any year, and that it would take 1 hour per 
incident.
    Under Sec.  821.30(c)(2), multiple distributors must provide data 
on current users of tracked devices, current device locations, and 
other information, upon request from a manufacturer or FDA. FDA has not 
made such a request and is not aware of any manufacturer making a 
request. Assuming one multiple distributor receives one request in a 
year from either a manufacturer or FDA, and that lists may be generated 
electronically, the Agency estimates a burden of 1 hour to comply.
    Under Sec.  821.30(d) distributors must verify data or make 
required records available for auditing, if a manufacturer provides a 
written request. FDA's estimate of the burden for distributor audit 
responses assumes that manufacturers audit database entries for 5 
percent of tracked devices distributed. Each audited database entry 
prompts one distributor audit response. Because lists may be generated 
electronically, FDA estimates a burden of 1 hour to comply.
    In the Federal Register of October 18, 2017 (82 FR 48516), 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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
     Activity/21 CFR section         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
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)...................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............               4
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
     Activity/21 CFR section         Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
     Activity/21 CFR section         Number of      disclosures    Total annual   Average burden    Total hours
                                    respondents   per respondent    disclosures   per disclosure
----------------------------------------------------------------------------------------------------------------
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)...........
                                 -------------------------------------------------------------------------------

[[Page 2165]]

 
    Total.......................  ..............  ..............  ..............  ..............          23,100
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden estimate for this information collection has not changed 
since the last OMB approval.
    This document also refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by OMB 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 0910-0191.

    Dated: January 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00568 Filed 1-12-18; 8:45 am]
 BILLING CODE 4164-01-P