82 FR 48516 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device Tracking

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 200 (October 18, 2017)

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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.

[Federal Register Volume 82, Number 200 (Wednesday, October 18, 2017)]
[Notices]
[Pages 48516-48519]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-22550]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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 or Agency) is

[[Page 48517]]

announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (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 December 18, 2017.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before December 18, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of December 18, 2017. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-N-5569 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Medical Devices; Device 
Tracking.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[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 
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,

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Drug, and Cosmetic Act (the 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) 
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 which 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.
    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 section         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.


                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                     Number of                    Average burden
     Activity/21 CFR section         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 section         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)...........
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          23,100
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\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 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 0910-0191.

    Dated: October 11, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-22550 Filed 10-17-17; 8:45 am]
 BILLING CODE 4164-01-P