Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device Tracking, 48516-48519 [2017-22550]
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Federal Register / Vol. 82, No. 200 / Wednesday, October 18, 2017 / Notices
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:
Christian Hussong, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5261, Silver Spring,
MD 20993–0002, 240–402–2246,
Christian.Hussong@fda.hhs.gov or ELP
Management, ELP@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
ethrower on DSK3G9T082PROD with NOTICES
I. Background
CDRH is responsible for ensuring the
safety and effectiveness of medical
devices marketed in the United States.
Additionally, CDRH assures patients
and providers have timely and
continued access to high-quality, safe,
and effective medical devices. Since
CDRH has identified Partnering with
Patients and Promoting a Culture of
Quality and Organizational Excellence
as strategic priorities, for the 2018 ELP,
our goal is to specifically understand
the perspective of our stakeholders and
understand implementation of these
topics within their institutions. The
Center encourages applicants to
consider including opportunities to
discuss patient perspective and
incorporating quality system design and
management in their proposals as they
contribute to the success of the device
development life cycle.
CDRH is committed to advancing
regulatory science, providing industry
with predictable, consistent,
transparent, and efficient regulatory
pathways, and helping to ensure
consumer confidence in medical
devices marketed in the United States
and throughout the world. The ELP is
intended to provide CDRH and other
FDA staff with an opportunity to
understand the laboratory and
manufacturing practices, quality system
management, patient perspective/input,
and other challenges and how they
impact the medical device development
life cycle. ELP is a collaborative effort to
enhance communication with our
stakeholders to facilitate medical device
reviews. The Center is committed to
understanding current industry
practices, innovative technologies,
regulatory impacts and needs, and how
patient perspective and quality systems
management advances the development
and evaluation of medical devices, and
to monitor the performance of marketed
devices.
These formal training visits are not
intended for FDA to inspect, assess,
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judge, or perform a regulatory function
(e.g., compliance inspection), but rather,
they are an opportunity to provide
CDRH and other FDA staff a better
understanding of the products they
review, how they are developed, the
voice of the patient, challenges related
to quality systems development and
management in the product life cycle,
and how medical devices fit into the
larger health care system. CDRH is
formally requesting participation from
industry, academia, and clinical
facilities, medical device incubators and
accelerators, health technology
assessment groups, and those that have
previously participated in the ELP or
other FDA site visit programs.
Additional information regarding the
CDRH ELP, including the table of areas
of interest, submission dates, a sample
request, and an example of the site visit
agenda, is available on CDRH’s Web site
at: https://www.fda.gov/
scienceresearch/
sciencecareeropportunities/
ucm380676.htm.
II. CDRH ELP
A. Areas of Interest
In the ELP training program, groups of
CDRH and other FDA staff will observe
operations in the areas of research,
device development, in making
coverage decisions and assessments,
incorporating patient information and
reimbursement, manufacturing, and
health care facilities. The areas of
interest for visits include various topics
identified by managers at CDRH and
other areas within FDA. These areas of
interest are listed on the ELP Web site
and are intended to be updated
quarterly.
To submit a proposal addressing one
of the Center’s training needs, visit the
link for the table of areas of interest at:
https://www.fda.gov/ScienceResearch/
ScienceCareerOpportunities/
UCM380676.htm. Once you have
determined an area of interest to address
in your ELP proposal, follow the
instructions in section III to complete
the site visit request template and
agenda provided at: https://
www.fda.gov/downloads/
ScienceResearch/
ScienceCareerOpportunities/
UCM392988.pdf and at: https://
www.fda.gov/downloads/
ScienceResearch/
ScienceCareerOpportunities/
UCM487190.pdf.
Submit all proposals at ELP@
fda.hhs.gov within the dates provided at
the ELP Web site at: https://
www.fda.gov/scienceresearch/
PO 00000
Frm 00041
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sciencecareeropportunities/
ucm380676.htm.
B. Site Selection
CDRH and FDA will be responsible
for its own staff travel expenses
associated with the site visits. CDRH
and FDA will not provide funds to
support the training provided by the site
to the ELP. Selection of potential
facilities will be based on CDRH and
FDA’s priorities for staff training and
resources available to fund this
program. In addition to logistical and
other resource factors, all sites must
have a successful compliance record
with FDA or another Agency with
which FDA has a memorandum of
understanding (if applicable). If a site
visit involves a visit to a separate
physical location of another firm under
contract with the site, that firm must
agree to participate in the ELP and must
also have a satisfactory compliance
history, and must be listed in the
proposal along with a Facility
Establishment Identifier number, if
applicable.
III. Request To Participate
Information regarding the CDRH ELP,
including a sample request and an
example of a site visit agenda, and
submission dates is available on CDRH’s
Web site at: https://www.fda.gov/
scienceresearch/
sciencecareeropportunities/
ucm380676.htm. Proposals to
participate should be submitted to ELP@
fda.hhs.gov, within the dates provided,
at the ELP Web site at https://
www.fda.gov/scienceresearch/
sciencecareeropportunities/
ucm380676.htm.
Dated: October 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–22626 Filed 10–17–17; 8:45 am]
BILLING CODE 4164–01–P
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.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
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Federal Register / Vol. 82, No. 200 / Wednesday, October 18, 2017 / Notices
ethrower on DSK3G9T082PROD with NOTICES
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:
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• 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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
PO 00000
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48517
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, PRAStaff@
fda.hhs.gov.
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 § 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 § 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 § 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 § 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
Number of
responses per
respondent
Number of
respondents
Activity/21 CFR section
Average
burden per
response
Total annual
responses
Total hours
Discontinuation of business—821.1(d) ................................
Exemption or variance—821.2 and 821.30(e) .....................
Notification of failure to comply—821.25(d) ........................
Multiple distributor data—821.30(c)(2) ................................
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
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
recordkeepers
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Activity/21 CFR section
Tracking information—821.25(a) .........................................
Record of tracking data—821.25(b) ....................................
Standard operating procedures—821.25(c) 2 ......................
Manufacturer data audit—821.25(c)(3) ................................
Multiple distributor data and distributor tracking records—
821.30(c)(2) and (d) .........................................................
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Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
12
12
12
12
1
46,260
1
1,124
12
555,120
12
13,488
76
1
63
1
912
555,120
756
13,488
22,000
1
22,000
1
22,000
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Federal Register / Vol. 82, No. 200 / Wednesday, October 18, 2017 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
recordkeepers
Activity/21 CFR section
Total ..............................................................................
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
........................
........................
........................
........................
Total hours
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
respondents
Activity/21 CFR section
Acquisition of tracked devices and final distributor data—
821.30(a) and (b) .............................................................
Multiple distributor data and distributor tracking records—
821.30(c)(2) and (d) .........................................................
Total ..............................................................................
1
Total annual
disclosures
Average
burden per
disclosure
Total hours
22,000
1
22,000
1
22,000
1,100
1
1,100
1
1,100
........................
........................
........................
........................
23,100
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 §§ 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
ethrower on DSK3G9T082PROD with NOTICES
Number of
disclosures
per
respondent
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
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would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; SBIR/STTR
Applications in Drug Discovery and
Development.
Date: November 13, 2017.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Sergei Ruvinov, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4158,
MSC 7806, Bethesda, MD 20892, 301–435–
1180, ruvinser@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR PanelNeural Regulation of Cancer.
Date: November 13, 2017.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Manzoor Zarger, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6208,
MSC 7804, Bethesda, MD 20892, (301) 435–
2477, zargerma@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Vascular
and Hematology.
Date: November 13, 2017.
Time: 2:00 p.m. to 4:15 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Larry Pinkus, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
PO 00000
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Health, 6701 Rockledge Drive, Room 4132,
MSC 7802, Bethesda, MD 20892, (301) 435–
1214, pinkusl@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; ParasitesVectors and Fungi.
Date: November 14–15, 2017.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Fouad A El-Zaatari, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3186,
MSC 7808, Bethesda, MD 20892, (301) 435–
1149, elzaataf@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Biomaterials, Delivery, and Nanotechnology.
Date: November 14–15, 2017.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications and/or proposals.
Place: Hilton Washington DC/Rockville,
1750 Rockville Pike, Rockville, MD 20852.
Contact Person: Nitsa Rosenzweig, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4152,
MSC 7760, Bethesda, MD 20892, (301) 404–
7419, rosenzweign@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR 17–
094: Maximizing Investigator’s Research
Award (R35).
Date: November 14, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Maqsood A Wani, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2114,
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]]>Agencies
[Federal Register Volume 82, Number 200 (Wednesday, October 18, 2017)]
[Notices]
[Pages 48516-48519]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22550]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.gpo.gov/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,
PRAStaff@fda.hhs.gov.
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,
[[Page 48518]]
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\
----------------------------------------------------------------------------------------------------------------
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)...........
-------------------------------------------------------------------------------
[[Page 48519]]
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)...........
-------------------------------------------------------------------------------
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 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
