Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Approval of Medical Devices, 72063-72066 [2016-25232]
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for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the
biological becomes effective and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the human biological product and
continues until FDA grants permission
to market the biological product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of USPTO may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human biological product will include
all of the testing phase and approval
phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA has approved for marketing the
human biologic product PLEGRIDY
(peginterferon beta–1a). PLEGRIDY is
indicated for treatment of patients with
relapsing forms of multiple sclerosis.
Subsequent to this approval, the USPTO
received patent term restoration
applications for PLEGRIDY (U.S. Patent
Nos. 7,446,173; 8,017,733; and
8,524,660) from Biogen Idec MA Inc.,
and the USPTO requested FDA’s
assistance in determining the patents’
eligibility for patent term restoration. In
a letter dated October 15, 2015, FDA
advised the USPTO that this human
biological product had undergone a
regulatory review period and that the
approval of PLEGRIDY represented the
first permitted commercial marketing or
use of the product. Thereafter, the
USPTO requested that FDA determine
the product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
PLEGRIDY is 2,643 days. Of this time,
2,186 days occurred during the testing
phase of the regulatory review period,
while 457 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i))
became effective: May 23, 2007. FDA
has verified the applicant’s claim that
the date the investigational new drug
application became effective was on
May 23, 2007.
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2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): May 16, 2013. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
PLEGRIDY (BLA 125499) was initially
submitted on May 16, 2013.
3. The date the application was
approved: August 15, 2014. FDA has
verified the applicant’s claim that BLA
125499 was approved on August 15,
2014.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 1,284 days, 762
days, or 346 days of patent term
extension, respectively.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and ask for a redetermination
(see DATES). Furthermore, any interested
person may petition FDA for a
determination regarding whether the
applicant for extension acted with due
diligence during the regulatory review
period. To meet its burden, the petition
must be timely (see DATES) and contain
sufficient facts to merit an FDA
investigation. (See H. Rept. 857, part 1,
98th Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
Dated: October 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–25222 Filed 10–18–16; 8:45 am]
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72063
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0825]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Premarket
Approval of Medical Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
requirements for premarket approval of
medical devices.
DATES: Submit either electronic or
written comments on the collection of
information by December 19, 2016.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
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’’).
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Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2013–N–0825 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Premarket Approval of Medical
Devices’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
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 Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 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.
Premarket Approval of Medical
Devices—21 CFR part 814—OMB
Control Number 0910–0231—Extension
Under section 515 of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360e) all devices
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placed into class III by FDA are subject
to premarket approval requirements.
Premarket approval (PMA) is the
process of scientific and regulatory
review to ensure the safety and
effectiveness of class III devices. An
approved PMA is, in effect, a private
license granted to the applicant for
marketing a particular medical device.
A class III device that fails to meet PMA
requirements is considered to be
adulterated under section 501(f) of the
FD&C Act 21 U.S.C. 351(f)) and cannot
be marketed. Premarket approval
requirements apply differently to
preamendments devices,
postamendments devices, and
transitional class III devices.
Manufacturers of class III
preamendments devices, devices that
were in commercial distribution before
May 28, 1976, are not required to submit
a PMA until 30 months after the
issuance of a final classification
regulation or until 90 days after the
publication of a final regulation
requiring the submission of a PMA,
whichever period is later. FDA may
allow more than 90 days after issuance
of a final rule for submission of a PMA.
A postamendments device is one that
was first distributed commercially on or
after May 28, 1976. Postamendments
devices determined by FDA to be
substantially equivalent to
preamendments class III devices are
subject to the same requirements as the
preamendments devices. FDA
determines substantial equivalence after
reviewing an applicant’s premarket
notification submitted in accordance
with section 510(k) of the FD&C Act (21
U.S.C. 360(k)). Postamendments devices
determined by FDA to be not
substantially equivalent to either
preamendments devices or
postamendments devices classified into
class I or II are ‘‘new’’ devices and fall
automatically into class III. Before such
devices can be marketed, they must
have an approved premarket approval
application or be must reclassified into
class I or class II.
The Food and Drug Modernization
Act of 1997 (FDAMA) (Pub. L. 105–115)
was enacted on November 21, 1997, to
implement revisions to the FD&C Act by
streamlining the process of bringing safe
and effective drugs, medical devices,
and other therapies to the U.S. market.
FDAMA added section 515(d)(6) to the
FD&C Act, which provided that PMA
supplements were required for all
device changes that affect safety and
effectiveness unless such changes are
modifications to manufacturing
procedures or method of manufacture.
That type of manufacturing change will
require a 30-day notice, or where FDA
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finds such notice inadequate, a 135-day
PMA supplement.
The implementing regulations,
contained in part 814 (21 CFR part 814),
further specify the contents of a PMA
for a medical device and the criteria
FDA will employ in approving, denying,
or withdrawing approval of a PMA and
supplements to PMAs. The regulations’
purpose is to establish an efficient and
thorough procedure for FDA’s review of
PMAs and supplements to PMAs for
class III medical devices. The
regulations facilitate the approval of
PMAs and supplements to PMAs for
devices that have been shown to be
reasonably safe and effective and
otherwise meet the statutory criteria for
approval. The regulations also ensure
the denial of PMAs and supplements to
PMAs for devices that have not been
shown to be reasonably safe and
effective and that do not otherwise meet
the statutory criteria for approval.
The industry-wide burden estimate
for PMAs is based on an FDA average
fiscal year (FY) annual rate of receipt of
PMA submissions data FY 2013 through
2015 and our expectation of
submissions to come in the next few
years. The burden data for PMAs is
based on data provided by applicants by
device type and cost element in an
earlier study.
Reporting Burden: The reporting
burden can be broken out by certain
sections of the PMA regulations and the
FD&C Act as follows:
§ 814.15(b)—Research Conducted
Outside the United States. Each foreign
study should be performed in
accordance with the ‘‘Declaration of
Helsinki’’ or the laws and regulations of
the country in which the study was
conducted. If the study was conducted
in accordance with the laws of the
country, the PMA applicant is required
to explain to FDA in detail the
differences between the laws of the
country and the ‘‘Declaration of
Helsinki.’’ Based on the number of
PMAs received that contained studies
from overseas, FDA estimates that the
burden estimate necessary to meet this
requirement is 50 hours.
§ 814.20—Application. Included in
this requirement are the conduct of
laboratory and clinical trials as well as
the analysis, review, and physical
preparation of the PMA application.
FDA estimates that 35 applicants,
including hospital re-manufacturers of
single-use devices, will be affected by
these requirements which are based on
the actual average of FDA receipt of new
PMA applications in FY 2013 through
2015. FDA’s estimate of the hours per
response (668) was derived through
FDA’s experience and consultation with
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industry and trade associations. In
addition, FDA also based its estimate on
the results of an earlier study that
accounts for the bulk of the hourly
burden for this requirement, which is
identified by applicants.
§ 814.37(a) through (c) and (e)—PMA
Amendments and Resubmitted PMAs.
As part of the review process, FDA often
requests the PMA applicant to submit
additional information regarding the
device necessary for FDA to file the
PMA or to complete its review and
make a final decision. The PMA
applicant may, also on their own
initiative, submit additional information
to FDA during the review process.
These amendments contain information
ranging from additional test results, reanalysis of the original data set, to
revised device labeling. Almost all
PMAs received by the Agency have
amendments submitted during the
review process.
§ 814.39(a)—PMA Supplements. This
information collection includes the
requirements for the range of PMA
supplements (panel track, 180-day feebased, 180-day non-fee based, and realtime supplements).
§ 814.39(d)—Special PMA
Supplements—Changes Being Affected.
This type of supplement is intended to
enhance the safety of the device or the
safe use of the device. The number of
PMA supplements received that fit this
category averaged 88 per year based on
the numbers received from FY 2013
through FY 2015. Because of the
minimal data required to be included in
this type of supplement, FDA estimates
that the burden hours necessary to
satisfy this requirement are 528 hours.
§ 814.39(f)—30-Day Notice. Under
section 515(d) of the FD&C Act,
modifications to manufacturing
procedures or methods of manufacture
that affect the safety and effectiveness of
a device subject to an approved PMA do
not require submission of a PMA
supplement under paragraph (a) of this
section and are eligible to be the subject
of a 30-day notice. A 30-day notice shall
describe in detail the change,
summarize the data or information
supporting the change, and state that the
change has been made in accordance
with the requirements of part 820 (21
CFR part 820). The applicant may
distribute the device 30 days after the
date on which FDA receives the 30-day
notice, unless FDA notifies the
applicant within 30 days from receipt of
the notice, that it is not adequate.
§ 814.82(a)(9)—Postapproval
Requirements. Postapproval
requirements concerns approved PMAs
that were not reclassified and require a
periodic report. After approval, all
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PMAs require a submission of an annual
report. A majority of the submitted
PMAs require associated postapproval
studies, i.e., followup of patients used in
clinical trials to support the PMA or
additional preclinical information that
is labor-intensive to compile and
complete; the remaining PMAs require
minimal information.
§ 814.84(b)—Periodic Reports.
Postapproval requirements described in
§ 814.82(a)(7) require submission of an
annual report for each approved PMA.
FDA estimates that respondents will
average about 10 hours in preparing
their reports to meet this requirement.
This estimate is based on FDA’s
experience and consultation with
industry.
Expedited or Priority Review—Section
515(d)(5) of the FD&C Act. FDA will
provide special review, which can
include expedited processing of a PMA
application, for certain devices intended
to treat or diagnose life threatening or
irreversibly debilitating diseases or
conditions. To receive special review,
the devices must meet one of the
following criteria:
• The device represents a
breakthrough technology;
• There are no approved alternatives;
• The use of the device offers
significant advantages over existing
approved alternatives;
• Availability is in the best interest of
the patients.
Agreement Meeting—Section 520(g)(7)
of the FD&C Act (21 U.S.C. 360j(g)(7)).
Applicants planning to submit a PMA
may submit a written request to reach
agreement with FDA on the key
parameters of the investigational plan.
Determination Meeting—Section
513(a)(3)(D) of the FD&C Act (21 U.S.C.
360c(a)(3)(D)). Applicants planning to
submit a PMA may submit a written
request to FDA for a meeting to
determine the type of information (valid
scientific evidence) necessary to support
the effectiveness of their device.
Panel of Experts—Section 515(c)(3) of
the FD&C Act. An original PMA or
panel track PMA supplement is taken to
an advisory panel of experts unless FDA
determines that the information in the
application substantially duplicates
information which has previously been
reviewed by the panel.
Day 100 Meeting—Section 515(d)(3)
of the FD&C Act. FDA must, upon the
written request of the applicant, meet
with that party within 100 days of
receipt of the filed PMA application to
discuss the review status of the
application. With the concurrence of the
applicant, a different schedule may be
established. Prior to this meeting, FDA
must inform the applicant in writing of
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any identified deficiencies and what
information is required to correct those
deficiencies. FDA must also promptly
notify the applicant if FDA identifies
additional deficiencies or of any
additional information required to
complete Agency review.
Recordkeeping
§ 814.82(a)(5) and (a)(6)—
Maintenance of Records. The
recordkeeping burden under this section
requires the maintenance of records,
used to trace patients and the
organization and indexing of records
into identifiable files to ensure the
device’s continued safety and
effectiveness. These records are required
of all applicants who have an approved
PMA.
PMAs have been required since 1976,
and there are 725 active PMAs that
could be subject to these requirements,
based on actual FDA data, and
approximately 30 new PMAs are
approved every year. The aggregate
burden for the estimated 422 PMA
holders of approved original PMAs for
the next few years is estimated to be
7,174 hours.
The applicant determines which
records should be maintained during
product development to document and/
or substantiate the device’s safety and
effectiveness. Records required by the
current good manufacturing practices
for medical devices regulation (21 CFR
part 820) may be relevant to a PMA
review and may be submitted as part of
an application. In individual instances,
records may be required as conditions of
approval to ensure the device’s
continuing safety and effectiveness.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity/21 CFR or FD&C Act section
Research conducted outside the United States (814.15(b))
PMA application (814.20) ....................................................
PMA amendments and resubmitted PMAs (814.37(a)–(c)
and (e)) .............................................................................
PMA supplements (814.39(a)) .............................................
Special PMA supplement—changes being affected
(814.39(d)) ........................................................................
30-day notice (814.39(f)) .....................................................
Postapproval requirements (814.82(a)(9)) ...........................
Periodic reports (814.84(b)) .................................................
Agreement meeting (520(g)(7)) ...........................................
Expedited review request (515(d)(5) of the FD&C Act) ......
Determination Meeting (513(1)(3)(D) of the FD&C Act) ......
Panel meeting (515(c)(3) of the FD&C Act) ........................
Day 100 meeting (515(d)(3) of the FD&C Act) ...................
Total ..............................................................................
1 There
Number of
responses
per
respondent
Total annual
responses
Average
burden per
response
Total hours
25
35
1
1
25
35
2
668
50
23,380
1,222
695
1
1
1,222
695
167
60
204,074
41,700
88
1,710
340
695
1
6
1
9
19
1
1
1
1
1
1
1
1
1
88
1,710
340
695
1
6
1
9
19
6
16
135
10
50
10
50
30
10
528
27,360
45,900
6,950
50
60
50
270
190
........................
........................
........................
........................
350,562
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity/21 CFR section
Number of
recordkeepers
Number of
records
per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Maintenance of records (814.82(a)(5) and (a)(6)) ...............
422
1
422
17
7,174
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
ACTION:
Authority: 42 U.S.C. 217a, Section 222 of
the Public Health Service Act, as amended.
The Committee is governed by the provisions
of Public Law 92–463, as amended (5 U.S.C.
App. 2), which sets forth standards for the
formation and use of advisory committees.
[FR Doc. 2016–25232 Filed 10–18–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Department of Health and
Human Services, Office of the Secretary,
Office of the Assistant Secretary for
Health.
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The Office of the Assistant
Secretary for Health (OASH), within the
Department of Health and Human
Services (HHS), is seeking nominations
of qualified candidates to be considered
for appointment as members of the
Chronic Fatigue Syndrome Advisory
Committee (CFSAC). CFSAC provides
advice and recommendations to the
Secretary of HHS, through the Assistant
SUMMARY:
Solicitation for Applications From
Individuals Interested in Being
Appointed to the Chronic Fatigue
Syndrome Advisory Committee
AGENCY:
Notice.
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Secretary for Health (ASH), on a broad
range of issues and topics related to
myalgic encephalomyelitis/chronic
fatigue syndrome (ME/CFS). The
appointments of two Committee
members are scheduled to end during
the 2016 calendar year. Nominations of
qualified candidates are being sought to
fill the positions that are scheduled to
be vacated.
DATES: Applications for individuals to
be considered for appointment to the
Committee must be received no later
than 5 p.m. EDT on November 18, 2016
at the address listed below.
ADDRESSES: All nominations should be
mailed or delivered to Commander,
(CDR) Gustavo Seinos, MPH, Designated
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]]>Agencies
[Federal Register Volume 81, Number 202 (Wednesday, October 19, 2016)]
[Notices]
[Pages 72063-72066]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25232]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0825]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Premarket Approval of Medical Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 requirements for premarket
approval of medical devices.
DATES: Submit either electronic or written comments on the collection
of information by December 19, 2016.
ADDRESSES: You may submit comments as follows:
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'').
[[Page 72064]]
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2013-N-0825 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Premarket Approval of Medical
Devices'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Division of Dockets Management
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 Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 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.
Premarket Approval of Medical Devices--21 CFR part 814--OMB Control
Number 0910-0231--Extension
Under section 515 of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360e) all devices placed into class III by FDA are
subject to premarket approval requirements. Premarket approval (PMA) is
the process of scientific and regulatory review to ensure the safety
and effectiveness of class III devices. An approved PMA is, in effect,
a private license granted to the applicant for marketing a particular
medical device. A class III device that fails to meet PMA requirements
is considered to be adulterated under section 501(f) of the FD&C Act 21
U.S.C. 351(f)) and cannot be marketed. Premarket approval requirements
apply differently to preamendments devices, postamendments devices, and
transitional class III devices.
Manufacturers of class III preamendments devices, devices that were
in commercial distribution before May 28, 1976, are not required to
submit a PMA until 30 months after the issuance of a final
classification regulation or until 90 days after the publication of a
final regulation requiring the submission of a PMA, whichever period is
later. FDA may allow more than 90 days after issuance of a final rule
for submission of a PMA.
A postamendments device is one that was first distributed
commercially on or after May 28, 1976. Postamendments devices
determined by FDA to be substantially equivalent to preamendments class
III devices are subject to the same requirements as the preamendments
devices. FDA determines substantial equivalence after reviewing an
applicant's premarket notification submitted in accordance with section
510(k) of the FD&C Act (21 U.S.C. 360(k)). Postamendments devices
determined by FDA to be not substantially equivalent to either
preamendments devices or postamendments devices classified into class I
or II are ``new'' devices and fall automatically into class III. Before
such devices can be marketed, they must have an approved premarket
approval application or be must reclassified into class I or class II.
The Food and Drug Modernization Act of 1997 (FDAMA) (Pub. L. 105-
115) was enacted on November 21, 1997, to implement revisions to the
FD&C Act by streamlining the process of bringing safe and effective
drugs, medical devices, and other therapies to the U.S. market. FDAMA
added section 515(d)(6) to the FD&C Act, which provided that PMA
supplements were required for all device changes that affect safety and
effectiveness unless such changes are modifications to manufacturing
procedures or method of manufacture. That type of manufacturing change
will require a 30-day notice, or where FDA
[[Page 72065]]
finds such notice inadequate, a 135-day PMA supplement.
The implementing regulations, contained in part 814 (21 CFR part
814), further specify the contents of a PMA for a medical device and
the criteria FDA will employ in approving, denying, or withdrawing
approval of a PMA and supplements to PMAs. The regulations' purpose is
to establish an efficient and thorough procedure for FDA's review of
PMAs and supplements to PMAs for class III medical devices. The
regulations facilitate the approval of PMAs and supplements to PMAs for
devices that have been shown to be reasonably safe and effective and
otherwise meet the statutory criteria for approval. The regulations
also ensure the denial of PMAs and supplements to PMAs for devices that
have not been shown to be reasonably safe and effective and that do not
otherwise meet the statutory criteria for approval.
The industry-wide burden estimate for PMAs is based on an FDA
average fiscal year (FY) annual rate of receipt of PMA submissions data
FY 2013 through 2015 and our expectation of submissions to come in the
next few years. The burden data for PMAs is based on data provided by
applicants by device type and cost element in an earlier study.
Reporting Burden: The reporting burden can be broken out by certain
sections of the PMA regulations and the FD&C Act as follows:
Sec. 814.15(b)--Research Conducted Outside the United States. Each
foreign study should be performed in accordance with the ``Declaration
of Helsinki'' or the laws and regulations of the country in which the
study was conducted. If the study was conducted in accordance with the
laws of the country, the PMA applicant is required to explain to FDA in
detail the differences between the laws of the country and the
``Declaration of Helsinki.'' Based on the number of PMAs received that
contained studies from overseas, FDA estimates that the burden estimate
necessary to meet this requirement is 50 hours.
Sec. 814.20--Application. Included in this requirement are the
conduct of laboratory and clinical trials as well as the analysis,
review, and physical preparation of the PMA application. FDA estimates
that 35 applicants, including hospital re-manufacturers of single-use
devices, will be affected by these requirements which are based on the
actual average of FDA receipt of new PMA applications in FY 2013
through 2015. FDA's estimate of the hours per response (668) was
derived through FDA's experience and consultation with industry and
trade associations. In addition, FDA also based its estimate on the
results of an earlier study that accounts for the bulk of the hourly
burden for this requirement, which is identified by applicants.
Sec. 814.37(a) through (c) and (e)--PMA Amendments and Resubmitted
PMAs. As part of the review process, FDA often requests the PMA
applicant to submit additional information regarding the device
necessary for FDA to file the PMA or to complete its review and make a
final decision. The PMA applicant may, also on their own initiative,
submit additional information to FDA during the review process. These
amendments contain information ranging from additional test results,
re-analysis of the original data set, to revised device labeling.
Almost all PMAs received by the Agency have amendments submitted during
the review process.
Sec. 814.39(a)--PMA Supplements. This information collection
includes the requirements for the range of PMA supplements (panel
track, 180-day fee-based, 180-day non-fee based, and real-time
supplements).
Sec. 814.39(d)--Special PMA Supplements--Changes Being Affected.
This type of supplement is intended to enhance the safety of the device
or the safe use of the device. The number of PMA supplements received
that fit this category averaged 88 per year based on the numbers
received from FY 2013 through FY 2015. Because of the minimal data
required to be included in this type of supplement, FDA estimates that
the burden hours necessary to satisfy this requirement are 528 hours.
Sec. 814.39(f)--30-Day Notice. Under section 515(d) of the FD&C
Act, modifications to manufacturing procedures or methods of
manufacture that affect the safety and effectiveness of a device
subject to an approved PMA do not require submission of a PMA
supplement under paragraph (a) of this section and are eligible to be
the subject of a 30-day notice. A 30-day notice shall describe in
detail the change, summarize the data or information supporting the
change, and state that the change has been made in accordance with the
requirements of part 820 (21 CFR part 820). The applicant may
distribute the device 30 days after the date on which FDA receives the
30-day notice, unless FDA notifies the applicant within 30 days from
receipt of the notice, that it is not adequate.
Sec. 814.82(a)(9)--Postapproval Requirements. Postapproval
requirements concerns approved PMAs that were not reclassified and
require a periodic report. After approval, all PMAs require a
submission of an annual report. A majority of the submitted PMAs
require associated postapproval studies, i.e., followup of patients
used in clinical trials to support the PMA or additional preclinical
information that is labor-intensive to compile and complete; the
remaining PMAs require minimal information.
Sec. 814.84(b)--Periodic Reports. Postapproval requirements
described in Sec. 814.82(a)(7) require submission of an annual report
for each approved PMA. FDA estimates that respondents will average
about 10 hours in preparing their reports to meet this requirement.
This estimate is based on FDA's experience and consultation with
industry.
Expedited or Priority Review--Section 515(d)(5) of the FD&C Act.
FDA will provide special review, which can include expedited processing
of a PMA application, for certain devices intended to treat or diagnose
life threatening or irreversibly debilitating diseases or conditions.
To receive special review, the devices must meet one of the following
criteria:
The device represents a breakthrough technology;
There are no approved alternatives;
The use of the device offers significant advantages over
existing approved alternatives;
Availability is in the best interest of the patients.
Agreement Meeting--Section 520(g)(7) of the FD&C Act (21 U.S.C.
360j(g)(7)). Applicants planning to submit a PMA may submit a written
request to reach agreement with FDA on the key parameters of the
investigational plan.
Determination Meeting--Section 513(a)(3)(D) of the FD&C Act (21
U.S.C. 360c(a)(3)(D)). Applicants planning to submit a PMA may submit a
written request to FDA for a meeting to determine the type of
information (valid scientific evidence) necessary to support the
effectiveness of their device.
Panel of Experts--Section 515(c)(3) of the FD&C Act. An original
PMA or panel track PMA supplement is taken to an advisory panel of
experts unless FDA determines that the information in the application
substantially duplicates information which has previously been reviewed
by the panel.
Day 100 Meeting--Section 515(d)(3) of the FD&C Act. FDA must, upon
the written request of the applicant, meet with that party within 100
days of receipt of the filed PMA application to discuss the review
status of the application. With the concurrence of the applicant, a
different schedule may be established. Prior to this meeting, FDA must
inform the applicant in writing of
[[Page 72066]]
any identified deficiencies and what information is required to correct
those deficiencies. FDA must also promptly notify the applicant if FDA
identifies additional deficiencies or of any additional information
required to complete Agency review.
Recordkeeping
Sec. 814.82(a)(5) and (a)(6)--Maintenance of Records. The
recordkeeping burden under this section requires the maintenance of
records, used to trace patients and the organization and indexing of
records into identifiable files to ensure the device's continued safety
and effectiveness. These records are required of all applicants who
have an approved PMA.
PMAs have been required since 1976, and there are 725 active PMAs
that could be subject to these requirements, based on actual FDA data,
and approximately 30 new PMAs are approved every year. The aggregate
burden for the estimated 422 PMA holders of approved original PMAs for
the next few years is estimated to be 7,174 hours.
The applicant determines which records should be maintained during
product development to document and/or substantiate the device's safety
and effectiveness. Records required by the current good manufacturing
practices for medical devices regulation (21 CFR part 820) may be
relevant to a PMA review and may be submitted as part of an
application. In individual instances, records may be required as
conditions of approval to ensure the device's continuing safety and
effectiveness.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR or FD&C Act Number of responses per Total annual Average burden Total hours
section respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Research conducted outside the 25 1 25 2 50
United States (814.15(b))......
PMA application (814.20)........ 35 1 35 668 23,380
PMA amendments and resubmitted 1,222 1 1,222 167 204,074
PMAs (814.37(a)-(c) and (e))...
PMA supplements (814.39(a))..... 695 1 695 60 41,700
Special PMA supplement--changes 88 1 88 6 528
being affected (814.39(d)).....
30-day notice (814.39(f))....... 1,710 1 1,710 16 27,360
Postapproval requirements 340 1 340 135 45,900
(814.82(a)(9)).................
Periodic reports (814.84(b)).... 695 1 695 10 6,950
Agreement meeting (520(g)(7))... 1 1 1 50 50
Expedited review request 6 1 6 10 60
(515(d)(5) of the FD&C Act)....
Determination Meeting 1 1 1 50 50
(513(1)(3)(D) of the FD&C Act).
Panel meeting (515(c)(3) of the 9 1 9 30 270
FD&C Act)......................
Day 100 meeting (515(d)(3) of 19 1 19 10 190
the FD&C Act)..................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 350,562
----------------------------------------------------------------------------------------------------------------
\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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maintenance of records (814.82(a)(5) and (a)(6))................... 422 1 422 17 7,174
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25232 Filed 10-18-16; 8:45 am]
BILLING CODE 4164-01-P
