Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Approval of Medical Devices, 65339-65341 [2013-25960]
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Number of
respondents
21 CFR section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
320.31(d) Bioavailability and Bioequivalence Safety Reports ..................................................................................
312.32(c)(1)(ii) and (c)(1)(iii)—IND Safety Reports 2 ...........
312.32(c)(1)(iv)—IND Safety Reports 3 ...............................
10
100
10
20
6
1
200
600
10
14
12
12
2,800
7,200
120
Total ..............................................................................
........................
........................
........................
........................
10,120
1 There
are no capital costs or operating and maintenance costs associated with this collection of information. The estimates are for the additional burdens beyond those already approved for current §§ 312.32 and 312.64.
2 Includes reports based on findings suggesting a significant risk in humans from epidemiological studies, pooled analysis of multiple studies,
other clinical studies, or in vitro testing. Reports from animal testing are not included.
3 Includes reports of clinically important increases in the rate of occurrence of serious, expected suspected adverse reactions.
Dated: October 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2013–25959 Filed 10–30–13; 8:45 am]
BILLING CODE 4160–01–P
Premarket Approval of Medical
Devices—(OMB Control Number 0910–
0231)—Extension
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0825]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Premarket
Approval of Medical Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by December
2, 2013.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0231. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
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SUMMARY:
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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
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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
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
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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 actual
average fiscal year (FY) annual rate of
receipt of PMA submissions data FY
2010 through 2012 and our expectations
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:
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. FDA estimates that
20,040 burden hours are necessary to
satisfy this requirement.
§ 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.
§ 814.39(d)—Special PMA
Supplements—Changes Being Affected
This type of supplements 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 80 per year based
on the numbers received from FY 2010
through FY 2012. 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 480 hours.
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§ 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 40
applicants, including hospital remanufacturers 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 2010 through 2012. 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 which 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.
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§ 814.39(a)—PMA Supplements
FDA believes that 39,000 burden
hours are needed to complete the
requirements for the range of PMA
supplements (180-day fee-based, 180day non-fee based, and real-time
supplements).
§ 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. FDA
estimates the burden to satisfy this
requirement is 24,000 hours.
§ 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 laborintensive to compile and complete; the
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remaining PMAs require minimal
information. Based on experience and
consultation with industry, FDA has
estimated that preparation of reports
and information required by this section
requires 31,050 hours.
§ 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. Thus, FDA estimates that the
periodic reporting burden required by
this section will take 6,000 hours.
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
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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 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 556 active PMAs that
could be subject to these requirements,
based on actual FDA data, and
approximately 25 new PMAs are
approved every year. The aggregate
burden for the estimated 600 PMA
holders of approved original PMAs for
the next few years is estimated to be
10,200 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.
In the Federal Register of July 23,
2013 (78 FR 44128), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
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
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
25
40
1
1
25
40
2
668
50
26,720
120
650
1
1
120
650
167
60
20,040
39,000
80
1,500
230
600
3
5
5
10
10
1
1
1
1
1
1
1
1
1
80
1,500
230
600
3
5
5
10
10
6
16
135
10
50
10
50
30
10
480
24,000
31,050
6,000
150
50
250
300
100
........................
........................
........................
........................
148,190
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
Activity/21 CFR section
Maintenance of records (814.82(a)(5) and (a)(6)) ...............
1 There
Number of
records per
recordkeeper
600
1
600
Average
burden per
recordkeeping
17
Total hours
10,200
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–25960 Filed 10–30–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Discretionary Grant Funds
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Total annual
records
Health Resources and Services
Administration (HRSA), HHS.
AGENCY:
Notice of Deviation: NonCompetitive Expansion Supplement
Funds to the Healthcare Systems Bureau
(HSB).
ACTION:
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HRSA will be issuing a noncompetitive award to the Children’s
Hospital of Alabama’s Regional Poison
Control Center. The 11-month award for
$126,144 will be made available in the
form of a supplement to grant funds to
the organization’s current grant,
H4BHS15500. Effective October 1, 2013,
the Regional Poison Control Center will
be Alabama’s sole poison control center.
The center’s responsibility to provide
poisoning triage and treatment to half
the state will be expanded to the entire
state. The grant supplement will allow
SUMMARY:
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]]>Agencies
[Federal Register Volume 78, Number 211 (Thursday, October 31, 2013)]
[Notices]
[Pages 65339-65341]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-25960]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0825]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Premarket Approval of
Medical Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
December 2, 2013.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0231.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Premarket Approval of Medical Devices--(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 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
[[Page 65340]]
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
actual average fiscal year (FY) annual rate of receipt of PMA
submissions data FY 2010 through 2012 and our expectations 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 40 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 2010 through 2012. 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 which 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. FDA
estimates that 20,040 burden hours are necessary to satisfy this
requirement.
Sec. 814.39(a)--PMA Supplements
FDA believes that 39,000 burden hours are needed to complete the
requirements for the range of PMA supplements (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 supplements 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 80 per year based on the
numbers received from FY 2010 through FY 2012. 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 480
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. FDA
estimates the burden to satisfy this requirement is 24,000 hours.
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. Based on
experience and consultation with industry, FDA has estimated that
preparation of reports and information required by this section
requires 31,050 hours.
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. Thus, FDA estimates that the periodic
reporting burden required by this section will take 6,000 hours.
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
[[Page 65341]]
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 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 556 active PMAs
that could be subject to these requirements, based on actual FDA data,
and approximately 25 new PMAs are approved every year. The aggregate
burden for the estimated 600 PMA holders of approved original PMAs for
the next few years is estimated to be 10,200 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.
In the Federal Register of July 23, 2013 (78 FR 44128), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity/21 CFR or FD&C act Number of responses per Total annual burden per Total hours
section respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Research conducted outside the 25 1 25 2 50
United States (814.15(b))......
PMA application (814.20)........ 40 1 40 668 26,720
PMA amendments and resubmitted 120 1 120 167 20,040
PMAs (814.37(a)-(c) and (e))...
PMA supplements (814.39(a))..... 650 1 650 60 39,000
Special PMA supplement--changes 80 1 80 6 480
being affected (814.39(d)).....
30-day notice (814.39(f))....... 1,500 1 1,500 16 24,000
Postapproval requirements 230 1 230 135 31,050
(814.82(a)(9)).................
Periodic reports (814.84(b)).... 600 1 600 10 6,000
Agreement meeting (520(g)(7))... 3 1 3 50 150
Expedited review request 5 1 5 10 50
(515(d)(5) of the FD&C Act)....
Determination Meeting 5 1 5 50 250
(513(1)(3)(D) of the FD&C Act).
Panel meeting (515(c)(3) of the 10 1 10 30 300
FD&C Act)......................
Day 100 meeting (515(d)(3) of 10 1 10 10 100
the FD&C Act)..................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 148,190
----------------------------------------------------------------------------------------------------------------
\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
Activity/21 CFR section Number of records per Total annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Maintenance of records 600 1 600 17 10,200
(814.82(a)(5) and (a)(6))......
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: October 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-25960 Filed 10-30-13; 8:45 am]
BILLING CODE 4160-01-P
