Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Approval of Medical Devices, 7839-7841 [2017-01188]
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Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Notices
immunogenicity safety data, FDA
cannot conclude that ACTHAR GEL
SYNTHETIC would be safe for human
use if it were introduced to the market
today.
Accordingly, the Agency will remove
ACTHAR GEL SYNTHETIC (seractide
acetate) injection, 80 units/mL and 40
units/mL, from the list of drug products
published in the Orange Book. FDA will
not accept or approve ANDAs that refer
to this drug product.
III. References
The following references have been
placed on display in the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,
and are available for viewing by
interested persons between 9 a.m. and 4
p.m., Monday through Friday; they are
also available electronically at https://
www.regulations.gov.
1. Armour Pharmaceutical Co., ‘‘ACTHAR®
Gel Synthetic (SERACTIDE ACETATE),
Synthetic Corticotropin,’’ Product
Labeling, 1979.
2. Lee, T. H., A. B. Lerner, and V. BuettnerJanusch, ‘‘On the Structure of Human
Corticotropin (Adrenocorticotropic
Hormone),’’ The Journal of Biological
Chemistry, vol. 236, pp. 2970–2974,
1961.
3. FDA, ‘‘Seractide Acetate: Institutional
Summary of Basis of Approval,’’ August
22, 1977.
Dated: January 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–01249 Filed 1–19–17; 8:45 am]
BILLING CODE 4164–01–P
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 February
22, 2017.
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
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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, Three White
Flint North 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
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.
ADDRESSES:
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 (PMA)
requirements. 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.
PMA 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
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Fmt 4703
Sfmt 4703
7839
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 PMA 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 (21 U.S.C. 360e(d)(6)), 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 30day 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
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 FYs 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
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Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Notices
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 is 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 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 FYs 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.
§ 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 and
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.
§ 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
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category averaged 88 per year based on
the numbers received from FYs 2013
through 2015. Because of the minimal
data required to be included in this type
of supplement, FDA estimates that the
number of burden hours necessary to
satisfy this requirement is 528.
§ 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
PMAs require a submission of an annual
report. A majority of the submitted
PMAs require associated post-approval
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; or
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• 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
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
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Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Notices
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 October 19,
2016 (81 FR 72063), 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 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
responses
Average
burden per
response
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: January 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
would constitute a clearly unwarranted
invasion of personal privacy.
[FR Doc. 2017–01188 Filed 1–19–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
mstockstill on DSK3G9T082PROD with NOTICES
National Institute on Drug Abuse;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App), notice is
hereby given of the following meeting.
The meeting 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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
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19:02 Jan 19, 2017
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Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; Virtual
Reality Tools to Enhance Evidence-Based
Treatment of Substance Use Disorders (5583).
Date: February 1, 2017.
Time: 8:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Gerald L. McLaughlin,
Ph.D., Scientific Review Officer, Office of
Extramural Policy and Review, National
Institute on Drug Abuse, NIH, DHHS, 6001
Executive Blvd., Room 4238, MSC 9550,
Bethesda, MD 20892–9550, 301–827–5819,
gm145a@nih.gov.
(Catalogue of Federal Domestic Assistance
Program No.: 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health, HHS)
PO 00000
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Dated: January 13, 2017.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–01253 Filed 1–19–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting 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
E:\FR\FM\23JAN1.SGM
23JAN1
]]>Agencies
[Federal Register Volume 82, Number 13 (Monday, January 23, 2017)]
[Notices]
[Pages 7839-7841]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-01188]
-----------------------------------------------------------------------
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
February 22, 2017.
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, Three White Flint North 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 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 (PMA) requirements. 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. PMA 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 PMA
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 (21 U.S.C. 360e(d)(6)), 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 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
FYs 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
[[Page 7840]]
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 is 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 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 FYs 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 and
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 FYs 2013 through 2015. Because of the minimal data
required to be included in this type of supplement, FDA estimates that
the number of burden hours necessary to satisfy this requirement is
528.
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 post-approval 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; or
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 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
[[Page 7841]]
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 October 19, 2016 (81 FR 72063), 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)........ 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
Activity/21 CFR section Number of records per Total annual Average burden Total hours
recordkeepers recordkeeper responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
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: January 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-01188 Filed 1-19-17; 8:45 am]
BILLING CODE 4164-01-P
