Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Approval of Medical Devices, 58396-58399 [2010-23912]
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58396
Federal Register / Vol. 75, No. 185 / Friday, September 24, 2010 / Notices
E-mail comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–33,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments
should be received within 60 days of
this notice.
Dated: September 16, 2010.
Sahira Rafiullah,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2010–23894 Filed 9–23–10; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Child Care and Development
Fund Plan for States/Territories for FFY
2012–2013 (ACF–118).
OMB No.: 0970–0114.
Description: The Child Care and
Development Fund (CCDF) Plan (the
Plan) for States and Territories is
required from each CCDF Lead agency
in accordance with Section 658E of the
Child Care and Development Block
Grant Act of 1990, as amended (Pub. L.
101–508, Pub. L. 104–193, and 42 U.S.C.
9858). The implementing regulations for
the statutorily required Plan are set forth
at 45 CFR 98.10 through 98.18. The
Plan, submitted on the ACF–118, is
required biennially, and remains in
effect for two years. The Plan provides
ACF and the public with a description
of, and assurance about, the States or
the Territories child care program. The
ACF–118 is currently approved through
April 30, 2012, making it available to
States and Territories needing to submit
Plan Amendments through the end of
the FY 2011 Plan Period. However, on
July 1, 2011, States and Territories will
be required to submit their FY 2012–
2013 Plans for approval by September
30, 2011. Consistent with the statute
and regulations, ACF requests extension
of the ACF–118 with minor corrections
and modifications. The Tribal Plan
(ACF–118a) is not affected by this
notice.
Respondents: State and Territorial
CCDF Lead Agencies.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
ACF–118 ..........................................................................................................
srobinson on DSKHWCL6B1PROD with NOTICES
Instrument
56
0.50
162.50
4,550
Estimated Total Annual Burden
Hours: 4,550.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
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other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: September 20, 2010.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2010–23889 Filed 9–23–10; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0250]
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.
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
Fax written comments on the
collection of information by October 25,
2010.
DATES:
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 e-mailed 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.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
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:
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srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 185 / Friday, September 24, 2010 / Notices
Premarket Approval of Medical
Devices—21 CFR Part 814/Food and
Drug Administration Modernization
Act of 1997 (FDAMA) Sections 201, 202,
205, 208, and 209 (OMB Control
Number 0910–0231)—Extension
Section 515 of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
360e) sets forth the requirements for
premarket approval of certain class III
medical devices. Class III devices are
either pre-amendments devices that
have been classified into class III, or
post-amendments devices which are not
substantially equivalent to a preamendments device, or transitional
devices. Class III devices are devices
such as implants, life sustaining or life
supporting devices, and/or devices
which otherwise present a potentially
unreasonable risk of illness or injury,
and/or are of substantial importance in
preventing impairment of human
health. Most premarket approval
applications (PMAs) are for postamendments class III devices.
Under section 515 of the act, an
application must contain certain
specific information, including full
reports of all information concerning
investigations showing whether the
device is reasonably safe and effective.
The application should also include a
statement of components, ingredients,
and properties of the principles of
operation for such a device. In addition,
the application should also include a
full description of the methods used in,
and the facilities and controls used for
the manufacture and processing of the
device and labeling specimens. The
implementing regulations, contained in
part 814 (21 CFR part 814), further
specifies the contents of a PMA for a
class III medical device and the criteria
FDA sets forth in approving, denying, or
withdrawing approval of a PMA as well
as supplements to PMAs. The purpose
of this regulation is to establish an
efficient and thorough procedure for
FDA’s review of PMAs and supplements
to PMAs for certain class III (premarket
approval) medical devices. The
regulations under part 814 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 disapproval 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. FDAMA (Public Law 105–
115) was enacted on November 21,
1997, to implement revisions to the act
by streamlining the process of bringing
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16:12 Sep 23, 2010
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safe and effective drugs, medical
devices, and other therapies to the U.S.
market. Several provisions of this act
affect the PMA process, such as section
515(d)(6) of the act. This section
provided that PMA supplements were
required for all device changes that
affect safety and effectiveness of a
device unless such changes are
modifications to manufacturing
procedures or method of manufacture.
This type of manufacturing change now
requires a 30-day notice, or where FDA
finds such notice inadequate, a 135-day
PMA supplement.
To make the PMA process more
efficient, in the past several years FDA
has done the following: (1) Made
changes to the PMA program based on
comments received, (2) complied with
changes to the program mandated by
FDAMA and the Medical Device User
Fee Modernization Act, and (3) worked
toward completion of its PMA
reinvention efforts.
Respondents to this information
collection are persons filing a PMA
application or a PMA supplement with
FDA for approval of certain class III
medical devices. Part 814 defines a
person as any individual, partnership,
corporation, association, scientific or
academic establishment, government
agency or organizational unit, or other
legal entity. These respondents include
entities meeting the definition of
manufacturers such as manufacturers of
commercial medical devices in
distribution prior to May 28, 1976 (the
enactment date of the Medical Device
Amendments). In addition, hospitals
that reuse single use devices (SUDs) are
also included in the definition of
manufacturers. It is expected that FDA
will receive one PMA application from
hospitals that remanufacture SUDs
annually. This figure has been included
in table 1 of this document, as part of
the reporting burden in § 814.20.
The industry-wide burden estimate
for PMAs is based on an FDA actual
average fiscal year (FY) annual rate of
receipt of 36 PMA original applications,
532 PMA supplements, and 505 30-day
notices using FY 2005 through 2009
data. The burden data for PMAs is based
on data provided by manufacturers by
device type and cost element in an
earlier study. The specific burden
elements for which FDA has data are as
follows:
• Clinical investigations—67 percent
of total burden estimate;
• Submission of additional data or
information to FDA during a PMA
review—12 percent;
• Additional device development cost
(e.g., testing)—10 percent; and
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58397
• PMA and PMA supplement
preparation and submissions, and
development of manufacturing and
controls data—11 percent.
Reporting Burden
The reporting burden can be broken
out by certain sections of the PMA
regulation as follows:
• § 814.15—Research Conducted
Outside the United States
Approximately 20 percent of the
clinical studies submitted in support of
a PMA application are conducted
outside the United States. Each 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 20 hours.
• Application in § 814.20(a) through
(c) and (e)
The majority of the 24,048 hourly
burden estimate is due in part to this
requirement. 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 36 manufacturers,
including hospital re-manufacturers of
SUDs, will be affected by these
requirements which are based on the
actual average of FDA receipt of new
PMA applications in FY 2005 through
2009. 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 manufacturers.
• § 814.37—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
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Federal Register / Vol. 75, No. 185 / Friday, September 24, 2010 / Notices
amendments submitted during the
review process. FDA estimates that
6,012 burden hours are necessary to
satisfy this requirement.
• PMA Supplements in § 814.39(a)
FDA believes that the amendments
mandated by FDAMA for § 814.39(f),
permitting the submission of the 30-day
notices in lieu of regular PMA
supplements, will result in an
approximate 20 percent reduction in the
total number of hours as compared to
regular PMA supplements. As a result,
FDA estimates that 40,200 hours of
burden are needed to complete the
requirements for regular PMA
supplements.
• Special PMA Supplements—
Changes Being Affected in § 814.39(d)
These types of supplements are
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 68 per
year based on the numbers received
from FY 2005 through FY 2009. 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
408 hours.
• 30-Day Notice in § 814.39(f)
Under section 515(d) of the 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 § 814.39(a) 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
manufacturer 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 8,080 hours.
• Post-Approval Requirements in
§ 814.82(a)(9)
Post-approval requirements concern
approved PMAs that were not
reclassified and require a periodic
report. After approval, all PMAs require
a submission of an annual report. On
average, approximately half of the
submitted PMAs (18), 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.
Based on experience and consultation
with industry, FDA has estimated that
preparation of reports and information
required by this section requires 2,430
hours.
• Reports in § 814.84(b)
Post-approval 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 6,480 hours.
Statutory Reporting Burden Estimate
(FDAMA)
The total statutory reporting burden
under the requirements of sections 201,
202, 205, 208, and 209 of FDAMA is
estimated to be 1,230 hours. This
burden estimate was based on actual
real and estimated FDA data tracked
from FY 2005 through FY 2009, and an
estimate was also derived to forecast
future expectations with regard to this
statutory data.
Recordkeeping in § 814.82(a)(5) and
(a)(6)
The recordkeeping burden under this
section requires the maintenance of
records, used to trace patients and the
organization and the indexing of records
into identifiable files to ensure the
device’s continued safety and
effectiveness. These records are required
only of those manufacturers who have
an approved PMA and who had original
clinical research in support of that
PMA. For a typical year’s submissions,
70 percent of the PMAs are eventually
approved with 90 percent of these
having original clinical trial data.
Therefore, approximately 25 PMAs a
year would be subject to these
requirements. Also, because the
requirements apply to all active PMAs,
all holders of an active PMA application
must maintain these records.
PMAs have been required since 1976,
and there are 698 active PMAs that
could be subject to these requirements,
based on actual FDA data. Each study
has approximately 200 subjects, and at
an average of 5 minutes per subject,
there is a total burden per study of 1,000
minutes, or 17 hours. The aggregate
burden for all 698 holders of approved
original PMAs, therefore, is 11,866
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 (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 June 8, 2010
(75 FR 32476), 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 BURDEN1
21 CFR Section/
FDAMA Section
No. of
Respondents
Total Annual
Responses
Hours per
Response
Total Hours
8
1
8
2
16
814.20
srobinson on DSKHWCL6B1PROD with NOTICES
814.15(b)
Annual Frequency
per Response
36
1
36
668
24,048
814.37(a) through (c) and (e)
36
1
36
167
6,012
814.39(a)
670
1
670
60
40,200
814.39(d)
68
1
68
6
408
814.39(f)
505
1
505
16
8,080
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Federal Register / Vol. 75, No. 185 / Friday, September 24, 2010 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
21 CFR Section/
FDAMA Section
No. of
Respondents
814.82(a)(9)
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
18
1
18
135
2,430
648
1
648
10
6,480
Section 201 (FDAMA) Agreement
Meeting
3
1
3
50
150
Section 202 (FDAMA) Expedited
Review Request
5
1
5
10
50
Section 205 (FDAMA) Effectiveness
Meeting
5
1
5
50
250
Section 208 (FDAMA) Classification
Panel Meetings
20
1
20
30
600
Section 209 (FDAMA) 100-day
meeting
28
1
28
10
280
2,050
13
2,050
1,214
89,004
814.84(b)
Totals
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of
Recordkeepers
814.82(a)(5) and (a)(6)
1 There
Annual Frequency
per Recordkeeping
698
Total Annual
Records
1
Hours per
Recordkeeper
698
17
Total Hours
11,866
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[FR Doc. 2010–23912 Filed 9–23–10; 8:45 am]
BILLING CODE 4160–01–S
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: ANA Consultant and Evaluator
Qualifications Form.
OMB No.: 0970–0265.
Description: The ANA Consultant and
Evaluator Qualifications Form is used to
collect information from prospective
proposal reviewers in compliance with
42 U.S.C. 2991d–1. The form allows the
Commissioner of ANA to select
qualified people to review grant
applications for Social and Economic
Development Strategies (SEDS), Native
Language Preservation and
Maintenance, and Environmental
Regulatory Enhancement. The panel
review process is a legislative mandate
in the ANA grant funding process.
Respondents: Native Americans,
Native Alaskans, Native Hawaiians and
other Pacific Islanders.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of responses per
respondent
Average
burden hours
per response
Total burden
hours
ANA Consultant and Evaluator Qualifications Form .......................................
srobinson on DSKHWCL6B1PROD with NOTICES
Instrument
300
1
1
300
Estimated Total Annual Burden
Hours: 300.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
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16:12 Sep 23, 2010
Jkt 220001
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
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]]>Agencies
[Federal Register Volume 75, Number 185 (Friday, September 24, 2010)]
[Notices]
[Pages 58396-58399]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-23912]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0250]
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 October
25, 2010.
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 e-mailed 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: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@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.
[[Page 58397]]
Premarket Approval of Medical Devices--21 CFR Part 814/Food and Drug
Administration Modernization Act of 1997 (FDAMA) Sections 201, 202,
205, 208, and 209 (OMB Control Number 0910-0231)--Extension
Section 515 of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 360e) sets forth the requirements for premarket approval of
certain class III medical devices. Class III devices are either pre-
amendments devices that have been classified into class III, or post-
amendments devices which are not substantially equivalent to a pre-
amendments device, or transitional devices. Class III devices are
devices such as implants, life sustaining or life supporting devices,
and/or devices which otherwise present a potentially unreasonable risk
of illness or injury, and/or are of substantial importance in
preventing impairment of human health. Most premarket approval
applications (PMAs) are for post-amendments class III devices.
Under section 515 of the act, an application must contain certain
specific information, including full reports of all information
concerning investigations showing whether the device is reasonably safe
and effective. The application should also include a statement of
components, ingredients, and properties of the principles of operation
for such a device. In addition, the application should also include a
full description of the methods used in, and the facilities and
controls used for the manufacture and processing of the device and
labeling specimens. The implementing regulations, contained in part 814
(21 CFR part 814), further specifies the contents of a PMA for a class
III medical device and the criteria FDA sets forth in approving,
denying, or withdrawing approval of a PMA as well as supplements to
PMAs. The purpose of this regulation is to establish an efficient and
thorough procedure for FDA's review of PMAs and supplements to PMAs for
certain class III (premarket approval) medical devices. The regulations
under part 814 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 disapproval 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. FDAMA
(Public Law 105-115) was enacted on November 21, 1997, to implement
revisions to the act by streamlining the process of bringing safe and
effective drugs, medical devices, and other therapies to the U.S.
market. Several provisions of this act affect the PMA process, such as
section 515(d)(6) of the act. This section provided that PMA
supplements were required for all device changes that affect safety and
effectiveness of a device unless such changes are modifications to
manufacturing procedures or method of manufacture. This type of
manufacturing change now requires a 30-day notice, or where FDA finds
such notice inadequate, a 135-day PMA supplement.
To make the PMA process more efficient, in the past several years
FDA has done the following: (1) Made changes to the PMA program based
on comments received, (2) complied with changes to the program mandated
by FDAMA and the Medical Device User Fee Modernization Act, and (3)
worked toward completion of its PMA reinvention efforts.
Respondents to this information collection are persons filing a PMA
application or a PMA supplement with FDA for approval of certain class
III medical devices. Part 814 defines a person as any individual,
partnership, corporation, association, scientific or academic
establishment, government agency or organizational unit, or other legal
entity. These respondents include entities meeting the definition of
manufacturers such as manufacturers of commercial medical devices in
distribution prior to May 28, 1976 (the enactment date of the Medical
Device Amendments). In addition, hospitals that reuse single use
devices (SUDs) are also included in the definition of manufacturers. It
is expected that FDA will receive one PMA application from hospitals
that remanufacture SUDs annually. This figure has been included in
table 1 of this document, as part of the reporting burden in Sec.
814.20.
The industry-wide burden estimate for PMAs is based on an FDA
actual average fiscal year (FY) annual rate of receipt of 36 PMA
original applications, 532 PMA supplements, and 505 30-day notices
using FY 2005 through 2009 data. The burden data for PMAs is based on
data provided by manufacturers by device type and cost element in an
earlier study. The specific burden elements for which FDA has data are
as follows:
Clinical investigations--67 percent of total burden
estimate;
Submission of additional data or information to FDA during
a PMA review--12 percent;
Additional device development cost (e.g., testing)--10
percent; and
PMA and PMA supplement preparation and submissions, and
development of manufacturing and controls data--11 percent.
Reporting Burden
The reporting burden can be broken out by certain sections of the
PMA regulation as follows:
Sec. 814.15--Research Conducted Outside the United States
Approximately 20 percent of the clinical studies submitted in
support of a PMA application are conducted outside the United States.
Each 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 20 hours.
Application in Sec. 814.20(a) through (c) and (e)
The majority of the 24,048 hourly burden estimate is due in part to
this requirement. 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 36
manufacturers, including hospital re-manufacturers of SUDs, will be
affected by these requirements which are based on the actual average of
FDA receipt of new PMA applications in FY 2005 through 2009. 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 manufacturers.
Sec. 814.37--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
[[Page 58398]]
amendments submitted during the review process. FDA estimates that
6,012 burden hours are necessary to satisfy this requirement.
PMA Supplements in Sec. 814.39(a)
FDA believes that the amendments mandated by FDAMA for Sec.
814.39(f), permitting the submission of the 30-day notices in lieu of
regular PMA supplements, will result in an approximate 20 percent
reduction in the total number of hours as compared to regular PMA
supplements. As a result, FDA estimates that 40,200 hours of burden are
needed to complete the requirements for regular PMA supplements.
Special PMA Supplements--Changes Being Affected in Sec.
814.39(d)
These types of supplements are 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 68 per year based on the
numbers received from FY 2005 through FY 2009. 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 408
hours.
30-Day Notice in Sec. 814.39(f)
Under section 515(d) of the 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 Sec. 814.39(a) 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 manufacturer 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 8,080 hours.
Post-Approval Requirements in Sec. 814.82(a)(9)
Post-approval requirements concern approved PMAs that were not
reclassified and require a periodic report. After approval, all PMAs
require a submission of an annual report. On average, approximately
half of the submitted PMAs (18), 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. Based on experience and consultation with industry, FDA
has estimated that preparation of reports and information required by
this section requires 2,430 hours.
Reports in Sec. 814.84(b)
Post-approval 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 6,480 hours.
Statutory Reporting Burden Estimate (FDAMA)
The total statutory reporting burden under the requirements of
sections 201, 202, 205, 208, and 209 of FDAMA is estimated to be 1,230
hours. This burden estimate was based on actual real and estimated FDA
data tracked from FY 2005 through FY 2009, and an estimate was also
derived to forecast future expectations with regard to this statutory
data.
Recordkeeping in Sec. 814.82(a)(5) and (a)(6)
The recordkeeping burden under this section requires the
maintenance of records, used to trace patients and the organization and
the indexing of records into identifiable files to ensure the device's
continued safety and effectiveness. These records are required only of
those manufacturers who have an approved PMA and who had original
clinical research in support of that PMA. For a typical year's
submissions, 70 percent of the PMAs are eventually approved with 90
percent of these having original clinical trial data. Therefore,
approximately 25 PMAs a year would be subject to these requirements.
Also, because the requirements apply to all active PMAs, all holders of
an active PMA application must maintain these records.
PMAs have been required since 1976, and there are 698 active PMAs
that could be subject to these requirements, based on actual FDA data.
Each study has approximately 200 subjects, and at an average of 5
minutes per subject, there is a total burden per study of 1,000
minutes, or 17 hours. The aggregate burden for all 698 holders of
approved original PMAs, therefore, is 11,866 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 (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 June 8, 2010 (75 FR 32476), 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section/ FDAMA Section Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.15(b) 8 1 8 2 16
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.20 36 1 36 668 24,048
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.37(a) through (c) and (e) 36 1 36 167 6,012
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.39(a) 670 1 670 60 40,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.39(d) 68 1 68 6 408
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.39(f) 505 1 505 16 8,080
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[[Page 58399]]
814.82(a)(9) 18 1 18 135 2,430
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.84(b) 648 1 648 10 6,480
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section 201 (FDAMA) Agreement Meeting 3 1 3 50 150
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section 202 (FDAMA) Expedited Review Request 5 1 5 10 50
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section 205 (FDAMA) Effectiveness Meeting 5 1 5 50 250
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section 208 (FDAMA) Classification Panel Meetings 20 1 20 30 600
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section 209 (FDAMA) 100-day meeting 28 1 28 10 280
--------------------------------------------------------------------------------------------------------------------------------------------------------
Totals 2,050 13 2,050 1,214 89,004
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Recordkeepers per Recordkeeping Records Recordkeeper Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
814.82(a)(5) and (a)(6) 698 1 698 17 11,866
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-23912 Filed 9-23-10; 8:45 am]
BILLING CODE 4160-01-S
