Agency Information Collection Activities; Proposed Collection; Comment Request; Pre-market Approval of Medical Devices, 35494-35497 [E7-12502]
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Federal Register / Vol. 72, No. 124 / Thursday, June 28, 2007 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. 2007N–0231]
[Docket No. 2007N–0015]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Adoption of Food and Drug
Administration Food Code by Local,
State and Tribal Governments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Adoption of FDA Food Code by Local,
State and Tribal Governments’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857,301–827–
4659.
In the
Federal Register of April 13, 2007 (72
FR 18659), the agency announced that
the proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0448. The
approval expires on June 30, 2010. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
SUPPLEMENTARY INFORMATION:
Dated: June 21, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–12499 Filed 6–27–07; 8:45 am]
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Agency Information Collection
Activities; Proposed Collection;
Comment Request; Pre-market
Approval of Medical Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
information collection requirements for
premarket approval of medical devices.
DATES: Submit written or electronic
comments on the collection of
information by August 27, 2007.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
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proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Pre-market Approval of Medical
Devices—21 CFR Part 814 / FDAMA
Sections 201; 202; 205; 208; 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
pre-market 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 pre-market 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
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Federal Register / Vol. 72, No. 124 / Thursday, June 28, 2007 / Notices
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 (pre-market
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.
The Food and Drug Modernization
Act of 1997 (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 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 four PMA applications from
hospitals that remanufacture SUDs
annually. This figure has been included
in table 1 of this document, as part of
the reporting burden in § 814.15.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Part 800/
Section/FDAMA
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours Per
Responses
Total Hours
814.15(b)
10
1
10
2
20
814.20
48
1
48
668
32,064
814.37(a-c) and (e)
48
1
48
167
8,016
814.39(a)
460
1
460
60
27,600
814.39(d)
70
1
70
6
420
814.39(f)
254
1
254
16
4,064
814.82(a)(9)
34
1
34
135
4,590
814.84(b)
34
1
34
10
340
Section 201 (FDAMA) Agreement Meeting
3
1
3
50
150
Section 202 (FDAMA) Expedited Reviews
7
1
7
10
70
Section 205 (FDAMA) Determination Meeting
5
1
5
50
250
Section 208 (FDAMA) Classification Panel Meetings
19
1
19
30
570
Section 209 (FDAMA) 100 day meeting
36
1
36
10
360
1,028
13
1,028
1,214
78,514
Totals
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
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21 CFR Part 800
842 (a) (5) & (6)
1 There
Annual Frequency
of Recordkeeping
1,128
1
Total Annual
Records
Hours per
Recordkeeper
1,128
17
are no capital costs or operating and maintenance costs associated with this collection of information.
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Total Hours
19,176
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The industry-wide burden estimate
for PMAs is based on an FDA actual
average fiscal year (FY) annual rate of
receipt of 48 PMA original applications,
530 PMA supplements, and 254 30-day
notices using FY 2002 through 2006
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:
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§ 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.
§ 814.20 (a) through (c) and (e)—
Application
The majority of the 32,064 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 48 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 2002 through
2006. 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
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the results of an earlier study which
accounts for the bulk of the hourly
burden for this requirement, identified
by manufacturers.
§ 814.37—PMA Amendments and ReSubmitted PMAs
As part of the review process, FDA
often requests PMA applicant to submit
additional information regarding the
device necessary for FDA to file the
PMA or to complete its review and
make a final decision. The PMA
applicant may, also on their own
initiative, submit additional information
to FDA during the review process.
These amendments contain information
ranging from additional test results, reanalysis of the original data set to
revised device labeling. Almost all
PMAs received by the agency have
amendments submitted during the
review process. FDA estimates that
8,016 burden hours are necessary to
satisfy this requirement.
§ 814.39 (a)—PMA Supplements
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 27,600 hours of
burden are needed to complete the
requirements for regular PMA
supplements.
§ 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 70 per year based
on the numbers received from FY 2002
through FY 2006. 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 420 hours.
§ 814.39(f)—30-Day Notice
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 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
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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 4,064 hours.
§ 814.82 (a)(9)—Post-Approval
Requirements
Post-approval requirements concerns
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 (34), require associated
post-approval studies, i.e., follow-up 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 4,590
hours.
§ 814.84(b)—Reports
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 340 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 1,400 hours. This
burden estimate was based on actual
real FDA data tracked from January 1,
1998, to the present, and an estimate
was also derived to forecast future
expectations with regard to this
statutory data.
§ 814.82 (a) (5) and (a)(6)—
Recordkeeping
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,
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70 percent of the PMAs are eventually
approved with 75 percent of these
having original clinical trial data.
Therefore, approximately 34 PMAs a
year (48 annual submissions x 70
percent), 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 1,128 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 1,128 holders of approved
original PMAs, therefore, is 19,176
hours (1,127 approved PMAs with
clinical data x 17 hours per PMA).
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.
Dated: June 21, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–12502 Filed 6–27–07; 8:45 am]
BILLING CODE 4160–01–S
Biologics Evaluation and Research
(CBER) notify FDA in writing. A
nominee may either be self-nominated
or nominated by an organization to
serve as a nonvoting industry
representative. Nomination will be
accepted for current vacancies effective
with this notice.
DATES: Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating the interest to
FDA by July 30, 2007, for vacancies
listed in the notice. Concurrently,
nomination material for prospective
candidates should be sent to FDA by
July 30, 2007.
ADDRESSES: All letters of interest and
nominations should be submitted in
writing to Gail Dapolito (see FOR
FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT: Gail
Dapolito, Center for Biologics
Evaluation and Research, Food and
Drug Administration (HFM–71), 1401
Rockville Pike, Rockville, MD 20892,
301–827–1289,
gail.dapolito@fda.hhs.gov
Section
120 of the FDA Modernization Act of
1997 (FDAMA) (21 U.S.C. 355) requires
that newly formed FDA advisory
committees include representatives
from the biologic manufacturing
industries. Although not required for
existing committees, to keep within the
spirit of FDAMA, the agency intends to
add nonvoting industry representatives
to its CBER advisory committee
identified below.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
I. CBER Allergenic Products Advisory
Committee
Food and Drug Administration
The Committee reviews and evaluates
available data concerning the safety,
effectiveness, and adequacy of labeling
of marketed and investigational
allergenic biological products or
materials that are administered to
humans for the diagnosis, prevention, or
treatment of allergies and allergic
disease, and makes appropriate
recommendations to the Commissioner
of Food and Drugs of its findings
regarding the affirmation or revocation
of biological product licenses, on the
safety, effectiveness, and labeling of the
products, on clinical and laboratory
studies of such products, on
amendments or revisions to regulations
governing the manufacture, testing and
licensing of allergenic biological
products, and on the quality and
relevance of FDA’s research programs
which provide the scientific support for
regulating these agents.
Request for Notification From Industry
Organizations Interested in
Participating in the Selection Process
for a Nonvoting Industry
Representative on the Allergenic
Products Advisory Committee and
Request for Nominations for a
Nonvoting Industry Representative on
the Allergenic Products Advisory
Committee
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is requesting that
any industry organizations interested in
participating in the selection of a
nonvoting industry representative to
serve on its Allergenic Products
Advisory Committee for the Center for
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35497
II. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see ADDRESSES) within 30 days
of publication of this document. Within
the subsequent 30 days, FDA will send
a letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations;
and a list of all nominees along with
their current resumes. The letter will
also state that it is the responsibility of
the interested organizations to confer
with one another and to select a
candidate, within 60 days after the
receipt of the FDA letter, to serve as the
nonvoting member to represent industry
interests for the Allergenic Products
Advisory Committee. The interested
organizations are not bound by the list
of nominees in selecting a candidate.
However, if no individual is selected
within 60 days, the Commissioner of
Food and Drugs will select the
nonvoting member to represent industry
interests.
III. Application Procedure
Individuals may self nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. A current
curriculum vitae and the name of the
committee of interest should be sent to
the FDA contact person within the 30
days. FDA will forward all nominations
to the organizations expressing interest
in participating in the selection process
for the committee. (Persons who
nominate themselves as nonvoting
industry representatives will not
participate in the selection process).
FDA has a special interest in ensuring
that women, minority groups,
individuals with physical disabilities,
and small businesses are adequately
represented on its advisory committees,
and therefore, encourages, nominations
for appropriately qualified candidates
from these groups. Specifically, in this
document, nominations for nonvoting
representatives of industry interests are
encouraged from the allergenic product
manufacturing industry.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: June 21, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7–12527 Filed 6–27–07; 8:45 am]
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]]>Agencies
[Federal Register Volume 72, Number 124 (Thursday, June 28, 2007)]
[Notices]
[Pages 35494-35497]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-12502]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0231]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Pre-market Approval of Medical Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
requirements for premarket approval of medical devices.
DATES: Submit written or electronic comments on the collection of
information by August 27, 2007.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments. Submit written comments on
the collection of information to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Pre-market Approval of Medical Devices--21 CFR Part 814 / FDAMA
Sections 201; 202; 205; 208; 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 pre-market 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 pre-market 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
[[Page 35495]]
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 (pre-market 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.
The Food and Drug Modernization Act of 1997 (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 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 four PMA applications 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.
814.15.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
21 CFR Part 800/ Section/ No. of Annual Frequency Total Annual Hours Per
FDAMA Respondents per Response Responses Responses Total Hours
----------------------------------------------------------------------------------------------------------------
814.15(b) 10 1 10 2 20
----------------------------------------------------------------------------------------------------------------
814.20 48 1 48 668 32,064
----------------------------------------------------------------------------------------------------------------
814.37(a-c) and (e) 48 1 48 167 8,016
----------------------------------------------------------------------------------------------------------------
814.39(a) 460 1 460 60 27,600
----------------------------------------------------------------------------------------------------------------
814.39(d) 70 1 70 6 420
----------------------------------------------------------------------------------------------------------------
814.39(f) 254 1 254 16 4,064
----------------------------------------------------------------------------------------------------------------
814.82(a)(9) 34 1 34 135 4,590
----------------------------------------------------------------------------------------------------------------
814.84(b) 34 1 34 10 340
----------------------------------------------------------------------------------------------------------------
Section 201 (FDAMA) Agreement 3 1 3 50 150
Meeting
----------------------------------------------------------------------------------------------------------------
Section 202 (FDAMA) Expedited 7 1 7 10 70
Reviews
----------------------------------------------------------------------------------------------------------------
Section 205 (FDAMA) 5 1 5 50 250
Determination Meeting
----------------------------------------------------------------------------------------------------------------
Section 208 (FDAMA) 19 1 19 30 570
Classification Panel
Meetings
----------------------------------------------------------------------------------------------------------------
Section 209 (FDAMA) 100 day 36 1 36 10 360
meeting
----------------------------------------------------------------------------------------------------------------
Totals 1,028 13 1,028 1,214 78,514
----------------------------------------------------------------------------------------------------------------
\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 Part 800 Recordkeepers of Recordkeeping Records Recordkeeper Total Hours
----------------------------------------------------------------------------------------------------------------
842 (a) (5) & (6) 1,128 1 1,128 17 19,176
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 35496]]
The industry-wide burden estimate for PMAs is based on an FDA
actual average fiscal year (FY) annual rate of receipt of 48 PMA
original applications, 530 PMA supplements, and 254 30-day notices
using FY 2002 through 2006 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.
Sec. 814.20 (a) through (c) and (e)--Application
The majority of the 32,064 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 48
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 2002 through 2006. 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, identified by manufacturers.
Sec. 814.37--PMA Amendments and Re-Submitted PMAs
As part of the review process, FDA often requests 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 8,016 burden hours are necessary to satisfy this
requirement.
Sec. 814.39 (a)--PMA Supplements
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 27,600 hours of burden are
needed to complete the requirements for regular PMA 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 70 per year based on the
numbers received from FY 2002 through FY 2006. 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 420
hours.
Sec. 814.39(f)--30-Day Notice
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 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
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 4,064 hours.
Sec. 814.82 (a)(9)--Post-Approval Requirements
Post-approval requirements concerns 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 (34), require associated post-approval
studies, i.e., follow-up 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 4,590 hours.
Sec. 814.84(b)--Reports
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 340 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 1,400
hours. This burden estimate was based on actual real FDA data tracked
from January 1, 1998, to the present, and an estimate was also derived
to forecast future expectations with regard to this statutory data.
Sec. 814.82 (a) (5) and (a)(6)--Recordkeeping
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,
[[Page 35497]]
70 percent of the PMAs are eventually approved with 75 percent of these
having original clinical trial data. Therefore, approximately 34 PMAs a
year (48 annual submissions x 70 percent), 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 1,128 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 1,128 holders of
approved original PMAs, therefore, is 19,176 hours (1,127 approved PMAs
with clinical data x 17 hours per PMA).
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.
Dated: June 21, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-12502 Filed 6-27-07; 8:45 am]
BILLING CODE 4160-01-S
