[Federal Register Volume 77, Number 54 (Tuesday, March 20, 2012)]
[Notices]
[Pages 16239-16244]
[FR Doc No: 2012-6707]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0389]

Medical Device User Fee Act; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting to discuss proposed recommendations for the reauthorization of
the Medical Device User Fee Act (MDUFA) for fiscal years (FYs) 2013
through 2017. MDUFA authorizes FDA to collect user fees and use them
for the process for the review of medical device applications. The
current legislative authority for MDUFA expires on October 1, 2012. New
legislation will be required for FDA to collect medical device user
fees for future FYs. Following discussions with the device industry and
periodic consultations with public stakeholders, the Federal Food,
Drug, and Cosmetic Act (FD&C Act) directs FDA to publish the
recommendations for the reauthorized program in the Federal Register,
hold a meeting at which the public may present its views on such
recommendations, and provide for a period of 30 days for the public to
provide written comments on such recommendations. FDA will then
consider such public views and comments and revise such recommendations
as necessary.

DATES: The public meeting will be held on March 28, 2012 from 9 a.m. to
5 p.m. Registration to attend the meeting must be received by March 26,
2012. Submit either electronic or written comments by April 16, 2012.
    Location: The meeting will be held at the Hubert H. Humphrey
Building, 200 Independence Avenue SW., Washington, DC 20201. For
directions and metro information please visit the following Web site:
http://www.hhs.gov/about/hhhmap.html. The public meeting will also be
available to be viewed online via webcast. Registration is required to
view the webcast.
    Contact Person: Cindy Garris, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg.
66, Rm. 4459, Silver Spring, MD 20993,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>,
email<EMAIL_ADDRESS>    Registration and Oral Presentations: If you wish to attend and/or
speak at the meeting or view the webcast, please register by March 26,
2012. To register for the meeting, please visit http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (or go to
the FDA Medical Devices News & Events--Workshops & Conferences calendar
and select this public meeting from the posted events list). Please
provide complete contact information for each attendee, including name,
title, affiliation, address, email address, and phone number.
Registrants wishing to speak during the open comment period should note
that when registering. We

will try to accommodate all persons who wish to speak. The time
allotted for an individual to speak may depend on the number of persons
who wish to speak. Registration is free and will be on a first-come,
first-served basis, with the following exception. Early registration is
recommended because seating is limited. FDA may limit the number of
participants from each organization based on space limitations.
Registrants will receive confirmation once they have been accepted.
Onsite registration on the day of the meeting will not be available.
    If you need special accommodations due to a disability, please
contact Cindy Garris (email<EMAIL_ADDRESS>or 301-
796-5861) at least 2 days before the meeting.
    Comments: FDA is holding this public meeting to hear stakeholders'
views on the draft recommendations for the reauthorized user fee
program (MDUFA III), including suggestions for any changes that FDA
should consider. FDA policy issues are beyond the scope of the user fee
program. Accordingly, the public comments should focus on MDUFA III
draft recommendations.
    Regardless of attendance at the public meeting, interested persons
may submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. All comments should be identified with the docket
number found in brackets in the heading of this document. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

SUPPLEMENTARY INFORMATION:

I. Introduction

    FDA is announcing its intention to hold a public meeting to discuss
proposed recommendations for the reauthorization of the Medical Device
User Fee Amendments of 2007 (MDUFA), which authorizes FDA to collect
user fees and use them for the process for the review of device
applications until October 1, 2012. Without new legislation, FDA will
no longer be able to collect user fees for future fiscal years to fund
the medical device review process.
    As required by section 738A(b)(2), (3), and (6) of the FD&C Act (21
U.S.C. 379j-1(b)(2), (3), and (6)), FDA obtained prior public input and
negotiated an agreement with regulated industry while periodically
consulting with patient and consumer advocacy groups and making minutes
of negotiation and stakeholder meetings publicly available (Ref. 1).
Section 738A(b)(4) of the FD&C Act , requires that, after holding
negotiations with regulated industry and before transmitting the
Agency's final recommendations to Congress for the reauthorized program
(MDUFA III), we do the following: (1) Present the draft recommendations
to the Committee on Energy and Commerce of the U.S. House of
Representatives and the Committee on Health, Education, Labor, and
Pensions of the U.S. Senate; (2) publish the draft recommendations in
the Federal Register; (3) provide a period of 30 days for the public to
provide written comments on the draft recommendations; (4) hold a
meeting at which the public may present its views on the draft
recommendations; and (5) after consideration of public views and
comments, revise the draft recommendations as necessary. This notice,
the 30 day comment period, and the public meeting will satisfy certain
of these requirements. After the public meeting, we will revise the
draft recommendations as necessary. In addition, the Agency will
present the draft recommendations to the Congressional committees.
    The purpose of the meeting is for the public to present its views
on the draft recommendations for the reauthorized program (MDUFA III).
In general, the meeting format will include a brief presentation by
FDA, but will focus on hearing from different stakeholder interest
groups (such as patient advocates, consumer advocates, industry, health
professionals, and academic researchers). The Agency will also provide
an opportunity for individuals to make presentations at the meeting and
for organizations and individuals to submit written comments to the
docket before and after the meeting. The following information is
provided to help potential meeting participants better understand the
history and evolution of the medical device user fee program and the
current status of the MDUFA III draft recommendations.

II. What is the medical device user fee program? What does it do?

    In the years preceding enactment of Medical Device User Fee and
Modernization Act of 2002 (MDUFMA) (Pub. L. 107-250), FDA's medical
device program suffered a long-term, significant loss of resources that
undermined the program's capacity and performance. MDUFMA was enacted
``in order to provide the Food and Drug Administration (FDA) with the
resources necessary to better review medical devices, to enact needed
regulatory reforms so that medical device manufacturers can bring their
safe and effective devices to the American people at an earlier time,
and to ensure that reprocessed medical devices are as safe and
effective as original devices'' (H.R. Rep. No. 107-728, at 21 (2002)).
MDUFMA had a 5-year time frame and contained two particularly important
features which relate to reauthorization:
     User fees for the review of medical device premarket
applications, reports, supplements, and premarket notification
submissions provided additional resources to make FDA reviews more
timely, predictable, and transparent to applicants. MDUFMA fees and
increased appropriations for the medical device program helped FDA
expand available expertise, modernized its information management
systems, provided new review options, and provided more guidance to
prospective applicants. The ultimate goal was for FDA to approve and
clear safe and effective medical devices more rapidly, benefiting
applicants, the health care community and, most importantly, patients.
     Negotiated performance goals for many types of premarket
reviews provided FDA with benchmarks for measuring review improvements.
These quantifiable goals became more demanding each year and included
FDA decision goals and cycle goals (cycle goals refer to FDA actions
prior to a final action on a submission). Under MDUFMA, FDA also agreed
to several commitments that did not have specific time frames or direct
measures of performance, such as expanding the use of meetings with
industry, maintenance of current performance in review areas where
specific performance goals had not been identified, and publication of
additional guidance documents.
    Medical device user fees and increased appropriations were
essential to support high-quality, timely medical device reviews, and
other activities critical to the device review program.
    MDUFMA provided for fee discounts and waivers for small businesses.
Small businesses make up a large proportion of the device industry, and
these discounts and waivers helped reduce the financial impact of the
user fees on this sector of the device industry, which plays an
important role in fostering innovation.
    FDA provided periodic reports on its progress towards meeting these
performance goals and commitments to stakeholders and Congress. FDA
also

provided an annual financial report to Congress, which provided
transparency and accountability regarding the Agency's use of the
additional resources provided by MDUFMA. Although FDA made progress
towards achieving MDUFMA's central objectives, progress was limited by
financial shortfalls and unpredictable fee revenues caused by
variability in pre-market submission quantities.
    In August 2005, Congress enacted the Medical Device User Fee
Stabilization Act (Pub. L. 109-45) (MDUFSA), which modified several
provisions of MDUFMA. MDUFSA: (1) Repealed the appropriations trigger
for FY 2003 and FY 2004 and allowed for tolerances of up to 1 percent
of the appropriations trigger for FY 2005-2007; (2) provided for
predictable application fees by establishing fixed annual fees for FY
2006 and FY 2007, although at a lower rate of increase than under the
original legislation; and (3) expanded the definition of ``small
business'' for FY 2006 and FY 2007. However, MDUFSA did not address the
issue of ensuring predictable revenues for FDA.
    In 2007, Congress reauthorized medical device user fees through FY
2012 under the Medical Device User Fee Amendments of 2007 (MDUFA II)
(title II of the Food and Drug Administration Amendments Act of
2007(FDAAA) (Pub. L. 110-85).
    Under MDUFA II, the user fee program remained intact, with a few
significant modifications to the program. The user fee framework was
changed to provide a more reliable and stable funding stream.
Specifically, MDUFA II included establishment registration as a new fee
type that provided a more predictable amount of funds to be collected
by the Agency in any given year. MDUFA II also included changes to the
performance goals. Compared to MDUFMA, there were fewer performance
goals under MDUFA II, yet the goals were more demanding. FDA published
the commitment letter outlining the goals in the last reauthorization,
as well as a number of reports that provide the public with useful
background on MDUFMA, FDAAA, and MDUFA II (Ref. 2). FDA also posted
video presentations on the medical device user fee program to give the
public more background information on the program (Ref. 3).

III. Proposed MDUFA III Recommendations

    In preparing the proposed recommendations to transmit to Congress
for MDUFA reauthorization, we have conducted discussions with the
device industry, and we have consulted with stakeholders as required by
law. We began the MDUFA reauthorization process with a public meeting
held on September 14, 2010 (75 FR 49502, August 13, 2010). The meeting
included presentations by FDA and a series of panels representing
different stakeholder groups, including patient advocates, consumer
groups, the device industry, health care professionals, and scientific
and academic experts.
    From January 2011 through February 2012, FDA conducted negotiations
with representatives of the device industry: The Advanced Medical
Technology Association (AdvaMed); the Medical Device Manufacturers
Association (MDMA); the Medical Imaging and Technology Alliance (MITA);
and, the American Clinical Laboratory Association (ACLA). FDA also held
monthly consultations with public stakeholders during that time period.
As directed by Congress, FDA posted minutes of these discussions on its
Web site (Ref. 4).
    The proposed recommendations for MDUFA III address many of the
priorities and concerns identified by public stakeholders and the
device industry, and many of the important challenges identified by
FDA. Each recommendation is briefly described with reference to the
applicable section of the draft commitment letter (Ref. 5).
    In conjunction with the proposed enhancements and performance goals
outlined in the draft commitment letter, FDA is proposing new user fees
and several statutory changes. The specific proposals are briefly
described with reference to the applicable section of the draft
legislative language (Ref. 6).

A. Process Improvements

    FDA is proposing several process improvements designed to increase
the consistency, predictability, transparency, and efficiency of the
device review program.
1. Pre-Submissions
    A Pre-Submission provides the opportunity for an applicant to
obtain FDA feedback prior to submission of an investigational device
exemption or marketing application. Although no specific resources are
being allocated through the proposed MDUFA III user fees for the Pre-
Submission program, FDA is proposing that we will institute a
structured process for managing Pre-Submissions, as resources permit,
and not to the detriment of meeting the quantitative review timelines
in this proposal and statutory obligations. FDA is proposing to issue a
draft guidance document and final guidance document on Pre-Submissions.
The draft commitment letter includes additional details on the manner
in which FDA intends to manage Pre-Submissions. These details can be
found in section I.A of the draft commitment letter.
2. Submission Acceptance Criteria
    FDA is proposing to implement revised submission acceptance
criteria through the publication of guidance. These revised criteria
are intended to ensure that FDA is only reviewing complete submissions.
The guidance will outline electronic copy of submissions (e-Copy) and
objective criteria for revised ``refuse to accept/refuse to file''
checklists. This recommendation can be found in section I.B of the
draft commitment letter. FDA is also proposing corresponding statutory
language mandating e-Copy of submissions; this statutory requirement
would be implemented through the guidance described in this paragraph.
(See section III.L of this document for further information about this
proposed statutory change).
3. Interactive Review
    FDA is proposing to continue to incorporate an interactive review
process to provide for, and encourage, informal communication between
FDA and applicants to facilitate timely completion of the review
process based on accurate and complete information. This recommendation
can be found in section I.C of the draft commitment letter.
4. Guidance Document Development
    FDA is proposing to apply user fee revenues to supplement the
improvement of the process of developing, reviewing, tracking, issuing,
and updating guidance documents. This recommendation can be found in
section I.D of the draft commitment letter.
5. Third Party Review
    Although no specific resources are being allocated through the
proposed MDUFA III user fees for the Third Party Review program, FDA is
recommending reauthorization of the program and will work with
interested parties to strengthen and improve the current program as
resources permit. This recommendation can be found in section I.E of
the draft commitment letter.
6. Patient Safety and Risk Tolerance
    FDA proposes to fully implement final guidance on factors to
consider when making benefit-risk determinations in medical device

premarket review. FDA also proposes to meet with patient groups during
MDUFA III to better understand the patient perspective on disease
severity or unmet medical need. FDA also proposes to increase its
utilization of FDA's Patient Representatives to provide patients' views
early in the medical product development process. This recommendation
can be found in section I.F of the draft commitment letter.
7. Low Risk Medical Device Exemptions
    FDA proposes to identify additional low risk medical devices to
exempt from premarket notification. This recommendation can be found in
section I.G of the draft commitment letter.
8. Emerging Diagnostics
    FDA proposes to work with industry to develop a transitional In
Vitro Diagnostics (IVD) approach for the regulation of emerging
diagnostics. This recommendation can be found in section I.H of the
draft commitment letter.

B. Review Performance Goals--Fiscal Years 2013 Through 2017 as Applied
to Receipt Cohorts

    FDA is proposing to meet more rigorous goals for MDUFA III while
streamlining management of the program. In making these proposals, we
have taken into account efficiencies planned for in MDUFA III
including: Additional scientific, regulatory, and leadership training;
additional staff, including those with expertise demanded by
increasingly complex device reviews; improved submission acceptance
criteria; and information technology improvements that allow us to
better track and manage the device review process.
    FDA is proposing to eliminate the ``two-tier'' goal structure that
we believe is an impediment to improving average total time to decision
and to reaching the ultimate goal of the medical device user fee
program--for safe and effective devices to reach patients and health
care professionals more quickly. FDA is proposing a more simplified
goal structure, which will be easier to implement and will improve
predictability of the program, leaving the program less prone to
unintended consequences. The simplified goal structure includes a
single, high percentage goal for each performance metric. This provides
more clarity to industry so applicants will know when to expect
feedback from the Agency on their marketing submissions, and allows the
Agency's review staff to better manage their time. This structure also
allows more flexibility in the Agency's management strategy, allowing
for adjustments as needed to ensure achievement of the desired
outcomes--specifically, reducing review cycles and reducing average
total time to decision.
    FDA is proposing decision goals of 180 FDA days for premarket
approval applications (PMAs) that do not require Advisory Committee
input and for 180-Day PMA Supplements, 320 FDA days for PMAs that do
require Advisory Committee input, 90 FDA days for Real-Time PMA
Supplements, and 90 FDA days for premarket notification (510(k))
submissions. FDA is proposing performance goals for Clinical Laboratory
Improvement Amendments (CLIA) waiver applications: 210 FDA days for
dual submission of a 510(k) and CLIA waiver application; 180 FDA days
for a CLIA waiver application not requiring Advisory Committee input;
and 330 FDA days for CLIA waiver applications that do require Advisory
Committee input. For each of these decision goals, FDA is proposing to
``ramp-up'' the percentage of applications that will be completed
within the goal time line during the 5-year time period to correspond
with the timetable for additional staff to be hired during MDUFA III.
The goal percentages will increase to 90 or 95 percent in the final
years of the program, depending on the submission type. Additionally,
FDA is proposing to institute an acceptance/filing communication and
Substantive Interaction goal for several submission types, which will
track the Agency's communication with the applicant at specified points
during the review process. FDA is proposing to retain the existing
goals for Biological Licensing Applications (BLAs) and their
supplements. Additional details regarding all of the quantitative
review performance goals can be found in section II of the draft
commitment letter.

C. Shared Outcome Goals

    FDA and representatives of the device industry believe that the
process improvements outlined in the draft commitment letter, when
implemented by all parties as intended, should reduce the average Total
Time to Decision for PMA applications and 510(k) submissions, provided
that the total funding of the device review program adheres to the
assumptions underlying the agreement. Reducing average total time to
decision is an important aspect of the ultimate goal of the user fee
program, so that safe and effective devices reach patients and health
care professionals more quickly. FDA proposes to report, on an annual
basis, the average Total Time to Decision, as defined in the draft
commitment letter, for PMA and 510(k) submissions, with shared goals
for FDA and industry of 395 calendar days for PMAs and 135 calendar
days for 510(k)s beginning with the FY 2013 receipt cohort, declining
to 385 calendar days for PMAs and 124 calendar days for 510(k)s for the
FY 2017 receipt cohort. Additional details regarding the shared outcome
goals can be found in section III of the draft commitment letter.

D. Infrastructure

    FDA is proposing to apply user fee revenues to improve scientific
and regulatory review capacity by reducing the ratio of review staff to
front line supervisors and enhancing and supplementing scientific
review capacity. FDA is seeking to obtain streamlined hiring authority
in order to accomplish this (see section III.M of this document). FDA
is proposing to apply user fee revenues to supplement training
programs. FDA is proposing to continue efforts to improve its IT
systems. Additional details regarding the infrastructure proposals can
be found in section IV of the draft commitment letter.

E. Independent Assessment of Review Process Management

    In order to implement continued program improvements and
efficiencies, FDA is proposing to conduct a comprehensive assessment of
the process for the review of device applications. FDA is proposing to
incorporate findings and recommendations of the independent assessment
into its management of the premarket review program. Additional details
regarding the independent assessment proposal can be found in section V
of the draft commitment letter.

F. Performance Reports

    FDA is proposing to report its progress toward meeting the goals in
the draft commitment letter through quarterly and annual reporting. The
proposed reporting structure includes more detailed reporting than the
Agency agreed to provide during MDUFA II. Additional details regarding
the performance reporting structure can be found in section VI of the
draft commitment letter.

G. MDUFA III Inflation and Fee Adjustments

    In calculating user fees for each new FY in MDUFA III, FDA proposes
to adjust the base revenue amount by inflation. This methodology is
specified in the draft legislative language. The

inflation adjuster accounts for changes in FDA's costs related to
payroll compensation and benefits as well as changes in non-payroll
costs through use of the Consumer Price Index. This weighted composite
inflation adjuster will provide a degree of assurance that fees during
MDUFA III keep pace with FDA's costs. Additionally, FDA proposes to
adjust establishment registration fees annually, as needed, to account
for any unanticipated variations in submission and registration
quantities that are likely to result in FDA collecting more or less
than the authorized amount of fees each year (as adjusted for
inflation). Additional details regarding the annual fee setting and
adjustments can be found in section 738(c) of the draft legislative
language.

H. Impact of MDUFA III Enhancements on User Fee Revenue

    Implementing the proposed enhancements discussed in the previous
sections of this document will require approximately $595 million,
before adjustments for inflation, in device user fee revenue over the
course of the 5-year MDUFA III period, FY 2013 through FY 2017.
Proposed user fee collections, before adjustments for inflation, are:
$97,722,301 in FY 2013; $112,580,497 in FY 2014; $125,767,107 in FY
2015; $129,339,949 in FY 2016; and $130,184,348 in FY 2017. This user
fee revenue will support approximately 208 additional full-time
equivalent (FTE) staff by the end of the MDUFA III period. In addition,
these fee levels will support the continued funding of approximately 32
FTEs over current staffing levels that FDA plans to hire by the end of
FY 2012 under MDUFA II using currently authorized and appropriated user
fees. Therefore, the net increase over current staffing levels will be
approximately 240 FTEs as a result of this proposal. Collections
slightly above proposed user fee spending in the early years of MDUFA
III will ensure that funds are available to hire additional staff in
order to meet the proposed commitments, and will be balanced by
collections slightly below proposed user fee spending in the later
years of MDUFA III. As in MDUFA II, the premarket application fee and
the establishment registration fee are set during the annual fee
setting, and other submission fees are determined as a percentage of
the premarket application fee. In MDUFA III, the percentage associated
with a premarket notification (510(k)) is being raised from 1.84
percent of a premarket application fee to 2.0 percent of a premarket
application fee. All other percentages remain the same as during MDUFA
II. Base fee amounts for premarket applications, prior to adjustments
for inflation, are proposed as: $248,000 in FY 2013; $252,960 in FY
2014; $258,019 in FY 2015; $263,180 in FY 2016; and $268,443 in FY
2017. Base fee amounts for establishment registration, prior to annual
adjustments, are proposed as: $2,575 in FY 2013; $3,200 in FY 2014;
$3,750 in FY 2015; $3,872 in FY 2016; and $3,872 in FY 2017. Additional
details regarding the MDUFA III fees can be found in section 738(a) and
(b) of the draft legislative language.

I. Establishment Registration Fee Exemptions

    The proposed legislative language eliminates exemptions under MDUFA
II that allowed certain types of establishments to meet their
requirement to register without incurring a fee. This amendment will
increase the base of establishments paying registration fees.
Additional details regarding this modification can be found in section
737(13) of the draft legislative language.

J. Fee Waiver or Reduction Authority

    FDA is proposing a provision for the Secretary of Health and Human
Services (Secretary), in the Secretary's sole discretion, to grant a
waiver or reduction of fees if the Secretary finds that such waiver or
reduction is in the interest of public health. Additional details
regarding this provision can be found in section 738(f) of the draft
legislative language.

K. Appropriations and Spending Triggers

    FDA is proposing to update the appropriations trigger and the
spending trigger to FY 2009 levels. This will provide assurance to
industry that user fees will be additive to Budget Authority
appropriations, as was the original intent of the user fee program and
of the appropriations and spending triggers. Additional details
regarding these updates can be found in section 738(h)(1)(A) and
(i)(2)(A)(ii) of the draft legislative language.

L. Electronic Copy of Submissions

    In order to implement revised submission acceptance criteria, FDA
is proposing statutory language requiring an electronic copy (e-Copy)
to be provided with any pre-submission or submission for devices. The
proposed language provides that implementation of this requirement
would occur following issuance of final guidance providing standards
for such electronic copy. Additional details regarding this provision
can be found under the heading ``Subchapter D--Information and
Education'' in the draft legislative language.

M. Streamlined Hiring Authority

    In order to facilitate the steep ramp-up in hiring necessary to
accomplish the goals agreed to in the draft commitment letter, FDA is
proposing statutory language that would grant streamlined hiring
authority to FDA for the first 3 years of MDUFA III. Additional details
regarding this provision can be found under the heading ``STREAMLINED
HIRING AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION TO SUPPORT
ACTIVITIES RELATED TO THE PROCESS FOR THE REVIEW OF DEVICE
APPLICATIONS'' in the draft legislative language.

IV. References

    The following references have been placed on display in the
Division of Dockets Management (see Comments) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but FDA is not responsible
for any subsequent changes to the Web sites after this document
publishes in the Federal Register.)
    1. The minutes from FDA's negotiation and stakeholder meetings are
available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm236902.htm.
    2. The MDUFA II commitment letter, key Federal Register documents,
MDUFA II-related guidance documents, legislation, performance reports,
and financial reports and plans are available at www.fda.gov/MDUFA.
    3. The pre-recorded video presentations are available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109316.htm. FDAAA-
specific information is available at http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/default.htm.
    4. The minutes from FDA's negotiation and stakeholder meetings are
available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm236902.htm.
    5. Further information can be found on FDA's Web site at http://
www.fda.gov/MedicalDevices/NewsEvents/

WorkshopsConferences/ucm292860.htm.
    6. Further information can be found on FDA's Web site at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm292860.htm.

V. Transcripts

    Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov and at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm292860.htm. It may be viewed at the Division of Dockets Management
(see Comments). A transcript will also be available in either hard copy
or on CD-ROM, after submission of a Freedom of Information request.
Written requests are to be sent to the Division of Freedom of
Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn
Dr., Element Bldg., Rockville, MD 20857. Transcripts of the meeting
will be available for review at the Division of Dockets Management and
on the Internet at http://www.regulations.gov approximately 30 days
after the public meeting.

    Dated: March 15, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6707 Filed 3-15-12; 4:15 pm]
BILLING CODE 4160-01-P


[Federal Register Volume 87, Number 170 (Friday, September 2, 2022)]
[Rules and Regulations]
[Pages 54131-54134]
[FR Doc No: 2022-19116]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-1067; Project Identifier MCAI-2022-01042-T;
Amendment 39-22169; AD 2022-18-18]
RIN 2120-AA64

Airworthiness Directives; Dassault Aviation Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
Dassault Aviation Model FALCON 7X airplanes. This AD was prompted by a
report of a failed extension of inboard slats during the landing phase,
which was not indicated to the flightcrew by the crew alerting system.
This AD requires revising the existing airplane flight manual (AFM) to
provide procedures for failed extension of inboard slats and flightcrew
indication during landing, as specified in a European Union Aviation
Safety Agency (EASA) AD, which is incorporated by reference. The FAA is
issuing this AD to address the unsafe condition on these products.

DATES: This AD becomes effective September 19, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of September
19, 2022.
    The FAA must receive comments on this AD by October 17, 2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to regulations.gov. Follow
the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For material incorporated by reference (IBR) in this AD, contact
EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
8999 000; email [email protected]pa.eu; internet easa.europa.eu. You may
find this IBR material on the EASA website at ad.easa.europa.eu. You
may view this material at the FAA, Airworthiness Products Section,
Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call 206-
231-3195. It is also available in the AD docket at regulations.gov by
searching for and locating Docket No. FAA-2022-1067.

Examining the AD Docket

    You may examine the AD docket at regulations.gov by searching for
and locating Docket No. FAA-2022-1067; or in person at Docket
Operations between 9 a.m. and 5 p.m., Monday through Friday, except
Federal holidays. The AD docket contains this AD, the mandatory
continuing airworthiness information (MCAI), any comments received, and
other information. The street address for Docket Operations is listed
above.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
Large Aircraft Section, FAA, International Validation Branch, 2200
South 216th St., Des Moines, WA 98198; telephone<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written data, views, or arguments
about this final rule. Send your comments to an address listed under
ADDRESSES. Include ``Docket No. FAA-2022-1067; Project Identifier MCAI-
2022-01042-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the final rule, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this final rule because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
regulations.gov, including any personal information you provide. The
agency will also post a report summarizing each substantive verbal
contact received about this final rule.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this AD contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this AD, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this AD. Submissions containing CBI should be sent to Tom
Rodriguez, Aerospace Engineer, Large Aircraft Section, FAA,
International Validation Branch, 2200 South 216th St., Des Moines, WA
98198; telephone<PHONE_NUMBER>; email [email protected]. Any
commentary that the FAA receives which is not specifically designated
as CBI will be placed in the public docket for this rulemaking.

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA Emergency AD 2022-0161-E, dated August
4, 2022 (EASA Emergency AD 2022-0161-E) (also referred to as the MCAI),
to correct an unsafe condition for all Dassault Aviation Model FALCON
7X airplanes.
    This AD was prompted by a report of a failed extension of inboard
slats during the landing phase, which was not indicated to the
flightcrew by the crew alerting system. The actual retracted inboard
slats position, however, was correctly depicted by the flight control
system synoptic. The FAA is issuing this AD to address failed extension
of inboard slats without flightcrew indication, which could lead to
reduced lift margin during approach and landing, and result in reduced
control of the airplane. See the MCAI for additional background
information.

Related Service Information Under 1 CFR Part 51

    EASA Emergency AD 2022-0161-E specifies revised procedures for the
existing AFM for failed extension of inboard slats and flightcrew
indication during landing. This material is reasonably available
because the interested parties have access to it through their normal
course of business or by the means identified in the ADDRESSES section.

FAA's Determination

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with this State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI
described above. The FAA is issuing this AD after determining that the
unsafe condition described previously is likely to exist or develop on
other products of the same type design.

Requirements of This AD

    This AD requires accomplishing the actions specified in EASA
Emergency AD 2022-0161-E, described previously, as incorporated by
reference, except for any differences identified as exceptions in the
regulatory text of this AD.
    EASA Emergency AD 2022-0161-E requires operators to ``inform all
flight crews'' of revisions to the AFM, and thereafter to ``operate the
aeroplane accordingly.'' However, this AD does not specifically require
those actions, as those actions are already required by FAA
regulations. FAA regulations require operators furnish to pilots any
changes to the AFM (for example, 14 CFR 121.137), and to ensure the
pilots are familiar with the AFM (for example, 14 CFR 91.505). As with
any other flightcrew training requirement, training on the updated AFM
content is tracked by the operators and recorded in each pilot's
training record, which is available for the FAA to review. FAA
regulations also require pilots to follow the procedures in the
existing AFM including all updates. 14 CFR 91.9 requires that any
person operating a civil aircraft must comply with the operating
limitations specified in the AFM. Therefore, including a requirement in
this AD to operate the airplane according to the revised AFM would be
redundant and unnecessary.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result,
EASA Emergency AD 2022-0161-E is incorporated by reference in this AD.
This AD requires compliance with EASA Emergency AD 2022-0161-E in its
entirety through that incorporation, except for any differences
identified as exceptions in the regulatory text of this AD. Using
common terms that are the same as the heading of a particular section
in EASA Emergency AD 2022-0161-E does not mean that operators need
comply only with that section. For example, where the AD requirement
refers to ``all required actions and compliance times,'' compliance
with this AD requirement is not limited to the section titled
``Required Action(s) and Compliance Time(s)'' in EASA Emergency AD
2022-0161-E. Service information required by EASA AD 2022-0161-E for
compliance will be available at regulations.gov by searching for and
locating Docket No. FAA-2022-1067 after this AD is published.

FAA's Justification and Determination of the Effective Date

    Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5
U.S.C. 551 et seq.) authorizes agencies to dispense with notice and
comment procedures for rules when the agency, for ``good cause,'' finds
that those procedures are ``impracticable, unnecessary, or contrary to
the public interest.'' Under this section, an agency, upon finding good
cause, may issue a final rule without providing notice and seeking
comment prior to issuance. Further, section 553(d) of the APA
authorizes agencies to make rules effective in less than thirty days,
upon a finding of good cause.
    An unsafe condition exists that requires the immediate adoption of
this AD without providing an opportunity for public comments prior to
adoption. The FAA has found that the risk to the flying public
justifies forgoing notice and comment prior to adoption of this rule
because of a report of a failed extension of inboard slats during the
landing phase, which was not indicated to the flightcrew by the crew
alerting system, and could lead to reduced lift margin during approach
and landing, and possibly result in reduced control of the airplane.
Additionally, this AD correlates with EASA Emergency AD 2022-0161-E,
and addresses the unsafe condition by revising, within 10 flight cycles
after the effective date of this AD, the procedures for failed
extension of inboard slats and flightcrew indication during landing.
Accordingly, notice and opportunity for prior public comment are
impracticable and contrary to the public interest pursuant to 5 U.S.C.
553(b)(3)(B).
    In addition, the FAA finds that good cause exists pursuant to 5
U.S.C. 553(d) for making this amendment effective in less than 30 days,
for the same reasons the FAA found good cause to forgo notice and
comment.

Regulatory Flexibility Act (RFA)

    The requirements of the RFA do not apply when an agency finds good
cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and
comment. Because the FAA has determined that it has good cause to adopt
this rule without notice and comment, RFA analysis is not required.

Costs of Compliance

    The FAA estimates that this AD affects 142 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
1 work-hour x $85 per hour = $85.............................              $0              $85          $12,070
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866, and
    (2) Will not affect intrastate aviation in Alaska.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

2022-18-18 Dassault Aviation: Amendment 39-22169; Docket No. FAA-
2022-1067; Project Identifier MCAI-2022-01042-T.

(a) Effective Date

    This airworthiness directive (AD) is effective September 19,
2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Dassault Aviation Model FALCON 7X
airplanes, certificated in any category.
    Note 1 to paragraph (c): Model FALCON 7X airplanes with Dassault
modification M1000 incorporated are commonly referred to as ``Model
FALCON 8X'' as a marketing designation.

(d) Subject

    Air Transport Association (ATA) of America Code 27, Flight
controls.

(e) Unsafe Condition

    This AD was prompted by a report of a failed extension of
inboard slats during the landing phase, which was not indicated to
the flightcrew by the crew alerting system. The FAA is issuing this
AD to address failed extension of inboard slats without flightcrew
indication, which could lead to reduced lift margin during approach
and landing, and result in reduced control of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA)
Emergency AD 2022-0161-E, dated August 4, 2022 (EASA Emergency AD
2022-0161-E).

(h) Exceptions to EASA Emergency AD 2022-0161-E

    (1) Where EASA Emergency AD 2022-0161-E refers to its effective
date, this AD requires using the effective date of this AD.
    (2) Where EASA Emergency AD 2022-0161-E requires operators to
``inform all flight crews, and, thereafter, operate the aeroplane
accordingly,'' this AD does not require those actions.
    (3) The ``Remarks'' section of EASA Emergency AD 2022-0161-E
does not apply to this AD.

(i) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation Branch, FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or responsible Flight
Standards Office, as appropriate. If sending information directly to
the Large Aircraft Section, International Validation Branch, send it
to the attention of the person identified in paragraph (j) of this
AD. Information may be emailed to: [email protected].
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or EASA; or Dassault
Aviation's EASA Design Organization Approval (DOA). If approved by
the DOA, the approval must include the DOA-authorized signature.

(j) Related Information

    For more information about this AD, contact Tom Rodriguez,
Aerospace Engineer, Large Aircraft Section, FAA, International
Validation Branch, 2200 South 216th St., Des Moines, WA 98198;
telephone<PHONE_NUMBER>; email [email protected].

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) Emergency AD
2022-0161-E, dated August 4, 2022.
    (ii) [Reserved]
    (3) For EASA Emergency AD 2022-0161-E, contact EASA, Konrad-
Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000;
email [email protected]; internet easa.europa.eu. You may find this
EASA AD on the EASA website at ad.easa.europa.eu.
    (4) You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St.,
Des Moines, WA. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
[email protected], or go to: archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on August 29, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-19116 Filed 8-31-22; 11:15 am]
BILLING CODE 4910-13-P