[Federal Register Volume 77, Number 54 (Tuesday, March 20, 2012)]
[Notices]
[Pages 16239-16244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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, 301-796-5861, FAX: 301-847-8142, 
email: <a href="/cdn-cgi/l/email-protection#0e434a5b484f5c6b6f7b7a66617c67746f7a6761604e686a6f2066667d20696178"><span class="__cf_email__" data-cfemail="4e030a1b080f1c2b2f3b3a26213c27342f3a2721200e282a2f6026263d60292138">[email protected]</span></a>.
    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

[[Page 16240]]

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: <a href="/cdn-cgi/l/email-protection#2f626b7a696e7d4a4e5a5b47405d46554e5b4640416f494b4e0147475c01484059"><span class="__cf_email__" data-cfemail="a5e8e1f0e3e4f7c0c4d0d1cdcad7ccdfc4d1cccacbe5c3c1c48bcdcdd68bc2cad3">[email protected]</span></a> 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:
    <bullet> 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.
    <bullet> 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

[[Page 16241]]

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

[[Page 16242]]

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

[[Page 16243]]

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/

[[Page 16244]]

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


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