Federal Register / Vol. 77, No. 54 / Tuesday, March 20, 2012 / Notices 16239 

matter; (3) a list of documents in the 

administrative file, or additional copies 

of such documents, that are deemed 

necessary for resolution of the issue(s); 

and (4) a statement that the previous 

supervisory level has already had the 

opportunity to review all of the material 

relied on for dispute resolution. The 

information that the Agency suggests 

submitting with a formal request for 

dispute resolution consists of: (1) 

Statements describing the issue from the 

perspective of the person with a 

dispute, (2) brief statements describing 

the history of the matter, and (3) the 

documents previously submitted to FDA 

under an OMB approved collection of 

information. 

Based on FDA’s experience with 

dispute resolution, the Agency expects 

that most persons seeking formal 

dispute resolution will have gathered 

the materials listed previously when 

identifying the existence of a dispute 

with the Agency. Consequently, FDA 

anticipates that the collection of 

information attributed solely to the 

guidance will be minimal. 

Description of respondents: A 

sponsor, applicant, or manufacturer of a 

drug or biological product regulated by 

the Agency under the Federal Food, 

Drug and Cosmetic Act or section 351 of 

the Public Health Service Act (42 U.S.C. 

262) (Pub. L. 99–660) who requests 

formal resolution of a scientific or 

procedural dispute. 

Burden Estimate: Provided below is 

an estimate of the annual reporting 

burden for requests for dispute 

resolution. Based on data collected from 

review divisions and offices within 

CDER and CBER, FDA estimates that 

approximately nine sponsors and 

applicants (respondents) submit 

requests for formal dispute resolution to 

CDER annually and approximately one 

respondent submits requests for formal 

dispute resolution to CBER annually. 

The total annual responses are the total 

number of requests submitted to CDER 

and CBER in 1 year, including requests 

for dispute resolution that a single 

respondent submits more than one time. 

FDA estimates that CDER receives 

approximately 18 requests annually and 

CBER receives approximately 1 request 

annually. The hours per response is the 

estimated number of hours that a 

respondent would spend preparing the 

information to be submitted with a 

request for formal dispute resolution in 

accordance with this guidance, 

including the time it takes to gather and 

copy brief statements describing the 

issue from the perspective of the person 

with the dispute, brief statements 

describing the history of the matter, and 

supporting information that has already 

been submitted to the Agency. Based on 

experience, FDA estimates that 

approximately 8 hours on average 

would be needed per response. 

Therefore, FDA estimates that 152 hours 

will be spent per year by respondents 

requesting formal dispute resolution 

under the guidance. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN

Requests for formal dispute resolution Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

CDER ................................................................................... 9 2 18 8 144 

CBER ................................................................................... 1 1 1 8 8 

Total .............................................................................. ........................ ........................ ........................ ........................ 152 

Dated: March 15, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–6690 Filed 3–19–12; 8:45 am] 

BILLING CODE 4160–01–P 

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. 

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: 

MDUFAReauthorization@fda.hhs.gov. 

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 


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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: MDUFAReauthorization@

fda.hhs.gov 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 


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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 PreSubmissions, 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 


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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 RealTime 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 


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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 rampup 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/DeviceRegulationand

Guidance/Overview/MedicalDeviceUser

FeeandModernizationActMDUFMA/

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/Device

RegulationandGuidance/Overview/

MedicalDeviceUserFeeand

ModernizationActMDUFMA/

ucm109316.htm. FDAAA-specific 

information is available at http://www.

fda.gov/RegulatoryInformation/

Legislation/FederalFoodDrugand

CosmeticActFDCAct/Significant

AmendmentstotheFDCAct/Foodand

DrugAdministrationAmendments

Actof2007/default.htm. 

4. The minutes from FDA’s 

negotiation and stakeholder meetings 

are available at http://www.fda.gov/

MedicalDevices/DeviceRegulationand

Guidance/Overview/MedicalDeviceUser

FeeandModernizationActMDUFMA/

ucm236902.htm. 

5. Further information can be found 

on FDA’s Web site at http://www.fda.

gov/MedicalDevices/NewsEvents/


srobinson on DSK4SPTVN1PROD with NOTICES
16244 Federal Register / Vol. 77, No. 54 / Tuesday, March 20, 2012 / Notices 

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/Medical

Devices/NewsEvents/Workshops

Conferences/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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Request for Comments on the Update 

of the Scholarships for Disadvantaged 

Students Program 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: The Health Resources and 

Services Administration (HRSA) 

updates and clarifies the 

implementation of the Scholarships for 

Disadvantaged Students (SDS) program 

under authority of Section 737 of the 

Public Health Service Act (PHS Act). 

The publication of the final notice will 

supersede all previous notices regarding 

the SDS program. 

DATES: Effective Date: The program 

clarifications described in this notice 

will be implemented in fiscal year (FY) 

2012 and beyond and will become 

effective for SDS funds awarded to 

schools in FY 2012 and beyond. 

Purpose: HRSA is updating the SDS 

program to increase the impact of the 

program in the areas addressed in the 

program’s authorizing statute. 

Specifically, the authorizing statute 

allows the Secretary to make grants to 

eligible entities that are carrying out a 

program for recruiting and retaining 

students from disadvantaged 

backgrounds, including students who 

are members of racial and ethnic 

minority groups. (PHS Act, Sec. 

737(d)(1)(B)). In addition, grantees 

provide scholarships to individuals who 

meet the following requirements: (1) are 

from disadvantaged backgrounds; (2) 

have a financial need for a scholarship; 

and (3) are enrolled (or accepted for 

enrollment) at an eligible health 

professions or nursing school as a fulltime student in a program leading to a 

degree in nursing or a health profession. 

(PHS Act, Sec. 737(d)(2)(A–C)). Under 

the statute, priority is given to eligible 

entities based on the proportion of 

graduating students going into primary 

care, the proportion of underrepresented 

minority students, and the proportion of 

graduates working in medically 

underserved communities. (PHS Act, 

Sec. 737(c)). 

Current Program: To be eligible, at 

least 10 percent of a school’s enrollment 

and graduates must be disadvantaged 

individuals, and eligible entities must 

be carrying out a recruitment and 

retention program for students from 

disadvantaged backgrounds. For the 

purposes of the SDS program, an 

individual from a disadvantaged 

background is defined as one who: (1) 

Comes from an environment that has 

inhibited the individual from obtaining 

the knowledge, skills, and abilities 

required to enroll in and graduate from 

a health profession or nursing school, or 

from a program providing education or 

training in allied health professions; or 

(2) comes from a family with an annual 

income below the established Census 

Bureau low-income thresholds, adjusted 

by the Secretary for health professions 

and nursing programs eligibility. 

Eligible entities are: schools of 

allopathic and osteopathic medicine; 

dentistry; optometry; pharmacy; 

podiatric medicine; veterinary 

medicine; nursing (associate, diploma, 

baccalaureate, and graduate degree); 

public health; chiropractic; allied health 

(baccalaureate and graduate degree 

programs of dental hygiene, medical 

laboratory technology, radiology 

technology, speech pathology, 

audiology, registered dieticians, and 

occupational therapy and physical 

therapy); mental and behavioral health 

(graduate degree programs in clinical 

psychology, clinical social work, 

professional counseling, marriage and 

family therapy); and physician assistant 

training. (PHS Act, Sec. 737(d)(1)(A)). 

Grant awards are determined by formula 

with the three priority areas based on 

the proportion of graduating students 

going into primary care, the proportion 

of underrepresented minority students, 

and the proportion of graduates working 

in medically underserved communities. 

There is also a requirement to award at 

least 16 percent of the available funds 

to nursing students (PHS Act Section 

740(a)). The amount of the scholarship 

may not exceed a recipient’s cost of 

tuition expenses, other reasonable 

educational expenses and reasonable 

living expenses incurred in attendance 

at such a school. The scholarship may 

be expended by the student only for 

such expenses. The average annual 

student award is $2,300. 

Issues: First, the SDS program grantee 

population has grown from 401 schools 

in FY 2000 to almost 700 health 

profession schools in FY 2011. Since all 

SDS eligible schools receive grant 

awards, the funding has been divided 

into ever decreasing amounts per school 

over the years. Many of the schools, in 

an effort to provide funding to each of 

their disadvantaged students, spread the 

award equally among the disadvantaged 

students and the smaller school award 

amounts result in smaller student 

scholarship amounts. While the student 

scholarship amounts have been 

decreasing, the tuition rates have been 

increasing. For many students with 

insufficient financial resources, the 

small award size is unlikely to provide 

enough funds to continue in school. 

Second, the primary care and 

underrepresented minority student 

priority weights currently used are too 

small to adequately incentivize and 

reward schools that are successful in 

graduating primary care 

underrepresented minority students or 

have excellent plans to improve their 

programs to recruit and retain students 

from disadvantaged backgrounds, 

including students who are members of 

racial and ethnic minority groups. Also, 

the primary care weights are not enough 

to incentivize schools to increase the 

proportion of graduating students going 

into primary care. Third, the practice of 

awarding grants for one year at a time 

does not allow the schools to select 

financially disadvantaged applicants 

with the assurance that a student will 

receive SDS financial aid for the entire 

time the student is enrolled. 

Proposed Changes: 

To provide larger award amounts to 

schools and to increase the retention 

and graduation of underrepresented 


srobinson on DSK4SPTVN1PROD with NOTICES