19528 Federal Register / Vol. 72, No. 74 / Wednesday, April 18, 2007 / Notices 

administers a national quarantine 

program to protect the U.S. against the 

introduction of diseases from foreign 

countries and the transmission of 

communicable disease between states; 

(10) facilitates appropriate cross-cutting 

collaboration with other NCs, CCID, 

other CDC programs, and external 

partners to promote effective 

surveillance for infectious threats to 

health; (11) designs and conducts 

epidemiologic studies to investigate the 

causes and risk factors for infectious 

diseases; (12) identifies, evaluates, and 

promotes the nationwide 

implementation of interventions 

designed to prevent infectious diseases, 

antimicrobial resistance, related adverse 

events, and medical errors among 

patients and healthcare personnel; (13) 

investigates and responds to outbreaks, 

emerging infections, and related adverse 

events among patients, healthcare 

providers, and others associated with 

the healthcare environment; (14) leads 

the improvement of domestic and 

international laboratory practices in 

clinical and public health laboratories 

through a quality systems approach; (15) 

provides services and expertise in 

development of quality systems to 

support compliance with FDA 

regulations on production, distribution, 

and use of laboratory diagnostic 

reagents; (16) provides support to CDC 

laboratories and investigators including 

provisions of animals, services, 

materials, and specialized expertise; and 

(17) provides emergency response 

coordination to CCID resources and 

enhanced epidemiologic, surveillance, 

and laboratory response capacity for 

bioterrorism and other infectious 

disease public health emergencies. 

Office of the Director (CVK1). (1) 

Directs and manages the science, 

programs and activities of the NCPDCID; 

(2) provides leadership and 

coordination for the development and 

implementation of programs to enhance 

the prevention and control of infectious 

diseases nationally and internationally; 

(3) provides leadership and guidance on 

policy, program planning and 

development, program integration, 

management, and operations; (4) 

identifies and coordinates synergies 

between national centers and relevant 

partners; (5) provides technical 

information services to facilitate 

dissemination of relevant public health 

information; (6) provides liaison with 

other Governmental agencies and 

international organizations; (7) 

coordinates, in collaboration with the 

appropriate CCD and CDC components, 

international health activities relating to 

the prevention and control of infectious 

diseases; (8) advises the Director CCID 

and the Director, CDC, on policy matters 

concerning NCPDCID programs and 

activities; (9) coordinates development 

and review or regulatory documents and 

congressional reports; and (10) analyzes 

health programs and proposed 

legislation with respect to NCPDCID 

programs, goals and objectives. 

Dated: April 10, 2007. 

William H. Gimson, 

Chief Operating Officer, Centers for Disease 

Control and Prevention (CDC). 

[FR Doc. 07–1905 Filed 4–17–07; 8:45 am] 

BILLING CODE 4160–18–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0068] 

Medical Device User Fee and 

Modernization Act; Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting to discuss our proposed 

recommendations for the 

reauthorization of the Medical Device 

User Fee and Modernization Act of 2002 

(MDUFMA I) for fiscal years (FY) 2008 

through 2012, as well as other proposals 

to improve the review of medical 

devices and the third party inspection 

program. These proposed 

recommendations were developed after 

discussions with the regulated industry. 

Section 105 of MDUFMA I directs FDA 

to publish these proposed 

recommendations in the Federal 

Register, hold a meeting at which the 

public may present its views on the 

recommendations, and provide for a 

period of 30 days for the public to 

provide written comments on the 

recommendations. The public meeting 

and comment period will provide an 

opportunity for public input on the 

proposed recommendations from all 

interested parties, including the 

regulated industry, scientific and 

academic experts, healthcare 

professionals, and representatives of 

patient and consumer advocacy groups. 

DATES: The public meeting will be held 

on April 30, 2007, from 12 noon to 5 

p.m. Registration to attend and to 

present at the meeting must be received 

by April 25, 2007. (See section III.B of 

this document for details on 

registration.) Submit written comments 

by May 18, 2007. Transcripts will be 

available approximately 30 days after 

the meeting. (See section III.C of this 

document for more details on transcript 

availability.) 

ADDRESSES: The public meeting will be 

held at the Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1066, Rockville, MD 20857. 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.fda.gov/dockets/ecomments. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: For 

information regarding this notice, 

contact: Erik Mettler, Office of Policy 

and Planning, Food and Drug 

Administration (HF–11), 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

3360, FAX: 301–594–6777, e-mail: 

Erik.Mettler@fda.hhs.gov. 

For information regarding 

registration, contact: Cynthia Garris, 

Office of Communication, Education, 

and Radiation Programs, Center for 

Devices and Radiological Health, Food 

and Drug Administration (HFZ–220), 

1350 Piccard Ave., Rockville, MD 

20850, phone: 240–276–3150 ext. 121, 

FAX: 240–276–3151; e-mail: 

cynthia.garris@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

MDUFMA I (Public Law 107–250, 

October 26, 2002) amended the Federal 

Food, Drug, and Cosmetic Act (the act) 

to provide FDA with the following new 

responsibilities and resources: 

• User fees for premarket reviews of 

certain device premarket applications 

(see sections 737 and 738 of the act (21 

U.S.C. 379i and 379j)); 

• Performance goals to improve 

medical device reviews (see section 

101(3) of MDUFMA I and section 

738(g)(1) of the act); 

• Establishment inspections to be 

conducted by accredited third-parties 

when certain conditions are met (see 

section 704(g) of the act (21 U.S.C. 374)); 

and 

• Improved oversight and 

coordination of reviews of combination 

products (products that combine 

devices, drugs, or biologics) (see section 

503(g) of the act (21 U.S.C. 353(g))). 

A. Medical Device User Fees and 

Performance Goals 

In the years prior to MDUFMA I, 

FDA’s resources for our device and 

radiological health programs had 

increased at a lower rate than FDA’s 


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Federal Register / Vol. 72, No. 74 / Wednesday, April 18, 2007 / Notices 19529 

costs. As stated in the House Report to 

H.R. 3580: 

The medical device industry is 

growing rapidly. The complexity of 

medical device technology is increasing 

at an equally rapid pace. Unfortunately, 

FDA’s device review program lacks the 

resources to keep up with the rapidly 

growing industry and changing 

technology. Because prompt approval 

and clearance of safe and effective 

medical devices is critical to improving 

public health, it is the sense of the 

Committee that adequate funding for the 

program is essential. (U.S. Congress, 

House Committee on Energy and 

Commerce, Medical Device User Fee 

and Modernization Act of 2002, report 

to accompany H.R. 3580, 107th Cong., 

2nd sess., part 1 (Washington: GPO, 

2002), pp. 23.) 

Section 102 of the House Report 

recognized the importance of user fees 

in improving the device review 

program: 

This title gives FDA the authority to 

collect user fees from manufacturers 

seeking to market medical devices. In 

this new program, manufacturers pay 

fees to FDA in exchange for FDA’s 

agreement to endeavor to meet device 

review performance goals that will 

significantly improve the timeliness, 

quality, and predictability of the 

agency’s review of devices. (Id. at 23–

24.) 

Under MDUFMA I, the industry 

provides funds through user fees that 

are available to FDA, in addition to 

appropriated funds, to spend on the 

device review process. Our authority to 

collect and spend user fees is 

‘‘triggered’’ only in years when a base 

amount of appropriated funds, adjusted 

for inflation, is appropriated and spent 

on the process for the review of device 

applications. 

In return for the additional resources 

provided by medical device user fees, 

FDA is expected to meet performance 

goals defined in a November 14, 2002, 

letter from the Secretary of the 

Department of Health and Human 

Services to the Chairman and Ranking 

Minority Members of the Committee on 

Health, Education, Labor and Pensions 

Committee of the U.S. Senate and the 

Committee on Energy and Commerce of 

the U.S. House of Representatives. This 

letter is generally referred to as the 

‘‘FDA Commitment Letter.’’ See 148 

Cong. Rec. S11549–01 (2002). A few 

goals applied during FY 2003 and FY 

2004, allowing FDA time to hire staff, 

build infrastructure, provide guidance 

to industry, and take other actions to 

implement the new law. More goals 

went into effect each year from FY 2005 

through FY 2007, and the goals become 

more ambitious each year. These goals 

include ‘‘FDA decision’’ goals, under 

which FDA makes a specific decision 

within a specified time (and similar 

goals for FDA to ‘‘review and act on’’

certain biologics applications within a 

specified time), and cycle goals, which 

refer to FDA actions prior to a final 

action on a submission. These goals 

apply to the review of device premarket 

approvals (PMAs), panel-track 

supplements, premarket reports, 

expedited PMAs, 180-day PMA 

supplements, and 510(k)s in FDA’s 

Center for Devices and Radiological 

Health (CDRH) and FDA’s Center for 

Biologics Evaluation and Research 

(CBER), and to Biologics License 

Applications (BLAs), BLA supplements, 

and BLA resubmissions, and BLA 

supplement resubmissions in CBER. 

Phased in over the 5 years of MDUFMA 

I, the final goals for FY 2007 included 

an FDA decision on: 

• 90 percent of PMAs, panel-track 

supplements, and premarket reports 

within 320 days; 

• 50 percent of PMAs, panel-track 

supplements, and premarket reports 

within 180 days; 

• 90 percent of expedited PMAs 

within 300 days; 

• 90 percent of 180-day PMA 

supplements within 180 days; 

• 80 percent of 510(k)s within 90 

days; 

• 90 percent of standard BLAs within 

10 months; 

• 90 percent of priority BLAs within 

6 months; 

• 90 percent of standard BLA efficacy 

supplements in 10 months; 

• 90 percent of priority BLA efficacy 

supplements within 6 months; 

• 90 percent of ‘‘Class 1’’ BLA 

resubmissions and BLA supplement 

resubmissions within 2 months; 

• 90 percent of ‘‘Class 2’’ BLA 

resubmissions and BLA supplement 

resubmissions within 6 months; and 

• 90 percent of BLA manufacturing 

supplements requiring prior approval 

within 4 months. 

The goals also included interim cycle 

goals that were phased in over time. 

FDA is on track to meet or exceed nearly 

all of these performance goals. These 

performance goals, as outlined in the 

FDA Commitment Letter, will no longer 

be in effect after MDUFMA I sunsets on 

October 1, 2007. See section 107 of 

MDUFMA I. 

B. Other Topics in MDUFMA I 

In addition to its provisions relating 

to medical device user fees and 

performance goals, MDUFMA I 

contained other provisions. These 

provisions include: 

• Authorization for a program that 

allows establishment inspections to be 

conducted by third party accredited 

persons (APs), under carefully 

prescribed conditions; 

• Establishment of a new office in the 

Office of the Commissioner to 

coordinate the review of combination 

products; 

• Authorization to require electronic 

registration of device establishments, 

once FDA finds that electronic 

registration is feasible; and 

• Explicit authorization for the 

‘‘modular’’ review of PMAs. 

The user fees provided by MDUFMA 

I, and the additional appropriations 

anticipated by the new law, have 

allowed us to make improvements in 

the device review program. FDA’s 

progress towards meeting MDUFMA I’s 

performance goals has been 

accomplished through: 

• Targeted hiring, including medical 

specialists, statisticians, software 

experts, and engineers; 

• Increased use of outside experts, 

particularly for novel technologies; 

• Improvements to FDA’s information 

technology systems, such as enhanced 

tracking of applications and reporting 

systems; and 

• Additional guidance documents 

that assist industry in preparing their 

applications to better address regulatory 

issues, such as how to qualify for small 

business fee waivers and discounts, how 

to prepare a ‘‘modular’’ premarket 

approval application, and how to obtain 

expedited review of a premarket 

submission. 

These actions have led to improved 

FDA review times and greater 

predictability in the device review 

process. 

In addition, we have made significant 

progress towards meeting other 

fundamental objectives of MDUFMA I. 

For example, FDA established an Office 

of Combination Products that is 

improving coordination of combination 

product reviews. Combination products 

are products comprised of different 

types of regulated articles (i.e., drugdevice, drug-biologic, and devicebiologic products). Although primary 

responsibility for the oversight of these 

products remains with the product 

Centers, the Office of Combination 

Products assigns combination products 

to the product Centers, ensures the 

timely and effective premarket review of 

combination products, and ensures the 

consistency and appropriateness of 

postmarket regulation of combination 

products. FDA also met the statutory 

requirement to establish a third-party 

inspection program. This option may be 

particularly useful to U.S. firms who 


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compete in international markets and 

are faced with multiple sets of 

regulatory requirements, as a single 

inspection may satisfy both U.S. and 

foreign requirements, and might also 

meet International Organization for 

Standardization (ISO) or other 

international standards requirements. 

In August 2005, Congress passed the 

Medical Device User Fee Stabilization 

Act (Public Law 109–43, August 1, 

2005) (MDUFSA), which modified 

several provisions of MDUFMA I. 

MDUFSA: 

• Repealed the FY 2003 and FY 2004 

appropriations trigger requirements; 

• Modified the FY 2005 through FY 

2007 minimum appropriation 

requirements for the device and 

radiological health line of FDA’s 

appropriation to be within 1 percent 

below the calculated appropriations 

trigger; 

• Fixed annual fees for FY 2006 and 

FY 2007 at an amount providing an 8.5 

percent rate of increase each year; 

• Expanded the definition of ‘‘small 

business’’ for FY 2006 and FY 2007, 

making more firms eligible for reduced 

small business fees; and 

• Repealed the ‘‘compensating 

adjustment’’ that allowed FDA to adjust 

user fee rates to make up for revenue 

lost when user fee revenues did not 

meet projections in a prior year. 

The user fee provisions of MDUFMA 

I will sunset on October 1, 2007 if not 

reauthorized. In preparing our proposed 

recommendations for reauthorization, 

we have conducted technical 

discussions with the regulated industry 

and have consulted with stakeholders 

each year at a public meeting as 

required by law. 

Congress directed FDA to publish in 

the Federal Register the proposed 

recommendations developed through 

this process after negotiations with the 

regulated industry, present the proposed 

recommendations to the congressional 

committees specified in the statute, hold 

a public meeting at which the public 

can present its views on the proposed 

recommendations, and provide for a 

period of 30 days for the public to 

provide written comments on the 

proposed recommendations. See section 

109 of MDUFMA I. 

The purpose of this notice is to 

publish the recommendations we 

propose to offer Congress and announce 

the dates for the upcoming public 

meeting and written comment period. 

After the public meeting and the close 

of the 30-day comment period, we will 

undertake a careful review of all the 

public comments we receive on these 

proposed recommendations. 

II. What We Are Proposing to 

Recommend to Congress? 

Our goal for the legislative package to 

reauthorize medical device user fees 

and to make other improvements 

(MDUFMA II) is to build upon the 

performance goals we are pursuing for 

FY 2007 while providing predictable 

user fees for industry and financial 

stability and predictability in funding 

for FDA over the next 5 years. Our 

proposed recommendations fall into the 

following two major categories: (1) 

Proposals to ensure sound financial 

footing for the medical device review 

program and (2) proposals to enhance 

the process for premarket review of 

device applications. 

A. Proposed Recommendations to 

Ensure Sound Financial Footing 

Although user fees have provided 

substantial resources to FDA since the 

beginning of the program, total 

resources for medical device review, 

including funds from both 

appropriations and user fees, have not 

kept up with our increasing costs. FDA 

has experienced an increase in our costs 

of pay and benefits per ‘‘full time 

equivalent’’ (FTE) averaging 5.8 percent 

per year over the most recent 5 years. 

Nonsalary costs, including the costs of 

rent and contract support, have also 

increased at the same rate per FTE. We 

are proposing changes to the financial 

provisions of MDUFMA I to place FDA 

on more sound financial footing so we 

can continue with the program and 

make enhancements to it. 

1. Adjustment of Total Revenue for 

Device Review to Ensure a 6.4 Percent 

Increase From Year to Year Over the 

Next 5 Years 

Detailed analysis of FDA’s recent 

costs history and anticipated increased 

costs over the next 5 years anticipate 

annual increases at 6.4 percent each 

year. Increases of 6.4 percent per year 

are necessary for FDA to be able to 

maintain the current level of staff to 

support the medical device review 

process. The primary drivers of this rate 

of increase are rent, security, and 

statutorily mandated payroll and 

benefits increases. In developing cost 

estimates for MDUFMA II, we used our 

FY 2005 spending on the device review 

process (including fees and 

appropriations) and estimated that the 

costs for the program would increase at 

6.4 percent each year. Table 1 of this 

document represents FDA’s estimate of 

the total resources it will need for 

device review from appropriations and 

user fees combined over the 5-year 

period 2008 through 2012. 

TABLE 1.—TOTAL RESOURCES NEEDED FOR THE DEVICE REVIEW PROCESS ($ MILLIONS) 

Fiscal Year 2008 2009 2010 2011 2012 5-Year Total 

Dollars (millions) $220 $234 $249 $265 $281 $1,249 

The annual fee increases assumed 

will ensure a stable program that will 

not increase over the 5 years of 

MDUFMA II, but that should remain 

stable in its capabilities and personnel 

strength. The proposed fee structure 

would have application fees lower than 

those paid in 2007 in almost all 

application categories over the 5 years 

of MDUFMA II, but would add new 

annual establishment and annual report 

fees and some new application fees 

(discussed more below). Total fee 

revenues in FY 2008 would increase by 

approximately 31 percent over 

estimated FY 2007 fee revenues, and by 

8.5 percent per year each subsequent 

year through FY 2012, as shown in table 

2 below. 

TABLE 2.—TOTAL ESTIMATED FEE REVENUES ($ MILLIONS) 

Fiscal Year 2008 2009 2010 2011 2012 5-Year Total 

Total $48.5 $52.5 $57.0 $61.9 $67.1 $287.0 


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Federal Register / Vol. 72, No. 74 / Wednesday, April 18, 2007 / Notices 19531 

2. More Stable Fee Structure 

All fee revenues in MDUFMA I were 

derived from application fees only, 

which fluctuated significantly from year 

to year. Under MDUFMA I, fee revenues 

repeatedly fell short of expectations. 

FDA is proposing to recommend two 

new fees in MDUFMA II that would 

generate about 50 percent of the total fee 

revenue and that would be more stable 

than application fees. The new fees are: 

(1) An annual establishment registration 

fee and (2) an annual fee for filing 

periodic reports. This would allow for 

significant reduction in MDUFMA II of 

existing application fees. 

The establishment fee would be paid 

once each year by each device 

manufacturer (including an 

establishment that sterilizes or 

otherwise makes a device for a 

specification developer or any other 

person), single-use reprocessor, and 

specification developer. It is proposed 

to start at $1,706 in 2008 and would 

generate about $21.8 million (45 percent 

of total fee revenues), assuming that 

12,750 establishments pay this fee. (The 

proposal would allow an increase in FY 

2010 over the annual rate of increase if 

fewer than 12,250 establishments pay 

the fee in FY 2009 to ensure that the fees 

collected from this source total 45 

percent of fee revenues. This increase 

would not be more than 8.5 percent 

above the annual rate of increase.) A 

firm would not be considered to be 

legally registered each year without the 

payment of this fee, which is to be 

completed electronically. 

The annual fee for filing periodic 

reports is proposed to start at $6,475 in 

FY 2008 and would generate about $2.5 

million in FY 2008, or about 5 percent 

of fee revenues assuming that we 

receive reports on 425 devices subject to 

periodic reporting and 10 percent pay 

the reduced small business fee of $ 

1,619. 

The remaining 50 percent of revenues 

would come from application fees. All 

proposed application fees would be 

significantly lower than they were in FY 

2007. The proposed fee for a PMA or 

BLA would be set at $185,000 in FY 

2008—34 percent less than the $281,600 

charged in FY 2007. The proposed fee 

for a panel-track supplement would be 

charged at 75 percent of the rate for a 

PMA, rather than at 100 percent of that 

rate as was the case in FY 2003 through 

FY 2007, so the proposed panel-track 

supplement fee in FY 2008 of $138,750 

would be 51 percent less than the FY 

2007 fee of $281,600. The fee for a 180- 

day PMA supplement is proposed at 15 

percent of the PMA fee, rather than at 

21.5 percent of that rate as was the case 

in FY 2003 through FY 2007, so the 

proposed 180-day PMA supplement fee 

in FY 2008 of $27,750 would be 54 

percent less than the FY 2007 fee of 

$60,544. The fee for a real-time 

supplement is proposed at 7 percent of 

the PMA fee, rather than at 7.2 percent 

of that rate as was the case in FY 2003 

through FY 2007, so the proposed realtime supplement fee in FY 2008 of 

$12,950 would be 36 percent less than 

the FY 2007 fee of $20,275. The fee for 

a 510(k) is proposed at 1.84 percent of 

the PMA fee, rather than at 1.42 percent 

of that rate as was the case in FY 2003 

through FY 2007, so the proposed 

510(k) fee in FY 2008 of $3,404 would 

be 18 percent less than the FY 2007 fee 

of $4,158. 

FDA is proposing two new fees for 

applications not currently subject to 

fees. They are: (1) A fee for 30-day 

notices (making modifications to 

manufacturing procedures or methods) 

that would be 1.6 percent of the fee for 

a full PMA (for a 30-day notice fee of 

$2,960 in FY 2008) and (2) a fee for a 

request for classification information 

under section 513(g) that would be 

assessed at 1.35 percent of the cost of a 

full PMA (for a 513(g) fee of $2,498 in 

FY 2008). Both of these applications 

require significant work by FDA, and 

the proposed fees reflect the work that 

they involve, on average. 

Each of the proposed fees would 

increase each year by 8.5 percent to 

ensure that fee revenues contribute their 

expected share to total program costs, 

and to provide industry with stability 

and predictability in the fee revenues it 

would expect to pay. 

3. Changes in the Fee Structure for 

Small Businesses 

In an effort to reduce the burden on 

small businesses, FDA is proposing to 

reduce the rates paid by firms meeting 

the definition of a small business under 

MDUFMA. The criteria for meeting the 

small business definition is not 

proposed to change, other than as 

discussed below for entities that do not 

file returns with the U.S. Internal 

Revenue Service, but the proposed fee 

rates for qualifying small businesses 

would be lower. We are proposing to 

reduce the rates for small businesses for 

premarket applications, panel-track 

PMA applications, BLA efficacy 

supplements, 180-day PMA 

supplements, real-time PMA 

supplements, and annual reports, from 

38 percent to 25 percent of the standard 

fee for the particular type of submission. 

We are also proposing to reduce the 

rates for small businesses for 30-day 

notices, 510(k) premarket notification 

submissions, and 513(g) requests for 

classification information from 80 

percent to 50 percent of the standard fee 

for the particular type of submission. 

These are significant reductions that 

should provide substantial relief to 

qualifying small businesses. 

The following table summarizes the 

reductions in fees for qualifying small 

businesses proposed for FY 2008. 

TABLE 3.—MEDICAL DEVICE USER FEES PROPOSED FOR FY 2008 

Type of Fee Standard Fee Small Business Fee 

Premarket application (PMA, BLA, premarket report, product development protocol) $185,000 $46,250 

Panel-track PMA supplement $138,750 $34,688 

180-day PMA supplement $27,750 $6,938 

BLA efficacy supplement $185,000 $46,250 

Real-time PMA supplement $12,950 $3,237 

30-day notice $2,960 $1,480 

510(k) premarket notification submission $3,404 $1,702 

Request for classification information $2,498 $1,249 

In addition, FDA is proposing that the 

small business provisions be expanded 

to allow a way for firms that do not file 

tax returns with the U. S. Internal 

Revenue Service to also qualify for 

small business rates, based on 

certifications from the national taxing 

authorities where the firm and each of 

its affiliates file their taxes, and signed 

affidavits from the head of the firm or 

its chief financial officer and from each 

of its affiliates. 


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1Under MDUFMA I, FDA issues a ‘‘not 

approvable’’ letter to indicate deficiencies in an 

application and to request additional information, 

which counts as an action that meets the goals for 

180-day PMA supplements. Under MDUFMA II, the 

reviewer in the same situation will be able to issue 

a ‘‘major deficiency’’ letter, which will not count 

towards meeting the 180-day PMA supplement 

goals. The MDUFMA II goal will be more ambitious 

in practice because it reflects a more meaningful 

decision, reached after FDA has worked with the 

sponsor to discuss deficiencies and to obtain 

additional information. 

4. Technical Changes to Increase 

Administrative Efficiency of the User 

Fee Program 

We are proposing a change to the 

current offset provision of MDUFMA I. 

The current provision requires us to 

reduce fees in a subsequent year if 

collections in any year exceed the 

amount appropriated, but does not have 

a parallel provision to increase fees in 

a subsequent year if collections fall 

short of amounts appropriated from 

fees. The modification we are 

recommending to propose would allow 

us to aggregate all fees collected over the 

first four years of MDUFMA II, from 

FY2008 through FY 2011 and compare 

that amount to the aggregate amount 

appropriated for the same period. A 

reduction would be made in fees in the 

final year only if the amount collected 

in the 4-year period exceeds the amount 

appropriated for the same period. We 

believe this aggregation over 4 years 

provides for greater financial stability 

for FDA than treating each year in 

isolation. 

5. Electronic Registration 

FDA is proposing to change section 

510(p) of the act (21 U.S.C. 360(p)) to 

facilitate the submission of registration 

and listing information by electronic 

means, except in those rare situations 

where FDA agrees that electronic 

submission is not feasible, in order to 

collect establishment registration fees 

for FY 2008. The modification would 

require electronic submission of 

registration and listing information 

without going through the rulemaking 

process to ensure timely collection of 

establishment registration fees for FY 

2008. We believe electronic registration 

is essential for efficient implementation 

of any proposal for an establishment 

registration fee. 

6. Triggers 

MDUFMA I has three triggers. One 

tied to appropriations for the device line 

and two tied to agency spending on 

device review and inspections. We are 

proposing to extend the current triggers 

through MDUFMA II. 

B. Enhancing the Process for Premarket 

Review 

In the area of premarket review, FDA 

is proposing to recommend 

enhancements in the following eight 

areas: (1) Performance goals; (2) 

interactive review; (3) guidance 

document development; (4) diagnostic 

imaging products; (5) in vitro 

diagnostics; (6) meetings; (7) quarterly 

performance reports; and (8) reviewer 

training. 

1. Performance Goals 

FDA is proposing to meet more 

rigorous goals for MDUFMA II that 

build on the progress made in 

MDUFMA I. In making these proposals, 

we have taken into account the 

efficiencies accomplished in MDUFMA 

I and planned for in MDUFMA II. These 

efficiencies include additional 

scientific, regulatory, and leadership 

training; additional staff, including 

those with expertise demanded by 

increasingly complex device reviews; 

expanded use of outside experts; and 

information technology improvements 

that allow us to better track and manage 

the device review process. 

In MDUFMA II, we are proposing to 

eliminate the cycle goals that we believe 

are an impediment to reaching the 

ultimate objective of MDUFMA—to get 

safe and effective devices to patients 

and healthcare professionals more 

quickly. In order to meet the 

performance goals in the FDA 

Commitment Letter, we put business 

processes in place to meet the goals for 

final decisions, as well as for interim 

cycle goals. However, FDA believes that 

an unintended consequence of the cycle 

goals is that, because we must 

determine whether or not to send a 

major deficiency letter, ‘‘not 

approvable’’ letter, or other interim 

action earlier in the review process, we 

are less likely to have sufficient time to 

engage in informal interactions with the 

applicant to resolve outstanding 

questions before making that 

determination. Consequently, we are 

more likely to issue a negative interim 

decision. We are proposing to eliminate 

these cycle goals and only have 

performance goals for final decisions. 

In MDUFMA II, we are proposing to 

improve our performance in reaching a 

final decision for the following 

applications: 

• A decision for 60 percent of 

nonexpedited PMAs and panel-track 

PMA supplements within 180 days and 

for 90 percent within 295 days; 

• A decision for 50 percent of 

expedited PMAs and expedited paneltrack PMA supplements within 180 

days and for 90 percent within 280 

days; 

• A decision for 90 percent of 510(k)s 

within 90 days and for 98 percent 

within 150 days; 

• A decision for 85 percent of 180- 

day PMA supplements within 180 days 

and for 95 percent within 210 days;1

and 

• A decision for 80 percent of realtime PMA supplements within 60 days 

and for 90 percent within 90 days. 

We are also adding a goal for PMA 

modules in MDUFMA II. We are 

proposing to take action on 75 percent 

of PMA modules within 90 days, and for 

90 percent within 120 days. 

Where specific quantitative goals have 

not been established, we are proposing 

that we would, at a minimum, maintain 

current performance in review areas, 

such as for investigational device 

exemptions (IDEs) and 30-day notices. 

2. Interactive Review 

Under the proposed 

recommendations, we would continue 

to incorporate an interactive review 

process to provide for, and encourage, 

informal communication between FDA 

and sponsors to facilitate timely 

completion of the review process based 

on accurate and complete information. 

Interactive review entails 

responsibilities for both FDA and 

sponsors. Interactive review is intended 

to: (a) Prevent unnecessary delays in the 

completion of the review; (b) avoid 

surprises to the sponsor at the end of the 

review process; (c) minimize the 

number of review cycles and the extent 

of review questions conveyed through 

formal requests for additional 

information; and (d) ensure timely 

responses from sponsors. We believe 

that all forms of communication should 

be used as tools to facilitate interactive 

review, including, but not limited to, 

the following: (a) E-mail; (b) one-on-one 

telephone calls; (c) telephone 

conferences; (d) videoconferencing; (e) 

fax; and (f) face-to-face meetings. 

3. Guidance Document Development 

Under the proposed 

recommendations, we would continue 

to develop guidance documents to the 

extent possible without adversely 

impacting the review timeliness for 

MDUFMA-related submissions. In 

addition, FDA would post a list of 

guidance documents it is considering 

for development and provide 

stakeholders an opportunity to provide 

comments and/or draft language for 

those topics as well as suggestions for 

new or different guidances. 


pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 72, No. 74 / Wednesday, April 18, 2007 / Notices 19533 

4. Diagnostic Imaging Products 

Diagnostic imaging devices that are 

sometimes used concurrently with 

diagnostic drug and biological products 

(such as contrast agents and 

radiopharmaceuticals)—so-called 

‘‘concomitant use products’’—present 

important questions of efficient 

regulation and consultation between 

product Centers that are similar to those 

raised by combination products. 

In response to these concerns, FDA 

would develop a guidance document, 

after consultation with affected parties, 

intended to ensure timely and effective 

review of, and consistent and 

appropriate postmarket regulation and 

product labeling requirements for, 

diagnostic imaging devices used with 

approved imaging contrast agents and/ 

or radiopharmaceuticals. We propose to 

publish draft guidance by the end of FY 

2008 and allow for a 90-day public 

comment period. We propose to issue a 

final guidance within one year of the 

close of the comment period. 

5. In Vitro Diagnostics (IVDs) 

To facilitate the development of IVD 

devices, FDA would continue to explore 

ways to clarify regulatory requirements 

and to reduce regulatory burden, as 

appropriate. FDA proposes to: 

• Draft or revise guidance on the 

conduct of clinical trials involving deidentified leftover specimens, clinical 

trial design issues for molecular 

diagnostic tests, migration studies, 

herpes simplex virus, enterovirus, and 

influenza testing; 

• Conduct a pilot program to evaluate 

integrating the 510(k) review and 

Clinical Laboratory Improvement 

Amendments (CLIA) waiver review 

processes for possible increased 

efficiencies. This pilot would include 

only voluntary participants from 

industry, and the applications involved 

in the pilot would not be counted 

toward the MDUFMA II performance 

goals. 

• Consider industry proposals on 

acceptable CLIA waiver study protocols, 

develop acceptable protocol designs, 

and make them available by adding 

appendices to the guidance or by 

posting redacted protocols on the OIVD 

Web site. 

• Track and report our performance 

on CLIA waiver applications and share 

this information with industry annually 

and then evaluate, at the end of year 

two, whether user fees and performance 

goals for CLIA waivers should be 

considered for MDUFMA III; 

• Review a list of class I and II low 

risk IVD devices, provided by industry, 

to determine whether any of them could 

be exempted from premarket 

notification and allow interested parties 

to petition for exemptions consistent 

with 510(m)(2); 

• Conduct a review of the pre-IDE 

program to address issues raised by 

industry. 

6. Meetings 

FDA would make every effort to 

schedule informal and formal meetings, 

both before and during the review 

process, in a timely way, and industry 

would make every effort to provide 

timely and relevant information to make 

the meetings as productive as possible. 

These meetings include, but are not 

limited to the following: pre-submission 

meetings, determination meetings, 

agreement meetings, and 100-day 

meetings. 

7. Quarterly Performance Reports 

FDA would report quarterly its 

progress toward meeting the 

quantitative goals described in this 

letter. In addition, for all submission 

types, we would track total time (time 

with FDA plus time with the company) 

from receipt or filing to final decision 

(approval, denial, substantial 

equivalence (SE), or nonsubstantial 

equivalence (NSE)). We would also 

provide, on an annual basis, deidentified review performance data for 

the branch with the shortest average 

review times and the branch with the 

longest average review times for 510(k)s, 

180-day supplements, and real-time 

supplements. 

8. Reviewer Training 

As resources permit, FDA would 

apply user fee revenues to support 

reviewer training that is related to the 

process for the review of devices, 

including training to enhance scientific 

expertise. We would provide summary 

information on the types of training 

provided to staff on an annual basis. 

C. Third Party Inspection Program 

FDA is proposing to recommend 

changes to the third party accredited 

person (AP) inspection program in three 

major areas. APs are firms trained and 

accredited by FDA to conduct biennial 

inspections of certain medical device 

firms for compliance with good 

manufacturing practices. The proposals 

are intended to increase the quantity of 

useful information FDA has about the 

compliance status of medical devices 

marketed in the United States and to 

permit FDA to focus its inspectional 

resources on those firms and products 

posing the greatest risk to public health. 

First, FDA is proposing to streamline 

the administrative burdens associated 

with qualifying for the program. For 

example, rather than having to petition 

FDA for clearance to use an AP, the 

proposal would require only that firms 

provide FDA with 30 days prior notice 

of their intent to use an AP listed on 

FDA’s Web site. 

Second, we are proposing to expand 

participation in the program. For 

example, the current AP program 

restricts qualified manufacturers of class 

II and class III medical devices to two 

consecutive AP inspections after which 

FDA must conduct the next inspection, 

unless the manufacturer petitions and 

receives a waiver from us. We are 

proposing to permit firms to use APs for 

an unlimited number of consecutive 

inspections without seeking a waiver. 

However, we would continue to 

conduct ‘‘for cause’’ or follow-up 

inspections whenever we deem such 

inspections appropriate. 

Third, we are proposing to permit 

device companies to voluntarily submit 

to FDA reports by third parties assessing 

conformance with an appropriate 

international quality systems standard, 

such as those set by the International 

Standards Organization. We would 

consider the information in these 

reports in setting our inspectional 

priorities. 

III. What Information Should You 

Know About the Meeting? 

A. When and Where Will the Meeting 

Occur? What Format Will We Use? 

Through this notice, we are 

announcing the convening of a public 

meeting to hear stakeholder views on 

the recommendations we propose to 

provide to Congress on the 

reauthorization of MDUFMA II. 

We will conduct the meeting on April 

30, 2007. (see ADDRESSES). In general, 

the meeting format will include brief 

presentations by FDA, but will focus on 

hearing from different stakeholder 

interest groups (such as patient 

advocates, consumer advocates, 

industry, health professionals, and 

academic researchers). We will also give 

individuals the opportunity to make 

presentations at the meeting, and for 

organizations and individuals to submit 

written comments to the docket after the 

meeting. 

B. How Do You Register for the Meeting 

or Submit Comments? 

If you wish to attend and/or make a 

presentation at the meeting, send an email message to Erik Mettler or Cynthia 

Garris (see FOR FURTHER INFORMATION

CONTACT) by April 25, 2007. Your e-mail 

should include the following 

information: Name, company, company 


pwalker on PROD1PC71 with NOTICES
19534 Federal Register / Vol. 72, No. 74 / Wednesday, April 18, 2007 / Notices 

address, company phone number, and email address. You will receive a 

confirmation within 2 business days. 

We also will accept walk-in 

registration at the meeting site, but 

space is limited, and we will close 

registration when maximum seating 

capacity (approximately 100) is reached. 

We will try to accommodate all 

persons who wish to make a 

presentation. The time allotted for 

presentations may depend on the 

number of persons who wish to speak. 

Additionally, regardless of whether 

you wish to make a presentation or 

simply attend the meeting, please notify 

us if you need any special 

accommodations (such as wheelchair 

access or a sign language interpreter). 

If you would like to submit comments 

regarding these proposed 

recommendations, please send your 

comments to the Division of Dockets 

Management (see ADDRESSES). Submit a 

single copy of electronic comments or 

two paper copies of any written 

comments, except that individuals may 

submit one paper copy. Comments are 

to be identified 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. Submit your 

comments no later than May 18, 2007. 

C. Will Meeting Transcripts Be 

Available? 

We will prepare a meeting transcript 

and make it available on our Web site 

(http://www.fda.gov) after the meeting. 

We anticipate that transcripts will be 

available approximately 30 working 

days after the meeting. The transcript 

will also be available for public 

examination at the Division of Dockets 

Management (HFA–305), 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20857, 

between 9 a.m. and 4 p.m. Monday 

through Friday. 

Dated: April 12, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–1919 Filed 4–16–07; 1:52 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[FDA 225–07–4301] 

Memorandum of Understanding 

Between the National Cancer Institute 

and the Food and Drug Administration 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is providing 

notice of a memorandum of 

understanding (MOU) between FDA and 

the National Cancer Institute (NCI), part 

of the National Institutes of Health 

(NIH) of the Department of Health and 

Human Services (DHHS). The purpose 

of this MOU is to establish a formal 

collaboration between FDA and NCI 

regarding the creation of a common 

standards-based data repository to 

facilitate the electronic exchange and 

analysis of data from research studies on 

investigational drugs in a fully secure 

manner. 

DATES: The agreement became effective 

March 2, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Randy Levin, Center for Drug Evaluation 

Research (HF–18), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–7784 email: randy.levin@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 20.108(c), 

which states that all written agreements 

and MOUs between FDA and others 

shall be published in the Federal 

Register, the agency is publishing notice 

of this MOU. 

Dated: April 5, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

BILLING CODE 4160–01–S 


pwalker on PROD1PC71 with NOTICES