Federal Register / Vol. 72, No. 197 / Friday, October 12, 2007 / Notices 58103 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Prescription Drug User Fee Rates for 

Fiscal Year 2008 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

rates for prescription drug user fees for 

fiscal year (FY) 2008. The Federal Food, 

Drug, and Cosmetic Act (the act), as 

amended by the Prescription Drug User 

Fee Amendments of 2007 (Title 1 of the 

Food and Drug Administration 

Amendments Act of 2007 (FDAAA)) 

(PDUFA IV), authorizes FDA to collect 

user fees for certain applications for 

approval of drug and biological 

products, on establishments where the 

products are made, and on such 

products. Base revenue amounts to be 

generated from PDUFA fees were 

established by PDUFA IV, with 

provisions for certain adjustments. Fee 

revenue amounts for applications, 

establishments, and products are to be 

established each year by FDA so that 

one-third of the PDUFA fee revenues 

FDA collects each year will be generated 

from each of these categories. This 

notice establishes fee rates for FY 2008 

for application fees for an application 

requiring clinical data ($1,178,000), for 

an application not requiring clinical 

data or a supplement requiring clinical 

data ($589,000), for establishment fees 

($392,700), and for product fees 

($65,030). These fees are effective on 

October 1, 2007, and will remain in 

effect through September 30, 2008. For 

applications and supplements that are 

submitted on or after October 1, 2007, 

the new fee schedule must be used. 

Invoices for establishment and product 

fees for FY 2008 will be issued in 

October 2007, using the new fee 

schedule. 

FOR FURTHER INFORMATION CONTACT: 

Yanming Chae, Office of Financial 

Management (HFA–120), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–5042. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Sections 735 and 736 of the act (21 

U.S.C. 379g and h), establish three 

different kinds of user fees. Fees are 

assessed on the following: (1) Certain 

types of applications and supplements 

for approval of drug and biological 

products, (2) certain establishments 

where such products are made, and (3) 

certain products (21 U.S.C. 379h(a)). 

When certain conditions are met, FDA 

may waive or reduce fees (21 U.S.C. 

379h(d)). 

For FY 2008 through FY 2012, the 

base revenue amounts for the total 

revenues from all PDUFA fees are 

established by PDUFA IV. The base 

revenue amount for FY 2008 is to be 

adjusted for workload, and that adjusted 

amount becomes the base amount for 

the remaining 4 FYs. That adjusted base 

revenue amount is subject to further 

adjustments for inflation and workload 

each year. Fees for applications, 

establishments, and products are to be 

established each year by FDA so that 

revenues from each category will 

provide one-third of the total revenue to 

be collected each year. 

This notice establishes the fee base 

revenue amount for FY 2008 after 

adjustment for workload, and then 

establishes the application, 

establishment, and product fees for FY 

2008. These fees are effective on 

October 1, 2007, and will remain in 

effect through September 30, 2008. 

II. Fee Revenue Amount for FY 2008, 

Including Adjustments for Workload 

The total fee revenue amount for FY 

2008 is $459,412,000, based on the fee 

revenue amount specified in the statute, 

including additional fee funding for 

drug safety and adjusted for inflation 

and changes in workload. The statutory 

amounts and these adjustments are 

described in the following paragraphs. 

Section II.A of this document provides 

the fee amounts specified in the statute. 

Section II.B of this document describes 

the one-time base adjustment to the 

statutory fee revenue amount under the 

FY 2007 method. Section II.C of this 

document describes the inflation 

adjustment to the adjusted fee revenue 

base amount. Section II.D of this 

document describes the workload 

adjustment to the inflation-adjusted fee 

revenue amount. 

A. Statutory Fee Revenue Amounts 

PDUFA IV specifies that the fee 

revenue amount for FY 2008 for all fees 

is $417,783,000 ($392,783,000 specified 

in 21 U.S.C. 379h(b)(1) plus an 

additional $25,000,000 for drug safety 

specified in 21 U.S.C. 379h(b)(4)). 

The statute specifies that 

$354,893,000 of the amount specified in 

21 U.S.C. 379h(b)(1) is to be further 

adjusted for workload. The workload 

adjustment on this amount is to be made 

in accordance with the workload 

adjustment provisions that were in 

effect for FY 2007, except that the 

adjustment for investigational new drug 

(IND) workload is based on the number 

of INDs with a submission in the 

previous 12 months rather than on the 

number of new commercial INDs 

submitted in the same 12-month period. 

B. One-time Base Adjustment to 

Statutory Fee Revenue Amount Under 

FY 2007 Method 

For each FY beginning in FY 2004, 

the Prescription Drug User Fee 

Amendments of 2002 (PDUFA III) 

provided that fee revenue amounts, after 

they had been adjusted for inflation, 

should be further adjusted to reflect 

changes in workload for the process for 

the review of human drug applications 

(see 21 U.S.C. 379h(c)(2)). 

The conference report accompanying 

PDUFA III, House of Representatives 

Report number 107–481, provides 

guidance on how the workload 

adjustment provision of PDUFA III is to 

be implemented. Following that 

guidance, FDA calculated the average 

number of each of the four types of 

applications specified in the workload 

adjustment provision (human drug 

applications, commercial IND 

applications, efficacy supplements, and 

manufacturing supplements) received 

over the 5-year period that ended on 

June 30, 2002 (base years), and the 

average number of each of these types 

of applications over the most recent 5- 

year period that ended June 30, 2007. 

PDUFA IV directs that this same method 

be used in making the workload 

adjustment apply to the 2008 statutory 

revenue amount, except that for this 

calculation the number of commercial 

IND applications with a submission in 

the previous 12 months is used for each 

12-month period rather than the number 

of commercial IND applications 

submitted (see 21 U.S.C. 379h(b), as 

amended by PDUFA IV). 

The results of these calculations are 

presented in the first two columns of 

table 1 of this document. Column 3 

reflects the percent change in workload 

over the two 5-year periods. Column 4 

shows the weighting factor for each type 

of application, estimating how much of 

the total FDA drug review workload was 

accounted for by each type of 

application in the table during the most 

recent 5 years. Column 5 of table 1 of 

this document is the weighted percent 

change in each category of workload. 

This was derived by multiplying the 

weighting factor in each line in column 

4 by the percent change from the base 

years in column 3. At the bottom right 

of the table the sum of the values in 

column 5 is added, reflecting a total 

increase in workload of 11.73 percent 

when compared to the base years. 


jlentini on PROD1PC65 with NOTICES
58104 Federal Register / Vol. 72, No. 197 / Friday, October 12, 2007 / Notices 

TABLE 1.—SUMMARY BASE WORKLOAD ADJUSTER CALCULATION TO BE APPLIED IN FY 2008 

Application Type 

Column 1 

5-Year 

AverageBase 

Years 

Column 2 

Latest 5- 

YearAverage 

Column 3 

Percent Change 

Column 4 

Weighting Factor 

Column 5 

Weighted 

PercentChange 

New drug applications (NDAs)/biologics 

license applications (BLAs) 119 .6 123 .8 3 .5% 35 .2% 1 .24% 

Active INDs 4,751 .8 5,528 .2 16 .3% 44 .2% 7 .22% 

Efficacy supplements 159 .2 163 .4 2 .6% 7 .4% 0 .20% 

Manufacturing supplements 2,100 .6 2,589 .2 23 .3% 13 .2% 3 .07% 

FY 2008 workload adjuster 11 .73% 

Increasing the PDUFA IV statutorilyspecified amount of $354,893,000 by the 

specified workload adjuster (11.73 

percent) results in an increase of 

$41,629,000, rounded to the nearest 

thousand. Adding this amount to the 

$417,783,000 statutorily-specified 

amount, before adjustment, results in a 

total adjusted PDUFA IV base revenue 

amount of $459,412,000. This figure is 

the adjusted PDUFA IV base revenue 

amount that will be adjusted in future 

years for inflation and workload. 

C. Inflation Adjustment to Adjusted Fee 

Revenue Base Amount 

PDUFA IV provides that fee revenue 

amounts for each FY after 2008 shall be 

adjusted for inflation. Since no inflation 

adjustment is applicable in FY 2008, no 

further adjustment is made to the 

revenue amount derived in section II.B 

of this document. 

D. Workload Adjustment to InflationAdjusted Fee Revenue Amount 

For each FY beginning in FY 2009, 

PDUFA IV provides that fee revenue 

amounts, after they have been adjusted 

for inflation, shall be further adjusted to 

reflect changes in workload for the 

process for the review of human drug 

applications (see 21 U.S.C. 379h(c)(2)). 

Because no further workload 

adjustment, other than the adjustment to 

the base amount in section II.B of this 

document, is applicable in FY 2008, no 

further adjustment is made to the 

revenue amount derived in section II.B 

of this document. 

III. Application Fee Calculations 

PDUFA IV provides that the rates for 

application, product, and establishment 

fees be established so that they will 

generate the fee revenue amounts 

specified in the statute, as adjusted for 

inflation and workload. 

A. Application Fee Revenues and 

Application Fees 

The application fee revenue amount 

that PDUFA IV establishes for each year 

is one third of the total adjusted fee 

revenue amount. The total fee revenue 

amount for FY 2008 is $459,412,000, as 

calculated in section II.B of this 

document. Application fees will be set 

to generate one-third of this amount, or 

$153,137,000, rounded to the nearest 

$1,000, in FY 2008. 

B. Estimate of Number of Fee-Paying 

Applications and Establishment of 

Application Fees 

For FY 2008 through FY 2012, FDA 

will estimate the total number of feepaying full application equivalents 

(FAEs) it expects to receive the next FY 

by averaging the number of fee-paying 

FAEs received in the 5 most recent FYs. 

This use of the rolling average of the 5 

most recent FYs is the same method that 

was applied during PDUFA III. 

In estimating the number of feepaying FAEs that FDA will receive in 

FY 2008, the 5-year rolling average for 

the most recent 5 years will be based on 

actual counts of fee-paying FAEs 

received for FY 2003 through FY 2007. 

For FY 2007, FDA is estimating the 

number of fee-paying FAEs for the full 

year based on the actual count for the 

first 9 months and estimating the 

number for the final 3 months, as we 

have done for the past 5 years. 

Table 2 of this document shows in 

column 1 the total number of each type 

of FAE received in the first 9 months of 

FY 2007, whether fees were paid or not. 

Column 2 shows the number of FAEs for 

which fees were waived or exempted 

during this period, and column 3 shows 

the number of fee-paying FAEs received 

through June 30, 2007. Column 4 

estimates the 12-month total fee-paying 

FAEs for FY 2007 based on the 

applications received through June 30, 

2007. All of the counts are in FAEs. A 

full application requiring clinical data 

counts as one FAE. An application not 

requiring clinical data counts as onehalf an FAE, as does a supplement 

requiring clinical data. An application 

that is withdrawn, or refused for filing, 

counts as one-fourth of an FAE if the 

applicant initially paid a full 

application fee, or one-eighth of an FAE 

if the applicant initially paid one-half of 

the full application fee amount. 

TABLE 2.—FY 2007 FAES RECEIVED THROUGH JUNE 30, 2007, AND PROJECTED THROUGH SEPTEMBER 30, 2007 

Application or Action 

Column 1 

Total Received 

ThroughJune 30, 2007 

Column 2 

Fee Exempt or 

WaivedThrough June 

30, 2007 

Column 3 

Total Fee Paying 

Through June 30, 2007 

Column 4 

12-Month Fee-Paying 

Projection 

Applications requiring clinical data 71 .8 18 .8 53 70 .7 

Applications not requiring clinical 

data 7 3 .5 3 .5 4 .7 

Supplements requiring clinical data 43 .5 5 38 .5 51 .3 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 72, No. 197 / Friday, October 12, 2007 / Notices 58105 

TABLE 2.—FY 2007 FAES RECEIVED THROUGH JUNE 30, 2007, AND PROJECTED THROUGH SEPTEMBER 30, 2007—

Continued 

Application or Action 

Column 1 

Total Received 

ThroughJune 30, 2007 

Column 2 

Fee Exempt or 

WaivedThrough June 

30, 2007 

Column 3 

Total Fee Paying 

Through June 30, 2007 

Column 4 

12-Month Fee-Paying 

Projection 

Withdrawn or refused to file .4 0 0 .4 0 .5 

Total 122 .7 27 .3 95 .4 127 .2 

In the first 9 months of FY 2007, FDA 

received 122.7 FAEs, of which 95.4 

were fee-paying. Based on data from the 

last 8 FYs, on average, 25 percent of the 

applications submitted each year come 

in the final 3 months. Dividing 95.4 by 

3 and multiplying by 4 extrapolates the 

amount to the full 12 months of the FY 

and projects the number of fee-paying 

FAEs in FY 2007 at 127.2. 

As table 3 of this document shows, 

the average number of fee-paying FAEs 

received annually in the most recent 5- 

year period, and including our estimate 

for FY 2007, is 130 FAEs. FDA will set 

fees for FY 2008 based on this estimate 

as the number of FAEs that will pay 

fees. 

TABLE 3.—FEE-PAYING FAES—5-YEAR AVERAGE

Fiscal Year 2003 2004 2005 2006 2007 5-Year Average 

Fee-paying FAEs 119.5 145.1 121.5 136.7 127.2 130 

The FY 2008 application fee is 

estimated by dividing the average 

number of full applications that paid 

fees over the latest 5 years, 130, into the 

fee revenue amount to be derived from 

application fees in FY 2008, 

$153,137,000. The result, rounded to the 

nearest $100, is a fee of $1,178,000 per 

full application requiring clinical data, 

and $589,000 per application not 

requiring clinical data or per 

supplement requiring clinical data. 

IV. Fee Calculations for Establishment 

and Product Fees 

A. Establishment Fees 

At the beginning of FY 2007, the 

establishment fee was based on an 

estimate that 375 establishments would 

be subject to, and would pay, fees. By 

the end of FY 2007, FDA estimates that 

425 establishments will have been 

billed for establishment fees, before all 

decisions on requests for waivers or 

reductions are made. As in previous 

years, FDA again estimates that a total 

of 25 establishment fee waivers or 

reductions will be made for FY 2007. In 

addition to the previous year estimates, 

FDA estimates that another 10 full 

establishment fees will be exempted this 

year based on the new orphan drug 

exemption in FDAAA (see 21 U.S.C. 

379h(k)). Subtracting 35 (25 plus the 

estimated 10 establishments under the 

new orphan exemption) establishments 

from 425 leaves a net of 390 fee-paying 

establishments. FDA will use 390 for its 

FY 2008 estimate of establishments 

paying fees, after taking waivers and 

reductions into account. The fee per 

establishment is determined by dividing 

the adjusted total fee revenue to be 

derived from establishments 

($153,137,000 by the estimated 390 

establishments, for an establishment fee 

rate for FY 2008 of $392,700 (rounded 

to the nearest $100). 

B. Product Fees 

At the beginning of FY 2007, the 

product fee was based on an estimate 

that 2,400 products would be subject to 

and pay product fees. By the end of FY 

2007, FDA estimates that 2,425 products 

will have been billed for product fees, 

before all decisions on requests for 

waivers or reductions are made. FDA 

assumes that there will be about 40 

waivers and reductions granted, the 

same amount estimated last year. In 

addition to the previous year estimates, 

FDA estimates that another 30 product 

fees will be exempted this year based on 

the new orphan drug exemption in 

FDAAA (see 21 U.S.C. 379h(k)). FDA 

estimates that 2,355 products will 

qualify for product fees in FY 2007, after 

allowing for waivers and reductions, 

including the orphan drug products 

eligible under the new FDAAA 

exemption, and will use this number for 

its FY 2008 estimate. Accordingly, the 

FY 2008 product fee rate is determined 

by dividing the adjusted total fee 

revenue to be derived from product fees 

($153,137,000) by the estimated 2,355 

products for a FY 2008 product fee of 

$65,030 (rounded to the nearest $10). 

V. Fee Schedule for FY 2008 

The fee rates for FY 2008 are set out 

in table 4 of this document: 

TABLE 4. 

Fee Category Fee Rates for FY 2008 

APPLICATIONS .........................................................................................................................................................

Requiring clinical data ............................................................................................................................................ $1,178,000 

Not requiring clinical data ...................................................................................................................................... $589,000 

Supplements requiring clinical data ....................................................................................................................... $589,000 

ESTABLISHMENTS ................................................................................................................................................... $392,700 

PRODUCTS ............................................................................................................................................................... $65,030 


jlentini on PROD1PC65 with NOTICES
58106 Federal Register / Vol. 72, No. 197 / Friday, October 12, 2007 / Notices 

VI. Implementation of Adjusted Fee 

Schedule 

A. Application Fees 

The appropriate application fee 

established in the new fee schedule 

must be paid for any application or 

supplement subject to fees under 

PDUFA that is received after September 

30, 2007. Payment must be made in U.S. 

currency by check, bank draft, or U.S. 

postal money order payable to the order 

of the Food and Drug Administration. 

Please include the user fee ID number 

on your check. Your payment can be 

mailed to: Food and Drug 

Administration, P.O. Box 70963, 

Charlotte, NC 28272–0963. 

If checks are to be sent by a courier 

that requests a street address, the 

courier can deliver the checks to: 

Wachovia Bank, Attn: Food and Drug 

Administration Lockbox 70963, 1525 

West WT Harris Blvd., rm. NC0810, 

Charlotte, NC 28262. (Note: This 

Wachovia Bank address is for courier 

delivery only.) 

Please make sure that the FDA post 

office box number (P.O. Box 70963) is 

written on the check. The tax 

identification number of the Food and 

Drug Administration is 53–0196965. 

Wire transfer payment may also be 

used. The routing and transit number is 

021030004 and the account number is 

75060099. Please include, as the 

reference, the NDA/BLA number and 

the user fee ID number. 

FDA is in the process of 

implementing alternate Web-based 

payment methods. For more information 

on these payment options and when 

they will be available, please visit FDA’s 

Web site at http://www.fda.gov, select 

the appropriate user fee type, and click 

on ‘‘User Fee Cover Sheet.’’

B. Establishment and Product Fees 

FDA will issue invoices for 

establishment and product fees for FY 

2008 under the new fee schedule in 

October 2007. Payment will be due 30 

days from the date of the invoice. FDA 

will issue invoices in November 2008 

for any products and establishments 

subject to fees for FY 2008 that qualify 

for fees after the October 2007 billing. 

Dated: October 4, 2007. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. 07–5052 Filed 10–9–07; 12:06 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D–0309] 

Draft Guidance for Industry and Food 

and Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Electrocardiograph Electrodes; 

Availability; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice that appeared in the Federal 

Register of October 4, 2007 (72 FR 

56771). The document announced the 

availability of a draft guidance entitled 

‘‘Class II Special Controls Guidance 

Document: Electrocardiograph 

Electrodes.’’ The document was 

published with an incorrect docket 

number. This document corrects that 

error. 

FOR FURTHER INFORMATION CONTACT: 

Joyce A. Strong, Office of Policy (HF–

27), Food and Drug Administration, 

5600 Fishers Lane, Rockville, MD 

20857, 301–827–7010. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

E7–19578, appearing on page 56771 in 

the Federal Register of Thursday, 

October 4, 2007, the following 

correction is made: 

1. On page 56771, in the third 

column, in the heading of the 

document, ‘‘[Docket No. 2007N–0309]’’

is corrected to read ‘‘[Docket No. 

2007D–0309]’’. 

Dated: October 5, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–20183 Filed 10–11–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Notice of Availability of Draft Policy 

Documents for Comment 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Extension of requests for 

comments deadline. 

SUMMARY: The Health Resources and 

Services Administration published a 

notice in the Federal Register of August 

29, 2007, requesting comments on draft 

Agency Guidance (Policy Information 

Notices (PINS)) to describe the policy 

and processes pertaining to requests 

from federally-funded health centers to 

change the scope of their Federal 

project. The PINS, ‘‘Defining Scope of 

Project and Policy for Requesting 

Changes,’’ ‘‘Changes in Scope Requests: 

Policy for Adding a New Target 

Population,’’ and ‘‘Specialty Services 

and Health Centers’ Scope of Project,’’

are available on the Internet at http:// 

bphc.hrsa.gov. 

Correction: In the Federal Register of 

August 29, 2007, FR Doc. E7–17092, on 

page 49724, in the first column, under 

DATES, the deadline for comments has 

been extended to October 19, 2007. 

Dated: October 5, 2007. 

Dennis P. Williams, 

Deputy Administrator. 

[FR Doc. E7–20171 Filed 10–11–07; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Current List of Laboratories Which 

Meet Minimum Standards To Engage in 

Urine Drug Testing for Federal 

Agencies 

AGENCY: Substance Abuse and Mental 

Health Services Administration, HHS. 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services (HHS) notifies Federal 

agencies of the laboratories currently 

certified to meet the standards of 

Subpart C of the Mandatory Guidelines 

for Federal Workplace Drug Testing 

Programs (Mandatory Guidelines). The 

Mandatory Guidelines were first 

published in the Federal Register on 

April 11, 1988 (53 FR 11970), and 

subsequently revised in the Federal 

Register on June 9, 1994 (59 FR 29908), 

on September 30, 1997 (62 FR 51118), 

and on April 13, 2004 (69 FR 19644). 

A notice listing all currently certified 

laboratories is published in the Federal 

Register during the first week of each 

month. If any laboratory’s certification 

is suspended or revoked, the laboratory 

will be omitted from subsequent lists 

until such time as it is restored to full 

certification under the Mandatory 

Guidelines. 

If any laboratory has withdrawn from 

the HHS National Laboratory 

Certification Program (NLCP) during the 

past month, it will be listed at the end, 

and will be omitted from the monthly 

listing thereafter. 


jlentini on PROD1PC65 with NOTICES