Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices 38451 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0339] 

Prescription Drug User Fee Rates for 

Fiscal Year 2010 

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) 2010. 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 2010 

for application fees for an application 

requiring clinical data ($1,405,500), for 

an application not requiring clinical 

data or a supplement requiring clinical 

data ($702,750), for establishment fees 

($457,200), and for product fees 

($77,720). These fees are effective on 

October 1, 2009, and will remain in 

effect through September 30, 2010. For 

applications and supplements that are 

submitted on or after October 1, 2009, 

the new fee schedule must be used. 

Invoices for establishment and product 

fees for FY 2010 will be issued in 

August 2009, using the new fee 

schedule. 

FOR FURTHER INFORMATION CONTACT: 

David Miller, Office of Financial 

Management (HFA–100), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–3917. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Sections 735 and 736 of the act (21 

U.S.C. 379g and 379h, respectively), 

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 (section 

736(a) of the act). When certain 

conditions are met, FDA may waive or 

reduce fees (section 736(d) of the act). 

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 fiscal years. That 

adjusted base revenue amount is 

increased for drug safety enhancements 

by $10,000,000 in each of the 

subsequent 4 fiscal years, and the 

increased total is further adjusted each 

year for inflation and workload. 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 uses the fee base revenue 

amount for FY 2008 published in the 

Federal Register of October 12, 2007 (72 

FR 58103), adjusts it for the 2010 drug 

safety increase (see section 736(b)(4) of 

the act) for inflation, and for workload, 

and then establishes the application, 

establishment, and product fees for FY 

2010. These fees are effective on 

October 1, 2009, and will remain in 

effect through September 30, 2010. 

II. Fee Revenue Amount for FY 2010 

The total fee revenue amount for FY 

2010 is $569,207,000, based on the fee 

revenue amount specified in the statute, 

including additional fee funding for 

drug safety and adjustments for inflation 

and changes in workload. The statutory 

amount and a one-time base adjustment 

are described in sections II.A and II.B of 

this document. The adjustment for 

inflation is described in section II.C of 

this document, and the adjustment for 

changes in workload in section II.D of 

this document. 

A. FY 2010 Statutory Fee Revenue 

Amounts Before Adjustments 

PDUFA IV specifies that the fee 

revenue amount before adjustments for 

FY 2010 for all fees is $437,783,000 

($392,783,000 specified in section 

736(b)(1) of the act plus an additional 

$45,000,000 for drug safety in FY 2010 

specified in section 736(b)(4) of the act). 

B. Base Adjustment to Statutory Fee 

Revenue Amount 

The statute also specifies that 

$354,893,000 of the base amount is to be 

further adjusted for workload increases 

through FY 2007 (see section 

736(b)(1)(B) of the act). The 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. 

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 section 736(c)(2) of the act). 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 

submissions specified in the workload 

adjustment provision (human drug 

applications, commercial INDs, 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 INDs with a submission in 

the previous 12 months is used for each 

12-month period rather than the number 

of new commercial INDs submitted (see 

section 736(b) of the act, 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. 


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TABLE 1.—SUMMARY WORKLOAD ADJUSTER CALCULATION TO BE APPLIED TO PDUFA IV STATUTORY BASE

Application Type 

Column 1 

5-Year Average 

Base Years (Ending 6/30/2002) 

Column 2 

5-Year Average 

(Ending 

6/30/2007) 

Column 3 

Percent Change 

Column 4 

Weighting Factor 

Column 5 

Weighted Percent 

Change 

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% 

Workload adjuster to be applied to the statutory base 11 .73% 

Increasing the PDUFA IV statutorily 

specified 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 

$437,783,000 statutorily specified 

amount from section II.A of this 

document, results in a total adjusted 

PDUFA IV base revenue amount of 

$479,412,000, before further adjustment 

for inflation and changes in workload 

after FY 2007. 

C. Inflation Adjustment to FY 2010 Fee 

Revenue Amount 

PDUFA IV provides that fee revenue 

amounts for each fiscal year after FY 

2008 shall be adjusted for inflation. The 

adjustment must reflect the greater of 

the following amounts: (1) The total 

percentage change that occurred in the 

Consumer Price Index (CPI) (all items; 

U.S. city average) during the 12-month 

period ending June 30 preceding the 

fiscal year for which fees are being set; 

(2) the total percentage pay change for 

the previous fiscal year for Federal 

employees stationed in the Washington, 

DC metropolitan area; or (3) the average 

annual change in cost, per full time 

equivalent (FTE) FDA position, of all 

personnel compensation and benefits 

paid for the first 5 of the previous 6 

fiscal years. PDUFA IV provides for this 

annual adjustment to be cumulative and 

compounded annually after FY 2008 

(see section 736(c)(1) of the act). 

The first factor is the CPI increase for 

the 12-month period ending in June 

2009. The CPI for June 2009 was 

215.693, and the CPI for June 2008 was 

218.815. (These CPI figures are available 

on the Bureau of Labor Statistics Web 

site at http://data.bls.gov/cgi-bin/ 

surveymost?bls by checking the first box 

under ‘‘Price Indexes’’ and then clicking 

‘‘Retrieve Data’’ at the bottom of the 

page.) (FDA has verified the Web site 

address, but FDA is not responsible for 

any subsequent changes to the Web site 

after this document publishes in the 

Federal Register.) The CPI for June 2009 

is 1.43 percent lower than the CPI for 

the previous 12-month period. 

The second factor is the increase in 

pay for the previous fiscal year (FY 2009 

in this case) for Federal employees 

stationed in the Washington, DC 

metropolitan area. This figure is 

published by the Office of Personnel 

Management, and found on their Web 

site at http://www.opm.gov/flsa/oca/ 

09tables/html/dcb.asp above the salary 

table. (FDA has verified the Web site 

address, but FDA is not responsible for 

any subsequent changes to the Web site 

after this document publishes in the 

Federal Register.) For FY 2009 it was 

4.78 percent. 

The third factor is the average change 

in FDA cost for compensation and 

benefits per FTE over the previous 5 of 

the most recent 6 fiscal years (FY 2003 

through 2008). The data on total 

compensation paid and numbers of FTE 

paid, from which the average cost per 

FTE can be derived, are published in 

FDA’s Justification of Estimates for 

Appropriations Committees. Table 2 of 

this document summarizes that actual 

cost and FTE use data for the specified 

fiscal years, and provides the percent 

change from the previous fiscal year and 

the average percent change over the 

most 5 recent fiscal years, which is 5.54 

percent. 

TABLE 2.—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGE

Fiscal Year 2004 2005 2006 2007 2008 

Annual Average Increase 

for Latest 5 

Years 

Total PC&B $1,042,749 $1,077,604 $1,114,704 $1,144,369 $1,215,627 

Total FTE 10,141 9,910 9,698 9,569 9,811 

PC&B per FTE $102,825 $108,739 $114,942 $119,591 $123,905 

% Change from previous year 8.59% 5.75% 5.70% 4.05% 3.61% 5.54% 

The inflation increase for FY 2010 is 

5.54 percent. This is the greater of the 

CPI change during the 12-month period 

ending June 30 preceding the fiscal year 

for which fees are being set (-1.43 

percent), the increase in pay for the 

previous fiscal year (FY 2009 in this 

case) for Federal employees stationed in 

the Washington, DC metropolitan area 

(4.78 percent), and the average annual 

change in cost, per FTE FDA position, 

of all personnel compensation and 

benefits paid for the first 5 of the 

previous 6 fiscal years (5.54 percent). 

Because the average change in pay per 

FTE (5.54 percent) is the highest of the 

three factors, it becomes the inflation 


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adjustment for total fee revenue for FY 

2010. 

The inflation adjustment for FY 2009 

was 5.64 percent. This is the greater of 

the CPI increase during the 12-month 

period ending June 30 preceding the 

fiscal year for which fees were being set 

(June 30, 2008, which was 5.05 percent), 

the increase in pay for FY 2008 for 

Federal employees stationed in 

Washington, DC (4.49 percent), or the 

average annual change in cost, per FTE 

FDA position, of all personnel 

compensation and benefits paid for the 

first 5 of the previous 6 fiscal years (5.64 

percent). 

PDUFA IV provides for this inflation 

adjustment to be cumulative and 

compounded annually after FY 2008 

(see section 736(c)(1) of the act). This 

factor for FY 2010 (5.54 percent) is 

compounded by adding one to it and 

then multiplying it by one plus the 

inflation adjustment factor for FY 2009 

(5.64 percent). The result of this 

multiplication of the inflation factors for 

the 2 years since FY 2008 (1.0554 times 

1.0564 percent) becomes the inflation 

adjustment for FY 2010. This inflation 

adjustment for FY 2010 is 11.15 percent. 

Increasing the FY 2010 fee revenue 

base of $479,412,000, by 11.15 percent 

yields an inflation-adjusted fee revenue 

amount for FY 2010 of $532,866,000, 

rounded to the nearest thousand dollars, 

before the application of the FY 2010 

workload adjustment. 

D. Workload Adjustment to the FY 2010 

Inflation Adjusted Fee Revenue Amount 

PDUFA IV does not allow FDA to 

adjust the total revenue amount for 

workload beginning in FY 2010 unless 

the independent accounting firm study 

is complete (see section 736(c)(2)(C) of 

the act). That study, conducted by 

Deloitte Touche, LLP, was completed on 

March 31, 2009, and is available online 

at http://www.fda.gov/ForIndustry/ 

UserFees/PrescriptionDrugUserFee/ 

ucm164339.htm. The study found that 

the adjustment methodology used by 

FDA reasonably captures changes in 

workload for reviewing human drug 

applications under PDUFA IV. 

Accordingly, FDA continues to use the 

workload adjustment methodology that 

it utilized in FY 2009, and FDA intends 

to continue using this methodology 

through the end of PDUFA IV. 

For each fiscal year 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 section 736(c)(2) 

of the act). PDUFA IV continues the 

PDUFA III workload adjustment with 

modifications, and provides for a new 

additional adjustment for changes in 

review activity. 

FDA calculated the average number of 

each of the four types of applications 

specified in the workload adjustment 

provision: (1) Human drug applications, 

(2) active commercial INDs 

(applications that have at least one 

submission during the previous 12 

months), (3) efficacy supplements, and 

(4) manufacturing supplements received 

over the 5-year period that ended on 

June 30, 2007 (base years), and the 

average number of each of these types 

of applications over the most recent 5- 

year period that ended June 30, 2009. 

The calculations are summarized in of 

table 3 of this document. The 5-year 

averages for each application category 

are provided in Column 1 (‘‘5-Year 

Average Base Years 2002–2007’’) and 

Column 2a (‘‘5 Year Average 2004– 

2009’’). 

PDUFA IV specifies that FDA make 

additional adjustments for changes in 

review activities to the first two 

categories (human drug applications 

and active commercial INDs). These 

adjustments, specified under PDUFA IV, 

are summarized in columns 2b and 2c 

in table 3 of this document. The number 

in the NDAs/BLAs line of column 2b of 

table 3 of this document is the percent 

by which the average workload for 

meetings, annual reports, and labeling 

supplements for NDAs and BLAs has 

changed from the 5-year period 2002 

through 2007 to the 5-year period 2004 

through 2009. Likewise, the number in 

the ‘‘Active commercial INDs’’ line of 

column 2b of table 3 of this document 

is the percent by which the workload for 

meetings and special protocol 

assessments for active commercial INDs 

has changed from the 5-year period 

2002 through 2007 to the 5-year period 

2004 through 2009. There is no entry in 

the last two lines of column 2b because 

the adjustment for changes in review 

workload does not apply to the 

workload for efficacy supplements and 

manufacturing supplements. 

Column 3 of table 3 of this document 

reflects the percent change in workload 

from column 1 to column 2c. 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 3 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 table 3 of this document is the sum 

of the values in column 5 that are 

added, reflecting an increase in 

workload of 6.82 percent for FY 2010 

when compared to the base years. 

TABLE 3.—WORKLOAD ADJUSTER CALCULATION FOR FY 2010 

Application Type 

Column 1 

5-Year Average Base 

Years 2002– 

2007 

Column 2a 

5-Year Average 2004– 

2009 

Column 2b 

Adjustment for 

Changes in 

Review Activity 

Column 2c is 

Column 2a Increased by 

Column 2b 

Column 3 

Percent 

Change (Column 1 to Column 2c) 

Column 4 

Weighting 

Factor 

Column 5 

Weighted Percent Change 

NDAs/BLAs 123 .8 133 .0 -0 .73% 132 .0 6 .6% 34 .8% 2 .31% 

Active commercial 

INDs1 5,528 .2 6,078 .0 -0 .71% 6,035 .0 9 .2% 44 .5% 4 .08% 

Efficacy supplements 163 .4 169 .4 NA 169 .4 3 .7% 8 .7% 0 .32% 

Manufacturing supplements 2,589 .2 2,613 .6 NA 2,613 .6 0 .9% 12 .0% 0 .11% 


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TABLE 3.—WORKLOAD ADJUSTER CALCULATION FOR FY 2010—Continued 

Application Type 

Column 1 

5-Year Average Base 

Years 2002– 

2007 

Column 2a 

5-Year Average 2004– 

2009 

Column 2b 

Adjustment for 

Changes in 

Review Activity 

Column 2c is 

Column 2a Increased by 

Column 2b 

Column 3 

Percent 

Change (Column 1 to Column 2c) 

Column 4 

Weighting 

Factor 

Column 5 

Weighted Percent Change 

FY 2010 workload adjuster 6 .82% 

1Table 3 published in the Federal Register of August 1, 2008 (73 FR 45017), showed the average number of active INDs for the base years 

of 2002–2007 as 5,755.8. FDA discovered that a small subset of INDs had been double counted in the number reported last year. That error has 

been corrected in the revised number of 5528.2 reflected in the table this year. Had the error not been made, the workload adjustment in FY 

2009 would have been 3.76 percent rather than the 2.98 percent published in the Federal Register last year. 

The 2010 workload adjuster reflected 

in the calculations in table 3 of this 

document is 6.82 percent. Therefore the 

inflation-adjusted revenue amount of 

$532,866,000 from section II.C of this 

document will be increased by the 2010 

workload adjuster of 6.82 percent, 

resulting in a total adjusted revenue 

amount in FY 2010 of $569,207,000, 

rounded to the nearest thousand dollars. 

E. Rent and Rent-Related Adjustment to 

the FY 2010 Adjusted Fee Revenue 

Amount 

PDUFA specifies that for FY 2010 and 

each subsequent fiscal year, the revenue 

amount will be decreased if the actual 

cost paid for rent and rent-related 

expenses for preceding fiscal years are 

less than estimates made for such fiscal 

years in FY 2006 (see section 736(c)(3) 

of the act). The only fiscal year which 

has been completed, and for which FDA 

has complete data at this time, is FY 

2008. Table 4 of this document shows 

the estimates of rent and rent-related 

costs for FY 2008 made in 2006 and the 

actual costs at the end of the fiscal year. 

TABLE 4.—COMPARISON OF ACTUAL AND ESTIMATED RENT AND RENT-RELATED EXPENSES FOR FY 2008 

Estimates Made in 2006 Actual FY 2008 Year-End Costs 

Center for Drug Evaluation and Research rent & rent-related expenses $46,732,000 $51,619,000 

Center for Biologics Evaluation and Research rent & rent-related 

expenses $22,295,000 $26,715,000 

TOTAL $69,027,000 $78,334,000 

Because FY 2008 costs for rent and 

rent-related items exceeded the 

estimates of these costs made in 2006, 

no decrease in the FY 2010 estimated 

PDUFA revenues is required under this 

provision of PDUFA. 

PDUFA specifies that one-third of the 

total fee revenue is to be derived from 

application fees, one-third from 

establishment fees, and one-third from 

product fees (see section 736(b)(2) of the 

act). Accordingly, one-third of the total 

revenue amount ($569,207,000), i.e., 

$189,736,000 (rounded to the nearest 

thousand dollars), is the total amount of 

fee revenue that will be derived from 

each of these fee categories. 

III. Application Fee Calculations 

A. Application Fee Revenues and 

Application Fees 

Application fees will be set to 

generate one-third of the total fee 

revenue amount, or $189,736,000, 

rounded to the nearest thousand dollars, 

in FY 2010, as calculated previously in 

this document. 

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 

fiscal year by averaging the number of 

fee-paying FAEs received in the 5 most 

recent fiscal years. This use of the 

rolling average of the 5 most recent 

fiscal years is the same method that has 

applied for the last 6 years. 

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

FY 2010, the 5-year rolling average for 

the most recent 5 years will be based on 

actual counts of fee-paying FAEs 

received for FY 2005 through FY 2009. 

For FY 2009, 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 7 years. 

Table 5 of this document shows, in 

column 1, the total number of each type 

of FAE received in the first 9 months of 

FY 2009, 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, 2009. Column 4 

estimates the 12-month total fee-paying 

FAEs for FY 2009 based on the 

applications received through June 30, 

2009. 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. 


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TABLE 5.—FY 2009 FULL APPLICATION EQUIVALENTS RECEIVED THROUGH JUNE 30, 2009, AND PROJECTED THROUGH

SEPTEMBER 30, 2009 

Application or Action 

Column 1 

Total Received 

Through 

6/30/2009 

Column 2 

Fee Exempt or 

Waived Through 

6/30/2009 

Column 3 

Total Fee Paying 

Through 

6/30/2009 

Column 4 

12-Month FeePaying Projection 

Applications requiring clinical data 88 .75 32 .75 56 74 .7 

Applications not requiring clinical data 15 .5 4 .5 11 14 .7 

Supplements requiring clinical data 47 .5 8 .5 39 52 

Withdrawn or refused to file 0 .625 0 0 .625 0 .8 

Total 153 .375 45 .75 106 .25 142 .2 

In the first 9 months of FY 2009, FDA 

received 153.375 FAEs, of which 106.25 

were fee-paying. Based on data from the 

last 10 fiscal years, on average, 25 

percent of the applications submitted 

each year come in the final 3 months. 

Dividing 106.25 by 3 and multiplying by 

4 extrapolates the amount to the full 12 

months of the fiscal year and projects 

the number of fee-paying FAEs in FY 

2008 at 142.2. 

As table 6 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 2009, is 135.0 FAEs. FDA will set 

fees for FY 2010 based on this estimate 

as the number of full application 

equivalents that will pay fees. 

TABLE 6.—FEE-PAYING FAE 5-YEAR AVERAGE

Fiscal Year 2005 2006 2007 2008 2009 5-Year Average 

Fee-Paying FAEs 121.5 136.7 134.4 140.0 142.2 135.0 

The FY 2010 application fee is 

estimated by dividing the average 

number of full applications that paid 

fees over the latest 5 years, 135.0, into 

the fee revenue amount to be derived 

from application fees in FY 2010, 

$189,736,000. The result, rounded to the 

nearest $100, is a fee of $1,405,500 per 

full application requiring clinical data, 

and $702,750 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 2009, the 

establishment fee was based on an 

estimate that 400 establishments would 

be subject to, and would pay, fees. By 

the end of FY 2009, FDA estimates that 

450 establishments will have been 

billed for establishment fees, before all 

decisions on requests for waivers or 

reductions are made. FDA again 

estimates that a total of 20 establishment 

fee waivers or reductions will be made 

for FY 2009. In addition, FDA estimates 

that another 15 full establishment fees 

will be exempted this year based on the 

orphan drug exemption in FDAAA (see 

section 736(k) of the act). Subtracting 35 

establishments (20 waivers plus the 

estimated 15 establishments under the 

orphan exemption) from 450 leaves a 

net of 415 fee-paying establishments. 

FDA will use 415 for its FY 2010 

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 ($189,736,000) by the 

estimated 415 establishments, for an 

establishment fee rate for FY 2010 of 

$457,200 (rounded to the nearest $100). 

B. Product Fees 

At the beginning of FY 2009, the 

product fee was based on an estimate 

that 2,380 products would be subject to 

and would pay product fees. By the end 

of FY 2009, FDA estimates that 2,450 

products will have been billed for 

product fees, before all decisions on 

requests for waivers, reductions, or 

exemptions are made. FDA assumes that 

there will be about 50 waivers and 

reductions granted. In addition, FDA 

estimates that another 20 product fees 

will be exempted this year based on the 

orphan drug exemption in FDAAA (see 

section 736(k) of the act). FDA estimates 

that 2,380 products will qualify for 

product fees in FY 2009, after allowing 

for waivers and reductions, including 

the orphan drug products eligible under 

the FDAAA exemption, and will use 

this number for its FY 2010 estimate. 

Accordingly, the FY 2010 product fee 

rate is determined by dividing the 

adjusted total fee revenue to be derived 

from product fees ($189,736,000) by the 

estimated 2,380 products for a FY 2010 

product fee of $79,720 (rounded to the 

nearest $10). 

V. Fee Schedule for FY 2010 

The fee rates for FY 2010 are set out 

in table 7 of this document: 

TABLE 7. 

Fee Category Fee Rates for 

FY 2010 

APPLICATIONS 

Requiring clinical data ....... $1,405,500 

Not requiring clinical data $702,750 

Supplements requiring clinical data ......................... $702,750 

ESTABLISHMENTS .............. $457,200 

PRODUCTS .......................... $79,720 

VIII. Fee Payment Options and 

Procedures 

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, 2009. 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 

identification (ID) number on your 


sroberts on DSKD5P82C1PROD with NOTICES
38456 Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices 

check, bank draft, or postal money 

order. 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, bank draft, or 

postal money order. 

Wire transfer payment may also be 

used. Please reference your unique user 

fee ID number when completing your 

transfer. The originating financial 

institution usually charges a wire 

transfer fee between $15.00 and $35.00. 

Please ask your financial institution 

about the fee and include it with your 

payment to ensure that your fee is fully 

paid. The account information is as 

follows: New York Federal Reserve 

Bank, US Dept of Treasury, TREAS 

NYC, 33 Liberty St., New York, NY 

10045, Acct. No.: 75060099, Routing 

No.: 021030004, SWIFT: FRNYUS33, 

Beneficiary: FDA, 5600 Fishers Lane, 

Rockville, MD 20857. 

Application fees can also be paid 

online with an electronic check (ACH). 

FDA has partnered with the U.S. 

Department of the Treasury to utilize 

Pay.gov, a Web-based payment 

application, for online electronic 

payment. The Pay.gov feature is 

available on the FDA Web site after the 

user fee ID number is generated. 

The tax identification number of the 

Food and Drug Administration is 53– 

0196965. 

B. Establishment and Product Fees 

FDA will issue invoices for 

establishment and product fees for FY 

2010 under the new fee schedule in 

August 2009. Payment will be due on 

October 1, 2009. FDA will issue 

invoices in November 2010 for any 

products and establishments subject to 

fees for FY 2010 that qualify for fees 

after the August 2009 billing. 

Dated: July 28, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–18457 Filed 7–31–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Privacy Act of 1974; Report of Altered 

Systems of Records 

AGENCY: Department of Health and 

Human Services (HHS), Health 

Resources and Services Administration 

(HRSA). 

ACTION: Notice of Altered Systems of 

Records (SOR). 

SUMMARY: In accordance with the 

requirements of the Privacy Act of 1974, 

the Health Resources and Services 

Administration (HRSA) is proposing to 

alter four existing systems of records 

(SORs) for the reasons indicated below: 

09–15–0002: Records of Patient’s 

Personal Valuables and Monies, HHS/ 

HRSA/BPHC 

HRSA is updating the system 

location, categories of individuals 

covered by the system, storage, 

retrievability, safeguards, retention and 

disposal, system manager, and 

notification procedure. HRSA is also 

adding a new routine use, number 3 

(breach notification language). 

09–15–0003: Contract Physicians and 

Consultants, HHS/HRSA/BPHC 

HRSA is updating the system 

location, categories of individuals 

covered by the system, categories of 

records in the system, authority for 

maintenance of the system, retention 

and disposal, and system manager. 

HRSA is also adding a new routine use, 

number 6 (breach notification language). 

09–15–0007: Patient’s Medical Record 

System Public Health Service 

Hospitals, HHS/HRSA/BPHC 

HRSA is updating the system location 

(Appendix 2—Federal Records Centers), 

categories of individuals covered by the 

system, categories of records in the 

system, authority for maintenance of the 

system, purpose of the system, physical 

safeguards, retention and disposal, 

system manager, and notification 

procedure. HRSA is deleting four 

routine uses, numbers 6 (Bureau of 

Prisons (BP) to report results of 

examination and treatment of patients 

examined and/or treated for and on 

behalf of the BP), 7 (Federal, state or 

private health benefit plans for billing 

purposes), 14 (Disclosure may be made 

to a private firm for the purpose of 

collating, analyzing, aggregating or 

otherwise refining records in this 

system. The contractor is required to 

maintain Privacy Act safeguards with 

respect to such records), and 19 (To 

organizations or individuals with 

agreements to provide photocopying or 

medical record data abstracting services. 

(a) PBS may inform the sexual and/or 

needle-sharing partner(s) of a subject 

individual who is infected with the 

human immunodeficiency virus (HIV) 

of their exposure to HIV, under the 

following circumstances: 

1. The information has been obtained 

in the course of clinical activities at PHS 

facilities carried out by PHS personnel 

or contractors; 

2. The PHS employee or contractor 

has made reasonable efforts to counsel 

and encourage the subject individual to 

provide the information to the 

individual’s sexual or needle-sharing 

partner(s); 

3. The PBS employee or contractor 

determines that the subject individual is 

unlikely to provide the information to 

the sexual or needle-sharing partner(s) 

or that the provision of such 

information cannot reasonably be 

verified; and 

4. The notification of the partner(s) is 

made, whenever possible, by the subject 

individual’s physician or by a 

professional counselor and shall follow 

standard counseling practices. (b) PHS 

may disclose information to State or 

local public health departments, to 

assist in the notification of the subject 

individual’s sexual and/or needlesharing partner(s), or in the verification 

that the subject individual has, notified 

such sexual or needle-sharing partner(s). 

HRSA is also adding one new routine 

use, number 16 (breach notification 

language). 

09–15–0028: Public Health Service 

Clinical Affiliation Trainee Records, 

HHS/HRSA/BPHC 

HRSA is updating the system 

location, authority for maintenance of 

the system, retrievability, safeguards, 

retention and disposal, and system 

manager. HRSA is also deleting one 

routine use, number 2 (to 

representatives of medical/allied health 

training program accreditation of PHS 

Training Programs), and adding a new 

routine use, number 6 (breach 

notification language). 

DATES: HRSA filed an altered system 

report with the Chair of the House 

Committee on Government Reform and 

Oversight, the Chair of the Senate 

Committee on Homeland Security and 

Governmental Affairs, and the 

Administrator, Office of Information 

and Regulatory Affairs, Office of 

Management and Budget (OMB) on July 

23, 2009. To ensure all parties have 

adequate time in which to comment, the 

altered systems, including the routine 

uses, will become effective 30 days from 


sroberts on DSKD5P82C1PROD with NOTICES