Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices 38429 

the General Services Administration, 

Regulatory Secretariat (VPR), 1800 F 

Street, Room 4041, Washington, DC 

20405, telephone (202) 501–4755. 

Please cite OMB Control No. 9000– 

0026, Change Order Accounting, in all 

correspondence. 

Dated: July 28, 2009. 

Al Matera, 

Director, Office of Acquisition Policy. 

[FR Doc. E9–18465 Filed 7–31–09; 8:45 am] 

BILLING CODE 6820–EP–P 

DEPARTMENT OF DEFENSE 

GENERAL SERVICES 

ADMINISTRATION 

NATIONAL AERONAUTICS AND 

SPACE ADMINISTRATION 

[OMB Control No. 9000–0094] 

Federal Acquisition Regulation; 

Submission for OMB Review; 

Debarment and Suspension 

AGENCIES: Department of Defense (DOD), 

General Services Administration (GSA), 

and National Aeronautics and Space 

Administration (NASA). 

ACTION: Notice of request for an 

extension to an existing OMB clearance. 

SUMMARY: Under the provisions of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35), the Federal 

Acquisition Regulation (FAR) 

Secretariat will be submitting to the 

Office of Management and Budget 

(OMB) a request to review and approve 

an extension of a currently approved 

information collection requirement 

concerning [subject]. A request for 

public comments was published in the 

Federal Register at 74 FR 18716 on 

April 24, 2009. No comments were 

received. 

Public comments are particularly 

invited on: Whether this collection of 

information is necessary for the proper 

performance of functions of the FAR, 

and whether it will have practical 

utility; whether our estimate of the 

public burden of this collection of 

information is accurate, and based on 

valid assumptions and methodology; 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and ways in which we can 

minimize the burden of the collection of 

information on those who are to 

respond, through the use of appropriate 

technological collection techniques or 

other forms of information technology. 

DATES: Submit comments on or before 

September 2, 2009. 

ADDRESSES: Submit comments regarding 

this burden estimate or any other aspect 

of this collection of information, 

including suggestions for reducing this 

burden to: FAR Desk Officer, OMB, 

Room 10102, NEOB, Washington, DC 

20503, and a copy to the General 

Services Administration, Regulatory 

Secretariat (VPR), 1800 F Street, NW., 

Room 4041, Washington, DC 20405. 

FOR FURTHER INFORMATION CONTACT: 

Edward Loeb, Contract Policy Division, 

GSA (202) 501–0650 or via e-mail at 

Edward.Loeb@gsa.gov. 

SUPPLEMENTARY INFORMATION: 

A. Purpose 

The FAR requires contracts to be 

awarded to only those contractors 

determined to be responsible. Instances 

where a firm or its principals have been 

indicted, convicted, suspended, 

proposed for debarment, debarred, or 

had a contract terminated for default are 

critical factors to be considered by the 

contracting officer in making a 

responsible determination, 52.209–5, 

Certification Responsibility Matters, 

requires the disclosure of this 

information. 

B. Annual Reporting Burden 

Respondents: 89,995. 

Responses per Respondent: 12.223. 

Annual Responses: 1,100,000. 

Hours per Response: 0.0833. 

Total Burden Hours: 91,667. 

Obtaining Copies of Proposals: 

Requesters may obtain a copy of the 

information collection documents from 

the General Services Administration, 

Regulatory Secretariat (VPR), 1800 F 

Street, NW., Room 4041, Washington, 

DC 20405, telephone (202) 501–4755. 

Please cite OMB Control No. 9000–0094, 

Debarment and Suspension, in all 

correspondence. 

Dated: July 28, 2009. 

Al Matera, 

Director, Office of Acquisition Policy. 

[FR Doc. E9–18466 Filed 7–31–09; 8:45 am] 

BILLING CODE 6820–EP–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0336] 

Animal Drug User Fee Rates and 

Payment Procedures for Fiscal Year 

2010 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

rates and payment procedures for fiscal 

year (FY) 2010 animal drug user fees. 

The Federal Food, Drug, and Cosmetic 

Act (the act), as amended by the Animal 

Drug User Fee Act of 2003 (ADUFA) and 

the Animal Drug User Fee Amendments 

of 2008 (ADUFA II), authorizes FDA to 

collect user fees for certain animal drug 

applications and supplements, on 

certain animal drug products, on certain 

establishments where such products are 

made, and on certain sponsors of such 

animal drug applications and/or 

investigational animal drug 

submissions. This notice establishes the 

fee rates for FY 2010. 

FOR FURTHER INFORMATION CONTACT: Visit 

FDA’s Web site at http://www.fda.gov/ 

ForIndustry/UserFees/AnimalDrug

UserFeeActADUFA/default.htm or 

contact Lisa Kable, Center for Veterinary 

Medicine (HFV–10), Food and Drug 

Administration, 7529 Standish Pl., 

Rockville, MD 20855, 240–276–9718. 

For general questions, you may also email the Center for Veterinary Medicine 

(CVM) at: cvmadufa@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 740 of the act (21 U.S.C. 379j12) establishes four different kinds of 

user fees: (1) Fees for certain types of 

animal drug applications and 

supplements, (2) annual fees for certain 

animal drug products, (3) annual fees 

for certain establishments where such 

products are made, and (4) annual fees 

for certain sponsors of animal drug 

applications and/or investigational 

animal drug submissions (21 U.S.C. 

379j-12(a)). When certain conditions are 

met, FDA will waive or reduce fees (21 

U.S.C. 379j-12(d)). 

For FY 2009 through FY 2013, the act 

establishes aggregate yearly base 

revenue amounts for each of these fee 

categories. Base revenue amounts 

established for years after FY 2009 are 

subject to adjustment for workload. Fees 

for applications, establishments, 

products, and sponsors are to be 

established each year by FDA so that the 

revenue for each fee category will 

approximate the level established in the 

statute, after the level has been adjusted 

for workload. 

For FY 2010, the animal drug user fee 

rates are: $209,400 for an animal drug 

application; $145,200 for a 

supplemental animal drug application 

for which safety or effectiveness data is 

required and for an animal drug 

application subject to the criteria set 

forth in section 512(d)(4) of the act (21 

U.S.C. 360b(d)(4)); $6,185 for an annual 


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38430 Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices 

product fee; $73,850 for an annual 

establishment fee; and $57,100 for an 

annual sponsor fee. FDA will issue 

invoices for FY 2010 product, 

establishment, and sponsor fees by 

December 31, 2009, and these invoices 

will be due and payable within 30 days 

of issuance of the invoice. 

The application fee rates are effective 

for applications submitted on or after 

October 1, 2009, and will remain in 

effect through September 30, 2010. 

Applications will not be accepted for 

review until FDA has received full 

payment of application fees and any 

other animal drug user fees owed. 

II. Revenue Amount for FY 2010 

A. Statutory Fee Revenue Amounts 

ADUFA II (Public Law 110–316 

signed by the President on August 14, 

2008) specifies that the aggregate 

revenue amount for FY 2010 for each of 

the 4 animal drug user fee categories is 

$4,320,000, before any adjustment for 

workload is made. (See 21 U.S.C. 379j12(b)(1) through (b)(4).) 

B. Inflation Adjustment to Fee Revenue 

Amount 

The amounts established in ADUFA II 

for each year for FY 2009 through FY 

2013 include an inflation adjustment; 

so, no further inflation adjustment is 

required. 

C. Workload Adjustment to Inflation 

Adjusted Fee Revenue Amount 

For each FY beginning in FY 2010, 

ADUFA provides that fee revenue 

amounts shall be further adjusted to 

reflect changes in review workload (21 

U.S.C. 379j-12(c)(1)). 

FDA calculated the average number of 

each of the five types of applications 

and submissions specified in the 

workload adjustment provision (animal 

drug applications, supplemental animal 

drug applications for which data with 

respect to safety or efficacy are required, 

manufacturing supplemental animal 

drug applications, investigational 

animal drug study submissions, and 

investigational animal drug protocol 

submissions) received over the 5-year 

period that ended on September 30, 

2002 (the base years), and the average 

number of each of these types of 

applications and submissions over the 

most recent 5-year period that ended 

June 30, 2009. 

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, reflecting how much of 

the total FDA animal drug review 

workload was accounted for by each 

type of application or submission 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, and 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 change in workload of 

-22% percent for FY 2010. This is the 

workload adjuster for FY 2010. 

TABLE 1.—WORKLOAD ADJUSTER CALCULATION (NUMBERS MAY NOT ADD DUE TO ROUNDING) 

Application Type 

Column 1 

5-Year Average 

(Base Years) 

Column 2 

Latest 5-Year Average 

Column 3 

Percent Change 

Column 4 

Weighting Factor 

Column 5 

Weighted % 

Change 

New Animal Drug Applications 

(NADAs) 28.80 12.40 -57% 0.0319 -2% 

Supplemental NADAs With Safety 

or Efficacy Data 23.40 13.60 -42% 0.0233 -1% 

Manufacturing Supplements 366.6 435.20 19% 0.1605 3% 

Investigational Study Submissions 336.60 242.80 -28% 0.5930 -17% 

Investigational Protocol Submissions 292.40 204.80 -30% 0.1913 -6% 

FY 2010 Workload Adjuster -22% 

ADUFA specifies that the workload 

adjuster may not result in fees that are 

less than the fee revenue amount in the 

statute (21 U.S.C. 379j-12(c)(1)(B)). 

Because applying the FY 2010 workload 

adjuster would result in fees less than 

the statutory amount, the workload 

adjustment will not be applied in FY 

2010. As a result, the statutory revenue 

target amount for each of the 4 

categories of fees stand at $4,320,000 

with the new total revenue target for 

fees in FY 2010 being $17,280,000. 

III. Adjustment for Excess Collections 

in Previous Years 

Under the provisions of ADUFA, if 

the agency collects more fees than were 

provided for in appropriations in any 

year, FDA is required to reduce its 

anticipated fee collections in a 

subsequent fiscal year by that amount 

(21 U.S.C. 379j-12(g)(4)) prior to its 

amendment under ADUFA II). Table 2 

of this document shows the amount of 

collections realized and the amount 

provided in appropriations acts, and the 

amount to be offset in a subsequent 

year, as of the end of the latest complete 

fiscal year, 2008, which is the final year 

of ADUFA. 

TABLE 2.—FEES COLLECTED, FEES APPROPRIATED, AND OFFSET FOR FUTURE COLLECTIONS—AS OF SEPTEMBER 30, 

2008 

Fiscal Year Cohort Fees Collected Fees Appropriated Amount to Offset Future 

Collections 

2004 $5,154,700 $5,000,000 $154,700 


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Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices 38431 

TABLE 2.—FEES COLLECTED, FEES APPROPRIATED, AND OFFSET FOR FUTURE COLLECTIONS—AS OF SEPTEMBER 30, 

2008—Continued 

Fiscal Year Cohort Fees Collected Fees Appropriated Amount to Offset Future 

Collections 

2005 $8,519,101 $8,354,000 $165,101 

2006 $10,945,866 $11,318,000 $0 

2007 $13,189,060 $11,604,000 $1,585,0601

2008 $11,177,600 $13,696,000 $0 

Total $1,904,861 

Amount Offset When Fees for FY 2008 Were Determined $320,000 

Amount Offset When Fees for FY 2009 Were Determined $1,344,0002

Remaining Balance to Be Offset When FY 2013 Fees Are Set $240,861 

1Some fees for FY 2007 were collected at the end of FY 2008 and were therefore not reflected in the Federal Register document announcing 

animal drug user fee rates and payment procedures for FY 2009 (September 15, 2008; 73 FR 53254). These additional fees amount to $240,861 

and represent the remaining balance to be offset. 2The amount shown in the corresponding chart last year was $1,342,316 (73 FR 53254). When the reduction was taken this amount was divided by 4, so it could be distributed among the 4 categories of fees (application fees, establishment fees, product fees and sponsor fees) and 

then it was rounded to the nearest thousand dollars, which amounted to $336,000, for each of these categories. Thus, the total reduction actually 

taken in FY 2009 was $336,000 times 4, or a total of $1,344,000. 

When ADUFA fees were established 

for FY 2008 and FY 2009, the amount 

of fee revenues for each year was 

reduced by $320,000 and $1,344,000 of 

collections in excess of appropriations, 

respectively. That leaves a total of 

$240,861 collected under ADUFA I 

remaining to be offset. ADUFA II 

amended the annual offset provision of 

ADUFA I to require one offset when FY 

2013 fees are set in August of 2012, if 

aggregate collections from FY 2009 

through 2011 plus the amount of fees 

estimated to be collected for FY 2012 

exceed aggregate appropriations over 

the same period (21 U.S.C. 379j-12(g)(4), 

as amended by ADUFA II). FDA will 

include the remaining $240,861 in 

excess collections from FY 2004 through 

FY 2008 in the calculations when it 

determines whether or not there will be 

an offset in FY 2013, the final year of 

ADUFA II. FDA is not offsetting for 

excess collections at this time. 

IV. Application Fee Calculations for FY 

2010 

The terms ‘‘animal drug application’’ 

and ‘‘supplemental animal drug 

application’’ are defined in section 739 

of the act (21 U.S.C. 379j-11(1) and (2)). 

A. Application Fee Revenues and 

Numbers of Fee-Paying Applications 

The application fee must be paid for 

any animal drug application or 

supplemental animal drug application 

that is subject to fees under ADUFA and 

that is submitted on or after September 

1, 2003. The application fees are to be 

set so that they will generate $4,320,000 

in fee revenue for FY 2010. This is the 

amount set out in the statute and no 

adjustments are required for FY 2010. 

The fee for a supplemental animal drug 

application for which safety or 

effectiveness data are required and for 

an animal drug application subject to 

criteria set forth in section 512(d)(4) is 

to be set at 50 percent of the animal 

drug application fee. (See 21 U.S.C. 

379j-12(a)(1)(A)(ii), as amended by 

ADUFA II.) 

To set animal drug application fees 

and supplemental animal drug 

application fees to realize $4,320,000, 

FDA must first make some assumptions 

about the number of fee-paying 

applications and supplements the 

agency will receive in FY 2010. 

The agency knows the number of 

applications that have been submitted 

in previous years. That number 

fluctuates significantly from year to 

year. In estimating the fee revenue to be 

generated by animal drug application 

fees in FY 2010, FDA is assuming that 

the number of applications that will pay 

fees in FY 2010 will equal the average 

number of submissions over the 4 most 

recent years (including an estimate for 

the current year). This may not fully 

account for possible year to year 

fluctuations in numbers of fee-paying 

applications, but FDA believes that this 

is a reasonable approach after 6 years of 

experience with this program. 

Over the past 4 years, the average 

number of animal drug applications that 

would have been subject to the full fee 

was 8.25, including the number for the 

most recent year, estimated at 6. Over 

this same period, the average number of 

supplemental applications and 

applications subject to the criteria set 

forth in section 512(d)(4) of the act that 

would have been subject to half of the 

full fee was 13.25, including the number 

for the most recent year, estimated at 9. 

Thus, for FY 2010, FDA estimates 

receipt of 8.25 fee paying original 

applications and 13.25 fee-paying 

supplemental animal drug applications 

and applications subject to the criteria 

set forth is section 512(d)(4) of the act 

which pay half of the full fee. 

B. Fee Rates for FY 2010 

FDA must set the fee rates for FY 2010 

so that the estimated 8.25 applications 

that pay the full fee and the estimated 

13.25 supplements and applications 

subject to the criteria set forth in section 

512(d)(4) of the act that pay half of the 

full fee will generate a total of 

$4,320,000. To generate this amount, the 

fee for an animal drug application, 

rounded to the nearest hundred dollars, 

will have to be $290,400, and the fee for 

a supplemental animal drug application 

for which safety or effectiveness data are 

required and for applications subject to 

the criteria set forth in section 512(d)(4) 

of the act will have to be $145,200. 

V. Product Fee Calculations for FY 2010 

A. Product Fee Revenues and Numbers 

of Fee-Paying Products 

The animal drug product fee (also 

referred to as the product fee) must be 

paid annually by the person named as 

the applicant in a new animal drug 

application or supplemental new animal 

drug application for an animal drug 

product submitted for listing under 


sroberts on DSKD5P82C1PROD with NOTICES
38432 Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices 

section 510 of the act (21 U.S.C. 360), 

and who had an animal drug 

application or supplemental animal 

drug application pending at FDA after 

September 1, 2003. (See 21 U.S.C. 379j12(a)(2).) The term ‘‘animal drug 

product’’ is defined in 21 U.S.C. 379j11(3). The product fees are to be set so 

that they will generate $4,320,000 in fee 

revenue for FY 2010. This is the amount 

set out in the statute and no adjustments 

are required for FY 2010. 

To set animal drug product fees to 

realize $4,320,000, FDA must make 

some assumptions about the number of 

products for which these fees will be 

paid in FY 2010. FDA developed data 

on all animal drug products that have 

been submitted for listing under section 

510 of the act, and matched this to the 

list of all persons who had an animal 

drug application or supplement pending 

after September 1, 2003. As of July 2009, 

FDA estimates that there are a total of 

776 products submitted for listing by 

persons who had an animal drug 

application or supplemental animal 

drug application pending after 

September 1, 2003. Based on this, FDA 

estimates that a total of 776 products 

will be subject to this fee in FY 2010. 

In estimating the fee revenue to be 

generated by animal drug product fees 

in FY 2010, FDA is assuming that 10 

percent of the products invoiced, or 

about 77.6, will not pay fees in FY 2010 

due to fee waivers and reductions. 

Based on experience with other user fee 

programs and the first 6 years of 

ADUFA, FDA believes that this is a 

reasonable basis for estimating the 

number of fee-paying products in FY 

2010. 

Accordingly, the agency estimates 

that a total of 698.4 (776 minus 77.6) 

products will be subject to product fees 

in FY 2010. 

B. Product Fee Rates for FY 2010 

FDA must set the fee rates for FY 2010 

so that the estimated 698.4 products that 

pay fees will generate a total of 

$4,320,000. To generate this amount 

will require the fee for an animal drug 

product, rounded to the nearest 5 

dollars, to be $6,185. 

VI. Establishment Fee Calculations for 

FY 2010 

A. Establishment Fee Revenues and 

Numbers of Fee-Paying Establishments 

The animal drug establishment fee 

(also referred to as the establishment 

fee) must be paid annually by the 

person who: (1) Owns or operates, 

directly or through an affiliate, an 

animal drug establishment; (2) is named 

as the applicant in an animal drug 

application or supplemental animal 

drug application for an animal drug 

product submitted for listing under 

section 510 of the act; (3) had an animal 

drug application or supplemental 

animal drug application pending at FDA 

after September 1, 2003; and (4) whose 

establishment engaged in the 

manufacture of the animal drug product 

during the fiscal year. (See 21 U.S.C. 

379j-12(a)(3).) An establishment subject 

to animal drug establishment fees is 

assessed only 1 such fee per fiscal year. 

(See 21 U.S.C. 379j-12(a)(3).) The term 

‘‘animal drug establishment’’ is defined 

in 21 U.S.C. 379j-11(4). The 

establishment fees are to be set so that 

they will generate $4,320,000 in fee 

revenue for FY 2010. This is the amount 

set out in the statute and no adjustments 

are required for FY 2010. 

To set animal drug establishment fees 

to realize $4,320,000, FDA must make 

some assumptions about the number of 

establishments for which these fees will 

be paid in FY 2010. FDA developed data 

on all animal drug establishments and 

matched this to the list of all persons 

who had an animal drug application or 

supplement pending after September 1, 

2003. As of July 2009, FDA estimates 

that there are a total of 65 

establishments owned or operated by 

persons who had an animal drug 

application or supplemental animal 

drug application pending after 

September 1, 2003. Based on this, FDA 

believes that 65 establishments will be 

subject to this fee in FY 2010. 

In estimating the fee revenue to be 

generated by animal drug establishment 

fees in FY 2010, FDA is assuming that 

10 percent of the establishments 

invoiced, or 6.5, will not pay fees in FY 

2010 due to fee waivers and reductions. 

Based on experience with the first 6 

years of ADUFA, FDA believes that this 

is a reasonable basis for estimating the 

number of fee-paying establishments in 

FY 2010. 

Accordingly, the agency estimates 

that a total of 58.5 establishments (65 

minus 6.5) will be subject to 

establishment fees in FY 2010. 

B. Establishment Fee Rates for FY 2010 

FDA must set the fee rates for FY 2010 

so that the estimated 58.5 

establishments that pay fees will 

generate a total of $4,320,000. To 

generate this amount will require the fee 

for an animal drug establishment, 

rounded to the nearest 50 dollars, to be 

$73,850. 

VII. Sponsor Fee Calculations for FY 

2010 

A. Sponsor Fee Revenues and Numbers 

of Fee-Paying Sponsors 

The animal drug sponsor fee (also 

referred to as the sponsor fee) must be 

paid annually by each person who: (1) 

Is named as the applicant in an animal 

drug application, except for an 

approved application for which all 

subject products have been removed 

from listing under section 510 of the act 

or has submitted an investigational 

animal drug submission that has not 

been terminated or otherwise rendered 

inactive; and (2) had an animal drug 

application, supplemental animal drug 

application, or investigational animal 

drug submission pending at FDA after 

September 1, 2003. (See 21 U.S.C. 379j11(6) and 379j-12(a)(4).) An animal drug 

sponsor is subject to only one such fee 

each fiscal year. (See 21 U.S.C. 379j12(a)(4).) The sponsor fees are to be set 

so that they will generate $4,320,000 in 

fee revenue for FY 2010. This is the 

amount set out in the statute, and no 

adjustments are required for FY 2010. 

To set animal drug sponsor fees to 

realize $4,320,000, FDA must make 

some assumptions about the number of 

sponsors who will pay these fees in FY 

2010. Based on the number of firms that 

would have met this definition in each 

of the past 6 years, FDA estimates that 

a total of 161 sponsors will meet this 

definition in FY 2010. 

Careful review indicates that about 

one third or 33 percent of all of these 

sponsors will qualify for minor use/ 

minor species waiver or reduction (21 

U.S.C. 379j-12(d)(1)(C)). Based on the 

agency’s experience to date with 

sponsor fees, FDA’s current best 

estimate is that an additional 20 percent 

will qualify for other waivers or 

reductions, for a total of 53 percent of 

the sponsors invoiced, or 85.3, who will 

not pay fees in FY 2010 due to fee 

waivers and reductions. FDA believes 

that this is a reasonable basis for 

estimating the number of fee-paying 

sponsors in FY 2010. 

Accordingly, the agency estimates 

that a total of 75.7 sponsors (161 minus 

85.3) will be subject to and pay sponsor 

fees in FY 2010. 

B. Sponsor Fee Rates for FY 2010 

FDA must set the fee rates for FY 2010 

so that the estimated 75.7 sponsors that 

pay fees will generate a total of 

$4,320,000. To generate this amount 

will require the fee for an animal drug 

sponsor, rounded to the nearest 50 

dollars, to be $57,100. 


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VIII. Fee Schedule for FY 2010 

The fee rates for FY 2010 are 

summarized in table 3 of this document. 

TABLE 3.—FY 2010 FEE RATES

Animal Drug User Fee Category Fee Rate for FY 2010 

Animal Drug Application Fees 

Animal Drug Application $290,400 

Supplemental Animal Drug Application for Which Safety or Effectiveness Data Are Required or Animal 

Drug Application Subject to the Criteria Set Forth in Section 512(d)(4) of the Act $145,200 

Animal Drug Product Fee $6,185 

Animal Drug Establishment Fee1 $73,850 

Animal Drug Sponsor Fee2 $57,100 

1An animal drug establishment is subject to only one such fee each fiscal year. 

2An animal drug sponsor is subject to only one such fee each fiscal year. 

IX. Procedures for Paying the FY 2010 

Fees 

A. Application Fees and Payment 

Instructions 

The appropriate application fee 

established in the new fee schedule 

must be paid for an animal drug 

application or supplement subject to 

fees under ADUFA that is submitted 

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, by wire transfer, 

or electronically using Pay.gov. (The 

Pay.gov payment option is available to 

you after you submit a cover sheet. Click 

the ‘‘Pay Now’’ button.) On your check, 

bank draft, or U.S. postal money order, 

please write your application’s unique 

Payment Identification Number (PIN), 

beginning with the letters AD, from the 

upper right-hand corner of your 

completed Animal Drug User Fee Cover 

Sheet. Also write the FDA post office 

box number (P.O. Box 953877) on the 

enclosed check, bank draft, or money 

order. Your payment and a copy of the 

completed Animal Drug User Fee Cover 

Sheet can be mailed to: Food and Drug 

Administration, P.O. Box 953877, St. 

Louis, MO, 63195–3877. 

If payment is made by wire transfer, 

send payment to: U.S. Department of 

Treasury, TREAS NYC, 33 Liberty St., 

New York, NY 10045, FDA Deposit 

Account Number: 75060099, U.S. 

Department of Treasury routing/transit 

number: 021030004, SWIFT Number: 

FRNYUS33. You are responsible for any 

administrative costs associated with the 

processing of a wire transfer. Contact 

your bank or financial institution 

regarding additional fees. 

If you prefer to send a check by a 

courier such as Federal Express 

(FEDEX) or United Parcel Service (UPS), 

the courier may deliver the check and 

printed copy of the cover sheet to: U.S. 

Bank, Attn: Government Lockbox 

953877, 1005 Convention Plaza, St. 

Louis, MO 63101. (Note: This address is 

for courier delivery only. If you have 

any questions concerning courier 

delivery contact the U.S. Bank at 314– 

418–4821. This telephone number is 

only for questions about courier 

delivery.) 

The tax identification number of the 

Food and Drug Administration is 

530196965. (Note: In no case should the 

payment for the fee be submitted to FDA 

with the application.) 

It is helpful if the fee arrives at the 

bank at least a day or two before the 

application arrives at FDA’s CVM. FDA 

records the official application receipt 

date as the later of the following: The 

date the application was received by 

FDA’s CVM, or the date U.S. Bank 

notifies FDA that your payment in the 

full amount has been received, or when 

the U.S. Treasury notifies FDA of 

receipt of an electronic or wire transfer 

payment. U.S. Bank and the U.S. 

Treasury are required to notify FDA 

within 1 working day, using the PIN 

described previously. 

B. Application Cover Sheet Procedures 

Step One—Create a user account and 

password. Log on to the ADUFA Web 

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

UserFees/AnimalDrugUserFeeAct

ADUFA/default.htm and, under Tools 

and Resources click ‘‘The Animal Drug 

User Fee Cover Sheet’’ and then click 

‘‘Create ADUFA User Fee Cover Sheet.’’ 

For security reasons, each firm 

submitting an application will be 

assigned an organization identification 

number, and each user will also be 

required to set up a user account and 

password the first time you use this site. 

Online instructions will walk you 

through this process. 

Step Two—Create an Animal Drug 

User Cover Sheet, transmit it to FDA, 

and print a copy. After logging into your 

account with your user name and 

password, complete the steps required 

to create an Animal Drug User Fee 

Cover Sheet. One cover sheet is needed 

for each animal drug application or 

supplement. Once you are satisfied that 

the data on the cover sheet is accurate 

and you have finalized the cover sheet, 

you will be able to transmit it 

electronically to FDA and you will be 

able to print a copy of your cover sheet 

showing your unique PIN. 

Step Three—Send the payment for 

your application as described in section 

IX.A of this document. 

Step Four—Please submit your 

application and a copy of the completed 

Animal Drug User Fee Cover Sheet to 

the following address: Food and Drug 

Administration, Center for Veterinary 

Medicine, Document Control Unit 

(HFV–199), 7500 Standish Pl., 

Rockville, MD 20855. 

C. Product, Establishment, and Sponsor 

Fees 

By December 31, 2009, FDA will issue 

invoices and payment instructions for 

product, establishment, and sponsor 

fees for FY 2010 using this Fee 

Schedule. Payment will be due and 

payable within 30 days of issuance of 

the invoice. FDA will issue invoices in 

November 2010 for any products, 

establishments, and sponsors subject to 

fees for FY 2010 that qualify for fees 

after the December 2009 billing. 


sroberts on DSKD5P82C1PROD with NOTICES
38434 Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices 

Dated: July 28, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–18459 Filed 7–31–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0340] 

Animal Generic Drug User Fee Rates 

and Payment Procedures for Fiscal 

Year 2010 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

rates and payment procedures for fiscal 

year (FY) 2010 generic new animal drug 

user fees. The Federal Food, Drug, and 

Cosmetic Act (the act), as amended by 

the Animal Generic Drug User Fee Act 

of 2008 (AGDUFA), authorizes FDA to 

collect user fees for certain abbreviated 

applications for generic new animal 

drugs, on certain generic new animal 

drug products, and on certain sponsors 

of such abbreviated applications for 

generic new animal drugs and/or 

investigational submissions for generic 

new animal drugs. This notice 

establishes the fee rates for FY 2010. 

For FY 2010, the generic animal drug 

user fee rates are: $75,000 for each 

abbreviated application for a generic 

new animal drug; $3,255 for each 

generic new animal drug product; 

$54,050 for each generic new animal 

drug sponsor paying 100 percent of the 

sponsor fee; $40,537 for each generic 

new animal drug sponsor paying 75 

percent of the sponsor fee; and $27,025 

for a generic new animal drug sponsor 

paying 50 percent of the sponsor fee. 

FDA will issue invoices for FY 2010 

product and sponsor fees by December 

31, 2009. These fees will be due and 

payable within 30 days of the issuance 

of the invoices. 

The application fee rates are effective 

for all abbreviated applications for a 

generic new animal drug submitted on 

or after October 1, 2009, and will remain 

in effect through September 30, 2010. 

Applications will not be accepted for 

review until the FDA has received full 

payment of related application fees and 

any other fees owed under the Animal 

Generic Drug User Fee program. 

FOR FURTHER INFORMATION CONTACT: Visit 

the FDA Web site at http://www.fda.gov/ 

ForIndustry/UserFees/Animal

GenericDrugUserFeeActAGDUFA/ 

default.htm or contact Bryan Walsh, 

Center for Veterinary Medicine (HFV– 

10), Food and Drug Administration, 

7529 Standish Pl., Rockville, MD 20855, 

240–276–9730. For general questions, 

you may also e-mail the Center for 

Veterinary Medicine (CVM) at: 

cvmagdufa@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 741 of the act (21 U.S.C. 379j– 

21) establishes three different kinds of 

user fees: (1) Fees for certain types of 

abbreviated applications for generic new 

animal drugs, (2) annual fees for certain 

generic new animal drug products, and 

(3) annual fees for certain sponsors of 

abbreviated applications for generic new 

animal drugs and/or investigational 

submissions for generic new animal 

drugs (21 U.S.C. 379j–21(a)). When 

certain conditions are met, FDA will 

waive or reduce fees for generic new 

animal drugs intended solely to provide 

for a minor use or minor species 

indication (21 U.S.C. 379j–21(d)). 

For FY 2009 through FY 2013, the act 

establishes aggregate yearly base 

revenue amounts for each of these fee 

categories. Base revenue amounts 

established for years after FY 2009 may 

be adjusted for workload. Fees for 

applications, products, and sponsors are 

to be established each year by FDA so 

that the revenue for each fee category 

will approximate the level established 

in the statute, after the level has been 

adjusted for workload. 

II. Revenue Amount for FY 2010 

A. Statutory Fee Revenue Amounts 

AGDUFA (Title II of Public Law 110– 

316 signed by the President on August 

14, 2008) specifies that the aggregate 

revenue amount for FY 2010 for 

abbreviated application fees is 

$1,532,000 and each of the other two 

generic new animal drug user fee 

categories, annual product fees and 

annual sponsor fees, is $1,787,000 each, 

before any adjustment for workload is 

made (see 21 U.S.C. 379j–21(b)). 

B. Inflation Adjustment to Fee Revenue 

Amount 

The amounts established in AGDUFA 

for each year for FY 2009 through FY 

2013 include an inflation adjustment, so 

no inflation adjustment is required. 

C. Workload Adjustment to Inflation 

Adjusted Fee Revenue Amount 

For each FY beginning after FY 2009, 

AGDUFA provides that statutory fee 

revenue amounts shall be further 

adjusted to reflect changes in review 

workload (21 U.S.C. 379j–21(c)(1)). 

FDA calculated the average number of 

each of the four types of applications 

and submissions specified in the 

workload adjustment provision 

(abbreviated applications for generic 

new animal drugs, manufacturing 

supplemental abbreviated applications 

for generic new animal drugs, 

investigational generic new animal drug 

study submissions, and investigational 

generic new animal drug protocol 

submissions) received over the 5-year 

period ended on September 30, 2008 

(the base years), and the average number 

of each of these types of applications 

and submissions over the most recent 5- 

year period that ended on June 30, 2009. 

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, reflecting how much of 

the total FDA generic new animal drug 

review workload was accounted for by 

each type of application or submission 

in the table during the most recent 5 

years. Column 5 of table 1 is the 

weighted percent change in each 

category of workload, and 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 1, the sum 

of the values in column 5 is calculated, 

reflecting a total change in workload of 

negative 11.2 percent for FY 2010. This 

is the workload adjuster for FY2010. 

TABLE 1.—WORKLOAD ADJUSTER CALCULATION

Application type 

Column 1 

5-Year Avg. (Base 

Years) 

Column 2 

Latest 5-Year Avg. 

Column 3 

Percent Change 

Column 4 

Weighting Factor 

Colum 5 

Weighted Percent 

Change 

Abbreviated New Animal Drug Applications (ANADAs) 44 .20 38 .00 -14% 59% -8 .3% 


sroberts on DSKD5P82C1PROD with NOTICES