15736 Federal Register / Vol. 74, No. 65 / Tuesday, April 7, 2009 / Notices 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. E-mail address: 

infocollection@acf.hhs.gov. All requests 

should be identified by the title of the 

information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Dated: April 1, 2009. 

Janean Chambers, 

Reports Clearance Officer. 

[FR Doc. E9–7705 Filed 4–6–09; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0148] 

Generic New Animal Drug User Fee 

Rates and Payment Procedures for 

Fiscal Year 2009 

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) 2009 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 a generic new animal 

drug, 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 2009. 

For FY 2009, the generic new animal 

drug user fee rates are: $41,400 for each 

abbreviated application for a generic 

new animal drug; $3,005 for each 

generic new animal drug product; 

$56,350 for each generic new animal 

drug sponsor paying 100 percent of the 

sponsor fee; $42,265 for each generic 

new animal drug sponsor paying 75 

percent of the sponsor fee; and $28,175 

for a generic new animal drug sponsor 

paying 50 percent of the sponsor fee. 

AGDUFA required FDA to issue 

invoices for FY 2009 product and 

sponsor fees by December 31, 2008, or 

within 30 days of enactment of an 

appropriation for these fees, whichever 

is later. The appropriations were 

enacted on March 11, 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 generic new 

animal drugs submitted on or after July 

1, 2008, and will remain in effect 

through September 30, 2009. 

FOR FURTHER INFORMATION CONTACT: Visit 

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

oc/adufa/agdufamain.html 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 email 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 are 

subject to adjustment 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 2009 

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 2009 for 

abbreviated application fees is 

$1,449,000 and the other two generic 

new animal drug user fee categories, 

annual product fees and annual sponsor 

fees, are $1,691,000 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 further inflation adjustment is 

required. 

C. Workload Adjustment 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)). No 

workload adjustment is to be made in 

fee revenue amounts for FY 2009. 

III. Abbreviated Application Fee 

Calculations for FY 2009 

The term ‘‘abbreviated application for 

a generic new animal drug’’ is defined 

in 21 U.S.C. 379j–21(k)(1). 

A. Application Fee Revenues and 

Numbers of Fee-Paying Applications 

The application fee must be paid for 

abbreviated applications for generic new 

animal drugs that are subject to fees 

under AGDUFA and that are submitted 

on or after July 1, 2008. The application 

fees are to be set so that they will 

generate $1,449,000 in fee revenue for 

FY 2009. This is the amount set out in 

the statute and no adjustments to it are 

required for FY 2009. 

To set fees for abbreviated 

applications for generic new animal 

drugs to realize $1,449,000, FDA must 

first make some assumptions about the 

number of fee-paying abbreviated 

applications it will receive over the 15 

months from July 1, 2008, through 

September 30, 2009. 

The agency knows the number of such 

applications that have been submitted 

in previous years. That number 

Federal Register / Vol. 74, No. 65 / Tuesday, April 7, 2009 / Notices 15737 

fluctuates significantly from year to 

year. FDA is assuming that the number 

of abbreviated applications that will pay 

fees in FY 2009 will equal the average 

number of submissions over the 4 most 

recent years. 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 about 5 years of 

experience with other user fee 

programs. Further, because the 

imposition of a fee may reduce 

somewhat the number of abbreviated 

applications submitted, FDA will use a 

12-month average estimate in estimating 

the number of abbreviated applications 

that will be subject to and pay fees in 

the 15-month period from July 1, 2008, 

through September 30, 2009. 

Over the past 4 years, the average 

number of abbreviated applications for 

generic new animal drugs that would 

have been subject to the fee was 38.75, 

including the number for the most 

recent year, which is estimated at 40. 

FDA will also assume that 10 percent of 

these applications, or 3.875, may be 

subject to fee waivers or reduction based 

on indications solely for minor use or 

minor species. 

Thus, for FY 2009, FDA estimates 

receipt of 34.55 (38.75 minus 3.875) feepaying abbreviated applications. 

B. Fee Rates for FY 2009 

FDA must set the fee rates for FY 2009 

so that the estimated 35 abbreviated 

applications that pay the fee will 

generate a total of $1,449,000. To 

generate this amount, the fee for an 

animal drug application, rounded to the 

nearest hundred dollars, will have to be 

$41,400. 

IV. Generic Product Fee Calculations 

for FY 2009 

A. Product Fee Revenues and Numbers 

of Fee-Paying Products 

The generic new animal drug product 

fee (also referred to as the product fee) 

must be paid annually by the person 

named as the applicant in an 

abbreviated application for a generic 

new animal drug or a supplemental 

abbreviated application for a generic 

new animal drug product submitted for 

listing under section 510 of the act (21 

U.S.C. 360), and who had an 

abbreviated application or a 

supplemental abbreviated application 

for a generic new animal drug product 

pending at FDA after September 1, 2008 

(see 21 U.S.C. 379j–21(a)(2)). The term 

‘‘generic new animal drug product’’ 

means each specific strength or potency 

of a particular active ingredient or 

ingredients in final dosage form 

marketed by a particular manufacturer 

or distributor, which is uniquely 

identified by the labeler code and 

product code portions of the national 

drug code, and for which an abbreviated 

application for a generic new animal 

drug or supplemental abbreviated 

application for a generic new animal 

drug has been approved (21 U.S.C. 379j– 

21(k)(6)). The product fees are to be set 

so that they will generate $1,691,000 in 

fee revenue for FY 2009. This is the 

amount set out in the statute and no 

further adjustments are required for FY 

2009. 

To set generic new animal drug 

product fees to realize $1,691,000, FDA 

must make some assumptions about the 

number of products for which these fees 

will be paid in FY 2009. FDA developed 

data on all generic new 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 FDA estimated would have an 

abbreviated application for a generic 

new animal drug or supplemental 

abbreviated application pending after 

September 1, 2008. FDA estimates there 

is a total of 626 products submitted for 

listing by persons who had an 

abbreviated application for a generic 

new animal drug or supplemental 

abbreviated application for a generic 

new animal drug pending after 

September 1, 2008. Based on this, FDA 

believes that a total of 626 products will 

be subject to this fee in FY 2009. 

In estimating the fee revenue to be 

generated by generic new animal drug 

product fees in FY 2009, FDA is 

assuming that 10 percent of the 

products invoiced, or 63, will not pay 

fees in FY 2009 due to fee waivers and 

reductions. Based on experience with 

other user fee programs and the first 5 

years of the Animal Drug User Fee Act 

program (ADUFA), FDA believes that 

this is a reasonable basis for estimating 

the number of fee-paying products in FY 

2009. 

Accordingly, the agency estimates 

that a total of 563 (626 minus 63) 

products will be subject to product fees 

in FY 2009. 

B. Product Fee Rates for FY 2009 

FDA must set the fee rates for FY 2009 

so that the estimated 563 products that 

pay fees will generate a total of 

$1,691,000. To generate this amount 

will require the fee for a generic new 

animal drug product, rounded to the 

nearest $5, to be $3,005. 

V. Generic New Animal Drug Sponsor 

Fee Calculations for FY 2009 

A. Sponsor Fee Revenues and Numbers 

of Fee-Paying Sponsors 

The generic new 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 

abbreviated application for a generic 

new animal drug, that has not been 

withdrawn by the applicant and for 

which approval has not been withdrawn 

by the secretary, or has submitted an 

investigational submission for a generic 

new animal drug that has not been 

terminated or otherwise rendered 

inactive and (2) had an abbreviated 

application for a generic new animal 

drug, supplemental abbreviated 

application for a generic new animal 

drug, or investigational submission for a 

generic new animal drug pending at 

FDA after September 1, 2008 (see 21 

U.S.C. 379j–21(k)(7) and 379j–21(a)(3)). 

A generic new animal drug sponsor is 

subject to only one such fee each fiscal 

year (see 21 U.S.C. 379j–21(a)(3)(B)). 

Applicants with more than 6 approved 

abbreviated applications will pay 100 

percent of the sponsor fee, applicants 

with 2 to 6 approved abbreviated 

applications will pay 75 percent of the 

sponsor fee, and applicants with 1 or 

fewer approved abbreviated 

applications will pay 50 percent of the 

sponsor fee (see 21 U.S.C. 379j– 

21(a)(3)(B)). The sponsor fees are to be 

set so that they will generate $1,691,000 

in fee revenue for FY 2009. This is the 

amount set out in the statute and no 

adjustments are required for FY 2009. 

To set generic new animal drug 

sponsor fees to realize $1,691,000, FDA 

must make some assumptions about the 

number of sponsors who will pay these 

fees in FY 2009. Based on the number 

of firms that would have met this 

definition in each of the past 5 years, 

FDA estimates that in FY 2009 11 

sponsors will pay 100 percent (full) fees, 

11 sponsors will pay 75 percent fees, 

and 28 sponsors will pay 50 percent 

fees. That totals the equivalent of 33.25 

full sponsor fees (11 times 100 percent 

or 11, plus 11 times 75 percent or 8.25, 

plus 28 times 50 percent or 14). 

FDA estimates that about 10 percent 

of all of these sponsors, or 3.25, may 

qualify for a minor use/minor species 

waiver or reduction. 

Accordingly, the agency estimates 

that the equivalent of 30 full sponsor 

fees (33.25 minus 3.25) are likely to be 

paid in FY 2009. 

B. Sponsor Fee Rates for FY 2009 

FDA must set the fee rates for FY 2009 

so that the estimated equivalent of 30 

15738 Federal Register / Vol. 74, No. 65 / Tuesday, April 7, 2009 / Notices 

full sponsor fees will generate a total of 

$1,691,000. To generate this amount 

will require the 100 percent fee for a 

generic new animal drug sponsor, 

rounded to the nearest $50, to be 

$56,350. Accordingly, the fee for those 

paying 75 percent of the full sponsor 

fee, rounded to the nearest $5, will be 

$42,265, and the fee for those paying 50 

percent of the full sponsor fee will be 

$28,175. 

VI. Fee Schedule for FY 2009 

The fee rates for FY 2009 are 

summarized in table 1 of this document. 

TABLE 1.—FY 2009 FEE RATES

Generic New Animal Drug User Fee Category Fee Rate for FY 2009 

Abbreviated Application for Generic New Animal Drug Fee $41,400 

Generic New Animal Drug Product Fee $3,005 

100 Percent Generic New Animal Drug Sponsor Fee* $56,350 

75 Percent Generic New Animal Drug Sponsor Fee* $42,265 

50 Percent Generic New Animal Drug Sponsor Fee* $28,175 

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

VII. Procedures for Paying the FY 2009 

Abbreviated New Animal Drug 

Application Fees 

A. Abbreviated Application Fees and 

Payment Instructions 

The appropriate application fee 

established in the new fee schedule 

must be paid for an abbreviated new 

animal drug application subject to fees 

under AGDUFA that was submitted on 

or after July 1, 2008. For those sponsors 

who have submitted an abbreviated new 

animal drug application between July 1, 

2008, and the publication date of this 

Federal Register notice, a cover sheet is 

not necessary, as the Food and Drug 

Administration will complete a cover 

sheet for you and invoice you 

accordingly. 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 by 

automatic clearing house (ACH) using 

Pay.gov. On your check, bank draft, or 

U.S. postal money order, please write 

your application’s unique Payment 

Identification Number, beginning with 

the letters ‘‘AG’’, from the upper righthand corner of your completed Animal 

Generic 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 Generic 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, Account Name: 

Food and Drug Administration, Account 

Number: 75060099, Routing Number: 

021030004, Swift Number: FRNYUS33. 

If you prefer to send a check by a 

courier such as FEDEX or UPS, the 

courier may deliver the check and 

printed copy of the cover sheet to: US 

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 US Bank at 314– 

418–4821. This phone 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 

check 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 

abbreviated application arrives at FDA’s 

Center for Veterinary Medicine. FDA 

records the official abbreviated 

application receipt date as the later of 

the following: The date the application 

was received by FDA’s Center for 

Veterinary Medicine, or the date US 

Bank notifies FDA that your check in 

the full amount of the payment due has 

been received or when the U.S. 

Department of Treasury notifies FDA of 

payment. US Bank is required to notify 

FDA within 1 working day, using the 

Payment Identification Number 

described previously. 

B. Application Cover Sheet Procedures 

Step One—Create a user account and 

password. Log onto the AGDUFA Web 

site at http://www.fda.gov/oc/adufa/ 

agdufamain.html and, under the 

‘‘Forms’’ heading, click on the link 

‘‘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 Generic 

Drug User Fee 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 Generic 

Drug User Fee Cover Sheet. One cover 

sheet is needed for each abbreviated 

animal drug application. 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 Payment 

Identification Number. 

Step Three—Send the payment for 

your application as described in section 

VII.A of this document. 

Step Four—Please submit your 

application and a copy of the completed 

Animal Generic 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 and Sponsor Fees 

Thirty days after the March 11, 2009, 

enactment of appropriations for generic 

animal drug user fees, FDA will issue 

invoices and payment instructions for 

product and sponsor fees for FY 2009 

using this fee schedule. Fees will be due 

and payable 30 days after the date the 

invoice is issued. FDA will issue 

invoices in November 2009 for any 

qualifying products and sponsors 

subject to fees received after this initial 

FY 2009 billing. 

Dated: April 1, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–7786 Filed 4–6–09; 8:45 am] 

BILLING CODE 4160–01–S