53258 Federal Register / Vol. 73, No. 179 / Monday, September 15, 2008 / Notices 

953877, 1005 Convention Plaza, St. 

Louis, Missouri 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 

application arrives at FDA’s Center for 

Veterinary Medicine (CVM). FDA 

records the official application receipt 

date as the later of the following: the 

date the application was received by 

CVM, or the date US Bank notifies FDA 

that your check in the full amount of the 

payment due has been received, or 

when the United States Treasury 

notifies FDA of receipt of an electronic 

payment. US Bank and the United 

States Treasury are 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 ADUFA Web 

site at http://www.fda.gov/oc/adufa 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 they use this site. Online 

instructions will walk you through this 

process. 

Step Two—Create an Animal 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 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 Payment 

Identification Number. 

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, 2008, FDA will issue 

invoices and payment instructions for 

product, establishment, and sponsor 

fees for FY 2009 using this fee schedule. 

Payment will be due and payable on or 

before January 31, 2009. FDA will issue 

invoices in November 2009 for any 

products, establishments, and sponsors 

subject to fees for FY 2009 but that 

qualified for fees after the December 

2008 billing. 

Dated: September 8, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–21450 Filed 9–12–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0479] 

Generic New Animal Drug User Fee 

Rates and Payment Procedures for 

Fiscal Year 2009 

AGENCY: Food and Drug Administration 

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. 

FDA will 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. 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. 

However, FDA may not collect 

application fees until enactment of an 

appropriation for these fees. Within 30 

days of enactment of an appropriation 

for these fees, FDA will issue invoices 

for applications received on or after July 

1, 2008, and will publish a Federal 

Register notice stating that for the 

remainder of fiscal year 2009 FDA will 

not accept any further abbreviated 

applications for generic new animal 

drugs for review until FDA has received 

full payment of application fees and any 

other generic new animal drug user fees 

owed. That Federal Register notice will 

also provide instructions for payment of 

abbreviated applications for generic new 

animal drug fees. 

FOR FURTHER INFORMATION CONTACT: Visit 

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

oc/agdufa or contact Roxanne 

Schweitzer, Center for Veterinary 

Medicine (HFV–10), Food and Drug 

Administration, 7529 Standish Place, 

Rockville, MD 20855, 240–276–9705. 

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

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 

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Federal Register / Vol. 73, No. 179 / Monday, September 15, 2008 / Notices 53259 

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 

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 five dollars, 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 

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53260 Federal Register / Vol. 73, No. 179 / Monday, September 15, 2008 / Notices 

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 of Health and Human 

Services, 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 six approved 

abbreviated applications will pay 100 

percent of the sponsor fee, applicants 

with two to six approved abbreviated 

applications will pay 75 percent of the 

sponsor fee, and applicants with one 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 

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 fifty dollars, to 

be $56,350. Accordingly, the fee for 

those paying 75 percent of the full 

sponsor fee, rounded to the nearest five 

dollars, 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 FY 2009 

Generic New Animal Drug User Fees 

FDA may not collect user fees for 

abbreviated applications, for generic 

new animal drug products, and for 

generic new animal drug sponsors until 

an appropriation of fees is provided by 

Congress (see 21 U.S.C. 379j–21(g)(1)). 

For this reason FDA may not begin to 

collect these fees at this time. 

Fees for generic new animal drug 

products and sponsors will be invoiced 

at the rates published in this notice on 

the later of December 31, 2008, or 30 

days after appropriation of generic new 

animal drug user fees by Congress. 

Invoices for fees for abbreviated 

applications for generic new animal 

drugs submitted on or after July 1, 2008, 

will be issued 30 days after 

appropriation of generic new animal 

drug user fees by Congress. After that 

time, FDA will not consider an 

abbreviated application for a generic 

abbreviated new animal drug complete 

unless the application fee for that 

application has been paid in advance. 

Within 30 days after appropriation of 

generic new animal drug user fees by 

Congress, FDA will publish another 

notice in the Federal Register providing 

payment instructions so that these fees 

may be paid in advance of the 

submission of such abbreviated 

applications from that time forward. 

Dated: September 3, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–21453 Filed 9–12–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Application of Platform 

Technologies for the Development of 

Therapeutics for Biodefense-A. 

Date: October 16–17, 2008. 

Time: 8:30 a.m. to 5:30 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: Gaithersburg Marriott 

Washingtonian Center, 9751 Washingtonian 

Boulevard, Gaithersburg, MD 20878. 

Contact Person: Alec Ritchie, PhD, 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institutes of Health/NIAID/DHHS, 

6700 B Rockledge Drive, MSC 7616, 

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