53254 Federal Register / Vol. 73, No. 179 / Monday, September 15, 2008 / Notices 

estimated total annual burden for 

followup reports of new medical 

information is shown in row 2 of table 

1 of this document. 

As previously noted, section 761(e)(1) 

of the act requires that responsible 

persons maintain records related to 

dietary supplement adverse event 

reports they receive, whether or not the 

adverse event is serious. Under the 

statute, the records must be retained for 

a period of 6 years. The draft guidance 

provides FDA’s recommendations as to 

what records industry should maintain 

to satisfy the statutory recordkeeping 

requirement. 

The guidance recommends that the 

responsible person document its 

attempts to obtain the minimum data 

elements for a serious adverse event 

report. Along with these records, the 

guidance recommends that the 

responsible person keep the following 

other records: (1) Communications 

between the responsible person and the 

initial reporter of the adverse event and 

with any other person(s) who provided 

information about the adverse event; (2) 

(for serious adverse events only) the 

responsible person’s serious adverse 

event report to FDA on MedWatch Form 

3500A, with attachments; (3) any new 

medical information about the adverse 

event received by the responsible 

person; (4) (for serious adverse events 

only) any reports to FDA of new 

medical information related to the 

serious adverse event report. We 

estimate that assembling and filing these 

records, including any necessary 

photocopying, will take approximately 

0.5 hours per adverse event report 

received by the responsible person. 

Once the documents pertaining to an 

adverse event report have been 

assembled and filed, FDA expects the 

records retention burden to be minimal, 

as the agency believes most 

establishments would normally keep 

this kind of record for at least several 

years after receiving the report, as a 

matter of usual and customary business 

practice. FDA requests comment on 

current adverse event recordkeeping 

practices in the dietary supplement 

industry, including the length of time 

such records are typically kept. 

According to a 2001 report by the 

Office of the Inspector General, between 

1994–1999 FDA received 2,547 adverse 

event reports involving dietary 

supplements, or about 500 reports per 

year, on average. According to the 

report, the actual number of adverse 

events relating to dietary supplements is 

likely to be at least 100 times that many, 

or more than 50,000 adverse events per 

year. Given that we have limited data on 

how many adverse events will be 

reported each year to the responsible 

person, we are using the 50,000 per year 

figure as an upper-bound estimate of 

reporting. This is almost certainly an 

overestimate of the number of reports 

the firms will receive, as it is unlikely 

that every adverse event that occurs will 

be reported to the responsible person. 

FDA requests comments on this 

estimate. 

We estimated in the economic impact 

analysis of the Dietary Supplement 

Good Manufacturing Practices final rule 

(the GMP final rule) (72 FR 34752, June 

25, 2007) that there are 1,460 

manufacturers, packers, and holders of 

dietary supplements (72 FR 34752 at 

34920). We assume that the estimated 

50,000 adverse event reports related to 

dietary supplements will be spread 

evenly among these firms. The estimate 

of the number of manufacturers, 

packers, and holders of dietary 

supplements from the GMP final rule is 

FDA’s best estimate of the number of 

firms that are ‘‘responsible persons’’ 

who must comply with the 

recordkeeping requirements of the 

DSNDCPA; however, it is not a precise 

estimate because the number of dietary 

supplement establishments covered by 

the GMP final rule is likely to be larger 

than the number of ‘‘responsible 

persons,’’ where a ‘‘responsible person’’ 

is a dietary supplement manufacturer, 

packer, or distributor whose name is 

listed on the label of a dietary 

supplement marketed in the United 

States (see section 761(b)(1) of the act). 

Thus, FDA’s estimate for the number of 

respondents in table 2 may be over 

inclusive. FDA requests comments on 

the number of firms that would be 

subject to the recordkeeping 

requirements of the DSNDCPA. 

The estimated total annual 

recordkeeping burden under the statute 

and this guidance is shown in table 2 of 

this document. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records2

Hours per 

Record Total Hours 

Dietary supplement adverse event 

records (21 U.S.C. 379aa– 

1(e)(1)) 1,460 4.2465 50,000 0.5 25,000 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2For purposes of estimating the number of records and hours per record, a ‘‘record’’ means all records kept for an individual adverse event report received by the responsible person. 

Dated: September 8, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–21454 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–0480] 

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 for user fees under the 

Animal Drug User Fee Act program 

(ADUFA). The Federal Food, Drug, and 

Cosmetic Act (the act), as amended by 

the Animal Drug User Fee Act of 2003 

(ADUFA I), and the Animal Drug User 

Fee Amendments of 2008 (ADUFA II), 

authorizes FDA to collect user fees for 

certain animal drug applications, 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 

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Federal Register / Vol. 73, No. 179 / Monday, September 15, 2008 / Notices 53255 

submissions. This notice establishes the 

fee rates for FY 2009. 

For FY 2009, the animal drug user fee 

rates are: $246,300 for an animal drug 

application; $123,150 for a 

supplemental animal drug application 

for which safety or effectiveness data is 

required and for an animal drug 

application subject to certain criteria; 

$4,925 for an annual product fee; 

$59,450 for an annual establishment fee; 

and $52,700 for an annual sponsor fee. 

FDA will issue invoices for FY 2009 

product, establishment, and sponsor 

fees by December 31, 2008, and these 

invoices will be due and payable on or 

before January 31, 2009. FDA will issue 

invoices in November 2009 for any 

products, establishments, and sponsors 

that are subject to fees for FY 2009 but 

that qualified for fees after the December 

2008 billing. 

The application fee rates are effective 

for applications submitted on or after 

October 1, 2008, and will remain in 

effect through September 30, 2009. 

Applications will not be accepted for 

review until FDA has received full 

payment of application fees and any 

other animal drug user fees owed. 

FOR FURTHER INFORMATION CONTACT: Visit 

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

oc/adufa or contact Roxanne 

Schweitzer, Center for Veterinary 

Medicine (HFV–10), Food and Drug 

Administration, 7529 Standish Pl., 

Rockville, MD 20855, 240–276–9705. 

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

at: cvmadufa@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 740 of the act (21 U.S.C. 379j– 

12) 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 (section 740(a) 

of the act). When certain conditions are 

met, FDA will waive or reduce fees 

(section 740(d) of the act). 

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, 

establishments, 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 

ADUFA II (Public Law 110–316 

signed by the President on August 14, 

2008) specifies that the aggregate 

revenue amount for FY 2009 for each of 

the four animal drug user fee categories 

is $3,815,000, before any adjustment for 

workload is made (see section 740(b)(1) 

through (b)(4) of the act). 

B. Inflation Adjustment to Fee Revenue 

Amount 

Because the amounts established in 

ADUFA II for each year for FY 2009 

through FY 2013 include an inflation 

adjustment, no further inflation 

adjustment is required. 

C. Workload Adjustment to Fee Revenue 

Amount 

For each FY beginning after FY 2009, 

ADUFA II provides that statutory fee 

revenue amounts shall be further 

adjusted to reflect changes in review 

workload (section 740(c)(1) of the act). 

No workload adjustment is to be made 

in fee revenue amounts for FY 2009. 

III. Adjustment for Excess Collections 

in Previous Years 

Under the provisions of ADUFA I, 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 year by that amount (section 

740(g)(4) of the act). Table 1 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, 2007. 

TABLE 1—FEES COLLECTED, FEES APPROPRIATED, AND OFFSET FOR FUTURE COLLECTIONS AS OF SEPTEMBER 30, 2007 

Fiscal Year Collections Realized Fees Appropriated Amount to Offset Future Collections 

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

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

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

2007 $12,946,515 $11,604,000 $1,342,515 

Total $1,662,316 

Amount offset when fees for FY 2008 were determined $320,000 

Remaining balance to be offset in FY 2009 $1,342,316 

When ADUFA fees were established 

for FY 2008, the amount of fee revenues 

for FY 2008 was reduced by a total of 

$320,000 of excess collections. That 

leaves a total of $1,342,316 to be offset 

against FY 2009 revenue collections, 

lowering the net amount that would 

otherwise be collected. One-fourth of 

this amount, rounded to the nearest 

thousand, or $336,000, rounded to the 

nearest thousand dollars, will be 

subtracted from the statutory fee 

revenue amounts for each of the four fee 

categories in setting the FY 2009 

adjusted revenue amount for each fee 

category. Thus, after adjustment for 

prior-year excess collections, the 

adjusted FY 2009 revenue target for 

each fee category is as follows: 

Application Fee Revenue Amount: 

$3,479,000 ($3,815,000 minus 

$336,000) 

Establishment Fee Revenue Amount: 

$3,479,000 ($3,815,000 minus 

$336,000) 

Product Fee Revenue Amount: 

$3,479,000 ($3,815,000 minus 

$336,000) 

Sponsor Fee Revenue Amount: 

$3,479,000 ($3,815,000 minus 

$336,000) 

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53256 Federal Register / Vol. 73, No. 179 / Monday, September 15, 2008 / Notices 

Thus, the adjusted revenue amount from 

all four categories after this adjustment 

totals $13,916,000. 

IV. Application Fee Calculations for FY 

2009 

The terms ‘‘animal drug applications’’ 

and ‘‘supplemental animal drug 

applications’’ are defined in section 

739(1) and (2) 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 $3,479,000 

in fee revenue for FY 2009. This is the 

amount set out in the statute after it has 

been adjusted for excess collections in 

previous years as set out in section III 

of this document. 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) of the act (21 U.S.C. 

360b(d)(4)) is to be set at 50 percent of 

the animal drug application fee (see 

section 740(a)(1)(A)(ii) of the act, as 

amended by ADUFA II). 

To set animal drug application fees 

and supplemental animal drug 

application fees to realize $3,479,000, 

FDA must first make some assumptions 

about the number of fee-paying 

applications and supplements it will 

receive in FY 2009. 

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 2009, FDA is assuming that 

the number of applications that will pay 

fees in FY 2009 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 5 years of 

experience with this program. 

Over the past 4 years, the average 

number of animal drug applications that 

have been subject to the full fee was 7.5, 

including the number for the most 

recent year, which is estimated at 4. 

Over this same period, the average 

number of supplemental applications 

and applications subject to the criteria 

set forth in section 512(d)(4) that would 

have been subject to half of the full fee 

was 13.25, including the number for the 

most recent year, which is estimated at 

9. 

Thus, for FY 2009, FDA estimates 

receipt of 7.5 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), which pay 

half of the full fee. 

B. Fee Rates for FY 2009 

FDA must set the fee rates for FY 2009 

so that the estimated 7.5 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) that pay half of the full fee 

will generate a total of $3,479,000. To 

generate this amount, the fee for an 

animal drug application, rounded to the 

nearest hundred dollars, will have to be 

$246,300, 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) will 

have to be $123,150. 

V. Product Fee Calculations for FY 2009 

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 an animal drug 

application or supplemental animal 

drug application for an animal drug 

product submitted for listing under 

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

and who had an animal drug 

application or supplemental animal 

drug application pending before FDA 

after September 1, 2003 (see section 

740(a)(2) of the act). The term ‘‘animal 

drug product’’ is defined in section 

739(3) of the act. The product fees are 

to be set so that they will generate 

$3,479,000 in fee revenue for FY 2009. 

This is the amount set out in the statute 

after it has been adjusted for excess 

collections in previous years as set out 

in section III of this document. 

To set animal drug product fees to 

realize $3,479,000, 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 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 August 

2008, FDA estimates that there are a 

total of 785 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 785 products 

will be subject to this fee in FY 2009. 

In estimating the fee revenue to be 

generated by animal drug product fees 

in FY 2009, FDA is assuming that 10 

percent of the products invoiced, or 

about 78.5, 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 

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 fees for a total of 706.5 products 

(785 minus 78.5) will be paid in FY 

2009. 

B. Product Fee Rates for FY 2009 

FDA must set the fee rates for FY 2009 

so that the estimated 706.5 products for 

which fees will be paid will generate a 

total of $3,479,000. To generate this 

amount will require the fee for an 

animal drug product, rounded to the 

nearest 5 dollars, to be $4,925. 

VI. Establishment Fee Calculations for 

FY 2009 

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 before 

FDA after September 1, 2003; and (4) 

whose establishment engaged in the 

manufacture of the animal drug product 

during the FY (see section 740(a)(3) of 

the act). An establishment subject to 

animal drug establishment fees is 

assessed only one such fee per FY (see 

section 740(a)(3) of the act). The term 

‘‘animal drug establishment’’ is defined 

in section 739(4) of the act. The 

establishment fees are to be set so that 

they will generate $3,479,000 in fee 

revenue for FY 2009. This is the amount 

set out in the statute after it has been 

adjusted for excess collections in 

previous years as set out in section III 

of this document. 

To set animal drug establishment fees 

to realize $3,479,000, FDA must make 

some assumptions about the number of 

establishments for which these fees will 

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Federal Register / Vol. 73, No. 179 / Monday, September 15, 2008 / Notices 53257 

be paid in FY 2009. 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 August 2008, 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 2009. 

In estimating the fee revenue to be 

generated by animal drug establishment 

fees in FY 2009, FDA is assuming that 

10 percent of the establishments 

invoiced, or 6.5, will not pay fees in FY 

2009 due to fee waivers and reductions. 

Based on experience with the first 5 

years of ADUFA, FDA believes that this 

is a reasonable basis for estimating the 

number of fee-paying establishments in 

FY 2009. 

Accordingly, the agency estimates 

that fees for a total of 58.5 

establishments (65 minus 6.5) will be 

paid in FY 2009. 

B. Establishment Fee Rates for FY 2009 

FDA must set the fee rates for FY 2009 

so that the estimated 58.5 

establishments for which fees will be 

paid will generate a total of $3,479,000. 

To generate this amount will require the 

fee for an animal drug establishment, 

rounded to the nearest 50 dollars, to be 

$59,450. 

VII. Sponsor Fee Calculations for FY 

2009 

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 that has not been 

withdrawn 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 before FDA after 

September 1, 2003 (see sections 739(6) 

and 740(a)(4) of the act). An animal drug 

sponsor is subject to only one such fee 

each FY (see section 740(a)(4) of the 

act). The sponsor fees are to be set so 

that they will generate $3,479,000 in fee 

revenue for FY 2009. This is the amount 

set out in the statute after it has been 

adjusted for excess collections in 

previous years as set out in section III 

of this document. 

To set animal drug sponsor fees to 

realize $3,479,000, 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 as of 

August 2008, FDA estimates that a total 

of 140 sponsors will meet this definition 

in FY 2009. 

Careful review indicates that about 

one-third or 33 percent of all of these 

sponsors will qualify for a minor use/ 

minor species waiver or reduction 

(section 740(d)(1)(C) of the act). Based 

on the agency’s experience 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 74 sponsors, who will not pay fees in 

FY 2009 due to fee waivers and 

reductions. FDA believes that this is a 

reasonable basis for estimating the 

number of fee-paying sponsors in FY 

2009. 

Accordingly, the agency estimates 

that a total of 66 sponsors (140 minus 

74) will pay sponsor fees in FY 2009. 

B. Sponsor Fee Rates for FY 2009 

FDA must set the fee rates for FY 2009 

so that the estimated 66 sponsors that 

pay fees will generate a total of 

$3,479,000. To generate this amount 

will require the fee for an animal drug 

sponsor, rounded to the nearest 50 

dollars, to be $52,700. 

VIII. Fee Schedule for FY 2009 

The fee rates for FY 2009 are 

summarized in table 2 of this document. 

TABLE 2—FY 2009 FEE RATES

Animal Drug User Fee Category Fee Rate for FY 2009 

Animal Drug Application Fee 

Animal drug application .................................................................................................................................................... $246,300 

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 ..................................................................................... $123,150 

Animal drug product fee ................................................................................................................................................... $4,925 

Animal drug establishment fee1 ........................................................................................................................................... $59,450 

Animal drug sponsor fee2 .................................................................................................................................................... $52,700 

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

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

IX. Procedures for Paying the FY 2009 

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 supplemental animal 

drug application subject to fees under 

ADUFA II that is submitted after 

September 30, 2008. Payment must be 

made in U.S. currency by check, bank 

draft, 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 

Now’’ button on the cover sheet). On 

your check, bank draft, or U.S. postal 

money order, or wire transfer, please 

write your application’s unique 

Payment Identification Number, 

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 via wire transfer, send payment to 

US 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 payment 

is made via Pay.gov, you will first create 

and submit a cover sheet for your 

organization, then click on the ‘‘Pay 

Now’’ button. You will then be taken to 

the Pay.gov site to make your payment 

electronically. 

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 

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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 

mstockstill on PROD1PC66 with NOTICES