Federal Register / Vol. 72, No. 148 / Thursday, August 2, 2007 / Notices 42415 

ESTIMATES OF ANNUALIZED BURDEN HOURS—Continued 

Respondents Number of 

respondents 

Number of 

responses/ 

respondent 

Average 

burden/response 

(in hrs.) 

Total burden 

(in hrs.) 

Physicians/certification ..................................................................................... 300 1 10/60 50 

Miners .............................................................................................................. 5000 1 20/60 1,666 

Mine operators ................................................................................................. 200 1 30/60 100 

X-ray facilities .................................................................................................. 25 1 30/60 13

Total .......................................................................................................... ........................ ........................ ........................ 2,329 

Dated: July 27, 2007. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E7–15027 Filed 8–1–07; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Animal Drug User Fee Rates and 

Payment Procedures for Fiscal Year 

2008 

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) 2008 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), 

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 

submissions. This notice establishes the 

fee rates for FY 2008. 

For FY 2008, the animal drug user fee 

rates are: $172,500 for an animal drug 

application; $86,250 for a supplemental 

animal drug application for which 

safety or effectiveness data is required; 

$4,125 for an annual product fee; 

$52,700 for an annual establishment fee; 

and $43,900 for an annual sponsor fee. 

FDA will issue invoices for FY 2008 

product, establishment and sponsor fees 

by December 30, 2007, and these 

invoices will be due and payable by 

January 31, 2008. 

The application fee rates are effective 

for applications submitted on or after 

October 1, 2007, and will remain in 

effect through September 30, 2008. 

Applications will not be accepted to 

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 

(CVM) at cvmadufa@fda.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 (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 2004 through FY 2008, the act 

establishes aggregate yearly base 

revenue amounts for each of these fee 

categories. Base revenue amounts 

established for years after FY 2004 are 

subject to adjustment for inflation and 

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 inflation and workload. 

II. Revenue Amount for FY 2008 and 

Adjustments for Inflation and 

Workload 

A. Statutory Fee Revenue Amounts 

ADUFA (Public Law 108–130) 

specifies that the aggregate revenue 

amount for FY 2008 for each of the four 

animal drug user fee categories is 

$2,500,000, before any adjustments for 

inflation or workload are made (21 

U.S.C. 379j–12(b)(1)–(4)). 

B. Inflation Adjustment to Fee Revenue 

Amount 

ADUFA provides that fee revenue 

amounts for each FY after 2004 shall be 

adjusted for inflation (see 21 U.S.C. 

379j–12(c)(1)). The adjustment must 

reflect the greater of the following: (1) 

The total percentage change that 

occurred in the Consumer Price Index 

(CPI) for all urban consumers (all items; 

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

period ending June 30 preceding the FY 

for which fees are being set, or (2) the 

total percentage pay change for the 

previous FY for Federal employees 

stationed in Washington, DC. ADUFA 

provides for this annual adjustment to 

be cumulative and compounded 

annually after FY 2004 (21 U.S.C. 379j–

12(c)(1)). 

The inflation adjustment for FY 2005 

was 4.42 percent. This was the greater 

of the CPI increase during the 12-month 

period ending June 30, 2004, (3.27 

percent) or the increase in pay for FY 

2004 for Federal employees stationed in 

Washington, DC (4.42 percent). 

The inflation adjustment for FY 2006 

was 3.71 percent. This was the greater 

of the CPI increase during the 12-month 

period ending June 30, 2005, (2.53 

percent) or the increase in pay for FY 

2005 for Federal employees stationed in 

Washington, DC (3.71 percent). 

The inflation adjustment for FY 2007 

was 4.32 percent. This was the greater 

of the CPI increase for the 12-month 

period ending June 30, 2006, (4.32 

percent) or the increase in pay for FY 

2006 for Federal employees stationed in 

Washington, DC (3.44 percent). 

The inflation adjustment for FY 2008 

is 2.69 percent. This is the greater of the 

CPI increase for the 12-month period 

ending June 30, 2007, (2.69 percent) or 

the increase in pay for FY 2007 for 

Federal employees stationed in 

Washington, DC (2.64 percent). 

Compounding these amounts (1.0442 

times 1.0371 times 1.0432 times 1.0269) 

yields a total compounded inflation 

adjustment of 16.01 percent for FY 

2008. 

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42416 Federal Register / Vol. 72, No. 148 / Thursday, August 2, 2007 / Notices 

The inflation-adjusted revenue 

amount for each category of fees for FY 

2008 is the statutory fee amount 

($2,500,000) increased by 16.01 percent, 

the inflation adjuster for FY 2008. The 

inflation-adjusted revenue amount is 

$2,900,000 for each category of fee, 

rounded to the nearest thousand dollars, 

for a total inflation-adjusted fee revenue 

amount of $11,600,000 for all four 

categories of fees in FY 2008. 

C. Workload Adjustment to Inflation 

Adjusted Fee Revenue Amount 

For each FY beginning in FY 2005, 

ADUFA provides that fee revenue 

amounts, after they have been adjusted 

for inflation, shall be further adjusted to 

reflect changes in review workload (21 

U.S.C. 379j–12(c)(2)). 

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 3-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 3-year period that ended 

May 31, 2007. 

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 3-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 3 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 the table the sum of the 

values in column 5 is added, reflecting 

a total change in workload of negative 

16.7 percent for FY 2008. This is the 

workload adjuster for FY 2008. 

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

Application Type Column 1 

3-Year Avg. (Base Years) 

Column 2 

Latest 3-Year Avg. 

Column 3 

Percent Change 

Column 4 

Weighting Factor 

Column 5 

Weighted Percent Change 

New Animal Drug Applications (NADAs) 22 13 -39% 4% -1.5% 

Supplemental NADA’s 

with Safety or Efficacy Data 31 12 -62% 2% -1.4% 

Manufacturing Supplements 368 409 +11% 16% +1.8% 

Investigational Study 

Submissions 272 217 -20% 60% -12.1% 

Investigational Protocol Submissions 283 229 -19% 18% -3.4% 

FY 2008 Workload Adjuster -16.7% 

ADUFA specifies that the workload 

adjuster may not result in fees that are 

less than the inflation-adjusted revenue 

amount (21 U.S.C. 379j–12(c)(2)(B)). For 

this reason, the workload adjustment 

will not be applied in FY 2008, and the 

inflation-adjusted revenue amount for 

each category of fees for FY 2008 

($2,900,000) becomes the revenue target 

for fees in FY 2008, for a total inflationadjusted fee revenue target in FY 2008 

of $11,600,000 for fees from all four 

categories. 

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 year by that amount (21 

U.S.C. 379j–12(g)(4)). 

In FY 2004, Congress appropriated a 

total of $5,000,000 to FDA in ADUFA 

fee revenue. As of July 1, 2007, 

collections for FY 2004 totaled 

$5,154,700—or $154,700 in excess of 

the appropriation limit. Also, in FY 

2005 Congress appropriated a total of 

$8,354,000 to FDA in ADUFA fee 

revenue, and FDA collected a total of 

$8,519,101 as of July 1, 2007. This is 

$165,101 in excess of appropriations. 

The total in excess collections for the 2 

years is $319,801. These are the only 

fiscal years since ADUFA began in 

which FDA has collected more in 

ADUFA fees than Congress 

appropriated. 

The total of $319,801 will be offset 

against FY 2008 revenue collections, 

lowering the net amount that would 

otherwise be collected. One-fourth of 

this amount, or $80,000, rounded to the 

nearest thousand dollars, will be 

subtracted from the FY 2008 adjusted 

revenue amount for each fee category in 

the previous section. Thus, after 

adjustment for prior-year excess 

collections, the adjusted FY 2008 

revenue target for each fee category is: 

• Application Fee Revenue Amount: 

$2,820,000 ($2,900,000 minus $80,000) 

• Establishment Fee Revenue 

Amount: $2,820,000 ($2,900,000 minus 

$80,000) 

• Product Fee Revenue Amount: 

$2,820,000 ($2,900,000 minus $80,000) 

• Sponsor Fee Revenue Amount: 

$2,820,000 ($2,900,000 minus $80,000) 

Thus the adjusted revenue amount from 

all 4 categories after this adjustment 

totals $11,280,000. 

IV. Final Year Adjustment 

Under the provisions of ADUFA, the 

Secretary of Health and Human Services 

may, in addition to the inflation and 

workload adjustments, further increase 

the fees and fee revenues if such an 

adjustment is necessary to provide for 

not more than 3 months of operating 

reserves of carryover user fees for the 

process for the review of animal drug 

applications for the first 3 months of FY 

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Federal Register / Vol. 72, No. 148 / Thursday, August 2, 2007 / Notices 42417 

2009. The rational for the amount of this 

increase shall be contained in the 

annual notice establishing fee revenues 

and fees for FY 2008 (21 U.S.C. 379j–

12(c)(3)). 

As of June 30, 2007, FDA has 

unallocated cash carryover balances of 

$4,453,000. In addition, the agency is 

estimating that application fees over the 

final 3 months of FY 2007 will add 

another $675,000 to this balance, for an 

estimated cash carryover of $5,128,000 

on September 30, 2007. 

In FY 2008, FDA expects to collect a 

total of $11,280,000 after adjustments, 

as noted at the end of section III of this 

document. To sustain current operations 

in FY 2008, FDA expects to obligate a 

total of $13,084,000 (compared with 

anticipated obligations in FY 2007 of 

about $12,355,000). The anticipated 

obligations of $13,084,000 will be about 

$1,768,000 more than anticipated 

collections. This will reduce the 

estimated carryover balance over the 

course of FY 2008 from $5,128,000 to an 

estimated $3,360,000 ($5,128,000 minus 

$1,768,000). 

To sustain operations supported from 

user fees for the first 3 months of FY 

2009, FDA estimates that it will need 

one-fourth of the $13,084,000 it expects 

to spend in FY 2008, or $3,271,000 

(rounded to the nearest thousand). 

However this amount will need to be 

increased for inflation by an estimated 

5.9 percent (the average amount by 

which FDA’s costs per full-time 

employee have increased over the past 

5 years). The amount needed to sustain 

operations for the first 3 months of FY 

2009 is thus estimated at $3,464,000 

(rounded to the nearest thousand), 

while the estimated carryover balance at 

the beginning of FY 2009 is estimated at 

only $3,360,000. Thus FDA will need an 

additional $104,000 as the final year 

adjustment to assure sufficient operating 

reserves for the first 3 months of FY 

2009. One-fourth of this amount or 

$26,000 will be added to the FY 2008 

adjusted revenue amount for each of the 

four fee categories in the previous 

section. Thus, after the final-year 

adjustment, the adjusted FY 2008 

revenue target for each fee category is: 

• Application Fee Revenue Amount: 

$2,846,000 ($2,820,000 plus $26,000) 

• Establishment Fee Revenue 

Amount: $2,846,000 ($2,820,000 plus 

$26,000) 

• Product Fee Revenue Amount: 

$2,846,000 ($2,820,000 plus $26,000) 

• Sponsor Fee Revenue Amount: 

$2,846,000 ($2,820,000 plus $26,000) 

Thus, after the final year adjustment, the 

adjusted FY 2008 revenue target from all 

fee types combined totals $11,384,000. 

V. Application Fee Calculations for FY 

2008 

The terms ‘‘animal drug applications’’

and ‘‘supplemental animal drug 

applications’’ are defined in 21 U.S.C. 

379j–11(1). 

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 $2,846,000 

in fee revenue for FY 2008. This is the 

amount set out in the statute after it has 

been adjusted for inflation and 

workload, as set out in section II of this 

document, for excess collections in 

previous years as set out in section III 

of this document, and for the final year 

adjustment as set out in section IV of 

this document. The fee for a 

supplemental animal drug application 

for which safety or effectiveness data are 

required is to be set at 50 percent of the 

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

379j–12(a)(1)(A)(ii)). 

To set animal drug application fees 

and supplemental animal drug 

application fees to realize $2,846,000, 

FDA must first make some assumptions 

about the number of fee-paying 

applications and supplements it will 

receive in FY 2008. 

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 2008, FDA is assuming that 

the number of applications that will pay 

fees in FY 2008 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 nearly 4 

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 10.25, including the number for the 

most recent year, estimated at 15. Over 

this same period, the average number of 

supplemental applications that would 

have been subject to half of the full fee 

was 12.5, including the number for the 

most recent year, estimated at 13. 

Thus, for FY 2008, FDA estimates 

receipt of 10.25 fee paying original 

applications and 12.5 fee-paying 

supplemental animal drug applications. 

B. Fee Rates for FY 2008 

FDA must set the fee rates for FY 2008 

so that the estimated 10.25 applications 

that pay the full fee and the estimated 

12.5 supplements that pay half of the 

full fee will generate a total of 

$2,846,000. To generate this amount, the 

fee for an animal drug application, 

rounded to the nearest hundred dollars, 

will have to be $172,500, and the fee for 

a supplemental animal drug application 

for which safety or effectiveness data are 

required will have to be $86,250. 

VI. Product Fee Calculations for FY 

2008 

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 at FDA after 

September 1, 2003, (21 U.S.C. 379j–

12(a)(2)). The term ‘‘animal drug 

product’’ is defined in 21 U.S.C. 379j–

11(3). The product fees are to be set so 

that they will generate $2,846,000 in fee 

revenue for FY 2008. This is the amount 

set out in the statute after it has been 

adjusted for inflation and workload, as 

set out in section II of this document, for 

excess collections in previous years as 

set out in section III of this document, 

and for the final year adjustment as set 

out in section IV of this document. 

To set animal drug product fees to 

realize $2,846,000, FDA must make 

some assumptions about the number of 

products for which these fees will be 

paid in FY 2008. 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 1, 

2007, FDA found a total of 767 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 believes that a total of 767 

products will be subject to this fee in FY 

2008. 

In estimating the fee revenue to be 

generated by animal drug product fees 

in FY 2008, FDA is assuming that 10 

percent of the products invoiced, or 77, 

will not pay fees in FY 2008 due to fee 

waivers and reductions. Based on 

experience with other user fee programs 

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42418 Federal Register / Vol. 72, No. 148 / Thursday, August 2, 2007 / Notices 

and the first 4 years of ADUFA, FDA 

believes that this is a reasonable basis 

for estimating the number of fee-paying 

products in FY 2008. 

Accordingly, the agency estimates 

that a total of 690 (767 minus 77) 

products will be subject to product fees 

in FY 2008. 

B. Product Fee Rates for FY 2008 

FDA must set the fee rates for FY 2008 

so that the estimated 690 products that 

pay fees will generate a total of 

$2,846,000. To generate this amount 

will require the fee for an animal drug 

product, rounded to the nearest five 

dollars, to be $4,125. 

VII. Establishment Fee Calculations for 

FY 2008 

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 FY (21 U.S.C. 379j–12(a)(3)). 

An establishment subject to animal drug 

establishment fees is assessed only one 

such fee per FY (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 

$2,846,000 in fee revenue for FY 2008. 

This is the amount set out in the statute 

after it has been adjusted for inflation 

and workload, as set out in section II of 

this document, for excess collections in 

previous years as set out in section III 

of this document, and for the final year 

adjustment as set out in section IV of 

this document. 

To set animal drug establishment fees 

to realize $2,846,000, FDA must make 

some assumptions about the number of 

establishments for which these fees will 

be paid in FY 2008. 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 1, 2007, FDA found a 

total of 60 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 60 establishments will be 

subject to this fee in FY 2008. 

In estimating the fee revenue to be 

generated by animal drug establishment 

fees in FY 2008, FDA is assuming that 

10 percent of the establishments 

invoiced, or six, will not pay fees in FY 

2008 due to fee waivers and reductions. 

Based on experience with the first 4 

years of ADUFA, FDA believes that this 

is a reasonable basis for estimating the 

number of fee-paying establishments in 

FY 2008. 

Accordingly, the agency estimates 

that a total of 54 establishments (60 

minus 6) will be subject to 

establishment fees in FY 2008. 

B. Establishment Fee Rates for FY 2008 

FDA must set the fee rates for FY 2008 

so that the estimated 54 establishments 

that pay fees will generate a total of 

$2,846,000. To generate this amount 

will require the fee for an animal drug 

establishment, rounded to the nearest 50 

dollars, to be $52,700. 

VIII. Sponsor Fee Calculations for FY 

2008 

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, (21 U.S.C. 379j–

11(6) and 379j–12(a)(4)). An animal 

drug sponsor is subject to only one such 

fee each FY (21 U.S.C. 379j–12(a)(4)). 

The sponsor fees are to be set so that 

they will generate $2,846,000 in fee 

revenue for FY 2008. This is the amount 

set out in the statute after it has been 

adjusted for inflation and workload, as 

set out in section II of this document, for 

excess collections in previous years as 

set out in section III of this document, 

and for the final year adjustment as set 

out in section IV of this document. 

To set animal drug sponsor fees to 

realize $2,846,000, FDA must make 

some assumptions about the number of 

sponsors who will pay these fees in FY 

2008. Based on the number of firms that 

would have met this definition in each 

of the past 4 years, FDA estimates that 

a total of 138 sponsors will meet this 

definition in FY 2008. 

Careful review indicates that about 

one third or 33 percent of all of these 

sponsors will qualify for minor use/ 

minor species exemption. 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 73, who will 

not pay fees in FY 2008 due to fee 

waivers and reductions. FDA believes 

that this is a reasonable basis for 

estimating the number of fee-paying 

sponsors in FY 2008. 

Accordingly, the agency estimates 

that a total of 65 sponsors (138 minus 

73) will be subject to sponsor fees in FY 

2008. 

B. Sponsor Fee Rates for FY 2008 

FDA must set the fee rates for FY 2008 

so that the estimated 65 sponsors that 

pay fees will generate a total of 

$$2,846,000. To generate this amount 

will require the fee for an animal drug 

sponsor, rounded to the nearest 50 

dollars, to be $43,900. 

IX. Fee Schedule for FY 2008 

The fee rates for FY 2008 are 

summarized in table 2 of this document. 

TABLE 2.—FY 2008 FEE RATES

Animal Drug User Fee Category Fee Rate for FY 2008 

Animal Drug Application Fee 

Animal Drug Application $172,500 

Supplemental Animal Drug Application for which Safety or Effectiveness Data are Required $86,250 

Animal Drug Product Fee $4,125 

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Federal Register / Vol. 72, No. 148 / Thursday, August 2, 2007 / Notices 42419 

TABLE 2.—FY 2008 FEE RATES—Continued 

Animal Drug User Fee Category Fee Rate for FY 2008 

Animal Drug Establishment Fee1 $52,700 

Animal Drug Sponsor Fee2 $43,900 

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. 

X. Procedures for Paying the FY 2008 

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, 2007. 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. On your check, 

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

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 (PO 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 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 

application arrives at FDA’s Center for 

Veterinary Medicine. FDA records the 

official 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. 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 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 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 Payment 

Identification Number. 

Step Three—Send the Payment for 

your application as described in section 

X.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 30, 2007, FDA will issue 

invoices and payment instructions for 

product, establishment, and sponsor 

fees for FY 2008 using this Fee 

Schedule. Payment will be due and 

payable by January 31, 2008. FDA will 

issue invoices in October 2008 for any 

products, establishments, and sponsors 

subject to fees for FY 2008 that qualify 

for fees after the December 2007 billing. 

Dated: July 27, 2007. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. 07–3782 Filed 7–30–07; 4:29 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission For OMB 

Review; Comment Request 

Periodically, the Health Resources 

and Services Administration (HRSA) 

publishes abstracts of information 

collection requests under review by the 

Office of Management and Budget 

(OMB), in compliance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). To request a copy of 

the clearance requests submitted to 

OMB for review, call the HRSA Reports 

Clearance Office on (301) 443–1129. 

The following request has been 

submitted to the Office of Management 

and Budget for review under the 

Paperwork Reduction Act of 1995: 

Proposed Project: The Smallpox 

Vaccine Injury Compensation Program 

(OMB No. 0915–0282)—Extension 

The Smallpox Emergency Personnel 

Protection Act (SEPPA) authorized the 

Secretary of Health and Human Services 

to establish The Smallpox Vaccine 

Injury Compensation Program, which 

provides benefits and/or compensation 

to certain persons harmed as a direct 

result of receiving smallpox covered 

countermeasures, including the 

smallpox vaccine, or as a direct result of 

contracting vaccinia through certain 

accidental exposures. 

The benefits available under the 

Program include compensation for 

unreimbursed medical care expenses, 

lost employment income, and survivor 

death benefits. To be considered for 

Program benefits, requesters (i.e., 

smallpox vaccine recipients, vaccinia 

contacts, survivors, or the 

representatives of the estates of 

deceased smallpox vaccine recipients or 

vaccinia contacts), or persons filing on 

mstockstill on PROD1PC66 with NOTICES