[Federal Register Volume 68, Number 142 (Thursday, July 24, 2003)]
[Proposed Rules]
[Pages 43661-43673]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-18849]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 130

[Docket No. 00-024-1]


Veterinary Diagnostic Services User Fees

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to increase the user fees for veterinary 
diagnostic services to reflect changes in our operating costs and 
changes in calculating our costs. We are also proposing to set rates 
for multiple fiscal years. These proposed actions are necessary to 
ensure that we recover the actual costs of providing these services. We 
are also proposing to provide for a reasonable balance, or reserve, in 
the veterinary diagnostics user fee account. The Food, Agriculture, 
Conservation, and Trade Act of 1990, as amended, authorizes us to set 
and collect these user fees.

DATES: We will consider all comments that we receive on or before 
September 22, 2003.

ADDRESSES: You may submit comments by postal mail/commercial delivery 
or by e-mail. If you use postal mail/commercial delivery, please send 
four copies of your comment (an original and three copies) to: Docket 
No. 00-024-1, Regulatory Analysis and Development, PPD, APHIS, Station 
3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state 
that your comment refers to Docket No. 00-024-1. If you use e-mail, 
address your comment to [email protected]. Your comment must 
be contained in the body of your message; do not send attached files. 
Please include your name and address in your message and ``Docket No. 
00-024-1'' on the subject line.
    You may read any comments that we receive on this docket in our 
reading room. The reading room is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 690-2817 before coming.
    APHIS documents published in the Federal Register, and related 
information, including the names of organizations and individuals who 
have commented on APHIS dockets, are available on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: For information concerning program 
operations, contact Dr. Randall Levings, Director, National Veterinary 
Services Laboratories, 1800 Dayton Road, P.O. Box 844, Ames, IA 50010; 
(515) 663-7357.
    For information concerning rate development for the proposed user 
fees, contact Mrs. Kris Caraher, Accountant, User Fees Section, MRPBS, 
APHIS, 4700 River Road Unit 39, Riverdale, MD 20737-1231; (301) 734-
8351.

SUPPLEMENTARY INFORMATION:

Background

    User fees to reimburse the Animal and Plant Health Inspection 
Service (APHIS) for the costs of providing veterinary diagnostic 
services and import and export related services for live animals and 
birds and animal products are contained in 9 CFR part 130 (referred to 
below as the regulations). These user fees are authorized by section 
2509(c) of the Food, Agriculture, Conservation and Trade Act of 1990, 
as amended (21 U.S.C. 136a), which provides that the Secretary of 
Agriculture may, among other things, prescribe regulations and collect 
fees to recover the costs of veterinary diagnostics relating to the 
control and eradication of communicable diseases of livestock or 
poultry within the United States.
    In this document, we are proposing to amend the regulations by 
increasing the user fees for certain veterinary diagnostic services, 
including certain diagnostic tests, reagents, and other veterinary 
diagnostic materials and services. Operating costs have increased since 
these user fees were established in a final rule published in the 
Federal Register on October 7, 1998 (63 FR 53783-53798, Docket No. 94-
115-2). Therefore, the user fees need to be updated to reflect those 
increases. However, the main reason for the increase in the fees is due 
to new cost-finding techniques employed by APHIS. The Statement of 
Federal Financial Accounting Standards (SFFAS) No. 4, ``Managerial Cost 
Accounting Standards and Concepts,'' issued by the Office of Management 
and Budget, mandated that APHIS capture cost accounting data in its 
program costs. We were required to accumulate and report the costs of 
veterinary diagnostic activities on a regular basis through the use of 
cost accounting systems and cost finding techniques. In order to comply 
with SFFAS No. 4, APHIS conducted an Activity Based Costing (ABC) 
project at the National Veterinary Services Laboratories (NVSL) in 
Ames, IA, which identified the sources of all costs for veterinary 
diagnostic services. As a result of that project, we determined that 
costs for user fee-related services were not adequately being recovered 
through user fee collections. Based on this determination, we are 
proposing new fees to recover these newly identified costs. Each of the 
updated user fees contains a proportionate share of the costs 
identified in the ABC study.
    The user fees that we are proposing for veterinary diagnostic goods 
and services would cover multiple fiscal years (2004 through 2007 and 
beyond). Establishing annual user fee changes in

[[Page 43662]]

advance would allow users to incorporate the fees into their budget 
planning.
    Veterinary diagnostics is the work performed in a laboratory to 
determine if a disease-causing organism or chemical agent is present in 
body tissues or cells and, if so, to identify those organisms or 
agents. Services in this category include: (1) Performing laboratory 
tests and providing diagnostic reagents and other veterinary diagnostic 
materials and services at the NVSL Foreign Animal Disease Diagnostic 
Laboratory (NVSL FADDL) in Greenport, NY; and (2) performing 
identification, serology, and pathobiology tests and providing 
diagnostic reagents and other veterinary diagnostic materials and 
services at NVSL in Ames, IA.
    APHIS veterinary diagnostic user fees fall into six categories:
    (1) Laboratory tests, reagents, and other veterinary diagnostic 
services performed at NVSL FADDL;
    (2) Laboratory tests performed as part of isolation and 
identification testing at NVSL in Ames;
    (3) Laboratory tests performed as part of serology testing at NVSL 
in Ames;
    (4) Laboratory tests performed at the pathobiology laboratory at 
NVSL in Ames;
    (5) Diagnostic reagents produced at NVSL in Ames or other 
authorized sites; and
    (6) Other veterinary diagnostic services or materials provided at 
NVSL in Ames.

Need for Regulation

    User fees recover the cost of operating a public system by charging 
those members of the public who use the system, rather than the public 
as a whole, for its operation. Financing veterinary diagnostic services 
and products by charging for the right to use the incremental service 
internalizes those costs to those who require the service and benefit 
from it.
    Veterinary diagnostic services and products enhance livestock 
production, trade, and research. The socially optimal prices for such 
commodities, of which veterinary diagnostics are inputs, are those 
price levels that induce the output level where the marginal benefit 
(what people are willing to pay for the good) is exactly equal to the 
marginal social cost (all costs associated with the production of the 
final output, including veterinary diagnostics). As it stands now, 
veterinary diagnostic services and products are provided at levels 
below their full cost to APHIS. These costs are, therefore, only partly 
incorporated into producers' costs of production. Our proposed 
revisions of the fee-for-service charges to recover the costs incurred 
by APHIS would move the private costs of individuals closer to the true 
cost of producing their outputs. The proposed annual increases, which 
would span fiscal years 2004 through 2007, would help ensure that the 
fees accurately reflect the cost of providing the service.

Development of Fee Structure

    User fee components. The user fees proposed in this document are 
based on average laboratory employee salaries and benefits in each of 
the fiscal years 2004 through 2007, and estimates of the number of 
direct labor hours required to provide each service. The proposed user 
fees have been calculated to recover the full costs for tests, 
diagnostic reagents, and other veterinary diagnostic services. These 
costs include direct labor costs, administrative support costs, premium 
costs (if any), agency overhead costs, and departmental charges. These 
components are described below; the user fee calculation for the 
proposed virus isolation fee for fiscal year (FY) 2004 is used 
throughout as an example.
    We are proposing to charge a specific dollar amount for each 
service we provide (i.e., for each test we perform or each diagnostic 
reagent or other veterinary diagnostic service we provide). We have 
attempted to minimize the costs of our services, thereby keeping APHIS 
user fees at the lowest possible level. If, in the future, a user 
requests a test, diagnostic reagent, or other veterinary diagnostic 
material or service that is not specifically listed in our regulations, 
we would charge the proposed hourly user fee set forth in proposed 
Sec.  130.19 for the amount of time required to perform the service, 
calculated to the nearest quarter of an hour.
    Each user fee varies based on the direct labor hours required to 
perform the test or provide the diagnostic reagent or other veterinary 
diagnostic material or service. For example, the time spent by 
laboratory personnel to prepare a sample, conduct the test, and read 
the test would be part of the direct labor hours for testing a tissue 
sample for disease-causing organisms. In cases where a test is 
performed for more than one disease, it may take different amounts of 
time for each disease. Those times have been averaged to calculate the 
user fee for the test. We have carefully calculated all of our proposed 
user fees to correctly reflect the direct labor hours required for each 
test, reagent, or service. We took into account variations in the time 
needed to provide a service by determining the average time necessary 
to provide the service; similar user fee components are used for other 
agency user fees throughout the regulations.
    Direct labor costs. Direct labor costs are the average salary and 
benefit costs of the laboratory employees performing the service 
multiplied by the estimated direct labor hours required. Average 
laboratory costs were used to calculate direct labor costs because we 
have determined that it is more accurate to use the average salary for 
laboratory employees to calculate the user fee. For example, the 
estimated average laboratory salary at the Diagnostic Virology Lab for 
FY 2004 is $28.85 per hour. On average, it takes 0.295 hours per virus 
isolation test, leading to direct labor costs of $8.51.
    Administrative support costs. Administrative support costs are 
incurred at the laboratories. They include clerical and administrative 
activities; direct materials; indirect labor hours; rent; billing and 
collection costs; travel and transportation for personnel, supplies, 
equipment, and other necessary items; training; legal counsel; capital 
equipment costs; general supplies for offices, washrooms, and cleaning; 
contractual services; grounds maintenance; and utilities. Direct 
materials include the cost of any materials needed to conduct the test 
or to provide the diagnostic reagent, slide set, tissue set, or 
service. For example, direct materials for conducting a laboratory test 
include, but are not limited to, glassware, chemicals, and other 
supplies necessary to perform the test. Indirect labor hours include 
supervision of personnel and time spent doing necessary work, such as 
repairing equipment, that is not directly connected with a specific 
test, diagnostic reagent, or other veterinary diagnostic material or 
service. Contractual services may include, but are not limited to, 
guard service, trash pickup, and maintenance. Utilities include water, 
telephone, electricity, natural and propane gas, and heating and diesel 
oil.
    The costs of administrative support are applied as a percentage of 
the base direct labor amount; at NVSL in Ames, administrative support 
is 296 percent of direct labor, and at NVSL FADDL, administrative 
support is 1,638 percent of direct labor. For example, the 
administrative support costs for the virus isolation test are 
calculated at 296 percent of its direct labor costs of $8.51 to be 
$25.19. The total direct labor and administrative support costs for one 
virus isolation test are $33.70.
    NVSL FADDL administrative support costs compared to NVSL in Ames 
costs.

[[Page 43663]]

Readers may note that our proposed user fees for tests performed at 
NVSL FADDL are higher than our proposed user fees for the same tests 
performed at NVSL in Ames. Both NVSL FADDL and NVSL in Ames work with 
infectious and contagious disease agents. However, NVSL FADDL, which is 
isolated from the U.S. mainland, is designed to work specifically with 
highly infectious diseases exotic to the United States. Because of 
this, special biosecurity measures are required at NVSL FADDL that are 
not required at NVSL in Ames. As a result, NVSL FADDL operating costs 
are higher than NVSL in Ames' operating costs. The user fees we are 
proposing reflect this difference in costs.
    Premium costs. Premium costs are expenses that are incurred solely 
for a specific test or service. For example, certain tests require 
expensive reagents in addition to the direct labor time and laboratory 
materials included in administrative support costs. Premium costs for 
the proposed flat rate user fees have been included in the proposed 
calculated fees. For example, each sterilization by gamma radiation at 
NVSL FADDL requires special radioactive materials, irradiation costs, 
and travel costs for an APHIS employee to hand-carry the material. 
Based on the high amount of costs involved, these premium costs have 
been added to the proposed specific fee involved rather than included 
as an administrative support cost that is spread among all fees for 
tests, reagents, and other services.
    Agency overhead. Agency overhead is the pro rata share, 
attributable to a particular diagnostic reagent, material, or 
veterinary diagnostic service, of the management and support costs for 
all Agency activities at the regional level and above. Included are the 
costs of providing budget and accounting services, management support 
at the headquarters and regional levels, including the Administrator's 
office, and personnel services, public information services, and 
liaison with Congress. Agency overhead is calculated at 16.15 percent 
of total direct labor and support costs. For example, the agency 
overhead for one virus isolation test is $5.44, which is the product of 
virus isolation direct labor and administrative support costs of $33.70 
multiplied by 16.15 percent.
    Departmental charges. Departmental charges are APHIS's share, 
expressed as a percentage of the total cost, of services provided 
centrally by the U.S. Department of Agriculture. Services the 
Department provides centrally include the Federal telephone service; 
mail; National Finance Center processing of payroll, billing, 
collections, and other money management; unemployment compensation; 
Office of Workers Compensation Programs; and central supply for storing 
and issuing commonly used supplies and departmental forms. The 
Department notifies APHIS how much the agency owes for these services.
    We have included a pro rata share of these departmental charges, as 
attributed to a particular test, diagnostic reagent, or other 
veterinary diagnostic material or service, in our user fee calculations 
at the rate of 5.23 percent. For example, departmental charges to 
perform one virus isolation test are $2.05. This amount equals 5.23 
percent of total direct labor costs, administrative support costs, and 
Agency overhead costs of $39.14 described above.
    Reserve. We are proposing to add an amount that would provide for a 
reasonable balance, or reserve, in the veterinary diagnostics user fee 
account. All user fees would contribute to the reserve proportionately. 
The reserve would ensure that we have sufficient operating funds in 
cases of fluctuations in activity volumes, bad debt, program shutdown, 
or customer insolvency. We intend to monitor the reserve balance 
closely and propose adjustments in our fees as necessary to ensure a 
reasonable balance. For example, the reserve amount included in the 
calculation for one virus isolation test is $2.06 per test. The total 
costs in this example thus far equal $43.25.
    Calculation of proposed user fees. The basic steps in the 
calculation for each particular service are: (1) Calculate direct labor 
costs by determining the average amount of direct labor required to 
perform the service and multiply the average direct labor hours by the 
average salary and benefit costs for laboratory employees; (2) 
calculate the pro rata share of administrative support costs; (3) 
determine the premium costs (if any); (4) calculate the pro rata share 
of agency overhead and departmental charges, respectively; (5) add all 
costs; and (6) round up to the next $0.25 for all fees less than $10 or 
round up or down to the nearest dollar for all fees greater than $10. 
For example, the total virus isolation cost per test for FY 2004 of 
$43.25 is rounded down to $43 per test. The result of these 
calculations is a user fee that covers the total cost to perform a 
particular test or provide a particular veterinary diagnostic material 
or service one time. As is the case with all APHIS user fees, we intend 
to review, at least annually, the user fees proposed in this document. 
We will publish any necessary adjustments in the Federal Register.
    In addition, we would remove the following tests because they are 
either obsolete, no longer being performed at NVSL in Ames or NVSL 
FADDL, or are being performed but being incorporated into another 
published rate:

Avian origin bacterial antiserums, mycoplasma
Equine origin glanders antiserum
Leptospira culturing
Leptospira serotyping
Mycobacterium avium serotyping
Mycology culture identification
Mycology/fungus culture or isolation
Mycoplasma isolation
Mycoplasma identification
Plasmid typing
Warburg
Virus isolation for Newcastle disease virus
Brucella milk ELISA
Mercaptoehanol
Mycology/fungus serology
Check tests, anaplasma complement fixation
Manual, Brucellosis complement fixation
Manual, Anaplasmosis, Johnes's disease

    We would also remove a footnote that appears in the tables in 
Sec. Sec.  130.15(a) and 130.16(a) and (b). The footnote describes a 
discount that applies to all diagnostic, non-import-related complement 
fixation, hemagglutination inhibition, fluorescent antibody, indirect 
fluorescent antibody virus neutralization, and peroxidase linked 
antibody tests. The discount applies to the 11th and subsequent tests 
on the same submission by the same submitter for the same test and 
antigen. We have reevaluated the time it takes to conduct these 
additional tests and have determined that it is no longer cost 
effective to perform the tests at a discount. Therefore, we would 
remove the footnote from those tables.
    Finally, in Sec. Sec.  130.15(a), 130.16(a), and 130.18, we would 
amend the tables by updating several of the entries to reflect the 
designations currently used by NVSL to refer to the particular test or 
service. There would be no change in the services or tests themselves; 
the names would simply be changed to be consistent with the terminology 
used by NVSL.

Executive Order 12866 and Regulatory Flexibility Act

    This proposed rule has been reviewed under Executive Order 12866. 
The rule has been determined to be not significant for the purposes of 
Executive Order 12866 and, therefore, has not been reviewed by the 
Office of Management and Budget.
    We are proposing to increase the user fees for veterinary 
diagnostic services to reflect changes in operating costs and changes 
in calculating our costs. These

[[Page 43664]]

proposed actions are necessary to ensure that we recover the actual 
costs of providing these services. We are also proposing to provide for 
a reasonable balance, or reserve, in the veterinary diagnostics user 
fee account. The reserve would ensure that we have sufficient operating 
funds in cases of fluctuations in activity volumes, bad debt, program 
shutdown, or customer insolvency. The Food, Agriculture, Conservation, 
and Trade Act of 1990, as amended, authorizes us to set and collect 
these user fees.

Estimated Impact of Changes in Veterinary Diagnostic User Fees

    The calculation of impacts of the revision of veterinary diagnostic 
user fees is hindered by the difficulty in determining the elasticities 
of demand for the covered services and products. Therefore, Government 
savings are assumed equivalent to the total additional user fee 
collections for each category addressed in this proposed rule. 
Projections of changes in collections are based on estimates of the 
annual volume of the affected services and products. Estimates of the 
annual volumes were made by the Financial Management Division of APHIS 
using actual volumes from prior years and input from the laboratories.

Change in Collections

    Table 1 summarizes the estimated changes in user fee collections 
for FY 2004 through FY 2007 that are necessary to recover fully the 
costs of performing these services. These proposed changes would result 
in a total increase in annual user fee collections of about $2.9 
million over the period discussed in the proposed rule (from $2.7 
million at current fee levels to $5.6 million in FY 2007). There would 
be increases in each year from FY 2004 to FY 2007. There would be an 
increase of about $2.4 million in FY 2004, about an additional increase 
of $101,200 increase in FY 2005, about a $231,500 increase in FY 2006, 
and about a $98,100 increase in FY 2007. If APHIS were to continue to 
collect user fees at the current rates over this time period, total 
collections would be approximately $10.8 million. At the proposed 
rates, the total would be about $21.4 million. Because the proposed 
changes in user fees are intended to cover cost changes that have 
already occurred and that are projected to occur over the period 
covered in the proposed rule, this difference of about $10.6 million 
demonstrates the shortfall in cost recovery that would occur absent the 
changes, and, conversely, the savings to taxpayers associated with this 
proposal.

         Table 1.--Summary of Current and Projected Collections of APHIS Veterinary Diagnostic User Fees
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                                    Collections   Estimated additional annual collections from user fee changes
                                       under    ----------------------------------------------------------------
        User fee categories         current fee
                                       levels      FY 2004      FY 2005      FY 2006      FY 2007       Total
----------------------------------------------------------------------------------------------------------------
FADDL, all........................     $164,754     $140,959       $9,990      $10,533      $10,975     $172,457
Identification Testing, NVSL......      431,920      304,900       26,497       22,913       26,067      380,377
Serology Testing, NVSL............    1,076,474      948,408        7,027      134,273        2,210    1,091,918
Pathobiology Testing, NVSL........       89,249       29,495        4,050        4,806        4,802       43,153
Diagnostic Reagents, NVSL.........      480,692      591,526       34,045       38,130       32,866      696,587
Other Veterinary Diagnostic             461,153      408,962       19,571       20,851       21,184      470,568
 Services, NVSL...................
                                   --------------
      Total.......................    2,704,242    2,424,299      101,180      231,506       98,124    2,855,059
----------------------------------------------------------------------------------------------------------------

    The largest increase in collections would occur in FY 2004. The fee 
increases in FY 2004 cover cost increases that have occurred since the 
last revision of these fees, in addition to cost increases expected to 
occur in FY 2004. The increase of about $2.4 million in veterinary 
diagnostic user fee collections in FY 2004 would be accounted for in 
the following manner. Collections from laboratory tests, reagents, and 
other veterinary services preformed at NVSL FADDL would increase by 
about $141,000; user fee collections for veterinary diagnostic 
isolation and identification tests performed at NVSL in Ames would 
increase by about $305,000; user fee collections for serology tests 
performed at NVSL in Ames would increase by about $948,000; user fee 
collections for veterinary diagnostic tests performed at the 
pathobiology laboratory at NVSL in Ames would increase by about 
$29,000; user fee collections for reagents produced at NVSL in Ames 
would increase by about $592,000; and user fee collections for other 
veterinary diagnostic services performed at NVSL in Ames would increase 
by about $409,000.

Impact on Users

    Veterinary diagnostic services and products are provided to animal 
importers and exporters, veterinarians, State and Federal agencies and 
laboratories, commercial laboratories, educational institutions, and 
foreign governments. To the extent that the proposed changes in user 
fees would impact operational costs, any entity that utilizes APHIS 
veterinary diagnostic products or services subject to user fees could 
be affected by the proposed fee increases. The degree to which any 
entity could be affected depends on its market power (the extent to 
which costs can be either absorbed or passed on to its buyers). While 
the lack of information on profit margins and operational expenses of 
the affected entities, or the supply responsiveness of the affected 
industry, prevents the precise prediction of the scale of impacts, some 
conclusions on overall impacts to domestic and international commerce 
can be drawn.
    The increases in user fees in this proposal represent significant 
percentages, primarily in the first year covered by this proposed rule. 
In all six categories, the average proposed fee change exceeds 80 
percent in the first year and 100 percent in total over the period 
covered in the proposed rule. If the user fees cannot be passed on to 
their customers, the profit margins of some entities may decline as 
user fees are increased. However, new techniques now allow APHIS to 
better identify the true costs of providing the veterinary diagnostic 
services and products covered by user fees. These techniques have shown 
that there are considerable differences between those true costs and 
the user fees APHIS has been charging. Operating costs have increased 
since the last time these fees were adjusted. In addition, it has been 
shown that the direct labor portion of the fee calculations was vastly 
underestimated for many of the fees in previous calculations. When a 
user fee does not cover all associated costs, those costs are shifted 
away from those receiving and benefitting from the service and

[[Page 43665]]

onto APHIS, and thus ultimately to the taxpayer.
    There is also reason to believe that the economic effects of the 
proposed changes on most users would be small. The majority of the user 
fees would increase by $50 or less. The majority of the proposed fees 
should also make only a small contribution to the total additional 
collections and, therefore, would have a minor impact on the users of 
those services. This is either because the proposed change is small or 
the projected volume associated with the user fee is small, or both. In 
addition, user fees are not charged when tests are provided in the 
United States in association with a Federal or cooperative disease 
control program. Also, in addition to the role they play in protecting 
American agriculture, the veterinary diagnostic services and products 
we provide facilitate international trade and thereby enhance the 
business interests of many of those requesting these services.
    Nearly 59 percent of the total projected change in collections 
would come from changes in only 9 of the 190 fees, and more than 93 
percent of the change would come from changes in just 43 of the fees 
covered in this proposed rule. These 43 proposed fee changes are 
projected to generate $10,000 or more each in additional annual 
collections by the end of the period covered by the proposed rule. 
Several factors suggest, however, that these fee increases should not 
have a significant impact on users. These fees include small fees 
applied to a large annual volume of users, large fees applied to a very 
small volume of users, fees that represent a small percentage of the 
overall costs associated with a user's output, single fees for reagents 
with numerous final users, and fees that enhance the marketability of 
the users' final outputs.

Small Change in Collections

    The majority of the individual user fee changes in this proposal 
would make only small contributions to the total additional 
collections, and, therefore, would have a minor effect on the users of 
those services. This is either because the change in the fee is small 
or the projected volume associated with the user fee is small, or both 
(see Table 2).
    1. More than 60 percent of the user fees would change by less than 
$50, and nearly 16 percent by less than $10.
    2. Nearly 50 percent of the user fees are projected to have an 
annual volume of 10 or fewer users, and about 65 percent fewer than 90.
    3. More than 31 percent of the user fees would change by $50 or 
less and have a projected annual volume of 50 or fewer users.
    4. More than 62 percent of the fees with more than 100 annual users 
would change by $25 or less, and about 62 percent of the fees that 
would change by more than $50 have an estimated annual volume of 10 or 
fewer users.

                                     Table 2.--Increases and Volumes Associated With Veterinary Diagnostic User Fees
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       Number of fees with estimated annual volume of:
                    Total increase in user fee:                     ------------------------------------------------------------------------------------
                                                                       10 or fewer        11 to 20         20 to 50        51 to 100      More than 100
--------------------------------------------------------------------------------------------------------------------------------------------------------
$10 or less........................................................               10                1                1                2               15
$10.01 to $25......................................................               16                3                3                1               26
$25.01 to $50......................................................               21                2                2                0               10
$50.01 to $100.....................................................               29                1                4                1                9
More than $100.....................................................               16                2                4                1                6
--------------------------------------------------------------------------------------------------------------------------------------------------------

Program Diseases

    When considering the proposed user fee changes, it is important to 
realize that user fees are not charged for tests and diagnostic 
reagents provided in the United States required in connection with 
current Federal or cooperative programs to control or eradicate various 
domestic diseases or pests, known as ``program diseases.'' Examples of 
program diseases are tuberculosis, brucellosis, and pseudorabies. In 
those situations, no user fee would be charged for veterinary 
diagnostics.

Large Contributions to Collections

    The following factors suggest that even those proposed user fee 
changes that would generate more than $10,000 in additional annual 
collections may have a minimal impact on users.
    Thirty-six of the 43 proposed user fees that we expect would 
generate more than $10,000 each in additional annual collections would 
change by less than $75 each, and 14 would change by less than $25 
each. In addition, most of the user fees covered in this proposal are 
collected in association with imports or exports. While those user fees 
would increase under this proposed rule, the fees continue to represent 
only a small fraction of the typical costs of purchasing and importing 
breeding grade registered animals into the United States, which can be 
between $1,500 and $5,000 per head. Purchase and import costs for 
feeder and slaughter animals are often significantly lower per animal 
but can easily exceed $1,500 per shipment depending on the number and 
type of animals in the shipment. About 18 percent of the total change 
in collections would come from a single user fee, that for complement 
fixation (CF) tests. About 90 percent of the CF test user fees are 
collected for import and export. The $5 change in the first year under 
the proposed fees and the $7 total change in the user fee for CF tests 
in Sec.  130.16 would be very small in relation to the value of the 
animals involved and to the costs associated with importing and 
exporting animals. By providing the tests, this movement is 
facilitated.
    A number of the proposed reagent user fees should generate 
considerable additional annual collections under this proposal. 
However, while these proposed changes represent considerable percentage 
increases in those fees, each purchasing laboratory can use the 
reagents to perform several hundred tests. Therefore, the purchasing 
laboratory can spread its costs across those several hundred tests for 
its customers. In addition, provision of the reagents enhances the 
purchasing laboratory's business, for without the reagents the tests 
would not be possible.
    Along this same line, the fact that check tests would generate 
considerable additional collections under this proposal should have 
only a small impact. By passing (getting the correct results on a check 
test kit), the laboratory is certified to conduct the particular test 
on samples that are received by the laboratory. Being certified by 
APHIS to conduct a test enhances a laboratory's ability to attract 
customers.

[[Page 43666]]

Laboratory Tests, Reagents, and other Veterinary Services Performed at 
NVSL FADDL

    The proposed user fee changes for NVSL FADDL veterinary diagnostic 
services and products could generate additional annual collections of 
about $141,000 in the first year and about $172,000 after all increases 
covered in this proposal have been implemented. These user fees cover 
veterinary diagnostic services and products associated with foreign 
animal diseases, including the diagnosis of foreign animal diseases, 
training in foreign animal disease recognition, reagent production, and 
vaccine testing. It should be noted that the NVSL FADDL laboratory is 
isolated from the mainland United States. Because the laboratory works 
with diseases exotic to the United States, special biosecurity measures 
are required at NVSL FADDL that are not required at NVSL in Ames, IA. 
The proposed user fees reflect the higher operating costs at NVSL 
FADDL.
    Most of the user fees in this category would increase substantially 
under this proposed rule. The average increase in the first year would 
be about 89 percent. However, the total impact of the proposed changes 
should be small. Of the 35 fees in this category, only 4 are associated 
with increased annual collections of more than $10,000 each over the 
entire time period covered in the proposal. These four fees would 
account for more than 86 percent of the additional collections in this 
category. By the end of FY 2007, collections from hourly fees would 
have increased by about $64,000 annually, collections for virus 
neutralization tests would have increased by about $55,000 annually, 
collections for enzyme linked immunosorbent assay tests would have 
increased by about $17,000, and collections for indirect fluorescent 
antibody tests would have increased by about $12,000. In addition, the 
nature of the work at NVSL FADDL should limit the impact of the 
proposed changes in the user fees. The user fee work at NVSL FADDL is 
restricted to work associated with foreign animal diseases, and this 
limits the volume of user fee work at the laboratory. The majority of 
the user fee work is associated with imports. For example, the virus 
neutralization test is often used as a prescreening test for foot-and-
mouth disease prior to an animal leaving its country of origin to 
ensure that the animal will not be refused entry into the United States 
and reexported. Also, a good deal of the user fee work at NVSL FADDL is 
performed in conjunction with the import of master seeds/cells for 
vaccines. The overall cost of developing and importing these vaccines 
is very high. Because of this, the user fees and the proposed increases 
in those fees represent a very small portion of an importer's costs.

Veterinary Diagnostic Isolation and Identification Tests Performed at 
NVSL in Ames

    The proposed user fee changes for veterinary diagnostic isolation 
and identification tests performed at NVSL in Ames could generate 
additional annual collections of about $305,000 in FY 2004 and about 
$380,000 by the end of FY 2007. The average proposed increase in the 
fees in this category is more than 100 percent in the first year. 
However, the total impact of the changes should be small. The average 
increase in the first year would be less than $36, and 12 of the 20 
fees in this category would change in total by less than $30 each. Only 
six of these fees should generate $10,000 or more in additional annual 
collections. Two of these fees are primarily associated with required 
testing at poultry slaughtering facilities, and are paid for by the 
Food Safety and Inspection Service (FSIS): Bacterial serotyping 
(Salmonella), which is projected to generate a total of about $119,000 
in additional annual collections, and phage typing (all other), which 
is projected to generate a total of about $14,000 in additional annual 
collections. User fees for these tests are only charged for research 
and for confirming the FSIS tests. The proposed changes in the user fee 
for virus isolation tests are projected to generate total additional 
collections of $75,000. However, the change in this fee would be only 
$11.50 in the first year and $16.50 in total for virus isolations other 
than for Newcastle disease.

Veterinary Diagnostic Serology Tests Performed at NVSL in Ames

    The proposed user fee changes for veterinary diagnostic serology 
tests performed at NVSL in Ames could generate additional annual 
collections of about $948,000 in FY 2004 and about $1.1 million by the 
end of FY 2007. The average total increase in the fees in this category 
would be more than 100 percent. However, the total impact of these 
proposed changes should be small. The average increase in the first 
year would be less than $9 and would increase by less than $10 in 
total. Only three of the fees in this category would increase in total 
by more than $20, and 16 would increase by less than $10. The proposed 
user fee for CF tests should generate about $509,000 in total 
additional annual collections, but the increase in this fee would be 
only $6 in the first year and $7 in total. About 90 percent of the CF 
test user fees are collected for import and export. The increases in 
this user fee would be very small in relation to the value of the 
animals involved and the costs associated with importing and exporting 
animals. For example, moving horses into or out of the United States 
generally requires four CF tests. Breeding stallions move between the 
northern and southern hemispheres to double the number of annual 
breeding seasons. These stallions, valued on average at approximately 
$400,000 and reaching $2 to $4 million, can command breeding fees of at 
minimum $10,000 per mare covered. Moving horses by air can cost between 
$6,000 and $9,000 per horse. The user fees represent a tiny portion of 
the total cost of moving these animals into the country, and by 
providing the tests, this movement is facilitated.

Veterinary Diagnostic Tests Performed at the Pathobiology Laboratory at 
NVSL in Ames

    The proposed changes in the user fees for veterinary diagnostic 
tests performed at the pathobiology laboratory at NVSL in Ames could 
generate additional annual collections of about $29,000 in FY 2004 and 
about $43,000 by the end of FY 2007. The average increase in the fees 
in this category would be less than $30 in the first year and $35 in 
total. Only two of the proposed fees in this category are projected to 
generate more than $10,000 each in additional total annual collections, 
and the rest less than $1,000 each. Both of these two fees would change 
by less than $10 each in the first year, and by less than $15 each in 
total.

Veterinary Diagnostic Reagents Produced at NVSL in Ames

    The proposed changes in user fees for veterinary diagnostic 
reagents produced at NVSL in Ames could generate additional annual 
collections of about $592,000 in FY 2004 and about $697,000 by the end 
of the FY 2007. The proposed changes to 16 of these fees should 
generate a total of more than $10,000 each in additional annual 
collections. The average increase in this category is less than $60 in 
the first year and $70 in total. Thirty-one of the fees increase by 
less than $50 each in total, and 20 by $25 or less each. While these 
proposed changes represent considerable percentage increases in those 
fees, the reagents are the basis for doing tests. The purchasing 
laboratory can use the reagent to perform several hundred tests. 
Therefore, the purchasing laboratory can spread its costs across those 
several hundred tests for its

[[Page 43667]]

customers. In addition, the ability to obtain these reagents from APHIS 
enhances the purchasing laboratory's business, for without the reagents 
the tests would not be possible.

Other Veterinary Diagnostic Services or Materials Provided at NVSL in 
Ames

    The proposed changes in user fees for other veterinary diagnostic 
services or materials provided at NVSL in Ames could generate 
additional annual collections of about $409,000 in FY 2004, and about 
$471,000 by the end of FY 2007. Providing check tests could account for 
about 47 percent of the total additional collections in this category, 
about $221,000. NVSL in Ames certifies laboratories to conduct certain 
tests, employing ``check test kits'' to perform the certification. The 
kits consist of about 20 sera (or live organisms if it is for culture), 
and the laboratory conducts the test it wants to be certified to 
perform using the sera in the check test kit. The laboratory must get a 
predetermined number of the sera right (positive or negative) in order 
to pass and be certified to run the tests. The proposed user fees for 
this service should not have a significant impact on the laboratories 
because being certified by APHIS to conduct a test enhances their 
ability to attract customers who pay the laboratory to conduct tests. 
Another large portion of the additional annual collections would be 
from the proposed fee for fetal bovine serum safety test. The proposed 
changes to this fee are projected to generate total additional annual 
collections of about $131,000 by the end of FY 2007. This fee is for 
testing fetal bovine serum to be sure it is free of foreign viruses. 
This serum is needed to grow viruses and is used by biologics 
manufacturers and diagnostic laboratories. Its value is high even 
relative to the large fee for the test.

Small Entities

    The Regulatory Flexibility Act requires that agencies specifically 
consider the economic impact associated with their rules on small 
entities. The Small Business Administration (SBA) has set size criteria 
according to the categories of the North American Industrial 
Classification System (NAICS), which is used as a guide in determining 
which economic entities meet the definition of a small business.
    The veterinary diagnostic services provided by APHIS at NVSL FADDL 
and NVSL in Ames are provided to determine if a disease-causing 
organism or chemical agent is present in body tissues or cells and to 
identify those organisms or agents. As such, the users of these 
services and products include importers, exporters, non-APHIS 
veterinarians, commercial laboratories and pharmaceutical 
manufacturers, State laboratories, universities, and foreign 
governments. These users may be affected by the proposed changes to 
user fees for veterinary diagnostic services and products.
    The SBA's criterion for a small entity engaged in importing and 
exporting live animals, poultry, and birds is 100 or fewer employees. 
The criterion for a small veterinary testing laboratory is $6 million 
or less in annual sales. The criterion for a small pharmaceutical 
manufacturing company is 750 or fewer employees.
    The number of entities specifically using the veterinary diagnostic 
products and services covered in this proposal that would qualify as a 
small entity under SBA criteria cannot be determined at this time. 
However, more than 99 percent \1\ of the entities in livestock 
wholesale, poultry wholesale, and other farm product raw material 
wholesale (including horses and mules) can be considered small. Under 
NAICS, import and export merchants, agents, and brokers are included in 
the wholesale trade sector. According to the latest available 
information,\2\ 94 percent of all testing laboratories, including 
veterinary testing laboratories, can be considered small. According to 
the 1997 Economic Census, at least 97.9 percent \3\ of all chemical 
manufacturers can be considered small. Pharmaceutical manufacturing is 
included in this category under NAICS. It is, therefore, likely that 
the majority of users affected can be considered small. However, 
because the overall impacts of the proposal are expected to be limited, 
the impacts on small entities should be limited as well.
---------------------------------------------------------------------------

    \1\ U.S. Census Bureau, 1997 Economic Census.
    \2\ U.S. Census Bureau, 1992 Economic Census.
    \3\ In 1997, 13,187 of 13,474 chemical manufacturing 
establishments had fewer than 500 employees.
---------------------------------------------------------------------------

Costs and Benefits of User Fees

    User fees for veterinary diagnostic services and products are 
intended to meet broad economic objectives. User fees promote the 
internalization of the real cost of providing veterinary diagnostic 
services and products in consumer transaction decisions. User fees also 
achieve savings in Government expenditures, and, therefore, reduce the 
tax support necessary for the system to operate at a given level. These 
tax funds can then be used in other programs or to reduce taxes overall 
and, thus, diminish the efficiency losses associated with the 
generation of taxes (deadweight loss plus collection costs).

Cost of Services

    User fees reduce Government expenditures for fee-based services by 
shifting the burden of financing Federal services from general 
taxpayers to users and by curtailing the amount demanded for veterinary 
diagnostic service-related products. The consumer response to user fees 
is a movement toward a more socially optimal level of demand where 
users incorporate the cost of veterinary diagnostic services and 
products into their private costs.
    As circumstances affecting the cost of providing services and 
products change, the amount of the user fees must be reevaluated to 
ensure that the user fee accurately reflects the cost of providing the 
services at that point in time. The socially optimal level of output, 
where the true cost is more fully incorporated into the transaction, is 
therefore maintained.

Benefits of Services

    The net gain associated with the adjustment in consumer demand is 
quantified by subtracting the consumer welfare losses from the savings 
in Government expenditures. The magnitude of this gain depends on the 
elasticities of demand for each particular service or product (consumer 
responsiveness to changes in user fees). These elasticities are 
unknown. The demand for veterinary diagnostic services and products is 
intertwined with the demand for the commodities of which the products 
and services are inputs. However, there is no evidence to suggest that 
a significant change in demand for veterinary diagnostics has occurred 
due to the imposition or alteration of user fees in the past. When 
consumer adjustment is small, there is a correspondingly low net social 
gain.
    Additional social gain can be expected from the reduction in losses 
associated with collecting and apportioning taxes to finance the 
veterinary diagnostic products and services. This reduction in losses 
arises from the internalization by consumers of the social cost of 
obtaining veterinary diagnostic products and services, and from the 
reduction in deadweight losses due to taxation.

Comparison of Benefits and Costs

    To evaluate the overall costs and benefits of the user fee program, 
the two types of net benefits must be compared with the cost of the 
user fees. Because the demand elasticities for the veterinary 
diagnostic service-related products are unknown, the only

[[Page 43668]]

measures are the savings in Government expenditures and the 
administrative cost involved in obtaining these savings. APHIS already 
has a user fee program and a mechanism for collecting these fees in 
place. This proposal would update existing fees. Therefore, increases 
in administrative costs would be very small. Differences between the 
level of the user fees and actual cost of performing the services have 
become considerable. Therefore, the Government savings associated with 
this proposal should be substantial. It is likely that the net gain in 
reducing the burden on taxpayers as a whole would outweigh the cost of 
administering the revisions of the user fees.
    The proposed user fee increases are needed to move toward economic 
efficiency. From the point of view of society, the optimal level of 
output is where the marginal benefit to society equals the marginal 
cost to society. User fees help to internalize the cost of performing 
the veterinary diagnostic services into the private transaction, and 
their revision helps ensure that the user fees adequately reflect the 
cost of performing the services over time.

Summary

    The impacts of the proposed increases in veterinary diagnostic user 
fees in this proposal are expected to be muted. The majority of the 
proposed changes to the user fees are either small, associated with few 
users, or both. Over the period covered by the proposed rule, more than 
60 percent of the individual increases are less than $50, nearly 16 
percent increase by less than $10, and about 65 percent are associated 
with 100 or fewer users. The majority of the proposed fees should also 
make only small contributions to the total additional collections and, 
therefore, would have a minor impact on the users of those services. 
This is either because the proposed change is small or the projected 
volume associated with the user fee is small, or both. Even in those 
instances in which the change in a user fee would generate a larger 
total increase in collections, the impact should not be significant 
because they are small fees applied to a large annual volume of users, 
large fees applied to a very small volume of users, fees that represent 
a small percentage of the overall costs associated with a user's 
output, single fees for reagents with numerous final users, or fees 
that enhance the marketability of the user's final outputs. Therefore, 
the increases are not generally expected to substantially reduce 
profits or impede exports or imports. Indeed, the full burden of the 
proposed user fee changes is not likely to be borne entirely by the 
purchasers of products and services.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action would 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12372

    This program/activity is listed in the Catalog of Federal Domestic 
Assistance under No. 10.025 and is subject to Executive Order 12372, 
which requires intergovernmental consultation with State and local 
officials. (See 7 CFR part 3015, subpart V.)

Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. If this proposed rule is adopted: (1) All State 
and local laws and regulations that are inconsistent with this rule 
will be preempted; (2) no retroactive effect will be given to this 
rule; and (3) administrative proceedings will not be required before 
parties may file suit in court challenging this rule.

Paperwork Reduction Act

    This proposed rule contains no new information collection or 
recordkeeping requirements under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501 et seq.).

List of Subjects in 9 CFR Part 130

    Animals, Birds, Diagnostic reagents, Exports, Imports, Poultry and 
poultry products, Quarantine, Reporting and recordkeeping requirements, 
Tests.

    Accordingly, we propose to amend 9 CFR part 130 as follows:

PART 130--USER FEES

    1. The authority citation for part 130 would continue to read as 
follows:

    Authority: 5 U.S.C. 5542; 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 
136 and 136a; 31 U.S.C. 3701, 3716, 3717, 3719, and 3720A; 7 CFR 
2.22, 2.80, and 371.4.

    2. In Sec.  130.14, paragraphs (a), (b), and (c), the tables would 
be revised to read as follows:


Sec.  130.14  User fees for FADDL veterinary diagnostics.

    (a) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                     User fee
                                                                                         ---------------------------------------------------------------
                  Reagent                                       Unit                       Oct. 1, 2003-   Oct. 1, 2004-   Oct. 1, 2005-
                                                                                          Sept. 30, 2004  Sept. 30, 2005  Sept. 30, 2006  Beginning Oct.
                                                                                                                                              1, 2006
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bovine antiserum, any agent...............  1 mL........................................         $150.00         $155.00         $160.00         $165.00
Caprine antiserum, any agent..............  1 mL........................................          184.00          189.00          195.00          202.00
Cell culture antigen/microorganism........  1 mL........................................          103.00          106.00          109.00          111.00
Equine antiserum, any agent...............  1 mL........................................          186.00          192.00          198.00          204.00
Fluorescent antibody conjugate............  1 mL........................................          169.00          172.00          176.00          179.00
Guinea pig antiserum, any agent...........  1 mL........................................          184.00          189.00          194.00          200.00
Monoclonal antibody.......................  1 mL........................................          222.00          229.00          235.00          243.00
Ovine antiserum, any agent................  1 mL........................................          176.00          181.00          187.00          193.00
Porcine antiserum, any agent..............  1 mL........................................          152.00          157.00          162.00          167.00
Rabbit antiserum, any agent...............  1 mL........................................          179.00          185.00          190.00          196.00
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (b) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                     User fee
                                                                                         ---------------------------------------------------------------
                   Test                                         Unit                       Oct. 1, 2003-   Oct. 1, 2004-   Oct. 1, 2005-
                                                                                          Sept. 30, 2004  Sept. 30, 2005  Sept. 30, 2006  Beginning Oct.
                                                                                                                                              1, 2006
--------------------------------------------------------------------------------------------------------------------------------------------------------
Agar gel immunodiffusion..................  Test........................................          $30.00          $31.00          $32.00          $33.00
Card......................................  Test........................................           17.00           17.00           18.00           18.00
Complement fixation.......................  Test........................................           36.00           37.00           38.00           40.00

[[Page 43669]]

 
Direct immunofluorescent antibody.........  Test........................................           22.00           23.00           24.00           25.00
Enzyme linked immunosorbent assay.........  Test........................................           26.00           27.00           28.00           29.00
Fluorescent antibody neutralization         Test........................................          194.00          201.00          208.00          215.00
 (classical swine fever).
Hemagglutination inhibition...............  Test........................................           57.00           59.00           61.00           63.00
Immunoperoxidase..........................  Test........................................           29.00           30.00           31.00           32.00
Indirect fluorescent antibody.............  Test........................................           35.00           36.00           37.00           39.00
In-vitro safety...........................  Test........................................          570.00          589.00          609.00          630.00
In-vivo safety............................  Test........................................        5,329.00        5,387.00        5,447.00        5,509.00
Latex agglutination.......................  Test........................................           23.00           24.00           25.00           26.00
Tube agglutination........................  Test........................................           28.00           28.00           29.00           30.00
Virus isolation (oesophageal/pharyngeal)..  Test........................................          180.00          186.00          192.00          199.00
Virus isolation in embryonated eggs.......  Test........................................          346.00          358.00          370.00          383.00
Virus isolation, other....................  Test........................................          155.00          160.00          166.00          171.00
Virus neutralization......................  Test........................................           52.00           54.00           56.00           58.00
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (c) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                     User fee
                                                                                         ---------------------------------------------------------------
       Veterinary diagnostic service                            Unit                       Oct. 1, 2003-   Oct. 1, 2004-   Oct. 1, 2005-
                                                                                          Sept. 30, 2004  Sept. 30, 2005  Sept. 30, 2006  Beginning Oct.
                                                                                                                                              1, 2006
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bacterial isolation.......................  Test........................................         $112.00         $115.00         $119.00         $123.00
Hourly user fee services \1\..............  Hour........................................          445.00          460.00          476.00          492.00
Hourly user fee services--Quarter hour....  Quarter hour................................          111.00          115.00          119.00          123.00
Infected cells on chamber slides or plates  Slide.......................................           49.00           50.00           51.00           53.00
Reference animal tissues for                Set.........................................          171.00          177.00          182.00          187.00
 immunohistochemistry.
Sterilization by gamma radiation..........  Can.........................................        1,740.00        1,799.00        1,860.00        1,923.00
Training (school or technical assistance).  Per person per day..........................          910.00          941.00          973.00        1,006.00
Virus titration...........................  Test........................................          112.00          115.00          110.00          123.00
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ For all veterinary diagnostic services for which there is no flat rate user fee, the hourly rate user fee will be calculated for the actual time
  required to provide the service.

* * * * *
    3. In Sec.  130.15, paragraphs (a) and (b), the tables would be 
revised to read as follows:


Sec.  130.15  User fees for veterinary diagnostic isolation and 
identification tests performed at NVSL(excluding FADDL) or other 
authorized site.

    (a) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                     User fee
                                                                                         ---------------------------------------------------------------
                   Test                                         Unit                       Oct. 1, 2003-   Oct. 1, 2004-   Oct. 1, 2005-
                                                                                          Sept. 30, 2004  Sept. 30, 2005  Sept. 30, 2006  Beginning Oct.
                                                                                                                                              1, 2006
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bacterial identification, automated.......  Isolate.....................................          $48.00          $50.00          $51.00          $53.00
Bacterial identification, non-automated...  Isolate.....................................           81.00           84.00           87.00           90.00
Bacterial isolation.......................  Sample......................................           33.00           34.00           35.00           36.00
Bacterial serotyping, all other...........  Isolate.....................................           51.00           52.00           53.00           55.00
Bacterial serotyping, Pasteurella           Isolate.....................................           16.00           17.00           18.00           18.00
 multocida.
Bacterial serotyping, Salmonella..........  Isolate.....................................           33.00           34.00           35.00           36.00
Bacterial toxin typing....................  Isolate.....................................          109.00          112.00          116.00          120.00
Bacteriology requiring special              Test........................................           83.00           86.00           89.00           92.00
 characterization.
DNA fingerprinting........................  Test........................................           54.00           56.00           58.00           59.00
DNA/RNA probe.............................  Test........................................           77.00           79.00           81.00           83.00
Fluorescent antibody......................  Test........................................           17.00           17.00           18.00           19.00
Mycobacterium identification (biochemical)  Isolate.....................................          104.00          107.00          111.00          114.00
Mycobacterium identification (gas           Procedure...................................           87.00           90.00           93.00           96.00
 chromatography).
Mycobacterium isolation, animal             Submission..................................          770.00          791.00          814.00          837.00
 inoculations.
Mycobacterium isolation, all other........  Submission..................................          136.00          141.00          146.00          151.00
Mycobacterium paratuberculosis isolation..  Submission..................................           65.00           67.00           70.00           72.00
Phage typing, all other...................  Isolate.....................................           38.00           39.00           41.00           42.00
Phage typing, Salmonella enteritidis......  Isolate.....................................           21.00           22.00           23.00           24.00
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 43670]]

    (b) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                     User fee
                                                                                         ---------------------------------------------------------------
                   Test                                         Unit                       Oct. 1, 2003-   Oct. 1, 2004-   Oct. 1, 2005-
                                                                                          Sept. 30, 2004  Sept. 30, 2005  Sept. 30, 2006  Beginning Oct.
                                                                                                                                              1, 2006
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fluorescent antibody tissue section.......  Test........................................          $27.00          $27.00          $28.00          $29.00
Virus isolation...........................  Test........................................           43.00           45.00           46.00           48.00
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *
    4. In Sec.  130.16, paragraphs (a) and (b), the tables would be 
revised to read as follows:


Sec.  130.16  User fees for veterinary diagnostic serology tests 
performed at NVSL (excluding FADDL) or at authorized sites.

    (a) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                     User fee
                                                                                         ---------------------------------------------------------------
                   Test                                         Unit                       Oct. 1, 2003-   Oct. 1, 2004-   Oct. 1, 2005-
                                                                                          Sept. 30, 2004  Sept. 30, 2005  Sept. 30, 2006  Beginning Oct.
                                                                                                                                              1, 2006
--------------------------------------------------------------------------------------------------------------------------------------------------------
Brucella ring (BRT).......................  Test........................................          $33.00          $34.00          $35.00          $36.00
Brucella ring, heat inactivated (HIRT)....  Test........................................           33.00           34.00           35.00           36.00
Brucella ring, serial (Serial BRT)........  Test........................................           49.00           51.00           53.00           54.00
Buffered acidified plate antigen            Test........................................            6.00            7.00            7.00            7.00
 presumptive.
Card......................................  Test........................................            4.00            4.00            4.00            4.00
Complement fixation.......................  Test........................................           15.00           15.00           16.00           16.00
Enzyme linked immunosorbent assay.........  Test........................................           15.00           15.00           16.00           16.00
Indirect fluorescent antibody.............  Test........................................           13.00           13.00           14.00           14.00
Microscopic agglutination-includes up to 5  Sample......................................           21.00           22.00           23.00           24.00
 serovars.
Microscopic agglutination-each serovar in   Sample......................................            4.00            4.00            4.00            4.00
 excess of 5 serovars.
Particle concentration fluorescent          Test........................................           33.00           34.00           35.00           36.00
 immunoassay (PCFIA).
Plate.....................................  Test........................................            6.00            7.00            7.00            7.00
Rapid automated presumptive...............  Test........................................            6.00            6.00            6.00            7.00
Rivanol...................................  Test........................................            6.00            7.00            7.00            7.00
Tube agglutination........................  Test........................................            6.00            7.00            7.00            7.00
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (b) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                     User fee
                                                                                         ---------------------------------------------------------------
                   Test                                         Unit                       Oct. 1, 2003-   Oct. 1, 2004-   Oct. 1, 2005-
                                                                                          Sept. 30, 2004  Sept. 30, 2005  Sept. 30, 2006  Beginning Oct.
                                                                                                                                              1, 2006
--------------------------------------------------------------------------------------------------------------------------------------------------------
Agar gel immunodiffusion..................  Test........................................          $15.00          $15.00          $16.00          $16.00
Complement fixation.......................  Test........................................           15.00           15.00           16.00           16.00
Enzyme linked immunosorbent assay.........  Test........................................           15.00           15.00           16.00           16.00
Hemagglutination inhibition...............  Test........................................           13.00           13.00           14.00           14.00
Indirect fluorescent antibody.............  Test........................................           13.00           13.00           14.00           14.00
Latex agglutination.......................  Test........................................           15.00           15.00           16.00           16.00
Peroxidase linked antibody................  Test........................................           14.00           14.00           15.00           15.00
Plaque reduction neutralization...........  Test........................................           16.00           17.00           17.00           18.00
Rabies fluorescent antibody neutralization  Test........................................           41.00           42.00           44.00           45.00
Virus neutralization......................  Test........................................           12.00           12.00           13.00           13.00
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *
    5. In Sec.  130.17, paragraph (a), the table would be revised to 
read as follows:


Sec.  130.17  User fees for other veterinary diagnostic laboratory 
tests performed at NVSL (excluding FADDL) or at authorized sites.

    (a) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                     User fee
                                                                                         ---------------------------------------------------------------
                   Test                                         Unit                       Oct. 1, 2003-   Oct. 1, 2004-   Oct. 1, 2005-
                                                                                          Sept. 30, 2004  Sept. 30, 2005  Sept. 30, 2006  Beginning Oct.
                                                                                                                                              1, 2006
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aflatoxin quantitation....................  Test........................................          $27.00          $28.00          $29.00          $30.00
Aflatoxin screen..........................  Test........................................           26.00           27.00           28.00           29.00

[[Page 43671]]

 
Agar gel immunodiffusion spp.               Test........................................           11.00           12.00           12.00           13.00
 identification.
Antibiotic (bioautography) quantitation...  Test........................................           59.00           61.00           63.00           65.00
Antibiotic (bioautography) screen.........  Test........................................          108.00          112.00          115.00          119.00
Antibiotic inhibition.....................  Test........................................           59.00           61.00           63.00           65.00
Arsenic...................................  Test........................................           16.00           16.00           17.00           17.00
Ergot alkaloid screen.....................  Test........................................           59.00           61.00           63.00           65.00
Ergot alkaloid confirmation...............  Test........................................           77.00           80.00           83.00           86.00
Feed microscopy...........................  Test........................................           59.00           61.00           63.00           65.00
Fumonisin only............................  Test........................................           33.00           35.00           36.00           37.00
Gossypol..................................  Test........................................           89.00           92.00           95.00           98.00
Mercury...................................  Test........................................          131.00          135.00          140.00          145.00
Metals screen.............................  Test........................................           40.00           41.00           43.00           44.00
Metals single element confirmation........  Test........................................           11.00           12.00           12.00           13.00
Mycotoxin: aflatoxin-liver................  Test........................................          108.00          112.00          115.00          119.00
Mycotoxin screen..........................  Test........................................           43.00           44.00           46.00           48.00
Nitrate/nitrite...........................  Test........................................           59.00           61.00           63.00           65.00
Organic compound confirmation.............  Test........................................           79.00           82.00           85.00           88.00
Organic compound screen...................  Test........................................          137.00          141.00          146.00          151.00
Parasitology..............................  Test........................................           26.00           27.00           28.00           29.00
Pesticide quantitation....................  Test........................................          119.00          123.00          128.00          132.00
Pesticide screen..........................  Test........................................           54.00           56.00           58.00           60.00
pH........................................  Test........................................           24.00           25.00           26.00           26.00
Plate cylinder............................  Test........................................           89.00           92.00           95.00           98.00
Selenium..................................  Test........................................           40.00           41.00           43.00           44.00
Silicate/carbonate disinfectant...........  Test........................................           59.00           61.00           63.00           65.00
Temperature disks.........................  Test........................................          118.00          122.00          126.00          130.00
Toxicant quantitation, other..............  Test........................................           99.00          103.00          106.00          110.00
Toxicant screen, other....................  Test........................................           30.00           31.00           32.00           33.00
Vomitoxin only............................  Test........................................           48.00           49.00           51.00           53.00
Water activity............................  Test........................................           30.00           31.00           32.00           33.00
Zearaleone quantitation...................  Test........................................           48.00           49.00           51.00           53.00
Zearaleone screen.........................  Test........................................           26.00           27.00           28.00           29.00
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *
    6. In Sec.  130.18, paragraphs (a) and (b), the tables would be 
revised to read as follows:


Sec.  130.18  User fees for veterinary diagnostic reagents produced at 
NVSL or other authorized site (excluding FADDL).

    (a) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                     User fee
                                                                                         ---------------------------------------------------------------
                  Reagent                                       Unit                       Oct. 1, 2003-   Oct. 1, 2004-   Oct. 1, 2005-
                                                                                          Sept. 30, 2004  Sept. 30, 2005  Sept. 30, 2006  Beginning Oct.
                                                                                                                                              1, 2004
--------------------------------------------------------------------------------------------------------------------------------------------------------
Anaplasma card test antigen...............  2 mL........................................          $87.00          $89.00          $92.00          $95.00
Anaplasma card test kit without antigen...  Kit.........................................          115.00          119.00          123.00          127.00
Anaplasma CF antigen......................  2 mL........................................           46.00           46.00           46.00           46.00
Anaplasma stabilate.......................  4.5 mL......................................          160.00          165.00          170.00          175.00
Avian origin bacterial antiserums.........  1 mL........................................           43.00           44.00           46.00           47.00
Bacterial agglutinating antigens other      5 mL........................................           49.00           51.00           52.00           54.00
 than brucella and salmonella pullorum.
Bacterial conjugates......................  1 mL........................................           87.00           90.00           93.00           96.00
Bacterial disease CF antigens, all other..  1 mL........................................           26.00           27.00           28.00           29.00
Bacterial ELISA antigens..................  1 mL........................................           27.00           27.00           28.00           29.00
Bacterial or protozoal, antiserums, all     1 mL........................................           54.00           56.00           58.00           60.00
 other.
Bacterial reagent culture\1\..............  Culture.....................................           66.00           68.00           70.00           73.00
Bacterial reference culture \2\...........  Culture.....................................          206.00          213.00          221.00          228.00
Bacteriophage reference culture...........  Culture.....................................          155.00          161.00          166.00          172.00
Bovine serum factor.......................  1 mL........................................           16.00           17.00           17.00           18.00
Brucella abortus CF antigen...............  60 mL.......................................          136.00          141.00          146.00          151.00
Brucella agglutination antigens, all other  60 mL.......................................          136.00          141.00          146.00          151.00
Brucella buffered plate antigen...........  60 mL.......................................          155.00          161.00          166.00          172.00
Brucella canis tube antigen...............  25 mL.......................................          102.00          105.00          107.00          109.00
Brucella card test antigen (packaged).....  Package.....................................           81.00           84.00           87.00           90.00
Brucella card test kit without antigen....  Kit.........................................          106.00          109.00          111.00          113.00
Brucella cells............................  Gram........................................           17.00           17.00           18.00           18.00
Brucella cells, dried.....................  Pellet......................................            5.00            5.00            5.00            6.00
Brucella ring test antigen................  60 mL.......................................          218.00          225.00          233.00          241.00
Brucella rivanol solution.................  60 mL.......................................           27.00           27.00           28.00           29.00
Dourine CF antigen........................  1 mL........................................           81.00           84.00           86.00           89.00

[[Page 43672]]

 
Dourine stabilate.........................  4.5 mL......................................          102.00          105.00          107.00          109.00
Equine and bovine origin babesia species    1 mL........................................          115.00          119.00          123.00          127.00
 antiserums.
Equine negative control CF antigen........  1 mL........................................          267.00          272.00          276.00          281.00
Flazo-orange..............................  3 mL........................................           11.00           12.00           12.00           13.00
Glanders CF antigen.......................  1 mL........................................           70.00           73.00           75.00           77.00
Hemoparasitic disease CF antigens, all      1 mL........................................          489.00          505.00          522.00          540.00
 other.
Leptospira transport medium...............  10 mL.......................................            4.00            4.00            4.00            4.00
Monoclonal antibody.......................  1 mL........................................           88.00           90.00           93.00           95.00
Mycobacterium spp. old tuberculin.........  1 mL........................................           21.00           22.00           23.00           24.00
Mycobacterium spp. PPD....................  1 mL........................................           16.00           17.00           18.00           18.00
Mycoplasma hemagglutination antigens......  5 mL........................................          163.00          168.00          174.00          180.00
Negative control serums...................  1 mL........................................           16.00           17.00           18.00           18.00
Rabbit origin bacterial antiserum.........  1 mL........................................           47.00           48.00           50.00           52.00
Salmonella pullorum microagglutination      5 mL........................................           14.00           14.00           15.00           15.00
 antigen.
Stabilates, all other.....................  4.5 mL......................................          623.00          640.00          659.00          678.00
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ A reagent culture is a bacterial culture that has been subcultured one or more times after being tested for purity and identity. It is intended for
  use as a reagent with a diagnostic test such as the leptospiral microagglutination test.
\2\ A reference culture is a bacterial culture that has been thoroughly tested for purity and identity. It should be suitable as a master seed for
  future cultures.

    (b) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                     User fee
                                                                                         ---------------------------------------------------------------
                  Reagent                                       Unit                       Oct. 1, 2003-   Oct. 1, 2004-   Oct. 1, 2005-
                                                                                          Sept. 30, 2004  Sept. 30, 2005  Sept. 30, 2006  Beginning Oct.
                                                                                                                                              1, 2006
--------------------------------------------------------------------------------------------------------------------------------------------------------
Antigen, except avian influenza and         2 mL........................................          $55.00          $57.00          $59.00          $61.00
 chlamydia psittaci antigens, any.
Avian antiserum except avian influenza      2 mL........................................           44.00           45.00           47.00           48.00
 antiserum, any.
Avian influenza antigen, any..............  2 mL........................................           30.00           31.00           32.00           33.00
Avian influenza antiserum, any............  6 mL........................................           93.00           96.00          100.00          103.00
Bovine or ovine serum, any................  2 mL........................................          115.00          119.00          123.00          127.00
Cell culture..............................  Flask.......................................          136.00          141.00          146.00          151.00
Chlamydia psittaci spp. of origin           Panel.......................................           88.00           90.00           93.00           95.00
 monoclonal antibody panel.
Conjugate, any............................  1 mL........................................           66.00           68.00           71.00           73.00
Diluted positive control serum, any.......  2 mL........................................           22.00           23.00           24.00           24.00
Equine antiserum, any.....................  2 mL........................................           41.00           42.00           44.00           45.00
Monoclonal antibody.......................  1 mL........................................           94.00           96.00           99.00          102.00
Other spp. antiserum, any.................  1 mL........................................           51.00           51.00           52.00           52.00
Porcine antiserum, any....................  2 mL........................................           95.00           99.00          102.00          105.00
Porcine tissue sets.......................  Tissue set..................................          152.00          153.00          155.00          157.00
Positive control tissues, all.............  2 cm2 section...............................           55.00           57.00           58.00           60.00
Rabbit origin antiserum...................  1 mL........................................           47.00           48.00           50.00           52.00
Reference virus, any......................  0.6 mL......................................          163.00          169.00          174.00          180.00
Viruses (except reference viruses),         0.6 mL......................................           27.00           28.00           29.00           30.00
 chlamydia psittaci agent or chlamydia
 psittaci antigen, any.
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *
    7. In Sec.  130.19 , paragraph (a), the table would be revised to 
read as follows:


Sec.  130.19  User fees for other veterinary diagnostic services or 
materials provided at NVSL(excluding FADDL).

    (a) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                     User fee
                                                                                         ---------------------------------------------------------------
                  Service                                       Unit                       Oct. 1, 2003-   Oct. 1, 2004-   Oct. 1, 2005-
                                                                                          Sept. 30, 2004  Sept. 30, 2005  Sept. 30, 2006  Beginning Oct.
                                                                                                                                              1, 2006
--------------------------------------------------------------------------------------------------------------------------------------------------------
Antimicrobial susceptibility test.........  Isolate.....................................          $95.00          $98.00         $101.00         $105.00
Avian safety test.........................  Test........................................        3,774.00        3,871.00        3,972.00        4,075.00
Check tests, culture......................  Kit \1\.....................................          162.00          167.00          171.00          176.00
Check tests, serology, all other..........  Kit \1\.....................................          326.00          337.00          349.00          361.00
Fetal bovine serum safety test............  Verification................................        1,061.00        1,078.00        1,096.00        1,114.00

[[Page 43673]]

 
Hourly user fee services:\2\
    Hour..................................  Hour........................................           84.00           84.00           84.00           84.00
    Quarter hour..........................  Quarter hour................................           21.00           21.00           21.00           21.00
    Minimum...............................  ............................................           25.00           25.00           25.00           25.00
Manual, brucellosis culture...............  1 copy......................................          104.00          107.00          111.00          114.00
Manual, tuberculosis culture (English or    1 copy......................................          155.00          161.00          166.00          172.00
 Spanish).
Manual, Veterinary mycology...............  1 copy......................................          155.00          161.00          166.00          172.00
Manuals or standard operating procedure     1 copy......................................           31.00           32.00           33.00           34.00
 (SOP), all other.
Manuals or SOP, per page..................  1 page......................................            2.00            2.00            2.00            2.00
Training (school or technical assistance).  Per person per day..........................          300.00          310.00          320.00          331.00
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Any reagents required for the check test will be charged separately.
\2\ For veterinary diagnostic services for which there is no flat rate user fee, the hourly rate user fee will be calculated for the actual time
  required to provide the service.

* * * * *

    Done in Washington, DC, this 18th day of July, 2003.
Peter Fernandez,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 03-18849 Filed 7-23-03; 8:45 am]
BILLING CODE 3410-34-P