[Federal Register Volume 72, Number 140 (Monday, July 23, 2007)]
[Proposed Rules]
[Pages 40082-40090]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-14162]


 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
 ========================================================================
 

  Federal Register / Vol. 72, No. 140 / Monday, July 23, 2007 / 
Proposed Rules  

[[Page 40082]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 130

[Docket No. APHIS-2006-0161]
RIN 0579-AC52


Veterinary Diagnostic Services User Fees

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: We are proposing to increase the user fees for the veterinary 
diagnostic services to reflect changes in our operating costs and 
expenses. 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, and Conservation 
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 21, 2007.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov, select ``Animal and Plant Health Inspection 
Service'' from the agency drop-down menu, then click ``Submit.'' In the 
Docket ID column, select APHIS-2006-0161 to submit or view public 
comments and to view supporting and related materials available 
electronically. Information on using Regulations.gov, including 
instructions for accessing documents, submitting comments, and viewing 
the docket after the close of the comment period, is available through 
the site's ``User Tips'' link.
     Postal Mail/Commercial Delivery: Please send four copies 
of your comment (an original and three copies) to Docket No. APHIS-
2006-0161, Regulatory Analysis and Development, PPD, APHIS, Station 3A-
03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state 
that your comment refers to Docket No. APHIS-2006-0161.
    Reading Room: 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.
    Other Information: Additional information about APHIS and its 
programs is available on the Internet at http://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT: For information concerning Veterinary 
Services (VS) Management Support, contact Ms. Inez Hockaday, Director, 
Management Support Staff, VS, APHIS, 4700 River Road Unit 44, 
Riverdale, MD 20737-1231; (301) 734-7517.
    For information concerning VS Program Operations at the National 
Veterinary Services Laboratory, contact Dr. Elizabeth Lautner, 
Director, National Veterinary Services Laboratories, 1800 Dayton Road, 
P.O. Box 844, Ames, IA 50010; (515) 633-7357.
    For information concerning user fee rate development, contact Mrs. 
Kris Caraher, User Fees Section Head, Financial Management Division, 
MRPBS, APHIS, 4700 River Road Unit 54, Riverdale, MD 20737-1232; (301) 
734-5901.

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.
    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 National Veterinary Services Laboratories 
(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

[[Page 40083]]

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 
2008 to 2012, would help ensure that the fees accurately reflect the 
cost of providing the services.

Development of Fee Structure

    User fee components. The user fees proposed in this document are 
based on employee salaries and benefits in each of the fiscal years 
2008 through 2012, estimates of the average number of direct labor 
hours required to provide each service, and average salaries for the 
laboratory where the work is performed. 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, administrative support, premium costs (if any), agency 
overhead costs, and departmental charges. We describe these components 
below, using the calculation for the proposed virus isolation test user 
fee for fiscal year 2008 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 in 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. 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. The 
calculations for these proposed user fees are consistent with the 
calculations used for the other 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 average 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 
the laboratory employees to calculate the user fee. For example, the 
estimated average laboratory salary at the Diagnostic Virology 
Laboratory, NVSL for fiscal year 2008 is $32.24 per hour. On average, 
it takes 0.295 hours per virus isolation test, leading to direct labor 
costs of $9.51.
    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. For example, the support costs for the 
virus isolation test are calculated at 296 percent of its direct labor 
costs of $9.51 to be $28.15. The total direct labor and administrative 
support costs for one virus isolation test are $37.66.
    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 
required for the proposed flat rate user fees have already been 
included in the calculations. 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 are added to the specific fee involved rather than included as an 
administrative support cost that is spread to all fees for tests, 
reagents, and other services. The virus isolation test, used as our 
example thus far, does not have any premium costs.
    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 $6.08, which is the product of 
virus isolation direct labor and administrative support costs of $37.66 
multiplied by 16.15 percent.
    Departmental charges. Departmental charges are APHIS' 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.

[[Page 40084]]

    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 4.2 percent. For example, departmental charges to 
perform one virus isolation test are $1.84. This amount equals 4.2 
percent of total direct labor costs, administrative support costs, and 
Agency overhead costs of $43.74 described above. The subtotal of the 
virus isolation test's direct labor, administrative support, Agency 
overhead, and departmental charges costs equals $45.58.
    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 $2.28 per test. The total 
costs in this example thus far equal $47.86.
    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; (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 costs per test for fiscal year 2008 
of $47.86 is rounded up to $48 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.

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.
    Below is a summary of the economic analysis for the changes in 
APHIS user fees proposed in this document. A copy of the full economic 
analysis, which includes comparisons of the change in each user fee, 
may be viewed on the Regulations.gov Web site or in our reading room. 
(Instructions for accessing Regulations.gov and information on the 
location and hours of the reading room are provided under the heading 
ADDRESSES at the beginning of this proposed rule.) In addition, copies 
may be obtained by calling or writing to the individual listed under 
FOR FURTHER INFORMATION CONTACT.
    APHIS is proposing to update the user fees covering the costs of 
providing veterinary diagnostics services to take into account the 
routine increases in the cost of doing business. The costs to operate 
the VS Veterinary Diagnostics Program at NVSL increase slightly from 
year to year due to increases in employee costs (cost of living 
increases, etc.) and other operational costs. These fees are necessary 
to provide for full-cost recovery of Agency activities.
    Calculating the potential impacts of these proposed changes to the 
veterinary diagnostics user fees is hindered by the difficulty in 
determining the elasticities of demand for the covered services. 
Therefore, Government savings are assumed equivalent to the total user 
fee collections for each category associated with the proposed rule.
    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.
    There is reason to believe that the impact on most users of the 
changes in this proposal would be small. About 76 percent of the fees 
change in total by $10 or less. The majority should also make only 
small contributions to the total additional collections and therefore 
have a minor impact on the users of those materials and 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 context of disease 
control or eradication programs. Also, in addition to the role they 
play in protecting American agriculture, veterinary diagnostic services 
and products facilitate international trade and thereby enhance the 
business interests of many of those requesting these services.
    Nearly 80 percent of the total projected change in collections 
would come from changes in only 13 of the 146 fees. Only these 13 
proposed fee changes are projected to generate $10,000 or more in 
additional annual collections by the end of the period covered in this 
proposal. Several factors suggest, however, that these fees should also 
not have a significant impact on users. These fees include small fees 
applied to a large annual volume of users, large fees but 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 
user's final output.
    To the extent that the proposed changes in user fees would impact 
operational costs, any entity that utilizes APHIS veterinary diagnostic 
services and materials could be impacted by the proposed changes. The 
degree to which an entity could be affected depends on its market 
power, that is, the extent to which costs are either absorbed or can be 
passed on to its buyers. Without information on either profit margins 
or operational expenses of the affected entities, or the effects of 
changes in operating costs on the affected industry, the scale of the 
impacts cannot be precisely predicted. However, some conclusions on the 
overall impacts to domestic and international commerce can be drawn.
    If the user fees cannot be passed on, the profit margins of some 
entities may decline as user fees for veterinary diagnostic services 
and materials are increased. However, the impacts are expected to be 
muted. The majority of the changes to the user fees are either small, 
associated with few users, or both. Over the period covered by the 
proposal, more than 51 percent of the individual increases are $5 or 
less, more than 76 percent increase by less than $10, and more than 83 
percent are associated with fewer than 500 users. The majority should 
also make only small contributions to the total additional collections 
and therefore 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 generates a larger total increase in 
collections, the impact should not be significant. This is because they 
are small fees applied to a large annual volume of users, large fees 
but applied

[[Page 40085]]

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 trade. 
Indeed, the full burden of the user fee changes is not likely to be 
borne entirely by the purchasers of veterinary diagnostic services and 
materials.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action will 
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 continues 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.  130.15, paragraphs (a) and (b), the tables are 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,      Oct. 1,      Oct. 1,      Oct. 1,     Beginning
                                                  2007-Sept.   2008-Sept.   2009-Sept.   2010-Sept.    Oct. 1,
                                                   30, 2008     30, 2009     30, 2010     30, 2011       2011
----------------------------------------------------------------------------------------------------------------
Bacterial identification,      Isolate.........       $53.00       $54.00       $55.00       $57.00       $58.00
 automated.
Bacterial identification, non- Isolate.........        90.00        92.00        94.00        96.00        98.00
 automated.
Bacterial isolation..........  Sample..........        36.00        37.00        38.00        39.00        40.00
Bacterial serotyping, all      Isolate.........        55.00        56.00        56.00        57.00        58.00
 other.
Bacterial serotyping,          Isolate.........        18.00        19.00        19.00        19.00        20.00
 Pasteurella multocida.
Bacterial serotyping,          Isolate.........        36.00        37.00        38.00        39.00        40.00
 Salmonella.
Bacterial toxin typing.......  Isolate.........       120.00       123.00       126.00       128.00       131.00
Bacteriology requiring         Test............        92.00        94.00        96.00        98.00       101.00
 special characterization.
DNA fingerprinting...........  Test............        59.00        61.00        62.00        63.00        64.00
DNA probe....................  Test............        83.00        85.00        86.00        88.00        89.00
Fluorescent antibody.........  Test............        19.00        19.00        20.00        20.00        20.00
Mycobacterium identification   Isolate.........       115.00       117.00       120.00       122.00       125.00
 (biochemical).
Mycobacterium identification   Procedure.......        96.00        99.00       101.00       103.00       105.00
 (gas chromatography).
Mycobacterium isolation,       Submission......       844.00       852.00       868.00       884.00       900.00
 animal inoculations.
Mycobacterium isolation, all   Submission......       151.00       154.00       158.00       161.00       165.00
 other.
Mycobacterium                  Submission......        72.00        74.00        75.00        77.00        79.00
 paratuberculosis isolation.
Phage typing, all other......  Isolate.........        42.00        43.00        44.00        45.00        46.00
Phage typing, Salmonella       Isolate.........        24.00        24.00        25.00        25.00        26.00
 enteritidis.
----------------------------------------------------------------------------------------------------------------

    (b) * * *

----------------------------------------------------------------------------------------------------------------
                                                                             User fee
                                                ----------------------------------------------------------------
             Test                    Unit          Oct. 1,      Oct. 1,      Oct. 1,      Oct. 1,     Beginning
                                                  2007-Sept.   2008-Sept.   2009-Sept.   2010-Sept.    Oct. 1,
                                                   30, 2008     30, 2009     30, 2010     30, 2011       2011
----------------------------------------------------------------------------------------------------------------
Fluorescent antibody tissue    Test............       $29.00       $30.00       $30.00       $31.00       $31.00
 section.
Virus isolation..............  Test............        48.00        49.00        50.00        51.00        52.00
----------------------------------------------------------------------------------------------------------------

* * * * *
    3. In Sec.  130.16, paragraphs (a) and (b), the tables are 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) * * *

[[Page 40086]]



--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                        User fee
                                                               -----------------------------------------------------------------------------------------
               Test                            Unit               Oct. 1, 2007-     Oct. 1, 2008-     Oct. 1, 2009-     Oct. 1, 2010-
                                                                 Sept. 30, 2008    Sept. 30, 2009    Sept. 30, 2010    Sept. 30, 2011    Beginning  Oct.
                                                                                                                                             1, 2011
--------------------------------------------------------------------------------------------------------------------------------------------------------
Brucella ring (BRT)...............  Test......................            $36.00            $37.00            $38.00            $39.00            $40.00
Brucella ring, heat inactivated     Test......................             36.00             37.00             38.00             39.00             40.00
 (HIRT).
Brucella ring, serial (Serial BRT)  Test......................             54.00             56.00             57.00             58.00             59.00
Buffered acidified plate antigen    Test......................              7.00              7.25              7.50              7.50              8.00
 presumptive.
Card..............................  Test......................              4.00              4.00              4.25              4.25              4.50
Complement fixation...............  Test......................             16.00             17.00             17.00             17.00             18.00
Enzyme-linked immunosorbent assay.  Test......................             16.00             17.00             17.00             17.00             18.00
Indirect fluorescent antibody.....  Test......................             14.00             15.00             15.00             15.00             16.00
Microscopic agglutination--         Sample....................             24.00             24.00             25.00             25.00             26.00
 includes up to 5 serovars.
Microscopic agglutination--each     Sample....................              4.25              4.50              4.50              4.50              4.75
 serovar in excess of 5 serovars.
Particle concentration fluorescent  Test......................             36.00             37.00             38.00             38.00             39.00
 immunoassay (PCFIA).
Plate.............................  Test......................              7.00              7.25              7.50              7.50              7.75
Rapid automated presumptive.......  Test......................              7.00              7.00              7.25              7.25              7.25
Rivanol...........................  Test......................              7.00              7.25              7.50              7.50              7.75
Tube agglutination................  Test......................              7.00              7.25              7.50              7.50              7.75
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (b) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                        User fee
                                                               -----------------------------------------------------------------------------------------
               Test                            Unit               Oct. 1, 2007-     Oct. 1, 2008-     Oct. 1, 2009-     Oct. 1, 2010-
                                                                 Sept. 30, 2008    Sept. 30, 2009    Sept. 30, 2010    Sept. 30, 2011    Beginning  Oct.
                                                                                                                                             1, 2011
--------------------------------------------------------------------------------------------------------------------------------------------------------
Agar gel immunodiffusion..........  Test......................            $16.00            $17.00            $17.00            $17.00            $18.00
Complement fixation...............  Test......................             16.00             17.00             17.00             18.00             18.00
Enzyme-linked immunosorbent assay.  Test......................             16.00             17.00             17.00             18.00             18.00
Hemagglutination inhibition.......  Test......................             14.00             15.00             15.00             15.00             16.00
Indirect fluorescent antibody.....  Test......................             14.00             15.00             15.00             15.00             16.00
Latex agglutination...............  Test......................             16.00             17.00             17.00             17.00             18.00
Peroxidase-linked antibody........  Test......................             15.00             16.00             16.00             16.00             17.00
Plaque reduction neutralization...  Test......................             18.00             18.00             19.00             19.00             19.00
Rabies fluorescent antibody         Test......................             45.00             46.00             47.00             49.00             50.00
 neutralization.
Virus neutralization..............  Test......................             13.00             13.00             14.00             14.00             14.00
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *
    4. In Sec.  130.17, paragraph (a), the table is 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, 2007-     Oct. 1, 2008-     Oct. 1, 2009-     Oct. 1, 2010-
                                                                 Sept. 30, 2008    Sept. 30, 2009    Sept. 30, 2010    Sept. 30, 2011    Beginning  Oct.
                                                                                                                                             1, 2011
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aflatoxin quantitation............  Test......................            $30.00            $31.00            $32.00            $32.00            $33.00
Aflatoxin screen..................  Test......................             29.00             29.00             30.00             30.00             31.00
Agar gel immunodiffusion spp.       Test......................             13.00             13.00             13.00             14.00             14.00
 identification.
Antibiotic (bioautography)          Test......................             66.00             67.00             68.00             70.00             72.00
 quantitation.

[[Page 40087]]

 
Antibiotic (bioautography) screen.  Test......................            119.00            122.00            125.00            128.00            130.00
Antibiotic inhibition.............  Test......................             66.00             67.00             68.00             70.00             72.00
Arsenic...........................  Test......................             17.00             18.00             18.00             19.00             19.00
Ergot alkaloid screen.............  Test......................             66.00             67.00             68.00             70.00             72.00
Ergot alkaloid confirmation.......  Test......................             86.00             88.00             89.00             91.00             94.00
Feed microscopy...................  Test......................             66.00             67.00             68.00             70.00             72.00
Fumonisin only....................  Test......................             37.00             38.00             39.00             40.00             40.00
Gossypol..........................  Test......................             98.00            100.00            103.00            105.00            107.00
Mercury...........................  Test......................            145.00            148.00            151.00            155.00            158.00
Metals screen.....................  Test......................             44.00             45.00             46.00             47.00             48.00
Metals single element confirmation  Test......................             13.00             13.00             13.00             14.00             14.00
Mycotoxin: aflatoxin-liver........  Test......................            119.00            122.00            125.00            128.00            130.00
Mycotoxin screen..................  Test......................             48.00             49.00             50.00             51.00             52.00
Nitrate/nitrite...................  Test......................             66.00             67.00             68.00             70.00             72.00
Organic compound confirmation.....  Test......................             88.00             90.00             92.00             94.00             96.00
Organic compound screen...........  Test......................            151.00            155.00            158.00            161.00            165.00
Parasitology......................  Test......................             29.00             29.00             30.00             30.00             31.00
Pesticide quantitation............  Test......................            132.00            135.00            138.00            141.00            144.00
Pesticide screen..................  Test......................             60.00             62.00             63.00             64.00             66.00
pH................................  Test......................             26.00             27.00             28.00             28.00             29.00
Plate cylinder....................  Test......................             98.00            100.00            103.00            105.00            107.00
Selenium..........................  Test......................             44.00             45.00             46.00             47.00             48.00
Silicate/carbonate disinfectant...  Test......................             66.00             67.00             68.00             70.00             72.00
Temperature disks.................  Test......................            130.00            133.00            136.00            139.00            142.00
Toxicant quantitation, other......  Test......................            110.00            112.00            115.00            117.00            120.00
Toxicant screen, other............  Test......................             33.00             33.00             34.00             35.00             36.00
Vomitoxin only....................  Test......................             53.00             54.00             55.00             56.00             58.00
Water activity....................  Test......................             33.00             33.00             34.00             35.00             36.00
Zearaleone quantitation...........  Test......................             53.00             54.00             55.00             56.00             58.00
Zearaleone screen.................  Test......................             29.00             29.00             30.00             30.00             31.00
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *
    5. In Sec.  130.18, paragraphs (a) and (b), the tables are 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, 2007-     Oct. 1, 2008-     Oct. 1, 2009-     Oct. 1, 2010-
                                                                 Sept. 30, 2008    Sept. 30, 2009    Sept. 30, 2010    Sept. 30, 2011    Beginning Oct.
                                                                                                                                             1, 2011
--------------------------------------------------------------------------------------------------------------------------------------------------------
Anaplasma card test antigen.......  2 mL......................            $95.00            $97.00            $99.00           $101.00           $103.00
Anaplasma card test kit without     Kit.......................            127.00            130.00            133.00            136.00            139.00
 antigen.
Anaplasma CF antigen..............  2 mL......................             46.00             46.00             46.00             47.00             47.00
Anaplasma stabilate...............  4.5 mL....................            175.00            178.00            181.00            185.00            188.00
Avian origin bacterial antiserums.  1 mL......................             48.00             49.00             50.00             51.00             52.00
Bacterial agglutinating antigens    5 mL......................             54.00             55.00             57.00             58.00             59.00
 other than brucella and
 salmonella pullorum.
Bacterial conjugates..............  1 mL......................             96.00             99.00            101.00            103.00            105.00
Bacterial disease CF antigens, all  1 mL......................             29.00             30.00             30.00             31.00             32.00
 other.
Bacterial ELISA antigens..........  1 mL......................             29.00             30.00             31.00             31.00             32.00
Bacterial or protozoal antiserums,  1 mL......................             60.00             61.00             63.00             64.00             66.00
 all other.
Bacterial reagent culture \1\.....  Culture...................             73.00             74.00             76.00             78.00             79.00
Bacterial reference culture \2\...  Culture...................            228.00            233.00            239.00            244.00            249.00
Bacteriophage reference culture...  Culture...................            172.00            176.00            180.00            183.00            188.00
Bovine serum factor...............  1 mL......................             18.00             18.00             19.00             19.00             19.00

[[Page 40088]]

 
Brucella abortus CF antigen.......  60 mL.....................            151.00            154.00            158.00            161.00            165.00
Brucella agglutination antigens,    60 mL.....................            151.00            154.00            158.00            161.00            165.00
 all other.
Brucella buffered plate antigen...  60 mL.....................            172.00            176.00            180.00            183.00            188.00
Brucella canis tube antigen.......  25 mL.....................            114.00            116.00            119.00            121.00            124.00
Brucella card test antigen          Package...................             90.00             92.00             94.00             96.00             98.00
 (packaged).
Brucella card test kit without      Kit.......................            113.00            114.00            116.00            117.00            119.00
 antigen.
Brucella cells....................  Gram......................             19.00             19.00             19.00             20.00             20.00
Brucella cells, dried.............  Pellet....................              6.00              6.00              6.25              6.25              6.25
Brucella ring test antigen........  60 mL.....................            241.00            246.00            252.00            257.00            263.00
Brucella rivanol solution.........  60 mL.....................             29.00             30.00             31.00             31.00             32.00
Dourine CF antigen................  1 mL......................             89.00             91.00             93.00             95.00             97.00
Dourine stabilate.................  4.5 mL....................            109.00            111.00            112.00            114.00            116.00
Equine and bovine origin babesia    1 mL......................            127.00            130.00            133.00            136.00            139.00
 species antiserums.
Equine negative control CF antigen  1 mL......................            282.00            283.00            286.00            290.00            293.00
Flazo-orange......................  3 mL......................             13.00             13.00             13.00             13.00             14.00
Glanders CF antigen...............  1 mL......................             77.00             79.00             81.00             82.00             84.00
Hemoparasitic disease CF antigens,  1 mL......................            541.00            553.00            565.00            577.00            590.00
 all other.
Leptospira transport medium.......  10 mL.....................              4.25              4.50              4.50              4.50              4.75
Monoclonal antibody...............  1 mL......................             95.00             97.00             99.00            101.00            103.00
Mycobacterium spp. old tuberculin.  1 mL......................             24.00             24.00             25.00             25.00             26.00
Mycobacterium spp. PPD............  1 mL......................             18.00             19.00             19.00             19.00             20.00
Mycoplasma hemagglutination         5 mL......................            180.00            184.00            188.00            192.00            197.00
 antigens.
Negative control serums...........  1 mL......................             18.00             19.00             19.00             19.00             20.00
Rabbit origin bacterial antiserum.  1 mL......................             52.00             53.00             54.00             55.00             56.00
Salmonella pullorum                 5 mL......................             15.00             16.00             16.00             16.00             17.00
 microagglutination antigen.
Stabilates, all other.............  4.5 mL....................            684.00            690.00            703.00            716.00           730.00
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 agglutination 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, 2007-     Oct. 1, 2008-     Oct. 1, 2009-     Oct. 1, 2010-
                                                                 Sept. 30, 2008    Sept. 30, 2009    Sept. 30, 2010    Sept. 30, 2011    Beginning Oct.
                                                                                                                                             1, 2011
--------------------------------------------------------------------------------------------------------------------------------------------------------
Antigen, except avian influenza     2 mL......................            $61.00            $62.00            $64.00            $65.00            $67.00
 and chlamydia psittaci antigens,
 any.
Avian antiserum except avian        2 mL......................             48.00             49.00             51.00             52.00             53.00
 influenza antiserum, any.
Avian influenza antigen, any......  2 mL......................             33.00             34.00             35.00             36.00             36.00
Avian influenza antiserum, any....  6 mL......................            103.00            105.00            108.00            110.00            113.00
Bovine or ovine serum, any........  2 mL......................            127.00            130.00            133.00            136.00            139.00
Cell culture......................  Flask.....................            151.00            154.00            158.00            161.00            165.00

[[Page 40089]]

 
Chlamydia psittaci spp. of origin   Panel.....................             95.00             96.00             98.00             99.00            101.00
 monoclonal antibody panel.
Conjugate, any....................  1 mL......................             73.00             75.00             76.00             78.00             80.00
Diluted positive control serum,     2 mL......................             24.00             25.00             25.00             26.00             27.00
 any.
Equine antiserum, any.............  2 mL......................             45.00             46.00             47.00             48.00             49.00
Monoclonal antibody...............  1 mL......................            102.00            104.00            106.00            108.00            110.00
Other spp. antiserum, any.........  1 mL......................             52.00             52.00             52.00             53.00             53.00
Porcine antiserum, any............  2 mL......................            105.00            108.00            110.00            113.00            115.00
Porcine tissue sets...............  Tissue set................            157.00            157.00            158.00            159.00            161.00
Positive control tissues, all.....  2 cm\2\ section...........             60.00             62.00             63.00             65.00             66.00
Rabbit origin antiserum...........  1 mL......................             52.00             53.00             54.00             55.00             56.00
Reference virus, any..............  0.6 mL....................            180.00            184.00            188.00            193.00            197.00
Viruses (except reference           0.6 mL....................             30.00             31.00             32.00             32.00             33.00
 viruses), chlamydia psittaci
 agent or chlamydia psittaci
 antigen, any.
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *
    6. In Sec.  130.19, paragraph (a), the table is 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, 2007-     Oct. 1, 2008-     Oct. 1, 2009-     Oct. 1, 2010-
                                                                 Sept. 30, 2008    Sept. 30, 2009    Sept. 30, 2010    Sept. 30, 2011       Beginning
                                                                                                                                           Oct.1,2011
--------------------------------------------------------------------------------------------------------------------------------------------------------
Antimicrobial susceptibility test.  Isolate...................           $105.00           $107.00           $109.00           $112.00           $114.00
Avian safety test.................  Test......................          4,082.00          4,090.00          4,099.00          4,109.00          4,180.00
Check tests, culture..............  Kit\1\....................            176.00            179.00            182.00            185.00            189.00
Check tests, serology.............  Kit\1\....................            361.00            369.00            377.00            385.00            394.00
Fetal bovine serum safety test....  Verification..............          1,119.00          1,122.00          1,134.00          1,147.00          1,160.00
Hourly user fees \2\..............
Hour..............................  Hour......................            104.00            104.00            108.00            112.00            112.00
Quarter hour......................  Quarter hour..............             26.00             26.00             27.00             28.00             28.00
Minimum...........................  ..........................             30.00             31.00             32.00             33.00             33.00
Manual, brucellosis culture.......  1 copy....................            115.00            117.00            120.00            122.00            125.00
Manual, tuberculosis culture        1 copy....................            172.00            176.00            180.00            183.00            188.00
 (English or Spanish).
Manual, Veterinary mycology.......  1 copy....................            172.00            176.00            180.00            183.00            188.00
Manuals or standard operating       1 copy....................             34.00             35.00             36.00             37.00             37.00
 procedure (SOP), all other.
Manuals or SOP, per page..........  1 page....................              2.25              2.50              2.50              2.75              2.75
Training (school or technical       Per person per day........            332.00            339.00            346.00            354.00            362.00
 assistance).
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Any reagents required for the check test will be charged separately.
\2\ For veterinary diagnostic services for which there is no flat user fee the hourly rate user fee will be calculated for the actual time required to
  provide the service.


[[Page 40090]]

* * * * *

    Done in Washington, DC, this 18th day of July 2007.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
 [FR Doc. E7-14162 Filed 7-20-07; 8:45 am]
BILLING CODE 3410-34-P ?>