[Federal Register: July 23, 2007 (Volume 72, Number 140)]
[Proposed Rules]
[Page 40082-40090]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jy07-12]
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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.
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[[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.
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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) * * *
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User fee
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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.
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(b) * * *
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User fee
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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]]
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User fee
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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
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* * * * *
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
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\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