Veterinary Diagnostic Services User Fees, 40082-40090 [E7-14162]
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40082
Proposed Rules
Federal Register
Vol. 72, No. 140
Monday, July 23, 2007
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.
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
Animal and Plant Health
Inspection Service, USDA.
ACTION: Proposed rule.
sroberts on PROD1PC70 with PROPOSALS
AGENCY:
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
https://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
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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
https://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
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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
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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 § 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
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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
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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.
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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
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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 fullcost 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
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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
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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 § 130.15, paragraphs (a) and (b),
the tables are revised to read as follows:
§ 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,
2007–Sept.
30, 2008
Oct. 1,
2008–Sept.
30, 2009
Oct. 1,
2009–Sept.
30, 2010
Oct. 1,
2010–Sept.
30, 2011
Beginning
Oct. 1, 2011
Bacterial identification, automated ..................
Bacterial identification, non-automated ...........
Bacterial isolation ............................................
Bacterial serotyping, all other .........................
Bacterial serotyping, Pasteurella multocida ....
Bacterial serotyping, Salmonella ....................
Bacterial toxin typing .......................................
Bacteriology requiring special characterization
DNA fingerprinting ...........................................
DNA probe ......................................................
Fluorescent antibody .......................................
Mycobacterium identification (biochemical) ....
Mycobacterium identification (gas chromatography).
Mycobacterium isolation, animal inoculations
Mycobacterium isolation, all other ..................
Mycobacterium paratuberculosis isolation ......
Phage typing, all other ....................................
Phage typing, Salmonella enteritidis ..............
Isolate .........................
Isolate .........................
Sample .......................
Isolate .........................
Isolate .........................
Isolate .........................
Isolate .........................
Test ............................
Test ............................
Test ............................
Test ............................
Isolate .........................
Procedure ...................
$53.00
90.00
36.00
55.00
18.00
36.00
120.00
92.00
59.00
83.00
19.00
115.00
96.00
$54.00
92.00
37.00
56.00
19.00
37.00
123.00
94.00
61.00
85.00
19.00
117.00
99.00
$55.00
94.00
38.00
56.00
19.00
38.00
126.00
96.00
62.00
86.00
20.00
120.00
101.00
$57.00
96.00
39.00
57.00
19.00
39.00
128.00
98.00
63.00
88.00
20.00
122.00
103.00
$58.00
98.00
40.00
58.00
20.00
40.00
131.00
101.00
64.00
89.00
20.00
125.00
105.00
Submission .................
Submission .................
Submission .................
Isolate .........................
Isolate .........................
844.00
151.00
72.00
42.00
24.00
852.00
154.00
74.00
43.00
24.00
868.00
158.00
75.00
44.00
25.00
884.00
161.00
77.00
45.00
25.00
900.00
165.00
79.00
46.00
26.00
(b) * * *
User fee
Test
Unit
Fluorescent antibody tissue section ...............
Virus isolation ..................................................
Test ............................
Test ............................
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*
*
*
*
*
3. In § 130.16, paragraphs (a) and (b),
the tables are revised to read as follows:
Oct. 1,
2007–Sept.
30, 2008
Oct. 1,
2008–Sept.
30, 2009
Oct. 1,
2009–Sept.
30, 2010
Oct. 1,
2010–Sept.
30, 2011
Beginning
Oct. 1, 2011
$29.00
48.00
$30.00
49.00
$30.00
50.00
$31.00
51.00
$31.00
52.00
§ 130.16 User fees for veterinary
diagnostic serology tests performed at
NVSL (excluding FADDL) or at authorized
sites.
(a) * * *
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User fee
Test
Unit
Brucella ring (BRT) ...........
Brucella ring, heat inactivated (HIRT).
Brucella ring, serial (Serial
BRT).
Buffered acidified plate
antigen presumptive.
Card ..................................
Complement fixation .........
Enzyme-linked
immunosorbent assay.
Indirect fluorescent antibody.
Microscopic agglutination—includes up to 5
serovars.
Microscopic agglutination—each serovar in
excess of 5 serovars.
Particle concentration fluorescent immunoassay
(PCFIA).
Plate ..................................
Rapid automated presumptive.
Rivanol ..............................
Tube agglutination ............
Test ..................
Test ..................
$36.00
36.00
$37.00
37.00
$38.00
38.00
$39.00
39.00
$40.00
40.00
Test ..................
54.00
56.00
57.00
58.00
59.00
Test ..................
7.00
7.25
7.50
7.50
8.00
Test ..................
Test ..................
Test ..................
4.00
16.00
16.00
4.00
17.00
17.00
4.25
17.00
17.00
4.25
17.00
17.00
4.50
18.00
18.00
Test ..................
14.00
15.00
15.00
15.00
16.00
Sample .............
24.00
24.00
25.00
25.00
26.00
Sample .............
4.25
4.50
4.50
4.50
4.75
Test ..................
36.00
37.00
38.00
38.00
39.00
Test ..................
Test ..................
7.00
7.00
7.25
7.00
7.50
7.25
7.50
7.25
7.75
7.25
Test ..................
Test ..................
7.00
7.00
7.25
7.25
7.50
7.50
7.50
7.50
7.75
7.75
Oct. 1, 2007–
Sept. 30, 2008
Oct. 1, 2008–
Sept. 30, 2009
Oct. 1, 2009–
Sept. 30, 2010
Oct. 1, 2010–
Sept. 30, 2011
Beginning
Oct. 1, 2011
(b) * * *
User fee
Test
Unit
Agar gel immunodiffusion
Complement fixation .........
Enzyme-linked
immunosorbent assay.
Hemagglutination inhibition
Indirect fluorescent antibody.
Latex agglutination ............
Peroxidase-linked antibody
Plaque reduction neutralization.
Rabies fluorescent antibody neutralization.
Virus neutralization ...........
Test ..................
Test ..................
Test ..................
$16.00
16.00
16.00
$17.00
17.00
17.00
$17.00
17.00
17.00
$17.00
18.00
18.00
$18.00
18.00
18.00
Test ..................
Test ..................
14.00
14.00
15.00
15.00
15.00
15.00
15.00
15.00
16.00
16.00
Test ..................
Test ..................
Test ..................
16.00
15.00
18.00
17.00
16.00
18.00
17.00
16.00
19.00
17.00
16.00
19.00
18.00
17.00
19.00
Test ..................
45.00
46.00
47.00
49.00
50.00
Test ..................
13.00
13.00
14.00
14.00
14.00
Oct. 1, 2007–
Sept. 30, 2008
*
*
*
*
*
4. In § 130.17, paragraph (a), the table
is revised to read as follows:
Oct. 1, 2008–
Sept. 30, 2009
Oct. 1, 2009–
Sept. 30, 2010
Oct. 1, 2010–
Sept. 30, 2011
Beginning
Oct. 1, 2011
§ 130.17 User fees for other veterinary
diagnostic laboratory tests performed at
NVSL (excluding FADDL) or at authorized
sites.
(a) * * *
User fee
sroberts on PROD1PC70 with PROPOSALS
Test
Unit
Aflatoxin quantitation .........
Aflatoxin screen ................
Agar gel immunodiffusion
spp. identification.
Antibiotic (bioautography)
quantitation.
Test ..................
Test ..................
Test ..................
$30.00
29.00
13.00
$31.00
29.00
13.00
$32.00
30.00
13.00
$32.00
30.00
14.00
$33.00
31.00
14.00
Test ..................
66.00
67.00
68.00
70.00
72.00
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16:41 Jul 20, 2007
Jkt 211001
Oct. 1, 2007–
Sept. 30, 2008
PO 00000
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Oct. 1, 2008–
Sept. 30, 2009
Fmt 4702
Sfmt 4702
Oct. 1, 2009–
Sept. 30, 2010
E:\FR\FM\23JYP1.SGM
Oct. 1, 2010–
Sept. 30, 2011
23JYP1
Beginning
Oct. 1, 2011
Federal Register / Vol. 72, No. 140 / Monday, July 23, 2007 / Proposed Rules
40087
User fee
Test
Unit
Antibiotic (bioautography)
screen.
Antibiotic inhibition ............
Arsenic ..............................
Ergot alkaloid screen ........
Ergot alkaloid confirmation
Feed microscopy ...............
Fumonisin only ..................
Gossypol ...........................
Mercury .............................
Metals screen ....................
Metals single element confirmation.
Mycotoxin: aflatoxin-liver ...
Mycotoxin screen ..............
Nitrate/nitrite ......................
Organic compound confirmation.
Organic compound screen
Parasitology ......................
Pesticide quantitation ........
Pesticide screen ................
pH ......................................
Plate cylinder ....................
Selenium ...........................
Silicate/carbonate disinfectant.
Temperature disks ............
Toxicant quantitation, other
Toxicant screen, other ......
Vomitoxin only ...................
Water activity ....................
Zearaleone quantitation ....
Zearaleone screen ............
Test ..................
119.00
122.00
125.00
128.00
130.00
Test
Test
Test
Test
Test
Test
Test
Test
Test
Test
..................
..................
..................
..................
..................
..................
..................
..................
..................
..................
66.00
17.00
66.00
86.00
66.00
37.00
98.00
145.00
44.00
13.00
67.00
18.00
67.00
88.00
67.00
38.00
100.00
148.00
45.00
13.00
68.00
18.00
68.00
89.00
68.00
39.00
103.00
151.00
46.00
13.00
70.00
19.00
70.00
91.00
70.00
40.00
105.00
155.00
47.00
14.00
72.00
19.00
72.00
94.00
72.00
40.00
107.00
158.00
48.00
14.00
Test
Test
Test
Test
..................
..................
..................
..................
119.00
48.00
66.00
88.00
122.00
49.00
67.00
90.00
125.00
50.00
68.00
92.00
128.00
51.00
70.00
94.00
130.00
52.00
72.00
96.00
Test
Test
Test
Test
Test
Test
Test
Test
..................
..................
..................
..................
..................
..................
..................
..................
151.00
29.00
132.00
60.00
26.00
98.00
44.00
66.00
155.00
29.00
135.00
62.00
27.00
100.00
45.00
67.00
158.00
30.00
138.00
63.00
28.00
103.00
46.00
68.00
161.00
30.00
141.00
64.00
28.00
105.00
47.00
70.00
165.00
31.00
144.00
66.00
29.00
107.00
48.00
72.00
Test
Test
Test
Test
Test
Test
Test
..................
..................
..................
..................
..................
..................
..................
130.00
110.00
33.00
53.00
33.00
53.00
29.00
133.00
112.00
33.00
54.00
33.00
54.00
29.00
136.00
115.00
34.00
55.00
34.00
55.00
30.00
139.00
117.00
35.00
56.00
35.00
56.00
30.00
142.00
120.00
36.00
58.00
36.00
58.00
31.00
Oct. 1, 2007–
Sept. 30, 2008
*
*
*
*
*
5. In § 130.18, paragraphs (a) and (b),
the tables are revised to read as follows:
Oct. 1, 2008–
Sept. 30, 2009
Oct. 1, 2009–
Sept. 30, 2010
Oct. 1, 2010–
Sept. 30, 2011
Beginning
Oct. 1, 2011
§ 130.18 User fees for veterinary
diagnostic reagents produced at NVSL or
other authorized site (excluding FADDL).
(a) * * *
User fee
sroberts on PROD1PC70 with PROPOSALS
Reagent
Unit
Anaplasma card test antigen.
Anaplasma card test kit
without antigen.
Anaplasma CF antigen .....
Anaplasma stabilate ..........
Avian origin bacterial
antiserums.
Bacterial agglutinating antigens other than brucella
and salmonella pullorum.
Bacterial conjugates ..........
Bacterial disease CF antigens, all other.
Bacterial ELISA antigens ..
Bacterial or protozoal
antiserums, all other.
Bacterial reagent culture 1
Bacterial reference culture 2.
Bacteriophage reference
culture.
Bovine serum factor ..........
2 mL .................
$95.00
$97.00
$99.00
$101.00
$103.00
Kit .....................
127.00
130.00
133.00
136.00
139.00
2 mL .................
4.5 mL ..............
1 mL .................
46.00
175.00
48.00
46.00
178.00
49.00
46.00
181.00
50.00
47.00
185.00
51.00
47.00
188.00
52.00
5 mL .................
54.00
55.00
57.00
58.00
59.00
1 mL .................
1 mL .................
96.00
29.00
99.00
30.00
101.00
30.00
103.00
31.00
105.00
32.00
1 mL .................
1 mL .................
29.00
60.00
30.00
61.00
31.00
63.00
31.00
64.00
32.00
66.00
Culture ..............
Culture ..............
73.00
228.00
74.00
233.00
76.00
239.00
78.00
244.00
79.00
249.00
Culture ..............
172.00
176.00
180.00
183.00
188.00
1 mL .................
18.00
18.00
19.00
19.00
19.00
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Sept. 30, 2008
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Oct. 1, 2008–
Sept. 30, 2009
Fmt 4702
Sfmt 4702
Oct. 1, 2009–
Sept. 30, 2010
E:\FR\FM\23JYP1.SGM
Oct. 1, 2010–
Sept. 30, 2011
23JYP1
Beginning Oct. 1,
2011
40088
Federal Register / Vol. 72, No. 140 / Monday, July 23, 2007 / Proposed Rules
User fee
Reagent
Unit
Brucella abortus CF antigen.
Brucella agglutination antigens, all other.
Brucella buffered plate
antigen.
Brucella canis tube antigen
Brucella card test antigen
(packaged).
Brucella card test kit without antigen.
Brucella cells .....................
Brucella cells, dried ...........
Brucella ring test antigen ..
Brucella rivanol solution ....
Dourine CF antigen ...........
Dourine stabilate ...............
Equine and bovine origin
babesia species
antiserums.
Equine negative control
CF antigen.
Flazo-orange .....................
Glanders CF antigen .........
Hemoparasitic disease CF
antigens, all other.
Leptospira transport medium.
Monoclonal antibody .........
Mycobacterium spp. old tuberculin.
Mycobacterium spp. PPD
Mycoplasma
hemagglutination antigens.
Negative control serums ...
Rabbit origin bacterial antiserum.
Salmonella pullorum
microagglutination antigen.
Stabilates, all other ...........
60 mL ...............
151.00
154.00
158.00
161.00
165.00
60 mL ...............
151.00
154.00
158.00
161.00
165.00
60 mL ...............
172.00
176.00
180.00
183.00
188.00
25 mL ...............
Package ...........
114.00
90.00
116.00
92.00
119.00
94.00
121.00
96.00
124.00
98.00
Kit .....................
113.00
114.00
116.00
117.00
119.00
Gram ................
Pellet ................
60 mL ...............
60 mL ...............
1 mL .................
4.5 mL ..............
1 mL .................
19.00
6.00
241.00
29.00
89.00
109.00
127.00
19.00
6.00
246.00
30.00
91.00
111.00
130.00
19.00
6.25
252.00
31.00
93.00
112.00
133.00
20.00
6.25
257.00
31.00
95.00
114.00
136.00
20.00
6.25
263.00
32.00
97.00
116.00
139.00
1 mL .................
282.00
283.00
286.00
290.00
293.00
3 mL .................
1 mL .................
1 mL .................
13.00
77.00
541.00
13.00
79.00
553.00
13.00
81.00
565.00
13.00
82.00
577.00
14.00
84.00
590.00
10 mL ...............
4.25
4.50
4.50
4.50
4.75
1 mL .................
1 mL .................
95.00
24.00
97.00
24.00
99.00
25.00
101.00
25.00
103.00
26.00
1 mL .................
5 mL .................
18.00
180.00
19.00
184.00
19.00
188.00
19.00
192.00
20.00
197.00
1 mL .................
1 mL .................
18.00
52.00
19.00
53.00
19.00
54.00
19.00
55.00
20.00
56.00
5 mL .................
15.00
16.00
16.00
16.00
17.00
4.5 mL ..............
684.00
690.00
703.00
716.00
730.00
Oct. 1, 2007–
Sept. 30, 2008
Oct. 1, 2008–
Sept. 30, 2009
Oct. 1, 2009–
Sept. 30, 2010
Oct. 1, 2010–
Sept. 30, 2011
Beginning Oct. 1,
2011
1A
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
sroberts on PROD1PC70 with PROPOSALS
Reagent
Unit
Antigen, except avian influenza and chlamydia
psittaci antigens, any.
Avian antiserum except
avian influenza antiserum, any.
Avian influenza antigen,
any.
Avian influenza antiserum,
any.
Bovine or ovine serum,
any.
Cell culture ........................
2 mL .................
$61.00
$62.00
$64.00
$65.00
$67.00
2 mL .................
48.00
49.00
51.00
52.00
53.00
2 mL .................
33.00
34.00
35.00
36.00
36.00
6 mL .................
103.00
105.00
108.00
110.00
113.00
2 mL .................
127.00
130.00
133.00
136.00
139.00
Flask .................
151.00
154.00
158.00
161.00
165.00
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16:41 Jul 20, 2007
Jkt 211001
Oct. 1, 2007–
Sept. 30, 2008
PO 00000
Frm 00007
Oct. 1, 2008–
Sept. 30, 2009
Fmt 4702
Sfmt 4702
Oct. 1, 2009–
Sept. 30, 2010
E:\FR\FM\23JYP1.SGM
Oct. 1, 2010–
Sept. 30, 2011
23JYP1
Beginning Oct. 1,
2011
Federal Register / Vol. 72, No. 140 / Monday, July 23, 2007 / Proposed Rules
40089
User fee
Reagent
Unit
Chlamydia psittaci spp. of
origin monoclonal antibody panel.
Conjugate, any ..................
Diluted positive control
serum, any.
Equine antiserum, any ......
Monoclonal antibody .........
Other spp. antiserum, any
Porcine antiserum, any .....
Porcine tissue sets ............
Positive control tissues, all
Rabbit origin antiserum .....
Reference virus, any .........
Viruses (except reference
viruses), chlamydia
psittaci agent or
chlamydia psittaci antigen, any.
Panel ................
95.00
96.00
98.00
99.00
101.00
1 mL .................
2 mL .................
73.00
24.00
75.00
25.00
76.00
25.00
78.00
26.00
80.00
27.00
2 mL .................
1 mL .................
1 mL .................
2 mL .................
Tissue set .........
2 cm2 section ...
1 mL .................
0.6 mL ..............
0.6 mL ..............
45.00
102.00
52.00
105.00
157.00
60.00
52.00
180.00
30.00
46.00
104.00
52.00
108.00
157.00
62.00
53.00
184.00
31.00
47.00
106.00
52.00
110.00
158.00
63.00
54.00
188.00
32.00
48.00
108.00
53.00
113.00
159.00
65.00
55.00
193.00
32.00
49.00
110.00
53.00
115.00
161.00
66.00
56.00
197.00
33.00
Oct. 1, 2007–
Sept. 30, 2008
*
*
*
*
*
6. In § 130.19, paragraph (a), the table
is revised to read as follows:
Oct. 1, 2008–
Sept. 30, 2009
Oct. 1, 2009–
Sept. 30, 2010
Oct. 1, 2010–
Sept. 30, 2011
Beginning Oct. 1,
2011
§ 130.19 User fees for other veterinary
diagnostic services or materials provided at
NVSL (excluding FADDL).
(a) * * *
User fee
Service
Unit
Antimicrobial susceptibility
test.
Avian safety test ...............
Check tests, culture ..........
Check tests, serology .......
Fetal bovine serum safety
test.
Hourly user fees 2.
Hour ..................................
Quarter hour ......................
Minimum ............................
Manual, brucellosis culture
Manual, tuberculosis culture (English or Spanish).
Manual, Veterinary mycology.
Manuals or standard operating procedure (SOP),
all other.
Manuals or SOP, per page
Training (school or technical assistance).
Isolate ...............
$105.00
$107.00
$109.00
$112.00
$114.00
Test ..................
Kit1 ....................
Kit1 ....................
Verification ........
4,082.00
176.00
361.00
1,119.00
4,090.00
179.00
369.00
1,122.00
4,099.00
182.00
377.00
1,134.00
4,109.00
185.00
385.00
1,147.00
4,180.00
189.00
394.00
1,160.00
Hour ..................
Quarter hour .....
...........................
1 copy ...............
1 copy ...............
104.00
26.00
30.00
115.00
172.00
104.00
26.00
31.00
117.00
176.00
108.00
27.00
32.00
120.00
180.00
112.00
28.00
33.00
122.00
183.00
112.00
28.00
33.00
125.00
188.00
1 copy ...............
172.00
176.00
180.00
183.00
188.00
1 copy ...............
34.00
35.00
36.00
37.00
37.00
1 page ..............
Per person per
day.
2.25
332.00
2.50
339.00
2.50
346.00
2.75
354.00
2.75
362.00
Oct. 1, 2007–
Sept. 30, 2008
Oct. 1, 2008–
Sept. 30, 2009
Oct. 1, 2009–
Sept. 30, 2010
Oct. 1, 2010–
Sept. 30, 2011
1 Any
Beginning
Oct.1,2011
reagents required for the check test will be charged separately.
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.
sroberts on PROD1PC70 with PROPOSALS
2 For
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40090
*
*
Federal Register / Vol. 72, No. 140 / Monday, July 23, 2007 / Proposed Rules
*
*
*
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 ?≤
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. FAA–2005–21470; Directorate
Identifier 2003–NM–45–AD]
RIN 2120–AA64
Airworthiness Directives; McDonnell
Douglas Model DC–10–10, DC–10–10F,
DC–10–15, DC–10–30 and DC–10–30F
(KC–10A and KDC–10) Airplanes;
Model DC–10–40 and DC–10–40F
Airplanes; and Model MD–11 and MD–
11F Airplanes
Federal Aviation
Administration (FAA), Department of
Transportation (DOT).
ACTION: Supplemental notice of
proposed rulemaking (NPRM);
reopening of comment period.
sroberts on PROD1PC70 with PROPOSALS
AGENCY:
SUMMARY: The FAA is revising an earlier
proposed airworthiness directive (AD)
for certain McDonnell Douglas Model
DC–10–10, DC–10–10F, DC–10–15, DC–
10–30 and DC–10–30F (KC–10A and
KDC–10) airplanes; Model DC–10–40
and DC–10–40F airplanes; and Model
MD–11 and MD–11F airplanes. The
original NPRM would have required, for
certain airplanes, modifying the thrust
reverser command wiring of the number
2 engine. For certain other airplanes, the
original NPRM would have required
modifying the thrust reverser system
wiring from the flight compartment to
engines 1, 2, and 3 thrust reversers. The
original NPRM also would have
required installing thrust reverser
locking systems on certain airplanes.
The original NPRM resulted from a
determination that the thrust reverser
systems on these McDonnell Douglas
airplanes do not adequately preclude
unwanted deployment of a thrust
reverser. This action revises the original
NPRM by revising, for certain airplanes,
the requirements for the modification of
the thrust reverser system wiring from
the flight compartment to engines 1, 2,
and 3 thrust reversers. We are proposing
this supplemental NPRM to prevent an
unwanted deployment of a thrust
reverser during flight, which could
VerDate Aug<31>2005
16:41 Jul 20, 2007
Jkt 211001
result in reduced controllability of the
airplane.
DATES: We must receive comments on
this supplemental NPRM by August 17,
2007.
ADDRESSES: Use one of the following
addresses to submit comments on this
supplemental NPRM.
• DOT Docket Web site: Go to
https://dms.dot.gov and follow the
instructions for sending your comments
electronically.
• Government-wide rulemaking Web
site: Go to https://www.regulations.gov
and follow the instructions for sending
your comments electronically.
• Mail: U.S. Department of
Transportation, Docket Operations, M–
30, West Building Ground Floor, Room
W12–140, 1200 New Jersey Avenue SE.,
Washington, DC 20590.
• Fax: (202) 493–2251.
• Hand Delivery: Room W12–140 on
the ground floor of the West Building,
1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5
p.m., Monday through Friday, except
Federal holidays.
Contact Boeing Commercial
Airplanes, Long Beach Division, 3855
Lakewood Boulevard, Long Beach,
California 90846, Attention: Data and
Service Management, Dept. C1–L5A
(D800–0024), for service information
identified in this proposed AD.
FOR FURTHER INFORMATION CONTACT:
Philip C. Kush, Aerospace Engineer,
Propulsion Branch, ANM–140L, FAA,
Los Angeles Aircraft Certification
Office, 3960 Paramount Boulevard,
Lakewood, California 90712–4137;
telephone (562) 627–5263; fax (562)
627–5210.
SUPPLEMENTARY INFORMATION:
Comments Invited
We invite you to submit any relevant
written data, views, or arguments
regarding this supplemental NPRM.
Send your comments to an address
listed in the ADDRESSES section. Include
the docket number ‘‘Docket No. FAA–
2005–21470; Directorate Identifier
2003–NM–45–AD’’ at the beginning of
your comments. We specifically invite
comments on the overall regulatory,
economic, environmental, and energy
aspects of this supplemental NPRM. We
will consider all comments received by
the closing date and may amend this
supplemental NPRM in light of those
comments.
We will post all comments submitted,
without change, to https://dms.dot.gov,
including any personal information you
provide. We will also post a report
summarizing each substantive verbal
contact with FAA personnel concerning
PO 00000
Frm 00009
Fmt 4702
Sfmt 4702
this supplemental NPRM. Using the
search function of that Web site, anyone
can find and read the comments in any
of our dockets, including the name of
the individual who sent the comment
(or signed the comment on behalf of an
association, business, labor union, etc.).
You may review the DOT’s complete
Privacy Act Statement in the Federal
Register published on April 11, 2000
(65 FR 19477–78), or you may visit
https://dms.dot.gov.
Examining the Docket
You may examine the AD docket on
the Internet at https://dms.dot.gov, or in
person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
The Docket Operations office (telephone
(800) 647–5527) is located on the
ground floor of the West Building at the
street address stated in the ADDRESSES
section. Comments will be available in
the AD docket shortly after the Docket
Management System receives them.
Discussion
We proposed to amend 14 CFR part
39 with a notice of proposed rulemaking
(NPRM) for an AD (the ‘‘original
NPRM’’) for certain McDonnell Douglas
Model DC–10–10, DC–10–10F, DC–10–
15, DC–10–30 and DC–10–30F (KC–10A
and KDC–10) airplanes; Model DC–10–
40 and DC–10–40F airplanes; and
Model MD–11 and MD–11F airplanes.
The original NPRM was published in
the Federal Register on June 16, 2005
(70 FR 35049). The original NPRM
proposed to require, for certain
airplanes, modifying the thrust reverser
command wiring of the number 2
engine. For certain other airplanes, the
original NPRM proposed to require
modifying the thrust reverser system
wiring from the flight compartment to
engines 1, 2, and 3 thrust reversers. The
original NPRM also proposed to require
installing thrust reverser locking
systems on certain airplanes.
Relevant Service Information
Since we issued the original NPRM,
Boeing has issued Boeing Alert Service
Bulletin MD11–78A007, Revision 4,
dated February 22, 2007 (Boeing Service
Bulletin MD11–78–007, Revision 02,
dated August 22, 2001, was referred to
as the appropriate source of service
information for modifying the thrust
reverser system wiring from the flight
compartment to engines 1, 2, and 3
thrust reversers in the original NPRM
for Model MD–11 and –11F airplanes).
Revision 4 of the alert service bulletin
requires additional work (wire changes
in the wing root and empennage with
metallic lightning overbraid and
E:\FR\FM\23JYP1.SGM
23JYP1
]]>Agencies
[Federal Register Volume 72, Number 140 (Monday, July 23, 2007)]
[Proposed Rules]
[Pages 40082-40090]
From the Federal Register Online via the Government Printing 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 https://
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 https://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 ?>
