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Rule

Veterinary Diagnostic Services User Fees

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Final rule.

SUMMARY:

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

DATES:

Effective Date: June 7, 2004.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

For information concerning program operations, contact Dr. Randall Levings, Director, National Veterinary Services Laboratories, 1800 Dayton Road, PO Box 844, Ames, IA 50010; (515) 663-7357.

For information concerning user fee rate development, contact Mrs. Kris Caraher, User Fees Section Head, Financial Systems and Services Branch, APHIS, 4700 River Road Unit 54, Riverdale, MD 20737-1232; (301) 734-5901.

End Further Info End Preamble Start Supplemental Information

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 § 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.

On July 24, 2003, we published in the Federal Register (68 FR 43661-43673, Docket No. 00-024-1) a proposed rule to increase the user fees for veterinary diagnostic services to reflect changes in our operating costs and changes in calculating our costs, and to establish rates for multiple fiscal years. Operating costs have increased since these user fees were established in a final rule published in the Federal Register on October 7, 1998 (63 FR 53783-53798, Docket No. 94-115-2). Therefore, the user fees need to be updated to reflect those increases. However, the main reason for the increase in the fees is cost data gathered through new cost-finding techniques employed by APHIS. The Statement of Federal Financial Accounting Standards (SFFAS) No. 4, “Managerial Cost Accounting Standards and Concepts,” issued by the Office of Management and Budget, mandated that APHIS capture cost accounting data in its program costs. We were required to accumulate and report the costs of veterinary diagnostic activities on a regular basis through the use of cost accounting systems and cost finding techniques. In order to comply with SFFAS No. 4, APHIS conducted an Activity Based Costing (ABC) project at the National Veterinary Services Laboratories in Ames, IA, which identified the sources of all costs for veterinary diagnostic services. As a result of that project, we determined that costs for user fee-related services were not adequately being recovered through user fee collections. Based on this determination, we proposed new fees to recover these newly identified costs. Each of the updated user fees contains a proportionate share of the costs identified in the ABC study.

We solicited comments concerning our proposal for 60 days ending September 22, 2003. We received two comments by that date, from a livestock exporting company and a State laboratory.

One commenter, the livestock exporter, stated that the proposed fee Start Printed Page 25306increases could force his company to move its operations to Canada, where he says costs are lower, or to cease operations. He described his company as the Pacific Northwest's only permanent livestock export inspection facility.

APHIS has received no directly appropriated funds to provide import- and export-related services for animals, animal products, birds, germ plasm, organisms, and vectors since fiscal year 1992. Rather, the Food, Agriculture, Conservation, and Trade Act of 1990, as amended, and the Animal Health Protection Act authorize the U.S. Department of Agriculture to prescribe and collect user fees for those services. Therefore, to continue to provide those services, we must recover our costs from the customers who benefit from those services.

For reasons described in the economic analysis we provided in the proposed rule, we do not anticipate that the fee increases in this rule will cause exports to decline or result in decreased testing. While APHIS hopes that this fee increase does not cause the commenter's inspection facility to close, such facilities operate throughout the United States; if the commenter's facility closed, inspections would be performed at the next closest or next convenient location. We are not making any changes to the proposed rule in response to this comment.

One commenter stated that the user fee increases in our proposed rule would result in a loss of revenue for the National Veterinary Services Laboratories, creating a need for further increases in the user fees.

In response, we would like to reiterate that our user fees are calculated for full cost recovery only. They are not designed to meet any other financial goals, including revenue generation.

One commenter suggested that the proposed fee increases would result in APHIS’ veterinary diagnostic services being used less frequently, which would in turn negatively affect the agency's proficiency levels and information base.

As mentioned previously, we do not expect that APHIS’ veterinary diagnostic services will be used less frequently under the new user fees. In any case, we believe that our veterinary diagnostic professionals have proficiency levels and an information base that are adequate to ensure continued competent performance.

One commenter stated that the fees in our proposed rule did not consider economies of scale.

As discussed in the proposed rule, we considered continuing a discount that applied to all diagnostic, non-import-related complement fixation, hemagglutination inhibition, fluorescent antibody, indirect fluorescent antibody virus neutralization, and peroxidase linked antibody tests. This discount applied to the 11th and subsequent tests on the same submission by the same submitter for the same test and antigen. However, we reevaluated the time it takes to conduct these additional tests and determined that it was no longer cost effective to perform the tests at a discount. If we determine that our veterinary diagnostic services can be provided at a discount at certain volumes, we will adjust our user fees accordingly in a subsequent rulemaking.

One commenter expressed concern about the effect the proposed user fees would have on U.S. exporters in general.

We realize that any increase in user fees will increase the up-front cost of doing business for exporters, and we have attempted to keep the costs of our services as low as possible. However, as we explained in the proposed rule, operating costs have increased since the user fees for veterinary diagnostic services were established in 1998, and the ABC project at the National Veterinary Services Laboratories demonstrated that APHIS has not been recovering the full costs of providing user-fee related services through its established user fees. Implementing the user fees in this final rule will ensure that APHIS is able to provide veterinary diagnostic services and recover the cost of these services by the user fees charged. We are making no changes to the proposed rule in response to this comment.

One commenter suggested that APHIS should not collect user fees for tests for animal diseases that can severely impact public health or have serious economic consequences for other reasons. The commenter gave as an example arboviral encephalitides, stating that the costs for diagnosing and controlling this disease were funded through tax dollars in New Jersey.

Our regulations exempt from user fees veterinary diagnostic services provided in connection with (1) Federal programs to control or eradicate diseases or pests of livestock or poultry in the United States (program diseases), (2) zoonotic disease surveillance when the Administrator has determined that there is a significant threat to human health, and (3) detection of foreign animal diseases. We believe that these exemptions address the problem of funding diagnostic services for animal diseases that could have major public health or economic impacts.

One commenter suggested that, with the fee increases proposed, APHIS would become more like a business than a service organization, and the agency's partnership with the States would be strained.

APHIS is committed to cooperating with the States in order to safeguard U.S. animal health, and, as described above, APHIS provides many services to help control dangerous animal diseases at no cost. However, we must charge user fees that accurately reflect the cost of providing veterinary diagnostic services in order to provide those services. We are making no changes in response to these comments.

However, we are making a change to one of the proposed user fees in this final rule. The proposed user fee schedule for virus titration, which was listed in a table in § 130.14(c), listed the fee for that service for fiscal year 2006 as $110.00. The correct fee is $119.00. We are correcting the error in this final rule.

Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, with the change discussed above.

Executive Order 12866 and Regulatory Flexibility Act

This 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.

In this final rule, we are increasing the user fees for veterinary diagnostic services to reflect changes in operating costs and changes in calculating our costs. These actions are necessary to ensure that we recover the actual costs of providing these services. We are also providing for a reasonable balance, or reserve, in the veterinary diagnostics user fee account. The reserve will ensure that we have sufficient operating funds in cases of fluctuations in activity volumes, bad debt, program shutdown, or customer insolvency. The Food, Agriculture, Conservation, and Trade Act of 1990, as amended, authorizes us to set and collect these user fees.

In our July 2003 proposed rule, under the heading “Executive Order 12866 and Regulatory Flexibility Act,” we provided a detailed analysis of the possible economic effects of the proposed fee increases on users of veterinary diagnostic services. The conclusions of that analysis are summarized below.

The impacts of the increases in veterinary diagnostic user fees in this final rule are expected to be muted. The majority of the changes to the user fees Start Printed Page 25307are either small, associated with few users, or both. Over the period covered by this final rule, more than 60 percent of the individual increases are less than $50, nearly 16 percent increase by less than $10, and about 65 percent are associated with 100 or fewer users. The majority of the fees in this final rule should also make only a small contribution to the total additional fee collections and, therefore, will have a minor impact on the users of those services. This is either because the 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 will generate a larger total increase in collections, the impact should not be significant because the fees are: Small fees applied to a large annual volume of users, large fees applied to a very small volume of users, fees that represent a small percentage of the overall costs associated with a user's output, single fees for reagents with numerous final users, or fees that enhance the marketability of the user's final outputs. Therefore, the increases are not generally expected to substantially reduce profits or impede exports or imports. Indeed, the full burden of the user fee changes is not likely to be borne entirely by the purchasers of products and services.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action 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 final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule.

Paperwork Reduction Act

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

Start List of Subjects

List of Subjects in 9 CFR Part 130

End List of Subjects Start Amendment Part

Accordingly, we are amending

End Amendment Part Start Part

PART 130—USER FEES

End Part Start Amendment Part

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

End Amendment Part Start Authority

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.

End Authority Start Amendment Part

2. In § 130.14, the tables in paragraphs (a) through (c) are revised to read as follows:

End Amendment Part
User fees for FADDL veterinary diagnostics.

(a) * * *

ReagentUnitUser fee
June 7, 2004-Sept. 30, 2004Oct. 1, 2004-Sept. 30, 2005Oct. 1, 2005-Sept. 30, 2006Beginning Oct. 1, 2006
Bovine antiserum, any agent1 mL$150.00$155.00$160.00$165.00
Caprine antiserum, any agent1 mL184.00189.00195.00202.00
Cell culture antigen/microorganism1 mL103.00106.00109.00111.00
Equine antiserum, any agent1 mL186.00192.00198.00204.00
Fluorescent antibody conjugate1 mL169.00172.00176.00179.00
Guinea pig antiserum, any agent1 mL184.00189.00194.00200.00
Monoclonal antibody1 mL222.00229.00235.00243.00
Ovine antiserum, any agent1 mL176.00181.00187.00193.00
Porcine antiserum, any agent1 mL152.00157.00162.00167.00
Rabbit antiserum, any agent1 mL179.00185.00190.00196.00

(b) * * *

TestUnitUser fee
June 7, 2004-Sept. 30, 2004Oct. 1, 2004-Sept. 30, 2005Oct. 1, 2005-Sept. 30, 2006Beginning Oct. 1, 2006
Agar gel immunodiffusionTest$30.00$31.00$32.00$33.00
CardTest17.0017.0018.0018.00
Complement fixationTest36.0037.0038.0040.00
Direct immunofluorescent antibodyTest22.0023.0024.0025.00
Enzyme linked immunosorbent assayTest26.0027.0028.0029.00
Fluorescent antibody neutralization (classical swine fever)Test194.00201.00208.00215.00
Hemagglutination inhibitionTest57.0059.0061.0063.00
ImmunoperoxidaseTest29.0030.0031.0032.00
Indirect fluorescent antibodyTest35.0036.0037.0039.00
In-vitro safetyTest570.00589.00609.00630.00
In-vivo safetyTest5,329.005,387.005,447.005,509.00
Latex agglutinationTest23.0024.0025.0026.00
Tube agglutinationTest28.0028.0029.0030.00
Virus isolation (oesophageal/pharyngeal)Test180.00186.00192.00199.00
Virus isolation in embryonated eggsTest346.00358.00370.00383.00
Virus isolation, otherTest155.00160.00166.00171.00
Start Printed Page 25308
Virus neutralizationTest52.0054.0056.0058.00

(c) * * *

Veterinary diagnostic serviceUnitUser fee
June 7, 2004-Sept. 30, 2004Oct. 1, 2004-Sept. 30, 2005Oct. 1, 2005-Sept. 30, 2006Beginning Oct. 1, 2006
Bacterial isolationTest$112.00$115.00$119.00$123.00
Hourly user fee services 1Hour445.00460.00476.00492.00
Hourly user fee services—Quarter hourQuarter hour111.00115.00119.00123.00
Infected cells on chamber slides or platesSlide49.0050.0051.0053.00
Reference animal tissues for immunohistochemistrySet171.00177.00182.00187.00
Sterilization by gamma radiationCan1,740.001,799.001,860.001,923.00
Training (school or technical assistance)Per person per day910.00941.00973.001,006.00
Virus titrationTest112.00115.00119.00123.00
1 For all veterinary diagnostic services for which there is no flat rate user fee, the hourly rate user fee will be calculated for the actual time required to provide the service.
Start Amendment Part

3. In § 130.15, the tables in paragraphs (a) and (b) are revised to read as follows:

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

(a) * * *

TestUnitUser fee
June 7, 2004-Sept. 30, 2004Oct. 1, 2004-Sept. 30, 2005Oct. 1, 2005-Sept. 30, 2006Beginning Oct. 1, 2006
Bacterial identification, automatedIsolate$48.00$50.00$51.00$53.00
Bacterial identification, non-automatedIsolate81.0084.0087.0090.00
Bacterial isolationSample33.0034.0035.0036.00
Bacterial serotyping, all otherIsolate51.0052.0053.0055.00
Bacterial serotyping, Pasteurella multocidaIsolate16.0017.0018.0018.00
Bacterial serotyping, SalmonellaIsolate33.0034.0035.0036.00
Bacterial toxin typingIsolate109.00112.00116.00120.00
Bacteriology requiring special characterizationTest83.0086.0089.0092.00
DNA fingerprintingTest54.0056.0058.0059.00
DNA/RNA probeTest77.0079.0081.0083.00
Fluorescent antibodyTest17.0017.0018.0019.00
Mycobacterium identification (biochemical)Isolate104.00107.00111.00114.00
Mycobacterium identification (gas chromatography)Procedure87.0090.0093.0096.00
Mycobacterium isolation, animal inoculationsSubmission770.00791.00814.00837.00
Mycobacterium isolation, all otherSubmission136.00141.00146.00151.00
Mycobacterium paratuberculosis isolationSubmission65.0067.0070.0072.00
Phage typing, all otherIsolate38.0039.0041.0042.00
Phage typing, Salmonella enteritidisIsolate21.0022.0023.0024.00

(b) * * *

TestUnitUser fee
June 7, 2004-Sept. 30, 2004Oct. 1, 2004-Sept. 30, 2005Oct. 1, 2005-Sept. 30, 2006Beginning Oct. 1, 2006
Fluorescent antibody tissue sectionTest$27.00$27.00$28.00$29.00
Virus isolationTest43.0045.0046.0048.00
Start Printed Page 25309 Start Amendment Part

4. In § 130.16, the tables in paragraphs (a) and (b) are revised to read as follows:

End Amendment Part
User fees for veterinary diagnostic serology tests performed at NVSL (excluding FADDL) or at authorized sites.

(a) * * *

TestUnitUser fee
June 7, 2004-Sept. 30, 2004Oct. 1, 2004-Sept. 30, 2005Oct. 1, 2005-Sept. 30, 2006Beginning Oct. 1, 2006
Brucella ring (BRT)Test$33.00$34.00$35.00$36.00
Brucella ring, heat inactivated (HIRT)Test33.0034.0035.0036.00
Brucella ring, serial (Serial BRT)Test49.0051.0053.0054.00
Buffered acidified plate antigen presumptiveTest6.007.007.007.00
CardTest4.004.004.004.00
Complement fixationTest15.0015.0016.0016.00
Enzyme linked immunosorbent assayTest15.0015.0016.0016.00
Indirect fluorescent antibodyTest13.0013.0014.0014.00
Microscopic agglutination-includes up to 5 serovarsSample21.0022.0023.0024.00
Microscopic agglutination-each serovar in excess of 5 serovarsSample4.004.004.004.00
Particle concentration fluorescent immunoassay (PCFIA)Test33.0034.0035.0036.00
PlateTest6.007.007.007.00
Rapid automated presumptiveTest6.006.006.007.00
RivanolTest6.007.007.007.00
Tube agglutinationTest6.007.007.007.00

(b) * * *

TestUnitUser fee
June 7, 2004-Sept. 30, 2004Oct. 1, 2004-Sept. 30, 2005Oct. 1, 2005-Sept. 30, 2006Beginning Oct. 1, 2006
Agar gel immunodiffusionTest$15.00$15.00$16.00$16.00
Complement fixationTest15.0015.0016.0016.00
Enzyme linked immunosorbent assayTest15.0015.0016.0016.00
Hemagglutination inhibitionTest13.0013.0014.0014.00
Indirect fluorescent antibodyTest13.0013.0014.0014.00
Latex agglutinationTest15.0015.0016.0016.00
Peroxidase linked antibodyTest14.0014.0015.0015.00
Plaque reduction neutralizationTest16.0017.0017.0018.00
Rabies fluorescent antibody neutralizationTest41.0042.0044.0045.00
Virus neutralizationTest12.0012.0013.0013.00
Start Amendment Part

5. In § 130.17, the table in paragraph (a) is revised to read as follows:

End Amendment Part
User fees for other veterinary diagnostic laboratory tests performed at NVSL (excluding FADDL) or at authorized sites.

(a) * * *

TestUnitUser fee
June 7, 2004-Sept. 30, 2004Oct. 1, 2004-Sept. 30, 2005Oct. 1, 2005-Sept. 30, 2006Beginning Oct. 1, 2006
Aflatoxin quantitationTest$27.00$28.00$29.00$30.00
Aflatoxin screenTest26.0027.0028.0029.00
Agar gel immunodiffusion spp. identificationTest11.0012.0012.0013.00
Antibiotic (bioautography) quantitationTest59.0061.0063.0065.00
Antibiotic (bioautography) screenTest108.00112.00115.00119.00
Antibiotic inhibitionTest59.0061.0063.0065.00
ArsenicTest16.0016.0017.0017.00
Ergot alkaloid screenTest59.0061.0063.0065.00
Ergot alkaloid confirmationTest77.0080.0083.0086.00
Feed microscopyTest59.0061.0063.0065.00
Fumonisin onlyTest33.0035.0036.0037.00
GossypolTest89.0092.0095.0098.00
MercuryTest131.00135.00140.00145.00
Metals screenTest40.0041.0043.0044.00
Metals single element confirmationTest11.0012.0012.0013.00
Start Printed Page 25310
Mycotoxin: aflatoxin-liverTest108.00112.00115.00119.00
Mycotoxin screenTest43.0044.0046.0048.00
Nitrate/nitriteTest59.0061.0063.0065.00
Organic compound confirmationTest79.0082.0085.0088.00
Organic compound screenTest137.00141.00146.00151.00
ParasitologyTest26.0027.0028.0029.00
Pesticide quantitationTest119.00123.00128.00132.00
Pesticide screenTest54.0056.0058.0060.00
pHTest24.0025.0026.0026.00
Plate cylinderTest89.0092.0095.0098.00
SeleniumTest40.0041.0043.0044.00
Silicate/carbonate disinfectantTest59.0061.0063.0065.00
Temperature disksTest118.00122.00126.00130.00
Toxicant quantitation, otherTest99.00103.00106.00110.00
Toxicant screen, otherTest30.0031.0032.0033.00
Vomitoxin onlyTest48.0049.0051.0053.00
Water activityTest30.0031.0032.0033.00
Zearaleone quantitationTest48.0049.0051.0053.00
Zearaleone screenTest26.0027.0028.0029.00
* * * * *
Start Amendment Part

6. In § 130.18, the tables in paragraphs (a) and (b) are revised to read as follows:

End Amendment Part
User fees for veterinary diagnostic reagents produced at NVSL or other authorized site (excluding FADDL).

(a) * * *

ReagentUnitUser fee
June 7, 2004-Sept. 30, 2004Oct. 1, 2004-Sept. 30, 2005Oct. 1, 2005-Sept. 30, 2006Beginning Oct. 1, 2006
Anaplasma card test antigen2 mL$87.00$89.00$92.00$95.00
Anaplasma card test kit without antigenKit115.00119.00123.00127.00
Anaplasma CF antigen2 mL46.0046.0046.0046.00
Anaplasma stabilate4.5 mL160.00165.00170.00175.00
Avian origin bacterial antiserums1 mL43.0044.0046.0047.00
Bacterial agglutinating antigens other than brucella and salmonella pullorum5 mL49.0051.0052.0054.00
Bacterial conjugates1 mL87.0090.0093.0096.00
Bacterial disease CF antigens, all other1 mL26.0027.0028.0029.00
Bacterial ELISA antigens1 mL27.0027.0028.0029.00
Bacterial or protozoal, antiserums, all other1 mL54.0056.0058.0060.00
Bacterial reagent culture 1Culture66.0068.0070.0073.00
Bacterial reference culture 2Culture206.00213.00221.00228.00
Bacteriophage reference cultureCulture155.00161.00166.00172.00
Bovine serum factor1 mL16.0017.0017.0018.00
Brucella abortus CF antigen60 mL136.00141.00146.00151.00
Brucella agglutination antigens, all other60 mL136.00141.00146.00151.00
Brucella buffered plate antigen60 mL155.00161.00166.00172.00
Brucella canis tube antigen25 mL102.00105.00107.00109.00
Brucella card testantigen (packaged)Package81.0084.0087.0090.00
Brucella card test kit without antigenKit106.00109.00111.00113.00
Brucella cellsGram17.0017.0018.0018.00
Brucella cells, driedPellet5.005.005.006.00
Brucella ring test antigen60 mL218.00225.00233.00241.00
Brucella rivanol solution60 mL27.0027.0028.0029.00
Dourine CF antigen1 mL81.0084.0086.0089.00
Dourine stabilate4.5 mL102.00105.00107.00109.00
Equine and bovine origin babesia species antiserums1 mL115.00119.00123.00127.00
Equine negative control CF antigen1 mL267.00272.00276.00281.00
Flazo-orange3 mL11.0012.0012.0013.00
Glanders CF antigen1 mL70.0073.0075.0077.00
Hemoparasitic disease CF antigens, all other1 mL489.00505.00522.00540.00
Leptospira transport medium10 mL4.004.004.004.00
Monoclonal antibody1 mL88.0090.0093.0095.00
Mycobacterium spp. old tuberculin1 mL21.0022.0023.0024.00
Mycobacterium spp. PPD1 mL16.0017.0018.0018.00
Mycoplasma hemagglutination antigens5 mL163.00168.00174.00180.00
Negative control serums1 mL16.0017.0018.0018.00
Rabbit origin bacterial antiserum1 mL47.0048.0050.0052.00
Start Printed Page 25311
Salmonella pullorum microagglutination antigen5 mL14.0014.0015.0015.00
Stabilates, all other4.5 mL623.00640.00659.00678.00
1 A reagent culture is a bacterial culture that has been subcultured one or more times after being tested for purity and identity. It is intended for use as a reagent with a diagnostic test such as the leptospiral microagglutination test.
2 A reference culture is a bacterial culture that has been thoroughly tested for purity and identity. It should be suitable as a master seed for future cultures.

(b) * * *

ReagentUnitUser fee
June 7, 2004-Sept. 30, 2004Oct. 1, 2004-Sept. 30, 2005Oct. 1, 2005-Sept. 30, 2006Beginning Oct. 1, 2006
Antigen, except avian influenza and chlamydia psittaci antigens, any2 mL$55.00$57.00$59.00$61.00
Avian antiserum except avian influenza antiserum, any2 mL44.0045.0047.0048.00
Avian influenza antigen, any2 mL30.0031.0032.0033.00
Avian influenza antiserum, any6 mL93.0096.00100.00103.00
Bovine or ovine serum, any2 mL115.00119.00123.00127.00
Cell cultureFlask136.00141.00146.00151.00
Chlamydia psittaci spp. of origin monoclonal antibody panelPanel88.0090.0093.0095.00
Conjugate, any1 mL66.0068.0071.0073.00
Diluted positive control serum, any2 mL22.0023.0024.0024.00
Equine antiserum, any2 mL41.0042.0044.0045.00
Monoclonal antibody1 mL94.0096.0099.00102.00
Other spp. antiserum, any1 mL51.0051.0052.0052.00
Porcine antiserum, any2 mL95.0099.00102.00105.00
Porcine tissue setsTissue set152.00153.00155.00157.00
Positive control tissues, all2 cm2 section55.0057.0058.0060.00
Rabbit origin antiserum1 mL47.0048.0050.0052.00
Reference virus, any0.6 mL163.00169.00174.00180.00
Viruses (except reference viruses), chlamydia psittaci agent or chlamydia psittaci antigen, any0.6 mL27.0028.0029.0030.00
Start Amendment Part

7. In § 130.19, the table in paragraph (a) is revised to read as follows:

End Amendment Part
User fees for other veterinary diagnostic services or materials provided at NVSL (excluding FADDL).

(a) * * *

ServiceUnitUser fee
June 7, 2004-Sept. 30, 2004Oct. 1, 2004-Sept. 30, 2005Oct. 1, 2005-Sept. 30, 2006Beginning Oct. 1, 2006
Antimicrobial susceptibility testIsolate$95.00$98.00$101.00$105.00
Avian safety testTest3,774.003,871.003,972.004,075.00
Check tests, cultureKit1162.00167.00171.00176.00
Check tests, serology, all otherKit1326.00337.00349.00361.00
Fetal bovine serum safety testVerification1,061.001,078.001,096.001,114.00
Hourly user fee services:2
HourHour84.0084.0084.0084.00
Quarter hourQuarter hour21.0021.0021.0021.00
Minimum25.0025.0025.0025.00
Manual, brucellosis culture1 copy104.00107.00111.00114.00
Manual, tuberculosis culture (English or Spanish)1 copy155.00161.00166.00172.00
Manual, Veterinary mycology1 copy155.00161.00166.00172.00
Manuals or standard operating procedure (SOP), all other1 copy31.0032.0033.0034.00
Manuals or SOP, per page1 page2.002.002.002.00
Training (school or technical assistance)Per person per day300.00310.00320.00331.00
1 Any reagents required for the check test will be charged separately.
2 For veterinary diagnostic services for which there is no flat rate user fee the hourly rate user fee will be calculated for the actual time required to provide the service.
Start Printed Page 25312
* * * * *
Start Signature

Done in Washington, DC, this 29th day of April 2004.

Peter Fernandez,

Acting Administrator, Animal and Plant Health Inspection Service.

End Signature End Supplemental Information

[FR Doc. 04-10309 Filed 5-5-04; 8:45 am]

BILLING CODE 3410-34-P