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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 the veterinary diagnostic services to reflect changes in our operating costs and expenses. 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, and Conservation Act of 1990, as amended, authorizes us to set and collect these user fees.

DATES:

Effective Date: January 18, 2008.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

For information concerning Veterinary Services (VS) Management Support, Start Printed Page 71745contact 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.

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 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.

On July 23, 2007, we published in the Federal Register (72 FR 40082-40090, Docket No. APHIS-2006-0161) a proposal [1] to amend the regulations by increasing 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.

We solicited comments concerning our proposal for 60 days ending September 22, 2007. We received one comment by that date, from a private citizen. The commenter supported the proposed rule. Therefore, for the reasons given in the proposed rule, we are adopting the proposed rule as a final rule.

In this final rule, we have made a minor change to the fiscal year 2011 user fees for complement fixation and enzyme-linked immunosorbent assay in § 130.16(a). In the proposed rule, we mistakenly stated that those two fees would be $17 for that year. The correct fee for both tests is $18.

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.

Below is a summary of the economic analysis for the changes in APHIS user fees in this final rule. The economic analysis provides a cost-benefit analysis and an analysis of the potential economic effects on small entities as required by the Regulatory Flexibility Act. 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 (see footnote 1 for instructions for accessing Regulations.gov) and may be obtained from the person listed under FOR FURTHER INFORMATION CONTACT.

APHIS is updating 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 Veterinary Services Veterinary Diagnostics Program at National Veterinary Services Laboratory 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 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 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 rule 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 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 fee changes are projected to generate $10,000 or more in additional annual collections by the end of the period covered in this rule. 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 changes in user fees would impact operational costs, any entity that utilizes APHIS veterinary diagnostic services and materials could be impacted by the 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 rule, 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 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 Start Printed Page 71746larger 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 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 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 § 130.15, paragraphs (a) and (b), the tables 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
Jan. 18, 2008-Sept. 30, 2008Oct. 1, 2008-Sept. 30, 2009Oct. 1, 2009-Sept. 30, 2010Oct. 1, 2010-Sept. 30, 2011Beginning Oct. 1, 2011
Bacterial identification, automatedIsolate$53.00$54.00$55.00$57.00$58.00
Bacterial identification, non-automatedIsolate90.0092.0094.0096.0098.00
Bacterial isolationSample36.0037.0038.0039.0040.00
Bacterial serotyping, all otherIsolate55.0056.0056.0057.0058.00
Bacterial serotyping, Pasteurella multocidaIsolate18.0019.0019.0019.0020.00
Bacterial serotyping, SalmonellaIsolate36.0037.0038.0039.0040.00
Bacterial toxin typingIsolate120.00123.00126.00128.00131.00
Bacteriology requiring special characterizationTest92.0094.0096.0098.00101.00
DNA fingerprintingTest59.0061.0062.0063.0064.00
DNA probeTest83.0085.0086.0088.0089.00
Fluorescent antibodyTest19.0019.0020.0020.0020.00
Mycobacterium identification (biochemical)Isolate115.00117.00120.00122.00125.00
Mycobacterium identification (gas chromatography)Procedure96.0099.00101.00103.00105.00
Mycobacterium isolation, animal inoculationsSubmission844.00852.00868.00884.00900.00
Mycobacterium isolation, all otherSubmission151.00154.00158.00161.00165.00
Mycobacterium paratuberculosis isolationSubmission72.0074.0075.0077.0079.00
Phage typing, all otherIsolate42.0043.0044.0045.0046.00
Phage typing, Salmonella enteritidisIsolate24.0024.0025.0025.0026.00

(b) * * *

TestUnitUser fee
Jan. 18, 2008-Sept. 30, 2008Oct. 1, 2008-Sept. 30, 2009Oct. 1, 2009-Sept. 30, 2010Oct. 1, 2010-Sept. 30, 2011Beginning Oct. 1, 2011
Fluorescent antibody tissue sectionTest$29.00$30.00$30.00$31.00$31.00
Virus isolationTest48.0049.0050.0051.0052.00
* * * * *
Start Amendment Part

3. In § 130.16, paragraphs (a) and (b), the tables 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) * * * Start Printed Page 71747

TestUnitUser fee
Jan. 18, 2008-Sept. 30, 2008Oct. 1, 2008-Sept. 30, 2009Oct. 1, 2009-Sept. 30, 2010Oct. 1, 2010-Sept. 30, 2011Beginning Oct. 1, 2011
Brucella ring (BRT)Test$36.00$37.00$38.00$39.00$40.00
Brucella ring, heat inactivated (HIRT)Test36.0037.0038.0039.0040.00
Brucella ring, serial (Serial BRT)Test54.0056.0057.0058.0059.00
Buffered acidified plate antigen presumptiveTest7.007.257.507.508.00
CardTest4.004.004.254.254.50
Complement fixationTest16.0017.0017.0018.0018.00
Enzyme linked immunosorbent assayTest16.0017.0017.0018.0018.00
Indirect fluorescent antibodyTest14.0015.0015.0015.0016.00
Microscopic agglutination—includes up to 5 serovarsSample24.0024.0025.0025.0026.00
Microscopic agglutination—each serovar in excess of 5 serovarsSample4.254.504.504.504.75
Particle concentration fluorescent immunoassay (PCFIA)Test36.0037.0038.0038.0039.00
PlateTest7.007.257.507.507.75
Rapid automated presumptiveTest7.007.007.257.257.25
RivanolTest7.007.257.507.507.75
Tube agglutinationTest7.007.257.507.507.75

(b) * * *

TestUnitUser fee
Jan. 18, 2008-Sept. 30, 2008Oct. 1, 2008-Sept. 30, 2009Oct. 1, 2009-Sept. 30, 2010Oct. 1, 2010-Sept. 30, 2011Beginning Oct. 1, 2011
Agar gel immunodiffusionTest$16.00$17.00$17.00$17.00$18.00
Complement fixationTest16.0017.0017.0018.0018.00
Enzyme linked immunosorbent assayTest16.0017.0017.0018.0018.00
Hemagglutination inhibitionTest14.0015.0015.0015.0016.00
Indirect fluorescent antibodyTest14.0015.0015.0015.0016.00
Latex agglutinationTest16.0017.0017.0017.0018.00
Peroxidase linked antibodyTest15.0016.0016.0016.0017.00
Plaque reduction neutralizationTest18.0018.0019.0019.0019.00
Rabies fluorescent antibody neutralizationTest45.0046.0047.0049.0050.00
Virus neutralizationTest13.0013.0014.0014.0014.00
* * * * *
Start Amendment Part

4. In § 130.17, paragraph (a), the table 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
Jan. 18, 2008-Sept. 30, 2008Oct. 1, 2008-Sept. 30, 2009Oct. 1, 2009-Sept. 30, 2010Oct. 1, 2010-Sept. 30, 2011Beginning Oct. 1, 2011
Aflatoxin quantitationTest$30.00$31.00$32.00$32.00$33.00
Aflatoxin screenTest29.0029.0030.0030.0031.00
Agar gel immunodiffusion spp. identificationTest13.0013.0013.0014.0014.00
Antibiotic (bioautography) quantitationTest66.0067.0068.0070.0072.00
Antibiotic (bioautography) screenTest119.00122.00125.00128.00130.00
Antibiotic inhibitionTest66.0067.0068.0070.0072.00
ArsenicTest17.0018.0018.0019.0019.00
Ergot alkaloid screenTest66.0067.0068.0070.0072.00
Ergot alkaloid confirmationTest86.0088.0089.0091.0094.00
Feed microscopyTest66.0067.0068.0070.0072.00
Fumonisin onlyTest37.0038.0039.0040.0040.00
GossypolTest98.00100.00103.00105.00107.00
MercuryTest145.00148.00151.00155.00158.00
Metals screenTest44.0045.0046.0047.0048.00
Metals single element confirmationTest13.0013.0013.0014.0014.00
Mycotoxin: aflatoxin-liverTest119.00122.00125.00128.00130.00
Mycotoxin screenTest48.0049.0050.0051.0052.00
Nitrate/nitriteTest66.0067.0068.0070.0072.00
Start Printed Page 71748
Organic compound confirmationTest88.0090.0092.0094.0096.00
Organic compound screenTest151.00155.00158.00161.00165.00
ParasitologyTest29.0029.0030.0030.0031.00
Pesticide quantitationTest132.00135.00138.00141.00144.00
Pesticide screenTest60.0062.0063.0064.0066.00
pHTest26.0027.0028.0028.0029.00
Plate cylinderTest98.00100.00103.00105.00107.00
SeleniumTest44.0045.0046.0047.0048.00
Silicate/carbonate disinfectantTest66.0067.0068.0070.0072.00
Temperature disksTest130.00133.00136.00139.00142.00
Toxicant quantitation, otherTest110.00112.00115.00117.00120.00
Toxicant screen, otherTest33.0033.0034.0035.0036.00
Vomitoxin onlyTest53.0054.0055.0056.0058.00
Water activityTest33.0033.0034.0035.0036.00
Zearaleone quantitationTest53.0054.0055.0056.0058.00
Zearaleone screenTest29.0029.0030.0030.0031.00
* * * * *
Start Amendment Part

5. In § 130.18, paragraphs (a) and (b), the tables 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
Jan. 18, 2008-Sept. 30, 2008Oct. 1, 2008-Sept. 30, 2009Oct. 1, 2009-Sept. 30, 2010Oct. 1, 2010-Sept. 30, 2011Beginning Oct. 1, 2011
Anaplasma card test antigen2 mL$95.00$97.00$99.00$101.00$103.00
Anaplasma card test kit without antigenKit127.00130.00133.00136.00139.00
Anaplasma CF antigen2 mL46.0046.0046.0047.0047.00
Anaplasma stabilate4.5 mL175.00178.00181.00185.00188.00
Avian origin bacterial antiserums1 mL48.0049.0050.0051.0052.00
Bacterial agglutinating antigens other than brucella and salmonella pullorum5 mL54.0055.0057.0058.0059.00
Bacterial conjugates1 mL96.0099.00101.00103.00105.00
Bacterial disease CF antigens, all other1 mL29.0030.0030.0031.0032.00
Bacterial ELISA antigens1 mL29.0030.0031.0031.0032.00
Bacterial or protozoal antiserums, all other1 mL60.0061.0063.0064.0066.00
Bacterial reagent culture1Culture73.0074.0076.0078.0079.00
Bacterial reference culture2Culture228.00233.00239.00244.00249.00
Bacteriophage reference cultureCulture172.00176.00180.00183.00188.00
Bovine serum factor1 mL18.0018.0019.0019.0019.00
Brucella abortus CF antigen60 mL151.00154.00158.00161.00165.00
Brucella agglutination antigens, all other60 mL151.00154.00158.00161.00165.00
Brucella buffered plate antigen60 mL172.00176.00180.00183.00188.00
Brucella canis tube antigen25 mL114.00116.00119.00121.00124.00
Brucella card test antigen (packaged)Package90.0092.0094.0096.0098.00
Brucella card test kit without antigenKit113.00114.00116.00117.00119.00
Brucella cellsGram19.0019.0019.0020.0020.00
Brucella cells, driedPellet6.006.006.256.256.25
Brucella ring test antigen60 mL241.00246.00252.00257.00263.00
Brucella rivanol solution60 mL29.0030.0031.0031.0032.00
Dourine CF antigen1 mL89.0091.0093.0095.0097.00
Dourine stabilate4.5 mL109.00111.00112.00114.00116.00
Equine and bovine origin babesia species antiserums1 mL127.00130.00133.00136.00139.00
Equine negative control CF antigen1 mL282.00283.00286.00290.00293.00
Flazo-orange3 mL13.0013.0013.0013.0014.00
Glanders CF antigen1 mL77.0079.0081.0082.0084.00
Hemoparasitic disease CF antigens, all other1 mL541.00553.00565.00577.00590.00
Leptospira transport medium10 mL4.254.504.504.504.75
Monoclonal antibody1 mL95.0097.0099.00101.00103.00
Mycobacterium spp. old tuberculin1 mL24.0024.0025.0025.0026.00
Mycobacterium spp. PPD1 mL18.0019.0019.0019.0020.00
Mycoplasma hemagglutination antigens5 mL180.00184.00188.00192.00197.00
Negative control serums1 mL18.0019.0019.0019.0020.00
Rabbit origin bacterial antiserum1 mL52.0053.0054.0055.0056.00
Salmonella pullorum microagglutination antigen5 mL15.0016.0016.0016.0017.00
Start Printed Page 71749
Stabilates, all other4.5 mL684.00690.00703.00716.00730.00
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) * * *

ReagentUnitUser fee
Jan. 18, 2008-Sept. 30, 2008Oct. 1, 2008-Sept. 30, 2009Oct. 1, 2009-Sept. 30, 2010Oct. 1, 2010-Sept. 30, 2011Beginning Oct. 1, 2011
Antigen, except avian influenza and chlamydia psittaci antigens, any2 mL$61.00$62.00$64.00$65.00$67.00
Avian antiserum except avian influenza antiserum, any2 mL48.0049.0051.0052.0053.00
Avian influenza antigen, any2 mL33.0034.0035.0036.0036.00
Avian influenza antiserum, any6 mL103.00105.00108.00110.00113.00
Bovine or ovine serum, any2 mL127.00130.00133.00136.00139.00
Cell cultureFlask151.00154.00158.00161.00165.00
Chlamydia psittaci spp. of origin monoclonal antibody panelPanel95.0096.0098.0099.00101.00
Conjugate, any1 mL73.0075.0076.0078.0080.00
Diluted positive control serum, any2 mL24.0025.0025.0026.0027.00
Equine antiserum, any2 mL45.0046.0047.0048.0049.00
Monoclonal antibody1 mL102.00104.00106.00108.00110.00
Other spp. antiserum, any1 mL52.0052.0052.0053.0053.00
Porcine antiserum, any2 mL105.00108.00110.00113.00115.00
Porcine tissue setsTissue set157.00157.00158.00159.00161.00
Positive control tissues, all2 cm2 section60.0062.0063.0065.0066.00
Rabbit origin antiserum1 mL52.0053.0054.0055.0056.00
Reference virus, any0.6 mL180.00184.00188.00193.00197.00
Viruses (except reference viruses), chlamydia psittaci agent or chlamydia psittaci antigen, any0.6 mL30.0031.0032.0032.0033.00
* * * * *
Start Amendment Part

6. In § 130.19, paragraph (a), the table 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
Jan. 18, 2008-Sept. 30, 2008Oct. 1, 2008-Sept. 30, 2009Oct. 1, 2009-Sept. 30, 2010Oct. 1, 2010-Sept. 30, 2011Beginning Oct. 1, 2011
Antimicrobial susceptibility testIsolate$105.00$107.00$109.00$112.00$114.00
Avian safety testTest4,082.004,090.004,099.004,109.004,180.00
Check tests, cultureKit 1176.00179.00182.00185.00189.00
Check tests, serologyKit 1361.00369.00377.00385.00394.00
Fetal bovine serum safety testVerification1,119.001,122.001,134.001,147.001,160.00
Hourly user fees: 2
HourHour104.00104.00108.00112.00112.00
Quarter hourQuarter Hour26.0026.0027.0028.0028.00
Minimum30.0031.0032.0033.0033.00
Manual, brucellosis culture1 copy115.00117.00120.00122.00125.00
Manual, tuberculosis Culture (English or Spanish)1 copy172.00176.00180.00183.00188.00
Manual, Veterinary mycology1 copy172.00176.00180.00183.00188.00
Manuals or standard operating procedure (SOP), all other1 copy34.0035.0036.0037.0037.00
Manuals or SOP, per page1 page2.252.502.502.752.75
Training (school or technical assistance)Per person per day332.00339.00346.00354.00362.00
1 Any reagents required for the check test will be charged separately. Start Printed Page 71750
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.
* * * * *
Start Signature

Done in Washington, DC, this 13th day of December 2007.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.

End Signature End Supplemental Information

Footnotes

[FR Doc. E7-24602 Filed 12-18-07; 8:45 am]

BILLING CODE 3410-34-P