[Federal Register: July 23, 2007 (Volume 72, Number 140)] [Proposed Rules] [Page 40082-40090] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr23jy07-12] ======================================================================== 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. ======================================================================== [[Page 40082]] DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Part 130 [Docket No. APHIS-2006-0161] RIN 0579-AC52 Veterinary Diagnostic Services User Fees AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: We are proposing to increase the user fees for the veterinary diagnostic services to reflect changes in our operating costs and expenses. We are also proposing to set rates for multiple fiscal years. These proposed actions are necessary to ensure that we recover the actual costs of providing these services. We are also proposing to provide for a reasonable balance, or reserve, in the veterinary diagnostics user fee account. The Food, Agriculture, and Conservation Act of 1990, as amended, authorizes us to set and collect these user fees. DATES: We will consider all comments that we receive on or before September 21, 2007. ADDRESSES: You may submit comments by either of the following methods: Federal eRulemaking Portal: Go to http://www.regulations.gov , select ``Animal and Plant Health Inspection Service'' from the agency drop-down menu, then click ``Submit.'' In the Docket ID column, select APHIS-2006-0161 to submit or view public comments and to view supporting and related materials available electronically. Information on using Regulations.gov, including instructions for accessing documents, submitting comments, and viewing the docket after the close of the comment period, is available through the site's ``User Tips'' link. Postal Mail/Commercial Delivery: Please send four copies of your comment (an original and three copies) to Docket No. APHIS- 2006-0161, Regulatory Analysis and Development, PPD, APHIS, Station 3A- 03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. APHIS-2006-0161. Reading Room: You may read any comments that we receive on this docket in our reading room. The reading room is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 690-2817 before coming. Other Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov. FOR FURTHER INFORMATION CONTACT: For information concerning Veterinary Services (VS) Management Support, contact Ms. Inez Hockaday, Director, Management Support Staff, VS, APHIS, 4700 River Road Unit 44, Riverdale, MD 20737-1231; (301) 734-7517. For information concerning VS Program Operations at the National Veterinary Services Laboratory, contact Dr. Elizabeth Lautner, Director, National Veterinary Services Laboratories, 1800 Dayton Road, P.O. Box 844, Ames, IA 50010; (515) 633-7357. For information concerning user fee rate development, contact Mrs. Kris Caraher, User Fees Section Head, Financial Management Division, MRPBS, APHIS, 4700 River Road Unit 54, Riverdale, MD 20737-1232; (301) 734-5901. SUPPLEMENTARY INFORMATION: Background User fees to reimburse the Animal and Plant Health Inspection Service (APHIS) for the costs of providing veterinary diagnostic services and import and export related services for live animals and birds and animal products are contained in 9 CFR part 130 (referred to below as the regulations). These user fees are authorized by section 2509(c) of the Food, Agriculture, Conservation, and Trade Act of 1990, as amended (21 U.S.C. 136a), which provides that the Secretary of Agriculture may, among other things, prescribe regulations and collect fees to recover the costs of veterinary diagnostics relating to the control and eradication of communicable diseases of livestock or poultry within the United States. Veterinary diagnostics is the work performed in a laboratory to determine if a disease-causing organism or chemical agent is present in body tissues or cells and, if so, to identify those organisms or agents. Services in this category include: (1) Performing laboratory tests and providing diagnostic reagents and other veterinary diagnostic materials and services at the National Veterinary Services Laboratories (NVSL) Foreign Animal Disease Diagnostic Laboratory (NVSL FADDL) in Greenport, NY; and (2) performing identification, serology, and pathobiology tests and providing diagnostic reagents and other veterinary diagnostic materials and services at NVSL in Ames, IA. APHIS veterinary diagnostic user fees fall into six categories: (1) Laboratory tests, reagents, and other veterinary diagnostic services performed at NVSL FADDL; (2) Laboratory tests performed as part of isolation and identification testing at NVSL in Ames; (3) Laboratory tests performed as part of serology testing at NVSL in Ames; (4) Laboratory tests performed at the pathobiology laboratory at NVSL in Ames; (5) Diagnostic reagents produced at NVSL in Ames or other authorized sites; and (6) Other veterinary diagnostic services or materials provided at NVSL in Ames. Need for Regulation User fees recover the cost of operating a public system by charging those members of the public who use the system, rather than the public as a whole, for its operation. Financing veterinary diagnostic services and products by charging for the right to use the incremental service internalizes those costs to those who require the service and benefit from it. Veterinary diagnostic services and products enhance livestock production, trade, and research. The socially optimal prices for such commodities, of which veterinary diagnostics are inputs, are those price levels that induce the output level where the marginal benefit (what people are willing to pay for the [[Page 40083]] good) is exactly equal to the marginal social cost (all costs associated with the production of the final output, including veterinary diagnostics). As it stands now, veterinary diagnostic services and products are provided at levels below their full cost to APHIS. These costs are, therefore, only partly incorporated into producers' costs of production. Our proposed revisions of the fee-for- service charges to recover the costs incurred by APHIS would move the private costs of individuals closer to the true cost of producing their outputs. The proposed annual increases, which would span fiscal years 2008 to 2012, would help ensure that the fees accurately reflect the cost of providing the services. Development of Fee Structure User fee components. The user fees proposed in this document are based on employee salaries and benefits in each of the fiscal years 2008 through 2012, estimates of the average number of direct labor hours required to provide each service, and average salaries for the laboratory where the work is performed. The proposed user fees have been calculated to recover the full costs for tests, diagnostic reagents, and other veterinary diagnostic services. These costs include direct labor, administrative support, premium costs (if any), agency overhead costs, and departmental charges. We describe these components below, using the calculation for the proposed virus isolation test user fee for fiscal year 2008 throughout as an example. We are proposing to charge a specific dollar amount for each service we provide (i.e., for each test we perform or each diagnostic reagent or other veterinary diagnostic service we provide). We have attempted to minimize the costs of our services, thereby keeping APHIS user fees at the lowest possible level. If, in the future, a user requests a test, diagnostic reagent, or other veterinary diagnostic material or service that is not specifically listed in our regulations, we would charge the proposed hourly user fee in Sec. 130.19 for the amount of time required to perform the service, calculated to the nearest quarter of an hour. Each user fee varies based on the direct labor hours required to perform the test or provide the diagnostic reagent or other veterinary diagnostic material or service. For example, the time spent by laboratory personnel to prepare a sample, conduct the test, and read the test would be part of the direct labor hours for testing a tissue sample for disease-causing organisms. In cases where a test is performed for more than one disease, it may take different amounts of time for each disease. Those times have been averaged to calculate the user fee. We have carefully calculated all of our proposed user fees to correctly reflect the direct labor hours required for each test, reagent, or service. We took into account variations in the time needed to provide a service by determining the average time necessary. The calculations for these proposed user fees are consistent with the calculations used for the other user fees throughout the regulations. Direct labor costs. Direct labor costs are the average salary and benefit costs of the laboratory employees performing the service multiplied by the average direct labor hours required. Average laboratory costs were used to calculate direct labor costs because we have determined that it is more accurate to use the average salary for the laboratory employees to calculate the user fee. For example, the estimated average laboratory salary at the Diagnostic Virology Laboratory, NVSL for fiscal year 2008 is $32.24 per hour. On average, it takes 0.295 hours per virus isolation test, leading to direct labor costs of $9.51. Administrative support costs. Administrative support costs are incurred at the laboratories. They include clerical and administrative activities; direct materials; indirect labor hours; rent; billing and collection costs; travel and transportation for personnel, supplies, equipment, and other necessary items; training; legal counsel; capital equipment costs; general supplies for offices, washrooms, and cleaning; contractual services; grounds maintenance; and utilities. Direct materials include the cost of any materials needed to conduct the test or to provide the diagnostic reagent, slide set, tissue set, or service. For example, direct materials for conducting a laboratory test include, but are not limited to, glassware, chemicals, and other supplies necessary to perform the test. Indirect labor hours include supervision of personnel and time spent doing necessary work, such as repairing equipment, that is not directly connected with a specific test, diagnostic reagent, or other veterinary diagnostic material or service. Contractual services may include, but are not limited to, guard service, trash pickup, and maintenance. Utilities include water, telephone, electricity, natural and propane gas, and heating and diesel oil. The costs of administrative support are applied as a percentage of the base direct labor amount; at NVSL in Ames, administrative support is 296 percent of direct labor. For example, the support costs for the virus isolation test are calculated at 296 percent of its direct labor costs of $9.51 to be $28.15. The total direct labor and administrative support costs for one virus isolation test are $37.66. Premium costs. Premium costs are expenses that are incurred solely for a specific test or service. For example, certain tests require expensive reagents in addition to the direct labor time and laboratory materials included in administrative support costs. Premium costs required for the proposed flat rate user fees have already been included in the calculations. For example, each sterilization by gamma radiation at NVSL FADDL requires special radioactive materials, irradiation costs, and travel costs for an APHIS employee to hand-carry the material. Based on the high amount of costs involved, these premium costs are added to the specific fee involved rather than included as an administrative support cost that is spread to all fees for tests, reagents, and other services. The virus isolation test, used as our example thus far, does not have any premium costs. Agency overhead. Agency overhead is the pro rata share, attributable to a particular diagnostic reagent, material, or veterinary diagnostic service, of the management and support costs for all Agency activities at the regional level and above. Included are the costs of providing budget and accounting services, management support at the headquarters and regional levels, including the Administrator's office, and personnel services, public information services, and liaison with Congress. Agency overhead is calculated at 16.15 percent of total direct labor and support costs. For example, the Agency overhead for one virus isolation test is $6.08, which is the product of virus isolation direct labor and administrative support costs of $37.66 multiplied by 16.15 percent. Departmental charges. Departmental charges are APHIS' share, expressed as a percentage of the total cost, of services provided centrally by the U.S. Department of Agriculture. Services the Department provides centrally include the Federal telephone service; mail; National Finance Center processing of payroll, billing, collections, and other money management; unemployment compensation; Office of Workers Compensation Programs; and central supply for storing and issuing commonly used supplies and departmental forms. The Department notifies APHIS how much the Agency owes for these services. [[Page 40084]] We have included a pro rata share of these departmental charges, as attributed to a particular test, diagnostic reagent, or other veterinary diagnostic material or service, in our user fee calculations at the rate of 4.2 percent. For example, departmental charges to perform one virus isolation test are $1.84. This amount equals 4.2 percent of total direct labor costs, administrative support costs, and Agency overhead costs of $43.74 described above. The subtotal of the virus isolation test's direct labor, administrative support, Agency overhead, and departmental charges costs equals $45.58. Reserve. We are proposing to add an amount that would provide for a reasonable balance, or reserve, in the veterinary diagnostics user fee account. All user fees would contribute to the reserve proportionately. The reserve would ensure that we have sufficient operating funds in cases of fluctuations in activity volumes, bad debt, program shutdown, or customer insolvency. We intend to monitor the reserve balance closely and propose adjustments in our fees as necessary to ensure a reasonable balance. For example, the reserve amount included in the calculation for one virus isolation test is $2.28 per test. The total costs in this example thus far equal $47.86. Calculation of proposed user fees. The basic steps in the calculation for each particular service are: (1) Calculate direct labor costs by determining the average amount of direct labor required to perform the service and multiply the average direct labor hours by the average salary and benefit costs for laboratory employees; (2) calculate the pro rata share of administrative support; (3) determine the premium costs (if any); (4) calculate the pro rata share of Agency overhead and departmental charges, respectively; (5) add all costs; and (6) round up to the next $0.25 for all fees less than $10 or round up or down to the nearest dollar for all fees greater than $10. For example, the total virus isolation costs per test for fiscal year 2008 of $47.86 is rounded up to $48 per test. The result of these calculations is a user fee that covers the total cost to perform a particular test or provide a particular veterinary diagnostic material or service one time. As is the case with all APHIS user fees, we intend to review, at least annually, the user fees proposed in this document. We will publish any necessary adjustments in the Federal Register. Executive Order 12866 and Regulatory Flexibility Act This proposed rule has been reviewed under Executive Order 12866. The rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget. Below is a summary of the economic analysis for the changes in APHIS user fees proposed in this document. A copy of the full economic analysis, which includes comparisons of the change in each user fee, may be viewed on the Regulations.gov Web site or in our reading room. (Instructions for accessing Regulations.gov and information on the location and hours of the reading room are provided under the heading ADDRESSES at the beginning of this proposed rule.) In addition, copies may be obtained by calling or writing to the individual listed under FOR FURTHER INFORMATION CONTACT. APHIS is proposing to update the user fees covering the costs of providing veterinary diagnostics services to take into account the routine increases in the cost of doing business. The costs to operate the VS Veterinary Diagnostics Program at NVSL increase slightly from year to year due to increases in employee costs (cost of living increases, etc.) and other operational costs. These fees are necessary to provide for full-cost recovery of Agency activities. Calculating the potential impacts of these proposed changes to the veterinary diagnostics user fees is hindered by the difficulty in determining the elasticities of demand for the covered services. Therefore, Government savings are assumed equivalent to the total user fee collections for each category associated with the proposed rule. Veterinary diagnostic services and products are provided to animal importers and exporters, veterinarians, State and Federal agencies and laboratories, commercial laboratories, educational institutions, and foreign governments. There is reason to believe that the impact on most users of the changes in this proposal would be small. About 76 percent of the fees change in total by $10 or less. The majority should also make only small contributions to the total additional collections and therefore have a minor impact on the users of those materials and services. This is either because the proposed change is small or the projected volume associated with the user fee is small, or both. In addition, user fees are not charged when tests are provided in the context of disease control or eradication programs. Also, in addition to the role they play in protecting American agriculture, veterinary diagnostic services and products facilitate international trade and thereby enhance the business interests of many of those requesting these services. Nearly 80 percent of the total projected change in collections would come from changes in only 13 of the 146 fees. Only these 13 proposed fee changes are projected to generate $10,000 or more in additional annual collections by the end of the period covered in this proposal. Several factors suggest, however, that these fees should also not have a significant impact on users. These fees include small fees applied to a large annual volume of users, large fees but very small volume of users, fees that represent a small percentage of the overall costs associated with a user's output, single fees for reagents with numerous final users, and fees that enhance the marketability of the user's final output. To the extent that the proposed changes in user fees would impact operational costs, any entity that utilizes APHIS veterinary diagnostic services and materials could be impacted by the proposed changes. The degree to which an entity could be affected depends on its market power, that is, the extent to which costs are either absorbed or can be passed on to its buyers. Without information on either profit margins or operational expenses of the affected entities, or the effects of changes in operating costs on the affected industry, the scale of the impacts cannot be precisely predicted. However, some conclusions on the overall impacts to domestic and international commerce can be drawn. If the user fees cannot be passed on, the profit margins of some entities may decline as user fees for veterinary diagnostic services and materials are increased. However, the impacts are expected to be muted. The majority of the changes to the user fees are either small, associated with few users, or both. Over the period covered by the proposal, more than 51 percent of the individual increases are $5 or less, more than 76 percent increase by less than $10, and more than 83 percent are associated with fewer than 500 users. The majority should also make only small contributions to the total additional collections and therefore have a minor impact on the users of those services. This is either because the proposed change is small or the projected volume associated with the user fee is small, or both. Even in those instances in which the change in a user fee generates a larger total increase in collections, the impact should not be significant. This is because they are small fees applied to a large annual volume of users, large fees but applied [[Page 40085]] to a very small volume of users, fees that represent a small percentage of the overall costs associated with a user's output, single fees for reagents with numerous final users, or fees that enhance the marketability of the user's final outputs. Therefore, the increases are not generally expected to substantially reduce profits or impede trade. Indeed, the full burden of the user fee changes is not likely to be borne entirely by the purchasers of veterinary diagnostic services and materials. Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities. Executive Order 12372 This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.) Executive Order 12988 This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. If this proposed rule is adopted: (1) All State and local laws and regulations that are inconsistent with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) administrative proceedings will not be required before parties may file suit in court challenging this rule. Paperwork Reduction Act This proposed rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). List of Subjects in 9 CFR Part 130 Animals, Birds, Diagnostic reagents, Exports, Imports, Poultry and poultry products, Quarantine, Reporting and recordkeeping requirements, Tests. Accordingly, we propose to amend 9 CFR part 130 as follows: PART 130--USER FEES 1. The authority citation for part 130 continues to read as follows: Authority: 5 U.S.C. 5542; 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 3701, 3716, 3717, 3719, and 3720A; 7 CFR 2.22, 2.80, and 371.4. 2. In Sec. 130.15, paragraphs (a) and (b), the tables are revised to read as follows: Sec. 130.15 User fees for veterinary diagnostic isolation and identification tests performed at NVSL (excluding FADDL) or other authorized site. (a) * * * ---------------------------------------------------------------------------------------------------------------- User fee ---------------------------------------------------------------- Test Unit Oct. 1, Oct. 1, Oct. 1, Oct. 1, Beginning 2007-Sept. 2008-Sept. 2009-Sept. 2010-Sept. Oct. 1, 30, 2008 30, 2009 30, 2010 30, 2011 2011 ---------------------------------------------------------------------------------------------------------------- Bacterial identification, Isolate......... $53.00 $54.00 $55.00 $57.00 $58.00 automated. Bacterial identification, non- Isolate......... 90.00 92.00 94.00 96.00 98.00 automated. Bacterial isolation.......... Sample.......... 36.00 37.00 38.00 39.00 40.00 Bacterial serotyping, all Isolate......... 55.00 56.00 56.00 57.00 58.00 other. Bacterial serotyping, Isolate......... 18.00 19.00 19.00 19.00 20.00 Pasteurella multocida. Bacterial serotyping, Isolate......... 36.00 37.00 38.00 39.00 40.00 Salmonella. Bacterial toxin typing....... Isolate......... 120.00 123.00 126.00 128.00 131.00 Bacteriology requiring Test............ 92.00 94.00 96.00 98.00 101.00 special characterization. DNA fingerprinting........... Test............ 59.00 61.00 62.00 63.00 64.00 DNA probe.................... Test............ 83.00 85.00 86.00 88.00 89.00 Fluorescent antibody......... Test............ 19.00 19.00 20.00 20.00 20.00 Mycobacterium identification Isolate......... 115.00 117.00 120.00 122.00 125.00 (biochemical). Mycobacterium identification Procedure....... 96.00 99.00 101.00 103.00 105.00 (gas chromatography). Mycobacterium isolation, Submission...... 844.00 852.00 868.00 884.00 900.00 animal inoculations. Mycobacterium isolation, all Submission...... 151.00 154.00 158.00 161.00 165.00 other. Mycobacterium Submission...... 72.00 74.00 75.00 77.00 79.00 paratuberculosis isolation. Phage typing, all other...... Isolate......... 42.00 43.00 44.00 45.00 46.00 Phage typing, Salmonella Isolate......... 24.00 24.00 25.00 25.00 26.00 enteritidis. ---------------------------------------------------------------------------------------------------------------- (b) * * * ---------------------------------------------------------------------------------------------------------------- User fee ---------------------------------------------------------------- Test Unit Oct. 1, Oct. 1, Oct. 1, Oct. 1, Beginning 2007-Sept. 2008-Sept. 2009-Sept. 2010-Sept. Oct. 1, 30, 2008 30, 2009 30, 2010 30, 2011 2011 ---------------------------------------------------------------------------------------------------------------- Fluorescent antibody tissue Test............ $29.00 $30.00 $30.00 $31.00 $31.00 section. Virus isolation.............. Test............ 48.00 49.00 50.00 51.00 52.00 ---------------------------------------------------------------------------------------------------------------- * * * * * 3. In Sec. 130.16, paragraphs (a) and (b), the tables are revised to read as follows: Sec. 130.16 User fees for veterinary diagnostic serology tests performed at NVSL (excluding FADDL) or at authorized sites. (a) * * * [[Page 40086]] -------------------------------------------------------------------------------------------------------------------------------------------------------- User fee ----------------------------------------------------------------------------------------- Test Unit Oct. 1, 2007- Oct. 1, 2008- Oct. 1, 2009- Oct. 1, 2010- Sept. 30, 2008 Sept. 30, 2009 Sept. 30, 2010 Sept. 30, 2011 Beginning Oct. 1, 2011 -------------------------------------------------------------------------------------------------------------------------------------------------------- Brucella ring (BRT)............... Test...................... $36.00 $37.00 $38.00 $39.00 $40.00 Brucella ring, heat inactivated Test...................... 36.00 37.00 38.00 39.00 40.00 (HIRT). Brucella ring, serial (Serial BRT) Test...................... 54.00 56.00 57.00 58.00 59.00 Buffered acidified plate antigen Test...................... 7.00 7.25 7.50 7.50 8.00 presumptive. Card.............................. Test...................... 4.00 4.00 4.25 4.25 4.50 Complement fixation............... Test...................... 16.00 17.00 17.00 17.00 18.00 Enzyme-linked immunosorbent assay. Test...................... 16.00 17.00 17.00 17.00 18.00 Indirect fluorescent antibody..... Test...................... 14.00 15.00 15.00 15.00 16.00 Microscopic agglutination-- Sample.................... 24.00 24.00 25.00 25.00 26.00 includes up to 5 serovars. Microscopic agglutination--each Sample.................... 4.25 4.50 4.50 4.50 4.75 serovar in excess of 5 serovars. Particle concentration fluorescent Test...................... 36.00 37.00 38.00 38.00 39.00 immunoassay (PCFIA). Plate............................. Test...................... 7.00 7.25 7.50 7.50 7.75 Rapid automated presumptive....... Test...................... 7.00 7.00 7.25 7.25 7.25 Rivanol........................... Test...................... 7.00 7.25 7.50 7.50 7.75 Tube agglutination................ Test...................... 7.00 7.25 7.50 7.50 7.75 -------------------------------------------------------------------------------------------------------------------------------------------------------- (b) * * * -------------------------------------------------------------------------------------------------------------------------------------------------------- User fee ----------------------------------------------------------------------------------------- Test Unit Oct. 1, 2007- Oct. 1, 2008- Oct. 1, 2009- Oct. 1, 2010- Sept. 30, 2008 Sept. 30, 2009 Sept. 30, 2010 Sept. 30, 2011 Beginning Oct. 1, 2011 -------------------------------------------------------------------------------------------------------------------------------------------------------- Agar gel immunodiffusion.......... Test...................... $16.00 $17.00 $17.00 $17.00 $18.00 Complement fixation............... Test...................... 16.00 17.00 17.00 18.00 18.00 Enzyme-linked immunosorbent assay. Test...................... 16.00 17.00 17.00 18.00 18.00 Hemagglutination inhibition....... Test...................... 14.00 15.00 15.00 15.00 16.00 Indirect fluorescent antibody..... Test...................... 14.00 15.00 15.00 15.00 16.00 Latex agglutination............... Test...................... 16.00 17.00 17.00 17.00 18.00 Peroxidase-linked antibody........ Test...................... 15.00 16.00 16.00 16.00 17.00 Plaque reduction neutralization... Test...................... 18.00 18.00 19.00 19.00 19.00 Rabies fluorescent antibody Test...................... 45.00 46.00 47.00 49.00 50.00 neutralization. Virus neutralization.............. Test...................... 13.00 13.00 14.00 14.00 14.00 -------------------------------------------------------------------------------------------------------------------------------------------------------- * * * * * 4. In Sec. 130.17, paragraph (a), the table is revised to read as follows: Sec. 130.17 User fees for other veterinary diagnostic laboratory tests performed at NVSL (excluding FADDL) or at authorized sites. (a) * * * -------------------------------------------------------------------------------------------------------------------------------------------------------- User fee ----------------------------------------------------------------------------------------- Test Unit Oct. 1, 2007- Oct. 1, 2008- Oct. 1, 2009- Oct. 1, 2010- Sept. 30, 2008 Sept. 30, 2009 Sept. 30, 2010 Sept. 30, 2011 Beginning Oct. 1, 2011 -------------------------------------------------------------------------------------------------------------------------------------------------------- Aflatoxin quantitation............ Test...................... $30.00 $31.00 $32.00 $32.00 $33.00 Aflatoxin screen.................. Test...................... 29.00 29.00 30.00 30.00 31.00 Agar gel immunodiffusion spp. Test...................... 13.00 13.00 13.00 14.00 14.00 identification. Antibiotic (bioautography) Test...................... 66.00 67.00 68.00 70.00 72.00 quantitation. [[Page 40087]] Antibiotic (bioautography) screen. Test...................... 119.00 122.00 125.00 128.00 130.00 Antibiotic inhibition............. Test...................... 66.00 67.00 68.00 70.00 72.00 Arsenic........................... Test...................... 17.00 18.00 18.00 19.00 19.00 Ergot alkaloid screen............. Test...................... 66.00 67.00 68.00 70.00 72.00 Ergot alkaloid confirmation....... Test...................... 86.00 88.00 89.00 91.00 94.00 Feed microscopy................... Test...................... 66.00 67.00 68.00 70.00 72.00 Fumonisin only.................... Test...................... 37.00 38.00 39.00 40.00 40.00 Gossypol.......................... Test...................... 98.00 100.00 103.00 105.00 107.00 Mercury........................... Test...................... 145.00 148.00 151.00 155.00 158.00 Metals screen..................... Test...................... 44.00 45.00 46.00 47.00 48.00 Metals single element confirmation Test...................... 13.00 13.00 13.00 14.00 14.00 Mycotoxin: aflatoxin-liver........ Test...................... 119.00 122.00 125.00 128.00 130.00 Mycotoxin screen.................. Test...................... 48.00 49.00 50.00 51.00 52.00 Nitrate/nitrite................... Test...................... 66.00 67.00 68.00 70.00 72.00 Organic compound confirmation..... Test...................... 88.00 90.00 92.00 94.00 96.00 Organic compound screen........... Test...................... 151.00 155.00 158.00 161.00 165.00 Parasitology...................... Test...................... 29.00 29.00 30.00 30.00 31.00 Pesticide quantitation............ Test...................... 132.00 135.00 138.00 141.00 144.00 Pesticide screen.................. Test...................... 60.00 62.00 63.00 64.00 66.00 pH................................ Test...................... 26.00 27.00 28.00 28.00 29.00 Plate cylinder.................... Test...................... 98.00 100.00 103.00 105.00 107.00 Selenium.......................... Test...................... 44.00 45.00 46.00 47.00 48.00 Silicate/carbonate disinfectant... Test...................... 66.00 67.00 68.00 70.00 72.00 Temperature disks................. Test...................... 130.00 133.00 136.00 139.00 142.00 Toxicant quantitation, other...... Test...................... 110.00 112.00 115.00 117.00 120.00 Toxicant screen, other............ Test...................... 33.00 33.00 34.00 35.00 36.00 Vomitoxin only.................... Test...................... 53.00 54.00 55.00 56.00 58.00 Water activity.................... Test...................... 33.00 33.00 34.00 35.00 36.00 Zearaleone quantitation........... Test...................... 53.00 54.00 55.00 56.00 58.00 Zearaleone screen................. Test...................... 29.00 29.00 30.00 30.00 31.00 -------------------------------------------------------------------------------------------------------------------------------------------------------- * * * * * 5. In Sec. 130.18, paragraphs (a) and (b), the tables are revised to read as follows: Sec. 130.18 User fees for veterinary diagnostic reagents produced at NVSL or other authorized site (excluding FADDL). (a) * * * -------------------------------------------------------------------------------------------------------------------------------------------------------- User fee ----------------------------------------------------------------------------------------- Reagent Unit Oct. 1, 2007- Oct. 1, 2008- Oct. 1, 2009- Oct. 1, 2010- Sept. 30, 2008 Sept. 30, 2009 Sept. 30, 2010 Sept. 30, 2011 Beginning Oct. 1, 2011 -------------------------------------------------------------------------------------------------------------------------------------------------------- Anaplasma card test antigen....... 2 mL...................... $95.00 $97.00 $99.00 $101.00 $103.00 Anaplasma card test kit without Kit....................... 127.00 130.00 133.00 136.00 139.00 antigen. Anaplasma CF antigen.............. 2 mL...................... 46.00 46.00 46.00 47.00 47.00 Anaplasma stabilate............... 4.5 mL.................... 175.00 178.00 181.00 185.00 188.00 Avian origin bacterial antiserums. 1 mL...................... 48.00 49.00 50.00 51.00 52.00 Bacterial agglutinating antigens 5 mL...................... 54.00 55.00 57.00 58.00 59.00 other than brucella and salmonella pullorum. Bacterial conjugates.............. 1 mL...................... 96.00 99.00 101.00 103.00 105.00 Bacterial disease CF antigens, all 1 mL...................... 29.00 30.00 30.00 31.00 32.00 other. Bacterial ELISA antigens.......... 1 mL...................... 29.00 30.00 31.00 31.00 32.00 Bacterial or protozoal antiserums, 1 mL...................... 60.00 61.00 63.00 64.00 66.00 all other. Bacterial reagent culture \1\..... Culture................... 73.00 74.00 76.00 78.00 79.00 Bacterial reference culture \2\... Culture................... 228.00 233.00 239.00 244.00 249.00 Bacteriophage reference culture... Culture................... 172.00 176.00 180.00 183.00 188.00 Bovine serum factor............... 1 mL...................... 18.00 18.00 19.00 19.00 19.00 [[Page 40088]] Brucella abortus CF antigen....... 60 mL..................... 151.00 154.00 158.00 161.00 165.00 Brucella agglutination antigens, 60 mL..................... 151.00 154.00 158.00 161.00 165.00 all other. Brucella buffered plate antigen... 60 mL..................... 172.00 176.00 180.00 183.00 188.00 Brucella canis tube antigen....... 25 mL..................... 114.00 116.00 119.00 121.00 124.00 Brucella card test antigen Package................... 90.00 92.00 94.00 96.00 98.00 (packaged). Brucella card test kit without Kit....................... 113.00 114.00 116.00 117.00 119.00 antigen. Brucella cells.................... Gram...................... 19.00 19.00 19.00 20.00 20.00 Brucella cells, dried............. Pellet.................... 6.00 6.00 6.25 6.25 6.25 Brucella ring test antigen........ 60 mL..................... 241.00 246.00 252.00 257.00 263.00 Brucella rivanol solution......... 60 mL..................... 29.00 30.00 31.00 31.00 32.00 Dourine CF antigen................ 1 mL...................... 89.00 91.00 93.00 95.00 97.00 Dourine stabilate................. 4.5 mL.................... 109.00 111.00 112.00 114.00 116.00 Equine and bovine origin babesia 1 mL...................... 127.00 130.00 133.00 136.00 139.00 species antiserums. Equine negative control CF antigen 1 mL...................... 282.00 283.00 286.00 290.00 293.00 Flazo-orange...................... 3 mL...................... 13.00 13.00 13.00 13.00 14.00 Glanders CF antigen............... 1 mL...................... 77.00 79.00 81.00 82.00 84.00 Hemoparasitic disease CF antigens, 1 mL...................... 541.00 553.00 565.00 577.00 590.00 all other. Leptospira transport medium....... 10 mL..................... 4.25 4.50 4.50 4.50 4.75 Monoclonal antibody............... 1 mL...................... 95.00 97.00 99.00 101.00 103.00 Mycobacterium spp. old tuberculin. 1 mL...................... 24.00 24.00 25.00 25.00 26.00 Mycobacterium spp. PPD............ 1 mL...................... 18.00 19.00 19.00 19.00 20.00 Mycoplasma hemagglutination 5 mL...................... 180.00 184.00 188.00 192.00 197.00 antigens. Negative control serums........... 1 mL...................... 18.00 19.00 19.00 19.00 20.00 Rabbit origin bacterial antiserum. 1 mL...................... 52.00 53.00 54.00 55.00 56.00 Salmonella pullorum 5 mL...................... 15.00 16.00 16.00 16.00 17.00 microagglutination antigen. Stabilates, all other............. 4.5 mL.................... 684.00 690.00 703.00 716.00 730.00 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ A reagent culture is a bacterial culture that has been subcultured one or more times after being tested for purity and identity. It is intended for use as a reagent with a diagnostic test such as the leptospiral agglutination test. \2\ A reference culture is a bacterial culture that has been thoroughly tested for purity and identity. It should be suitable as a master seed for future cultures. (b) * * * -------------------------------------------------------------------------------------------------------------------------------------------------------- User fee ----------------------------------------------------------------------------------------- Reagent Unit Oct. 1, 2007- Oct. 1, 2008- Oct. 1, 2009- Oct. 1, 2010- Sept. 30, 2008 Sept. 30, 2009 Sept. 30, 2010 Sept. 30, 2011 Beginning Oct. 1, 2011 -------------------------------------------------------------------------------------------------------------------------------------------------------- Antigen, except avian influenza 2 mL...................... $61.00 $62.00 $64.00 $65.00 $67.00 and chlamydia psittaci antigens, any. Avian antiserum except avian 2 mL...................... 48.00 49.00 51.00 52.00 53.00 influenza antiserum, any. Avian influenza antigen, any...... 2 mL...................... 33.00 34.00 35.00 36.00 36.00 Avian influenza antiserum, any.... 6 mL...................... 103.00 105.00 108.00 110.00 113.00 Bovine or ovine serum, any........ 2 mL...................... 127.00 130.00 133.00 136.00 139.00 Cell culture...................... Flask..................... 151.00 154.00 158.00 161.00 165.00 [[Page 40089]] Chlamydia psittaci spp. of origin Panel..................... 95.00 96.00 98.00 99.00 101.00 monoclonal antibody panel. Conjugate, any.................... 1 mL...................... 73.00 75.00 76.00 78.00 80.00 Diluted positive control serum, 2 mL...................... 24.00 25.00 25.00 26.00 27.00 any. Equine antiserum, any............. 2 mL...................... 45.00 46.00 47.00 48.00 49.00 Monoclonal antibody............... 1 mL...................... 102.00 104.00 106.00 108.00 110.00 Other spp. antiserum, any......... 1 mL...................... 52.00 52.00 52.00 53.00 53.00 Porcine antiserum, any............ 2 mL...................... 105.00 108.00 110.00 113.00 115.00 Porcine tissue sets............... Tissue set................ 157.00 157.00 158.00 159.00 161.00 Positive control tissues, all..... 2 cm\2\ section........... 60.00 62.00 63.00 65.00 66.00 Rabbit origin antiserum........... 1 mL...................... 52.00 53.00 54.00 55.00 56.00 Reference virus, any.............. 0.6 mL.................... 180.00 184.00 188.00 193.00 197.00 Viruses (except reference 0.6 mL.................... 30.00 31.00 32.00 32.00 33.00 viruses), chlamydia psittaci agent or chlamydia psittaci antigen, any. -------------------------------------------------------------------------------------------------------------------------------------------------------- * * * * * 6. In Sec. 130.19, paragraph (a), the table is revised to read as follows: Sec. 130.19 User fees for other veterinary diagnostic services or materials provided at NVSL (excluding FADDL). (a) * * * -------------------------------------------------------------------------------------------------------------------------------------------------------- User fee ----------------------------------------------------------------------------------------- Service Unit Oct. 1, 2007- Oct. 1, 2008- Oct. 1, 2009- Oct. 1, 2010- Sept. 30, 2008 Sept. 30, 2009 Sept. 30, 2010 Sept. 30, 2011 Beginning Oct.1,2011 -------------------------------------------------------------------------------------------------------------------------------------------------------- Antimicrobial susceptibility test. Isolate................... $105.00 $107.00 $109.00 $112.00 $114.00 Avian safety test................. Test...................... 4,082.00 4,090.00 4,099.00 4,109.00 4,180.00 Check tests, culture.............. Kit\1\.................... 176.00 179.00 182.00 185.00 189.00 Check tests, serology............. Kit\1\.................... 361.00 369.00 377.00 385.00 394.00 Fetal bovine serum safety test.... Verification.............. 1,119.00 1,122.00 1,134.00 1,147.00 1,160.00 Hourly user fees \2\.............. Hour.............................. Hour...................... 104.00 104.00 108.00 112.00 112.00 Quarter hour...................... Quarter hour.............. 26.00 26.00 27.00 28.00 28.00 Minimum........................... .......................... 30.00 31.00 32.00 33.00 33.00 Manual, brucellosis culture....... 1 copy.................... 115.00 117.00 120.00 122.00 125.00 Manual, tuberculosis culture 1 copy.................... 172.00 176.00 180.00 183.00 188.00 (English or Spanish). Manual, Veterinary mycology....... 1 copy.................... 172.00 176.00 180.00 183.00 188.00 Manuals or standard operating 1 copy.................... 34.00 35.00 36.00 37.00 37.00 procedure (SOP), all other. Manuals or SOP, per page.......... 1 page.................... 2.25 2.50 2.50 2.75 2.75 Training (school or technical Per person per day........ 332.00 339.00 346.00 354.00 362.00 assistance). -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ Any reagents required for the check test will be charged separately. \2\ For veterinary diagnostic services for which there is no flat user fee the hourly rate user fee will be calculated for the actual time required to provide the service. [[Page 40090]] * * * * * Done in Washington, DC, this 18th day of July 2007. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E7-14162 Filed 7-20-07; 8:45 am] BILLING CODE 3410-34-P
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