Unknown. Final rule

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--- schema: federal-register doc_type: fedreg source_file: FR-2003-10-06.xml --- 68 193 Monday, October 6, 2003 Contents Agriculture Agriculture Department See Animal and Plant Health Inspection Service See Forest Service See Natural Resources Conservation Service Air Force Air Force Department NOTICES Meetings: Scientific Advisory Board, 57674 03-25213 Animal Animal and Plant Health Inspection Service RULES Viruses, serums, toxins, etc.: Desiccated biological products; moisture content, 57607-57608 03-25251 PROPOSED RULES Viruses, serums, toxins, etc.:

Bovine virus diarrhea and bovine rhinotracheitis vaccines; standard requirements, 57638-57639 03-25252 NOTICES Agency information collection activities; proposals, submissions, and approvals, 57653-57654 03-25253 03-25254 Meetings: Exotic big cats; care and maintenance symposia, 57655 03-25256 Veterinary services user fees; 2003 FY reimbursable overtime charges, 57655-57660 03-25255 Antitrust Antitrust Division NOTICES National cooperative research notifications: Advanced Technology Institute, 57709-57710 03-25206 Army Army Department See Engineers Corps Centers Centers for Disease Control and Prevention NOTICES Meetings:

National Institute for Occupational Safety and Health, National Institues of Health, and National Cancer Institute— Lung cancer and diesel exhaust among non-metal miners; cohort mortality study with nested case-control study, 57696 03-25233 Centers Centers for Medicare & Medicaid Services RULES Medicare: Hospital inpatient prospective payment systems and 2004 FY rates Correction, 57731-57758 03-25192 Coast Guard Coast Guard RULES Drawbridge operations: Florida, 57614-57616 03-25047 Ports and waterways safety:

Ninth Coast Guard District; Illinois Waterway System; barges loaded with dangerous cargoes; reporting requirements, 57616-57624 03-25296 Commerce Commerce Department See International Trade Administration See National Oceanic and Atmospheric Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 57663 03-25196 Defense Defense Department See Air Force Department See Engineers Corps Education Education Department NOTICES Grants and cooperative agreements; availability, etc.:

Postsecondary education— Jacob K. Javits Fellowship Program, 57675 03-25303 Meetings: National Institutional Quality and Integrity Advisory Committee, 57675-57677 03-25289 Employee Employee Benefits Security Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 57711-57712 03-25267 Employment Employment and Training Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 57712-57713 03-25287 Energy Energy Department See Federal Energy Regulatory Commission NOTICES Grants and cooperative agreements; availability, etc.:

Plasma Physics Junior Faculty Development Program, 57677-57678 03-25269 Engineers Engineers Corps RULES Danger zones and restricted area regulations: Charleston, SC; Cooper River and Tributaries in vicinity of Naval Weapons Station, 57624 03-25205 PROPOSED RULES Danger zones and restricted areas: Sheboygan County, WI; Lake Michigan shoreline between Manitowac and Port Washington, 57642-57643 03-25204 NOTICES Environmental statements; notice of intent: Los Angeles County, CA— Port of Long Beach, Pier S marine terminal development, 57674-57675 03-25203 EPA Environmental Protection Agency NOTICES Reports and guidance documents; availability, etc.:

Clean Water Act— Ferrocyanide; qualification as a cyanide within meaning of toxic pollutants list, 57690-57691 03-25272 Facilities Subject to Corrective Action Under Subtitle C of Resource Conservation and Recovery Act; Results-Based Approaches and Tailored Oversight Guidance, 57691-57692 03-25273 Water supply: Public water supply supervision program— West Virginia, 57692 03-25274 Executive Executive Office of the President See Trade Representative, Office of United States Federal Accounting Federal Accounting Standards Advisory Board NOTICES Committees; establishment, renewal, termination, etc.:

Agency charter amendment, 57692 03-25276 FAA Federal Aviation Administration RULES Airworthiness directives: Boeing, 57609-57611 03-24976 Bombardier, 57611-57613 03-24679 PROPOSED RULES Airworthiness directives: Boeing, 57639-57642 03-25230 FCC Federal Communications Commission NOTICES Agency information collection activities; proposals, submissions, and approvals, 57692-57694 03-25200 03-25202 Meetings: Technological Advisory Council, 57695 03-25241 Federal Emergency Federal Emergency Management Agency RULES Flood elevation determinations:

Various States, 57625-57629 03-25215 NOTICES Radiological Emergency Preparedness: Indian Point Energy Center, 57702 03-25216 Federal Energy Federal Energy Regulatory Commission NOTICES Agency information collection activities; proposals, submissions, and approvals, 57678-57683 03-25223 03-25226 Electric rate and corporate regulation filings: Fresno Power Investors, L.P., et al., 57685-57687 03-25257 Plymouth Energy LLC, et al., 57687-57689 03-25220 Meetings: Outreach Integrated Licensing Process, 57689-57690 03-25451 Practice and procedure:

Off-the-record communications, 57690 03-25228 *Applications, hearings, determinations, etc.:* Dominion Cover Point LNG LP, 57683 03-25219 Sitka, AK, 57683-57684 03-25450 Texas-New Mexico Power Co., 57684 03-25221 Universal Electric Power Corp., 57684 03-25227 Valley Electric Association, Inc., 57685 03-25222 Federal Highway Federal Highway Administration NOTICES Environmental statements; notice of intent: Syracuse, UT, 57728-57729 03-25239 Fish Fish and Wildlife Service PROPOSED RULES Endangered and threatened species:

Critical habitat designations— Tennessee and Cumberland River Basin mussels; technical correction, 57643-57646 03-25184 Finding on petitions, etc— Tibetan Antelope, 57646-57652 03-25207 NOTICES Endangered and threatened species: Incidental take permits— Cochise County, AZ and Hidalgo County, NM; Chiricahua leopard frog, 57702-57703 03-25236 Recovery plans— San Francisco lessingia and Raven's manzanita, 57703-57704 03-25238 Food Food and Drug Administration RULES Animal drugs, feeds, and related products:

Progesterone intravaginal inserts, 57613-57614 03-25249 PROPOSED RULES Human drugs— Oral health care drug products (OTC)— Antigingivitis/antiplaque products; monograph establishment; correction, 57642 03-25044 NOTICES Reports and guidance documents; availability, etc.: Continuous marketing applications— Pilot 1; fast track products under Prescription Drug User Fee Act of 1992; reviewable units, 57697-57698 03-25306 Continuous marketing applictions— Pilot 2; fast track products development under Prescription Drug User Fee Act of 1992; scientific feedback and interactions, 57696-57697 03-25305 Forest Forest Service NOTICES Environmental statements; notice of intent:

Beaverhead-Deerlodge National Forest, MT; correction, 57660-57662 03-25235 Meetings: Resource Advisory Committees— Yakutat, 57662 03-25212 Health Health and Human Services Department See Centers for Disease Control and Prevention See Centers for Medicare & Medicaid Services See Food and Drug Administration See Health Resources and Services Administration See National Institutes of Health NOTICES Meetings: Vital and Health Statistics National Committee, 57695 03-25284 Organization, functions, and authority delegations:

Office of Budget, Technology and Finance, 57695-57696 03-25283 Health Health Resources and Services Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 57698-57699 03-25250 Homeland Homeland Security Department See Coast Guard See Federal Emergency Management Agency Indian Indian Affairs Bureau NOTICES Committees; establishment, renewal, termination, etc.: Land Consolidation Program Working Group, 57704 03-25232 Re-Engineering (To-Be) Process and Fiduciary Trust Improvement Efforts Working Group, 57704-57705 03-25231 Environmental statements; notice of intent:

St. Regis Band of Mohawk Indians; Sullivan County, NY; Mohawk Mountain resort and casino, 57705-57706 03-25394 Grants and cooperative agreements; availability, etc.: Tribal courts, 57706 03-25229 Interior Interior Department See Fish and Wildlife Service See Indian Affairs Bureau See Land Management Bureau See National Park Service See Special Trustee for American Indians Office NOTICES Committees; establishment, renewal, termination, etc.: Grand Staircase-Escalante National Monument Advisory Committee, 57702 03-25195 International International Trade Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 57663-57664 03-25197 Antidumping:

Hard red spring wheat from— Canada, 57666-57667 03-25279 Light-walled rectangular pipe and tube from— Mexico and Turkey, 57667-57670 03-25282 Silicon metal from— Brazil, 57670-57672 03-25280 Antidumping and countervailing duties: Carbon and alloy steel wire rod from— Various countries, 57664-57666 03-25281 Justice Justice Department See Antitrust Division Labor Labor Department See Employee Benefits Security Administration See Employment and Training Administration See Occupational Safety and Health Administration RULES Nondiscrimination on basis of race, color, national origin, handicap, or age in federally assisted programs or activities Correction, 57730 C3-21140 NOTICES Agency information collection activities; proposals, submissions, and approvals, 57710-57711 03-25268 Land Land Management Bureau NOTICES Meetings:

Resource Advisory Councils— John Day/Snake, 57706 03-25234 NASA National Aeronautics and Space Administration RULES Acquisition regulations: Interagency acquisitions; five year limitation, 57629 03-25290 NOTICES Committees; establishment, renewal, termination, etc.: Education Advisory Committee, 57714 03-25270 NIH National Institutes of Health NOTICES Agency information collection activities; proposals, submissions, and approvals, 57699-57701 03-25294 03-25295 Meetings: National Heart, Lung, and Blood Institute, 57701 03-25291 National Institute of Environmental Health Sciences, 57701 03-25292 03-25293 NOAA National Oceanic and Atmospheric Administration RULES Fishery conservation and management:

Alaska; fisheries of Exclusive Economic Zone— Pacific cod, 57636-57637 03-25265 Pollock, 57634-57636 03-25264 NOTICES Damage Assessment and Restoration Program: Indirect cost rates (2002 FY), 57672-57673 03-25237 Permits: Marine mammals, 57673-57674 03-25271 National Park National Park Service NOTICES Environmental statements; availability, etc.: Glacier Bay National Park and Preserve, AK, 57706-57708 03-25208 National Register of Historic Places: Pending nominations, 57708-57709 03-25209 03-25211 National Transportation National Transportation Safety Board NOTICES Meetings;

Sunshine Act, 57714 03-25411 NRCS Natural Resources Conservation Service NOTICES Field office technical guides; changes: Tennessee, 57662-57663 03-25258 Nuclear Nuclear Regulatory Commission NOTICES *Applications, hearings, determinations, etc.:* Florida Power Corp., 57714-57715 03-25243 Southern Nuclear Operating Co., 57715 03-25242 Occupational Occupational Safety and Health Administration NOTICES Meetings: Ergonomics National Advisory Committee, 57713 03-25266 Office of U.S.

Trade Office of United States Trade Representative See Trade Representative, Office of United States Overseas Overseas Private Investment Corporation NOTICES Meetings; Sunshine Act, 57715-57716 03-25361 03-25362 Research Research and Special Programs Administration RULES Hazardous materials: Editorial corrections and clarifications, 57629-57634 03-24814 SEC Securities and Exchange Commission RULES Investment companies: Advertising rules; amendments, 57759-57782 03-25114 NOTICES Self-regulatory organizations; proposed rule changes:

Chicago Board Options Exchange, Inc., 57716-57720 03-25263 International Securities Exchange, Inc., 57720-57721 03-25261 Pacific Exchange, Inc., 57721-57723 03-25259 03-25260 Philadelphia Stock Exchange, Inc., 57724-57726 03-25262 Social Social Security Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 57726-57727 03-25244 Special Special Trustee for American Indians Office NOTICES Committees; establishment, renewal, termination, etc.:

Land Consolidation Program Working Group, 57704 03-25232 Re-Engineering (To-Be) Process and Fiduciary Trust Improvement Efforts Working Group, 57704-57705 03-25231 State State Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 57727-57728 03-25278 Art objects; importation for exhibition: Jasper Johns: Numbers, 57728 03-25277 Surface Surface Transportation Board NOTICES Railroad operation, acquisition, construction, etc.: Camas Prairie Railnet, Inc., 57729 03-25099 Trade Trade Representative, Office of United States NOTICES Meetings:

Industry Sector Advisory Committees— Services, 57728 03-25288 Transportation Transportation Department See Federal Aviation Administration See Federal Highway Administration See Research and Special Programs Administration See Surface Transportation Board Separate Parts In This Issue Part II Health and Human Services Department, Centers for Medicare & Medicaid Services, 57731-57758 03-25192 Part III Securities and Exchange Commission, 57759-57782 03-25114 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.

To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 68 193 Monday, October 6, 2003 Rules and Regulations DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Part 113 [Docket No. 01-067-2 ] Viruses, Serums, Toxins, and Analogous Products; Determination of Moisture Content in Desiccated Biological Products AGENCY:

Animal and Plant Health Inspection Service, USDA. ACTION: Final rule. SUMMARY: We are amending the Virus-Serum-Toxin Act regulations for the determination of moisture content in desiccated biological products to require that such determinations be made using a gravimetric method that expresses moisture content as the percentage of weight a product loses during a drying cycle, and to require that the maximum percentage of moisture permitted for a satisfactory test must be specified in a filed Outline of Production.

The gravimetric method has been adopted as an international standard by scientific experts and regulatory authorities in the United States, Canada, Japan, and the European Union. In addition, we are amending the regulations pertaining to general requirements for live bacterial vaccines and general requirements for live virus vaccines to specify the gravimetric method when testing for moisture content. These actions will update the regulations by providing a uniform method of determining moisture content in desiccated products and ensure the stability of that product during its dating period.

EFFECTIVE DATE: November 5, 2003. FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Chief of Operational Support, Licensing and Policy Development, Center for Veterinary Biologics, VS, APHIS, 4700 River Road Unit 148, Riverdale, MD 20737-1231;

(301)734-8245. SUPPLEMENTARY INFORMATION: Background The Virus-Serum-Toxin Act regulations in 9 CFR part 113 (referred to below as the regulations) prescribe standard requirements for the preparation and testing of veterinary biological products. Standard requirements consist of test methods, procedures, and criteria that define the standards for purity, safety, potency, and efficacy for a given type of veterinary biologic product. When a standard procedure for testing veterinary biological products is validated and approved by the Animal and Plant Health Inspection Service (APHIS) for general use, it is proposed for codification in the regulations. Section 113.29 of the regulations sets forth the requirement for determination of moisture content in desiccated biological products. On August 5, 2002, we published in the **Federal Register** (67 FR 50606-50608, Docket No. 01-067-1) a proposal to amend the regulations for determination of moisture content in desiccated biological products to specify that such determinations be made using a gravimetric method, and to require that the maximum percentage of moisture permitted for a satisfactory test must be specified in a filed Outline of Production. The proposed rule was intended to update the regulations by providing a uniform method of determining moisture content in desiccated products and ensure the stability of that product during its dating period. We solicited comments on our proposed rule for 60 days ending on October 4, 2002. We received two comments by that date, from a veterinary biologics manufacturer and a national trade association representing veterinary biologics manufacturers. Both commenters supported the proposed rule. One commenter did, however, request that we “clarify the exceptions to the use of the proposed method.” The commenter recommended that if we intend to handle such instances via outline exemptions, then that should be stated. Additionally, the commenter asked that we indicate whether one valid reason for an exemption would be that a firm does not have the equipment necessary to conduct the test. In this final rule, we are adopting the gravimetric method as the standard procedure for determining moisture content. As a Standard Requirement test, the gravimetric method should be used whenever the test for moisture content is performed. However, we note that exemptions to the use of the gravimetric method, like exemptions to any test prescribed in the various standard requirements found in part 113, may be granted for any valid reason in accordance with § 113.4, “Exemptions to tests.” Exemption requests are evaluated on a product-by-product basis, and in our review of such requests, we focus on the methods, equipment, and procedures that would be used in place of those prescribed in the Standard Requirement. It is the validity of the alternative methods and procedures that serves as the basis for the granting of an exemption. Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, without change. 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. We are amending the Virus-Serum-Toxin Act regulations for determination of moisture content in desiccated biological products to require that such moisture determinations be made using a gravimetric method that determines residual moisture by measuring the percentage of weight a product loses during a product drying cycle. In addition, this rule provides that the maximum percentage of moisture permitted for a satisfactory test must be specified in a filed Outline of Production. The effect of this action will be to provide a standardized method for the determination of moisture content in desiccated biological products that has been adopted internationally and ensure that such moisture determinations are uniform and reproducible. This rule will affect all licensed manufacturers of veterinary biologics that test desiccated vaccines for moisture content. Currently, there are approximately 135 veterinary biologics establishments, including permittees. According to the standards of the Small Business Administration, most veterinary biologics establishments would be classified as small entities. We do not expect that this rule will impose any additional testing or economic burden on these manufacturers because manufacturers currently test their products for moisture content by methods specified in their filed Outline of Production and the reagents and equipment necessary to perform the gravimetric test for moisture content that will be required under this rule are expected to be comparable in cost. 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. It is not intended to have retroactive effect. This rule will not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule. The Virus-Serum-Toxin Act does not provide administrative procedures which must be exhausted prior to a judicial challenge to the provisions of this rule. Paperwork Reduction Act This final rule contains no new information or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). List of Subjects in 9 CFR Part 113 Animal biologics, Exports, Imports, Reporting and recordkeeping requirements. Accordingly, we are amending 9 CFR part 113 as follows: PART 113—[AMENDED] 1. The authority citation for part 113 continues to read as follows: Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4. 2. Section 113.29 is revised to read as follows: § 113.29 Determination of moisture content in desiccated biological products. Methods provided in this section must be used when a determination of moisture content in desiccated biological products is prescribed in an applicable Standard Requirement or in the filed Outline of Production for the product. Firms currently using methods other than those provided in this section for determining the moisture content in desiccated biological products have until November 5, 2004 to update their Outlines of Production to be in compliance with this requirement.

(a)Final container samples of completed product shall be tested. The weight loss of the sample due to drying in a vacuum oven shall be determined. All procedures should be performed in an environment with a relative humidity less than 45 percent. The equipment necessary to perform the test is as follows:

(1)Cylindrical weighing bottles with airtight glass stoppers.

(2)Vacuum oven equipped with validated thermometer and thermostat. A suitable air-drying device should be attached to the inlet valve.

(3)Balance, accurate to 0.1 mg (rated precision ±0.01mg).

(4)Desiccator jar equipped with phosphorous pentoxide, silica gel, or equivalent.

(5)Desiccated vaccine in original sealed vial. Sample and control should be kept at room temperature in their original airtight containers until use.

(b)Test procedure:

(1)Thoroughly cleaned and labeled sample-weighing bottles with stoppers should be allowed to dry at 60 ±3 °C under vacuum at less than 2.5 kPa.

(i)Transfer hot bottles and stoppers into the desiccator and allow to cool to room temperature.

(ii)After bottles have cooled, insert stoppers and weigh and record the weights of the bottles as “A.”

(iii)Return weighing bottles to the desiccator.

(2)Remove the sample container seal.

(i)Using a spatula, break up the sample plug and transfer the required amount of sample to the previously tared weighing bottle.

(ii)Insert the stopper and weigh and record the weights of the weighing bottles as “B.”

(3)Place the weighing bottle with the stopper at an angle in the vacuum oven. Set the vacuum to < 2.5 kPa and the temperature to 60 ±3 °C.

(4)After a minimum of 3 hours of drying time, turn off the vacuum pump and allow dry air to bleed into the oven until the pressure inside the oven is equalized with the prevailing atmospheric pressure.

(5)While the bottle is still warm, replace the stopper in its normal position and transfer the weighing bottle to the desiccator.

(i)Allow a minimum of 2 hours for the weighing bottle to cool to room temperature or for its weight to reach equilibrium.

(ii)Weigh, and record the weight as “C.”

(6)Calculate the percentage of moisture in the original sample as follows: (B−C)/(B−A) ×

(100)= Percentage of residual moisture, where: A = tare weight of weighing bottle B−A = weight of sample before drying B−C = weight of sample after drying

(7)The results are considered satisfactory if the percentage of residual moisture is less than or equal to the manufacturer's specification. 3. In § 113.64, paragraph

(e)is amended by adding a new paragraph (e)(3) to read as follows: § 113.64 General requirements for live bacterial vaccines.

(e)* * *

(3)Final container samples of completed product from each serial and subserial must be tested for moisture content in accordance with the test provided in § 113.29. 4. Section 113.300 is amended by revising paragraph

(e)to read as follows: § 113.300 General requirements for live virus vaccines.

(e)*Moisture content.*

(1)The maximum moisture content in desiccated vaccines must be stated in the filed Outline of Production.

(2)Final container samples of completed product from each serial or subserial must be tested for moisture content in accordance with the test prescribed in § 113.29. Done in Washington, DC, this 30th day of September 2003. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 03-25251 Filed 10-3-03; 8:45 am]

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