Unknown. Final rule

2,359 words·~11 min read·/register/2003/04/28/03-10416

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

--- schema: federal-register doc_type: fedreg source_file: FR-2003-04-28.xml --- 68 81 Monday, April 28, 2003 Contents Agriculture Agriculture Department See Commodity Credit Corporation See Food Safety and Inspection Service See Forest Service Alcohol Alcohol, Tobacco, Firearms, and Explosives Bureau NOTICES Agency information collection activities; proposals, submissions, approvals, 22415-22416 03-10411 Architectural Architectural and Transportation Barriers Compliance Board NOTICES Meetings:

Access Board, 22358 03-10398 Arts Arts and Humanities, National Foundation See National Foundation on the Arts and the Humanities Centers Centers for Disease Control and Prevention NOTICES Agency information collection activities; proposals, submissions, and approvals, 22386 03-10336 Children Children and Families Administration NOTICES Adoption and Foster Care Analysis and Reporting System; improvement, 22386-22387 03-10294 Coast Guard Coast Guard RULES Drawbridge operations:

Florida, 22294-22296 03-10290 Ports and waterways safety: Alaska Marine Highway System vessels in Southeast Alaska; security zone, 22298-22301 03-10292 Portland Captain of Port Zone, ME— Escorted vessel transits; security zones, 22305-22308 03-10425 Passenger vessels; security zones, 22303-22305 03-10424 Safety and security zones, etc.; list of temporary rules, 22301-22303 03-10423 St. Croix, U.S. Virgin Islands; security zone, 22296-22298 03-10293 NOTICES Agency information collection activities; proposals, submissions, and approvals, 22407 03-10289 Health Information Privacy Program:

Protected health information; appropriate uses and disclosures, 22407-22408 03-10422 Meetings: Houston/Galveston Navigation Safety Advisory Committee, 22408-22409 03-10291 Commerce Commerce Department See International Trade Administration See National Oceanic and Atmospheric Administration See Patent and Trademark Office CITA Committee for the Implementation of Textile Agreements NOTICES Cotton, wool, and man-made textiles: Fiji, 22361 03-10362 Indonesia, 22361-22362 03-10361 Qatar, 22362-22363 03-10364 Singapore, 22363 03-10360 Textile and apparel categories:

Caribbean Basin Trade Partnership Act; short supply requests— Shirting fabrics for use in blouses, 22363-22364 03-10363 Commodity Commodity Credit Corporation NOTICES Domestic Sugar Program; 2002-crop cane sugar marketing allotments and allocations; revisions, 22355-22357 03-10391 Corporation Corporation for National and Community Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 22364-22365 03-10303 Delaware Delaware River Basin Commission NOTICES Meetings and hearings, 22365-22366 03-10323 Drug Drug Enforcement Administration NOTICES *Applications, hearings, determinations, etc.:* Church of the Living Tree; correction, 22453 C3-8590 Knoll Pharmaceutical Co., 22416 03-10397 Education Education Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 03-10320 22366-22368 03-10321 03-10325 Employment Employment and Training Administration PROPOSED RULES Senior Community Service Employment Program, 22519-22561 03-9579 NOTICES Adjustment assistance:

Adecco, North American, LLC, 22417-22418 03-10348 Adecco Staffing Services Workers, 22417 03-10350 Alcatel USA Marketing, Inc., 22418 03-10343 Andrews Wire Co., 22418 03-10347 Edgcomb Metals, 22418 03-10357 Maya Kanulie, 22419 03-10354 Express Personnel Services, 22418 03-10340 Fishing Vessel LONNY A., 22418 03-10355 Fishing Vessel MISS SYNOVA, 22418-22419 03-10353 George Wilson, 22419 03-10352 National Refractories & Minerals Corp., 22419 03-10344 Olin Corp., 22419 03-10342 Raytheon Aircraft, 22419 03-10345 Reliant Fastener, 22419-22420 03-10356 Sanmina-SCI, 22420 03-10341 Shephard Clothing Co., Inc., 22420 03-10346 Shrimping Vessel VAGABOND, 22420 03-10351 NAFTA transitional adjustment assistance:

General Cable Corp., 22420 03-10339 Power One, 22420-22421 03-10349 Energy Energy Department See Federal Energy Regulatory Commission See Western Area Power Administration NOTICES Environmental statements; notice of intent: Portsmouth, OH and Paducah, KY; depleted uranium hexafluoride conversion facilities; construction, operation, and decontamination/decommissioning, 22368-22369 03-10373 Meetings: Environmental Management Site-Specific Advisory Board— Paducah Gaseous Diffusion Plant, KY, 22369 03-10374 EPA Environmental Protection Agency NOTICES Meetings:

Science Advisory Board, 22377-22379 03-10399 Executive Executive Office of the President See Presidential Documents FAA Federal Aviation Administration PROPOSED RULES Airworthiness directives: Dowty Aerospace Propellers, 22339-22341 03-10334 NOTICES Committees; establishment, renewal, termination, etc.: National Parks Overflights Advisory Group, 22449-22450 03-10288 FBI Federal Bureau of Investigation NOTICES Committees; establishment, renewal, termination, etc.: Criminal Justice Information Services Advisory Policy Board, 22416 03-10358 FCC Federal Communications Commission RULES Nondiscrimination on basis of disability in federally conducted programs and activities, 22315-22319 03-10284 Radio stations; table of assignments:

Arizona and New Mexico, 22321 03-10327 California, 22321-22322 03-10328 Oklahoma and Texas, 22322-22323 03-10329 Various States, 22319-22321 03-10326 NOTICES Agency information collection activities; proposals, submissions, and approvals, 22379 03-10285 Federal Energy Federal Energy Regulatory Commission NOTICES Electric rate and corporate regulation filings: El Paso Merchant Energy, L.P., et al., 22371-22372 03-10304 Midwest Independent Transmission System Operator, Inc., et al., 22372-22373 03-10322 Meetings;

Sunshine Act, 22373-22376 03-10585 03-10586 *Applications, hearings, determinations, etc.:* Allegheny Energy Supply Units 3, 4, & 5, LLC, 22369-22370 03-10307 Brookhaven Energy L.P., 22370 03-10306 Capital Power, Inc., 22370 03-10308 Entergy Services, Inc., 22371 03-10305 S.D. Warren Co., 22371 03-10309 Federal Motor Federal Motor Carrier Safety Administration RULES Motor carrier safety standards: Drivers’ hours of service— Fatigue prevention; driver rest and sleep for safe operations, 22455-22517 03-9971 Federal Reserve Federal Reserve System NOTICES Banks and bank holding companies:

Change in bank control, 22379-22380 03-10420 Formations, acquisitions, and mergers, 22380 03-10315 03-10419 Privacy Act: Systems of records, 22381-22385 03-10316 FTC Federal Trade Commission NOTICES Agency information collection activities; proposals, submissions, and approvals; correction, 22453 C3-9852 Fish Fish and Wildlife Service RULES Alaska National Interest Lands Conservation Act; Title VIII implementation (subsistence priority): Fish; subsistence taking and customary trade, 22308-22313 03-10106 PROPOSED RULES Endangered and threatened species:

Critical habitat designations— Cactus ferruginous pygmy-owl; Arizona distinct population segment, 22353-22354 03-10531 NOTICES Comprehensive conservation plans; availability, etc.: Seedskadee National Wildlife Refuge, WY, 22409 03-10335 Endangered and threatened species and marine mammal permit applications, 22409-22410 03-10319 Environmental statements; availability, etc.: Incidental take permits— Notomas Basin, Sacramento and Sutter Counties, CA; giant garter snake, valley elderberry longhorn beetle, etc., habitat conservation plan, 22410-22411 03-10359 Environmental statements; notice of intent:

Incidental take permits— Montana; Montana Natural Resources and Conservation Department; forested State Trust lands, 22412-22414 03-10333 Food Food and Drug Administration RULES Animal drugs, feeds, and related products: Chlortetracycline and sulfamethazine, 22294 03-10418 Praziquantel, pyrantel pamoate, and febantel tablets, 22293-22294 03-10416 PROPOSED RULES Food for human consumption: Infant formula; current good manufacturing practice, quality control procedures, etc., 22341-22343 03-10301 NOTICES Agency information collection activities; proposals, submissions, and approvals, 03-10300 22387-22389 03-10414 Biological products:

Patent extension; regulatory review period determinations— PREVNAR, 22389-22390 03-10302 Human drugs: Patent extension; regulatory review period determinations— AROMASIN, 22390-22391 03-10298 Meetings: Medical Devices Advisory Committee, 22391 03-10299 Reports and guidance documents; availability, etc.: FDA Modernization Act of 1997— Recognized Standards List modifications (Recognition List Number: 008), 22391-22400 03-10417 Inspection by Accredited Persons Program; implementation under Medical Device User Fee and Modernization Act of 2002; accreditation criteria, 22400-22405 03-10415 Food Food Safety and Inspection Service NOTICES Meetings:

Applied epidemiology and other tools use to protect public health, 22357-22358 03-10393 Forest Forest Service RULES Alaska National Interest Lands Conservation Act; Title VIII implementation (subsistence priority): Fish; subsistence taking and customary trade, 22308-22313 03-10106 NOTICES Meetings: Resource Advisory Committees— Lincoln County, 22358 03-10332 GSA General Services Administration RULES Federal travel: Per diem rates; per diem rate tables in Chapter 301 removed, and prescribed maximum per diem rates for Continental United States, 22314-22315 03-10313 NOTICES Acquisition regulations:

Transmittal for Transportation Schedules and Related Basic Documents (SF 1186); form revision, 22385 03-10312 Health Health and Human Services Department See Centers for Disease Control and Prevention See Children and Families Administration See Food and Drug Administration See Health Resources and Services Administration RULES Health insurance reform: Health Insurance Portability and Accountability Act of 1996— Civil money penalties; investigations procedures, penalties imposition, and hearings; correction, 22453 C3-9497 NOTICES Federal claims; interest rates on overdue debts, 22385-22386 03-10152 Health Health Resources and Services Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 22405-22406 03-10295 Meetings:

Primary Care Medicine and Dentistry Training Advisory Committee, 22406 03-10296 Homeland Homeland Security Department See Coast Guard Interior Interior Department See Fish and Wildlife Service See Land Management Bureau See Minerals Management Service IRS Internal Revenue Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 03-10405 22450-22452 03-10406 03-10407 03-10408 International International Trade Administration NOTICES Antidumping:

Stainless steel bar from— India, 22358-22359 03-10368 Countervailing duties: Alloy magnesium from— Canada, 22359-22360 03-10369 Justice Justice Department See Alcohol, Tobacco, Firearms, and Explosives Bureau See Drug Enforcement Administration See Federal Bureau of Investigation Labor Labor Department See Employment and Training Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 22416-22417 03-10337 03-10338 Land Land Management Bureau NOTICES Public land orders:

Colorado, 22414 03-10317 Utah, 22414-22415 03-10318 Minerals Minerals Management Service NOTICES Outer Continental Shelf operations: Oil and gas lease sales— Restricted joint bidders list, 22415 03-10330 National Foundation National Foundation on the Arts and the Humanities NOTICES Meetings: Arts and Humanities, President's Committee, 22421 03-10370 Combined Arts Advisory Panel, 22421 03-10372 Fellowships Advisory Panel, 22421-22422 03-10371 NOAA National Oceanic and Atmospheric Administration RULES Fishery conservation and management:

Northeastern United States fisheries— Monkfish, 22325-22333 03-10409 Northeast multispecies, 22333-22338 03-10410 International fisheries regulations: Pacific halibut— Catch sharing plan; correction, 22323-22325 03-10281 National Science National Science Foundation NOTICES Meetings: Education and Human Resources Advisory Committee, 22422 03-10314 Nuclear Nuclear Regulatory Commission NOTICES Petitions; Director's decisions: AmerGen Energy Co., LLC, 22422-22423 03-10394 Patent Patent and Trademark Office PROPOSED RULES Patent cases:

Patent statute; changes to implement 2002 inter partes reexamination and other technical amendments, 22343-22353 03-10412 Postal Postal Rate Commission NOTICES Meetings; Sunshine Act, 22423 03-10480 Presidential Presidential Documents EXECUTIVE ORDERS Government agencies and employees: Federal Physicians Comparability Allowance Amendments of 2000; application to certain Foreign Service and CIA benefits systems (EO 13297), 22563-22566 03-10606 SEC Securities and Exchange Commission NOTICES Investment Company Act of 1940:

Exemption applications— SEI Index Funds et al., 22423-22425 03-10379 Self-regulatory organizations; proposed rule changes: American Stock Exchange LLC, 22425-22426 03-10386 03-10387 Chicago Board Options Exchange, Inc., 22426-22429 03-10388 Depository Trust Co., 22429-22433 03-10382 03-10383 03-10384 03-10385 Fixed Income Clearing Corp., 22433-22434 03-10381 National Association of Securities Dealers, Inc., 22434-22445 03-10389 03-10390 Options Clearing Corp., 22445-22446 03-10378 Philadelphia Stock Exchange, Inc., 22446-22449 03-10377 03-10380 SBA Small Business Administration NOTICES *Applications, hearings, determinations, etc.:* Main Street Mezzanine Fund, L.P., 22449 03-10287 Textile Textile Agreements Implementation Committee See Committee for the Implementation of Textile Agreements Transportation Transportation Department See Federal Aviation Administration See Federal Motor Carrier Safety Administration Treasury Treasury Department See Internal Revenue Service Western Western Area Power Administration NOTICES Floodplain and wetlands protection; environmental review determinations; availability, etc.:

Cheyenne-Miracle Mile 115-kilovolt Transmission Line Rebuild Project, WY, 22376-22377 03-10375 Separate Parts In This Issue Part II Transportation Department, Federal Motor Carrier Safety Administration, 22455-22517 03-9971 Part III Labor Department, Employment and Training Administration, 22519-22561 03-9579 Part IV Executive Office of the President, Presidential Documents, 22563-22566 03-10606 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 81 Monday, April 28, 2003 Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Praziquantel, Pyrantel Pamoate, and Febantel Tablets AGENCY:

Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration

(FDA)is amending the animal drug regulations to reflect approval of a supplemental new animal drug application

(NADA)filed by Bayer Corp., Agriculture Division, Animal Health. The supplemental NADA provides for use of a larger size of praziquantel/pyrantel pamoate/febantel tablet for the removal of several species of internal parasites in dogs. DATES: This rule is effective April 28, 2003. FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7543, e-mail: *mberson@cvm.fda.gov.* SUPPLEMENTARY INFORMATION: Bayer Corp., Agriculture Division, Animal Health, P.O. Box 390, Shawnee Mission, KS 66201, filed a supplement to NADA 141-007 that provides for use of a larger size of DRONTAL PLUS (praziquantel/pyrantel pamoate/febantel) Tablets for the removal of several species of internal parasites in dogs. The supplemental NADA is approved as of February 10, 2003, and the regulations are amended in 21 CFR 520.1872 to reflect the approval. The basis of approval is discussed in the freedom of information summary. In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. The agency has determined under 21 CFR 25.33(d)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. List of Subjects in 21 CFR Part 520 Animal drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is amended as follows: PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: Authority: 21 U.S.C. 360b. 2. Section 520.1872 is amended by adding new paragraph (a)(3), and by revising the table in paragraph (c)(1)(i) to read as follows: § 520.1872 Praziquantel, pyrantel pamoate, and febantel tablets.

(a)* * *

(3)Tablet No. 3: 136 milligrams

(mg)praziquantel, 136 mg pyrantel base, and 680.4 mg febantel.

(c)* * *

(1)* * *

(i)* * * Weight of animal Kilograms Pounds Number of tablets per dose Tablet no. 1 Tablet no. 2 Tablet no. 3 0.9 to 1.8 2 to 4 1/2 2.3 to 3.2 5 to 7 1 3.6 to 5.4 8 to 12 1 1/2 5.9 to 8.2 13 to 18 2 8.6 to 11.4 19 to 25 2 1/2 11.8 to 13.6 26 to 30 1 14.1 to 20.0 31 to 44 1 1/2 20.4 to 27.2 45 to 60 2 1 27.7 to 40.9 61 to 90 1 1/2 41.3 to 54.5 91 to 120 2 Dated: April 4, 2003. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 03-10416 Filed 4-25-03; 8:45 am]

Connectionstraces to 5

Traces to 5 documents

CFR

U.S. Code

3 references not yet in our index