FEDERAL REGISTER VOLUME 35 • NUMBER 166 Wednesday, 26,1970 • , D.C. Pages 13563-13634

Agencies in this issue— The President Agricultural Research Service > Agriculture Department Civil Aeronautics Board Consumer and Marketing Service Customs Bureau Farmers Home Administration Federal Communications Commission Federal Insurance Administration Federal Power Commission Fish and Wildlife Service Food and Drug Administration General Services Administration Internal Revenue Service Interstate Commerce Commission Land Management Bureau Maritime Administration Mines Bureau National Highway Safety Bureau National Transportation Safety Board Securities and Exchange Commission Small Business Administration Tariff Commission Wage and Hour Division Detailed list of Contents appears inside. Announcing First 10-Year Cumulation

TABLES OF LAWS AFFECTED in Volumes 70-79 of the

UNITED STATES STATUTES AT LARGE

Lists all prior laws and other Federal in­ public laws enacted during the years 1956- struments which were amended, repealed, 1965. Includes index of popular name or otherwise affected by the provisions of acts affected in Volumes 70-79.

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1 1 aHf» D IT f’IC T rO Published dally, Tuesday through Saturday (no publication on Sundays, Mondays, or ■ ■ H r iir^ l I t i l on toe day after an official Federal holiday), by the Office of the Federal Register, National $ Archives and Records Service, General Services Administration, Washington, D.C. 20408, Area Code 202 Phone 962-8626 pursuant to the authority contained in the Federal Register Act, approved July 26, 1935 (49 Stat. 500, as amended; 44 U.S.C., Ch, 15), under regulations prescribed by the Administrative Committee of the Federal Register, ap­ proved by the President (1 CFR Ch. I). Distribution is made only by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402. The F ederal R egister will be furnished by mail to subscribers, free of postage, for $2.50 per month dr $25 per year, payable in advance. The charge for individual copies is 20 cents for each issue, or 20 cents for each group of pages as actually bound. Remit check or money order, made payable to the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402. The regulatory material appearing herein is keyed to the Code op F ederal Regulations, which is published, under 50 titles, pursuan to section 11 of the Federal Register Act, as amended (44 U.S.C. 1510). The Code of Federal Regulations is sold by the Superintendent of Documents. Prices of new books are listed in the first F ederal R egister issue of each month. There are no restrictions on *the republication of material appearing in the F ederal R egister or the Code op F ederal regulations. Contents

FEDERAL COMMUNICATIONS Notices THE PRESIDENT 0,0-Diethyl 0-3,5,6-trichloro-2- COMMISSION pyridyl phosphorothioate; ex­ PROCLAMATION Proposed Rule Making . tension of temporary toler­ National Hispanic Heritage Week, ances ______13612 1970 ------13567 Inclusion of coded information in Drugs for human or veterinary aural transmissions of radio and use; efficacy study implementa­ EXECUTIVE ORDER TV stations for purposes of pro­ tion (24 documents),___ 13589-13611 Providing for details and trans­ gram identification; extension LeGear Laboratories, me.; neo­ fers of Federal employees to in­ of time ------13585 mycin in animal feed™ ____ 13611 ternational organizations------13569 Notices Shell Chemical Co.; pesticide chemical petition______13612 Hearings, etc.: EXECUTIVE AGENCIES Dowdy, Charles W. (WROA), GENERAL SERVICES and Sumter Broadcasting Co., AGRICULTURAL RESEARCH me. (WISK)______13614 ADMINISTRATION SERVICE Stanley, Al G. (KATO), and Rules and Regulations Rules and Regulations Tri-County Broadcasting Co_ 13614 Contract cost principles and pro­ Hog cholera and other communi­ cedures; miscellaneous amend­ cable swine diseases; areas quar­ FEDERAL INSURANCE ments ______13579 antined ______13572 ADMINISTRATION HEALTH, EDUCATION, AND AGRICULTURE DEPARTMENT Rules and Regulations WELFARE DEPARTMENT See also Agricultural Research Identification of flood - prone See Food and Drug Administra­ Service; Consumer and Market­ tion. ing Service; Farmers Home Ad­ areas; list of flood hazard areas; ministration. correction ______— 13579 HOUSING AND URBAN Notices DEVELOPMENT DEPARTMENT FEDERAL POWER COMMISSION Texas; designation of areas for See Federal Insurance Adminis­ emergency loans------13589 Proposed Rule Making tration. CIVIL AERONAUTICS BOARD Initial rates for future sales of nat­ INTERIOR DEPARTMENT Rules and Regulations ural gas for all areas; extension of time______—------13585 See Fish and Wildlife Service; Responsibility of air carriers for Land Management Bureau; amounts collected by travel Notices Mines Bureau. agents in payment for charter Hearings, etc.: flights; limitation of rule to Atapaz Petroleum, me., et al— 13621 INTERNAL REVENUE SERVICE U.S.-originated charters (5 doc­ Cities Service Oil Co. et al—__ 13623 Notices uments) ______13572-13574 Continental Oil Co. et al------13624 Grants of relief regarding fire­ Notices Ginther, Warren & Co. et al----- 13625 Kerr-McGee Corp. et al_---- 1— 13626 arms acquisition, shipment, Hearings, etc.: etc.: East African Airways Corp------13612 Eaton, Clarence______13586 International Air Transport As­ FISH AND WILDLIFE SERVICE Newman, Dewey Pleasant_____ 13586 sociation ______J3612 Villa, Michael C______13587 Lineas Aereas Costarricenses, Proposed Rule Making S.A. (LACSA) ______— 13612 Use of certain national wildlife INTERSTATE COM M ERCE- Ross Aviation, me. (2 docu­ refuges: COMMISSION ments) ______13613 Hunting: United Air Lines, m e______13614 ; St. Vincent------13582 Notices New ; Bosque del Fourth section application for COMMERCE DEPARTMENT Apache ------13582 relief______13628 See Maritime Administration. North Carolina; Pungo__ — 13582 Motor carriers: Hunting and sport fishing^ In­ Alternate route deviation notices CONSUMER AND MARKETING diana; Muscatatuck------13582 (2 documents) ______13628 SERVICE Applications and certain other FOOD AND DRUG proceedings______13629 Rules and Regulations Intrastate applications______13630 Fresh fruits, vegetables, and other ADMINISTRATION Transfer proceedings______13631 products; issuance of inspection Rules and Regulations United Services & Projects, Inc.; certificates______13571 Food additives; cyclized rubber in filing of petition for declaratory CUSTOMS BUREAU paper and paperboard compo­ order______13632 nents ______13576 Notices New animal drugs for implanta­ LABOR DEPARTMENT Tomato products from Greece;, tion or injection; methocar­ See Wage and Hour Division. countervailing duty proceed-. bamol; correction------13576 ings------13586 Pickles and pickle products; con­ LAND MANAGEMENT BUREAU firmation of effective date of farm ers h o m e order regarding standardizing Notices administration quantity of contents declara­ Nevada; offering of land for sale__ 13587 tion ___ 13575 New Mexico; classification of pub­ Rules and Regulations lic lands for multiple use Public information, availability of Proposed Rule Making management______13587 materials and records; miscel­ Insecticide mixture; clarification laneous amendments______13571 of pesticide tolerances------— 13583 (Continued on next page) - 13565 13566 CONTENTS

MARITIME ADMINISTRATION SECURITIES AND EXCHANGE TARIFF COMMISSION Notices COMMISSION Notices American President Lines, Ltd.; Notices Electrolytic capacitors; report to application ______13621 Hearings, etc.: the President______13627 Columbia Gas System, Inc___ 13616 MINES BUREAU Ohio Power Co. and Cambridge TRANSPORTATION DEPARTMENT Rules and Regulations Housing, Inc______13617 See, National Highway Safety Grants for advancement of health Bureau; National Transporta­ and safety in coal mines------13576 SMALL BÜSINESS tion Safety Board. ADMINISTRATION TREASURY DEPARTMENT NATIONAL HIGHWAY SAFETY Notices See Customs Bureau; Internal BUREAU Declaration of disaster loan areas: Revenue Service. Proposed Rule Making Georgia ------13618 Puerto Rico______13618 Motor vehicle safety regulations; WAGE AND HOUR DIVISION consumer information; acceler­ Notices ation and passing ability------13583 Certificates authorizing employ­ ment at special minimum NATIONAL TRANSPORTATION wages: Full-time students working out­ SAFETY BOARD side of school hours in retail Rules and Regulations or service establishments or Surface transportation accident in agriculture ______13618 hearings; rules of practice------13574 Learners ______13620

List of CFR Parts Affected

The following numerical guide is a list of the parts of each title of the Code of Federal Regulations affected by documents published in today's issue. A cumulative list of parts affected, covering the current month to date, appears at the end of each issue beginning with the second issue of the month. A cumulative guide is published separately at the end of each month. The guide lists the parts and sections affected by documents published since January 1, 1970, and specifies how they are affected.

3 CFR 14 CFR 41 CFR P roclamation: 207. 13572 1-15______13579 13573 3997____ — ------— — 13567 13573 47 CFR E xecutive O rders: 214. 13574 P roposed R u l es: 10804 (revoked by EO 11552)___ 13569 295. 13574 73___ -______13585 11552______13569 "*40 13574 49 CFR 7 CFR P roposed R u l es: 9 v,i n P roposed R u l es: 51------13571 2___-______13585 575...... 13583 1813______- _____ 13571 50 CFR 21 CFR P roposed R u les: 9 CFR l ______—. 191 i qrvr 32 (4 documents)______13582 76------13572 ìsitoi::::::::::: iliv i 33------— ------13582 P roposed R ules: 120______13583 24 CFR 1915____ 13579 30 CFR 53______13576 Presidential Documents

Title 3— THE PRESIDENT Proclamation 3997 NATIONAL HISPANIC HERITAGE WEEK, 1970 By the President of the of America A Proclamation For more than two centuries Americans have taken great pride in the contributions which men and women of Hispanic origin have made to the development of the United States. The careful work of early Spanish explorers, teachers, and agricul­ turalists built a solid and graceful foundation for progress in many parts of our country, and their legacy is one of gentility and art. The striking churches and homes they built long ago are monuments to their vision; the lovely Hispanic names they gave to the lands they explored and tilled are epitaphs of their taste. More recent generations have helped to give new dimensions and fresh vitality to our music, our literature* and our food, and have brought a particular warmth and openness to our spiritual values and to our style of living. In recognition of these gifts to our national life, the Congress re­ quested in 1968 that the President designate a week to include Sep­ tember 15 and 16 as National Hispanic Heritage^Week. NOW, THEREFORE, I, , President of the United States of America? do hereby proclaim the week beginning September 13,1970, as National Hispamc Heritage Week. I call upon all Americans, particularly those in the field of education, to observe that week with appropriate ceremonies and activities, and I hope that the week will encourage many Americans to. extend a cordial welcome to the recently arrived immigrants and visitors among us who represent the rich heritage of Hispanic lands. IN WITNESS WHEREOF, I have hereunto set my hand this 24th day of August, in the year of our Lord nineteen hundred seventy, and of the Independence of the United States of America the one hundred ninety-fifth.

[F.R. Doc. 70-11371; Filed, Aug. 24, 1970; 4:55 p.m.]

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, , 1970

THE PRESIDENT 13569

Executive Order 11552 PROVIDING FOR DETAILS AND TRANSFERS OF FEDERAL EMPLOYEES TO INTERNATIONAL ORGANIZATIONS By virtu© of the authority vested in me by section 301 of title 3 and section 3584 of title 5, United States Code, and as President of the United States, it is ordered as follows: Section 1. Leadership and coordination. The Secretary of State shall provide leadership and coordination for the effort of the Federal Government to increase and improve its participation in international organizations through transfers and details of well-qualified Federal employees, and shall develop policies, procedures, and programs con­ sistent with this order to advance and encourage such participation. Sec. 2. Federal agency cooperation. Each agency in the executive branch of the Federal Government shall to the maximum extent feasible and with due regard to its manpower requirements assist and encourage details and transfers of employees to international organiza­ tions by observing the following policies and procedures: (1) Vacancies in international organizations shall be brought to the notice of well-qualified agency employees whose abilities and levels of responsibility in the Federal service are commensurate with those required to fill such vacancies. (2) Subject to prior approval of his agency, no leave shall be charged an employee who is absent for a maximum of three days for interview for a proposed detail or transfer at the formal request of an international organization or a Federal official; an agency may approve official travel for necessary travel within the United States in connection w ith such an interview. (3) An agency, upon request of an appropriate authority, shall provide international organizations with detailed assessments of the technical or professional qualifications of individual employees being formally considered for details and transfers to specific positions. (4) Upon return of an employee to his agency, the agency shall give due consideration to the employee’s overall qualifications, including those which may have been acquired during his service with the inter­ national organization, in determining the position and grade in which he is reemployed. S ec. 3. Delegations, (a) Except as otherwise provided in this order, there is hereby delegated to the United States Civil Service Commis­ sion the authority vested in the President by sections 3582(b) and 3584of title 5, United States Code. (b) The following are hereby delegated to the Secretary of State: (1) The authority vested in the President by sections 3343 and 3581 of title 5, United States Code, to determine whether it is in the national interest to extend a detail or transfer of an employee beyond five years. (2) The authority vested in the President by section 3582(b) of title 5, United States Code, to define and specify “pay, allowances, post differential, and other monetary benefits” to be paid by the agency upon reemployment, disability, or death. Sec. 4. Revocation. Executive Order No. 10804 of February 12,1959, is hereby revoked.

T he W h ite H ouse, August 1970. [F.R. Doc. 70-11372; Filed, Aug. 24,1970; 4: 55 p.m.]

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970

13571

Rules and Regulations

and standards for fresh fruits, vegeta­ 1. In § 1813.5(b) (1), subdivision (iii) Title 7— AGRICULTURE bles, and other products is hereby is revised to read: amended to read as follows: Chapter I— Consumer and Marketing § 1813.5 Availability of identifiable § 51.19 Issuance of certificates. records. Service (Standards, Inspection, * * * * * Marketing Practices), Department of (a) A separate certificate shall be issued for each lot inspected, except that (b) * * * Agriculture when an application covers more than (1) * * * PART 51— FRESH FRUITS, VEGETABLES one lot a single certificate may be issued (iii) Specifically exempted from dis­ AND OTHER PRODUCTS (INSPEC­ to cover all such lots. The person signing closure by statute. Examples of FHA and issuing the certificate shall be one records in this category are those con­ TION, CERTIFICATION AND STAND­ of the following: taining information concerning FHA bor­ ARDS) (1) The inspector who performed the rowers’ trade secrets, enterprise proc­ Subpart— Regulations 1 inspection; esses, operations, amount or source of (2) Another employee of the Inspec­ any income and style of work. (Disclos­ I ssuance of Certificates tion Service who has been given power ure of such information not otherwise The Agricultural Marketing Act of of attorney by the inspector and au­ authorized by law could subject a Federal 1946 authorizes official inspection and thorized by the Administrator to affix employee to criminal prosecution.) certification of fresh fruits and vegeta­ the inspector’s signature to an inspec­ 2. In $ 1813.7, paragraph (a) is re­ bles and other products.* Such inspec­ tion certificate; vised to read: tion and certification is voluntary and (3) Another employee of the Inspec­ § 1813.7 Compulsory process. is made available only upon request of tion Service who has been authorized by financially interested parties and upon the Administrator to act in a supervisory (a) Action to he taken on subpoenas payment of a fee to cover the cost of capacity: or other compulsory process. In any case the service. where it is sought by subpoena or other Statement of considerations leading Provided, That in all cases the inspec­ compulsory process to require the pro­ to amendment of regulations. The cur­ tion certificate shall be prepared in ac­ duction or disclosure of any record, ma­ rent regulations require each official cordance with the official memoranda of terial, or information acquired by an certificate issued to be signed by the the inspector or inspectors who per­ inspector who performed the inspection. formed the inspection: And provided employee of the FHA in the performance However, another employee of the In­ further, That whenever a certificate is­ of his official duties, or because of his spection Service is authorized, under sued is signed by a person given power official status, the employee will appear these regulations, to affix the inspector’s of attorney by the inspector, that per­ at the time and place required by the name to an inspection certificate only son’s signature must appear along with subpoena or other compulsory process, the name of the inspector. when given power of attorney by the and will follow the instructions of the inspector, and provided the certificate (b) When the inspection is made for is prepared in accordance with the in­ the purpose of determining whether food State Director, with the advice and as­ spector’s findings. products for use by the applicant com­ sistance of the OGC, regarding the in­ The amendment (relating solely to ply with contract specifications therefor, formation that may or may not be Agency practice and personnel) will, in a formal certificate need not be issued, disclosed under § 1813.5. When the em­ addition, allow persons acting in a but the fact of such compliance or non- ployee appears, he will take the records supervisory capacity to sign and issue compliance may be indicated by affixing with him, keep them in his possession, the official certificate, provided it is an appropriate stamp or mark on such properly prepared. This would provide products or the containers thereof, at and testify therefrom with respect to in­ for prompt issuance of certificates where the discretion of the inspector. formation which is not exempt from no power of attorney has been given and (Secs. 203, 205, 60 Stat. 1087, as amended, disclosure under § 1813.5(b). If the in­ the inspector is absent or located some 1090 as amended, 7 U.S.C. 1622, 1624) formation requested is exempt from dis­ distance away from the office where the closure under § 1813.5(b), the party official certificate is prepared. Dated , 1970, to become ef­ The amendment further provides that fective at 12:01 a.m. September 10, 1970. initiating the subpoena or other com­ whenever a certificate issued is signed G. R . G range, pulsory process will be informed that by a person given power of attorney by Acting Administrator. FHA regulations prohibit the employee the inspector, that person’s signature [F.R. Doc. 70-11270; Filed, Aug. 25, 1970; from disclosing the information. If the must appear along with the name of the 8:50 a.m.] party who initiated the subpoena or inspector. other compulsory process declines to Pursuant to the authority contained in withdraw the request for the exempt in­ the Agricultural Marketing Act of 1946 Chapter XVIII— Farmers Home Admin­ formation, the matter will be referred (60 Stat. 1087 et seq., as amended; 7 istration, Department of Agriculture U.S.C. 1621 et seq.), §51.19 Issuance to the Administrator for determination of Certificates of the Subpart—Regula­ SUBCHAPTER A— GENERAL REGULATIONS and further instructions. tions governing inspection, certification [FHA Instruction 104.1] ***** PART 1813— PUBLIC INFORMATION, (Sec. 552, 81 Stat. 54, 5 U.S.C. 552; sec. 559, 1 None of the requirements in the regula­ AVAILABILITY OF MATERIALS AND 80 Stat. 388,5 U.S.C. 559) tions of this subpart shall excuse failure to comply with any Federal, State, county, or RECORDS Dated: ,1970. municipal laws applicable to products cov­ J . R . H anson, ered in the regulations in this subpart. Miscellaneous Amendments Acting Administrator, 1 Among such other products are the fol­ Part 1813, Title 7, Code of Federal Reg­ Farmers Home Administration. lowing: Raw nuts, Christmas trees and ever­ greens; flowers and flower bulbs; and onion ulations (35 F.R. 11120), is amended as [F.R. Doc. 70-11218; Filed, Aug. 25, 1970; sets. follows : 8:46 a.m.]

FEDERAL REGISTER, V O L 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 No. 166----- 2 13572 RULES AND REGULATIONS subdivision (iii) relating to Jackson the amendments are impracticable, un­ Title 9— ANIMALS AND County is added to read: necessary, and contrary to the public in­ (22) Oklahoma. * * * terest, and good cause is found for mak­ ANIMAL PRODUCTS (iii) That portion of Jackson County ing them effective less than 30 days after publication in the F ederal R egister. Chapter I— Agricultural Research bounded by a line beginning at the junction of State Highways 34 and 44; Service, Department of Agriculture Done at Washington, D.C., this 20th thence, following State Highway 34 in day of August 1970. SUBCHAPTER C— INTERSTATE TRANSPORTATION a northerly direction to the Jackson- OF ANIMALS AND POULTRY Greer County line; thence, following the G eorge W. I rving, Jr., [Docket No. 70-247] Jackson-Greer County line in an east-’ Administrator, erly direction to the west bank of the Agricultural Research Service. PART 76— HOG CHOLERA AND Salt Fork of the Red River; thence, [F.R. Doc. 70-11269; Filed, Aug. 25, 1970; OTHER COMMUNICABLE SWINE following the west bank of the Salt Fork 8:50 a.m.] DISEASES of the Red River in a generally south­ easterly direction to State Highway 44 Areas Quarantined (also U.S. Highway 62); thence, follow­ Pursuant to provisions of the Act of ing State Highway 44 in a generally Title 14— AERONAUTICS AND May 29, 1884, as amended, the Act of southwesterly direction to its junction February 2, 1903, as amended, the Act with State Highway 34. SPACE of March 3, 1905, as amended, the Act 3. In § 76.2, the reference to the State of September 6, 1961, and the Act of of in the introductory por­ Chapter II— Civil Aeronautics Board July 2, 1962 (21 U.S.C. 111-113, 114g, tion of paragraph (e), and paragraph SUBCHAPTER A— ECONOMIC REGULATIONS 115, 117, 120, 121, 123-126, 134b, 134f), (e) (5) relating to the State of Missis­ Part 76, Title 9, Code of Federal Regula­ sippi are deleted. [Reg. ER-639; Arndt. 13] tions, restricting the interstate move­ (Secs. 4-7, 23 Stat. 32, as amended, secs. PART 207—-CHARTER TRIPS AND ment of swine and certain products be­ 1, 2, 32 Stait. 791-792, as amended, secs. 1-4, SPECIAL SERVICES cause of hog cholera and other com­ 33 Stat. 1264, 1265, as amended, sec. 1, 75 municable swine diseases, is hereby Stat. 481, secs. 3 and 11, 76 Stat. 130, 132; Responsibility of Air Carriers for amended in the following respects: 21 U.S.C. I ll, 112, 113, 114g, 115, 117, 120, Amounts Collected by Travel Agents 121, 123-126, 134b, 134f; 29 F.R. 16210, as 1. In § 76.2, in paragraph (e) (10) re­ amended) in Payment for Charter Flights— lating to the State of North Carolina, a Limitation of Rule to U.S.-Originated new subdivision (iv) relating to North­ Effective date. The foregoing amend­ ampton County is added to read: ments shall become effective upon Charters (10) North Carolina. * * * issuance. Adopted by the Civil Aeronautics (iv) That portion of Northampton The amendments quarantine a portion Board at its office in Washington, D.C., County bounded by a line beginning at of Northampton County, N.C., and a por­ on the 19th day of August 1970. the junction of Secondary Roads 1500 tion of Jackson County, Okla., because By ER-616, adopted May 5, 1970, ef­ and 1505; thence, following Secondary of the existence of hog cholera. This ac­ fective June 8, 1970, 35 F.R. 7295, the Road 1500 in a generally southwesterly tion is deemed necessary to prevent Board amended Part 207 of the economic direction to U.S. Highway 158; thence, further spread of the disease. The re­ regulations (14 CFR Part 207) to make following US. Highway 158 in a gen­ strictions pertaining to the interstate air carriers responsible for amounts col­ erally southwesterly direction to Sec­ movement of swine and swine products lected by travel agents in payment for ondary Road 1108; thence, following from or through quarantined areas as charter flights. For the reasons set forth Secondary Road 1108 in a southeasterly contained in 9 CFR Part 76, as amended, in ER-638 published simultaneously direction to Secondary Road 1121; will apply to such counties. herewith, the Board hereby amends Part thence, following Secondary Road 1121 The amendments also exclude portions 207, effective August 26, 1970, so as to in a northeasterly direction to Second­ of Lafayette and Jackson Counties in make such rule applicable only to U.S.- ary Road 1119; thence, following Sec­ Mississippi from the areas quarantined originated charters: ondary Road 1119 in a southeasterly because of hog cholera. Therefore, the Amend § 207.4(b) to read: direction to Secondary Road 1118; restrictions pertaining to the interstate § 207.4 Tariffs to be filed for charier thence, following Secondary Road 1118 movement of swine and swine products trips and special services. in a southeasterly and thence in a north­ from or through quarantined areas as * # * * * easterly direction to Secondary Road contained in 9 CFR Part 76, as amended, (b) Every charter tariff shall contain 1502; thence, following Secondary Road will not apply to the excluded areas, but 1502 in a northeasterly direction to Sec­ the following provision: Payments for a will continue to apply to the quarantined charter flight made to any person to ondary Road 1514; thence, following areas described in § 76.2. Further, the Secondary Road 1514 in a northwesterly whom the carrier, directly or indirectly, restrictions pertaining to the interstate has paid a commission or has agreed to direction to Secondary Road 1515; movement of swine and swine products thence, following Secondary Road 1515 pay a commission with respect to such from nonquarantined areas contained flight, shall be considered payment to the in a northeasterly direction to Second­ in said Part 76 will apply to the areas ary Road 1511; thence, following Sec­ excluded from quarantine. carrier: Provided, however, That this re­ ondary Road 1511 in a generally north­ Insofar as the amendments impose quirement shall not be applicable to erly direction to Secondary Road 1501; foreign-originated charters. thence, following Secondary Road 1501 certain further restrictions necessary to prevent the interstate spread of hog (Secs. 204(a), 401, 403, 404, 411, Federal Avia­ in a westerly direction to Secondary cholera, they must be made effective im­ tion Act of 1958, as amended, 72 Stat. 743, Road 1503; thence, following Secondary mediately to accomplish their purpose 754 (as amended by 76 Stat. 143, 82 Stat. Road 1503 in a northwesterly direction in the public interest. Insofar as they re­ 867), 758 (as amended by 74 Stat. 445), 760, to Secondary Road 1504; thence, follow­ and 769; 49 U.S.C. 1324, 1371, 1373, 1374, ing Secondary Road 1504 in a north­ lieve restrictions, they should be made 1381) easterly direction to Secondary Road effective promptly in order to be of maxi­ 1505; thence, following Secondary Road mum benefit to affected persons. By the Civil Aeronautics Board. 1505 in a «northwesterly direction to its Accordingly, under the administrative [ seal] H arry J . Zink, junction with Secondary Road 1500. procedure provisions in 5 U.S.C. 553, it is Secretary. 2. In § 76.2, in paragraph (e) (22) re­ found upon good cause that notice and [F.R. Doo. 70-11278; Filed, Aug. 25, 1970; lating to the State of Oklahoma, a new other public procedure with respect to 8:51 am.]

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 RULES AND REGULATIONS 13573

[Beg. ER-638; Amdt. 5] inclusive tour charter program.® It is also (c) Every charter tariff shall contain in keeping with the Board’s declination the following provision: Payments for a PART 208— TERMS, CONDITIONS, to exercise jurisdiction under Part 3786 charter flight made to any person to AND LIMITATIONS OF CERTIFI­ over foreign tour operators to the extent whom the carrier, directly or indirectly, CATES TO ENGAGE IN SUPPLEMEN­ that they make use of inclusive tour has paid a commission or has agreed to TAL AIR TRANSPORTATION charters of supplemental air carriers for pay a commission with respect to such foreign-originated tours.1 In the Sudflug flight, shall be considered payment to Responsibility of Air Carriers for case, supra, the reasons for the Board’s the carrier: Provided, however, That this Amount Collected by Travel Agents declining to exercise jurisdiction over requirement shall not be applicable to in Payment for Charter Flights— foreign tour operators included the facts foreign-originated charters. Limitation of Rule to U.S.-Originated that it would be extremely burdensome ***** for foreign tour operators to comply with Charters (Secs. 204(a), 401, 403, 404, 411, Federal the requirements of sections 402 and 801 Aviation Act of 1958, as amended, 72 Stat. Adopted by the Civil Aeronautics of the Act; that regulation of foreign tour 743, 754 (as amended by 76 Stat. 143, 82 Stat. Board at its office in Washington, D.C., operators was not required to protect 867), 758 (as amended by 74 Stat. 445), 760, on the 19th day of August 1970. American-flag carriers, since any diver­ and 7S9; 49 U.S.C. 1324, 1371, 1373, 1374, By ER-615 adopted May 5,1970, effec­ sion should be negligible; and that regu­ 1381) tive June 8,1970, 35 F.R. 7295, the Board lation was not required for the safety By the Civil Aeronautics Board. amended Part 208 et al.1 of the economic of tour passengers, since the Board would continue to require the direct carrier to [seal] H arry J. Zin k , regulations to make air carriers respon­ Secretary. sible for amounts collected by travel demonstrate that it is fit, willing, and agents in payment for charter flights. able in terms of financing, organization, [F.R. Doc. 70-11279; Filed, Aug. 25, 1970; The purpose o t the rule was to protect equipment, personnel and otherwise to 8:51 a.m.] the public from defalcations by travel perform the air transportation. agents and other persons who receive Similar reasons lead us to confine this [Beg. ER-640; Amdt. 6] payments for air transportation from rule to U S.-originated flights. The sub­ charterers. ject rule, if made applicable to foreign- PART 212— CHARTER TRIPS BY Recent inquiries have questioned originated charters, would benefit FOREIGN AIR CARRIERS whether these regulations were intended principally charterers and charter par­ to cover foreign-originated flights. ticipants who are foreign nationals. We Responsibility of Foreign Air Carriers Neither the comments filed in the rule believe that requiring carriers to assume for Amounts Collected by Travel making proceeding nor the Board in its responsibility for payments by foreign Agents in Payment for Charter consideration of the record therein fo­ national charterers to travel agents is a Flights— Limitation of Rule to U.S.- matter which is properly the concern of cused on the applicability of the rule to Originated Charters foreign-originated charter flights. A lit­ foreign governments and for them to eral reading of the rule would seem to regulate. Adopted by the Civil Aeronautics cover all flights whether U.S.-originated Moreover, viewed realistically, effective Board at its office in Washington, D.C., or foreign-originated.* Upon considera­ regulation of foreign-originated flights on the 19th day of August 1970. tion of this matter on the Board’s own would- present formidable practical prob­ By ER-617, adopted May 5,1970, effec­ motion, we have determined to amend lems. Investigation of the activities of tive June 8,1970, 35 P.R. 7297, the Board the rule so as to make it applicable only foreign national charterers and enforce­ amended Part 212 of the economic regu­ to UB.-originated charters.3 ment of such a charter rule would be ex­ lations (14 CFR Part 212) to make for­ The limitation of the rule to U.S.- ceedingly difficult since the activities, eign air carriers responsible for amounts originated charters is consistent with the solicitation, and nearly all other aspects collected by travel agents in payment for Board’s past policy of refraining from of the charter will take place outside charter flights. For the reasons set forth exercising jurisdiction under section 402 this country and will involve dealings in ER-638 published simultaneously with respect to inbound operations of primarily with citizens and residents of herewith, the Board hereby amends Part foreign indirect air carriers of property,* foreign countries. The discovery and In­ 212 effective August 26, 1970, so as to and the declination to assert section 402 vestigation of violations and the extra­ make such rule applicable only to U.S.- territorial enforcement of Board regu­ jurisdiction over foreign tour operators lations would be extremely difficult. originated charters: who participate in a foreign air carrier’s Since this amendment merely excludes Amend § 212.3(b) to read as follows: foreign-originated charter flights from § 212.3 Tariffs to be filed for charter 1 Similar amendments were made in Part the coverage of the rule imposing respon­ trips. 207 (Charter Trips and Special Services), sibility on air carriers for amounts col­ ***** Part 212 (Charter Trips by Foreign Air Car­ lected by travel agents in payment for riers), Part 214 (Terms, Conditions, and charter flights and will not impose an (b) Every charter tariff shall contain Limitations of Foreign Air Carrier Permits additional burden on any person, notice the following provision: Payments for a Authorizing Charter Transportation Only), charter flight made to any person to Part 221 (Construction, Publication, Filing and public procedure thereon are unnec­ and Posting of Tariffs of Air Carriers and essary and the rule may be made effec­ whom the carrier, directly or indirectly, Foreign Air Carriers), and P art 295 (Trans­ tive on less than 30 days’ notice. has paid a commission or has agreed to atlantic Supplemental Air Transportation). Accordingly, the Civil Aeronautics pay a commission with respect to such 2 E.g., §208.32(c) provides that every Board amends Part 208 of the Economic charter tariff shall contain a provision that Regulations (14 CPR Part 208) effective flight, shall be considered payment to payments for a charter flight made to any August 26, 1970, as follows: the carrier: Provided, however, That this person to whom the carrier, directly or in­ requirement shall not be applicable to directly, has paid a commission or has agreed Amend § 208.32(c) to read as follows: to pay a commission with respect to such § 208.32 Tariffs and terms of service. foreign-originated charters. flight, shall be considered payment to the * * * * * (Secs. 204(a), 402, 403, 404, 411, Federal carrier. Aviation Act of 1958, as amended, 72 Stat. * Similar amendments are being issued 743, 757, 758 (as amended by 74 Stat. 445), simultaneously with respect to Parts 207, 212, E Sudflug, Süddeutsche Fluggesellscaf t 760, 769; 49 U.S.C. 1324, 1372, 1373, 1374, 214, and 295 (ER-639, ER-640, ER-641, and mbH, Order E-^24697, served Jan. 31, 1967. 1381) ER-642, respectively). Affirmed, Pan American World Airways v. * Order E-9179. The Board subsequently re­ O.A.B., 392 F.2d 483 (C.A.D.O. 1968). By the Civil Aeronautics Board. affirmed that action and at the same time * Inclusive Tours by Supplemental Air [seal] H arry J. Zin k , relieved United States freight forwarders Carriers, Certain Foreign Air Carriers, and from the provisions of the Act with respect Tour Operators. • Secretary. to inbound operations. Orders E-13141 and T Regulation No. SPR-28, adopted Jan. 7, [F.R. Doc. 70-11280; Filed, Aug. 25, 1970; E-13142. 1969, effective Feb. 10, 1969, 34 F.R. 432. 8:51 a.m.]

FEDERAL REGISTER. VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 13574 RULES AND REGULATIONS

[Reg. ER-641; Arndt. 4] above rule foreign-originated charter of practice in Part 440 are adapted to PART 214— TERMS, CONDITIONS, flights. the special nature of the Board’s acci­ Amend § 295.13(b) to read as follows: AND LIMITATIONS OF FOREIGN AIR dent hearings. CARRIER PERMITS AUTHORIZING § 295.13 Tariffs to be on file. Since the regulations in Part 440 are procedural in nature, notice and public CHARTER TRANSPORTATION ONLY ♦ * * * * * (b) Every charter tariff shall containprocedure hereon are not required, and Responsibility of Foreign Air Carriers the following provision: Payments for a the regulations may be made effec­ tive upon publication in the F ederal for Amounts Collected by Travel charter flight made to any person to R egister. Agents in Payment for Charter whom the carrier, directly or indirectly, has paid a commission or has agreed to Accordingly, the National Transporta­ Flights— Limitation of Rule to U.S.- tion Safety Board hereby adopts Part Originated Charters pay a commission with respect to such flight, shall be considered payment to 440 of the Procedural Regulations (14 Adopted by the Civil Aeronautics Board the carrier: Provided, however, That CFR Part 400) effective upon publica­ at its office in Washington, D.C., on the this requirement shall not be applicable tion in the F ederal R egister, set forth 19th day of August 1970. to foreign-originated charters. below. ^ Sec. By ER^618, adopted May 5,1970, effec­ (Secs. 204(a), 401, 403, 404, 411, Federal Avia­ tive June 8,1970, 35 F.R. 7298, the Board tion Act of 1958, as amended, 72 Stat. 743, 754 440.1 Applicability. amended Part 214 of the economic reg- (as amended by 76 Stat. 143, 82 Stat. 867), 440.2 Nature of hearing. ulatioris (14 CFR Part 214) to make for­ 758 (as amended by 74 Stat. 445), 760, 769; 49 I nitial P rocedure U.S.C. 1324, 1371, 1373, 1374, 1381) eign charter carriers responsible for 440.10 Determination to hold hearing. amounts collected by travel agents in By the Civil Aeronautics Board. 440.11 Board of Inquiry. payment for charter flights. For the rea­ 440.12 Technical panel. sons set forth in ER-638, published si­ [seal] H arry J . Zin k , 440.13 Notice of hearing. multaneously herewith, the Board hereby Secretary. 440.14 Designation of parties. amends Part 214 effective August 26, [F.R. Doc. 70-11282; Filed, Aug. 25, 1970; Conduct op Hearing 1970, so as to make such rule applicable 8:51' a.m.] 440.20 Powers of Chairman of Board of only to U.S.-originated charters: Inquiry. Amend § 214.13(b) to read as follows: Chapter III— National Transportation 440.21 Prehearing conference. § 214.13 Tariffs to be on file. 440.22 Sessions open to public. Safety Board 440.23 Examination of witnesses. ***** [NTSB Reg. PR-6] 440.24 Evidence. (b) Every charter tariff shall contain 440.25 Recommendations by parties. the following provision: Payments for a PART 440— RULES OF PRACTICE IN 440.26 Stenographic transcript. charter flight made to any person to 440.27 Public docket. . SURFACE TRANSPORTATION ACCI­ 440.28 Payment of witnesses. whom the carrier, directly or indirectly, DENT HEARINGS has paid a commission or has agreed to Authority: The provisions of this Part 440 pay a commission with respect to such Preamble: Section 5(b) (1) of the De­ issued under sections 5(b) (1), 5(d) (4), 5(k), flight, shall be considered payment to the partment of Transportation Act (49 and 5(1), 80 Stat. 935, 936; 49 U.S.C. 1654. carrier: Provided, however, That this re­ US.C. 1654(b) (1)) authorizes the Na­ § 440.1 Applicability. quirement shall not be applicable to for- tional Transportation Safety Board to eign-originated charters. determine cause or probable cause, and Unless otherwise specifically ordered by report the facts, conditions, and circum­ the Board, the provisions of this part (Secs. 204(a), 402, 403, 404,411, Federal Avia­ shall govern all surface transportation tion Act of 1958, as amended, 72 Stat. 743, 757, stances relating to surface transportation 758 (as amended by 74 Stat. 445), 760, 769; accidents; and section 5(d) (4) of the accident investigation hearings con­ 49 U.S.C. 1324, 1372, 1373, 1374, 1381) Act (49 U.S.C. 1654(d)(4)) authorizes ducted under the authority of sections the Board to conduct rail, highway, and 5(b) and 5(d) (4) of the Department of By the Civil Aeronautics Board. pipeline accident investigations. Accord­ Transportation Act' (49 U.S.C. 1654 (b), [ seal] H arry J . Zin k , ingly, public hearings are frequently (d )(4)). Secretary. held by the Board pursuant to authority § 440.2 Nature of hearing. [F.R. Doc. 70-11281; Filed, Aug. ' 25, 1970; contained in section 5(1) of the Act (49 8:51 am .] U.S.C. 1654(D). Surface transportation accident hear­ At the present time, the Procedural ings are convened to assist the Board in Regulations of the Safety Board do not determining cause or probable cause of [Reg. ER-642; Arndt. 6] include rules of practice which make an accident, reporting the facts, condi­ known to the public its procedures in tions, and circumstances of the accident, PART 295— TRANSATLANTIC SUPPLE­ surface transportation accident investi­ and ascertaining measures which will MENTAL AIR TRANSPORTATION gation hearings. The purpose of this Part tend to prevent accidents and promote transportation safety. Such hearings are Responsibility of Air Carriers for 440 is to codify and publish in permanent form the rules followed by the Board in factfinding procedures with no formal Amount Collected by Travel Agents such hearings. From past experience, the issues and no adverse parties. These in Payment for Charter Flights— Safety Board has determined that the hearings are not subject to the provisions Limitation of Rule to U.S.-Originated rules of practice in Part 440 will serve of the Administrative Procedure Act. Charters adequately to govern the course of its I nitial P rocedure hearings for all land-mode transporta­ Adopted by the Civil Aeronautics tion accident investigations. § 440.10 Determination to hold hearing. Board at its office in Washington, D.C., It should be emphasized that surface The Chairman of the Board, or his on the 19th day of August 1970. transportation accident investigations designee, may order a hearing in any sur­ By ER-620, adopted May 5,1970, effec­ are held by the Safety Board to assist in face transportation accident whenever tive June 8, 1970, 35 F.R. 7298, the determining cause or probable cause and he deems it necessary in the public Board amended Part 295 of the Economic preparing a report of the facts, condi­ interest. Regulations (14 CFR Part 295) to make tions, and circumstances relating to such air carriers responsible for amounts col­ accidents, as well as to ascertain the § 440.11 Board o f Inquiry. lected by travel agents in payment for measures which will best tend to pre­ The Board of Inquiry shall consist of charter flights. For the reasons set forth vent similar accidents in the future. Such a Member of the Board who shall be in ER-638 published simultaneously investigations are not held for the pur­ Chairman of the Board of Inquiry, a herewith, the Board hereby amends Part pose of determining the rights or liabili­ Hearing Officer when assigned, the Direc­ 295 effective August 26, 1970, so as to ties of' private parties, and the Board tor of the Bureau of Surface Transporta­ exempt from the applicability of the makes no attempt to do so. The rules tion Safety or his designee, and, where

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 RULES AND REGULATIONS 13575 appropriate, the General Counsel or his § 440.21 Prehearing conference. drawn from the testimony and exhibits designee. It shall be the duty of the Board (a) The Chairman of the Board of submitted at the hearing. Such recom­ of Inquiry to examine witnesses and to Inquiry shall hold a prehearing confer­ mendations shall be submitted within secure, in the form of a public record, all the time specified by the presiding of­ ence with the parties to the hearing at a ficer at the close of the hearing, and known facts pertaining to the accident convenient time and place prior to the and surrounding circumstances and con­ hearing. At such prehearing conference, shall be made a part of the docket. ditions from which cause may be de­ Parties to the hearing shall serve copies the presiding officer shall advise the of s such recommendations on all other termined and recommendations for parties of the witnesses to be called at corrective action may be formulated. the hearing, the areas in which they will parties. § 440.12 Technical panel. be examined, and the exhibits which will § 440.26 Stenographic transcript. be offered in evidence. A verbatim report of the hearing shall The Director, Bureau of Surface (b) Parties shall submit at the pre- Transportation Safety, shall designate be taken. Copies of the transcript may hearing conference copies of any addi­ be obtained by any interested person members of the Bureau’s technical staff tional documentary exhibits they desire who shall participate in the hearing and from the official reporter upon payment to offer. (Copies of all exhibits proposed of the fees fixed therefor. initially develop the testimony of for admission by the Board of Inquiry witnesses. and the parties shall be provided to the § 440.27 Public docket. § 440.13 Notice o f hearing. Board of Inquiry and all parties, insofar The public docket shall include the as available at that time.) transcript, exhibits, briefs, and all other The Chairman of the Board of Inquiry . (c) A party who, at the time of the pertinent information concerning the shall designate a time and place for the prehearing conference, fails to advise accident. A copy of the docket shall be hearing which meets the needs of the the presiding officer of additional exhibits made available to any person for review Board. Notice to all known interested he intends to submit or additional wit­ at the Washington office of the Board. persons shall be given. nesses he desires to examine, shall be Photographic copies of exhibits in the § 440.14 Designation of parlies. precluded from introducing such evi­ public docket may be obtained from the (a) The Chairman of the Board of dence unless the presiding officer deter­ Documents Branch of the Board upon Inquiry shall designate as parties to the mines for good cause shown that such payment of the cost of reproduction. hearing those persons, agencies, com­ evidence should be admitted. § 440.28 Payment of witnesses. panies, and associations whose participa­ § 440.22 Sessions open to public. Any witness subpoenaed to attend the tion in the hearing is deemed necessary (a) All hearings shall normally be open hearing under this part shall be paid in the public interest and whose special to the public (subject to the provision such fees for his travel and attendance knowledge will contribute to the develop­ that the condition of any person present as shall be certified by the Chairman of ment of pertinent evidence. shall not be allowed to interfere with the the Board of Inquiry. (b) Persons representing claimants or proper and the orderly -function of the By the National Transportation Safety insurers will not be designated as parties Board of Inquiry). to the hearing. (b) Sessions shall not be open to the Board. (c) Prior to the prehearing confer­ public when evidence of a classified na­ [ seal] J ohn H . R eed, ence, as provided in § 440.21, the Board ture or which affects national security Chairman. of Inquiry shall furnish the parties a is to be received. August 21, 1970. list of witnesses, including the areas in § 440.23 Examination of witnesses. [F.R, Doc. 70-11233; Filed, Aug. 25, 1970; which they will be examined, and a list 8:47 a.m.] of all available exhibits, (or copies as (a) Witnesses shall be initially ex­ available) the Board intends to introduce amined by the Board of Inquiry or its at the hearing. Following receipt of staff. Following such examination, par­ designation, and no later than the date ties to the hearing will be given the op­ established by the Chairman of the portunity to examine such witnesses. Title 21— FOOD AND DRUGS Board of Inquiry, said parties shall fur­ (b) Materiality, relevancy, and com­ Chapter I— Food and Drug Adminis­ nish the Board of Inquiry with names of petency of witnesses’ testimony, exhibits, tration, Department of Health, any additional witnesses they desire to or physical evidence shall not be the sub­ Education, and Welfare examine, a statement of the areas in ject of objections in the legal sense by which such witnesses should be exam­ a party to the hearing or any other per­ SUBCHAPTER A— GENERAL ined, and copies of any additional son. Such matters shall be controlled by PART 1— regulations fo r th e e n ­ exhibits they may desire to have offered rulings of the officer presiding on his own f o r c e m e n t OF THE FEDERAL in evidence. motion. If the examination of a witness by a party is interrupted by a ruling of FOOD, DRUG, AND COSMETIC ACT Conduct o f H earing the presiding officer, opportunity shall AND THE FAIR PACKAGING AND § 440.20 Powers of Chairman of Board be given to show materiality, relevancy, LABELING ACT of Inquiry. or competency of the testimony or evi­ Confirmation of Effective Date of Order dence sought to be elicited from the The Board Member acting as Chair­ Regarding Standardizing Quantity man of the Board of Inquiry, or, in his witness. absence, his designee, shall have the fol­ of Contents Declaration on Pickles § 440.24 Evidence. and Pickle Products lowing powers: The officer presiding shall receive all (a) To open, continue, or adjourn the testimony and evidence which might be In the matter of standardizing, in vol­ hearing; of aid in determining the cause of ac­ umetric terms, the declaration of net (b) To issue subpenas; cident. He may exclude any testimony or quantity of contents on pickles and pickle (c) To administer oaths and affirma­ exhibits which are not pertinent to the products including relishes but excluding tions. investigation or are merely cumulative one or two whole pickles in clear plastic (d) To determine the admissibility of as well as testimony which a party is bags: ✓ and to receive evidence and to regulate precluded from introducing by § 440.21 Pursuant to provisions of the Fair the course of the hearing; (c) unless he determines that for good Packaging and Labeling Act (secs. 4, 5 (a), 6(a), 80 Stat. 1297-1300; 15 U.S.C. (e> To dispose of procedural requests cause shown such testimony should be admitted. 1453-55) and the Federal Food, Drug, or similar matters; and and Cosmetic Act (sec. 701,52 Stat. 1055, (f) To take any other action neces­§ 440.25 Recommendations by parties. as amended; 21 U.S.C. 371) 'and under sary or incident to the orderly conduct Any party may submit proposed con­ authority delegated to the Commissioner of the hearing. clusions and recommendations to be (21 CFR 2.120), notice is given that no

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 13576 RULES AND REGULATIONS objections were filed to the order in the (FAP OB2452) filed by Reichhold Chemi­ thority contained in the Federal Coal above-identified matter published in the cal Inc., RCI Building, White Plains, N.Y. Mine Safety Act, as amended (30 U.S.C. F ederal R egister of June 10, 1970 (35 10602, and on the basis of an improved 451). The Federal Coal Mine Health and F.R. 8928). Accordingly, the regulation analytical procedure indicating that po­ Safety Act of 1969 (Public Law 91-173), established thereby, § 1.8b(r), shall be­ tential residual-free phenol is in the approved December 30, 1969, repealed come effective December 31, 1970. order of 4,000 parts per million in cyclized the provisions of the earlier Act and pro­ Dated: , 1970. rubber for use in components of food- vides a new and different authority for contact paper and paperboard, concludes similar purposes. The regulations of Part S am D. F in e , that § 121.2526 should be amended to 53 published on February 16, 1967, are Associate Commissioner change from 400 to 4,000 parts per mil­ therefore revoked and a new Part 53- for Compliance. lion the maximum residual-free phenol Grants for the Advancement of Health [F.R. Doc. 70-11240; Filed, Aug. 25, 1970; content permitted in such rubber. and Safety in Coal Mines is promulgated. 8:48 a.m.] Therefore, pursuant to provisions of Since these regulations involve matters the Federal Food, Drug, and Cosmetic relating to the making of grants, notice Act (sec. 409(c)(1), 72 Stat. 1786; 21 of proposed rulemaking is unnecessary SUBCHAPTER B— FOOD AND FOOD PRODUCTS U.S.C. 348(c)(1)) and under authority and, therefore, the new, revised Part 53 PART 121— FOOD ADDITIVES delegated to the Commissioner (21 CFR set forth below shall be effective on the date of publication in the F ederal Subpart F:—Food Additives Resulting 2.120), § 121.2526 (b) (2) is amended by revising the item “Cyclized rubber * * *” R egister. From Contact With Containers or to read as follows: F red J . R ussell, Equipment and Food Additives Acting Secretary of the Interior. § 121.2526 Components of paper and Otherwise Affecting Food August paperboard in contact with aqueous 19, 1970. C yclized R ubber in P aper and and fatty foods. Part 53 of Title 30, Code of Federal P aperboard Components * * * * * Regulations, is revised to read as follows: The Commissioner of Food and Drugs, (b) * * * Subpart A— General having evaluated the data in a petition (2) * * * Sec. 53.1 Purpose and scope. List of substances Limitations 53.2 Definitions. 53.3 Purpose of making, and entities eli­ * * * * * * gible to receive grants. Cyclized rubber produced when natural pale crepe For use only in coatings for paper and Subpart B— Applications for Grants rubber dissolved in phenol is catalytically cy­ paperboard intended for use in con­ clized so that the finished cyclized rubber has a tact with food only of the types iden­ 53.4 Manner of submission. melting point of 293° F.-3110 F. as determined 53.5 Information required with applica­ tified in paragraph (c) of this section, tions. by ASTM Method E-28-58T and contains no table 1, under types VIH and IX. more th an 4,000 p.p.m. of residual-free phenol Subpart C— Approval of Applications and as determined by a gas liquid chromatographic Limitations method available upon request from., the Com­ 53.6 Requirements for approval. missioner of Food and Drugs. 53.7 Defective applications and modifica­ * * * * * * ^ tions. 53.8 Limitations. Any person who will be adversely af­ SUBCHAPTER C— DRUGS 53.9 Appeals. fected by the foregoing order may at any time within 30 days after its date of PART 135b— NEW ANIMAL DRUGS SubpartD— Fiscal and Accounting F ederal R egister FOR IMPLANTATION OR INJECTION 53.10 Procedures for obtaining payments. publication in the file 53.11 Title to property. with the Hearing Clerk, Department of 53.12 Accounting records. Health, Education, and Welfare, Room Methocarbamol; Correction 6-62, 5600 Fishers Lane, Rockville, Md. In F.R. Doc. 70-8939 appearing at page Subpart E— Reports 20852, written objections thereto in quin­ 11232 in the issue of Tuesday;" July 14, 53.13 Reports. tuplicate. Objections shall show wherein 1970, in the establishment of new 53.14 Acknowledgment of Federal Govern­ the person filing will be adversely af­ § 135b.l7, the word “bisulfate” in the ment participation. fected by the order and specify with par­ 64th line of the first column on page ticularity the provisions of the order 11232 should read “bisulfite”. Subpart F— Consultation and Coordination 53.15 Cooperation. deemed objectionable and the grounds Dated: , 1970. for the objections. If a hearing is re­ Subpart G— Audits and Inspections S am F in e, T quested, the objections must state the D. 53.16 Audits. issues for the hearing. A hearing will be Associate Commissioner 53.17 Inspections. granted if the objections are supported for Compliance. 53.18 Covenants. by grounds legally sufficient to justify [F.R. Doc. 70-11242; Filed, Aug. 25, 1970; Authority : The provisions of this Part 53 the relief sought. Objections may be 8:48 a.m.] issued under secs. 503 and 508 of the Fed­ accompanied by a memorandum or brief eral Coal Mine Health and Safety Act oi in support thereof. 1969 (Public Law, 91-173). Effective date. This order shall become Title 30— MINERAL RESOURCES Subpart A— General effective on its date of publication in the Chapter I— Bureau of Mines, § 53.1 Purpose and scope. F ederal R egister. Department of the Interior The regulations in this part are issued (Sec. 409(c)(1), 72 Stat. 1786; 21 U.S.C. procedures 348(c)(1)) SUBCHAPTER M— RULES AND REGULATIONS FOR in order to provide uniform THE ADMINISTRATION OF GRANTS for making grants to States under the Dated: , 1970. provisions of section 503 of the Federal PART 53— GRANTS FOR ADVANCE­ R . E. D uggan, Coal Mine Health and Safety Act of 1969 Acting Associate Commissioner MENT OF HEALTH AND SAFETY (Public Law 91-173, 83 Stat. 742). for Compliance. IN COAL MINES- § 53.2 Definitions. [F.R. Doc. 70-11241; Filed, Aug. 25, 1970; Part 53 of Title 30, Code of Federal As used in the regulations in this part 8:48 a.m.] Regulations, was promulgated under au­ and in grant instruments entered into

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 RULES AND REGULATIONS 13577 pursuant to the regulations in this part: grants under section 503 of the Act Subpart C— Approval of Applications (a) “Government” means the United throughout the State, and contain sat­ and Limitations States of America. isfactory, evidence that such agency will (b) “Secretary” means the Secretary have the authority to carry out the pur­ § 53.6 Requirements for approval. of the Interior or his authorized poses of section 503 of the Act; The Secretary shall be obligated to representative. (d) Give assurance that such agency approve only those applications or re­ (c) “Bureau” means the Bureau of has or will employ an adequate and com­ quests for renewals that meet all of the Mines of the U.S. Department of the petent staff of trained inspectors qualified requirements set forth in § 53.5. Interior. - under the laws of such State to make coal (d) “Director” means the Director of mine inspections within such State; § 53.7 Defective applications and modi­ the Bureau of Mines or his authorized (e) Provide for the extension and im­ fications. representative. provement of the State program for the (a) Any application or request for re­ (e) “State” means any State in which improvement of Coal Mine Health and newal that does not meet all of the re­ coal mining takes place. Safety in the State, and provide that no quirements of § 53.5 shall be returned (f) “Fiscal Year” means the year pe­ advance notice of an inspection will be promptly and the State shall be re­ riod beginning on July 1 and ending on provided anyone. quested to modify, amend, or revise the June 30 following. (f) Contain assurances that grants application as necessary in order to meet (g) “Act” means the Federal Coal provided under section 503 of the Act the requirements and to resubmit the Mine Health and Safety Act of 1969. - will supplement, not supplant, existing application. State Coal. Mine Health and Safety (b) The Secretary will not finally dis­ § 53.3 Purpose of making» and entities programs. approve any State application or mod­ eligible to receive grants. (g) State the period of time during ification, amendment or revision thereof (a) The Secretary (in coordination which each of the program (s) will be without first affording the State agency with the Secretary of Health, Education, pursued. reasonable notice and opportunity for and Welfare and the Secretary of Labor) (h) Contain a financial plan which in­ a public hearing. is authorized by section 503(a) of the Act cludes the salient points of the plan in­ to make grants to any State in which coal volved in pursuing the programs and § 53.8 Limitations. mining takes place (1) to assist in de­ the relationship of anticipated costs to (a) Applications will be considered veloping and enforcing effective coal activity and expected rate of effort. The only for programs that meet the pur­ mine health and safety laws and regula­ financial plan shall also include and set poses and objectives of section 503 of tions; (2) to improve State workmen’s forth: the Act. compensation and occupational disease (1) Total cost of the program. (b) Grants will be made on a fiscal laws and programs related to coal mine (2) Amounts to be provided from non- year basis or portion thereof. Grants employment; and (3) to promote Fed­ Federal funds and the amount from will be renewed where appropriate, but eral-State coordination and cooperation Federal funds for each quarter of the only upon receipt of a request for re­ in improving the health and safety con­ first fiscal year and for each subsequent newal in accordance with §§53.4 and ditions in the coal mines. fiscal year during the proposed life of 53.5. (b) Grants will be made to a State the program. (c) Each grant shall be covered by a through its official coal mine inspection (3) The relationship between direct grant instrument between the Govern­ or safety agency. and indirect expenditures for each ment and the State. The grant agree­ quarter of the first fiscal year for Federal ment shall establish the purposes and Subpart B— Applications for Grants and for non-Federal funds. objectives, and the total estimated cost § 53.4 Manner o f submission. (i) Provide for such fiscal control and of the program during the fiscal year for fund accounting procedures as may be which the grant is to be made and the (a) Applications should be submitted necessary to comply with the require­ approved financial plan. in an original and three copies to the ments of this part and as may be ap­ (d) The amount granted to any State Director, Bureau of Mines, U.S. Depart­ propriate to assure proper disbursement for a fiscal year under this section shall ment of the Interior, Washington, D.C. and accounting of grants made under not exceed 80 per centum of the amount 20240. this part. expended by such State in such year (b) Applications must be submitted (j) Provide the name and title of the for carrying out the approved programs. through the State’s official coal mine in­ person who will direct the program. (The Secretary may allocate funds be­ spection or safety agency. (k) Provide the approximate number tween States and may fix the grant at § 53.5 Information required with appli­ and general qualifications of the person­ less than 80 per centum, and the per­ cations. nel who will work on the program. centages may be unequal between pro­ Applications shall be in the form of (l) Indicate the location or locations grams and between States.) proposals. Such proposals must: at which the various projects in the pro­ (e) None of the funds granted by the (a) Set forth the programs, policies, gram (s) will be pursued. Government or provided by the State and methods to be followed in carrying (m) Provide assurances that, if the shall be used for any purpose not specif­ grant is made, the required funds from ically provided in the grant instrument. out the application in accordance with (f) Any State accepting a grant or the purposes of section 503(a) of the Act. non-Federal sources will be forthcoming. (n) Indicate whether the programs grants under section 503 of the Act shall An application may provide for the plan­ agree that neither the Government nor ning of programs for-the purposes and ^or any part of the programs has been objectives of the Act, and the carrying or will be submitted to other organiza­ any of its officers, agents, or employees out of programs to train State coal mine tions or under other programs for the shall be responsible or liable for any loss, inspectors. purpose of obtaining a grant. expense, damage to property, or for (o) Agree that the official coal mine death or bodily injury to persons, which (b) Provide for research and planning may arise from or be incident to any studies to carry out plans designed to im­ inspection or Safety agency designated pursuant to paragraph (c) of this sec­ project or grant coming hereunder and prove State workmen’s compensation and the State shall agree to hold the Govern­ occupational disease laws and programs, tion will make the reports required by 53.13 and that it will abide by all other ment and its officers, agents, or em­ as they relate to compensation to miners ployees harmless from all such claims. for occupationally caused diseases and terms and conditions set forth in this Part 53 and such additional conditions (g) Reimbursement for travel ex­ injuries and arising out of employment penses shall be in accordance with the m any coal mine; which the Secretary may prescribe in State’s regular lawfully established poli­ (c) Designate the State coal mine in­ furtherance of, and consistent with, the cies and procedures, except they may not spection or safety agency as the sole purposes and objectives of séction 503 of exceed those authorized in standardized agency responsible for administering the Act. Government regulations.

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 13578 RULES AND REGULATIONS

(h) The State shall comply with the grant hereunder to the State shall be carried out in whole or in part with funds requirements of title VI of the Civil withheld. received under provisions of the Act. Rights Act of 1964 (42 U.S.C. 2000d) which provides that no person in the § 53.11 Title to property. Subpart F— Consultation and United States shall on the grounds of Title to property purchased with grants Coordination race, color, or national origin be excluded made hereunder and/or with matching from participation in, be denied the State funds may be vested in the State § 53.15 Cooperation. benefits of, or be subjected to discrimina­ upon a finding and determination by the (a) As contemplated by the Act, the tion under any program or activity re­ Director that such vesting will further Director will cooperate with the States in ceiving Federal financial assistance and the objectives of the Bureau of Mines. accomplishing the purposes of the grant, to the implementing regulations issued including but not limited to the furnish­ by the Secretary of the Interior with § 53.12 Accounting records. ing of advice and assistance to promote the approval of the President (43 CFR (a) States that receive funds under the objectives of the Act and the coordi­ Part 17). the Act, shall be responsible for main­ nation of projects. (i) Any grant for a project which taining books of account that accurately, (b) In addition to cooperating in involves a federally assisted construc­ completely and currently reflect the carrying out the purposes of the grant, tion contract, as defined in Executive financial transactions involving grants the Director shall, separate and apart Order 11246, September 24,1965 (30 FH. financed under the Act and also trans­ therefrom, cooperate with such States 12319), shall be subject to the conditions actions financed with matching funds when feasible and at the discretion of the that the grantee shall comply with the from sources other than the Federal Director in training Federal and State requirements of the said Executive order Government. In addition, the State shall inspectors jointly, and in establishing a and with applicable rules, regulations, maintain files of all papers necessary to system by which State and Federal in­ and procedures prescribed pursuant explain and prove the validity of the spection reports of coal mines located in thereto. transactions recorded. the State are exchanged for the purpose (b) Such State records, with all sup­ § 53.9 Appeals. of improving health and safety condi­ porting and related documents shall, at tions in such mines. (a) The proposed disapproval by the all reasonable times, be made available, Secretary of any initial State application upon request, for inspection and audit by Subpart G— Audits and Inspections or modification for grant funds shall be the Director, the Secretary, and by the § 53.16 Audits. x given to the State by the issuance of a Comptroller General of the United States notice to that effect setting forth the or his authorized representatives. (a) In addition ta the provisions of reasons for the proposed disapproval. (c) The States’ records relating to § 53.12, representatives of the Secretary The State through its designated coal each grant shall be retained and made and of the Comptroller General of the mine inspection or safety agency may re­ available until the expiration of 3 years United States may conduct on-site quest a public hearing within 30 days after the Government’s last payment to audits and inspections of State agencies after receipt of the notice of proposed which have received Federal funds under the State under each grant. this Part 53. disapproval for the purpose of appealing (d) The State shall include the follow­ such decision, by the mailing of a notice ing provisions in any contract for serv­ (b) Audits conducted at the direction of appeal to the Director. ices, equipment, or supplies that requires or on behalf of the Secretory may extend (b) Any decision of the Secretary payments exceeding $2,500 from funds to a determination and finding of fact finally disapproving any initial applica­ granted under the Act, and/or from concerning compliance with the provi­ tion or modification shall be final and funds used to match such granted funds : sions of the Act, the grant agreement, the conclusive unless the State within 30 regularity and accuracy of financial Representatives of the Secretary of the In­ transaction and recording, adequacy of days from the date of such decision shall terior and of the Comptroller General of the file a petition in the U.S. Court of Ap­ United States shall, until the expiration of 3 internal control, and reliability of finan­ peals for the District of Columbia stat­ years after final payment undèr this contract, cial reporting. As a part of such audits, ing that such decision should be modified have access to and the right to examine any examinations will be made on a selective or set aside in whole or in part. The fil­ directly pertinent books, records, documents, basis to determine that matching funds ing of a petition shall not stay the appli­ papers, and other supporting data relating have been received and properly ex­ cation of the decision of the Secretary to this contract. pended by recipients of matching-fund except as ordered by the U.S. Court of For the purposes of this requirement, grants under the Act and that the State Appeals for the District of Columbia. contracts for public utility services at maintains a proper relationship between the costs paid with funds provided under Subpart D— Fiscal and Accounting rates established for uniform application to the general public are excluded. the Act. Professional audit techniques § 53.10 Procedures for obtaining pay­ will be applied, and accepted principles ments. Subpart E— Reports of business administration will be the governing criteria. (a) Payment of grant funds to the § 53.13 Reports. State will be made on vouchers prepared, At such times and in such detail as the § 53.17 Inspections. signed, and submitted by the grantee in" The Director may, with such personnel three copies to the Director. Such Secretary shall require, the State shall furnish to the Secretory a statement as he considers qualified and with such vouchers will constitute applications for procedures he deems suitable, perform funds to be paid to the State for ex­ capable of being reproduced with respect to each project showing the work done, inspections of projects. Such inspections penditures made under an approved may cover acceptability of progress, con­ financial plan. the benefits derived, the status of the project, expenditures, and amounts obli­ sistency with approved plans, and other (b) The State shall also submit evi­ gated, and such other information as may factors the Director deems important to dence that a proper relationship is be­ be required. achieve the purposes of the Act and the ing maintained between expenditures of grant. § 53.14 Acknowledgement of Federal grant and non-Federal funds. § 53.18 Covenants. (c) Whenever the Secretary finds Government participation. there is a failure by the State to expend Appropriate acknowledgement shall be All grant instruments and contracts funds in accordance with the terms and given by the State to the Department of awarded thereunder by States shall con­ conditions governing the Government’s the Interior’s participation in financing tain the following provisions: grant, he shall notify the State that each project. Such acknowledgement The payment of any fee, commission or further payments will not be made to the compensation of any kind, or the giving of shall be included in all publications, news any gift or gratuity of any kind, either State until he is satisfied that there will releases, and other information media directly or indirectly, by or on behalf of a no longer be any such failure. Until the developed to publicize, describe, or re­ contractor under this grant, to any officer, Secretary is so satisfied, payment of any port on activities and accomplishments employee, or agent of the grantee either as

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 RULES AND REGULATIONS 13579 an inducement for the award of a contract gave gifts or gratuities to an officer, employee, from sums otherwise obligated under the under the grant or as an acknowledgement or agent of the grantee in connection with grant any amount found to have been paid by of a contract previously awarded thereunder the contract award or administration under a contractor as a fee, commission, or compen­ or as an inducement or acknowledgement for the grant, it shall be conclusively presumed sation, or as a gift or gratuity to an officer, a determination or any other action favorable that the cost of such expense was included employee, or agent of the grantee. to such contractor is prohibited. Upon a in the contract and ultimately borne or in­ showing that a contractor under this grant tended to be borne by the United States, in [F.R. Doc. 70-11209; Filed, Aug. 25, 1970; paid fees, commissions, or compensation, or which case the Government shall withhold 8:45 a.m.]

Title 24— HOUSING AND HOUSING CREDIT Chapter VII— Federal Insurance Administration, Department of Housing and Urban Development SUBCHAPTER B— NATIONAL FLOOD INSURANCE PROGRAM PART 1915— IDENTIFICATION OF FLOOD-PRONE AREAS List of Flood Hazard Areas; Correction In the amendment to the List of Mood Hazard Areas, § 1915.3, published at 35 F.R. 12601 on August 7, 1970, an incor­ rect effective date was listed for and New Jersey. The data for the effective dates in the last column of such list, and the column heading, are corrected to read as follows:

Effective date of id en tifica tio n * * * * * * * * * * * * * * ♦ of areas which State have special flood hazards

* * * * * * * * * * * * * • * * * * ♦ # * # * * * * * * * * * * * ♦ * * Massachusetts... July 10,1970. * * * * * * * * * * * * * * * New Jersey...... D o . * * * * * * * * * * * * ♦ * * Aug. 6, 1970. D o ...... * * * * ♦ * * * * * * * * * * * * * * * *

(National Flood Insurance Act of 1968 (title XIII of the Housing and Urban Development Act of 1968), effective Jan. 28, 1969 (33 F.R. 17804, Nov. 28, 1968), as amended (secs. 408-410, Public Law 91-152, Dec. 24, 1969), 42 U.S.C. 4001-4127; Secretary’s delegation of authority to Federal Insurance Administrator, 34 F.R. 2680, Feb. 27, 1969) Issued: August 26, 1970. G eOrge K . B ernstein, Federal Insurance Administrator. \R. Doc. 70-11221; Filed, Aug. 25,1970; 8:46 a.m.1 205-34 are revised; and new § 1-15.205— as extensive illustrations or descriptions Title 41— PUBLIC CONTRACTS 41(a-l) is added, as follows: of the company’s products or § 1—15.205—33 Recruitment costs. capabilities; AND PROPERTY MANAGEMENT (5) Is designed to “pirate” personnel (a) Subject to paragraphs (b), (c), from another Government contractor; or Chapter 1— Federal Procurement and (d) of this § 1-15.205-33, and pro­ (6) Includes color (in publications). Regulations vided that the size of the staff recruited and maintained is in keeping with work­ (c) Costs of excessive salaries, fringe PART 1-15-—CONTRACT COST load requirements, costs of help-wanted benefits and special emoluments that PRINCIPLES AND PROCEDURES advertising, operating costs of an em­ have been offered to prospective em­ ployment office necessary to secure and ployees, designed to “pirate” personnel Miscellaneous Amendments maintain an adequate labor force, costs from another Government contractor, or This amendment makes changes in of operating an aptitude and educational in excess of the standard practices in the and additions to Subpart 1-15.2. The testing prdgram, travel costs of em­ industry, are unallowable. changes deal with problems that have ployees while engaged in recruiting per­ (d) Relocation costs incurred incident arisen in connection with contractors’ sonnel, travel costs of applicants for in­ to recruitment of new employees are sub­ advertising costs considered to be exces­ terviews for prospective employment, and ject to § 1-15.205-25. Where such costs sive for the recruitment of personnel, relocation costs incurred incident to re­ have been allowed either as an allocable high rental costs as compared to costs cruitment of new employees are allow­ direct or indirect cost and the newly of ownership, the accrual of income taxes able to the extent that such costs are hired employee resigns for reasons within for contingencies which may never ma­ incurred pursuant to a well managed re­ his control within 12 months after hire, terialize, ahd the allowability of over­ cruitment program. Where the contractor the contractor shall be required to refund head resulting from settlement activities uses employment agencies, costs not in or credit such relocation costs to the following termination. excess of standard commercial rates for Government. The table of contents for Part 1-15 is such services are allowable. £ 1—15.205—34 Rental costs (including amended to provide the following revised (b) Costs of help-wanted advertising sale and leaseback of property). entry: are unallowable if the advertising: (a) This § 1-15.205-34 is applicable to Sec. (1) Is for other than for personnel re­ the cost of renting or leasing all prop­ 1-15.205-34 Rental costs (including sale quired for the performance of obligations erty, real and personal, except automatic and leaseback of property). under a Government contract, except as data processing equipment (ADPE)— Subpart 1-15.2— Principles and Pro­ provided in § 1-15.205-1 (b) ; see § 1-15.205-50. (2) Does not describe specific positions (b) As used in this section, the words cedures for Use in Cost-Reimburse­ or classes of positions; ment Type Supply and Research and phrases defined in this paragraph ( 3 ) Is excessive in relation to the num­ (b) shall have the meanings set forth Contracts With Commercial Organi­ ber and importance of the positions, or zations below. in relation to the practices of industry; (1) “Short-term leasing” means leas­ Sections 1-15.205-41 and 1-15:205-42 (4) Includes material that is noting where the cumulative term of the use are amended; §§ 1-15.205-33 -and 1-15.- relevant for recruitment purposes, such or occupancy (initial term plus additional

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 No. 166----- 3 13580 RULES AND REGULATIONS terms whether or not pursuant to a re­ charges only for the current use of the tractor would be allowed had he retained newal option) is 2 years or less for per­ property including, but hot limited to, title to the property, except that rental sonal property and 5 years or less for real any incidental service costs such as main­ cost may be allowed: property. tenance, insurance, and applicable taxes. (1) In accordance with paragraphs (2) “Long-term leasing” means leas­ (d) (1) Rental costs under long-term

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 RULES AND REGULATIONS 13581

§ 1-15.205—42 Termination costs. tion of property acquired or produced for that the amount allocated is otherwise consistent with §§ 1-15.201-4 and 1-15.- ***** the contract; and 203(c). The indirect expense so allocated (f) Settlement expenses. Settlement (3) Indirect costs related to salary and expenses, including the following, are wages incurred as settlement expenses in shall exclude the same and similar costs generally allowable: subparagraphs (1) and (2) of this para­ claimed directly or indirectly as settle­ (1) Accounting, legal, clerical, and graph; normally, such indirect costs shall ment expenses. be limited to payroll taxes, fringe benefits, similar costs reasonably necessary for— (Sec. 205(c), 63 Stat. 390; 40 U.S.C. 486(c)) (1) The preparation and presentation occupancy cost, and immediate supervi­ to contracting officers of settlement sion. Effective date. This amendment is claims and supporting data with respect (g) Subcontractor claims. Subcontrac­effective October 1, 1970, but may be to the terminated portion of the contract, tor claims, including the allocable portion observed earlier. unless the termination is for the default of claims which are common to the con­ Dated: August 19, 1970. of the contractor (see § l-8.604(b) (1) of tract and to other work of the contractor, J ohn W. Chapman, Jr., this chapter); and are generally allowable. An appropriate Acting Administrator of (ii) The termination and settlement of General Services. subcontracts. share of the contractor’s indirect expense (2) Reasonable costs for the storage, may be allocated to the amount of set­ [F.R. Doc. 70-11208; Filed, Aug. 25, 1970; transportation, protection, and disposi­ tlements with subcontractors; provided, 8:45 a.m.]

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 13582

Proposed Rule Making

as amended; 16 U.S.C. 668dd), it is pro­ written comments, suggestions, or objec­ DEPARTMENT OF THE INTERIOR posed to amend 50 CFR Part 32 by the tions, with respect to the proposed addition of Bosque del Apache National amendment, to the Director, Bureau of Fish and Wildlife Service Wildlife Refuge, N. Mex., to the list of Sport Fisheries and Wildlife, Washing­ [ 50 CFR Part 32 ] areas open to the hunting of big game ton, D.C. 20240, within 30 days of the as legislatively permitted. date of publication of this notice in the ST. VINCENT NATIONAL WILDLIFE It has been determined that regulated Federal Register. REFUGE, FLA. hunting of big game may be permitted Section 32.31 is amended by the follow­ as designated on the Bosque del Apache ing addition: Hunting National Wildlife Refuge without detri­ ment to the objectives for which the area § 32.31 List of open areas; big game. Notice is hereby given that pursuant * * * : * • to the authority vested in the Secretary was established. of the Interior by the Migratory Bird It is the policy of the Department of North Carolina Conservation Act of February 18,1929, as the Interior, whenever practicable, to Pungo National Wildlife Refuge. amended (45 Stat. 1222; 16 U.S.C. 715), afford the public an opportunity to par­ * * * * * and the National Wildlife Refuge System ticipate in the rulemaking process. Ac­ J ohn S. Gottschalk, Administration Act of 1966 (80 Stat. 927 cordingly, interested persons may submit Director, Bureau of as amended; 16 U.S.C. 668dd), it is pro­ written comments, suggestions, or objec­ Sport Fisheries and Wildlife. posed to amend 50 CFR Part 32 by the tions, with respect to this proposed addition of St. Vincent National Wild­ amendment, to the Director, Bureau of August 21, 1970. life Refuge, Fla., to the list of areas open Sport Fisheries and Wildlife, Washing­ [F.R. Doc. 70-11212; Filed, Aug. 25, 1970; to the hunting of big game as legisla­ ton, D.C. 20240, within 30 days of the date 8:45 a.m.] tively permitted. of publication of this notice in the F ed­ It has been determined that regulated eral R egister. [ 50 CFR Parts 32, 33 1 hunting of big game may be permitted Section 32.31 is amended by the follow­ as designated on the St. Vincent National ing addition: MUSCATATUCK NATIONAL WILDLIFE Wildlife Refuge without detriment to the § 32.31 List of open areas; big game. REFUGE, IND. objectives for which the area was established. ***** Hunting and Sport Fishing It is the policy of the Department of New Mexico Notice is hereby given that pursuant to the Interior, whenever practicable, to Bosque del Apache National Wildlife Refuge. the authority vested in the Secretary of afford the public an opportunity to par­ * * * * * the Interior by the Migratory Bird Con­ servation Act of February 18, 1929, as ticipate in the rulemaking process. Ac­ J ohn S. G ottschalk, cordingly, interested persons may submit- Director, Bureau of amended (45 Stat. 1222; 16 U.S.C. 715), written comments, suggestions, or objec­ Sport Fisheries and Wildlife. and the National Wildlife Refuge Sys­ tions, with respect to this proposed tem Administration Act of 1966 (80 Stat. amendment, to the Director, Bureau of August 21,1970. 927 as amended; 16 U.S.C. 668dd), it is Sport Fisheries and Wildlife, Washing­ [F.R. Doc. 70-11211; Filed, Aug. 25, 1970; proposed to amend 50 CFR Parts 32 and ton, D.C. 20240, within 30 days of the date 8:45 a.m.] 33 by the addition of Muscatatuck Na­ of publication of this notice in the F ed­ tional Wildlife Refuge, Ind., to the list of eral R egister. areas open to the hunting of upland Section 32.31 is amended by the follow­ E 50 CFR Part 32 ] game and sport fishing as legislatively ing addition; permitted. PUNGO NATIONAL WILDLIFE REFUGE, It has been determined that regulated § 32.31 List of open areas; big game. N.C. hunting of upland game and sport fish­ * * * * * ing may be permitted as designated on Hunting F lorida the Muscatatuck National Wildlife St. Vincent National Wildlife Refuge. v Notice is hereby given that pursuant Refuge without detriment to the objec­ * x * * * * to the authority vested in the Secretary tives for which the area was established. of the Interior by the Migratory Bird It is the policy of the Department of J ohn S. G ottschalk, Conservation Act of February 18, 1929, the Interior, whenever practicable, to Director, Bureau of as amended (45 Stat. 1222; 16 U.S.C. afford the public an opportunity to par­ Sport Fisheries and Wildlife. 715), and the National Wildlife Refuge ticipate in the rulemaking process. Ac­ August 21,1970. System Administration Act of 1966 (80 cordingly, interested persons may sub­ mit written comments-, suggestions, or [F.R. Doc. 70-11213; Filed, Aug. 25, 1970; Stat. 927 as amended; 16 U.S.C. 668dd), 8:45 a.m.] it Is proposed to amend 50 CFR Part 32 objections, with respect to the proposed by the addition of Pungo National Wild­ amendment, to the Director, Bureau of life Refuge, N.C., to the list of areas open Sport Fisheries and Wildlife, Washing­ E 50 CFR Part 32 1 to the hunting of big game as legisla­ ton, D.C. 20240, within 30 days of the tively permitted. date of publication of this notice in the BOSQUE DEL APACHE NATIONAL It has been determined that regulated Federal Register. WILDLIFE REFUGE, N. MEX. hunting of big game may be permitted 1. Section 32.21 is amended by the fol­ as designated on the Pungo National lowing addition: ~ Hunting Wildlife Refuge without detriment to § 32.21 List of open areas; upland game. Notice is hereby given that pursuant the objectives for which the area was established. * * * * to the authority vested in the Secretary Indiana of the Interior by the Migratory Bird It is the policy of the Department of M uscatatuck National Wildlife Refuge. Conservation Act of February 18,1929, as the Interior, whenever practicable, to amended (45 Stat. 1222; 16 U.S.C. 715), afford the public an opportunity to par­ * * * * * and the National Wildlife Refuge System ticipate in the rulemaking process. Ac­ 2. Section 33.4 is amended by the fol" » Administration Act of 1966 (80 Stat. 927 cordingly, interested persons may submit lowing addition:

FEDERAL REGISTER, VOL. 35, NO. 166— -WEDNESDAY, AUGUST 26, 1970 PROPOSED RULE MAKING 13583

§ 33.4 List of open areas; sport fishing. of an economic poison under the Federal posed Part 568, Vehicles Manufactured in Insecticide, Fungicide, and Rodenticide Two or More Stages (35 F.R. 4639, Mar. * * * * * Act containing the subject insecticide 17, 1970). Fixed values for assumed air I ndiana may request, within 30 days after pub­ resistance are also set forth in the pro­ Muscatatuck National Wildlife Refuge. lication hereof in the F ederal R egister, posed regulation. * * * * * referral of this proposal to an advisory The description of the vehicle test con­ J ohn S. G ottschalk, committee in accordance with section ditions would be simplified by substi­ Director, Bureau of 408(*e) of the act. tuting the terms “gross axle weight rat­ Sport Fisheries and Wildlife. Interested persons may, within 30 days ing” and “gross vehicle weight rating” after publication hereof in the F ederal for the more particularized existing de­ . August 21, ,1970. R egister, file with the Hearing Clerk, scription of the loading conditions. In­ [P.E. Doc. 70-11214; Piled, Aug. 25, 1970; Department of Health, Education, and stead of itemizing the accessories and 8:45 a.m.] Welfare, Room 6-62, 5600 Fishers Lane, equipment to be operated during the Rockville, Md. 20852, written comments testing, the procedures would specify (preferably in quintuplicate) regarding that all accessories and equipment whose this proposal. Comments may be accom­ operation affects engine performance are DEPARTMENT OF HEALTH, panied by a memorandum or brief in sup­ operating in the maximum power-con­ port thereof. suming condition. The test procedures would also be amended to make explicit EDUCATION, AND WELFARE Dated: August 18, 1970. that gear changes during acceleration Food and Drug Administration are permitted. R . E. D uggan, Truck tractors present problems for [ 21 CFR Part 120 1 Acting Associate Commissioner for Compliance. performance information, since the char­ INSECTICIDE MIXTURE acteristics of the towed trailer strongly [F.R. Doc. 70-11239; Filed, Aug. 25, 1970; affect the results. It is proposed that Proposed Clarification of Pesticide 8:48 a.m.] these vehicles, like other trucks, be tested Tolerances at gross vehicle weight rating, distributed according to gross axle weight ratings. Based on consideration given the data This would result in less expensive test submitted by the Chevron Chemical Co., DEPARTMENT OF procedures than utilizing a “standard” 940 Hensley Street, Richmond, Calif. semitrailer. While the data obtained 94804, and other relevant material, would not precisely reflect the perform­ §120.255 was established (Feb. 1, 1969; TRANSPORTATION ance while towing a trailer, it should be 34 F.R. 1588) to provide for negligible National Highway Safety JBureau more reproducible and more directly residues of the insecticide mixture de­ comparable from one vehicle to another. scribed below in or on the raw agricul­ [ 49 CFR Part 575 J Interested persons are invited to sub­ tural commodities corn grain and corn [Docket No. 70-19; Notice 1] mit written data, views, or arguments fodder and forage at 0.05 part per million. pertaining to the proposed amendment. The term com grain applies to field MOTOR VEHICLE SAFETY Comments should identify the docket com harvested in a dry condition ap­ REGULATIONS number and be submitted to: Docket proximately 30 to 60 days after the nor­ Consumer Information; Acceleration Section, National Highway Safety Bu­ mal harvest period for the vegetable reau, Room 4223,400 Seventh Street SW., sweet corn. To clarify the tolerances for and Passing Ability Washington, D.C. 20591. It is requested, this insecticide mixture and because the The Consumer Information require­ but not required, that 10 copies be sub­ Chevron Chemical Co., submitted mate­ ment concerning acceleration and pass­ mitted. All comments received before the rial on residues in whole com plants at ing ability, 49 CFR 575.106, was published close of business on November 23, 1970, the time of harvest for sweet corn, the in its final form on May 23,1969 (34 F.R. will be considered, and will be available Commissioner of Food and Drugs con­ 8112), with minor amendments on July in the docket at the above address for cludes that the regulation Should be re­ 16, 1969 (34 F .R. 11974), and April 30, examination both before and after the vised as proposed below. 1970 (35 F.R. 6867). This notice proposes closing date. To the extent possible, com­ Therefore, pursuant to provisions of the extension of that requirement to ments filed after the above date will afso the Federal Food, Drug, and Cosmetic multipurpose passenger vehicles, trucks be considered by the Bureau. However, Act (sec. 408(e), 68 Stat. 514; 21 U.S.C. and buses. the rule making action may proceed at 346a(e)) and under authority delegated Adequate vehicle power is an especially any time after that date, and comments to the Commissioner (21 CFR 2.120), it important safety factor where larger received after the closing date and too is proposed that § 120.255 be revised to vehicles are concerned. It is recognized late for consideration in regard to the read as follows: that a large proportion of trucks and action will be treated as suggestions for buses are produced by multistage manu­ future rule making. The Bureau will con­ §120.255 m-(l-M ethylbutyl)phenyl tinue to. file relevant material, as it be­ methylcarbamate and m(l-ethyl- facture, with the basic automotive manu­ propyl)phenyl methylcarbamate; tol­ facturer delivering an incomplete vehicle comes available, in the docket after the erances for residues. to subsequent processors for completion, closing date, and it is recommended that usually by addition of a body. This has interested persons continue to examine ^ Tolerances are established for negligi­ been an obstacle, up to now, to the pro­ the docket for new materials. ble residues of an insecticide that is a duction of consumer information con­ Proposed effective date: October 1, mixture consisting of 75 percent m-( 1- cerning the operational capabilities of 1971. methylbutyl) phenyl methylcarbamate the vehicles, since the final-stage manu­ This notice of proposed rule making is andg5 percent m -(1-ethylpropyl) phenyl facturer cannot in most cases be expected issued under the authority of sections 112 methylcarbamate in or on the raw agri­ to generate such information concerning and 119 of the National Traffic and Motor cultural commodities corn grain, fresh the incomplete vehicles as delivered to Vehicle Safety Act (15 U.S.C. 1401,1407), com including sweet com (kernels plus him. Under the proposed amendment, the and the delegations of authority at 49 cob with husk removed), and corn fodder incomplete vehicle manufacturer would CFR 1.51 (35 F.R. 4955) and 49 CFR and forage at 0.05 part per million (such be required to produce this information, 501.8 (35 F.R. 11126). based on stated assumptions concerning tolerances to cover residues of both com­ Issued on August 18,1970. ponents) . the final equipment of the vehicle, and include the data in the document that R odolfo A. D iaz, ;Any person who has registered or sub­ would be required to be furnished with Acting Associate Director, mitted an application for the registration the incomplete vehicle under the pro­ Motor Vehicle Programs.

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 13584 PROPOSED RULE MAKING

§ 375.106 Acceleration and passing (e) Conditions and procedures—(1) hypothetical maneuvers described in ability. Vehicle, road and ambient conditions. subparagraph (2) of this paragraph shall (a) Purpose and scope. This section The data provided in the format of Fig­ be based on the vehicle’s actual perform­ requires manufacturers of motor vehicles ure 1 shall represent a level of perform­ ance capability in a maximum-rate ac­ to provide information on vehicle accel­ ance that can be equaled or exceeded by celeration, with transmission in gear eration and passing ability under low- each vehicle in the group to which the and without use of clutch or brake before and high-speed conditions. table applies, under the following con­ beginning the acceleration, but with gear (b) Application. This section applies ditions: changes as appropriate during the to passenger cars, multipurpose passen­ (1) The vehicle is loaded to its gross maneuver, as follows: ger vehicles, trucks, buses, and motor­ vehicle weight rating, distributed prc*- (i) Accelerate the vehicle as rapidly as cycles. portionally to its gross axle weight rat­ possible from a constant speed of 20 (c) Definitions. “Gross axle weight ings. m.pJi. to at least 35 m.pJi. or to the rating” (GAWR) means the valuo speci­ (ii) Fuel and lubricants are selected maximum speed if it is lower than 35 fied by the vehicle manufacturer as the and adjustments are made according to m.p.h. loaded weight on a single axle measured the manufacturer’s recommendations. (ii) Accelerate the vehicle as rapidly at the tire-ground interfaces. (iii) Break-in period is completed ac­ as possible from a constant speed of 50 “Gross vehicle weight rating” (GVWR) cording to the manufacturer’s recom­ m.p.h. to at least 80 m.p.h. or to the means the value specified by the manu­ mendations. maximum speed if it is lower than 80 facturer as the loaded weight of a single (iv) Engine is at normal operating m.p.h. vehicle. temperature. (iii) Record the distance traveled (D) (d) Required information. (1) Each (v) All accessories and equipment that as a function of time (T) as determined manufacturer of completed vehicles shall affect engine performance, and that may in accordance with both subdivisions (i) furnish the information specified in sub­ be operated while the vehicle is in and (ii) of this subparagraph. divisions (i) through (iii) of this sub- motion, are operating in the maximum (4) Graphic determination of passing paragraph, in the form illustrated in power-consuming condition. time and distance. Ascertain the vehicle’s Figure 1. Each vehicle in the group to (vi) Ambient temperature is between capability to perform the hypothetical which the information applies shall be 59° F. and 85° F., ambient dry baro­ maneuvers by the following method. capable, under the conditions and proce­ metric pressure is between 28.50 and 29.50 inches of mercury, and relative Symbols: (All times are In seconds and all dures specified in this section, of per­ distances in feet. For the purposes of the forming at least as well as the table humidity is between 30 percent and 60 determination speeds m ust be converted to indicates. percent. feet per second.) (1) Vehicle description. The group of (vii) The roadway lane has a grade I —Separation between passing and pace vehicles to which the table applies, iden­ of zero percent, and the road surface has vehicles at beginning and end of the tified in the terms by which they are a skid number of 75. maneuver: 40 feet for the low-speed pass and 100 feet for the high-speed described to the public by the manu­ (viii) Wind velocity is zero. pass; facturer. (2) Hypothetical maneuvers. The data L = Length of the passing vehicle; (ii) Passing time and distance. The provided shall represent the performance V= Speed of the pace vehicle: 20 m.p.h. time in seconds and the distance in feet capability of the vehicle in performing for the low-speed pass and 50 m.p.h. hypothetically required to pass a ve­ the two hypothetical maneuvers de­ for the high-speed pass; hicle 55 feet long traveling at 20 and 50 scribed below. The passing distances are D=z Distance; miles per hour (m.p.h.), under the con­ the distances traveled by the passing T=Tlm e. ditions of paragraph (e) of this section. vehicle during the maneuvers described (i) Plot a straight line having a slope If the vehicle for which information is in subdivisions (i) and (ii) of this sub- equal to the speed (V) of the pace*ve­ provided would be unable to perform a paragraph. The passing times are the hicle, starting at point T =0, D~2I+L+ passing maneuver because it cannot times required to travel the passing 55, as illustrated in Figure 2. exceed 20 or 50 m.p.h., the notation “not distances. (ii) Using the data obtained in sub- capable” shall be entered. (i) The vehicle for which the informa­ paragraph (3) (iii) of this paragraph, (iii) Notice. The following notice, tion is provided (“passing vehicle”) plot the distance vs. time curve for the placed in proximity to the figure: “The follows another vehicle (“pace vehicle”) passing vehicle at maximum accelera­ information presented represents results that is 55 feet long, with the leading tion, with starting point at T=O, D=O, obtainable by skilled drivers under con­ edge of the passing vehicle 40 feet behind and stopping at the point where the ve­ trolled road and vehicle conditions, and the trailing edge of the pace vehicle, and hicle reaches the limiting speed (35 or the information may not be correct both vehicles traveling 20 m.p.h. The 80 m.p.h. respectively) or its maximum under other conditions.” pace vehicle travels at constant speed speed if lower. If this curve intersects (2) Each incomplete vehicle manufac­ throughout. The passing vehicle or com­ the curve for the pace vehicle plotted in turer shaH, for each incomplete vehicle bination is in a different lane from the subdivision (i) of this subparagraph be­ with which a document must be fur­ pace vehicle. The passing maneuver be­ fore the point where the passing vehicle nished under § 568.4 of this chapter, in­ gins when the passing vehicle accelerates reaches the limiting or maximum speed, clude in the document the passing time at its maximum rate up to a limiting it need not be plotted beyond the point and distance information specified in speed of 35 m.p.h„ or to its maximum of intersection. subparagraph (1) (ii) of this paragraph, speed if less than 35 m.p.h.'It maintains (iii) If the curve plotted in subdivi­ under the conditions and procedures that speed, or maximum acceleration if sion (ii) of this subparagraph does not specified in this section. The information. unable to reach either the limiting or intersect the curve for the pace vehicle shall also contain a description of the maximum speed, until the end of the before the point where the passing ve­ power-consuming equipment and acces­ maneuver, which occurs when its trailing hicle reaches the limiting or maximum sories assumed to be included in the ve­ edge is 40 feet ahead of the leading edge speed, extend the passing vehicle’s curve hicle, including as a minimum all equip­ of the pace vehicle. from that point with a straight line ment necessary for operation or required (ii) Same as subdivision (i) of this whose slope equals either the limiting by law. The following additional as­ subparagraph, with the substitution of or maximum speed respectively. sumptions shall be made: an initial speed of 50 m.pJi. (instead of (iv) The intersections of the curves (i) Passenger cars. The vehicle as 20 m.p.h.), a limiting speed of 80 m.pJi. for the pace vehicle and passing vehicle completed has a frontal area of 34 square (instead of 35 m.p.h.), and beginning obtained in either subdivision (ii) °r feet. and ending separation of 100 feet (in­ (iii) of this subparagraph, plotted for (ii) Multipurpose passenger vehicles, stead of 40 feet). both the low-speed and the high-speed trucks and buses. The vehicle as com­ (3) Performance determination. Thepass, represent tiie passing times and pleted has a frontal area of 102 square determination of the vehicle’s passing distances to be provided in the form of feet. times and distances in performing the Figure I.

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 PROPOSED RULE MAKING 13585 mese i requested by IDC. Accordingly, it is or­

,HIS FIGURE indicates p a s s in g t im e s a n o dista n ces t h a t c a n b e m et o k FEDERAL COMMUNICATIONS dered, That the time for filing comments exceeded by the veh ic les t o w h ic h it a p p lie s , in t h e s it u a tio n s and reply comments in this proceeding is diagrammed belo w . extended, to and including December 14, THE low-speed PASS ASSUMES AN INITIAL SPEED OF 20 MPH AND A LIMITING COMMISSION SPEED OF 3SMPH. THE HIGH-SPEED PASS ASSUMES AN INITIAL SPEED OF SO MFIt 1970, and January 18, 1971, respectively. anoalimitino speed o f bo m ph .

noiicd the information presen ted represents resu lts o b t a in a b l e b v [ 47 CFR Part 73 1 Authority for this action is contained SKILLED DRIVERS UNDER CONTROLLED ROAD AND VEHICLE CONDITIONS, [Docket No. 18877] in sections 4 (i) and 303 (r) of the Com­ AND THE INFORMATION MAY NOT BE CORRECT UN0ER OTHER CONDITIONS. munications Act of 1934, as amended,

DESCRIPTION OF VEHICLES IÒ WHICHTHIS TABLE APPLIES: INCLUSION OF CODED INFORMA­ and § 0.281(d) (8) of the Commission’s rules. SUMMARY TABLE! TION IN TRANSMISSIONS OF RADIO LOWS PEED P A S S .... ______FEET; „SECONDS AND TV STATIONS Adopted: August 19,1970. HIGH-SPEED PASS.. ------FEET:______SECONDS Order Extending Time for Filing Released: August 20,1970. jnw.SPEFP Comments and Reply Comments [seal] G eorge S„ S m it h , JtOTAlMSStMO DISTAN«, Ttlf ItMfflNO SWIOi l i MHT In the matter of amendment of Part Chief, Broadcast Bureau. ioTAlf AMMO TIMI, (ICONOS 73 of the Commission’s rules and regula­ [P.R. Doc. 70-11224; Piled, Aug. 25, 1970; ED------irt M«v| tions to permit the inclusion of coded 8:46 a.m.] •CZPo ‘ f CONSTANT 20 MTIl information in the aural transmissions TRUCK of radio and TV stations for the purpose of program identification, RM—1589. yiftM.SKtP 1. Comments in this proceeding, FEDERAL POWER COMMISSION UfflAimiOrSOMiH _T0TAt fASStNO DISTAN«, K t f_ begun by notice of proposed rule making [ 18 CFR Part 2 1 TOTAI PASSINO TIMI, SICONOS released June 12, 1970 (PCC 70-615) (35 [Docket No. R-389A] CD—ior—« F.R. 10031) are now due August 21 and ~ l---- IP October 1, 1970, respectively. Petitions r o CONSTANT SO MPH INITIAL RATES FOR FUTURE SALES OF ip requesting extensions of time have been filed by Audicom, Inc., the rule-making NATURAL GAS FOR ALL AREAS petitioner, on , and Interna­ Notice of Extension of Time rirai 2 tional Digisonics Corp. (IDC), on IhlM DEIESÈiüiAflOH or PASSIHS TIME AND DISTANCE . Audicom requests until No­ August 21,1970. vember 20, 1970, or approximately 3 Upon consideration of the requests months; IDC requests at least 120 days. filed by Pan American Petroleum Corp. Counsel for Audicom has sta'ted that this and Independent Natural Gas Associa­ party does not object to the longer pe­ tion of America, notice is hereby given riod requested by IDC. Both petitions that the time is extended to and includ­ assert the need for more time to make ing August 26, 1970, within which an­ tests and gather data concerning the swers may be filed to the petition filed Audicom proposed system of including by “People Organized to Win Effective coded information in aural broadcast Regulation (POWER)’’ on July 30, 1970 signals; IDC has entered into a contract (35 F.R .13139). with a research firm to study the ques­ By direction of the Commission. tion of listener perception of audio tones. K enneth F . P lumb, 2. Under the circumstances, it appears Acting Secretary. [P.R. Doc. 70-11174; piled, Aug. 25, 1970; that the public interest would be served [F.R. Doc. 70-11342; Piled, Aug. 25, 1970; 8:45 a.m.] by extending the time for comments as 8:52 a.m.]

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 13586

Notices

This notice is published pursuant to Eaton bé, and he hereby is, granted relief DEPARTMENT OF THE TREASURY § 16.24(d) of the Customs Regulations from any and all disabilities imposed by (19 CFR 16.24(d)). Bureau of Customs Federal laws with respect to the acquisi­ [seal] M yles J . Ambrose, tion, receipt, transfer, shipment, or pos­ TOMATO PRODUCTS FROM GREECE Commissioner of Customs. session of firearms and incurred by reason of the conviction hereinabove Notice of Countervailing Duty Approved: August 21,1970. described. Proceedings E xjgene T. R ossides, Signed at Washington, D.C., this 14th Information has been received pur­ Assistant Secretary day of August 1970. of the Treasury. suant to the provisions of § 16.24(b) [seal] R andolph W . T hrower, of the Customs Regulations (19 CFR [F.R. Doc. 70-11271; Filed, Aug. 25, 1970; Commissioner of Internal Revenue. 16.24(b) ) which appears to indicate that 8:50 a.m.] certain payments, bestowals, rebates, or [FJR. Doc. 70-11274; Filed, Aug. 25, 1970; refunds granted by Greece on the ex­ 8:51 a.m.] portation of tomato products constitute Internal Revenue Service the payment or bestowal or a bounty or DEWEY PLEASANT NEWMAN grant, directly or indirectly, within the CLARENCE EATON meaning of section 303 of the Tariff Act Notice of Granting of Relief Notice of Granting of Relief of 1930 (19 U.S.C. 1303), upon the Notice is hereby given that Clarence Notice is hereby given that Dewey manufacture, production, or exportation Eaton, 6410 , Detroit, Mich. 48204, Pleasant Newman, Route 3, Bassett, Va, of the merchandise to which the pay­ has applied for relief from disabilities 24055, has applied for relief from dis­ ments, bestowals, rebates, or refunds abilities imposed by Federal laws with apply. imposed by Federal laws with respect to the acquisition, receipt, transfer, ship­ respect to the acquisition, receipt, trans­ The available information indicates ment, or possession of firearms incurred fer, shipment, or possession of firearms that the approximate amount of the by reason of his conviction on or about incurred by reason of his conviction on payments or bestowals ranges from May 12, 1949, in the Recorder’s Court, March 1, 1950, in the U.S. District Court $38.27 to $84.86 per metric ton on tomato Detroit, Mich., of a crime punishable in Danville, Va. 24055, of a crime punish­ paste, depending on thé concentration by imprisonment for a term exceeding able by imprisonment for a term ex­ and packing. The payments or bestowals 1 year. Unless relief is granted, it will be ceeding 1 year. Unless relief is granted, on tomato juice appear to be $13.31 per unlawful for Mr. Eaton because of such it will be unlawful for Dewey Pleasant metric ton and on peeled tomatoes conviction, to ship, transport, or receive Newman, because of such conviction, to appear to be $29.95 per metric ton. in interstate or foreign commerce any ship, transport, or receive in interstate Available information also indicates firearm or ammunition, and he would be or foreign commerce any firearm or am­ that rebates, refunds (or payments ineligible for a license under chapter-44, munition, and he would be ineligible for a equalling) of certain bank charges, in title 18, United States Code as a firearms license under chapter 44, title 18, United the amount of $13.31 per metric ton of or ammunition importer, manufacturer, States Code as a firearms or ammunition exported tomato products, and of social dealer, or collector. In addition;-' under importer, manufacturer, dealer, or col­ security taxes, in the amount of § 2.61 title VII of the Omnibus Crime Control lector. In addition, under title VII of the per metric ton of exported tomato prod­ and Safe Streets Act of 1968, as amended Omnibus Crime Control and Safe Streets ucts, are being made. There also appears (82T Stat. 236; 18 U.S.C., Appendix), be­ Act of 1968, as apiended (82 Stat. 236; 18 to be rebate or refund of income taxes cause of such conviction, it would be un­ U.S.C., Appendix), because of such con­ in an amount undetermined at this lawful for Mr. Eaton to receive, possess, viction, it would be unlawful for Mr. time. or transport in commerce or affecting Newman to receive, possess, or transport After the expiration pf the time limits commerce, any firearm. in commerce or affecting commerce, any set forth in this notice, a determination Notice is hereby given that I have firearm. will be made whether a bounty or grant considered Mr. Clarence Eaton’s applica­ Notice is hereby given that I have con­ is being paid or bestowed in connection tion and: sidered Dewey Pleasant Newman’s ap­ with any such manufacture, production, plication and: (1) I have found that the conviction (1) I have found that the conviction or export. If it is determined that a was made upon a charge which did not bounty or grant is being paid or be­ was made upon a charge which did not involve the use of a firearm or other involve the use of a firearm or other stowed, an appropriate countervailing weapon or a violation of chapter 44, title duty order will be issued and published weapon or a violation of chapter 44, title 18, United States Code, or of the Na­ 18, United States Code, or. of the National in accordance with § 16.24 of the Cus­ tional Firearms Act; and toms Regulations (19 CFR 16.24). Firearms Act; and (2) It has been established to my (2) It has been established to my sat­ Before a determination is made con­ satisfaction that the circumstances re­ isfaction that the circumstances regard­ sideration will be given to any relevant garding the conviction and the appli­ ing the conviction and the applicant’s data, views, or arguments submitted in cant’s record and reputation are such record and reputation are such that the writing with respect to thé existence or that the applicant will not be likely to applicant will not be likely to act in a nonexistence, and the net amount of a act in a manner dangerous to public manner dangerous to public safety, and bounty or grant. Such submissions safety, and that the granting of the relief that the granting of the relief would not should be addressed to the Commissioner would not be contrary to the public be contrary to the public interest. of Customs, 2100 K Street NW., Wash­ interest. ington, D.C. 20226, in time to be re­ Therefore, pursuant to the authority Therefore, pursuant to the authority vested in the Secretary of the Treasury ceived by his office not later than 30 days vested in the Secretary of the Treasury by section 925(c) , title 18, United States from the date of publication of this by section 925(c) , title 18, United States Code and delegated to me by 26 CFR notice in the F ederal R egister. No hear­ Code and delegated to me by 26 CFR 178.144: It is ordered, That Dewey Pleas­ ing will be held. 178.144: It is ordered, That Mr. Clarence ant Newman be, and he hereby is,

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 NOTICES 13587 granted relief from any and all disabili­ withdrawn or reserved for Federal use ties imposed by Federal laws with re­ DEPARTMENT OF THE INTERIOR^ or purpose. spect to the acquisition, receipt, trans­ 2. As a result of comments received fer, shipment, or possession of firearms Bureau of Land Management following publication of the notice of and incurred by reason of the convic­ [Serial No. N-4419] proposed classification (35 F.R. 5128- tion hereinabove described. 5129), and at a public hearing held in NEVADA Signed at Washington, D.C., this 18th Roswell, N. Mex., on May 26, 1970, the Notice of Offering of Land for Sale land described as lots 2, 3, SW%NE% day of August 1970. and SEy4NWy4 sec. 2, T. 9 S., R. 24 E., [seal! R andolph W. T hrower, August 18, 1970. N. Mex. Principal Meridian, is eliminated Commissioner of Internal Revenue. Notice is hereby given that under the from this classification notice. At 10 am . [F.R. Doc. 70-11272; Piled, Aug. 25, 1970; provisions of the Public Land Sale Act on , 1970, the land described 8:51 a.m.] of September 19, 1964 (78 Stat. 988, 43 as lots 2, 3, SW&NE& and SE&NW& U.S.C. 1421-1427), 43 CFR Subpart 2243, sec. 2, T. 9 S., R. 24 E., shall be relieved MICHAEL C. VILLA and pursuant to an application from the of its segregative effect. The record Notice of Granting of Relief city of Elko, Nev., the Secretary of the showing the comments received and other information is on file and can be Notice is hereby given that Michael C. Interior will offer for sale the following tract of land: examined in the Roswell District Office, Villa, 506 Warren, Boise, Idaho 83706, Roswell, N. Mex. The public lands af­ has applied for relief from disabilities Mount Diablo Meridian, Nevada fected by this classification are located imposed by Federal laws with respect to T. 34 N„ R. 55 E„ within the following described areas and the acquisition, receipt, transfer, ship­ Sec. 24, W &NEft, NW}4. are shown on map designated Roswell ment, or possession of firearms incurred The area described contains 240 acres. District Planning Unit No. 06-11 on file by reason of his conviction on March 3, It is the intention of the Secretary to in the Roswell District Office, Bureau of 1965, in the District Court, County of Land Management, 1902 South Main Weld, Greeley, Colo., of a crime punish­ enter into an agreement with the city of Elko to permit the city to purchase the Street, Roswell, N. Mex. 88201, and at able by imprisonment for a term exceed­ the Land Office of the Bureau of Land ing one year. Unless relief is granted, it land at its appraised market value, $24,000. The city will also be required to Management, U.S. Post Office and Fed­ will be unlawful for Michael C. Villa be­ eral Building, Santa Fe, N. Mex. 87501. cause of such conviction, to ship, trans­ pay for the publication of notice of this port, or receive in interstate or foreign offering. New Mexico P rincipal Meridian commerce any firearm or ammunition, The land will be sold subject to all T. 4 S., R. 23 E., and he would be ineligible for a license valid existing rights. Reservations will Sec. 33. under chapter 44, title 18, United States be made to the United States for rights- T. 5 S., R. 23 E., Code as a firearms or ammunition im­ of-way for ditches and canals in accord­ Sec. 3, lot 3, and S^SW % ; porter, manufacturer, dealer or collector. ance with the Act of , 1890 Sec. 4, Sy2Ni/2, NW&SW^, and S&S^; In addition, under title VII of the Omni­ (26 Stat. 391; 43 U.S.C. 945). All min­ Sec. 9, N]4 and S E ^ ; erals are to be reserved to the United Sec. 10, NE%NEi4, w y2Ey2, W&, and bus Crime Control and Safe Streets Act States and withdrawn from appropria­ Ei/2SEi4; of 1968, as amended (82 Stat. 236; 18 sec. u , NEi/4, Ei/2Nwy4, n w %n w ,J4, swv4 U.S.C., Appendix), because of such con­ tion under the public land laws, includ­ SW%, N%SE]4, and SE^SE^; viction, it would be unlawful for Mr. ing the general mining laws. Sec. 12, sy2; Villa to receive, possess, or transport in Any adverse claimants to the above- Sec. 13, Ny2NEi4; commerce or affecting commerce, any described land should file their claims Sec. 14, NBftNBKk NW&NW&.-and S y2 firearm. or objections with the undersigned with­ SW>/4; in thirty days of the filing of this notice. Secs. 15, 22, and 23; Notice is hereby given that I have con­ Sec. 24, S%S%; sidered Michael C. Villa’s application R olla E. Chandler, Secs. 25 and 26. and:. : -/z. . Manager, Nevada Land Office. T. 5 S., R. 24 E., Sec. 9, SW ^; (1) I have found that the conviction [P.R. Doc. 70-11210; Piled, Aug. 25, 1970; was made upon a charge which did not Sec. 10, S y2; 8:45 a.m.] Sec. 11, W%SW%; involve the use of a firearm or other Sec. 13, Ey2; weapon or a violation of chapter 44, title Sec. 14, Ey2, NW&NWJ4, SE%NW%, and 18, United States Code, or of the Na­ [New Mexico 10622] SW&SW&; tional Firearms Act; and NEW MEXICO Sec. 15, Ni/2, Ny2SWi4, and NW^SE&i (2) It has been established to my sat­ Sec. 22, Ey2, E&NW y4 , SW&NW^, and isfaction that the circumstances regard­ Notice of Classification of Public sw y4; ing the. conviction and the applicant’s Lands for Multiple-Use Manage­ Sec. 23, Ny2NEi4 and Wy2; Sec. 24, N ^ N ^ ; record and reputation are such that the ment Sec. 25, SE14NE14 and Sy2; applicant will not be likely to act in a August 19,1970. Sec. 26, NWy4NWy4 and sy>; manner dangerous to public safety, and 1. Pursuant to the Act of Septem­ Secs. 27, 28, 29, 30, 31, and 34; that the granting of the relief would not ber 19, 1964 (43 U.S.C. 1411-18) and the Sec. 35, Ey2, N&NW*4, SW^NW^. and be contrary to the public interest. regulations in 43 CFR Parts 2400 and sw>/4. Therefore, pursuant to the authority T. 6 S., R. 24 E., 2460, the public lands within the areas Sec. 1, lots 9, 10, 11, and 12; vested in the Secretary of the Treasury described below are hereby classified for Sec. 12, Ny2 and SE^'; by section 925(c), title 18, United States multiple-use management. Publication of Sec. 13, Ny2, Ny2sy2, and SW &SW ^. 9?de and delegated to me by 26 CFR this notice has the effect of segregating T. 7 S., R. 24 E., 178144: n is ordered, That Michael C. the described lands from appropriation Sec. 23, SE]4; villa be, and he hereby is, granted relief only under the agricultural land laws Sec. 24, S%; horn any and all disabilities imposed by (43 U.S.C. Parts 7 and 9; 25 U.S.C. sec. Sec. 25; ederal laws with respect to the acquisi­ 334) and from sales under section 2455 Sec. 26, E%; tion, receipt, transfer, shipment, or pos­ Sec. 35, Ey2. of the Revised Statutes (43 U.S.C. 1171) T. 8 S„ R. 24 E„ session of firearms and incurred by and the lands shall remain open to all Sec. 1, lot 4, SW ^N W ^, and Sy2; eason of the conviction hereinabove other applicable forms of appropriations, Sec. 3, SW& and Ey2SE&; described. including the mining and mineral leas­ Sec. 10, Ny2, NV&SW&, and SEi4; Signed at Washington, D.C., this 14th ing laws. As used herein, “public lands’’ Secs. 11, 12, 13, and 14; day of August 1970. means any lands withdrawn or reserved Sec. 15, NE14 and NE^SE^J by Executive Order No. 6910 of Novem­ Sec. 24, Ni/2, Ny2Sy2, and SE& SW ^. [seal] : R andolph W. T hrower, ber 26, 1934, as amended, or within a T. 9 S., R. 24 E., commissioner of Internal Revenue. Sec. 1, SE]4; grazing district established pursuant to Sec. 11, SE&NE1/4 and E%SEi4; [PR. Doc. 70-11273; Piled, Aug. 25, 1970; the Act of June 28, 1934 (48 Stat. 1269), Sec. 12, Ey2, sy2NWi4, and SW1^ 8:51 a.m.] as amended, which are not otherwise Sec. 13;

No. 166—— 4 FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 13588 NOTICES

Sec. 14, E y E y and W4; E y S E y ; Sec. 2, NEyswy, N y SEyswy, and Sec. 12, sy2; Sec. 23, Ei/2NEy4. W yN W y, and S y ; S W yS E y; Sec. 13, NEy4NEi4, Wy2NEy4, and NWU- Soo 24* Sec. 4, lot 2, S W yN E y, and wy.SE 14; Sec. 14, sy2; Sec. 25,’ Nwy, NySWy, and SEyswy; Sec. 5, lots 1, 2, 3, 4, S W yN E y, S y Sec. 15, Sy2; Sec. 26, SE 1,4 SE yS W y N E y , S y SE y NE y, NWy4, SWy, and WySEy; Sec. 17, SE%SWy4; SEyNWySEyNEy, SyNEySEyNEy, Sec. 6, lots 1, 2, 6, 7, SyNEy, Ey2 Sec. 18, lot 2, SV4NE^4, and Ey4NWy; NE y NE y SE y NE y , NW‘/4 diagonal one- SWy4, and SEy; Sec. 19, lots 1, 2, 3, 4, W ^ E ^ , and half of NW % SE % SW V4, and N W yS E y; Sec. 7* Ey2wy2; Sec. 27, N E yN E y, s y N E y , and Wy2; Sec! 8,’ SW yN E y and S y N w y ; •Sec. 20, NEy4NWi4, Ny2S E y, and SEV4 Sec. 35, N y N E y and SW yN E y. Sec. 9, W y N E y and S W yS E y; SE%; T. 5 S., R. 25 E., Sec. 10, SyNEy, SEyNWy, NEyswy, Sec. 21, Ey2 and NE%NWy4; Sec. 13, Ey2Ey2 and W%SE%i and NWySEy; Sec. 22, Ni^; Sec. 14, W yN W y and NW‘/4SW}4; Sec. 11, Ey2Ey2 and S W yS E y; Sec. 25; Sec. 15, N E y , NyNWy, SWyNWy, and Sec. 12; Sec. 26, E y2 and NWy4; NW1/4SW ‘/4; Sec. 13, NWy4 ; Sec. 27, SW%; Secs. 19 and 20; sec. 14, Ey2Ey2, syNwy, swy, Nwy Sec. 29, S E ^ N E ^ , Ni/2NWy4, SW^NWy, Sec. 21, Ny2Ny2 and S W ySW y; SE y, and N y swysEy; NWÎ4SW%, and SE%; Sec. 22, E y , NWy4, and N»/2SWy; Sec. .15, E»/2, Eywy, SW yNW y, and Sec. 30, lots 1, 2, 3, 4, NEÎ4, E^NW y, sec. 23, sy2NEy4, wyNwy. NEy4swy4, wy2swy4; and NEyswy; and N y S E y ; Sec. 18, lots 1, 2, 3, 4, and E y w y ; Sec. 31, lots 3, 4, N E ^S W ^, and SEy Sec. 24, SEyNWy and SWy; Sec.. 19; SE%; Sec. 25, NWy4 and sy2; Sec. 20, Ey2; Sec. 33, Ey2 and Sy2SWy4; Sec. 27, E y , E i/2W1/2, SWyNWy, and Sec. 21, Ny2, w y s w y , and E y S E y ; Sec. 34, sy2. w y s w y ; sec. 22, s y N E y , wy2, N y2sEi/4 , sy2 T. 8 S., R. 26 E., sec. 28, syN E y, Nwy4, Ny2sy2, SEy SWySEy, and SE y SEy; Sec. 1; SWy, and sySEy; Sec 23' Sec. 4, lot 4, S W yN E y, sy2NWy, and Sec. 29, wy2; Sec! 24! sy2Ny2 and sy2; sy2; Secs. 30 and 31; Sec. 25; Sec. 5; Sec. 33, N E y N E y , SWy, WySEy, and Sec. 26, E y2 and NyNWy; Sec. 6, lots 1, 4, S E yN E y, NEySEy, SE 14 SE 14; Sec. 27, N y N y ; and s y S E y ; Sec. 34, N y and S W ySW y; Sec. 28, N y N E y ; Sec. 7, lot 4, B y and S E y s w y ; Sec. 35, SW'/4NWy4 and SW y. Sec. 29, Ny2NWy4 and SW yN W y; Secs. 8, 9, 11, 12, 15, and 17; T. 6 S., R. 25 E., Sec. 30, N y N E y and s y s E y ; Sec. 18, Ey2; Sec. 1, lots 1, 2, 3, and 4; Sec. 31, lots 1, 2, E y N E y . N W yN E y, Sec. 19, lots 1, 2, 3, 4, N E y, and Ey2W‘/2; Sec. 3, lots 1, 2, 3, and 4; NEyNWy, and SEySWy; Sec. 24, E y ; Sec. 4, lots 1, 2, 3, and 4; Sec. 35, E y . Secs 25 and 26; Sec. 5, lots 1, 2, 3, and 4; T. 5 S., R. 26 E., Sec. 27, E y ; Sec. 6, lots 1, 2, 3, and 4; Sec. 30, lots 3, 4, E ysw y, and SEy; Sec. 30, lot 3; Sec. 7, lots 1, 2, 3, N E y, Ei/2NWy4, N Ey Sec. 31. Sec. 31, lots 3, 4, N E y, and NEySW y; SWy, and NySEy; T. 6 S., R. 26 E., sec. 33, Ey, syNwy, and swy; Secs. 8, 9, and 10; Sec. 1, lots 1, 2, 3, and 4; Secs. 34 and 35. Sec. 12, N'/2NWi/4 and NySEy; Sec. 3, lots 1, 3, and 4; T. 9 S., R. 26 E„ Sec. 13, N ‘/2NWy4 and S»/2; Sec. 4, lots 1, 2, and 4; Sec. 3, lots 1, 2, s y N E y , and SEy; sec. 14, sy 2sy 2; Sec. 5, lots 1, 2, 3, and 4; Sec. 4, lots 3, 4, s y N W y , and SWy; Sec. 15; Sec. 6, lots 1, 2, 3, and 4; Sec. 5, lot 1 and sysy2; Sec. 17, NEyNEy, NyNWy, SWyNWy, Sec. 7, lot 3, N E y s w y , and N y S E y ; Sec. 6, lot 4 and s y s É ÿ ; and Nwyswy; Sec. 8, EyNEy and SEy; Sec. 7, lots 2, 3, 4, E y , and EySW y; sec. 21, ei/2, Ey2wy2, and wyswy; Sec. 9, Wy2Ey2 and SWy4NW'/4; &6C 8* Sec. 22, N E y, w y2, and N‘/2S E y; Sec. 10, EyNEy and wySEy; sec. 9, Ey, Nwy, Eyswy, and swy Sec. 23, N y ; sec. 11, wyisrwy; swy; Sec. 26; Sec. 12; Sec. 19, lots 1, 2, 3, 4, and E y w y ; Sec. 27, Nwy4, NySWy, and sysEy; Sec. 13, Ey2w y2; Sec. 29, s y ; Sec. 28, E y ; Sec. 14, NySWy and NWySEy; Sec. 30, lots 1, 2, 3, 4, and E y w y ; Sec. 33, NEyNEy, w yEy, and EySEy. Sec. 15, wy2Ey2, syNW y, and SWy; Sec. 31. T. 7 S., R. 25 E., Sec. 17, WyNEy, SEySWy, and SEy T. 6 S., R. 27 E., Sec. 1, lots 3, 4, and s y N w y ; S E y ; . Sec. 5> lots 1, 2, 3, and 4; Secs. 3 and 4; Sec. 18, SWyNEy, wySEy, and SEy Sec. 6, lots 1, 2, 3, and 4; Sec. 9, s y s w y and S E y ; S E y; Sec. 7, lots 1, 2, 3, 4, N EyN Ey, Ey Secs. 10,15,19, and 20; Sec. 19, E y2; wy, wySEy, and SEy SEy; Sec. 21, w y2; Sec. 20, E y E y , S y N W y , and SW y; Sec. 8, s y s w y ; Sec. 22, Ni/2, wyswy, and NwysEy; Sec. 21, Ei/2Ei/2, w y N w y , and NW>/4 Sec. 9, E y , syN w y, and sw y; Sec. 24, E»/2SEy; swy4; Sec. 10, w y; 4 Sec. 25, Ni/2 and S E y; Sec. 22, NWyNEy, SyNEy, W y2, and Sec. 15, N w y ; Sec. 26, Ny2\ S E y ; Sec. 19, lots 2, 3, 4, Ey, and Eywy; Sec. 27, NwyNwy, syN y, sw y, and Sec. 23, E y , S y N w y , and S W ^; Sec. 20; w y s E y ; Sec. 24, NWy4NWy4; Sec. 21, N y N E y and W y ; Secs. 28, 29, 30, 31, 33, and 34; Sec. 25, Ey4NEy4, NW%NE^4, wy2, and Secs. 28, 29, and 30; Sec. 35, Ey2 and SWy. . sy2SEy4; sec. 33> Ny, N y sw y , and SEyswy. T 8 S R 25 E. Sec. 26; T. 7 S., R. 27 E., Sec. ”l, lots 1* 2, 3, 4, S»/2N y , N y s y , Sec. 27, Ey2, NW14, Ny2SWy4, and S E ^ sec. 5, lots 2, 3, 4, s w y N E y , syNwy, N y2 SW y SE y , and SE % SE »4; SW%; sw y, and NWySEy; Secs. 3 and 4; Sec. 28, NE14, SEÎ4NWy4. and N E ^S W ^; Secs. 6 and 7; sec. 5, Ey, Eyw y, and wyswy; §ec. 29. Ey2NEy4, SWÎ4NEÎ4, Wy2, and Sec. 8, Wy; Sec. 6, lots 3, 4, E y s w y , and S E y ; SE1^; Sec. 17, w y ; Sec. 30, lots 1, 2, NE^4, and Ey2NW»4; Sec. 18, lot 4. Ey, and SEyswy; Sec. 7; Sec. 19, lots 1, 2, 3, 4, N Ey, E y w y . Sec. 8, E y s w y ; 3oc 31* Sec. 9, N Ey and E y N W y ; Sec. 32! NWÌ/4NES4 and Ey2NW»4; and W y S E y ; Sec. 33, E%NEy4, NWÎ4NWÎ4, N^SWy4. Sec. 20, N y N w y ; Secs. 10 and 11; Sec. 30, lots 1, 2, 3, 4, and E y w y ; sec. 12, ev2nev4, s y N w y N E y , s w y SEiySWi/4, and SEÎ4; N E y, w y 2, and S E y ; Sec. 34, Ny.NEy4, w y2SWy4, and SE14 Sec. 31, lots 1, 2, 3, 4, and E y w y . Sec. 13, E y and NW y; swy4; The areas described aggregate 113.- Sec. 14, N y ; Sec. 35. 595.33 acres more or less. Sec. 15, N y ; T. 7 S., R. 26 E., Sec. 18, lots 1, 2, 3, 4, N E y, and E y W y ? Sec. 1, Ei/2S E ^; 3. For a period of 30 days from date Sec. 24, Ey2; Sec. 3, lots 2, 3, 4. SW%NEi4, and SE&; of publication in the F ederal R egister. Sec. 25, N Ey. Sec. 4, lots 1, 2, and 3; this classification shall be subject to tne

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 NOTICES 13589 exercise of administrative review and The Academy evaluated this product to the Bureau of Veterinary Medicine, modification by the Secretary of the as probably effective for treating infec­ Food and Drug Administration, 5600 Interior as provided for in 43 CFR 2461.3. tions in cattle, sheep, swine, dogs and Fishers Lane, Rockville, Md. 20852. For a period of 30 days interested parties turkeys when such infections are caused The holder of the new animal drug may submit comments to the Secretary by pathogens sensitive to benzathine application for the listed drug has been of the Interior, LLM, 721, Washing­ penicillin G. The Academy states that: mailed a copy of the NAS-NRC report. ton, D.C. 20240. (1) The dosage directions should be on Any other interested person may obtain W. J. Anderson, the basis of body weight and species a copy by writing to the Food and Drug State Director. (units per pound or kilogram); in small Administration, Press Relations Staff, 200 C Street SW., Washington, D.C. [F.R. Doc. 70-11219; Piled, Aug. 25, 1970; animals, the recommended dosage should 8:46 a.m.] provide blood levels equivalent to a mini­ 20204. mum daily dose of 10,000 units of pro­ This notice is issued pursuant to pro­ caine penicillin G per pound of body visions of the Federal Food, Drug, and weight; in large animals, the recom­ Cosmetic Act (secs. 502, 512, 52 Stat. DEPARTMENT OF AGRICULTURE mended dosage should provide blood 1050-51, 82 Stat. 343-51; 21 U.S.C. 352, levels equivalent to a minimum daily dose 360b) and under authority delegated to Office of the Secretary of 3,000 units procaine'penicillin G per the Commissioner of Food and Drugs pound of body weight; in some instances, (21 CFR 2.120). TEXAS because of decreasing bacterial sensitiv­ Dated: August 17, 1970. Designation of Areas for Emergency ity higher doses may be necessary; (2) treatment for hypersensitivity reactions ~ S am D. F in e , Loans to penicillin should be stated on the la­ Associate Commissioner For the purpose of making emergency bel; (3) the clinical use of penicillin for Compliance. loans pursuant to section 321 of the Con­ products in treating staphylococcal in­ [F.R. Doc. 70-11243; Filed, Aug. 25, 1970; solidated Farmers Home Administration fections should be proceeded by sensitiv­ 8:48 a.m.] Act of 1961 (7 U.S.C. 1961) as modified ity testing of the causative organism; by section 7 of the Disaster Relief Act (4) each disease claim should be properly of 1969 (42 U.S.C. 1855fff>, it has been qualified as “appropriate for use in [DESI 0135NV] determined that in the hereinafter- (name of disease) caused by pathogens OXYTETRACYCLINE-VITAMIN MIX­ named counties in the State of Texas sensitive to (name of drug),” and if the TURE FOR USE IN DRINKING WATER natural disasters have caused a need for disease cannot be so qualified, the claim agricultural credit not readily available must be dropped; and (5) the effective­ Drugs for Veterinary Use; Drug Efficacy from commercial banks, cooperative ness of the labeling recommendation, to Study Implementation lending agencies, or other responsible increase the dose if the infection is se­ sources. vere or if the animal does not respond The Food and Drug Administration T exas in 24 hours, should be documented. has evaluated a report received from the National Academy of Sciences-National Aransas. Nueces. The Food and Drug Administration concurs in the Academy’s findings. Research Council, Drug Efficacy Study Bee. _ Refugio. Group, oh the following preparation: Jim Wells, r " San Patricio. In accordance with § 3.25 Antibiotics Live Oak. Gland-O-Lac Gol-A-Cin; each pound used in food-producing animals, an order contains oxytetracycline fermentation Pursuant to the authority set forth published in the F ederal R egister of solubles and meals and oxytetracycline above, emergency loans will not be May 17, 1969 (34 F.R. 7849), amended quaternary salts equivalent to 25 grams made in the above-named counties after § 146a.77 Benzathine penicillin G for of oxytetracycline hydrochloride, 1,600,- June 30, 1971, except to applicants who aqueous injection to require the state­ 000 U.S.P. units vitamin A, 1,300,000 I.C. previously received emergency or special ment “Warning—Not for use in animals units vitamin D3, 4,500 micrograms of livestock loan assistance and can qual­ which are raised for food production.” vitamin B« activity, 1,300 milligrams of ify under established policies and This announcement is published (1) riboflavin, 5,500 milligrams niacin, 1,196 procedures. to inform the holders of new animal drug milligrams of d-pantothenic acid, 750 Done at Washington, D.C., this 21st applications of the findings of the Acad­ milligrams of menadione sodium bisul- day of August 1970. emy and the Food and Drug Administra­ fit’e; by The Gland-O-Lac Co., Subsidiary tion and (2) to inform all interested of E. R. Squibb & Sons, Inc., Agricultural Clifford M. H ardin, persons that such articles may be mar­ Research Center, Three Bridges, N.J. Secretary of Agriculture. keted provided they are the subject of 08887. [P.R. Doc. 70-11268; Piled, Aug. 25, 1970; approved new animal drug applications The Academy classified this product as 8:50 a.m.] and otherwist comply with all other re­ probably not effective for use in water quirements of the Federal Food, Drug, to reduce, treat, and prevent infection in and Cosmetic Act. turkeys and chickens, stimulate feed Holders of new animal drug appli­ intake or help maintain high egg pro­ DEPARTMENT OF HEALTH, cations are provided 6 months from the duction. The report also stated: (1) Each date of publication of this announce­ disease should be properly qualified as EDUCATION, AND WELFARE ment in the F ederal R egister to submit “appropriate for use in (name of dis­ adequate documentation in support of ease) caused by pathogens sensitive to Food and Drug Administration the labeling used. (name of drug),” and if the disease [DESI 0130NV] Each holder of a new animal drug claim cannot be so qualified the claim application which became effective prior must be dropped; (2) claims made re­ BENZATHINE PENICILLIN G to October 10, 1962, is requested to sub­ garding “for prevention of” or “to pre­ Drugs for Veterinary Use; Drug Efficacy mit updating information as needed to vent” should be replaced with “as an Study Implementation make the application current with re­ aid in the control of” or “to aid in the gard to manufacture of the drug, includ­ control of”; (3) substantial evidence The Food and Drug Administration ing information on drug components and was not presented to establish that each bas evaluated a report received from the composition, and also including infor­ ingredient designated as active makes a National Academy of Sciences-National mation regarding manufacturing meth­ contribution to the total effect claimed Research Council, Drug Efficacy Study ods, facilities, and controls, in accord­ for the drug combination; and (4) the Group, on the following preparation: ance with the requirement of section 512 label should warn that treated ani­ Ricillin Long-Acting; contains 200,000 of the act. mals must actually consume enough units of benzathine penicillin G per Written comments regarding this an­ medicated water to provide a therapeutic cubic centimeter; by Wyeth Laboratories nouncement, including requests for an dose under the conditions that prevail, toe., Box 8299, Philadelphia, Pa. 19101. informal conference, may be addressed and as a precaution the label should

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 13590 NOTICES state the desired oral dose per unit of [DESI 0141 NV] The Food and Drug Administration animal weight per day for each species OXYTETRACYCLINE SOLUBLE POW­ concurs with the Academy’s findings; as a guide to effective use of the pre­ however, the Administration concludes paration in drinking water. DER WITH VITAMINS AND NUX the appropriate claim for faster weight The Food and Drug Administration VOMICA EXTRACT gains and improved feed efficiency concurs with the Academy’s findings. Drugs for Veterinary Use; Drug Efficacy should be “For increased rate of weight This evaluation is concerned only with gain and improved feed efficiency (under the drug’s effectiveness and safety to the Study Implementation appropriate conditions of use).” animal to which administered. It does The Food and Drug Administration This evaluation is concerned only with not take into account the safety for food has evaluated a report received from the the drug’s effectiveness and safety to the use of food derived from drug-treated National Academy of Sciences-National animal to which administered. It does animals. Nothing herein will constitute a Research Council, Drug Efficacy Study not take into account the safety for food bar to further proceedings with respect Group, on the following preparation: use of food derived from drug-treated to questions of safety of the drug or its Vit-a-Cin; each pound contains Oxytet­ animals. Nothing herein will constitute metabolites as residues in food products racycline fermentation solubles, and Oxy­ a bar to further proceedings with re­ derived from treated animals. tetracycline quaternary salt representing spect to questions of safety of the drug This announcement is published (1) to 4 grams of Oxytetracycline hydrochloride or its metabolites as residues in food inform manufacturers of the subject activity, 0.8 milligram of vitamin B12 products derived from treated animals. drug of the findings of the Academy and activity, 200,000 Ü.S.P. units of vitamin A This announcement is published (1) the Food and Drug Administration and palmitate, 160,000 I.C. units of vitamin to inform manufacturers of the subject (2) to inform all interested persons that D 3, 33.76 milligrams of menadione drug of the findings of the Academy and such articles to be marketed must be the sodium bisulfite (source of vitamin K the Food and Drug Administration and subject of approved new animal drug activity), 832 milligrams of niacin, 208 (2) to inform all'interested persons that applications and otherwise comply with milligrams of riboflavin, 4 grams of such articles to be marketed must be the all other requirements of the Federal choline chloride, 191 milligrams of d subject of approved new animal drug Food, Drug, and Cosmetic Act. pantothenic acid, and 1.0 percent nux applications and otherwise comply with Manufacturers of the subject drug are vomica extract (furnishing 5 grains of all other requirements of the Federal provided 6 months from the date of pub­ strychnine); by The Gland-O-Lac Co., Food, Drug, and Cosmetic Act. lication of this announcement in the Subsidiary of E. R. Squibb & Sons, Inc., Manufacturers of the subject drug are F ederal R egister to submit adequate Agricultural Research Center, Three provided 6 months from the date of pub­ documentation in support of the labeling Bridges, N.J. 08887. lication of this announcement in the used. The Academy classified this product as F ederal R egister to submit adequate Each holder of a new animal drug ap­ probably not effective for use in poultry documentation in support of the labeling plication which became effective prior to drinking water for treatment and pre­ used. October 10, 1962, is requested to submit vention of bacterial infections and in­ Each holder of a new animal drug updating information as needed to make creased rate of growth in chickens and application which became effective prior the application current with regard to turkeys. The Academy stated: to October 10, 1962, is requested to sub­ manufacture of the drug, including in­ 1. Each disease claim should be prop­ mit updating information as needed to formation on drug components and erly qualified as “appropriate for use in make the application current with re­ composition, and also including infor­ (name of disease) caused by pathogens gard to manufacture of the drug, in­ cluding information on drug components mation regarding manufacturing sensitive to (name of drug) ” and if the disease claim cannot be so qualified the and composition, and also including methods, facilities, and controls, in ac­ claim must be dropped. information regarding manufacturing cordance with the requirements of 2. The label should warn that treated methods, facilities, and controls, in ac­ section 512 of the act. a n im als must actually consume enough cordance with the requirements of sec­ Written comments regarding this an­ medicated water to provide a therapeutic tion 512 of the act. nouncement, including requests for an dose under the conditions that prevail Written comments regarding this an­ and as a precaution the label should nouncement, including requests for an informal conference, may be addressed state the desired oral dose per unit of informal conference, may be addressed to the Bureau of Veterinary Medicine, animal weight per day for each species to the Bureau of Veterinary Medicine, Food and Drug Administration, 5600 as a guide to effective use of the prep­ Food and Drug Administration, 5600 Fishers Lane, Rockville, Md. 20852. , aration in drinking water. Fishers Lane, Rockville, Md. 20852. The manufacturer of the listed arug 3. Claims made regarding “for pre­ The manufacturer of the listed drug has been mailed a copy of the NAS-NRC vention of” or “to prevent” should be replaced with “as an aid in the control has been mailed a copy of the NAS- report. Any other interested person may of” or “to aid in the control of.” NRC report. Any other interested per­ also obtain a copy by writing to the 4. Claims for growth promotion or son may obtain a copy by writing to the Food and Drug Administration, Press stimulation are disallowed and claims Food and Drug Administration, Press Relations Staff, 200 C Street SW., for faster gains and/or feed efficiency Relations Staff, 200 C Street SW., Wash­ Washington, D.C. 20204. should be stated as “may result in faster ington, D.C. 20204. This notice is issued pursuant to pro­ gains and/or improved feed efficiency This notice is issued pursuant to pro­ visions of the Federal Food, Drug, and under appropriate conditions.” visions- of the Federal Food, Drug, and Cosmetic Act (secs. 502, 512, 52 Stat. 5. Substantial evidence was not pre­ Cosmetic Act (secs. 502, 512, 52 Stat. 1050-51, 82 Stat. 343-51; 21 U.S.C. 352, sented to establish that each ingredient 1050-51, 82 Stat. 343-51; 21 U.S.C. 352, 360b) and under authority delegated to designated as active makes a contribu­ 360b) and under authority delegated to the Commissioner of Food and Drugs tion to the total effect claimed for the the Commissioner of Food and Drugs (21 CFR 2.120). drug combination. (21 CFR 2.120). Dated: August 17, 1970. 6. The statement that the product Dated: August 17, 1970. may aid in maintaining egg production S am D. F ine, S am D. F ine, Associate Commissioner and hatchability should be revised to Associate Commissioner for Compliance. include “under appropriate conditions for Compliance. [F.R. Doc. 70-11244; Filed, Aug. 25, 1970; by controlling pathogenic micro-orga­ [FJEt. Doo. 70-11245; Filed, Aug. 25, 1970; 8:48 a.m.] nisms.” 8:48 a.m .]

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 NOTICES 13591

[DESI 3402] tion), and 8 (methods, facilities, and § 130.9 of the regulations (21 CFR 130.4, controls) of the new-drug application 130.9) may be required, including results VASOPRESSIN TANNATE IN OIL form FD-356H to the extent described of animal and clinical tests intended to Drugs for Human Use; Drug Efficacy for abbreviated new-drug applications, show whether the drug is safe and Study Implementation § 130.4(f), published in the F ederal effective. R egister April 24, 1970 (35 F.R. 6574). A copy of the NAS-NRC report has The Pood and Drug Administration (One supplement may contain all the in­ been furnished to the firm referred to has evaluated a report received from the formation described in this paragraph.) above. Any other interested person may National Academy of Sciences-National 2. Such supplements should be sub­ obtain a copy by request to the appropri­ Research Council, Drug Efficacy Study mitted within the following time periods ate office named below. Group, on the following drug: after the date of publication of this Communications forwarded in re­ Pitressin Tannate in Oil Ampoules notice in the F ederal R egister. sponse to this announcement should be containing vasopressin tannate; mar­ a. 60 days for revised labeling—the identified with the reference number keted by Parke, Davis and Co., Joseph supplement should be submitted under DESI 3402 and be directed to the atten­ Campau at the River, Detroit, Mich. the provisions of § 130.9 (d) and (e) of tion of the following appropriate office 48232 (NDA 3-402). the new drug regulations (21 CFR 130.9) and addressed (unless otherwise speci­ The drug-is regarded as a new drug which permit certain changes to be put fied), to the Food and Drug Administra­ (21 U.S.C. 321 (p)). Supplemental new- into effect at the earliest possible time. tion, 5600 Fishers Lane, Rockville, Md. drug applications are required to revise b. 60 days for updating information. 20852: the labeling in and to update previ­ 3. Marketing of the drug may continue Supplements (identify with NDA number) : ously approved applications providing until the supplemental applications sub­ Office of Marketed Drugs (BD-200), Bureau for such drug. A new-drug application mitted in accord with the preceding sub- of Drugs. is required from any person marketing paragraphs 1 and 2 are acted upon: Pro­ Original abbreviated new-drug applications: such drug without approval. vided, That within 60 days after the (Identify as such), Office of Marketed The Pood and Drug Administration date of this publication, the labeling of Drugs (BD-200), Bureau of Drugs. All other communications regarding this an­ is prepared to approve new-drug ap­ the preparation shipped within the juris­ nouncement: Special Assistant for Drug plications arid supplements to pre­ diction of the Act is in accord with the Efficacy Study Im plem entation (BD-201), viously approved new-drug applications labeling conditions described in this Bureau of Drugs. under conditions described in this announcement. Requests for NAS-NRC Reports: Press Rela­ announcement. E. New applications. 1. Any other per- , tions Office (CE 200), Pood and Drug Ad­ A. Effectiveness classification. The son who distributes or intends to dis­ ministration, 200 C Street SW., Washing­ Pood and Drug Administration has con­ tribute such drug which is intended for ton, D.C.20204. sidered the Academy report, as well as the conditions of use for which it has This notice is issued pursuant to provi­ other available evidence, and concludes been shown to be effective, as described sions of the Federal Food, Drug, and Cos­ that the drug is effective for the con­ under A above, should submit an metic Act (secs. 502, 505; 52 Stat. 1050- trol or prevention of the symptoms of abbreviated new-drug application meet­ 53, as amended; 21 U.S.C. 352, 355) and complications of diabetes insipidus due ing the conditions specified in § 130.4(f) under authority delegated to the Com­ to a deficiency of endogenous posterior (1) and (2), published in the F ederal missioner of Food and Drugs (21 CFR pituitary antidiuretic hormone. egister R April 24, 1970 (35 F.R. 6574). 2 .120). B. Form of drug. Vasopressin tan­ Such applications should include pro­ nate preparations are in sterile oleag­ posed labeling which is in accord with Dated: July 30,1970. inous form suitable for parenteral the labeling conditions described herein. Sam D. F in e , administration. 2. Distribution of any such prepara­ Associate Commissioner C. Labeling conditions. 1. The label tion currently on the market without an for Compliance. bears the statement “Caution: Federal approved new-drug application may be law prohibits dispensing without continued provided that: [F.R. Doc. ' 70-11246; Piled Aug. 25, 1970; prescription.” a. Within 60 days from the date of 8:48 a.m.] 2. The drug is labeled to comply withpublication of this announcement in the all requirements of the Act and regula­ F ederal R egister, the labeling of such [DESI 4837] tions. Its labeling bears adequate infor­ preparation shipped within the jurisdic­ mation for safe and effective use of the tion of the Act is in accord with the CERTAIN ANTIFUNGAL DRUGS drug and is in accord with the guide­ labeling conditions described herein. Drugs for Human Use; Drug Efficacy lines for uniform labeling published in b. The manufacturer, packer, or dis­ Study Implementation the F ederal R egister of February 6, tributor of such drug submits, within 60 1970. The “Indications” section is as days from the date of this publication, The Food and Drug Administration follows: a new-drug application to the Food and has evaluated reports received from the I ndications Drug Administration. National Academy of Sciences-National Pitressin Tannate in oil is indicated for c. The applicant submits within a rea­ Research Council, Drug Efficacy Study the control or prevention of the symptoms sonable time additional information that Group, on the following drugs for topical and complications of diabetes insipidus due may be required for the approval of the use: to a deficiency of endogenous posterior pitui­ application as specified in a written com­ 1. Cerosal Ointment containing sali­ tary antidiuretic hormone. munication from the Food and Drug cylic acid, cerium salicylate, butylpara- D. Previously approved applications. Administration. ben, thymol, chlorobutanol, dioctyl 1. Each holder of a “deemed approved” d. The application has not been ruled sodium sulfosuccinate; marketed by new-drug application (i.e., an applica­ incomplete or unapprovable. Kahlenberg Laboratories, Inc., Post tion which became effective bn the basis F. Unapproved use or form of drug. Office Box 3318, Sarasota, Fla. 33578 of safety prior to Oct. 10, 1962) for such 1. If the article is labeled or advertised (NDA 4-837). drug is requested to seek approval of tjie for use in any condition other than those 2. Sporostacin Solution containing claims of effectiveness and bring the ap­ provided for in this announcement, it chlordantoin and benzalkonium chloride; plication into conformance by submitting may be regarded as an unapproved new marketed by Ortho Pharmaceutical supplements containing: drug subject to regulatory proceedings Corp., Raritan, N.J. 08869 (NDA 12-569). a. Revised labeling as needed to con­ until such recommended use is approved 3. Keralac, nail lacquer, containing form to the labeling conditions described in a new-drug application, or is other­ chloranil; marketed by Philip T. Paul, herein for the drug and complete current wise in accord with this announcement. doing business as Salem Pharmacal, 23 container labeling, unless recently 2. If the article is proposed for mar­Summit Road, Naugatuck, Conn. 06770 submitted. keting in another form or for use other (NDA 11-379). b. Updating information as needed to than the use provided for in this an­ These drugs are regarded as new drugs. make the application current in regard nouncement, appropriate additional in­ The effectiveness classification and mar­ to items 6 (components), 7 (composi­ formation as described in § 130.4 or keting status are described below.

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 13592 NOTICES

A. Effectiveness classification. The Requests for NAS-NRC Reports: Press Re­ 12. Flaxedil Injection containing gal- Food and Drug Administration has con­ lations Staff (CE-200), Pood and Drug Ad­ lamine triethiodide, marketed by Davis sidered the Academy reports, as well as m inistration, 200 “C” Street SW., Wash­ ington, D.C. 20204. and Geek, Division of American other available evidence, and concludes Cyanamid.Co., 1 Casper Street, Danbury that the drugs are possibly effective for This notice is issued pursuant to pro­ Conn. 06810 (NDA 7-842). all labeled indications as antifungal visions of the Federal Food, Drug, and 13. Mylaxen Injection containing drugs. Cosmetic Act (secs. 502, 505, 52 Stat. hexafluorenium bromide, marketed by B. Marketing status. 1. Holders of pre­ 1050-53, as amended; 21 U.S.C. 352, 355) Neisler Laboratories, Division of Mallin- viously approved new drug applications and under authority delegated to the ckrodt Chemical Works, Post Office Box and any person marketing any such drug Commissioner of Food and Drugs (21 5439, St. Louis, Mo. 63160 (NDA 9-789). without approval will be allowed 6 CFR 2.120). The drugs are regarded as new drugs. months from the date of publication of Dated: July 23,1970. (21 U.S.C. 321 (p.)) Supplemental new this announcement in the F ederal R egis­ drug applications are required to revise ter to obtain and to submit in a supple­ S am D. F in e , the labeling in and to update previously mental or original new drug application Associate Commissioner approved applications providing for such data to provide substantial evidence of for Compliance. drugs. A new drug application is re­ effectiveness for those indications for IF.R. Doc. 70-11247; Filed, Aug. 25, 1970; quired from any person marketing such which these drugs have been classified as 8:48 a.m.] drugs without approval. possibly effective. To be acceptable for The Food and Drug Administration is consideration in support of the effective­ prepared to approve new drug applica­ ness of a drug, any such data must be [DESI 5657] tions and supplements to previously ap­ previously unsubmitted, well-organized, [Docket No. FDC-D-226; NDA 5-657, etc ] proved new drug applications under con­ and include data from adequate and ditions described in this announcement. well-controlled clinical investigations CERTAIN DRUGS USED AS ADJUNCTS 1. Dimethyl tubocurarine iodide—A. (identified for ready review) as de­ TO ANESTHESIA TO INDUCE SKELE­ Effectiveness classification. The Food scribed in § 130.12(a) (5) of the regula­ TAL MUSCLE RELAXATION and Drug Administration has considered tions published as a final order in the the report of the National Academy of F ederal R egister of May 8, 1970 (35 F.R. Drugs for Human Use; Drug Efficacy Sciences-National Research Council, 7250). Carefully conducted and docu­ Study Implementation Drug Efficacy^ Study Group, as well as mented clinical studies obtained under other available evidence, and concludes uncontrolled or partially-controlled sit­ The Food and Drug Administration that dimethyl tubocurarine iodide injec­ uations are not acceptable as a sole basis has evaluated reports received from the tion is effective for the indications stated for the approval of claims of effective­ National Academy of Sciences-National in the labeling conditions set forth in ness, but such studies may be considered Research Council, Drug Efficacy Study I. B. on their merits for corroborative support Group, on the following anesthetic drugs B. Labeling conditions. 1. The label of efficacy and evidence of safety. use for skeletal muscular relaxation: bears the statement, “Caution: Fed­ JL Metubine Iodide Injection contain­ eral law prohibits dispensing without 2. At the end of the 6-month period,ing dimethyl tubocurarine iodide, mar­ any such data will be evaluated to deter­ prescription.” keted by Eli Lilly and Co., Post Office 2. The drug is labeled to comply with mine whether there is substantial evi­ • Box 618, Indianapolis, Ind. 46206 (NDA dence of effectiveness for such uses. After 6-632). . \ all requirements of the Act and regula­ that evaluation, the conclusions concern­ tions. Its labeling bears adequate infor­ 2. Mecostrin Injection containing mation for safe and effective use of the ing the drugs will be published in the dimethyl tubocurarine chloride, mar­ F ederal R egister. If no studies have been keted by E. R. Squibb and Sons, Inc., drug and is in accord with the guide-, undertaken or if the studies do not pro­ Georges Road, New Brunswick, N.J. lines for uniform labeling published in vide substantial evidence of effectiveness, (NDA 7-371). the F ederal R egister of February 6, procedures will be initiated to withdraw 3. Tubarine Injection containing tubo­ 1970. The “Indications” section is as approval of the new drug applications curarine chloride, marketed by Bur­ follows: (Labeling guidelines for the for such drugs, pursuant to the provisions roughs Wellcome and Co., Inc., 1 Scars- drug are available from the Administra­ of section 505(e) of the Federal Food, dale Road, Tuckahoe, N.Y. 10707 (NDA tion on request.) Drug, and Cosmetic Act. Withdrawal of 6-283). I ndications approval of the applications will cause 4. Tubocurarine Chloride Injection, Dimethyl tubocurarine iodide is indicated any such drugs on the market to be new marketed by Endo Laboratories, Inc., as an adjunct to anesthesia to induce skele­ drugs for which an approval is not in 1000 Stewart Avenue, Garden City, N.Y. tal muscle relaxation. It may be employed effect. 11533 (NDA 6-505). to reduce the intensity of muscle contrac­ The above named holders of the new- 5. Tubocurarine Chloride Injection, tion of pharmacologically or electrically in­ drug applications for these drugs have marketed by Abbott Laboratories, 14th duced convulsion. It may be used as a been mailed a copy of the NAS-NRC re­ diagnostic agent for myasthenia gravis and Sheridan Road, North , 111. where the results of tests with neostigmine port. Any interested person may obtain 60064 (NDA 6-095). or edrophonium are inconclusive. a copy of these reports by writing to the 6. Tubocurarine Chloride Injection, office named below. marketed by Eli Lilly & Co. (NDA.6-325). II. Dimethyl tubocurarine chloride— Communications forwarded in re­ 7. Tubocurarine Chloride Injection, A. Effectiveness classification. The Food sponse to this announcement should be marketed by E. R. Squibb & Sons (NDA and Drug Administration has considered identified with the reference number 5-657). the report of the National Academy of DESI 4837 and be directed to the atten­ 8. Anectine Sterile Powder for Injec­ Sciences-National Research Council, tion of the following appropriate office tion and Sterile Solution containing suc- Drug Efficacy Study Group, as well as and addressed (unless otherwise speci­ dnylcholine chloride, marketed by other available evidence, and concludes Burroughs-Wellcome and Co., Inc. that dimethyl tubocurarine chloride in­ fied) to the Food and Drug Administra­ jection is effective for the indications tion, 5600 Fishers Lane, Rockville, Md. (NDA 8-453). 9. Quelicin Chloride Injection con­ stated in the labeling conditions set 20852. taining succinycholine chloride, mar­ forth in TI. B. Supplements (Identify with NDA number): keted by Abbott Laboratories (NDA B. Labeling conditions. 1. The label Office of Marketed Drugs (BD-200), Bu­ 8-845). bears the statement “Caution: Fed­ reau of Drugs. 10. Sucostrin Injection containing suc- eral law prohibits dispensing without Original new-drug applications: Office of New Drugs (BD-100), Bureau of Drugs. cinylcholine chloride, marketed by E. R. prescription.” All other communications regarding this an­ Squibb & Sons, Inc. (NDA 8-847) .- 2. The drug is labeled to comply with nouncement: Special Assistant for Drug 11. Syncurine Injection containing all requirements of the Act and regula­ Efficacy Study Im plem entation (BD-201), decamethonium bromide, marketed by tions. Its labeling bears adequate infor­ Bureau of Drugs. Burroughs-Wellcome & Co. (NDA 6-931). mation for safe and effective use of the

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 NOTICES 13593 drug and te in accord with the guidelines tions. Its labeling bears adequate in­ VU. Hexafluorenium bromide—A. Ef­ for uniform labeling published in the formation for safe and effective use of fectiveness classification. The Food and Federal R egister of February 6, 1970. the drug and is in accord with the guide­ Drug Administration has considered the The “Indications” section is as follows: lines for uniform labeling published in report of the National Academy of Sci­ (Labeling guidelines for the drug are the F ederal R egister of February 6, ences-National Research Council, Drug available from the Administration on 1970. The “Indications” section is as fol­ Efficacy Study Group, as well as other request.) lows: (Labeling guidelines for the drug available evidence, and concludes that I ndications are available from the Administration hexafluorenium bromide is effective for Dimethyl tubocurarine chloride is indi­ on request.) the indications stated in the labeling con­ I ndications cated an as adjunct to anesthesia to induce ditions set forth in VII.B. skeletal muscle relation. I t may he em­ Succinylcholine chloride is indicated as B. Labeling conditions. 1. The label ployed to reduce the intensity of muscle an adjunct to anesthesia to induce skeletal bears the statement, “Caution: Fed­ contractions of pharmacologically or elec­ muscle relaxation. It may be employed to eral law prohibits dispensing without trically induced convulsions. I t may be used reduce the intensity of muscle contractions prescription.” as a diagnostic agent for myasthenia gravis of pharmacologically or electrically induced where the results of the tests with neostig­ convulsions. 2. The drug is labeled to comply with mine or edrophonium are inconclusive. all requirements of the Act and regula­ V. Décaméthonium bromide—A. Effec­ tions. Its labeling bears adequate infor­ III. Tubocurarine chloride—A. Effec­ tiveness classification. The Food and mation for safe and effective use of the tiveness classification. The Food and Drug Administration has considered the drug and is in accord with the guidelines Drug Administration has considered the report of the National Academy of Sci­ ences-National Research Council, Drug for uniform labeling published in the reports of the National Academy of F ederal R egister of February 6, 1970. Sciences-National Research Council, Efficacy Study Group, as well as other (Labeling guidelines for the drug are Drug Efficacy Study Group, as well as available evidence, and concludes that available from the Administration on re­ other available evidence, and concludes décaméthonium bromide injection is ef­ quest.) The “Indications” section is as that tubocurarine chloride injection: fective for the indications stated in the follows: 1. Is effective for the indications labeling conditions set forth in VJB. I ndications stated in the labeling conditions set B. Labeling conditions. 1. The label Hexafluorenium bromide is Indicated as an forth in HI. B. bears the statement, “Caution: Fed­ adjunct for use with succinylcholine to pro­ 2. Lacks substantial evidence of effec­ eral law prohibits dispensing without long the neuromuscular blockade and obviate tiveness for use in treating spasticity of prescription.” the muscular fasciculations sometimes seen central nervous system origin and to 2. The drug is labeled to comply with when succinylcholine is administered. provide relief in various types of muscle all requirements of the Act and regula­ VIIL Form of drug. Preparations con­ spasm. tions. Its labeling bears adequate infor­ B. Labeling conditions. 1. Thé label taining dimethyl tubocurarine iodide, mation for safe and effective use of the dimethyl tubocurarine chloride, tubocu­ bears the statement, “Caution: Federal drug and is in accord with the guide­ law prohibits dispensing without rarine chloride, succinylcholine chloride, lines for uniform labeling published in décaméthonium bromide, gallamine tri­ prescription.” the F ederal R egister of February 6, 2. The drug is labeled to comply with ethiodide, or hexafluorenium bromide are 1970. (Labeling guidelines for the drug sterile solutions or sterile powders for all requirements of the Act and regula­ are available from the Administration on tions. Its labeling bears adequate in­ dilution and are suitable for parenteral request.) The “Indications” section is administration. formation for safe and effective use of as follows: the drug and is in accord with the guide­ I ndications IX. Marketing status. Marketing of the drugs may continue under the conditions lines for uninform labeling published in Décaméthonium bromide is Indicated as an the Federal R egister of February 6, adjunct to anesthesia to induce skeletal described in paragraphs XI and XII of 1970. The “Indications” section is as muscle relaxation. It may be employed to this announcement except that those in­ follows: (Labeling guidelines for the reduce the intensity of muscle contractions dications referenced in paragraph X may drug are available from the Administra­ of pharmacologically or electrically induced continue to be used as described therein. tion on request.) convulsions. X. Indications permitted during ex­ I ndications VI. Gallamine triethiodide—A. Effec­ tended period for obtaining substantial Tubocurarine chloride Is indicated as an tiveness classification. The Food and evidence. Those indications for which adjunct to anesthesia 1» induce skeletal Drug Administration has considered the succinylcholine chloride is described in muscle relaxation. It may be employed to report of the National Academy of Sci­ paragraph IVA. above as possibly effec­ reduce the intensity of muscle contraction, ences-National Research Council, Drug tive (not included in the labeling condi­ or pharmacologically or electrically induced Efficacy Study Group, as well as other tions in paragraph IV.B.) may continue convulsions. It may be used as a diagnostic to be used for 6 months following the agent for myasthenia gravis where the re­ available evidence, and concludes that sults of tests with neostigmine or edropho­ gallamine triethiôdide injection is ef­ date of this publication to allow addi­ nium are inconclusive. fective for the indications stated in the tional time within which holders of pre­ viously approved applications or persons IV. Succinylcholine chloride pijec- labeling conditions set forth in VI.B. B. Labeling conditions. 1. The labelmarketing the drug without approval tion—A. Effectiveness classification. The may obtain and submit to the Food and Food and Drug Administration has con­ bears the statement, “Caution: Fed­ Drug Administration data to provide sub­ sidered reports of the National Academy eral law prohibits dispenisng without stantial evidence of effectiveness. of Sciences-National Research Council, prescription.” 2. The drug is labeled to comply with XI. Previously approved applications. Drug Efficacy Study Group, as well as A. Each holder of a “deemed approved” other available evidence, and concludes all requirements of the Act and regula­ new drug application (i.e., an applica­ that succinylcholine chloride Injection: tions. Its labeling bears adequate infor­ mation for safe and effective use of the tion which became effective on the basis 1. Is effective for the indications of safety prior to Oct. 10, 1962) for such stated in the labeling conditions set forth drug and is in accord with the guide­ in IV. B. lines for uniform labeling published in drug is requested to seek approval of the the F ederal R egister of February 6,1970. claims of effectiveness and bring the ap­ 2. is possibly effective for use toward plication into conformance by submit­ the end of an operation when effect of (Labeling guidelines for the drug are ting supplements containing: another longer-acting relaxant has be­ available from the Administration on re­ 1. Revised labeling as needed to con­ gun to wear off. quest.) The “Indications” section is as B. Labeling conditions. 1. The label form to the labeling conditions described bears the statement, “Caution: Federal follows: herein for the drug and complete cur­ law prohibits dispensing without I ndications rent container labeling, unless recently submitted. Prescription.” Gallamine triethiodide is indicated as an The drug is labeled to comply with adjunct to anesthesia to induce skeletal mus­ 2. Updating information as needed to au requirements of the Act and regula­ cle relaxation. make the application current in regard

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 13594 NOTICES to items 6 (components), 7 (composi­ if such applications are supplemented, Communications forwarded in response tion) , and 8 (methods, facilities, and con­ in accord with this notice, to delete such to this announcement should be identi­ trols) of the new drug application form indications. Promulgation of the pro­ fied with the reference number DESI FD-356H to the extent described for ab­ posed order would cause any drug for 5657 and be directed to the attention of breviated new drug applications, § 130.4 human use containing the same com­ the appropriate office listed below and (f), published in the F ederal R egister ponents and offered for the indications addressed (unless otherwise specified) to April 24, 1970 (35 F.R. 6574). (One sup­ for which substantial evidence of effec­ the Food and Drug Administration, 5600 plement may contain all the information tiveness is lacking, to be a new drug for Fishers Lane, Rockville, Md. 20852 : described in this paragraph.) which an approved new-drug application Requests for NAS-NRC report: Press Rela­ B. Such supplements should be sub­ is not in effect. Any such drug then on tions Office (CE-200), 200 C Street SW., mitted within the following time periods the market would be subject to regula­ W ashington, D.C. 20204. after the date of publication of this no­ tory proceedings. Supplements : Office of Marketed Drugs (BD- tice in the F ederal R egister: 2. In accordance with the provisions of 200), Bureau of Drugs. 1. 60 days for revised labeling—the section 505 of the Act (21 U.S.C. 355) and Original abbreviated new drug applications: Office of Marketed Drugs (BD-200), Bu­ supplement should be submitted under the regulations promulgated thereunder reau of Drugs. the provisions of § 130.9 (d) and (e) of (21 CFR Part 130, the Commissioner will Request for Hearing (Identify with Docket the new drug régulations (21 CFR 130.9) give the holders of any such applications, number), Hearing Clerk, Office of General which permit certain changes to be put and any interested person who would be Counsel (GC-1), Room 6-62, Parklawn. into effect a t the earliest possible time. adversely affected by such an order, an Any other communications regarding' this 2. 60 days for updating information. opportunity for a hearing to show why announcement : Special Assistant for Drug C. Marketing of the drug may continue such indications should not be deleted Efficacy Study Im plem entation (BD-201), Until the supplemental applications sub­ from labeling. A request for a hearing Bureau of Drugs. mitted in accord with the preceding sub- must be filed within 30 days after the This notice is issued pursuant to pro­ paragraphs A and B are acted upon, pro­ date of publication of this notice in the visions of the Federal Food, Drug, and vided that within 60 days after the date F ederal R egister. A request for a hear­ Cosmetic Act (secs. 502, 505, 52 Stat. of this publication, the labeling of the ing may not rest upon mere allegations 1050-53, as amended; 21 U.S.C. 352, 355) preparation shipped within the jurisdic­ or denials but must set forth specific and under authority delegated to the tion of the Act is in accord with the facts showing that there is a genuine Commissioner of Food and Drugs (21 labeling conditions described in this and substantial issue of fact that re­ CFR 2.120). announcement. quires a hearing, together with a well- XII. New applications. A. Any other organized and full-factual analysis of the Dated: August 5,1970. person who distributes or intends to dis­ clinical and other investigational data S am D. F in e, tribute such drug which is intended for the objector is prepared to prove in a Associate Commissioner the conditions of use for which it has hearing. Any data submitted in response for Compliance. shown to be effective, as described above, to this notice must be previously unsub­ [F.R. Doc. 70-11248; Filed, Aug. 25, 1970; should submit an abbreviated new drug mitted and include data from adequate 8:48 a.m.] application meeting the conditions spec­ and well-controlled clinical investiga­ ified in § 130.4(f) (1) and (2), published tions (identified for ready review) as de­ in the F ederal R egister April 24, 1970 scribed in § 130.12(a) (5) of the regula­ [DESI 5856] (35 F.R. 6574). Such applications should tions published in the F ederal R egister [Docket No. FDC-D-187; NDA 5-856 etc.] include proposed labeling which is in ac­ of May 8, 1970 (35 F.R. 7252). Carefully cord with the labeling conditions de­ conducted and documented clinical CERTAIN ANTICONVULSANT DRUGS scribed herein. studies obtained under uncontrolled or B. Distribution of any such prepara­ partially controlled situations are not Drugs for Human Use; Drug Efficacy tion currently on the market without an acceptable as a sole basis for approval Study Implementation approved new drug application may be of claims of effectiveness, but such stud­ The Food and Drug Administration continued provided that : ies may be considered on their merits for has evaluated reports received from the 1. Within 60 days from the date of corroborative support of efficacy and evi­ National Academy of Sciences-National publication of this announcement in the dence of safety. If a hearing is requested Research Council, Drug Efficacy Study F ederal R egister, the labeling of such and is justified by the response to this Group, on the following anticonvulsant preparation shipped within the jurisdic­ notice, the issues will be defined, a hear­ drugs for parenteral or oral use: tion of the Act is in accord with the ing examiner will be named, and he shall 1. Dilantin Powder for Injection con­ labeling conditions described herein. issue a written notice of the time taining sodium diphenylhydantoin, mar­ 2. The manufacturer, packer, or dis­ and place at which the hearing will keted by Parke, Davis and Co., Joseph tributor of such drug submits, within 60 commence. Campau at the River, Detroit, Mich. days from the date of this publication, a XIV. Unapproved use or form of drug.48232 (NDA 10-151). new drug application to the Food and 1. If the article is labeled or advertised 2. Zarontin Capsules containing etho- Drug Administration. for use in any condition other than those provided for in this announcement, it suximide, marketed by Parke, Davis and 3. The applicant submits within a rea­ may be regarded as an unapproved new Co. (NDA 12-380). sonable time additional information that drug subject to regulatory proceedings 3. Dilantin (Oral) Suspension contain­ may be requested for the approval of the until such recommended use is approved ing diphenylhydantoin, marketed by application as specified in a written com­ Parke, Davis and Co. (NDA 8-762). munication from the Food and Drug in a new drug application, or is other­ wise in accord with this announcement. 4. Mysoline Tablets containing primi­ Administration. \ 2. If the article is proposed for mar­ done, marketed by Ayerst Laboratories, 4. The application has not been ruled keting in another form or for a use other 685 Third Avenue, New York, N.Y. 10017 incomplete Or unapprovable. than the use provided for in this an­ (NDA 9-170). XIII. Opportunity for a hearing. 1. The nouncement, appropriate additional in­ 5. Milontin Kapseals containing phen- Commissioner of Food and Drugs pro­ formation as described in § 130.4 or suximide, marketed by Parke, Davis and poses to issue an order under the pro­ § 130.9 of the regulations (21 CFR, 130.4, Co. (NDA 8-855). visions of section 505(e) of the Federal 130.9) may be required, including re­ 6. Milontin (Oral) Suspension con­ Food, Drug, and Cosmetic Act withdraw­ sults of animal and clinical tests in­ ing approval of all new-drug applications taining phensuximide, marketed by tended to show whether the drug is safe Parke, Davis and Co. (NDA 8-855). and all amendmënts and supplements and effective. thereto providing for the indications for A copy of the NAS-NRC report has 7. Celontin Kapseals containing meth- which substantial evidence of effective­ been furnished to each firm referred to suximide, marketed by Parke, Davis and ness is lacking as described in this an­ above. Any other interested person may Co. (NDA 10-596). nouncement. An order withdrawing ap­ obtain a copy by request to the appro­ 8. Perganone Tablets containing etho- proval of the applications will not issue priate office named below. toin, marketed by Abbott Laboratories,

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 NOTICES 13595

14th and Sheridan Road, North Chicago, movements and in the treatment of cer­ 1. Phenacemide (oral) : HI. 60064 (NDA 10-841). tain psychoses. I ndications 9. Tridione Tablets containing tri­ B. Form of drug. These drug prepara­ For the control of severe epilepsy, partic­ methadione, marketed by Abbott Labora­ tions are in a form suitable for oral ularly mixed forms of psychomotor seizures, tories (NDA 5—856). administration. Sodium diphenylhydan­ refractory to other drugs. 10. Tridione Capsules containing tri- toin is also in powder form suitable for methadione, marketed by Abbott Labo­ preparation of a solution for parenteral D. Indications permitted during ex­ ratories (NDA 5-856). administration. tended period for obtaining substantial 11. Tridione Oral Solution containing C. Labeling conditions. 1. The labels evidence. 1. Those indications for which trimethadione, marketed by Abbott Labo­ bear the statement, “Caution: Federal diphenylhydantoin is described in para­ ratories (NDA 5-856). law prohibits dispensing without pre­ graph A above as probably effective are 12. Paradione Capsules containing scription.” included in the labeling conditions in paramethadione, marketed by Abbott 2. The drugs are labeled to comply with paragraph C and may continue to be Laboratories (NDA 6-800). all requirements of the Act and regula­ used for 12 months following the date of 13. Paradione Oral Solution contain­ tions. Their labeling bears adequate in­ this publication to allow additional time ing paramethadione, marketed by Abbott formation for safe and effective use of the within which holders of previously ap­ Laboratories (NDA 6-800). drugs and is in accord with the guidelines proved applications or persons market­ 14. Mysoline (Oral) Suspension con­ for uniform labeling published in the ing the drug without approval may ob­ taining primidone, marketed by Ayerst F ederal R egister of February 6, 1970. tain and submit to the Food and Drug Laboratories (NDA 10-401). The “Indications” sections are as follows: Administration data to provide substan­ 15. Mesantoin Tablets containing me- a. Sodium Diphenylhydantoin (par­ tial evidence of effectiveness. phenytoin, marketed by Sandoz Phar­ enteral) : 2. Those indications for which etho­ I ndications toin and methsuximide are described in maceuticals, Division of Sandoz, Inc., paragraph A above as possibly effective Route 10, Hanover, N.J. 07936 (NDA For control of status epilepticus and of (not included in the labeling conditions 6-008). seizures occurring during neurosurgery. 16. Gemonil Tablets containing meth- In paragraph C) may continue to be used arbital, marketed by Abbott Laboratories b. Ethosuximide (oral) : for 6 months following the date of this I ndications publication to .allow additional time (NDA 8-322). within which holders of previously ap­ 17. Phenurone Tablets containing For the control of petit mal seizures. phenacemide, marketed by Abbott Lab­ proved applications or persons market­ c. Diphenylhydantoin (oral) : ing such drugs without approval may ob­ oratories (NDA 7-707). tain and submit to the Food and Drug The drugs are regarded as new drugs I ndications Administration data to provide substan­ (21 U.S.C. 320 (p)). Supplemental new- For the control of grand mal and psycho­ tial evidence of effectiveness. drug applications are required to revise motor seizures, and for symptomatic relief E. Marketing status. Marketing of the the labeling in and to update previously of vascular headache, l.e., migraine, and of drugs may continue under the conditions approved applications providing for such trigeminal neuralgia. drugs. A new-drug application is required described in paragraphs F and G of this from any person marketing such drugs d. Primidone (oral) : announcement except that those indica­ I ndications tions referenced in paragraph D may without approval. continue to be used as described therein. The Pood and Drug Administration is For control of grand mal, psychomotor, or F. Previously approved applications. prepared to approve new-drug applica­ focal seizure. 1. Each holder of a “deemed approved” tions and supplements to previously ap­ e. Phensuximide (oral) : new-drug application (i.e., an applica­ proved new-drug applications under con­ tion which became effective on the basis ditions described in this announcement. I ndications of safety prior to Oct. 10, 1962) for such Diphenylhydantoin; E thosuximide; For the control of petit mal seizures. drug is requested to seek approval of Ethotoin; M eph en y to in ; M etharbi- f. Methsuximide (oral) : the claims of effectiveness and bring the tal; Methsuximide; P aramethadione; application into conformance by sub­ I ndications Phenacemide; P hensuximide; P r im i­ mitting supplements containing : done; S odium D iphenylhydantoin; For the control of petit mal seizures that a. Revised labeling as needed to con­ T rimethadione are refractory to other drugs. form to the labeling conditions described g. Ethotoin (oral) : herein for the drug, and complete cur­ A. Effectiveness classification. The rent container labeling, unless recently Food and Drug Administration has con­ I ndications sidered the Academy reports, as well as submitted. other available evidence, and concludes For the control of grand mal and psycho­ b. Adequate data to assure the biologic that: motor seizures. availability of the drug in the formula­ h. Trimethadione (oral) : tion which is marketed. If such data are 1. These drugs are effective or probably already included in the application, effective for the indications which appear I ndications specific reference thereto may be made. in the “Indications” section of this an­ For the control of petit mal seizures that c. Updating information as needed to nouncement. The probably effective indi­ are refractory to other drugs. makH the application current in regard cation is for oral diphenylhydantoin for to items 6 (components), 7 (composi­ symptomatic relief of vascular headache, i. Paramethadione (oral) : tion), and 8 (methods, facilities, and i.e„ migraine, and of trigeminal neuralgia. I ndications controls) of the new-drug application 2. Methsuximide for oral use is possibly For the control of petit mal seizures that form FD-356H to the extent described effective as an anticonvulsant for treat­ are refractory to other drugs. for abbreviated new-drug applications, ment of patients with psychomotor j. Mephenytoin (oral) : § 130.4(f), published in the F ederal epilepsy. R egister April 24, 1970 (35 F.R. 6574). 3. Ethotoin for oral use is possibly I ndications (One supplement may contain all the effective for control of petit mal and petit For the control of grand mal, focal, Jack­ information described in this para­ mal variants. sonian, and psychomotor seizures that are re­ graph.) 4. Diphenylhydantoin in oral dosago fractory to other drugs. 2. Such supplements should be sub­ form lacks substantial evidence of effec­ k. Metharbital (oral) : mitted within the following periods after tiveness for its recommended use in con­ the date of publication of this notice in vulsive states other than idiopathic I ndications the F ederal R egister: epilepsy, as in chorea or Parkinson’s syn­ For the control of grand mal, petit mal, a. 60 days for revised labeling—the drome, to improve control of voluntary myoclonic, and mixed type of seizures. supplement should be submitted under

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 No. 166-— 5 13596 NOTICES the provisions of § 130.9 (d) and (e) of dications for which substantial evidence Supplements (identify with NDA number): the new-drug regulations (21 CFR 130.9) of effectiveness is lacking, to be a new Office of Marketed Drugs (BD-200), Bureau which permit certain changes to be put drug for which an approved new-drug of Drugs. into effect at the earliest possible time. application is not in effect. Any such Original abbreviated new-drug applications b. 180 days for biologic availability (identify as such): Office of Marketed drug then on the market would be sub­ Drugs (BD-200), Bureau of Drugs. data. ject to regulatory proceedings. Request for hearing (identify with Docket c. 60 days for updating information. 2. In accordance with the provisions of number) : Hearing Clerk, Office of General 3. Marketing of the drug may con­section 505 of the Act (21 U.S.C. 355) and Counsel (GC-1), Room 6-62, Parklawn tinue until the supplemental applications the regulations promulgated thereunder Building. submitted in accord with the preceding (21 CFR Part 130), the Commissioner All other communications regarding this an­ subparagraphs 1 and 2 are acted upon, will give the holders of any such applica­ nouncement: Special Assistant for Drug provided that within 60 days after the Efficacy Study Implementation (BD-201), tions, and any interested person who Bureau of Drugs. date of this publication, the labeling of would be adversely affected by such an Requests of NAS-NRC report: Press Relations the preparation shipped within the ju­ order, an opportunity for a hearing to Staff (CÉ-200), Pood and Drug Adminis­ risdiction of the Act is in accord with show why such indications should not be tration, 200 C Street SW., Washington D C the labeling conditions described in this deleted from labeling. A request for a 20204. announcement. (It may continue to in­ hearing must be filed within 30 days after clude the indications referenced in para­ This notice is issued pursuant to pro­ the date of publication of this notice in visions of the Federal Food, Drug, and graph D for the period stated.) the F ederal R egister. A request for a G. New applications. 1. Any other per­ Cosmetic Act (secs. 562, 505, 52 Stat. hearing may not rest upon mere allega­ 1050-53, as amended; 21 U.S.C. 352, 355) son who distributes or intends to dis­ tions or denials but must set forth spe­ tribute such drug which is intended for cific facts showing that a genuine and and under authority delegated to the the conditions of use for which it has Commissioner of Food and Drugs (21 substantial issue of fact requires a hear­ CFR 2.120). been shown to be effective, as described ing, together with a well-organized and under A above, should submit an ab­ full-factual analysis of the clinical and Dated: July 30, 1970. breviated new-drug application meeting other investigation data the objector is the conditions specified in § 130.4(f) (1), S am D. F in e, prepared to prove in a hearing. Any data Associate Commissioner (2), and (3), published in the F ederal submitted in response to this notice must for Compliance. R egister of April 24,1970 (35 F.R. 6574). be previously unsubmitted and include Such applications should include pro­ data from adequate and well-controlled [P.R. Doc. 70-11249; Piled, Aug. 25, 1970; posed labeling which is in accord with clinical investigations (identified for 8:48 a.m.] the labeling conditions described herein ready review) as described in § 130.12(a) and adequate data to assure the biologic (5) of the regulations published in the [DESI 6134] availability of the drug in the formula­ F ederal R egister of May 8 , 1970 (35 F.R. METHADONE HYDROCHLORIDE tion which is marketed or proposed for 7250). Carefully conducted and docu­ marketing. mented clinical studies obtained under Drugs for Human Use; Drug Efficacy 2. Distribution of any such prepara­ uncontrolled or partially controlled situa­ Study Implementation tion currently on the market without an tions are not acceptable as a sole basis The Food and Drug Administration approved new-drug application may be for approval of claims of effectiveness, continued provided that: has evaluated reports received from the but such studies may be considered on National Academy of Sciences-National a. Within 60 days from the date of their merits for corroborative support of Research Council, Drug Efficacy Study publication of this announcement in the efficacy and evidence of safety. If a hear­ Group, on the following drugs for oral F ederal R egister, the labeling of such ing is requested and is justified by the or parenteral use containing methadone preparation shipped within the jurisdic­ response to this notice, the issues will be hydrochloride: tion of the Act is in accord with the defined, a hearing examiner will be 1. a. Dolophine Hydrochloride Syrup; labeling conditions described herein. (It named, and he shall issue a written notice b. Dolophine Hydrochloride Tablets; may continue to include the indications of the time and place at which the hear­ c. Dolophine Hydrochloride Ampoules; referenced in paragraph D for the pe­ ing will commence. all marketed by Eli Lilly and Company, riod stated.) 1. Unapproved use or form of drug. 1. Post Office Box 618, Indianapolis. Ind. b. The manufacturer, packer, or dis­ If the article is labeled or advertised for 46206 (NDA 6-134). tributor of such drug submits, within use in any condition other than those 2. Methadone Hydrochloride Injec­ 180 days from the date of publication, provided for in this announcement, it tion; marketed by the Upjohn Company, a new-drug application to the Food and may be regarded as an unapproved new 7171 Portage Road, Kalamazoo, Mich. Drug Administration. drug subject to regulatory proceedings 49001 (NDA 6-311). c. The applicant submits within a rea­ until such recommended use is approved 3. Methadone Hydrochloride Steri- sonable time additional information that in a new drug application, or is otherwise Vial; marketed by Parke, Davis & Com­ may be required for the approval of the in accord with this announcement. pany, Joseph Campau at the River, De­ application as specified in a written com­ 2. If the article is proposed for market­ troit, Mich. 48232 (NDA 6-310). munication from the Food and Drug ing in another form or for use other than 4. Methadone Hydrochloride Injec­ Administration. the use provided for in this announce­ tion; marketed by The Wm. S. Merrell d. The application has not been ruled ment, appropriate additional information Company, Division of Richardson-Mer- incomplete or unapprovable. as described in § 130.4 or § 130.9 of the rell, Inc., Lockland Station, Cincinnati, H. Opportunity for a hearing. 1. The regulations (21 CFR 130.4, 130.9) may be Ohio 45215 (NDA 6-370). Commissioner of Food and Drugs pro­ required, including results of animal and 5. Methadone Hydrochloride Injec­ poses to issue an order under the provi­ clinical tests intended to show whether tion; marketed by S. E. Massengill Co., sions of section 505(e) withdrawing the drug is safe and effective. 527 Fifth Street, Bristol, Tenn. 37620 approval of all new-drug applications A copy of the NAS-NRC report has (NDA 6-345) . and all amendments and supplements been furnished to each firm referred to The drugs are regarded as new drugs thereto providing for the indications for above. Any other interested person may (21 U.S.C. 321 (p)). Supplemental new which substantial evidence of effective­ obtain a copy by request to the appro­ drug applications are required to revise ness is lacking as described in paragraph priate office named below. the labeling in and to update previously A of this announcement. An order with­ Communications forwarded in response approved applications providing for such drawing approval of the applications to this announcement should be identi­ drugs. A new-drug application is re­ will not issue if such applications are fied with the reference number DESI quired from any person marketing such supplemented, in accord with this no­ 5856 and directed to the attention of the drugs without approval. tice, to delete such indications. Promul­ following appropriate office and ad­ The Food and Drug Administration is gation of the proposed order would cause dressed (unless otherwise specified) to prepared to approve new-drug applica­ any drug for human use containing the the Food and Drug Administration, 5600 tions and supplements to previously ap­ same components and offered for the in­ Fishers Lane, Rockville, Md. 20852: proved new-drug applications under

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 NOTICES 13597

administration of methadone, and it should which repeated, small, incremental doses are conditions described in this announce­ be prescribed and administered with the administered over the course of several ment. same degree of caution appropriate to the hours while the patient’s condition and vital A. Effectiveness classification. - The use of morphine. Like other narcotics, metha­ signs are under careful observation. Pood and Drug Administration has con­ done is subject to the provisions of the Fed­ Special risk patients. Methadone should be sidered the Academy reports, as well as eral narcotic laws. given with caution and the initial dose other available evidence, and concludes Interaction with other central nervous should be reduced in certain patients such that methadone hydrochloride is effec­ system, depressants. Methadone should be as the elderly or debilitated, and those with used with great caution and in reduced severe impairment of hepatic or renal func­ tive for the relief of moderate to severe dosage in patients who are concurrently re­ tion, hypothyroidism, Addison’s disease, and pain; for the control of cough in those prostatic hypertrophy, or urethral stricture. patients in whom antitussives with less ceiving other narcotic analgesics, general anesthetics, phenothiazines, other tranquil­ Adverse R eactions abuse liability have proven inadequate; izers, sedative-hypnotics, tricyclic anti­ and for suppressing the narcotic ab­ depressants and other CNS depressants The major hazards of methadone, as with stinence syndrome in the course of with­ (including alcohol). Respiratory depression, other narcotic analgesics, are respiratory de­ drawal therapy for narcotic dependence. hypotension and profound sedation or coma pression and, to a lesser degree, circulatory may result. depression; respiratory arrest, shock and B. Form of drug. Methadone hydro­ cardiac arrest have occurred. chloride preparations are in syrup, tab­ Head injury and increased intracranial pressure. The respiratory depressant effects The most frequently observed adverse re­ let, or sterile solution form suitable for of methadone and its capacity to elevate actions include light headedness, dizziness, oral or parenteral administration. cerebrospinal fluid pressure may be markedly sedation, nausea, vomiting, and sweating. C. Labeling conditions. 1. The label exaggerated in the presence of increased in­ These effects seem to be more prominent in bears the statement “Caution: Fed­ tracranial pressure. Furthermore, narcotics ambulatory patients and in those who are eral law prohibits dispensing without produce side effects which may obscure the not suffering severe pain. In such individ­ prescription.” clinical course of patients with head injuries. uals, lower doses are advisable. Some adverse In such patients, methadone must be used reactions in ambulatory patients may be 2. The drug is labeled to comply with with extreme caution and only if its use is alleviated if the patient lies down. all requirements of the Act and regula­ deemed essential. Other adverse reactions include: tions promulgated thereunder and those Asthma and other respiratory conditions. Central nervous system : Euphoria, dys­ parts of its labeling indicated below are Methadone should be used with extreme phoria, weakness, headache, agitation, dis­ substantially as follows: (Optional addi­ caution in patients having an acute asth­ orientation, visual disturbances. tional information, applicable to the matic attack, patients with chronic obstruc­ Gastrointestinal: Dry mouth, constipa­ drug, may be proposed under other ap­ tive pulmonary disease or cor pulmonale, tion, biliary tract spasm. patients with a substantially decreased -re­ Cardiovascular: Flushing of the face, propriate paragraph headings and should spiratory reserve, and patients with pre­ bradycardia, palpitation, faintness, syncope. follow the information set forth below.) existing respiratory depression, hypoxia or Genitourinary: Urinary retention. Allergic: Pruritus, urticaria, other skin Description hypercapnia. In such patients, even usual therapeutic doses of narcotics may decrease rashes, and rarely hemorrahic urticaria. (Descriptive information to be included respiratory drive while simultaneously in­ Other: Pain at injection site; local tissue “by tbe manufacturer or distributor should creasing airway resistance to the point of irritation and induration following subcu­ be confined to an appropriate description taneous injection, particularly when re­ of the physical and chemical properties of apnea. Hypotensive effect. The administration of peated; antidiuretic effect. the drug and the formulation.) methadone may result in severe hypotension D osage and Administration Actions in an individual whose ability to maintain his blood pressure has already been com­ For relief of pain. Dosage should be ad­ Methadone hydrochloride is a synthetic promised by a depleted blood volume or justed according to the severity of the pain narcotic analgesic with multiple actions concurrent administration of drugs such as and the response of the patient. It may quantitatively similar to those of morphine; the phenothiazines or certain anesthetics. occasionally be necessary to exceed the usual the most prominent of these actions involve Usage in ambulatory patients. Methadone dosage recommended below in cases of ex­ the central nervous system and organs com­ may impair the mental and/or physical abili­ ceptionally severe pain or in those patients posed of smooth muscle. The principal ties required for the performance of poten­ who have become tolerant to the analgesic actions of therapeutic value are analgesia tially hazardous tasks _such as driving a oar effect of narcotics. While subcutaneous ad­ and sedation. Methadone also possesses or operating machinery. The patient should ministration is suitable for occasional use, significant antitussive activity. The metha­ be cautioned accordingly. intramuscular administration is preferred done abstinence syndrome, while qualita­ Methadone, like other narcotics, may pro­ when repeated doses are required. tively similar to th a t of morphine, differs duce orthostatic hypotension in ambulatory Usual adult dosage: 2.5-10 mg I.M., S.C. in that thé onset is slower, the course is more patients. or oral, every 3 or 4 hours as necessary. prolonged and the symptoms are less severe. Usage in pregnancy. Safe use in pregnancy For suppressing the narcotic abstinence Methadone, in 8 to 10 mg parenteral doses, has not been established relative to possible syndrome. The narcotic upon which the pa­ is approximately equivalent in analgesic adverse effects on fetal development. There­ tient is dependent is replaced by methadone effect to 10 mg of morphine; with single fore, methadone should not be used in (preferably administered orally two or four dose administration, the onset and duration pregnant women unless, in the judgment of times a day) in a dosage sufficient to sup­ of analgesic action of the two drugs are the physician, the potential benefits out­ press the abstinence syndrome. After a satis­ similar. weigh the possible hazards. factory stabilization dose has been found, When administered orally, methadone is Methadone is not recommended for obstet­ the total daily dose is reduced by approxi­ approximately one-half as potent as with rical analgesia because its long duration of mately 20 percent each day. The majority parenteral administration; oral administra­ action increases the probability of respira­ of patients can be completely withdrawn tion results in a delay of the onset, a lower­ tory depression in the newborn. in 10 days or less. As an antitussive: (with appropriate for­ ing of the peak and an increase in the Use in children. Methadone is not recom­ duration of analgesic effeèt. m ulation) mended for use as an analgesic in children Usual adult dosage: 1 to 2 mg every 4-6 I ndications because documented clinical experience has been insufficient to establish a suitable hours For the relief of moderate to severe pain. dosage regimen for the pediatric age group. Usual children’s dosage 3 to 12 years: 0.5 For suppressing the narcotic abstinence to 1 mg every 4-6 hours syndrome in the course of withdrawal P recautions Overdosage. Symptoms: Serious overdosage therapy for narcotic dependence. Acute abdominal conditions. The admin­ with methadone is characterized by respira­ For the control of cough in those patients istration of methadone or other narcotics tory depression (a decrease in respiratory in whom antitussives with less abuse liability may obscure the diagnosis or clinical course rate and/or tidal volume, Cheyne-Stokes have proven inadequate. in patients with acute abdominal conditions. respiration, cyanosis), extreme somnolence Interaction with monoamine oxidase in­ progressing to stupor or coma, maximally Contraindications hibitors (MAOI). Therapeutic doses of constricted pupils, skeletal muscle flaccidity, Hypersensitivity of methadone. meperidine have precipitated severe reactions cold and clammy skin, and sometimes brady­ in patients concurrently receiving monoa­ cardia and hypotension. In severe overdosage, Warnings mine oxidase inhibitors, or those who have particularly in the intravenous route, apnea, circulatory collapse, cardiac arrest and death Drug dependence. Methadone can produce received such agents within 14 days. Similar drug dependence of the morphine type and reactions have not thus far been reported may occur. therefore has the potential for being abused. with methadone, but should the use of Treatment: Primary attention should be Psychic dependence, physical dependence methadone be necessary in such patients, given to the re-establishment of adequate and tolerance may develop upon repeated a sensitivity test should be performed in respiratory exchange through provision of a

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 13598 NOTICES patient airway and institution of assisted or 3. Marketing of the drug may con­ controlled ventilation. The narcotic antago­ address given below, within 30 days after nists, nalorphine hydrochloride and leval- tinue until the supplemental applica­ the publication of this notice in the lorphan tartrate, are specific antidotes tions submitted in accord with the pre­ F ederal R egister. against respiratory depression which may ceding subparagraphs 1 and 2 are acted A copy of the NAS-NRC report has result from overdosage or unusual sensitivity upon, provided that within 60 days after been furnished to each firm referred to to narcotics, including methadone. There­ the date of this publication, the labeling above. Any other interested person may fore, an appropriate dose of one or these of the preparation shipped within the obtain a copy by request to the appro­ antagonists should be administered, prefer­ jurisdiction of the Act is in accord with priate office named below. ably by the intravenous route, simultaneously the labeling conditions described in this with efforts at respiratory resuscitation. Communications forwarded in re­ An antagonist should not be administered announcement. sponse to this announcement should be in the absence of clinically significant respi­ F. New applications. 1. Any other per­ identified with the reference number ratory or cardiovascular depression. son who distributes or intends to dis­ DESI 6134 and be directed to the atten­ Oxygen, intravenous fluids, vasopressors tribute such drug which is intended for tion of the following appropriate office and other supportive measures should be the conditions’ of use for which it has and addressed (unless otherwise speci­ employed as indicated. been shown to be effective, as described fied) to the Food and Drug Administra­ Note: In an individual physically depend­ under A above, should submit an ab­ tion, 5600 Fishers Lane, Rockville, Md ent on narcotics, the administration of the breviated new drug application meeting 20852: usual dose of a narcotic antagonist will precipitate an acuite withdrawal syndrome. the conditions specified in § 130.4(f) (1), Supplements (identify with NDA number) : The severity of this syndrome will depend (2), and (3), published in the F ederal Office of Marketed Drugs (BD-200), Bu­ on the degree of physical dependence and R egister of April 24, 1970 (35 F.R. reau of Drugs. the dose of antagonist administered. The 6574). Such applications should include Original abbreviated new-drug applications use of a narcotic antagonist in such indi­ proposed labeling which is in accord with (identify as such) : Office of Marketed viduals should be avoided if possible. If a the labeling conditions described herein Drugs (BD-200), Bureau of Drugs. narcotic antagonist must be used to treat and adequate data to assure the biologic All other communications regarding this an­ serious respiratory depression in the physi­ availability of the drug in the formula­ nouncement: Special Assistant for Drug cally dependent patient, the antagonist Efficacy Study Im plementation (BD-201), should be administered with extreme care tion which is marketed or proposed for Bureau of Drugs. and only one-fifth to one-tenth the usual marketing. Bequests for NAS-NRC report: Press Rela­ initial dose administered. 2. Distribution of any such prepara­ tions Staff (CE-200), Pood and Drug Ad­ tion currently on the market without an m inistration, 200 C Street SW., Washing­ D. Marketing status. Marketing of the approved new drug application may be ton, D.C.20204. drugs may continue under the conditions continued provided that: This notice is issued pursuant to pro­ described in paragraphs E and F of this a. Within 60 days from the date of visions of the Federal Food, Drug, and announcement. publication of this announcement in the Cosmetic Act (secs. 502, 505, 52 Stat. E. Previously approved applications. F ederal R egister, the labeling of such 1050-53, as amended; 21 U.S.C. 352, 355) 1. Each holder of a “deemed approved”- preparation shipped within the jurisdic­ and under authority delegated to the new drug application (i.e., an applica­ tion of the Act is in accord with the Commissioner of Food and Drugs (21 tion which became effective on the basis labeling conditions described herein. CFR 2.120). of safety prior to Oct. 10, 1062) for such b. The manufacturer, packer, or dis­ drug is requested to seek approval of the tributor of such drug submits, within Dated: August 5,1970. claims of effectiveness and bring the 180 days from the date of this publica­ Sam D. F in e, application into conformance by sub­ tion, a new drug application to the Food Associate Commissioner mitting supplements containing: and Drug Administration. for Compliance. a. Revised labeling as needed to con­ c. The applicant submits within a rea­ form to the labeling conditions described sonable time, additional information that [F.R. Doc. 70-11250; Filed, Aug. 25, 1970; herein for the drug, and complete cur­ may be required for the approval of the 8:49 a.m .] rent container labeling, unless recently application as specified in a written submitted. communication from the Food and Drug [DESI 6472] b. Adequate data to assure the biologic Administration. availability of the drug in the formula­ d. The application has not been ruled CERTAIN PARENTERAL ELECTROLYTE tion which is marketed. If such data are incomplete or unapprovable. SOLUTIONS: LACTATED POTASSIO already included in the application, G. Unapproved use or form of drug. SALINE INJECTION; AND AMMO­ specific reference thereto may be made. 1. If the article is labeled or advertised NIUM CHLORIDE INJECTION c. Updating information as needed to for use in any condition other than those make the application current in regard provided for in this announcement, it Drugs for Human Use; Drug Efficacy to items 6 (components), 7 (composi­ may be regarded as an unapproved new Study Implementation tion), and 8 (methods, facilities, and drug subject to regulatory proceedings The Food and Drug Administration controls) of the new drug application until such recommended use is ap­ has evaluated reports received from the form FD-356H to the extent described proved in a new drug application, or is National Academy of Sciences-National for abbreviated new drug applications, otherwise in accord with this announce­ Research Council, Drug Efficacy Study § 130.4(f), published in the F ederal ment. Group, on the following electrolyte solu­ R egister April 24, 1970 (35 F.R. 2. If the article is proposed for mar­ 6574). (One supplement may contain keting in another form or for use other tions for parenteral use: all the information described in this than the use provided for in this an­ 1. Ammonium Chloride in Distilled paragraph.) nouncement, appropriate additional in­ Water containing ammonium chloride 2. Such supplements should be sub­ formation as described in § 130.4 or 0.9 percent (NDA 6-580) ; and mitted within the following periods after § 130.9 of the regulations (21 CFR 130.4, 2. Lactated Potassio Saline Injection; the date of publication of this notice in 130.9) may be required, including re­ containing potassium chloride, sodium the F ederal R egister : sults of animal and clinical tests in­ chloride, and sodium lactate (NDA a. 60 days for revised labeling—the tended to show whether the drug is safe 6-472), both marketed by Don Baxter, supplement should be submitted under and effective. Inc., 1015 Grandview Avenue, Glendale, the provisions of § 130.9 (d) and (e) of Representatives of the Administration Calif. 91201. the new drug regulations (21 CFR 130.9) are willing to meet with any interested These drugs are regarded as new drugs. which permit certain changes to be put person who desires to have a conference The effectiveness classification and mar­ into effect at the earliest possible time. concerning proposed changes in the keting status are described below. b. 180 days for biologic availability labeling set forth herein. Requests for A. Effectiveness classification. The Food data. such meetings should be made to the Of­ and Drug Administration has considered c. 60 days for updating information. fice of Marketed Drug (BD-200), at the the Academy reports and concludes that:

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 NOTICES 13599

1. Lactated potassic saline injection is All other communications regarding this an­ tion, excessive alkalinizing medication, possibly effective as a replacement solu­ nouncement: Special Assistant for Drug or overuse of organomercurial diuretics. Efficacy Study Implementation (BD-201), B. Form of drug. These preparations tion for parenteral use in infants with Bureau of Drugs. dehydration due to diarrhea. Requests for NAS-NRC Reports: Press Rela­ are in sterile solution form suitable for 2. Ammonium chloride injection, 0.9 tions Staff (CE—200) , Pood and Drug Ad­ parenteral administration. percent, is possibly effective in the treat­ m inistration, 200 C Street SW„ Washing­ C. Labeling conditions. 1. The label ment of chloride loss due to vomiting, ton, D.C.20204. bears the statement “Caution: Federal gastric fistula drainage, gastric suction, law prohibits dispensing without pre­ This notice is issued pursuant to pro­ scription.” excessive alkalinizing medication, or visions of the Federal Food, Drug, and overuse of organomercurial diuretics. Cosmetic Act (secs. 502, 505, 52 Stat. 2. The drugs are labeled to comply B. Marketing status. 1. Holders of with all requirements of the Act and 1050-53, as amended; 21 U.S.C. 352, 355) regulations. Their labeling bears ade­ previously approved new drug applica­ and under authority delegated to the tions and any person marketing any such Commissioner of Food and Drugs (21 quate information for safe and effective drug without approval will be allowed CFR 2.120). use of the drugs and is in accord with 6 months from the date of publication of the guidelines for uniform labeling pub­ this announcement in the F ederal Dated: July 27,1970. lished in the F ederal R egister of Febru­ ary 6, ,1970. The “Indications” sections Register to obtain and to submit in a S am D. F in e , supplemental or original new drug ap­ Associate Commissioner are as follows: plication data to provide substantial evi­ for Compliance. Potassium Chloride Injection: dence of effectiveness for those indica­ [P.R. Doc. 70-11251; Piled, Aug. 25, 1970; I ndication tions for which these drugs have been 8:49 ajn.] This drug is indicated in the treatment oî classified as possibly effective. To be ac­ potassium deficiency states when oral re­ ceptable for consideration in support of placement therapy is not feasible. the effectiveness of a drug, any such data [DESI 6580] must be previously unsubmitted, well- Ammonium Chloride 0.9 percent in organized, and include data from ade­ CERTAIN PARENTERAtT ELECTROLYTE Sodium Chloride Injection: quate and well-controlled clinical investi­ SOLUTIONS: POTASSIUM CHLORIDE Indication gations (identified for ready review) as INJECTION; AND AMMONIUM Ammonium chloride may be indicated in described in § 130.12(a) (5) of the regula­ CHLORIDE IN SODIUM CHLORIDE the treatment of patients with: (1) hypo­ chloremic states and (2) metabolic alkalosis. tions published as a final order in the INJECTION Federal R egister of May 8, 1970 (35 D. Marketing status. Marketing of the F.R. 7250). Carefully conducted and Drugs for Human Use; Drug Efficacy drugs may continue under the condi­ documented clinical studies obtained Study Implementation tions described in paragraphs E and F of under uncontrolled or partially- this announcement. controlled situations are not acceptable The Pood and Drug Administration has evaluated reports received from the E. Previously approved applications. 1. as a sole basis for the approval of claims Each holder of a “deemed approved” new of effectiveness, but such studies may be National Academy of Sciences-National Research Council, Drug Efficacy Study drug application (i.e., an application considered on their merits for corrobora­ which became effective on the basis of tive support of efficacy and evidence of Group, on the following electrolyte solu­ tions for parenteral use: safety prior to Oct. 10, 1962) for such safety. drug is requested to seek approval of the 2. At the end of the 6-month period, 1. Potassium Chloride Injection, 15 percent, marketed by Eli Lilly and Com­ claims of effectiveness and bring the ap­ any such data will be evaluated to deter­ plication into conformance by submitting mine whether there is substantial evi­ pany, P.O. Box 618, Indianapolis, Ind., 46206 (NDA 7-865). ✓ supplements containing: dence of effectiveness for such uses. a. Revised labeling as needed to con­ After that evaluation, the conclusions 2. Ammonium Chloride, 0.9 percent, in Normal Saline Injection, containing form to the labeling conditions described concerning the drugs will be published herein for the drug and complete cur­ in the F ederal R egister. If no studies ammonium chloride and sodium chloride, marketed by Don Baxter, Inc,, 1015 rent container labeling, unless recently have been undertaken or if the studies submitted. do not provide substantial evidence of Grandview Avenue, Glendale, Calif., 91201 (NDA 6-580). b. Updating information as needed to effectiveness, procedures will be initiated make the application current in regard to withdraw approval of the new drug The drugs are regarded as new drugs (21 U.S.C. 321 (p )). Supplemental new to items 6 (components), 7 (composi­ applications for such drugs, pursuant to tion), and 9 (methods, facilities, and the provisions of section 505(e) of the drug applications are required to revise the labeling in and to update previously controls) of the new drug application Federal Food, Drug, and Cosmetic Act. form FD-356H to the extent described Withdrawal of approval of the applica­ approved applications providing for such drugs. A new drug application is re­ for abbreviated new drug applications, tions will cause any such drugs on the § 130.4(f), published in the F ederal market to be new drugs for which an quired from any person marketing such drugs without approval. R egister April 24, 1970 (35 F.R. 6574). approval is not in effect. (One supplemént may contain all the The above named holders of the new- The Food and Drug Administration is prepared to approve new drug appli­ information described in this para­ drug applications for these drugs have graph.) been mailed a copy of the NAS-NRC re­ cations and supplements to previously 2. Such supplements should be sub­ port. Any interested person may obtain approved new drug applications under mitted within the following time periods a copy of these reports by writing to the conditions described in this announce­ ment. after the date of publication of this office named below. notice in the F ederal R egister: Communications forwarded in response A. Effectiveness classification. The a, 60 days for revised labeling—the sup­ to this announcement should be identi­ Food and Drug Administration has con­ plement should be submitted under the fied with the reference number DESI sidered the Academy reports on these provisions of § 130.9 (d) and (e) of the 6472 and be directed to the attention of drugs, as well as other available evidence, new dfug regulations (21 CFR 130.9) the following appropriate office and ad­ and concludes that: which permit certain changes to be put dressed (unless otherwise specified) to 1. Potassium chloride injection, 15 per­ into effect at the earliest possible time. the Food and Drug Administration, 5600 cent, is effective for treatment of potas­ b. 60 days for updating information. Fishers Lane, Rockville, Md. 20852: sium deficiency when oral replacement 3. Marketing of the drug may continue therapy is not feasible. Supplements (identify with NDa number) : until the supplemental applications sub­ Offiee of Marketed Drugs (BD-200), Bu­ 2. Ammonium chloride 0.9 percent in mitted in accord with the preceding sub- reau of Drugs. sodium chloride injection is effective for paragraphs 1 and 2 are acted upon, pro­ Original new-drug applications: Office of New treatment of chloride loss due to vomit­ vided that within 60 days after the date ruga (BD-100), Bureau of Drugs. ing, gastric fistula drainage, gastric suc­ of this publication, the labeling of the

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 13600 NOTICES preparation shipped within the jurisdic­ All other communications regarding this an­ adequately documented. The role of his­ tion of the Act is in accord with the label­ nouncement: Special Assistant for Drug Efficacy Study Implementation (BD-201), tamine as a causative agent in laminitis ing conditions described in this an­ Bureau of Drugs. and pulmonary emphysema could also nouncement. Bequests for NAS-NRC report: Press Rela­ be questioned, but there is evidence that P. New applications. 1. Any other per­ tions Staff (CE-200), Food and Drug antihistaminic therapy is rational. son who distributes or intends to distrib­ Administration, 200 C Street SW., Washing­ 3. It is suggested that the label and/ ute such drug which is intended for the ton, D.C. 20204. or package insert include dosage recom­ conditions of use for which it has been This notice is issued pursuant to pro­ mendations based on a pound of weight shown to be effective, as described under basis and that the indications for use be A above, should submit an abbreviated visions of the Federal Food, Drug, and Cosmetic Act (secs. 502, 505, 52 Stat. limited to those conditions in which new drug application meeting the condi­ antihistaminic therapy may be expected tions specified in § 130.4(f) (1) and (2), 1050-53, as amended; 21 U.S.C. 352, 355) and under authority delegated to the to lead to alleyiation of some signs of published in the F ederal R egister April disease. Efficacy is not well established 24,1970 (35 F.R. 6574). Such applications Commissioner of Food and Drugs (21 CFR 2.120). except in the case of exposure to an should include proposed labeling which antigen to which the animal has a pre­ is, in accord with the labeling conditions Dated: July 27,1970. existing sensitivity. The sedative and described herein. Sam D. F ine, antiemetic actions of antihistaminic 2. Distribution of any such prepara­ Associate Commissioner drugs on the central nervous system may tion currently on the market without an for Compliance. have prophylactic or therapeutic value approved new drug application may be in selected situations. continued provided th a t: [F.R. Doc. 70-11252; Filed, Aug. 25, 1970; 4. The-labeling should include infor­ a. Within 60 days from the date of 8:49 a.m.] mation on side effects such as: (a) De­ publication of this announcement in pression of the central nervous system the F ederal R egister, the labeling of [DESI 6602V] and the incoordination that may occur such preparation shipped within the at therapeutic dose levels; (b) disturb­ jurisdiction of the Act is in accord with CERTAIN DRUG PRODUCTS CONTAIN­ ances in gastrointestinal functions that the labeling conditions described herein. ING DOXYLAMINE SUCCINATE may occur; and (c) overdosage that may b. The manufacturer, packer, or dis­ Drugs for Veterinary Use; Drug Efficacy give rise to excitement, ataxia, and tributor of such drug submits, within 60 convulsions. days from the date of this publication, a Study Implementation 5. Evidence must be provided that the new drug application to the Food and The Food and Drug Administration has tablets disintegrate in the gastrointes­ Drug Administration. evaluated reports received from the Na­ tinal tract of the medicated species to c. The applicant submits, within a tional Academy of Sciences-National Re­ produce the desired therapeutic effect. reasonable time, additional information search Council, Drug Efficacy Study The Food and Drug Administration that may be required for the approval Group, on the following preparations concurs with the Academy’s findings. of the application as specified in a writ­ marketed by Jensen-Salsbery Laborato­ This evaluation is- concerned only with ten communication from the Food and ries, Division of Richardson-Merrell, Inc., these drugs’ effectiveness and safety to Drug Administration. 520 West 21st Street, Kansas City, Mo. the animal to which administered. It d. The application has not been ruled 64141: - does not take into account the safety incomplete or unapprovable. 1. Jen-Sal A-H Tablets; tablets con­ for food use of food derivecLfrom drug- G. Unapproved use or form of drug.taining 25 or 100 milligrams of doxyla- treated animals. Nothing herein will 1. If the article is labeled or advertised mine succinate. constitute, a bar to further proceedings for use in any condition other than those 2, Jen-Sal A-H Solution; each cubic with respect to questions of safety of provided for in this announcement, it centimeter contains 11.36 milligrams of the drugs or their metabolites as res­ may be regarded as an unapproved new doxylamine succinate. idues in food products derived from drug subject to regulatory proceedings The Academy report stated that A-H treated animals. until such recommended use is approved Tablets for small animals (25 milligrams This announcement is published (1) in a new drug application or is other­ of drug) are probably effective as an oral to inform the holders of new animal drug wise in accord with this announcement. antihistaminic for urticaria, allergic applications of the findings of the Acad­ 2. If the article is proposed for mar­ dermatitis, and other allergic syndromes. emy and the Food and Drug Administra­ keting in another form or for a use other A-H Tablets for large animals (100 mil­ tion and (2) to inform all interested than the use provided for in this an­ ligrams of drug), are probably effective persons that such articles may be mar­ nouncement, appropriate additional in­ as an oral antihistaminic for equine and keted provided they are the subject of formation as described in § 130.4 or bovine laminitis, equine pulmonary em­ approved new animal drug applications § 130.9 of the regulations (21 CFR 130.4, physema, and other allergic syndromes. and otherwise comply with all other re­ 130.9) may be required, including re­ The A-H Solution is probably effective as quirements of the Federal Food, Drug, sults of animal and clinical tests intended an antihistaminic for the same condi­ and Cosmetic Act. to show whether the drug,is safe and tions of use as annotated for the A-H Holders of the new animal drug appli­ effective. Tablets. The Academy’s report also A copy of the NAS-NRC report has cations are provided 6 months from the stated: ederal been furnished to each firm referred to date of publication hereof in the F above. Any other interested person may 1. Documentation consists of case re­ R egister to submit adequate documen­ obtain a copy by request to the appro­ ports with no controlled studies to tation in support of the labeling used. priate office named below. indicate the efficacy of doxylamine suc­ Each holder of a new animal drug ap­ Communications forwarded in re­ cinate for the conditions of use indicated. plication which became effective prior sponse to this announcement should be 2. Extensive literature attests to the to October 10, 1962, is requested to sub­ identified with the reference number fact that doxylamine succinate is an an­ mit updating information as needed to DESI 6580 and be directed to the atten­ tihistaminic agent. Literature available make the application current with re­ tion of the following appropriate office does not, however, indicate that hista­ gard to manufacture of the drug, in­ and addressed (unless otherwise speci­ mine release occurs in adequate levels to cluding information on drug components fied) to the Food and Drug Administra­ be a clinical problem in septic metritis, and composition, and also including tion, 5600 Fishers Lane, Rockville, Md. gangrenous mastitis, toxic engorgement, information regarding manufacturing 20852: and mycotic stomatitis. The use of anti- methods, facilities, and controls, in ac­ cordance with the requirements of sec­ Supplements (identify with NDA number): histaminics in treating these conditions Office of Marketed Drugs (BD-200), Bureau is questionable; documentation does not tion 512 of the act. of Drugs. support the claim for use of the drug as Written comments regarding this an­ Original abbreviated new drug applications an adjuvant for toxemias. The use of the nouncement, including requests for a» (identify as such): Office of Marketed drug in treating selected allergic dis­ informal conference, may be addressed to Drugs (BD-200), Bureau of Drugs. orders is more justifiable but still not the Bureau of Veterinary Medicine, Food

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 NOTICES 13601 and Drug Administration, 5600 Fishers any such data must be previously unsub­ and any person marketing any such Lane, Rockville, Md. 20852. mitted, well-organized, and include data drug without approval will be allowed 6 The holder of the new animal drug from adequate and well-controlled clin­ months from the date of publication of applications for the listed drugs has been, ical investigations (identified for ready this announcement in the F ederal R eg­ mailed a copy of the NAS-NRC reports. review) as described in § 130.12(a) (5) ister to obtain and to submit in a sup­ Any other interested person may also ob­ of the regulations published as a final plemental or original new drug applica­ tain a copy by writing to the Food and order in the F ederal R egister of May 8, tion data to provide substantial evidence Drug Administration, Press Relations 1970 (35 F.R. 7250). Carefully conducted of effectiveness for those indications for Staff, 200 C Street SW., Washington, and documented clinical studies ob­ which this drug has been classified as D.C. 20204. tained under uncontrolled or partially- possibly effective. To be acceptable for This notice is issufed pursuant to pro­ controlled situations are not acceptable consideration in support of the effective­ visions of the Federal Food, Drug, and as a sole basis for the approval of claims ness of a drug, any such data must be Cosmetic Act (secs. 502, 512, 52 Stat. of effectiveness, but such studies may be previously unsubmitted, well-organized, 1050-51, 82 Stat. 343-51; 21 U.S.C. 352, considered on their merits for corrobo­ and include data from adequate and 360b) and under authority delegated to rative support of efficacy and evidence well-controlled clinical investigations the Commissioner of Food and Drugs of safety. (identified for ready review) as described (21 CFR 2.120). 2. At the end of the 12-month period, in § 130.12(a) (5) of the regulations pub­ any such data will be evaluated to de­ lished as a final order in the F ederal Dated: August 17, 1970. termine whether there is substantial evi­ R egister of May 8, 1970 (35 F.R . 7250). S am D. F in e , dence of effectiveness of the drug for Carefully conducted and documented Associate Commissioner such uses. The conclusions concerning clinical studies obtained under uncon­ for Compliance. the drug will be published in the F ederal trolled or partially controlled situations [F.R. Doc. 70-11253; Filed, Aug. 25, 1970; R egister. If no studies have been under­ are not acceptable as a sole basis for the 8:49 a.m.l taken or if the studies do not provide approval of claims of effectiveness, but substantial evidence of effectiveness, such studies may be considered on their procedures will be initiated to withdraw merits for corroborative support of effi­ [DESI 6813] approval of the new drug application for cacy and evidence of safety. CERTAIN ANTIPARKINSON DRUGS the drug, pursuant to the provisions of 2. At the end of the 6-month period, section 505(e) of the Federal Food, Drug, any such data will be evaluated to deter­ Drugs for Human Use; Drug Efficacy and Cosmetic Act. Withdrawal of ap­ mine whether there is substantial evi­ Study Implementation proval of the application will cause any dence of effectiveness for such uses. After such drugs on the market to be new drugs that evaluation, the conclusions concern­ The Food and Drug Administration for which an approval is not in effect. ing the drug will be published in the has evaluated reports received from the F ederal R egister. If no studies have National Academy of Sciences-National 3. Within 60 days from publication hereof in the F ederal R egister, persons been undertaken or if the studies do not Research Council, Drug Efficacy Study marketing the drug without approval provide substantial evidence of effective­ Group, on the following antiparkinson should revise labeling as needed and the ness, procedures will be initiated to with­ drugs: holder of any approved new drug appli­ draw approval of the new drug applica­ 1. Artane Sequels, containing 5 milli­ cation, for such drug should submit a tions for such drugs, pursuant to the grams trihexyphenidyl hydrochloride per provisions of section 505(e) of the Fed­ sustained-release capsule; Lederle Labo­ supplement to his application to pro­ ratories, Division of American Cyanamid vide for revised labeling as needed, eral Food, Drug, and Cosmetic Act. Co., Pearl River, N.Y. 10965 (NDA which, taking into account the comments Withdrawal of approval of the applica­ 12-947). of the Academy, furnishes adequate in­ tions will cause any such drugs on the 2. Panparnit Tablets, containing 12.5 formation for safe and effective use of market to be new drugs for which an or 50 milligrams caramiphen hydro­ the drug, is in accord with the guidelines approval is not in effect. chloride; Geigy Chemical Corp.,‘t Saw for uniform labeling published in the The above-named holders of the new- Mill River Road, Ardsley, N.Y. 10502 F ederal R egister of February 6, 1970 drug applications for these drugs have (NDA 6-813). (21 CFR 3.74) and recommends use of been mailed a copy of the NAS-NRC re­ These drugs are regarded as new drugs. the drug for the probably effective indi­ port. Any interested person may obtain The effectiveness classification and mar­ cations as follows: a copy of these reports by writing to the keting status are described below. I ndications office named below. I . Trihexyphenidyl hydrochloride, sus­ This drug Is indicated as an adjunct in idle Communications forwarded in re­ tained-release capsules—A. Effectiveness therapy of all forms of parkinsonism (post­ sponse to this announcement should be classification. The Food and Drug Ad­ encephalitic, arteriosclerotic, and idiopath­ identified with the reference number ministration has considered the Academy ic). It is useful in the prevention or control DESI 6813 and be directed to the atten­ report and concludes that trihexypheni­ of extrapyramidal disorders due to central tion of the following appropriate office dyl hydrochloride in sustained-release nervous system drugs such as reserpine and and addressed (unless otherwise speci­ form is probably effective as an adjunct phenothiazines. fied) to the Food and Drug Administra­ in the therapy of all forms of parkinson­ The supplement should be submitted tion, 5600 Fishers Lane, Rockville, Md. ism (postencephalitic, arteriosclerotic, under the provisions of § 130.9 (d) and 20852: and idiophatic), and for use in the pre­ (e) of the new drug regulations (21 Supplements (Identify with NDA number) : vention or control of extrapyramidal CFR 130.9 (d) and (e) X which permit Office of Marketed Drugs (BD-200), Bu­ disorders due to central nervous sys­ certain changes to be put into effect at reau of Drugs. tem drugs such as reserpine and the earliest possible time, and the re­ Original new-drug applications: Office of phenothiazines. vised labeling should be put into use New Drugs (BD-100), Bureau of Drugs. B. Marketing status. 1. Those indica­ within the 60-day period. (Labeling AU other communications regarding this an­ tion for which the drug is described in guidelines for the drug are available nouncement: Special Assistant for Drug paragraph A above as probably effective from the Administration on request.) Efficacy Study Im plementation (BD-201), Bureau of Drugs. may continue to be used for 12 months H . Caramiphen hydrochloride tab­ lets—A. Effectiveness classification. The Requests for NAS-NRC reports: Press Rela­ following the date of this publication to tions Office (CE—200), Food and Drug allow additional time within which hold­ Food and Drug Administration has con­ Administration, 200 C Street SW., Wash­ ers of previously approved applications sidered tiie Academy report and con­ ington, D.C. 20204. or persons marketing the drug without cludes that caramiphen hydrochloride approval may obtain and submit to the tablets are possibly effective for the re­ This notice is issued pursuant to pro­ Food and Drug Administration data to lief of rigidity and tremor in Parkinson’s visions of the Federal Food, Drug, and Provide substantial evidence of effective­ syndrome. Cosmetic Act (secs. 502, 505; 52 Stat. ness. To be acceptable for consideration B . Marketing status. 1. Holders of pre­ 1050-53, as amended; 21 UJS.C. 352,355) in support of the effectiveness of a drug, viously approved new drug applications and tinder authority delegated to the

FEDIRAI. REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 13602 NOTICES

Commissioner of Food and Drugs (21 The above-named firms and any other 300-unit polymyxin B disc should give a zone CFR 2.120). holders of applications approved for a of over 11 mm. when tested against a poly­ drug of the kind described above are myxin B-sensitive bacterial strain. Dated: July 23,1970. Polymyxin B sulfate is not absorbed from requested to submit, within 60 days fol­ the normal alimentary tract. Since the drug Sam D. F ine, lowing publication of this announcement loses 50 percent of its activity in the pres­ Associate Commissioner in the F ederal R egister, amendments ence of serum, blood levels are low 2-4 mg./ for Compliance. to their antibiotic applications to pro­ kg. parenterally in adults gives a range of [F.R. Doc. 70-11254; Filed, Aug. 25, 1970; vide for revised labeling. Separate label­ 1-8 mcg./ml. serum level over a 6-hour 8:49 a.m.] ing should be submitted for sterile and period). Repeated injections may give a tablet forms of the drug and those parts cumulative effect. Levels tend to be higher of the labeling indicated below should in infants and children. The drug is excreted [DESI 7501] slowly by the kidneys. Tissue diffusion is be substantially as follows (optional ad­ poor and the drug does not pass the blood CERTAIN POLYMYXIN B SULFATE ditional information applicable to the brain barrier into the cerebrospinal fluid. PREPARATIONS drug may be proposed under other In therapeutic dosage, polymyxin B sulfate appropriate paragraph headings and causes some nephrotoxicity with tubule Drugs for Human Use; Drug Efficacy should follow the information given damage to a very slight degree. With prior Study Implementation below) : kidney damage of considerable degree, the nephrotoxicity of the drug may preclude its The Food and Drug Administration P olymyxin B Sulfate for P arenteral and/ or therapeutic use. Ophthalmic Administration has evaluated reports received from the INDICATIONS National Academy of Sciences-National Acute Infections Caused by Susceptible Research Council, Drug Efficacy Study Warning Group, on the following forms of poly­ Strains of Pseudomonas aeruginosa. Poly­ (Should be in boldface type and en­ myxin B sulfate is a drug of choice in the myxin B sulfate: closed in a box) treatment of infections of the urinary tract, 1. Aerosporin Sterile Powder for prep­ meninges, and blood stream caused by sus­ aration of solutions (NDA 7-501) and, Caution: When This Drug Is Given ceptible strains of Ps. aeruginosa. It may also 2. Aerosporin Compressed Tablets Intramuscularly and/or Intratheoally, be used topically and subconjunctivally in (NDA 7-934) , marketed by Burroughs It Should Be Given Only to Hospital­ the treatm ent of infections of the eye caused Wellcome & Co., Inc., 1 Scars dale Road, ized Patients, So As To Provide Con­ by susceptible strains of Ps. aeruginosa. stant Supervision by a Physician. It may be indicated in serious infections Tuckahoe, N.Y. 10707. Renal Function Should Be Carefully caused by susceptible strains of the follow­ 3. Polymyxin B Sulfate Sterile, powder Determined and Patients With Renal ing organisms, when less potentially toxic for preparation of solutions (NDA 7- Damage and Nitrogen Retention drugs are ineffective or contraindicated: 570 and 8-136) and Should Have Reduced Dosage. Patients H. influenzae, specifically meningeal 4. Polymyxin B Sulfate Soluble Tab­ With Nephrotoxicity Due to Polymyxin infections. lets (NDA 8-318), marketed by Chas. B Sulfate Usually Show Albuminuria, Escherichia coli, specifically urinary tract Pfizer & Co., Inc., 235 East 42d Street, Cellular Casts and Azotemia. Dimin­ infections. ishing Urine Output and a Rising Bun Aerobacter aerogenes, specifically bac­ New York, N.Y. 10017. Are Indications for Discontinuing teremia. The Food and Drug Administration Therapy With This Drug. Klebsiella pneumoniae, specifically bac­ has concluded that polymyxin B sulfate Neurotoxic Reactions May Be Mani­ teremia. sterile powder is effective for the treat­ fested by Irritability, Weakness, Note. In Meningeal Infections, Polymyxin ment of infections of the urinary tract, Drowsiness, Ataxia, Perioral Pares­ B Sulfate Should Be Administered Only by meninges, blood stream and eye caused thesia, Numbness of the Extremities the Intrathecal Route. and Blurring of Vision. These Are by susceptible strains of Pseudomonas contraindications aeruginosa. It may also be effective in Usually Associated With High Serum Levels Found in Patients With Im­ This drug is contraindicated in persons certain serious infections caused by sus­ paired Renal Function and/or Nephro­ with a prior history of hypersensitivity reac­ ceptible strains of H. influenzae, E. coli, toxicity. The Concurrent Use of Other tions to the polymyxins. Aerobacter aerogenes and Klebsiella Nephrotoxic and Neurotoxic Drugs, pneumoniae when less potentially toxic Particularly Kanamycin, Streptomy­ PRECAUTIONS drugs are ineffective or contraindicated. cin, Polymyxin E (Colistin), Neomy­ See “W arning” box. It is also concluded that oral prepara­ cin, and Viomycin Should Be Avoided. Baseline renal function should be done tions of polymyxin B sulfate are prob­ The Neurotoxicity of Polymyxin B prior to therapy, with frequent monitoring ably effective for infections of the gas­ Sulfate Can Result in Respiratory of renal function and blood levels of the Paralysis From Neuromuscular Block­ drug during parenteral therapy. Blood levels trointestinal tract caused by Shigella ade, Especially When the Drug Is should be maintained at approximately 3-5 and for diarrhea in infants due to en- Given Soon After Anesthesia and/or mcg./ml. with proper adjustment of dosage teropathogenic E. coli. Muscle Relaxants. and interval of administration. Preparations containing polymyxin B Avoid concurrent use of a curariform sulfate are subject to the antibiotic cer­ muscle relaxant and other neurotoxic drugs tification procedures pursuant to section DESCRIPTION (ether, tubocurarine, succinylcholine, gal- 507 of the Federal Food, Drug, and Cos­ 500,000 units (equivalent of 50 mg. Poly­ lamine, decamethonium and sodium citrate) myxin B Sulfate U.S.P. reference standard) which may precipitate respiratory depression. metic Act. Requests for certification of If signs of respiratory paralysis appear, respi­ the drugs in the dosage forms described powder for preparation of solutions for in­ tramuscular, intravenous drip, intrathecal, ration should be assisted as required, and the above should provide for labeling infor­ and/or ophthalmic use. (Other descriptive drug discontinued. mation in accord with labeling guidelines information to be included by the manufac­ Concomitant use of other nephrotoxic developed on the basis of this réévalua­ turer or distributor should be confined to an drugs should be avoided or used with extreme tion of the drug and published in this appropriate description of the physical and caution. announcement. chemical properties of the drug and the As with other antibiotics, use of this drug may result in overgrowth of nonsusceptible Batches of the drug which bear label­ formulation.) actions 1 organisms, including fungi. If superinfection ing with indications evaluated as prob­ occurs, appropriate therapy should be ably effective and are otherwise in ac­ Polymyxin B sulfate is one of a group of instituted. cord with the labeling conditions herein basic polypeptide antibiotics derived from B. Usage in Pregnancy: will be accepted for release or certifica­ poly myxa (B. aerosporus) and has a bacteri­ The safety of this drug in human cidal action against almost all gram-negative pregnancy has not been established. tion by the Food and Drug Administra­ bacilli except the Proteus group. Polymyxins tion for a period of 12 months from the increase the permeability of bacterial cell, ADVERSE REACTIONS publication date of this announcement wall membranes. All gram-positive bacteria, See "Warning” box. to allow any applicant to obtain and sub­ fungi, and the gram-negative cocci, N. gon- Nephrotoxic reactions: mit data to provide substantial evidence orrhoeae and N. meningitidis, are resistant. Albuminuria. of effectiveness of the drug for use in Sensitivity plate testing: If the Kirby- Cylinduria. those conditions. Bauer method of disc sensitivity is used, a Azotemia.

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 NOTICES 13603

Rising blood levels without any Increase in No t e . Avoid total systemic and ophthalmic and Aeroibacter aerogenes, and for pre­ dosage. instillation over 2.5 mg./Kg./day. operative preparation of the intestine. Neurotoxic reactions: P o l y m y x in B S u l f a t e f o r O ra l Oral preparations of the drug with label­ Facial flushing. A dministration ing bearing these claims will no longer be acceptable for certification or release Dizziness progressing to ataxia. description Drowsiness. after the publication date of this Peripheral paresthesias-circumoral and stock­ (To be supplied by the manufacturer: This announcement. ing-glove. is to be confined to an appropriate descrip­ Apnea due to concurrent use of curariform tion of the physical and chemical properties The Food and Drug Administration muscle relaxants, other neurotoxic drugs of the drug, and the formulation.) further concludes that polymyxin B sul­ or inadvertent overdosage. fate in any of the dosage forms referred Signs of meningeal irritation with intra­ a c t io n s to above is possibly effective for other thecal administration, e.g., fever, headache, Polymyxin B sulfate is one of a group of labeled indications. Batches of the drug stiff neck and increased cell count and basic polypeptide antibiotics derived from which bear labeling with those indica­ protein in cerebrospinal fluid. B. polymyxa (B. aerosporus) and has a bac­ tions and are otherwise in accord with Other reactions occasionally reported: tericidal action against almost all gram­ the labeling conditions herein will be ac­ Drug fever. negative bacilli except the Proteus group. ceptable for release or certification by Urticarial rash. Polymyxins increase the permeability of bac­ terial cell wall membranes. All gram positive the Food and Drug Administration for a Pain (severe) at intramuscular injection period of 6 months from the publication sites. ' .r* bacteria, fungi, and the gram-negative cocci, Thrombophlebitis at intravenous injection N. gonorrhoea and N. meningitidis, are date of this announcement to allow any sites. resistant. applicant to obtain and submit data to ADMINISTRATION AND DOSAGE Sensitivity plate testing: If the Kirby- provide substantial evidence of effec­ Bauer method of disc sensitivity is used, a tiveness of the drug for use in those Intravenous. Dissolve 50 mg. polymyxin B 300 unit polymyxin B sulfate disc should give sulfate in 300-500 cc. of 5 percent dextrose a zone of over 11 mm. when tested against a conditions. in water for continuous intravenous drip. polymyxin B sensitive bacterial strain. Any person who would be adversely Adults and Children. 1.5-2.5 mg./Kg. body The drug is not absorbed in the normal affected by deletion of the claims for weight/day in individuals with normal kid­ alimentary tract; however, with partial or which oral forms of the drug lack sub­ ney function. This amount should be re­ complete intestinal obstruction or with in­ stantial evidence of effectiveness, as de­ duced from 1.5 mg./Kg. downward for in ­ flamed or ulcerated intestinal tract mucosa scribed in this announcement, may dividuals with kidney impairment. Infu­ there may be considerable absorption. sions may be given every 12 hours; however, within 30 days following the publication the total daily dose must not exceed 2.5 indications date of the announcement submit com­ mg./Kg./day. 1. Infections of the gastrointestinal tract ments or pertinent data bearing on the Infants. Infants with normal kidney func­ caused by Shigella. effectiveness of the drug for such use. tion may receive up to 4 mg./Kg./day with­ 2. Diarrhea in infants due to enteropath- To be acceptable for consideration in out adverse effects. ogenic E. coli. Intramuscular. Not recommended routinely support of the effectiveness of a drug, because of severe pain at injection sites, par­ CONTRAINDICATIONS any such data must be previously un­ ticularly in Infants and children. Dissolve This drug is contraindicated in individuals submitted, well-organized, and include 50 mg. polymyxin B sulfate in 2 cc. sterile with a history of hypersensitivity reaction to data from adequate and well-controlled distilled water (Water for Injection, U.S.P.) the polymyxins. clinical investigations (identified for or sterile physiologic saline (Sodium Chloride ready review) as described in § 130.12 Injection, U.S.P.) or 1 percent procaine PRECAUTIONS hydrochloride solution. (a) (5) of the regulations published as Adults and children. 2.5-3 mg./Kg./day. Although absorption of polymyxin B from a final order in the F ederal R egister of This should be reduced in the presence of the normal intestinal tract is negligible, May 8, 1970 (35 F.R. 7250). Carefully renal impairment. The dosage may be divided under certain circumstances of bowel dis­ conducted and documented clinical stud­ and given at either 4- or 6-hour intervals. ease or obstruction the absorption may be ies obtained under uncontrolled or par­ Infants. Infants with normal kidney func­ considerable. This factor should be taken tially controlled situations are not ac­ tion may receive up to 4 mg./Kg./day without into consideration in individuals with known or suspected kidney disease and decreased ceptable as a sole basis for the approval adverse effects. of claims of effectiveness, but such stud­ Note. Doses as high as 4.5 mg./Kg./day kidney function to avoid nephrotoxic and have been used in limited clinical studies in neurotoxic reactions. If symptoms of these ies may be considered on their merits treating prematures and newborn infants reactions occur the drug should be discon­ for corroborative support of efficacy and for Pseudomonas sepsis. tinued. As with other antibiotics, use of this evidence of safety. Intrathecal—A treatment of choice for Ps. drug may result in overgrowth of non- Representatives of the Administration aeruginosa meningitis. Dissolve 50 mg. poly­ susceptible organisms, including fungi. If superinfection occurs, appropriate therapy are willing to meet with any interested myxin B sulfate in 10 cc. of sterile physiologic person who desires to have a conference saline (Sodium Chloride Injection, U.S.P.) should be instituted. for 5 mg. per ml. dosage unit. Usage in Pregnancy: concerning proposed changes in the la­ Adults and children over 2 years of age. The safety of this drug in human preg­ beling set forth in this announcement. Dosage is 5 mg. once daily intrathecally for nancy has not been established. Requests for such meetings should be 3-4 days, then 5 mg. once every other day for ADVERSE REACTIONS made to the Division of Anti-Infective at least 2 weeks after cultures of the cere­ Drugs (BD-140), at the address given brospinal fluid are negative and sugar con­ Adverse reactions to oral polymyxin B are not usually encountered except under below, within 30 days after publication tent has returned to normal. of this notice in the F ederal R egister. Children under 2 years of age. 2 mg. once circumstances where there is considerable daily, intrathecally for 3-4 days or 2.5 mg. absorption through diseased intestine and A copy of the NAS-NRC report has once every other day. Continue with a dose in the presence of diminished kidney func­ been furnished to each firm referred to of 2.5 mg. once every other day for at least tion. When this occurs, nephrotoxic and above. Any other interested person may 2 weeks after cultures of the cerebrospinal neurotoxic symptoms may occur. obtain a copy by request to the appro­ fluid are negative and sugar content has re­ DOSAGE AND ADMINISTRATION priate office named below. turned to normal. Ophthalmic. Dissolve 50 mg. polymyxin B Infants and children up to 2 years of Communications forwarded in re­ sulfate in 20-50 cc. sterile distilled water age : 25-50 mg. t.i.d. sponse to this announcement should be (Water for Injection, U.S.P.) or sterile physi­ Children ages 2-5 years: 50-75 mg. t.i.d. identified with the reference number ologic saline (Sodium Chloride Injection, Older children and adults: 75-100 mg. DESI 7501 and be directed to the at­ U.S.P.) for a 1-2.5 mg. per cc. concentration. q.i.d. tention of the following appropriate of­ For the treatment of Ps. aeruginosa infec­ tions of the eye, a concentration of 0.1 per­ The Food and Drug Administration re­ fice and addressed (unless otherwise cent to 0.25 percent (1 mg. to 2.5 mg. per gards oral forms of polymyxin B sulfate specified) to the Food and Drug Admin­ cc.) is administered 1-3 drops every hour, in­ as lacking substantial evidence of effec­ istration, 5600 Fishers Lane, Rockville, creasing the intervals as response indicates. tiveness for their claimed indications: in Md. 20852: Subconjunctival injection of up to 10 mg./ the treatment of infections of the gastro­ day m a y be used for the treatment of Ps. Amendments (Identify with NDA number): aeruginosa infections of the cornea and intestinal tract caused by Pseudomonas Division of Anti-Infective Drugs (BD- conjunctiva. aeruginosa, Proteus species, Salmonella 140) , Office of New Drugs, Bureau of Drugs.

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 No. 166----- 6 13604 NOTICES All other communications regarding this whether there is substantial evidence of announcement : Special Assistant for Drug 3. Triburon Ointment (NDA 11-675) ; Efficacy Study Im plementation (BD-201), effectiveness for such uses. After that both containing triclobisonium chloride Bureau of Drugs. evaluation, the conclusions concerning and marketed by Roche Laboratories, Requests for NAS-NRC Report: Press Rela­ the drug will be published in the F ederal Division of Hoffmann-La Roche, Inc.*, tions Staff (CE-200), Pood and Drug R egister. If no studies have been under­ 340 Kingsland Avenue, Nutley, N j ’ Administration, 200 C Street SW., Wash­ taken or if the studies do not provide 07110. ington, D.C. 20204. substantial evidence of effectiveness, pro­ These drugs are regarded as new This notice is issued pursuant to pro­ cedures will be initiated to withdraw drugs. The effectiveness classification visions of the Federal Food, Drug, and approval of the new-drug applications and marketing status are described Cosmetic Act (secs, 502, 507, 52 Stat. for such drug, pursuant to the provisions below. 1050-51, as amended, 59 Stat. 463, as of section 505(e) of the Federal Food, A. Effectiveness classification. The amended; 21 U.S.C. 352, 357) and under Drug, and Cosmetic Act. Withdrawal of Food and Drug Administration has authority delegated to the Commissioner approval of the applications will cause considered the Academy reports as well of Food and Drugs (21 CFR 2.120). any such drugs on the market to be new as other available evidence, and con­ drugs for which an approval is not in cludes that: Dated; August 5, 1970. effect. 1. Chlorquinaldol is possibly effective Sam D. F ine, The above-named holder of the new- drug application for this drjig has been for its recommended uses, i.e., the treat­ Associate Commissioner ment of athlete’s foot, folliculitis, furun­ for Compliance. mailed a copy of the NAS-NRC reports. Any interested person may obtain a copy culosis (to minimize spread of infec­ [P.R. Doc. 70-11255; Piled, Aug. 25, 1970; of the reports by writing to the office tion), impetigo contagiosa, infected 8:49 am .] dermatitides, infected seborrhea, pyo­ named below. derma, and sycosis barbae. Communications forwarded in re­ i [DESI 8021] sponse to this announcement should be 2. Triclobisonium chloride is possibly identified with the reference number effective for its recommended uses, i.e., CERTAIN DRUGS CONTAINING DESI 8021 and be directed to the atten­ the treatment of primary pyodermas and MEPARFYNOL secondarily infected dermatoses; for the tion of the following appropriate office control of infections in bums and surgi­ Drugs for Human Use; Drug Efficacy and addressed (unless otherwise speci­ fied) to the Food and Drug Administra­ cal and traumatic wounds; and in pre­ Study Implementation tion, 5600 Fishers Lane, Rockville, Md. venting infection in skin grafting. The Food and Drug Administration 20852: B. Marketing status. 1. Holders of has evaluated the reports of the Na­ previously approved new-drug applica­ Supplements (identify with NDA number) ; such tional Academy of Sciences-National Office of Marketed Drugs (BD-200), Bu­ tions and any person marketing any Research Council, Drug Efficacy Study reau of Drugs. drug without approval will be allowed Group, on Dormison Capsules contain­ Original new-drug applications: Office of New 6 months from the date of publication ing meparfynol, marketed by Schering Drugs (BD—100), Bureau of Drugs. of this announcement in the F ederal Corp., 1011 Morris Avenue, Union, N.J. All other communications regarding this an­ R egister to obtain and to submit in a 07083 (NDA’s 8-021 and 8-895). nouncement: Special Assistant for Drug supplemental or original new-drug appli­ This drug is regarded as a new drug. Efficacy Study Im plementation (BD-201), cation data to provide substantial evi­ Bureau of Drugs. dence of effectiveness for those indica­ The effectiveness classification and mar­ Requests for NAS-NRC Reports: Press Rela­ keting status are described below. tions Staff (CE-200), Pood and Drug Ad­ tions for which these drugs have been A. Effectiveness classification. The m inistration, 200 C Street SW., Washing­ classified as possibly effective. To be ac­ Food and Drug Administration has con­ ton, D.C.20204. ceptable for. consideration in support of the effectiveness of a drug, any such sidered the Academy reports and con­ This notice is issued pursuant to pro­ cludes that meparfynol is possibly effec­ data must be previously unsubmitted, visions of the Federal Food, Drug, and well-organized, and include data from tive for its labeled indications as a Cosmetic Act (secs. 502, 505, 52 Stat. sedative-hypnotic agents adequate and well-controlled clinical 1050-53, as amended; 21 U.S.C. 352, 355) investigations (identified for ready re­ B. Marketing status. 1. Holders of and under authority delegated to the view) as described in § 130.12(a) (5) of previously approved new-drug applica­ Commissioner of Food and Drugs (21 the regulations published as a final order tions and any person marketing any such CFR 2.120). drug without approval will be allowed 6 in the F ederal R egister of May 8, 1970 Dated: July 24,1970. (35 FR . 7250). Carefully conducted and months from the date of publication of documented clinical studies obtained this announcement in the F ederal R eg­ Sam D. F ine, under uncontrolled or partially con­ ister to obtain and to submit in a sup­ Associate Commissioner trolled situations are not acceptable as a plemental or original new-drug applica­ for Compliance. sole basis for the approval of claims of tion data to provide substantial evidence [P.R. Doc. 70-11256; Filed, Aug. 25, 1970; effectiveness, but such studies may be of effectiveness for those indications for 8:49 a.m.] considered on their merits for corrobo­ which this drug has been classified as rative support of efficacy and evidence possibly effective. To be acceptable for consideration in support of the effective­ [DESI 8836] of safety. ness of a drug, any such data must be 2. At the end of the 6-month period, previously unsubmitted, well-organized, CERTAIN TOPICAL ANTI-INFECTIVE any such data will be evaluated to deter­ and include data from adequate and DRUGS mine whether there is substantial evi­ well-controlled clinical investigations dence of effectiveness for such uses. After Drugs for Human Use; Drug Efficacy that evaluation, the conclusions concern­ (identified for ready review) as - de­ Study Implementation scribed in § 130.12(a) (5) of the regula­ ing the drugs will be published in the tions published as a final order in the The Food and Drug Administration F ederal R egister. If no studies have been undertaken or if the studies do not F ederal R egister of May 8, 1970 (35 F R . has evaluated reports received from the 7250). Carefully conducted and docu­ National Academy of Sciences-National provide substantial evidence of effective­ mented clinical studies obtained under Research Council, Drug Efficacy Study ness, procedures will be in itiated to uncontrolled or partially controlled situ­ Group, on the following anti-infective withdraw approval of the new-drug ap­ ations are not acceptable as a sole basis drugs for topical use. plications for such drugs, pursuant to the provisions of section 505(e) of the for the approval of claims of effective­ 1. Sterosan Cream and Ointment; Federal Food, Drug, and Cosmetic Act. ness, but such studies may be considered containing chlorquinaldoL marketed by on their merits for corroborative support Geigy Chemical Corp., Ardsley, N.Y. Withdrawal of approval of the applica­ of efficacy and evidence of safety. 10502 (NDA &-836). tions will cause any such drugs on the 2. At the end of the 6-month period, 2. Triburon Cream (NDA 11-925); market to be new drugs for which an such data will be evaluated to determine and approval is not in effect.

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 NOTICES 13605

The above-named holders of the new- The drugs are regarded as new drugs tions referenced in paragraph D may drug applications for these drugs have (21 U.S.C. 321 (p)). Supplemental new continue to be used as described therein. drug applications are required to revise F. Previously approved applications. been mailed a copy of the NAS-NRC 1. Each holder of a “deemed approved” report. Any interested person may obtain the labeling in and to update previously approved applications providing for such new drug application (i.e., an application a copy of these reports by writing to the which became effective on the basis of office named below. drugs. A new drug application is re­ Communications forwarded in re­ quired from any person marketing such safety prior to Oct. 10, 1962) for such sponse to this announcement should be drugs without approval. drug is requested to seek approval of the identified with the reference number The Food and Drug Administration is claims of effectiveness and bring the ap­ DESI 8836 and directed to the attention prepared to approve new drug applica­ plication into conformance by submitting of the following appropriate office and tions and supplements to previously ap­ supplements containing: addressed (unless otherwise specified) proved new drug applications under con­ a. Revised labeling as needed to con­ ditions described in this announcement. form to the labeling conditions described to the Food and Drug Administration, herein for the drug, and complete cur­ 5600 Fishers Lane, Rockville, Md. 20852: A. Effectiveness classification. The Food and Drug Administration has con­ rent container labeling, unless recently Supplements -(identify with NDA number) : sidered the Academy reports, as well submitted. Office of Marketed Drugs (BD-200), Bureau b. Updating information as needed to of Drugs. as other available evidence on ophthal­ Original new-drug applications : Office of mic preparations of hydrocortisone and make the application current in regard to New Drugs (BD-100), Bureau of Drugs. hydrocortisone acetate, and concludes items 6 (components), 7 (composition), ah other communications regarding this that these drugs : and 8 (methods, facilities, and controls) announcement: Special Assistant for Drug of the new drug application form FD- Efficacy Study Implementation (BD-201), 1. Are effective for the indications 356H to the extent described for abbrevi­ Bureau of Drugs. listed in the “Indications” section of this ated new drug applications, § 130.4(f), Requests for NAS-NRC Reports: Press Rela­ announcement. published in the F ederal R egister April tions Office (CE—200), Pood and Drug Ad­ 2. Are possibly effective for their 24, 1970 (35 F.R. 6574). (One supplement ministration, 200 C Street SW., Washing­ recommended uses in the treatment may contain all the information de­ ton, D.C. 20204. of afflictions of the uveal tract, includ­ scribed in this paragraph.) This notice is issued pursuant te pro­ ing chorioretinitis due to Boeck’s 2. Such supplements should be sub­ visions of the Federal Food, Drug, and sarcoid, syphilis, toxdplasmosis, non­ mitted within the following periods after Cosmetic Act (secs. 502, 505, 52 Stat. specific chorioretinitis; and for non- the date of publication of this notice in 1050-53, as amended; 21 U.S.C. 352, 355) purulent blepharitis. the F ederal R egister: and under authority delegated to the 3. Lack substantial evidence of effec­ a. 60 days for revised labeling—the Commissioner of Food and Drugs (21 tiveness for use in the treatment of supplement should be submitted under CFR 2.120). spastic entropion. the provisions of § 130.9 (d) and (e) of Dated: July 24,1970. B. Form of drug. These preparations the new drug regulations (21 CFR 130.9) are in suspension, solution, or oint­ which permit certain changes to be put S am D. F in e , ment form suitable for ophthalmic into effect at the earliest possible time. Associate Commissioner administration. b. 60 days for updating information. for Compliançe. C. Labeling conditions. 1. The label c. Marketing of the drug may continue (P.R. Doc. 70-11257; Piled, Aug. 25, 1970; bears the statement "Caution: Fed­ until the supplemental applications sub­ 8:49 a.m.] eral law prohibits dispensing without mitted in accord with the preceding sub- prescription.” The label of liquid prepa­ paragraphs 1 and 2 are acted upon: Provided, That within 60 days after the [DESI 9130] rations indicates that the product is sterile. The label of ointments contains date of this publication, the labeling of [Docket No. FDC-D-221; NDA 9-130 etc.] a statement that the product is or is not the preparation shipped within the juris­ sterile. diction of the Act is in accord with the CERTAIN HYDROCORTISONE OR labeling conditions described in this an­ HYDROCORTISONE ACETATE OPH­ 2. The drug is labeled to comply with nouncement. (It may continue to include THALMIC DRUGS all requirements of the Act and regula­ tions. Its labeling bears adequate direc­ the indications referenced in paragraph Drugs for Human Use; Drug Efficacy tions for safe and effective use of the D for the period stated.) G. New applications.!. Any other per­ Study Implementation drug and is in accord with the guidelines son who distributes or intends to distrib­ for uniform labeling published in the ute such drug which is intended for the The Food and Drug Administration F ederal R egister of February 6, 1970. has evaluated reports received from the The “Indications” section is as follows: conditions of use for which it has been National Academy of Sciences-National shown to be effective, as described under Research Council, Drug Efficacy Study I n d ic a t io n s A above, should submit an abbreviated Group, on the following ophthalmic Inflammation of the palpebral and bulbar new drug application meeting the condi­ drugs for topical use: conjunctiva, cornea, and anterior segment of tions specified in § 130.4(f) (1) and (2) 1. Hydrin-2, ophthalmic suspension th e globe. published in the F ederal R egister of containing 2 percent hydrocortisone ace­ D. Indications permitted during ex­ April 24, 1970 (35 F.R.' 6574). Such ap­ tate, marketed by Broemmel Pharma­ plications should include proposed label­ tended period for obtaining substantial ing which is in accord with the labeling ceuticals, 1235 Sutter Street, San Fran­ evidence. Those indications for which the cisco, Calif. 94109 (NDA 1(5-231). drug is described in paragraph A above conditions described herein. 2. Optef Drops, eye drops containing as possibly effective (not included in the 2. Distribution of any such prepara­ 0.2 percent hydrocortisone, marketed by labeling conditions in paragraph C) may tion currently on the market without The Upjohn Co., 7171 Portage Road, continue to be used for 6 months fol­ an approved new drug application may Kalamazoo, Mich. 49002 (NDA 10-645). lowing the date of this publication to al­ be continued provided that: 3. Cortril, ophthalmic ointment con­ low additional time within which holders a. Within 60 days from the date of taining 0.5 percent or 2.5 percent hydro­ of previously approved applications or publication of this announcement in the cortisone acetate, marketed by Charles persons marketing the drug without ap­ F ederal R egister, the labeling of such Pfizer and Co., Inc., 235 East 42d Street, proval may obtain and submit to the preparation shipped within the jurisdic­ New York, N.Y. 10017 (NDA 9-130). Food and Drug Administration data to tion of the Act is in accord with the 4. Isopto, eye drops containing 0.5 provide substantial evidence of effective­ labeling conditions described herein. (It or 2.5 percent hydrocortisone ness. may continue to include the indication with 0.5 percent hydroxypropyl methyl- E. Marketing status. Marketing of the referenced in paragraph D for the period cellulose, marketed by Alcon Labora- drugs may continue under the conditions stated.) K)nes, Inc., 6201 South Freeway, Fort described in paragraphs F and G of this b. The manufacturer, packer, or dis­ Worth, Tex. 76134 (NDA 9-825). announcement except that those indica­ tributor of such drug submits, within 60

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 13606 NOTICES days from the date of this publication, 1. Unapproved use or form of drug. of erythromycin thiocyanate; by Abbott a new drug application to the Food and 1. If the article is labeled or advertised Laboratories, 14th and Sheridan Road Drug Administration. for use in any condition other than those North Chicago, HI. 60064. c. The applicant submits, within a rea­ provided for in this announcement, it The Academy evaluated this product sonable time, additional information that may be regarded as an unapproved new as probably effective for use as an aid in may be required for the approval of the drug subject to regulatory proceedings the management of diseases of chickens application as specified in a written com­ until such recommended use is approved and turkeys when such diseases are munication from the Food and Drug in a new drug application or is otherwise caused by pathogens sensitive to erythro­ Administration. in accord with this announcement. mycin thiocyanate. The Academy stated: d. The application has not been ruled 2. If the article is proposed for market­ 1. Documentation is needed to support incomplete or unapprovable. ing in another form or for a use other the systemic effect and claimed thera­ than the use provided for in this an­ peutic efficacy of the recommended H. Opportunity for a hearing. 1. Thenouncement, appropriate additional in­ dosages. Commissioner of Food and Drugs pro­ formation as described in § 130.4 or 2. The label should warn that treated poses to issue an order under the provi­ § 130.9 of the regulations (21 CFR 130.4, animals must actually consume enough sions of section 505(e) of the Federal 130.9) may be required, including results medicated water to provide a therapeu­ Food, Drug, and Cosmetic Act withdraw­ of animal and clinical tests intended to tic dose under the conditions that prevail ing approval of all new-drug applications show whether the drug is safe and and as a precaution the label should state and all amendments and supplements effective. the desired oral dose per unit of animal thereto providing for the indications for A copy of the NAS-NRC report has weight per day for each specie as a guide which substantial evidence of effective­ been furnished to each firm referred to to effective use of the preparation in ness is lacking as described in paragraph above. Any other interested person may drinking water. A3 of this announcement. An order with­ obtain a copy by request to the appro­ 3. Each disease claim should be prop­ drawing approval of the application will priate office named below. <• erly qualified as “appropriate for use in not issue if such applications are supple­ Communications forwarded in re-, (name of disease) caused by pathogens mented, in accord with this notice, to sponse to this announcement should be sensitive to (name of drug),” and if the delete such indications. Promulgation of identified with the reference number disease claim cannot be so qualified the the proposed order would cause any drug DESI 9130 and be directed to the atten­ claim must be dropped. for human use containing the same com­ tion of the following appropriate office 4. Claim made regarding “for preven­ ponents and offered for the indications and addressed (unless otherwise speci­ tion of” or “to prevent” should be re­ for which substantial evidence of effec­ fied) to the Food and Drug Administra­ placed with “as an aid in the control of” tiveness is lacking to be a new drug for tion, 5600 Fishers Lane, Rockville, Md. or “to aid in the control of”. which an approved new-drug application 20852: The Food and Drug Administration is not in effect. Any such drug then on the concurs with the Academy’s findings. market would be subject to regulatory Supplements (identify with NPA number): Office of Marketed Drugs (BD-200), Bureau This evaluation is concerned only with proceedings. of Drugs. the drug’s effectiveness and safety to the 2. In accordance with the provisions Original abbreviated new drug applications animal to which administered. It does of section 505 of the Act (21 U.S.C. 355) (identify as such): Office of Marketed not take into account the safety for food and the regulations promulgated there­ Drugs (BD-200), Bureau of Drugs. use of food derived from drug-treated under (21 CFR Part 130), the Commis­ Request for Hearing (Identify with Docket animals. Nothing herein will constitute a sioner will give the holders of any such num ber): Hearing Clerk, Office of General Counsel (GC-1), Room 6-62, Parklawn. bar to further proceedings with respect applications, and any interested person All other communications regarding this an­ to questions of safety of the drug or its who would be adversely affected by such nouncement: Special Assistant for Drug metabolites as residues in food products an order, an opportunity for a hearing Efficacy Study Implementation (BD-201), derived from treated animals. to show why such indications should Bureau of Drugs. This announcement is published (I) not be deleted from labeling. A request Requests for NAS-NRC report: Press Rela­ to inform the holders of new animal for a hearing must be filed within 30 days tions Staff (CE-200), Pood and Drug Ad­ drug applications of the findings of the after the date of publication of this notice ministration, 200 C Street SW., Washing­ Academy and the Food and Drug Ad­ in the F ederal R egister. A request for ton, D.C. 20204. ministration and (2) to inform all in­ a hearing may not rest upon mere alle­ This notice is issued pursuant to pro­ terested persons that such articles to be gations or denials but must set forth visions of the Federal Food, Drug, and marketed must be the subject of ap­ specific facts showing that there is a Cosmetic Act ^ (secs. 502, 505, 52 Stat. proved new animal drug applications and genuine and substantial issue of fact that 1050-53, as amended; 21 U.S.C. 352, 355) otherwise comply with all other require­ requires a hearing, together with a well- and under authority delegated to the ments of the Federal Food, Drug, and organized and full-factual analysis of the Commissioner of Food and Drugs (21 Cosmetic Act. clinical and other investigational data CFR 2.120). Holders of new animal drug applica­ the objector is prepared to prove in a Dated: >uly 28,1970. tions are provided 6 months from the hearing. Any data submitted in response, date of publication hereof in the Fed­ to this notice must be previously unsub­ S am D. F ine, eral R egister to submit adequate docu­ mitted and include data from adequate Associate Commissioner mentation in support of the labeling and well-controlled clinical investiga­ for Compliance. Used. tions (identified for ready review) as [F.R. Doc. 70-11258; Piled, £ug. 25, 1970; Each holder of a new animal drug ap­ described in § 130.12(a) (5) of the regu­ 8:49 a.m.] plication which became effective prior to lations published in the F ederal R egister October 10, 1962, is requested to submit of May 8, 1970 (35 F.R. 7250). Carefully updating information as needed to make conducted and documented clinical [DESI 10092V] the application current with regard to studies obtained under uncontrolled or manufacture of the drug, including in­ partially controlled situations are not DRUG PRODUCT CONTAINING formation on drug components and com­ acceptable as a sole basis for approval ERYTHROMYCIN THIOCYANATE position, and also including information of claims of effectiveness, but such studies Drugs for Veterinary Use; Drug Efficacy regarding manufacturing methods, fa­ may be considered on their merits for cilities, and controls, in accordance with corroborative support of efficacy and evi­ Study Implementation the requirements of section 512 of the dence of safety. If a hearing is requested The Food and Drug Administration has act. and is justified by the response to this evaluated a report received from the Na­ Written comments regarding this an­ notice,‘-the issues will be defined, a hear­ tional Academy of Sciences-National Re­ nouncement, including requests for an ing examiner will be named, and he shall search Council, Drug Efficacy Study informal conference, may be addressed issue a written notice of the time and Group, on the following preparation: to the Bureau of Veterinary Medicine, place at which the hearing will Gallimycin; each pound of this water Food and Drug Administration, 5600 commence. soluble poultry product contains 25 grams Fishers Lane, Rockville, Md. 20852.

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 NOTICES 13607

The holder of the new animal drug cal investigations (identified for ready The drug is regarded as a new drug. application for the listed drug has been review) as described in § 130.12(a) (5) of The effectiveness classification and mar­ mailed a copy of the NAS-NRC report. the regulations published as a final order keting status are described below. Any other interested person may obtain in the F ederal R egister of May 8, 1970 A. Effectiveness classification. The a copy by writing to the Pood and Drug (35 F.R. 7250). Carefully conducted and Food and Drug Administration has con­ Administration, Press Relations Staff, documented clinical studies obtained sidered the Academy report and other 200 C Street SW., Washington, D.C. under uncontrolled or partially controlled available evidence and concludes that 20204. situations are not acceptable as a sole oxymorphone hydrochloride in supposi­ This notice is issued pursuant to pro­ basis for the approval of claims of effec­ tory form is possibly effective for the visions of the Federal Pood, Drug, and tiveness, but such studies may be con­ relief of moderate to severe pain. Cosmetic Act (secs. 502, 512, 52 Stat. sidered on their merits for corroborative B. Marketing status. 1. Holders of pre­ 1050-51, 82 Stat. 343-51; 21 U.S.C. 352, support of efficacy and evidence of safety. viously approved new drug applications 360b) and under authority delegated to This announcement of the proposed and any person marketing any such drug the Commissioner of Pood and Drugs action implementation of the NAS-NRC without approval will be allowed* .6 (21 CFR 2.120). reports for these drugs is made to give months from the date of publication of Dated: August 18,1970. notice to persons who might be adversely this announcement in the F ederal R eg­ affected by their withdrawal from the ister to obtain and to submit in a S am D. F in e , market. Promulgation of an order with­ supplemental or original new drug ap­ Associate Commissioner drawing approval of the new-drug appli­ plication data to provide substantial evi­ for Compliance. cations will cause any such drug on the dence of effectiveness for the indication [F.R. Doc. 70-11259; Filed, Aug. 25, 1970; market to be a new drug for which an for which this drug has been classified as 8:49 a.m.] approved new-drug application is not in possibly effective. To be acceptable for effect and will make it subject to regula­ consideration in support of the effective­ tory action. ness of a drug, any such data must be [DESI 10971] The above-named holders of the new- previously unsubmitted, well-organized, CONJUGATED ESTROGENS WITH drug applications for these drugs have and include data from adequate and MEPROBAMATE been mailed a copy of the NAS-NRC re­ well-controlled clinical investigations port. Any interested person may obtain (identified for ready review) as described Drugs for Human Use; Drug Efficacy a copy of the report by writing to the in § 130.12(a) (5) of the regulations pub­ Study Implementation appropriate office named below. lished as a final order in the F ederal Communications forwarded in re­ R egister of May 8, 1970 (35 F.R. 7250). The Pood and Drug Administration has sponse to this announcement should be Carefully conducted and documented evaluated two reports received from the identified with the reference number clinieal studies obtained under uncon­ National Academy of Sciences-National DESI 10971 and be directed to the atten­ trolled or partially controlled situations Research Council, Drug Efficacy Study tion of the following appropriate office: are not acceptable'as a sole basis for the Group, on the following drugs containing approval of claims of effectiveness, but conjugated estrogens with meprobamate: Requests for NAS—NRO report: Food and such studies may be considered on their PMB-200 and PMB-400 tablets, mar­ Drug Administration, Press Relations Of­ fice (CE—200), 200 O Street SW., Washing­ merits for corroborative support of effi­ keted by Ayerst Laboratories, Division of ton, D.C. 20204. cacy and evidence of safety. American Home Products Corporation, All other communications regarding this an­ 2. At the end of the 6-month period, 685 Third Avenue, New York, N.Y. 10017 nouncement: Special Assistant for Drug any such data will be evaluated to deter­ (NDA 10-971). Efficacy Study Im plem entation (BD-201), mine whether there is substantial evi­ Milprem-200 and Milprem-400 tablets, Bureau of Drugs, Food and Drug Ad­ dence of effectiveness for such uses. After' marketed by Wallace Laboratories, Divi­ ministration, 5600 Fishers Lane, Rockville, that evaluation, the conclusions concern­ sion of Carter-Wallace, Inc., Half Acre Md. 20852. ing the drug will be published in the Road, Cranbury, N.J. 08512 (NDA This notice is issued pursuant to pro­ F ederal R egister. If no studies have been 11-045). visions of the Federal Food, Drug, and undertaken or if the studies do not pro­ The Pood and Drug Administration has Cosmetic Act (secs. 592, 505, 52 Stat. vide substantial evidence of effectiveness, considered the Academy reports, as well 1050-53, as amended; 21 U.S.C. 352, 355) procedures will be initiated to withdraw as other available evidence, and con­ under authority delegated to the Com­ approval of the new drug applications cludes there is a lack of substantial evi­ missioner of Food and Drugs (21 CFR for such drug, pursuant to the provisions dence, within the meaning of the Federal 2 .120). of section 505(e) of the Federal Food, Pood, Drug, and Cosmetic Act, that such Dated: July 30, 1970. Drug, and Cosmetic Act. Withdrawal of fixed combination drug will have the approval of the applications will cause effect it purports or is represented to have V S am D. F ine:, any such drug on the market to be a new under the conditions of use prescribed, Associate Commissioner drug for which an approval is not in recommended, or suggested in the label­ for Compliance. effect. ing and that each component of the [F.R. Doc. 70-11260; Filed, Aug. 25, 1970; The above-named holder of the new- combination drug contributes to the total 8:49 ajn.] effects claimed for such drug. drug application for this drug has been Accordingly, the Commissioner of Pood mailed a copy of the NAS-NRC report. [DESI 11738] Any interested person may obtain a copy and Drugs intends to initiate proceedings of the report by writing to the office to withdraw approval of the above-listed OXYMORPHONE HYDROCHLORIDE new-drug applications. named below. Prior to initiating such action, how­ RECTAL SUPPOSITORIES Communications forwarded in re­ sponses to this announcement should be ever, the Commissioner invites the Drugs for Human Use; Drug Efficacy holders of the new-drug applications for identified with the reference number these drugs and any interested person Study Implementation DESI 11738 and be directed to the atten­ who might be adversely affected by their The Food and Drug Administration has tion of the following appropriate office removal from the market, to submit evaluated a report received from the Na­ and addressed (unless otherwise speci­ Pertinent data bearing on the proposal tional Academy of Sciences-National Re­ fied) to the Food and Drug Administra­ J^thin 30 days after publication hereof search Council, Drug Efficacy Study tion, 5600 Fishers Lane, Rockville, Md. in the F ederal R egister. Group, on the following drug: 20852: To be acceptable for consideration in Numorphan Hydrochloride Rectal Supplements (Identify with NDA number): support of the effectiveness of a drug, any Suppositories; containing oxymorphone Office of Marketed Drugs (BD-200), Bureau such data must be previously unsub- hydrochloride; marketed by Endo Lab­ of Drugs. uutted, well-organized, and include data oratories Inc., 1000 Stewart Avenue, Original new-drug applications: Office of New irom adequate and well-controlled clini­ Garden City, N.Y. 11533 (NDA 11-738). Drugs (BD—100), Bureau of Drugs.

FEDERAL REGISTER, VOL. 35, NO. Ì 66— WEDNESDAY, AUGUST 26, 1970 13608 NOTICES All other communications regarding this depression; endogenous depression is in the labeling conditions in section IV announcement: Special Assistant for Drug more likely to be alleviated than are above) may continue to be used for 6 Efficacy Study Im plem entation (BD-201), Bureau of Drugs. other depressive states. months following publication hereof in Requests for NAS-NRC Reports: Press Rela­ 2. This drug is regarded as possibly the F ederal R egister to allow additional tions Staff (CE-200), Pood and Drug Ad­ effective for the following labeled indi­ time for holders of previously approved ministration, 200 C Street SW., Washing­ cations : Amitriptyline hydrochloride has applications, or persons'marketing the ton, D.C. 20204. a tranquilizing component to its action drug without approval, to obtain and This notice is issued pursuant to pro­ which is particularly helpful in alleviat­ submit to the Pood and Drug Adminis­ visions of the Federal Food, Drug, and ing the anxiety that often accompanies tration data providing substantial evi­ Cosmetic Act (secs. 502, 505, 52 Sfcat. depression; amitriptyline hydrochloride dence of effectiveness. To be acceptable 1050-53, as amended; 21 U.S.C. 352, 355) is indicated in Schizo-Affective Depress for consideration in support of the ef­ and under authority delegated to the sions; and, when the injection of ami­ fectiveness of a drug, any such data Commissioner of Food and Drugs (21 triptyline hydrochloride is administered must be previously unsubmitted, well- CFR 2.120). intramuscularly, patients may show organized, and include data from ade- rapid, marked reaction, with reduction quate and well-controlled clinical inves­ Dated: July 23,1970. of anxiety and agitation prior to the tigations (identified for ready review) as S am D. F in e , elevation of mood. described in § 130.12(a) (5) of the regu­ Associate Commissioner 3. This drug lacks substantial evi­ lations published as a final order in the for Compliance. dence of effectiveness for its indication F ederal R egister of May 8, 1970 (35 for relief of headache. F.R. 7250). Carefully conducted and [P.R. Doc. 70-11261; Filed, Aug. 25, 1970; II. Imipramine hydrochloride—A. Ef­ documented clinical studies obtained 8:50 a.m.] fectiveness classification. The Food and under uncontrolled or partially con­ Drug Administration has considered the trolled situations are not acceptable as a [DESI 11836] * reports of the Academy, as well as other sole basis for the approval of claims of [Docket No. FDC-D-219; NDA 11-836, etc,] available evidence, and concludes that: effectiveness, but such studies may be 1. Imipramine hydrochloride is effec­ considered on their merits for corrobora­ ANTIDEPRESSANT DRUGS: AMITRIP­ tive for the relief of symptoms of de­ tive support of efficacy and evidence of TYLINE HYDROCHLORIDE, IMIPRA- pression; endogenous depression is more safety. MINE HYDROCHLORIDE likely to be alleviated than are other VH. Previously approved applications. depressive states. A. Each holder of a “deemed approved” Drugs for Human Use; Drug Efficacy 2. The drug is regarded as possibly ef­ new drug application (i.e., an applica­ Study Implementation fective for the following labeled indica­ tion which became effective on the basis tions: For senile depression and depres­ of safety prior to October 10, 1962) for The Food and Drug Administration sion associated with organic lesions such drugs is requested to seek approval has evaluated reports received from the (cerebral arteriosclerosis, parkinson­ of the claims of effectiveness and bring National Academy of Sciences-National ism) ; and for the depression associated the application into conformance by sub­ Research Council, Drug Efficacy Study with other psychiatric disorders (schizo­ mitting supplements containing: Group, on the following antidepressant phrenia, alcoholism, mental deficiency). 1. Revised labeling as needed to con­ drugs. 3. There is a lack of substantial evi­ form with the labeling conditions de­ 1. Injection Elavil H d, containing 10 dence of effectiveness of the drug for the scribed herein for the drug, and complete milligrams amitriptyline hydrochloride indication enuresis. current container labeling unless per milliliter (NDA 12-704), and m . Form of drug. Amitriptyline hy­ recently submitted. 2. Elavil HC1 Film Coated Tablets, drochloride and imipramine hydrochlo­ 2. Adequate data to assure the biologic containing 10 milligrams, 25 milligrams ride preparations are in tablet form availability of the drug in the formula­ or 50 milligrams amitriptyline hydro­ suitable for oral use or in solution form tion which is marketed; if such data are chloride per tablet (NDA 12-703); mar­ suitable for intramuscular injection. already included in the application, keted by Merck Sharp and Dohme, Di­ IV. Labeling conditions. 1. The labels specific reference thereto may be made. vision of Merck and Co., Inc., West Point, bear the statement “Caution: Federal 3. Updating information as needed to Pa. 19486. law prohibits dispensing without pre­ make the application current. 3. Tofranil Ampuls containing 25 milli­ scription.” B. Such supplements should be sub­ grams imipramine hydrochloride per 2 2. The drugs are labeled to comply mitted within the following time periods milliliters (NDA 11-838), and with all requirements of the Act and 4. Tofranil Tablets, containing 10 after the date of publication of this an­ regulations. Their labeling bears ade­ nouncement in the F ederal R egister, milligrams or 25 milligrams imipramine quate information for safe and effective 1. 60 days for revised labeling—the hydrochloride per tablet (NDA 11-836); use of the drugs and is in accord with supplements should be submitted under marketed by Geigy Pharmaceuticals Di­ the guidelines for uniform labeling pub­ the provisions of § 130.9 (d) and (e) of vision of Geigy Chemical Corp., Saw Mill lished in the F ederal R egister of Feb­ the new drug regulations (21 CFR 130.9) Road, Ardsley, N.Y. 10502. ruary 6, 1970. The “Indications” sections which permit certain changes to be put The drugs are regarded as new drugs are as follows: into effect at the earliest possible time. (21 U.S.C. 321(p)). Supplemental new Labeling guidelines for the drugs are 2. 180 days for biologic availability drug applications are required to revise available from the Administration on the labeling in and to update previously data. request. 3. 60 days for updating information. approved applications providing for such I n d ic a t io n s drugs. A new drug application is re­ C. Marketing of the drugs may con­ quired from any person marketing such For the relief of symptoms of depression. tinue until the supplemental applica­ drugs without approval. Endogenous depression is more likely to be tions submitted in accord with the pre­ The Food and Drug Administration is alleviated than are other depressive states. ceding subparagraphs A and B are acted prepared to approve new drug applica­ V. Marketing Status. Marketing of the upon, provided that within 60 days after tions and supplements to previously ap­ drugs may continue under conditions de­ the date of this publication, the labeling proved new drug applications under scribed in items VII and VUI of this an­ of the preparation shipped within the conditions described in this announce­ nouncement except those claims jurisdiction of the Act is in accord with ment. referenced in item VI below may con­ the labeling conditions described herein. I. Amitriptyline hydrochloride—A. Ef­tinue to be included in the labeling for (It may continue to include the indica­ fectiveness classification. The Food and the period stated. tions referenced in paragraph VI for the Drug Administration has considered the VI. Claims permitted during extended period stated.) Academy reports as well as other avail­ period for obtaining substantial evidence. v m . New applications. A. Any other able evidence, and concludes that; Those claims for which the drugs are person who distributes or intends to dis­ 1. Amitriptyline hydrochloride is ef­ described in paragraphs I.A and n.A tribute such drugs which are intended fective for the relief of symptoms of above as possibly effective (not included for the conditions of use for which they

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 NOTICES 13609 have been shown to be effective, as de­ sioner will give the holders of any such Request for hearing: (Identify with Docket Number) Hearing Clerk, Office of General scribed under paragraph I.A above for applications, and any interested person Counsel (GC-1), Room 6-62, Parklawn. amitriptyline hydrochloride and para­ who would be adversely affected by such All other communications regarding this graph n.A above for imipramine hydro­ an order, an opportunity for a hearing announcement: Special Assistant For Drug chloride, should submit a new drug ap­ to show why such indications should not Efficacy Study Im plementation (BD-201), plication containing full information re­ be deleted from labeling. A request for Bureau of Drugs. quired by the new drug application form a hearing must be filed within 30 days Requests for NAS-NRC report: Press Rela­ FD-356H (21 CFR 130.4(c) ). Such ap­ after the date of publication of this no­ tions Staff (CE—200), Food and Drug Ad­ F ederal R egister. m inistration, 200 C Street SW., Washing­ plications should include proposed label­ tice in the A request ton, D.C. 20204. ing which is in accord with the labeling for a hearing may not rest upon mere al­ conditions described herein and ade­ legations or denials, but must set forth This notice is issued pursuant to pro­ quate data to assure the biologic avail­ specific facts showing that there is a visions of the Federal Food, Drug, and ability of the drug in the formulation genuine and substantial issue of fact Cosmetic Act (secs. 502, 505, 52 Stat. which is marketed or proposed for that requires a hearing, together with 1050-53, as amended; 21 U.S.C. 352, 355) marketing. a well-organized and full-factual analy­ and under authority delegated to the B. Distribution of any such prepara­ sis of the clinical and other investiga­ Commissioner of Food and Drugs (21 tion currently on the market without an tional data the objector is prepared to CFR 2.120). approved new drug application may be prove in a hearing. Any data submitted Dated: August 4, 1970. continued provided that: in response to this notice must be pre­ 1. Within 60 days from the date of viously unsubmitted and include data S am D. F ine, publication of this announcement in from adequate and well-controlled clini­ Associate Commissioner the F ederal . R egister, the labeling of cal investigations (identified for ready for Compliance. such preparation shipped within the ju­ review) as described in § 130.12(a) (5) [F.R. Doc. 70-11262; Filed, Aug, 25, 1970; risdiction of the Act is in accord with the of the regulations published in the F ed­ 8:50 a.m.] labeling conditions described herein. (It eral R egister of May 8, 1970 (35 F.R. may continue to include the indications 7250). Carefully conducted and docu­ referenced in paragraph VI for the pe­ mented clinical studies obtained under [DESI 12258V] riod stated.) uncontrolled or partially controlled sit­ TRIAMCINOLINE ACETONIDE-NEO- 2. The manufacturer, packer, or dis­ uations are not acceptable as a sole basis M YCIN SULFATE-THIOSTREPTON tributor of such drugs submits, within for approval of claims of effectiveness, 180 days from the date of this publica­ but such studies may be considered on NYSTATIN OINTMENT tion, a new-drug application to the Food their merits for corroborative support of Drugs for Veterinary Use; Drug Efficacy and Drug Administration. efficacy and evidence of safety. If a hear­ Study Implementation 3. The applicant submits additional ing is requested and is justified by the re­ information that may be required for sponse to this notice, the issues will be The Food and Drug Administration the approval of the application within defined, a hearing examiner will be has evaluated a report received from the a reasonable time as specified in a writ­ named, and he shall issue a written no­ National Academy of Sciences-National ten communication from the Food and tice of the time and place at which the Research Council, Drug Efficacy Study Drug Administration. hearing will commence. Group, on the following preparation: XI. Unapproved use or form of drug.Panolog Ointment; each cubic centi­ 4. The application has not been ruled meter contains 1 milligram of triamcino­ incomplete or unapprovable. A. If the article is labeled or advertised for use in any condition other than those lone acetonide, neomycin sulfate equiva­ IX. Exemption from periodic report­ lent to 2.5 milligrams of neomycin base, ing. The periodic reporting requirements provided for in this announcement, it may be regarded as an unapproved new 2500 units of thiostrepton, and 100,000 of §§ 130.35(e) and 130.13(b)(4) are units of nystatin; by E. R. Squibb & Sons, waived in regard to applications ap­ drug subject to regulatory proceedings until such recommended use is approved Inc., Georges Road, New Brunswick, N.J. proved for these drugs solely for the con­ 08903. ditions of use for which the drugs are in a new drug application or is otherwise in accord with this announcement. The Academy stated that this product regarded as effective as described herein. is probably effective for cutaneous dis­ X. Opportunity for a hearing. 1. The B. If the article is proposed for mar­ orders of bacterial or mondial infection Commissioner of Pood and Drugs pro­ keting in another form or for a use other in cats and dogs. The Academy further poses to issue an order under the pro­ than the use provided for in this an­ stated: (1) Documentation is needed to visions of section 505(e) of the Federal nouncement, appropriate additional in­ support the broad antifungal claim as Food, Drug, and Cosmetic Act withdraw­ formation as described in § 130.4 or only specific effects against Monilia ing approval of all new-drug applica­ § 130.9 of the regulations (21 CFR 130.4, albicans are substantiated; and (2) each tions and all amendments and supple­ 130.9) may be required, including results ingredient in a preparation containing ments thereto providing for the indica­ of animal and clinical tests intended to more than one drug must be effective, or tions for which substantial evidence of show whether the drug is safe and contribute to the effectiveness of the effectiveness is lacking as described in effective. preparation, to warrant acceptance as a paragraphs I.A and II.A of this an­ A copy of the NAS-NRC report has therapeutic ingredient. nouncement. An order withdrawing ap­ been furnished to each firm referred to The Food and Drug Administration proval of the applications will not issue if above. Any other interested person may concurs with the Academy’s findings. such applications are supplemented, in obtain a copy by request to the appro­ This announcement is published (1) to accord with this notice, to delete such in­ priate office named below. inform the holders of new animal drug dications. Promulgation of the proposed Communications forwarded in re­ applications of the findings of the order would cause any drug for human sponse to this announcement should be Academy and the Food and Drug Admin­ use containing the same components and identified with the reference number istration and (2) to inform all interested offered for the indications for which DESI 11836 and be directed to the at­ persons that such articles may be mar­ substantial evidence of effectiveness is tention of the following appropriate keted provided they are the subject of lacking to be a new drug for which an office and addressed (unless otherwise approved new animal drug applications approved new-drug application is not in specified) to the Food and Drug Admin­ and otherwise comply with all other re­ effect. Any such drug then on the istration, 5600 Fishers Lane, Rockville, quirements of the Federal Food, Drug, market would be subject to regulatory Md. 20852: and Cosmetic Act. Proceedings. Supplements (identify with NDA number): Holders of new animal drug applica­ 2. In accordance with the provisions Office of Marketed Drugs (BD-200), Bureau tions are provided 6 months from the of section 505 of the Act (21 U.S.C. 355) of Drugs. date of publication hereof in the F ederal and the regulations promulgated there­ Original new-drug applications: Office of New R egister to submit adequate documenta­ under (21 CFR Part 130), the Commis­ Drugs (BD-100), Bureau of Drugs. tion in support of the labeling used.

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 13610 NOTICES

Each holder of a new animal drug ap­ 3. This drug lacks substantial evidence 4. At the end of the 6-month and 12- plication which became effective prior to of effectiveness for its recommended use month periods, any such data will be October 10, 1962, is requested to submit in moderate to severe emotional disor­ evaluated to determine whether there is updating information as needed to make ders, especially agitated states associated substantial evidence of effectiveness of the application current with regard to with neuroses; for the relief of mild agi­ the drug for such uses. The conclusions manufacture of the drug, including in­ tation, unrest, and sleeplessness in simple concerning the drug will be published in formation on drug components and com­ neuroses and psychoneurotic disorders; the F ederal Register. If no studies have position, and also including information in alcoholic psychosis to control with­ been undertaken or if the studies do not regarding manufacturing methods, drawal symptoms; or as an adjunct to provide substantial evidence of effective­ facilities, and controls, in accordance antiepileptic medication. ness, procedures will be initiated to with­ with the requirements of section 512 of B. Marketing status. 1, Within 60 days draw approval of the new-drug applica­ the act. of the date of publication of this an­ tions for the drug, pursuant to the provi­ Written comments regarding this an­ nouncement in the F ederal R egister, the sions of section 505(e) of the Federal nouncement, including requests for an holder of any previously approved new- Food, Drug, and Cosmetic Act. With­ informal conference, may be addressed drug applications for a dnig described drawal of approval of the applications to the Bureau of Veterinary Medicine, in paragraph A. 3. above is requested to will cause any such drug on the market Pood and Drug Administration, 5600 submit a supplement to his application to be a new drug for which an approval Fishers Lane, Rockville, Md. 20852. to provide for revised labeling, as needed, is not in effect. The holder of the new animal drug which deletes those indications for which 5. Labeling revised pursuant to this application for the listed drug has been such drug has been classified as lacking notice should take into account the com­ mailed a copy of the NAS-NRC report. substantial evidence of effectiveness and ments of the Academy, furnish adequate Any other interested person may obtain which contains an “Indications” section information for safe and effective use of a copy by writing to the Pood and Drug in accord with that described below. Such the drug, and be in accord with the Administration, Press Relations Staff, supplements should be submitted under guidelines for uniform labeling pub­ 200 C Street SW„ Washington, D.C. the provisions of § 130.9(d) and (e) of lished in the F ederal R egister' of Feb­ 20204. the new-drugs regulations (21 CPR 130.9 ruary 6, 1970 (21 CFR 3.74), and recom­ This notice is issued pursuant to provi­ (d) and (e) ), which permit certain mend use of the drug (for the probably sions of the Federal Pood, Drug, and changes to be put into effect at the ear­ effective indication) as follows: (The Cosmetic Act (secs. 502, 512, 52 Stat. liest possible time, and the revised label­ possibly effective indications may also be 1050-51, 82 Stat. 343-51; 21 U.S.C. 352, ing should be put into use within the included for six months.) 360b) and under authority delegated to 60-day period. Failure to do so may re­ I n d ic a t io n s the Commissioner of Food and Drugs (21 sult in a proposal to withdraw approval CPR 2.120). Chlorprothixene is indicated for the con­ of the new-drug application. trol of moderate to severe agitation, anxiety, Dated: August 17,1970. 2. If any such preparation is on the and tension when such symptoms are mani­ market without an approved new-drug festations of schizophrenia. S am D. P in e , application, its labeling should be revised Associate Commissioner to delete any claim for which substantial The above-named holder of the new- for Compliance. evidence of effectiveness is lacking as drug applications for this drug has been [FU. Doc. 70-11263; Filed, Aug. 25, 1970; described in paragraph A. 3. above and to mailed a copy of the NAS-NRC reports. 8:50 am .] Any interested person may obtain a copy be in accord with the “Indications” sec­ of these reports by writing to the office tion described below. Failure to delete named below. [DESI 12486] such indications and put the revised la­ Communications forwarded in re­ beling into use within 60 days after the sponse to this announcement should be CHLORPROTHIXENE date of publication hereof in the F ederal R egister may cause the drug to be sub­ identified with the reference number Drugs for Human Use; Drug Efficacy ject to regulatory proceedings. DESI 12486 and dirècted to the attention Study Implementation 3. Indications for the drug described of the following appropriate office and The Pood and Drug Administration has in paragraph A above as probably effec­ addressed (unless otherwise specified) to evaluated reports received from the Na­ tive may continue to be used for 12 the Food and Drug Administration, 5600 tional Academy of Sciences-National Re­ months, and indications described as pos­ Fishers Lane, Rockville, Md. 20852: search Council, Drug Efficacy Study sibly effective may continue to be used Group, on the following chlorprothixene- for 6 months, following the date of this Supplements (identify with NDA number) : publication to allow additional time Office of Marketed Drugs (BD-200), Bu­ containing products, marketed by Roche reau of Drugs. Laboratories, Division of Hoffmann-La within which holders of previously ap­ Original new-drug applications: Office of Roche, Inc., 340 Kingsland Avenue, Nut- proved applications or persons market­ New Drugs (BD-100), Bureau of Drugs. ley, N.J. 07110. ing- the drug without approval may All other communications regarding this an­ 1. Taractan Tablets (NDA12-486). obtain and submit to the Pood and Drug nouncement: Special Assistant for Drug 2. Taractan Injection (NDA 12-487). Administration data to provide substan­ Efficacy Study Im plem entation (BD-201). These drugs are regarded as new drugs. tial evidence of effectiveness. To be ac­ Bureau of Drugs. ceptable for consideration in support of Bequests for NAS-NRC reports: Press Rela­ The effectiveness classification and mar­ tions Office (CE-200), Food and Drug keting status are described below. the effectiveness of a drug, any such Administration, 200 C Street SW., Wash­ A. Effectiveness classification. The data must be previously unsubmitted, ington, D.C. 20204. Pood and Drug Administration has con­ well-organized, and include data from sidered the Academy reports, as well as adequate and well-controlled clinical in­ This notice is issued pursuant to pro­ other available evidence, arid concludes vestigations (identified for ready review) visions of the Federal Food, Drug, and that: as described in § 130.12(a) (5) of the reg­ Cosmetic Act (secs. 502, 505, 52 Stat. 1. Chlorprothixene is probably effec­ ulations published as a final order in the 1050-53, as amended; 21 U.S.C. 352, 355) tive for the control of moderate to severe F ederal R egister of May 8, 1970 (35 agitation, anxiety, and tension when P.R. 7250). Carefully conducted and and under authority delegated to the such symptoms are manifestations of documented clinical studies obtained Commissioner of Food and Drugs (21 schizophrenia. under uncontrolled or partially con­ CFR 2.120). 2. This drug is possibly effective in ag­ trolled situations are not acceptable as Dated: July 30, 1970. itated states associated with psychotic a sole basis for the approval of claims of depression; as an antiemetic for the man­ Sam D. Fine, agement of nausea and vomiting associ­ effectiveness, but such studies may be Associate Commissioner ated with radiation therapy or following considered on their merits for corrobora­ for Compliance. surgery; and in potentiating analgesics tive support of efficacy and evidence of [FR . Doc. 70-11264; Filed, Aug. 25, 1970; and anesthetics. safety. 8:50 a.m.]

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 NOTICES 13611

[DESI12612V] missioner of Food and Drugs (21 CFR drawal of approval of the applications 2.120), will cause any such drugs on the market FURACIN-MICOFUR EAR SOLUTION to be a new drug for which an approval VETERINARY Dated: August 17,1970. is not in effect. S am D. F in e , The above-named holder of the new- Drugs for Veterinary Use; Drug Efficacy Associate Commissioner drug application for this drug has been Study Implementation for Compliance. mailed a copy of the NAS-NRC report. The Pood and Drug Administration has [F.R. Doc. 70-11265; Filed, Aug. 25, 1970; Any interested person may obtain a copy evaluated a report received from the Na­ 8:50 a.m.] of this report by writing to the office tional Academy of Sciences-National Re­ named below. search Council, Drug Efficacy Study Communications forwarded in re­ Group, on the following preparation: [DESI 12939] sponse to this announcement should be Furacin-Micofur Ear Solution Veteri­ PENICILLINASE identified with the reference number nary with anesthetic; contains 0.2 per­ DESI 12939 and be directed to the atten­ cent nitrofurazone, 0.375 percent nifu- Drugs for Human Use; Drug Efficacy tion of the following appropriate office roxime, and 2.0 percent diperodon Study Implementation and addressed (unless otherwise speci­ hydrochloride; by Eaton Laboratories, fied) to the Food and Drug Administra­ Division of The Norwich Pharmacal Co., The Food and Drug Administration tion, 5600 Fishers Lane, Rockville, Md. has evaluated a report received from the 20852: Post Office Box 191, Scientific Depart­ National Academy of Sciences-National ment, Norwich, N.Y. 13815. Supplements (identify with NDA number) : The Academy report stated that this Research Council, Drug Efficacy Study Office of Marketed Drugs (BD-200), Bureau product is probably effective for treat­ Group, on the following drug: of Drugs. ment of bacterial ear infections in dogs Neutrapen containing 800,000 units Original new-drug applications: Office of New when such infections are caused by or­ penicillinase per vial, marketed by Riker Drugs (BD-100), Bureau of Drugs. ganisms sensitive to the drug. The Acad­ Laboratories, 19901 Nordhoff Street, All other communications regarding this Northridge, Calif. 91326 (NDA 12-939). announcement: Special Assistant for Drug emy report stated that documentation is Efficacy Study Im plem entation (BD-201), needed regarding the effect of nifu- The drug is regarded as a new drug. Bureau of Drugs. roxime and that the label should state The effectiveness classification and mar­ Requests for NAS-NRC Reports: Press Rela­ that sensitivity may develop. The Food keting status are described below. tions Staff (CE-200), Food and Drug Ad­ and Drug Administration concurs with A. Effectiveness classification. The ministration, 200 C Street SW., Washing­ the Academy’s findings. Food and Drug Administration has con­ ton, D.C. 20204. This announcement is published (1) to sidered the Academy report and con­ This notice is issued pursuant to pro­ inform the holders of new animal drug cludes that penicillinase is possibly effec­ visions of the Federal Food, Drug, and applications of the findings of the Acad­ tive for the treatment of allergic reac­ Cosmetic Act (secs. 502, 505, 52 Stat. emy and the Pood and Drug Administra­ tions to penicillin G. 1050-53, as amended; 21 U.S.C. 352, 355) tion and (2) to inform all interested per­ B. Marketing status. 1. Holders of and under authority delegated to the sons that such articles may be marketed previously approved new-drug applica­ Commissioner of Food and Drugs (21 provided they are the subject of approved tions and any person marketing any such CFR 2.120). new animal drug applications and other­ drug without approval will be allowed 6 wise comply with all other requirements months from the date of publication of Dated: July 30,1970. of the Federal Pood, Drug, and Cosmetic this announcement in the F ederal S am D. F in e, Act. R egister to obtain and to submit in a Associate Commissioner Holders of new animal drug applica­ supplemental or original new-drug appli­ for Compliance. tions are provided 6 months from the date cation data to provide substantial evi­ [F.R. Doc. 70-11266; Filed, Aug. 25, 1970; of publication hereof in the F ederal dence of effectiveness for the indications 8:50 a.m.] Register to submit adequate documenta­ for which this drug has been classified tion in support of the labeling used. as possibly effective. To be acceptable Each holder of a new animal drug ap­ for consideration in support of the effec­ LeGEAR LABORATORIES, INC. plication which became effective prior to tiveness of a drug, any such data must be October 10, 1962, is requested to submit previously unsubmitted, well-organized, Neomycin in Animal Feed updating information as needed to make and include data from adequate and An announcement was published in the application current with regard to well-controlled clinical investigations the F ederal R egister of June 10, 1970 manufacture of the drug, including in­ (identified for ready review) as described (35 F.R. 8955), concerning the product formation on drug components and com­ in § 130.12(a) (5) of the regulations pub­ Neomycin Crumbles Fortified, which position, and also including information lished as a final order in the F ederal contains neomycin sulfate and vitamins regarding manufacturing m e th o d s , R egister of May 8, 1970 (35 FJEt. 7250). A, D3, and E, and is marketed by LeGear facilities, and controls, in accordance Carefully conducted and documented Laboratories, Inc., 4161 Beck Avenue, St. with the requirements of section 512 of clinical studies obtained under uncon­ Louis, Mo. 63116. the act. trolled or partially controlled situations Among other things the announcement Written comments regarding this an­ are not acceptable as a sole basis for the stated that all stocks of neomycin in­ nouncement, including requests for an approval of claims of effectiveness, but tended for use in animal feed, and all informal conference, may be addressed siich studies may be considered on their animal feeds bearing or containing neo­ to the Bureau of Veterinary Medicine, merits for corroborative support of mycin, within the jurisdiction of the Pood and Drug Administration, 5600 efficacy and evidence of safety. Federal Food, Drug, and Cosmetic Act Fishers Lane, Rockville, Md. 20852. 2. At the end of the 6-month period, are deemed to be adulterated within the The holder of the new animal drug any such data will be evaluated to deter­ meaning of section 501(a) (5) or (6) of application for the listed drug has been mine whether there is substantial evi­ the Act and are subject to appropriate mailed a copy of the NAS-NRC report. dence of effectiveness for such use. After regulatory action. Any other interested person may obtain that evaluation, the conclusions con­ Since publication of the announce­ a copy by writing to the Food and Drug cerning the drug will be published in the ment, the Food and Drug Administra­ Administration, Press Relations Staff, F ederal R egister. If no studies have tion has received comment from inter­ 200 C Street SW., Washington, D.C. been undertaken or if the studies do not ested parties and the Administration has 20204. provide substantial evidence of effective­ further evaluated the status of animal This notice is issued pursuant to provi­ ness, procedures will be initiated to with­ feeds containing neomycin. Based on the sions of the Federal Food, Drug, and Cos­ draw approval of the new-drug applica­ comment received and réévaluation of metic Act (secs. 502, 512,52 Stat. 1050-51, tions for such drugs, pursuant to the available information, the Commissioner 82 Stat. 343-51; 21 U.S.C. 352, 360b) and provisions of section 505(e) of the Fed­ of Food and Drugs concludes that the under authority delegated to the Com­ eral Food, Drug, and Cosmetic Act. With­ above cited findings regarding neomycin

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 No. 166-— 7 13612 NOTICES products should be amended so as to insecticide 0,0-diethyl 0-3,5,6-trichloro- Federal Aviation Act of 1958 (the Act) apply only to (1) Neomycin Crumbles 2-pyridyl phosphorothioate in or on the and Part 261 of the Board’s Economic Fortified and similar products, and (2) raw agricultural commodities meat and Regulations, between various air car­ neomycin intended for use in such prod­ fat of turkeys at 0.05 part per million riers, foreign air carriers, and other ucts. Therefore, the last sentence in the on July 25, 1969 (notice was published carriers, embodied in the resolutions of penultimate paragraph of the announce­ in the F ederal R egister of August 1, Traffic Conference 1 of the International ment is amended to read as follows: 1969 (34 F.R. 12600)), which will expire Air Transport Association (IATA), and “Therefore, notice is given to LeGear July 25, 1970. adopted by mail vote. The agreement Laboratories, Inc., and to all interested The firm has requested a 1-year ex­ has been assigned the above-designated persons, that Neomycin Crumbles Forti­ tension for obtaining additional experi­ C.A.B. Agreement number. fied, all products similar in composition mental data. The Commissioner of Food The agreement would specify, for ap­ and labeling to Neomycin Crumbles and Drugs concludes that such exten­ plication on routes operated by Cia. Fortified, and all stocks of neomycin sion will protect the public health. A Mexicana de Aviacion, S.A., between the intended for use in such products, within condition under which these temporary United States and Mexico, where not the jurisdiction of the Federal Food, tolerances are extended is that the in­ presently IATA-agreed, a limited number Drug, and Cosmetic Act are deemed to secticide will be used in accordance with of general cargo rates, specific commod­ be adulterated within the meaning of the temporary permit issued by the U.S. ity rates, and minimum charges for air section 501(a) (5) or (6) of the Act and Department of Agriculture. Distribution freight. These rates, which stem from the are subject to appropriate regulatory will be under The Dow Chemical Co. recent entry of this carrier into IATA, action.” name. will result in both increases and de­ This notice is issued pursuant to pro­ As extended, these temporary toler­ creases from rates previously in effect. visions of the Federal Food, Drug, and ances expire July 25, 1971. Pursuant to authority duly delegated Cosmetic Act (secs. 501(a) (5), (6), This action is taken pursuant to pro­ by the Board in the Board’s regulations, 512(a), 52 Stat. 1049, as amended, 82 visions of the Federal Food, Drug, and 14 CFR 385.14, it is not found, on a ten­ Stat. 343; 21 U.S.C. 351(a), (5), (6), Cosmetic Act (sec. 408(j), 68 Stat. 516; tative basis, that the following resolu­ 360b(a)). 21 U.S.C. 346a(j)) and under authority tions, incorporated in the above- delegated to the Commissioner (21 CFR described agreement, are adverse to the Dated: August 17,1970. 2 .120). public interest or in violation of the S am D. F in e , Dated: August. 18, 1970. Act: Associate Commissioner C.A.B. agreement IATA resolutions for Compliance. R. E. D uggan, 21923 : Acting Associate Commissioner [F.R. Doc. 70-11237; Filed, Aug. 25, 1970; R—1 ______100(Mail 857)591 8:47 a.m.] for Compliance. R-2 ______100(Mail 857)551 [F.R. Doc. 70-11238; Filed, Aug. 25, 1970; R - 3 ______100(Mail 857)590 8:47 a.m.] Accordingly, it is ordered, That: SHELL CHEMICAL CO. Action on Agreement C.A.B. 21923, R -l through R-3, be and hereby is Notice of Filing of Petition Regarding deferred with a view toward eventual Pesticide Chemicals CIVIL AERONAUTICS BOARD approval. Pursuant to provisions of the Federal [Docket No. 22381] Persons entitled to petition the Board for review of this order, pursuant to the Food, Drug, and Cosmetic Act (sec. EAST AFRICAN AIRWAYS CORP. 408(d)(1), 68 Stat. 512; 21 U.S.C. 346a Board’s regulations, 14 CFR 385.50, may, (d)(1)), notice is given that a petition Notice of Hearing within 10 days after the date of service (PP 0F0998) has been filed by the Shell of this order, file such petitions in sup­ Notice is hereby given, pursuant to the port of or in opposition to our proposed Chemical Co., Suite 1103, 1700 K Street provisions of the Federal Aviation Act NW., Washington, D.C, 20006, proposing action herein. the establishment of tolerances (21 CFR of 1958, as amended, that a hearing in Part 120) for negligible residues of the the above-entitled proceeding will be This order will be published in the held on September 9, 1970, at 10 a.m., F ederal R egister. herbicide 2- (4-chloro-6-ethylamino-s- d.s.t., in Room 503, Universal Building, triazin-2-ylamino) - 2 - methylpropioni- 1825 Connecticut Avenue NW., Wash­ [seal] H arry J. Zink, trile in or on the raw agricultural com­ Secretary. modities forage and fodder of corn (field, ington, D.C., before the undersigned sweet and popcorn), sweet com (kernels examiner. [F.R. Doc. 70-11285; Filed, Aug. 25, 1970; plus cob with husk removed), and the For information concerning the issues 8:52 a.m.] grain of field com and popcorn at 0.1 part involved and other details in this pro­ per million. ceeding, interested persons are referred [Docket No. 22384] to the documents which are in the docket The analytical method proposed in the LINEAS AEREAS COSTARRICENSES, petition for determining residues of the of this proceeding on file in the Docket herbicide is a gas chromatographic pro­ Section of the Civil Aeronautics Board. S.A. (LACSA) cedure with an electron-capture detector. Dated at Washington, D.C., August 20, Notice of Hearing 1970. Dated: August 18,1970. Notice is hereby given pursuant to the [seal] E dward T. S todola, R . E. D uggan, Hearing Examiner.' Federal Aviation Act of 1958, as Acting Associate Commissioner amended, that a hearing in the above- for Compliance. [F.R. Doc. 70-11276; Filed, Aug. 25, 1970; 8:51 a.m.] entitled proceeding is assigned to be held [F.R. Doc. 70-11236; Filed, Aug. 25, 1970; ofi September 29,1970, at 10 a.m., e.d.s.t., 8:47 a.m.] in Room 805, Universal Building, 1825 [Docket No. 20993; Order 70-8-79] Connecticut Avenue NW., Washington, 0,0-DIETHYL 0-3,5,6-TRICHL0R0-2- INTERNATIONAL AIR TRANSPORT D.C., before the undersigned examiner. PYRIDYL PHOSPHOROTHIOATE ASSOCIATION Dated at Washington, D.C., August 20, Notice of Extension of Temporary Order Regarding .Rate Matters 1970. Tolerances Issued under delegated authority Au­ [seal] Louis W. S ornson, Hearing Examiner. The Dow Chemical Co., Post Office Box gust 19,1970. 1706, Midland, Mich. 48640, was granted An agreement has been filed with the [F.R. Doc. 70-11275; Filed, Aug. 25 1970; temporary tolerances for residues of the Board, pursuant to section 412(a) of the 8:51 a.m.]

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 NOTICES 13613

[Docket No. 22441; Order 70-8-80] fair and reasonable rate of compensation cially noticed, it is proposed to issue an to be paid to Ross Aviation, Inc.; order1 to include the following findings ROSS AVIATION, INC. 2. Further procedures herein shall be and conclusions: Order To Show Cause in accordance with 14 CFR Part 302, and 1. The fair and reasonable final serv­ notice of any objection to the rate or to ice mail rate to be paid on and after Au­ Issued under delegated authority Au­ the other findings and conclusions pro­ gust 5, 1970, to Ross Aviation, Inc., pur­ gust 19,1970. posed herein, shall be filed within 10 days, suant to section 406 of the Act for the A final service mail rate for the trans­ and if notice is filed, writteh answer and transportation of mail by aircraft, the portation of mail by aircraft, established supporting documents shall be filed facilities used and useful therefor, and by Order 69-4-40, April 8,1970, in Docket within 30 days after service of this order; the services connected therewith, shall be 20769, is currently in effect for the above- 3. If notice of objection is not filed 51.14 cents per great circle aircraft mile captioned air taxi, operating under 14 within 10 days after service of this order, between Cheyenne and Rock Springs, via CFR Part 298. This rate is based on six or if notice is filed and answer is not filed Rawlins, Wyo. round trips per week between Riverton, within 30 days after service of this order, 2. This final rate, to be paid entirely by Wyo., and Denver, Colo., via Worland, all persons shall be deemed to have the Postmaster General, is based on five Casper, and Cheyenne, Wyo. waived the right to a hearing and all round trips per week flown with Piper The Postmaster General filed a peti­ other procedural steps short of a final Aztec twin-engine aircraft equipped for tion on August 5, 1970, stating that the decision by the Board, and the Board all-weather operation. volume of mail involved does not justify may enter an order incorporating the Accordingly, pursuant to the Federal weekend trips on this route and he has findings and conclusions proposed herein Aviation Act of 1958, and particularly been authorized by the carrier to petition and fix and determine the final rate sections 204(a) and 406 thereof, and for a new rate of 51.21 cents per great specified herein; regulations promulgated in 14 CFR, Part circle aircraft mile, based on five round 4. If answer is filed presenting issues 302, 14 CFR Part 298, and 14 CFR trips per week. The carrier and the Post for hearing, the issues involved in de­ 385.16(f): Office Department have, agreed that the termining the fair and reasonable final It is ordered, That: proposed rate is a fair and reasonable rate shall be limited to those specifically 1. Ross Aviation, Inc., the Postmaster rate for these services. raised by the answer, except insofar as General, and Frontier Airlines, Inc., and The Board finds it in the public inter­ other issues are raised in accordance all other interested persons are directed est to fix and determine the fair and with Rule 307 of the rules of practice (14 to show cause why the Board should not reasonable rate of compensation to, be CFR 302.307); and adopt the foregoing proposed findings paid by the Postmaster General for the 5. This order shall be served upon Ross and conclusions and fix, determine, and transportation of mail by aircraft be­ Aviation, Inc., the Postmaster General, publish the final rate specified above for tween the aforesaid points. Upon consid­ Western Air Lines, Inc., and Frontier Air­ the transportation of mail by aircraft, eration of the petition and other matters lines, Inc. officially noticed, it is proposed to issue the facilities used and useful" therefor, and order1 to include the following find­ This order will be published in the and the services connected therewith as F ederal R egister. specified above as the fair and reason­ ings and conclusions: able rate of compensation to be paid 1. The fair and reasonable final serv­ [seal] H arry J. Zin k , ice mail rate to be paid on and after Au­ Secretary. to Ross Aviation, Inc.; 2. Farther procedures herein shall be gust 5, 1970, to Ross Aviation, Inc., [F.R. Doc. 70-11283; Filed, Aug. 25, 1970; pursuant to section 406 of the Act for 8:52 a.m.] in accordance with 14 CFR Part 302, and the transportation of mail by aircraft, notice of any objection to the rate or to the facilities used and useful therefor, the other findings and conclusions pro­ and the services connected therewith, [Docket No. 22440; Order 70-8-81] posed herein, shall be filed within 10 days, shall be 51.21 cents per great circle air­ and if notice is filed, written answer and craft mile between Riverton, Wyo., and ROSS AVIATION, INC. supporting documents shall be filed Denver, Colo., via Worland, Casper, and Order To Show Cause within 30 days after service of this order; Cheyenne, Wyo. 3. If notice of objection is not filed 2. This final rate, to be paid entirely by Issued under delegated authority Au­ within 10 days after service of this order, the Postmaster General, is based on five gust 19,1970. or if notice is filed and answer is not filed round trips per week flown with Beech- A final service mail rate for the trans­ within 30 days after service of this order, craft E-185 aircraft equipped for all- portation of mail by aircraft, established all persons shall be deemed to have weather operation. by Order 70-1-32, January 7, 1970, in waived the right to a hearing and all Accordingly, pursuant to the Federal Docket 19993, is currently in effect for the other procedural steps short of a final de­ Aviation Act of 1958, and particularly above-captioned air taxi, operating un­ cision by the Board, and the Board may sections 204(a) and 406 thereof, and reg­ der 14 CFR Part 298. This rate is based enter an order incorporating the findings ulations promulgated in 14 CFR Part 302, on six round trips per week between and conclusions proposed herein and fix 14 CFR Part 298, and 14 CFR 385.16(f): Cheyenne and Rock Springs, via Rawlins, and determine the final rate specified It is ordered, That: Wyo. herein; 1. Ross Aviation, Inc., the Postmaster The Postmaster General filed a peti­ 4. If answer is filed presenting issues General, Western Air Lines, Inc., Fron­ tion on August 5, 1970, stating that the for hearing, the issues involved in deter­ tier Airlines, Inc., and all other interested volume of mail involved does not justify mining the fair and reasonable final rate persons are directed to show cause why weekend trips on this route and he has shall be limited to those specifically the Board should not adopt the foregoing been authorized by the carrier to peti­ raised by the answer, except insofar as Proposed findings and conclusions and tion for a new rate of 51.14 cents per other issues are raised in accordance With fix, determine, and publish the final rate great circle aircraft mile, based on five Rule 307 of the rules of practice (14 CFR specified above for the transportation of round trips per week. The carrier and the 302.307); and mail by aircraft, the facilities used and Post Office Department have agreed that 5. This order shall be served upon Ross useful therefor, and the services con­ the proposed rate is a fair and reasonable Aviation, Inc., the Postmaster General, nected therewith as specified above as the rate for these services. and Frontier Airlines, Inc. The Board finds it in the public inter­ est to fix and determine the fairand rea­ 1 As this order to show cause is not a final 1 As this order to show cause is not a final action, it is not regarded as subject to the sonable rate of compensation to be paid action, it is not regarded as subject to the review provisions of 14 CFR Part 385. These by the Postmaster General for the trans­ review provisions of 14 CFR Part 385. These provisions will apply to final action taken by portation of mail by aircraft between provisions will apply to final action taken the staff under authority delegated in the aforesaid points. Upon consideration by the staff under authority delegated in 5 385.16(g). of the petition and other matters offi­ § 385.16(g).

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 13614 NOTICES This order will be published in the for waiver of the rule, the applicant days of the mailing of this order, file F ederal R egister. claims that the proposed operation will with the Commission in triplicate, a writ­ provide a first primary service to 14,199 ten appearance stating an intention to [seal] H arry J . Zin k , persons or 36.4 percent of the population appear on the date fixed for the hearing Secretary. of Gulfport; provide a first primary serv­ and present evidence on the issues speci­ [F.R. Doc. 70-11284; Filed, Aug. 25, 1070; ice to 6,476 persons or 14.7 percent of the fied in this order. 8:52 a.m.] persons residing in Biloxi, Miss.; bring 6. It is further ordered, That the ap­ a second service to 42,563 persons; and plicants herein shall, pursuant to [Docket No. 22157] a third service to 22,490 persons. In addi­ § 311(a) (2) of the Communications tion, applicant has submitted a study in­ Act of 1934, as amended, and § 1.594 of UNITED AIR LINES, INC. dicating that no other frequency could the Commission’s rules, give notice of the be used to provide primary service to the hearing, either individually or, if feasible Notice of Hearing Regarding Specific unserved areas in Gulfport and Biloxi. and consistent with the rules, jointly, Commodity Rates on Periodicals, Although the foregoing considerations within the time and in the manner pre­ Floral Products, and Seafood would tend to support a waiver, the mu­ scribed in such rule, and shall advise the tually exclusive proposal of WISK would Commission of the publication of such Notice is hereby given, pursuant to the substantially aggravate the coverage notice as required by § 1.594(g) of the provisions of the Federal Aviation Act of rules. 1958, as amended, that a hearing in the problem and would preclude the WROA proposal from providing the requisite un­ Adopted: August 5,1970. above-entitled proceeding will be held on served area coverage.1 Accordingly, in­ , 1970, at 10 a.m., e.d.s.t., in Released: August 18,1970. Room 805, Universal Building, 1825 Con­ stead of ruling on the request at this necticut Avenue NW., Washington, D.C., stage, an issue will be specified to give F ederal Communications before the undersigned Examiner. both applicants the opportunity of sub­ Com m ission, For information concerning the issues mitting data in support of or in opposi­ [seal] B en F. W aple, involved, interested persons are referred tion to the waiver. Secretary. to the Board’s Order 70-5-2, May 1,1970, 3. Except as indicated below, the ap­ [F.R. Doc. 70-11222; FUed, Aug. 25, 1970; plicants are qualified to construct and 8:46 a.m.] instituting the investigation. operate as proposed. However, because Dated at Washington, D.C., August 20, of their mutual exclusivity, the Com­ 1970. mission is unable to make the statutory [Dockets Nos. 18936, 18937; FCC 70-849] finding that a grant of the application [seal] G reer M. M urph y, would serve the public interest, con­ AL G. STANLEY (KATO) AND Hearing Examiner. venience, and necessity, and is of the TRI-COUNTY BROADCASTING CO. [F.R. Doc; 70-11277; Filed, Aug. 25, 1970; opinion that the appliactions must be Memorandum Opinion and Order 8:51 a.m.] designated for hearing on the issues set forth below. Designating Applications for Con­ 4. Accordingly, it is ordered, That, pur­ solidated Hearing on Stated Issues suant to section 309(e) of the Communi­ In regard applications of A1 G. Stanley FEDERAL COMMUNICATIONS cations Act of 1934, as amended, the ap­ (KATO), Safford, Ariz., has: 1230 kc., plications are designated ior hearing in 250 w., U, requests: 1380 kc., 500 w.( 5 COMMISSION a consolidated proceeding, at a time and kw.-LS, DA-N, U, File No. BP-16980; place to be specified in a subsequent and Marshall Darris, Jr., Frank Carl [Dockets Nos. 18941, 18942; FCO 70-850] order, upon the following issues: Hancock, and Zenos J. Howard, doing (1) To determine the areas and popu­ business as Tri-County Broadcasting Co., CHARLES W. DOWDY (WROA) AND lations which may be expected to gain or SUMTER BROADCASTING CO., INC. Safford, Ariz., requests: 1380 kc., 500 w., lose primary service from the proposed 5 kw.-LS, DA-N, U, File No. BP-17378; (WISK) operations of stations WROA and WISK for construction permits. and the availability of other primary 1. The Commission has before it the Memorandum Opinion and Ord£r aural service to such areas and popula­ Designating Applications for Con­ above-captioned and described mutually tions (1 mv/m or greater in the case of exclusive applications; correspondence solidated Hearing on Stated Issues FM). with reference to the applications; and In regard applications of Charles W. (2) To determine whether the pro­ a series of pleadings listed below. Dowdy (WROA), Gulfport, Miss., has: posal of Charles W. Dowdy would pro­ 2. The KATO application was filed by 1390 kc., 1 kw., Day, Class m , requests: vide coverage of the city sought to be Willard Shoecraft who, at the time of 1390 kc., 5 kw., DA-2, U, Class III, File served, as required by § 73.188(a) (1) of the filing of the application, was the No. BP-17910; and Sumter Broadcasting the Commission’s rules and, if not, licensee of KATO. During the pendency Co.', Inc. (WISK), Americus, Ga., has: whether circumstances exist which would of the application, Shoecraft was granted 1390 kc., 5 kw., Day, Class III, requests: warrant a waiver of said section. authority to assign the KATO license to 1390 kc., 1 kw., 5 kw.-LS, DA-N, U, Class (3) To determine, in the light of sec­ A1 G. Stanley on November 29, 1968 in, File No. BP-18224; for construction tion 307(b) of the Communications Act (BAL-6488), and the assignment was permits. of 1934, as amended, which of the pro­ consummated on January 1, 1969. On 1. The Commission has under consid­ posals would better provide a fair, effi­ February 12,1969, the KATO application eration the above-captioned applications cient and equitable distribution of radio was amended to reflect the change in which are mutually exclusive in that the service. ownership of KATO. It was while Shoe­ proposed operation of station WISK (4) To determine, in the light of-the craft was the licensee of KATO th a t the would preclude the WROA proposal from evidence adduced pursuant to the fore­ correspondence and pleadings under con­ providing a first primary nighttime serv­ going issues which, if either, of the ap­ sideration were received. During the ex­ ice to 25 percent of the area or popula­ plications should be granted. change of correspondence and pleadings tion of the proposed service area as re­ 5. It is further ordered, That, to avail both Shoecraft and Tri-County Broad­ quired by § 73.24(b) (3) of the rules. themselves of the opportunity to be casting Co. (Tri-County) sought the dis­ Emerald Broadcasting Co. (KTHO), 8 heard, the applicants herein, pursuant missal of the other’s application, and FCC 2d 443, 10 RR 2d 267 (1967). to § 1.221(c) of the Commission’s rules, in each has sought the dismissal of various 2. The proposed operation of WROA person or by attorney, shall, within 20 pleadings filed by the other. Although fails to meet the requirements of § 73.188 Stanley has not specifically adopted the the (a)(1) of the rules, in that the proposed 1 The proposed WISK operation would contentions made by Shoecraft, and nighttime interference-free contour (10.8 cause a substantial increase in the nighttime number of pleadings filed exceeds the mv/m) does not cover all of the city of RSS lim itation of the proposed WROA number contemplated by § 1.45(c) °i Gulfport, Miss. In support of a request operation. the Commission’s rules, the Commission

FEDERAL REGISTER, VOL. 35, NO. 165— WEDNESDAY, AUGUST 26, 1970 NOTICES 13615 deems it necessary to dispose of all the Commission advised Tri-County that it tion in the Arizona court not be con­ contentions, charges and countercharges would be necessary to restudy its en­ cluded upon the termination of this pro­ which have been made in order to dispose gineering proposal to determine if ade­ ceeding, any grant to Tri-County will be of the substantive questions which have quate protection is afforded to all without prejudice to any action the been raised. For reasons indicated here­ existing stations. On April 8, 1970, Tri- Commission may deem necessary as a inafter, the requests to dismiss the ap­ County’s application was amended as a result of the court action. plications will be denied. The pleadings result of which it appears that adequate 8. One allegation of Shoecraft con­ and other requests will be dismissed, but protection to all existing stations will be cerning the solicitation by Tri-County’s the questions raised will be considered achieved. Therefore, the Tri-County ap­ principals of an ex parte communica­ on the Commission’s own motion. plication need not be dismissed on the tion in connection with its application 3. Neither application was acceptable ground of alleged interference to KOTA. requires comment. This allegation is under the Commission’s criteria when 6. Other grounds urged by Shoecraft in based on a letter of ,1966, from tendered. As a result of amendments and support of his request to dismiss the a Congressman addressed to a former other considerations to be noted below, Tri-County application concern two of Chairman of the Commission, in which the Commission has found both applica­ Tri-County’s partners, Marshall Darris, it is stated that the writer is a friend of Jr., and Frank Carl Hancock, who were Tri-County’s principals and that the tions acceptable and not subject to Congressman had been contacted be­ dismissal. formerly employed by Shoecraft as KATO manager and chief engineer, re­ cause it seemed that the “opposition 4. In requesting the dismissal of the radio owners” (presumably Shoecraft) KATO application, Tri-County alleges spectively. Shoecraft charges Tri-County with “underhanded” tactics in preparing were friends of the Congressman from that the KATO proposal would cause that area and that the author of the nighttime interference to XEKT, Tecate, its application while Darris and Hancock letter “might be of assistance in balanc­ Baja California, Mexico, and that the were still employed at KATO; with mak­ ing Congressional interest.” KATO proposal shows only slightly less ing false statements in denying rumors 9. Tri-County defends the communica­ than objectionable radiation toward sta­ that Tri-County’s principals were pre­ tion on the ground that Tri-County’s tion KTSM, El Paso, Tex., with no maxi­ paring the application during the time principals had no knowledge of the pro­ mum expected value of radiation speci­ it was actually in preparation; with so­ hibition against soliciting ex parte com­ fied on the proposed radiation pattern. liciting an ex parte communication munications, had no “evil intent,” and With respect to the interference to concerning the merits of its application, sought no preferential treatment. Tri- XEKT, Commission studies indicate that and with defrauding KATO by convert­ County further argues that the occur­ adequate protection to XEKT will be ing station funds to Darris’ and Han­ rence does not merit the sanction of dis­ afforded. Regarding protection to KTSM, cock’s own use by receiving cash, goods, qualification from further participation the Commission’s rules do not require and services in return for advertising on in this proceeding provided by § 1.1251 of maximum expected operating values in KATO, Shoecraft also charged Darris the Commission’s rules. a case such as KATO’s, especially since with attempting to involve Shoecraft in 10. Tri-County does not deny that it the radiation proposed is not seriously the violation of rules of the Commission. either solicited or encouraged a presen­ restricted in the direction of KTSM. Tri-County countered by accusing Shoe­ tation in connection with its pending ap­ 5. Shoecraft, diming the time he was craft of conducting “rigged contests”, plication. Accordingly, the Commission applicant for improved KATO facilities, falsification of logs and other violations finds that the matter should be explored urged the dismissal of the Tri-County of the Commission’s rules, and of con­ in hearing to determine its effect on Tri- application on the ground, among others, ducting a campaign of harassment, mali­ County’s requisite and comparative that, if the signal of Station KWK, St. cious prosecution and defamation against qualification. Louis, Mo. (1380 kc., 5 kw., DA-N, U), Tri-County’s principals. 11. A review of the financial data sub­ is excluded from computations to deter­ 7. The contention between the former mitted by Tri-County indicates that it is mine nighttime interference to Station KATO licensee and his former employees not entirely clear what the current fi­ KOTA, Rapid City, S. Dak. (1380 kc., 5 appears to have arisen as a result of the nancial plan is. The original material kw., DA-N, U), the proposed Tri-County preparation and filing of the Tri-County showed reliance on credit from an equip­ operation would cause interference at application which conflicts with- the ment supplier, a bank loan, and appar­ night to KOTA. This question was first KATO proposal. Apparently, a substan­ ently capital contributions from each of raised by the Commission under the fol­ tial part of the preparation of the Tri- the partners. On the basis of the first lowing circumstances: On May 29, 1963, County application was done while Dar­ showing, it appeared that Tri-County the Commission ordered the revocation of ris and Hancock were KATO staff would require approximately $65,000 to the license of Station KWK. KWK Radio, members. While there is evidence that meet construction costs and 1-year’s Inc., 34 FCC 1039, 25 RR 577; reconsider­ Darris and Hancock may have been less operating expenses. In March of this ation denied, 35 FCC 561, 1 RR 2d 457; than forthright in making their inten­ year, two of the original partners en­ affirmed, KWK Radio, Inc. v. Federal tions known, there is nothing to prevent tered into an agreement with a new part­ Communications Commission, 119 U.S. them from competing with a former em­ ner, Zenos J. Howard, and the new App. D.C. 144, 337 F. 2d 540, 2 RR 2d 2071 ployer—or his successor—for a stand­ partnership submitted additional finan­ (1964) ; cert, denied, KWK Radio, Inc. v. ard broadcast assignment in Safford. cial material on April 8, 1970. The new Federal Communications Commission, Many of the charges and countercharges material seems to imply that two of the 380 U.S. 910 (1965). The former licensee exchanged by Shoecraft and the Tri- partners, Darris and Hancock, will ac­ of KWK was permitted to continue oper­ County principals lack factual support quire interests of one-third each in the ation during the period when the Com­ and are the subject of a civil suit in the partnership in return for personal serv­ mission’s revocation order was under Superior Court of Arizona, Pima County. ices. Howard, it seems, is to furnish an judicial review. While some considera­ Shoecraft, et al. v. Valley National Bank, unspecified amount for construction and tion was being given to the adoption of et al., No. 91957. Therefore, the Com­ initial operating costs. Howard is to be procedures to permit the possible con­ mission will not dismiss the Tri-County repaid out of operating revenue at in­ tinuation of service by KWK under new application on the various grounds urged terest of not less than 7 percent nor management, the Tri-County application nor will issues be specified with respect more than 9Vz percent at some unspeci­ was nevertheless processed with the pos­ to some of the charges, principally for fied time. It may be assumed that, due sibility in view that the KWK service the reason that much that is alleged is to rising costs since the original finan­ might not be continued. However, in the without adequate factual support. The cial information was filed, Tri-County meantime, the Commission authorized Commission does, however, expect to be will now require something in excess of an interim operation of KWK and has advised of the developments in the Shoe­ $65,000. Howard’s balance sheet, fur­ granted an application proposing per­ craft litigation. See § 1.65 of the Com­ nished by Tri-County, does not show manent operation of KWK on a regular mission’s rules. It may be that matters, liquid assets in excess of current liabili­ basis. Great River Broadcasting, Inc., proved in the court action may require ties in a sufficient amount to meet what­ et al., 18 FCC 2d 212,16 RR 2d 669 (1969). the enlargement of issues in this pro­ ever may be Tri-County’s cash require­ Following the Great River decision, the ceeding. In any event, should the litiga­ ments, and there is no indication of the

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 13616 NOTICES availability of additional funds from Co. have engaged in conduct prohibited October 18, Shoecraft Petition to Dismiss Ap­ other sources. Accordingly, Tri-County by §§ 1.1221 and 1.1225 of the Commis­ plication of Tri-County. will be required to establish its financial sion’s rules, and, if so, what effect such October 24, Tri-County Motion to Dismiss qualification at the hearing, and an ap­ Petition for Reconsideration of Acceptance conduct has on the applicant’s requisite of Application and for Dismissal of Appli­ propriate issue will be specified for that and comparative qualifications. cation of Tri-County. purpose. (4) To determine whether the Tri- October 31, Tri-County Opposition to Peti­ 12. At various times during the pend­ County Broadcasting Co., is financially tion to Dismiss Application of Tri-County. ency of the Tri-County application, qualified to construct and operate its November 9, Shoecraft Reply to Opposition to statements have been filed concerning proposed station. Petition to Dismiss Application of Tri- the policy of the proposed station with (5) To determine the efforts made by County. respect to program service. Tri-County the Tri-County Broadcasting Co., tò as­ November 14, Shoecraft Reply to Motion to Dismiss Petition for Reconsideration of mentions personal knowledge and broad­ certain the community needs and in­ Acceptance of Application and for Dismissal cast experience of the partners, contacts terests of'the area to be served and the of Application of Tri-County. with unspecified citizens and representa­ means by which it proposes to meet those November 16, Tri-County Answer to Reply tives of various organizations, local resi­ needs. to Opposition to Petition to Dismiss Appli­ dence, and participation in local organi­ (6) To determine which of the pro­ cation of Tri-County. zations. Tri-County states that it intends posals would better serve the public November 17, Shoecraft Motion to Dismiss to provide local news coverage and to interest. Answer to Reply to Opposition to Petition cooperate with educational institutions, to Dismiss Application of Tri-County. (7) To determine, in the light of the November 22, Tri-County Answer to Reply to government agencies and departments, evidence adduced pursuant to the fore­ Motion to Dismiss Petition for Reconsider­ charitable and civic organizations and going issues, which, if either, of the ap­ ation of Acceptance of Application and for agricultural agencies. In the application plications should be granted. Dismissal of Application of Tri-County. is a general statement regarding the na­ 15. It is further ordered, That the re­ November 23, Tri-County Answer to Motion ture of some of its programs. More re­ quests to dismiss the applications are to Dismiss Answer to Reply to Opposition cently, Tri-County filed a number of denied and all other requests and thè to Petition to Dismiss Application. copies of a questionnaire entitled “Com­ petitions are dismissed. November 30, Shoecraft Opposition to Re­ munity Survey” reflecting the views of quest to Accept an Additional Pleading residents of Safford, Thatcher, Tucson, 16. It is further ordered, That in the (This document was in opposition to Tri- and Globe, Ariz., and states that the event of a grant of the application of County’s foregoing “answer” in which Tri- the Tri-County Broadcasting Co., the County requested the Commission to needs, interests and problems of the area consider its pleading filed on November 16 are substantially the same as indicated construction permit shall include the notw ithstanding the lim itation imposed on in previous surveys. Upon examination following condition: This authorization the filing of pleadings by section 1.45 of the of all the material on file, it is not clear is without prejudice to any action the Commission’s rules.) whether the applicant has consulted a Commission may deem necessary as a December 19, Shoecraft Response to Reply to representative cross section of the eco­ result of the final judgment in the case, Motion to Dismiss Petition for Reconsidera­ nomic, social, political, cultural and of Shoecraft, et al. v. Valley National tion of Acceptance of Application and for other elements in its proposed service Bank, et al., No. 91957, Superior Court Dismissal of Application. area or whether the applicant has com­ of Arizona, Pima County. [PJt. Doc. 70-11223; Piled, Aug, 25, 1970; plied with other requirements in as­ 17. It is further ordered, That, to avail 8:46 am .] certaining community, problems. See themselves of the opportunity to be “Primer on Ascertainment of Commu­ heard, the applicants herein, pursuant to nity Problems by Broadcast Applicants,” § 1.221(c) of the Commission’s rules, in 34 F.R. 20282, 20 FCC 2d 880, Pike and person or by attorney, shall, within 20 SECURITIES AND EXCHANGE Fischer R.R., Current Service, page days of the mailing of this order, file with 53:273 (1969). Therefore, an issue will the Commission in triplicate, a written COMMISSION be specified which will permit Tri- appearance stating an intention to ap­ County to adduce evidence on its efforts pear on the date fixed for the hearing and [70-4905] to ascertain the community needs and present evidence on the issues specified in COLUMBIA GAS SYSTEM, INC. interests of the area to be served. this order. 13. Except as indicated by the issues 18. It is further ordered, That the ap­ Notice of Proposed Issue and Sale of specified below, the applicants are quali­ plicants herein shall, pursuant to section Debentures at Competitive Bidding fied to construct and operate as pro­ 311(a) (2) of the Communications Act of August 19, 1970. posed. However, since the proposals are 1934, as amended, and § 1.594 of the mutually exclusive, they must be desig­ Commission’s rules, give notice of the Notice is hereby given that The Co­ nated for hearing in a consolidated pro­ hearing, either individually or, if feasible lumbia Gas System, Inc. (Columbia), ceeding on the issues specified below. and consistent with the rules, jointly, 120 East 41st Street, New York, N.Y. 14. Accordingly, it is ordered, That, within the time and in the manner pre­ 10017, a registered holding company, pursuant to section 309(e) of the Com­ scribed in such rules, and shall advise the has filed a declaration with this Com­ munications Act of 1934, as amended, the Commission of the publication of such mission pursuant to the Public Utility applications are designated for hearing notice as required by § 1.594(g) of the Holding Company Act of 1935 (Act), in a consolidated proceeding, at a time rules. designating sections 6 and 7 of the Act and place to be specified in a subsequent and Rule 50 promulgated thereunder as order, upon the following issues: Adopted: August 5,1970. applicable to the proposed transaction. (1) To determine the areas and popu­ Released: August 18,1970. All interested persons are referred to the lations which would receive primary declaration, which is summarized below, service from the proposal of the Tri- F ederal Communications for a complete statement of the proposed County Broadcasting Co. and the~avail- Co m m issio n, transaction. ability of other primary aural service (1 [seal] B en F. W aple, Columbia proposes to issue and sell, mv/m or greater in the case of FM) to Secretary. subject to the competitive bidding re­ such areas and populations. , Chronological list of pleadings, all received quirements of Rule 50 under the Act, (2) To determine the areas and popu­ in October, November, and December of 1966: $50 million principal amount o f ---- lations which may be expected to gain October 10,1 Shoecraft Petition for Recon­ percent debentures, series due October or lose primary service from the proposed sideration of Acceptance of Application and 1995. The interest rate of the debentures operation of station KATO and the avail­ for Dismissal of Application of Tri-County (which will be a multiple of one-eighth ability of other primary aural service Broadcasting Co. (Tri-County). (1 mv/m or greater in the case of FM) of 1 percent) and the price, exclusive of accrued interest, to be paid to Columbia to such areas and populations. 1 Dates Indicate the day on which the re­ (3) To determine whether the prin­ spective documents were received by the (which will be not less than 98 Ms percent cipals of the Tri-County Broadcasting Commission. nor more than 101 Vz percent of the

FEDERAL REGISTER, VOL. 35, NO. 166-^-WEDNESDAY, AUGUST 26, 1970 NOTICES 13617 principal amount thereof) will be de­ [70-4881] Any bank borrowings will be evidenced termined by the competitive bidding. by short-term notes, to mature not more The debentures will be issued under an OHIO POWER CO. AND CAMBRIDGE than 1 year from the date of issue, to indenture between Columbia and Mor­ HOUSING, INC. bear interest at the prime rate, and to gan Guaranty Trust Co. of New York, Notice of Proposed Acquisition of be prepayable by Cambridge at any time Trustee, dated as of June 1, 1961, as without premium or penalty. In order to heretofore supplemented by various Capital Stock and Notes of Newly make the prime rate available to Cam­ indentures and as to be further supple­ Organized Housing Company bridge, Ohio Power may be required by mented by a fifteenth supplemental in­ August 19, 1970. banks to guarantee the notes. Ohio denture to be dated as of October 1,1970. Power requests authorization to make Notice is hereby given that Ohio Power such guarantees, if required. Columbia will not have the right to re­ Co. (Ohio Power), a public-utility sub­ deem any of the debentures prior to Any borrowings from Ohio Power will sidiary company of American Electric be evidenced by short-term notes, to October 1, 1975, directly or indirectly, Power Co., Inc., a registered holding com­ with borrowed funds, or in anticipation pany, and its wholly owned subsidiary mature not later than 1 year from the of funds to be borrowed, having an company, Cambridge Housing, Inc. date of issue and to bear interest at an effective annual interest cost to Colum­ (Cambridge), 310 Cleveland Avenue, annual rate equal to the effective an­ bia of less than the effective annual Canton, Ohio 44701, a nonutility com­ nual interest cost, to Ohio Power, from interest cost of the debentures to pany recently organized under Ohio law, time to time, of short-term borrowings, Columbia. have filed an application-declaration, or in the absence of such borrowings The net proceeds from the sale of the and amendments thereto, with this Com­ by Ohio Power at the time of such loans debentures will be added to the general mission pursuant to the Public Utility to Cambridge, at the prime commercial funds of Columbia and together with Holding Company Act of 1935 (Act), rate in effect, from time to time, at funds then available and funds to be designating sections 6, 7, 9(a)(1), 9(c) Manufacturers Hanover Trust Company generated from operations, will be used (3), 10, 11, and 12 and Rules 43 and 45 of New York. by Columbia to finance, among other promulgated thereunder as applicable to It is stated that Cambridge will re­ things, part of the cost of its subsidiary the proposed transactions. All interested tire all such notes from the proceeds companies’ 1970 construction program, persons are referred to the application- of the aforementioned permanent mort­ estimated at $200 million. declaration, which is summarized below, gage loan. It is stated that no State or Federal for a complete statement of the proposed The filing also states that, since Cam­ commission, other than, this Commis­ transactions. * bridge will take accelerated depreciation sion, has jurisdiction over the proposed Ohio Power distributes electric energy for Federal income tax purposes on de­ transaction. A statement of the fees, at retail in various cities and towns in preciable property and will have sub­ commissions, and expenses related to the the State of Ohio, including the city of stantial interest payments which are proposed transaction is to be filed by Cambridge. Cambridge was organized for deductible expenses for tax purposes, it amendment. the purpose of constructing, owning, and is anticipated that Cambridge will have Notice is further given that any inter­ operating low- and moderate-income tax losses each year during the period ested person may, not later than Sep­ housing projects under section 236 of the it owns the properties to be constructed. tember 10, 1970, request in writing that National Housing Act, as amended. It It is requested that an exception to the a hearing be held on such matter, stat­ is stated that Cambridge is a “limited Commission’s Rule 45(b)(6) be granted ing the nature of his interest, the distribution’’ corporation under regula­ which will permit the allocation of such reasons for such request, and the issues tions issued by the Federal Housing Ad­ tax losses to Ohio Power. of fact or law raised by said declaration ministration (FHA), which would qualify The application-declaration states which he desires to controvert; or he that company for mortgage financing as­ that no approval or consent of any regu­ may request that he be notified if the sistance therefrom such as to reduce the latory body, other than this Commis­ Commission should order a hearing effective interest rate to be paid thereon sion, is necessary for the proposed trans­ thereon. Any such request should be by Cambridge to 1 percent per annum. actions. No fees or expenses are expected addressed: Secretary, Securities and Ex­ It is stated that the city of Cambridge to be incurred by Ohio Power or Cam­ change Commission, Washington, D.C. has experienced stagnation in the con­ bridge in connection with the proposed 20549. A copy of such request should be struction of new housing (despite recent transactions except miscellaneous ex­ served personally or by mail (airmail if significant industrial and commercial penses estimated at not to exceed $500. the person being served is located more growth) which has most acutely affected The Division advises that the record than 500 miles from the point of mail­ the low- and moderate-income groups. in this proceeding appears to be com­ ing) upon the declarant at the above- It is further stated that Ohio Power de­ plete. The applicants-declarants request stated address, and proof of service (by sires to participate, through Cambridge, that, if no interested person requests a affidavit or, in case of an attorney at in the construction of low- and moder­ hearing, the matter be considered by the law, by certificate) should be filed with ate-income housing projects to assist in Commission on the basis of the present the request. At any time after said date, the alleviation of the housing shortage. record as it now stands. the declaration, as filed or as it may be As an initial project, Cambridge proposes Notice is further given that any inter­ amended, may be permitted to become to construct approximately 100 housing ested person may, not later than Sep­ effective as provided in Rule 23 of the units on 12 acres of land in Cambridge. tember 2, 1970, request in writing that general rules and regulations promul­ The total cost of the project will be ap­ a hearing be held on such matter, stat­ gated under the Act, or the Commission proximately $2,500,000, of which approxi­ ing the nature of his interest, the rea­ may grant exemption from its rules as mately 90 percent will be financed by a sons for such request, and the issues provided in Rules 20(a) and 100 thereof mortgage loan insured by the FHA. of fact or law raised by the filing which or take such other action as it may deem Ohio Power proposes to acquire, and he desires to controvert, or he may re­ appropriate. Persons who request a hear­ Cambridge proposes to issue, up to 500 quest that he be notified if the Com­ ing or advice as to whether a hearing is shares of common stock, par value $1,000, mission should order, a hearing thereon. ordered will receive notice of further de­ to provide equity capital as required. Any such request should be addressed: velopments in this matter, including the Cambridge further proposes to obtain Secretary, Securities and Exchange date of the hearing (if ordered) and any funds of up to $2,500,000 for preoperating Commission, Washington, D.C. 20549. A Postponements thereof. and construction expenditures (1) by ob­ copy of such request should be served For the Commission, by the Division taining construction advances approved personally or by mail (airmail if the of Corporate Regulation, pursuant to by the FHA, (2) by conventional bor­ person being served is located more than delegated authority. rowings from local banks (to be guaran­ 500 miles from the point of mailing) upon the applicants-declarants at the [seal] Orval L. D uB o is, teed by Ohio Power if required), or (3) above-stated address, and proof of serv­ Secretary. by borrowing from Ohio Power, depend­ ice (by affidavit or, in case of an attor­ [F-R. Doc. 70-11234; Filed, Aug. 25, 1970; ing on the availability and. attractive­ ney at law, by certificate) should be filed 8:47 ajn.] ness of each alternative. with the request. Persons who request a

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 13618 NOTICES hearing or advice as to whether a hear­ August 8, 1970”, and substituting “Feb­ Covey & Dayton, agriculture; Cokeville, ing is ordered will receive notice of fur­ ruary 28, 1971” for “December 31, 1970” Wyo.; 5-25-71. Dalton Grocery, foodstore; 3408 North ther developments in this matter, in­ in paragraph 2 thereof. Whitehall Road, North Muskegon, Mich.; cluding the date of the hearing (if or­ Dated: August 13, 1970. 5- 20-71. dered) and any postponements thereof. Dick’s Super Market, foodstores, 5-25-71; H ilary S andoval, Jr., By the Commission. Wells Street, Darlington, Wis.; 255 McGregor Administrator. Plaza, Plattevllle, Wis. [SEAL3 ORVAL L. D uBOIS, [F.R. Doc. 70-11217; Filed, Aug. 25, 1970; Dickson’s, furniture store; 201 East Cham­ Secretary. 8:46 a.m.] bers Street, Cleburne, Tex.; 6-7-71. Dill’s, variety-departm ent store; Public [F.R. Doc. 70-11235; Filed, Aug. 25, 1970; Square, Dover, Tenn.; 5-31-71. 8:47 a.m.] Eagle Stores Co., Inc., variety-department store; 102 East Broadway, Maryville, Tenn.; DEPARTMENT OF LABOR 6- 11-71. Wage and Hour Division Eisenberg Department Store, Inc., apparel SMALL BUSINESS store; 401 Schoonmaker Avenue, Monessen, CERTIFICATES AUTHORIZING EM­ Pa.; 6-18-71. PLOYMENT OF FULL-TIME STU­ Anthony Euser Greenhouses, agriculture; ADMINISTRATION Route 1, Broomfield, Colo.; 5-28-70 to 4-8-71. [Declaration of Disaster Loan Area 784] DENTS WORKING OUTSIDE OF Evanna Plantation, Inc., agriculture; Cary, SCHOOL HOURS AT SPECIAL Miss.; 6-4-71. GEORGIA MINIMUM WAGES IN RETAIL OR Faisonia Plantation, agriculture; Rou/te 2, Indianola, Miss.; 6-11-71. Declaration of Disaster Loan Area SERVICE ESTABLISHMENTS OR IN Fantle’s, Inc., variety-department store; AGRICULTURE 100 South Main Avenue, Sioux Falls, S. Dak.; Whereas, it has been reported that 6-5-71. during the month of August 1970, be­ Notice is hereby given that pursuant to Fisher Brothers, agriculture; 846 Oak Av­ cause of the effects of certain disasters, section 14 of the Fair Labor Standards enue, Muskegon, Mich.; 6-15-71. damage resulted to residences and busi­ Act of 1938 (52 Stat. 1060, as amended, Food Giant Super Markets, Inc., foodstores, ness property located in Chatham 29 U.S.C. 201 et seq.), the regulation on 5- 23-71: Nos. 1 and 2, Tucson, Ariz. County, Ga.; employment of full-time students (29 Garrett Drug Co., drugstores, 6-17-71: Nos. Whereas, the Small Business Adminis­ CFR Part 519), and Administrative 1, 3, and 4, Nashville, Tenn. tration has investigated and has received Gilmore-Puckett Lumber Co., hardware Order No. 595 (31 F.R. 12981), the es­ store; Armory, Miss.; 5-19-71. other reports of investigations of condi­ tablishments listed in this notice have Goldblatt Bros., Inc., variety-department tions in the areas affected; been issued special certificates author­ stores, 5-31-71: 14 Country Fair Shopping Whereas, after reading and evalu­ izing the employment of full-time Center, Champaign, 111.; 333 State Street, ating reports of such conditions, I find students working outside of school hours Chicago, 111. that the conditions in such areas con­ at hourly rates lower than the minimum Golob Super Market, foodstore; Arma, stitute a catastrophe within the purview wage rates otherwise applicable under Kans.; 6-14-71. W. T. Grant Co., variety-department store; of the Small Business Act, as amended. section 6 of the act. While effective and No. 494, Leominster, Mass.; 6-15-71. Now, therefore, as Administrator of expiration dates are shown for those cer­ Hack’s, Inc., furniture and appliance store; the Small Business Administration, I tificates issued for less than a year, only 3390 West Green Bay Avenue, Milwaukee, hereby determine that: the expiration dates are shown for cer­ Wis.; 4-20-71. 1. Applications for disaster loans un­ tificates issued for a year. The minimum Harrys Market, foodstore; Main Street, der the provisions of section 7(b) (1) of certificate rates are not less than 85 Somerset, Ky.; 5-21-71. the Small Business Act, as amended, percent of the applicable statutory Hart-Albin Co., variety-department store; minimum. Billings, Mont.; 5-20-71. may be received and considered by the Herbst Variety, Inc., variety-department office below indicated from persons or The following certificates provide for store; 108-110 North Main Street, Washing­ firms whose property situated in the an allowance not to exceed the propor­ ton, 111.; 5-28-71. aforesaid county, and areas adjacent tion of the total hours worked by full­ L. D. Holmes & Sons, agriculture; Route 1, thereto, suffered damage or destruction time students at rates below $1 an hour Johnston, S.C.; 6-14-71. resulting from floods occurring on Au­ to the total number of hours worked by Hornbeak Grocery, foodstore; Ridgely, all employees in the establishment dur­ Tenn.; 5-28-71. gust 8 and 9, 1970, and continuing Host International, Inc., restaurants, 4-20- thereafter. ing the base period in occupations of the 71: Nos. 703, 704, 705, 706, 707, 708, 709, 710, Office same general classes in which the estab­ 711, 712, 713, 714, 715, 716, 717, and 718, Small Business Administration Regional lishment employed full-time students at Indiana Toll Road, Indiana. Office, 1401 Peachtree Street NE., Atlanta, wages below $1 an hour in the base C. A. House, Co., Inc., music store; 10th Ga. 30309 period. and Main Streets, Wheeling, W. Va.; 5-12-71. Avellone Pharmacy, Inc., drugstore; 27251 Ideal Poultry Breeding Farms, Inc., agri­ 2. Applications for disaster loans un­ Wolf Road, Bay Village, Ohio; 6-18-71. culture; Cameron, Tex.; 6-16-71. der the authority of this Declaration Badt’s Pharmacy, Inc., drugstore; 248 Jackson County Hospital & Nursing Home, will not be accepted subsequent to hospital; Scottsboro, Ala.; 6-14-71. North Paw Paw Street, Coloma, Mich.; 5-25- K & K 5c-10c Store, variety-department February 28, 1971. 71. Bethania Hospital, hospital; 1600 11th store; 7342 Granby Street, Norfolk, Va.; Dated: August 13, 1970. Street, Wichita Falls, Tex.; 6-8-71. 6- 7-71. Richard W. Bishop, agriculture; 8995 Pe­ K aufman’s, apparel store; 1301 11th Ave­ H ilary S andoval, Jr., nue, Altoona, Pa.; 6-18-71. Administrator. terson Road, Whitehall, Mich.; 5-21-71. C. H. Block & Co., Inc., agriculture; Tunica, S. S. Kresge Co., variety-department stores: [F.R. Doc. 70-11220; Filed, Aug. 25, 1970; Miss.; 6-15—71. No. 303, Arlington Heights, HI., 6-5-71; No. 8:46 a.m.] Walt Boe’s Super Market, Inc., foodstore; 4560, Kansas City, Kans., 5-28-71; No. 689, 57 North Broadway, Pelican Rapids, Minn.; Grandview, Mo., 6-19-71; No. 704, Dallas, 6-9-71. Tex., 6-3-71. [Declaration of Disaster Loan Area 776; Bonson’s Shop Rite, foodstore; Eagle River, S. H. Kress & Co., variety-department store; Arndt. 1] 201 West California Street, Gainesville, Tex.; Wis.; 5-30-71. 5- 23-71. Bristol County Agricultural High School, Kuhn’s Variety Store, variety-department agriculture; Segreganset, Mass.; 5-31-71. Andrew Buist, Sr., agriculture; 1055 Chip- store; Waldron Street and Public Square, Declaration of Disaster Loan Area pawa Street, Jenison, Mich.; 6-4-71. Corinth, Miss.; 6-3-71. Declaration of Disaster Loan Area 776, Cary Plantation, agriculture; Cary, Miss.; Lenger Super Market, Inc., foodstore; 16 6-4-71. West Burton Street, Grand Rapids, Mich.; dated June 19, 1970, for Puerto Rico, is Central Community Hospital, hospital; 6- 11-71. hereby amended as follows: Elkader, Iowa; 6-12-70 to 5-22-71. Frank Lockage’s Store for Men, appar®1 By changing the period in paragraph 1 Ceo Music Co., Inc., music store; 1004 Main store; 2761 Peck Street, Muskegon Heights, thereof to a comma, and adding “and Street, Wheeling, W. Va.; 5-12-71. Mich.; 5-20»-71.

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST. 26, 1970 NOTICES 13619

Low Cost Drug Center, Inc., drugstore; 101 year employment experience of other Guerin’s IGA Foodliner, foodstore; Morgan North Main, Logan, Utah; 6-9-71. establishments, either because they came City, La.; bagger, stock clerk, carryout, Mansfield General Hospital, hospital; 335 into existence after the beginning of the cleanup; 13 to 17 percent; 6-14-71. Glessner Avenue, Mansfield, Ohio; 5-6-71. H. E. B. Food Store, foodstores, for the Maplecrest Center, Inc., nursing home; 174 applicable base year or because they did occupations of bottler, packager, sacker, 10 tyrain Street, Madison, Maine; 6-9-71. not have available base-year records. percent, 6-16-71: No. 110, Georgetown, Tex.; Maymore Leader Drug, drugstore; 4503 The certificates permit the employment No. 109, Marble Falls, Tex. Mayfield Road, South Euclid, Ohio; 6-18-71. of full-time students at rates of not less H & L, Inc., foodstore; 6704 Main, Caseville, W. O. McCurdy & Sons, agriculture; Fre­ than 85 percent of the statutory mini­ Mich.; carryout, stock clerk; 13 to 20 percent; mont, Iowa; 6—1—71. mum in the classes of occupations listed, 6-12-71. McDonald’s Hamburgers, restaurant; 9783A and provide for the indicated monthly Hack’s, Inc., furniture and appliance store; St. Charles Rock Road, St. Louis, Mo.; 6-9-71. 7833 West Capitol Drive, Milwaukee, Wis.; limitations on the percentage of full­ general office work; 20 to 44 percent; 4-20-71. Mclllhenny Co., agriculture; Avery Island, time student hours of employment at, La.; 5-24-71. Handy-Andy, Inc., foodstore; No. 175, Aus­ McVille Friendship Manor, nursing home; rates below the applicable statutory min­ tin, Tex.; packager, sacker, salesclerk, porter, Me Ville, N. Dak.; 6-14-71. imum to total hours of employment of sorter, cashier, checker; 18 to 30 percent; Michael’s, variety-department store; Pon­ all employees. 6-6-71. Harvey’s, Inc., variety-department stores, totoc, Miss.; 6—15—71. Bishop Cafeteria Co., restaurants, for the Mid-Nebraska Lutheran Home, nursing for the occupation of salesclerk, 11 to 25 per­ occupations of tray carrier, counter server, cent: 3838 Broadway, Gary, Inc., 6-8-71; 152 home; Newman Grove, Nebr.; 5-28-70 to 5- bus help, 0 to 20 percent, 6-18-71: College 8-71. Square Shopping Center, Cedar Falls, Iowa; West Lincolnway, Valparaiso, Ind., 6-17-71. Mr. Z’s IGA Foodliner, foodstore; 1417 West Robert Hoffman IGA Foodliner, foodstore; Crossroads Shopping Center, Waterloo, Iowa. Third and Allen Streets, Montgomery City, Sixth, Emporia, Kans.; 6-11-71. Browdy’s Fine Foods, foodstore; 2807 Morgan & Lindsey, Inc., variety-depart­ Mo.; salesclerk, stock clerk, carryout, clean­ Cahaba Road, M ountain Brook, Ala.; carry up; 20 percent; 6-17-71. ment store; No. 3036, Pascagoula, Miss.; 5- out, bus boy (girl); 15 percent; 6-11-71. 26-71. Charlie’s Red & White Food Store, food- Import Plaza, variety-department store; Mother of Mercy Nursing Home, nursing store; 632 East Buena Visita Avenue, North One Northwest Couch, Portland, Oreg.; pric­ home; Albany, Minn.; 6-17-71. Augusta, S.C.; stock clerk, bagger; 15 to 20 ing clerk, stock clerk, dusting clerk, cashier; G. C. Murphy Co., variety-departm ent percent; 6-2-71. 69 percent; 5-31-71. store; No. 87, Pittsburgh, Pa.; 6-16-71. Dick’s Super Market, foodstore; 138 South Kopper Kettle Restaurant, restaurants, for The Music Center, music store; 46 Fourth Iowa, Dodgeville, Wis.; bagger, stock clerk, the occupations of busboy (girl), dishwasher, Street SW., Huron, S. Dak.; 5-28-71. clean up; 17 to 23 percent; 6-9-71. general help, 22 to 41 percent, 6—14-71; 1-80 Olson’s Grocery, foodstore; Bagley, Minn.; The Dillon Co., Inc., foodstores, for the and Minden Inter-Change, Minden, Iowa; 5-13-71. occupations of cashier, checker, carry out, 1-29 and U.S. Highway 30, Missouri Valley, The Orme School and Orme Ranch, agri­ wrapper, clerk, maintenance, 11 to 32 per­ Iowa; 1-80 and U.S. Highway 81, York, Nebr. culture; Mayer, Ariz.; 5-31-71. cent, 6-8-71; No. 44, Junction City, Kans.; S. S. Kresge Co., variety-departm ent stores, Powers Co., Inc., agriculture; Cary, Miss.; No. 43, Lawrence, Kans.; No. 46 M anhattan, for the occupations of salesclerk, stock clerk, 5-23-71. Kans.; No. 47, Topeka, Kans. checker-cashier, office clerk, except as other­ Rhea’s, Inc., foodstores, 6-9-71: 441 Mar­ Donenfeld’s, Inc., variety-department wise indicated: No. 4600, Chicago, 111., 21 to 26 ket Street, Pittsburgh, Pa.; 536 Smithfield stores, for the occupations of display clerk, percent, 6-2-71; No. 4227, Des Plaines, HI., 11 Street, Pittsburgh, Pa. salesclerk, gift wrapper, cashier, checker, to 20 percent, 5-22-71; No. 4148, Hammond, Rivin’s IGA, foodstore; Wagner, S. Dak.; 5- sales writer, office clerk, stock clerk, receiv­ Ind., 10 percent, 5-24—71; No. 4152; Misha­ 26-71. ing clerk, shipping clerk, fur-storage clerk, waka, Ind., 10 percent, 6-7-71; 109 East Sec­ Robie’s Food Center, Inc., foodstores, 6-11- switchboard operator, 4 to 16 percent, 5-13— ond Street, Muscatine, Iowa, 3 to 10 percent, 71: 604 South State Street, Abbeville, La.; 71: 2700 Miamisburg-Centerville Road, Day- 6-8-71 (salesclerk, stock clerk, checker-cash­ 1001 East Main Street, Jeanerette, La. ton, Ohio; 5200 Salem Avenue, Dayton, Ohio. ier); 609 Commercial Street, Atchison, Stevens, apparel store; 221 East Capitol Duckwall Stores Co., variety-department Kans., 5 to 35 percent, 6-9-71; No. 4006, Street, Jackson, Miss.; 6-6-71. store; No. 55, Topeka, Kans.; salesclerk, stock Louisville, Ky., 11 to 16 percent, 6-11-71 Sward Kemp Drug, drugstore; 207 South clerk; 16 to 28 percent; 6-2-71. (salesclerk, stock clerk, maintenance, office Washington, Redwood Falls, Minn.; 6-9-71. Egg-A-Day Farm Store, foodstore; 1575 clerk, checker-cashier, customer service) ; No. T.G. & Y. Stores Co., variety-department Center Point Road, Birmingham, Ala.; sales­ 4180, Louisville, Ky., 11 to 25 percent, 6-11-71 stores: No. 129, Kansas City, Mo., 6-5-71; clerk, stock clerk, cashier, janitorial; 21 to (salesclerk, stock clerk, maintenance, check­ No. 39, Oklahoma City, Okla., 5-26-71; No. 56, 44 percent; 6-3-71. er-cashier, office clerk, customer service) ; No. Oklahoma City, Okla., 5-31-71; No. 14, Elgin West Pharmacy, drugstore; 575 279, St. Paul, Minn., 18 to 30 percent, 6-8-71; Watonga, Okla., 6-4-71; No. 172, Memphis, North McLean Boulevard, Elgin, HI.; phar­ No. 585, Lincoln, Nebr., 3 to 10 percent, Team., 6-1-71. macy clerk, stock clerk, office clerk; 4 to 17 6-16-71; No. 4130, Omaha, Nebr., 3_to 10 The Tankard Nurseries, agriculture; Ex- percent; 6-5-71. percent, 6-17-71; No. 4233, Youngstown, Ohio, more, Va.; 5-31-71. Emporia Foods Distributors East, Inc., 10 percent, 6-12-71 (stock clerk, mainte­ Tate’s Supermarket, Inc., foodstore; 58 foodstore; 12th and Sylvan, Emporia, Kans.; nance, office clerk, food preparation, food Franklin Street, Clymer, Pa.; 5-22—71. packager, meat trimmer, cashier, carryout, sales, cashier, salesclerk, customer service); Thigpen Hardware Co., hardware store; 107- store clerk; 11 to 16 percent; 6-14—71. No. 4202, Greenviìle, S.C., UL to 22 percent, 11 South Harvey Avenue, Picayune, Miss.; Food Fair, Inc., foodstores, 4 to 21 percent: 6-8-71 (salesclerk). 6-15-71. Corbin, Ky., stock clerk, carryout, bagger, L & K Food Market, foodstore; Highway 75 Timberville Department Store; foodstore; cleanup, 6-14-71; Somerset, Ky„ bagger, car­ at Wortham, Willis, Tex.; carry, out, sacker; Timberville, Va.; 6-8-71. ryout, cleanup, pricing clerk, tagging clerk, 20 to 22 percent; 5-31-71. Tomlinson’s, Inc., variety-departm ent stock clerk, 5-26-71. Lemer Shops, apparel stores, for the occu­ store; 1212 Carolina Avenue, Hartsville, S.C.; pations of salesclerk, cashier, credit clerk, 10 5- 31-71. Food Giant Super Markets, Inc., food store; No. 5, Tucson, Ariz.; carryout; 13 to 45 per­ to 28 percent, 6-12-71, except as otherwise Vann Brothers, agriculture; Trenton, S.C.; cent; 5-23-71. indicated: Nos. 403, 470, 477, and 479, 6- 4-71. Phoenix, Ariz. (15 percent, 5-22-71); No. 437, Van Solkema Farms, Inc., agriculture; 8513 Garrett Drug Co., drugstore; No. 5, Nash­ Colorado Springs, Colo.; Nos. 411, 452, and Harlow Avenue, Byron Center, Mich.; 5-27- ville, Tenn.; drugstore worker; 21 to 25 462, Denver, Colo.; No. 463, Lakewood, Colo.; 71. percent; 6-17-71. No. 406, Pueblo, Colo.; No. 460, Westminster, B. Weille & Son, Inc., apparel store; 409-13 Gerald’s IGA, foodstore; Tribune, Kans.; Colo.; No. 203, Berwyn, HI. (15 to 32 percent) ; ' Broadway, Paducah, Ky.; 5-24-71. stock clerk, sacker, carryout, janitorial; 14 to Nos. 201, 226, 229, 230, 241, and 247, Chicago, Western Auto Store, variety-departm ent 53 percent; 6-18-71. IH.,(15 to 32 percent); No. 275, Melrose Park, stOTe; 201 East Panoal, Carthage, Tex.; 6-8-71. W. T. Grant Co., variety-department stores, HI. (15 to 32 percent); No. 161, Portland, West Side Market, foodstore; 133 North for the occupations of salesclerk, stock clerk, Maine (3 to 40 percent, 5-31-71); No. 179, Walker, Montgomery City, Mo.; 5-28-71. 4 to 18 percent, 5-36-71, except as otherwise Marlow Heights, Md. (11 to 34 percent, Willie’s Super Market, Inc., foodstore; 2422 indicated: No. 873, Fontana, Calif.; No. 301, 5-31-71); No. 220, Flint, Mich. (4 to 10 per­ Second Avenue North, Birmingham, Ala.; Fresno, Calif. (5-31-71); No. 224, Garden cent, 5-22-71) ; No. 249, Grand Rapids, Mich. 5-26-71. Grove, Calif. (6-16-71); No. 424, Inglewood, (4 to 10 percent, 5-22-71); No. 235, Jackson, Willis Nursery Co., agriculture; Ottawa, Calif. (4 to 14 percent, 6-16-71); No. 694, Mich. (4 to 10 percent, 5-22-71); No. 246, Kans.; 6-14-71. Riverside, Calif.; 1826 19th Avenue, Lewiston, Kalamazoo, Mich. (4 to 10 percent, 5-22-71) ; Wood’s 5 & 10c Stores, Inc., variety-depart­ Idaho (salesclerk, 2 to 14 percent, 5-31-71); Nos. 219, 268, and 305, St. Louis, Mo. (10 to ment store; Whitevllle, N.C.; 6-13-71. No. 1066, Niles, Mich, (salesclerk, stock clerk, 17 percent, 5-31-71); No. 240, Omaha, Nebr. office clerk, cashier, 3 to 22 percent, 5-20-71); (10 to 17 percent, 5-31-71); No. 421, Reno, The following certificates were issued No. 963, New Kensington, Pa. (salesclerk, 6 Nev. (2 to 14 percent, 5-31-71); No. 447, w> establishments relying on the base- to 20 percent). Provo, Utah (2 to 14 percent, 5-31-71); No.

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 No. 166----- 8 13620 NOTICES

407, Salt Lake City, Utah (2 to 14 percent, Pullman Pharmacy, drugstore; 11254 South Town & Country Supermarket, foodstore; 5-31-71); Nos. 77 and 306, Norfolk, Va. (11 Michigan Avenue, Chicago, HI.; pharmacy Central and Cherry Streets, Harrison, Ark.; to 20 percent, 5-27-71); Nos. 40, 52, and 76, clerk, stock clerk, office clerk; 9 to 18 percent; sacker, carryout, cleanup, stock clerk; 8 to Richmond, Va. (11 to 20 percent, 5-27-71) ; 6-5-71. 31 percent; 5-30-71. No. 53, Seven Comers, Va. (11 to 20 percent, Raylass Department Store, variety-depart­ Uncle Ray’s Inc., foodstore; 946 West 5- 27-71). ment stores, for the occupations of stock Huron, Vassar, Mich.; stock clerk, carryout; Lofton's variety-department store; Brook- clerk, salesclerk, office clerk, marker, jani­ 13 to 20 percent; 5-27-71. haven, Miss.; salesclerk, gift wrapper; 6 to 26 torial, cashier, wrapper, 13 to 34 percent, Whittaker, Inc., foodstores; No. 5, Okla­ percent, 6-16-71. 5-30-71, except as otherwise Indicated: homa City, Okla., packager, carryout, delivery Magic Mart—Parham, Inc., variety-depart­ Scottsboro Shopping Center, Scottsboro, help, 30 percent, 5-25-71; No. 6, Oklahoma ment store; 105 North Rodney Parham Road, Ala. (office clerk, salesclerk, stock clerk, City, Okla., sacker, carryout, 15 percent, Little Rock, Ark.; salesclerk, stock clerk, jani­ marker, cleanup, 6-14-71); Brainerd Village 6-2-71. torial; 6 to 17 percent; 6-15-71. Shopping Center, Chattanooga, Tenn.; 607 Wood’s 5 & 10

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 NOTICES 13621 issued under the supplemental industry (teen’s and misses’ slacks, shorts, jumpers, (Trade Route No. 29, U.S. Pacific/Far regulations are as listed. and shirts). East) from 54 sailings per annum to 62 Rockwell Manufacturing Corp., St. Paul, sailings per annum. Apparel Industry Learner Regulations Va.; 8-5-70 to 2-4-71; 20 learners (ladies’ (29 CFR 522,1 to 522.9, as amended, and brassieres and girdles). American President Lines, Ltd., in its 29 CFR 522.20 to 522.25, as amended). application called attention to the recent The following normal labor turnover Glove Industry Learner Regulations sale of the “SS President Roosevelt” in certificates authorize 10 percent of the (29 CFR 522.1 to 522.9, as amended, and advising that the company has total number of factory production 29 CFR 522.60 to 522.65, as amended). lost the potential to make approximately workers except as otherwise indicated. Indianapolis Glove Co., Inc., Houlka, Miss.; eight transpacific sailings per annum by 7- 30-70 to 7-29-71; 10 percent of the total that action. Angelica Uniform Co., Winfield, Mo.; 7-31- number of machine stitchers for normal Any person, firm, or corporation 70 to 7-30-71; 10 learners (men’s washable labor turnover purposes (work gloves). service uniform coats). having any interest in such application Ashland Crafts, Inc., Ashland, Ky.; 8-8-70 Wells Lamont Corp., Oak Grove, La.; and desiring a hearing on issues perti­ to 8-7-71 (children’s dresses). 8- 3-70 to 8-2-71; 10 learners for normal labor nent to section 605(c) of the Merchant Blackville M anufacturing Corp., Black- turnover purposes (work gloves). Marine Act, 1936, as amended, 46 U.S.C. ville, S.C.; 8-2-70 to 8-1-71 (ladies’ dresses Hosiery Industry Learner Regulations 1175, should, by the close of business on and blouses). (29 CFR 522.1 to 522.9, as amended, and September 10, 1970, notify the Secretary, Clayburne M anufacturing Co., Inc., Clay­ ton, Ga.; 8-5-70 to 8-4-71 (men’s sport 29 CFR 522.40 to 522.43, as amended). Maritime Subsidy Board in writing in shirts).. Virginia Maid Hosiery Mills, Inc., Pulaski, triplicate, and file petition for leave to Diaper Jeans, Inc., Denison, Tex.; 8-10-70 Va.; 8-8-70 to 8-7-71; 5 percent of the total intervene in accordance with the rules of to (infants’ and children’s wear). number of factory production workers for practice and procedure of the Maritime Dickson M anufacturing Co., Plant No. 1, normal labor turnover purposes (ladies’ Subsidy Board. Dickson, Tenn.; 8-8-70 to 8-7-71 (men’s seamless nylons). In the event a section 605(c) hearing is work shirts). ordered to be held, the purpose thereof Don Juan M anufacturing Corp., Hertford, Knitted Wear Industry Learner Regu­ N.C.; 8-11-70 to 8-10-71 (men’s and boys’ lations (29 CFR 522.1 to 522.9, as will be to receive evidence relevant to (1) shirts). amended and 29 CFR 522.30 to 522.35, whether the application is one with re­ Garan, Inc., Clinton, Ky.; 8-9-70 to 8-8-71 as amended). spect to a vessel to be operated on a serv­ (boys’ and men’s shirts, girls’ and ladies’ ice, route, or line served by citizens of blouses). Junior Form Lingerie Corp., Boswell, Pa.; the United States which would be in Gwen Fashions, Inc., McAlisterville, Pa.; 8-3-70 to 8-2-71; 5 percent of the total num­ ber of factory production workers for normal addition to the existing service, or serv­ 8-10-70 to 8-9-71 (women’s dresses). ices, and if so, whether the service already The Hercules Trouser Co., Wellston, Ohio; labor turnover purposes (ladies’ slips and 7-30-70 to 7-29-71 (men’s and boys’ pants). sleepwear). provided by vessels of U.S. registry in Iva Manufacturing Co., Iva, S.C.; 7-30-70 Signal K nitting Mills, Inc., New Tazewell, such service, route, or line is inadequate, to 7-29-71; 10 learners (ladies’ cotton Tenn.; 7-28-70 to 7-27-71; 5 percent of the and (2) whether in the accomplishment blouses, shift dresses, and culottes). total number of factory production workers of the purpose and policy of the Act addi­ Jamestown Manufacturing *Co., James­ for normal labor turnover purposes (men’s tional vessels should be operated thereon. town, Tenn.; 8-6-70 to 8-5-71 (men’s and and boys’ T-shirts, athletic shirts, and If no request for hearing and petition boys’ sport shirts and pants). briefs). foT leave to intervene is received within Jester Kids Klothes, Inc., Tarpon Springs, Fla.; 8-1-70 to 7-31-71 (children’s clothes). Each learner certificate has been is­ the specified time, or if the Maritime Kellwood Co., Calhoun City, Miss.; 8-8—70 sued upon the representations of the /Subsidy Board determines that petitions to 8-7-71 (boys’ semidress trousers). employer which, among other things, for leave to intervene filed within the Ozark M anufacturing Co., Inc., Ozark, were that employment of learners at specified time do not demonstrate suf­ Ala.; 8-10-70 to &-9-71 (ladies’ blouses). special minimum rates is necessary in ficient interest to warrant a hearing, the Plantersville Sportswear, Inc., Planters- order to prevent curtailment of oppor­ Maritime Subsidy Board will take such ville, Miss.; 8-5-70 to 8-4-71 (men’s slacks). tunities for employment, and that expe­ action as may be deemed appropriate. RCM Enterprises, Inc., Bacon ton, Ga.; rienced workers for the learner occupa­ 7- 31-70 to 7-30-71; 10 learners (ladies’ and Dated: ,1970. girls’ blouses). tions are not available. Any person Salant & Salant Inc., Marked Tree, Ark.; aggrieved by the issuance of any of these By order of the Maritime Subsidy 8- 5-70 to 8-4-71 (children’s pants). certificates may seek a review or recon­ Board. Henry I. Siegel Co., Inc., Dickson, Tenn.; sideration thereof within 15 days after J ames S. D awson, Jr., 8-1-70 to 7-31-71 (ladies’, girls’, men’s, and publication of this notice in the F ederal Secretary. boys’ pants). R egister pursuant to the provisions of Henry I. Siegel Co., Inc., Hohenwald, [F.R. Doc. 70-11378; Filed, Aug. 25, 1970; Tenn.; 8-3-70 to 8-2-71 (men’s and boys’ 29 CFR 522.9. The certificates may be 9:52 a.m.] pants). ", annulled or withdrawn, as indicated Sportswear Unlimited, Iva, S.C.; 7-30-70 therein, in the manner provided in 29 to 7-29-71; 10 learners (ladies’ blouses and CFR Part 528. dresses). Signed at Washington, D.C., this 17th FEDERAL POWER COMMISSION Wildwood Clothing Co., Inc, Wildwood, day of August 1970. N.J.; 8-1-70 to 7-31-71; 10 learners (ladies’ [Docket No. RI71-136 etc.] and men’s slacks and shorts). R obert G. G ronewald, ATAPAZ PETROLEUM, INC, ET AL. Williamson-Dickie Manufacturing Co., Mc­ Authorized Representative Allen, Tex.; 8-11-70 to 8-10-71 (men’s work of the Administrator. Order Providing for Hearings on and pants). [F.R. Doc. 70-11215; Filed, Aug. 25, 1970; Suspension of Proposed Changes in Woodbury Manufacturing Co., Inc., Wood­ 8:46 a.m.] bury, Tenn.;' 8-6-70 to 8-5-71 (men’s and Rates 1 boys’ shirts, women’s and girls’ blouses). August 14, 1970. Woolf oik M anufacturing Corp., Louisa, The respondents named herein have Va.; 8- 7_7o to 8-6-71 (men’s and boys’ filed proposed increased rates and pants). DEPARTMENT OF COMMERCE charges of currently effective rate sched­ pie following plant expansion certifi­ Maritime Administration ules for sales of natural gas under Com­ cates were issued authorizing the number [Docket No. S-253] mission jurisdiction, as set forth in of learners indicated. Appendix A hereof. AMERICAN PRESIDENT LINES, LTD. Daisy Garment Makers, Washington, N.C.; The proposed changed rates and 1 70 to 1-31-71; 32 learners (children’s Notice of Application charges may be unjust, unreasonable, un­ dresses). duly discriminatory, or preferential, or Shirt Corp., Hamburg, Ark.; Notice is hereby given that American otherwise unlawful. -70 to 1-31-71; 75 learners (boys’ shirts). President Lines, Ltd., has applied for an Kenmar Manufacturing Corp., Parkers- increase in maximum sailings on its sub­ 1 Does not consolidate for hearing or dispose °urg, w. Va.; 8-7-70 to 2-6-71; 35 learners sidized Trans-Pacific Freight Service of the several matters herein.

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 13622 NOTICES The Commission finds: It is in the held concerning the lawfulness of the position of these proceedings or expira­ public interest and consistent with the proposed changes. tion of the suspension period. Natural Gas Act that the Commission (B) Pending hearings and decisions (D) Notices of intervention or peti­ enter upon hearings regarding the law­ thereon, the rate supplements herein are tions to intervene may be filed with the fulness of the proposed changes, and that suspended and their use deferred until Federal Power Commission, Washington, the supplements herein be suspended and date shown in the “Date Suspended Un­ D.C. 204â6, in accordance with the rules their use be deferred as ordered below. til” column, and thereafter until made of practice and procedure (18 CFR 1.8 The Commission orders: effective as prescribed by the Natural and 1.37(f) ) on or before September 28, (A) Under the Natural Gas Act, par­Gas Act. 1970. ticularly sections 4 and 15, the regula­ (C) Until otherwise ordered by the By the Commission. tions pertaining thereto (18 CFR Ch. D , Commission, neither the suspended sup­ and the Commission’s rules of practice plements, nor the rate schedules sought Cseal] G ordon M. G rant, and procedure, public hearings shall be to be altered, shall be changed until dis- Secretary.

Appendix A

Cents per Mcf* Rate in R a te S u p - Amount Date Effective Date ■ ■ ------effect stib- Docket Respondent sched- pie- Purchaser and producing area of filing date suspended ject to No. ule ment annual tendered unless until— Rate in Proposed refund in N o . N o . increase suspended effect increased rate dockets N os.

RI71-136— Atapaz Petroleum, Inc., 1 4 Natural Gas Pipeline Co. of $8,733 7-20-70 8-20-70 1-20-71 16.4615 17.4653 RI-70-677. Post Office Box 1828, Mid­ America (Lockridge Field; Ward land, Tex. 7970L County, Tex., RR. District No. 8) (Permian Basin Area). RI71-137.. Pennzoil United, Inc., 900 18 3 ____ d o ------6,776 7-20-70 8-20-70 1-20-71 16.4615 . 17.4653 RI-70-525. Southwest Tower, Houston, Tex. 77002. RI71-138— Terra Resources, Inc., 5 «12 Mountain Fuel Supply Co. 1,663 7-23-70 8-28-70 1-23-71 ■15.384 16.0 Fourth National Bank (Nitchie Gulch Unit, Sweet­ Bldg., Tulsa, Okla. 74119. water County, Wyo.). RI71-139-. Kerr-McGee Corp., Kerr- 86 2 Natural Gas Pipeline Co. of 24,096 7-22-70 8-22-70 1-22-71 16.659 17.68 McGee Bldg., Oklahoma America (Indian Basin Field, C ity , O kla. 73102. Eddy County, N. Mex.) (Permian Basin). RI71-140.. Sun Oil Co., Post Office Box 124 7 Transwestern Pipeline Co. 12,113 7-20-70 8-20-70 1-20-71 20.5897 27.319 RI69-53. 2880, Dallas, Tex. 75221. (Kermit Field, Winkler County, Tex., RR. District No. 8) (Permian Basin). RI71-141.. Phillips Petroleum Co., 279 18 El Paso Natural Gas Co. 57,936 7-21-70 8-21-70 1-21-71 ■18.7775 > 19.7925 RI76-1187. Bartlesville, Okla. 74004. (Hogsback Area, Sublette and Lincoln Counties, Wyo.). RI71-142— Humble Oil & Refining 471 3 Northern Natural Gas Co. 79,497 7-17-70 8-17-70 lr17-71 13.7213 «14.6046 RI71-87. Co., Post Office Box 2180, (Pikes Peak Field, Pecos Houston, Tex. 77001. County, Tex., RR. District 8)(Permian Basin). RI71-143— Dixie M. McLane Trust, 1 2 El Paso Natural Gas Co. (Basin 308 7-23-70 9- 1-70 2- 1-71 >13.0 >14.0 2700 Republic National Dakota Field, Rio Arriba Bank Bldg., Dallas, Tex. County, N. Mex., San Juan 75201. B a sin ). RI71-144-. Getty Oil Co., Post Office 144 4 Natural Gas Pipeline Co. of 1,402 7-16-70 8-16-70 1-16-71 « 16.659 «17.646 Box 1404, Houston, Tex. America (Indian Basin Field, 77001. Eddy County, N . Mex.)(Pei> mian Basin). RI70-658...... d o - - ...... 148 4 Transwestem Pipeline Co. * 51,728 7-17-70 8-17-70 1-17-71 *14.552 • » 21.7505 (Halley Field, Winkler County, • 16.49 • >21.7505 Tex., RR. District No. 8) (Permian Basin)...... d o — —— - — —...... - 170 8 El Paso Natural Gas Co. (Gomez 3,710 7-17-70 8-17-70 1-17-71 15.97 17.5656 RI70-659. Ellenburger Field, Pecos County, Tex., RR. District No. 8)(Permian Basin). RI71-145-. Texas Pacific Oil Co., Inc., 80 1 Kansas-Nebraska Natural Gas 120 7-17-70 9- 1-70 2- 1-71 15.0 16.0 1700 One Main PI., Co. (Wind River Basin Field, Dallas, Tex. 75250. Fremont and Natrona Counties, Wyo.). RI70-356. RI71-146-. Getty Oil Co., Post Office 36 12 United Gas Pipe Line Co. 822 7-20-70 8-20-70 1-20-71 >15.5 >16.0 Box 1404, Houston, (Baxterville Field, Lamar and Marion Counties, Miss.); Tex. 77001. RI76-356, ...... d o ------63 9 Southern Natural Gas Co. 18,821 7-20-70' 8-20-70 1-20-71 >15.5 >16.0 (Gwinville Field, Jefferson Davis and Simpson Counties, M iss.). RI65-55L RI71-147— J. C. Trahan, Drilling 26 5 Trunkline Gas Co. (Cage Ranch 775 7-24-70 8-24-70 1-24-71 14.37484 15.45 Contractor, Inc., 2625 Field, Brooks County, Tex.) Line Ave.,* Shreveport, (RR. District No. 4). L a . 71101. RI70-28L RI71-148— Mobil Oil Corp., Post 4 U 4 Trunkline Gas Co. (Kelsey 15,904 7-23-70 9- 1-70 2- 1-71 16.06 17.06375 Office Box 1774, Houston, Field, Brooks County, Tex.) Tex. 77001. (R R. District No. 4). RI71-149-- Butler-Johnson, Inc., Post 2 4 United Gas P/L Co. (South 400 7-21-70 9- 1-70 2- 1-71 «•18.75 >•19.75 Office Box 306, Shreve­ Downsville Field, Lincoln port, La. 71102. Parish, North Field, Louisiana); RI71-150— Petroleum, Inc., 300 West 23 3 El Paso Natural Gas Co. 2,048 7-22-70 8-22-70 1-22-71 •17.0 • «*21.016 Douglas, Wichita, Kans. (Nelson Unit, Beaver County, Okla.) (Panhandle Area). 67202. RI67-334. RI71-151-. Hamilton, Frederic C. & 6 2 Cities Service Gas Co. (North 2,837 7-22-70 8-31-70 1-31-71 uu 17.0 m«18.0 Ferris F., d.b.a. Hamilton Lovedale Field, Harper Brothers, Ltd., 1517 County, -Okla.) (Panhandle Denver Club Bldg., A rea). Denver, Colo. 80202. See footnotes at end of table.

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 NOTICES 13623

Appendix A—Continued Cents per Mcf* Rate in Rate Sup- Amount Date Effective Date —------—— effect sub sched- pie­ Purchaser and producing area of filing date suspended ject to Docket Respondent annual tendered unless until— Rate In Proposed refund in No. lite ment suspended effect Increased rate dockets No. No. increase Nos.

9- 1-70 2- 1-71 U 17.0637» « 18.0675 RI70-518, RI71-152-.. Union Oil Co. of California, 95 2 Northern Natural Gas Co. (Mor­ $8,732 7-22 70 Union Oil Center, Los rison Ranch Field, Roberts Angeles, Calif. 90017. County, Tex., RR. District No. 10). « 12.0 «13.0 RI67-272. RI71-153... Mobil Oil Corp., Post 267 3 Cities Service Gas Co. (Guymon- 676 7-23-70 9- 1-70 2- 1-71 Office Box 1774, Houston, Hugoton Field, Texas County, Tex. 77001. Okla.) (Panhandle Area). 299 6 Panhandle Eastern P/L Co. 377 7-23-70 9-15-70 2-15-71 12.0 13.0 RI67-275...... do— --...... -— ------(Hugoton Field, Morton County, Kans.). 460 3 Arkansas Louisiana Gas Co. 828 7-23-70 9- 1-70 2- 1-71 «17.0 «17.2 RI70-1333...... do...... -...... -...... (Northeast Hillsdale Field, Grant and Custer Counties) (Oklahoma Other Area). 464 1 Transwestem P/L Co. (Guymon 1,758 7-23-70 8-23-70 1-23-71 «17.0 «20.5 Field. Cimarron County, Okla.)(Panhandle Area)..

* Unless otherwise stated pressure base is 14.65 p.s.l.a. * Includes 1.75-cent tax reimbursement. iApplicable to production from Nitchie Gulch Unit Well No. 11-9. »Excludes 0.443 cent from processing of liquids under the contract s liquid revenue » Pressure base is 15.025 p.s.i.a. . . ■ . sharing provisions. »Includes 2.08-cent downward B.t.u. adjustment and 0.87-cent treating cost. i# Includes 0.015-cent tax reimbursement. »Subject to upward and downward B.t.u. adjustment from a base of 1,038 B.t.u. »»Subject to downward B.t.u. adjustment. per cubic foot. u Includes a 1-cent charge paid by buyer to seller for gathering, dehydrating and »Residue gas not derived from new gas-well gas. delivering the gas. * New gas from Devonian formation. _ „t. . . . i3 Subject to upward and downward B.t.u. adjustment. »Includes 1.148-cent upward adjustment for gas containing 1,056 B.t.u. per cubic foot. Phillips’ proposed increase, in addition to charges of currently effective rate sched­ the Secretary of the Commission its providing for a periodic increase, includes ules for sales of natural gas under Com­ agreement and undertaking to comply partial reimbursement of a severance tax mission jurisdiction, as set forth in With the refunding and reporting pro­ recently enacted by the State of Wyoming Appendix A hereof. cedure required by the Natural Gas Act and is applicable to past production back and § 154.102 of the regulations there­ to January 1, 1968. After the amount of tax The proposed changed rates and reimbursement applicable to past production charges may be unjust, unreasonable, under, accompanied by a certificate has been recovered, Phillips shall file an ap­ unduly discriminatory, or preferential, showing service of copies thereof upon propriate rate decrease to reduce the pro­ or otherwise unlawful. all purchasers under the rate schedule posed rate herein so as to provide for-tax involved. Unless respondents are advised reimbursement for future production only. The Commission finds: It is in the Phillips will also be required to refund any public interest and consistent with the to the contrary within 15 days after the reimbursement relating to the Wyoming tax Natural Gas Act that the Commission filing of their respective agreements and collected in this proceeding in th e event the enter upon hearings regarding the law­ undertakings, such agreements and un­ tax is for any reason held invalid upon fulness of the proposed changes, and dertakings shall be deemed to have been Judicial review. that the supplements herein be sus­ Atapaz, Pennzoil, Terra, Kerr-McGee, and accepted.* Phillips request effective dates for which pended and their use be deferred as (C) Until otherwise ordered by the adequate notice has not been given and ordered below. Humble and Kerr-McGee request a suspen­ Commission, neither the suspended sup­ The Commission orders: plements, nor the rate schedules sought sion period of 1 day. Good cause has not (A) Under the Natural Gas Act, been shown for waiving the 30-day statutory to be altered, shall be changed until dis­ particularly sections 4 and 15, the notice period or for limiting the suspension position of these proceedings or expira­ period to 1 day. Accordingly, the above re­ regulations pertaining thereto (18 CFR tion of the suspension period. quests are denied. Ch. I), and the Commission’s rules of All of the producers’ proposed increased (D) Notices of intervention or peti­ practice and procedure, public hearings rates and charges exceed the applicable area tions to intervene may be filed with the increased rate ceilings set forth in the Com­ shall be held concerning the lawfulness mission’s statem ent of general policy No. Federal Power Commission, Washington, 61-1, as amended (18 CFR 2.56). of the proposed changes. (B) Pending hearings and decisions D.C. 20426, in accordance with the rules [F.R. Doc. 70-11124; Filed, Aug. 25, 1970; of practice and procedure (18 CFR 1.8 thereon, the rate supplements herein are 8:45 a.m.] and 1.37(f)) on or before September 28, suspended and their use deferrèd until [Docket No. RI71-130, etc.] date shown in the “Date Suspended Un­ 1970. CITIES SERVICE OIL CO. ET AL. til” column, and thereafter until made By the Commission. Order Providing for Hearing on and effective as prescribed by the Natural [seal] G ordon M. G rant, Suspension of Proposed Changes in Gas Act '.^Provided, however, That the Secretary. Rates, and Allowing Rate Changes supplements to the rate schedules filed To Become Effective Subject to by respondents, as set forth herein, shall • I t an acceptable general undertaking, as provided in Order No. 377, has previously Refund 1 become effective subject to refund on been filed by a producer, then it will not be August 13,1970. the date and in the manner herein pre­ necessary for that producer to file an agree­ The respondents named herein have scribed if within 20 days from the date ment and undertaking as provided herein. In such circumstances the producer’s pro­ filed proposed changes in rates and of the issuance of this order respondents posed increased rate will become effective as 1Does not consolidate for hearing or dis­ shall each execute and file under its of the expiration of the suspension period pose of the several matters herein. above-designated docket number with without any further action by the producer.

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 13624 NOTICES

Appendix A

Amount Effective Cents per Mcf* Rate in Docket Rate Sup­ of Date date No. Respondent sched­ ple­ Purchaser and producing area annual filing unless pended Proposed ject to re­ ule ment increase tendered suspended until— Rate in increased fund in No. No. effect rate dockets Nos;

RI71-130-. Cities Service Oil Co...... 178 »25 Tennessee Gas Pipeline Co., a $9,934 7-20-70 7-20-70 7-21-70 19.5 20.0 RI70-876. division of Tenneco Inc. (Grand Isle Block 43 Field, Offshore Louisiana) (Disputed Zone). 24 Tennessee Gas Pipeline Co., a 10,585 7-20-70 . 8-20-70 8-21-70 19.5 20.0 division of Tenneco Inc. (West Cameron Block 193 Field, Off­ shore Louisiana) (Federal Domain). RI71-131-. Continental Oil Co...... 341 »4 ___do...... -...... 2,500 7-17-70 8-17-70 8-18-70 19.5 20.0 RI71-132-. Mobile Oil Corp...... 176 »28 Transcontinental Gas Pipe Line 7,300 7-17-70 8-17-70 8-18-70 19.0 20.0 Corp. (West Cameron Block 110 Field, Offshore Louisiana) (Federal Domain). RI71-133-. Union Carbide Petroleum 1 * 3 Michigan Wisconsin Pipe Line 20,391 7-23-70 8-23-70 8-24-70 19.5 20.0 Corp. Co. (Ship Shoal Area, Offshore Louisiana) (Federal Domain). RI71-134-- Continental Oil Co...... 158 ‘15 «16 Transcontinental Gas Pipe Line 3,195 7-23-70 8-23-70 8-24-70 19.0 20.0 . Corp. (West Cameron Block 1,825 7-23-70 8-23-70 8-24-70 19.0 20.0 110 and Eugene Island Block 126 Fields, Offshore Louisiana) (Federal Domain). RI71-135-. Getty Oil Co—-...... 163 7 4 Tennessee Gas Pipeline Co., a 10,585 7-24-70 8-24-70 8-25-70 19.5 20.0 division of Tenneco Inc. (West Cameron Block 192 Field, Off- shore Louisiana) (Federal Domain).

*The pressure base is 15.025 p.s.i.a. * Applicable only to gas well gas sales from the newly discovered reservoirs. > Applies to the PN, QM, OE, PQ, OR, and OPU Reservoirs. ‘Applies to gas well gas sales from the 1-1 and 2-B upper sand reservoirs. 2 Applies to the KM D-5 Reservoir. • Applies to gas well gas sales from J-l and 1-3 sand reservoirs. * Footnote not used. 7 Applies to the KM D-5 Reservoir. All of the proposed increased rates involved charges of currently effective rate sched­ ment and undertaking to comply with here, except for the one relating to Cities’ ules for sales of natural gas under Com­ FPC Gas Rate Schedule No. 178, were sub­ the refunding and reporting procedure mitted pursuant to paragraph (A) of mission jurisdiction, as set forth in required by the Natural Gas Act and Opinion No. 546-A with respect to gas well Appendix A hereof. § 154.102 of the regulations thereunder, gas which qualifies for a third vintage price The proposed changed rates and accompanied by a certificate showing in accordance with Opinion No. 567. These charges may be unjust, unreasonable, service of copies thereof upon all pur­ increases should be1 suspended for 1 day unduly discriminatory, of preferential, chasers under the rate schedule involved. upon expiration of the statutory notice or otherwise unlawful. Unless respondents are advised to the period. Thereafter, the proposed rate may be The Commission finds: It is in the placed in effect subject to refund pending contrary within 15 days after the filing public interest and consistent with the of th e ir, respective agreements and the outcome of Docket No. AR69-1. Natural Gas Act that the Commission The proposed increase under Cities’ FPC enter upon hearings regarding the law­ undertakings, such agreements and Gas Rate Schedule No. 178 relates to gas well undertakings shall be deemed to have gas produced from newly discovered reser­ fulness of the proposed changes, and voirs in the disputed zone, offshore Loui­ that the supplements herein be sus­ been accepted.2 siana. The rate proposed equals the ceiling pended and their use Jie deferred as (C) Until otherwise ordered by the established in Opinion No. 546 for third ordered below. Commission, neither the suspended sup­ vintage gas well gas produced from within The Commission orders: the State’s taxing jurisdiction but exceeds plements, nor the rate schedules sought the ceiling for gas produced in the Federal (A) Under the Natural Gas Act, to be altered, shall be changed until dis­ domain. This increase shall be suspended for particularly sections 4 and 15, the position of these proceedings or expira­ 1 day from the date of filing and thereafter regulations pertaining thereto (18'CFR Cities may collect the proposed rate subject Ch. I), and the Commission’s rules of tion of the suspension period. to refund of those amounts attributable to practice and procedure, public hearings (D) Notices of intervention or peti­ the 1.5-cent difference in the offshore and shall be held concerning the lawfulness tions to intervene may be filed with the onshore area rate paid for gas finally held of the proposed changes. to have been produced from the Federal Federal Power Commission, Washington, domain. (B) Pending hearings and decisions D.C. 20426, in accordance with the rules [F.R. Doc. 70-11125; Filed, Aug. 25, 1970; thereon, the rate supplements herein are of practice and procedure (18 CFR 1.8 8:45 a.m.] suspended and their use deferred until and 1.37(f)) on or before October 12, [Docket No. RI71-169, etc.] date, shown in the “Date Suspended 1970. Until” column, and thereafter until made CONTINENTAL OIL CO. ET AL. effective as prescribed by the Natural By the Commission. Order Providing for Hearing on and Gas Act: Provided, however, That the [ seal] K enneth F. P lumb, Suspension of Proposed Changes in supplements to the rate schedules filed Acting Secretary. Rates, and Allowing Rate Changes by respondents, as set forth herein, shall To Become .Effective Subject to become effective subject to refund on the * If an acceptable general undertaking, as Refund 1 date and in the manner herein prescribed provided in Order No. 377, has previously been filed by a producer, then it will not be August 17, 1970. if within 20 days from the date of the necessary for that producer to file an agree­ The respondents named herein have issuance of this order respondents shall m ent and undertaking as provided herein. filed proposed changes in rates and each execute and file under its above- In such circumstances the producer’s pro­ posed increased rate will become effective as 1Does not consolidate for hearing or dis­ designated docket number with the of the expiration of the suspension period pose of the several matters herein. Secretary of the Commission its agree­ w ithout any further action by the producer.

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 NOTICES 13625

A ppendix A

Rate Sup- Amount Effective Cents per Mcf* Rate In ached- pie- of Date date Date - —------effect sub- Docket Purchaser and producing area annual filing unless Suspended Rate In Proposed ject to re- No- Respondent ule ment increase tendered suspended until— effect increased fund in No. No. rate dockets Nos;

‘ 8-28-70 U8.5 «20.0 RI71-169- Continental Oil Co., Post 367 1 Michigan Wisconsin Pipe Line $10,800 7-27-70 8-27-70 Office Box 2197, Houston, Co. (Eugene Island Blocks 247 and 265, Offshore Louisiana). Tex. 77001. 8-27-70 8-28-70 15.0 15.0563 RI71-170-. Mobil Oil Corp., Post Office 84 9 Tennessee Gas Pipeline Co., a 12 7-27-70 Box 1774, Houston, Tex. division of Tenneco Inc. (La Reforma Field, Starr County, 77001. Tex., RR. District No. 4). 7-28-70 7-29-70 a « 19.159 ‘ « 19. 2308 RI71-171. Gulf Oil Corp-. Post Office 380 2 Panhandle Eastern P/L Co. 156 7-28-70 Box 1589, Tulsa, Okla. (North Gruver Field, Hansford County, Tex., RR. 74102. District No. 10). 9-23-70 9-24-70 • 11.1306 « 12.1425 RI6S-1. RI71-172._ Humble Oil & Refining Co., 20 11 Phillips Petroleum Co. (Texas 657 7-29-70 Post Office Box 2180, Hugoton Field, Sherman Houston, Tex. 77001. County, Tex., RR. District No. 10).

•Pressure base is 14.65 p.s.i.a. unless otherwise stated, * Includes 2.159-cent upward B.t.u. adjustment. i Pressure base is 15.025 p.s.i.a / , . « Subject to upward and downward B.t.u. adjustment; > Or 1 day from date of initial delivery, whichever is later. * Sweet gas rate, subject to a deduction 0.4466 cent if gas Is sour. Continental’s proposed increase, involving [Docket No. RI71-154 etc.] (A) Under the Natural Gas Act, par­ a sale in the Federal Domain, was subm itted ticularly sections 4 and 15, the regula­ pursuant to paragraph (A) of Opinion IJo. GINTHER, WARREN & CO. ET AL. tions pertaining thereto (18 CFR Ch. I), 546-A. This increase shall be suspended for Order Providing For Hearings on and and the Commission’s rules of practice 1 day from the expiration of the statutory and procedure, public hearings shall be notice period or 1 day from the date of initial Suspension of Proposed Changes in held concerning the lawfulness of the delivery whichever is later. Thereafter, the Rates 1 proposed changes. proposed rate may be collected subject to August 14,1970. refund pending the outcome of Docket No. (B) Pending hearings and decisions AR69-1. The respondents named herein have thereon, the rate supplements herein are The proposed increases by Mobil and Gulf filed proposed increased rates and suspended and their use deferred until reflect reimbursement for the October 1, charges of currently effective rate sched­ date shown in the “Date Suspended 1969, increase in the Texas Production Tax. ules for sales of natural gas under Com­ Until” column, and thereafter until made Pursuant to Order No. 390 these increases mission jurisdiction, as set forth in Ap­ effective as prescribed by the Natural shall be suspended for 1 day from the pendix A hereof. Gas Act. requested effective dates. The proposed changed rates and (C) Until otherwise ordered by the Humble’s proposed increase relates to a Commission, neither the suspended sup­ sale of gas to Phillips. Phillips resells such charges may be unjust, unreasonable, un­ gas after gathering and processing to Mich­ duly discriminatory, or preferential, or plements, nor the rate schedules sought igan Wisconsin at a rate of 16.22 cents plus to be altered, shall be changed until dis­ otherwise unlawful. position of these proceedings or expira­ applicable tax reimbursement which is in The Commission finds : It is in the pub­ effect subject to refund in Docket No. BI70- tion of the suspension period. 28. In these circumstances the suspension lic interest and consistent with the Nat­ (D) Notices of intervention or petitions period for Humble’s proposed rate shall be ural Gas Act that the Commission enter to intervene may be filed with the Fed­ limited to 1 day from the expiration of the upon hearings regarding the lawfulness eral Power Commission, Washington, statutory notice period. of the proposed changes, and that the D.C., 20426, in accordance with the rules All of the producers* proposed increased supplements herein be suspended and of practice and procedure (18 CFR 1.8 rates and charges exceed the area increased and 1.37(f)) on or before September 28, rate ceilings set forth in the Commission’s their use be deferred as ordered below. 1970. x statement of general policy No. 61-1, as The Commission orders: amended ( 18 CFR 2.56). By the Commission. [F.R. Doc. 70-11126; Filed, Aug. 25, 1970; 1 Does not consolidate for hearing or dis­ [seal] K enneth F. P lumb, 8:45 a.m.] pose of the several matters herein. Acting Secretary.

FEDERAI REGISTER, VOL 35, NO. 166—-WEDNESDAY, AUGUST 2é, 1970 13626 NOTICES

Appendix A

Amount Effective Cents per Mcf* Rate in Docket Rate Sup­ of Date date ]Date sus­ ■ effect sub­ No. Respondent sched­ ple­ Purchaser and producing area annual filing unless pended Rate in Proposed ject to re­ ule ment increase tendered suspended until— effect increased fund in No. No. rate

RI71-154-. Ginther, Warren & Co...... 12 1 Tennessee Gas Pipeline Co., a $1,330 7-30-70 8-30-70 1-30-71 16.0 17.06375 ■ division of Tenneco Inc. (Ann- Mag Field, Brooks County, Tex., RR. district No. 4). 1 12 Tennessee Gas Pipeline Co., a 171,600 7-30-70 8-30-70 1-30-71 15.33333 20.1 G-1728L division of Tenneco Inc. (Sarco Creek Field, Goliad County, Tex., RR. District No. 2). RI71-155.. Texaco, Inc...... 224 3 Panhandle Eastern Pipe Line Co. 100 7-24-70 10- 1-70 3- 1-71 16.0 17.0 RI69 -794. (Northeast Carthage Field, Texas County, Okla., Pan­ handle Area). RI71-166— Gulf Oil Corp...... 293 2 Panhandle Eastern Pipe Line Co. 2,981 7-29-70 9- 1-70 2- 1-71 17.0638 18.0675 RI70-1160. (Frantz Upper Morrow Field, Ochiltree County, Tex., RR. District No. 10). RI71-157.. Mobil Oil Corp...... 42 16 Texas Eastern Transmission 180 7-27-70 8-27-70 1-27-71 15.6 16.6726 RÏ67-272. Corp. (Willow Springs Field, Gregg County, Tex., RR. District No. 6). RI71-158-. Ashland Oil, Inc...... 132 10 Kansas Nebraska Natural 40 7-27-70 10- 1-70 3- 1-71 118.61 118.81 RI70-116; Gas Co., Inc. (Grand Valley (Camrick) Field, Texas County, Okla., Panhandle Area). 139 8 El Paso Natural Gas Co. 400 7-27-70 9- 1-70 2- 1-71 2 23. 015 2 25.015 RI70-365. (Clear Lake Field, Beaver \ County, Okla., Panhandle Area). RI71-169-- Texaco, Inc...... -...... 437 2 Arkansas Louisiana Gas Co. (Hill­ 343 7-21-70 9- 1-70 2- 1-71 * 4 20.64 >4 20.88 RI70-140& side, Field, Grant County, Okla., Other Area). RI71-160-. Galaxy Oil Co...... 1 ‘2 Arkansas Louisiana Gas Co., 660 7-27-70 8-27-70 1-27-71 ‘ 15.0 « 16. 015 (Kinta & Wilburton Fields, Haskell & Latimer Counties, Okla., Other Area). RI71-161-- Graham-Michaelis Drilling 50 10 Northern Natural Gas Co. 122 7-27-70 8-27-70 1-27-71 ‘ 16.0 ‘ 17.0 Co. (Harper Ranch Field, Clark County, Kans.). RI71-162-. Freguson Oil Co., Inc...... 4 2 Panhandle Eastern Pipe Line 5,760 7-27-70 8-27-70 1-27-71 4 16.0 ‘ 18.0 Co. (No. 1-A Loewen Unit, * Meade County, Kans.). RI71-163-- Getty Oil Co...... -...... 124 7 Michigan Wisconsin Pipe Line 4,620 7-17-70 8-17-70 1-17-71 4 717.7 4 719.2 RI69-646. Co. (Northeast and Southwest 990 7 « 17.8 7 » 19.2 Cedardale Fields, Woodward County, Okla. Panhandle Area and Major County, Okla. Other Area). ^ RI71-164.. Cleary Petroleum Corp., 32 3 Arkansas Louisiana Gas Co. 15,694 7-24-70 8-24-70 1-24-71 15.0 18.0 agent. (Keota Area, Haskell County, Okla. Other Area). RI71-165.. Cleary Petroleum Corp __ 31 2 ___ do...... 5,906 7-24-70 8-24-70 1-24-71 15.0 18.0 RI71-166-- Union Oil Company of 152 4 Kansas-Nebraska Natural Gas 1,825 7-29-70 9- 1-70 2- 1-71 15.0 16.0 California. Co., Inc. (Badwater Area, Fremont and Natrona • Counties, Wyo.). RI71-167-- Pan American Petroleum__ 493 5 Transwestern Pipeline Co. 36,314 7-30-70 8-30-70 1-30-71 19.64 21. 7562 RI70-781. (Halley Field, Winkler County, Tex. RR. District No. 8, Permian Basin). RI71-168-- Read & Stevens, I n c u—...... - (,0) - El Paso Natural Gas Co. 22,192 7-27-70 8-27-70 1-27-71 16.58 U 19.62 (Acreage in Chaves County, N. Mex., Permian Basin).

‘Unless otherwise stated, pressure base is 14.65 p.s.i.a. ‘ « Subject to downward B.t.u. adjustment. > Subject to downward B.t.u. adjustment. 7 Applicable to Oklahoma Panhandle Area Production. 2 Exclusive of 0.62 cent paid by buyer for liquids. “ * Applicable to Oklahoma Other Area Production. 3 Includes base rates of 17 cents before increase and 17.2 cents after increase plus 9 Includes 0.7-cent upward B.t.u.-adjustment (1,070 B.t.u. gas), upward B.t.u. adjustment. __ 10 N o rate schedule on file—pertains to contract dated Apr. 14,1970. 4 Subject to upward and downward B.t.u. adjustments. » Applicant issued a small producer certificate in Docket No. CS70-42. 9 Applicable only to original certificated acreage in Docket No. CI70-366. 19 Iricludes 1.62 cents per Mcf upward B.t.u. adjustment. Ginther, Galaxy, Ferguson, and Bead & [Docket No. RI71-90, etc.] charges of currently effected rate sched­ Stevens, Inc., request effective dates for ules for sales of natural gas under Com­ which adequate notice has been given. Mobil KERR-McGEE CORP. ET AL. requests that the suspension period be lim­ mission jurisdiction, as set forth in Ap­ Order Providing for Hearing on and pendix A hereof. ited to 1 day if its proposed rates are sus­ The proposed changed rates and pended. Good cause has not been shown for Suspension of Proposed Changes in charges may be unjust, unreasonable, un­ waiving the 30-day statutory notice period Rates, and Allowing Rate Changes duly discriminatory, or preferential, or or for limiting the suspension period to 1 To Become Effective Subject to otherwise unlawful. day. The requests are therefore denied. Refund 1 The Commission finds: It is in the All of the producers’ proposed increased August 5,1970. public interest and consistent with the rates and charges exceed the applicable area The respondents named herein have Natural Gas Act that the Commission increased rate ceilings set forth in the Com­ enter upon hearings regarding the law­ mission’s statement of policy No. 61-1, as filed proposed changes in- rates and fulness of. the proposed changes, and that amended (18 CFB 2.56). the supplements herein be suspended [F.R. Doc. 70-11127; Filed, Aug. 25, 1970; 1 Does not consolidate for hearing or dis­ and their use be deferred as ordered 8:45 a.m.] pose of the several matters herein. below.

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 NOTICES 13627

The Commission orders: each execute and file under its above- plements, nor the rate schedules sought (A) Under the Natural Gas Act, par­ designated docket number with the Sec­ to be altered, shall be changed until dis­ ticularly sections 4 and 15, the regula­ retary of the Commission its agreement position of these proceedings or expira­ tions pertaining thereto (18 CFR Ch. I ) , and undertaking to comply with the re­ tion of the suspension period. and the Commission’s rules of practice funding and reporting procedure re­ (D) Notices of intervention or peti­ and procedure, public hearings shall be quired by the Natural Gas Act and tions to intervene may be filed with the held concerning the lawfulness of the § 154.102 of the regulations thereunder, Federal Power Commission, Washington, proposed changes. accompanied by a certificate showing D.C. 20426, in accordance with the rules (B) Pending hearings and decisions service of copies thereof upon all pur­ and practice and procedure (18 CFR 1.8 thereon, the rate supplements herein are chasers under the rate schedule involved. and 1.37(f) ) on or before September 15, suspended and their use deferred until Unless respondents are advised to the 1970. date shown in the “Date Suspended contrary within 15 days after the filing of Until" column, and thereafter until made their respective agreements and under­ By the Commission. effective as prescribed by the Natural Gas takings, such agreements and undertak­ [seal] ' G ordon M. G rant, Act: Provided, however, That the sup­ ings shall be deemed to have been Secretary. plements to the rate schedules filed by accepted.2 respondents, as set forth herein, shall (C) Until otherwise ordered by the necessary for that producer to file an agree­ become effective subject to refund on the Commission, neither the suspended sup- ment and undertaking as provided herein. In such circumstances the producer’s pro­ date and in the manner herein prescribed 2 if an acceptable general undertaking, as posed increased rate will become effective as if within 20 days from the date of the is­ provided in Order No. 377, has previously of the expiration of the suspension period suance of this order respondents shall been filed by a producer, then it will not be without any further action by the producer.

Appendix A

R a te S up ­ A m o u n t E ffectiv e Cents per Mcf* Rate in Docket sched- ple­ of D a te d a te D ate sus------effect su b - No. Respondent ule m en t Purchaser and producing area annual filing unless pended Rate in Proposed ject to re­ N o . N o . increase tendered suspended until— effect increased fund In rate dockets Nos;

RI71-90.-. Kerr McGee Corp., Kerr- 110 1 Transcontinental Gas Pipe Line $22,050 7-17-70 8-17-70 * 8-18-70 < 18.5 «20 .0 McGee Bldg., Oklahoma Corp. (Ship Shoal Block 239 C ity, Okla. 73102. U nit, Offshore Louisiana). RI71-91...... d o...... I l l 1 Transcontinental Gas Pipe Lin» 120,450 7-17-70 8r-17-70 * 8-18-70 *18.5 4 20:0 Corp. (Ship Shoal Block 230 Field, Offshore Louisiana). RI71-92... Getty Oil Co., Post Office 181 1 Michigan Wisconsin Pipeline Co. 900 7-17-70 8-17-70 » 8-18-70 «18.5 ‘ 20.0 • Box 1404, Houston, Tex. (E u g en e Isla n d B lo ck 226. 77001. Iberia and St. Mary Parish, Offshore Louisiana). RI71-93... Bright A Schifl, 2355 Stem- 7 6 South Texas Natural Gas 360 7-17-70 7-17-70 7-18-70 16.0 16.06 mons Bldg., Dallas, Tex. Gathering Co. (Northeast 75207. Thomsonville Field, Webb and Jim Hogg Counties, Tex. RR. District No. 4). RI71-94... Sun Oil Co., Post Office Box 189 2 Northern Natural Gas Co. 220 7-13-70 9-, 1-70 9 - 2-70 12.0 13.0 > 2880, Dallas, Tex. 75221. (Hugoton Field, Haskell Coun­ ty, Kans.). ] RI71-95... Mobil Oll Corp., Post Office 147 32 Warren Petroleum Co. (Pan- 12 7-13-70 8-13-70 8-14-70 13.3088 13.4505 RI79-1193. Box 1774, Houston, Tex. handle Field, Wheeler County, 77001. Tex. RR. District No. 10)...... d o ...... 148 35 ...... d o ...... 17 7-13-70 8-13-70 8-14-70 13.3088 13.4505 RI79-1193.

’Except where otherwise indicated, pressure base Is 14.65 p.s.i.a. 415.025 p.s.i.a. * Or 1 day from the date of initial delivery, whichever 4s later. The proposed rate increases from 18.5 cents Mobil’s proposed rates relate to sales to tion 301(c)(1) of the Trade Expansion to 20 cents per Mcf filed pursuant to Opin­ Warren. Warren processes and resells the gas Act of 1962. ion No. 546—A by Kerr-McGee and Getty in­ under its FPC Gas Rate Schedule No. 51 to In the investigation (TEA-F-11), the volve sales of third vintage gas well gas from Transwestem at a rate which in effect sub­ offshore Louisiana. These increases shall be ject to refund in Docket No. RI70-850. In Commission was to determine whether, suspended for X day from August 17,1970, the view thereof, a suspension period of 1 day as a result in major part of concessions expiration date of the 30-day statutory no­ from the expiration of the statutory notice granted under trade agreements, articles tice period, or 1 day from the date of initial period is appropriate. like or directly competitive with the delivery, whichever is later. Thereafter, the All of the proposed increased rates involved electrolytic capacitors produced by the proposed rates may be placed in effect sub­ here exceed the increased rate ceilings set Ion Capacitor Corp. are being imported ject to refund under the provisions of sec­ forth in the Commission’s statement of gen­ into the United States in such increased tion 4(e) of the Natural Gas Act pending the eral policy No. 61—1, as amended. outcome of Docket No. AR69-1. quantities as to cause, or threaten to The proposed increase filed by Bright & [F.R. Doc. 70-11128; Filed, Aug. 25, 1970; cause, serious injury to the firm. Schiff reflects partial reimbursement for the 8:45 a.m.] The vote of the Commission was increase from 7 percent to 7.5 percent in the equally divided. Commissioners Sutton Texas Production Tax. Bright & Schiff re­ and Leonard found in the negative. quests a retroactive effective date of Oc­ Commissioners Clubb and Moore found tober 1, 1969, for its filing. Good cause does in the affirmative. not exist for granting such request and it is TARIFF COMMISSION therefore denied. In accordance with Orders A part of the material contained in No. 390 issued October 10, 1969, we shall sus­ ELECTROLYTIC CAPACITORS the report may not be made public since pend the proposed rate for 1 day from the Report to the President it includes information that would dis­ date of filing. close the operations of an individual Sun’s proposed increase involves a contract August 21, 1970. firm. The Commission, therefore, is dated after the issuance of the Commis­ The U.S. Tariff Commission today re­ releasing to the public only those por­ sion’s statement of general policy No. 61—1. The proposed rate does not exceed the in­ ported to the President the result of an tions of the report that do not contain itial rate ceiling set forth in the policy state­ investigation of a petition for adjust­ business confidential information. ment. In these circumstances we believe it ment assistance filed by the Ion Capaci­ The public report (TC. Pub. 335), appropriate to suspend the proposed rate for 1 day from the expiration of the statutory tor Corp., Columbia City, Ind. The which contains statements of the reasons notice period. investigation was conducted under sec­ for the Commissioners’ findings, will be

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 No. 166----- 9 13628 NOTICES released as soon as possible. Copies will Protests against the use of any pro­ secutively for convenience in identifica­ be available on request as long as the posed deviation route herein described tion and protests, if any, should refer to supply lasts. Requests should be ad­ may be filed with the Interstate Com­ such letter-notices by number. dressed to the Secretary, U.S. Tariff merce Commission in the manner and Commission, Eighth and E Streets NW, form provided in such rules (49 CFR M otor Carriers of P roperty Washington, D.C. 20436. 1042.2(c) (9)) at any time, but will not No. MC 30605 (Deviation No. 15), operate to stay commencement of the THE SANTA FE TRAIL TRANSPOR­ By direction of the Commission. proposed operations unless filed within TATION COMPANY, 1413 Railway Ex­ [seal] K enneth R. M ason, 30 days from the date of publication. change, 80 East Jackson Boulevard, Secretary Successively filed letter-notices of the Chicago, 111. 60604, filed , 1970. [F.R. Doc. 70-11267; Filed, Aug. 25, 1970; same carrier under the Commission’s Carrier proposes to operate as a common 8:50 ajn.] Revised Deviation Rules-Motor Carriers carrier, by motor vehicle, of general com­ of Property, 1969, will be numbered con­ modities, with certain exceptions, over secutively for convenience in identifica­ a deviation route as follows: From Pratt, tion, and protests, if any, should refer to Kans., over U.S. Highway 54 to Santa INTERSTATE COMMERCE such letter-notices by number. Rosa, N. Mex., thence over U.S. Highway 66 (Interstate Highway 40) to Moriarty M otor Carriers op P assengers (Calvert), N. Mex., and return over the COMMISSION No. MC 61616 (Deviation No. 36), same route, for operating convenience FOURTH SECTION APPLICATION FOR MIDWEST BUSLINES, INC., 433 West only. The notice indicates that the car­ Washington Avenue, North Little Rock, rier is presently authorized to transport RELIEF Ark. 72114, filed August 7,1970. Carrier’s the same commodities, over pertinent August 21, 1970. representative: Nathaniel Davis, same service routes as follows: (1) From Protests to the granting of an applica­ address as applicant. Carrier proposes Wichita, Kans., over U.S. Highway 54 to tion must be prepared in accordance with to operate as slcommon carrier, by motor junction U.S. Highway 154, thence over § 1100.40 of the general rules of practice vehicle, of passengers and their baggage, U.S. Highway 154 to Dodge City, Kans., (49 CPR 1100.40) and filed within 15 and express and newspapers in the same thence over U.S. Highway 50S to Garden days from the date of publication of vehicle with passengers, over a deviation City, Kans., thence over U.S. Highway 50 this notice in the F ederal R egister. route as follows: From Monroe, La., over to Pueblo, Colo.; (2) from Dodge City, Interstate Highway 20 to junction Kans., over U.S. Highway 50S to junction L ong-and-S hort H aul Louisiana Highway 133, thence over unnumbered highway, immediately north FSA No. 42035—Newsprint paper from Louisiana Highway 133 to Start, La., and of Sylvia, Kans.; (3) from Kinsley, Arkansas, Louisiana, and Texas, also re­ return over the same route, for operat­ Kans., over U.S. Highway 183 to Gibson, turned shipments of winding cores. Filed ing convenience only. The notice in­ Kans., thence over unnumbered highway by Southwestern Freight Bureau, agent dicates that the carrier is presently au­ via Charlet, Trousdale, Hopewell, and (No. B-180), for interested rail carriers. thorized to transport passengers and the Byers, Kans., to Strickler, Kans., thence Rates on newsprint paper, also returned same property, over a pertinent service over U.S. Highway 281 via Iuka, Kans., to shipments of newsprint paper winding route as follows: From Monroe, La., over Pratt Kans.; (4) from Denver Colo., over cores, in carloads, as described in the U.S. Highway 80 to Rayville, La., thence U.S. Highway 85 to junction relocated application, from Sheldon, Tex., to points over Louisiana Highway 137 to Archi­ U.S. Highway 85 near Crow, Colo., thence in southwestern territory, including bald, La., and return over the same over relocated U.S. Highway 85 to junc­ Mississippi River crossings, Memphis, route. tion U.S. Highway 85 south of Green­ Tenn., and south; western trunkline and By the Commission. horn, Colo., thence over U.S. Highway 85 Illinois territories, and from Poise- via Rowe and Glorieta, N. Mex., to Al­ Southern, La., Hei’ty, Tex., and Pine [seal] J oseph M. H arrington, buquerque, N. Mex. (also from Denver as Bluff, Ark., to points in Kansas, also Acting Secretary. specified to Rowe, N. Mex., thence over returned shipments of winding cores in [F.R. Doc. 70-11229; Filed, Aug. 25, 1970; unnumbered highway via Pecos, N. Mex., the reverse direction. 8:47 a.m.] to Glorieta, N. Mex., thence over U.S. Grounds for relief—Revision of rate Highway 85 to Albuquerque); (5) from structure disrupted by general increases Albuquerque, N. Mex., over U.S. Highway and increased delivery costs. [Notice 28] 66 to junction new Mexico Highway 41, Tariff—Supplement 111 to Southwest­ MOTOR CARRIER ALTERNATE ROUTE thence over New Mexico Highway 41 to ern Freight Bureau, agent, tariff ICC junction U.S. Highway 60, thence over 4716. DEVIATION NOTICES US. Highway 60 to Willard, N. Mex.; (6) from Willard, N. Mex., over U.S. By the Commission. August 21,1970. The following letter-notices of pro­ Highway 60 to junction New Mexico [seal] J oseph M. H arrington, posals to operate over deviation routes Highway 6, thence over New Mexico Acting Secretary. for operating convenience only have been Highway 6 to Belen, N. Mex.; (7) from [F.R. Doc. 70-11226; Filed, Aug. 25, 1970; filed with the Interstate Commerce Com­ Wichita, Kans., over U.S. Highway 54 to 8:47 a.m.] mission under the Commission’s Revised Pratt, Kans.; (8) from Dodge City, Deviation Rules-Motor Carriers of Prop­ Kans., over U.S. Highway 50 to the erty, 1969 (49 CFR 1042.4(d) (11)) and Kansas-Colorado State line; (9) from • [Notice 18] notice thereof to all interested persons the Colorado-Kansas State line over US. is hereby given as provided in such rules Highway 50 to Pueblo, Colo.; (10) from MOTOR CARRIER ALTERNATE ROUTE junction U.S. Highway 50 Bypass and DEVIATION NOTICES (49 CFR 1042.4(d) (ID ). „ Protests against the use of any pro­ U.S. Highway 85 north of Pueblo, Colo., August 21, 1970. posed deviation route herein described over US. Highway 50 Bypass to junction The following letter-notices of pro­ may be filed with the Interstate Com­ U.S. Highway 50; and (11) from Pueblo, posals to operate over deviation routes merce Commission in the manner and Colo., over Colorado Highway 96 to for operating convenience only have been form provided in such rules (49 CFR Boone, Colo., thence over Colorado High­ filed with the Interstate Commerce Com­ 1042.4(d) (12)) at any time, but will not way 209 to junction U.S. Highway 50, mission under the Commission’s Revised operate to stay commencement of the and return over the same routes. Deviation Rules-Motor Carriers of Pas­ proposed operations unless filed within By the Commission. 30 days from the date of publication. sengers, 1969 (49 CFR 1042.2(c)(9)) Successively filed letter-notices of the [seal] J oseph M. H arrington, and notice thereof to all interested per­ same carrier under the Commission’s Acting Secretary. sons is hereby given as provided in such Revised Deviation Rules-Motor Carriers [F.R. Doc. 70-11228; Filed, Aug. 25, 1970; rules (49 CFR 1042.2(c) (9)). of Property, 1969, will be numbered con­ 8:47 a.m.]

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 NOTICES 13629

{Notice 78] No. MC 105461 (Sub-No. 86) (Republi- , setting forth in detail the precise manner cation), filed January 12,1970, published in which it has been so prejudiced. M O TO R CARRIER APPLICATIONS AND in the F ederal R egister issue of Febru­ Application for Certificate or P ermit CERTAIN OTHER PROCEEDINGS- ary 19, 1970, and republished this issue. W h ich Is T o B e P rocessed Concur­ Applicant: HERR’S MOTOR EXPRESS, August 21, 1970, rently W it h Application U nder S ec­ INC., Box 8, Quarryville, Pa. 17566. Appli­ The following publications are gov­ tion 5 G overned by S pecial R ule 240 cant’s representative: Bernard N. Gin- to the E xtent Applicable erned by the new Special Rule 247 of the gerich, 114 West State Street, Quarry­ Commission’s rules of practice, published ville, Pa. 17566. The modified procedure No. MC 47904 (Sub-No. 3), filed Au­ in the F ederal R egister, issue of Decem­ has been followed in this proceeding and gust 6, 1970. Applicant: INTERCITY ber 3,1963, which became effective Janu­ an order of the Commission, Operating TRANSPORTATION COMPANY, a cor­ ary 1,1964. Rights Board, dated July 28, 1970, and poration, 600 Turnpike Street, South The publications hereinafter set forth served August 13, 1970, finds that the Easton, Mass. 02375. Applicant’s repre­ reflect the scope of the applications as present and future public convenience sentative: Frank J. Weiner, 6 Beacon filed by applicant, and may include de­ and necessity require operation by ap­ Street. , Mass. 02108. Authority scriptions, restrictions, or limitations plicant, in interstate or foreign com­ sought to operate as a common carrier, which are not in a form acceptable to merce, as a common carrier by motor by motor vehicle, over irregular routes, the Commission. Authority which ulti­ vehicle, over irregular routes, of used transporting: General commodities (ex­ mately may be granted as a result of the empty containers, from points in Atlan­ cept those of unusual value, and except applications here noticed will not neces­ tic, Burlington, Monmouth, and Ocean dangerous explosives, household goods sarily reflect the phraseology set forth in Counties, N.J., to Philadelphia, Pa. Be­ as defined in Practices of Motor Com­ the application as filed, but also will elim­ cause it is possible that other persons, mon Carriers of Household Goods, 17 inate any restrictions which are not ac­ who have relied upon the notice of the M.C.C. 467, commodities in bulk, commo­ ceptable to the Commission. dities requiring special equipment and application as published, may have an those injurious or containmating to other Motor Carriers of P roperty interest in and would be prejudiced by a lack of proper notice of the authority lading), between points in Massachu­ No. MC 29566 (Sub-No. 134) (Repub­ described in the findings herein, a notice setts. N o te: The instant application is a lication) , filed August 14, 1969, published of the authority actually granted will be matter directly related to MC-F-10919, F ederal R egister published in the F ederal R egister issue in the issue of Septem­ published in the F ederal R egister and ber 18, 1969, and republished this is­ issuance of a certificate in this proceed­ of August 19, 1970. Applicant states that sue. Applicant: SOUTHERN FREIGHT ing will be withheld for a period of 30 tacking can take place at any common LINES, INC., 1400 Kansas Avenue, Kan­ days from the date of such publication, point with the authority sought to be pur­ sas City, Kans. 66105. Applicant’s repre­ during which period any proper party chased in the directly related applica­ sentative: Vernon M. Masters (same ad­ in interest may file a petition to reopen tion. If a hearing is deemed necessary, dress as above). By application filed the proceeding or for other appropriate applicant requests it be held at Boston, August 14, 1969, as amended, INTER­ relief setting forth in detail the Mass. STATE MOTOR FREIGHT SYSTEM, of precise manner in which it has been Applications U nder Sections 5 Grand Rapids, Mich., successor-in-inter­ and 210a(b) est to Southwest Freight Lines, Inc., of so prejudiced. No. MC 129778 (Republication) filed The following applications are gov­ Kansas City, Mo., seeks a certificate of March 19, 1968, published in the F ederal public convenience and necessity. The erned by the Interstate Commerce Com­ R egister issue of April 4, 1968, and re­ mission's special rules governing notice modified procedure has been followed, published this issue. Applicant: EAST and an order of the Commission, Operat­ 6f filing of applications by motor carriers PENN TRANSPORTATION CO., a cor­ of property or passengers under sections ing Rights Board, dated May 28, 1970, poration, Box 387, Pottsville, Pa. ApplK and served June 16, 1970, finds; that the 5(a) and 210a(b) of the Interstate Com­ cant’s representative: S. Harrison Kahn, merce Act and certain other proceedings present and future public convenience Suite 733, Investment Building, Washing­ and necessity require operation by appli­ ton, D.C. 20005. A decision and order of with respect thereto (49 CFR 1.240). cant, in interstate or foreign commerce, the Commission, Review Board No. 3, MOTOR CARRIERS OF PROPERTY as a common carrier by motor vehicle, dated August 7, 1970, and served Au­ over irregular routes, of cellulose mate­ No. MC-rF-10907. (Correction) (C & H gust 13, 1970, upon consideration of the TRANSPORTATION CO., INC.—Pur­ rials and products, paper and paper prod­ application and the record in the pro­ ucts, and materials, equipment, and chase—W. J. SHANNON TRUCKING ceeding, including the Examiner’s re­ CO.), published in the August 5, 1970 supplies used in the production and dis­ port and recommended order, finds that tribution of the above-described com­ issue of the F ederal R egister on pages the present and future public conven­ 12511 and 12512. This correction is to modities (except in each instance com­ ience and necessity require operation by modities in bulk), between the plantsite applicant, in interstate or foreign com­ show the correct name of the party to ac­ of the Charmin Paper Products Co. near quire control of the operating rights is merce, as a common carrier by motor TYLER CORPORATION, in lieu of Neely’s Landing, Mo., on the one hand, vehicle, over irregular routes, of passen­ and, on the other, points in Arkansas gers and their baggage in the same ve­ C. A. RUNDELL, JR. (except Blytheville and points in its hicle with passengers, in charter opera­ No. MC-F—10908. (Correction) (ROB­ commercial zone), Colorado, Illinois (ex­ tions, beginning and ending at points in ERTSON TANK LINES, INC.—Pur­ cept points on and south of U.S. Highway Schuylkill County, Pa., extending to chase—ALLEN TRUCKING COMPANY, 460), Iowa, Kansas, Nebraska, and Okla­ points in Delaware, Maryland, New INC.), published in the August 5, 1970 homa. Because it is possible that other Jersey, New York, Virginia, and the issue of the F ederal R egister on page parties, who have relied upon the notice District of Columbia. Because it is pos­ 12512. This correction to. show that the of the application as published, may have sible that other parties who have relied correct name of the company controlling an interest in and would be prejudiced upon the notice of the application as ROBERTSON TANK LINE, INC., is by the lack of proper notice of the au­ previously published may have an inter­ ROBERTSON DISTRIBUTION SYS­ thority described in this order, a notice est in and would be prejudiced by the lack TEM, INC., and the parties to acquire of the authority actually granted will of proper notice of the authority de­ control of the operating rights through be published in the F ederal R egister and scribed in the findings in this order, a ROBERTSON DISTRIBUTION SYS­ issuance of a certificate in this proceed­ TEM, INC., are L. M. ROBERTSON, notice of the authority actually granted ELIZABETH ROBERTSON, and IRVIN ing will be withheld for a period of 30 will be published in the F ederal R egis­ days from the date of such publication ter and issuance of a certificate in this L. SMART in lieu of EDWARD O. GAY­ during which period any proper party proceeding will be withheld for a period LORD. in interest may file a petition to reopen of 30 days from the date of such publica­ No. MC-F-10909. (Correction) (CHEM­ or for other appropriate relief setting tion, during which period any proper ICAL EXPRESS COMPANY—Con­ forth in detail the precise manner in parly in interest may file a petition to trol—QUALITY TRANSPORT, INC.), which it has been so prejudiced. reopen or for other appropriate relief published in the August 5, 1970 issue of

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 13630 NOTICES the F ederal R egister on page 12512. This Application has been filed for temporary INC., 502-504 North Barry Street, Olean, correction is to show (A) CEMENT authority under section 210a(b). N.Y. 14760, and for acquisition by TRANSPORTS, INC., MC-124238, 1200 No. MC-F-10928. Authority sought for SHORT LINE TERMINAL AGENCY, Simons Building, Dallas, Tex. 75201, is purchase by YARBROUGH TRANSFER INC., and in turn DAVID RUKIN, BAR­ authorized to operate as a common car­ COMPANY, 1500 Doune Street, Winston- NETT RUKIN, and JULIUS EISEN, all rier in Arkansas, Louisiana, Oklahoma, Salem, N.C. 27107, of the operating rights of 17 Franklin Turnpike, Mahwah, N.J. and New Mexico, and "eliminate and is of BELVIE LEE PRICE, doing business 07430, of control of such rights through controlled by” preceding (D) ELLS­ as PRICE MOVING SERVICE, 1042 the purchase. Applicants’ attorney: WORTH BROS. TRUCK LINE, INC., as North Oakland Street, Gastonia, N.C. John R. Sims, Jr., Suite 605, 711 14th ELLSWORTH BROS. TRUCK LINE, 28052, and for acquisition by JOHN D. Street NW., Washington, D.C. 20005. INC. is controlled by CHEMICAL EX­ YARBROUGH, also of Winston-Salem, Operating rights sought to be trans­ PRESS COMPANY. N.C., of control of such rights through ferred: Passengers, and their baggage, No. MC-F-10925. Authority sought for the purchase. Applicants’ attorney and express, and newspapers, in the same control by IML FREIGHT, INC., Post representative: Charles Ephraim, 1411 K vehicle with passengers, as a common Office Box 2277 (2175 S. 3270 W.) , Salt Street NW., Washington, D.C. 20005 and carrier over regular route, between Port- Lake City, Utah 84110, of THOMAS H. Frank Patton Cooke, 317-21 Commercial ville, N.Y., and Coming, N.Y., serving all MARROW TRUCKING CO., 8050 Othello Building, Gastonia, N.C. 28052. Operat­ intermediate points, with restriction. Street, San Diego, Calif. 92111, andrfor ing rights sought to be transferred: Vendee is authorized to operate as a acquisition by CHARLES C. GATES, Household goods as defined by the Com­ common carrier in New York.'Applica­ JR., 999 South Broadway, Denver, Colo., mission, as a common carrier over irreg­ tion has not been filed for temporary of control of THOMAS H. MARROW- ular routes, between points in Gaston authority under section 210a (b). TRUCKING CO., through the acquisi­ County, N.C., on the one hand, and, on By the Commission. tion by GATES CORPORATION. Ap­ the other, points in Georgia, South Caro­ plicants’ attorneys: Frank Loughran and lina, and Tennessee. Vendee is author­ [seal] J oseph M. H arrington, Marshall G. Berol Loughran, Berol & ized to operate as a common carrier in Acting Secretary. Hegarty, 100 Bush Street, 21st Floor, North Carolina and under a certificate [F.R. Doc. 70-11232; Filed, Aug. 25, 1970; San Francisco, Calif. 94104. Operating of registration within the State of North 8:47 a.m.) rights and property sought to be con­ Carolina. Application has been filed for trolled: Under a certificate of registra­ temporary authority under section tion, in Docket No. MC-120516 Sub 2, 210a(b). N o te: N o. MC-112288 Sub 5 is NOTICE OF FILING OF MOTOR covering the transportation of property, a matter directly related. CARRIER INTRASTATE APPLICATIONS as a common carrier in interstate com­ No. MC-F-10930. Authority sought for merce, within the State of California. purchase by BOB YOUNG TRUCKING, August 21, 1970. IML FREIGHT, INC., is authorized to INC., New Industrial Drive, Bethlehem, The following applications for motor operate as a common carrier in Colorado, Pa. 18017, of the operating rights of common carrier authority to operate in Utah, Nevada, Nebraska, California, H. A. JAEGER, INC. (EDWARD A. intrastate commerce seek concurrent Illinois, Wyoming, Iowa, Arizona, Idaho, RYAN, TRUSTEE IN BANKRUPTCY), motor carrier authorization in interstate Kansas, Missouri, Oregon, Washington, 550 Union Avenue, Middlesex, N. J. 08846, or foreign commerce within the limits of Ohio, Kentucky, Indiana, Pennsylvania, and for acquisition by ROBERT DOUG­ the intrastate authority sought, pursu­ New Jersey, New York, Massachusetts, LAS YOUNG and RUTH R. YOUNG, ant to section 206(a) (6) of the Inter­ and the District of Columbia. Applica­ both also of Bethlehem, Pa., of control of state Commerce Act, as amended tion has been filed for temporary author­ such rights through the purchase. Appli­ October 15, 1962. These applications are ity under section 210a(b). cants’ attorney and representatives: governed by Special Rule 1,245 of the No. MC-F-10927. Authority sought for Morris Mindlin, 1509 Easton Avenue, Commission’s rules of practice, published purchase by COSSITT MOTOR EX­ Bethlehem, Pa. 18017, and Donald E. in the F ederal R egister, issue of April 11, PRESS, INC., 63 West Kendrick Avenue, Clarick, 303 George Street, New Bruns­ 1963, page 3533, which provides, among Hamilton, N.Y. 13346, of the operating wick, N.J. 08903. Operating rights sought other things, that protests and requests rights and property of JOHN C. PETER­ to be transferred: Such commodities as for information concerning the time and SON, doing business as DAPSON’S EX­ require specialized handling or rigging place of State Commission hearings or PRESS, 213 Main Street, Oriskany Falls, 3because of size or weight, as a common other proceedings, any subsequent N.Y. 13425, and for acquisition by carrier, over irregular routes, between changes therein, any other related mat­ L. ALLEN COSSITT, also of Hamilton, points in New Jersey, on the one hand, ters shall be directed to the State Com­ N.Y., of control of such rights and prop­ and, on the other, points in Pennsyl­ mission with which the application is erty through the purchase. Applicants’ vania on and east of U.S. Highway 15, filed and shall not be addressed to or attorneys: Norman M. Pinksy and Her­ those in New York on and east of a line filed with the Interstate Commerce bert M. Canter, both of 345 South Warren beginning at the Pennsylvania-New York Commission. Street, Syracuse, N.Y. 13202. Operating State line, and extending along New State Docket No. MT-8866, filed rights sought to be transferred: General York Highway 14 to Elmira, N.Y., thence July 22, 1970. Applicant: PERRY MOR­ commodities, except those of unusual along New York Highway 13 to Cortland, GAN BROWN, doing business as value, classes A and B explosives, house­ N.Y., thence along U.S. Highway 11 to MILLER’S MOVING & CARTING, 915 hold goods as defined by the Commission, Syracuse, N.Y., and on and south of a Niagara Avenue, Niagara Falls, N.Y. commodities in bulk, commodities requir­ line beginning at Syracuse, N.Y., and 14305. Applicant’s representative: Ron­ ing special equipment and those injuri­ extending along New York Highway 5 to ald D. Anton, 770 Main Street, Niagara ous or contaminating to other lading, as Schenectady, N.Y., thence along New Falls, N.Y. 14301. Certificate of public a common carrier over regular route, be­ York Highway 7 to the New York- convenience and necessity sought to tween Utica, N.Y., and Morrisville, N.Y., Vermont State line. Vendee is authorized operate a freight service as follows: serving all intermediate points, and the to operate as a common carrier in Penn­ Transportation of household goods, be­ off-route points of Solsville, Pratts Hol­ sylvania, New Jersey, and New York. tween all points in New York State. Both low, Stockbridge, Hamilton, Munnsville, Application has been filed for temporary interstate and intrastate authority is Knoxboro, Augusta, Randallsville, and authority under section 210a(b). sought. Easton, N.Y. Vendee is authorized to HEARING: Not yet assigned. Requests operate as a common carrier in New MOTOR CARRIER OF PASSENGERS for procedural information, including No. MC-F-10926. Authority sought for the time for filing protests, concerning York, Pennsylvania, Massachusetts, this application should be addressed to Connecticut, Rhode Island, Maine, Ver­ purchase by HUDSON TRANSIT COR­ the New York Public Service Commis­ mont, New Hampshire, Maryland, New PORATION, Route 17K, Montgomery, sion, 44 Holland Avenue, Albany, NX Jersey, Virginia, West Virginia, Ohio, N.Y. 12549, of a portion of the operating 12208, and should not be directed to the Delaware, and the District of Columbia. rights Of BLUE BIRD COACH LINES, Interstate Commerce Commission.

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 NOTICES 13631 postpone the effective date of the order consin. Robert J. Kay, Geisler & Kay, 433 State Docket No. (unknown), filed West Washington Avenue, Suite 500, Tnlv 16, 1970. Applicant: JOHN FAW­ in that proceeding pending its disposi­ tion. The matters relied upon by peti­ Madison, Wis. 53703, attorneys for CETT doing business as WESTERN transferee. FREIGHTWAYS, 4230 Alta Vista Lane, tioners must be specified in their petitions with particularity. No. MC-FC-72312. By order of Au­ Dallas Tex. 75229. Applicant’s repre­ gust 18, 1970, the Motor Carrier Board sentative: Grady L. Fox, 222 Amarillo No. MC-FC-72121. By order of Au­ gust 17, 1970, the Motor Carrier Board approved the transfer to Bob Curtis Building, Amarillo, Tex. 79101. Certifi­ Trucking, Inc, 930 West First Street, cate of public convenience and necessity approved the transfer to Joe and Michael Coury, a partnership, St. Paul, Winner, S. Dak. 57580, of the operating sought to operate a freight service as rights in certificates Nos. MC-111427 follows: Transportation of General com­ Minn., of that portion of the operating rights in certificate No. MC-10935 issued (Sub-No. 3), MC-111427 (Sub-No. 5), modities (except household goods, live­ April 23, 1970, to Paul D. Kessler, doing and MC-111427 (Sub-No. 6) issued stock, and classes A and B explosives), business as Paul Kessler Trucking, May 22, 1957, September 24, 1965, and from Dallas to Seymour over State High­ Dresser, Wis., authorizing the transpor­ , 196$, to Robert Curtis, doing way 183 to Fort Worth, thence over tation of general commodities, with business asBobCurtisTrucking, Winner, State Highway 199 to Seymour, serving specified exceptions, from South St. S. Dak. 57580, collectively authorizing all intermediate points with return serv­ Paul, St. Paul, Newport, and Min­ the transportation of specified agricul­ ice over the same route; between Sey­ neapolis, Minn., to Osceola, Garfield, tural machinery and implements and mour and Breckenridge over U.S. High­ Lincoln, Balsam Lake, and St. Croix other specified commodities from, to, or way 183, serving Throckmorton and Falls, Wis. S. Rubenstein, 301 North between specified points in South Dakota, Woodson as intermediate points; from Fifth Street, , Minn. 55403, Iowa, and Nebraska. Dallas to Breckenridge over State High­ representative for applicants. No. MC-FC-72317. By order of Au­ way 183 to Fort Worth, thence U.S. No. MC-FC-72233. By order of Au­ gust 17, 1970, the Motor Carrier Board Highway 180 to Breckenridge, serving all gust 17,1970, the Motor Carrier Board on approved the transfer to Marlin A. intermediate points, and with return reconsideration, approved the transfer to Chanay and Marilyn Chanay, a partner­ service over the same route; between Van’s Auto Express, Inc., Kingston, N.Y., ship, doing business as Chanay Truck Jacksboro and Throckmorton over State of certificate of registration No. MC- Line, WellsviUe, Kans, of the operating Highway 24, serving Graham and other 96686 (Sub-No. 1) issued to Murtaugh’s rights in certificates Nos. MC-69299; MC- intermediate points; between Olney and Express, Inc., Poughkeepsie, N.Y., evi­ 69299 (Sub-No. 1)*, and MC-29299 (Sub- Graham over State Highway 251, serv­ dencing a right to engage in interstate or No. 2) issued October" 9, 1943, Novem­ ing all intermediate points; between foreign commerce, in the transportation ber 1, 1946, and April 27, 1950, respec­ Olney and Throckmorton over State of commodities, within the State of New tively, to Artie Chanay (Helen K. Highway 79, serving all intermediate York. Arthur J. Piken, 160 Jamaica Chanay, Executrix), Wellsville, Kans., points; between Graham and Brecken­ Avenue, Jamaica, N.Y. 11432, attorney authorizing the transportation of gen­ ridge over State Highway 67, serving all for applicants. eral commodities, with usual exceptions, intermediate points; and between Min­ No. MC-FC-72288. By order of Au­ and livestock between Wellsville, Kans., eral Wells and the junction of U.S. gust 17, 1970, the Motor Carrier Board and Kansas City, Mo.; and livestock, Highway 281 and State Highway 199 approved the transfer to Madonia and building material, farm machinery, and over U.S. Highway 281. Applicant Would Caravella Transportation, Inc., Luen- feed between Rantoul and Stanton, interchange at any point where service burg, Mass., of certificate of registration Kans., and Kansas City, Mo.; and available or as traffic required. Both No. MC-97617 (Sub-No. 1) , issued Jan­ general commodities, with usual excep­ intrastate and interstate authority uary 7,1964, to Niemi Manufacturing Co., tions, from Kansas City, Mo., to Shawnee, sought. Inc., Luenburg, Mass., evidencing a right Kans. John L. Richeson, First National HEARING: Approximately 30 days to engage in transportation in Interstate Bank Building, Ottawa, Kans. 66067, after date of publication in the F ederal Commerce as described in Certificate No. attorney for applicants. Register. Requests for procedural infor­ 1676, dated June 16, 1947, issued by the No. MC-FC-72318. By order of August mation, including the time for filing pro­ Massachusetts Department of Public 18, 1970, the Motor Carrier Board ap­ tests, concerning this application should Utilities. Carleton E. Blackwell, 76 Sum­ proved the transfer to Wheeler’s Towing be addressed to the Railroad Commis­ mer Street, Fitchburg, Mass. 01420, at­ & Service, Inc., Omaha, Nebr., of the sion of Texas, Capitol Station, Post torney" for applicants. operating rights in certificates Nos. MC- Office Drawer EE., Austin, Tex. 78111, No. MC-FC-72310. By order of Au­ 117167 and MC-117167 (Sub-No. 1) is­ and should not be directed to the Inter­ gust 17, 1970, the Motor Carrier Board sued June 1, 1959 and May 22, 1961, to state Commerce Commission. approved the transfer to Lionel D. Ste­ Edwin J. Barrett, doing business as Bar­ By the Commission. phens, Cuyahoga Falls, Ohio, of the li­ rett’s Auto Service, Omaha, Nebr., au­ cense in No. MC-12574 issued April 28, thorizing the tranportation of wrecked [seal] J oseph M. H arrington', 1965, to Orville D. Anderson, Greenville, and disabled motor vehicles and trailers Acting Secretary. Pa., authorizing service as a broker in from points in seven specified States to [PH. Doc. 70-11231; Filed, Aug. 25, 1970; connection with the transportation of Omaha, Nebr., and from Omaha, Nebr., 8:47 a.m.] passengers and their baggage, in round- to Des Moines, Iowa. Vernon J. Morgan, trip tours, beginning and ending at Cleve­ Prorate & Reciprocity c/o Wheeler’s land, Ohio, and points within 50 miles Towing & Service, Inc., 6902 Railroad {Notice 578] thereof, and extending to points in the Avenue, Omaha, Nebr., representative of MOTOR CARRIER TRANSFER United States, except points in Alaska applicants. PROCEEDINGS and Hawaii S. Harrison Kahn, Suite 733, No. MC-FC-72323. By order of August Investment Building, Washington, D.C. 17, 1970, the Motor Carrier Board ap­ August 21, 1970. 20005, attorney for applicants. proved the transfer to Midwest Harve- Synopses of orders entered pursuant to Nd. MC-FC-72311. By order of Au­ store Transport, Inc., Rochester, Minn., section 212(b) of the Interstate Com­ gust 18, 1970, the Motor Carrier Board of the operating rights in certificates merce Act, and rules and regulations approved the transfer to Gary W. Han- Nos. MC—117068 and MC-117068 (Sub- Prescribed thereunder (49 CFR Part kel, doing business as Hankel Transfer, No. 7) issued January 16, 1968, and 1132), appear below: Belleville, Wis, 6f the operating rights in September 29, 1969, to Allen I. Koenig, As provided in the Commission’s spe­ certificate No. MC-124449 issued April 13, doing business as Midwest Harvestore cial rules of practice any interested per­ 1964, in the name of Slaney Transfer, Transport Co., Rochester, Minn., au­ son may file a petition seeking recon­ Inc, Dodgeville, Wis, and acquired by thorizing the transportation of animal sideration of the following numbered Hankel & Olson, Inc, Verona, Wis, pur­ waste storage tanks, livestock scales, proceedings within 20 days from the date suant to No. MC-FC-71232, consum­ livestock feed bunkers, forage metering of publication of this notice. Pursuant to mated August 24, 1969, authorizing the devices, animal waste spreader tanks, section 17(8) of the Interstate Commerce transportation of fertilizer from Fulton, and steel silos from Kankakee, 111., to Act, the filing of such a petition will HI, to points in specified counties in Wis­ points in Minnesota, Iowa, North Dakota,

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 13632 NOTICES and South Dakota; and farm tractor necticut, Rhode Island, Massachusetts, Petitioner prays that the Interstate cabs, parts, and accessories from Man­ and Pennsylvania. It also holds intra­ Commerce Commission issue an order (1) kato, Minn., to points in Iowa, Illinois, state authority (Certificate 8294) from declaring the circumstances under which Indiana, Nebraska, and North Dakota. the Public Service Commission of the petitioner’s operations in the described Paul F. Sullivan, 701 Washington Build­ State of New York authorizing the trans­ transportation of misplaced, delayed, ing, 15th and New York Avenue NW., portation of personal effects, in trunks, and misrouted luggage between airports Washington, D.C. 20005, attorney for ap­ bags, suitcases, footlockers, duffle bags or located in New York State, on the one plicants. other similar containers, between air­ hand, and, on the other, points in New ports in , on the one hand, York, are not subject to the jurisdiction [seal] J oseph M. H arrington, and, on the other, all points in the of the Interstate Commerce Commission, Acting Secretary. counties of Nassau and Suffolk. and (2) declaring that the Interstate [F.R. Doc. 70-11225; Filed, Aug. 25f 1970; Petitioner states that it has made a Commerce Commission has jurisdiction 8:46 a.m.] substantial investment in equipment to over the motor transportation of lug­ transport misplaced, delayed, and mis- gage, between points in the State of New [Nos. MC-C—6867 (Sub-No. 1), MC-127653 routed luggage of airline passengers. It York when said baggage had an imme­ (Sub-No. 1)] further avers that the New York Public diately prior or subsequent movement by Service Commission entered a decision air to or from points either within or UNITED SERVICES & PROJECTS, INC. on April 7, 1970, in Case MT-8767, in outside of the State of New York. Notice of Filing of Petition for Tan Line, Inc., which characterizes all It is further noted that a similar pro­ Declaratory Order movements of luggage that is misplaced, ceeding has been instituted by Fourmen delayed, or misrouted, from the New Delivery Service, Inc., in No. MC-C-6867, August 21, 1970. York City Airports to points in New York by petition filed June 3, 1970, and pub­ Petitioner: United Services & Projects, State, as being intrastate in nature and lished in the F ederal R egister on Inc., 145-79 226th Street, Rosedale, N.Y. as being beyond the scope of the regula­ June 24,1970. Petitioner’s representative: Arthur J. tory authority of the Interstate Com­ Any interested person desiring to par­ Piken, 160-16 Jamaica Avenue, Jamaica, merce Commission. Petitioner further ticipate may file an original and six N.Y. 11432. By petition filed June 19,1970, says that Tan Line, Inc., has a related copies of his written representations, petitioner states that it holds certificate application for the same authority now views, or arguments, in support of, or No. MC-127653 (Sub-No. 1), issued June pending before the Interstate Commerce against the petition within 30 days from 5,1967, authorizing the transportation of Commission in No. MC 133701, and that it opposed the grant of authority in both the date of this publication in the Fed­ luggage and such personal property eral R egister. usually carried by airline passengers, be­ of the above-cited proceedings. Its op­ tween Kennedy International Airport position to the intrastate application was By the Commission. and La Guardia Airport, of New York, based on its view that, in part, the in­ N.Y., Newark Airport, Newark, N.J., and volved traffic is interstate in character, [seal] J oseph M. H arrington, Teterboro Airport at or near Teterboro, and therefore beyond the jurisdiction of Acting Secretary. N.J., on the one hand, and, on the other, the Public Service Commission of New [F.R. Doc. 70-11230; Filed, Aug. 25, 1970; points in New Jersey, New York, Con­ York. 8:47 a.m.]

CUMULATIVE LIST OF PARTS AFFECTED— AUGUST

The following numerical guide is a list of parts of each title of the Code of Federal Regulations affected by documents published to date during August.

3 CFR Page 7 CFR—Continued Pa«e 7 CFR—Continued Page P roclamation: 701______12639 Proposed Rules: 3997______13567 718______12640 201______12847 725______—____ 13076 362______12478 E xecutive O rders: 811______es______13189 711 ______12404 2513 (revoked in part by PLO 814______13003 729 ..______13135 4882)______12657855______12529 906 _____ *______13453 10804 (revoked by EO 876______12640,12887 907 ______13290 11552)______13569 906______13449 908 ______13290 11248 (amended by EO 11550) _ 12315 908___ 12529, 12829, 13076, 13281, 13511 913______13292 11399 (amended by EO 11551) _ 12885 910____ -_____ 12322,12642,13006,13449 Q1Q _ 12478 11550 ______12315 919______13359 925______— 12478 11551 ______12885 921______12643 932______12345 11552 ______13569 923______12392 945 ______13135 925 ______13359 946 ______13454 5 CFR 926 ______13450 948______-_____ 13370 213_____ 12341, 927 ______12705 958______12544 12387, 12531, 12644, 12747, 13075, 931______12392, 12643 966______13520 13359,13423 947 _:______12455 Qfll . 12767.13135 335______13075948 ______12887,13281 989______—___ l2544 550______12387 958 ______12529 qq1 _ 12660 890______13075 980______12530 0Q3 _ 13136. 13219 P roposed R u l es: 991______— 13450 1007 _ 13454 2470 ______13527 993______12323 1030______l2545 2471 ______13527 1036______13281 1036______12978 1137______13007 7 CFR 1421______12393, 12706, 12829 1061______-______l2613 26_...... — 12321 1427 12707 1098.:______13521 51______13571 1434______12597,13077 moo ... 12767. 13457 58______12639 1443 12455 12747 1134______—— 13371 225______12391 1602 12597 1136______-_____ 13378 265______13076 1813______13571 ______13391

FEDERAL REGISTER, VOL. 35, NO. 166— WEDNESDAY, AUGUST 26, 1970 FEDERAL REGISTER 13633

8 CFR Page 14 CFR—Continued Page 20 CFR Page Proposed R u les: P roposed R ules—Co n tin u ed 405______— 12330,12889 602______12393 211------13452 39___ 13460 242______13452 71______12348, P roposed R u l e s: 12349, 12556—1255G, 12769, 12847, 405______12346, 9 CFR 12953-12956, 13138, 13292, 13293, 12545,12660,12727,13023 Hg ______12388, 13461-13463 ” 12460, 12644, 12707, 12747, 12833, 75______13463 21 CFR 12887, 13007, 13077, 13190, 13359, 93— ______13463 1 ______W______13575 13423, 13424, 13511, 13572 121______12479,13138 2 ______13196 78______12747 123______13138 207—______13370 3 ______-____ 12890 Proposed R u l e s: 19______12461 208______*______13370 27______13365 201______12769 212______13220, 13370 120 ______13123, 13196, 13197 214______13370 121 ______12332, 10 CFR 249—______13370 12390, 12598, 12755, 12890, 13124, 12649 295______/______— 13370 13197, 13436, 13576 Proposed R u les: 399______12770, 13370 130______— 12652,12891 12770 135a______12719 Ch. I------15 CFR 30______12412 135b______13576 40------12412 366______13514 135c______13366 70— ------12412 377______12389, 12837 135d______12332 170______12412 379____ 13195 135e______12332 135g______12332,12333 12 CFR 16 CFR 141d______——______12719 204______— 13512 13 ______12753, 12754, 12837-12843 146c____ -______12653 329______12460 245______13122 146d_____ -12719 526— ______12388 252______12718 148e______13436 501______a______12461, 13195 148m______12654 545______12834 148n______12653 555_____ 12834 P roposed R u l es: 191— ______12892, 13198 604 ____1______13360 250—— ______12958 605 ___ 12461 416—______12727 320___ —— ______12461 P roposed R u l e s: 428______12671 P roposed R u l e s: 204______12777 3______t ______12411, 12479 17 CFR 45______12951 13 CFR 240______12390 120______12951, 13525, 13583 270___ 13122 130______12952 122______-______12529 135______12479 302______- _____ 13282 P roposed R u les: 144______12479 231______-______12853 191______- __ 13137,13138 14 CFR 1______13115 18 CFR 22 CFR 15 ______12708 21______12748,13008 154______12329 201______12611, 13009 25...... 13191 300______13364 39______12325, P roposed R u l es: 24 CFR 12326, 12531,12532, 12649, 12650, 2______13030, 13139, 13585 7______-______13011 12749, 12834,12835,13008, 13116, 10 1______12668 1914 _ 12599, 12600, 12757, 12896, 13286 13513 104 ______12958 1915 ______- 12601, 61______12708 105 ______12958 12602, 12758, 12897, 13286, 13579 65______— 12326 141______12668,12958 71______12327, 154______12559 25 CFR 201______12668 12328, 12533, 12650, 12750-12752, P roposed R u l e s: 12835-12837, 12888, 13115-13118, 204 ______12958 13193, 13362, 13363, 13424-13426, 205 ______12958 221______13022 13513 260______12668,12958 73- v 12328, 13118 26 CFR 75...... ______13118 19 CFR 32______13436 91______13115 4 ______12391, 13366 270______13514 95______13119 8 ______13434 285______—------13514 07_...... 12328, 12598, 12889, 13193 9 ______13434 Ch. II______12462 121______12708, 13191 14 ______;______13*434 P roposed R u l e s: 123___ . 13426 15 ______4______13434 1______12342, 171...... 16 ______13435 12343, 12400, 12467, 12477, 12544, 207 ______17 ______13435 208 ______12612, 13289, 13529 212—_ 2 2 ______- ______- 13435 31 12343 23 ______-______13435 151______12911 214— 54 ______13435 301______12343 225—_ HI______13435 241___ 13194 146 _/ ______13436 245__ 147 ” ______13436 28 CFR 295__ 153______13436 0______13077 298__ _ 12534, 13426 378- 173 ______13429 440— 174 ______13429 29 CFR 175 ______13432 462______13516 Proposed Rules: 176 ______13433 784______13342 25_____ 13138 P roposed R u l e s: 1500_____ l 2756 36____ 1 1 ______13289 1607______12333 13634 FEDERAL REGISTER

29 CFR— Continued Page 41 CFR— Continued Page 46 CFR Page P roposed R u les: 4-3------12602 401 103...... 12614 4-4------13018 531______4-7------12604 30 CFR 4-12------12338 47 CFR 4-16------12607 53------13576 4- 50------13018 o______300______12336 l _ 5- 1------13285 21 _ _ 302------12337 5-16_„------13286 - 12462, 12892 P roposed R u les: 5A-2------12607, 13437 23______75------12911 5A-72 ------12721 73______80______12765 5A-73------13438 81______5A-75------13438 83______31 CFR 8-2------12340,13366 85______8- 3_--- 13366 8 7 ______10______13205 89______500------13124 8-6------_____------12340 91______9- 51------12396 93______32 CFR 12B-3__------12654 12B-75------12654 95______132------12654 101-19------a------12542, 12608 9 9 ______248------12756 101-26------12721, 13133, 13439 P roposed R u l es: 720------13078 101-27------12721 2______12771, 12772, 13395 726------13078 101-32------13440 64______750 ------13086 ------12957 101-38------12609 73 ______------12481, 751 ------13086 114-43------12722 12483, 12661, 752 ------13086 12775, 13139, 13585 114-46------12722 74 ______------12775 753 ------13086 87______755 ------13086 ------12771, 13395 42 CFR 89______------13294 756 ------13086 91______757 ------13086 37------132O6 . 12772,13294,13395 81------12722, 93______------12772,13294 870------12534 95______882------12395 12723, 12756, 12757, 12843, 13441 ------13294 P roposed R ules : 1453------13017 49 CFR 1499------12338,13017 4______13525 81—12660, 12726, 13022, 1302~3~ 13459 l ______12763 32A CFR 71______12317 43 CFR 171____ _ 12609 BDSA (Ch. VI): 173_____ M-1A______12897 3810—------12723 12610 178_____ 12610 OIA (Ch. X) : P ublic Land O rders: 190_____ OI Reg. 1______12759 13248 1756 (revoked by PLO 4881) __ 12657 192_____ 13248 2198 (see PLO 4882)______12657 235 ___ 12463 33 CFR 2199 (modified and extended in 236 ___ 12465 23------_---- 12541 part by PLO 4870)____ _ 12655 Ch. m__ 13517 92------12395, 13017 2224 (revoked by PLO 4883) __ 13441 393_____ 13018 117------;_____12396,12720 2379 (modified and extended in 1033__ _ 12910 P roposed R u les: part by PLO 4870)______12655 1047 __ 13368 110------13219 3258 (see PLO 4875)______12656 1048 __ 12764 1102______117—------12554,12727 4582 (see PLO 4881) ______12657 13216 4870 ------12655 P roposed R u les: 4871 ------12655 36 CFR 4872— ------___------12655 178------13464, 13465 2------12542 4873 ------___------12655 192_------13470 5------12542 4874 ------12655 393------13024 7------13017,13206 4875 ------12656568------13139 9------12542 4876 ------12656 571____ 12847, 4877 ------12656 12956,13025,13465,13469 38 CFR 575------12849, 13294, 13527, 13583 4878.------126561048______12483 17 ----- 13125 4879 ------12657 18 -- 13133 4880 ------12657 21------,12844 4881 ------12657 50 CFR 4882 ------12657 2______12658 39 CFR 4883 ------13441 10 _ 13368 113------12462 11 ______12658 119------12760 45 CFR 14______,______r.____ 12391 135------12845 16___ 12658 73------_____ 12902 28______13019,13287 P roposed R u l es: 175------____----- 12543 32______12465, 126------'------13452 181------13442 600------___ 13133 12466, 12543, 12611, 12724, 12725, 127— ------13452 13019-13021, 13133, 13134, 13217, 134...... 13519 901------_____ 12516 903 ------____ 12517 13287, 13369, 13448, 13449, 13517, 41 CFR 904 ------__------12521 13518 905 ------12522273______13287 1-8------13133 907------__-----12523 P roposed R u les: 1-15------13579 908 ------12524 IQOftO 1-16------13133 17_IIIZIIIIIZII_12726," 12847, 13519 Ch. 2------12542 P roposed R u les: 32 ______13452, 13582 4-2------13018 250------1234633 ______13582