Ünltïv * Washington, Thursday, October 14, 1948
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FEDERAL REGISTER 1934 VOLUME 13 \ NUMBER 201 * ÜNlTïV * Washington, Thursday, October 14, 1948 TITLE 21— FOOD AND DRUGS 10.0-ml. aliquot of this solution by the following method: CONTENTS Chapter l-^-Food and Drug Adminis (ii) Reagents—(a) Sodium nitrite solu Agriculture Department Pase tration, Federal Security Agency tion. Dissolve 0.1 gm. of sodium nitrite in 100 ml. distilled water. Prepare fresh Proposed rule making: P art 141—T ests and Methods of Assay solution every other day. Milk handling, Lima, Ohio, area. 6020 for Antibiotic D rugs (b) Ammonium sulfamate solution. Peas, canned, field and black- P art 146—Certification of Batches of Dissolve 0.5 gm. of ammonium sulfamate eye; U. S. standards for grades P en icillin- or S treptomycin-C on in 100 ml. distilled water. (Corr.)__________________ 6019 taining Drugs (c) N- (1-naphthyl) -ethylenediamine Sugar consumption require solution. Dissolve 0.1 gm. of N- (1 -naph ments, quotas, and quota de MISCELLANEOUS AMENDMENTS thyl) -ethylenediamine dihydrochloride ficits, 1949________________ 6019 By virtue of the authority vested in the in 100 ml. distilled water. Prepare fresh Federal Security Administrator by the solution every other day. Alien Property, Office of provisions of section 507 of the Tederal (iii) Standard curve. Prepare a stand Notices: Food, Drug, and Cosmetic Act (52 Stat. ard stock solution containing 275.5 ml. of Vesting orders, etc.: 1040, 1055, as amended by 59 Stat. 463 procaine hydrochloride U. ¡3. P. in a Epp, Leonhard____________ 6041 and 61 Stat. 11; 21 U. S. C., Sup. 357), liter of distilled water. A standard Klein, Karl_______________ 6042 the regulations for tests and methods of working solution containing 2.755 mg. Mosle, Dorothea C__.______ 6042 assay of antibiotic drugs (12 F. R. 2215;" per liter is prepared by diluting 10.0 ml. Pieroni, Louis_____________ 6042 13 F. R. 439, 2475, 3969, 4186) and cer of the -standard stock solution to a liter Vahlkamp, Minnie________ 6041 tification of batches of penicillin- or with distilled water. (Each milliliter of streptomycin-containing drugs (12 F. R. the standard working solution is equiva Fédéral Communications Com- - 2231, 4369, 8723; 13 F. R. 436, 1087, 2291, lent to 6 units of procaine penicillin.) mission 2475, 2950, 3969, 4186, 5152) are amended Transfer, respectively, 2.0, 4.0, 6.0, 8.0, Notices : as indicated below: and 10.0 ml. of the standard working 1. Part 141 is amended by adding thesolution and 10.0 ml. of distilled water to International Convention for following new section: each of six 25-ml. volumetric flasks. Add Safety of Life at Sea, 1948; 8.0, 6.0, 4.0, and 2.0 ml. of water to the ' notice to U. S. shipowners, § 141.32 Procaine penicillin and "buff ship radio station licensees, ered crystalline penicillin for aqueous first four flasks, respectively, to give each injection—(a) Potency, sterility, mois a volume of 10.0 ml. To each flask add etc— 1___ 6034 ture, pyrogens, toxicity, pH. Proceed as 0.5 ml. of 4N HC1, 1.0 ml. of the sodium Schedule of hearings, October directed in § 141.29. nitrite solution, 1.0 ml. of the ammonium 1948 to June 1949_________ 6035 sulfamate solution, and 1.0 ml. of the (b) Buffered crystalline penicillin con Federal Power Commission tent—(1) Preparation of sample. Add N-(1-naphthyl) -ethylenediamine solu 20 ml. of distilled water to the contents tion, with mixing after each addition. Notices: of a vial of the sample and shake well. Make each flask to a volume of 25 ml. Hearings, etc.: Centrifuge, decant, and centrifuge the with distilled water. Read the percent Atlantic Seaboard Corp____ 6032 decanted liquid to obtain 12 to 15 ml. of light transmission of the colored solu Foley, G. F_______________ 6033 clear solution. tions using a 2.0 cm. cell and a 550 u Lone Star Gas Co_________ 6032 (2) Iodometric assay for total peni filter in a suitable photoelectric color Mesabi Pipe Line Co_______ 6033 cillin. Dilute a 5.0-ml. aliquot of the imeter. The instrument is balanced so Mesabi Pipe Line Co. and clear solution prepared in accordance that the zero concentration reads 100% Trunkline Gas Supply Co__ 6033 with subparagraph (1) of this paragraph light transmission. Prepare a standard curve on semilog paper, plotting the per Northwestern Public Service to 50 ml. with 1% phosphate buffer at Co------- ------------- 6033 pH 6.0. Determine the total quantity of cent light transmission on the loga penicillin in a 2.0-ml. aliquot of this so rithmic ordinate scale and the concen Fish and Wildlife Service lution by the iodometric assay procedure tration as units of procaine penicillin on Rules and regulations: described in § 141.5 (e). the abscissa. (iv) Procedure. By means of a volu Railroad Valley National Wild (3) Colorimetric determination of pro life Refuge, Nevada; hunting- 6018 caine penicillin, (i) Transfer a 10.0-ml. metric pipette transfer to a 25-ml. volu aliquot of the solution prepared in sub- metric flask 10.0 ml. of the solution pre Food and Drug Administration paragraph (2) of this paragraph to a pared in subparagraph (3) (i) of this Proposed rule making : 1-liter volumetric flask and make to vol paragraph. Add 0.5 ml. of 4N HC1, 1.0 Bread and related products; ume with distilled water. Determine the ml. of the sodium nitrite solution, 1.0 ml. definitions and standards of quantity of procaine penicillin in a (Continued on next page) identity__________________ 6024 6015 6016 RULES AND REGULATIONS CONTENTS— Continued CODIFICATION GUIDE— Con. National Park Service page Title 49— Transportation and Page FEDERAL^REGISTER Proposed rule making: Railroads '»34 ¿¡F Chapter I—Interstate Commerce t'N ITtO ’ Labor standards applicable to employees of concessioners; Commission : hearing on wages and over Part 95—Car service.— -----6018 Published daily, except Sundays, Mondays, time compensation------------- 6019 Title 50— Wildlife and days following official Federal holidays, Securities and Exchange Com Chapter I — Fish and Wildlife by the Division of the Federal Register, the Service, Department of the National Archives, pursuant to the authority mission contained in the Federal Register Act, ap Interior: proved July 26, 1935 (49 Stat. 500, as Notices : Part 21—Pacific region national amended; 44 U. S. C., ch. 8B), under regula Hearings, etc.: wildlife refugeS*— ----------- 6018 tions prescribed by the Administrative Com Engineers Public Service Co— 6034 mittee, approved by the President. Distribu Pennsylvania Gas and Elec tion is made only by the Superintendent of tric Corp. and North Shore of the ammonium sulfamate solution, Documents, Government Printing Office, Gas Co ----------------------- 6034 and 1.0 ml. of the N-(1-naphthyl) -ethyl- Washington 25, D. C. enediamine solution with mixing after The regulatory material appearing herein is each addition. Make to 25.0 ml. with dis keyed to the Code of Federal Regulations, CODIFICATION GUIDE which is published, under 50 titles, pursuant tilled water. Set the colorimeter at 100% to section 11 of the Federal Register Act, as A numerical list of the parts of the Code light thansmission with the 0% concen amended June 19, 1947. of Federal Regulations affected by documents tration blank as directed above and ob The F ederal R egister will be furnished by published in this issue. Proposed rules, as tain the percent light transmission of the mail to subscribers, free of postage, for $1.50 opposed to final actions, are identified as sample. The concentration obtained per month or $15.00 per year, payable in ad such. directly from the standard curve corre vance. The charge for individual copies sponding to the percent light transmis (minimum 15tf) varies in proportion to the Title 7— Agriculture Page sion of the sample X20 equals the concen size of the issue. Remit check or money Chapter I—Production and tration of procaine penicillin in 2 ml. of order, made payable to the Superintendent M ark etin g Administration the solution prepared in subparagraph of Documents, directly to the Government (Standards, Inspections, Printing Office, Washington 25, D. C. (2) of this paragraph. There are no restrictions on the republica Marketing Practices) : The content of buffered crystalline tion of material appearing in the F ederal Part 52—Procëssed fruits, vege penicillin in the sample vial is equal to R egister. tables, and other products the difference between the total number (inspection, certification and of units of penicillin in 2.0 ml. of the standards) (proposed)------- . 6019 solution as determined by subparagraph Chapter VUI—Production and Now Available (2) of this paragraph and the total num M arketing Administration ber of units of procaine penicillin in 2.0 (Sugar Branch) : ml. of this same solution as determined UNITED STATES Part 821—Sugar quotas (pro above, multiplied by 100. GOVERNMENT posed)_________________ i— 6019 The content of buffered crystalline Chapter IX—Production and penicillin in the batch is satisfactory MANUAL M arketing Administration when determined by the method de (Marketing Agreements and scribed in this paragraph if it is not less 1948 Edition Orders) : than 85% of that which it is represented Proposed, rule making------------ 6020 (Revised through June 30) to contain. Title 21— Food and Drugs Xc) Procaine penicillin. The procaine Published by the Division of the Federal Chapter I—Pood and Drug Ad penicillin content of the batch is the dif Register, the National Archives ministration, Federal Security ference between the potency determined by the method described in paragraph 722 pages— $1.00 a copy , Agency: Part 17—Bread and related (a) of this section and the content of Order from Superintendent of Documents, p ro d u c ts ; definitions and buffered crystalline penicillin deter United States Government Printing Office, .