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VOLUME 19

JUTTERAj
I SCRIPTA I

9 3 4

O N n to

NUMBER 163

Washington, Saturday, August 27, 1954

TITLE 5 ADMINISTRATIVE
PERSONNEL
Chapter I Civil. Service Commission P art 6E xceptions P rom C ompetitive S ervice
teee
SECURITIES AND EXCHANGE COMMISSION

Effective upon publication in the F e d
R e g ist e r , paragraph f is added to 6.326 as set out belw.
6.326 Securities and Exchange Com mission.
f The Executive Director.

eral
E. S. 1753, sec. 2, 22, Stat. 403; 5 P . S. C. 631, 633; E. O. 10440, 18 F. R. 1823, 3 CFR, 1953

Supp.
U nited S tates C ivil S erv ice C ommission , seal
Wm. C. H ull , Executive Assistant
F. R. Doc. 54-6583; Filed, Aug. 20, 1954;
8:57 a. m.

TITLE 21 FOOD AND DRUGS
Chapter I Food and Drug Admin istration, Department of Health, Education, and Welfare Part 14leB acitracin and B acitracinContaining D rugs; T ests and M eth
ods of Assay Part 146aCertification of P enicillin and P enicillin -C ontaining D rugs Part 146bCertification of S treptomy cin or D ihydrostreptomycin and S treptomycinor D ihydrostrepto mycinContaining D rugs Part 146cCertification of Chlortet racycline or T etracycline and Chlortetracyclineor T etracy clineContaining D rugs miscellaneous amendments
By virtue of the authority vested in the Secretary by the provisions of the Federal .Food, Drug, and Cosmetic Act sec. 507, 59 Stat. 463, as amended by 61
Stat. 11 , 63 Stat. 409, 67 Stat. 389; sec.
701; 52 Stat, 1055; 21 U. S. C. 357, 371;
67 Stat. 18, the regulations for tests and methods of assay for antibiotic and anti biotic-containing drugs 21 CFR Fart 141e; 19 F. r . 1141 and certification of antibiotic and antibiotic-containing drugs 21 CFR Parts 146a, 146b, 146c; 19

F. R. 672, 673, 1141, 2696 are amended as indicated below:
1. Section 141e.417, a 1 is amended to read:
141e.417 Powder bacitracin m eth ylene disalicylate and streptomycin sul fate oral veterinarya Potency1
Bacitracin content. Proceed as directed in 141e.401 a, except in lieu of the directions for preparing the sample in I4le.401 a 1 ii, prepare the sam ple as follows: Place an accurately weighed sample of approximately 5
grams in a blending jar, add 40 milli liters of 2.0-percent sodium bicarbonate and swirl until the sample is thoroughly wetted. Allow to stand for 15 minutes with occasional swirling. After standing for 15 minutes, add 30 milliliters of 1 percent potassium phosphate buffer at pH 6.0 and allow to stand for 1 hour, with occasional swirling. Add 30 milli liters of acetone and blend for 2 minutes;
allow to stand for 2 minutes and reblend for 2 minutes. Allow to settle for 15
minutes, and filter through filter paper on a Buchner funnel. Remove an aliquot of the filtrate and add sufficient semicarbazide 1.0-percent solution, at pH
6.5-7.0, to inactivate 1 hour at room temperature the streptomycin con tained in the solution. After inactiva tion, remove an aliquot of this solution and dilute to 1 unit per milliliter with 1.0-;percent phosphate buffer. Its po tency is satisfactory if it contains not less than 85 percent of the units of baci tracin activity that it is represented to contain.
2. In 146a.89 Procaine penicillinstreptomycin-neomycin in oil , paragraph b is amended by changing the colon after the word certified to a comma and inserting the following clause: except that the expiration date shall be 24 months after the month dur ing which the batch was certified if the person who requests certification has submitted to the Commissioner results of tests andNassays showing that such drug as prepared by him is stable for such period of time:.
3. Section 146b.ll7 a 1 is amended to read:
146b.ll7 Dihydrostreptomycin-strep tomycin sulfates solution a Standards of identity, strength, quality, and purity.
Continued on p. 5333

CONTENTS
Agricultural Marketing Service.
Proposed rule making :
Milk handling in Lima, Ohio;
extension of time for filing exceptions to recommended decision___________________
Rules and regulations:
Carrots with short trimmed tops, U. S. standards; correc tion_______
Grapes, Tokay, grown in San J o a q u i n and Sacramento Counties in California; regu lation by grades and sizes Lemons grown in California and Arizona; limitation of ship ments_____________________
Oranges, Valencia, grown in Arizona and designated part of California; limitation of handling______
Agriculture Department See Agricultural Marketing Serv ice; Rural Electrification Ad ministration.
Civil Aeronautics Administra tion Rules and regulations:
Standard instrument approach procedures; procedure altera tions_____ _________________
Civil Aeronautics Board Notices:
Scandinavian Airlines System;
prehearing conference-------Civil Service Commission Rules and regulations:
Competitive service, exceptions from; Securities and Ex change Commission ---------Commerce Department See Civil Aeronautics Administra tion; Patent Office.
Federal Civil Defense Admin istration Notices:
Secretary of Agriculture or his designee; further amending delegation of authority of July 31, 1953_________________
Federal Power Commission Notices:
Hearings, etc.:
Ohio Fuel Gas Co------------Tennessee Gas Transmission Co__ - _____
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