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.X P N A U , .

1 IT T r O X

FEDERAL
VOLUME 23

REGSTE
1934

a/ited

NUMBER 188

Washington, Thursday, September 25, 1958

TITLE 21 FOOD AND DRUGS
Chapter I Food and Drug Adminis tration, Department of Health, Edu cation, and Welfare Subchapter C Drugs P art DICYCLOMINE
TIONS ;

130 N

e w
D rugs
HYD R O CH LO R ID E

AM ENDM ENT

OF

PREPARA

L A B E L IN G

RE

Q U IR E M E N TS

There was published in the F e d e r a l of July 23; 1958 23 F. R. 5582, 6213, notice of a proposed amendment to 130.102 a 8. No comments hav ing been filed with respect to the pro-, posed amendment within the 30-day period stipulated in the above-referenced notice, the amendment set out below is hereby ordered, effective 30 days from the date of its publication in the F e d e r a l R e g i s t e r , pursuant to the authority vested in the Secretary of Health, Edu cation, and Welfare by the Federal Food, Drug, and Cosmetic Act secs. 503, 505, 701; 65 Stat. 649, 52 Stat. 1052, 1055, as amended; 21 U. S. C. 353, 355, 371 and delegated to the Commissioner of Food and Drugs by the Secretary 21 CFR, 1957 Supp 130.101 b .
Section 130.102 a 8 is amended by deleting therefrom subdivision vii d, reading as follows:
R e g is t e r
d Use if dryness of the throat, blur ring of vision, dizziness, or rapid pulse occurs.
Sec. 7 p l, 52 S t a t . 1055; 21 U . S . C . 371. I n
terprets o r a p p lie s secs. 503, 505, 52 S ta t .
1052, 65 S ta t . 649; 21 U . S . C . 353, 355

Dated: September 19, 1958.
seal
G e o . P . L a r Ri c k ,
Commissioner of Food and Drugs.
F . R . D o c . 58-7820; P ile d , S e p t.
8 :4 6 a.m .

24, 1958;

P art 146

G e n e r a l R e g u l a t io n s fo r t h e C e r t if ic a t io n o f A n t ib io t i c a n d A n t i
b io t ic - C o n t a i n i n g
D rugs
a n im a l feedsc o n t a in in g a n t ib io t ic
drugs
Under the authority vested in the Secretary of Health, Education, and Welfare by the Federal Food, Drug, and Cosmetic Act sec. 507, 59 Stat. 463, as
amended, sec. 701, 52 Stat. 1055, as amended; 21 U. S. C. 357, 371 and dele gated to the Commissioner of Food and Drugs by the Secretary 22 F. R. 1045, the general regulations for the certifica tion of antibiotic and antibiotic-contain ing drugs 23 F. R. 6121 are amended as indicated below:
Section 146.26 is amended by changing paragraph b 40 to read as follows:
146.26 Animal feed containing peni cillin
b
40 It is intended as an aid in main taining or increasing egg .production, hatchability of eggs, reduction of the effects of stress, prevention of early mor tality of chicks, and reduction of the effects of diseases when due to organ isms that are sensitive to bacitracin or to a mixture of bacitracin and penicillin, for maintaining appetite and for improv ing feed efficiency as related to egg production; its labeling bears adequate directions and warnings for such use;
and it Contains, per ton of feed, the equivalent of 50 grams of bacitracin or a mixture of 37.5 grams of bacitracin and 12.5 grams of penicillin when fed during the first 4 to 6 weeks of egg production, and not less than the equivalent of 10
grams of bacitracin or a mixture of 7.5
grams of bacitracin and 2.5 grams of penicillin when fed during the remainder of the laying period; except that if it is intended for use to increase egg hatchability or prevention of early mortality of chicks or for use in the presence of dis ease outbreaks or during periods of stress, it shall contain, per ton of feed, the equivalent of 100 grams of bacitracin or a mixture of 75 grams of bacitracin and 25 grams of penicillin.
Notice and public procedure are not necessary prerequisites to the promulga tion of this order, and I so find, since it was drawn in collaboration with inter ested members of the affected industry, since it relaxes existing requirements, and since it would be contrary to public interest to delay providing for the afore said amendments.
I further find that animal feed con taining antibiotic drugs and conforming with the conditions prescribed in this order need not comply with the require C o n t i n u e d o n p . 7 453

CONTENTS
Agriculture Department
PaS

See C o m m o d i t y Stabilization Service.

Army Department Notices:
Gilmer, Albert W.; notice of ap pointment and statement of business interests---------------

7467

Civil Aeronautics Administra tion Rules and regulations:
Standard instrument approach procedures; alterations-.____

7455

Civil Aeronautics Board Notices :
Hearings, etc.:
Trans World Airlines, Inc----Washington-Baltimore ade quacy of service investiga tion ,____________:_________ _
Welling, Dale R _____________
Rules and regulations :
Performance credit for trans port c a t e g o r y airplanes equipped with standby power;
special civil e ir regulation
7471
7471
7471

7453

Coast Gard Rules and regulations:
Licensing of officers and motorboat operations and registra t i o n of staff officers; U. S.
M a r i t i m e Administrations Radar School, New7 York, N. Y _______________________ _

7467

Commerce Department See Civil Aeronautics Administra tion; National Bureau of Stand ards.

Commodity Stabilization Service Notices:
Corn; notice of referendum and regulations pertaining thereto______________________
Rules and regulations:
Wheat; marketing quota regu lations for 1958 and subse quent crop years____________

7470

7464

Customs Bureau Notices:
Potatoes, Irish or white; tariffrate quota for quota year be ginning Sept. 15, 1958--------7451

7467