[Federal Register Volume 62, Number 43 (Wednesday, March 5, 1997)]
[Rules and Regulations]
[Pages 9929-9930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-5312]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs for Use in Animal Feeds; Laidlomycin Propionate
Potassium
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Hoffmann-LaRoche, Inc. The supplemental
NADA provides for use of dry laidlomycin propionate potassium Type A
articles for making liquid Type B medicated feeds used to make dry Type
C medicated feeds. The Type C feeds are for cattle fed in confinement
for slaughter for increased rate of weight gain and improved feed
efficiency.
EFFECTIVE DATE: March 5, 1977.
FOR FURTHER INFORMATION CONTACT: Russell G. Arnold, Center for
Veterinary Medicine (HFV-142), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1674.
SUPPLEMENTARY INFORMATION: Hoffmann-LaRoche, Inc., Nutley, NJ 07110,
filed supplemental NADA 141-025, which provides for use of
Cattylyst 50 (50 grams (g) per pound laidlomycin propionate
potassium) dry Type A articles to make liquid, 100 to 2,000 g per ton
(g/t) laidlomycin propionate potassium Type B feeds, used to make dry,
5 to 10 g/t laidlomycin propionate potassium Type C feeds. The Type C
feeds are for cattle fed in confinement for slaughter for increased
rate of weight gain and improved feed efficiency. The supplemental NADA
is approved as of March 5, 1997, and Sec. 558.305 (21 CFR 558.305) is
amended to reflect the approval.
In addition, certain mixing directions for liquid feeds are
required for use of laidlomycin propionate potassium liquid Type B
feeds to make Type C feeds. Those directions had not been previously
codified in the regulation. At this time, existing Sec. 558.305(b) is
redesignated as Sec. 558.305(d) and new paragraph (b) is added to
include those directions. New Sec. 558.305(c) is established and
reserved for future use.
The supplement is for a new formulation of an approved product used
to make another approved product. Approval does not affect the basis of
approval or the conditions of use of the currently approved
application. No additional safety or effectiveness data are required.
Therefore, a freedom of information summary is not required. A summary
of safety and effectiveness data and information submitted to support
approval of the original application may be seen in the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857, between 9 a.m. and 4 p.m.,
Monday through Friday.
Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval does not
qualify for marketing exclusivity because the supplement does not
contain substantial evidence of effectiveness of the drugs involved,
any studies of animal safety or, in the case of food-producing animals,
human food safety studies (other than bioequivalence or residue
studies) required for approval and conducted or sponsored by the
applicant.
The agency has determined under 21 CFR 25.24(d)(1)(iii) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is
amended as follows:
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: Secs. 512, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b, 371).
2. Section 558.305 is amended by redesignating paragraph (b) as
paragraph (d), by adding new paragraphs (b) and (c), and by revising
the title of redesignated paragraph (d)(3) to read as follows:
Sec. 558.305 Laidlomycin propionate potassium.
* * * * *
(b) Special considerations. (1) Laidlomycin liquid Type B feeds may
be manufactured from dry laidlomycin Type A articles. The liquid Type B
feeds must have a pH of 6.0 to 8.0, dry matter of 62 to 75 percent, and
bear appropriate mixing directions as follows:
[[Page 9930]]
(i) For liquid Type B feeds stored in recirculating tank systems:
Recirculate immediately prior to use for no less than 10 minutes,
moving not less than 1 percent of the tank contents per minute from the
bottom of the tank to the top. Recirculate daily as described even when
not used.
(ii) For liquid Type B feeds stored in mechanical, air, or other
agitation type tank systems: Agitate immediately prior to use for not
less than 10 minutes, creating a turbulence at the bottom of the tank
that is visible at the top. Agitate daily as described even when not
used.
(2) The expiration date for the liquid Type B feed is 21 days after
date of manufacture. The expiration date for the dry Type C feed made
from the liquid Type B feed is 7 days after date of manufacture.
(c) [Reserved]
(d) * * *
(3) Additional limitations. * * *
Dated: February 6, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 97-5312 Filed 3-4-97; 8:45 am]
BILLING CODE 4160-01-F
