[Federal Register Volume 61, Number 18 (Friday, January 26, 1996)]
[Rules and Regulations]
[Pages 2414-2415]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1323]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558


New Animal Drugs For Use In Animal Feeds; Chlortetracycline, 
Sulfathiazole, Penicillin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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[[Page 2415]]


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 Fermenta Animal Health Co. The supplement 
provides for use of fixed combination Type A medicated articles 
containing chlortetracycline, sulfathiazole, and penicillin in making 
Type B and C medicated swine feeds for swine from 10 pounds to 6 weeks 
post-weaning.

EFFECTIVE DATE: January 26, 1996.

FOR FURTHER INFORMATION CONTACT: James F. McCormack, Center for 
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1607.

SUPPLEMENTARY INFORMATION: Fermenta Animal Health Co., 10150 North 
Executive Hills Blvd., Kansas City, MO 64153, filed a supplement to 
NADA 39-077 CSP<SUP>TM 250 (20 grams (g) of chlortetracycline (as the 
hydrochloride), 20 g of sulfathiazole, and 10 g of penicillin (as 
penicillin procaine), per pound) and CSP<SUP>TM 500 (40 g of 
chlortetracycline (as the hydrochloride), 40 g of sulfathiazole, and 20 
g of penicillin (as penicillin procaine), per pound). The NADA provides 
for use of fixed combination Type A medicated articles to make Type B 
and C medicated swine feeds for prestarter, starter, grower, and 
finisher rations. The supplement provides for prestarter and starter 
rations to be given to swine from 10 pounds of body weight to 6 weeks 
postweaning for reduction of incidence of cervical abscesses, treatment 
of bacterial enteritis (salmonellosis or necrotic enteritis caused by 
Salmonella choleraesuis and vibrionic dysentery), maintenance of weight 
gains in the presence of atropic rhinitis, increased rate of weight 
gain and improved feed efficiency. The supplement is approved as of 
January 26, 1996, and the regulations are amended in Sec. 558.155 (21 
CFR 558.155) to reflect the approval. The basis of approval is 
discussed in the freedom of information summary.
    In addition, the agency is revising the section heading for 
Sec. 558.155 to reflect the active ingredients as on the label, i.e., 
that the product is known as chlortetracycline with sulfathiazole and 
penicillin, not as chlortetracycline hydrochloride with procaine 
penicillin and sulfathiazole. The approvals paragraph does specify the 
salts and esters approved for use.
    In Sec. 558.155(d) the feed consumption table is removed. The 
performance or therapeutic claims of the product are based on ad 
libitum consumption and not the minimum desired daily feed intake 
consumption values reported in the table. This, together with changes 
in weaning weights, renders the table obsolete. Also, the indications 
for use are editorially revised to clarify the indications for each 
feeding group.
    The product, chlortetracycline, sulfathiazole, and penicillin, in 
combination in a Type A medicated article, is a new animal drug used to 
make Type B and Type C medicated feeds. As provided in Sec. 558.4(b), 
the combination drug product is a Category II drug because it requires 
a withdrawal period at its lowest continuous use level. Therefore, it 
requires an approved Form FDA 1900 for making Type B or Type C 
medicated feeds as in approved NADA 39-077 and in Sec. 558.155.
    In accordance with the freedom of information provisions of part 20 
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 514.11(e)(2)(ii)), a 
summary of safety and effectiveness data and information submitted to 
support approval of this application may be seen in the Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., 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 supplemental approval 
does not qualify for marketing exclusivity because the supplement does 
not contain reports of new clinical or field investigations (other than 
bioequivalence or residue studies) or human food safety studies (other 
than bioequivalence or residue studies) essential to the approval and 
conducted or sponsored by the applicant.
    The agency has determined under 21 CFR 25.24(d)(1)(i) 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: Sec. 512, 701 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360b, 371).

    2. Section 558.155 is amended by revising the section heading and 
paragraphs (d)(2) and (d)(3) to read as follows:


Sec. 558.155  Chlortetracycline, sulfathiazole, penicillin.

-* * * * *
    (d) *  *  *
    (2) Indications for use. For reduction of incidence of cervical 
abscesses. Treatment of bacterial enteritis (salmonellosis or necrotic 
enteritis caused by Salmonella choleraesuis and vibrionic dysentery). 
Maintenance of weight gains in the presence of atrophic rhinitis. Swine 
10 pounds of body weight to 6 weeks post-weaning: Increased rate of 
weight gain and improved feed efficiency. Swine 6 to 16 weeks post-
weaning: Increased rate of weight gain.
    (3) Limitations. For swine raised in confinement (dry-lot) or on 
limited pasture. Feed as sole ration. Withdraw 7 days prior to 
slaughter.

    Dated: January 3, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 96-1323 Filed 1-25-96; 8:45 am]
BILLING CODE 4160-01-F