[Federal Register Volume 62, Number 53 (Wednesday, March 19, 1997)]
[Rules and Regulations]
[Pages 12951-12952]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6876]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558
New Animal Drugs for Use in Animal Feeds; Bacitracin Methylene
Disalicylate and Chlortetracycline
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 new animal drug application
(NADA) filed by Alpharma Inc. The NADA provides for using currently
approved, single ingredient, Type A medicated articles in making
combination drug, Types B and C medicated, swine feeds containing
bacitracin methylene disalicylate and chlortetracycline. The Type C
medicated feed is used for increased rate of weight gain and improved
feed efficiency due to the activity of bacitracin, and treatment of
enteritis and pneumonia caused by certain bacteria susceptible to
chlortetracycline.
EFFECTIVE DATE: March 19, 1997.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-133), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1644.
SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Dr., Fort Lee,
NJ 07024, filed NADA 141-059, which provides for combining separately
approved, Type A medicated articles containing BMD
(bacitracin methylene disalicylate (bacitracin MD)) and CTC
(chlortetracycline) in making combination drug, Type C medicated swine
feed. The Type C medicated feed
[[Page 12952]]
contains 10 to 30 grams (g) of bacitracin MD and approximately 400 g of
CTC per ton varying with body weight and food consumption to provide 10
milligrams of CTC per pound of body weight per day. The feed is
indicated for increased rate of weight gain and improved feed
efficiency due to the activity of bacitracin, and treatment of
bacterial enteritis caused by Escherichia coli and Salmonella
choleraesuis and bacterial pneumonia caused by Pasteurella multocida
susceptible to CTC. The NADA is approved as of September 18, 1996, and
the regulations are amended by revising 21 CFR 558.76(d)(1) and by
adding 21 CFR 558.128(c)(3)(xiv) to reflect the approval. The basis for
approval is discussed in the freedom of information summary.
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, 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)(ii) of the Federal Food, Drug, and Cosmetic
Act, this approval does not qualify for marketing exclusivity because
the application contains no new clinical or field investigations (other
than bioequivalence or residue studies) essential to the approval of
the application and conducted or sponsored by the applicant.
The agency has determined under 21 CFR 25.24(d)(1)(ii) 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 558.76 is amended in the table in paragraph (d)(1) under
entry (iv) by adding a new item for Chlortetracycline approximately 400
to read as follows:
Sec. 558.76 Bacitracin methylene disalicylate.
* * * * *
(d) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Bacitracin methylene
disalicylate in grams per Combination in grams Indications for use Limitations Sponsor
ton per ton
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* * * * * *
*
(iv) 10 to 30 * * * * * * * * * * * *
Chlortetracycline Swine; for increased Feed for not more 046573
approximately 400, rate of weight gain than 14 days to
varying with body and improved feed provide 10
weight and food efficiency; for milligrams of
consumption to treatment of chlortetracycline
provide 10 bacterial enteritis per pound of body
milligrams per pound caused by weight per day; as
of body weight per Escherichia coli and chlortetracycline
day. Salmonella provided by No.
choleraesuis and 046573 in Sec.
bacterial pneumonia 510.600(c) of this
caused by chapter.
Pasteurella
multocida
susceptible to
chlortetracycline.
* * * * * *
*
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* * * * *
3. Section 558.128 is amended by adding new paragraph (c)(3)(xiv)
to read as follows:
Sec. 558.128 Chlortetracycline.
* * * * *
(c) * * *
(3) * * *
(xiv) Bacitracin methylene disalicylate in accordance with
Sec. 558.76.
Dated: February 6, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-6876 Filed 3-18-97; 8:45 am]
BILLING CODE 4160-01-F
