Animal drugs, feeds, and related products: New drug applications— Neomycin sulfate,

Text

---

Federal Register: December 17, 1999 (Volume 64, Number 242)Rules and RegulationsPage 70576-70578From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr17de99-9

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs for Use in Animal Feeds; Neomycin Sulfate

AGENCY: Food and Drug Administration, HHS. ACTION: Final rule.

SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filedby Pharmacia & Upjohn Co. The supplemental NADA provides for use of neomycin sulfate Type A medicated articles to make Type B and C medicated feeds for cattle, swine, sheep, and goats, and medicated milk replacers for calves, piglets, lambs, and goat kids.

EFFECTIVE DATE: December 17, 1999.

FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0212.

SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., 7000 Portage Rd., Kalamazoo, MI 49001-0199, filedsupplemental NADA 140-976 that provides for use of neomycin sulfate Type A medicated articles to make Type B and C medicated feeds for cattle, swine, sheep, and goats, and medicated milk replacers for calves, piglets, lambs, and goat kids, for treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin. The products were the subject of a National Academy of Sciences/National Research Council (NAS/NRC) Drug Efficacy Study Group review of the product's effectiveness (DESI 11-315V). The results of the NAS/NRC review and FDA's conclusions based on that review were published in the Federal Register of January 19, 1971 (36 FR 837). The sponsor fileda supplemental NADA that reflects compliance with the results of the NAS/NRC review and FDA's conclusions based on that review. The supplement is approved as of November 3, 1999, and 21 CFR 558.364 is added to reflect the approval. The basis for approval is discussed in the freedom of information summary.

Also, 21 CFR 558.4 is amended in the ``Category II'' table in paragraph (d) to add an entry for neomycin sulfate.

In accordance with the freedom of information provisions of 21 CFR part 20 and 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, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

FDA has determined under 21 CFR 25.33(a)(3) 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.

This rule does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because it is a rule of ``particular applicability.'' Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 558

Animal drugs, Animal feeds.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under the 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: 21 U.S.C. 360b, 371.

2. Section 558.4 is amended in the ``Category II'' table in paragraph (d) by adding an entry alphabetically for neomycin sulfate to read as follows:

Sec. 558.4 Medicated feed applications.

* * * * *

  (d) * * *

Category II

Assay limits Drug

Assay limits Type B maximum percent\1\ type percent\1\ type A (100x)

B/C\2\

*

*

*

* *

*

* Neomycin sulfate 80-120

100 g/lb (22.0%) 70-125 *

*

*

* *

*

*

\1\ Percent of labeled amount. \2\ Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limit, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B medicated feed with lower assay limits to make a Type C medicated feed.

* * * * *

3. Section 558.364 is added to subpart B to read as follows:

Sec. 558.364 Neomycin sulfate.

  (a) Approvals. Type A medicated article: 325 grams per pound to 000009 in Sec. 510.600(c) of this chapter.

  (b) Related tolerances. See Sec. 556.430 of this chapter.

  (c) [Reserved]

  (d) Conditions of use. Neomycin sulfate is used as follows:

[Page 70577]

Neomycin Sulfate

Combination

Indications for Use

Limitations

Sponsor

  (1) 400 to 1,600

Cattle, swine, sheep, To provide 10

000009 grams per ton (g/t)

and goats. For

milligrams (mg) of of dry type C feed.

treatment and

neomycin sulfate per control of

pound of body weight colibacillosis

per day for a (bacterial

maximum of 14 days. enteritis) caused by The concentration of Escherichia coli neomycin sulfate susceptible to

required in neomycin.

medicated feed must be adjusted to compensate for variation in age and weight of animal, the nature and severity of disease signs, and environmental temperature and humidity, each of which affects feed consumption. If symptoms persist after using for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 48 hours beyond remission of disease symptoms. Discontinue treatment prior to slaughter as follows: Cattle 1 day, swine 3 days, sheep 2 days, and goats 3 days. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle or lactating dairy goats. Do not use in female dairy cattle 20 months of age or older or female dairy goats 12 months of age or older. For use in dry feeds only. Not for use in liquid feed supplements.

[Page 70578]

  (2) 400 to 2,000 g/t

Do.

To provide 10 mg of 000009 of type C milk

neomycin sulfate per replacer.

pound of body weight per day for a maximum of 14 days. Amount consumed will vary depending on animal's consumption and weight. If symptoms persist after using for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 48 hours beyond remission of disease symptoms. Discontinue treatment prior to slaughter as follows: Cattle 1 day, swine 3 days, sheep 2 days, and goats 3 days. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle or lactating dairy goats. Do not use in female dairy cattle 20 months of age or older or female dairy goats 12 months of age or older. For use in milk replacers only.

Dated: December 1, 1999. Andrew J. Beaulieu, Deputy Director, Center for Veterinary Medicine.

FR Doc. 99-32426Filed12-16-99; 8:45 amBILLING CODE 4160-01-F

---