[Federal Register: April 7, 2006 (Volume 71, Number 67)]
[Rules and Regulations]
[Page 17701-17702]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07ap06-6]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 520
New Animal Drugs; Change of Sponsor; Soluble Bacitracin Methylene
Disalicylate and Streptomycin Sulfate Oral Powder
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the
[[Page 17702]]
animal drug regulations to reflect a change of sponsor for a new animal
drug application (NADA) for bacitracin methylene disalicylate and
streptomycin sulfate oral powder from Veterinary Specialties, Inc., to
Alpharma Inc.
DATES: This rule is effective April 7, 2006.
FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail:
david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Veterinary Specialties, Inc., 387 North
Valley Ct., Barrington, IL 60010, has informed FDA that it has
transferred ownership of, and all rights and interest in, NADA 65-107
for ENTROMYCIN (bacitracin methylene disalicylate and streptomycin
sulfate) Powder to Alpharma Inc., One Executive Dr., Fort Lee, NJ
07024. Accordingly, the regulations are amended in 21 CFR 520.154b to
reflect this change of sponsorship and a current format.
Following these changes of sponsorship, Veterinary Specialties,
Inc., is no longer the sponsor of an approved application. Accordingly,
21 CFR 510.600(c) is being amended to remove the entries for Veterinary
Specialties, Inc.
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
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 520
Animal drugs.
0
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 parts 510 and
520 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600, in the table in paragraph (c)(1) remove the entry
for ``Veterinary Specialties, Inc.''; and in the table in paragraph
(c)(2) remove the entry for ``062925''.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
4. Revise Sec. 520.154b to read as follows:
Sec. 520.154b Bacitracin methylene disalicylate and streptomycin
sulfate powder.
(a) Specifications. Each gram of powder contains 200 units
bacitracin methylene disalicylate and streptomycin sulfate equivalent
to 20 milligrams of streptomycin.
(b) Sponsor. See No. 046573 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer 1 level
teaspoonful per 10 pounds of body weight three times daily, mixed in a
small quantity of liquid or feed.
(2) Indications for use. For the treatment of bacterial enteritis
caused by pathogens susceptible to bacitracin and streptomycin such as
Escherichia coli, Proteus spp., Staphylococcus spp., and Streptococcus
spp., and for the symptomatic treatment of associated diarrhea.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Dated: March 30, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 06-3353 Filed 4-6-06; 8:45 am]
BILLING CODE 4160-01-S