[Federal Register: October 20, 2003 (Volume 68, Number 202)]
[Rules and Regulations]
[Page 59880-59881]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20oc03-4]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, and 529
New Animal Drugs; Change of Sponsor
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 a change of sponsor for 12 approved new
animal drug applications (NADAs) and 1 abbreviated new animal drug
application (ANADA) from Anthony Products Co. to Cross Vetpharm Group,
Ltd.
DATES: This rule is effective October 20, 2003.
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: dnewkirk@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Anthony Products Co., 5600 Peck Rd.,
Arcadia, CA 91006, has informed FDA that it has transferred ownership
of, and all rights and interest in, the following 12 approved NADAs and
one approved ANADA to Cross Vetpharm Group, Ltd., Broomhill Rd.,
Tallaght, Dublin 24, Ireland.
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Application No. 21 CFR Section Trade Name
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NADA 046-780 522.1720 PHEN-BUTA-VET (phenylbutazone) Injection
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NADA 096-671 522.1720 PHEN-BUTA-VET (phenylbutazone) Injection
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NADA 096-672 520.1720a PHEN-BUTA-VET (phenylbutazone) Tablets
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NADA 098-288 522.1883 PREDNIS-A-VET (prednisolone sodium phosphate) Injection
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NADA 099-604 522.540 DEX-A-VET (dexamethasone sodium phosphate) Injection
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NADA 099-605 522.540 DEX-A-VET (dexamethasone sodium phosphate) Injection
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NADA 099-606 522.540 DEXAMETH-A-VET (dexamethasone) Injection
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NADA 099-607 522.540 DEXAMETH-A-VET (dexamethasone) Injection
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NADA 118-550 522.1010 FUROS-A-VET (furosemide) Injection
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NADA 119-141 522.1962 TRANQUAZINE (promazine hydrochloride) Injection
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NADA 138-405 522.2063 Pyrilamine Maleate Injection
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NADA 140-583 522.480 ACTH Gel
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ANADA 200-115 529.1044a GENTAMEX 100 (gentamicin sulfate)
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Accordingly, the agency is amending the regulations in 21 CFR
520.1720a, 522.480, 522.540, 522.1010, 522.1720, 522.1883, 522.1962,
522.2063, and 529.1044a to reflect the transfer of ownership. Sections
522.1883 and 522.1962 are also being revised to reflect a current
format.
Following these changes of sponsorship, Anthony Products Co. is no
longer the sponsor of an approved application. Accordingly, Sec.
510.600(c) is being amended to remove the entries for Anthony Products
Co.
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 Parts 520, 522, and 529
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,
520, 522, and 529 are amended as follows:
PART 510-NEW ANIMAL DRUGS
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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.
[[Page 59881]]
Sec. 510.600 [Amended]
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2. Section 510.600 Names, addresses, and drug labeler codes of sponsors
of approved applications is amended in the table in paragraph (c)(1) by
removing the entry for ``Anthony Products Co.'' and in the table in
paragraph (c)(2) by removing the entry for ``000864''.
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.
Sec. 520.1720a [Amended]
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4. Section 520.1720a Phenylbutazone tablets and boluses is amended in
paragraph (b)(3) by removing ``000864''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
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5. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.480 [Amended]
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6. Section 522.480 Repository corticotropin injection is amended in
paragraph (b)(2) by removing ``000864'' and by adding in its place
``061623''.
Sec. 522.540 [Amended]
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7. Section 522.540 Dexamethasone injection is amended in paragraphs
(b)(2)(i) and (c)(2) by removing ``000864'' and by adding in its place
``061623''.
Sec. 522.1010 [Amended]
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8. Section 522.1010 Furosemide is amended in paragraph (b)(2) by
removing ``000864'' and by adding in its place ``061623''.
Sec. 522.1720 [Amended]
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9. Section 522.1720 Phenylbutazone injection is amended in paragraph
(b)(1) by removing ``and 059130'' and by adding in its place ``059130,
and 061623''; in paragraph (b)(2) by removing ``Nos. 000010 and
000864'' and by adding in its place ``No. 000010''; and by removing
paragraph (b)(4).
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10. Section 522.1883 is revised to read as follows:
Sec. 522.1883 Prednisolone sodium phosphate.
(a) Specifications. Each milliliter of solution contains 20
milligrams (mg) prednisolone sodium phosphate (equivalent to 14.88 mg
of prednisolone).
(b) Sponsor. See No. 061623 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer intravenously
in a dosage of 2 1/2 to 5 mg per pound of body weight, initially for
shock and shock-like states, followed by equal maintenance doses at 1-,
3-, 6-, or 10-hour intervals as determined by the condition of the
animal.
(2) Indications for use. Administer when a rapid adrenal
glucocorticoid and/or anti-inflammatory effect is necessary.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
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11. Section 522.1962 is amended:
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a. By removing ``injection'' from the heading;
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b. By removing footnote 1;
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c. In paragraph (b) by removing ``000864'' and by adding in its place
``061623'';
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d. By removing paragraphs (c)(3) and (c)(4);
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e. By revising paragraphs (a) and (c)(2); and
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f. By adding a heading to (c)(1).
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The amendments read as follows:
Sec. 522.1962 Promazine hydrochloride.
(a) Specifications. Each milliliter of solution contains 50
milligrams (mg) promazine hydrochloride.
* * * * *
(c) * * *
(1) Amounts and indications for use. (i) * * *
* * * * *
(2) Limitations. Not for use in horses intended for food. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
Sec. 522.2063 [Amended]
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12. Section 522.2063 Pyrilamine maleate injection is amended in
paragraph (b) by removing ``000864'' and by adding in its place
``061623''.
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
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13. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 529.1044a [Amended]
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14. Section 529.1044a Gentamicin sulfate intrauterine solution is
amended in paragraph (b) by removing ``000864, 057561, and 059130'' and
by adding in its place ``057561, 059130, and 061623''.
Dated: October 2, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 03-26336 Filed 10-17-03; 8:45 am]
BILLING CODE 4160-01-S