[Federal Register Volume 68, Number 202 (Monday, October 20, 2003)]
[Rules and Regulations]
[Pages 59880-59881]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-26336]


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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: 
[email protected].

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

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.

[[Page 59881]]

Sec.  510.600  [Amended]

0
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]

0
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

0
5. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.


Sec.  522.480  [Amended]

0
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]

0
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]

0
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]

0
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).

0
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.

0
11. Section 522.1962 is amended:
0
a. By removing ``injection'' from the heading;
0
b. By removing footnote 1;
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c. In paragraph (b) by removing ``000864'' and by adding in its place 
``061623'';
0
d. By removing paragraphs (c)(3) and (c)(4);
0
e. By revising paragraphs (a) and (c)(2); and
0
f. By adding a heading to (c)(1).
0
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]

0
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

0
13. The authority citation for 21 CFR part 529 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.


Sec.  529.1044a  [Amended]

0
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