[Federal Register Volume 65, Number 40 (Tuesday, February 29, 2000)]
[Rules and Regulations]
[Pages 10704-10705]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-4668]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520


Oral Dosage Form New Animal Drugs; Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect the change of sponsor for 13 new animal 
drug applications (NADA's) from I. D. Russell Co., Laboratories to 
Alpharma Inc.

DATES:  This rule is effective February 29, 2000.

FOR FURTHER INFORMATION CONTACT: Thomas J. McKay, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0213.

SUPPLEMENTARY INFORMATION: I. D. Russell Co., Laboratories, 1301 Iowa 
Ave., Longmont, CO 80501, has informed FDA that it has transferred the 
ownership of, and all rights and interest in, the following approved 
NADA's to Alpharma Inc., One Executive Dr., Fort Lee, NJ 07024:

[[Page 10705]]



 
------------------------------------------------------------------------
              NADA No.                           Product name
------------------------------------------------------------------------
6-019                                Zuco Poultry Tabs
6-081                                Korum
6-776                                10% Sulfaquinoxaline
6-860                                Ruco Tablets
6-891                                Liquid Sul-Q-Nox
8-902                                Hepasol
100-094                              Poultry Sulfa
100-175                              20% Sulfaquinoxaline
100-176                              34% Sulfaquinoxaline
130-435                              Oxytet Soluble
200-106                              R-Pen
200-189                              Lincomycin Soluble
200-274                              Lincomycin Injectable 30%
------------------------------------------------------------------------

    The agency is amending parts 510 and 520 (21 CFR parts 510 and 520) 
to reflect the change of sponsor. The agency is amending 
Sec. 510.600(c)(1) and (c)(2) to remove the sponsor name for I. D. 
Russell Co., Laboratories because the firm no longer is the holder of 
any approved NADA's.
    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 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.
    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

    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.

    2. Section 510.600 Names, addresses, and drug labeler codes of 
sponsors of approved applications is amended in the table in paragraphs 
(c)(1) by removing the entry for ``I. D. Russell Co., Laboratories'' 
and in the table in paragraph (c)(2) by removing the entry for 
``017144''.

PART 520 ORAL DOSAGE FORM NEW ANIMAL DRUGS

    3. The authority citation for 21 CFR part 520 continues to read as 
follows:

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


Sec. 520.1263c  [Amended]

    4. Section 520.1263c Lincomycin hydrochloride soluble powder is 
amended in paragraph (b) by removing ``017144'' and adding in its place 
``046573''.


Sec. 520.1660d  [Amended]

    5. Section 520.1660d Oxytetracycline hydrochloride soluble powder 
is amended in paragraphs (b)(2), (d)(1)(ii)(A)(3), (d)(1)(ii)(B)(3), 
(d)(1)(ii)(C)(3), and (d)(1)(iii)(C) by removing ``017144'' and adding 
in its place ``046573''.


Sec. 520.1696b  [Amended]

    6. Section 520.1696b Penicillin G potassium in drinking water is 
amended in paragraph (b) by removing ``017144,''.


Sec. 520.2088  [Amended]

    7. Section 520.2088 Roxarsone tablets is amended in paragraph 
(c)(2) by removing ``017144'' and adding in its place ``046573''.


Sec. 520.2089  [Amended]

    8. Section 520.2089 Roxarsone liquid is amended in paragraph (b) by 
removing ``017144'' and adding in its place ``046573''.


Sec. 520.2325a  [Amended]

    9. Section 520.2325a Sulfaquinoxaline drinking water is amended in 
paragraph (a)(3) by removing ``017144'' and adding in its place 
``046573''.

    Dated: February 16, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 00-4668 Filed 2-28-00; 8:45 am]
BILLING CODE 4160-01-F