[Federal Register Volume 68, Number 21 (Friday, January 31, 2003)]
[Rules and Regulations]
[Pages 4914-4915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-2295]



[[Page 4914]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 526, and 558


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 25 approved new 
animal drug applications (NADAs) and abbreviated new animal drug 
applications (ANADAs) from Bimeda, Inc., to Cross Vetpharm Group Ltd.

DATES: This rule is effective January 31, 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: Bimeda, Inc., 291 Forest Prairie Rd., 
LeSueur, MN 56058, has informed FDA that it has transferred ownership 
of, and all rights and interest in, the following 25 approved NADAs and 
ANADAs to Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 
24, Ireland.

------------------------------------------------------------------------
     NADA Number                          Trade Name
------------------------------------------------------------------------
010-092               GALLIMYCIN 50
------------------------------------------------------------------------
010-346               COMBUTHAL Powder
------------------------------------------------------------------------
012-123               ERYTHRO-100, -200; GALLIMYCIN Injectable
------------------------------------------------------------------------
035-157               GALLIMYCIN 100; GALLIMYCIN 500
------------------------------------------------------------------------
035-455               ERYTHRO-36 Dry; GALLIMYCIN-36 Dry
------------------------------------------------------------------------
035-456               GALLIMYCIN-36 Sterile
------------------------------------------------------------------------
038-241               ERYTHRO (High Lev)/Zoalene Plus Arsanilic Acid
------------------------------------------------------------------------
038-242               ERYTHRO (Low Lev)/Amp Plus Etho
------------------------------------------------------------------------
038-624               PRO-GALLIMYCIN-10
------------------------------------------------------------------------
038-661               SPECTAM Water Soluble Concentrate
------------------------------------------------------------------------
041-955               Erythromycin Medicated Premix
------------------------------------------------------------------------
044-756               TEVCODYNE
------------------------------------------------------------------------
055-059               TEVCOCIN Tablets
------------------------------------------------------------------------
093-515               SPECTAM Tablets
------------------------------------------------------------------------
095-218               Dexamethasone Tablets, 0.25 mg
------------------------------------------------------------------------
100-128               Supersweet Medipak TYLAN 10
------------------------------------------------------------------------
101-690               ERYTHRO-100 Injection
------------------------------------------------------------------------
107-506               CARBAM Tablets
------------------------------------------------------------------------
118-032               CARBAM PALATABS
------------------------------------------------------------------------
118-979               BUTATRON Gel
------------------------------------------------------------------------
120-615               SUSTAIN III Bolus
------------------------------------------------------------------------
126-504               Nitrofurazone Ointment
------------------------------------------------------------------------
200-050               Neomycin 325 Soluble Powder
------------------------------------------------------------------------
200-103               Penicillin G Potassium, USP
------------------------------------------------------------------------
200-144               Oxytetracycline HCl Soluble Powder; TETROXY
------------------------------------------------------------------------

    Accordingly, the agency is amending the regulations in 21 CFR 
520.390a, 520.540b, 520.622a, 520.823, 520.1484, 520.1660d, 520.1696b, 
520.1720a, 520.1720d, 520.2123a, 520.2123b, 520.2260b, 522.820, 
522.2444b, 524.1580b, 526.820, 558.248, and 558.625 to reflect the 
transfer of ownership.
    Following this change of sponsorship, Bimeda, Inc., is no longer 
the sponsor of any approved application. Accordingly, 21 CFR 510.600(c) 
is being amended to remove the entries for Bimeda, 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 Parts 520, 522, 524, and 526

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.

    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, 524, 526, and 558 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.


Sec.  510.600  [Amended]

    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 ``Bimeda, Inc.'' and in the table in 
paragraph (c)(2) by removing the entry for ``061133''.

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.  520.390a  [Amended]

    4. Section 520.390a Chloramphenicol tablets is amended in paragraph 
(b)(2) by removing ``061133'' and by adding in its place ``061623''.


Sec.  520.540b  [Amended]

    5. Section 520.540b Dexamethasone tablets and boluses is amended in 
paragraph (b)(2) by removing ``061133'' and by adding in its place 
``061623''.


Sec.  520.622a  [Amended]

    6. Section 520.622a Diethylcarbamazine citrate tablets is amended 
in paragraph (a)(3) by removing ``061133'' and by adding in its place 
``061623''.


Sec.  520.823  [Amended]

    7. Section 520.823 Erythromycin phosphate is amended in paragraphs 
(b) by removing ``061133'' and by adding in its place ``061623''.


Sec.  520.1484  [Amended]

    8. Section 520.1484 Neomycin sulfate soluble powder is amended in 
paragraph (b)(2) by removing ``061133'' and by adding in its place 
``061623''.


Sec.  520.1660d  [Amended]

    9. Section 520.1660d Oxytetracycline hydrochloride soluble powder 
is amended in paragraph (b)(7) by removing ``061133'' and by adding in 
its place ``061623''.


Sec.  520.1696b  [Amended]

    10. Section 520.1696b Penicillin G potassium in drinking water is 
amended in paragraph (b) by removing ``061133'' and by adding in its 
place ``061623''.


Sec.  520.1720a  [Amended]

    11. Section 520.1720a Phenylbutazone tablets and boluses is amended 
in paragraph (b)(3) by

[[Page 4915]]

removing ``061133'' and by adding in its place ``061623''.


Sec.  520.1720d  [Amended]

    12. Section 520.1720d Phenylbutazone gel is amended in paragraph 
(b) by removing ``061133'' and by adding in its place ``No. 061623''.


Sec.  520.2123a  [Amended]

    13. Section 520.2123a Spectinomycin dihydrochloride pentahydrate 
tablets is amended in paragraph (b) by removing ``061133'' and by 
adding in its place ``061623''.


Sec.  520.2123b  [Amended]

    14. Section 520.2123b Spectinomycin dihydrochloride pentahydrate 
soluble powder is amended in paragraph (b) by removing ``061133'' and 
by adding in its place ``061623''.


Sec.  520.2260b  [Amended]

    15. Section 520.2260b Sulfamethazine sustained-release boluses is 
amended in paragraphs (c)(1) and (e)(1) by removing ``061133'' and by 
adding in its place ``061623''.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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

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


Sec.  522.820  [Amended]

    17. Section 522.820 Erythromycin injection is amended in paragraph 
(a) by removing ``061133'' and by adding in its place ``No. 061623''.


Sec.  522.2444b  [Amended]

    18. Section 522.2444b Sodium thiopental, sodium pentobarbital for 
injection is amended in paragraph (b) by removing ``061133'' and by 
adding in its place ``061623''.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

    19. The authority citation for 21 CFR part 524 continues to read as 
follows:

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


Sec.  524.1580b  [Amended]

    20. Section 524.1580b Nitrofurazone ointment is amended in 
paragraph (b) by removing ``061133'' and by adding in its place 
``061623''.

PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

    21. The authority citation for 21 CFR part 526 continues to read as 
follows:

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


Sec.  526.820  [Amended]

    22. Section 526.820 Erythromycin is amended in paragraph (b) by 
removing ``061133'' and by adding in its place ``061623''.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    23. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.


Sec.  558.248  [Amended]

    24. Section 558.248 Erythromycin thiocyanate is amended in 
paragraphs (a)(1) and (a)(2) by removing ``061133'' and by adding in 
its place ``061623''; and in the table in paragraph (d)(1) in the 
``Sponsor'' column by removing ``061133'' wherever it appears and by 
adding in its place ``061623''.


Sec.  558.625  [Amended]

    25. Section 558.625 Tylosin is amended in the table in paragraph 
(b)(39) by removing ``061133'' and by adding in its place ``061623''.

    Dated: January 6, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 03-2295 Filed 1-30-03; 8:45 am]
BILLING CODE 4160-01-S