[Federal Register Volume 67, Number 215 (Wednesday, November 6, 2002)]
[Rules and Regulations]
[Page 67521]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-28156]



[[Page 67521]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, and 524


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) from A. H. Robins Co. to Fort Dodge 
Animal Health, Division of Wyeth.

DATES: This rule is effective November 6, 2002.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: A. H. Robins Co., P.O. Box 518, Fort Dodge, 
IA 50501-0518, has informed FDA that it has transferred ownership of, 
and all rights and interest in, the following 12 approved NADAs to Fort 
Dodge Animal Health, Division of Wyeth, 800 Fifth St. NW., Fort Dodge, 
IA 50501:

------------------------------------------------------------------------
        NADA Number                          Product Name
------------------------------------------------------------------------
034-879....................  DOPRAM-V Injectable
038-838....................  ROBAXIN-V Injectable
045-715....................  ROBAXIN-V Tablets
091-065....................  ROBIZONE-V
093-105....................  ROBIZONE-V
098-640....................  ROBIZONE Injectable 20%
101-777....................  Robinul-V Injectable
106-111....................  Telazol
136-651....................  Guailaxin
141-003....................  Derm-Otic Ointment
141-004....................  Robamox-V
141-005....................  Robamox-V Tablets
------------------------------------------------------------------------

    Accordingly, the agency is amending the regulations in 21 CFR 
520.88b, 520.88f, 520.1380, 520.1720a, 522.775, 522.1066, 522.1085, 
522.1380, 522.1720, 522.2470, and 524.1600a to reflect the transfer of 
ownership and to reflect current format.
    Following this change of sponsorship, A. H. Robins Co. is no longer 
the sponsor of any approved application. Accordingly, 21 CFR 510.600(c) 
is being amended to remove the entries for A. H. Robins 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 524

    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, 
520, 522, and 524 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 ``A. H. Robins Co.'' and in the table 
in paragraph (c)(2) by removing the entry for ``000031''.

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.  520.88b  [Amended]

    4. Section 520.88b Amoxicillin trihydrate for oral suspension is 
amended in paragraph (c) by removing ``000031 and 000093'' and by 
adding in its place ``000093 and 000856''.


Sec.  520.88f  [Amended]

    5. Section 520.88f Amoxicillin trihydrate tablets is amended in 
paragraph (b) by removing ``000031 or 000093'' and by adding in its 
place ``000093 and 000856''.


Sec.  520.1380  [Amended]

    6. Section 520.1380 Methocarbamol tablets is amended in paragraph 
(c) by removing ``000031'' and by adding in its place ``000856''.


Sec.  520.1720a  [Amended]

    7. Section 520.1720a Phenylbutazone tablets and boluses is amended 
in paragraph (b)(3) by removing ``000031''.

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

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

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


Sec.  522.775  [Amended]

    9. Section 522.775 Doxapram hydrochloride injection is amended in 
paragraph (b) by removing ``000031'' and by adding in its place 
``000856''.


Sec.  522.1066  [Amended]

    10. Section 522.1066 Glycopyrrolate injection is amended in 
paragraph (b) by removing ``000031'' and by adding in its place 
``000856''.


Sec.  522.1085  [Amended]

    11. Section 522.1085 Guaifenesin sterile powder is amended in 
paragraph (b) by removing ``No. 000031'' and by adding in its place 
``Nos. 000856''.


Sec.  522.1380  [Amended]

    12. Section 522.1380 Methocarbamol injection is amended in 
paragraph (b) by removing ``000031'' and by adding in its place ``No. 
000856''.


Sec.  522.1720  [Amended]

    13. Section 522.1720 Phenylbutazone injection is amended in 
paragraph (b)(1) by removing ``000031'' and by numerically adding 
``000856''.


Sec.  522.2470  [Amended]

    14. Section 522.2470 Tiletamine hydrochloride and zolazepam 
hydrochloride for injection is amended in paragraph (b) by removing 
``000031'' and by adding in its place ``000856''.

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

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

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


Sec.  524.1600a  [Amended]

    16. Section 524.1600a Nystatin, neomycin, thiostrepton, and 
triamcinolone acetonide ointment is amended in paragraph (b) by 
removing ``000031'' and by numerically adding ``000856''.

    Dated: October 28, 2002.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 02-28156 Filed 11-5-02; 8:45 am]
BILLING CODE 4160-01-S