[Federal Register Volume 65, Number 144 (Wednesday, July 26, 2000)]
[Rules and Regulations]
[Pages 45876-45877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18828]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 522


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 (NADA's) from Merial Ltd. to Phoenix 
Scientific, Inc.

DATES: This rule is effective July 26, 2000.

FOR FURTHER INFORMATION CONTACT: Thomas J. McKay, Center for Veterinary 
Medicine (HFV-102), Food and Drug

[[Page 45877]]

Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0213.

SUPPLEMENTARY INFORMATION: Merial Ltd., 2100 Ronson Rd., Iselin, NJ 
08830-3077, has informed FDA that it has transferred ownership of, and 
all rights and interests in, the following approved NADA's to Phoenix 
Scientific, Inc., 3915 South 48th St. Terrace, PO Box 6457, St. Joseph, 
MO 64506-0457:

 
------------------------------------------------------------------------
              NADA No.                           Product Name
------------------------------------------------------------------------
033-157                              SPECTAM (spectinomycin)
                                      Scour Halt
040-040                              SPECTAM (spectinomycin)
                                      Injection
045-416                              BUTATRONTM (phenylbutazone)
                                      Injection
048-287                              Oxytetracycline-50
                                      (oxytetracycline) Injection
055-002                              TEVOCIN (chloramphenicol) Injection
093-483                              SPECTAM (spectinomycin)
                                      Injectable
119-142                              PVL Iron Dextran Injectable
123-815                              Dexamethasone Sodium Phosphate
                                      Injection
124-241                              PVL Oxytocin Injection
128-089                              ZONOMETH (dexamethasone) Sterile
                                      Solution
200-147                              GENTA-JECT (gentamicin
                                      sulfate) Injection
200-153                              NEO 200 (neomycin sulfate) Oral
                                      Solution
------------------------------------------------------------------------

Accordingly, the agency is amending the regulations in parts 520 and 
522 (21 CFR parts 520 and 522) in Secs. 520.1485, 520.2122, 522.390, 
522.540, 522.1044, 522.1183, 522.1662a, 522.1680, and 522.2120 to 
reflect the transfer of ownership. An entry for Phoenix Scientific, 
Inc., already exists in Sec. 522.1720 Phenylbutazone Injection 
following the approval of a supplemental ANADA 200-126 (61 FR 54332, 
October 18, 1996).
    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 in 21 CFR Parts 520 and 522

    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 520 and 
522 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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


Sec. 520.1485  [Amended]

    2. Section 520.1485 Neomycin sulfate oral solution is amended in 
paragraph (b) by removing ``050604''.


Sec. 520.2122  [Amended]

    3. Section 520.2122 Spectinomycin dihydrochloride oral solution is 
amended in paragraph (b)(1) by removing ``050604'' and adding in its 
place ``059130''.

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

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

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


Sec. 522.390  [Amended]

    5. Section 522.390 Chloramphenicol injection is amended in 
paragraph (b) by removing ``050604'' and adding in its place 
``059130''.


Sec. 522.540  [Amended]

    6. Section 522.540 Dexamethasone injection is amended in paragraphs 
(d)(2)(i) and (e)(2) by removing ``050604'' and adding in its place 
``059130''.


Sec. 522.1044  [Amended]

    7. Section 522.1044 Gentamicin sulfate injection is amended in 
paragraph (b)(4) by removing ``050604'' and adding in its place 
``059130''.


Sec. 522.1183  [Amended]

    8. Section 522.1183 Iron hydrogenated dextran injection is amended 
in paragraph (e)(1) by removing ``050604'' and adding in its place 
``059130''.


Sec. 522.1662a  [Amended]

    9. Section 522.1662a Oxytetracycline hydrochloride injection is 
amended in paragraph (i)(2) by removing ``050604'' and adding in its 
place ``059130''.


Sec. 522.1680  [Amended]

    10. Section 522.1680 Oxytocin injection is amended in paragraph (b) 
by removing ``050604'' and adding in its place ``059130''.


Sec. 522.2120  [Amended]

    11. Section 522.2120 Spectinomycin dihydrochloride injection is 
amended in paragraph (b) by removing ``050604'' and adding in its place 
``059130''.

    Dated: July 18, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 00-18828 Filed 7-25-00; 8:45 am]
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