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Rule

New Animal Drugs; Change of Sponsor

A Rule by the Food and Drug Administration on 10/10/2002

Document Details

Information about this document as published in the Federal Register.

Printed version:
PDF
Publication Date:
10/10/2002
Agencies:
Food and Drug Administration
Dates:
This rule is effective October 10, 2002.
Effective Date:
10/10/2002
Document Type:
Rule
Document Citation:
67 FR 63054
Page:
63054-63055 (2 pages)
CFR:
21 CFR 510
21 CFR 520
21 CFR 522
21 CFR 558
Document Number:
02-25880
Document Details
Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 15 approved new animal drug applications (NADAs) from Cyanamid Agricultural de Puerto Rico, Inc., to Fort Dodge Animal Health.

DATES:

This rule is effective October 10, 2002.

Start Further Info

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: lluther@cvm.fda.gov.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

Cyanamid Agricultural de Puerto Rico, Inc., P.O. Start Printed Page 63055Box 243, Manati, PR 00701, has informed FDA that it has transferred ownership of, and all rights and interest in, the following 15 approved NADAs to Fort Dodge Animal Health, A Division of American Cyanamid Co., P.O. Box 1339, Fort Dodge, IA 50501:

NADA ­NumberTrade Name
039-356RIPERCOL L Bolus; TRAMISOL Cattle Wormer Bolus
039-357RIPERCOL L Soluble Drench Powder
042-740RIPERCOL L; TRAMISOL Soluble Drench Powder for Sheep
042-837RIPERCOL L Wormer Oblets; TRAMISOL Sheep Wormer Oblets
044-015TRAMISOL Type A Medicated ­Article
045-455TRAMISOL Type A Medicated ­Article
045-513RIPERCOL L
049-553RIPERCOL L
092-237RIPERCOL L-Piperazine ­Soluble
093-688RIPERCOL L-Piperazine
101-079TRAMISOL 10% Pig Wormer; TRAMISOL Hog Wormer
102-437TRAMISOL Injectable Solution
104-184STYQUIN
107-085TRAMISOL
126-237TRAMISOL Gel

Accordingly, the agency is amending the regulations in 21 CFR 520.1242a, 520.1242b, 520.1242c, 520.1242e, 520.1242f, 522.234, 522.1244, and 558.315 to reflect the transfer of ownership and to reflect current format.

Following this change of sponsorship, Cyanamid Agricultural de Puerto Rico, Inc., is no longer the sponsor of any approved application. Accordingly, 21 CFR 510.600(c) is being amended to remove the entries for Cyanamid Agricultural de Puerto Rico, 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.

Start List of Subjects

List of Subjects

21 CFR Part 510

  • Administrative practice and procedure
  • Animal drugs
  • Labeling
  • Reporting and recordkeeping requirements

21 CFR Parts 520 and 522

  • Animal drugs

21 CFR Part 558

  • Animal drugs
  • Animal feeds
End List of Subjects Start Amendment Part

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 558 are amended as follows:

End Amendment Part Start Part

PART 510—NEW ANIMAL DRUGS

End Part Start Amendment Part

1. The authority citation for 21 CFR part 510 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

End Authority
[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 “Cyanamid Agricultural de Puerto Rico, Inc.” and in the table in paragraph (c)(2) by removing the entry for “043781”.

Start Part

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

End Part Start Amendment Part

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

End Amendment Part Start Authority

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

End Authority
[Amended]

4. Section 520.1242a Levamisole hydrochloride drench and drinking water is amended in paragraph (b)(1) by removing “043781” and by adding in its place “No. 053501”.

[Amended]

5. Section 520.1242b Levamisole hydrochloride tablet or oblet (bolus) is amended in paragraph (c) by removing “043781” and by adding in its place “053501”.

[Amended]

6. Section 520.1242c Levamisole hydrochloride and piperazine dihydrochloride is amended in paragraph (b) by removing “043781” and by adding in its place “053501”.

[Amended]

7. Section 520.1242e Levamisole hydrochloride effervescent tablets is amended in paragraph (b) by removing “043781” and by adding in its place “053501”.

[Amended]

8. Section 520.1242f Levamisole hydrochloride gel is amended in paragraph (b) by removing “043781” and by adding in its place “053501”.

Start Part

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

End Part Start Amendment Part

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

End Amendment Part Start Authority

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

End Authority
[Amended]

10. Section 522.234 Butamisole hydrochloride is amended in paragraph (b) by removing “043781” and by adding in its place “053501”.

[Amended]

11. Section 522.1244 Levamisole phosphate injection is amended in paragraph (b) by removing “043781” and by adding in its place “053501”.

Start Part

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

End Part Start Amendment Part

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

End Amendment Part Start Authority

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

End Authority
[Amended]

13. Section 558.315 Levamisole hydrochloride (equivalent) is amended in paragraph (a) by removing “043781” and by adding in its place “No. 053501”.

Start Signature

Dated: September 26, 2002.

Andrew J. Beaulieu,

Acting Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.

End Signature End Supplemental Information

[FR Doc. 02-25880 Filed 10-9-02; 8:45 am]

BILLING CODE 4160-01-S

Published Document