Legal Status
Legal Status
Rule
New Animal Drugs; Change of Sponsor
A Rule by the Food and Drug Administration on
Document Details
Information about this document as published in the Federal Register.
- Printed version:
- 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
-
Enhanced Content - Table of Contents
This tables of contents is a navigational tool, processed from the headings within the legal text of Federal Register documents. This repetition of headings to form internal navigation links has no substantive legal effect.
- AGENCY:
- ACTION:
- SUMMARY:
- DATES:
- FOR FURTHER INFORMATION CONTACT:
- SUPPLEMENTARY INFORMATION:
- List of Subjects
- 21 CFR Part 510
- 21 CFR Parts 520 and 522
- 21 CFR Part 558
- PART 510—NEW ANIMAL DRUGS
- PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
- PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
- PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
Enhanced Content - Table of Contents
-
Enhanced Content - Submit Public Comment
- This feature is not available for this document.
Enhanced Content - Submit Public Comment
-
Enhanced Content - Read Public Comments
- This feature is not available for this document.
Enhanced Content - Read Public Comments
-
Enhanced Content - Sharing
- Shorter Document URL
- https://www.federalregister.gov/d/02-25880 https://www.federalregister.gov/d/02-25880
Enhanced Content - Sharing
-
Enhanced Content - Document Tools
These tools are designed to help you understand the official document better and aid in comparing the online edition to the print edition.
-
These markup elements allow the user to see how the document follows the Document Drafting Handbook that agencies use to create their documents. These can be useful for better understanding how a document is structured but are not part of the published document itself.
Display Non-Printed Markup Elements
Enhanced Content - Document Tools
-
-
Enhanced Content - Developer Tools
This document is available in the following developer friendly formats:
- JSON: Normalized attributes and metadata
- XML: Original full text XML
- MODS: Government Publishing Office metadata
More information and documentation can be found in our developer tools pages.
Enhanced Content - Developer Tools
Published Document
This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.
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 InfoFOR 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 InformationSUPPLEMENTARY 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 Number | Trade Name |
|---|---|
| 039-356 | RIPERCOL L Bolus; TRAMISOL Cattle Wormer Bolus |
| 039-357 | RIPERCOL L Soluble Drench Powder |
| 042-740 | RIPERCOL L; TRAMISOL Soluble Drench Powder for Sheep |
| 042-837 | RIPERCOL L Wormer Oblets; TRAMISOL Sheep Wormer Oblets |
| 044-015 | TRAMISOL Type A Medicated Article |
| 045-455 | TRAMISOL Type A Medicated Article |
| 045-513 | RIPERCOL L |
| 049-553 | RIPERCOL L |
| 092-237 | RIPERCOL L-Piperazine Soluble |
| 093-688 | RIPERCOL L-Piperazine |
| 101-079 | TRAMISOL 10% Pig Wormer; TRAMISOL Hog Wormer |
| 102-437 | TRAMISOL Injectable Solution |
| 104-184 | STYQUIN |
| 107-085 | TRAMISOL |
| 126-237 | TRAMISOL 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 SubjectsList 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
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 PartPART 510—NEW ANIMAL DRUGS
End Part Start Amendment Part1. The authority citation for 21 CFR part 510 continues to read as follows:
End Amendment Part Start AuthorityAuthority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
End Authority2. 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 PartPART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
End Part Start Amendment Part3. The authority citation for 21 CFR part 520 continues to read as follows:
End Amendment Part Start AuthorityAuthority: 21 U.S.C. 360b.
End Authority4. 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”.
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”.
6. Section 520.1242c Levamisole hydrochloride and piperazine dihydrochloride is amended in paragraph (b) by removing “043781” and by adding in its place “053501”.
7. Section 520.1242e Levamisole hydrochloride effervescent tablets is amended in paragraph (b) by removing “043781” and by adding in its place “053501”.
8. Section 520.1242f Levamisole hydrochloride gel is amended in paragraph (b) by removing “043781” and by adding in its place “053501”.
Start PartPART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
End Part Start Amendment Part9. The authority citation for 21 CFR part 522 continues to read as follows:
End Amendment Part Start AuthorityAuthority: 21 U.S.C. 360b.
End Authority10. Section 522.234 Butamisole hydrochloride is amended in paragraph (b) by removing “043781” and by adding in its place “053501”.
11. Section 522.1244 Levamisole phosphate injection is amended in paragraph (b) by removing “043781” and by adding in its place “053501”.
Start PartPART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
End Part Start Amendment Part12. The authority citation for 21 CFR part 558 continues to read as follows:
End Amendment Part Start AuthorityAuthority: 21 U.S.C. 360b, 371.
End Authority13. Section 558.315 Levamisole hydrochloride (equivalent) is amended in paragraph (a) by removing “043781” and by adding in its place “No. 053501”.
Start SignatureDated: September 26, 2002.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 02-25880 Filed 10-9-02; 8:45 am]
BILLING CODE 4160-01-S