[Federal Register Volume 67, Number 197 (Thursday, October 10, 2002)]
[Rules and Regulations]
[Pages 63054-63055]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-25880]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 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 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.
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: Cyanamid Agricultural de Puerto Rico, Inc.,
P.O.
[[Page 63055]]
Box 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:
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NADA [chyph]Number Trade Name
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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 [chyph]Article
045-455................. TRAMISOL Type A Medicated [chyph]Article
045-513................. RIPERCOL L
049-553................. RIPERCOL L
092-237................. RIPERCOL L-Piperazine [chyph]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
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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.
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.
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:
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 ``Cyanamid Agricultural de Puerto
Rico, Inc.'' and in the table in paragraph (c)(2) by removing the entry
for ``043781''.
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. 520.1242a [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''.
Sec. 520.1242b [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''.
Sec. 520.1242c [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''.
Sec. 520.1242e [Amended]
7. Section 520.1242e Levamisole hydrochloride effervescent tablets
is amended in paragraph (b) by removing ``043781'' and by adding in its
place ``053501''.
Sec. 520.1242f [Amended]
8. Section 520.1242f Levamisole hydrochloride gel is amended in
paragraph (b) by removing ``043781'' and by adding in its place
``053501''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
9. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.234 [Amended]
10. Section 522.234 Butamisole hydrochloride is amended in
paragraph (b) by removing ``043781'' and by adding in its place
``053501''.
Sec. 522.1244 [Amended]
11. Section 522.1244 Levamisole phosphate injection is amended in
paragraph (b) by removing ``043781'' and by adding in its place
``053501''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
12. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.315 [Amended]
13. Section 558.315 Levamisole hydrochloride (equivalent) is
amended in paragraph (a) by removing ``043781'' and by adding in its
place ``No. 053501''.
Dated: 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