[Federal Register Volume 64, Number 150 (Thursday, August 5, 1999)]
[Rules and Regulations]
[Pages 42596-42597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20141]
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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 six new animal drug
applications (NADA's) from Roussel-UCLAF SA, Animal Health Division to
Hoechst Roussel Vet.
EFFECTIVE DATE: August 5, 1999.
FOR FURTHER INFORMATION CONTACT: Thomas J. McKay, Center for Veterinary
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-0213.
SUPPLEMENTARY INFORMATION: Roussel-UCLAF SA, Animal Health Division,
102 Route de Noisy, 93235 Romainville Cedex, France, has informed FDA
that it has transferred ownership of, and all rights and interests in,
the approved NADA's (130-951, 131-310, 138-612, 140-824, 140-897, and
140-992) to Hoechst Roussel Vet, 30 Independence Blvd., P.O. Box 4915,
Warren, NJ 07059.
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. Accordingly, the agency is amending the
regulations in 21 CFR parts 510, 520, 522, and 558 to reflect the
change of sponsor. The agency is also amending 21 CFR 510.600(c)(1) and
(c)(2) to remove the sponsor name for Roussel UCLAF SA because the firm
no longer is the holder of any approved NADA's.
[[Page 42597]]
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 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 ``Roussel-UCLAF SA'' and in the table
in paragraph (c)(2) by removing the entry for ``012579''.
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. 520.48 [Amended]
4. Section 520.48 Altrenogest solution is amended in paragraph (b)
by removing ``012579'' and adding in its place ``012799''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
5. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.2476 [Amended]
6. Section 522.2476 Trenbolone acetate is amended in paragraph (b)
by removing ``012579'' and adding in its place ``012799''.
Sec. 522.2477 [Amended]
7. Section 522.2477 Trenbolone acetate and estradiol is amended in
paragraph (a) by removing ``012579'' and adding in its place
``012799''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
8. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.265 [Amended]
9. Section 558.265 Halofuginone hydrobromide is amended in
paragraph (a) by removing ``012579'' and adding in its place
``012799''.
Dated: June 29, 1999.
Claire M. Lathers
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 99-20141 Filed 8-4-99; 8:45 am]
BILLING CODE 4160-01-F
