[Federal Register Volume 62, Number 139 (Monday, July 21, 1997)]
[Rules and Regulations]
[Pages 38905-38906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-19066]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, and 522
Animal Drugs, Feeds, and Related Products
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 remove those portions reflecting approval of one
new animal drug application (NADA) held by Babineaux's Veterinary
Products for diethylcarbamazine citrate syrup, and two NADA's held by
Schein Pharmaceutical/Steris Laboratories for phenylbutazone injection
and oxytocin injection. In a notice published elsewhere in this issue
of the Federal Register, FDA is withdrawing approval of these NADA's as
requested by their sponsors.
EFFECTIVE DATE: July 31, 1997.
FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1722.
SUPPLEMENTARY INFORMATION: Babineaux's Veterinary Products, Inc., 6425
Airline Hwy., Metairie, LA 70003, is the sponsor of NADA 46-147 for
Dirocide (diethylcarbamazine citrate) Syrup. Schein Pharmaceutical,
Inc./Steris Laboratories, Inc., 620 North 51st Ave., Phoenix, AZ 85043-
4705, is the sponsor of NADA 48-391 for phenylbutazone injection, and
NADA 49-183 for oxytocin injection.
The sponsors requested withdrawal of approval of the NADA's under
21 CFR 514.115(d) because the products are no longer being marketed.
The regulations are amended in 21 CFR 520.622b(a)(2), 522.1680(b),
and 522.1720(b)(2) to remove those portions which reflect approval of
these NADA's.
[[Page 38906]]
Also, with the withdrawal of approval of NADA 46-147, Babineaux's
Veterinary Products is no longer the sponsor of any approved NADA's.
Therefore, 21 CFR 510.600(c)(1) and (2) are amended to remove entries
for this firm.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 520
Animal drugs.
21 CFR Part 522
Animal drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
the authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510,
520, and 522 are amended as follows:
PART 510--NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: Secs. 201, 301, 501 502, 503, 512, 701, 721 of the
Federal Food, Drug, and Cosmetic Act (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 paragraph (c)(1) by
removing the entry for ``Babineaux's Veterinary Products, Inc.'' and in
paragraph (c)(2) by removing the entry for ``021188''.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: Secs. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
Sec. 520.622b [Amended]
4. Section 520.622b Diethylcarbamazine citrate syrup is amended in
paragraph (a)(2) by removing the phrase ``Nos. 021188 and'' and adding
in its place ``No.''.
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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
Sec. 522.1680 [Amended]
6. Section 522.1680 Oxytocin injection is amended in paragraph (b)
by removing the number ``000402''.
Sec. 522.1720 [Amended]
7. Section 522.1720 Phenylbutazone injection is amended in
paragraph (b)(2) by removing the number ``000402''.
Dated: July 17, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-19066 Filed 7-18-97; 8:45 am]
BILLING CODE 4160-01-F
