[Federal Register: May 9, 2001 (Volume 66, Number 90)]
[Rules and Regulations]
[Page 23588-23589]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09my01-12]
[[Page 23588]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, and 558
Animal Drugs, Feeds, and Related Products; Trichlorfon, etc.;
Withdrawal of Approval of NADAs
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 that reflect approval of 11
new animal drug applications (NADAs) listed below. In a notice
published elsewhere in this issue of the Federal Register, FDA is
withdrawing approval of the NADAs.
DATES: This rule is effective May 21, 2001.
FOR FURTHER INFORMATION CONTACT: Pamela K. Esposito, Center for
Veterinary Medicine (HFV-210), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-5593.
SUPPLEMENTARY INFORMATION: The following sponsors have requested that
FDA withdraw approval of the NADAs listed below because the products
are no longer manufactured or marketed:
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21 CFR Cite
NADA Number Product Affected
Sponsor (Drug) (Sponsor Drug
Labeler Code)
------------------------------------------------------------------------
Purina Mills, Inc., P.O. Box NADA 48-915 520.2520a
66812, St. Louis, MO 63166- Purina (017800)
6812. Bot Control
(trichlorfon).
Golden Sun Feeds, Inc., 111 NADA 97-567 558.625(b)(17)
South Fifth St., Estherville, Tylan 10 (021780)
IA 51334. Premix (tylosin
phosphate).
.............................. NADA 97-615 Swine 558.630(b)(4) and
Med-A-Mix TS 8000 (b)(10) (021780)
Premix,
Tylan 5,
10, 20, 40 Sulfa-G
(tylosin phosphate
and sulfamethazine).
Quali-Tech Products, Inc., 318 NADA 110-440 558.274(a)(2),
Lake Hazeltine Dr., Chaska, MN Hygromix (a)(3), (a)(4),
55318-1093. Hygrowormer (c)(1)(i), and
Hyanthelmix (c)(1)(ii)
(hygromycin B). (016968)
Steris Laboratories Inc., 620 NADA 45-578 522.1258 (000402)
North 51st Ave., Phoenix, AZ Lidocaine
85043-4705. Hydrochloride With
Epinephrine
Injection 2%.
.............................. NADA 44-585 Oxytocin 522.1680 (000402)
Injection.
.............................. NADA 45-737 Sodium 522.1704(b)
Pentobarbital (000402)
Injection.
.............................. NADA 45-848 522.1720 (000402)
Phenylbutazone
Injection.
.............................. NADA 110-349 522.540(c)(2)
Dexamethasone (000402)
Injection.
.............................. NADA 110-350 522.540(b)(2)(ii
Dexamethasone ) (000402)
Injection.
.............................. NADA 117-973 522.1884(c)
Prednisolone Sodium (000402)
Succinate for
Injection.
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Following the withdrawal of approval of these NADAs, Golden Sun
Feeds, Inc., is no longer the sponsor of any approved applications.
Therefore, 21 CFR 510.600(c) is amended to remove entries for the
sponsor.
Steris Laboratories currently has another approved application for
dexamethasone injection (NADA 104-606). Therefore, the regulation is
not amended to reflect the withdrawal of approval of NADA 110-349
(dexamethasone injection).
Steris Laboratories NADA 44-585 oxytocin injection is not codified
under 21 CFR 522.1680 oxytocin injection. Also, Steris Laboratories
NADA 45-848 phenylbutazone injection is not codified under 21 CFR
522.1720 phenylbutazone injection. Therefore, amendments of the cited
regulations are not required.
As provided below, the animal drug regulations are amended to
reflect the withdrawal of approvals.
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 ``Golden Sun Feeds, Inc.'', and in the
table in paragraph (c)(2) by removing the entry ``021780''.
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. 520.2520a [Removed]
4. Section 520.2520a Trichlorfon oral is removed.
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. 522.1258 [Removed]
6. Section 522.1258 Lidocaine injection with epinephrine is
removed.
Sec. 522.1704 [Amended]
7. Section 522.1704 Sodium pentobarbital injection is amended by
removing and reserving paragraph (b).
Sec. 522.1884 [Amended]
8. Section 522.1884 Prednisolone sodium succinate injection is
amended by removing the second sentence of
[[Page 23589]]
paragraph (c) and by removing paragraph (d)(2)(iv).
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
9. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.274 [Amended]
10. Section 558.274 Hygromycin B is amended as follows:
a. In paragraph (a)(2) by removing ``016968 and'';
b. By removing and reserving paragraph (a)(3);
c. In paragraph (a)(4) by removing ``016968,'';
d. In the table in paragraph (c)(1) in the fifth column of the
first entry in items (i) and (ii) by removing ``016968,''.
Sec. 558.625 [Amended]
11. Section 558.625 Tylosin is amended by removing and reserving
paragraph (b)(17).
Sec. 558.630 [Amended]
12. Section 558.630 Tylosin and sulfamethazine is amended by
removing and reserving paragraph (b)(4), and in paragraph (b)(10) by
removing ``021780,''.
Dated: May 2, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-11621 Filed 5-8-01; 8:45 am]
BILLING CODE 4160-01-S