[Federal Register Volume 61, Number 129 (Wednesday, July 3, 1996)]
[Rules and Regulations]
[Pages 34727-34729]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16886]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 520, 522, 529, and 558
Animal Drugs, Feeds, and Related Products; 29 Various New Animal
Drug Products and Type A Medicated Articles
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 29 new
animal drug applications (NADA's) held by Bayer Corp., Agriculture
Division, Animal Health (formerly Miles, Inc., Agriculture Division,
Animal Health Products), Hubbard Milling Co., Hoffmann-LaRoche, Inc.,
and Ohmeda, Inc. The NADA's provide for the use of 29 various new
animal drug products and Type A medicated articles used to manufacture
finished medicated animal feeds. In a notice published elsewhere in
this issue of the Federal Register, FDA is withdrawing approval of the
NADA's.
EFFECTIVE DATE: July 15, 1996.
FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0159.
SUPPLEMENTARY INFORMATION: In a notice published elsewhere in this
issue of the Federal Register, FDA is withdrawing approval of the
following NADA's:
[[Page 34728]]
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Sponsor name and
NADA No. Drug name address
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6-462......................... Diethylcarbamazine Bayer Corp.,
tablets. Agriculture
Division, Animal
Health, P.O. Box
390, Shawnee
Mission, KS
66201.
10-540........................ Calcium disodium Do.
edetate injection.
11-380........................ Diethylcarbamazine Do.
powder.
12-054........................ Protokylol Do.
hydrochloride
tablets and
injection.
12-103........................ Triamcinolone Do.
tablets.
12-392........................ Triamcinolone Do.
injection.
12-598........................ Disophenol sodium Do.
injection.
15-161........................ Trichlorfon powder.. Do.
15-965........................ Coumaphos Type A Do.
medicated article.
30-045........................ Triamcinolone/ Do.
neomycin sulfate
ointment.
34-394........................ Niclosamide tablets. Do.
35-263........................ Styrylpyridinium Do.
chloride,
diethylcarbamazine
(as base) oral
liquid.
45-287........................ Coumaphos crumbles.. Do.
48-645........................ Tylosin Type A Hubbard Milling
medicated articles Co., 424 North
(5, 10, 20, and 40 Riverfront Dr.,
grams per pound). P.O. Box 8500,
Mankato, MN 56002-
8500.
49-555........................ Styrylpyridinium Bayer Corp.
chloride,
diethylcarbamazine
control diet HRH/
MSD.
91-628........................ Diethylcarbamazine Do.
citrate syrup.
93-372........................ Chlortetracycline Hoffmann-LaRoche,
calcium complex Inc., Nutley, NJ
Type A medicated 07110.
articles.
94-402........................ Tylosin and Hubbard Milling
sulfamethazine Type Co.
A medicated
articles.
95-078........................ Trichlorfon oral Bayer Corp.
liquid.
96-031........................ Styrylpyridinium Do.
chloride,
diethylcarbamazine
citrate tablets.
100-201....................... Trichlorfon paste... Do.
100-356....................... Styrylpyridinium Do.
chloride,
diethylcarbamazine
control diet HRH.
100-670....................... Niclosamide Type A Do.
medicated article.
101-078....................... Dichlorophene and Do.
toluene capsules.
120-327....................... Diethylcarbamazine Do.
chewable tablets.
120-670....................... Styrylpyridinium, Do.
diethylcarbamazine
edible tablets.
121-291....................... Enflurane liquid Ohmeda, Inc.,
(anesthetic). Pharmaceutical
Products
Division, P.O.
Box 804, Liberty
Corner, NJ 07938-
0804.
121-813....................... Styrylpyridinium, Bayer Corp.
diethylcarbamazine
film-coated tablets.
133-509....................... Pyrantel tartrate Hubbard Milling
Type A medicated Co.
articles.
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The sponsors requested withdrawal of approval of the NADA's. This
final rule removes 21 CFR 520.500, 520.620a, 520.620b, 520.1520,
520.2022, 520.2160a, 520.2160b, 520.2160c, 520.2160d, 520.2480,
520.2520c, 520.2520d, 522.281, 522.740, 522.2022, 522.2480, 529.810,
558.367, and 558.565, and amends 21 CFR 520.580, 520.622a, 520.622b,
520.2520a, 558.185, 558.485, 558.625, and 558.630.
List of Subjects
21 CFR Parts 520, 522, and 529
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 520,
522, 529, and 558 are amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
Sec. 520.500 [Removed]
2. Section 520.500 Coumaphos crumbles is removed.
Sec. 520.580 [Amended]
3. Section 520.580 Dichlorophene and toluene capsules is amended in
paragraph (b)(2) by removing ``000859,''.
Sec. 520.620a [Removed]
4. Section 520.620a Diethylcarbamazine is removed.
Sec. 520.620b [Removed]
5. Section 520.620b Diethylcarbamazine chewable tablets is removed.
Sec. 520.622a [Amended]
6. Section 520.622a Diethylcarbamazine citrate tablets is amended
in paragraph (a) by removing ``000859 and''.
7. Section 520.622b is amended by revising paragraph (b)(2) to read
as follows:
Sec. 520.622b Diethylcarbamazine citrate syrup.
* * * * *
(b)(1) * * *
(2) Sponsors. See No. 017030 for use as in paragraphs (b)(3)(ii)(a)
and (b)(3)(ii)(c) of this section.
* * * * *
Sec. 520.1520 [Removed]
8. Section 520.1520 Niclosamide tablets is removed.
Sec. 520.2022 [Removed]
9. Section 520.2022 Protokylol hydrochloride tablets is removed.
Sec. 520.2160a [Removed]
10. Section 520.2160a Styrylpyridinium, diethylcarbamazine tablets
is removed.
[[Page 34729]]
Sec. 520.2160b [Removed]
11. Section 520.2160b Styrylpyridinium chloride, diethylcarbamazine
(as base) is removed.
Sec. 520.2160c [Removed]
12. Section 520.2160c Styrylpyridinium, diethylcarbamazine edible
tablets is removed.
Sec. 520.2160d [Removed]
13. Section 520.2160d Styrylpyridinium, diethylcarbamazine film-
coated tablets is removed.
Sec. 520.2480 [Removed]
14. Section 520.2480 Triamcinolone tablets is removed.
Sec. 520.2520a [Amended]
15. Section 520.2520a Trichlorfon oral is amended in paragraph (b)
by removing the phrase ``Nos. 017800 and 000859'' and adding in its
place ``No. 017800''.
Sec. 520.2520c [Removed]
16. Section 520.2520c Trichlorfon oral liquid is removed.
Sec. 520.2520d [Removed]
17. Section 520.2520d Trichlorfon paste is removed.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
18. 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. 522.281 [Removed]
19. Section 522.281 Calcium disodium edetate injection is removed.
Sec. 522.740 [Removed]
20. Section 522.740 Disophenol sodium injection is removed.
Sec. 522.2022 [Removed]
21. Section 522.2022 Protokylol hydrochloride injection is removed.
Sec. 522.2480 [Removed]
22. Section 522.2480 Triamcinolone injection is removed.
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
23. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
Sec. 529.810 [Removed]
24. Section 529.810 Enflurane is removed.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
25. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: Secs. 512, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b, 371).
Sec. 558.185 [Amended]
26. Section 558.185 Coumaphos is amended by removing and reserving
paragraph (a)(1).
Sec. 558.367 [Removed]
27. Section 558.367 Niclosamide is removed.
Sec. 558.485 [Amended]
28. Section 558.485 Pyrantel tartrate is amended by removing and
reserving paragraph (a)(16).
Sec. 558.565 [Removed]
29. Section 558.565 Styrylpyridinium chloride, diethylcarbamazine
is removed.
Sec. 558.625 [Amended]
30. Section 558.625 Tylosin is amended by removing and reserving
paragraph (b)(72).
Sec. 558.630 [Amended]
31. Section 558.630 Tylosin and sulfamethazine is amended in
paragraph (b)(10) by removing ``012190,''.
Dated: June 3, 1996.
Michael J. Blackwell,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 96-16886 Filed 7-2-96; 8:45 am]
BILLING CODE 4160-01-F