[Federal Register Volume 63, Number 21 (Monday, February 2, 1998)]
[Rules and Regulations]
[Pages 5254-5255]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-2410]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 524, and 558
[Docket No. 97N-0508]
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 eight
new animal drug applications (NADA's) for which the sponsors have
requested withdrawal of approval. The NADA's provide for use of
products which are no longer made or marketed. In a notice published
elsewhere in this issue of the Federal Register, FDA is withdrawing
approval of the NADA's.
EFFECTIVE DATE: February 12, 1998.
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: In a notice published elsewhere in this
issue of the Federal Register, FDA has withdrawn approval of the
following NADA's:
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Sponsor name and
NADA No. Drug name address
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38-247........................ Hygromycin B Type A Mountaire Feeds,
medicated article. Inc., 124 East
Fifth, P.O. Box
5391, North Little
Rock, AR 72119,
formerly Mountaire
Vitamins, Inc.,
400 North Poplar
St., P.O. Box
9210, North Little
Rock, AR 72119
44-013........................ Tylosin Type A do.
medicated article.
65-273........................ Chloramphenicol Zenith Goldline
capsules, USP. Pharmaceuticals,
Inc., 140 Legrand
Ave., Northvale,
NJ 07647, formerly
Zenith
Laboratories,
Inc., 50 Williams
Dr., Ramsey, NJ
07446
65-456........................ Tetracycline HCl do.
capsules, USP.
95-736........................ Hygromycin B Type A Mountaire Feeds,
medicated article. Inc.
98-895........................ Starbar GX-118 Wellmark
Topical International,
(phosmet)(prolate). 1000 Tower Lane,
Bensenville, IL
60106, formerly
Sandoz Agro, Inc.,
1300 East Touhy
Ave., Des Plaines,
IL 60018
137-138....................... Pyrantel tartrate Mountaire Feeds,
Type A medicated Inc.
article.
139-239....................... Banminth (pyrantel Growmark, Inc., 950
tartrate) Type A North Meridian
medicated article. St., Indianapolis,
IN 46204-3909,
formerly at 1701
Towanda Ave.,
Bloomington, IL
61701
------------------------------------------------------------------------
The sponsors requested withdrawal of approval of the NADA's under
21 CFR 514.115(d) because the products are no longer made or marketed.
The regulations are amended in 21 CFR 520.390b(b)(1),
520.2345a(b)(4), 524.1742(b), 558.274(a)(6) and (c)(1)(i),
558.485(a)(21) and (a)(25), and 558.625(b)(84) to remove those portions
which reflect approval of these NADA's.
Also, with withdrawal of approval of these NADA's, these firms are
no longer sponsors of approved NADA's. Therefore, 21 CFR 510.600(c)(1)
and (c)(2) are amended to remove entries for the firms.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520 and 524
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
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, 524, 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
[[Page 5255]]
removing the entries for ``Growmark, Inc.,'' ``Mountaire Vitamins,
Inc.,'' ``Sandoz Agro, Inc.,'' and ``Zenith Laboratories, Inc.,'' and
in the table in paragraph (c)(2) by removing the entries for
``000172'', ``011536'', ``020275'', and ``043734''.
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. 520.390b [Amended]
4. Section 520.390b Chloramphenicol capsules is amended in
paragraph (b)(1) by removing ``000172''.
Sec. 520.2345a [Amended]
5. Section 520.2345a Tetracycline hydrochloride capsules is amended
by removing paragraph (b)(4).
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
6. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 524.1742 [Amended]
7. Section 524.1742 N-(Mercaptomethyl) phthalimide S-(O,O-dimethyl
phosphorodithioate) emulsifiable liquid is amended in paragraph (b) by
removing the phrase ``and 011536''.
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. 558.274 [Amended]
9. Section 558.274 Hygromycin B is amended by removing and
reserving paragraph (a)(6) and in the table in paragraph (c)(1)(i),
under the ``sponsor'' column, by removing ``043734''.
Sec. 558.485 [Amended]
10. Section 558.485 Pyrantel tartrate is amended by removing and
reserving paragraphs (a)(21) and (a)(25).
Sec. 558.625 [Amended]
11. Section 558.625 Tylosin is amended by removing and reserving
paragraph (b)(84).
Dated: January 8, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-2410 Filed 1-30-98; 8:45 am]
BILLING CODE 4160-01-F
