[Federal Register Volume 62, Number 205 (Thursday, October 23, 1997)]
[Rules and Regulations]
[Pages 55159-55160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-28011]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, and 558
New Animal Drugs and Related Products; 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 three new animal
drug applications (NADA's) and three abbreviated new animal drug
applications (ANADA's) from Wade-Jones Co., Inc., and its manufacturing
subsidiary Arkansas Micro Specialties, Inc., to Alpharma Inc. The
agency is also correcting a final rule that appeared in the Federal
Register of June 20, 1996 (61 FR 31398).
EFFECTIVE DATE: October 23, 1997.
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: Wade-Jones Co., Inc., 409 North Bloomington,
Lowell, AR 72745, and its manufacturing subsidiary Arkansas Micro
Specialties, Inc., P.O. Box 308, Highway 71 North, Lowell, AR 72745,
has informed FDA that it has transferred ownership of, and all rights
and interests in, the following approved NADA's and ANADA's to Alpharma
Inc., One Executive Dr., Fort Lee, NJ 07024.
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NADA/ANADA Ingredient
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065-140 Tetracycline Hcl Soluble Powder
140-443 Hygromycin B Type A Medicated Articles
140-578 Tetracycline Hcl Soluble Powder
200-122 Penicillin G Potassium Soluble Powder
200-130 Neomycin Sulfate Soluble Powder
200-233 Lincomycin Hcl Soluble Powder
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The agency is amending parts 510, 520, and 558 (21 CFR parts 510,
520 and 558) to reflect the change of sponsor. The agency is amending
Sec. 510.600(c)(1) and (c)(2) to remove the sponsor name for Wade-Jones
Co., Inc., and Arkansas Micro Specialties, Inc., because the firm no
longer is the holder of any approved NADA's.
The agency is also correcting a final rule that appeared in the
Federal Register of June 20, 1996 (61 FR 31398). This document amended
the animal drug regulations to reflect approval of a supplemental NADA
filed by The Upjohn Co., and two supplemental ANADA's, one filed by
Pfizer, Inc., and the other filed by Rhone Merieux, Inc, respectively.
In Sec. 520.1484(c)(3), the drug labeler code (047864) for Wade-Jones
Co., Inc., was inadvertently omitted from the document. After that
document published, Wade-Jones Co., Inc., transferred ownership of and
all rights and interest to Alpharma Inc. Accordingly, this document
adds a drug labeler code for Alpharma Inc. and, thereby, corrects the
error in the final rule (61 FR 31398).
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 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, 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 entries for ``Arkansas Micro Specialties,
Inc.''and ``Wade-Jones'' and in the table in paragraph (c)(2) by
removing the entries ``047863'' and ``047864''.
[[Page 55160]]
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. 520.1484 [Amended]
4. Section 520.1484 Neomycin sulfate soluble powder is amended in
paragraph (b) by removing ``047864'' and adding in its place ``046573''
and in paragraph (c)(3) by revising the words in the last sentence
``for sponsors 000009, 000069, 050604'' to read as ``for sponsors
000009, 000069, 046573, 050604''.
Sec. 520.1696b [Amended]
5. Section 520.1696b Penicillin G potassium in drinking water is
amended in paragraph (b) by removing ``047864, and'' and adding in its
place ``046573,''.
Sec. 520.2345d [Amended]
6. Section 520.2345d Tetracycline hydrochloride soluble powder is
amended in paragraphs (a)(1), (d)(1)(iii), and (d)(2)(iii) by removing
``047864'', and adding in its place ``046573'' and in paragraph (a)(4)
by removing ``047863'' and adding in its place ``046573''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
7. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.274 [Amended]
8. Section 558.274 Hygromycin B is amended in paragraph (a)(8) by
removing ``047863'' and in the table in paragraphs (c)(1)(i) and
(c)(1)(ii), under the ``sponsor'' column, by removing ``047863'' and
numerically adding ``046573''.
Dated: September 9, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 97-28011 Filed 10-22-97; 8:45 am]
BILLING CODE 4160-01-F
