[Federal Register Volume 59, Number 106 (Friday, June 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-13588]
[[Page Unknown]]
[Federal Register: June 3, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 510, 520, and 524
Animal Drugs, Feeds, 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 five new animal
drug applications (NADA's) from Purina Mills, Inc., to PM Resources,
Inc.
EFFECTIVE DATE: June 3, 1994.
FOR FURTHER INFORMATION CONTACT: Benjamin A. Puyot, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1646.
SUPPLEMENTARY INFORMATION: Purina Mills, Inc., P.O. Box 66812, St.
Louis, MO 63166-6812, has informed FDA that it has transferred
ownership of, and all rights and interests in, the following approved
NADA's to PM Resources, Inc., 13001 St. Charles Rock Rd., Bridgeton, MO
63044:
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NADA number Ingredient Trade name
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007-076................ Sulfaquinoxaline Sodium Sulfa-Nox Liquid.
008-244................ Sulfaquinoxaline Sodium Sulfa-Nox Concentrate.
010-886................ Piperazine Phosphate Purina Liquid Wormer.
Monohydrate.
043-215................ Famphur................ Purina Grub-Kill.
092-150................ Pyrantel Tartrate...... Purina Horse & Colt
Wormer.
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Accordingly, the agency is amending the regulations in 21 CFR Parts
510.600(c)(1) and (c)(2), 520.1806(b), 520.2045(b)(2), 520.2325a(c)(2),
and 524.900(c) to reflect the change of sponsor.
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.
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 524 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).
2. Section 510.600 is amended in the table in paragraph (c)(1) by
alphabetically adding a new entry for ``PM Resources, Inc.,'' and in
the table in paragraph (c)(2) by numerically adding a new entry for
``060594'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
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Firm name and address Drug labeler code
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*****
PM Resources, Inc.,13001 St. 060594
Charles Rock Rd., Bridgeton, MO
63044.
*****
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(2) * * *
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Drug labeler code Firm name and address
------------------------------------------------------------------------
*****
060594............................. PM Resources, Inc.,13001 St.
Charles Rock Rd., Bridgeton, MO
63044
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PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
3. 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. 520.1806 [Amended]
4. Section 520.1806 Piperazine monohydrochloride liquid is amended
in paragraph (b) by adding ``and 060594'' after ``017135''.
Sec. 520.2045 [Amended]
5. Section 520.2045 Pyrantel tartrate powder; pyrantel tartrate
pellets is amended in paragraph (b)(2) by removing ``017800'' and
adding in its place ``060594''.
Sec. 520.2325a [Amended]
6. Section 520.2325a Sulfaquinoxaline drinking water is amended in
paragraph (c)(2) by removing ``017800'' and adding in its place
``060594''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
7. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
Sec. 524.900 [Amended]
8. Section 524.900 Famphur is amended in paragraph (c) by removing
``017800'' and adding in its place ``060594''.
Dated: May 26, 1994.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 94-13588 Filed 6-2-94; 8:45 am]
BILLING CODE 4160-01-F
