[Federal Register Volume 60, Number 175 (Monday, September 11, 1995)]
[Rules and Regulations]
[Pages 47051-47053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-22369]
=======================================================================
-----------------------------------------------------------------------
[[Page 47052]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, and 558
New Animal Drugs; Change of Sponsor
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor name from Premiere Agri
Technologies, Inc., to ADM Animal Health & Nutrition Div., and a change
of sponsor of several new animal drug applications (NADA's) from
wholly-owned subsidiaries to ADM Animal Health & Nutrition Div.
EFFECTIVE DATE: September 11, 1995.
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: ADM Animal Health & Nutrition Div., P.O. Box
2508, Fort Wayne, IN 46801-2508, has informed FDA of a change of
sponsor name in approved NADA 91-582 (Tylosin) from Premiere Agri
Technologies, Inc. ADM Animal Health & Nutrition Div., has also
informed FDA that it has assumed sponsorship of the following NADA's
previously owned by its subsidiaries:
------------------------------------------------------------------------
Former sponsor name and
NADA No. Drug name address
------------------------------------------------------------------------
48-480a.... Chlortetracycline............ Feed Specialties Co., Inc.,
1877 NE. 58th Ave., Des
Moines, IA 50313.
65-256..... Chlortetracycline Do.
hydrochloride.
107-957.... Tylosin and sulfamethazine... Do.
108-484.... Tylosin and sulfamethazine... Do.
110-045.... Tylosin...................... Good-Life, Division of
Central Soya Co., Inc.,
Good-Life Dr., P.O. Box
687, Effingham, IL 62401.
110-439.... Hygromycin B................. Feed Specialties Co., Inc.
118-877.... Pyrantel tartrate............ Do.
128-411.... Tylosin and sulfamethazine... Good-Life, Division of
Central Soya Co., Inc.
131-956.... Tylosin and sulfamethazine... MAC-PAGE, Inc., 1600 South
Wilson Ave., Dunn, NC
28334.
132-448.... Bambermycins................. Feed Specialties Co., Inc.
133-490.... Pyrantel tartrate............ MAC-PAGE, Inc.
140-842.... Hygromycin B................. Do.
------------------------------------------------------------------------
Accordingly, the agency is amending the regulations in 21 CFR
510.600(c)(1) and (c)(2) by removing Feed Specialties, Co., Inc., Good-
Life, Division of Central Soya Co., and MAC-PAGE, Inc., because the
firms are no longer the sponsors of any approved NADA's. The agency is
also amending the drug labeler codes in 21 CFR 520.445b, 558.95,
558.274, 558.485, 558.625, and 558.630 providing for use of the above
mentioned veterinary drug products. The sponsor labeler code of
Premiere Agri Technologies, Inc., is being retained for the new
sponsor.
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: 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).
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 for ``Premiere Agri Technologies, Inc.,''
and by alphabetically adding a new entry for ``ADM Animal Health &
Nutrition Div., by removing the entries for ``Feed Specialties Co.,
Inc., Good-Life, Division of Central Soya Co., and MAC-PAGE, Inc.'';
and in the table in paragraph (c)(2) in the entry for ``012286'' by
removing the sponsor name ``Premiere Agri Technologies, Inc.,'' and
adding in its place ``ADM Animal Health & Nutrition Div.,'' and by
removing the entries for ``017274, 021810, and 047427''.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
3. The authority citation of 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. 520.445b [Amended]
4. Section 520.445b Chlortetracycline powder (chlortetracycline
hydrochloride or chlortetracycline bisulfate) is amended in paragraphs
(b) and (d)(4)(iii)(C) by removing ``017274'' and adding in its place
``012286''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
5. 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. 558.95 [Amended]
6. Section 558.95 Bambermycins is amended in paragraph (a)(4) by
removing the entry for ``017274'' and numerically adding ``012286''.
Sec. 558.274 [Amended]
7. Section 558.274 Hygromycin B is amended in paragraph (a)(7) and
in the table in paragraphs (c)(1)(i) and (c)(1)(ii) by removing the
entry for ``047427'' and numerically adding ``012286''.
Sec. 558.485 [Amended]
8. Section 558.485 Pyrantel tartrate is amended in paragraph
(a)(11) by
[[Page 47053]]
removing ``017274'' and adding in its place ``012286''.
Sec. 558.625 [Amended]
9. Section 558.625 Tylosin is amended in paragraph (b)(52) by
removing ``021810'' and adding in its place ``012286''.
Sec. 558.630- [Amended]
10. Section 558.630 Tylosin and sulfamethazine is amended in
paragraphs (b)(3) and (b)(8) by removing ``017274'' and adding
``012286'' and in paragraph (b)(10) by removing ``017274, 021810, and
047427'' and numerically adding ``012286''.
Dated: August 31, 1995.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine
[FR Doc. 95-22369 Filed 9-8-95; 8:45 am]
BILLING CODE 4160-01-F