[Federal Register Volume 62, Number 58 (Wednesday, March 26, 1997)]
[Rules and Regulations]
[Pages 14300-14301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7541]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 510 and 558
Animal Drugs, Feeds, and Related Products; Hygromycin B, Pyrantel
Tartrate, and Tylosin
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 the
two new animal drug applications (NADA's) held by Land O'Lakes, Inc.,
(one for use of tylosin and one for tylosin/sulfamethazine Type A
medicated articles), and three NADA's held by ADM Animal Health and
Nutrition Div. (one for use of pyrantel tartrate, one for hygromycin B,
and one for tylosin/sulfamethazine Type A medicated articles). In a
notice published elsewhere in this issue of the Federal Register, FDA
is withdrawing approval of these NADA's. The sponsors requested the
withdrawal of approval of the NADA's.
EFFECTIVE DATE: April 2, 1997.
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: Land O'Lakes, Inc., Agricultural Services,
2827 Eighth Avenue South, Fort Dodge, IA 50501, is the sponsor of
NADA's 42-489 tylosin (see 21 CFR 558.625(b)(53)) and 98-156 tylosin/
sulfamethazine (see Sec. 558.630(b)(3) (21 CFR 558.630(b)(3)). ADM
Animal Health and Nutrition Div., P.O. Box 2508, Fort Wayne, IN 46801-
2508, is the sponsor of NADA 118-874 pyrantel tartrate (see 21 CFR
558.485(a) (4)) (formerly held by Henwood Feed Additives, Inc.), NADA
127-825 hygromycin B (see 21 CFR 558.274(a)(4) and (c)(1)(i) and
(c)(1)(ii)), and NADA 127-826 tylosin/sulfamethazine (see
Sec. 558.630(b)(10)) (both formerly held by Music City Supplement Co.).
The sponsors requested withdrawal of approval of the NADA's. The animal
drug regulations are amended to remove those portions which reflect
approval of these NADA's.
Also, with the withdrawal of approval of these NADA's, Land O'Lakes
and Music City Supplement Co. are no longer sponsors of approved
NADA's. Therefore, 21 CFR 510.600(c)(1) and (c)(2) are amended to
remove entries for these firms.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
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 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 paragraph (c)(1) by
removing the entries for ``Land O'Lakes, Inc.,'' and ``Music City
Supplement Co.'', and in paragraph (c)(2) by removing the entries for
``017519'' and ``034500''.
[[Page 14301]]
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
3. 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. 558.274 [Amended]
4. Section 558.274 Hygromycin B is amended in paragraphs (a)(4) and
(c)(1)(i) and (c)(1)(ii) by removing the number ``017519,''.
Sec. 558.485 [Amended]
5. Section 558.485 Pyrantel tartrate is amended by removing and
reserving paragraph (a)(4).
Sec. 558.625 [Amended]
6. Section 558.625 Tylosin is amended by removing and reserving
paragraph (b)(53).
Sec. 558.630 [Amended]
7. Section 558.630 Tylosin and sulfamethazine is amended in
paragraph (b)(3) by removing the number ``,034500'' and in paragraph
(b)(10) by removing the number ``017519,''.
Dated: March 13, 1997.
Michael J. Blackwell,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 97-7541 Filed 3-25-97; 8:45 am]
BILLING CODE 4160-01-F
