[Federal Register Volume 66, Number 86 (Thursday, May 3, 2001)]
[Rules and Regulations]
[Page 22118]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11158]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 21 CFR Parts 510, 522, and 558


 Animal Drugs, Feeds, and Related Products; Technical Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is updating the animal 
drug regulations to reflect changes to previously approved new animal 
drug applications (NADAs). Several sponsors currently listed as 
sponsors of approved applications and specified in the animal drug 
approval regulations are incorrect. This action is being taken to 
improve the accuracy of the regulations.

DATES: This rule is effective May 3, 2001.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-4567.

SUPPLEMENTARY INFORMATION: FDA has found several errors in the agency's 
regulations concerning approval of animal drugs, feeds, and related 
products including the list of sponsors of approved applications. To 
correct those errors, FDA is amending 21 CFR 510.600(c)(1) and (c)(2) 
to remove 28 sponsor names and their corresponding drug labeler codes 
(DLCs) because the firms are no longer the holders of any approved 
NADAs. This document is also amending the animal drug approval 
regulations by correcting nonsubstantive DLC errors in 21 CFR 522.2120, 
558.274, 558.625, and 558.630.
    Publication of this document constitutes final action on these 
changes under the Administrative Procedure Act (5 U.S.C. 553). Notice 
and public procedure are unnecessary because FDA is merely correcting 
nonsubstantive errors.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 522

    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, 
522, 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 ``Albion Laboratories, Inc.'', 
``Balfour Guthrie & Co.'', ``Diamond Shamrock Corp.'', ``DuPont Merck 
Pharmaceutical Co.'', ``Farmers Feed & Supply Co.'', ``Franklin 
Laboratories, Inc.'', ``Gland-O-Lac Co.'', ``Michael Gordon, Inc.'', 
``Henwood Feed Additives'', ``Heska Corp.'', ``Hubbard Milling Co.'', 
``Lemmon Co.'', ``Mattox & Moore, Inc.'', ``McClellan Laboratories, 
Inc.'', ``Nixon and Co.'', ``Osborn Laboratories, Inc.'', ``Peter Hand 
Foundation'', ``Premier Malt Products, Inc.'', ``Protein Blenders, 
Inc.'', ``The Rath Packing Co.'', ``Rhone Merieux Canada, Inc.'', 
``Shell Chemical Co.'', ``Square Deal Fortification Co.'', ``Sterling 
Winthrop, Inc.'', ``Syntex Animal Health, Inc.'', ``V.P.O., Inc.'', 
``Vet-A-Mix, Inc.'', and ``Westchester Veterinary Products, Inc.'', and 
in the table in paragraph (c)(2) by removing the entries for ``000033, 
000056, 000693, 000934, 010290, 010290, 011461, 011485, 011789, 012190, 
012487, 025001 026186, 027863, 028260, 032707, 033999, 036108, 043728, 
043729, 043732, 043735, 043737, 043738, 043743, 043744, 047015, 049047, 
and 063604''.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    3. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.


Sec. 522.2120  [Amended]

    4. Section 522.2120 Spectinomycin dihydrochloride injection is 
amended in paragraph (b) by removing ``Nos. 000033 and 059130'' and 
adding in its place ``No. 059130''.

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: 21 U.S.C. 360b, 371.


Sec. 558.274  [Amended]

    6. Section 558.274 Hygromycin B is amended by removing and 
reserving paragraph (a)(5); by removing ``011790 and'' in paragraph 
(a)(7); and by removing ``026186,'' from the ``Sponsor'' column in the 
table in paragraphs (c)(1)(i) and (c)(1)(ii).


Sec. 558.625  [Amended]

    7. Section 558.625 Tylosin is amended by removing and reserving 
paragraphs (b)(16), (b)(19), and (b)(34), and in paragraph (b)(79) by 
removing ``012286'' and adding in its place ``017519''.


Sec. 558.630  [Amended]

    8. Section 558.630 Tylosin and sulfamethazine is amended in 
paragraph (b)(8) by removing ``, 026186''.

    Dated: April 23, 2001.
Linda Tollefson,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 01-11158 Filed 5-2-01; 8:45 am]
BILLING CODE 4160-01-S