[Federal Register Volume 66, Number 47 (Friday, March 9, 2001)]
[Rules and Regulations]
[Pages 14072-14074]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5680]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 526, and 558


New Animal Drugs; Change of Sponsor

AGENCY: Food and Drug Administration

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect the change of sponsor for 25 approved new 
animal drug applications (NADA's) from Merial Ltd. to Bimeda, Inc.

DATES: This rule is effective March 9, 2001.

FOR FURTHER INFORMATION CONTACT: Norman J. Turner, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0214.

SUPPLEMENTARY INFORMATION: Merial Ltd., 2100 Ronson Rd., Iselin, NJ 
08830-3077, has informed FDA that it has transferred ownership of, and 
all rights and interests in, the following approved NADA's to Bimeda, 
Inc., 288 County Rd. 28, LeSueur, MN 56058-9322.
    Accordingly, the agency is amending the regulations in 21 CFR parts 
510, 520, 522, 524, 526, and 558 to reflect the change of sponsor. The 
agency is also amending Sec. 510.60(c)(1) and (c)(2) to add the sponsor 
name and drug labeler code for Bimeda, Inc.
    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 Parts 520, 522, 524, and 526

    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, 522, 524, 526, and 558 are amended as follows:

[[Page 14073]]

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.

    2. Section 510.600 is amended in the table in paragraph (c)(1) by 
alphabetically adding an entry for ``Bimeda, Inc.'' and in the table in 
paragraph (c)(2) by numerically adding an entry for ``061133'' to read 
as follows:


Sec. 510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

 
------------------------------------------------------------------------
       Firm name and address                  Drug labeler code
------------------------------------------------------------------------
 
  *                    *                    *                    *
                   *                    *                    *
Bimeda, Inc., 288 County Rd. 28,     061133
 LeSueur, MN 56058-9322
  *                    *                    *                    *
                   *                    *                    *
------------------------------------------------------------------------

    (2) * * *

 
------------------------------------------------------------------------
         Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
  *                    *                    *                    *
                   *                    *                    *
061133                               Bimeda, Inc., 288 County Rd. 28,
                                      LeSueur, MN 56058-9322
  *                    *                    *                    *
                   *                    *                    *
------------------------------------------------------------------------

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. 520.390a  [Amended]

    4. Section 520.390a Chloramphenicol tablets is amended in paragraph 
(b)(2) by removing ``050604'' and by adding in its place ``061133''.


Sec. 520.540b  [Amended]

    5. Section 520.540b Dexamethasone tablets and boluses is amended in 
paragraph (b)(2) by removing ``050604'' and by adding in its place 
``061133''.


Sec. 520.622a  [Amended]

    6. Section 520.622a Diethylcarbamazine citrate tablets is amended 
in paragraph (a)(3) by removing ``050604'' and by adding in its place 
``061133''.


Sec. 520.622c  [Amended]

    7. Section 520.622c Diethylcarbamazine citrate chewable tablets is 
amended in paragraph (b)(4) by removing ``050604'' and by adding in its 
place ``061133''.


Sec. 520.823  [Amended]

    8. Section 522.823 Erythromycin phosphate is amended in paragraph 
(b) by removing ``050604'' and by adding in its place ``061133''.


Sec. 520.1484  [Amended]

    9. Section 520.1484 Neomycin sulfate soluble powder is amended in 
paragraph (b) by removing ``050604, and'' and by adding ``, and 
061133'' after ``051259''.


Sec. 520.1660d  [Amended]

    10. Section 520.1660d Oxytetracycline hydrochloride soluble powder 
is amended in paragraph (b)(7) by removing ``050604'' and by adding in 
its place ``061133''.


Sec. 520.1696b  [Amended]

    11. Section 520.1696b Penicillin G potassium in drinking water is 
amended in paragraph (b) by removing ``050604, and'' and by adding ``, 
and 061133'' after ``053501''.


Sec. 520.1720a  [Amended]

    12. Section 520.1720a Phenylbutazone tablets and boluses is amended 
in paragraph (b)(3) by removing ``and 059130'' and by adding in its 
place ``059130, and 061133''.


Sec. 520.1720d  [Amended]

    13. Section 520.1720d Phenylbutazone gel is amended in paragraph 
(b) by removing ``050604'' and by adding in its place ``061133''.


Sec. 520.2123a  [Amended]

    14. Section 520.2123a Spectinomycin dihydrochloride pentahydrate 
tablets is amended in paragraph (b), by removing ``050604'' and by 
adding in its place ``061133''.


Sec. 520.2123b  [Amended]

    15. Section 520.2123b Spectinomycin dihydrochloride pentahydrate 
soluble powder is amended in paragraph (b) by removing ``050604'' and 
by adding in its place ``061133''.


Sec. 520.2260b  [Amended]

    16. Section 520.2260b Sulfamethazine sustained-release boluses is 
amended in paragraphs (c)(1) and (e)(1) by removing ``050604'' and by 
adding in its place ``061133''.

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

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

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


Sec. 522.820  [Amended]

    18. Section 522.820 Erythromycin injection is amended in paragraph 
(a) by removing ``050604'' and by adding its place ``061133''.


Sec. 522.2444b  [Amended]

    19. Section 522.2444b Sodium thiopental, sodium pentobarbital for 
injection is amended in paragraph (b) by removing ``050604'' and by 
adding in its place ``061133''.

[[Page 14074]]

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

    20. The authority citation for 21 CFR part 524 continues to read as 
follows:

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


Sec. 524.1580b  [Amended]

    21. Section 524.1580b Nitrofurazone ointment is amended in 
paragraph (b) by removing ``and 051259'' and by adding in its place 
``051259, and 061133''.

PART 526--INTRAMAMMARY DOSAGE FORMS

    22. The authority citation for 21 CFR part 526 continues to read as 
follows:

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


Sec. 526.820  [Amended]

    23. Section 526.820 Erythromycin is amended in paragraph (b) by 
removing ``050604'' and by adding in its place ``061133''.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    24. The authority citation for 21 CFR part 558 continues to read as 
follows:

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


Sec. 558.58  [Amended]

    25. Section 558.58 Amprolium and ethopabate is amended in the table 
in paragraph (d)(1), in item (iii), for the entry ``Arsanilic acid 90 
(0.01 pct) plus erythromycin 4.6 to 18.5'', under the ``Sponsor'' 
column by adding ``061133''.
    26. Section 558.62 is amended by revising paragraph (a)(1), by 
adding paragraph (a)(3), and in the table in paragraph (c)(1) by 
redesignating entries (c)(1)(iii), (c)(1)(iv), and (c)(1)(v) as entries 
(c)(1)(iv), (c)(1)(vi), and (c)(1)(vii), respectively, and by adding 
new entries (c)(1)(iii) and (c)(1)(v) to read as follows:


Sec. 558.62  Arsanilic acid.

    (a) * * *
    (1) To 015565: 20, 50, and 100 percent for use as in the table in 
paragraph (c)(1), entry (ii), item 1; entry (ii), item 2; entry (iv); 
entry (vi); and entry (vii) of this section.
    *    *    *    *    *
    (3) To 061133: 90 grams per pound arsanilic acid and 4.6 grams per 
pound erythromycin equivalents as erythromycin thiocyanate for use as 
in paragraph (c)(1), entry (iii); 90 grams per pound arsanilic acid and 
9.25 grams per pound erythromycin equivalents as erythromycin 
thiocyanate for use as in paragraph (c)(1), entry (v).
    *    *    *    *    *
    (c) * * *
    (1) * * *

 
------------------------------------------------------------------------
 Arsanilic
  acid in    Combination   Indications for
 grams per  in grams per         use           Limitations      Sponsor
    ton          ton
------------------------------------------------------------------------
  *                    *                    *                    *
                   *                    *                    *
(iii)       Erythromycin  Chickens; growth  As erythromycin
             4.6           promotion and     thiocyanate;      012487
                           feed              withdraw 5 days
                           efficiency;       before
                           improving         slaughter; as
                           pigmentation.     sole source of
                                             organic
                                             arsenic.
 
  *                    *                    *                    *
                   *                    *                    *
(v)         Erythromycin  Chickens; growth  As erythromycin
             9.25          promotion and     thiocyanate;      012487
                           feed              withdraw 5 days
                           efficiency;       before
                           improving         slaughter; as
                           pigmentation.     sole source of
                                             organic
                                             arsenic.
  *                    *                    *                    *
                   *                    *                    *
------------------------------------------------------------------------

    *    *    *    *    *


Sec. 558.248  [Amended]

    27. Section 558.248 Erythromycin thiocyanate is amended in 
paragraphs (a)(1) and (a)(2) by removing ``050604'' and by adding in 
its place ``061133'', and in the table in paragraph (d)(1), in entries 
(i) through (vi), under the ``Sponsor'' column by removing ``050604'' 
wherever it appears and by adding in its place ``061133''.


Sec. 558.625  [Amended]

    28. Section 558.625 Tylosin is amended in paragraph (b)(39) by 
removing ``50604'' and by adding in its place ``061133''.

    Dated: January 29, 2001
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 01-5680 Filed 3-8-01; 8:45 am]
BILLING CODE 4160-01-F