[Federal Register Volume 66, Number 180 (Monday, September 17, 2001)]
[Rules and Regulations]
[Pages 47959-47962]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-23043]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, and 558


New Animal Drugs; Change of Sponsor; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor for 43 approved new 
animal drug applications (NADAs) and 16 approved abbreviated new animal 
drug applications (ANADAs) from Hoechst Roussel Vet to Intervet, Inc. 
Technical amendments are also being made. This action is being taken to 
improve the accuracy of the agency's regulations.

DATES: This rule is effective September 17, 2001.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209.

SUPPLEMENTARY INFORMATION: Hoechst Roussel Vet, Perryville Corporate 
Park III, P.O. Box 4010, Clinton, NJ 08809-4010, has informed FDA that 
it has transferred ownership of, and all rights and interest in, the 
following NADAs and ANADAs to Intervet, Inc., P.O. Box 318, 405 State 
St., Millsboro, DE 19966.

------------------------------------------------------------------------
            NADA Number                          Product Name
------------------------------------------------------------------------
34-478.............................  LASIX Injection
34-621.............................  LASIX Tablets and Boluses
44-759.............................  FLAVOMYCIN Type A
                                      Medicated Article
45-188.............................  LASIX Packets
95-543.............................  AMPROL HI-E/
                                      FLAVOMYCIN
95-547.............................  AMPROL HI-E/
                                      FLAVOMYCIN/3-
                                      NITRO
95-548.............................  AMPROL/3-NITRO/
                                      FLAVOMYCIN
95-549.............................  AMPROL/3-NITRO/
                                      FLAVOMYCIN
98-340.............................  FLAVOMYCIN/Monensin
98-341.............................  FLAVOMYCIN/3-
                                      NITRO/COBAN
101-628............................  FLAVOMYCIN/3-
                                      NITRO/ZOALENE
101-629............................  FLAVOMYCIN/
                                      ZOALENE
102-380............................  LASIX Syrup
104-494............................  PANACUR 10% Suspension
111-278............................  PANACUR Granules 22%
120-648............................  PANACUR/SAFE-
                                      GUARD Paste
121-473............................  PANACUR Granules 22%
128-620............................  PANACUR/SAFE-
                                      GUARD 10% Suspension
130-185............................  FLAVOMYCIN/Amprolium
130-661............................  FLAVOMYCIN/CARB-O-
                                      SEP
130-951............................  STENOROL Type A Medicated
                                      Article
131-310............................  REGU-MATE Solution
131-675............................  SAFE-GUARD Type A
                                      Medicated Article
132-872............................  PANACUR/SAFE-
                                      GUARD 10% Paste
137-483............................  FLAVOMYCIN/
                                      STENOROL
137-600............................  SAFE-GUARD Type A
                                      Medicated Article
138-612............................  FINAPLIX-S;
                                      FINAPLIX-H Implants
139-189............................  SAFE-GUARD ENPROAL
                                      Feedblocks
139-473............................  STENOROL/STAFAC
140-339............................  FLAVOMYCIN/
                                      NICARB
140-340............................  STENOROL/
                                      LINCOMIX
140-533............................  STENOROL/3-
                                      NITRO/BMD
140-584............................  STENOROL/BMD
140-824............................  STENOROL Type A Medicated
                                      Article
140-843............................  MONTEBAN/
                                      FLAVOMYCIN/3-
                                      NITRO
140-845............................  FLAVOMYCIN/
                                      MONTEBAN
140-897............................  REVALOR-S;
                                      REVALOR-G Implants

[[Page 47960]]

 
140-918............................  STENOROL/
                                      FLAVOMYCIN
140-919............................  STENOROL/BMD
140-954............................  SAFE-GUARD Type A/
                                      LINCOMIX
140-992............................  REVALOR-200;
                                      REVALOR-H Implants
141-034............................  GAINPRO Type A Medicated
                                      Article
141-129............................  AVATEC/
                                      FLAVOMYCIN
200-075............................  SACOX Type A Medicated
                                      Article
200-080............................  SACOX/3-NITRO/
                                      FLAVOMYCIN
200-081............................  SACOX/3-NITRO/
                                      BMD
200-082............................  SACOX/BMD
200-083............................  SACOX/
                                      FLAVOMYCIN
200-086............................  SACOX/ALBAC/3-
                                      NITRO
200-089............................  SACOX/BACIFERM
200-090............................  SACOX/LINCOMIX/
                                      3-NITRO
200-091............................  SACOX/3-NITRO/
                                      AUREOMYCIN
200-092............................  SACOX/STAFAC
200-093............................  SACOX/LINCOMIX
200-094............................  SACOX/STAFAC/3-
                                      NITRO
200-095............................  SACOX/
                                      AUREOMYCIN
200-096............................  SACOX/
                                      TERRAMYCIN
200-097............................  SACOX/3-NITRO
200-143............................  SACOX/3-NITRO/
                                      BACIFERM
------------------------------------------------------------------------

    Accordingly, the agency is amending the regulations in 21 CFR 
520.48, 520.905a, 520.905b, 520.905c, 520.905d, 520.905e, 520.1010a, 
520.1010b, 520.1010c, 522.1010, 522.2476, 522.2477, 558.55, 558.58, 
558.95, 558.198, 558.258, 558.265, 558.355, 558.363, 558.366, and 
558.550 to reflect the transfers of ownership. In addition, the 
sections in 21 CFR parts 520 and 522 are being revised to reflect 
current format.
    Following the change of sponsor of these NADAs, Hoechst Roussel Vet 
is no longer the sponsor of any approved applications. Therefore, 21 
CFR 510.600(c) is amended to remove the entries for this sponsor.
    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 and 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, 
520, 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 entry for ``Hoechst Roussel Vet'' and in the 
table in paragraph (c)(2) by removing the entry for ``012799''.

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.
    4. Section 520.48 is revised to read as follows:


Sec. 520.48  Altrenogest solution.

    (a) Specifications. Each milliliter (mL) of solution contains 2.2 
milligrams (mg) altrenogest.
    (b) Sponsor. See No. 057926 in Sec. 510.600(c) of this chapter.
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) Conditions of use--(1) Amount. 1.0 mL per 110 pounds body 
weight (0.044 mg per kilogram) daily for 15 consecutive days.
    (2) Indications for use. For suppression of estrus in mares.
    (3) Limitations. For oral use in horses only; avoid contact with 
the skin. Do not administer to horses intended for use as food.


Sec. 520.905a  [Amended]

    5. Section 520.905a Fenbendazole suspension is amended in paragraph 
(b) by removing ``012799'' and by adding in its place ``057926''.


Sec. 520.905b  [Amended]

    6. Section 520.905b Fenbendazole granules is amended in paragraph 
(b) by removing ``012799'' and by adding in its place ``057926''.


Sec. 520.905c  [Amended]

    7. Section 520.905c Fenbendazole paste is amended in paragraph (b) 
by removing ``012799'' and by adding in its place ``057926''.


Sec. 520.905d  [Amended]

    8. Section 520.905d Fenbendazole powder is amended in paragraph (b) 
by removing ``012799'' and by adding in its place ``057926''.


Sec. 520.905e  [Amended]

    9. Section 520.905e Fenbendazole blocks is amended in paragraph (b) 
by removing ``012799'' and by adding in its place ``057926''.
    10. Section 520.1010 is revised to read as follows:


Sec. 520.1010  Furosemide.

    (a) Specifications. (1) Each tablet contains 12.5 or 50 milligrams 
(mg) furosemide.
    (2) Each bolus contains 2 grams (g) furosemide.
    (3) Each packet of powder contains 2 g furosemide.
    (4) Each milliliter of syrup contains 10 mg furosemide.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter for use of dosage forms and strengths listed in

[[Page 47961]]

paragraph (a) of this section for uses as in paragraph (d) of this 
section.
    (1) No. 000010 for tablets in paragraph (a)(1) of this section for 
conditions of use in paragraphs (d)(2)(i), (d)(2)(ii)(A), and (d)(3) of 
this section.
    (2) No. 000093 for tablets in paragraph (a)(1) of this section for 
conditions of use in paragraphs (d)(2)(i) and (d)(2)(ii)(B) of this 
section.
    (3) No. 057926 for tablets in paragraph (a)(1) of this section for 
conditions of use in paragraphs (d)(2)(i), (d)(2)(ii)(A), and (d)(3) of 
this section; for boluses in paragraph (a)(2) of this section and 
powder in paragraph (a)(3) of this section for conditions of use in 
paragraph (d)(1) of this section; and for syrup in paragraph (a)(4) of 
this section for conditions of use in paragraphs (d)(2)(i) and 
(d)(2)(ii)(A).
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) Conditions of use. It is used as follows:
    (1) Cattle--(i) Amount. 1 to 2 mg per pound (/lb) body weight using 
powder, or one 2-g bolus per animal, per day.
    (ii) Indications for use. For treatment of physiological parturient 
edema of the mammary gland and associated structures.
    (iii) Limitations. Treatment not to exceed 48 hours post-
parturition. Milk taken during treatment and for 48 hours after the 
last treatment must not be used for food. Cattle must not be 
slaughtered for food within 48 hours following last treatment.
    (2) Dogs--(i) Amount. 1 to 2 mg/lb body weight, once or twice 
daily.
    (ii) Indications for use--(A) For treatment of edema (pulmonary 
congestion, ascites) associated with cardiac insufficiency and acute 
noninflammatory tissue edema.
    (B) For treatment of edema (pulmonary congestion, ascites) 
associated with cardiac insufficiency.
    (3) Cats--(i) Amount. 1 to 2 mg/lb body weight, once or twice 
daily.
    (ii) Indications for use. For treatment of edema (pulmonary 
congestion, ascites) associated with cardiac insufficiency and acute 
noninflammatory tissue edema.


Sec. 520.1010a  [Removed]

    11. Section 520.1010a Furosemide tablets or boluses is removed.


Sec. 520.1010b  [Removed]

    12. Section 520.1010b Furosemide powder is removed.


Sec. 520.1010c  [Removed]

    13. Section 520.1010c Furosemide syrup is removed.

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

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

    Authority: 21 U.S.C. 360b.
    15. Section 522.1010 is revised to read as follows:


Sec. 522.1010  Furosemide.

    (a) Specifications. Each milliliter of solution contains 50 
milligrams (mg) of furosemide diethanolamine.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (d) of this section.
    (1) No. 000010 for use as in paragraphs (d)(1) and (d)(2)(ii) of 
this section.
    (2) No. 000864 for use as in paragraph (d)(2)(ii) of this section.
    (3) No. 057926 for use as in paragraphs (d)(1), (d)(2)(i), and 
(d)(3) of this section.
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) Conditions of use--(1) Dogs and cats--(i) Amount. 1.25 to 2.5 
mg per pound (/lb) body weight once or twice daily, intramuscularly or 
intravenously.
    (ii) Indications for use. For the treatment of edema (pulmonary 
congestion, ascites) associated with cardiac insufficiency and acute 
noninflammatory tissue edema.
    (2) Horses--(i) Amount. 250 to 500 mg per animal once or twice 
daily, intramuscularly or intravenously.
    (A) Indications for use. For the treatment of edema (pulmonary 
congestion, ascites) associated with cardiac insufficiency, and acute 
noninflammatory tissue edema.
    (B) Limitations. Do not use in horses intended for food.
    (ii) Amount. 0.5 mg/lb body weight once or twice daily, 
intramuscularly or intravenously.
    (A) Indications for use. For treatment of acute noninflammatory 
tissue edema.
    (B) Limitations. Do not use in horses intended for food.
    (3) Cattle--(i) Amount. 500 mg/animal once daily, intramuscularly 
or intravenously; or 250 mg/animal twice daily at 12-hour intervals, 
intramuscularly or intravenously.
    (ii) Indications for use. For the treatment of physiological 
parturient edema of the mammary gland and associated structures.
    (iii) Limitations. Treatment not to exceed 48 hours post-
parturition. Milk taken during treatment and for 48 hours (four 
milkings) after the last treatment must not be used for food. Cattle 
must not be slaughtered for food within 48 hours following last 
treatment.
    16. Section 522.2476 is revised to read as follows:


Sec. 522.2476  Trenbolone acetate.

    (a) [Reserved]
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (d) of this section.
    (1) No. 021641 for use as in paragraphs (d)(1) and (d)(2) of this 
section.
    (2) No. 057926 for use as in paragraphs (d)(1)(i)(A), (d)(1)(ii), 
(d)(1)(iii), (d)(2)(i)(A), (d)(2)(ii), and (d)(2)(iii) of this section.
    (c) Related tolerances. See Sec. 556.739 of this chapter.
    (d) Conditions of use--(1) Steers fed in confinement for 
slaughter--(i) Amount. Use 126 days prior to slaughter; should be 
reimplanted once after 63 days.
    (A) 140 milligrams (mg) trenbolone acetate (one implant consisting 
of 7 pellets, each pellet containing 20 mg trenbolone acetate) per 
implant dose.
    (B) 140 mg trenbolone acetate (one implant consisting of 8 pellets, 
each of 7 pellets containing 20 milligrams trenbolone acetate, and 1 
pellet containing 29 mg tylosin tartrate) per implant dose.
    (ii) Indications for use. For improved feed efficiency.
    (iii) Limitations. Implant subcutaneously in ear only. Do not use 
in animals intended for subsequent breeding or in dairy animals.
    (2) Heifers fed in confinement for slaughter--(i) Amount. Use last 
63 days prior to slaughter.
    (A) 200 mg trenbolone acetate (one implant consisting of 10 
pellets, each pellet containing 20 mg trenbolone acetate) per implant 
dose.
    (B) 200 mg of trenbolone acetate (one implant consisting of 11 
pellets, each of 10 pellets containing 20 mg of trenbolone acetate, and 
1 pellet containing 29 mg of tylosin tartrate) per implant dose.
    (ii) Indications for use. For increased rate of weight gain and 
improved feed efficiency.
    (iii) Limitations. Implant subcutaneously in ear only. Do not use 
in animals intended for subsequent breeding or in dairy animals.
    17. Section 522.2477 is amended by revising paragraph (b) to read 
as follows:


Sec. 522.2477  Trenbolone acetate and estradiol.

* * * * *
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
uses as in paragraph (d) of this section.
    (1) No. 021641 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(B),

[[Page 47962]]

(d)(1)(ii), (d)(1)(iii), and (d)(3) of this section.
    (2) No. 057926 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(C), 
(d)(1)(i)(D), (d)(1)(ii), (d)(1)(iii), (d)(2), (d)(3)(i)(A), 
(d)(3)(ii), and (d)(3)(iii) of this section.
* * * * *

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

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

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


Sec. 558.55  [Amended]

    19. Section 558.55 Amprolium is amended in the table in paragraphs 
(d)(2)(iii) by removing ``012799'' wherever it appears under the 
``Limitations'' and ``Sponsor'' columns and by adding in its place 
``057926''.


Sec. 558.58  [Amended]

    20. Section 558.58 Amprolium and ethopabate is amended in the table 
in paragraphs (d)(1)(ii) and (d)(1)(iii) by removing ``012799'' 
wherever it appears in the ``Limitations'' column and by adding in its 
place ``057926''.


Sec. 558.95  [Amended]

    21. Section 558.95 Bambermycins is amended in paragraphs (a)(1), 
(a)(2), (a)(5), (d)(1)(vi)(b), and (d)(1)(vii)(b) by removing 
``012799'' and by adding in its place ``057926''; and in paragraphs 
(d)(1)(xi)(b), and (d)(1)(xii)(b) by removing ``012799 and 046573'' and 
by adding in its place ``046573 and 057926''.


Sec. 558.198  [Amended]

    22. Section 558.198 Diclazuril is amended in the table in 
paragraphs (d)(1)(iii) by removing ``012799'' under the ``Limitations'' 
column and by adding in its place ``057926.''


Sec. 558.258  [Amended]

    23. Section 558.258 Fenbendazoleis amended in paragraph (a) by 
removing ``012799'' and by adding in its place ``057926''.


Sec. 558.265  [Amended]

    24. Section 558.265 Halofuginone hydrobromide is amended in 
paragraph (a) by removing ``012799'' and by adding in its place 
``057926''.


Sec. 558.355  [Amended]

    25. Section 558.355 Monensin is amended in paragraphs (b)(10), 
(f)(2)(v)(b), and (f)(2)(vi)(b) by removing ``012799'' and by adding in 
its place ``057926''.


Sec. 558.363  [Amended]

    26. Section 558.363 Narasin is amended in paragraphs (a)(4), 
(a)(5), (d)(1)(vii)(B), and (d)(1)(xii)(B) by removing ``012799'' and 
by adding in its place ``057926''.


Sec. 558.366  [Amended]

    27. Section 558.366 Nicarbazin is amended in the table in paragraph 
(c) in the entry for ``Bambermycins 1 to 2'' under the ``Sponsor'' 
column by removing ``012799'' and by adding in its place ``057926''.


Sec. 558.550  [Amended]

    28. Section 558.550 Salinomycin is amended in paragraph (a)(2) by 
removing ``012799'' and by adding in its place ``057926''; and in 
paragraphs (d)(1)(xv)(c) and (d)(1)(xvi)(c) by removing ``012799 and 
046573'' and by adding in its place ``046573 and 057926''.

    Dated: August 31, 2001.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 01-23043 Filed 9-14-01; 8:45 am]
BILLING CODE 4160-01-S