Implantation or Injectable Dosage Form New Animal Drugs; Hyaluronate Sodium Injection, 39204 [E6-10879]

Download as PDF 39204 Federal Register / Vol. 71, No. 133 / Wednesday, July 12, 2006 / Rules and Regulations Approval of this supplemental ANADA did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required. FDA has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. 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 in 21 CFR Part 520 Animal drugs. I 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 part 520 is amended as follows: Authority: 21 U.S.C. 360b. 2. In § 520.446, revise paragraphs (b)(1) and (b)(2); remove paragraph (c); redesignate paragraph (d) as paragraph (c); and revise newly redesignated paragraph (c) to read as follows: I Clindamycin capsules and wwhite on PROD1PC61 with RULES * * * * (b) * * * (1) Nos. 000009 and 059130 for use of capsules described in paragraph (a)(1) of this section. (2) No. 051311 for use of tablets described in paragraph (a)(2) of this section. (c) Conditions of use in dogs—(1) Amount. Wounds, abscesses, and dental infections: 2.5 to 15 mg per pound (/lb) body weight every 12 hours for a maximum of 28 days. Osteomyelitis: 5.0 to 15 mg/lb body weight every 12 hours for a minimum of 28 days. (2) Indications for use. For the treatment of skin infections (wounds and abscesses) due to susceptible strains of coagulase-positive staphylococci (Staphylococcus aureus or S. intermedius), deep wounds and abscesses due to susceptible strains of Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum, and Clostridium perfringens, dental infections due to 16:27 Jul 11, 2006 Jkt 208001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; Hyaluronate Sodium Injection ACTION: 1. The authority citation for 21 CFR part 520 continues to read as follows: VerDate Aug<31>2005 BILLING CODE 4160–01–S Food and Drug Administration, HHS. I * Dated: June 27, 2006. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. E6–10877 Filed 7–11–06; 8:45 am] AGENCY: PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS § 520.446 tablets. susceptible strains of S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens, and osteomyelitis due to susceptible strains of S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The supplemental NADA provides for a revised food safety warning on labeling for hyaluronate sodium injectable solution. DATES: This rule is effective July 12, 2006. FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for Veterinary Medicine (HFV–110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–7540, email: melanie.berson@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., a Division of Pfizer, Inc., 235 East 42d St., New York, NY 10017, filed a supplement to NADA 112–048 for HYLARTIN (sodium hyaluronate) Injection, approved for veterinary prescription use by intra-articular injection for the treatment of joint dysfunction in horses due to noninfectious synovitis associated with equine osteoarthritis. The supplemental NADA provides for a revised food safety warning on the labeling. The application is approved as of May 30, 2006, and the regulations are amended in 21 CFR 522.1145 to reflect the approval. PO 00000 Frm 00002 Fmt 4700 Sfmt 4700 Approval of this supplemental NADA did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required. The agency has determined under 21 CFR 25.33(d)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. 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 in 21 CFR Part 522 Animal drugs. I 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 part 522 is amended as follows: PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 522 continues to read as follows: I Authority: 21 U.S.C. 360b. § 522.1145 [Amended] 2. In § 522.1145, in the heading remove the word ‘‘injection’’; and in paragraph (a)(3)(iii) remove the sentence ‘‘Not for use in horses intended for food.’’ and add in its place ‘‘Do not use in horses intended for human consumption’’. I Dated: June 27, 2006. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. E6–10879 Filed 7–11–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds; Melengestrol, Lasalocid, and Tylosin AGENCY: Food and Drug Administration, HHS. ACTION: E:\FR\FM\12JYR1.SGM Final rule. 12JYR1

Agencies

[Federal Register Volume 71, Number 133 (Wednesday, July 12, 2006)]
[Rules and Regulations]
[Page 39204]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-10879]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Hyaluronate Sodium Injection

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 reflect approval of a supplemental new animal drug 
application (NADA) filed by Pharmacia & Upjohn Co., a Division of 
Pfizer, Inc. The supplemental NADA provides for a revised food safety 
warning on labeling for hyaluronate sodium injectable solution.

DATES: This rule is effective July 12, 2006.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail: 
melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., a Division of 
Pfizer, Inc., 235 East 42d St., New York, NY 10017, filed a supplement 
to NADA 112-048 for HYLARTIN (sodium hyaluronate) Injection, approved 
for veterinary prescription use by intra-articular injection for the 
treatment of joint dysfunction in horses due to noninfectious synovitis 
associated with equine osteoarthritis. The supplemental NADA provides 
for a revised food safety warning on the labeling. The application is 
approved as of May 30, 2006, and the regulations are amended in 21 CFR 
522.1145 to reflect the approval.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    The agency has determined under 21 CFR 25.33(d)(1) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.
    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 in 21 CFR Part 522

    Animal drugs.

0
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 part 522 is 
amended as follows:

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

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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


Sec.  522.1145  [Amended]

0
2. In Sec.  522.1145, in the heading remove the word ``injection''; and 
in paragraph (a)(3)(iii) remove the sentence ``Not for use in horses 
intended for food.'' and add in its place ``Do not use in horses 
intended for human consumption''.

    Dated: June 27, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E6-10879 Filed 7-11-06; 8:45 am]
BILLING CODE 4160-01-S

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