Oral Dosage Form New Animal Drugs; Phenylbutazone Paste, 60550 [E7-21054]

Download as PDF 60550 Federal Register / Vol. 72, No. 206 / Thursday, October 25, 2007 / Rules and Regulations § 1301.56 Final determination. The General Counsel makes the final determination whether a demand for testimony or production of records or official testimony in a legal proceeding in which TVA is not a party shall be granted. All final determinations are within the sole discretion of the General Counsel. The General Counsel will notify the requesting party and, when necessary, the court or other authority of the final determination, the reasons for the grant or denial of the request, and any conditions that the General Counsel may impose on the production of testimony or records or official information. § 1301.57 Waiver. The General Counsel may grant a waiver of any procedure described by this part where a waiver is considered necessary to promote a significant interest of TVA or the United States, or for other good cause. Maureen H. Dunn, General Counsel. [FR Doc. E7–20907 Filed 10–24–07; 8:45 am] BILLING CODE 8120–08–P DEPARTMENT OF HEALTH AND HUMAN SERVICES supplement to NADA 140–958 that provides for use of EQUIPHEN (phenylbutazone) Paste in horses for relief of inflammatory conditions associated with the musculoskeletal system. The supplemental NADA provides for a revised human food safety warning on product labeling. The supplemental NADA is approved as of September 26, 2007, and the regulations are amended in 21 CFR 520.1720c 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. 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 Food and Drug Administration Animal drugs. 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Phenylbutazone Paste AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. 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 Luitpold Pharmaceuticals, Inc. The supplemental NADA provides for a revised human food safety warning for phenylbutazone paste, used in horses for relief of inflammatory conditions associated with the musculoskeletal system. DATES: This rule is effective October 25, 2007. 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: Luitpold Pharmaceuticals, Inc., Animal Health Division, Shirley, NY 11967, filed a rwilkins on PROD1PC63 with RULES SUMMARY: VerDate Aug<31>2005 18:00 Oct 24, 2007 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: I Jkt 214001 PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: I Authority: 21 U.S.C. 360b. § 520.1720c [Amended] 2. In § 520.1720c, in paragraph (c)(3), remove ‘‘Not for use in horses intended for food.’’ and add in its place ‘‘Do not use in horses intended for human consumption.’’ I Dated: October 17, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7–21054 Filed 10–24–07; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Spinosad AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Elanco Animal Health. The NADA provides for veterinary prescription use of spinosad chewable tablets to kill fleas and for the prevention and treatment of flea infestations on dogs for 1 month. DATES: This rule is effective October 25, 2007. 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: Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed NADA 141–277 that provides for veterinary prescription use of COMFORTIS (spinosad) Chewable Tablets to kill fleas and for the prevention and treatment of flea infestations (Ctenocephalides felis) on dogs for 1 month. The NADA is approved as of September 25, 2007, and the regulations in 21 CFR part 520 are amended by adding § 520.2130 to reflect the approval. In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 5 years of marketing exclusivity beginning on the date of approval. FDA 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, E:\FR\FM\25OCR1.SGM 25OCR1

Agencies

[Federal Register Volume 72, Number 206 (Thursday, October 25, 2007)]
[Rules and Regulations]
[Page 60550]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-21054]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Phenylbutazone Paste

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 Luitpold Pharmaceuticals, Inc. The 
supplemental NADA provides for a revised human food safety warning for 
phenylbutazone paste, used in horses for relief of inflammatory 
conditions associated with the musculoskeletal system.

DATES: This rule is effective October 25, 2007.

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: Luitpold Pharmaceuticals, Inc., Animal 
Health Division, Shirley, NY 11967, filed a supplement to NADA 140-958 
that provides for use of EQUIPHEN (phenylbutazone) Paste in horses for 
relief of inflammatory conditions associated with the musculoskeletal 
system. The supplemental NADA provides for a revised human food safety 
warning on product labeling. The supplemental NADA is approved as of 
September 26, 2007, and the regulations are amended in 21 CFR 520.1720c 
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.
    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.

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 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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


Sec.  520.1720c  [Amended]

0
2. In Sec.  520.1720c, in paragraph (c)(3), remove ``Not for use in 
horses intended for food.'' and add in its place ``Do not use in horses 
intended for human consumption.''

    Dated: October 17, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-21054 Filed 10-24-07; 8:45 am]
BILLING CODE 4160-01-S

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