Implantation or Injectable Dosage Form New Animal Drugs; Penicillin G Procaine Aqueous Suspension, 14177 [E8-5217]

Download as PDF Federal Register / Vol. 73, No. 52 / Monday, March 17, 2008 / Rules and Regulations Chapter I, Title 18, Code of Federal Regulations, as follows: Commission certifies that this Final Rule will not have a significant economic impact on a substantial number of small entities. VI. Document Availability 33. In addition to publishing the full text of this document in the Federal Register, the Commission provides all interested persons an opportunity to obtain this document via the Internet through the Commission’s Home Page (https://www.ferc.gov) and from its Public Reference Room during normal business hours (8:30 a.m. to 5 p.m. Eastern time) at 888 First Street, NE., Room 2A, Washington, DC 20426. 34. From the Commission’s Home Page on the Internet, the full text of this document is available in the Commission’s document management system, eLibrary, in PDF and Microsoft Word format for viewing, printing, and downloading. To access this document in eLibrary, type the docket number (excluding the last three digits of the docket number), in the Docket Number field. 35. User assistance is available for eLibrary and the Commission’s Web site during normal business hours. For assistance, please contact FERC Online Support at (202) 502–6652 (toll-free at 1–866–208–3676), e-mail ferconlinesupport@ferc.gov, or contact the Public Reference Room at (202) 502– 8371, TTY (202) 502–8659, e-mail: public.referenceroom@ferc.gov. VII. Effective Date and Congressional Notification 36. These changes in the regulations are effective April 16, 2008. The Commission has determined, with the concurrence of the Administrator of the Office of Information and Regulatory Affairs of OMB that this rule is not a ‘‘major rule’’ as defined in section 351 of the Small Business Regulatory Enforcement Fairness Act of 1996.21 List of Subjects 18 CFR Part 141 Electric power, Reporting and recordkeeping requirements. jlentini on PROD1PC65 with RULES 18 CFR Part 385 Administrative practice and procedure, Electric power, Penalties, Pipelines, Reporting and recordkeeping requirements. By the Commission. Kimberly D. Bose, Secretary. In consideration of the foregoing, the Commission amends parts 141 and 385, I 21 5 U.S.C. 804(2). VerDate Aug<31>2005 16:00 Mar 14, 2008 Jkt 214001 PART 141—STATEMENTS AND REPORTS (SCHEDULES) 1. The authority citation for part 141 continues to read as follows: I Authority: 15 U.S.C. 79; 16 U.S.C. 791a– 828c, 2601–2645; 31 U.S.C. 9701; 42 U.S.C. 7101–7352. § 141.61 [Removed and Reserved] 2. Section 141.61 is removed and reserved: I PART 385—RULES OF PRACTICE AND PROCEDURE 3. The authority citation for part 385 continues to read as follows: I Authority: 5 U.S.C. 551–557; 15 U.S.C. 717–717z, 3301–3432; 16 U.S.C. 791a–825v, 2601–2645; 28 U.S.C. 2461; 31 U.S.C. 3701, 9701; 42 U.S.C. 7101–7352, 16441, 16451– 16463; 49 U.S.C. 60502; 49 App. U.S.C. 1–85 (1988). § 385.2011 [Amended] 4. Section 385.2011, paragraph (a)(8) is removed and reserved. I [FR Doc. E8–5251 Filed 3–14–08; 8:45 am] BILLING CODE 6717–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 14177 IVX Animal Health, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503, filed a supplement to NADA 65–110 for PENG MAX (penicillin G procaine) Aqueous Suspension used for the treatment of animal diseases associated with several bacterial pathogens. The supplemental NADA provides for changing a pathogen name from Erysipelothrix insidiosato Erysipelothrix rhusiopathiae on product labeling. The supplemental NADA is approved as of February 12, 2008, and the regulations are amended in 21 CFR 522.1696b 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(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. SUPPLEMENTARY INFORMATION: List of Subjects in 21 CFR Part 522 Animal drugs. 21 CFR Part 522 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 supplemental new animal drug application (NADA) filed by IVX Animal Health, Inc. The supplemental NADA provides for changing scientific nomenclature for a swine pathogen on labeling for penicillin G procaine aqueous suspension. DATES: This rule is effective March 17, 2008. FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for Veterinary Medicine (HFV–130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276– 8341, e-mail: cindy.burnsteel@fda.hhs.gov. PO 00000 Frm 00025 Fmt 4700 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: I Implantation or Injectable Dosage Form New Animal Drugs; Penicillin G Procaine Aqueous Suspension Sfmt 4700 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. § 522.1696b [Amended] 2. In § 522.1696b, in paragraph (d)(2)(ii), remove ‘‘Erysipelothrix insidiosa’’ and add in its place ‘‘Erysipelothrix rhusiopathiae’’. I Dated: March 6, 2008. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. E8–5217 Filed 3–14–08; 8:45 am] BILLING CODE 4160–01–S E:\FR\FM\17MRR1.SGM 17MRR1

Agencies

[Federal Register Volume 73, Number 52 (Monday, March 17, 2008)]
[Rules and Regulations]
[Page 14177]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-5217]


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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; 
Penicillin G Procaine Aqueous Suspension

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 IVX Animal Health, Inc. The supplemental 
NADA provides for changing scientific nomenclature for a swine pathogen 
on labeling for penicillin G procaine aqueous suspension.

DATES: This rule is effective March 17, 2008.

FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8341, e-mail: 
cindy.burnsteel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: IVX Animal Health, Inc., 3915 South 48th 
Street Ter., St. Joseph, MO 64503, filed a supplement to NADA 65-110 
for PEN-G MAX (penicillin G procaine) Aqueous Suspension used for the 
treatment of animal diseases associated with several bacterial 
pathogens. The supplemental NADA provides for changing a pathogen name 
from Erysipelothrix insidiosato Erysipelothrix rhusiopathiae on product 
labeling. The supplemental NADA is approved as of February 12, 2008, 
and the regulations are amended in 21 CFR 522.1696b 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(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 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.  522.1696b  [Amended]

0
2. In Sec.  522.1696b, in paragraph (d)(2)(ii), remove ``Erysipelothrix 
insidiosa'' and add in its place ``Erysipelothrix rhusiopathiae''.

    Dated: March 6, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-5217 Filed 3-14-08; 8:45 am]
BILLING CODE 4160-01-S

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