Intramammary Dosage Forms; Cephapirin Benzathine, 12262 [E8-4473]

Download as PDF 12262 Federal Register / Vol. 73, No. 46 / Friday, March 7, 2008 / Rules and Regulations areas south of the United States must land for CBP processing. same line, in the ‘‘Name’’ column, ‘‘San Antonio International Airport.’’ Authority Dated: March 3, 2008. Michael Chertoff, Secretary. [FR Doc. E8–4578 Filed 3–6–08; 8:45 am] This change is made under the authority of 5 U.S.C. 301, 19 U.S.C. 1433, 1644a, 1624, and 6 U.S.C. 203. BILLING CODE 9111–14–P The Regulatory Flexibility Act and Executive Order 12866 This amendment expands the list of designated airports at which certain aircraft may land for customs processing. As described in this document, certain international flights have been arriving at SAT, pursuant to statute, from November 2000, through November 9, 2006. The expansion of the list of designated airports to include SAT will not result in any new impact on affected parties but will result in a continuation of the previous situation. Therefore, CBP certifies that this rule will not have significant economic impact on a substantial number of small entities. Accordingly, the document is not subject to the regulatory analysis or other requirements of 5 U.S.C. 603 and 604 of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). The Office of Management and Budget has determined that this rule is not a significant regulatory action as defined under Executive Order 12866. Signing Authority This amendment to the regulations is being issued in accordance with 19 CFR 0.2(a) pertaining to the authority of the Secretary of Homeland Security (or his or her delegate) to prescribe regulations not related to customs revenue functions. List of Subjects in 19 CFR Part 122 Air carriers, Aircraft, Airports, Customs duties and inspection, Freight. Amendments to Regulations Part 122, Code of Federal Regulations (19 CFR part 122) is amended as set forth below: I PART 122—AIR COMMERCE REGULATIONS 1. The authority citation for part 122, 19 CFR, continues to read as follows: I Authority: 5 U.S.C. 301; 19 U.S.C. 58b, 66, 1431, 1433, 1436, 1448, 1459, 1590, 1594, 1623, 1624, 1644, 1644a, 2071 note. jlentini on PROD1PC65 with RULES * * § 122.24 * * * [Amended] 2. In § 122.24(b) the chart is amended by adding to the list of airports, in alphabetical order in the ‘‘Location’’ column, ‘‘San Antonio Tex’’ and on the I VerDate Aug<31>2005 17:51 Mar 06, 2008 Jkt 214001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 526 Intramammary Dosage Forms; Cephapirin Benzathine AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. Frm 00002 Fmt 4700 List of Subjects in 21 CFR Part 526 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 526 is amended as follows: PART 526—INTRAMAMMARY DOSAGE FORMS 1. The authority citation for 21 CFR part 526 continues to read as follows: I 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 Fort Dodge Animal Health, Division of Wyeth. The supplemental NADA provides for a revision to the labeling of cephapirin benzathine intramammary infusion administered to dairy cows entering their dry period for the treatment of mastitis. DATES: This rule is effective March 7, 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: Fort Dodge Animal Health, Division of Wyeth, 800 Fifth St. NW., Fort Dodge, IA 50501, filed a supplement to NADA 108–114 that revises labeling of CEFADRI (cephapirin benzathine) Intramammary Infusion administered to dairy cows entering their dry period for the treatment of mastitis. The application is approved as of February 7, 2008, and the regulations are amended in 21 CFR 526.363 to reflect the approval, an editorial change, and a current format. 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, SUMMARY: PO 00000 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. Sfmt 4700 Authority: 21 U.S.C. 360b. § 526.363 [Amended] 2. In § 526.363, at the end of paragraph (d)(2), add ‘‘, including penicillin-resistant strains’’; and in the second sentence of paragraph (d)(3), remove ‘‘use’’ and add in its place ‘‘used’’. I Dated: February 27, 2008. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. E8–4473 Filed 3–6–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 600 [Docket No. FDA–2008–N–0135] (formerly Docket No. 2007N–0284] Revision of the Requirements for Live Vaccine Processing; Confirmation of Effective Date AGENCY: Food and Drug Administration, HHS. Direct final rule; confirmation of effective date. ACTION: SUMMARY: The Food and Drug Administration (FDA) is confirming the effective date of March 18, 2008, for the direct final rule that appeared in the Federal Register of October 18, 2007 (72 FR 59000). The direct final rule amends the biologics regulations by providing options to the existing requirements for the processing of live vaccines. This document confirms the effective date of the direct final rule. E:\FR\FM\07MRR1.SGM 07MRR1

Agencies

[Federal Register Volume 73, Number 46 (Friday, March 7, 2008)]
[Rules and Regulations]
[Page 12262]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-4473]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 526


Intramammary Dosage Forms; Cephapirin Benzathine

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 Fort Dodge Animal Health, Division of 
Wyeth. The supplemental NADA provides for a revision to the labeling of 
cephapirin benzathine intramammary infusion administered to dairy cows 
entering their dry period for the treatment of mastitis.

DATES: This rule is effective March 7, 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: Fort Dodge Animal Health, Division of Wyeth, 
800 Fifth St. NW., Fort Dodge, IA 50501, filed a supplement to NADA 
108-114 that revises labeling of CEFA-DRI (cephapirin benzathine) 
Intramammary Infusion administered to dairy cows entering their dry 
period for the treatment of mastitis. The application is approved as of 
February 7, 2008, and the regulations are amended in 21 CFR 526.363 to 
reflect the approval, an editorial change, and a current format.
    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 526

    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 526 is 
amended as follows:

PART 526--INTRAMAMMARY DOSAGE FORMS

0
1. The authority citation for 21 CFR part 526 continues to read as 
follows:

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


Sec.  526.363  [Amended]

0
2. In Sec.  526.363, at the end of paragraph (d)(2), add ``, including 
penicillin-resistant strains''; and in the second sentence of paragraph 
(d)(3), remove ``use'' and add in its place ``used''.

    Dated: February 27, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-4473 Filed 3-6-08; 8:45 am]
BILLING CODE 4160-01-S

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