Implantation or Injectable Dosage Form New Animal Drugs; Tilmicosin, 9333-9334 [2010-4206]

Download as PDF Federal Register / Vol. 75, No. 40 / Tuesday, March 2, 2010 / Rules and Regulations absence of extraordinary circumstances. The FAA has determined this rulemaking action qualifies for the categorical exclusion identified in paragraph 312f and involves no extraordinary circumstances. Regulations That Significantly Affect Energy, Supply, Distribution, or Use The FAA has analyzed this NPRM under Executive Order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (May 18, 2001). We have determined that it is not a ‘‘significant energy action’’ under the executive order because it is not a ‘‘significant regulatory action’’ under Executive Order 12866, and it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. WReier-Aviles on DSKGBLS3C1PROD with RULES Availability of Rulemaking Documents You can get an electronic copy of rulemaking documents using the Internet by— 1. Searching the Federal eRulemaking Portal (https://www.regulations.gov); 2. Visiting the FAA’s Regulations and Policies Web page at https:// www.faa.gov/regulations_policies/ or 3. Accessing the Government Printing Office’s Web page at https:// www.gpoaccess.gov/fr/. You can also get a copy by sending a request to the Federal Aviation Administration, Office of Rulemaking, ARM–1, 800 Independence Avenue, SW., Washington, DC 20591, or by calling (202) 267–9680. Make sure to identify the amendment number or docket number of this rulemaking. You may search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT’s complete Privacy Act statement in the Federal Register published on April 11, 2000 (Volume 65, Number 70; Pages 19477– 78) or you may visit https:// DocketsInfo.dot.gov. Small Business Regulatory Enforcement Fairness Act The Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996 requires FAA to comply with small entity requests for information or advice about compliance with statutes and regulations within its jurisdiction. If you are a small entity and you have a question regarding this document, you may contact your local FAA official, or the person listed under the FOR FURTHER INFORMATION CONTACT heading at the VerDate Nov<24>2008 14:52 Mar 01, 2010 Jkt 220001 beginning of the preamble. You can find out more about SBREFA on the Internet at https://www.faa.gov/ regulations_policies/rulemaking/ sbre_act/. List of Subjects in 14 CFR part 91 Aircraft, Noise control, Reporting and recordkeeping requirements. The Amendment PART 91—GENERAL OPERATING AND FLIGHT RULES 1. The authority citation for part 91 continues to read as follows: ■ Authority: 49 U.S.C. 106(g), 1155, 40103, 40113, 40120, 44101, 44111, 44701, 44709, 44711, 44712, 44715, 44716, 44717, 44722, 46306, 46315, 46316, 46504, 46506, 46507, 47122, 47508, 47528–47531, articles 12 and 29 of the Convention on International Civil Aviation (61 stat 1180). 2. Amend § 91.703 by adding paragraph (a)(5) to read as follows: ■ § 91.703 Operations of civil aircraft of U.S. registry outside of the United States. (a) * * * (5) For aircraft subject to ICAO Annex 16, carry on board the aircraft documents that summarize the noise operating characteristics and certifications of the aircraft that demonstrate compliance with this part and part 36 of this chapter. * * * * * Issued in Washington, DC, on February 18, 2010. J. Randolph Babbitt, Administrator. [FR Doc. 2010–4316 Filed 3–1–10; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 [Docket No. FDA–2010–N–0002] Implantation or Injectable Dosage Form New Animal Drugs; Tilmicosin 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 PO 00000 Frm 00007 Fmt 4700 drug application (NADA) filed by Elanco Animal Health, A Division of Eli Lilly & Co. The supplemental NADA provides a dose range for use of an injectable solution of tilmicosin phosphate for treatment of respiratory disease in cattle and additional pathogens for which this therapy is effective. DATES: In consideration of the foregoing, the Federal Aviation Administration amends Chapter 1 of Title 14, Code of Federal Regulations, as follows: ■ Sfmt 4700 9333 This rule is effective March 2, 2010. 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. Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a supplement to NADA 140–929 for MICOTIL 300 (tilmicosin injection, USP) Injection, available by veterinary prescription for use in the treatment and control of respiratory disease in cattle and the treatment of respiratory disease in sheep. The supplemental NADA establishes a dose range and adds pathogens for which this therapy is effective in the management of bovine respiratory disease. As a consequence of revising the dosage, the preslaughter withdrawal period has been recalculated. The supplemental NADA is approved as of December 30, 2009, and the regulations in 21 CFR 522.2471 are amended 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)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval qualifies for 3 years of marketing exclusivity beginning on the date of approval. The agency has determined under 21 CFR 25.33 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 SUPPLEMENTARY INFORMATION: E:\FR\FM\02MRR1.SGM 02MRR1 9334 Federal Register / Vol. 75, No. 40 / Tuesday, March 2, 2010 / Rules and Regulations 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. ■ 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: ■ Authority: 21 U.S.C. 360b. 2. In § 522.2471, revise paragraphs (e)(1)(i), (e)(1)(ii), and (e)(1)(iii) to read as follows: ■ § 522.2471 Tilmicosin. * * * * * (e) * * * (1) * * * (i) Amount. 10 to 20 milligrams per kilograms (mg/kg) of body weight as a single subcutaneous injection. (ii) Indications for use. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni. For the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica. (iii) Limitations. Do not use in female dairy cattle 20 months of age or older. Use of this antibiotic in this class of cattle may cause milk residues. Do not slaughter within 42 days of last treatment. * * * * * Dated: February 16, 2010. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 2010–4206 Filed 3–1–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES WReier-Aviles on DSKGBLS3C1PROD with RULES Food and Drug Administration [Docket No. FDA–2010–N–0002] Food and Drug Administration, HHS. 14:52 Mar 01, 2010 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 ADM Alliance Nutrition, Inc. The supplemental NADA provides for use of a higher concentration chlortetracycline Type A medicated article for the manufacture of medicated feeds for livestock and poultry. DATES: This rule is effective March 2, 2010. 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. ADM Alliance Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305–3115, filed a supplement to NADA 48–480 that provides for the use of CHLORATET 50 (chlortetracycline), a Type A medicated article containing 50 grams of chlortetracycline per pound, for the manufacture of medicated feeds for livestock and poultry. The supplement provides for use of Type A medicated articles containing 90 or 100 grams of chlortetracycline per pound. The supplemental NADA is approved as of January 7, 2010, and the regulations are amended in 21 CFR 558.128 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 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. Jkt 220001 PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 1. The authority citation for 21 CFR part 558 continues to read as follows: ■ Authority: 21 U.S.C. 360b, 371. 2. In § 558.128, revise paragraph (b)(2) to read as follows: ■ § 558.128 Chlortetracycline. * * * * * (b) * * * (2) No. 012286: 50, 90, or 100 grams per pound of Type A medicated article. * * * * * Dated: February 16, 2010. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 2010–4205 Filed 3–1–10; 8:45 am] BILLING CODE 4160–01–S SUPPLEMENTARY INFORMATION: 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 part 558 is amended as follows: ■ New Animal Drugs for Use in Animal Feeds; Chlortetracycline VerDate Nov<24>2008 Final rule. List of Subject in 21 CFR Part 558 21 CFR Part 558 AGENCY: ACTION: PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 DEPARTMENT OF LABOR Employee Benefits Security Administration 29 CFR Part 2520 RIN 1210–AB21 Multiemployer Pension Plan Information Made Available on Request AGENCY: Employee Benefits Security Administration, Labor. ACTION: Final rule. SUMMARY: This document contains a final rule implementing section 101(k) of the Employee Retirement Income Security Act of 1974, as amended by the Pension Protection Act of 2006. Section 101(k) requires the administrator of a multiemployer plan to provide copies of certain actuarial and financial documents about the plan to participants, beneficiaries, employee representatives and contributing employers upon request. The final rule affects plan administrators, participants and beneficiaries and contributing employers of multiemployer plans. DATES: This final rule is effective on April 1, 2010. FOR FURTHER INFORMATION CONTACT: June Solonsky or Stephanie L. Ward, Office of Regulations and Interpretations, Employee Benefits Security Administration, (202) 693–8500. This is not a toll-free number. SUPPLEMENTARY INFORMATION: A. Background Section 101(k) of the Employee Retirement Income Security Act E:\FR\FM\02MRR1.SGM 02MRR1

Agencies

[Federal Register Volume 75, Number 40 (Tuesday, March 2, 2010)]
[Rules and Regulations]
[Pages 9333-9334]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-4206]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2010-N-0002]


Implantation or Injectable Dosage Form New Animal Drugs; 
Tilmicosin

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 Elanco Animal Health, A Division of Eli 
Lilly & Co. The supplemental NADA provides a dose range for use of an 
injectable solution of tilmicosin phosphate for treatment of 
respiratory disease in cattle and additional pathogens for which this 
therapy is effective.

DATES:  This rule is effective March 2, 2010.

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: Elanco Animal Health, A Division of Eli 
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a 
supplement to NADA 140-929 for MICOTIL 300 (tilmicosin injection, USP) 
Injection, available by veterinary prescription for use in the 
treatment and control of respiratory disease in cattle and the 
treatment of respiratory disease in sheep. The supplemental NADA 
establishes a dose range and adds pathogens for which this therapy is 
effective in the management of bovine respiratory disease. As a 
consequence of revising the dosage, the preslaughter withdrawal period 
has been recalculated. The supplemental NADA is approved as of December 
30, 2009, and the regulations in 21 CFR 522.2471 are amended 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)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval 
qualifies for 3 years of marketing exclusivity beginning on the date of 
approval.
    The agency has determined under 21 CFR 25.33 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

[[Page 9334]]

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.

0
2. In Sec.  522.2471, revise paragraphs (e)(1)(i), (e)(1)(ii), and 
(e)(1)(iii) to read as follows:


Sec.  522.2471  Tilmicosin.

* * * * *
    (e) * * *
    (1) * * *
    (i) Amount. 10 to 20 milligrams per kilograms (mg/kg) of body 
weight as a single subcutaneous injection.
    (ii) Indications for use. For the treatment of bovine respiratory 
disease (BRD) associated with Mannheimia haemolytica, Pasteurella 
multocida, and Histophilus somni. For the control of respiratory 
disease in cattle at high risk of developing BRD associated with M. 
haemolytica.
    (iii) Limitations. Do not use in female dairy cattle 20 months of 
age or older. Use of this antibiotic in this class of cattle may cause 
milk residues. Do not slaughter within 42 days of last treatment.
* * * * *

    Dated: February 16, 2010.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 2010-4206 Filed 3-1-10; 8:45 am]
BILLING CODE 4160-01-S

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