Implantation or Injectable Dosage Form New Animal Drugs; Lincomycin; Correction, 65052-65053 [E6-18679]

Download as PDF 65052 Federal Register / Vol. 71, No. 215 / Tuesday, November 7, 2006 / Rules and Regulations § 385.2011 Procedures for filing on electronic media (Rule 2011). (a) * * * (9) FERC Form No. 60, Annual report of centralized service companies. * * * * * (c) What to file. * * * (3) With the exception of the Form Nos. 1, 2, 2–A, 6 and 60, the electronic media must be accompanied by the traditional prescribed number of paper copies. * * * * * [FR Doc. E6–18061 Filed 11–6–06; 8:45 am] BILLING CODE 6717–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Ivermectin, Pyrantel, and Praziquantel Tablets 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 an original new animal drug application (NADA) filed by Virbac AH, Inc. The NADA provides for veterinary prescription use of chewable tablets in dogs containing ivermectin, pyrantel pamoate, and praziquantel for the treatment and control or prevention of various internal parasites. DATES: This rule is effective November 7, 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: Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137, filed NADA 141–257 for IVERHART MAX (ivermectin, pyrantel pamoate, praziquantel) Chewable Tablets that provides for veterinary prescription use of chewable tablets in dogs containing ivermectin, pyrantel pamoate, and praziquantel for the treatment and control or prevention of various internal parasites. The NADA is approved as of October 13, 2006, and 21 CFR part 520 is amended by adding new § 520.1199 to reflect the approval. The basis of approval is discussed in the freedom of information summary. In accordance with the freedom of information provisions of 21 CFR part ycherry on PROD1PC64 with RULES SUMMARY: VerDate Aug<31>2005 14:06 Nov 06, 2006 Jkt 211001 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)(ii) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 3 years of marketing exclusivity beginning October 13, 2006. 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. 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: PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: I (ii) 12.1 to 25 lb: one tablet as described in paragraph (a)(2) of this section. (iii) 25.1 to 50 lb: one tablet as described in paragraph (a)(3) of this section. (iv) 50.1 to 100 lb: one tablet as described in paragraph (a)(4) of this section. (v) Greater than 100 lb: use the appropriate combination of tablets. (2) Indications for use. Prevents canine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for 1 month (30 days) after infection and for the treatment and control of roundworm (Toxocara canis, Toxascaris leonina), hookworm (Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense) and tapeworm (Dipylidium caninum, Taenia pisiformis) infections. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Dated: October 23, 2006. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. E6–18684 Filed 11–6–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; Lincomycin; Correction AGENCY: Authority: 21 U.S.C. 360b. I 2. Add § 520.1199 to read as follows: ACTION: Food and Drug Administration, HHS. § 520.1199 Ivermectin, pyrantel, and praziquantel tablets. (a) Specifications. Each chewable tablet contains: (1) 34 micrograms (mcg) ivermectin, 28.5 milligrams (mg) pyrantel pamoate, and 28.5 mg praziquantel; (2) 68 mcg ivermectin, 57 mg pyrantel pamoate, and 57 mg praziquantel; (3) 136 mcg ivermectin, 114 mg pyrantel pamoate, and 114 mg praziquantel; or (4) 272 mcg ivermectin, 228 mg pyrantel pamoate, and 228 mg praziquantel. (b) Sponsors. See No. 051311 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer monthly according to body weight as follows: (i) 6 to 12 lb: one tablet as described in paragraph (a)(1) of this section. PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 Final rule; correction. SUMMARY: The Food and Drug Administration (FDA) is correcting a document amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) that appeared in the Federal Register of September 1, 2006 (71 FR 51995). FDA is correcting the date of approval of an ANADA for a generic lincomycin injectable solution which was drafted in error. This correction is being made to improve the accuracy of the Federal Register. DATES: This rule is effective November 7, 2006. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV–6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–276–9019, email: george.haibel@fda.hhs.gov. E:\FR\FM\07NOR1.SGM 07NOR1 Federal Register / Vol. 71, No. 215 / Tuesday, November 7, 2006 / Rules and Regulations In FR Doc. E6–14509, appearing on page 51995 in the Federal Register of September 1, 2006, the following correction is made: 1. On page 51995, in the third column, in the third sentence of the SUPPLEMENTARY INFORMATION section, the date of ANADA approval ‘‘July 27, 2006’’ is corrected to read ‘‘August 2, 2006’’. SUPPLEMENTARY INFORMATION: Dated: October 20, 2006. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. E6–18679 Filed 11–6–06; 8:45 am] BILLING CODE 4160–01–S 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds; Bambermycins Food and Drug Administration, HHS. Final rule; technical amendment. ycherry on PROD1PC64 with RULES ACTION: SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to correct an inadvertent error in the conditions of use of bambermycins free-choice cattle feeds. This action is being taken to improve the accuracy of the animal drug regulations. DATES: This rule is effective November 7, 2006. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV–6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301–827–4567, email: george.haibel@fda.hhs.gov. SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations in 21 CFR 558.95 to correct an inadvertent error in the conditions of use of bambermycins free-choice cattle feeds. The error was introduced in a final rule for liquid and free-choice medicated feeds that published May 27, 2004 (69 FR 30194). This action is being taken to improve the accuracy and readability of the animal drug regulations. 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. VerDate Aug<31>2005 14:06 Nov 06, 2006 Jkt 211001 1. The authority citation for 21 CFR part 558 continues to read as follows: I Authority: 21 U.S.C. 360b, 371. 2. In § 558.95, revise the last sentence of paragraph (d)(4)(iii)(d) to read as follows: I Bambermycins. * Food and Drug Administration List of Subjects in 21 CFR Part 558 Animal drugs, Animal feeds. PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS § 558.95 DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: 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: I * * * * (d) * * * (4) * * * (iii) * * * (d) * * * Daily bambermycins intakes in excess of 20 mg/head/day have not been shown to be more effective than 20 mg/head/day. * * * * * Dated: October 20, 2006. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. E6–18680 Filed 11–6–06; 8:45 am] BILLING CODE 4160–01–S LEGAL SERVICES CORPORATION 45 CFR Part 1624 Prohibition Against Discrimination on the Basis of Disability Legal Services Corporation. Final rule. AGENCY: ACTION: SUMMARY: This Final Rule amends the Legal Services Corporation’s regulation on prohibitions against discrimination on the basis of disability. These changes are intended to improve the utility of the regulation for LSC, its grantees and other interested persons, by updating the terminology used throughout the regulation, to add a reference to compliance with the Americans with Disabilities Act and by adding language to the enforcement provision setting forth LSC policy regarding investigation of complaints of violation of this regulation. This Final Rule is effective on December 7, 2006. FOR FURTHER INFORMATION CONTACT: Mattie Cohan, Senior Assistant General Counsel, Office of Legal Affairs, Legal Services Corporation, 3333 K Street, NW., Washington DC 20007; 202–295– 1624 (ph); 202–337–6519 (fax); mcohan@lsc.gov. DATES: PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 65053 SUPPLEMENTARY INFORMATION: Background Section 504 of the Rehabilitation Act of 1973 (29 U.S.C. 706), as amended, prohibits discrimination on the basis of handicap by recipients of Federal assistance. As recipients of federal assistance, Legal Services Corporation (LSC) grant recipients are subject to the non-discrimination requirements of Section 504. At the same time, while the Corporation is not obligated to enforce Section 504 of the Rehabilitation Act (since it is not an agency, department or instrumentality of the Federal government), it does have the authority to ensure that LSC grant recipients comply with its provisions. LSC chose to exercise this authority and adopted the Part 1624 regulation implementing the non-discrimination requirements in Section 504 in 1979. The regulation has not been amended since that time. On October 29, 2005, the LSC Board of Directors directed that LSC initiate a rulemaking to consider revisions to LSC’s regulation at 45 CFR part 1624. At the Board’s further direction, prior to the development of this Notice of Proposed Rulemaking (‘‘NPRM’’), LSC convened a Rulemaking Workshop 1 to consider revisions to this Part. The intention of the rulemaking proceeding was intended to provide the opportunity for an unlimited and thorough review of the regulation with the intent of updating and improving the rule as appropriate. LSC convened a Rulemaking Workshop on December 13, 2005 to discuss Part 1624. The following persons participated in the Workshop: John ‘‘Chip’’ Gray, South Brooklyn Legal Services; John Herrion, United Spinal Association; Linda Perle, Center for Law and Social Policy; Don Saunders, National Legal Aid and Defender Association; Helaine Barnett, LSC President (welcoming remarks only); Karen Sarjeant, LSC Vice President for Programs and Compliance; Charles Jeffress, LSC Chief Administrative Officer; Mattie Condray, LSC Office of Legal Affairs; Curtis Goffe, LSC Office of Compliance and Enforcement; Tillie Lacayo, LSC Office of Program Performance; Mark Freedman, LSC 1 Under LSC’s Rulemaking Protocol, a Rulemaking Workshop is a meeting at which the participants (which may include LSC Board members, staff, grantees and other interested parties) ‘‘hold open discussions designed to elicit information about problems or concerns with the regulation (or certain aspects thereof) and provide an opportunity for sharing ideas regarding how to address those issues. * * * [A] Workshop is not intended to develop detailed alternatives or to obtain consensus on regulatory proposals.’’ 67 FR 69762, 69763 (November 19, 2002). E:\FR\FM\07NOR1.SGM 07NOR1

Agencies

[Federal Register Volume 71, Number 215 (Tuesday, November 7, 2006)]
[Rules and Regulations]
[Pages 65052-65053]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-18679]


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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; 
Lincomycin; Correction

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule; correction.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is correcting a 
document amending the animal drug regulations to reflect approval of an 
abbreviated new animal drug application (ANADA) that appeared in the 
Federal Register of September 1, 2006 (71 FR 51995). FDA is correcting 
the date of approval of an ANADA for a generic lincomycin injectable 
solution which was drafted in error. This correction is being made to 
improve the accuracy of the Federal Register.

DATES:  This rule is effective November 7, 2006.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9019, e-mail: 
george.haibel@fda.hhs.gov.



[[Page 65053]]

SUPPLEMENTARY INFORMATION:
    In FR Doc. E6-14509, appearing on page 51995 in the Federal 
Register of September 1, 2006, the following correction is made:
    1. On page 51995, in the third column, in the third sentence of the 
SUPPLEMENTARY INFORMATION section, the date of ANADA approval ``July 
27, 2006'' is corrected to read ``August 2, 2006''.

    Dated: October 20, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6-18679 Filed 11-6-06; 8:45 am]
BILLING CODE 4160-01-S

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