Oral Dosage Form New Animal Drugs; Oxytetracycline, 36483 [E6-10053]

Download as PDF Federal Register / Vol. 71, No. 123 / Tuesday, June 27, 2006 / Rules and Regulations Federal Register approved the incorporation by reference of this document in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Contact Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124–2207, for a copy of this service information. You may review copies at the Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street, SW., Room PL–401, Nassif Building, Washington, DC; on the Internet at https://dms.dot.gov; or at the National Archives and Records Administration (NARA). For information on the availability of this material at the NARA, call (202) 741–6030, or go to https:// www.archives.gov/federal_register/ code_of_federal_regulations/ ibr_locations.html. Issued in Renton, Washington, on June 15, 2006. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. 06–5652 Filed 6–26–06; 8:45 am] BILLING CODE 4910–13–P NADA is approved as of May 9, 2006, and the regulations in 21 CFR 520.1660d are amended 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 § 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. 30 CFR Part 57 ‘‘Diesel Particulate Matter Exposure of Underground Metal and Nonmetal Miners,’’ and published in the Federal Register on Thursday, May 18, 2006 (71 FR 28924). DATES: The corrections to the preamble are effective June 27, 2006. The correction to § 57.5060(d) is effective August 16, 2006. FOR FURTHER INFORMATION CONTACT: Patricia W. Silvey, Acting Director, Office of Standards, Regulations, and Variances, MSHA, 1100 Wilson Blvd., Room 2350, Arlington, Virginia 22209– 3939; 202–693–9440 (telephone); or 202–693–9441 (facsimile). This document is available on the Internet at https://www.msha.gov/ REGSINFO.HTM. SUPPLEMENTARY INFORMATION: As published, the preamble and rule text contain errors which may be misleading and need to be corrected. Accordingly, the preamble is corrected as follows: 1. On page 28926, in the second column, in the third full paragraph, at the end of the paragraph, insert ‘‘(70 FR 55019).’’ 2. On page 28926, in the third column, at the end of the third line, insert ‘‘(71 FR 4331).’’ 3. On page 28928, in the first column, in the second paragraph, eighth line from the bottom, change ‘‘regulation’’ to ‘‘standard.’’ 4. On page 28929, in Table IV–3, under the column entitled, ‘‘Description,’’ in the fourth paragraph, in the last line, change ‘‘PM10’’ to ‘‘PM10.’’ 5. On page 28971, in the first column, first full paragraph, in the last line, delete the word ‘‘approach,’’ and replace it with the word ‘‘be.’’ 6. On page 29007, in the second column, in the reference for ‘‘Gavett,’’ in the last line, change ‘‘0124(l–3)’’ to ‘‘0124(1–3).’’ 7. On page 29007, in the third column, in the tenth line from the bottom, change ‘‘12(l–2)’’ to ‘‘12(1–2).’’ 8. On page 29008, in the first column, in the eighth line from the bottom, change ‘‘B6C3Fl’’ to ‘‘B6C3F1.’’ In addition, the rule text is corrected as follows: RIN 1219-AB29 § 57.5060 21 CFR Part 520 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: Oral Dosage Form New Animal Drugs; Oxytetracycline PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration AGENCY: Food and Drug Administration, HHS. wwhite on PROD1PC61 with RULES ACTION: 1. The authority citation for 21 CFR part 520 continues to read as follows: I Final rule. Authority: 21 U.S.C. 360b. 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 Pfizer, Inc. The supplemental NADA revises labeling of oxytetracycline soluble powder with the current genus for the causative bacteria for American foul brood of honeybees. DATES: This rule is effective June 27, 2006. FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for Veterinary Medicine (HFV–130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 10017–5755, filed a supplement to NADA 8–622 that provides for use of TERRAMYCIN–343 (oxytetracycline HCl) Soluble Powder for treatment of various bacterial diseases of livestock. The supplemental NADA revises labeling with the current genus for the causative bacteria for American foul brood of honeybees. The supplemental VerDate Aug<31>2005 16:03 Jun 26, 2006 Jkt 208001 36483 § 520.1660d [Amended] 2. In paragraph (d)(2)(ii) of § 520.1660d, remove ‘‘Bacillus’’ and add in its place ‘‘Paenibacillus’’. I Dated: June 7, 2006. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. E6–10053 Filed 6–26–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF LABOR Mine Safety and Health Administration Diesel Particulate Matter Exposure of Underground Metal and Nonmetal Miners Mine Safety and Health Administration (MSHA), Labor. ACTION: Final rule; corrections. AGENCY: SUMMARY: This document contains corrections to the final rule addressing PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 [Corrected] 1. On page 29012, in the first column, under § 57.5060 paragraph (d), fourth line, delete the ‘‘s’’ from the word ‘‘exposures’’ so that the sentence now reads, ‘‘The mine operator must install, use, and maintain feasible engineering and administrative controls to reduce a miner’s exposure to or below the applicable DPM PEL established in this section.’’ I E:\FR\FM\27JNR1.SGM 27JNR1

Agencies

[Federal Register Volume 71, Number 123 (Tuesday, June 27, 2006)]
[Rules and Regulations]
[Page 36483]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-10053]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Oxytetracycline

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 Pfizer, Inc. The supplemental NADA revises 
labeling of oxytetracycline soluble powder with the current genus for 
the causative bacteria for American foul brood of honeybees.

DATES: This rule is effective June 27, 2006.

FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: 
joan.gotthardt@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017-5755, filed a supplement to NADA 8-622 that provides for use of 
TERRAMYCIN-343 (oxytetracycline HCl) Soluble Powder for treatment of 
various bacterial diseases of livestock. The supplemental NADA revises 
labeling with the current genus for the causative bacteria for American 
foul brood of honeybees. The supplemental NADA is approved as of May 9, 
2006, and the regulations in 21 CFR 520.1660d are amended 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 Sec.  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.  520.1660d  [Amended]

0
2. In paragraph (d)(2)(ii) of Sec.  520.1660d, remove ``Bacillus'' and 
add in its place ``Paenibacillus''.

    Dated: June 7, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E6-10053 Filed 6-26-06; 8:45 am]
BILLING CODE 4160-01-S

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.