Oral Dosage Form New Animal Drugs; Tiamulin Soluble Powder, 13098-13099 [05-5380]

Download as PDF 13098 DATES: Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations On page 10231, column 3, fourth heading, replace OMB No. 0648 0506 with OMB No. 0648–0518. Effective on April 1, 2005. FOR FURTHER INFORMATION CONTACT: Patsy A. Bearden, 907–586–7008 or patsy.bearden@noaa.gov. Classification SUPPLEMENTARY INFORMATION: Background In January 2004, the U.S. Congress amended section 313(j) of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) through the Consolidated Appropriations Act of 2004 (Pub. L. 108–199, section 801). As amended, section 313(j)(1) requires the Secretary to approve and implement by regulation the so-called Crab Rationalization Program (Program), as it was approved by the North Pacific Fishery Management Council (Council) between June 2002 and April 2003, and all trailing amendments, including those reported to Congress on May 6, 2003. In June 2004, the Council consolidated its actions on the Program into the Council motion, which is contained in its entirety in Amendment 18 to the Fishery Management Plan for Bering Sea/Aleutian Islands King and Tanner Crabs (FMP). Additionally, in June 2004, the Council developed Amendment 19 to the FMP, which represents minor changes necessary to implement the Program. The Notice of Availability for these amendments was published in the Federal Register on September 1, 2004 (69 FR 53397). NMFS approved Amendments 18 and 19 on November 19, 2004. NMFS published a proposed rule to implement Amendments 18 and 19 in the Federal Register on October 29, 2004 (69 FR 63200). NMFS published a final rule to implement Amendments 18 and 19 on March 2, 2005 (70 FR 10174). Need for Corrections In the final rule, published on March 2, 2005 (70 FR 10174), five of the eight OMB control numbers listed in the crab final rule classification section were incorrect. This final rule replaces the incorrect numbers with correct OMB control numbers in the classification section of the final rule and in the regulatory text at 15 CFR part 902.1. On page 10231, column 2, third heading, replace OMB No. 0648–0272 with OMB No. 0648–0517. On page 10231, column 3, first heading, replace OMB No. 0648–0503 with OMB No. 0648–0516. On page 10231, column 3, second heading, replace OMB No. 0648–0504 with OMB No. 0648–0514. On page 10231, column 3, third heading, replace OMB No. 0648–0503 with OMB No. 0648–0515. VerDate jul<14>2003 14:42 Mar 17, 2005 Jkt 205001 The Administrator, Alaska Region, NMFS (Regional Administrator), has determined that this final rule is necessary for the conservation and management of the BSAI crab fisheries. The Regional Administrator also has determined that this final rule is consistent with the Magnuson-Stevens Act and other applicable laws. This final rule has been determined to be not significant for the purposes of Executive Order 12866. Pursuant to 5 U.S.C. 553(b)(B), the Assistant Administrator of Fisheries, NOAA (AA) finds good cause to waive prior notice and opportunity for public comment otherwise required by the section. NOAA finds that prior notice and comment are unnecessary as this rule is purely technical in nature, having no substantive impact whatsoever. This action merely corrects OMB control numbers for approved collections-of-information, in no way altering those approved collections. NOAA finds that because of the nonsubstantive nature of the correction, no particular public interest exists in this final rule for which there is justification or need for prior notice and opportunity for comment. Because this correcting amendment does not institute any substantive obligations for the public, the requirement for a 30-day delay in the effective date to this action pursuant to 5 U.S.C. 553(d) does not apply. Because prior notice and opportunity for public comment are not required for this rule by 5 U.S.C., or any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., are inapplicable. 2. In § 902.1, the table in paragraph (b) under 50 CFR is amended by revising in numerical order entries for § 679.5(l)(3)(i), § 679.5(l)(4), § 680.4, § 680.5, § 680.6, § 680.20, § 680.21, § 680.40(f), (g), (h), (i), (j), (k), (l), and (m), § 680.41, § 680.43, and § 680.44 (a) through (f) to read as follows: I § 902.1 OMB control numbers assigned pursuant to the Paperwork Reduction Act. * * * (b) * * * * * CFR part or section where the information collection requirement is located Current OMB control number (All numbers begin with 0648-) ***** 50 CFR ***** 679.5(l)(3)(i), (l)(4) -0272, -0517 ***** 680.4 -0514 680.5 -0515 680.6 -0518 680.20 -0516 680.21 -0514 ***** 680.40(f), (g), (h), (i), (j), (k), (l), and (m) -0514 680.41 -0514 680.43 -0514 680.44(a), (b), (c), (d), (e) -0515 680.44(f) -0514 ***** List of Subjects in 15 CFR Part 902 Reporting and recordkeeping requirements. Dated: March 11, 2005. William T. Hogarth Assistant Administrator for Fisheries, National Marine Fisheries Service. For the reasons set out in the preamble, 15 CFR part 902 is amended as follows: I PART 902—NOAA INFORMATION COLLECTION REQUIREMENTS UNDER THE PAPERWORK REDUCTION ACT; OMB CONTROL NUMBERS 1. The authority citation for part 902 continues to read as follows: I PO 00000 Authority: 44 U.S.C. 3501 et seq. Frm 00010 Fmt 4700 Sfmt 4700 [FR Doc. 05–5349 Filed 3–17–05; 8:45 am] BILLING CODE 3510–22–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 520 Oral Dosage Form New Animal Drugs; Tiamulin Soluble Powder AGENCY: Food and Drug Administration, HHS. ACTION: E:\FR\FM\18MRR1.SGM Final rule. 18MRR1 Federal Register / Vol. 70, No. 52 / Friday, March 18, 2005 / Rules and Regulations SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Phoenix Scientific, Inc. The ANADA provides for use of tiamulin soluble powder to prepare medicated drinking water for the treatment of swine dysentery and swine pneumonia. DATES: This rule is effective March 18, 2005. FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary Medicine (HFV–104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–0223, email: daniel.benz@fda.gov. SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503, filed a supplement to ANADA 200–344 that provides for use of Tiamulin Soluble Antibiotic to prepare medicated drinking water for the treatment of swine dysentery and swine pneumonia. Phoenix Scientific, Inc.’s Tiamulin Soluble Antibiotic is approved as a generic copy of Boehringer Ingelheim Vetmedica, Inc.’s DENAGARD (tiamulin) Soluble Antibiotic approved under NADA 134–644. The ANADA is approved as of February 16, 2005, and the regulations are amended in 21 CFR 520.2455 to reflect the approval. The basis of approval is discussed in the freedom of information summary. FDA is also amending the regulations in 21 CFR 520.2455 to reflect a more recent genus name for the causative pathogen for swine dysentery and in the tables in 21 CFR 510.600(c) to reflect accepted style for the sponsor’s street address. These actions are being taken to improve the accuracy of the regulations. 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. 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 VerDate jul<14>2003 14:42 Mar 17, 2005 Jkt 205001 13099 it is a rule of ‘‘particular applicability.’’ Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801–808. DEPARTMENT OF HEALTH AND HUMAN SERVICES List of Subjects 21 CFR Part 573 21 CFR Part 510 Food Additives Permitted in Feed and Drinking Water of Animals; Poly(2– vinylpyridine-co-styrene); Salts of Volatile Fatty Acids Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. Food and Drug Administration AGENCY: Food and Drug Administration, HHS. 21 CFR Part 520 Final rule; technical amendment. ACTION: 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 parts 510 and 520 are amended as follows: I SUMMARY: The Food and Drug Administration (FDA) is amending the animal food additive regulations to correct the specifications for two food additives used in cattle feed. Incorrect symbols describing permitted levels of heavy metals such as lead and arsenic are being corrected with text to reflect PART 510—NEW ANIMAL DRUGS the maximum permitted levels of these two impurities in these food additives. I 1. The authority citation for 21 CFR This action is being taken to improve part 510 continues to read as follows: the accuracy of the agency’s regulations. DATES: This rule is effective March 18, Authority: 21 U.S.C. 321, 331, 351, 352, 2005. 353, 360b, 371, 379e. FOR FURTHER INFORMATION CONTACT: § 510.600 [Amended] Sharon Benz, Center for Veterinary Medicine (HFV–220), Food and Drug I 2. Section 510.600 is amended in the Administration, 7519 Standish Pl., table in paragraph (c)(1) in the entry for Rockville, MD 20855, 240–453–6864, e‘‘Phoenix Scientific, Inc.’’ and in the mail: sbenz@cvm.fda.gov. table in paragraph (c)(2) in the entry for ‘‘059130’’ by removing ‘‘St. Terrace’’ and SUPPLEMENTARY INFORMATION: FDA has found that part 573 (21 CFR part 573) by adding in its place ‘‘Street Ter.’’. of the Code of Federal Regulations does not accurately reflect the approved PART 520—ORAL DOSAGE FORM specifications for two food additives NEW ANIMAL DRUGS used in cattle feed, poly(2– vinylpyridine-co-styrene) and salts of I 3. The authority citation for 21 CFR volatile fatty acids. The greater than part 520 continues to read as follows: symbols in the tables describing the Authority: 21 U.S.C. 360b. permitted levels of heavy metals such as lead and arsenic were incorrect. FDA is § 520.2455 [Amended] amending the regulations in §§ 573.870 and 573.914 to correctly reflect the I 4. Section 520.2455 is amended in paragraph (b) by removing ‘‘Sponsor. See maximum permitted levels of these two impurities in these food additives. This No. 000010’’ and by adding in its place action is being taken to improve the ‘‘Sponsors. See Nos. 000010 and accuracy of the agency’s regulations. 059130’’; and in paragraph (d)(1)(i) by Publication of this document removing ‘‘Treponema’’ and by adding constitutes final action on these changes in its place ‘‘Brachyspira’’. under the Administrative Procedure Act Dated: March 9, 2005. (5 U.S.C. 553). Notice and public Stephen F. Sundlof, procedure are unnecessary because FDA Director, Center for Veterinary Medicine. is merely correcting nonsubstantive errors. [FR Doc. 05–5380 Filed 3–17–05; 8:45 am] BILLING CODE 4160–01–S PO 00000 List of Subjects in 21 CFR 573 Animal feeds, Food additives. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the I Frm 00011 Fmt 4700 Sfmt 4700 E:\FR\FM\18MRR1.SGM 18MRR1

Agencies

[Federal Register Volume 70, Number 52 (Friday, March 18, 2005)]
[Rules and Regulations]
[Pages 13098-13099]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-5380]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520


Oral Dosage Form New Animal Drugs; Tiamulin Soluble Powder

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule.

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[[Page 13099]]

SUMMARY:  The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of an abbreviated new animal drug 
application (ANADA) filed by Phoenix Scientific, Inc. The ANADA 
provides for use of tiamulin soluble powder to prepare medicated 
drinking water for the treatment of swine dysentery and swine 
pneumonia.

DATES:  This rule is effective March 18, 2005.

FOR FURTHER INFORMATION CONTACT:  Daniel A. Benz, Center for Veterinary 
Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0223, e-mail: daniel.benz@fda.gov.

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th 
Street Ter., St. Joseph, MO 64503, filed a supplement to ANADA 200-344 
that provides for use of Tiamulin Soluble Antibiotic to prepare 
medicated drinking water for the treatment of swine dysentery and swine 
pneumonia. Phoenix Scientific, Inc.'s Tiamulin Soluble Antibiotic is 
approved as a generic copy of Boehringer Ingelheim Vetmedica, Inc.'s 
DENAGARD (tiamulin) Soluble Antibiotic approved under NADA 134-644. The 
ANADA is approved as of February 16, 2005, and the regulations are 
amended in 21 CFR 520.2455 to reflect the approval. The basis of 
approval is discussed in the freedom of information summary.
    FDA is also amending the regulations in 21 CFR 520.2455 to reflect 
a more recent genus name for the causative pathogen for swine dysentery 
and in the tables in 21 CFR 510.600(c) to reflect accepted style for 
the sponsor's street address. These actions are being taken to improve 
the accuracy of the regulations.
    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.
    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

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

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 parts 510 and 
520 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.


Sec.  510.600  [Amended]

0
2. Section 510.600 is amended in the table in paragraph (c)(1) in the 
entry for ``Phoenix Scientific, Inc.'' and in the table in paragraph 
(c)(2) in the entry for ``059130'' by removing ``St. Terrace'' and by 
adding in its place ``Street Ter.''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 520 continues to read as 
follows:

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


Sec.  520.2455  [Amended]

0
4. Section 520.2455 is amended in paragraph (b) by removing ``Sponsor. 
See No. 000010'' and by adding in its place ``Sponsors. See Nos. 000010 
and 059130''; and in paragraph (d)(1)(i) by removing ``Treponema'' and 
by adding in its place ``Brachyspira''.

    Dated: March 9, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-5380 Filed 3-17-05; 8:45 am]
BILLING CODE 4160-01-S
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