Oral Dosage Form New Animal Drugs; Sulfadimethoxine Soluble Powder, 73136-73137 [05-23813]

Download as PDF 73136 Federal Register / Vol. 70, No. 236 / Friday, December 9, 2005 / Rules and Regulations jurisdiction in which the complaint has been filed. Paragraph (a) further provides that the names, addresses, and jurisdictional responsibilities of the various OGC offices will be published in the Federal Register and made available on-line at SSA’s Internet site, https:// www.socialsecurity.gov. The current procedures for service of complaints and summonses in cases that do not involve judicial review of individual benefit claims arising under titles II, VIII, and/or XVI of the Act are unaffected by this change, and are set forth in a new paragraph (b). Since complaints and summonses in cases falling within the purview of § 423.1 are appropriately served upon the Commissioner, we have also removed from that section the current reference to service upon ‘‘other employees of the Social Security Administration in their official capacities.’’ Regulatory Procedures Pursuant to section 702(a)(5) of the Social Security Act, 42 U.S.C. 902(a)(5), as amended by section 102 of Public Law 103–296, SSA follows the Administrative Procedure Act (APA) rulemaking procedures specified in 5 U.S.C. 553 in the development of its regulations. The APA provides exceptions to its notice and public comment procedures when an agency finds there is good cause for dispensing with such procedures on the basis that they are impracticable, unnecessary, or contrary to the public interest. In the case of these final rules, we have determined that, under 5 U.S.C. 553(b)(B), good cause exists for dispensing with the notice and public comment procedures. Good cause exists because these regulations merely conform our rules on service of process to our internal distribution of responsibility for the handling and processing of litigation, contain no substantive changes in policy or interpretation, and have no significant effect upon claimants for benefits or payments under the programs we administer and no significant effect upon the public. In addition, these rules provide only rules of practice and procedure which do not require public comment procedures. Therefore, opportunity for prior comment is unnecessary, and we are issuing these regulations as final rules. In addition, we find good cause for dispensing with the 30-day delay in the effective date of a substantive rule provided by 5 U.S.C. 553(d). For the reasons cited above, we find that it is in the public interest to make this final rule effective on the date of publication. VerDate Aug<31>2005 16:58 Dec 08, 2005 Jkt 208001 Executive Order 12866, as Amended by Executive Order 13258 We certify that these final regulations will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act, as amended, 5 U.S.C. 601 et seq., as they affect only individuals. Therefore, a regulatory flexibility analysis as provided in the Regulatory Flexibility Act, as amended, is not required. of the Social Security Act, summonses and complaints to be served by mail on the Social Security Administration or the Commissioner of Social Security should be sent to the office in the Social Security Administration’s Office of the General Counsel that is responsible for the processing and handling of litigation in the particular jurisdiction in which the complaint has been filed. The names, addresses, and jurisdictional responsibilities of these offices are published in the Federal Register, and are available on-line at the Social Security Administration’s Internet site, https://www.socialsecurity.gov. (b) Other suits. In cases that do not involve claims described in paragraph (a) of this section, summonses and complaints to be served by mail on the Social Security Administration or the Commissioner of Social Security should be sent to the General Counsel, Social Security Administration, Room 617, Altmeyer Building, 6401 Security Boulevard, Baltimore, MD 21235. Paperwork Reduction Act [FR Doc. 05–23836 Filed 12–8–05; 8:45 am] These final regulations impose no additional information collection requirements requiring OMB clearance under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, et seq. BILLING CODE 4191–02–P (Catalog of Federal Domestic Assistance Program Nos. 96.001, Social Security— Disability Insurance; 96.002, Social Security—Retirement Insurance; 96.004, Social Security—Survivors Insurance; 96.006, Supplemental Security Income) Food and Drug Administration List of Subjects in 20 CFR Part 423 AGENCY: We have consulted with the Office of Management and Budget (OMB) and determined that these proposed regulations do not meet the criteria for a significant regulatory action under Executive Order (E.O.) 12866, as amended by E.O. 13258. Thus, they were not subject to OMB review. We have also determined that these rules meet the plain language requirement of Executive Order 12866, as amended by Executive Order 13258. Regulatory Flexibility Act Courts. Oral Dosage Form New Animal Drugs; Sulfadimethoxine Soluble Powder ACTION: For the reasons set forth in the preamble, we are amending part 423 of title 20 of the Code of Federal Regulations as follows: I PART 423—SERVICE OF PROCESS 1. The authority citation for part 423 continues to read as follows: I Authority: Secs. 701 and 702(a)(5) of the Social Security Act (42 U.S.C. 901 and 902(a)(5)). 2. Section 423.1 is revised to read as follows: I § 423.1 Suits against the Social Security Administration and its employees in their official capacities. (a) Suits involving claims arising under Titles II, VIII, and/or XVI. In cases seeking judicial review of final Agency decisions on individual claims for benefits under titles II, VIII, and/or XVI Frm 00014 21 CFR Part 520 Food and Drug Administration, HHS. Dated: December 5, 2005. Jo Anne B. Barnhart, Commissioner of Social Security. PO 00000 DEPARTMENT OF HEALTH AND HUMAN SERVICES Fmt 4700 Sfmt 4700 Final rule. 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 Cross Vetpharm Group Ltd. The ANADA provides for the oral use of sulfadimethoxine soluble powder to create a solution administered as a drench to cattle or in the drinking water of chickens, turkeys, or cattle for the treatment of coccidiosis or various bacterial diseases. DATES: This rule is effective December 9, 2005. FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for Veterinary Medicine (HFV–104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–9808, email: john.harshman@fda.gov. SUPPLEMENTARY INFORMATION: Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland, filed E:\FR\FM\09DER1.SGM 09DER1 Federal Register / Vol. 70, No. 236 / Friday, December 9, 2005 / Rules and Regulations ANADA 200–376 that provides for use of SULFAMED–G (sulfadimethoxine) Soluble Powder to create a solution administered as a drench to cattle or in the drinking water of chickens, turkeys, or cattle for the treatment of coccidiosis or various bacterial diseases. Cross Vetpharm Group Ltd.’s SULFAMED–G Soluble Powder is approved as a generic copy of Pfizer, Inc.’s ALBON (sulfadimethoxine) Soluble Powder, approved under NADA 46–285. The ANADA is approved as of November 14, 2005, and the regulations are amended in 21 CFR 520.2220a 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 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. 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 Subject in 21 CFR Part 520 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 520 is amended as follows: I PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: I Authority: 21 U.S.C. 360b. 2. Section 520.2220a is amended by revising paragraphs (a)(2) and (b); and by adding two sentences at the end of paragraph (d)(3)(iii) to read as follows: I § 520.2220a Sulfadimethoxine oral solution and soluble powder. (a) * * * VerDate Aug<31>2005 16:58 Dec 08, 2005 Jkt 208001 (2) For soluble powder, each 107 grams contain the equivalent of 94.6 grams of sulfadimethoxine (as the sodium salt); see Nos. 000069, 051259, 057561, 059130, and 061623 in § 510.600(c) of this chapter. (b) Special considerations. Federal law prohibits the extralabel use of this product in lactating dairy cattle. * * * * * (d) * * * (3) * * * (iii) * * * A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Dated: November 30, 2005. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 05–23813 Filed 12–8–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 524 Ophthalmic and Topical Dosage Form New Animal Drugs; Miconazole Nitrate Cream; Miconazole Nitrate Lotion; Miconazole Nitrate Spray AGENCY: Food and Drug Administration, Final rule. Animal drugs. 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 First Priority, Inc. The ANADA provides for topical use of miconazole nitrate as a spray or lotion on dogs and cats for the treatment of certain fungal infections. DATES: This rule is effective December 9, 2005. FOR FURTHER INFORMATION CONTACT: Linda M. Wilmot, Center for Veterinary Medicine (HFV–104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–1069, email: linda.wilmot@fda.gov. SUPPLEMENTARY INFORMATION: First Priority, Inc., 1585 Todd Farm Dr., Elgin, IL 60123, filed ANADA 200–362 for PRICONAZOLE (miconazole nitrate) Lotion 1% and PRICONAZOLE (miconazole nitrate) Spray 1% for topical use on dogs and cats for the treatment of certain fungal infections. First Priority’s PRICONAZOLE Lotion 1% and PRICONAZOLE Spray 1% are approved as generic copies of ScheringPlough Animal Health Corp.’s SUMMARY: PO 00000 CONOFITE Lotion 1% and Spray 1%, approved under NADA 95–184. The ANADA is approved as of November 14, 2005, and 21 CFR 524.1443 is amended 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 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. 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 524 HHS. ACTION: 73137 Frm 00015 Fmt 4700 Sfmt 4700 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 524 is amended as follows: I PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 524 continues to read as follows: I Authority: 21 U.S.C. 360b. § 524.1443 [Amended] 2. Section 524.1443 is amended in paragraph (b) by removing ‘‘No. 051259’’ and by adding in its place ‘‘Nos. 051259 and 058829’’. I Dated: November 30, 2005. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 05–23811 Filed 12–8–05; 8:45 am] BILLING CODE 4160–01–S E:\FR\FM\09DER1.SGM 09DER1

Agencies

[Federal Register Volume 70, Number 236 (Friday, December 9, 2005)]
[Rules and Regulations]
[Pages 73136-73137]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-23813]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Sulfadimethoxine Soluble 
Powder

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 an abbreviated new animal drug 
application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA 
provides for the oral use of sulfadimethoxine soluble powder to create 
a solution administered as a drench to cattle or in the drinking water 
of chickens, turkeys, or cattle for the treatment of coccidiosis or 
various bacterial diseases.

DATES: This rule is effective December 9, 2005.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-9808, e-mail: 
john.harshman@fda.gov.

SUPPLEMENTARY INFORMATION: Cross Vetpharm Group Ltd., Broomhill Rd., 
Tallaght, Dublin 24, Ireland, filed

[[Page 73137]]

ANADA 200-376 that provides for use of SULFAMED-G (sulfadimethoxine) 
Soluble Powder to create a solution administered as a drench to cattle 
or in the drinking water of chickens, turkeys, or cattle for the 
treatment of coccidiosis or various bacterial diseases. Cross Vetpharm 
Group Ltd.'s SULFAMED-G Soluble Powder is approved as a generic copy of 
Pfizer, Inc.'s ALBON (sulfadimethoxine) Soluble Powder, approved under 
NADA 46-285. The ANADA is approved as of November 14, 2005, and the 
regulations are amended in 21 CFR 520.2220a 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 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.
    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 Subject 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.

0
2. Section 520.2220a is amended by revising paragraphs (a)(2) and (b); 
and by adding two sentences at the end of paragraph (d)(3)(iii) to read 
as follows:


Sec.  520.2220a  Sulfadimethoxine oral solution and soluble powder.

    (a) * * *
    (2) For soluble powder, each 107 grams contain the equivalent of 
94.6 grams of sulfadimethoxine (as the sodium salt); see Nos. 000069, 
051259, 057561, 059130, and 061623 in Sec.  510.600(c) of this chapter.
    (b) Special considerations. Federal law prohibits the extralabel 
use of this product in lactating dairy cattle.
* * * * *
    (d) * * *
    (3) * * *
    (iii) * * * A withdrawal period has not been established for this 
product in preruminating calves. Do not use in calves to be processed 
for veal.

    Dated: November 30, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-23813 Filed 12-8-05; 8:45 am]
BILLING CODE 4160-01-S

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