Oral Dosage Form New Animal Drugs; Lincomycin and Spectinomycin Soluble Powder, 40880-40881 [05-13975]

Download as PDF 40880 Federal Register / Vol. 70, No. 135 / Friday, July 15, 2005 / Rules and Regulations companion proposed rule, after the needed revisions to the TS are made. Dated at Rockville, Maryland, this 6th day of July, 2005. For the Nuclear Regulatory Commission. Martin J. Virgilio, Acting Executive Director for Operations. [FR Doc. 05–13933 Filed 7–14–05; 8:45 am] BILLING CODE 7590–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I [Docket No. 2005N–0201] Change of Name and Address; Technical Amendment AGENCY: Food and Drug Administration, HHS. Final rule; technical amendment. ACTION: The Food and Drug Administration (FDA) is amending its regulations to reflect a change in the name and address for the Association of Official Analytical Chemists International (AOAC). This action is editorial in nature and is intended to improve the accuracy of the agency’s regulations. SUMMARY: DATES: This rule is effective July 15, 2005. FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy and Planning (HF–27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–7010. SUPPLEMENTARY INFORMATION: This document amends FDA’s regulations to reflect the name and address change of AOAC by removing the outdated name and address wherever it appears and by adding the new name and address in its place in 21 CFR parts 2, 10, 101, 102, 106, 114, 130, 131, 133, 135, 136, 137, 139, 145, 146, 150, 155, 156, 160, 161, 163, 164, 166, 168, 169, 172, 173, 176, 177, 178, 184, 189, 211, 226, 520, and 573. Publication of this document constitutes final action on these changes under the Administrative Procedure Act (5 U.S.C. 553). Notice and public procedure are unnecessary because FDA is merely correcting nonsubstantive errors. I Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR chapter I is amended as follows: VerDate jul<14>2003 15:17 Jul 14, 2005 Jkt 205001 Chapter I [Nomenclature changes] 1. Parts 2, 101, 102, 106, 114, 130, 131, 133, 135, 136, 137, 139, 145, 146, 150, 155, 156, 160, 161, 163, 164, 166, 168, 169, 172, 173, 176, 177, 178, 184, 189, 211, 226, 520, and 573 are amended by removing the text set forth below wherever it appears and adding new text in its place as follows: I A. Remove: ‘‘Association of Official Analytical Chemists International, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877–2504’’, or ‘‘Association of Official Analytical Chemists International, 481 North Frederic Ave., suite 500, Gaithersburg, MD 20877–2504’’, or ‘‘Association of Official Analytical Chemists International, 481 North Frederick Ave., suite 500, Gaithersbuerg, MD 20877–2504’’, or ‘‘Association of Official Analytical Chemists International, 481 North Frederick Ave., Suite 500, Gaithersburg, MD 20877–2504’’, or ‘‘Association of Official Analytical Chemists International, 481 North Frederick Ave, suite 500, Gaithersburg, MD 20877–2504’’, or ‘‘AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877–2504’’, or ‘‘Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201–3301’’, or ‘‘Association of Official Analytical Chemists, P.O. Box 540, Benjamin Franklin Station, Washington, DC 20044’’. I B. Add: ‘‘Association of Official Analytical Chemists International, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877’’. I PARTS 2, 10, 101, and 211 [AMENDED] 2. In addition to the amendments set forth in the previous paragraph, in 21 CFR parts 2, 10, 101, and 211 add the word ‘‘International’’ after the words ‘‘Association of Official Analytical Chemists’’ in the following places: a. Section 2.19 where it appears in the first sentence, after the words ‘‘to utilize the methods of analysis of the’’; b. Section 10.95(d)(8)(v); c. Section 101.70(f); d. Section 101.81(c)(2)(ii)(B)(2) in the first sentence; e. Appendix A to part 101; and f. Section 211.194(a)(2) in the third sentence. I Dated: July 8, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–13898 Filed 7–14–05; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00002 Fmt 4700 Sfmt 4700 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Lincomycin and Spectinomycin 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 lincomycin and spectinomycin soluble powder to create a solution administered in the drinking water of chickens as an aid in the control of airsacculitis. DATES: This rule is effective July 15, 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: Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland, filed ANADA 200–380 that provides for use of SPECLINX–50 (spectinomycin dihydrochloride pentahydrate and lincomycin hydrochloride monohydrate) Water Soluble Powder to create a solution administered in the drinking water of chickens. This solution acts as an aid in the control of airsacculitis caused by either Mycoplasma synoviae or M. gallisepticum susceptible to lincomycinspectinomycin and complicated chronic respiratory disease (air sac infection) caused by Escherichia coli and M. gallisepticum susceptible to lincomycinspectinomycin. Cross Vetpharm Group Ltd.’s SPECLINX–50, Water Soluble Powder is approved as a generic copy of Pharmacia & Upjohn Co.’s L-S 50 Water Soluble Powder, approved under NADA 046–109. The ANADA is approved as of June 7, 2005, and the regulations are amended in 21 CFR 520.1265 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 \\ALPHA3\E\FR\FM\15JYR1.SGM 15JYR1 Federal Register / Vol. 70, No. 135 / Friday, July 15, 2005 / Rules and Regulations 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. Payable in Terminated Single-Employer Plans and Allocation of Assets in Single-Employer Plans prescribe interest assumptions for valuing and paying benefits under terminating singleemployer plans. This final rule amends the regulations to adopt interest assumptions for plans with valuation dates in August 2005. Interest assumptions are also published on the PBGC’s Web site (https://www.pbgc.gov). DATES: Effective August 1, 2005. FOR FURTHER INFORMATION CONTACT: Catherine B. Klion, Attorney, Legislative and Regulatory Department, Pension Benefit Guaranty Corporation, 1200 K Street, NW., Washington, DC 20005, 202–326–4024. (TTY/TDD users may call the Federal relay service toll-free at 1–800–877–8339 and ask to be connected to 202–326–4024.) SUPPLEMENTARY INFORMATION: The List of Subjects in 21 CFR Part 520 PBGC’s regulations prescribe actuarial assumptions—including interest Animal drugs. assumptions—for valuing and paying I Therefore, under the Federal Food, plan benefits of terminating singleDrug, and Cosmetic Act and under authority delegated to the Commissioner employer plans covered by title IV of of Food and Drugs and redelegated to the the Employee Retirement Income Security Act of 1974. The interest Center for Veterinary Medicine, 21 CFR assumptions are intended to reflect part 520 is amended as follows: current conditions in the financial and annuity markets. PART 520—ORAL DOSAGE FORM Three sets of interest assumptions are NEW ANIMAL DRUGS prescribed: (1) A set for the valuation of benefits for allocation purposes under I 1. The authority citation for 21 CFR section 4044 (found in Appendix B to part 520 continues to read as follows: Part 4044), (2) a set for the PBGC to use Authority: 21 U.S.C. 360b. to determine whether a benefit is § 520.1265 [Amended] payable as a lump sum and to determine lump-sum amounts to be paid by the I 2. Section 520.1265 is amended in PBGC (found in Appendix B to Part paragraph (b)(2) by removing ‘‘No. 059130’’ and by adding in its place ‘‘Nos. 4022), and (3) a set for private-sector pension practitioners to refer to if they 059130 and 061623’’. wish to use lump-sum interest rates Dated: July 1, 2005. determined using the PBGC’s historical Catherine P. Beck, methodology (found in Appendix C to Acting Director, Center for Veterinary Part 4022). Medicine. Accordingly, this amendment (1) adds [FR Doc. 05–13975 Filed 7–14–05; 8:45 am] to Appendix B to Part 4044 the interest BILLING CODE 4160–01–S assumptions for valuing benefits for allocation purposes in plans with valuation dates during August 2005, (2) adds to Appendix B to Part 4022 the PENSION BENEFIT GUARANTY interest assumptions for the PBGC to CORPORATION use for its own lump-sum payments in 29 CFR Parts 4022 and 4044 plans with valuation dates during August 2005, and (3) adds to Appendix Benefits Payable in Terminated Single- C to Part 4022 the interest assumptions Employer Plans; Allocation of Assets for private-sector pension practitioners in Single-Employer Plans; Interest to refer to if they wish to use lump-sum Assumptions for Valuing and Paying interest rates determined using the Benefits PBGC’s historical methodology for valuation dates during August 2005. AGENCY: Pension Benefit Guaranty For valuation of benefits for allocation Corporation. purposes, the interest assumptions that ACTION: Final rule. the PBGC will use (set forth in SUMMARY: The Pension Benefit Guaranty Appendix B to part 4044) will be 3.40 percent for the first 20 years following Corporation’s regulations on Benefits VerDate jul<14>2003 15:17 Jul 14, 2005 Jkt 205001 PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 40881 the valuation date and 4.75 percent thereafter. These interest assumptions represent a decrease (from those in effect for July 2005) of 0.20 percent for the first 20 years following the valuation date and are otherwise unchanged. The interest assumptions that the PBGC will use for its own lump-sum payments (set forth in Appendix B to part 4022) will be 2.25 percent for the period during which a benefit is in pay status and 4.00 percent during any years preceding the benefit’s placement in pay status. These interest assumptions represent a decrease (from those in effect for July 2005) of 0.25 percent for the period during which a benefit is in pay status and are otherwise unchanged. For private-sector payments, the interest assumptions (set forth in Appendix C to part 4022) will be the same as those used by the PBGC for determining and paying lump sums (set forth in Appendix B to part 4022). The PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect, as accurately as possible, current market conditions. Because of the need to provide immediate guidance for the valuation and payment of benefits in plans with valuation dates during August 2005, the PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication. The PBGC has determined that this action is not a ‘‘significant regulatory action’’ under the criteria set forth in Executive Order 12866. Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply. See 5 U.S.C. 601(2). List of Subjects 29 CFR Part 4022 Employee benefit plans, Pension insurance, Pensions, Reporting and recordkeeping requirements. 29 CFR Part 4044 Employee benefit plans, Pension insurance, Pensions. In consideration of the foregoing, 29 CFR parts 4022 and 4044 are amended as follows: I \\ALPHA3\E\FR\FM\15JYR1.SGM 15JYR1

Agencies

[Federal Register Volume 70, Number 135 (Friday, July 15, 2005)]
[Rules and Regulations]
[Pages 40880-40881]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-13975]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Lincomycin and Spectinomycin 
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 lincomycin and spectinomycin soluble 
powder to create a solution administered in the drinking water of 
chickens as an aid in the control of airsacculitis.

DATES: This rule is effective July 15, 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: Cross Vetpharm Group Ltd., Broomhill Rd., 
Tallaght, Dublin 24, Ireland, filed ANADA 200-380 that provides for use 
of SPECLINX-50 (spectinomycin dihydrochloride pentahydrate and 
lincomycin hydrochloride monohydrate) Water Soluble Powder to create a 
solution administered in the drinking water of chickens. This solution 
acts as an aid in the control of airsacculitis caused by either 
Mycoplasma synoviae or M. gallisepticum susceptible to lincomycin-
spectinomycin and complicated chronic respiratory disease (air sac 
infection) caused by Escherichia coli and M. gallisepticum susceptible 
to lincomycin-spectinomycin. Cross Vetpharm Group Ltd.'s SPECLINX-50, 
Water Soluble Powder is approved as a generic copy of Pharmacia & 
Upjohn Co.'s L-S 50 Water Soluble Powder, approved under NADA 046-109. 
The ANADA is approved as of June 7, 2005, and the regulations are 
amended in 21 CFR 520.1265 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

[[Page 40881]]

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 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.  520.1265  [Amended]

0
2. Section 520.1265 is amended in paragraph (b)(2) by removing ``No. 
059130'' and by adding in its place ``Nos. 059130 and 061623''.

    Dated: July 1, 2005.
Catherine P. Beck,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 05-13975 Filed 7-14-05; 8:45 am]
BILLING CODE 4160-01-S
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