New Animal Drugs; Change of Sponsor; Change of Sponsor Address; Lincomycin and Spectinomycin Soluble Powder; Sulfadimethoxine Oral Solution and Soluble Powder; Tiamulin, 56769-56770 [2012-22646]

Download as PDF 56769 Federal Register / Vol. 77, No. 179 / Friday, September 14, 2012 / Rules and Regulations Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2012, 77 FR 49699 (August 16, 2012). PART 772—[AMENDED] 24. The authority citation for 15 CFR part 772 is revised to read as follows: ■ Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2012, 77 FR 49699 (August 16, 2012). PART 774—[AMENDED] 25. The authority citation for 15 CFR part 774 is revised to read as follows: ■ Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C. 7430(e); 22 U.S.C. 287c, 22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 30 U.S.C. 185(s), 185(u); 42 U.S.C. 2139a; 42 U.S.C. 6212; 43 U.S.C. 1354; 15 U.S.C. 1824a; 50 U.S.C. app. 5; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 15, 2012, 77 FR 49699 (August 16, 2012). Dated: September 7, 2012. Kevin J. Wolf, Assistant Secretary for Export Administration. [FR Doc. 2012–22719 Filed 9–13–12; 8:45 am] BILLING CODE 3510–33–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 520 [Docket No. FDA–2012–N–0002] New Animal Drugs; Change of Sponsor; Change of Sponsor Address; Lincomycin and Spectinomycin Soluble Powder; Sulfadimethoxine Oral Solution and Soluble Powder; Tiamulin AGENCY: Food and Drug Administration, HHS. ACTION: List of Subjects Final rule. The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for three abbreviated new animal drug applications (ANADAs) from Teva Animal Health, Inc., to Phibro Animal Health Corp. FDA is also amending the regulations to reflect a change of sponsor’s address for Phibro Animal Health Corp. and for Eka Chemicals, Inc. DATES: This rule is effective September 14, 2012. FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for Veterinary Medicine (HFV–100), Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855, 240–276–8300, Email: steven.vaughn@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Teva Animal Health, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503, has informed FDA that it has transferred ownership of, and all rights and interest in, ANADA 200–258 for Sulfadimethoxine Soluble Powder, ANADA 200–344 for Tiamulin Soluble Antibiotic, and ANADA 200–345 for Lincomycin-Spectinomycin Soluble Powder to Phibro Animal Health Corp., 65 Challenger Rd., 3d floor, Ridgefield Park, NJ 07660. In addition, Phibro Animal Health Corp. has informed FDA of a change of address to GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666. Eka Chemicals, Inc., 1775 West Oak Commons Ct., Marietta, GA 30062 has informed FDA of a change of address to 1850 Parkway Pl. SE., suite 1200, Marietta, GA 30067. Accordingly, the Agency is amending the regulations in 21 CFR 510.600 to reflect these changes. 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. SUMMARY: 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. 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 parts 510 and 520 are amended as follows: PART 510—NEW ANIMAL DRUGS 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. 2. In § 510.600, in the table in paragraph (c)(1), revise the entries for ‘‘Eka Chemicals, Inc.’’ and ‘‘Phibro Animal Health’’; and in the table in paragraph (c)(2), revise the entries for ‘‘061088’’ and ‘‘066104’’ to read as follows: ■ § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. * * * (c) * * * (1) * * * * * Drug labeler code * * * * * * Eka Chemicals, Inc., 1850 Parkway Pl. SE., suite 1200, Marietta, GA 30067 ......................................................................... * * * * * * * Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666 ...... wreier-aviles on DSK5TPTVN1PROD with RULES Firm name and address * * * * * * * (2) * * * VerDate Mar<15>2010 14:15 Sep 13, 2012 Jkt 226001 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 E:\FR\FM\14SER1.SGM 14SER1 061088 066104 * 56770 Federal Register / Vol. 77, No. 179 / Friday, September 14, 2012 / Rules and Regulations Drug labeler code Firm name and address * 061088 ........................... * * * * Eka Chemicals, Inc., 1850 Parkway Pl. SE., suite 1200, Marietta, GA 30067 * 066104 ........................... * * * * * * Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666 * * * 3. The authority citation for 21 CFR part 520 continues to read as follows: ■ Authority: 21 U.S.C. 360b. FOR FURTHER INFORMATION CONTACT: [Amended] 4. In paragraph (b)(2) of § 520.1265, remove ‘‘Nos. 057561, 059130, and 061623’’ and in its place add ‘‘Nos. 057561, 061623, and 066104’’. ■ § 520.2220a [Amended] 5. In paragraph (a)(2) of § 520.2220a, remove ‘‘Nos. 000069, 054925, 057561, 058829, 059130, and 061623’’ and in its place add ‘‘Nos. 000069, 054925, 057561, 058829, 061623, and 066104’’. ■ § 520.2455 [Amended] 6. In paragraph (b)(2) of § 520.2455, remove ‘‘No. 059130’’ and in its place add ‘‘No. 066104’’. ■ Dated: September 6, 2012. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. 2012–22646 Filed 9–13–12; 8:45 am] BILLING CODE 4160–01–P PENSION BENEFIT GUARANTY CORPORATION 29 CFR Parts 4022 and 4044 Allocation of Assets in SingleEmployer Plans; Benefits Payable in Terminated Single-Employer Plans; Interest Assumptions for Valuing and Paying Benefits Pension Benefit Guaranty Corporation. ACTION: Final rule. AGENCY: This final rule amends the Pension Benefit Guaranty Corporation’s regulations on Benefits Payable in Terminated Single-Employer Plans and Allocation of Assets in Single-Employer Plans to prescribe interest assumptions under the benefit payments regulation for valuation dates in October 2012 and interest assumptions under the asset allocation regulation for valuation dates in the fourth quarter of 2012. The wreier-aviles on DSK5TPTVN1PROD with RULES SUMMARY: VerDate Mar<15>2010 14:15 Sep 13, 2012 * interest assumptions are used for valuing and paying benefits under terminating single-employer plans covered by the pension insurance system administered by PBGC. DATES: Effective October 1, 2012. PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS § 520.1265 * Jkt 226001 Catherine B. Klion (Klion.Catherine@PBGC.gov), Manager, Regulatory and Policy Division, 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: PBGC’s regulations on Allocation of Assets in Single-Employer Plans (29 CFR Part 4044) and Benefits Payable in Terminated Single-Employer Plans (29 CFR Part 4022) prescribe actuarial assumptions—including interest assumptions—for valuing and paying plan benefits under terminating singleemployer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions in the regulations are also published on PBGC’s Web site (https:// www.pbgc.gov). The interest assumptions in Appendix B to Part 4044 are used to value benefits for allocation purposes under ERISA section 4044. PBGC uses the interest assumptions in Appendix B to Part 4022 to determine whether a benefit is payable as a lump sum and to determine the amount to pay. Appendix C to Part 4022 contains interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using PBGC’s historical methodology. Currently, the rates in Appendices B and C of the benefit payment regulation are the same. The interest assumptions are intended to reflect current conditions in the financial and annuity markets. Assumptions under the asset allocation regulation are updated quarterly; assumptions under the benefit payments regulation are updated monthly. This final rule updates the benefit payments interest assumptions for October 2012 PO 00000 Frm 00016 Fmt 4700 * Sfmt 4700 * * * and updates the asset allocation interest assumptions for the fourth quarter (October through December) of 2012. The fourth quarter 2012 interest assumptions under the allocation regulation will be 3.07 percent for the first 20 years following the valuation date and 3.00 percent thereafter. In comparison with the interest assumptions in effect for the third quarter of 2012, these interest assumptions represent no change in the select period (the period during which the select rate (the initial rate) applies), an increase of 0.12 percent in the select rate, and a decrease of 0.66 percent in the ultimate rate (the final rate). The October 2012 interest assumptions under the benefit payments regulation will be 0.75 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. In comparison with the interest assumptions in effect for September 2011, these interest assumptions are unchanged. 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 current market conditions as accurately as possible. Because of the need to provide immediate guidance for the valuation and payment of benefits under plans with valuation dates during October 2012, PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication. 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). E:\FR\FM\14SER1.SGM 14SER1

Agencies

[Federal Register Volume 77, Number 179 (Friday, September 14, 2012)]
[Rules and Regulations]
[Pages 56769-56770]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-22646]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520

[Docket No. FDA-2012-N-0002]


New Animal Drugs; Change of Sponsor; Change of Sponsor Address; 
Lincomycin and Spectinomycin Soluble Powder; Sulfadimethoxine Oral 
Solution and Soluble Powder; Tiamulin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor for three abbreviated 
new animal drug applications (ANADAs) from Teva Animal Health, Inc., to 
Phibro Animal Health Corp. FDA is also amending the regulations to 
reflect a change of sponsor's address for Phibro Animal Health Corp. 
and for Eka Chemicals, Inc.

DATES: This rule is effective September 14, 2012.

FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 
Standish Pl., Rockville, MD 20855, 240-276-8300, Email: 
steven.vaughn@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Teva Animal Health, Inc., 3915 South 48th 
Street Ter., St. Joseph, MO 64503, has informed FDA that it has 
transferred ownership of, and all rights and interest in, ANADA 200-258 
for Sulfadimethoxine Soluble Powder, ANADA 200-344 for Tiamulin Soluble 
Antibiotic, and ANADA 200-345 for Lincomycin-Spectinomycin Soluble 
Powder to Phibro Animal Health Corp., 65 Challenger Rd., 3d floor, 
Ridgefield Park, NJ 07660.
    In addition, Phibro Animal Health Corp. has informed FDA of a 
change of address to GlenPointe Centre East, 3d floor, 300 Frank W. 
Burr Blvd., suite 21, Teaneck, NJ 07666. Eka Chemicals, Inc., 1775 West 
Oak Commons Ct., Marietta, GA 30062 has informed FDA of a change of 
address to 1850 Parkway Pl. SE., suite 1200, Marietta, GA 30067. 
Accordingly, the Agency is amending the regulations in 21 CFR 510.600 
to reflect these changes.
    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.

    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.

0
2. In Sec.  510.600, in the table in paragraph (c)(1), revise the 
entries for ``Eka Chemicals, Inc.'' and ``Phibro Animal Health''; and 
in the table in paragraph (c)(2), revise the entries for ``061088'' and 
``066104'' to read as follows:


Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
               Firm name and address                  Drug labeler code
------------------------------------------------------------------------
 
                              * * * * * * *
Eka Chemicals, Inc., 1850 Parkway Pl. SE., suite                  061088
 1200, Marietta, GA 30067..........................
 
                              * * * * * * *
Phibro Animal Health Corp., GlenPointe Centre East,               066104
 3d floor, 300 Frank W. Burr Blvd., suite 21,
 Teaneck, NJ 07666.................................
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

[[Page 56770]]



------------------------------------------------------------------------
         Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
061088.............................  Eka Chemicals, Inc., 1850 Parkway
                                      Pl. SE., suite 1200, Marietta, GA
                                      30067
 
                              * * * * * * *
066104.............................  Phibro Animal Health Corp.,
                                      GlenPointe Centre East, 3d floor,
                                      300 Frank W. Burr Blvd., suite 21,
                                      Teaneck, NJ 07666
 
                              * * * * * * *
------------------------------------------------------------------------

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.  520.1265  [Amended]

0
4. In paragraph (b)(2) of Sec.  520.1265, remove ``Nos. 057561, 059130, 
and 061623'' and in its place add ``Nos. 057561, 061623, and 066104''.


Sec.  520.2220a  [Amended]

0
5. In paragraph (a)(2) of Sec.  520.2220a, remove ``Nos. 000069, 
054925, 057561, 058829, 059130, and 061623'' and in its place add 
``Nos. 000069, 054925, 057561, 058829, 061623, and 066104''.


Sec.  520.2455  [Amended]

0
6. In paragraph (b)(2) of Sec.  520.2455, remove ``No. 059130'' and in 
its place add ``No. 066104''.

    Dated: September 6, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-22646 Filed 9-13-12; 8:45 am]
BILLING CODE 4160-01-P

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