Oral Dosage Form New Animal Drugs; Change of Sponsor, 40229 [2011-17151]

Download as PDF Federal Register / Vol. 76, No. 131 / Friday, July 8, 2011 / Rules and Regulations §§ 240.12a–10T and 240.12h–1 eligible to meet the requirements of these exemptions is a small entity. [Amended] 5. In § 240.12a–10T(b), remove the words ‘‘July 16, 2011’’ and add, in their place, the words ‘‘April 16, 2012’’. ■ 6. In § 240.12h–1(h)T, in the last sentence, remove the words ‘‘July 16, 2011’’ and add, in their place, the words ‘‘April 16, 2012’’. ■ VIII. Statutory Authority and Text of the Rules and Amendments The amendments described in this release are being adopted under the authority set forth in Sections 18, 19 and 28 of the Securities Act; Sections 12(h), 23(a) and 36 of the Exchange Act; and Section 304(d) of the TIA. List of Subjects in 17 CFR Parts 230, 240 and 260 PART 260—GENERAL RULES AND REGULATIONS, TRUST INDENTURE ACT OF 1939 7. The authority citation for part 260 continues to read as follows: ■ Reporting and recordkeeping requirements, Securities. Authority: 15 U.S.C. 77eee, 77ggg, 77nnn, 77sss, 78ll(d), 80b–3, 80b–4, and 80b–11. Text of the Rules and Amendments * We are temporarily amending 17 CFR parts 230, 240, and 260 as follows and the expiration dates in the temporary rules and amendments published January 22, 2009 (74 FR 3967), extended in a release published on September 17, 2009 (74 FR 47719), and further extended in a release published on November 26, 2010 (75 FR 72660), are further extended from July 16, 2011 to April 16, 2012. PART 230—GENERAL RULES AND REGULATIONS, SECURITIES ACT OF 1933 1. The authority citation for part 230 continues to read, in part, as follows: * * § 260.4d–11T * * [Amended] 8. In § 260.4d–11T, in the last sentence, remove the words ‘‘July 16, 2011’’ and add, in their place, the words ‘‘April 16, 2012’’. ■ [FR Doc. 2011–17132 Filed 7–7–11; 8:45 am] §§ 230.146 and 230.239T [Amended] 2. In § 230.146(c)T, in the last sentence, remove the words ‘‘July 16, 2011’’ and add, in their place, the words ‘‘April 16, 2012’’. ■ 3. In § 230.239T(e), remove the words ‘‘July 16, 2011’’ and add, in their place, the words ‘‘April 16, 2012’’. ■ PART 240—GENERAL RULES AND REGULATIONS, SECURITIES EXCHANGE ACT OF 1934 4. The authority citation for part 240 continues to read, in part, as follows: wreier-aviles on DSKGBLS3C1PROD with RULES ■ 15:25 Jul 07, 2011 Jkt 223001 [Amended] 2. In paragraph (b)(2) of § 520.2045, remove ‘‘051311’’ and in its place add ‘‘061623’’. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: July 1, 2011. Elizabeth Rettie, Deputy Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 2011–17151 Filed 7–7–11; 8:45 am] 21 CFR Part 520 BILLING CODE 4160–01–P [Docket No. FDA–2011–N–0003] AGENCY: Food and Drug Administration, HHS. ACTION: Bureau of Prisons [BOP–1088–F] The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) from Virbac AH, Inc., to Cross Vetpharm Group Ltd. DATES: This rule is effective July 8, 2011. SUMMARY: FOR FURTHER INFORMATION CONTACT: PO 00000 DEPARTMENT OF JUSTICE 28 CFR Part 549 Final rule. Steven D. Vaughn, Center for Veterinary Medicine (HFV–100), Food and Drug Authority: 15 U.S.C. 77c, 77d, 77g, 77j, Administration, 7520 Standish Pl., 77s, 77z–2, 77z–3, 77eee, 77ggg, 77nnn, Rockville, MD 20855, 240–276–8300, e77sss, 77ttt, 78c, 78d, 78e, 78f, 78g, 78i, 78j, mail: steven.vaughn@fda.hhs.gov. 78j–1, 78k, 78k–1, 78l, 78m, 78n, 78o, 78o– SUPPLEMENTARY INFORMATION: Virbac 4, 78p, 78q, 78s, 78u–5, 78w, 78x, 78ll, 78mm, 80a–20, 80a–23, 80a–29, 80a–37, 80b– AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137, has informed FDA 3, 80b–4, 80b–11, and 7201 et seq.; and 18 U.S.C. 1350; and 12 U.S.C. 5221(e)(3) unless that it has transferred ownership of, and otherwise noted. all rights and interest in, NADA 092– 150 for Purina Horse & Colt Wormer * * * * * VerDate Mar<15>2010 § 520.2045 ■ BILLING CODE 8011–01–P Oral Dosage Form New Animal Drugs; Change of Sponsor * PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS Authority: 21 U.S.C. 360b. * * List of Subjects 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: 1. The authority citation for 21 CFR part 520 continues to read as follows: Food and Drug Administration * (pyrantel tartrate) to Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland. Accordingly, the regulations are amended in 21 CFR 520.2045 to reflect the transfer of ownership. 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. ■ By the Commission. Dated: July 1, 2011. Elizabeth M. Murphy, Secretary. Authority: 15 U.S.C. 77b, 77c, 77d, 77f, 77g, 77h, 77j, 77r, 77s, 77z–3, 77sss, 78c, 78d, 78j, 78l, 78m, 78n, 78o, 78t, 78w, 78ll(d), 78mm, 80a–8, 80a–24, 80a–28, 80a–29, 80a– 30, and 80a–37, unless otherwise noted. * 40229 Frm 00013 Fmt 4700 Sfmt 4700 RIN 1120–AB20 Psychiatric Evaluation and Treatment Bureau of Prisons, Justice. Final rule. AGENCY: ACTION: In this document, the Bureau of Prisons (Bureau) finalizes regulations on providing psychiatric treatment and medication to inmates. These revised regulations are clarified and updated to reflect current caselaw. DATES: This rule is effective on August 12, 2011. FOR FURTHER INFORMATION CONTACT: Sarah Qureshi, Office of General Counsel, Bureau of Prisons, phone (202) 307–2105. SUPPLEMENTARY INFORMATION: The Bureau finalizes regulations on SUMMARY: E:\FR\FM\08JYR1.SGM 08JYR1

Agencies

[Federal Register Volume 76, Number 131 (Friday, July 8, 2011)]
[Rules and Regulations]
[Page 40229]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17151]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2011-N-0003]


Oral Dosage Form New Animal Drugs; Change of Sponsor

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 a new animal drug 
application (NADA) from Virbac AH, Inc., to Cross Vetpharm Group Ltd.

DATES: This rule is effective July 8, 2011.

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, e-mail: 
steven.vaughn@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Virbac AH, Inc., 3200 Meacham Blvd., Ft. 
Worth, TX 76137, has informed FDA that it has transferred ownership of, 
and all rights and interest in, NADA 092-150 for Purina Horse & Colt 
Wormer (pyrantel tartrate) to Cross Vetpharm Group Ltd., Broomhill Rd., 
Tallaght, Dublin 24, Ireland. Accordingly, the regulations are amended 
in 21 CFR 520.2045 to reflect the transfer of ownership.
    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.

    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.  520.2045  [Amended]

0
2. In paragraph (b)(2) of Sec.  520.2045, remove ``051311'' and in its 
place add ``061623''.

    Dated: July 1, 2011.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 2011-17151 Filed 7-7-11; 8:45 am]
BILLING CODE 4160-01-P

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