Oral Dosage Form New Animal Drugs; Fenbendazole Granules, 19429 [06-3586]

Download as PDF 19429 Rules and Regulations Federal Register Vol. 71, No. 72 Friday, April 14, 2006 This section of the FEDERAL REGISTER contains regulatory documents having general applicability and legal effect, most of which are keyed to and codified in the Code of Federal Regulations, which is published under 50 titles pursuant to 44 U.S.C. 1510. The Code of Federal Regulations is sold by the Superintendent of Documents. Prices of new books are listed in the first FEDERAL REGISTER issue of each week. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Fenbendazole Granules 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 a supplemental new animal drug application (NADA) filed by Intervet, Inc. The supplemental NADA provides for minor changes to the labeling of over-the-counter fenbendazole granules, used for the treatment and control of certain internal parasites in dogs. DATES: This rule is effective April 14, 2006. hsrobinson on PROD1PC61 with RULES FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for Veterinary Medicine (HFV–110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–7540, email: melanie.berson@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Intervet, Inc., P.O. Box 318, 29160 Intervet Lane, Millsboro, DE 19966, filed a supplement to NADA 121–473 that provides for over-the-counter use in dogs of SAFEGUARD (fenbendazole) Canine, orally administered granules used for the treatment and control of certain internal parasites. The supplemental NADA provides for minor changes to product labeling. The supplemental NADA is approved as of March 17, 2006, and the regulations are amended in 21 CFR 520.905b to reflect the approval. Approval of this supplemental NADA did not require review of additional safety or effectiveness data or VerDate Aug<31>2005 14:22 Apr 13, 2006 Jkt 208001 information. Therefore, a freedom of information summary is not required. The agency has determined under 21 CFR 25.33(d)(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. I Therefore, under the Federal Food, Drug, and Cosmetic Act and under the 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 1. The authority citation for 21 CFR part 520 continues to read as follows: I Authority: 21 U.S.C. 360b. § 520.905b [Amended] 2. In paragraph (d)(2)(ii) of § 520.905b, remove the word ‘‘removal’’ and add, in its place, the words ‘‘treatment and control’’. I Dated: April 6, 2006. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 06–3586 Filed 4–13–06; 8:45 am] BILLING CODE 4160–01–S PENSION BENEFIT GUARANTY CORPORATION 29 CFR Parts 4022 and 4044 Benefits Payable in Terminated SingleEmployer Plans; Allocation of Assets in Single-Employer Plans; Interest Assumptions for Valuing and Paying Benefits Pension Benefit Guaranty Corporation. ACTION: Final rule. AGENCY: SUMMARY: The Pension Benefit Guaranty Corporation’s regulations on Benefits PO 00000 Frm 00001 Fmt 4700 Sfmt 4700 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 May 2006. Interest assumptions are also published on the PBGC’s Web site (https://www.pbgc.gov). DATES: Effective May 1, 2006. 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 PBGC’s regulations prescribe actuarial assumptions—including interest assumptions—for valuing and paying plan benefits of terminating singleemployer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions are intended to reflect current conditions in the financial and annuity markets. Three sets of interest assumptions are prescribed: (1) A set for the valuation of benefits for allocation purposes under section 4044 (found in Appendix B to Part 4044), (2) a set for the PBGC to use to determine whether a benefit is payable as a lump sum and to determine lump-sum amounts to be paid by the PBGC (found in Appendix B to Part 4022), and (3) a set for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using the PBGC’s historical methodology (found in Appendix C to Part 4022). This amendment (1) Adds to Appendix B to Part 4044 the interest assumptions for valuing benefits for allocation purposes in plans with valuation dates during May 2006, (2) adds to Appendix B to Part 4022 the interest assumptions for the PBGC to use for its own lump-sum payments in plans with valuation dates during May 2006, and (3) adds to Appendix C to Part 4022 the interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using the E:\FR\FM\14APR1.SGM 14APR1

Agencies

[Federal Register Volume 71, Number 72 (Friday, April 14, 2006)]
[Rules and Regulations]
[Page 19429]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-3586]



========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 
Prices of new books are listed in the first FEDERAL REGISTER issue of each 
week.

========================================================================


Federal Register / Vol. 71, No. 72 / Friday, April 14, 2006 / Rules 
and Regulations

[[Page 19429]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Fenbendazole Granules

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 a supplemental new animal drug 
application (NADA) filed by Intervet, Inc. The supplemental NADA 
provides for minor changes to the labeling of over-the-counter 
fenbendazole granules, used for the treatment and control of certain 
internal parasites in dogs.

DATES: This rule is effective April 14, 2006.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail: 
melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Intervet, Inc., P.O. Box 318, 29160 Intervet 
Lane, Millsboro, DE 19966, filed a supplement to NADA 121-473 that 
provides for over-the-counter use in dogs of SAFE-GUARD (fenbendazole) 
Canine, orally administered granules used for the treatment and control 
of certain internal parasites. The supplemental NADA provides for minor 
changes to product labeling. The supplemental NADA is approved as of 
March 17, 2006, and the regulations are amended in 21 CFR 520.905b to 
reflect the approval.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    The agency has determined under 21 CFR 25.33(d)(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 the 
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.  520.905b  [Amended]

0
2. In paragraph (d)(2)(ii) of Sec.  520.905b, remove the word 
``removal'' and add, in its place, the words ``treatment and control''.

    Dated: April 6, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 06-3586 Filed 4-13-06; 8:45 am]
BILLING CODE 4160-01-S

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.