18648 Federal Register / Vol. 76, No. 65 / Tuesday, April 5, 2011 / Rules and Regulations 

earlier CPSC application included a 

reference to one of the required test 

methods. Previously CPSC-accepted 

third party conformity assessment 

bodies for 16 CFR part 1303 (including 

those that had one of the specified test 

methods in their accreditation scope 

document that was supplied with their 

earlier CPSC application) must reapply 

to maintain CPSC acceptance because 

the CPSC did not record references to 

test methods. If accepted, the third party 

conformity assessment body will remain 

on the list of accepted third party 

conformity bodies whose accreditations 

the CPSC has accepted for 16 CFR part 

1303. 

IV. Acceptance of Children’s Product 

Certifications Based on Third Party 

Conformity Assessment Body Testing to 

16 CFR Part 1303 

The September 22, 2008 Federal 

Register Notice of Requirements for 

Accreditation of Third Party Conformity 

Assessment Bodies to Assess 

Conformity with Part 1303 of Title 16, 

Code of Federal Regulations established 

that each manufacturer (including the 

importer) or private labeler of children’s 

products subject to the lead paint ban 

must have products that are 

manufactured after December 21, 2008 

tested by a laboratory accredited (by the 

CPSC) and must issue a certificate of 

compliance with the lead paint ban 

based upon that testing. 

This amended notice of requirements 

published today addresses only the 

CPSC acceptance criteria for a third 

party conformity assessment body for 

testing to the lead paint ban at 16 CFR 

part 1303. This amended notice does 

not affect the already-established 

criteria for CPSC acceptance of 

certificates of compliance. A product 

manufacturer’s certificate of compliance 

to 16 CFR part 1303 must be based on 

testing by a third party conformity 

assessment body that is posted on the 

CPSC Web site as accepted for 16 CFR 

part 1303 at the time the product is 

tested. The Commission will accept a 

certificate of compliance with 16 CFR 

part 1303, Ban of Lead-Containing Paint 

for a children’s product based on testing 

performed by an accredited (CPSCaccepted) third party conformity 

assessment body (including a 

government-owned or governmentcontrolled conformity assessment body, 

or a firewalled conformity assessment 

body) if the testing was conducted on a 

date for which the third party 

conformity assessment body was listed 

as accepted by the CPSC for testing to 

the lead paint ban at 16 CFR part 1303. 

Dated: March 30, 2011. 

Todd A. Stevenson, 

Secretary, Consumer Product Safety 

Commission. 

[FR Doc. 2011–7905 Filed 4–4–11; 8:45 am] 

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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; 

Robenacoxib 

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 original new animal drug 

application (NADA) filed by Novartis 

Animal Health US, Inc. The NADA 

provides for the veterinary prescription 

use of robenacoxib tablets in cats for the 

control of postoperative pain and 

inflammation. 

DATES: This rule is effective April 5, 

2011. 

FOR FURTHER INFORMATION CONTACT: 

Amy L. Omer, Center for Veterinary 

Medicine (HFV–114), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8336, 

e-mail: amy.omer@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Novartis 

Animal Health US, Inc., 3200 Northline 

Ave., suite 300, Greensboro, NC 27408, 

filed NADA 141–320 that provides for 

the veterinary prescription use of 

ONSIOR (robenacoxib) Tablets in cats 

for the control of postoperative pain and 

inflammation associated with 

orthopedic surgery, ovariohysterectomy, 

and castration. The NADA is approved 

as of March 8, 2011, and the regulations 

are amended in 21 CFR part 520 by 

adding § 520.2075 to reflect the 

approval. 

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. 

The agency has determined under 

21 CFR 25.33 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. 

Under section 512(c)(2)(F)(i) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360b(c)(2)(F)(i)), this 

approval qualifies for 5 years of 

marketing exclusivity beginning on the 

date of approval. 

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 

■ 1. The authority citation for 21 CFR 

part 520 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

■ 2. Add § 520.2075 to read as follows: 

§ 520.2075 Robenacoxib. 

(a) Specifications. Each tablet 

contains 6 milligrams (mg) robenacoxib. 

(b) Sponsors. See No. 058198 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use in cats—(1) 

Amount. Administer 0.45 mg per pound 

(/lb) (1 mg/kilogram (kg)) once daily. 

(2) Indications for use. For the control 

of postoperative pain and inflammation 

associated with orthopedic surgery, 

ovariohysterectomy, and castration in 

cats weighing at least 5.5 lb (2.5 kg) and 

at least 6 months of age; for up to a 

maximum of 3 days. 

(3) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

Dated: March 31, 2011. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2011–8053 Filed 4–4–11; 8:45 am] 

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WReier-Aviles on DSKGBLS3C1PROD with RULES