Federal Register / Vol. 76, No. 65 / Tuesday, April 5, 2011 / Rules and Regulations 18645 

disseminating any record about an 

individual, to ensure that the record is 

accurate, relevant, timely, and complete; 

(g) Maintain no record describing how 

an individual exercises his or her First 

Amendment rights unless such 

maintenance is expressly authorized by 

statute or by the individual about whom 

the record is maintained or is pertinent 

to and within the scope of an authorized 

law enforcement activity; 

(h) When required by the Privacy Act, 

maintain an accounting in the specified 

form of all disclosures of records by the 

agency to persons, organizations, or 

agencies; 

(i) Maintain and use records with care 

in order to prevent the unauthorized or 

inadvertent disclosure of a record to 

anyone; and 

(j) Notify the appropriate agency 

official of any record that contains 

information that the Privacy Act does 

not permit the agency to maintain. 

§ 304.33 Preservation of records. 

The agency will preserve all 

correspondence pertaining to the 

requests that it receives under this 

subpart, as well as copies of all 

requested records, until disposition or 

destruction is authorized by title 44 of 

the United States Code or the National 

Archives and Records Administration’s 

General Records Schedule 14. Records 

will not be disposed of while they are 

the subject of a pending request, appeal, 

or lawsuit under the Act. 

§ 304.34 Other rights and services. 

Nothing in this subpart shall be 

construed to entitle any person, as of 

right, to any service or to the disclosure 

of any record to which such person is 

not entitled under the Privacy Act. 

Dated: March 30, 2011. 

Shawne C. McGibbon, 

General Counsel. 

[FR Doc. 2011–7976 Filed 4–4–11; 8:45 am] 

BILLING CODE 6110–01–P 

CONSUMER PRODUCT SAFETY 

COMMISSION 

16 CFR Part 1303 

[CPSC Docket No. CPSC–2008–0033] 

Third Party Testing for Certain 

Children’s Products; Notice of 

Requirements for Accreditation of 

Third Party Conformity Assessment 

Bodies—Lead Paint 

AGENCY: U.S. Consumer Product Safety 

Commission. 

ACTION: Notice of requirements; revision 

of testing terms. 

SUMMARY: The U.S. Consumer Product 

Safety Commission (‘‘CPSC,’’ 

‘‘Commission,’’ or ‘‘we’’) is amending the 

criteria and process for Commission 

acceptance of accreditation of third 

party conformity assessment bodies for 

testing to the lead paint ban regulations. 

We are taking this action to require 

CPSC and/or ASTM published test 

methods to be referenced by a third 

party conformity assessment body in the 

scope of its accreditation. 

DATES: Effective date: The revised 

requirements are effective April 5, 2011. 

Comment date: Comments in 

response to this notice of requirements 

should be submitted by May 5, 2011. 

Comments on this notice should be 

captioned, ‘‘Third Party Testing for 

Certain Children’s Products; 

Requirements for Accreditation of Third 

Party Conformity Assessment Bodies— 

Lead Paint.’’ 

ADDRESSES: You may submit comments, 

identified by Docket No. CPSC–2008– 

0033, by any of the following methods: 

Electronic Submissions: Submit 

electronic comments in the following 

way: 

Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

To ensure timely processing of 

comments, the Commission is no longer 

accepting comments submitted by 

electronic mail (e-mail) except through 

http://www.regulations.gov. 

Written Submissions: Submit written 

submissions in the following way: 

Mail/Hand delivery/Courier (for 

paper, disk, or CD–ROM submissions) 

preferably in five copies, to: Office of the 

Secretary, U.S. Consumer Product 

Safety Commission, Room 820, 4330 

East West Highway, Bethesda, MD 

20814; telephone (301) 504–7923. 

Instructions: All submissions received 

must include the agency name and 

docket number for this notice. All 

comments received may be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. Do not 

submit confidential business 

information, trade secret information, or 

other sensitive or protected information 

(such as a Social Security Number) 

electronically; if furnished at all, such 

information should be submitted in 

writing. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Robert ‘‘Jay’’ Howell, Assistant Executive 

Director for he Office of Hazard 

Identification and Reduction, U.S. 

Consumer Product Safety Commission, 

4330 East West Highway, Bethesda, MD 

20814; e-mail: rhowell@cpsc.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 14(a)(3)(B)(i) of the Consumer 

Product Safety Act (CPSA), as added by 

section 102(a)(2) of the Consumer 

Product Safety Improvement Act of 

2008 (CPSIA), Public Law 110–314, 

directed the CPSC to publish a notice of 

requirements for accreditation of third 

party conformity assessment bodies to 

test children’s products for conformity 

with the Commission’s regulations at 16 

CFR part 1303, Ban of Lead-Containing 

Paint and Certain Consumer Products 

Bearing Lead-Containing Paint (the lead 

paint ban). In the Federal Register of 

September 22, 2008, the Commission 

published a notice of requirements for 

accreditation of third party conformity 

assessment bodies to test children’s 

products for conformity with the lead 

paint ban under 16 CFR part 1303 

(73 FR 54564). 

In response to the September 22, 2008 

notice of requirements, the International 

Laboratory Accreditation Cooperation 

(ILAC) and the American Association 

for Laboratory Accreditation (A2LA) 

submitted letters asking us to specify 

test methods to ensure that accreditation 

bodies are able to determine the 

acceptable technologies and methods for 

lead analyses. The September 22, 2008 

notice of requirements stated that the 

accreditation must be to the 

International Standards Organization 

(ISO)/International Electrotechnical 

Commission (IEC) Standard ISO/IEC 

17025:2005, ‘‘General Requirements for 

the Competence of Testing and 

Calibration Laboratories,’’ and that the 

scope of the accreditation must include 

testing to the requirements of 16 CFR 

part 1303. However, these requirements 

for accreditation did not reference a 

specific test method, although the CPSC 

staff’s test method (CPSC–CH–E1003– 

09) was made available on the CPSC 

Web site at: http://www.cpsc.gov/about/ 

cpsia/CPSC-CH-E1003-09.pdf. 

Therefore, to require certain test 

methods that are acceptable to the CPSC 

for testing for lead in paint, we are 

amending the notice of requirements to 

state that the scope of the third party 

conformity assessment body’s 

accreditation shall specify certain test 

methodologies. 

The Commission is revising the 

September 22, 2008 notice of 

requirements to require reference of 

specific test methods for CPSC 

acceptance of accreditation of third 

party conformity assessment bodies to 

assess conformity with 16 CFR part 

WReier-Aviles on DSKGBLS3C1PROD with RULES

18646 Federal Register / Vol. 76, No. 65 / Tuesday, April 5, 2011 / Rules and Regulations 

1303. One or more of the following test 

methods must be referenced: The 

existing CPSC Standard Operating 

Procedure for Determining Lead (Pb) in 

Paint and Other Similar Surface 

Coatings, CPSC–CH–E1003–09 and/or 

CPSC–CH–E1003–09.1 and/or, ASTM 

F2853–10, ‘‘Standard Test Method for 

Determination of Lead in Paint Layers 

and Similar Coatings or in Substrates 

and Homogenous Materials by Energy 

Dispersive X-Ray Fluorescence 

Spectrometry Using Multiple 

Monochromatic Excitation Beams.’’ 

Test Method CPSC–CH–E1003–09 

was revised in Test Method CPSC–CH– 

E1003–09.1 to reflect ministerial edits 

and remove the statement that the rules 

for accreditation for lead in paint testing 

do not explicitly require the use of a 

particular standard operating procedure. 

Additionally, the following statement 

was added. ‘‘Adjustments may be 

necessary to achieve total digestion for 

certain paints and should be based on 

sound chemistry knowledge and 

appropriate acids for the sample 

material being analyzed.’’ It is still based 

on standard test procedures, such as 

ASTM International (formerly the 

American Society for Testing and 

Materials) ASTM E1645, ASTM 

E1613–04, and Association of Official 

Analytical Chemists (AOAC) standard 

AOAC 974.02. This test method will be 

made available on the CPSC Web site at: 

http://www.cpsc.gov/about/cpsia/CPSC– 

CH–E1003–09_1.pdf. 

In addition to the CPCS’s test 

methods, CPSC staff finds that ASTM 

F2853–10, ‘‘Standard Test Method for 

Determination of Lead in Paint Layers 

and Similar Coatings or in Substrates 

and Homogenous Materials by Energy 

Dispersive X-Ray Fluorescence 

Spectrometry Using Multiple 

Monochromatic Excitation Beams.’’ 

which uses a specific type of X-Ray 

Fluorescence (XRF) technology, may be 

used as a test method and is as effective, 

precise, and reliable as method 

CPSC–CH–E1003–09 posted on the 

CPSC Web site. The standard is 

available on the ASTM Web site at: 

http://www.astm.org/Standards/ 

F2853.htm. Supporting data about the 

associated interlaboratory research 

report has been filed with ASTM and 

can be obtained by contacting ASTM 

and requesting Research Report RR:F40– 

1001. Our findings are based on a study 

conducted in August 2009, as updated 

in December 2010, which evaluates the 

effectiveness, precision, and reliability 

of XRF methods and other alternative 

methods for measuring lead in paint or 

other surface coatings when used in 

children’s products. The studies on XRF 

are published on the CPSC’s Web site at: 

http://www.cpsc.gov/ABOUT/Cpsia/ 

leadinpaintmeasure.pdf and http:// 

www.cpsc.gov/ABOUT/Cpsia/ 

leadinpaintmeasure_update.pdf. XFR 

methods and equipment other than 

those specified in ASTM F2853–10 are 

not considered effective for testing in 

paint and surface coatings for the 

purpose of determining conformity with 

16 CFR part 1303 at this time. We are 

working with the National Institute of 

Standards and Technology (NIST) to 

develop and release a lead in paint 

standard reference material (SRM) 2569, 

consisting of a thin, uniform film with 

thickness and lead concentrations 

appropriate to testing of painted 

surfaces, and which would be suitable 

for validating ASTM F2853–10. This 

SRM may become available in 2011. We 

also are aware that other commercial 

reference materials are now available 

that may be suitable for validating 

ASTM F2853–10. 

Many third party conformity 

assessment bodies operate on a two year 

cycle for review and renewal of 

accreditation. Accordingly, in order to 

give third party conformity assessment 

bodies sufficient time to amend their 

scope documents to reflect the specific 

test methods accepted by the 

Commission, CPSC–CH–E1003–09 

and/or CPSC–CH–E1003–09.1 and/or 

ASTM F2853–10, CPSC-accepted third 

party conformity assessment bodies that 

are listed on the CPSC Web site as 

approved to 16 CFR part 1303 (without 

reference to a test method) will have 

two years from the date of publication 

of this notice in the Federal Register to 

reapply and be accepted by the CPSC for 

CPSC–CH–E1003–09 and/or CPSC–CH– 

E1003–09.1 and/or ASTM F2853–10 for 

testing to the lead in paint regulation at 

16 CFR part 1303. After that date, 

previously accepted third party 

conformity assessment bodies that test 

for 16 CFR part 1303 must have been 

accepted by the CPSC for one or more 

of the required test methods to maintain 

CPSC-accepted status. All accreditations 

must be by an accreditation body that is 

a signatory to the International 

Laboratory Accreditation Cooperation— 

Mutual Recognition Arrangement 

(ILAC–MRA) and the scope of the 

accreditation must include: 

• 16 CFR part 1303 (CPSC–CH– 

E1003–09 and/or CPSC–CH–E1003– 

09.1), and/or 

• 16 CFR part 1303 (ASTM F2853– 

10). 

New applicants seeking CPSC 

acceptance of accreditation to test to 

16 CFR part 1303 will have the option 

to apply without reference to a specific 

test method under 16 CFR part 1303 or 

to apply to the CPSC for acceptance to 

test to 16 CFR part 1303 according to 

one or more test methods for up to one 

year after publication of this notice in 

the Federal Register. After one year 

from the publication of this notice in the 

Federal Register, the option for third 

party conformity assessment bodies to 

apply for CPSC-acceptance of 

accreditation to 16 CFR part 1303 

without reference to a CPSC required 

test method will not be permitted. 

To make it easier for interested parties 

to understand the nature of the 

revisions, we are republishing the notice 

of requirements in its entirety for 

readability. The republished notice 

incorporates several nonsubstantive 

changes or grammatical changes, such 

as replacing the term ‘‘laboratory’’ with 

‘‘third party conformity assessment 

body.’’ These changes were made to 

make the notice of requirements 

consistent with other recent notices of 

requirements published in the Federal 

Register. See, e.g., Third Party Testing 

for Certain Children’s Products; 

Children’s Sleepwear, Sizes 0 Through 

6X and 7 Through 14: Requirements for 

Accreditation of Third Party Conformity 

Assessment Bodies, (75 FR 70911 

(November 19, 2010)); Third Party 

Testing for Certain Children’s Products; 

Youth All-Terrain Vehicles: 

Requirements for Accreditation of Third 

Party Conformity Assessment Bodies, 

(75 FR 52616 (August 27, 2010)). 

II. Accreditation Requirements 

The notice of requirements that 

appeared in the Federal Register on 

September 22, 2008 (73 FR 5456) is 

amended to read as follows: 

A. Baseline Third Party Conformity 

Assessment Body Accreditation 

Requirements 

For a third party conformity 

assessment body to be CPSC-accepted as 

accredited to test children’s products for 

conformity with the lead paint ban and 

16 CFR part 1303, it must be accredited 

to ISO/IEC 17025–2005 by an 

accreditation body that is a signatory to 

the ILAC–MRA, and the accreditation 

must be registered with, and accepted 

by, the Commission. A listing of 

ILAC–MRA signatory accreditation 

bodies is available on the Internet at: 

http://ilac.org/membersbycategory.html. 

The scope of the accreditation must 

include 16 CFR part 1303 (CPSC–CH– 

E1003–09 and/or CPSC–CH–E1003– 

09.1) and/or 16 CFR part 1303 (ASTM 

F2853–10). 

The Commission will maintain on its 

Web site an up-to-date listing of third 

party conformity assessment bodies 

whose accreditations it has accepted 

and the scope of each accreditation. 

WReier-Aviles on DSKGBLS3C1PROD with RULES

Federal Register / Vol. 76, No. 65 / Tuesday, April 5, 2011 / Rules and Regulations 18647 

Once the Commission adds a third party 

conformity assessment body to that list, 

the third party conformity assessment 

body may commence testing of 

children’s products to support the 

manufacturer’s certification that the 

product complies with 16 CRF part 

1303. 

B. Additional Accreditation 

Requirements for Firewalled Conformity 

Assessment Bodies 

In addition to the baseline 

accreditation requirements in Section 

II.A of this document above, firewalled 

conformity assessment bodies seeking 

accredited status by the CPSC must 

submit to the Commission copies, in 

English, of their training documents, 

showing how employees are trained to 

notify the Commission immediately and 

confidentially of any attempt by the 

manufacturer, private labeler, or other 

interested party to hide or exert undue 

influence over the third party 

conformity assessment body’s test 

results. This additional requirement 

applies to any third party conformity 

assessment body in which a 

manufacturer or private labeler of a 

children’s product to be tested by the 

third party conformity assessment body 

owns an interest of 10 percent or more. 

While the Commission is not addressing 

common parentage of a third party 

conformity assessment body and a 

children’s product manufacturer at this 

time, it will be vigilant to see whether 

this issue needs to be addressed in the 

future. 

As required by section 14(f)(2)(D) of 

the CPSA, the Commission must accept 

formally, by order, the application from 

a third party conformity assessment 

body before the third party conformity 

assessment body can become accredited 

by the CPSC as a firewalled conformity 

assessment body. 

C. Additional Accreditation 

Requirements for Governmental 

Conformity Assessment Bodies 

In addition to the baseline 

accreditation requirements of part II.A 

of this document above, the CPSIA 

permits accreditation of a third party 

conformity assessment body owned or 

controlled, in whole or in part, by a 

government if: 

• To the extent practicable, 

manufacturers or private labelers 

located in any nation are permitted to 

choose conformity assessment bodies 

that are not owned or controlled by the 

government of that nation; 

• The third party conformity 

assessment body’s testing results are not 

subject to undue influence by any other 

person, including another governmental 

entity; 

• The third party conformity 

assessment body is not accorded more 

favorable treatment than other third 

party conformity assessment bodies in 

the same nation who have been 

accredited; 

• The third party conformity 

assessment body’s testing results are 

accorded no greater weight by other 

governmental authorities than those of 

other accredited third party conformity 

assessment bodies; and 

• The third party conformity 

assessment body does not exercise 

undue influence over other 

governmental authorities on matters 

affecting its operations or on decisions 

by other governmental authorities 

controlling distribution of products 

based on outcomes of the third party 

conformity assessment body’s 

conformity assessments. 

The Commission will accept the 

accreditation of a governmental third 

party conformity assessment body if it 

meets the baseline accreditation 

requirements of part II.A of this 

document above and meets the 

additional conditions stated here. To 

obtain this assurance, CPSC staff will 

engage the governmental entities 

seeking accreditation. 

III. How does a third party conformity 

assessment body apply for acceptance 

of its accreditation? 

The Commission has established an 

electronic accreditation acceptance and 

registration system accessed via the 

Commission’s Internet site at: http:// 

www.cpsc.gov/about/cpsia/ 

labaccred.html. The applicant provides, 

in English, basic identifying information 

concerning its location, the type of 

accreditation it is seeking, and 

electronic copies of its accreditation 

certificate and scope statement by its 

ILAC–MRA signatory accreditation 

body, and firewalled third party 

conformity assessment body training 

document(s), if relevant. 

Commission staff will review the 

submission for accuracy and 

completeness. In the case of baseline 

third party conformity assessment 

bodies and government-owned or 

government-operated conformity 

assessment bodies, when that review 

and any necessary discussions with the 

applicant are completed satisfactorily, 

the third party conformity assessment 

body in question is added to the CPSC’s 

list of accredited third party conformity 

assessment bodies at: http:// 

www.cpsc.gov/about/cpsia/ 

labaccred.html. In the case of a 

firewalled conformity assessment body 

seeking accredited status, when the 

CPSC staff’s review is complete, the 

CPSC staff transmits its 

recommendation on accreditation to the 

Commission for consideration. (A third 

party conformity assessment body that 

ultimately may seek acceptance as a 

firewalled third party conformity 

assessment body also initially can 

request acceptance as a third party 

conformity assessment body accredited 

for testing of children’s products other 

than those of its owners.) If the 

Commission accepts a CPSC staff 

recommendation to accredit a firewalled 

conformity assessment body, the 

firewalled conformity assessment body 

will be added to the CPSC’s list of 

accredited third party conformity 

assessment bodies. In each case, the 

Commission will notify the third party 

conformity assessment body 

electronically of acceptance of its 

accreditation. All information to 

support an accreditation acceptance 

request must be provided in the English 

language. 

Once the Commission adds a third 

party conformity assessment body to the 

list, the third party conformity 

assessment body then may begin testing 

children’s products to support 

certification of compliance with 16 CFR 

part 1303, for which it has been 

accredited. 

New applicants for CPSC acceptance 

of accreditation to 16 CFR part 1303 will 

have the option to apply to the CPSC 

without reference to a specific test 

method or to apply for CPSC acceptance 

to include a specific reference to 16 CFR 

part 1303 (CPSC–CH–E1003–09 and/or 

CPSC–CH–E1003–09.1) and/or 16 CFR 

part 1303 (ASTM F2853–10) for up to 

one year after publication of this notice 

in the Federal Register. After one year, 

the option to apply for accreditation to 

16 CFR part 1303 without reference to 

a CPSC required test method will not be 

permitted. 

CPSC-accepted third party conformity 

assessment bodies for 16 CFR part 1303 

without a reference to one of the 

specified test methods have up to two 

years from the date of publication of this 

notice in the Federal Register to reapply 

and become accepted by the CPSC for 

16 CFR part 1303 (CPSC–CH–E1003–09 

and/or CPSC–CH–E1003–09.1) and/or 

16 CFR part 1303 (ASTM F2853–10). To 

maintain CPSC-accepted status, third 

party conformity assessment bodies that 

are CPSC-accepted for 16 CFR part 1303 

without reference to one of the required 

test methods must reapply with, and be 

accepted by, the CPSC within the twoyear period, irrespective of whether the 

scope document from their accreditation 

body that was supplied with their 

WReier-Aviles on DSKGBLS3C1PROD with RULES

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] 

BILLING CODE 6355–01–P 

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] 

BILLING CODE 4160–01–P 

WReier-Aviles on DSKGBLS3C1PROD with RULES