22610 Federal Register / Vol. 76, No. 78 / Friday, April 22, 2011 / Rules and Regulations 

1610. A continuing guaranty remains 

valid for three years (and at such other 

times as any change occurs in the legal 

business status of the person filing the 

guaranty). 

III. The Response to the Requests 

A. Request To Extend the Testing and 

Certification Date by an Additional 60 

Days 

We decline to extend the date by 

which a manufacturer of a children’s 

product subject to 16 CFR part 1610 

must have such product tested by a 

third party conformity assessment body 

accredited to do so and must issue a 

certificate of compliance based on that 

testing. We have the authority to grant 

such a request only if there is 

insufficient laboratory capacity. The 

existence of 67 CPSC-accepted labs 

accredited to test to 16 CFR part 1610 

as of November 16, 2010, belies the 

claim of insufficient laboratory capacity, 

even if the laboratories are not 

distributed geographically as the AAFA 

would prefer. 

We also disagree with the AAFA’s 

assertion, as another basis for an 

extension, that some manufacturers are 

not fully aware that children’s product 

certifications must be based on testing 

conducted by CPSC-accepted third party 

laboratories, and that many companies 

are unaware that the stay of enforcement 

on the testing and certification 

requirements had been lifted for 

children’s apparel. The CPSIA became 

law in August 2008, and we published 

the notice of requirements pertaining to 

16 CFR part 1610 in the Federal 

Register on August 18, 2010. The 

statute’s existence, as well as the 

publication of the notice of 

requirements for 16 CFR part 1610, 

provided notice of these manufacturers’ 

legal obligations. Additionally, the 

Commission encourages the apparel and 

textile trade associations to educate the 

industry on their obligations under the 

CPSIA and FFA. 

Finally, we note that section 

14(a)(3)(E) of the CPSA authorizes the 

Commission to extend the deadline for 

certification ‘‘by not more than 60 days.’’ 

Such a time period is measured from the 

date on which such certification would 

have been required. In this case, the 

certification requirement became 

effective for products manufactured 

after November 16, 2010; therefore, a 60- 

day extension, had it been granted, 

would have expired in mid-January 

2011. Thus, the AAFA’s request for an 

extension is moot. 

B. Request To Accept, for Children’s 

Product Certification Purposes, Tests 

Pursuant to 16 CFR Part 1610 

Conducted by Accredited Third Party 

Laboratories Since August 18, 2009 

We have considered AAFA’s request 

and, through this notice, are revising 

our position regarding ‘‘Limited 

Acceptance of Children’s Product 

Certifications Based on Third Party 

Conformity Assessment Body Testing 

Prior to the Commission’s Acceptance of 

Accreditation.’’ Due to the nature of the 

wearing apparel industry, there is a 

possible significant time lapse between 

fabric testing and the finished garment. 

This could mean that some products 

that were tested previously by 

laboratories that have since become 

CPSC-accepted, would need to be 

retested. Therefore, we agree that 

revising our position on ‘‘retrospective’’ 

testing is appropriate because it will 

reduce further the potential need for 

redundant testing. We will accept 

children’s product certifications based 

on third party conformity assessment 

body testing, prior to our acceptance of 

accreditation, under the following 

conditions: 

• At the time of product testing, the 

product was tested by a third party 

conformity assessment body that was 

ISO/IEC 17025 accredited by an 

accreditation body that is a signatory to 

the ILAC–MRA; 

• The third party conformity 

assessment body’s application for 

testing using the test methods in 16 CFR 

part 1610 is accepted by the CPSC on or 

before November 16, 2010; 

• The product was tested under 16 

CFR part 1610 on or after August 18, 

2009; 

• The accreditation scope in effect for 

the third party conformity assessment 

body at the time of testing expressly 

included testing to 16 CFR part 1610; 

• The test results show compliance 

with the applicable current standards 

and/or regulations; and 

• The third party conformity 

assessment body’s accreditation, 

including inclusion in its scope of 16 

CFR part 1610, remains in effect through 

the effective date for mandatory third 

party testing and manufacturer 

certification for conformity with 16 CFR 

part 1610. 

Dated: April 19, 2011. 

Todd A. Stevenson, 

Secretary, Consumer Product Safety 

Commission. 

[FR Doc. 2011–9790 Filed 4–21–11; 8:45 am] 

BILLING CODE 6355–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 522 

[Docket No. FDA–2011–N–0003] 

Implantation or Injectable Dosage 

Form New Animal Drugs; Enrofloxacin 

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 Bayer 

HealthCare LLC. The supplemental 

NADA provides for the addition of a 

pathogen to the indications for use of 

enrofloxacin solution in cattle, as a 

single injection, for the treatment of 

respiratory disease. 

DATES: This rule is effective April 22, 

2011. 

FOR FURTHER INFORMATION CONTACT: 

Cindy L. Burnsteel, Center for 

Veterinary Medicine (HFV–130), Food 

and Drug Administration, 7500 Standish 

Pl., Rockville, MD 20855, 240–276– 

8341, e-mail: 

cindy.burnsteel@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Bayer 

HealthCare LLC, Animal Health 

Division, P.O. Box 390, Shawnee 

Mission, KS 66201, filed a supplement 

to NADA 141–068 for BAYTRIL 100 

(enrofloxacin), an injectable solution. 

The supplemental NADA provides for 

the addition of Mycoplasma bovis to the 

pathogens in the indication for use of 

enrofloxacin solution in cattle, as a 

single injection, for the treatment of 

bovine respiratory disease (BRD). The 

supplemental NADA is approved as of 

March 10, 2011, and the regulation in 21 

CFR 522.812 is amended to reflect the 

approval. 

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and § 514.11(e)(2)(ii), 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. 

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

Federal Food, Drug, and Cosmetic Act 

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

supplemental approval qualifies for 3 


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Federal Register / Vol. 76, No. 78 / Friday, April 22, 2011 / Rules and Regulations 22611 

years of marketing exclusivity beginning 

on the date of approval. 

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. 

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 522 

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 522 is amended as follows: 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 522 continues to read as follows: 

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

■ 2. In § 522.812, revise paragraph 

(e)(2)(ii) to read as follows: 

§ 522.812 Enrofloxacin. 

* * * * * 

(e) * * * 

(2) * * * 

(ii) Indications for use—(A) Singledose therapy: For the treatment of 

bovine respiratory disease (BRD) 

associated with Mannheimia 

haemolytica, Pasteurella multocida, 

Histophilus somni, and Mycoplasma 

bovis in beef and non-lactating dairy 

cattle. 

(B) Multiple-day therapy: For the 

treatment of bovine respiratory disease 

(BRD) associated with Mannheimia 

haemolytica, Pasteurella multocida, and 

Histophilus somni in beef and nonlactating dairy cattle. 

* * * * * 

Dated: April 15, 2011. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 2011–9765 Filed 4–21–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 301 

[TD 9518] 

RIN 1545–BJ52 

Specified Tax Return Preparers 

Required To File Individual Income Tax 

Returns Using Magnetic Media; 

Correction 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Correction to final regulations. 

SUMMARY: This document describes a 

correction to final regulations (TD 9518) 

that were published in the Federal 

Register on Wednesday, March 30, 2011 

(76 FR 17521) providing guidance to 

specified tax return preparers who 

prepare and file individual income tax 

returns using magnetic media pursuant 

to section 6011(e)(3) of the Internal 

Revenue Code. 

DATES: This correction is effective on 

April 22, 2011, and is applicable to 

individual income tax returns filed after 

December 31, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Keith L. Brau, (202) 622–4940 (not a 

toll-free number). 

SUPPLEMENTARY INFORMATION: 

Background 

The final regulations that are the 

subject of this correction are under 

section 6011 of the Internal Revenue 

Code. 

Need for Correction 

As published, final regulations (TD 

9518) contain an error that may prove to 

be misleading and is in need of 

clarification. 

Correction of Publication 

Accordingly, the publication of the 

final regulations (TD 9518) which were 

the subject of FR Doc. 2011–7571 is 

corrected as follows: 

On page 17528, column 2, under CFR 

Part Heading ‘‘PART 301—PROCEDURE 

AND ADMINISTRATION’’, the language 

‘‘Par. 4. The authority citation for part 

301 is amended by adding an entries in 

numerical order to read, in part, as 

follows:’’ is corrected to read ‘‘Par. 4. 

The authority citation for part 301 is 

amended by adding entries in numerical 

order to read, in part, as follows:’’. 

LaNita Van Dyke, 

Chief, Publications and Regulations Branch, 

Legal Processing Division, Associate Chief 

Counsel (Procedure and Administration). 

[FR Doc. 2011–9737 Filed 4–21–11; 8:45 am] 

BILLING CODE 4830–01–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

32 CFR Part 311 

[Docket ID: DoD–2011–OS–0004] 

Privacy Act of 1974; Implementation 

AGENCY: Office of the Secretary, DoD. 

ACTION: Direct final rule with request for 

comments. 

SUMMARY: The Office of the Secretary of 

Defense is exempting those records 

contained in DMDC 12 DoD, entitled 

‘‘Joint Personnel Adjudication System 

(JPAS)’’, when investigatory material is 

compiled solely for the purpose of 

determining suitability, eligibility, or 

qualifications for Federal civilian 

employment, military service, Federal 

contracts, or access to classified 

information, but only to the extent that 

such material would reveal the identity 

of a confidential source. 

This direct final rule makes 

nonsubstantive changes to the Office of 

the Secretary Privacy Program rules. 

These changes will allow the 

Department to add an exemption rule to 

the Office of the Secretary of Defense 

Privacy Program rules that will exempt 

applicable Department records and/or 

material from certain portions of the 

Privacy Act. This change will allow the 

Department to move part of the 

Department’s personnel security 

program records from the Defense 

Security Service Privacy Program to the 

Office of the Secretary of Defense 

Privacy Program. This direct final rule 

is consistent with the rule previously 

published at 32 CFR 321.13(h) and 

another rule is being published to 

remove and reserve 321.13(h). This will 

improve the efficiency and effectiveness 

of DoD’s program by preserving the 

exempt status of the applicable records 

and/or material when the purposes 

underlying the exemption(s) are valid 

and necessary. 

This rule is being published as a 

direct final rule as the Department of 

Defense does not expect to receive any 

adverse comments, and so a proposed 

rule is unnecessary. 


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