32362 Federal Register / Vol. 78, No. 104 / Thursday, May 30, 2013 / Rules and Regulations 

FDA did not receive comments that 

would affect the Paperwork Reduction 

Act burden estimates made in the 2011 

IFR (76 FR 25542 at 25544). Therefore 

the estimated Paperwork Reduction Act 

burden for this final rule is the same as 

the estimated burden in the 2011 IFR. 

VII. Analysis of Environmental Impact 

The Agency has carefully considered 

the potential environmental effects of 

this action. FDA has concluded under 

21 CFR 25.30(h) 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. 

VIII. Federalism 

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. FDA has 

determined that the rule does not 

contain policies that have substantial 

direct effects on the States, on the 

relationship between the National 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Accordingly, the 

Agency has concluded that the rule does 

not contain policies that have 

federalism implications as defined in 

the Executive Order and, consequently, 

a federalism summary impact statement 

is not required. 

List of Subjects in 21 CFR Part 1 

Cosmetics, Drugs, Exports, Food 

labeling, Imports, Labeling, Reporting 

and recordkeeping requirements. 

PART 1—GENERAL ENFORCEMENT 

REGULATIONS 

■ Accordingly, the interim rule 

amending 21 CFR part 1, which was 

published at 76 FR 25542 on May 5, 

2011, is adopted as a final rule without 

change. 

Dated: May 22, 2013. 

Kathleen Sebelius, 

Secretary of Health and Human Services. 

Dated: May 22, 2013. 

Janet Napolitano, 

Secretary of Homeland Security. 

[FR Doc. 2013–12833 Filed 5–29–13; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF STATE 

22 CFR Parts 120 and 126 

RIN 1400–AD38 

[Public Notice 8335] 

Implementation of the Defense Trade 

Cooperation Treaty Between the 

United States and Australia; 

Announcement of Effective Date for 

Regulations 

ACTION: Final rule; announcement of 

effective date. 

SUMMARY: This rule provides an 

effective date for previously published 

regulations implementing the Treaty 

Between the Government of the United 

States of America and the Government 

of Australia Concerning Defense Trade 

Cooperation (referred to herein as ‘‘the 

Treaty’’). 

DATES: Effective Date: The rule, 

‘‘Implementation of the Defense Trade 

Cooperation Treaty Between the United 

States and Australia,’’ published on 

April 11, 2013 (Public Notice 8270, 78 

FR 21523) is effective May 16, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Sarah J. Heidema, Office of Defense 

Trade Controls Policy, Directorate of 

Defense Trade Controls, Bureau of 

Political-Military Affairs, U.S. 

Department of State, Washington, DC 

20522–0112, telephone (202) 663–2809, 

email heidemasj@state.gov. 

SUPPLEMENTARY INFORMATION: The rule 

(Public Notice 8270, 78 FR 21523), 

published on April 11, 2013, amends 

the International Traffic in Arms 

Regulations to implement the Treaty, 

and identifies via a supplement the 

defense articles and defense services 

that may not be exported pursuant to 

the Treaty. The Department of State 

indicated in the rule that it would 

become effective upon the entry into 

force of the Treaty, and that the 

Department of State would publish 

another rule announcing its effective 

date. The Treaty entered into force on 

May 16, 2013. Therefore, the rule is in 

effect as of that date. The Department’s 

regulatory analyses with respect to this 

Rule were published at 78 FR 21523, 

and are hereby incorporated by 

reference. 

Dated: May 20, 2013. 

Rose E. Gottemoeller, 

Acting Under Secretary, Arms Control and 

International Security, Department of State. 

[FR Doc. 2013–12610 Filed 5–29–13; 8:45 am] 

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