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.

Rules and Regulations Federal Register

13879 

Vol. 76, No. 50 

Tuesday, March 15, 2011 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

DEPARTMENT OF THE TREASURY 

19 CFR Part 12 

[CBP Dec. 11–06] 

RIN 1515–AD73 

Extension of Import Restrictions 

Imposed on Certain Archaeological 

and Ethnological Materials From 

Colombia 

AGENCY: Customs and Border Protection, 

Department of Homeland Security; 

Department of the Treasury. 

ACTION: Final rule. 

SUMMARY: This document amends the 

U.S. Customs and Border Protection 

(CBP) regulations to reflect an extension 

of import restrictions on certain 

archaeological and ethnological 

materials from Colombia. The 

restrictions, which were originally 

imposed by CBP Decision (CBP Dec.) 

06–09, are due to expire on March 15, 

2011. The Assistant Secretary for 

Educational and Cultural Affairs, United 

States Department of State, has 

determined that factors continue to 

warrant the imposition of import 

restrictions. Accordingly, these import 

restrictions will remain in effect for an 

additional 5 years, and the CBP 

regulations are being amended to reflect 

this extension through March 15, 2016. 

These restrictions are being extended 

pursuant to determinations of the 

United States Department of State made 

under the terms of the Convention on 

Cultural Property Implementation Act 

that implemented the United Nations 

Educational, Scientific and Cultural 

Organization (UNESCO) Convention on 

the Means of Prohibiting and Preventing 

the Illicit Import, Export and Transfer of 

Ownership of Cultural Property. CBP 

Dec. 06–09 contains the Designated List 

of archaeological and ethnological 

materials of Colombia to which the 

restrictions apply. 

DATES: Effective Date: March 15, 2011. 

FOR FURTHER INFORMATION CONTACT: For 

legal aspects, Charles Steuart, Chief, 

Intellectual Property Rights and 

Restricted Merchandise Branch, 

Regulations and Rulings, Office of 

International Trade, (202) 325–0020. For 

operational aspects, Michael Craig, 

Chief, Interagency Requirements 

Branch, Trade Policy and Programs, 

Office of International Trade, (202) 863– 

6558. 

SUPPLEMENTARY INFORMATION: 

Background 

Pursuant to the provisions of the 1970 

United Nations Educational, Scientific 

and Cultural Organization (UNESCO) 

Convention, implemented by the 

Convention on Cultural Property 

Implementation Act (Pub. L. 97–446, 19 

U.S.C. 2601 et seq.), the United States 

entered into a bilateral agreement with 

Colombia on March 15, 2006, 

concerning the imposition of import 

restrictions on certain archeological and 

ethnological materials from Colombia. 

On March 17, 2006, CBP published CBP 

Dec. 06–09 in the Federal Register (71 

FR 13757), which amended 19 CFR 

12.104g(a) to reflect the imposition of 

these restrictions and included a list 

designating the types of articles covered 

by the restrictions. 

Import restrictions listed in 19 CFR 

12.104g(a) are ‘‘effective for no more 

than five years beginning on the date on 

which the agreement enters into force 

with respect to the United States. This 

period can be extended for additional 

periods not to exceed five years if it is 

determined that the factors which 

justified the initial agreement still 

pertain and no cause for suspension of 

the agreement exists’’ (19 CFR 

12.104g(a)). On July 22, 2010, the 

Department of State received a request 

by the Government of Colombia to 

extend the Agreement. Subsequently, 

after the Department of State proposed 

to extend the Agreement and reviewed 

the findings and recommendations of 

the Cultural Property Advisory 

Committee, the Assistant Secretary for 

Educational and Cultural Affairs, United 

States Department of State, determined 

that the cultural heritage of Colombia 

continues to be in jeopardy from pillage 

of archaeological and ethnological 

resources and made the necessary 

determinations to extend the import 

restrictions for an additional five years. 

Diplomatic notes have been exchanged 

on March 1, 2011, reflecting the 

extension of those restrictions for an 

additional five-year period. 

Accordingly, CBP is amending 19 CFR 

12.104g(a) to reflect this extension of the 

import restrictions. 

The Designated List of archaeological 

and ethnological materials from 

Colombia covered by these import 

restrictions is set forth in CBP Dec. 

06–09. The Designated List and 

accompanying image database may also 

be found at the following Internet Web 

site address: http://exchanges.state.gov/ 

heritage/culprop/cofact.html. 

The restrictions on the importation of 

these archaeological and ethnological 

materials from Colombia are to continue 

in effect through March 15, 2016. 

Importation of such material continues 

to be restricted unless the conditions set 

forth in 19 U.S.C. 2606 and 19 CFR 

12.104c are met. 

Inapplicability of Notice and Delayed 

Effective Date 

This amendment involves a foreign 

affairs function of the United States and 

is, therefore, being made without notice 

or public procedure (5 U.S.C. 553(a)(1)). 

In addition, CBP has determined that 

such notice or public procedure would 

be impracticable and contrary to the 

public interest because the action being 

taken is essential to avoid interruption 

of the application of the existing import 

restrictions (5 U.S.C. 553(b)(B)). For the 

same reasons, a delayed effective date is 

not required under 5 U.S.C. 553(d)(3). 

Regulatory Flexibility Act 

Because no notice of proposed 

rulemaking is required, the provisions 

of the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.) do not apply. 

Executive Order 12866 

Because this rule involves a foreign 

affairs function of the United States, it 

is not subject to Executive Order 12866. 

Signing Authority 

This regulation is being issued in 

accordance with 19 CFR 0.1(a)(1). 


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13880 Federal Register / Vol. 76, No. 50 / Tuesday, March 15, 2011 / Rules and Regulations 

List of Subjects in 19 CFR Part 12 

Cultural property, Customs duties and 

inspection, Imports, Prohibited 

merchandise. 

Amendment to CBP Regulations 

For the reasons set forth above, part 

12 of Title 19 of the Code of Federal 

Regulations (19 CFR part 12), is 

amended as set forth below: 

PART 12—SPECIAL CLASSES OF 

MERCHANDISE 

■ 1. The general authority citation for 

part 12 and the specific authority 

citation for § 12.104g continue to read as 

follows: 

Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1202 

(General Note 3(i), Harmonized Tariff 

Schedule of the United States (HTSUS)), 

1624; 

* * * * * 

Sections 12.104 through 12.104i also 

issued under 19 U.S.C. 2612; 

* * * * * 

§ 12.104g [Amended] 

■ 2. In § 12.104g, paragraph (a), the table 

is amended in the entry for Colombia by 

adding, after the reference to ‘‘CBP Dec. 

06–09’’, the words ‘‘extended by CBP 

Dec. 11–06’’. 

Alan Bersin, 

Commissioner, U.S. Customs and Border 

Protection. 

Approved: March 9, 2011. 

Timothy E. Skud, 

Deputy Assistant Secretary of the Treasury. 

[FR Doc. 2011–5879 Filed 3–14–11; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 312 and 314 

[Docket No. FDA–2011–N–0130] 

Investigational New Drug Applications 

and Abbreviated New Drug 

Applications; Technical Amendment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending its 

investigational new drug application 

(IND) regulations and abbreviated new 

drug application regulations to correct 

inaccurate cross-references to the IND 

regulations and the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act). This 

action is being taken to ensure accuracy 

and clarity in the Agency’s regulations. 

DATES: This rule is effective March 15, 

2011. 

FOR FURTHER INFORMATION CONTACT: 

Olivia A. Pritzlaff, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, Bldg. 51, Rm. 

6308, 10903 New Hampshire Ave., 

Silver Spring, MD 20993–0002, 301– 

796–3506. 

SUPPLEMENTARY INFORMATION: FDA is 

amending its regulation in 21 CFR 

312.83 to correct an inaccurate crossreference to other sections of the IND 

regulations. FDA is amending its 

regulation in 21 CFR 314.94 to correct 

an inaccurate cross-reference to a 

section of the FD&C Act. 

Publication of this document 

constitutes final action on these changes 

under the Administrative Procedure Act 

(5 U.S.C. 553). FDA has determined that 

notice and public comment are 

unnecessary because this amendment to 

the regulations provides only technical 

changes to correct inaccurate crossreferences to the IND regulations and 

the FD&C Act. 

List of Subjects 

21 CFR Part 312 

Drugs, Exports, Imports, 

Investigations, Labeling, Medical 

research, Reporting and recordkeeping 

requirements, Safety. 

21 CFR Part 314 

Administrative practice and 

procedure, Confidential business 

information, Drugs, Reporting and 

recordkeeping requirements. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR parts 312 

and 314 are amended as follows: 

PART 312—INVESTIGATIONAL NEW 

DRUG APPLICATION 

■ 1. The authority citation for 21 CFR 

part 312 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 355, 360bbb, 371; 42 U.S.C. 262. 

§ 312.83 [Amended] 

■ 2. Section 312.83 is amended by 

removing ‘‘312.34 and 312.35’’ and by 

adding in its place ‘‘312.305 and 

312.320’’. 

PART 314—APPLICATIONS FOR FDA 

APPROVAL TO MARKET A NEW DRUG 

■ 3. The authority citation for 21 CFR 

part 314 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 355, 356, 356a, 356b, 356c, 371, 374, 

379e. 

§ 314.94 [Amended] 

■ 4. Section 314.94 is amended in 

paragraph (a)(8)(iv) by removing 

‘‘505(j)(4)(D)’’ and by adding in its place 

‘‘505(j)(5)(F)’’. 

Dated: March 9, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–5946 Filed 3–14–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 301 

[TD 9516] 

RIN 1545–BG73 

Disclosure of Return Information in 

Connection With Written Contracts 

Among the IRS, Whistleblowers, and 

Legal Representatives of 

Whistleblowers 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Final regulations and removal of 

temporary regulations. 

SUMMARY: This document contains final 

regulations relating to the disclosure of 

return information by an officer or 

employee of the Treasury Department, 

to a whistleblower and, if applicable, 

the legal representative of the 

whistleblower, to the extent necessary 

in connection with a written contract 

among the IRS, the whistleblower and, 

if applicable, the legal representative of 

the whistleblower, for services relating 

to the detection of violations of the 

internal revenue laws or related statutes. 

The final regulations will affect officers 

and employees of the Treasury 

Department who disclose return 

information to whistleblowers or their 

legal representatives in connection with 

written contracts among the IRS, 

whistleblowers and, if applicable, their 

legal representatives, for services 

relating to the detection of violations of 

the internal revenue laws or related 

statutes. The final regulations will also 

affect any whistleblower or legal 

representative of a whistleblower who 

receives return information in 

connection with a written contract 

among the IRS, the whistleblower and, 

if applicable, the legal representative of 

the whistleblower, for services relating 

to the detection of violations of the 

internal revenue laws or related statutes. 


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