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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