2011-5946. 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 cross-reference 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 cross-references 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.