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Rule

Investigational New Drug Applications and Abbreviated New Drug Applications; Technical Amendment

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.

 

Table of Contents Back to Top

DATES: Back to Top

This rule is effective March 15, 2011.

FOR FURTHER INFORMATION CONTACT: Back to Top

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: Back to Top

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 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 Act.

List of Subjects Back to Top

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:

begin regulatory text

PART 312—INVESTIGATIONAL NEW DRUG APPLICATION Back to Top

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 Back to Top

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)”.

end regulatory text

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

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