Document ID: FDA-2011-N-0130-0001
Agency: fda
Document Type: Rule
Title: Investigational New Drug Applications and Abbreviated New Drug Applications
Posted Date: 2011-03-15T04:00Z

[Federal Register: March 15, 2011 (Volume 76, Number 50)]
[Rules and Regulations]               
[Page 13880]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15mr11-2]                         

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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.

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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

0
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.

Sec.  312.83  [Amended]

0
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

0
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.

Sec.  314.94  [Amended]

0
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]
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