Justia Regulation Tracker

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[Federal Register: October 29, 2009 (Volume 74, Number 208)]
[Rules and Regulations]               
[Page 55770-55771]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29oc09-10]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 312

[Docket No. FDA-2009-N-0464]

 
Investigational 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 to add an 
address for applicants to submit INDs for in vivo bioavailability and 
bioequivalence studies in humans. INDs for these studies that are 
intended to support abbreviated new drug applications (ANDAs) should be 
sent directly to the

[[Page 55771]]

Office of Generic Drugs. This action is being taken to ensure accuracy 
and clarity in the agency's regulations.

DATES: This rule is effective October 29, 2009.

FOR FURTHER INFORMATION CONTACT: Peter Chen, Center for Drug Evaluation 
and Research (HFD-615), Food and Drug Administration, 7500 Standish 
Pl., Rockville, MD 20855, 240-276-8436.

SUPPLEMENTARY INFORMATION: FDA is amending its regulations in part 312 
(21 CFR part 312) to clarify where ANDA applicants should submit INDs 
for in vivo bioavailability and bioequivalence studies in humans. This 
document adds the address for the Office of Generic Drugs in Sec.  
312.140(a)(1).
    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 add an 
address for the submission of INDs related to ANDAs.

List of Subjects in 21 CFR Part 312

    Drugs, Exports, Imports, Investigations, Labeling, Medical 
research, Reporting and recordkeeping requirements, Safety.

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Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
312 is amended as follows:

PART 312--INVESTIGATIONAL NEW DRUG APPLICATION

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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.

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2. Section 312.140 is amended by revising paragraph (a)(1) to read as 
follows:

Sec.  312.140  Address for correspondence.

    (a) * * *
    (1) For drug products regulated by CDER. Send the IND submission to 
the Central Document Room, Center for Drug Evaluation and Research, 
Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD 
20705-1266; except send an IND submission for an in vivo 
bioavailability or bioequivalence study in humans to support an 
abbreviated new drug application to the Office of Generic Drugs (HFD-
600), Center for Drug Evaluation and Research, Food and Drug 
Administration, Metro Park North II, 7500 Standish Pl., Rockville, MD 
20855.
* * * * *

    Dated: October 23, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-26095 Filed 10-28-09; 8:45 am]

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