Food and Drug Administration, HHS.
Final rule; technical amendment.
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 Start Printed Page 55771Office of Generic Drugs. This action is being taken to ensure accuracy and clarity in the agency's regulations.
This rule is effective October 29, 2009.Start Further Info
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.End Further Info End Preamble Start Supplemental 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 § 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.Start List of Subjects
List of Subjects in 21 CFR Part 312
- Medical research
- Reporting and recordkeeping requirements
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs,End Amendment Part Start Part
PART 312—INVESTIGATIONAL NEW DRUG APPLICATIONEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part Start Amendment Part
2. Section 312.140 is amended by revising paragraph (a)(1) to read as follows:End Amendment Part
(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.Start Signature
Dated: October 23, 2009.
Assistant Commissioner for Policy.
[FR Doc. E9-26095 Filed 10-28-09; 8:45 am]
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