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HHS/FDA

RIN: 0910-AC48

Publication ID: Fall 2003

Title: Applications for FDA Approval To Market a New Drug: Patent Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications
Abstract: The final rule would clarify the types of patents for which information must or must not be submitted to FDA. The final rule would also revise the patent declaration to make it more detailed. The rule would also revise the regulations regarding the approval date for certain abbreviated new drug applications or "505(b)(2) applications" by stating that there is only one opportunity for a 30-month stay in the approval date of an ANDA or 505(b)(2) application.
Agency: Department of Health and Human Services(HHS)	Priority: Economically Significant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Completed Actions
Major: Yes	Unfunded Mandates: Private Sector
CFR Citation: 21 CFR 314.52(a)(3) 21 CFR 314.53(b) 21 CFR 314.53(c)(1) 21 CFR 314.53(c)(2) 21 CFR 314.95(a)(3)
Legal Authority: 21 USC 321 21 USC 331 21 USC 351 to 353 21 USC 355 21 USC 355a 21 USC 356 21 USC 356a 21 USC 356b 21 USC 356c 21 USC 371 21 USC 374 21 USC 379e

Legal Deadline: None

Timetable:

Action	Date	FR Cite
NPRM	10/24/2002	67 FR 65448
NPRM Comment Period End	12/23/2002
Final Rule	06/18/2003	68 FR 36676

Regulatory Flexibility Analysis Required: No	Government Levels Affected: None
Small Entities Affected: No	Federalism: No
Included in the Regulatory Plan: No
Agency Contact: Jarilyn Dupont Director of Regulatory Policy Department of Health and Human Services Food and Drug Administration WO Building 32, Room 4245, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-4830 Fax:301 847-3541 Email: jarilyn.dupont@fda.hhs.gov