Effective date of approval of a 505(b)(2) application or abbreviated new drug application under section 505(i) of the Act

Abbreviated NDAs & 505(b)(2) Applications; Proposed Revisions to Implement Portions of the Medicare Prescription Drug, Improvement, & Modernization Act of 2003 & Other Changes - Proposed Rule

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0786 can be found here:

Documents and Forms

Document Name Document Type

no available documents/forms check other ICs listed under this ICR

Information Collection (IC) Details

IC Title:	Effective date of approval of a 505(b)(2) application or abbreviated new drug application under section 505(i) of the Act	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 314.107(e)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 140	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 75 %

	Requested	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	308	308
Annual IC Time Burden (Hours)	154	154
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.