Applications for FDA Approval to Market a New Drug: Patent Listing... 30-month Stays

Applications for FDA Approval to Market a New Drug: Patient Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That...

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0513 can be found here:

Documents and Forms

Document Name Document Type
Form 3542 Applications for FDA Approval to Market a New Drug: Patent Listing... 30-month Stays Form
3542 PATENT INFORMATION SUBMITTED UPON AND FDA-3542 4_24_07.doc Form

Information Collection (IC) Details

IC Title:	Applications for FDA Approval to Market a New Drug: Patent Listing... 30-month Stays	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	3542	PATENT INFORMATION SUBMITTED UPON AND	FDA-3542 4_24_07.doc		No	No	Paper Only

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 96	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	308	308
Annual IC Time Burden (Hours)	1,540	1,540
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.