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⚠️ Notice: This information collection may be referencing outdated material.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 3542a 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... Form
3542a PATENT INFORMATION SUBMITTED UPON AND FDA-3542a 4_24_07.doc Form

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	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...	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

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	3542a	PATENT INFORMATION SUBMITTED UPON AND	FDA-3542a 4_24_07.doc		No	No	Printable Only

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 114	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	Previously Approved
Annual Number of Responses for this IC	365	-116	481
Annual IC Time Burden (Hours)	7,300	-492,505	499,805
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

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