Information Collection

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...

IC 6229 under ICR 201007-0910-003 · OMB 0910-0513.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
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:

table that charts list of 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

Federal Enterprise Architecture Business Reference Module

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 233

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	606	241	365
Annual IC Time Burden (Hours)	12,120	4,820	7,300
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

table that charts IC Documents
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.