Information Collection

Form FDA 3542a

IC 179904 under ICR 201611-0910-004 · 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⚠️ Notice: This information collection may be referencing outdated material.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 FDA 3542a Form FDA 3542a	Form and Instruction
FDA 3542a Patent Information Submitted with the Filing of An NDA, Form FDA 3542a.pdf	Form and Instruction

IC Title:

Form FDA 3542a

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Unchanged

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 314.50(h) 21 CFR 314.53

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 and Instruction	FDA 3542a	Patent Information Submitted with the Filing of An NDA, Amendment, or Supplement	Form FDA 3542a.pdf		No		Fillable Printable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 241

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 25 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	819	819
Annual IC Time Burden (Hours)	16,380	16,380
Annual IC Cost Burden (Dollars)	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.