Interviews

Review Transparency & Communication for New Molecular Entity NDAs & Original BLAs

Documents and Forms

Document Name Document Type
PDUFA VII - Commitment Letter 2023 through 2027.pdf www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-fiscal-years-2023-2027 Other-Agency Performance Goals
PDUFA VII - Commitment Letter 2023 through 2027.pdf www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-fiscal-years-2023-2027 Other-Agency Performance Goals
BsUFA III Commitment Letter 2023 through 2027.pdf www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iii-fiscal-years-2023-2027 Other-Agency Performance Goals
BsUFA III Commitment Letter 2023 through 2027.pdf www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iii-fiscal-years-2023-2027 Other-Agency Performance Goals

Information Collection (IC) Details

IC Title:	Interviews	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Performance Goals			PDUFA VII - Commitment Letter 2023 through 2027.pdf	https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-fiscal-years-2023-2027	Yes	Yes	Fillable Fileable
Other-Agency Performance Goals			BsUFA III Commitment Letter 2023 through 2027.pdf	https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iii-fiscal-years-2023-2027	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 120	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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	120	-15	135
Annual IC Time Burden (Hours)	180	-23	203
Annual IC Cost Burden (Dollars)	0	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.