Citizen petitions and petitions related to ANDA, certain NDAs, and certain BLAs

Administrative Practices and Procedures; Formal Hearings

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0191 can be found here:

Documents and Forms

Document Name Document Type
505q FinalGuidance-9-17-19.pdf Other-Agency Guidance Document
505q FinalGuidance-9-17-19.pdf Other-Agency Guidance Document

Information Collection (IC) Details

IC Title:	Citizen petitions and petitions related to ANDA, certain NDAs, and certain BLAs	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 10.30; 10.31

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance Document			505q FinalGuidance-9-17-19.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 200	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 99 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	200	-20	220
Annual IC Time Burden (Hours)	4,800	-480	5,280
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.