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⚠️ Notice: This information collection may be referencing outdated material.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

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: 220	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	220	13	207
Annual IC Time Burden (Hours)	5,280	312	4,968
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.