Information Collection

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

IC 216306 under ICR 202005-0910-003 · OMB 0910-0191.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
505q FinalGuidance-9-17-19.pdf	Other-Agency Guidance Document

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:

table that charts list of 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 %

table that charts list of burden
	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

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.