Subpart C - Abbreviated Applications

Applications for FDA Approval to Market a New Drug

Documents and Forms

Document Name Document Type
GFI Good-ANDA-Submission-Practices-Guidance-for-Industry JAN 2018.pdf www.fda.gov/regulatory-information/search-fda-guidance-documents/good-anda-submission-practices-guidance-industry Other-Agency Guidance
GFI Good-ANDA-Submission-Practices-Guidance-for-Industry JAN 2018.pdf www.fda.gov/regulatory-information/search-fda-guidance-documents/good-anda-submission-practices-guidance-industry Other-Agency Guidance

Information Collection (IC) Details

IC Title:	Subpart C - Abbreviated Applications	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 314.92 - 314.99

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance			GFI Good-ANDA-Submission-Practices-Guidance-for-Industry JAN 2018.pdf	https://www.fda.gov/regulatory-information/search-fda-guidance-documents/good-anda-submission-practices-guidance-industry	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 354	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	21,744	-5,590	27,334
Annual IC Time Burden (Hours)	1,997,542	-442,252	2,439,794
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.