Information Collection

Subpart C - Abbreviated Applications

IC 184600 under ICR 202512-0910-013 · OMB 0910-0001.

Documents and Forms

Documents and forms in this information collection
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

IC Title:

Agency IC Tracking Number:

CDER

Is this a Common Form? No

IC Status: Unchanged

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 314.92 - 314.99

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				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 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	21,744	21,744
Annual IC Time Burden (Hours)	1,997,542	1,997,542
Annual IC Cost Burden (Dollars)	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.

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