Information Collection

Establishment and Product License Applications

IC 5736 under ICR 199808-0910-005 · OMB 0910-0124.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0124 can be found here:

Documents and Forms

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Information Collection (IC) Details

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IC Title:	Establishment and Product License Applications	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Migrated

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Available Electronically?	Can Be Submitted Electronically?
Form	FDA-3098C/3098D	No	No
Form	FDA-3066/3086	No	No
Form	FDA-3314	No	No
Form	FDA-3098A/3098B	No	No
Form	FDA-3096/3098	No	No
Form	FDA-2599/2599A	No	No
Form	FDA-2600/2600B	No	No
Form	FDA-3213/3214	No	No
Form	FDA-3098E/3210	No	No

Line of Business:

Subfunction:

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 376	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	1,830	1,830
Annual IC Time Burden (Hours)	73,200	73,200
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.