Information Collection

New Drug And Antibiotic Application And Regulations

IC 109266 under ICR 198608-0910-005 · OMB 0910-0001.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0001 can be found here:

Documents and Forms

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Information Collection (IC) Details

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IC Title:	NEW DRUG AND ANTIBIOTIC APPLICATION AND REGULATIONS	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-356-H	No	No
Form	1639, 1675	No	No
Form	2252, 2253	No	No

Line of Business:

Subfunction:

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 655	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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	84,754	7,229	12,020	65,505
Annual IC Time Burden (Hours)	5,132,764	1,364,400	2,268,798	1,499,566
Annual IC Cost Burden (Dollars)	0	0	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.