Draft Guidance for Industry: How to Use E-Mail to Submit a Study Protocol

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0524 can be found here:

Documents and Forms

Document Name Document Type
Form 3536 Draft Guidance for Industry: How to Use E-Mail to Submit a Study Protocol Form and Instruction
3536 Protocol for Non- Clinical Laboratory and Effectiveness Form FDA 3536.pdf Form and Instruction
Guidance - 0910-0524.pdf Guidance for Industry: How to Submit a Protocol in Electronic Format by E-Mail IC Document

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Draft Guidance for Industry: How to Use E-Mail to Submit a Study Protocol	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 50.58.120 21 CFR 500.514.117

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	3536	Protocol for Non- Clinical Laboratory and Effectiveness Studies	Form FDA 3536.pdf		Yes	Yes	Fillable Printable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 190	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	103	3	100
Annual IC Time Burden (Hours)	21	1	20
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

Title	Document	Date Uploaded
Guidance for Industry: How to Submit a Protocol in Electronic Format by E-Mail	Guidance - 0910-0524.pdf

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