Information Collection

Sponsor notification to the DMC regarding waivers

IC 203248 under ICR 201509-0910-004 · OMB 0910-0581.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0581 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
FINAL GUIDANCE 0581 9-17-15.Pdf	Other-Guidance

IC Title:

Sponsor notification to the DMC regarding waivers

Agency IC Tracking Number:

CBER

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 312.56 21 CFR 812.40 21 CFR 812.46 21 CFR 312.50

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-Guidance			FINAL GUIDANCE 0581 9-17-15.Pdf		Yes	No	Paper Only

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 1

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 25 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	1	1
Annual IC Time Burden (Hours)	0	0
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.