Information Collection

.46.116(h) – [2018 Requirements] – Posting clinical trial consent form

IC 246947 under ICR 202104-0990-003 · OMB 0990-0260.

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Information Collection (IC) Details

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IC Title:	.46.116(h) â [2018 Requirements] â Posting clinical trial consent form	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 45 CFR 46

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 100	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Not-for-profit institutions, Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	300	300
Annual IC Time Burden (Hours)	150	150
Annual IC Cost Burden (Dollars)	0	0

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