.46.116(a) and (b) (Pre-2018 Requirements)/ .46.116 (b), (c) and (d) [2018 Requirements] – Elements of informed consent and broad consent

Protection of Human Subjects: Common Rule (56 FR 28001)

Documents and Forms

Document Name Document Type

no available documents/forms check other ICs listed under this ICR

Information Collection (IC) Details

IC Title:	.46.116(a) and (b) (Pre-2018 Requirements)/ .46.116 (b), (c) and (d) [2018 Requirements] – Elements of informed consent and broad consent	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: 6,000	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 25 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	150,000	150,000
Annual IC Time Burden (Hours)	75,000	75,000
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

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.