Reporting: Substantiation for Pre-existing, Not Widely Established Dietary Supplement Claims

Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0626 can be found here:

Documents and Forms

Document Name Document Type
Dietary Supplements Guidance for Industry Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Fede Other-Guidance

Information Collection (IC) Details

IC Title:	Reporting: Substantiation for Pre-existing, Not Widely Established Dietary Supplement Claims	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance			Dietary Supplements Guidance for Industry Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act#pra.mht		Yes	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 667	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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	667	0	667
Annual IC Time Burden (Hours)	80,040	-80,040	160,080
Annual IC Cost Burden (Dollars)	0	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.