Information Collection

Reporting: Substantiation for Widely Known Established Dietary Supplement Claims

IC 184677 under ICR 201108-0910-012 · OMB 0910-0626.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
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

IC Title:

Reporting: Substantiation for Widely Known 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:

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			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 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	667	667
Annual IC Time Burden (Hours)	29,348	29,348
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.