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

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: Unchanged

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	Previously Approved
Annual Number of Responses for this IC	667	667
Annual IC Time Burden (Hours)	80,040	80,040
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.