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Reporting: Substantiation for Novel Dietary Supplement Claims

IC 199073 under ICR 201502-0910-006 · OMB 0910-0626.

Documents and Forms
Document Name
Document Type
Other-Guidance
Information Collection (IC) Details

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Reporting: Substantiation for Novel Dietary Supplement Claims
 
No Unchanged
 
Voluntary
 
21 CFR 510

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

Health Consumer Health and Safety

 

667 0
   
Private Sector Businesses or other for-profits
 
   0 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 667 0 0 0 0 667
Annual IC Time Burden (Hours) 80,040 0 0 0 0 80,040
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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