Uses outside approved indication

Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug and Cosmetic Act

OMB: 0910-0762

IC ID: 209965

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

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Uses outside approved indication
No Modified

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Guidance 0762_Guidance.pdf Yes No Paper Only

Health Consumer Health and Safety


148 14
Private Sector Businesses or other for-profits
   100 %

  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 148 0 0 0 0 148
Annual IC Time Burden (Hours) 74 0 0 0 0 74
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
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            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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