Content and format of an abbreviated application

Abbreviated NDAs & 505(b)(2) Applications; Proposed Revisions to Implement Portions of the Medicare Prescription Drug, Improvement, & Modernization Act of 2003 & Other Changes - Proposed Rule

OMB: 0910-0786

IC ID: 214790

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Content and format of an abbreviated application CDER
 
No New
 
Mandatory
 
21 CFR 314.94(a)(12)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability

Health Health Care Services

 

108 0
   
Private Sector Businesses or other for-profits
 
   75 %

  Requested 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 108 0 108 0 0 0
Annual IC Time Burden (Hours) 216 0 216 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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