Submission of Controlled Correspondence

Generic Drug User Fee Program

OMB: 0910-0727

IC ID: 262988

Information Collection (IC) Details

View Information Collection (IC)

Submission of Controlled Correspondence
 
No New
 
Required to Obtain or Retain Benefits
 
21 CFR 10.115; Good guidance practice 21 CFR 314.445; Guidance documents

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance 0727 Competitive Generic Therapies Final guidance OCT 2022.pdf Yes Yes Fillable Fileable
Other-Agency Guidance 0727 Cover Letter Attachments for Controlled Correspondence and ANDA Submissions JUNE 2023.pdf Yes Yes Fillable Fileable
Other-Agency Guidance 0727 - CPAs draft guidance SEPT 2022.pdf Yes Yes Fillable Fileable
Other-Agency Guidance 0727 Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA - OCT 2022.pdf Yes Yes Fillable Fileable
Other-Agency Guidance 0727 Controlled Correspondence draft DEC 2022.pdf Yes Yes Fillable Fileable
Other-Agency Guidance 0727 Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

500 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 5,000 0 0 5,000 0 0
Annual IC Time Burden (Hours) 25,000 0 0 25,000 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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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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