Guidance for Industry: Formal Dispute Resolution; Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice

Guidance for Industry: Formal Dispute Resolution; Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice

OMB: 0910-0563

IC ID: 6285

Information Collection (IC) Details

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Guidance for Industry: Formal Dispute Resolution; Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice
 
No Modified
 
Voluntary
 
21 CFR 312.130 21 CFR 314.430 21 CFR 20

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Instruction ucm070279.pdf http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070279.pdf Yes No Printable Only

Health Public Health Monitoring

 

2 0
   
Private Sector Businesses or other for-profits
 
   50 %

  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 2 0 0 0 0 2
Annual IC Time Burden (Hours) 68 0 0 0 0 68
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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