Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling - Proposed Rule

Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling - Proposed Rule

OMB: 0910-0624

IC ID: 185243

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Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling - Proposed Rule
 
No New
 
Required to Obtain or Retain Benefits
 
21 CFR 314.50

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

Health Public Health Monitoring

 

885 0
   
Private Sector Businesses or other for-profits
 
   0 %

  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 1,613 1,613 0 0 0 0
Annual IC Time Burden (Hours) 32,260 32,260 0 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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