CBER 513(g) Requests

Guidance FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act

OMB: 0910-0705

IC ID: 215616

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

View Information Collection (IC)

CBER 513(g) Requests
No Modified

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Instruction 0705_ Agency Guidance_513(g).pdf Yes No Printable Only
Instruction 0705_Agency Guidance_eCopy.pdf Yes Yes Printable Only

Health Consumer Health and Safety


4 0
Private Sector Businesses or other for-profits, Not-for-profit institutions
   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 4 0 0 0 0 4
Annual IC Time Burden (Hours) 48 0 0 0 0 48
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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