Certification to Accompany Drug, Biological Product, and Device Applications or Submissions

This ICR collects information which will be submitted to FDA with new investigational and marketing applications/submissions and certain additional submissions to such applications for human drugs, biological products, and medical devices. It will be used by the FDA to confirm that sponsors/applicants/submitters have complied with the certification provisions in section 402(j)(5)(B) of the Public Health Service Act with regard to any applicable clinical trials referenced in the investigational or marketing applications/submissions with which the certification is submitted. FDA has developed Form FDA 3674 to facilitate the certification process for sponsors and provide FDA a means of correlating the clinical trials contained in the applications/submissions to FDA with the information contained in the ClinicalTrials.gov data bank.

The latest form for Certification to Accompany Drug, Biological Product, and Device Applications or Submissions expires 2021-03-31 and is listed under ICR 201801-0910-004.

New Applications (IND) - CDER and CBER

Federal Enterprise Architecture: Health - Consumer Health and Safety

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.