OMB control number
Applications for FDA Approval to Market a New Drug
OMB 0910-0001 · HHS/FDA.
This information collection supports continued implementation of Food and Drug Administration regulations governing applications for FDA approval to market a new drug. Respondents to the collection are individuals or entities submitting such applications to the agency in accordance with applicable statutory and regulatory provisions, and commitments established with industry in accordance with user fee performance goals.
The latest form for Applications for FDA Approval to Market a New Drug expires 2027-07-31 and can be found here.
Document Name |
|---|
Form and Instruction |
Form |
Justification for No Material/Nonsubstantive Change |
Justification for No Material/Nonsubstantive Change |
Supporting Statement A |
Form FDA 3331a Subpart B - Applications
0001 83C to add 0754 burden - mailing of important drug information DEC 2025.docx
Subpart B - Applications Subpart B - Applications
Federal Enterprise Architecture: Health - Public Health Monitoring
| Form FDA 3542a | Patent Information Submitted with an NDA, or Supplement | Fillable Fileable | Form |
| Form FDA 2253 | TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE | Fillable Fileable | Form |
| Form FDA 2252 | Transmittal of annual drug and biologic report under 314.81 | Fillable Fileable | Form |
| Form FDA 3331a | NDA - Field Alert Report | www.fda.gov/drugs/surveillance/field-alert-reports | Form and instruction |
| Form FDA 356h | Application to Market a New Drug, Abbreviated New Drug, or Biologic, for Human Use | Fillable Fileable | Form |
| Form FDA 3542 | Patent Information Submitted Upon and After Approval of an NDA or Supplement | Fillable Fileable | Form |
Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.