Information Collection Request

Applications for FDA Approval to Market a New Drug

ICR 202402-0910-003 · OMB 0910-0001 · Received in OIRA

⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0001 can be found here:

Forms and Documents

Document Name	Status
Form FDA 3331a Subpart B - Applications Form and Instruction	Modified
Form FDA 3938 PART 314: Subparts E through I Form	Modified
0001 NDAs SSA 2024 REV.docx Supporting Statement A	2024-03-06
0014 and 0338 PDUFA Forms Change Request Sept 2022.docx Justification for No Material/Nonsubstantive Change	2022-09-01

IC Document Collections

IC ID	Document Title	Status
5662	Subpart B - Applications Form and Instruction	Modified
184605	PART 314: Subparts E through I Form	Modified
184601	Subpart D - FDA Action on Applications Other-Agency Guidance	Modified
184600	Subpart C - Abbreviated Applications Other-Agency Guidance	Modified

ICR Details

Status	Received in OIRA
Agency/Subagency	HHS/FDA
OMB Control No	0910-0001
Type of Information Collection	Revision of a currently approved collection
Previous ICR Reference No	202209-0910-003
Agency Tracking No	CDER
Date Submitted to OIRA	1969-12-31
Requested Expiration Date	1969-12-31