Orphan Drug Designation: requests content and format; notifications of changes; deficiency letters; annual reports; assurance of sufficient quantities; meeting requests

Orphan Drugs

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0167 can be found here:

Documents and Forms

Document Name Document Type
0167 Guidance-Meetings with OPD.pdf Other-Guidance
0167 Guidance-Meetings with OPD.pdf Other-Guidance
FDA 4035 FDA Orphan Drug Designation Request Form 0167 FDA-4035.pdf Form and Instruction
FDA 4035 FDA Orphan Drug Designation Request Form 0167 FDA-4035.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	Orphan Drug Designation: requests content and format; notifications of changes; deficiency letters; annual reports; assurance of sufficient quantities; meeting requests	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 316.12 21 CFR 316.14 21 CFR 316.10 21 CFR 316.20 21 CFR 316.21 21 CFR 316.22 21 CFR 316.24 21 CFR 316.22 21 CFR 316.27 21 CFR 316.30 21 CFR 316.36

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance			0167 Guidance-Meetings with OPD.pdf		Yes	Yes	Fillable Fileable
Form and Instruction	FDA 4035	FDA Orphan Drug Designation Request Form	0167 FDA-4035.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 4,577	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	4,577	4,576	1
Annual IC Time Burden (Hours)	123,673	123,623	50
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.