Information Collection

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

IC 5770 under ICR 202011-0910-012 · OMB 0910-0167.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
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

View Information Collection (IC)

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:

table that charts list of 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

Federal Enterprise Architecture Business Reference Module

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 %

table that charts list of burden
	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

table that charts IC Documents
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.