Orphan Drug: Content and format of a request for designation; Verification of status; Amendment to designation

Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form FDA 3671)

⚠️ Notice: This information collection may be referencing outdated material.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

no available documents/forms check other ICs listed under this ICR

Information Collection (IC) Details

IC Title:	Orphan Drug: Content and format of a request for designation; Verification of status; Amendment to designation	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 316.20 21 CFR 316.21 21 CFR 316.26

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

Line of Business: Health

Subfunction: Immunization Management

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 214	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Requested	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	428	86	342
Annual IC Time Burden (Hours)	64,200	19,740	44,460
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

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No associated records found

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