Information Collection

Orphan Drug: Content and format of a request for designation; verification of status; amendment to designation

IC 181014 under ICR 201408-0910-001 · 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⚠️ Notice: This information collection may be referencing outdated material.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

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Information Collection (IC) Details

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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 316.26 21 CFR 316.21 21 CFR 316.20

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: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 225	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 2 %

	Approved	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	450	22	428
Annual IC Time Burden (Hours)	67,500	3,300	64,200
Annual IC Cost Burden (Dollars)	0	0	0

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