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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)
OMB: 0910-0167
IC ID: 181014
OMB.report
HHS/FDA
OMB 0910-0167
ICR 201106-0910-010
IC 181014
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0167 can be found here:
2023-12-19 - Extension without change of a currently approved collection
2020-12-29 - Revision of a currently approved collection
Documents and Forms
Document Name
Document Type
Form FDA3671
Orphan Drug: Content and format of a request for designation; verification of status; amendment to designation
Form and Instruction
FDA3671 Common EMEA/FDA Application for Orphan Medicinal Product
FDA 3671.pdf
Form and Instruction
Information Collection (IC) Details
View Information Collection (IC)
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
Form and Instruction
FDA3671
Common EMEA/FDA Application for Orphan Medicinal Product Designation
FDA 3671.pdf
Yes
Yes
Fillable Fileable Signable
Federal Enterprise Architecture Business Reference Module
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:
40 %
Approved
Program Change Due to New Statute
Program Change Due to Agency Discretion
Change Due to Adjustment in Agency Estimate
Change Due to Potential Violation of the PRA
Previously Approved
Annual Number of Responses for this IC
428
0
0
86
0
342
Annual IC Time Burden (Hours)
64,200
0
0
19,740
0
44,460
Annual IC Cost Burden (Dollars)
0
0
0
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.