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Content and format of an abbreviated application
Abbreviated NDAs & 505(b)(2) Applications; Proposed Revisions to Implement Portions of the Medicare Prescription Drug, Improvement, & Modernization Act of 2003 & Other Changes - Proposed Rule
OMB: 0910-0786
IC ID: 214790
OMB.report
HHS/FDA
OMB 0910-0786
ICR 201501-0910-016
IC 214790
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0786 can be found here:
2016-10-06 - New collection (Request for a new OMB Control Number)
Documents and Forms
Document Name
Document Type
no available documents/forms check other ICs listed under this ICR
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Content and format of an abbreviated application
Agency IC Tracking Number:
CDER
Is this a Common Form?
No
IC Status:
New
Obligation to Respond:
Mandatory
CFR Citation:
21 CFR 314.94(a)(12)
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Federal Enterprise Architecture Business Reference Module
Line of Business:
Health
Subfunction:
Health Care Services
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
108
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
Percentage of Respondents Reporting Electronically:
75 %
Requested
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
108
0
108
0
0
0
Annual IC Time Burden (Hours)
216
0
216
0
0
0
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.