Information Collection

Proposed Rule - Adverse Drug Experience Reporting Requirements For Marketed Prescription Drugs Without Approved New Drug Or Abbreviated New Drug Applications

IC 165481 under ICR 198606-0910-002 · OMB 0910-0210.

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Information Collection (IC) Details

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IC Title:

PROPOSED RULE - ADVERSE DRUG EXPERIENCE REPORTING REQUIREMENTS FOR MARKETED PRESCRIPTION DRUGS WITHOUT APPROVED NEW DRUG OR ABBREVIATED NEW DRUG APPLICATIONS

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Migrated

Obligation to Respond: Mandatory

CFR Citation:

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

Federal Enterprise Architecture Business Reference Module

Line of Business:

Subfunction:

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 1

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	1,200	1,199	1
Annual IC Time Burden (Hours)	1,600	1,599	1
Annual IC Cost Burden (Dollars)	0	0	0

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