Information Collection

Guidance; Reports on the Status of Postmarketing Studies/Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997

IC 199081 under ICR 201409-0910-004 · OMB 0910-0001.

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Information Collection (IC) Details

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IC Title:	Guidance; Reports on the Status of Postmarketing Studies/Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Removed

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 314.81 (B) (2)

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: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 152	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	-935	935
Annual IC Time Burden (Hours)	-468	468
Annual IC Cost Burden (Dollars)	0	0

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