Information Collection

Mammography Standards Quality Act Requirements - Reporting

IC 5881 under ICR 202507-0910-007 · OMB 0910-0309.

Documents and Forms

Document Name Document Type
Form FDA 3422 Governmental Entity Declaration Mammography Standards Quality Act Requirements - Reporting Form and Instruction
FDA 3422 Governmental Entity Declaration 0309_Governmental Entity Declaration_Form FDA 3422.pdf Form and Instruction

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Mammography Standards Quality Act Requirements - Reporting	Agency IC Tracking Number:	CDRH

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 900; subparts A, B, and C (To search for a specific CFR, visit the Code of Federal Regulations.)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	FDA 3422	Governmental Entity Declaration	0309_Governmental Entity Declaration_Form FDA 3422.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 9,659	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Not-for-profit institutions

Percentage of Respondents Reporting Electronically: 95 %

	Requested	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	11,303	-44,868,371	44,879,674
Annual IC Time Burden (Hours)	12,036	-3,957,484	3,969,520
Annual IC Cost Burden (Dollars)	0	-33,528,188	33,528,188

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.

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