Mammography Facilities, Standards, and Lay Summaries for Patients

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0309 can be found here:

Documents and Forms

Document Name Document Type
Form Form FDA 3422 Mammography Facilities, Standards, and Lay Summaries for Patients Form and Instruction
Form FDA 3422 GOVERNMENTAL ENTITY DECLARATION form FDA 3422.pdf Form and Instruction

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Mammography Facilities, Standards, and Lay Summaries for Patients	Agency IC Tracking Number:	CDRH

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 900.3 21 CFR 900.4 21 CFR 900.6 21 CFR 900.11 21 CFR 900.12 21 CFR 900.15 21 CFR 900.18 21 CFR 900.21 21 CFR 900.22 21 CFR 900.23 21 CFR 900.24 21 CFR 900.25

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	Form FDA 3422	GOVERNMENTAL ENTITY DECLARATION	form FDA 3422.pdf		Yes	Yes	Fillable Fileable Signable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 8,654	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 95 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	35,208,523	0	35,208,523
Annual IC Time Burden (Hours)	3,940,856	14	3,940,842
Annual IC Cost Burden (Dollars)	26,303,177	1,893,071	24,410,106

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.