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⚠️ Notice: This information collection may be referencing outdated material.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 FDA 3422 Mammography Facilities, Standards, and Lay Summaries for Patients Form and Instruction
FDA 3422 Governmental Entity Form 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:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 900 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	FDA 3422	Governmental Entity	Form 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: 8,699	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 20 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	35,391,604	-634,681	36,026,285
Annual IC Time Burden (Hours)	3,858,703	544,340	3,314,363
Annual IC Cost Burden (Dollars)	19,768,411	5,131,090	14,637,321

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.