Information Collection

Mammography Facilities, Standards, and Lay Summaries for Patients

IC 5881 under ICR 200703-0910-014 · OMB 0910-0309.

⚠️ Notice: This information collection may be referencing outdated material.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

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 900.900.3 21 CFR 900.900.4 21 CFR 900.900.6 21 CFR 900.900.11 21 CFR 900.900.12 21 CFR 900.900.15 21 CFR 900.900.18 21 CFR 900.900.21 21 CFR 900.900.22 21 CFR 900.900.23 21 CFR 900.900.24 21 CFR 900.900.25

Information Collection Instruments:

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

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 8,855	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 20 %

	Approved	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	36,026,285	26,285	36,000,000
Annual IC Time Burden (Hours)	3,314,363	94,427	3,219,936
Annual IC Cost Burden (Dollars)	14,637,321	-4,853,679	19,491,000

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.