Information Collection

Mammography Facilities, Standards, and Lay Summaries for Patients

IC 5881 under ICR 202009-0910-010 · 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⚠️ Notice: This information collection may be referencing outdated material.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

Documents and forms in this information collection
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: Unchanged

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:

table that charts list of 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

Federal Enterprise Architecture Business Reference Module

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 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	35,208,523	35,208,523
Annual IC Time Burden (Hours)	3,940,856	3,940,856
Annual IC Cost Burden (Dollars)	26,303,177	26,303,177

Documents for IC

table that charts IC Documents
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.