Information Collection

New Burden from Rulemaking (Third-Party Disclosure) - New assessment categories and breast density reporting in mammography report (one-time burden)-900.12(c)(1)(iv)-(c)(1)(vi)

IC 235521 under ICR 201903-0910-026 · OMB 0910-0309.

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Information Collection (IC) Details

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IC Title:	New Burden from Rulemaking (Third-Party Disclosure) - New assessment categories and breast density reporting in mammography report (one-time burden)-900.12(c)(1)(iv)-(c)(1)(vi)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 900.12

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 8,691	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

	Requested	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	8,691	8,691
Annual IC Time Burden (Hours)	199,893	199,893
Annual IC Cost Burden (Dollars)	0	0

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