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HHS/FDA | RIN: 0910-AH04 | Publication ID: Spring 2018 |
Title: Mammography Quality Standards Act; Amendments to Part 900 Regulations | |
Abstract:
FDA is proposing to amend its regulations governing mammography. The amendments would update the regulations issued under the Mammography Quality Standards Act of 1992 (MQSA). FDA is taking this action to address changes in mammography technology and mammography processes that have occurred since the regulations were published in 1997 and to address breast density reporting to patient and health care providers. |
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Agency: Department of Health and Human Services(HHS) | Priority: Economically Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: Yes | Unfunded Mandates: No |
EO 13771 Designation: Regulatory | |
CFR Citation: 21 CFR 900 | |
Legal Authority: 21 U.S.C. 360i 21 U.S.C. 360nn 21 U.S.C. 374(e) 42 U.S.C. 263b |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: Yes | Government Levels Affected: None |
Small Entities Affected: Businesses | Federalism: No |
Included in the Regulatory Plan: Yes | |
RIN Data Printed in the FR: Yes | |
Agency Contact: Erica Payne Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health, 10903 New Hampshire Avenue, WO 66, Room 5517, Silver Spring, MD 20993 Phone:301 796-3999 Fax:301 847-8145 Email: erica.payne@fda.hhs.gov |