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HHS/FDA RIN: 0910-AH04 Publication ID: Fall 2017 
Title: Mammography Quality Standards Act; Regulatory Amendments 
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 healthcare providers.

 
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

Statement of Need:

FDA is proposing to update the mammography regulations that were issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act).  FDA is taking this action to address changes in mammography technology and mammography processes.

FDA is also proposing updates to modernize the regulations by incorporating current science and mammography best practices, including addressing breast density reporting to patients and health care providers.

These updates are intended to improve the delivery of mammography services.

Summary of the Legal Basis:

Mammography is an X-ray imaging examination device that is regulated under the authority of the FD&C Act.  FDA is proposing these amendments to the mammography regulations (set forth in 21 CFR part 900) under section 354 of the Public Health Service Act (42 U.S.C. 263b), and sections 519, 537, and 704(e) of the FD&C Act (21 U.S.C. 360i, 360nn, and 374(e)).

Alternatives:

The Agency will consider different options so that the health benefits to patients are maximized and the economic burdens to mammography facilities are minimized.

Anticipated Costs and Benefits:

The primary public health benefits of the rule will come from the potential for earlier breast cancer detection, improved morbidity and mortality, resulting in reductions in cancer treatment costs.  The primary costs of the rule will come from industry labor costs and costs associated with supplemental testing and biopsies.

Risks:

If a final regulation does not publish, the potential reduction in fatalities and earlier breast cancer detection, resulting in reduction in cancer treatment costs, will not materialize to the detriment of public health.

Timetable:
Action Date FR Cite
NPRM  10/00/2018 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: State 
Small Entities Affected: Businesses  Federalism: Yes 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: Yes 
Agency Contact:
Erica Blake-Payne
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health, WO 66, Room 5522, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-3999
Fax:301 847-8145
Email: erica.payne@fda.hhs.gov