Draft Proposed Regulations on Quality Standards and Certification Requirements for Mammography Facilities; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. 95D-0014]

Draft Proposed Regulations on Quality Standards and Certification

Requirements for Mammography Facilities; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability of draft proposed regulations.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the

availability of draft proposed regulations prepared by the Center for

Devices and Radiological Health (CDRH) to implement the Mammography

Quality Standards Act of 1992 (MQSA). The drafts contain minimum

quality standards for mammography facilities in the following areas:

Personnel standards, medical outcomes audits, medical records and

mammography reports, quality assurance, mobile mammography,

accreditation bodies, implant imaging, mammography equipment,

variances, consumer complaint mechanism, and quality control.

DATES: Written comments by April 11, 1995.

ADDRESSES: Submit written requests for single copies of the draft

regulations to the Center for Devices and Radiological Health (HFZ-

240), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD

20850. Send two self-addressed adhesive labels to assist that office in

processing your requests. Submit written comments on the draft proposed

regulations to the Dockets Management Branch (HFA-305), Food and Drug

Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.

Requests and comments should be identified with the docket number found

in brackets in the heading of this document. A copy of the draft

proposed regulations and received comments are available for public

examination in the Dockets Management Branch (address above) between 9

a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Charles K. Showalter, Center for

Devices and Radiological Health, Center for Devices and Radiological

Health (HFZ-240), 9200 Corporate Blvd., Rockville, MD 20850, 301-594-

3311.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of draft

proposed regulations regarding quality standards and certification

requirements for mammography facilities in the following areas:

Personnel standards, medical outcomes audits, medical records and

mammography reports, quality assurance, mobile mammography,

accreditation bodies, implant imaging, mammography equipment,

variances, consumer complaint mechanism, and quality control. These

proposed regulations are being developed to implement the MQSA (Pub. L.

102-539), which was enacted to establish quality standards for

mammography. The MQSA requires that, to provide mammography services

legally after October 1, 1994, all facilities, except facilities of the

Department of Veterans Affairs, must be both accredited by an approved

accrediting body and certified by the Secretary of Health and Human

Services (the Secretary). The authority to approve accrediting bodies

and to certify facilities has been delegated by the Secretary to FDA.

Pursuant to authorization from Congress, FDA promulgated interim

regulations to ensure that mammography facilities meet minimum quality

standards. These regulations, which were published in the Federal

Register on December 21, 1993 (58 FR 67558 and 58 FR 67565), and

amended on September 30, 1994 (59 FR 49808), became effective on

October 1, 1994, and will remain in effect until final regulations are

promulgated.

FDA is currently developing proposed regulations for quality

standards in various subject areas, including the 11 areas referenced

above. Under the MQSA, FDA established a National Mammography Quality

Assurance Advisory Committee (NMQAAC) to advise the agency on the

appropriate level of quality standards for mammography facilities and

accrediting bodies. Advanced drafts of proposed regulations are

provided routinely to all members of the advisory committee for their

advice and recommendation, and periodic public meetings of the advisory

committee are being held.

An advisory committee meeting was held on January 23 through

January 25, 1995. The meeting was announced in the Federal Register of

December 21, 1994 (59 FR 65776). It was held at the Dupont Plaza Hotel,

Embassy Room, 1500 New Hampshire Ave. NW., Washington, D.C.

In order to gather additional information on these particular

topics, FDA decided to share the drafts of these proposed regulations

with certain individuals who were invited as guests to the January 23

through 25, 1995, advisory committee meeting to enable them to provide

comments at the meeting on the feasibility of efficient implementation

of these draft proposed standards by the radiology community. These

invited guests have particular expertise in one or more of the areas

addressed by the draft proposals. The agency is publishing this notice

in order to make the same draft documents available to the general

public.

Although all members of the general public will have an

opportunity to comment on the proposed regulations when they are

published in the spring of 1995, interested persons who wish to comment

on the draft proposals may submit written comments to the Dockets

Management Branch (address above) on or before April 11, 1995. Two

copies of any comments should be submitted, except that individuals may

submit one copy. Comments are to be identified with the docket number

found in brackets in the heading of this document. The draft proposed

regulations and comments received may be seen in the Dockets Management

Branch between 9 a.m. and 4 p.m., Monday through Friday.

FDA will consider any comments received in developing final

regulations.

Dated: January 23, 1995.

William K. Hubbard,

Interim Deputy Commissioner for Policy.

[FR Doc. 95-2006 Filed 1-23-95; 3:40 pm]

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