[Federal Register Volume 60, Number 17 (Thursday, January 26, 1995)]
[Proposed Rules]
[Page 5152]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-2006]



=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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]
BILLING CODE 4160-01-F