[Federal Register Volume 59, Number 250 (Friday, December 30, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-32139]


[[Page Unknown]]

[Federal Register: December 30, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94N-0351]

 

Draft Proposed Regulations on Mammography X-ray Equipment 
Standards and on Medical Physicists Standards; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of two draft proposed regulations prepared by the Center 
for Devices and Radiological Health (CDRH). One draft contains 
standards for mammography x-ray equipment and the other draft contains 
medical physicists standards. The draft documents are intended to 
implement the Mammography Quality Standards Act of 1992 (the MQSA). The 
MQSA requires the establishment of a Federal certification and 
inspection program for mammography facilities, regulations and 
standards for accrediting bodies for mammography facilities, and 
standards for mammography equipment, personnel, and practices, 
including quality assurance. Prior to publishing the proposed 
regulations, FDA is making available two draft regulations concerning 
personnel qualifications for medical physicists and the quality 
standards for mammography equipment in order to receive additional 
information about these subjects.

DATES: Written comments by January 30, 1995.

ADDRESSES: Submit written requests for single copies of the draft 
proposed 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 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 the 
October 1994 draft proposed regulations regarding mammography x-ray 
equipment, and the December 2, 1994, draft mammography medical 
physicist standards regulations that are being developed to implement 
the MQSA (Pub. L. 102-539) that was enacted to establish minimum 
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 accreditation 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 of December 21, 1993 (58 FR 67558 and 67565), and amended on 
September 30, 1994 (59 FR 49809), 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 for mammography x-ray equipment. Prior to publishing proposed 
regulations on this subject, FDA has made the draft available to 
mammography x-ray equipment manufacturers in order to gather additional 
information about the technical capabilities of mammography equipment 
currently in use and the feasibility of efficient implementation of the 
draft proposed equipment standards by the radiology community. Further, 
FDA has shared a draft proposed regulation concerning medical 
physicists' qualifications with the Conference of Radiation Control 
Program Directors and the American Association of Physicists in 
Medicine in order to obtain information from these organizations about 
the potential impact of the draft proposal on the availability of 
medical physicists. The agency is publishing this notice in order to 
make the two draft proposed regulations available to the public.
    Although all members of the 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 January 30, 1995. Two copies of any 
comments are to 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 received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.
    FDA will consider any received comments in developing final 
regulations.-

    Dated: December 23, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-32139 Filed 12-29-94; 8:45 am]
BILLING CODE 4160-01-F