[Federal Register Volume 61, Number 191 (Tuesday, October 1, 1996)]
[Notices]
[Pages 51294-51295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25197]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0322]


Mammography Facility Performance, Calendar Year 1995; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the document entitled ``Mammography Facility 
Performance, Calendar Year 1995.'' This document, mandated by Congress 
in the Mammography Quality Standards Act of 1992 (the MQSA), is 
intended to inform physicians and the general public about mammography 
facility performance in the calendar year 1995.

ADDRESSES: Submit written requests for single copies of the document 
entitled ``Mammography Facility Performance, Calendar Year 1995'' to 
MQSA, c/o SciComm, Inc., P.O. Box 30224, Bethesda, MD 20824-9998. 
Requests should be identified with the docket number found in brackets 
in the heading of this document. Send two self-addressed adhesive 
labels to assist that office in processing your requests. The document 
is also available on the Internet (http://www.fda.gov). ``Mammography 
Facility Performance, Calendar Year 1995'' is available for public 
examination in the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Carole Sierka, Office of Health and 
Industry Programs, Center for Devices and Radiological Health (HFZ-
240), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 
20850, 301-594-3534, FAX 301-594-3306.

SUPPLEMENTARY INFORMATION: The MQSA of 1992 (Pub. L. 102-539) was 
enacted on October 27, 1992. Under the MQSA, FDA is required annually 
to compile and make available to physicians and to the general public 
information assisting in the selection of an FDA-certified facility. 
The report must include a list of facilities:
    (1) That have been convicted under Federal or State laws relating 
to fraud and abuse, false billings, or kickbacks;
    (2) that have been subject to sanctions under MQSA together with a 
statement of the reasons for the sanctions;
    (3) that have had certificates revoked or suspended, together with 
a statement of the reasons for the revocation or suspension;
    (4) against which the Secretary of the Department of Health and 
Human Services has sought an injunction under MQSA, together with a 
statement of the reasons for the action;
    (5) whose accreditation has been revoked, together with a statement 
of the reasons for the revocation;

[[Page 51295]]

    (6) against which a State has taken adverse action; and
    (7) that meets such other measures of performance as the Secretary 
may develop.
    The information compiled in this report must be accompanied by 
information that will assist in the interpretation of the report.
    Accordingly, FDA is making the list and explanatory information 
available through this report. This report also provides background 
information on quality mammography and directs consumers on how to 
acquire a list of FDA-certified mammography facilities.

    Dated: September 27, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-25197 Filed 9-27-96; 12:11 pm]
BILLING CODE 4160-01-F