[Federal Register Volume 65, Number 178 (Wednesday, September 13, 2000)]
[Notices]
[Pages 55265-55266]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-23478]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1497]


Draft Compliance Guidance: The Mammography Quality Standards Act 
Final Regulations Document #4; 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availability of the draft guidance entitled ``Compliance Guidance: The 
Mammography Quality Standards Act Final Regulations Document #4.'' This 
draft guidance is neither final nor is it in effect at this time. The 
final regulations implementing the Mammography Quality Standards Act of 
1992 (the MQSA) became effective April 28, 1999. The draft guidance 
document is intended to help facilities and their personnel meet the 
MQSA final regulations.

DATES: Submit written comments concerning this draft guidance by 
December 12, 2000.

ADDRESSES: Submit written requests for single copies on a 3.5" diskette 
of the draft guidance entitled ``Compliance Guidance: The Mammography 
Quality Standards Act Final Regulations Document #4'' to the Division 
of Small

[[Page 55266]]

Manufacturers Assistance (HFZ-220), Center for Devices and Radiological 
Health (CDRH), Food and Drug Administration, 1350 Piccard Dr., 
Rockville, MD 20850. Send two self-addressed adhesive labels to assist 
that office in processing your request, or fax your request to 301-443-
8818. Submit written comments concerning this draft guidance to the 
Dockets Management Branch (HFA 305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Comments should be 
identified with the docket number found in brackets in the heading of 
this document. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Charles A. Finder, Center for Devices 
and Radiological Health (HFZ 240), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-594-3332.

SUPPLEMENTARY INFORMATION:

I. Background

    The MQSA was passed on October 27, 1992, to establish national 
quality standards for mammography. After October 1, 1994, the MQSA 
required all mammography facilities, except facilities of the U.S. 
Department of Veterans Affairs, to be accredited by an approved 
accreditation body and certified by the Secretary of Health and Human 
Services (the Secretary). The authority to approve accreditation bodies 
and to certify facilities was delegated by the Secretary to FDA. In the 
Federal Register of October 28, 1997 (62 FR 55976), FDA published the 
MQSA final regulations. The final regulations became effective April 
28, 1999, and replaced the interim regulations (58 FR 67558 and 58 FR 
67565, December 21, 1993). Development of this guidance document began 
in December 1999.

II. Significance of Guidance

    This draft guidance document represents the agency's current 
thinking on the final regulations implementing the MQSA. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the applicable statute, regulations, or both.
    The agency has adopted good guidance practices (GGP's), which set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (62 FR 8961, February 27, 
1997). This draft guidance document is issued as a Level 1 guidance 
consistent with GGP's.

III. Electronic Access

    In order to receive the draft guidance entitled ``Compliance 
Guidance: The Mammography Quality Standards Act Final Regulations 
Document #4'' via your fax machine, call the CDRH Facts-On-Demand 
system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. At 
the first voice prompt press 1 to enter the system. At the second voice 
prompt press 1 to order a document. Enter the document number (1159) 
followed by the pound sign (#). Follow the remaining voice prompts to 
complete your request.
    Persons interested in obtaining a copy of the draft guidance may 
also do so using the Internet. CDRH maintains an entry on the Internet 
for easy access to information including text, graphics, and files that 
may be downloaded to a personal computer with access to the Internet. 
Updated on a regular basis, the CDRH home page includes ``Compliance 
Guidance: The Mammography Quality Standards Act Final Regulations 
Document #4,'' device safety alerts, Federal Register reprints, 
information on premarket submissions (including lists of approved 
applications and manufacturers' addresses), small manufacturers' 
assistance, information on video conferencing and electronic 
submissions, mammography matters, and other device-oriented 
information. The CDRH home page may be accessed at http://www.fda.gov/cdrh. ``Compliance Guidance: The Mammography Quality Standards Act 
Final Regulations Document #4'' will be available at http://www.fda.gov/cdrh/mammography.

IV. Comments

    Interested persons may submit to Dockets Management Branch (address 
above) written comments regarding this draft guidance by December 12, 
2000. Two copies of any comments are to be submitted, except that 
individual may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. The 
draft guidance document and received comments are available for public 
examination in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: August 29, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-23478 Filed 9-12-00; 8:45 am]
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