[Federal Register Volume 63, Number 166 (Thursday, August 27, 1998)]
[Notices]
[Page 45828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-23030]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0697]


Compliance Guidance: The Mammography Quality Standards Act Final 
Regulations Draft; 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availability of the draft guidance document entitled ``Compliance 
Guidance: The Mammography Quality Standards Act Final Regulations.'' 
This draft guidance document is not final nor is it in effect at this 
time. The final regulations implementing the Mammography Quality 
Standards Act of 1992 (the MQSA) will become effective April 28, 1999, 
and will replace the interim regulations which, under the MQSA, 
currently regulate mammography facilities. The draft guidance document 
is intended to assist facilities and their personnel to meet the MQSA 
final regulations.

DATES: Written comments must be received by November 25, 1998.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the draft guidance document entitled ``Compliance Guidance: 
The Mammography Quality Standards Act Final Regulations'' to the 
Division of Small Manufacturers Assistance (HFZ-220), Center for 
Devices and Radiological Health, 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. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the draft guidance.
    Submit written comments on this draft guidance to the Dockets 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.
FOR FURTHER INFORMATION CONTACT: Walid G. Mourad, 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. On 
October 28, 1997, FDA published the MQSA final regulations in the 
Federal Register. The final regulations will become effective April 28, 
1999, and will replace the interim regulations (58 FR 67558 and 58 FR 
67565) which, under the MQSA, currently regulate mammography 
facilities. Development of the guidance began in August 1997 and is 
based in part on discussions with, and input from, the National 
Mammography Quality Assurance Advisory Committee.

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 ``Compliance Guidance: The Mammography 
Quality Standards Act Final Regulations'' via your fax machine, call 
the CDRH Facts-On-Demand (FOD) system at 800-899-0381 or 301-827-0111 
from a touch-tone telephone. At the first voice prompt press 1 to 
access DSMA Facts, at second voice prompt press 2, and then enter the 
document number (1259) followed by the pound sign (#). Then follow the 
remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the draft guidance 
document may also do so using the World Wide Web (WWW). CDRH maintains 
an entry on the WWW for easy access to information including text, 
graphics, and files that may be downloaded to a personal computer with 
access to the Web. Updated on a regular basis, the CDRH home page 
includes the ``Compliance Guidance: The Mammography Quality Standards 
Act Final Regulations'', 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. The ``Compliance Guidance: The Mammography Quality Standards Act 
Final Regulations'' will be available at http://www.fda.gov/cdrh/
dmqrp.html.

IV. Comments

    Interested persons may, on or before November 25, 1998, submit to 
the Dockets Management Branch (address above) written comments 
regarding this draft guidance. 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 guidance document and received comments may be 
seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: August 7, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-23030 Filed 8-26-98; 8:45 am]
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