[Federal Register Volume 64, Number 53 (Friday, March 19, 1999)]
[Notices]
[Pages 13589-13590]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6665]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-0302]


Draft ``Compliance Guidance: The Mammography Quality Standards 
Act Final Regulations Document #2;'' 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availability of the draft guidance entitled ``Compliance Guidance: The 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 #2.'' 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draft guidance is neither final nor is it in effect at this time.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) 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 The draft guidance document is intended to 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DATES: Written comments concerning this draft guidance must be received 
by June 17, 1999.

ADDRESS: See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the draft guidance. 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single copies on a 3.5'' diskette of the draft guidance document 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 Document #2'' 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. Written comments 
concerning this draft guidance must be submitted to the Dockets 
Management Branch (HFA-

[[Page 13590]]

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: 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 55852), FDA published the 
MQSA final regulations. The final regulations will become effective 
April 28, 1999, and will replace the interim regulations (58 FR 67558 
and 58 FR 67565, December 21, 1993) which, under the MQSA, currently 
regulate mammography facilities. Development of this guidance document 
began in August 1998 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 ``Compliance Guidance: The Mammography Quality 
Standards Act Final Regulations Document #2'' 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 (1498) 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 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 
WWW. Updated on a regular basis, the CDRH home page includes 
``Compliance Guidance: The Mammography Quality Standards Act Final 
Regulations Document #2,'' 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 #2'' will be available at 
``http://www.fda.gov/cdrh/dmqrp.html''.

 IV. Comments

     Interested persons may, on or before June 17, 1999, submit to 
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 draft 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: March 10, 1999.
 Linda S. Kahan,
 Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 99-6665 Filed 3-18-99; 8:45 am]
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