[Federal Register Volume 64, Number 235 (Wednesday, December 8, 1999)]
[Notices]
[Pages 68696-68697]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-31777]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-4910]


Draft Compliance Guidance: The Mammography Quality Standards Act 
Final Regulations Document #3; 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availability of a draft guidance entitled ``Compliance Guidance: The 
Mammography Quality Standards Act Final Regulations Document #3.'' This 
draft guidance document is intended to assist facilities and their 
personnel to implement the Mammography Quality Standards Act of 1992 
(the MQSA).

DATES: Written comments concerning this draft guidance must be received 
by March 8, 2000.
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of the draft guidance document entitled ``Compliance Guidance: The 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 Document  # 3'' 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information on electronic access to the draft guidance.
     Submit written comments concerning this draft guidance to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.
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 to FDA by the Secretary to FDA. 
On October 28, 1997, FDA published the MQSA final regulations in the 
Federal Register. The final regulations became effective April 28, 
1999, and replaced the interim regulations (58 FR 67558 and 58 FR 
67565). Development of this draft

[[Page 68697]]

guidance document began in March 1999.

 II. Significance of Guidance

     This draft guidance document represents the agency's current 
thinking on the final regulations implementing the MQSA. The draft 
guidance is not final nor is it in effect at this time. 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 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  #3'' 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 (1496) 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 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  # 3,'' 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 # 3'' will be available at http://
www.fda.gov/cdrh/mammography.

 IV. Comments

     Interested persons may, on or before March 8, 2000, 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 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: November 24, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 99-31777 Filed 12-7-99; 8:45 am]
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