[Federal Register Volume 65, Number 138 (Tuesday, July 18, 2000)]
[Notices]
[Pages 44538-44539]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18060]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-4910]


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 the guidance document entitled ``Compliance Guidance: 
The Mammography Quality Standards Act Final Regulations Document #3.'' 
The final regulations implementing the Mammography Quality Standards 
Act of 1992 (the MQSA) became effective April 28, 1999, replacing the 
interim regulations. The guidance document is intended to assist 
facilities and their personnel to meet the MQSA final regulations.

DATES: Submit written comments concerning this guidance document at any 
time.

ADDRESSES: Submit written requests for single copies on a 3" diskette 
of the 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 (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. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance document. Submit 
written comments on the guidance document to the contact person listed 
below.

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

    This guidance document was published as a draft proposal for public 
comment in the Federal Register of December 8, 1999 (64 FR 68696). It 
has been discussed with the National Mammography Quality Assurance 
Advisory Committee at two separate meetings (July 1999 and January 
2000). The guidance document has been modified from the original draft 
proposal to address public comments. While there are several clarifying 
changes in the guidance document, there were no major substantive 
changes.

II. Significance of Guidance

    This 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 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 system at 800-899-0381 or 301-827-0111 
from a touchtone 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 guidance document 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 previously 
issued ``Compliance Guidance for the Mammography Quality Standards Act 
Final Regulations Document #3,'' device safety alerts, Federal Register 
reprints, information on premarket submissions

[[Page 44539]]

(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/guidance-rev.html.

IV. Comments

    Interested persons may submit to the contact person (address above) 
written comments regarding this guidance at any time. Such comments 
will be considered when determining whether to amend the current 
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.

    Dated: June 29, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-18060 Filed 7-17-00; 8:45 am]
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