[Federal Register Volume 66, Number 100 (Wednesday, May 23, 2001)]
[Notices]
[Pages 28527-28528]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-12909]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1497]


The Mammography Quality Standards Act Final Regulations Document 
#4; Final Guidance for Industry and FDA; 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 entitled ``The Mammography Quality 
Standards Act Final Regulations Document #4; Final Guidance for 
Industry and FDA.'' The final regulations implementing the Mammography 
Quality Standards Act of 1992 (the MQSA) became effective April 28, 
1999. The final guidance document is intended to assist facilities and 
their personnel to meet the MQSA final regulations.

DATES: Submit written comments at any time.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the guidance document entitled ``The Mammography Quality 
Standards Act Final Regulations Document #4; Final Guidance for 
Industry and FDA'' 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. Submit written comments 
concerning this 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 
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    The draft guidance document was issued for public comment in the 
Federal Register of September 13, 2000 (65 FR 55265). The comment 
period ended on December 13, 2000. The draft guidance was discussed 
with the National Mammography Quality Assurance Advisory Committee at 
the September 28, 2000, meeting. The final guidance document has been 
modified from the original draft guidance to address the seven public 
comments received. There were several clarifying changes made to the 
document, particularly dealing with the issues of what constitutes a 
``major repair'' and when the physicist must perform onsite 
evaluations. Several decision tree flow diagrams were added to the 
document to help clarify these issues. Overall, there were no major 
substantive changes made to the document.

II. Significance of the Guidance

    This guidance document represents the agency's current thinking on 
the MQSA final regulations guidance. 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 statutes and regulations.
    The agency has adopted the good guidance practices (GGPs) 
regulation, which sets forth the agency's regulations for the 
development, issuance, and use of guidance documents (21 CFR 10.115; 65 
FR 56468, September 19, 2000). This guidance document is issued as a 
level 1 guidance consistent with GGPs.

III. Electronic Access

    In order to receive ``The Mammography Quality Standards Act Final 
Regulations Document #4; Final Guidance for Industry and FDA'' via your 
fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 
301-827-0111 from a touch-tone telephone. 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 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 Internet access. Updated on a 
regular basis, the CDRH home page includes the civil money penalty 
guidance documents package, 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 Mammography Quality Standards Act Final Regulations 
Document#4; Final Guidance for Industry and FDA'' will also be 
available on CDRH's mammography Web site at http://www.fda.gov/cdrh/mammography. Guidance documents are also available on the Dockets 
Management Branch Web site at http://www.fda.gov.ohrms/dockets/default.htm.

[[Page 28528]]

IV. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this guidance at any time. 
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 are available for public examination in 
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: May 16, 2001.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 01-12909 Filed 5-22-01; 8:45 am]
BILLING CODE 4160-01-S