[Federal Register Volume 71, Number 75 (Wednesday, April 19, 2006)]
[Notices]
[Pages 20111-20113]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-5785]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket No. 2005D-0195


Guidance for Industry and FDA Staff; The Mammography Quality 
Standards Act Final Regulations: Modifications and Additions to Policy 
Guidance Help System 9; 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: Modifications and Additions to Policy 
Guidance Help System 9.'' This guidance document is intended 
to assist facilities and their personnel in meeting the Mammography 
Quality Standards Act (MQSA) final regulations.

DATES: Submit written or electronic comments on this guidance at any 
time. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``The Mammography Quality Standards Act Final 
Regulations:

[[Page 20112]]

Modifications and Additions to Policy Guidance Help System 9'' 
to the Division of Small Manufacturers, International, and Consumer 
Assistance (HFZ-220), Center for Devices and Radiological Health, Food 
and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send 
one self-addressed adhesive label 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.
    Submit written comments concerning this guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments. Identify comments with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Charles Finder, Center for Devices and 
Radiological Health (HFZ-240), Food and Drug Administration, 1350 
Piccard Drive., Rockville, MD 20850, 301-594-3332

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 15, 2005 (70 FR 41043), FDA issued 
a notice of availability for, and an opportunity for public comment on, 
``The Mammography Quality Standards Act Final Regulations: 
Modifications and Additions to Policy Guidance Help System 9'' 
draft guidance. During the public comment period, 6 respondents 
submitted a total of 38 comments. In addition, the National Mammography 
Quality Assurance Advisory Committee reviewed the draft guidance during 
its September 26 to 27, 2005, meeting and provided additional comments. 
FDA reviewed and considered all the comments, and in response FDA has 
modified the draft guidance as follows by:
    1. Further clarifying Small Field Digital Mammography (SFDM) 
requirements,
    2. Adding the phrase ``final interpretation quality'' to the 
section on retention and transfer of Full Field Digital Mammography 
(FFDM) images,
    3. Clarifying that FFDM images used for final interpretation 
contain certain identifying information,
    4. Clarifying under what circumstances the 8 hours of new 
mammographic modality training can be included as part of other initial 
interpreting physician requirements,
    5. Further clarifying the table describing acceptability of the 
American Registry of Radiologic Technologists (ARRT(M)) certificate,
    6. Modifying the guidance regarding the testing of single use 
cushion pads,
    7. Modifying the table listing medical physicist involvement in 
certain FFDM repairs,
    8. Clarifying the conditions under which electronic Quality Control 
test data may be retained.
    This document provides guidance on the following issues:
    1. Definitions of final interpretation and lossless and lossy 
digital compression,
    2. Use of Small Field Digital Mammography (SFDM) image receptors,
    3. Clarification relating to reestablishing processor operating 
levels,
    4. Impact of the Health Insurance Portability and Accountability 
Act (HIPAA) requirements on certain MQSA activities,
    5. Retention of medical outcomes audit records,
    6. Steps to take when patients do not wish to receive their lay 
summaries,
    7. Combining medical reports,
    8. The effect of film digitization and compression of Full Field 
Digital Mammography (FFDM) digital data on retention, transfer, and 
interpretation of mammographic images,
    9. Clarification of continuing education requirements,
    10. Use of foreign-trained physicians,
    11. Use of the ARRT(M) certificate to meet certain radiologic 
technologist requirements,
    12. Quality Control testing when using cushion pads on compression 
devices,
    13. Medical physicist involvement in certain FFDM repairs,
    14. Use of printers and monitors that were not specifically 
approved as part of an FFDM unit,
    15. Digitization of paper records and personnel documents.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on the issues described in the previous 
paragraphs. 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 requirements of the 
applicable statute and regulations.

III. Electronic Access

    In order to receive ``The Mammography Quality Standards Act Final 
Regulations: Modifications and Additions to Policy Guidance Help System 
9'' by 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 1538 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 by 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 device safety alerts, 
Federal Register reprints, information on premarket submissions 
(including lists of approved applications and manufacturers' 
addresses), small manufacturer's assistance, information on video 
conferencing and electronic submissions, Mammography Matters, and other 
device-oriented information. The CDRH Web site may be accessed at 
http://www.fda.gov/cdrh. A search capability for all CDRH guidance 
documents is available at http://www.fda.gov/cdrh/guidance.html. 
Guidance documents are also available on the Division of Dockets 
Management Internet site at http://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in this guidance were approved under OMB 
control number 0910-0580.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(See ADDRESSES), written or electronic comments regarding this document 
at any time. Submit electronic comments to http://www.fda.gov/dockets/ecomments. Submit two paper copies of any mailed comments, except that 
individuals may submit one paper copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Comments received may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.


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    Dated: April 10, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-5785 Filed 4-18-06; 8:45 am]
BILLING CODE 4160-01-S