[Federal Register: July 15, 2005 (Volume 70, Number 135)]
[Notices]               
[Page 41043-41045]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15jy05-84]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0195]

 
Draft Guidance for Industry and Food and Drug Administration 
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availability of the draft guidance entitled ``The Mammography Quality 
Standards Act Final Regulations: Modifications and Additions to Policy 
Guidance Help System 9.'' The draft guidance document is 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DATES:  Submit written or electronic comments on this draft guidance by 
October 13, 2005.

ADDRESSES:  Submit written requests for single copies on a 3.5'' 
diskette of the draft guidance document entitled ``The Mammography 
Quality Standards Act Final Regulations: 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    Submit written comments concerning this draft guidance and the 
information collection provisions 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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 Dr., Rockville, MD 20850, 301-594-3332.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance is intended to provide guidance to mammography 
facilities and their personnel. It represents the FDA's current 
thinking on various aspects of the final regulations implementing the 
MQSA (Public Law 102-539). Once finalized, this draft guidance document 
will add to and update material in the Policy Guidance Help System 
(PGHS) in order to address recurring inquiries to the Center for 
Devices and Radiological Health (CDRH) about these issues. The PGHS is 
a computerized system accessible through FDA's Web site that is 
intended to provide useful information to mammography facilities and 
their personnel on issues relating to MQSA. The guidance only addresses 
those portions of the PGHS that are being revised.
    This draft guidance addresses the following issues:
    1. Definitions of final interpretation and lossless and lossy 
digital compression;
    2. Use of Small Field Digital Mammography image receptors;
    3. Clarification relating to reestablishing processor operating 
levels;
    4. Impact of the Health Insurance Portability and Accountability 
Act 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 American Registry of Radiologic Technologists 
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; and
    15. Digitization of paper records and personnel documents.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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

    To receive ``The Mammography Quality Standards Act Final 
Regulations: Modifications and Additions to Policy Guidance Help System 
9'' by fax, 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

[[Page 41044]]

order a document. Enter the document number (1538) followed by the 
pound sign (). Follow the remaining voice prompts to complete 
your request.
    To receive ``The Mammography Quality Standards Act Final 
Regulations: Modifications and Additions to Policy Guidance Help System 
9,'' you may either send a fax request to 301-443-8818 to 
receive a hard copy of the document, or send an e-mail request to 
gwa@cdrh.fda.gov to receive a hard copy or an electronic copy. Please 

use the document number 1538 to identify the guidance you are 
requesting.
    Persons interested in obtaining a copy of the draft 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh A search capability for all CDRH guidance documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html.
 Guidance documents are also available on the Division of 

Dockets Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.


IV. Paperwork Reduction Act of 1995

    This draft guidance document contains information collection 
provisions that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 
U.S.C. 3501-3520). Under the PRA, Federal agencies must obtain approval 
from OMB for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3 and includes agency requests or requirements that members of the 
public submit reports, keep records, or provide information to a third 
party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information in the following paragraphs.
    With respect to the following collection of information, FDA 
invites comments on the following items: (1) Whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Mammography Quality Standards Act Final Regulations: 
Modifications and Additions to Policy Guidance Help System 9
    Description: The Mammography Quality Standards Act Final 
Regulations: Modifications and Additions to Policy Guidance Help System 
9 provides guidance to mammography facilities and their 
personnel on a variety of issues involving the quality standards for 
mammography (Sec. 900.12 (21 CFR 900.12)). Use of the guidance results 
in new collections of information. Facilities are required to provide 
patients with lay summaries of the results of their mammography 
examinations (Sec. 900.12(c)(2)). This guidance document provides 
information on how to address a patient's refusal to receive a lay 
summary and recommends that the facility document why it was unable to 
meet this requirement. Additionally, the guidance addresses 
interpreting physician initial requirements (Sec.  
900.12(a)(1)(i)(B)(2)), including recommendations on how to document 
the alternative to Board Certification for foreign-trained physicians.
    Respondents: The likely respondents are mammography facilities and 
their personnel who are subject to the MQSA quality standards 
requirements.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                      Annual Frequency  of      Total Annual         Hours per
   Activity      No. of  Respondents        Response              Responses          Response       Total Hours
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Reporting of                     915                     1                   915             0.5             458
 refusal of
 lay summary
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                                                 No. of        Annual Frequency     Total Annual
                         Activity                            Recordkeepers     of Recordkeeping       Records       Hours per  Record     Total Hours
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Documentation of foreign-trained physicians'                              92                  1                 92                  8                736
 qualifications
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    There are a total of 9,150 MQSA-certified facilities. Using past 
experience, FDA estimates that 10 percent of these facilities will 
receive patient requests that lay summary results not be sent. We also 
estimate that the facility will spend 0.5 hours per patient obtaining 
the patient's written request, filing that form in the patient's record 
and forwarding the summary to the patient's designee. With respect to 
foreign-trained physicians, past experience indicates that this 
situation arises very infrequently. We estimate that only 1 percent of 
MQSA-certified facilities will have to maintain records documenting the 
qualifications of foreign-trained physicians.

[[Page 41045]]

    This draft guidance also contains information collection provisions 
that have been approved by OMB in accordance with the PRA under 
existing regulations. The collections of information described in this 
guidance document for Sec.  900.12 were previously approved under OMB 
control number 0910-0309 entitled ``Mammography Facilities, Standards, 
and Lay Summaries for Patients 21 CFR Part 900.''

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments regarding this 
document. Submit a single copy of electronic comments or 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.

    Dated: June 10, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-13974 Filed 7-14-05; 8:45 am]

BILLING CODE 4160-01-S