[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Draft Guidance for Industry and Food and Drug Administration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availability of the draft guidance entitled ``The Mammography Quality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 The draft guidance document is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DATES: Submit written or electronic comments on this draft guidance by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diskette of the draft guidance document entitled ``The Mammography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Submit written comments concerning this draft guidance and the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This draft guidance is intended to provide guidance to mammography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