[Federal Register Volume 64, Number 53 (Friday, March 19, 1999)]
[Notices]
[Pages 13589-13590]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6665]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-0302]
Draft ``Compliance Guidance: The Mammography Quality Standards
Act Final Regulations Document #2;'' 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availability of the draft guidance entitled ``Compliance Guidance: The
Mammography Quality Standards Act Final Regulations Document #2.'' This
draft guidance is neither final nor is it in effect at this time. The
final regulations implementing the Mammography Quality Standards Act of
1992 (the MQSA) will become effective April 28, 1999, and will replace
the interim regulations which, under the MQSA, currently regulate
mammography facilities. The draft guidance document is intended to
assist facilities and their personnel to meet the MQSA final
regulations.
DATES: Written comments concerning this draft guidance must be received
by June 17, 1999.
ADDRESS: See the SUPPLEMENTARY INFORMATION section for information on
electronic access to the draft guidance. Submit written requests for
single copies on a 3.5'' diskette of the draft guidance document
entitled ``Compliance Guidance: The Mammography Quality Standards Act
Final Regulations Document #2'' 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. Written comments
concerning this draft guidance must be submitted to the Dockets
Management Branch (HFA-
[[Page 13590]]
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.
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 MQSA was passed on October 27, 1992, to establish national
quality standards for mammography. After October 1, 1994, the MQSA
required all mammography facilities, except facilities of the U.S.
Department of Veterans Affairs, to be accredited by an approved
accreditation body and certified by the Secretary of Health and Human
Services (the Secretary). The authority to approve accreditation bodies
and to certify facilities was delegated by the Secretary to FDA. In the
Federal Register of October 28, 1997 (62 FR 55852), FDA published the
MQSA final regulations. The final regulations will become effective
April 28, 1999, and will replace the interim regulations (58 FR 67558
and 58 FR 67565, December 21, 1993) which, under the MQSA, currently
regulate mammography facilities. Development of this guidance document
began in August 1998 and is based in part on discussions with, and
input from, the National Mammography Quality Assurance Advisory
Committee.
II. Significance of Guidance
This draft 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 draft 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 #2'' via your fax machine,
call the CDRH Facts-On-Demand (FOD) system at 800-899-0381 or 301-827-
0111 from a touch-tone telephone. At the first voice prompt press 1 to
access DSMA Facts, at second voice prompt press 2, and then enter the
document number (1498) followed by the pound sign (#). Then follow the
remaining voice prompts to complete your request.
Persons interested in obtaining a copy of the draft guidance may
also do so using the World Wide Web (WWW). CDRH maintains an entry on
the WWW for easy access to information including text, graphics, and
files that may be downloaded to a personal computer with access to the
WWW. Updated on a regular basis, the CDRH home page includes
``Compliance Guidance: The Mammography Quality Standards Act Final
Regulations Document #2,'' 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''. ``Compliance Guidance: The Mammography Quality
Standards Act Final Regulations Document #2'' will be available at
``http://www.fda.gov/cdrh/dmqrp.html''.
IV. Comments
Interested persons may, on or before June 17, 1999, submit to
Dockets Management Branch (address above) written comments regarding
this draft 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. The draft guidance document and received comments may be
seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: March 10, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 99-6665 Filed 3-18-99; 8:45 am]
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