[Federal Register Volume 65, Number 38 (Friday, February 25, 2000)]
[Notices]
[Pages 10096-10097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-4406]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-0302]


Compliance Guidance: The Mammography Quality Standards Act Final 
Regulations Document 2; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Compliance Guidance: The 
Mammography Quality Standards Act Final Regulations Document 2.'' The 
guidance document is intended to assist facilities and their personnel 
to meet the Mammography Quality Standards Act of 1992 (the MQSA) final 
regulations. The final regulations implementing the MQSA became 
effective April 28, 1999, replacing the interim regulations.

DATES: Submit written comments concerning this guidance at any time.

ADDRESSES: Submit written requests for single copies on a 3.5"" 
diskette of the 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. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance.
    Submit written comments on ``Compliance Guidance: The Mammography 
Quality Standards Act Final Regulations Document 2'' to the contact 
person listed below.

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. The MQSA required that to provide 
mammography services legally after October 1, 1994, all facilities, 
except facilities of the U.S. Department of Veterans Affairs, must 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, 
FDA published the MQSA final regulations. The final regulations became 
effective April 28, 1999, and replaced the interim regulations (58 FR 
67558 and 58 FR 67565, December 21, 1993) which, under the MQSA, 
previously regulated mammography facilities. The document addresses new 
questions that FDA has received since the publication of ``Compliance 
Guidance: The Mammography Quality Standards Act Final Regulations'' on 
August 27, 1998.
    The guidance document was published as a draft proposal for public 
comment on March 19, 1999 (64 FR 13589). It was discussed with the 
National Mammography Quality Assurance Advisory Committee in November 
1998 and a working group of the Conference of Radiation Control Program 
Directors in May 1999. The document has been modified from the original 
draft proposal to address public comments. While there are many 
clarifying changes in the document,

[[Page 10097]]

there were no major substantive changes.

II. Significance of Guidance

    This 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 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 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 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 access to the Internet. 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/mammography.

IV. Comments

    Interested persons may, at any time, submit to the contact person 
(address above) written comments regarding this guidance. Such comments 
will be considered when determining whether to amend the current 
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.

    Dated: February 9, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-4406 Filed 2-24-00; 8:45 am]
BILLING CODE 4160-01-F