E9-24435. Draft Guidance for Industry and Food and Drug Administration Staff; the Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance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 #13; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13.” This document is intended to provide guidance to mammography facilities and their personnel. It represents FDA's current thinking on the final regulations implementing the Mammography Quality Standards Act of 1992 (MQSA). This guidance document updates previous guidance. This draft guidance is not final nor is it in effect at this time.

DATES:

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by January 7, 2010.

ADDRESSES:

Submit written requests for single copies of the draft guidance document entitled “The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13” to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-847-8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance.

Submit written comments concerning this draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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.regulations.gov. 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, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4646, Silver Spring, MD 20993-0002, 301-796-5715.

SUPPLEMENTARY INFORMATION:

I. Background

MQSA (Pub. L. 102-539) was signed into law on October 27, 1992, to establish national quality standards for mammography. It is codified at 42 U.S.C. 263b. The MQSA requires that, in order to lawfully provide mammography services after October 1, 1994, all facilities, except facilities of the Department of Veterans Affairs, must be accredited by an approved accreditation body and certified by the Secretary of Health and Human Services (the Secretary) or by an approved State certification agency (section 354(b) of the MQSA; 42 U.S.C. 263b(b)). In June 1993, the authority to approve accreditation bodies and State certification agencies and to certify facilities was delegated by the Secretary to the FDA (58 FR 32543). On October 28, 1997, the FDA first published final regulations implementing the MQSA in the Federal Register (21 CFR part 900) (62 FR 55852). The MQSA has twice been amended since its enactment, through the Mammography Quality Standards Reauthorization Acts (MQSRA) of 1998 and 2004 (Pub. L. 105-248 and Pub. L. 108-365).

This draft guidance updates the Policy Guidance Help System and addresses or contains the following:

1. Updated contact information for accreditation bodies and certification agencies;

2. General guidance regarding Additional Mammography Reviews (AMRs);

3. Previously approved alternative standards;

4. Centers for Medicare and Medicaid Services (CMS) reimbursement;

5. Mechanisms to inform physicians and patients of mammography results;

6. Labeling of mammographic images;

7. Mammographic modality and its impact on personnel experience requirements;

8. Clarification of the personnel 6-month exemption period;

9. Information on calibrating the air kerma measuring instrument;

10. Medical physicist involvement as it applies to cassette replacement;

11. Full Field Digital Mammography (FFDM) and use of single-use cushion pads;

12. Quality control testing of computer controlled compression devices;

13. Mammography equipment evaluations of laser printers;

14. Quality control testing of monitors and laser printers;

15. Mammography equipment evaluations of new FFDM units; and

16. Mammography equipment evaluations of off-site laser printers and monitors.

In November 1998, FDA compiled all to-date final FDA guidances related to MQSA and put them into a computerized searchable database called the Policy Guidance Help System (PGHS). The PGHS is available on the Internet at http://www.fda.gov/​cdrh/​mammography/​robohelp/​start.htm.

FDA periodically updates the information in the PGHS, and this document serves as a further update. Individuals wishing to receive automatic notification of future updates may subscribe to our e-mail ListServ by visiting http://service.govdelivery.com/​service/​subscribe.html?​code=​USFDA_​45 and following the directions there.

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 Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13.” 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

Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. To receive “The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13,” you may either send an e-mail request to [e-mail] to receive an electronic copy of the document or send a fax request to 301-847-8149 to receive a hard copy. Please use the document number (1695) to identify the guidance you are requesting.

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 manufacturers' 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 at http://www.regulations.gov.

IV. Paperwork Reduction Act

This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information 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 21 CFR part 900 have been approved under OMB Control No. 0910-0309.

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. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Dated: October 1, 2009.

Jeffrey Shuren,

Acting Director, Center for Devices and Radiological Health.