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Rule

Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide; Guidance for Industry and Food and Drug Administration Staff; Availability

A Rule by the Food and Drug Administration on 08/26/2024

Published Document: 2024-19059 (89 FR 68364)

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Department of Health and Human Services
Food and Drug Administration
  1. 21 CFR Part 900
  2. [Docket No. FDA-2013-N-0134]

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notification of availability.

SUMMARY:

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled “Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide.” The Mammography Quality Standards Act of 1992 (MQSA) final rule amended FDA's regulations to address, among other things, standards for accreditation bodies, certifying agencies, mammography equipment, quality assurance testing, and clinical image quality, as well as to require certain breast density information be provided by mammography facilities to patients and their healthcare providers. The small entity compliance guide (SECG) is intended to help small entities comply with the MQSA final rule.

DATES:

August 26, 2024.

ADDRESSES:

You may submit either electronic or written comments on Agency guidances at any time as follows:

Electronic Submissions

Submit electronic comments in the following way:

  • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
  • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

  • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2013-N-0134 for “Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

  • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted onhttps://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not ( printed page 68365) in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

An electronic copy of the guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the SECG entitled “Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide” to the Office of Policy, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT:

Preetham Sudhaker, Division of Mammography Quality Standards, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993, 301-796-5911.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of March 10, 2023 (88 FR 15126), FDA issued a final rule to update the mammography regulations that were issued under the MQSA and the Federal Food, Drug, and Cosmetic Act.[1] The final rule, amending 21 CFR 900.1 through 900.25, becomes effective September 10, 2024. FDA has prepared this SECG to assist small entities in complying with the requirements established in FDA regulations as they apply to mammography facilities.

This level 2 guidance is being issued consistent with our good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG represents the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in the following table have been approved by OMB:

21 CFR part; guidance; or FDA form Topic OMB Control No.
900; Form FDA 3422 Mammography Quality Standards 0910-0309

III. Electronic Access

Persons interested in obtaining a copy of the SECG may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/​medical-devices/​device-advice-comprehensive-regulatory-assistance/​guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also available at https://www.regulations.gov and https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents. Persons unable to download an electronic copy of “Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide” may send an email request to to receive an electronic copy of the document. Please use the document number GUI00007024 and complete title to identify the guidance you are requesting.

Dated: August 20, 2024.

Lauren K. Roth,

Associate Commissioner for Policy.

Footnotes

1.  The Office of the Federal Register has published this document under the category “Rules and Regulations” pursuant to 1 CFR 5.9(b). The Office of the Federal Register's categorization is solely for purposes of publication in the Federal Register and does not change the nature of the document and is not intended to affect its validity, content, or intent. See 1 CFR 5.1(c).

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[FR Doc. 2024-19059 Filed 8-23-24; 8:45 am]

BILLING CODE 4164-01-P

Published Document: 2024-19059 (89 FR 68364)