[Federal Register Volume 89, Number 165 (Monday, August 26, 2024)]
[Rules and Regulations]
[Pages 68364-68365]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19059]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 900

[Docket No. FDA-2013-N-0134]


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

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 on https://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

[[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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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            0910-0309
                                 Standards.
------------------------------------------------------------------------

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 [email protected] 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.
[FR Doc. 2024-19059 Filed 8-23-24; 8:45 am]
BILLING CODE 4164-01-P