[Federal Register Volume 87, Number 41 (Wednesday, March 2, 2022)]
[Notices]
[Pages 11712-11713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04405]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1317]


Appeal Options Available to Mammography Facilities Concerning 
Adverse Accreditation Decisions, Suspension/Revocation of Certificates, 
or Patient and Physician Notification Orders; Guidance for Industry and 
Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance entitled ``Appeal Options 
Available to Mammography Facilities Concerning Adverse Accreditation 
Decisions, Suspension/Revocation of Certificates, or Patient and 
Physician Notification Orders.'' This guidance document describes the 
processes available to mammography facilities to request additional 
review of an adverse appeals decision on a facility's accreditation, 
and/or a suspension or revocation of certificate, and/or a patient and 
physician notification order. This guidance supersedes section 4.5 of 
the Center for Devices and Radiological Health (CDRH) Appeals Processes 
guidance document dated July 2, 2019.

DATES: The announcement of the guidance is published in the Federal 
Register on March 2, 2022.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidance 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-2020-D-1317 for ``Appeal Options Available to Mammography 
Facilities Concerning Adverse Accreditation Decisions, Suspension/
Revocation of Certificates, or Patient and Physician Notification 
Orders.'' 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 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 guidance document entitled 
``Appeal Options Available to Mammography Facilities Concerning Adverse 
Accreditation

[[Page 11713]]

Decisions, Suspension/Revocation of Certificates, or Patient and 
Physician Notification Orders'' to the Office of the Center Director, 
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: Abiy Desta, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 32, Rm. 4282, Silver Spring, MD 20993-0002, 301-796-5699.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Mammography Quality Standards Act (42 U.S.C. 263b), all 
mammography facilities, except facilities of the Department of Veteran 
Affairs, must be accredited by an approved accreditation body and 
certified by FDA (or an approved State certification agency) to provide 
mammography services (42 U.S.C. 263b(b)(1) and (d)(1)(iv)). For a 
facility to be certified it must meet certain requirements including: 
(1) Be accredited by an FDA-approved accreditation body; (2) undergo 
periodic review of its clinical images by its accreditation body; (3) 
have an annual survey by a medical physicist; (4) meet federally 
developed quality standards for personnel qualifications, equipment, 
radiation dose, quality assurance programs, recordkeeping, and 
reporting; and (5) undergo periodic inspection to assure it meets the 
federally developed quality standards.
    This guidance document describes the processes available to 
mammography facilities to request additional review of an adverse 
appeals decision on a facility's accreditation and/or a suspension or 
revocation of certificate, and/or a patient and physician notification 
order. It provides general information about each process, as well as 
guidance on how to submit related requests to the Division of 
Mammography Quality Standards and FDA. This guidance supersedes section 
4.5 of the CDRH Appeals Processes guidance document dated July 2, 2019 
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/center-devices-and-radiological-health-cdrh-appeals-processes).
    A notice of availability of the draft guidance appeared in the 
Federal Register of July 21, 2020 (85 FR 44097). FDA received no 
comments and no substantive changes have been made in the final 
guidance.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Appeal Options Available to Mammography 
Facilities Concerning Adverse Accreditation Decisions, Suspension/
Revocation of Certificates, or Patient and Physician Notification 
Orders.'' It does not establish any rights for any person and is not 
binding on FDA or the public. You can use an alternative approach if it 
satisfies the requirements of the applicable statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the internet. A search capability 
for all CDRH 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 ``Appeal 
Options Available to Mammography Facilities Concerning Adverse 
Accreditation Decisions, Suspension/Revocation of Certificates, or 
Patient and Physician Notification Orders'' may send an email request 
to [email protected] to receive an electronic copy of the 
document. Please use the document number 19004 and complete title to 
identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in the following FDA regulation and guidance have been 
approved by OMB as listed in the following table:

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                                                            OMB control
      21 CFR part or guidance               Topic               No.
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``Guidance for Industry and Food    Appeals Process.....       0910-0738
 and Drug Administration Staff;
 Center for Devices and
 Radiological Health Appeals
 Processes''.
900...............................  Mammography                0910-0309
                                     Facilities.
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    Dated: February 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-04405 Filed 3-1-22; 8:45 am]
BILLING CODE 4164-01-P