Notice2022-04405
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
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Published
March 2, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 41 (Wednesday, March 2, 2022)</title>
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[Federal Register Volume 87, Number 41 (Wednesday, March 2, 2022)]
[Notices]
[Pages 11712-11713]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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
(<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/center-devices-and-radiological-health-cdrh-appeals-processes">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/center-devices-and-radiological-health-cdrh-appeals-processes</a>).
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 <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>.
This guidance document is also available at <a href="https://www.regulations.gov">https://www.regulations.gov</a>
and <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>. 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 <a href="/cdn-cgi/l/email-protection#e9aaadbba1c4ae9c808d88878a8ca98f8d88c781819ac78e869f"><span class="__cf_email__" data-cfemail="5c1f180e14711b2935383d323f391c3a383d7234342f723b332a">[email protected]</span></a> 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
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