[Federal Register Volume 85, Number 140 (Tuesday, July 21, 2020)]
[Notices]
[Pages 44097-44098]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15759]



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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or Patient and Physician Notification Orders; Draft Guidance for 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the availability of the draft guidance entitled ``Appeal Options 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, when final, will supersede 
section 4.5 of the Center for Devices and Radiological Health (CDRH) 
Appeals Processes guidance document dated July 2, 2019. This draft 
guidance is not final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by September 21, 2020 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any 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 draft guidance document entitled 
``Appeal Options Available to Mammography Facilities Concerning Adverse 
Accreditation 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: 
be accredited by an FDA-approved accreditation body; undergo periodic 
review of its clinical

[[Page 44098]]

images by its accreditation body; have an annual survey by a medical 
physicist; meet federally developed quality standards for personnel 
qualifications, equipment, radiation dose, quality assurance programs, 
recordkeeping, and reporting; and 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, when final, will 
supersede 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).
    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 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 draft 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/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This guidance document is also available 
at https://www.regulations.gov. 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 CDRH-Guidance@fda.hhs.gov 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

    FDA tentatively concludes that this draft guidance contains no 
collection 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.
    However, this draft guidance refers to previously approved FDA 
collections of information. These 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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     21 CFR part or guidance              Topic          OMB control 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: July 15, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-15759 Filed 7-20-20; 8:45 am]
BILLING CODE 4164-01-P


