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Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Physician Notification Orders; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 44097-44098 [2020-15759]
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Federal Register / Vol. 85, No. 140 / Tuesday, July 21, 2020 / Notices
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Orders; Draft Guidance for Industry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.
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announcing the availability of the draft
guidance entitled ‘‘Appeal Options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 This draft guidance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written comments on the draft guidance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this draft guidance before it begins work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:
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
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
VerDate Sep<11>2014
17:42 Jul 20, 2020
Jkt 250001
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
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
44097
‘‘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-201509-18/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 selfaddressed 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
E:\FR\FM\21JYN1.SGM
21JYN1
44098
Federal Register / Vol. 85, No. 140 / Tuesday, July 21, 2020 / Notices
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-fdaguidance-documents/center-devicesand-radiological-health-cdrh-appealsprocesses).
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:
21 CFR part or guidance
Topic
‘‘Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological Health Appeals Processes‘‘.
900 .......................................................................................................................................................
Appeals Process ...........
0910–0738
Mammography Facilities
0910–0309
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1529]
Independent Third-Party Assessment
of Investigational New Drug Food and
Drug Administration-Sponsor
Communication Practices in
Prescription Drug User Fee Act VI;
Public Meeting; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
jbell on DSKJLSW7X2PROD with NOTICES
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.
The Food and Drug
Administration (FDA, the Agency, or
we) is hosting a public meeting entitled
‘‘Independent Third-Party Assessment
of IND FDA-Sponsor Communication
Practices in PDUFA VI,’’ and an
SUMMARY:
VerDate Sep<11>2014
17:42 Jul 20, 2020
Jkt 250001
opportunity for public comment. The
meeting will include a presentation
from an independent third-party
contractor about its assessment of FDAsponsor communications during the
investigational new drug (IND) stage of
drug/biologic development in the
Prescription Drug User Fee Act
(PDUFA) VI; a series of presentations by
and a panel discussion with invited
regulatory and industry representatives,
and an open public comment period.
This meeting is intended to satisfy
FDA’s commitment to host a public
meeting about the assessment no later
than March 2021.
DATES: The public meeting will be held
on August 11, 2020, from 9:30 a.m. to
12:30 p.m. and will take place virtually
by webcast only. Registration to attend
the meeting and other information can
be found at https://
indassessmentmeeting.eventbrite.com.
See the SUPPLEMENTARY INFORMATION
section for registration date and
information.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before September 11, 2020. The
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
OMB control No.
https://www.regulations.gov electronic
filing system will accept comments
until 11:59 p.m. Eastern Time at the end
of September 11, 2020. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
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
E:\FR\FM\21JYN1.SGM
21JYN1
]]>Agencies
[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]
[[Page 44097]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 [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
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:
------------------------------------------------------------------------
21 CFR part or guidance Topic OMB control No.
------------------------------------------------------------------------
``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.
------------------------------------------------------------------------
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
