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, 44098-44099 [2020-15729]
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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of the draft guidance may do so by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draft guidance contains no collection of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However, this draft guidance refers to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
Federal Register / Vol. 85, No. 140 / Tuesday, July 21, 2020 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
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–N–1529 for ‘‘Independent ThirdParty Assessment of IND FDA-Sponsor
Communication Practices in PDUFA VI;
Public Meeting; Request for Comments.’’
Received comments, those filed in a
timely manner (see ADDRESSES), 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
VerDate Sep<11>2014
17:42 Jul 20, 2020
Jkt 250001
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.
FOR FURTHER INFORMATION CONTACT:
Kimberly Taylor, 240–402–5193,
Kimberly.taylor@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
This public meeting is intended to
meet performance commitments
included in PDUFA VI. This user fee
program was reauthorized as part of the
FDA Reauthorization Act of 2017
(FDARA), signed by the President on
August 18, 2017. The complete set of
performance goals for PDUFA is
available at https://www.fda.gov/
downloads/ForIndustry/UserFees/
PrescriptionDrugUserFee/
UCM511438.pdf.
Section I.I of the PDUFA VI goals
(‘‘PDUFA Reauthorization Performance
Goals and Procedures Fiscal Years 2018
Through 2022’’ (p. 21)), entitled
‘‘Enhancing Regulatory Science and
Expediting Drug Development,’’ details
FDA’s commitments to promote
innovation through enhanced
communication between FDA and
sponsors during drug development; it
also describes FDA’s commitment to
contract with an independent third
party to assess FDA-sponsor
communication practices during the
IND stage of drug/biologic development
in PDUFA VI and identify best practices
and areas for improvement. An
independent third-party contractor,
Eastern Research Group, Inc., has
completed the assessment of FDAsponsor communication practices
during the IND stage of drug/biologic
development in PDUFA VI. FDA has
published the report to its website at
https://www.fda.gov/media/138379/
download.
II. Topics for Discussion at the Public
Meeting
This meeting will provide FDA with
the opportunity to share the
PO 00000
Frm 00061
Fmt 4703
Sfmt 9990
44099
independent third-party assessment of
FDA-sponsor communications during
the IND stage of drug/biologic
development in PDUFA VI. This
meeting will also be an opportunity to
share any challenges and lessons
learned relating to communications
between FDA and IND sponsors. The
format of the meeting will consist of a
presentation of assessment results,
followed by a series of presentations by
and a panel discussion with invited
regulatory and industry representatives
regarding their experiences with and
approaches to communications during
the IND stage of drug development. The
meeting will conclude with an open
public comment period.
III. Attending the Public Meeting
Registration: To register for the public
meeting, please visit the following
website: https://
indassessmentmeeting.eventbrite.com.
Please provide complete contact
information for each attendee, including
name, title, affiliation, address, email,
and telephone.
Persons interested in attending this
public meeting must register by August
10, 2020, at 11:59 p.m. Eastern Time.
Registrants will receive confirmation
once they have been accepted.
Streaming Webcast of the Public
Meeting: The webcast for this meeting
will be available to registrants. If you
have never attended a Connect Pro
event before, test your connection at
https://collaboration.fda.gov/common/
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview. FDA has
verified the website addresses in this
document, as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
Transcripts: Please be advised that as
soon as a transcript of the public
meeting is available, it will be accessible
at https://www.regulations.gov. It may
be viewed at the Dockets Management
Staff, (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240–402–
7500.
Dated: July 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–15729 Filed 7–20–20; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\21JYN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 140 (Tuesday, July 21, 2020)]
[Notices]
[Pages 44098-44099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15729]
-----------------------------------------------------------------------
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.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
SUMMARY: 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
opportunity for public comment. The meeting will include a presentation
from an independent third-party contractor about its assessment of FDA-
sponsor 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 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
[[Page 44099]]
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-N-1529 for ``Independent Third-Party Assessment of IND FDA-
Sponsor Communication Practices in PDUFA VI; Public Meeting; Request
for Comments.'' Received comments, those filed in a timely manner (see
ADDRESSES), 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.
FOR FURTHER INFORMATION CONTACT: Kimberly Taylor, 240-402-5193,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
This public meeting is intended to meet performance commitments
included in PDUFA VI. This user fee program was reauthorized as part of
the FDA Reauthorization Act of 2017 (FDARA), signed by the President on
August 18, 2017. The complete set of performance goals for PDUFA is
available at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf.
Section I.I of the PDUFA VI goals (``PDUFA Reauthorization
Performance Goals and Procedures Fiscal Years 2018 Through 2022'' (p.
21)), entitled ``Enhancing Regulatory Science and Expediting Drug
Development,'' details FDA's commitments to promote innovation through
enhanced communication between FDA and sponsors during drug
development; it also describes FDA's commitment to contract with an
independent third party to assess FDA-sponsor communication practices
during the IND stage of drug/biologic development in PDUFA VI and
identify best practices and areas for improvement. An independent
third-party contractor, Eastern Research Group, Inc., has completed the
assessment of FDA-sponsor communication practices during the IND stage
of drug/biologic development in PDUFA VI. FDA has published the report
to its website at https://www.fda.gov/media/138379/download.
II. Topics for Discussion at the Public Meeting
This meeting will provide FDA with the opportunity to share the
independent third-party assessment of FDA-sponsor communications during
the IND stage of drug/biologic development in PDUFA VI. This meeting
will also be an opportunity to share any challenges and lessons learned
relating to communications between FDA and IND sponsors. The format of
the meeting will consist of a presentation of assessment results,
followed by a series of presentations by and a panel discussion with
invited regulatory and industry representatives regarding their
experiences with and approaches to communications during the IND stage
of drug development. The meeting will conclude with an open public
comment period.
III. Attending the Public Meeting
Registration: To register for the public meeting, please visit the
following website: https://indassessmentmeeting.eventbrite.com. Please
provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone.
Persons interested in attending this public meeting must register
by August 10, 2020, at 11:59 p.m. Eastern Time. Registrants will
receive confirmation once they have been accepted.
Streaming Webcast of the Public Meeting: The webcast for this
meeting will be available to registrants. If you have never attended a
Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a
quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview. FDA has verified the website addresses in this
document, as of the date this document publishes in the Federal
Register, but websites are subject to change over time.
Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff,
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240-402-7500.
Dated: July 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15729 Filed 7-20-20; 8:45 am]
BILLING CODE 4164-01-P
