Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data; Public Workshop; Request for Comments, 58816-58817 [2017-26978]
Download as PDF
58816
Federal Register / Vol. 82, No. 239 / Thursday, December 14, 2017 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–6312]
Patient-Focused Drug Development:
Developing and Submitting Proposed
Draft Guidance Relating to Patient
Experience Data; Public Workshop;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
announcing the following public
workshop entitled ‘‘Patient-Focused
Drug Development: Developing and
Submitting Proposed Draft Guidance
Relating to Patient Experience Data.’’
The purpose of the public workshop is
to convene a discussion on how a
person seeking to develop and submit
proposed draft guidance relating to
patient experience data for
consideration by FDA may submit such
proposed draft guidance to the Agency.
This workshop will inform development
of patient-focused drug development
guidance as required by the 21st
Century Cures Act (Cures Act). FDA
plans to publish a background
document approximately 2 weeks before
the workshop date.
DATES: The public workshop will be
held on March 19, 2018, from 1 p.m. to
5 p.m. Submit either electronic or
written comments on this public
workshop by May 18, 2018. See the
SUPPLEMENTARY INFORMATION section for
additional registration information.
ADDRESSES: The public workshop will
be held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993.
Entrance for the public workshop
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm. Workshop updates,
agenda, and background document will
be made available at https://
www.fda.gov/Drugs/NewsEvents/
ucm582081.htm prior to the workshop.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
21:28 Dec 13, 2017
Jkt 244001
on or before May 18, 2018. The https://
www.regulations.gov electronic filing
system will accept comments until
midnight Eastern Time at the end of
May 18, 2018. 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
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–
2017–N–6312 for ‘‘Patient-Focused Drug
Development: Developing and
Submitting Proposed Draft Guidance
Relating to Patient Experience Data.’’
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
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
FOR FURTHER INFORMATION CONTACT:
Meghana Chalasani, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146,
Silver Spring, MD 20993–0002, 240–
402–6525, Fax: 301–847–8443,
Meghana.Chalasani@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
This public workshop is intended to
support FDA implementation of
requirements for guidance development
under section 3002 of the Cures Act
(Pub. L. 114–255). Section 3002 of Title
III, Subtitle A, of the Cures Act directs
E:\FR\FM\14DEN1.SGM
14DEN1
Federal Register / Vol. 82, No. 239 / Thursday, December 14, 2017 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
FDA to develop patient-focused drug
development guidance to address a
number of areas, including how a
person seeking to develop and submit a
proposed draft guidance relating to
patient experience data for
consideration by FDA may submit such
proposed draft guidances.
In FDA’s ‘‘Plan for Issuance of
Patient-Focused Drug Development
Guidance,’’ (the Plan) available at
https://www.fda.gov/downloads/
ForIndustry/UserFees/
PrescriptionDrugUserFee/
UCM563618.pdf, the Agency proposed
issuing a guidance addressing this topic
described in section 3002 during the
second quarter of 2018. FDA recognizes
that, like the other patient-focused drug
development guidances described in the
Plan, developing this draft guidance
will also benefit from public input from
the wider community of patients,
patient advocates, academic researchers,
expert practitioners, drug developers,
and other stakeholders prior to FDA’s
drafting of the guidance. Accordingly,
the Agency is scheduling this public
workshop. After this public workshop,
FDA will take into consideration the
stakeholder input from the workshop
and the public docket, and publish a
draft guidance by the end of fiscal year
2018.
II. Purpose and Scope of Meeting
FDA is announcing a public
workshop to convene a discussion on
topics related to developing and
submitting proposed draft guidance
relating to patient experience data by an
external stakeholder. The purpose of
this public workshop is to obtain input
from stakeholders on considerations for
development and submission of
proposed draft guidance relating to
patient experience data submitted by an
external stakeholder, including: (1)
Defining the scope of the proposed draft
guidance, (2) developing the proposed
draft guidance, and (3) submitting the
proposed draft guidance to FDA,
including the process and format. The
Agency is seeking information and
comments from a broad range of
stakeholders, including patients, patient
advocates, academic and medical
researchers, expert practitioners, drug
developers, and other interested
persons. FDA will publish a background
document outlining the topic areas that
will be addressed in the draft guidance
approximately 2 weeks before the
workshop date at the following website:
https://www.fda.gov/Drugs/NewsEvents/
ucm582081.htm.
After this public workshop, FDA will
take into consideration the stakeholder
input from the workshop and the public
VerDate Sep<11>2014
21:28 Dec 13, 2017
Jkt 244001
docket, and publish a draft guidance by
the end of fiscal year 2018.
III. Participating in the Public
Workshop
Registration: Interested parties are
encouraged to register early. To register
electronically, please visit https://pfddproposeddraftguidance.eventbrite.com.
Persons without access to the internet
can call 240–402–6525 to register. If you
are unable to attend the public
workshop in person, you can register to
view a live webcast. You will be asked
to indicate in your registration if you
plan to attend in person or via the
webcast. Seating will be limited, so
early registration is recommended.
Registration is free and will be on a firstcome, first-served basis. However, FDA
may limit the number of participants
from each organization based on space
limitations. Registrants will receive
confirmation once they have been
accepted. Onsite registration on the day
of the public workshop will be based on
space availability. If you need special
accommodations because of a disability,
please contact Meghana Chalasani (see
FOR FURTHER INFORMATION CONTACT) at
least 7 days before the public workshop.
Open Public Comment: There will be
time allotted during the public
workshop for open public comment.
Sign-up for this session will be on a
first-come, first-serve basis on the day of
the public workshop. Individuals and
organizations with common interests are
urged to consolidate or coordinate, and
request time for a joint presentation. No
commercial or promotional material
will be permitted to be presented or
distributed at the public workshop.
Transcripts: As soon as a transcript is
available of the public workshop, FDA
will post it at https://www.fda.gov/
Drugs/NewsEvents/ucm582081.htm.
Dated: December 11, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26978 Filed 12–13–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The invention listed below is
owned by an agency of the U.S.
Government and is available for
SUMMARY:
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
58817
licensing to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
FOR FURTHER INFORMATION CONTACT: Dr.
Natalie Greco, 301–761–7898;
Natalie.Greco@nih.gov. Licensing
information and copies of the patent
applications listed below may be
obtained by communicating with the
indicated licensing contact at the
Technology Transfer and Intellectual
Property Office, National Institute of
Allergy and Infectious Diseases, 5601
Fishers Lane, Rockville, MD 20852; tel.
301–496–2644. A signed Confidential
Disclosure Agreement will be required
to receive copies of unpublished patent
applications.
SUPPLEMENTARY INFORMATION:
Technology description follows.
Monoclonal Antibody Specific for DNA/
RNA Hybrid Molecules
Description of Technology
NIAID has a hybridoma available for
non-exclusive licensing that produces a
monoclonal antibody specific for DNA/
RNA hybrids. This antibody, which has
been extensively characterized by NIH
researchers, is already a widely-used
research tool. It is currently the only
monoclonal antibody available that is
specific for DNA/RNA hybrids, making
it a unique reagent. It is used in
immuno-fluorescence (IF) microscopy,
where it can be used to detect sites of
transcriptional activity and potentially
sites of viral replication. It has also been
used in DNA/RNA immunoprecipitation
(DRIP) experiments by a variety of
researchers.
Aside from its use as a research tool,
this antibody has potential to be used in
diagnostic kits for viral/bacterial
infections, cancers, and a variety of
other human diseases. DNA/RNA
hybrids arise during normal cellular
function, but they are typically present
in cells at low levels. When DNA/RNA
hybrids are found at high levels in a
cell, it indicates that the cell is
‘‘abnormal’’. For example, the cell may
be cancerous or infected with a virus.
NIH researchers have also incorporated
the antibody into a micro-array
platform, expanding its potential for use
in diagnostic devices.
This technology is available for
licensing for commercial development
in accordance with 35 U.S.C. 209 and 37
CFR part 404, as well as for further
development and evaluation under a
research collaboration.
E:\FR\FM\14DEN1.SGM
14DEN1
Agencies
[Federal Register Volume 82, Number 239 (Thursday, December 14, 2017)]
[Notices]
[Pages 58816-58817]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26978]
[[Page 58816]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-6312]
Patient-Focused Drug Development: Developing and Submitting
Proposed Draft Guidance Relating to Patient Experience Data; Public
Workshop; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the following public workshop entitled ``Patient-Focused Drug
Development: Developing and Submitting Proposed Draft Guidance Relating
to Patient Experience Data.'' The purpose of the public workshop is to
convene a discussion on how a person seeking to develop and submit
proposed draft guidance relating to patient experience data for
consideration by FDA may submit such proposed draft guidance to the
Agency. This workshop will inform development of patient-focused drug
development guidance as required by the 21st Century Cures Act (Cures
Act). FDA plans to publish a background document approximately 2 weeks
before the workshop date.
DATES: The public workshop will be held on March 19, 2018, from 1 p.m.
to 5 p.m. Submit either electronic or written comments on this public
workshop by May 18, 2018. See the SUPPLEMENTARY INFORMATION section for
additional registration information.
ADDRESSES: The public workshop will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993. Entrance for the public workshop
participants (non-FDA employees) is through Building 1 where routine
security check procedures will be performed. For parking and security
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
Workshop updates, agenda, and background document will be made
available at https://www.fda.gov/Drugs/NewsEvents/ucm582081.htm prior
to the workshop.
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 May 18, 2018. The https://www.regulations.gov
electronic filing system will accept comments until midnight Eastern
Time at the end of May 18, 2018. 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 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-2017-N-6312 for ``Patient-Focused Drug Development: Developing and
Submitting Proposed Draft Guidance Relating to Patient Experience
Data.'' 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.
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.gpo.gov/fdsys/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.
FOR FURTHER INFORMATION CONTACT: Meghana Chalasani, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240-
402-6525, Fax: 301-847-8443, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
This public workshop is intended to support FDA implementation of
requirements for guidance development under section 3002 of the Cures
Act (Pub. L. 114-255). Section 3002 of Title III, Subtitle A, of the
Cures Act directs
[[Page 58817]]
FDA to develop patient-focused drug development guidance to address a
number of areas, including how a person seeking to develop and submit a
proposed draft guidance relating to patient experience data for
consideration by FDA may submit such proposed draft guidances.
In FDA's ``Plan for Issuance of Patient-Focused Drug Development
Guidance,'' (the Plan) available at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM563618.pdf, the Agency
proposed issuing a guidance addressing this topic described in section
3002 during the second quarter of 2018. FDA recognizes that, like the
other patient-focused drug development guidances described in the Plan,
developing this draft guidance will also benefit from public input from
the wider community of patients, patient advocates, academic
researchers, expert practitioners, drug developers, and other
stakeholders prior to FDA's drafting of the guidance. Accordingly, the
Agency is scheduling this public workshop. After this public workshop,
FDA will take into consideration the stakeholder input from the
workshop and the public docket, and publish a draft guidance by the end
of fiscal year 2018.
II. Purpose and Scope of Meeting
FDA is announcing a public workshop to convene a discussion on
topics related to developing and submitting proposed draft guidance
relating to patient experience data by an external stakeholder. The
purpose of this public workshop is to obtain input from stakeholders on
considerations for development and submission of proposed draft
guidance relating to patient experience data submitted by an external
stakeholder, including: (1) Defining the scope of the proposed draft
guidance, (2) developing the proposed draft guidance, and (3)
submitting the proposed draft guidance to FDA, including the process
and format. The Agency is seeking information and comments from a broad
range of stakeholders, including patients, patient advocates, academic
and medical researchers, expert practitioners, drug developers, and
other interested persons. FDA will publish a background document
outlining the topic areas that will be addressed in the draft guidance
approximately 2 weeks before the workshop date at the following
website: https://www.fda.gov/Drugs/NewsEvents/ucm582081.htm.
After this public workshop, FDA will take into consideration the
stakeholder input from the workshop and the public docket, and publish
a draft guidance by the end of fiscal year 2018.
III. Participating in the Public Workshop
Registration: Interested parties are encouraged to register early.
To register electronically, please visit https://pfdd-proposeddraftguidance.eventbrite.com. Persons without access to the
internet can call 240-402-6525 to register. If you are unable to attend
the public workshop in person, you can register to view a live webcast.
You will be asked to indicate in your registration if you plan to
attend in person or via the webcast. Seating will be limited, so early
registration is recommended. Registration is free and will be on a
first-come, first-served basis. However, FDA may limit the number of
participants from each organization based on space limitations.
Registrants will receive confirmation once they have been accepted.
Onsite registration on the day of the public workshop will be based on
space availability. If you need special accommodations because of a
disability, please contact Meghana Chalasani (see FOR FURTHER
INFORMATION CONTACT) at least 7 days before the public workshop.
Open Public Comment: There will be time allotted during the public
workshop for open public comment. Sign-up for this session will be on a
first-come, first-serve basis on the day of the public workshop.
Individuals and organizations with common interests are urged to
consolidate or coordinate, and request time for a joint presentation.
No commercial or promotional material will be permitted to be presented
or distributed at the public workshop.
Transcripts: As soon as a transcript is available of the public
workshop, FDA will post it at https://www.fda.gov/Drugs/NewsEvents/ucm582081.htm.
Dated: December 11, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26978 Filed 12-13-17; 8:45 am]
BILLING CODE 4164-01-P