Enhancing Patient Engagement Efforts Across the Food and Drug Administration; Establishment of a Public Docket; Request for Comments, 13632-13634 [2017-04982]
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Federal Register / Vol. 82, No. 48 / Tuesday, March 14, 2017 / Notices
TABLE 2—CLASS II DEVICES (§ 866.5750—RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL TEST SYSTEMS)—
Continued
Allergen code
Allergen product
Source
(taxonomical name)
k23 ..............................
k33 ..............................
k70 ..............................
k71 ..............................
k72 ..............................
k73 ..............................
k74 ..............................
k75 ..............................
k76 ..............................
k77 ..............................
k78 ..............................
k79 ..............................
k80 ..............................
k81 ..............................
k83 ..............................
k84 ..............................
k85 ..............................
k86 ..............................
k87 ..............................
k89 ..............................
k99 ..............................
k201 ............................
k202 ............................
k204 ............................
k205 ............................
k206 ............................
k208 ............................
Straw Dust ...........................................................................
Oak ......................................................................................
Green coffee bean ...............................................................
Castor bean .........................................................................
Ispaghula .............................................................................
Silk waste .............................................................................
Silk .......................................................................................
Isocyanate TDI (Toluene diisocyanate) ...............................
Isocyanate MDI (Diphenylmethane diisocyanate) ...............
Isocyanate HDI (Hexamethylen diisocyanate) ....................
Ethylene oxide .....................................................................
Phthalic anhydride ...............................................................
Formaldehyde/Formalin .......................................................
Ficus ....................................................................................
Cotton seed .........................................................................
Sunflower seed ....................................................................
Chloramin T .........................................................................
Trimellitic anhydride, TMA ...................................................
Asp o 21, alpha-amylase .....................................................
Orris root ..............................................................................
HSA (Human Serum Albumin) (Hom s HSA) ......................
Car p 1, Papain ...................................................................
Ana c 2, Bromelain ..............................................................
Maxatase .............................................................................
Alcalase ...............................................................................
Savinase, Protease 1 (Bac l Subtilisin) ...............................
Gal d 4, Lysozyme ...............................................................
k209
k210
k211
k212
k213
k213
k214
k225
k226
k301
k501
k502
k503
k504
Hexahydrophtalic anhydrid ..................................................
Maleic anhydride ..................................................................
Methyltetrahydrophtalic anhydrid .........................................
Abachi wood dust ................................................................
Pepsin (Sus s Pepsin) .........................................................
TCPA ...................................................................................
Bougainvillea ........................................................................
Horse radish peroxidase (Arm r HRP) ................................
Ascorbate oxidase (Cuc p ascorbate oxidase) ...................
Flour dust .............................................................................
Savinase customer specific .................................................
Lipolase customer specific ..................................................
Termamyl customer specific ................................................
Clazinase customer specific ................................................
NA.
NA.
Coffea spp.
Ricinus communis.
Plantago psyllium/Plantago ovata.
NA.
Bombyx mori.
NA.
NA.
NA.
NA.
NA.
NA.
Ficus benjamina (Ficus spp.).
Gossypium hirsutum.
Helianthus annuus.
NA.
NA.
Aspergillus oryzae.
Iris florentina.
Homo sapiens.
Carica papaya.
Ananas comosus.
Bacillus licheniformis.
Bacillus spp.
Bacillus spp.
Gallus domesticus (Gallus gallus domesticus; Gallus
spp.).
NA.
NA.
NA.
Triplochiton scleroxylon.
Sus scrofa (Sus scrofa domesticus; Sus spp.).
NA.
Bougainvillea spp.
Armoracia rusticana.
Cucurbita pepo.
Triticum spp.
Proprietary knowledge of customer.
Proprietary knowledge of customer.
Proprietary knowledge of customer.
Proprietary knowledge of customer.
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
V. Reference
asabaliauskas on DSK3SPTVN1PROD with NOTICES
The following reference is on display
in the Division of Dockets Management
(see ADDRESSES) and is available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; it is also available electronically
at https://www.regulations.gov. FDA has
verified the Web site address, as of the
date this document publishes in the
Federal Register, but Web sites are
subject to change over time.
1. FDA Guidance, ‘‘Procedures for Class II
Device Exemptions from Premarket
Notification, Guidance for Industry and
CDRH Staff,’’ February 19, 1998,
available at https://www.fda.gov/
downloads/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/UCM080199.pdf.
VerDate Sep<11>2014
17:42 Mar 13, 2017
Jkt 241001
Dated: March 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–04938 Filed 3–13–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0455]
Enhancing Patient Engagement Efforts
Across the Food and Drug
Administration; Establishment of a
Public Docket; Request for Comments
ACTION:
Notice; request for comments.
The Food and Drug
Administration (FDA or Agency) is
establishing a public docket to solicit
SUMMARY:
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
input on ongoing efforts to enhance
mechanisms for patient engagement at
the Agency. Engaging with patients,
their caregivers, and advocates has long
been a priority of the Agency. In this
tradition, FDA intends to enhance
future patient engagement by providing
a more transparent, accessible, and
robust experience for patient
communities. To achieve these goals,
FDA is considering establishing a new
Office of Patient Affairs. This concept
was directly informed by the public
feedback solicited through the prior
public docket regarding FDA’s
stakeholder engagement responsibilities
outlined by the Food and Drug
Administration Safety and Innovation
Act (FDASIA). The purpose of this
notice is to outline FDA’s proposal for
the future of patient engagement at the
Agency so that the perspectives of
E:\FR\FM\14MRN1.SGM
14MRN1
Federal Register / Vol. 82, No. 48 / Tuesday, March 14, 2017 / Notices
patient communities can be better
captured.
Submit either electronic or
written comments by June 12, 2017.
ADDRESSES: You may submit comments
as follows:
DATES:
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’’).
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–0455 for ’’ Enhancing Patient
Engagement Efforts Across FDA;
Establishment of a Public Docket;
Request for Comments.’’ 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 Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
VerDate Sep<11>2014
17:42 Mar 13, 2017
Jkt 241001
• 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 Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Sharnell Ligon, Office of Medical
Products and Tobacco, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6125, Silver Spring,
MD 20993, 301–796–5253, FAX: 301–
847–3532.
SUPPLEMENTARY INFORMATION: FDA has
long recognized the importance of
engaging with patients, caregivers, and
their advocates in the medical product
development process. On July 9, 2012,
the President signed into law FDASIA
(Pub. L. 112–144), which expands
FDA’s authorities and strengthens the
Agency’s ability to safeguard and
advance public health in several areas,
including increasing stakeholder
involvement in FDA regulatory
processes. Section 1137 of FDASIA,
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
13633
Patient Participation in Medical Product
Discussions, codified in section 569C of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360bbb–8c), directs the
Secretary of Health and Human Services
to ‘‘develop and implement strategies to
solicit the views of patients during the
medical product development process
and consider the perspectives of
patients during regulatory discussions.’’
On November 4, 2014, FDA issued a
Federal Register notice establishing a
docket (FDA–2014–N–1698) for public
commenters to submit information
related to FDA’s implementation of
FDASIA’s Patient Participation in
Medical Product Discussions under
FDASIA section 1137 (79 FR 65410). In
response to public comments, and
recognizing a need for improved
coordination and support for patient
engagement across medical product
centers, the Office of the Commissioner
launched an effort to enhance
mechanisms for patient engagement at
FDA.
As part of this effort, the Agency has
identified the following objectives for its
patient engagement activities:
• Develop a nuanced understanding
of the patient experience of disease by:
Æ Gathering patient perspective on
what is clinically meaningful,
Æ assessing attitudes towards benefitrisk and tolerance of uncertainty, and
Æ enhancing the science of eliciting
and integrating patient input.
• Support patients and their
advocates in understanding regulatory
processes and navigating the FDA by:
Æ Communicating relevant FDA
positions, procedures, and activities,
Æ connecting patients and their
advocates with the appropriate
resources, and
Æ resolving discrete challenges and
needs.
To achieve these objectives, the
Agency is considering establishing a
central ‘‘Office of Patient Affairs’’ which
will be tasked with supporting and
coordinating patient engagement
activities across medical product centers
and other offices that engage with
patients and their advocates on matters
pertaining to medical products. In order
to improve the transparency,
coordination, and implementation of
FDA’s patient engagement activities, the
responsibilities of this central office
would include:
• Offering a single, central entry point
to the Agency for the patient
community,
• providing triage and navigation
services for inbound inquiries from
patient stakeholders,
• hosting and maintaining robust data
management systems that would
E:\FR\FM\14MRN1.SGM
14MRN1
13634
Federal Register / Vol. 82, No. 48 / Tuesday, March 14, 2017 / Notices
incorporate and formalize knowledge
shared with FDA by patient
stakeholders and FDA’s relationships
with patient communities, and
• developing a scalable and forwardlooking platform for communicating
with patient stakeholders, particularly
online channels.
Under this proposal to enhance
mechanisms for patient engagement at
FDA, a new ‘‘Office of Patient Affairs’’
would be directly accountable to the
medical product Centers through clear
governance structures. In addition, a
regular evaluation of this central office
and of FDA’s overall patient engagement
efforts is proposed. This evaluation will
include feedback from external
stakeholders (including patients and
their advocates) on a biennial basis to
best ensure the Agency’s ongoing
responsiveness to the needs of patient
communities.
Dated: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–04982 Filed 3–13–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0402]
Generic Drug User Fee Amendments of
2012; Regulatory Science Initiatives;
Public Workshop; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
workshop entitled ‘‘Generic Drug User
Fee Amendments of 2012; Regulatory
Science Initiatives.’’ The topics to be
discussed will provide an overview of
the current status of regulatory science
initiatives for generic drugs and an
opportunity for public input on research
priorities in this area. FDA is seeking
this input from a variety of
stakeholders—industry, academia,
patient advocates, professional societies,
and other interested parties—as it
fulfills its commitment under the
Generic Drug User Fee Amendments of
2012 (GDUFA) to develop an annual list
of regulatory science initiatives specific
to generic drugs. FDA will take the
information it obtains from the public
workshop into account in developing
the fiscal year (FY) 2018 Regulatory
Science Plan.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:42 Mar 13, 2017
Jkt 241001
The public workshop will be
held on May 3, 2017, from 8:30 a.m. to
4:30 p.m. The registration deadline to
attend either in person, or virtually via
web cast, is April 5, 2017. Comments
regarding this public workshop may be
submitted March 2, 2017, through June
2, 2017.
ADDRESSES: The public workshop will
be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503, Section A), Silver Spring,
MD 20993–0002. 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.
You may submit comments as
follows:
DATES:
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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
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–
2013–N–0402 for ‘‘Generic Drug User
Fee Amendments of 2012; Regulatory
Science Initiatives; Public Workshop;
Request for Comments.’’ 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 Division of Dockets
Management 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 Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Stephanie Choi, Center for Drug
E:\FR\FM\14MRN1.SGM
14MRN1
Agencies
[Federal Register Volume 82, Number 48 (Tuesday, March 14, 2017)]
[Notices]
[Pages 13632-13634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04982]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0455]
Enhancing Patient Engagement Efforts Across the Food and Drug
Administration; Establishment of a Public Docket; Request for Comments
ACTION: Notice; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
establishing a public docket to solicit input on ongoing efforts to
enhance mechanisms for patient engagement at the Agency. Engaging with
patients, their caregivers, and advocates has long been a priority of
the Agency. In this tradition, FDA intends to enhance future patient
engagement by providing a more transparent, accessible, and robust
experience for patient communities. To achieve these goals, FDA is
considering establishing a new Office of Patient Affairs. This concept
was directly informed by the public feedback solicited through the
prior public docket regarding FDA's stakeholder engagement
responsibilities outlined by the Food and Drug Administration Safety
and Innovation Act (FDASIA). The purpose of this notice is to outline
FDA's proposal for the future of patient engagement at the Agency so
that the perspectives of
[[Page 13633]]
patient communities can be better captured.
DATES: Submit either electronic or written comments by June 12, 2017.
ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-0455 for '' Enhancing Patient Engagement Efforts Across FDA;
Establishment of a Public Docket; Request for Comments.'' 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 Division of Dockets Management 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 Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Sharnell Ligon, Office of Medical
Products and Tobacco, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6125, Silver Spring, MD 20993, 301-796-5253, FAX:
301-847-3532.
SUPPLEMENTARY INFORMATION: FDA has long recognized the importance of
engaging with patients, caregivers, and their advocates in the medical
product development process. On July 9, 2012, the President signed into
law FDASIA (Pub. L. 112-144), which expands FDA's authorities and
strengthens the Agency's ability to safeguard and advance public health
in several areas, including increasing stakeholder involvement in FDA
regulatory processes. Section 1137 of FDASIA, Patient Participation in
Medical Product Discussions, codified in section 569C of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-8c), directs the
Secretary of Health and Human Services to ``develop and implement
strategies to solicit the views of patients during the medical product
development process and consider the perspectives of patients during
regulatory discussions.''
On November 4, 2014, FDA issued a Federal Register notice
establishing a docket (FDA-2014-N-1698) for public commenters to submit
information related to FDA's implementation of FDASIA's Patient
Participation in Medical Product Discussions under FDASIA section 1137
(79 FR 65410). In response to public comments, and recognizing a need
for improved coordination and support for patient engagement across
medical product centers, the Office of the Commissioner launched an
effort to enhance mechanisms for patient engagement at FDA.
As part of this effort, the Agency has identified the following
objectives for its patient engagement activities:
Develop a nuanced understanding of the patient experience
of disease by:
[cir] Gathering patient perspective on what is clinically
meaningful,
[cir] assessing attitudes towards benefit-risk and tolerance of
uncertainty, and
[cir] enhancing the science of eliciting and integrating patient
input.
Support patients and their advocates in understanding
regulatory processes and navigating the FDA by:
[cir] Communicating relevant FDA positions, procedures, and
activities,
[cir] connecting patients and their advocates with the appropriate
resources, and
[cir] resolving discrete challenges and needs.
To achieve these objectives, the Agency is considering establishing
a central ``Office of Patient Affairs'' which will be tasked with
supporting and coordinating patient engagement activities across
medical product centers and other offices that engage with patients and
their advocates on matters pertaining to medical products. In order to
improve the transparency, coordination, and implementation of FDA's
patient engagement activities, the responsibilities of this central
office would include:
Offering a single, central entry point to the Agency for
the patient community,
providing triage and navigation services for inbound
inquiries from patient stakeholders,
hosting and maintaining robust data management systems
that would
[[Page 13634]]
incorporate and formalize knowledge shared with FDA by patient
stakeholders and FDA's relationships with patient communities, and
developing a scalable and forward-looking platform for
communicating with patient stakeholders, particularly online channels.
Under this proposal to enhance mechanisms for patient engagement at
FDA, a new ``Office of Patient Affairs'' would be directly accountable
to the medical product Centers through clear governance structures. In
addition, a regular evaluation of this central office and of FDA's
overall patient engagement efforts is proposed. This evaluation will
include feedback from external stakeholders (including patients and
their advocates) on a biennial basis to best ensure the Agency's
ongoing responsiveness to the needs of patient communities.
Dated: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-04982 Filed 3-13-17; 8:45 am]
BILLING CODE 4164-01-P