[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]


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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.

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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

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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: http://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

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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