[Federal Register Volume 81, Number 215 (Monday, November 7, 2016)]
[Notices]
[Pages 78169-78170]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26784]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-3462]


Establishment of the Patient and Care-Partner Connection; 
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is 
establishing a public docket to receive input on the Center for Devices 
and Radiological Health's (CDRH) new program, entitled the Patient and 
Care-partner Connection (P&CC). P&CC will partner with patient 
organizations to provide a means for CDRH staff to formally engage with 
patients and care-partners. The purpose of this partnership is to gain 
perspective and feedback from patients, care-partners, and patient 
organizations on particular topics of interest, such as, the scope and 
nature of P&CC and how to partner with patient organizations. The 
Agency is interested in facilitating staff engagement with patients and 
care-partners regarding specific disease states and/or medical devices 
used for treatment, diagnosis, or assessment.

DATES: Submit either electronic or written comments by January 6, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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-2016-N-3462 for ``Establishment of the Patient and Care-partner 
Connection; 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 http://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 http://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

[[Page 78170]]

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 http://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: Anne Hammer, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5400, Silver Spring, MD 20993, 301-796-4642, FAX: 
301-847-8510, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    One of the three CDRH 2016-2017 Strategic Priorities is to 
``Partner with Patients'' \1\ (Ref. 1). This priority reflects and 
builds on our strong commitment to patients, who are our most important 
customers. CDRH believes that to successfully achieve this mission, we 
must consider and engage with patients as partners. With regard to this 
priority, CDRH also understands that family or care-partners are 
integral to patient care and management of disease, and we are also 
committed to engaging them in order to fulfill this mission. FDA will 
work with both groups to advance the development and evaluation of 
innovative medical devices and to monitor the performance of marketed 
devices. In addition, partnerships will be leveraged, by promoting a 
culture of meaningful patient engagement and interaction between CDRH 
staff and patients and care-partners.
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    \1\ CDRH's 2016-2017 Strategic Priorities, in addition to 
``partner[ing] with patients,'' include ``Establish a National 
Evaluation System for Medical Devices'' and ``Promote a Culture of 
Quality and Organizational Excellence.''
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    To achieve this goal, FDA intends to establish a new program, 
called the Patient and Care-partner Connection (P&CC). This program is 
designed to provide CDRH staff with a formal process by which they can 
engage with patients and care-partners to obtain input on key issues. 
P&CC will broaden CDRH's exposure to patients' and care-partners' 
experiences regarding specific disease states and/or medical devices 
used for the patient's treatment, diagnosis, or assessment. It will not 
solicit or provide external policy advice or opinion.
    Additionally, P&CC will provide an avenue for designated groups of 
patients and care-partners to address specific questions pertinent to 
their treatment, diagnosis, or assessment by partnering with patient 
organizations in an effort to connect their members with CDRH staff, 
when the need for input arises. Patient organizations shall be 
501(c)(3) organizations that have infrastructure conducive to 
soliciting patient and caregiver participation, and whose membership 
possesses relevant experience. Topics will be highly focused and 
restricted to specified disease states and/or medical devices.
    Patients and care-partners will participate in P&CC on a gratuitous 
basis. Patients and care-partners will also report any conflict of 
interests they may have that are pertinent to the discussion, although 
conflicts of interest may not disqualify a patient or care-partner from 
participating in P&CC.

II. Patient and Care-Partner Connection Program

    The Agency is seeking comments from interested persons on P&CC in 
general, and on the following questions:

General

     What are potential barriers to inclusion for patients and 
care-partners?
     What can FDA do to avoid or remedy any barriers to 
inclusion?
     What might patients and care-partners see as appropriate 
and effective engagement with FDA?
     How appropriate is the program title, ``Patient and Care-
partner Connection''?
     What, if any, other titles should FDA consider?

Inclusion

     What types of organizations are appropriate for such a 
partnership?
     What are potential barriers to effective communication 
between FDA, partner organizations, patients, and care-partners?
     How can FDA engage patients, especially those who are hard 
to reach or from underserved communities who are typically 
underrepresented in such initiatives?

Communication

     What lines of questioning would be considered appropriate?
     What characteristics of such a program might patients and 
care-partners view especially positively and/or negatively?
     What methods or qualities of communication might be 
preferred or convenient for patients and care-partners?

III. Reference

    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 http://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, Center for Devices and Radiological Health, ``2016-2017 
Strategic Priorities,'' available at http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/UCM481588.pdf.

    Dated: October 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26784 Filed 11-4-16; 8:45 am]
 BILLING CODE 4164-01-P