81_FR_78384 81 FR 78169 - Establishment of the Patient and Care-Partner Connection; Establishment of a Public Docket; Request for Comments

81 FR 78169 - Establishment of the Patient and Care-Partner Connection; Establishment of a Public Docket; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 215 (November 7, 2016)

Page Range78169-78170
FR Document2016-26784

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.

Federal Register, Volume 81 Issue 215 (Monday, November 7, 2016) 
[Federal Register Volume 81, Number 215 (Monday, November 7, 2016)]
[Notices]
[Pages 78169-78170]
From the Federal Register Online  [www.thefederalregister.org]
[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

Federal Register / Vol. 81, No. 215 / Monday, November 7, 2016 / Notices 78169 II. Significance of Guidance Dated: November 1, 2016. that if you include your name, contact Leslie Kux, information, or other information that This guidance is being issued Associate Commissioner for Policy. identifies you in the body of your consistent with FDA’s good guidance [FR Doc. 2016–26783 Filed 11–4–16; 8:45 am] comments, that information will be practices regulation (21 CFR 10.115). posted on http://www.regulations.gov. BILLING CODE 4164–01–P The guidance represents the current • If you want to submit a comment thinking of FDA on ‘‘Clinical with confidential information that you Considerations for Investigational DEPARTMENT OF HEALTH AND do not wish to be made available to the Device Exemptions (IDEs) for HUMAN SERVICES public, submit the comment as a Neurological Devices Targeting Disease written/paper submission and in the Progression and Clinical Outcomes.’’ It Food and Drug Administration manner detailed (see ‘‘Written/Paper does not establish any rights for any [Docket No. FDA–2016–N–3462] Submissions’’ and ‘‘Instructions’’). person and is not binding on FDA or the Written/Paper Submissions public. You can use an alternative Establishment of the Patient and Care- approach if it satisfies the requirements Partner Connection; Establishment of Submit written/paper submissions as of the applicable statutes and a Public Docket; Request for follows: • Mail/Hand delivery/Courier (for regulations. Comments written/paper submissions): Division of III. Electronic Access AGENCY: Food and Drug Administration, Dockets Management (HFA–305), Food HHS. and Drug Administration, 5630 Fishers Persons interested in obtaining a copy ACTION: Notice; establishment of docket; Lane, Rm. 1061, Rockville, MD 20852. of the guidance may do so by request for comments. • For written/paper comments downloading an electronic copy from submitted to the Division of Dockets the Internet. A search capability for all SUMMARY: The Food and Drug Management, FDA will post your Center for Devices and Radiological Administration (FDA or Agency) is comment, as well as any attachments, Health guidance documents is available establishing a public docket to receive except for information submitted, at http://www.fda.gov/MedicalDevices/ input on the Center for Devices and marked and identified, as confidential, DeviceRegulationandGuidance/ Radiological Health’s (CDRH) new if submitted as detailed in GuidanceDocuments/default.htm. program, entitled the Patient and Care- ‘‘Instructions.’’ Guidance documents are also available partner Connection (P&CC). P&CC will Instructions: All submissions received at http://www.regulations.gov. Persons partner with patient organizations to must include the Docket No. FDA– unable to download an electronic copy provide a means for CDRH staff to 2016–N–3462 for ‘‘Establishment of the of ‘‘Clinical Considerations for formally engage with patients and care- Patient and Care-partner Connection; Investigational Device Exemptions partners. The purpose of this Establishment of a Public Docket; (IDEs) for Neurological Devices partnership is to gain perspective and Request for Comments.’’ Received Targeting Disease Progression and feedback from patients, care-partners, comments will be placed in the docket Clinical Outcomes’’ may send an email and patient organizations on particular and, except for those submitted as request to CDRH-Guidance@fda.hhs.gov topics of interest, such as, the scope and ‘‘Confidential Submissions,’’ publicly to receive an electronic copy of the nature of P&CC and how to partner with viewable at http://www.regulations.gov document. Please use the document patient organizations. The Agency is or at the Division of Dockets number 1500021 to identify the interested in facilitating staff Management between 9 a.m. and 4 p.m., guidance you are requesting. engagement with patients and care- Monday through Friday. partners regarding specific disease states • Confidential Submissions—To IV. Paperwork Reduction Act of 1995 and/or medical devices used for submit a comment with confidential treatment, diagnosis, or assessment. information that you do not wish to be This guidance refers to previously DATES: Submit either electronic or made publicly available, submit your approved collections of information written comments by January 6, 2017. comments only as a written/paper found in FDA regulations. These submission. You should submit two ADDRESSES: You may submit comments collections of information are subject to copies total. One copy will include the as follows: review by the Office of Management and information you claim to be confidential Budget (OMB) under the Paperwork Electronic Submissions with a heading or cover note that states Reduction Act of 1995 (44 U.S.C. 3501– Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS 3520). The collections of information in following way: CONFIDENTIAL INFORMATION.’’ The 21 CFR part 812 have been approved • Federal eRulemaking Portal: http:// Agency will review this copy, including under OMB control number 0910–0078; www.regulations.gov. Follow the the claimed confidential information, in the collections of information in 21 CFR instructions for submitting comments. its consideration of comments. The parts 801 and 809 have been approved Comments submitted electronically, second copy, which will have the under OMB control number 0910–0485; including attachments, to http:// claimed confidential information the collections of information in 21 CFR www.regulations.gov will be posted to redacted/blacked out, will be available part 50 have been approved under OMB the docket unchanged. Because your for public viewing and posted on http:// control number 0910–0755; and the comment will be made public, you are www.regulations.gov. Submit both collections of information in the solely responsible for ensuring that your copies to the Division of Dockets sradovich on DSK3GMQ082PROD with NOTICES guidance document entitled ‘‘Request comment does not include any Management. If you do not wish your for Feedback on Medical Device confidential information that you or a name and contact information to be Submissions: The Pre-submission third party may not wish to be posted, made publicly available, you can Program and Meetings With Food and such as medical information, your or provide this information on the cover Drug Administration Staff’’ have been anyone else’s Social Security number, or sheet and not in the body of your approved under OMB control number confidential business information, such comments and you must identify this 0910–0756. as a manufacturing process. Please note information as ‘‘confidential.’’ Any VerDate Sep<11>2014 16:02 Nov 04, 2016 Jkt 241001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\07NON1.SGM 07NON1

78170 Federal Register / Vol. 81, No. 215 / Monday, November 7, 2016 / Notices information marked as ‘‘confidential’’ partners’ experiences regarding specific partners view especially positively and/ will not be disclosed except in disease states and/or medical devices or negatively? accordance with 21 CFR 10.20 and other used for the patient’s treatment, • What methods or qualities of applicable disclosure law. For more diagnosis, or assessment. It will not communication might be preferred or information about FDA’s posting of solicit or provide external policy advice convenient for patients and care- comments to public dockets, see 80 FR or opinion. partners? 56469, September 18, 2015, or access Additionally, P&CC will provide an III. Reference the information at: http://www.fda.gov/ avenue for designated groups of patients regulatoryinformation/dockets/ and care-partners to address specific The following reference is on display default.htm. questions pertinent to their treatment, in the Division of Dockets Management Docket: For access to the docket to diagnosis, or assessment by partnering (see ADDRESSES) and is available for read background documents or the with patient organizations in an effort to viewing by interested persons between electronic and written/paper comments connect their members with CDRH staff, 9 a.m. and 4 p.m., Monday through received, go to http:// when the need for input arises. Patient Friday; it is also available electronically www.regulations.gov and insert the organizations shall be 501(c)(3) at http://www.regulations.gov. FDA has docket number, found in brackets in the organizations that have infrastructure verified the Web site address, as of the heading of this document, into the conducive to soliciting patient and date this document publishes in the ‘‘Search’’ box and follow the prompts caregiver participation, and whose Federal Register, but Web sites are and/or go to the Division of Dockets membership possesses relevant subject to change over time. Management, 5630 Fishers Lane, Rm. experience. Topics will be highly 1. FDA, Center for Devices and Radiological 1061, Rockville, MD 20852. focused and restricted to specified Health, ‘‘2016–2017 Strategic Priorities,’’ FOR FURTHER INFORMATION CONTACT: disease states and/or medical devices. available at http://www.fda.gov/ Patients and care-partners will downloads/AboutFDA/CentersOffices/ Anne Hammer, Center for Devices and participate in P&CC on a gratuitous OfficeofMedicalProductsandTobacco/ Radiological Health, Food and Drug CDRH/CDRHVisionandMission/ Administration, 10903 New Hampshire basis. Patients and care-partners will UCM481588.pdf. Ave., Bldg. 66, Rm. 5400, Silver Spring, also report any conflict of interests they may have that are pertinent to the Dated: October 31, 2016. MD 20993, 301–796–4642, FAX: 301– 847–8510, anne.hammer@fda.hhs.gov. discussion, although conflicts of interest Leslie Kux, may not disqualify a patient or care- Associate Commissioner for Policy. SUPPLEMENTARY INFORMATION: partner from participating in P&CC. [FR Doc. 2016–26784 Filed 11–4–16; 8:45 am] I. Background BILLING CODE 4164–01–P II. Patient and Care-Partner Connection One of the three CDRH 2016–2017 Program Strategic Priorities is to ‘‘Partner with Patients’’ 1 (Ref. 1). This priority reflects The Agency is seeking comments DEPARTMENT OF HEALTH AND and builds on our strong commitment to from interested persons on P&CC in HUMAN SERVICES patients, who are our most important general, and on the following questions: customers. CDRH believes that to Food and Drug Administration General successfully achieve this mission, we [Docket No. FDA–2013–N–0868] must consider and engage with patients • What are potential barriers to as partners. With regard to this priority, inclusion for patients and care-partners? Agency Information Collection • What can FDA do to avoid or Activities; Proposed Collection; CDRH also understands that family or remedy any barriers to inclusion? Comment Request; Guidance for care-partners are integral to patient care • What might patients and care- Industry: Use of Serological Tests To and management of disease, and we are partners see as appropriate and effective Reduce the Risk of Transmission of also committed to engaging them in engagement with FDA? Trypanosoma cruzi Infection in Whole order to fulfill this mission. FDA will • How appropriate is the program Blood and Blood Components work with both groups to advance the title, ‘‘Patient and Care-partner Intended for Transfusion development and evaluation of Connection’’? innovative medical devices and to • What, if any, other titles should AGENCY: Food and Drug Administration, monitor the performance of marketed FDA consider? HHS. devices. In addition, partnerships will ACTION: Notice. be leveraged, by promoting a culture of Inclusion meaningful patient engagement and • What types of organizations are SUMMARY: The Food and Drug interaction between CDRH staff and appropriate for such a partnership? Administration (FDA or we) is patients and care-partners. • What are potential barriers to announcing an opportunity for public To achieve this goal, FDA intends to effective communication between FDA, comment on the proposed collection of establish a new program, called the partner organizations, patients, and certain information by the Agency. Patient and Care-partner Connection care-partners? Under the Paperwork Reduction Act of (P&CC). This program is designed to • How can FDA engage patients, 1995 (the PRA), Federal Agencies are provide CDRH staff with a formal especially those who are hard to reach required to publish notice in the process by which they can engage with or from underserved communities who Federal Register concerning each patients and care-partners to obtain proposed collection of information, sradovich on DSK3GMQ082PROD with NOTICES are typically underrepresented in such input on key issues. P&CC will broaden initiatives? including each proposed extension of an CDRH’s exposure to patients’ and care- existing collection of information, and Communication to allow 60 days for public comment in 1 CDRH’s 2016–2017 Strategic Priorities, in • What lines of questioning would be response to the notice. This notice addition to ‘‘partner[ing] with patients,’’ include ‘‘Establish a National Evaluation System for considered appropriate? solicits comments on establishing Medical Devices’’ and ‘‘Promote a Culture of • What characteristics of such a notification of a consignee and Quality and Organizational Excellence.’’ program might patients and care- consignee notification of a recipient’s VerDate Sep<11>2014 16:02 Nov 04, 2016 Jkt 241001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\07NON1.SGM 07NON1


Document Created: 2018-02-14 08:21:23
Document Modified: 2018-02-14 08:21:23
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; establishment of docket; request for comments.
DatesSubmit either electronic or written comments by January 6, 2017.
ContactAnne 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]
FR Citation81 FR 78169 
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