
[Federal Register Volume 81, Number 54 (Monday, March 21, 2016)]
[Rules and Regulations]
[Pages 14975-14976]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06240]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 14

[Docket No. FDA-2016-N-0001]


Patient Engagement Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the 
standing advisory committees' regulations to add the Patient Engagement 
Advisory Committee.

DATES: This rule is effective March 21, 2016.

FOR FURTHER INFORMATION CONTACT: Letise Williams, Office of Center 
Director, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 
email: Letise.Williams@fda.hhs.gov, 301-796-8398.

SUPPLEMENTARY INFORMATION: The Patient Engagement Advisory Committee 
(the Committee) was established on October 6, 2015 (80 FR 57007, 
September 21, 2015).
    The Committee will provide advice to the Commissioner of Food and 
Drugs (the Commissioner), or designee, on complex issues relating to 
medical devices, regulation of devices, and their use by patients.
    The Committee will be composed of a core of nine voting members 
including the Chair. Members and the Chair are selected by the 
Commissioner or designee from among authorities who are knowledgeable 
in areas such as clinical research, primary care patient experience, 
and healthcare needs of patient groups in the United States, or who are 
experienced in the work of patient and health professional 
organizations, methodologies for eliciting patient preferences, and 
strategies for communicating benefits, risks, and clinical outcomes to 
patients and research subjects. Members will be invited to serve for 
overlapping terms of up to 4 years. Almost all non-Federal members of 
this committee serve as Special Government Employees. The core of 
voting members may include one technically qualified member, selected 
by the Commissioner or designee, who is identified with consumer 
interests and is recommended by either a consortium of consumer-
oriented organizations or other interested persons.
    The function of the Committee is to provide advice to the 
Commissioner on complex issues relating to medical devices, the 
regulation of devices, and their use by patients. Agency guidance and 
policies, clinical trial or registry design, patient preference study 
design, benefit-risk determinations, device labeling, unmet clinical 
needs, available alternatives, patient reported outcomes, and device-
related quality of life or health status issues are among the topics 
that may be considered by the Committee. The Committee provides 
relevant skills and perspectives in order to improve communication of 
benefits, risks, and clinical outcomes, and increase integration of 
patient perspectives into the regulatory process for medical devices. 
It performs its duties by identifying new approaches, promoting 
innovation, recognizing unforeseen risks or barriers, and identifying 
unintended consequences that could result from FDA policy.
    The Committee name and function were established with the Committee 
charter on October 6, 2015. Therefore, the Agency is amending 21 CFR 
14.100 to add the Committee name and function to its current list as 
set forth in the regulatory text of this document.
    Under 5 U.S.C. 553(b)(3)(B) and (d) and 21 CFR 10.40(d) and (e), 
the Agency finds good cause to dispense with notice and public comment 
procedures and to proceed to an immediate effective date on this rule. 
Notice and public comment and a delayed effective date are unnecessary 
and are not in the public interest as this final rule is merely 
codifying the addition of the name and function of the Patient 
Engagement Advisory Committee to reflect the committee charter.
    Therefore, the Agency is amending 21 CFR 14.100 to add paragraph 
(d)(5) as set forth in the regulatory text of this document.

[[Page 14976]]

List of Subjects in 21 CFR Part 14

    Administrative practice and procedure, Advisory committees, Color 
additives, Drugs, Radiation protection.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
14 is amended as follows:

PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

0
1. The authority citation for 21 CFR part 14 continues to read as 
follows:

    Authority: 5 U.S.C. App. 2; 15 U.S.C. 1451-1461; 21 U.S.C. 41-
50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 
U.S.C. 201, 262, 263b, 264; Pub. L. 107-109; Pub. L. 108-155; Pub. 
L. 113-54.


0
2. In Sec.  14.100, add paragraph (d)(5) to read as follows:


Sec.  14.100  List of standing advisory committees.

* * * * *
    (d) * * *
    (5) Patient Engagement Advisory Committee.
    (i) Date Established: October 6, 2015.
    (ii) Function: Provides advice to the Commissioner on complex 
issues relating to medical devices, the regulation of devices, and 
their use by patients. Agency guidance and policies, clinical trial or 
registry design, patient preference study design, benefit-risk 
determinations, device labeling, unmet clinical needs, available 
alternatives, patient reported outcomes, and device-related quality of 
life or health status issues are among the topics that may be 
considered by the Committee. The Committee provides relevant skills and 
perspectives in order to improve communication of benefits, risks, and 
clinical outcomes, and increase integration of patient perspectives 
into the regulatory process for medical devices. It performs its duties 
by identifying new approaches, promoting innovation, recognizing 
unforeseen risks or barriers, and identifying unintended consequences 
that could result from FDA policy.
* * * * *

    Dated: March 15, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-06240 Filed 3-18-16; 8:45 am]
BILLING CODE 4164-01-P


