[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: [email protected], 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.
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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]
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