80 FR 57007 - Establishment of the Patient Engagement Advisory Committee; Establishment of a Public Docket; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 182 (September 21, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 182 (September 21, 2015)
| Page Range | 57007-57008 | |
| FR Document | 2015-23521 |
[Federal Register Volume 80, Number 182 (Monday, September 21, 2015)] [Notices] [Pages 57007-57008] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-23521] [[Page 57007]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-3166] Establishment of the Patient Engagement Advisory Committee; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; establishment of public docket; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the establishment of the Patient Engagement Advisory Committee (the Committee). 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 may consider topics such as 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, and other patient- related topics. The Agency is also announcing the establishment of a public docket for comments on the potential topics. DATES: Comments received by November 20, 2015, will be provided to the Agency. ADDRESSES: Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Comments are to be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Letise Williams, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5441, 301-796-8398, FAX: 301-847-8510. SUPPLEMENTARY INFORMATION: I. Background The Committee will provide advice to the Commissioner or designee, on complex issues relating to medical devices, the regulation of devices, and their use by patients. The Committee may consider topics such as: 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, and other patient-related topics. The Committee will provide relevant skills and perspectives, in order to improve communication of benefits, risks, clinical outcomes, and increase integration of patient perspectives into the regulatory process for medical devices. It will perform its duties by discussing and providing advice and recommendation in ways such as: Identifying new approaches, promoting innovation, recognizing unforeseen risks or barriers, and identifying unintended consequences that could result from FDA policy. A. Composition of the Committee The Committee will consist of a core of nine voting members, including the Chair. Members and the Chair are selected by the Commissioner or designee from experts who are knowledgeable in areas such as clinical research, primary care patient experience, and health care needs of patient groups in the United States. Selected Committee members may also be 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 voting members may include one consumer representative who is a technically qualified member, selected by the Commissioner or designee, identified with consumer interests, and is recommended by either a consortium of consumer oriented organizations or other interested persons. The Commissioner or designee will also have the authority to select from a group of individuals nominated by industry to serve temporarily as non-voting members who are identified with industry interests. The number of temporary non-voting members selected for a particular meeting will depend on the meeting topic. B. Topics FDA is also soliciting public feedback on potential topics for this Committee to discuss and advise the Agency. The following topics may include, but are not limited to:Where can patients provide input across the medical device total product lifecycle? What should be the focus of that input (e.g., input on unmet medical needs; input on endpoints of interest for particular diseases/conditions; input on feasibility of clinical study plans and protocols to reduce barriers to patient participation and retention; input on draft patient labeling; postmarket data reported directly from patients; input on potential risk communication related to products already on the market)? How should the process of soliciting patient input for various purposes work? How should FDA directly engage patients for input related to medical device premarket considerations (e.g., in considering public health impact criterion for eligibility for Expedited Access Program)? How should FDA engage patients for input related to medical device performance once products are available on the market? Under what conditions should health care professional or patient labeling include information about patient preference studies or patient reported outcomes (PROs)? How should sponsors present patient preference information or PROs in the health care professional and patient labeling? How should labeling indicate that only a portion of patients in a patient preference study were willing to accept certain risks in order to achieve probable benefits? How should sponsors and the FDA ensure that patients receive and understand patient preference information? How can patient preferences be obtained in an unbiased manner if the device study has already enrolled and/or been published? How do patients view clinical study informed consent forms? Elsewhere in this issue of the Federal Register, FDA is publishing separate documents regarding: 1. Request for Nominations for Voting Members for the Patient Engagement Advisory Committee 2. Request for Nominations of Individuals and Consumer Organizations for the Patient Engagement Advisory Committee 3. Request for Nominations of Individuals and Industry Organizations for the Patient Engagement Advisory Committee FDA intends to publish a final rule in the Federal Register, adding the Patient Engagement Advisory Committee to 21 CFR part 14.100. [[Page 57008]] II. Comments FDA is opening a docket for 60 days to provide an opportunity for public comment on the potential topics. Interested persons may submit either electronic comments regarding the potential topics to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Divisions of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. Dated: September 15, 2015. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2015-23521 Filed 9-18-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 182 / Monday, September 21, 2015 / Notices 57007
DEPARTMENT OF HEALTH AND registry design, patient preference study • Where can patients provide input
HUMAN SERVICES design, benefit-risk determinations, across the medical device total product
device labeling, unmet clinical needs, lifecycle? What should be the focus of
Food and Drug Administration available alternatives, patient reported that input (e.g., input on unmet medical
[Docket No. FDA–2015–N–3166] outcomes and device-related quality of needs; input on endpoints of interest for
life or health status issues, and other particular diseases/conditions; input on
Establishment of the Patient patient-related topics. The Committee feasibility of clinical study plans and
Engagement Advisory Committee; will provide relevant skills and protocols to reduce barriers to patient
Establishment of a Public Docket; perspectives, in order to improve participation and retention; input on
Request for Comments communication of benefits, risks, draft patient labeling; postmarket data
clinical outcomes, and increase reported directly from patients; input on
AGENCY: Food and Drug Administration, integration of patient perspectives into potential risk communication related to
HHS. the regulatory process for medical products already on the market)? How
ACTION: Notice; establishment of public devices. It will perform its duties by should the process of soliciting patient
docket; request for comments. discussing and providing advice and input for various purposes work?
SUMMARY: The Food and Drug
recommendation in ways such as: • How should FDA directly engage
Identifying new approaches, promoting patients for input related to medical
Administration (FDA or Agency) is
innovation, recognizing unforeseen risks device premarket considerations (e.g., in
announcing the establishment of the
or barriers, and identifying unintended considering public health impact
Patient Engagement Advisory
consequences that could result from criterion for eligibility for Expedited
Committee (the Committee). The
FDA policy. Access Program)?
Committee will provide advice to the
Commissioner of Food and Drugs (the A. Composition of the Committee • How should FDA engage patients
Commissioner) or designee, on complex for input related to medical device
The Committee will consist of a core performance once products are available
issues relating to medical devices,
of nine voting members, including the on the market?
regulation of devices, and their use by
Chair. Members and the Chair are • Under what conditions should
patients. The Committee may consider
selected by the Commissioner or health care professional or patient
topics such as Agency guidance and
designee from experts who are labeling include information about
policies, clinical trial or registry design,
knowledgeable in areas such as clinical patient preference studies or patient
patient preference study design, benefit-
research, primary care patient reported outcomes (PROs)?
risk determinations, device labeling,
experience, and health care needs of • How should sponsors present
unmet clinical needs, available
patient groups in the United States. patient preference information or PROs
alternatives, patient reported outcomes
Selected Committee members may also in the health care professional and
and device-related quality of life or
be experienced in the work of patient patient labeling?
health status issues, and other patient-
and health professional organizations; • How should labeling indicate that
related topics. The Agency is also
methodologies for eliciting patient only a portion of patients in a patient
announcing the establishment of a
preferences; and strategies for preference study were willing to accept
public docket for comments on the
communicating benefits, risks and certain risks in order to achieve
potential topics.
clinical outcomes to patients and probable benefits?
DATES: Comments received by research subjects. Members will be
November 20, 2015, will be provided to • How should sponsors and the FDA
invited to serve for overlapping terms of
the Agency. ensure that patients receive and
up to 4 years. Almost all non-Federal
ADDRESSES: Submit electronic understand patient preference
members of this committee serve as
comments to http:// information?
Special Government Employees. The
www.regulations.gov. Submit written voting members may include one • How can patient preferences be
comments to the Division of Dockets consumer representative who is a obtained in an unbiased manner if the
Management (HFA–305), Food and Drug technically qualified member, selected device study has already enrolled and/
Administration, 5630 Fishers Lane, Rm. by the Commissioner or designee, or been published?
1061, Rockville, MD 20852. Comments identified with consumer interests, and • How do patients view clinical study
are to be identified with the docket is recommended by either a consortium informed consent forms?
number found in brackets in the of consumer oriented organizations or Elsewhere in this issue of the Federal
heading of this document. other interested persons. Register, FDA is publishing separate
FOR FURTHER INFORMATION CONTACT: The Commissioner or designee will documents regarding:
Letise Williams, Center for Devices and also have the authority to select from a 1. Request for Nominations for Voting
Radiological Health, Food and Drug group of individuals nominated by Members for the Patient Engagement
Administration, 10903 New Hampshire industry to serve temporarily as non- Advisory Committee
Ave., Bldg. 66, Rm. 5441, 301–796– voting members who are identified with 2. Request for Nominations of
8398, FAX: 301–847–8510. industry interests. The number of Individuals and Consumer
SUPPLEMENTARY INFORMATION: temporary non-voting members selected Organizations for the Patient
for a particular meeting will depend on Engagement Advisory Committee
I. Background the meeting topic. 3. Request for Nominations of
rmajette on DSK7SPTVN1PROD with NOTICES
The Committee will provide advice to Individuals and Industry Organizations
B. Topics for the Patient Engagement Advisory
the Commissioner or designee, on
complex issues relating to medical FDA is also soliciting public feedback Committee
devices, the regulation of devices, and on potential topics for this Committee to FDA intends to publish a final rule in
their use by patients. The Committee discuss and advise the Agency. The the Federal Register, adding the Patient
may consider topics such as: Agency following topics may include, but are Engagement Advisory Committee to 21
guidance and policies, clinical trial or not limited to: CFR part 14.100.
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![57008 Federal Register / Vol. 80, No. 182 / Monday, September 21, 2015 / Notices
II. Comments Room 1581, Bethesda, MD 20892, 301–496– Dated: September 15, 2015.
2116, balabanr@nhlbi.nih.gov. David Clary,
FDA is opening a docket for 60 days Information is also available on the
to provide an opportunity for public Program Analyst, Office of Federal Advisory
Institute’s/Center’s home page: Committee Policy.
comment on the potential topics. www.nhlbi.nih.gov/meetings/index.htm,
[FR Doc. 2015–23565 Filed 9–18–15; 8:45 am]
Interested persons may submit either where an agenda and any additional
electronic comments regarding the information for the meeting will be posted BILLING CODE 4140–01–P
potential topics to http:// when available.
www.regulations.gov or written (Catalogue of Federal Domestic Assistance
comments to the Division of Dockets Program Nos. 93.233, National Center for DEPARTMENT OF HEALTH AND
Management (see ADDRESSES). It is only Sleep Disorders Research; 93.837, Heart and HUMAN SERVICES
Vascular Diseases Research; 93.838, Lung
necessary to send one set of comments. National Institutes of Health
Diseases Research; 93.839, Blood Diseases
Identify comments with the docket and Resources Research, National Institutes
number found in brackets in the of Health, HHS) Center for Scientific Review; Notice of
heading of this document. Received Closed Meetings
Dated: September 15, 2015.
comments may be seen in the Divisions
of Dockets Management between 9 a.m. Michelle Trout, Pursuant to section 10(d) of the
and 4 p.m., Monday through Friday, and Program Analyst, Office of Federal Advisory Federal Advisory Committee Act, as
will be posted to the docket at http:// Committee Policy. amended (5 U.S.C. App.), notice is
www.regulations.gov. [FR Doc. 2015–23505 Filed 9–18–15; 8:45 am] hereby given of the following meetings.
BILLING CODE 4140–01–P The meetings will be closed to the
Dated: September 15, 2015. public in accordance with the
Jill Hartzler Warner, provisions set forth in sections
Associate Commissioner for Special Medical DEPARTMENT OF HEALTH AND 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Programs. HUMAN SERVICES as amended. The grant applications and
[FR Doc. 2015–23521 Filed 9–18–15; 8:45 am] the discussions could disclose
BILLING CODE 4164–01–P National Institutes of Health confidential trade secrets or commercial
property such as patentable material,
National Institute of Allergy and and personal information concerning
DEPARTMENT OF HEALTH AND Infectious Diseases; Notice of Closed individuals associated with the grant
HUMAN SERVICES Meeting applications, the disclosure of which
Pursuant to section 10(d) of the would constitute a clearly unwarranted
National Institutes of Health invasion of personal privacy.
Federal Advisory Committee Act, as
National Heart, Lung, and Blood amended (5 U.S.C. App.), notice is Name of Committee: Center for Scientific
Institute; Notice of Closed Meeting hereby given of the following meeting. Review Special Emphasis Panel Member
The meeting will be closed to the Conflict: Cancer Immuno Therapeutics.
Pursuant to section 10(d) of the public in accordance with the Date: October 1, 2015.
Federal Advisory Committee Act, as provisions set forth in sections Time: 2:00 p.m. to 5:00 p.m.
amended (5 U.S.C. App.), notice is 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Agenda: To review and evaluate grant
hereby given of a meeting of the Board as amended. The grant applications and applications.
Place: National Institutes of Health, 6701
of Scientific Counselors, NHLBI. the discussions could disclose
Rockledge Drive, Bethesda, MD 20892,
The meeting will be closed to the confidential trade secrets or commercial (Telephone Conference Call).
public as indicated below in accordance property such as patentable material, Contact Person: Malaya Chatterjee, Ph.D.,
with the provisions set forth in section and personal information concerning Scientific Review Officer, Center for
552b(c)(6), Title 5 U.S.C., as amended individuals associated with the grant Scientific Review, National Institutes of
for the review, discussion, and applications, the disclosure of which Health, 6701 Rockledge Drive, Room 6192,
evaluation of individual intramural would constitute a clearly unwarranted MSC 7804, Bethesda, MD 20892, (301) 806–
programs and projects conducted by the invasion of personal privacy. 2515, chatterm@csr.nih.gov.
NATIONAL HEART, LUNG, AND This notice is being published less than 15
Name of Committee: National Institute of
BLOOD INSTITUTE, including days prior to the meeting due to the timing
Allergy and Infectious Diseases Special
consideration of personnel Emphasis Panel NIAID Clinical Trial limitations imposed by the review and
Implementation Grant (R01). funding cycle.
qualifications and performance, and the
competence of individual investigators, Date: October 20, 2015. Name of Committee: Center for Scientific
Time: 1:00 p.m. to 2:30 p.m. Review Special Emphasis Panel PAR Panel:
the disclosure of which would Investigations on Primary Immunodeficiency
Agenda: To review and evaluate grant
constitute a clearly unwarranted applications. Diseases.
invasion of personal privacy. Place: National Institutes of Health, Room Date: October 15, 2015.
Name of Committee: Board of Scientific 3E73, 5601 Fishers Lane, Rockville, MD Time: 1:00 p.m. to 4:00 p.m.
Counselors, NHLBI. 20892, (Telephone Conference Call). Agenda: To review and evaluate grant
Date: October 27, 2015. Contact Person: Jane K. Battles, Ph.D., applications.
Time: 8:00 a.m. to 5:00 p.m. Scientific Review Officer, Scientific Review Place: National Institutes of Health, 6701
Agenda: To review and evaluate personal Program, Division of Extramural Activities, Rockledge Drive, Bethesda, MD 20892,
qualifications and performance, and National Institutes of Health/NIAID, 5601 (Virtual Meeting).
rmajette on DSK7SPTVN1PROD with NOTICES
competence of individual investigators. Fishers Lane, Room 3F30B, Rockville, MD Contact Person: Jin Huang, Ph.D.,
Place: National Institutes of Health, Porter 20852, 240–669–5029, battlesja@ Scientific Review Officer, Center for
Neuroscience Research Center, Building 35A, mail.nih.gov. Scientific Review, National Institutes of
Convent Drive, Bethesda, MD 20892. (Catalogue of Federal Domestic Assistance Health, 6701 Rockledge Drive, Room 4095G,
Contact Person: Robert S. Balaban, Ph.D. Program Nos. 93.855, Allergy, Immunology, MSC 7812, Bethesda, MD 20892, 301–435–
Scientific Director, National Heart, Lung, and and Transplantation Research; 93.856, 1230, jh377p@nih.gov.
Blood Institute, National Institutes of Health, Microbiology and Infectious Diseases Name of Committee: Center for Scientific
Building 10, 10 Center Drive, CRC, 4th Floor, Research, National Institutes of Health, HHS) Review Special Emphasis Panel PAR–13–
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Document Created: 2015-12-15 09:39:25
Document Modified: 2015-12-15 09:39:25
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice; establishment of public docket; request for comments. | |
| Dates | Comments received by November 20, 2015, will be provided to the Agency. | |
| Contact | Letise Williams, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5441, 301-796-8398, FAX: 301-847-8510. | |
| FR Citation | 80 FR 57007 |
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