80 FR 49248 - Physiological Closed-Loop Controlled Devices; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 158 (August 17, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 158 (August 17, 2015)
| Page Range | 49248-49250 | |
| FR Document | 2015-20127 |
[Federal Register Volume 80, Number 158 (Monday, August 17, 2015)] [Notices] [Pages 49248-49250] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-20127] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-2734] Physiological Closed-Loop Controlled Devices; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Physiological Closed-Loop Controlled (PCLC) Devices.'' The topic to be discussed is challenges related to the design, development, and evaluation of critical care PCLC devices. FDA considers PCLC devices an emerging technology and aims to hold a workshop focusing on design, development and performance evaluation of PCLC systems intended for use in critical care environments. Such devices include closed-loop anesthetic delivery, closed-loop vasoactive drug and fluid delivery, and closed-loop mechanical ventilation. Dates and Times: The public workshop will be held on October 13 and 14, 2015, from 8 a.m. to 5 p.m. Location: The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, Rm. 1503 (The Great Room), Silver Spring, MD 20993. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. Contact Persons: Bahram Parvinian, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2534, Silver Spring, MD 20993, 301-796-6445, email: [email protected]; and Allison Kumar, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5402, Silver Spring, MD 20993, 301-796-6369, email: [email protected]. Registration: Registration is free and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by 4 p.m., October 1, 2015. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permits, onsite registration on the day of the public workshop will be provided beginning at 7 a.m. If you need special accommodations due to a disability, please contact Susan Monahan, Office of Communication and Education (OCE), Center for Devices and Radiological Health, Food and Drug Administration, 301-796-5661, email: [email protected] no later than September 29, 2015. To register for the public workshop, please visit FDA's Medical Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this meeting/public workshop from the posted events list.) Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone number. Those without Internet access should contact Susan Monahan to register. Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list. Streaming Webcast of the Public Workshop: This public workshop will also be Webcast. Persons interested in viewing the Webcast must register online by 4 p.m., October 1, 2015. Early registration is recommended because Webcast connections are limited. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and will be sent connection access information after October 7, 2015. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. (FDA has [[Page 49249]] verified the Web site addresses in this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) Requests for Oral Presentations: This public workshop includes a public comment session and topic-focused sessions. During online registration you may indicate if you wish to present during a public comment session or participate in a specific session, and which topics you wish to address. FDA has included general topics in this document. FDA will do its best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the focused sessions. Following the close of registration, FDA will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by September 15, 2015. All requests to make oral presentations must be received by September 1, 2015. If selected for presentation, any presentation materials must be emailed to Bahram Parvinian and Allison Kumar (see Contact Persons) no later than October 1, 2015. No commercial or promotional material will be permitted to be presented or distributed at the public workshop. Comments: FDA is holding this public workshop to obtain information on challenges related to the design, development, and evaluation of critical care PCLC devices. In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public workshop topics. The deadline for submitting comments related to this public workshop is September 1, 2015. Regardless of attendance at the public workshop, interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 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. In addition, when responding to specific questions as outlined in section II of this document, please identify the question you are addressing. Received comments may be seen in the Division 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. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may be viewed at the Division of Dockets Management (see Comments). A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. The address of the Division of Freedom of Information is available on the Agency's Web site at http://www.fda.gov. A link to the transcripts will also be available approximately 45 days after the public workshop on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list). SUPPLEMENTARY INFORMATION: I. Background PCLC medical devices are an emerging technology in the intensive care and emergency medicine settings that provides autonomous therapy adjustments to manipulate a physiological variable. For example, a closed-loop oxygen delivery device may automatically adjust the fraction of inspired oxygen when an individual's oxygen saturation level drifts too high or too low. PCLCs could benefit patients and practitioners by automating a number of tasks including adjustments to mechanical ventilation, anesthetic delivery, and fluid resuscitation. These devices may provide practitioners more resources to consider the course of treatment for an individual patient and improve resource allocation during times of medical surge (e.g., from mass casualty incidents). PCLC medical devices may also allow additional therapeutic and diagnostic capabilities by providing precise control of physiological variables by continuous manipulation of therapy that is impractical for a medical practitioner to perform. Recent advances in medical device technology and control systems science have increased the development of PCLC medical devices. PCLCs shift specific assignments of data interpretation and therapy manipulation from a practitioner to a medical device. This may or may not introduce new risks to patients, but could introduce new medical device hazards that, considered during design and development, can be mitigated throughout the device life-cycle. Addressing technical and clinical challenges for a PCLC medical device to be robust, stable, and effective in its environment of use will ensure patient safety and promote innovation and development of PCLC medical devices. This workshop seeks to involve industry, academia, medical societies, patient groups, standard bodies, and other relevant stakeholders in addressing the challenges in the development and implementation of PCLC medical devices in critical care environments. Participants in the workshop will include scientists and engineers developing PCLC medical devices, as well as end users including physicians, nurses, and patients. The intent of the workshop is to discuss benefit-risk considerations, design strategies, pre-clinical testing, and clinical evaluation for specific product areas of PCLC medical devices. Ideas generated during this workshop may facilitate development of new draft guidances and/or standards for PCLC medical devices. II. Topics for Discussion at the Public Workshop This workshop is aimed to address the scientific, clinical and regulatory considerations associated with these devices, including, but not limited to, the following topic areas: 1. Benefit-risk considerations at varying levels of closed-loop medical device autonomy 2. Challenges related to the design and development of critical care PCLC devices a. System performance analysis for different controller types (e.g., rule based/knowledge based, proportional-integral derivative, fuzz logic, adaptive predictive, neural networks) b. Fault detection and fallback modes c. User interfaces and operational transparency 3. Knowledge gap between clinicians and system engineers a. Clinician involvement in system design b. Control system terminology 4. Pre-clinical evaluation a. Evidence needed to demonstrate a stable and robust controller b. Use of computer simulations including verification, validation and uncertainty quantification of physiological models used for design and evaluation of PCLC systems. c. Real time bench testing 5. Clinical evaluation (e.g., study design, clinical endpoints, outside the U.S. data) a. Clinical validity of sensors b. Patient populations c. Environments of use d. User related level of expertise. [[Page 49250]] 6. Human factors of autonomous medical devices (e.g., usability, training, clinical decisionmaking) Dated: August 11, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-20127 Filed 8-14-15; 8:45 am] BILLING CODE 4164-01-P
![49248 Federal Register / Vol. 80, No. 158 / Monday, August 17, 2015 / Notices
• As one condition under which FDA will be posted to the docket at http:// Health, Food and Drug Administration,
does not generally intend to take action www.regulations.gov. 10903 New Hampshire Ave., Bldg. 66,
for certain violations of the FD&C Act if Rm. 2534, Silver Spring, MD 20993,
IV. Electronic Access
this and the other conditions are 301–796–6445, email:
followed, FDA is proposing that State- Persons with access to the Internet Bahram.Parvinian@fda.hhs.gov; and
licensed pharmacies and veterinarians may obtain the draft guidance at either Allison Kumar, Center for Devices and
report any product defect or serious http://www.fda.gov/AnimalVeterinary/ Radiological Health, Food and Drug
adverse event associated with animal GuidanceComplianceEnforcement/ Administration, 10903 New Hampshire
drugs they compound from bulk drug GuidanceforIndustry/ucm042450.htm or Ave., Bldg. 66, Rm. 5402, Silver Spring,
substances to FDA within 15 days of http://www.regulations.gov. MD 20993, 301–796–6369, email:
becoming aware of the product defect or Dated: August 11, 2015. Allison.Kumar@fda.hhs.gov.
serious adverse event. Outsourcing Leslie Kux, Registration: Registration is free and
facilities are required to report adverse Associate Commissioner for Policy.
available on a first-come, first-served
events associated with the drugs they basis. Persons interested in attending
[FR Doc. 2015–20174 Filed 8–14–15; 8:45 am]
compound. FDA believes it is important this public workshop must register
BILLING CODE 4164–01–P
to receive this information from State- online by 4 p.m., October 1, 2015. Early
licensed pharmacies and veterinarians registration is recommended because
because there are no other State facilities are limited and, therefore, FDA
DEPARTMENT OF HEALTH AND
Departments of Health or Federal may limit the number of participants
HUMAN SERVICES
Agencies (e.g., the Centers for Disease from each organization. If time and
Control and Prevention) charged with Food and Drug Administration space permits, onsite registration on the
identifying and tracing animal injuries day of the public workshop will be
or disease associated with an animal [Docket No. FDA–2015–N–2734] provided beginning at 7 a.m.
drug compounded by these entities. If you need special accommodations
Physiological Closed-Loop Controlled due to a disability, please contact Susan
FDA has the following specific
Devices; Public Workshop; Request Monahan, Office of Communication and
questions with respect to this proposed
for Comments Education (OCE), Center for Devices and
condition:
Æ How many State-licensed AGENCY: Food and Drug Administration, Radiological Health, Food and Drug
pharmacies and veterinarians HHS. Administration, 301–796–5661, email:
compound animal drugs from bulk drug ACTION: Notice of public workshop; susan.monahan@fda.hhs.gov no later
substances and would potentially be request for comments. than September 29, 2015.
reporting product defects and serious To register for the public workshop,
adverse events to FDA? SUMMARY: The Food and Drug please visit FDA’s Medical Devices
Æ Are State-licensed pharmacies and Administration (FDA) is announcing the News & Events—Workshops &
veterinarians reporting the same or following public workshop entitled Conferences calendar at http://
similar information to any State ‘‘Physiological Closed-Loop Controlled www.fda.gov/MedicalDevices/
regulatory agency (e.g., State boards of (PCLC) Devices.’’ The topic to be NewsEvents/WorkshopsConferences/
pharmacy, State boards of veterinary discussed is challenges related to the default.htm. (Select this meeting/public
medicine)? If so, how many reports on design, development, and evaluation of workshop from the posted events list.)
average does each State-licensed critical care PCLC devices. FDA Please provide complete contact
pharmacy and veterinarian submit to considers PCLC devices an emerging information for each attendee, including
these State agencies each year? technology and aims to hold a workshop name, title, affiliation, address, email,
Æ For purposes of the guidance, how focusing on design, development and and telephone number. Those without
should FDA define the terms ‘‘product performance evaluation of PCLC Internet access should contact Susan
defect’’ and ‘‘serious adverse event?’’ systems intended for use in critical care Monahan to register. Registrants will
Æ Can FDA achieve the same environments. Such devices include receive confirmation after they have
objective of identifying and tracing the closed-loop anesthetic delivery, closed- been accepted. You will be notified if
source of injuries or disease associated loop vasoactive drug and fluid delivery, you are on a waiting list.
with an animal drug compounded from and closed-loop mechanical ventilation. Streaming Webcast of the Public
a bulk drug substance through means Dates and Times: The public Workshop: This public workshop will
other than product defect and serious workshop will be held on October 13 also be Webcast. Persons interested in
adverse event reporting, and if so, what and 14, 2015, from 8 a.m. to 5 p.m. viewing the Webcast must register
other means? For example, would Location: The public workshop will online by 4 p.m., October 1, 2015. Early
reports of product defects alone achieve be held at FDA’s White Oak Campus, registration is recommended because
the same objective? 10903 New Hampshire Ave., Building Webcast connections are limited.
31 Conference Center, Rm. 1503 (The Organizations are requested to register
III. Request for Comments all participants, but to view using one
Great Room), Silver Spring, MD 20993.
Interested persons may submit either Entrance for the public meeting connection per location. Webcast
electronic comments regarding this participants (non-FDA employees) is participants will be sent technical
document to http://www.regulations.gov through Building 1 where routine system requirements after registration
or written comments to the Division of security check procedures will be and will be sent connection access
mstockstill on DSK4VPTVN1PROD with NOTICES
Dockets Management (see ADDRESSES). It performed. For parking and security information after October 7, 2015. If you
is only necessary to send one set of information, please refer to http:// have never attended a Connect Pro
comments. Identify comments with the www.fda.gov/AboutFDA/ event before, test your connection at
docket number found in brackets in the WorkingatFDA/BuildingsandFacilities/ https://collaboration.fda.gov/common/
heading of this document. Received WhiteOakCampusInformation/ help/en/support/meeting_test.htm. To
comments may be seen in the Division ucm241740.htm. get a quick overview of the Connect Pro
of Dockets Management between 9 a.m. Contact Persons: Bahram Parvinian, program, visit http://www.adobe.com/
and 4 p.m., Monday through Friday, and Center for Devices and Radiological go/connectpro_overview. (FDA has
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![49250 Federal Register / Vol. 80, No. 158 / Monday, August 17, 2015 / Notices
6. Human factors of autonomous Building, 5600 Fishers Lane, Rockville, authorization of the funding for the site
medical devices (e.g., usability, training, MD 20857. visit or relocation.
clinical decisionmaking) FOR FURTHER INFORMATION CONTACT: To Need and Proposed Use of the
Dated: August 11, 2015. request more information on the Information: This information will
Leslie Kux, proposed project or to obtain a copy of facilitate NHSC scholar and S2S
Associate Commissioner for Policy. the data collection plans and draft clinicians’ receipt of federal travel funds
instruments, email paperwork@hrsa.gov that are used to visit high-need NHSC
[FR Doc. 2015–20127 Filed 8–14–15; 8:45 am]
or call the HRSA Information Collection sites. The Travel Request Worksheet is
BILLING CODE 4164–01–P
Clearance Officer at (301) 443–1984. also used to initiate the relocation
SUPPLEMENTARY INFORMATION: When process after a NHSC scholar or S2S
submitting comments or requesting participant has successfully been
DEPARTMENT OF HEALTH AND
information, please include the matched to an approved practice site.
HUMAN SERVICES
information request collection title for This information will be used by the
Health Resources and Services reference. NHSC in order to make travel
Administration Information Collection Request Title: arrangements for NHSC scholar and S2S
National Health Service Corps Scholar/ clinicians to potential practice sites and
Agency Information Collection Students to Service Travel Worksheet. to assist them in relocation
Activities: Proposed Collection: Public OMB No. 0915–0278—Extension. arrangements once clinicians have
Comment Request Abstract: Clinicians participating in secured employment at one of these
the HRSA National Health Service sites.
AGENCY: Health Resources and Services Corps (NHSC) Scholarship Program and Likely Respondents: Clinicians
Administration, HHS. the Students to Service (S2S) Loan participating in the National Health
ACTION: Notice. Repayment Program use the online Service Corps Scholarship Program and
Travel Request Worksheet to receive the Students to Service Loan Repayment
SUMMARY: In compliance with the Program.
travel funds from the federal
requirement for opportunity for public Burden Statement: Burden in this
government to visit eligible NHSC sites
comment on proposed data collection context means the time expended by
to which they may be assigned in
projects (Section 3506(c)(2)(A) of the persons to generate, maintain, retain,
accordance with the Public Health
Paperwork Reduction Act of 1995), the disclose or provide the information
Service Act (PHSA), section 331(c)(1).
Health Resources and Services The travel approval process is requested. This includes the time
Administration (HRSA) announces initiated when a NHSC scholar or S2S needed to review instructions; to
plans to submit an Information participant notifies the NHSC of an develop, acquire, install and utilize
Collection Request (ICR), described impending interview at one or more technology and systems for the purpose
below, to the Office of Management and NHSC-approved practice sites. The of collecting, validating and verifying
Budget (OMB). Prior to submitting the Travel Request Worksheet is also used information, processing and
ICR to OMB, HRSA seeks comments to initiate the relocation process after an maintaining information, and disclosing
from the public regarding the burden NHSC scholar or S2S participant has and providing information; to train
estimate, below, or any other aspect of successfully been matched to an personnel and to be able to respond to
the ICR. approved practice site in accordance a collection of information; to search
DATES: Comments on this Information with the PHSA, section 331(c)(3). Upon data sources; to complete and review
Collection Request must be received no receipt of the Travel Request Worksheet, the collection of information; and to
later than October 16, 2015. the NHSC will review and approve or transmit or otherwise disclose the
ADDRESSES: Submit your comments to disapprove the request and promptly information. The total annual burden
paperwork@hrsa.gov or mail the HRSA notify the scholar or S2S participant, hours estimated for this Information
Information Collection Clearance and the NHSC logistics contractor Collection Request are summarized in
Officer, Room 10–29, Parklawn regarding travel arrangements and the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of Total burden per Total burden
Form name responses per
respondents responses response hours
respondent (in hours)
Travel Request Worksheet .................................................. 250 2 500 .0667 33
Total .............................................................................. 250 2 500 .0667 33
HRSA specifically requests comments technology to minimize the information DEPARTMENT OF HEALTH AND
on (1) the necessity and utility of the collection burden. HUMAN SERVICES
proposed information collection for the
mstockstill on DSK4VPTVN1PROD with NOTICES
Jackie Painter, Office of the Secretary
proper performance of the agency’s
functions, (2) the accuracy of the Director, Division of the Executive Secretariat.
estimated burden, (3) ways to enhance [FR Doc. 2015–20135 Filed 8–14–15; 8:45 am] Notice of Interest Rate on Overdue
Debts
the quality, utility, and clarity of the BILLING CODE 4165–15–P
information to be collected, and (4) the Section 30.18 of the Department of
use of automated collection techniques Health and Human Services’ claims
or other forms of information collection regulations (45 CFR part 30)
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Document Created: 2015-12-15 11:06:59
Document Modified: 2015-12-15 11:06:59
| 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 of public workshop; request for comments. | |
| FR Citation | 80 FR 49248 |
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