Biomedical Engineering Society and FDA Frontiers in Medical Devices: Innovations in Modeling and Simulation, 17757-17758 [2015-07551]

Download as PDF Federal Register / Vol. 80, No. 63 / Thursday, April 2, 2015 / Notices Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC–5610 (Annex J), or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex J), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before June 1, 2015. For information on the Commission’s privacy policy, including routine uses permitted by the Privacy Act, see https://www.ftc.gov/ftc/ privacy.htm. David C. Shonka, Principal Deputy General Counsel. [FR Doc. 2015–07552 Filed 4–1–15; 8:45 am] BILLING CODE 6750–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Solicitation of Written Comments on Draft National Pain Strategy The National Institute of Neurological Disorders and Stroke (NINDS) Office of Pain Policy is soliciting public comment on the draft National Pain Strategy. DATES: Comments on the draft National Pain Strategy must be received no later than 5 p.m. EST on May 20, 2015. ADDRESSES: The draft National Pain Strategy is available at: https:// iprcc.nih.gov/docs/ DraftHHSNationalPainStrategy.pdf. Written comments sent electronically are preferred and may be addressed to NPSPublicComments@NIH.gov. Written responses should be addressed to Linda Porter, Ph.D., NINDS/NIH, 31 Center Drive, Room 8A31, Bethesda, MD 20892. SUMMARY: tkelley on DSK3SPTVN1PROD with NOTICES FOR FURTHER INFORMATION CONTACT: Contact Linda Porter, Ph.D., NINDS/ NIH, 31 Center Drive, Room 8A31, Bethesda, MD 20892, porterl@ninds.nih.gov. The draft National Pain Strategy reflects the work of many offices across the Department of Health and Human Services, Department of Defense, and Department of Veterans Affairs. The draft National SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 18:52 Apr 01, 2015 Jkt 235001 Pain Strategy also reflects input from scientific and clinical experts and pain patient advocates. It includes objectives and plans related to key areas of pain and pain care, including professional education and training, public education and communication, service delivery and reimbursement, prevention and care, disparities, and population research. I. Background A core recommendation of the 2011 IOM Report: Relieving Pain in America is: ‘‘The Secretary of the Department of Health and Human Services should develop a comprehensive, population health-level strategy for pain prevention, treatment, management, education, reimbursement, and research that includes specific goals, actions, time frames, and resources.’’ The IOM report highlighted specific objectives for the strategy: • Describe how efforts across government agencies, including publicprivate partnerships, can be established, coordinated, and integrated to encourage population-focused research, education, communication, and community-wide approaches that can help reduce pain and its consequences and remediate disparities in the experience of pain among subgroups of Americans. • Include an agenda for developing physiological, clinical, behavioral, psychological, outcomes, and health services research and appropriate links across these domains. • Improve pain assessment and management programs within the service delivery and financing programs of the federal government. • Proceed in cooperation with the Interagency Pain Research Coordinating Committee and the National Institutes of Health’s Pain Consortium and reach out to private-sector participants as appropriate. • Involve the appropriate agencies and entities. • Include ongoing efforts to enhance public awareness about the nature of chronic pain and the role of self-care in its management. The Department of Health and Human Services charged the Interagency Pain Research Coordinating Committee (IPRCC) with creating a comprehensive population health-level strategy to begin addressing these objectives. The NINDS Office of Pain Policy, on behalf of DHHS, requests input on the draft National Pain Strategy. Frm 00044 Fmt 4703 Sfmt 4703 III. Potential Responders HHS invites input from a broad range of individuals and organizations that have interests in advancing the fundamental understanding of pain and improving pain-related treatment strategies. Some examples of these organizations include, but are not limited to the following: • Caregivers or health system providers (e.g., physicians, physician assistants, nurses, pharmacists) • Researchers • Foundations • Health care, professional, and educational organizations/societies • Insurers and business groups • Medicaid- and Medicare-related organizations • Patients and their advocates • Pharmaceutical Industry • Public health organizations • State and local public health agencies When responding, please self-identify with any of the above or other categories (include all that apply) and your name. Anonymous submissions will not be considered. Written materials submitted for consideration should not exceed 5 pages, not including appendices and supplemental documents. Responders may submit other forms of electronic materials to demonstrate or exhibit concepts of their written responses. We request that comments be identified by section, subsection, and page number of the draft so they may be addressed accordingly. All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. Dated: March 25, 2015. Walter J. Koroshetz, Acting Director, National Institute of Neurological Disorders and Stroke, National Institutes of Health. [FR Doc. 2015–07626 Filed 4–1–15; 8:45 am] BILLING CODE CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–0001] Biomedical Engineering Society and FDA Frontiers in Medical Devices: Innovations in Modeling and Simulation AGENCY: Food and Drug Administration, HHS. II. Information Request PO 00000 17757 ACTION: Notice of Public Conference The Food and Drug Administration (FDA) in co-sponsorship with the E:\FR\FM\02APN1.SGM 02APN1 17758 Federal Register / Vol. 80, No. 63 / Thursday, April 2, 2015 / Notices tkelley on DSK3SPTVN1PROD with NOTICES Biomedical Engineering Society (BMES) is announcing a public conference entitled ‘‘Frontiers in Medical Devices: Innovations in Modeling and Simulation’’. The purpose of this conference is to provide a forum to discuss strategies to effectively utilize computational modeling and simulation in the development and evaluation of medical devices. Date and Time: The conference will be held on May 18 through 20, 2015, from 8 a.m. to 6 p.m. Location: The public conference will be held at the Marriott Inn and Conference Center, University of Maryland, 3501 University Blvd. East, Hyattsville, MD 20783. Contact Person: Donna R. Lochner, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 62, Rm. 3220, Silver Spring, MD 20993, 301–796–6309, Donna.Lochner@ fda.hhs.gov. Registration: To register for the public conference please visit FDA’s Medical Devices News, Events, Workshops, and Conferences calendar at https:// www.bmes.org/meddevicesconference. There is a registration fee to attend the public conference to cover the expenses, and attendees must register in advance. The fees vary depending upon membership status in BMES, and include BMES members ($450), nonBMES members (includes 1 year BMES membership) ($600), and Government rate (BMES memberships and meals are not included) ($250). Students will be offered a discounted fee of $300 (BMES member) or $350 (non-BMES member) (includes 1 year BMES membership). A full listing of the registration fees can be found on the Web site listed. Although the facilities are spacious, registration will be on a first-come, first-served basis. If you need special accommodations due to a disability, please contact Betse Lyons at Betse@bmes.org or 301–459– 1999, 8201 Corporate Drive, Suite 1125, Landover, MD 20785–2224, FAX: 301– 459–2444, no later than May 4, 2015. To register for the public conference, please visit BMES Frontiers in Medical Devices registration page at https:// bmes.org/meddevicesregistration. Those without Internet access should contact Betse Lyons at 301–459–1999 to register. SUPPLEMENTARY INFORMATION: I. Background The Center for Devices and Radiological Health (CDRH) believes that computer modeling and simulation (M&S) has the potential to substantially augment traditional models used to evaluate medical devices; i.e., animal, VerDate Sep<11>2014 18:52 Apr 01, 2015 Jkt 235001 bench, and human models, and to accelerate and streamline the total product life cycle of a medical device. The use of computer models to simulate multiple use conditions and to visualize and display complex processes and data can revolutionize the way medical outcomes and medical devices are understood. Non-proprietary computer models could benchmark device performance, yet lack of access to biomedical data to construct the models and rigorous methods to validate the models limit their credibility and use. To foster good science for M&S in the medical device community, CDRH needs to leverage the expertise in industry and academia to advance M&S for regulatory uses. II. Topics for Discussion at the Public Workshop A large number of issues will be discussed at the conference with the overall theme being the application of modeling and simulation for medical devices at different stages in the total product life cycle. Topics include, but are not limited to the following: • Model foundations for device design ideation; • concept development and design optimization; • modeling for robust design; • design verification and validation; • patient specific design; • integration of modeling with clinical studies; • modeling and device commercialization. This public workshop may also form the basis for future discussions related to computer modeling and simulation that could benefit U.S. public health. Dated: March 27, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–07551 Filed 4–1–15; 8:45 am] BILLING CODE CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose Frm 00045 Fmt 4703 Sfmt 4703 Name of Committee: National Institute of Mental Health Special Emphasis Panel; Mentoring Programs for HIV/AIDS Researchers 2. Date: March 30, 2015. Time: 11:00 a.m. to 1:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Aileen Schulte, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6140, MSC 9608, Bethesda, MD 20892–9608, 301–443–1225, aschulte@mail.nih.gov This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program No. 93.242, Mental Health Research Grants, National Institutes of Health, HHS) Dated: March 27, 2015. Carolyn A. Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–07507 Filed 4–1–15; 8:45 am] BILLING CODE CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0481] Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Investigational Uses AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on SUMMARY: National Institute Of Mental Health; Notice of Closed Meeting PO 00000 confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. E:\FR\FM\02APN1.SGM 02APN1

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[Federal Register Volume 80, Number 63 (Thursday, April 2, 2015)]
[Notices]
[Pages 17757-17758]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07551]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Biomedical Engineering Society and FDA Frontiers in Medical 
Devices: Innovations in Modeling and Simulation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of Public Conference

-----------------------------------------------------------------------

    The Food and Drug Administration (FDA) in co-sponsorship with the

[[Page 17758]]

Biomedical Engineering Society (BMES) is announcing a public conference 
entitled ``Frontiers in Medical Devices: Innovations in Modeling and 
Simulation''. The purpose of this conference is to provide a forum to 
discuss strategies to effectively utilize computational modeling and 
simulation in the development and evaluation of medical devices.
    Date and Time: The conference will be held on May 18 through 20, 
2015, from 8 a.m. to 6 p.m.
    Location: The public conference will be held at the Marriott Inn 
and Conference Center, University of Maryland, 3501 University Blvd. 
East, Hyattsville, MD 20783.
    Contact Person: Donna R. Lochner, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 62, Rm. 3220, Silver Spring, MD 20993, 301-796-6309, 
Donna.Lochner@fda.hhs.gov.
    Registration: To register for the public conference please visit 
FDA's Medical Devices News, Events, Workshops, and Conferences calendar 
at https://www.bmes.org/meddevicesconference. There is a registration 
fee to attend the public conference to cover the expenses, and 
attendees must register in advance. The fees vary depending upon 
membership status in BMES, and include BMES members ($450), non-BMES 
members (includes 1 year BMES membership) ($600), and Government rate 
(BMES memberships and meals are not included) ($250). Students will be 
offered a discounted fee of $300 (BMES member) or $350 (non-BMES 
member) (includes 1 year BMES membership). A full listing of the 
registration fees can be found on the Web site listed. Although the 
facilities are spacious, registration will be on a first-come, first-
served basis.
    If you need special accommodations due to a disability, please 
contact Betse Lyons at Betse@bmes.org or 301-459-1999, 8201 Corporate 
Drive, Suite 1125, Landover, MD 20785-2224, FAX: 301-459-2444, no later 
than May 4, 2015.
    To register for the public conference, please visit BMES Frontiers 
in Medical Devices registration page at https://bmes.org/meddevicesregistration. Those without Internet access should contact 
Betse Lyons at 301-459-1999 to register.

SUPPLEMENTARY INFORMATION:

I. Background

    The Center for Devices and Radiological Health (CDRH) believes that 
computer modeling and simulation (M&S) has the potential to 
substantially augment traditional models used to evaluate medical 
devices; i.e., animal, bench, and human models, and to accelerate and 
streamline the total product life cycle of a medical device. The use of 
computer models to simulate multiple use conditions and to visualize 
and display complex processes and data can revolutionize the way 
medical outcomes and medical devices are understood. Non-proprietary 
computer models could benchmark device performance, yet lack of access 
to biomedical data to construct the models and rigorous methods to 
validate the models limit their credibility and use. To foster good 
science for M&S in the medical device community, CDRH needs to leverage 
the expertise in industry and academia to advance M&S for regulatory 
uses.

II. Topics for Discussion at the Public Workshop

    A large number of issues will be discussed at the conference with 
the overall theme being the application of modeling and simulation for 
medical devices at different stages in the total product life cycle. 
Topics include, but are not limited to the following:
     Model foundations for device design ideation;
     concept development and design optimization;
     modeling for robust design;
     design verification and validation;
     patient specific design;
     integration of modeling with clinical studies;
     modeling and device commercialization.
    This public workshop may also form the basis for future discussions 
related to computer modeling and simulation that could benefit U.S. 
public health.

    Dated: March 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07551 Filed 4-1-15; 8:45 am]
BILLING CODE CODE 4164-01-P

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