Towards an Artificial Pancreas: A Food and Drug Administration, National Institutes of Health, Juvenile Diabetes Research Foundation Public Workshop, 23470-23471 [E8-9375]

Download as PDF 23470 Federal Register / Vol. 73, No. 84 / Wednesday, April 30, 2008 / Notices day notice requesting public comment on the information collection provisions. No comments were received. TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section and FDA Form Annual No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 316.10, 316.12, and 316.14 5 1 5 130 650 316.20, 316.21, and 316.26 171 2.0 342 130 44,460 316.20, 316.21, and 316.26 Form FDA 3671 40 1 40 32 1,280 316.22 30 1 30 2 60 316.27 25 1 25 4 100 316.30 500 1 500 2 1,000 316.36 1 1 1 15 15 Total 47,565 1There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: April 23, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–9467 Filed 4–29–08; 8:45 am] DATES: BILLING CODE 4160–01–S REGISTRATION TO ATTEND THE PUBLIC WORKSHOP). The public workshop will be held on July 21, 2008, from 7:55 a.m. to 6 p.m., and on July 22, 2008, from 8 a.m. to 12:45 p.m. Registration is available until 5 p.m. on June 20, 2008 (See Food and Drug Administration Towards an Artificial Pancreas: A Food and Drug Administration, National Institutes of Health, Juvenile Diabetes Research Foundation Public Workshop AGENCY: Food and Drug Administration, HHS. rwilkins on PROD1PC63 with NOTICES ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA), in collaboration with the National Institutes of Health (NIH) and the Juvenile Diabetes Research Foundation (JDRF), is holding a public workshop focused upon the state of the art in the research and development of an artificial pancreas. The public workshop entitled ‘‘Towards an Artificial Pancreas: A Food and Drug Administration, National Institutes of Health, and Juvenile Diabetes Research Foundation Workshop’’ will provide a public forum for discussing the progress and remaining challenges in the development of closed-loop systems designed to regulate glycemic control, as an aid in the management of diabetes mellitus. It is intended to provide stakeholders with information that will accelerate the development of an artificial pancreas. VerDate Aug<31>2005 17:09 Apr 29, 2008 Jkt 214001 The public workshop will be held at the Lister Hill Auditorium on the NIH Campus (https://www.nih.gov/ science/campus/) located at 9000 Rockville Pike, Bethesda, MD 20892. Parking on the NIH campus is limited. Attendees are encouraged to take public transportation. There is limited parking available at the Natcher Building. See https://www.nih.gov/about/ directions.htm for more information. FOR FURTHER INFORMATION CONTACT: Arleen Pinkos, Center for Devices and Radiological Health (HFZ–440), 2098 Gaither Rd., Rockville, MD 20850, 240– 276–0702, FAX 240–276–0651, e-mail: arleen.pinkos@fda.hhs.gov. ADDRESSES: DEPARTMENT OF HEALTH AND HUMAN SERVICES REGISTRATION TO ATTEND THE PUBLIC WORKSHOP: Those interested in attending the public workshop may register online at https:// www.blsmeetings.net/ artificialpancreas08/reg.cfm. There is no registration fee to attend the meeting; however, all participants must submit a registration form. Space is limited, so please submit your registration early to reserve a space. Registration will be accepted through June 20, 2008; however, onsite registration will be permitted on a space-available basis. Persons without Internet access may call Akia Richardson at 301–313–0244 ext. 49, by June 20, 2008, to register for onsite attendance. PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 If you need special accommodations due to a disability, please contact L’Tonya Frazier at 301–594–4453 at least 7 days in advance. SUPPLEMENTARY INFORMATION: I. Background The artificial pancreas is one of FDA’s Critical Path Initiatives, a program dedicated to accelerating the availability of much needed medical products. The Interagency Artificial Pancreas Working Group, a group of multi-disciplined scientists and clinicians from FDA and NIH, was established to support this initiative. The goals of the Artificial Pancreas Initiative are twofold: to provide infrastructure for narrowing the gap between basic biomedical knowledge and clinical application of novel technologies, and to cross-fertilize and partner with stakeholders in order to identify and overcome the clinical and scientific challenges to the development of an artificial pancreas. Through collaborative efforts, such as this workshop, the group strives to develop innovative strategies to achieve their goals. II. Agenda World renowned experts will present information on topics that are instrumental to the development of an artificial pancreas, and each session will be followed by roundtable discussions. Session topics will include: • State of the art design of closedloop glycemic control systems • Results of recently conducted clinical trials • Clinical trial design, including how to define successes and failures of closed-loop systems E:\FR\FM\30APN1.SGM 30APN1 23471 Federal Register / Vol. 73, No. 84 / Wednesday, April 30, 2008 / Notices • Algorithms and in silico models • Engineering challenges • Patient considerations • Metabolic monitoring • Use of closed-loop systems in nondiabetic intensive care patients • Paths for developing marketable closed-loop systems The agenda for this public workshop is available on the internet at https:// www.blsmeetings.net/ artificialpancreas08/agenda.pdf. More information about this public workshop is available at https:// www.blsmeetings.net/ artificialpancreas08. Dated: April 21, 2008. Daniel G. Schultz, Director, Center for Devices and Radiological Health. [FR Doc. E8–9375 Filed 4–29–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on (301) 443–1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: Ryan White HIV/ AIDS Program Part F Dental Services Report (OMB No. 0915–0151— Extension The Dental Reimbursement Program (DRP) and the Community-Based Dental Partnership Program under Part F of the Ryan White HIV/AIDS Program offer funding to accredited dental education programs to support the provision of oral health services for HIV-positive individuals. Institutions eligible for these programs are accredited schools of dentistry, post-doctoral dental education programs and dental hygiene programs. The DRP Application is the Dental Services Report that schools and programs use to apply for funding of non-reimbursed costs incurred in providing oral health care to patients with HIV, or to report annual program data. Awards are authorized under section 2692(b) of the Public Health Service Act (42 U.S.C. 300ff–111(b)). The Dental Services Report collects data in four different areas: Program information, patient demographics and services, funding, and training. It also Number of respondents Instrument Dental Services Report ........................................................ Responses per respondent 80 Total responses 1 Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to 202–395–6974. Please direct all correspondence to the ‘‘attention of the desk officer for HRSA.’’ DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: April 23, 2008. Alexandra Huttinger, Director, Division of Policy Review and Coordination. [FR Doc. E8–9490 Filed 4–29–08; 8:45 am] In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104–13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget under the Paperwork rwilkins on PROD1PC63 with NOTICES BILLING CODE 4165–15–P VerDate Aug<31>2005 17:09 Apr 29, 2008 Jkt 214001 Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection; Comment Request PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 requests applicants to provide narrative descriptions of their services and facilities, as well as their links and collaboration with community-based providers of oral health services. The primary purpose of collecting this information annually is to verify eligibility and determine reimbursement amounts for DRP applicants, as well as to document the program accomplishments of Community-Based Dental Partnership Program grant recipients. This information also allows HRSA to learn about (1) The extent of the involvement of dental schools and programs in treating patients with HIV, (2) the number and characteristics of clients who receive HIV/AIDS programsupported oral health services, (3) the types and frequency of the provision of these services, (4) the non-reimbursed costs of oral health care provided to patients with HIV, and (5) the scope of grant recipients’ community-based collaborations and training of providers. In addition to meeting the goal of accountability to Congress, clients, advocacy groups, and the general public, information collected in the Dental Services Report is critical for HRSA, State and local grantees, and individual providers, to help assess the status of existing HIV-related health service delivery systems. The reporting burden for reviewing the Dental Services Report Instructions and completing the Report is estimated as: 80 Hours per response Total burden hours 20 1600 Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, call the HRSA Reports Clearance Officer on (301) 443–1129. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. E:\FR\FM\30APN1.SGM 30APN1

Agencies

[Federal Register Volume 73, Number 84 (Wednesday, April 30, 2008)]
[Notices]
[Pages 23470-23471]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-9375]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Towards an Artificial Pancreas: A Food and Drug Administration, 
National Institutes of Health, Juvenile Diabetes Research Foundation 
Public Workshop

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public workshop.

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

SUMMARY:  The Food and Drug Administration (FDA), in collaboration with 
the National Institutes of Health (NIH) and the Juvenile Diabetes 
Research Foundation (JDRF), is holding a public workshop focused upon 
the state of the art in the research and development of an artificial 
pancreas. The public workshop entitled ``Towards an Artificial 
Pancreas: A Food and Drug Administration, National Institutes of 
Health, and Juvenile Diabetes Research Foundation Workshop'' will 
provide a public forum for discussing the progress and remaining 
challenges in the development of closed-loop systems designed to 
regulate glycemic control, as an aid in the management of diabetes 
mellitus. It is intended to provide stakeholders with information that 
will accelerate the development of an artificial pancreas.

DATES:  The public workshop will be held on July 21, 2008, from 7:55 
a.m. to 6 p.m., and on July 22, 2008, from 8 a.m. to 12:45 p.m. 
Registration is available until 5 p.m. on June 20, 2008 (See 
REGISTRATION TO ATTEND THE PUBLIC WORKSHOP).

ADDRESSES:  The public workshop will be held at the Lister Hill 
Auditorium on the NIH Campus (https://www.nih.gov/science/campus/
index.html) located at 9000 Rockville Pike, Bethesda, MD 20892.
    Parking on the NIH campus is limited. Attendees are encouraged to 
take public transportation. There is limited parking available at the 
Natcher Building. See https://www.nih.gov/about/directions.htm for more 
information.

FOR FURTHER INFORMATION CONTACT: Arleen Pinkos, Center for Devices and 
Radiological Health (HFZ-440), 2098 Gaither Rd., Rockville, MD 20850, 
240-276-0702, FAX 240-276-0651, e-mail: arleen.pinkos@fda.hhs.gov.
REGISTRATION TO ATTEND THE PUBLIC WORKSHOP: Those interested in 
attending the public workshop may register online at https://
www.blsmeetings.net/artificialpancreas08/reg.cfm. There is no 
registration fee to attend the meeting; however, all participants must 
submit a registration form. Space is limited, so please submit your 
registration early to reserve a space. Registration will be accepted 
through June 20, 2008; however, onsite registration will be permitted 
on a space-available basis.
    Persons without Internet access may call Akia Richardson at 301-
313-0244 ext. 49, by June 20, 2008, to register for onsite attendance.
    If you need special accommodations due to a disability, please 
contact L'Tonya Frazier at 301-594-4453 at least 7 days in advance.

SUPPLEMENTARY INFORMATION:

I. Background

    The artificial pancreas is one of FDA's Critical Path Initiatives, 
a program dedicated to accelerating the availability of much needed 
medical products. The Interagency Artificial Pancreas Working Group, a 
group of multi-disciplined scientists and clinicians from FDA and NIH, 
was established to support this initiative. The goals of the Artificial 
Pancreas Initiative are twofold: to provide infrastructure for 
narrowing the gap between basic biomedical knowledge and clinical 
application of novel technologies, and to cross-fertilize and partner 
with stakeholders in order to identify and overcome the clinical and 
scientific challenges to the development of an artificial pancreas. 
Through collaborative efforts, such as this workshop, the group strives 
to develop innovative strategies to achieve their goals.

II. Agenda

    World renowned experts will present information on topics that are 
instrumental to the development of an artificial pancreas, and each 
session will be followed by roundtable discussions. Session topics will 
include:
     State of the art design of closed-loop glycemic control 
systems
     Results of recently conducted clinical trials
     Clinical trial design, including how to define successes 
and failures of closed-loop systems

[[Page 23471]]

     Algorithms and in silico models
     Engineering challenges
     Patient considerations
     Metabolic monitoring
     Use of closed-loop systems in non-diabetic intensive care 
patients
     Paths for developing marketable closed-loop systems
    The agenda for this public workshop is available on the internet at 
https://www.blsmeetings.net/artificialpancreas08/agenda.pdf.
    More information about this public workshop is available at https://
www.blsmeetings.net/artificialpancreas08.

    Dated: April 21, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-9375 Filed 4-29-08; 8:45 am]
BILLING CODE 4160-01-S

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