Pediatric Device Consortia Grant Program, 20665-20666 [2013-07948]

Download as PDF mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Notices requirements, and investigator-initiated research. Topics for discussion include the following: (1) What FDA Expects in a Pharmaceutical Clinical Trial; (2) Adverse Event Reporting—Science, Regulation, Error, and Safety; (3) Part 11 Compliance—Electronic Signatures; (4) Informed Consent Regulations; (5) IRB Regulations and FDA Inspections; (6) Keeping Informed and Working Together; (7) FDA Conduct of Clinical Investigator Inspections; (8) Meetings With FDA: Why, When, and How; (9) Investigator-Initiated Research; (10) Medical Device Aspects of Clinical Research; (11) Working With FDA’s Center for Biologics Evaluation and Research; and (12) The Inspection is Over—What Happens Next? Possible FDA Compliance Actions. Extended periods of question and answer and discussion have been included in the program schedule. This program offers 13.3 hours of continuing medical education (CME) and continuing nursing education (CNE) credit. CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. CNE for Nurses: Society of Clinical Research Associates is an approved provider of continuing nursing education by the Pennsylvania State Nurses Association (PSNA), an accredited approver by the American Nurses Credentialing Center’s Commission (ANCC) on Accreditation. ANCC/PSNA Provider Reference Number: 205–3–A–09. FDA has made education of the drug and device manufacturing community a high priority to help ensure the quality of FDA-regulated drugs and devices. The workshop helps to achieve objectives set forth in section 406 of the FDA Modernization Act of 1997 (21 U.S.C. 393), which includes working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. The workshop also is consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104–121), as outreach activities by Government agencies to small businesses. Dated: April 1, 2013. Peter Lurie, Acting Associate Commissioner for Policy and Planning. [FR Doc. 2013–07894 Filed 4–4–13; 8:45 am] BILLING CODE 4160–01–P VerDate Mar<15>2010 17:14 Apr 04, 2013 Jkt 229001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0012] Pediatric Device Consortia Grant Program AGENCY: Food and Drug Administration, HHS. ACTION: The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the Office of Orphan Products Development (OOPD) Pediatric Device Consortia (PDC) Grant Program. The goal of the PDC Grant Program is to facilitate the development, production, and distribution of pediatric medical devices. The PDC will provide grants to nonprofit consortia which provide expert advising and support services to innovators of pediatric devices. These services should include business and regulatory consulting as well as device testing capabilities. This program is intended to further the development of multiple pediatric devices; thus, grants are not awarded to support the development of a single device project. Although administered by the OOPD, this grant program is intended to encompass devices that could be used in all pediatric conditions and diseases, not just rare diseases. The pediatric population (neonates, infants, children, and adolescents) includes patients who are 21 years of age or younger at the time of diagnosis or treatment. DATES: Important dates are as follows: 1. The application due date is June 1, 2013. 2. The anticipated start date is September, 2013. 3. The opening date is May 1, 2013. 4. The expiration date is June 2, 2013. ADDRESSES: Submit the paper application to: Vieda Hubbard, Grants Management (HFA–500), 5630 Fishers Lane, Rm. 2034, Rockville, MD 20857. For more information, see section III of the SUPPLEMENTARY INFORMATION section of this notice. FOR FURTHER INFORMATION CONTACT: Linda C. Ulrich, Director, Pediatric Device Consortia Grants Program, Food and Drug Administration, Bldg. 32, Rm. 5271, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–8660; or Vieda Hubbard, Grants Management Specialist, Office of Acquisitions & Grant Services, Food and Drug Administration, 5630 Fishers Lane, Rm. 2034, Rockville, MD 20857, 301– 827–7177. Frm 00054 Fmt 4703 For more information on this funding opportunity announcement (FOA) and to obtain detailed requirements, please refer to the full FOA located at https:// grants.nih.gov/grants/guide/ or https:// www.fda.gov/ForIndustry/Developing ProductsforRareDiseasesConditions/ default.htm. SUPPLEMENTARY INFORMATION: I. Funding Opportunity Description Notice. SUMMARY: PO 00000 20665 Sfmt 4703 RFA–FD–13–010 93.103 A. Background The development of pediatric medical devices currently lags behind the development of devices for adults. Pediatric patients often differ from adults in terms of their size, growth, development, body chemistry, and disease propensity, adding to the challenges of pediatric device development. There currently exists a great need for pediatric medical devices, including devices designed originally for pediatric patients as well as existing adult devices adapted for pediatric use. Recent passage of the Food and Drug Administration Safety and Improvement Act (FDASIA) (Pub. L. 112–144) reauthorized support of section 305 of the Pediatric Medical Device Safety and Improvement Act of 2007 (Pub. L. 110– 85), which requires HHS to provide demonstration grants to nonprofit consortia to promote pediatric device development. While the consortia themselves are nonprofit entities, their contacts and membership can include for-profit partners. B. Research Objectives The Pediatric Device Consortia Grant Program aims to fund networks of pediatric medical device advisors who are able to provide a platform of experienced regulatory, business planning, and device development services (such as intellectual property advising; prototyping; engineering; laboratory and animal testing; grant writing; and clinical trial design) to help foster and guide the advancement of medical devices for pediatric patients. A successful PDC brings together individuals and institutions that can support pediatric medical device progression through all stages of development—concept formation, prototyping, preclinical, clinical, manufacturing, marketing, and commercialization. The consortia are expected to support a mix of projects at all stages of development, particularly the later stages of clinical, manufacturing, and marketing. E:\FR\FM\05APN1.SGM 05APN1 20666 Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Notices Specifically, the consortia will facilitate the development, production, and distribution of pediatric medical devices by: (1) Encouraging innovation and connecting qualified individuals with pediatric device ideas with potential manufacturers; (2) mentoring and managing pediatric device projects through the development process, including product identification, prototype design, device development, and marketing; (3) connecting innovators and physicians to existing Federal and non-Federal resources; (4) assessing the scientific and medical merit of proposed pediatric device projects; and (5) providing assistance and advice as needed on business development, personnel training, prototype development, and postmarketing needs. C. Eligibility Information The grants are available to any domestic, public or private, nonprofit entity (including State and local units of government). Federal agencies that are not part of HHS may apply. Agencies that are part of HHS may not apply. Organizations that engage in lobbying activities, as described in section 501(c)(4) of the Internal Revenue Code of 1968, are not eligible to receive grant awards. DiseasesConditions/default.htm. (FDA has verified the Web site addresses throughout this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) Persons interested in applying for a grant may obtain an application at https://grants.nih.gov/grants/forms.htm. For all paper application submissions, the following steps are required: • Step 1: Obtain a Dun and Bradstreet (DUNS) Number. • Step 2: Register With System for Award Management. Steps 1 and 2, in detail, can be found at https://www07.grants.gov/applicants/ organization_registration.jsp. After you have followed these steps, submit paper applications to: Vieda Hubbard, Grants Management Specialist, Office of Acquisitions & Grant Services, 5630 Fishers Lane, Rm. 2034, Rockville, MD 20857, phone: 301–827–7177. Dated: April 2, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–07948 Filed 4–4–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES II. Award Information/Funds Available Food and Drug Administration A. Award Amount The estimated amount of funds available for support of four to five consortia awarded as a result of this announcement is $3 million for fiscal year 2013. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although PDC financial plans include support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. [Docket No. FDA–2013–N–0345] mstockstill on DSK4VPTVN1PROD with NOTICES B. Length of Support Grants will be awarded on a competitive basis up to $750,000 in total (direct plus indirect) costs per year for up to 5 years, contingent upon favorable annual review and an additional midcycle review after 21⁄2 years of funding. III. Paper Application, Registration, and Submission Information To submit a paper application in response to this FOA, applicants should first review the full announcement located at https://grants.nih.gov/grants/ guide/ or https://www.fda.gov/For Industry/DevelopingProductsforRare VerDate Mar<15>2010 17:14 Apr 04, 2013 Jkt 229001 Food and Drug Administration/National Institutes of Health/National Science Foundation Public Workshop on Computer Methods for Medical Devices AGENCY: Food and Drug Administration, HHS. Notice of public workshop; request for comments. ACTION: The Food and Drug Administration (FDA) is announcing its fifth public workshop on Computer Methods for Medical Devices entitled ‘‘FDA/NIH/NSF Workshop on Computer Models and Validation for Medical Devices.’’ The purpose of the workshop is to present, discuss, and receive input on an FDA library of models and data relevant to medical devices (day 1) and present, discuss, and receive input on a strategy to assess the credibility of computer models used to evaluate medical devices (day 2). DATES: Dates and Times: The workshop will be held on June 11 and 12, 2013, from 8:30 a.m. to 5:30 p.m. Location: The public workshop will be held at FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 SUMMARY: PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993–0002. 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: https:// www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ ucm241740.htm. Contact Persons: Donna 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; or Tina M. Morrison, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1272, Silver Spring, MD 20993, 301–796–6310, Tina.Morrison@fda.hhs.gov. Registration: Registration is free and will be on a first-come, first-served basis. Persons interested in attending this public workshop must register online by 4 p.m. on May 31, 2013. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 8 a.m. To register for the public workshop, please visit FDA’s Medical Devices News & Events—Workshops & Conferences calendar at https:// www.fda.gov/MedicalDevices/ NewsEvents/WorkshopsConferences/ default.htm. Select this public workshop from the posted events list. Please provide complete contact information for each attendee, including name, title, affiliation, mailing address, email address, and telephone number. Those without Internet access should contact Susan Monahan to register (301– 796–5661 or Susan.Monahan@fda.hhs.gov). Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list. If you need special accommodations due to a disability, please contact Susan Monahan (Susan.Monahan@fda.hhs.gov or 301–796–5661) no later than May 28, 2013. Streaming Webcast of the Public Workshop: This workshop will also be available via Webcast. Persons interested in viewing the Webcast must register online by 4 p.m. on May 31, 2013. Early registration is recommended because Webcast connections are limited. Organizations are requested to E:\FR\FM\05APN1.SGM 05APN1

Agencies

[Federal Register Volume 78, Number 66 (Friday, April 5, 2013)]
[Notices]
[Pages 20665-20666]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07948]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0012]


Pediatric Device Consortia Grant Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of grant funds for the support of the Office of Orphan 
Products Development (OOPD) Pediatric Device Consortia (PDC) Grant 
Program. The goal of the PDC Grant Program is to facilitate the 
development, production, and distribution of pediatric medical devices. 
The PDC will provide grants to nonprofit consortia which provide expert 
advising and support services to innovators of pediatric devices. These 
services should include business and regulatory consulting as well as 
device testing capabilities. This program is intended to further the 
development of multiple pediatric devices; thus, grants are not awarded 
to support the development of a single device project.
    Although administered by the OOPD, this grant program is intended 
to encompass devices that could be used in all pediatric conditions and 
diseases, not just rare diseases. The pediatric population (neonates, 
infants, children, and adolescents) includes patients who are 21 years 
of age or younger at the time of diagnosis or treatment.

DATES: Important dates are as follows:
    1. The application due date is June 1, 2013.
    2. The anticipated start date is September, 2013.
    3. The opening date is May 1, 2013.
    4. The expiration date is June 2, 2013.

ADDRESSES: Submit the paper application to: Vieda Hubbard, Grants 
Management (HFA-500), 5630 Fishers Lane, Rm. 2034, Rockville, MD 20857. 
For more information, see section III of the SUPPLEMENTARY INFORMATION 
section of this notice.

FOR FURTHER INFORMATION CONTACT:

Linda C. Ulrich, Director, Pediatric Device Consortia Grants Program, 
Food and Drug Administration, Bldg. 32, Rm. 5271, 10903 New Hampshire 
Ave., Silver Spring, MD 20993-0002, 301-796-8660; or
Vieda Hubbard, Grants Management Specialist, Office of Acquisitions & 
Grant Services, Food and Drug Administration, 5630 Fishers Lane, Rm. 
2034, Rockville, MD 20857, 301-827-7177.

    For more information on this funding opportunity announcement (FOA) 
and to obtain detailed requirements, please refer to the full FOA 
located at https://grants.nih.gov/grants/guide/ or https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm.

SUPPLEMENTARY INFORMATION: 

I. Funding Opportunity Description

RFA-FD-13-010
93.103

A. Background

    The development of pediatric medical devices currently lags behind 
the development of devices for adults. Pediatric patients often differ 
from adults in terms of their size, growth, development, body 
chemistry, and disease propensity, adding to the challenges of 
pediatric device development. There currently exists a great need for 
pediatric medical devices, including devices designed originally for 
pediatric patients as well as existing adult devices adapted for 
pediatric use. Recent passage of the Food and Drug Administration 
Safety and Improvement Act (FDASIA) (Pub. L. 112-144) reauthorized 
support of section 305 of the Pediatric Medical Device Safety and 
Improvement Act of 2007 (Pub. L. 110-85), which requires HHS to provide 
demonstration grants to nonprofit consortia to promote pediatric device 
development. While the consortia themselves are nonprofit entities, 
their contacts and membership can include for-profit partners.

B. Research Objectives

    The Pediatric Device Consortia Grant Program aims to fund networks 
of pediatric medical device advisors who are able to provide a platform 
of experienced regulatory, business planning, and device development 
services (such as intellectual property advising; prototyping; 
engineering; laboratory and animal testing; grant writing; and clinical 
trial design) to help foster and guide the advancement of medical 
devices for pediatric patients. A successful PDC brings together 
individuals and institutions that can support pediatric medical device 
progression through all stages of development--concept formation, 
prototyping, preclinical, clinical, manufacturing, marketing, and 
commercialization. The consortia are expected to support a mix of 
projects at all stages of development, particularly the later stages of 
clinical, manufacturing, and marketing.

[[Page 20666]]

    Specifically, the consortia will facilitate the development, 
production, and distribution of pediatric medical devices by: (1) 
Encouraging innovation and connecting qualified individuals with 
pediatric device ideas with potential manufacturers; (2) mentoring and 
managing pediatric device projects through the development process, 
including product identification, prototype design, device development, 
and marketing; (3) connecting innovators and physicians to existing 
Federal and non-Federal resources; (4) assessing the scientific and 
medical merit of proposed pediatric device projects; and (5) providing 
assistance and advice as needed on business development, personnel 
training, prototype development, and post-marketing needs.

C. Eligibility Information

    The grants are available to any domestic, public or private, 
nonprofit entity (including State and local units of government). 
Federal agencies that are not part of HHS may apply. Agencies that are 
part of HHS may not apply. Organizations that engage in lobbying 
activities, as described in section 501(c)(4) of the Internal Revenue 
Code of 1968, are not eligible to receive grant awards.

II. Award Information/Funds Available

A. Award Amount

    The estimated amount of funds available for support of four to five 
consortia awarded as a result of this announcement is $3 million for 
fiscal year 2013. Because the nature and scope of the proposed research 
will vary from application to application, it is anticipated that the 
size and duration of each award will also vary. Although PDC financial 
plans include support for this program, awards pursuant to this funding 
opportunity are contingent upon the availability of funds and the 
receipt of a sufficient number of meritorious applications.

B. Length of Support

    Grants will be awarded on a competitive basis up to $750,000 in 
total (direct plus indirect) costs per year for up to 5 years, 
contingent upon favorable annual review and an additional mid-cycle 
review after 2\1/2\ years of funding.

III. Paper Application, Registration, and Submission Information

    To submit a paper application in response to this FOA, applicants 
should first review the full announcement located at https://grants.nih.gov/grants/guide/ or https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm. (FDA has 
verified the Web site addresses throughout this document, but FDA is 
not responsible for any subsequent changes to the Web sites after this 
document publishes in the Federal Register.) Persons interested in 
applying for a grant may obtain an application at https://grants.nih.gov/grants/forms.htm. For all paper application submissions, 
the following steps are required:
     Step 1: Obtain a Dun and Bradstreet (DUNS) Number.
     Step 2: Register With System for Award Management.
    Steps 1 and 2, in detail, can be found at https://www07.grants.gov/applicants/organization_registration.jsp. After you have followed 
these steps, submit paper applications to: Vieda Hubbard, Grants 
Management Specialist, Office of Acquisitions & Grant Services, 5630 
Fishers Lane, Rm. 2034, Rockville, MD 20857, phone: 301-827-7177.

    Dated: April 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-07948 Filed 4-4-13; 8:45 am]
BILLING CODE 4160-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.