Pediatric Device Consortia Grant Program, 20488-20489 [E9-10329]

Download as PDF 20488 Federal Register / Vol. 74, No. 84 / Monday, May 4, 2009 / Notices Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Meeting tjames on PRODPC75 with NOTICES Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Cancer Institute Board of Scientific Advisors. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. Name of Committee: National Cancer Institute Board of Scientific Advisors. Date: June 22–23, 2009. Time: June 22, 2009, 8 a.m. to 6 p.m. Agenda: Director’s Report: Ongoing and New Business; Reports of Program Review Group(s); and Budget Presentations; Reports of Special Initiatives; RFA and RFP Concept Reviews; and Scientific Presentations. Place: National Institutes of Health, Building 31, 31 Center Drive, 6th Floor, Conference Room 10, Bethesda, MD 20892. Time: June 23, 2009, 8:30 a.m. to 12 p.m. Agenda: Reports of Special Initiatives; RFA and RFP Concept Reviews; and Scientific Presentations. Place: National Institutes of Health, Building 31, 31 Center Drive, 6th Floor, Conference Room 10, Bethesda, MD 20892. Contact Person: Paulette S. Gray, PhD, Executive Secretary, Director, Division of Extramural Activities, National Cancer Institute, National Institutes of Health, 6116 Executive Boulevard, 8th Floor, Rm. 8001, Bethesda, MD 20892, 301–496–5147, grayp@mail.nih.gov. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. Information is also available on the Institute’s/Center’s home page: deainfo.nci.nih.gov/advisory/bsa.htm, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and VerDate Nov<24>2008 15:26 May 01, 2009 Jkt 217001 Dated: April 27, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–10097 Filed 5–1–09; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0199] 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 Grant Program (PDCGP). The goal of the PDCGP is to promote pediatric device development by providing grants to nonprofit consortia whose business model and approach to device development will either result in, or substantially contribute to, market approval of medical devices designed specifically for use in children. Although administered by the OOPD, this grant program is intended to encompass devices that could be used in all pediatric conditions or 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 15, 2009. 2. The anticipated start date is September 2009. 3. The opening date is May 1, 2009. 4. The expiration date is June 16, 2009. FOR FURTHER INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT: Linda C. Ulrich or Debra Y. Lewis, Pediatric Device Consortia Grants Program, Office of Orphan Products Development (HF–35), Food and Drug Administration, 5600 Fishers Lane, rm. 6A–55, Rockville, MD 20857, 301–827–3666. Camille Peake, Division of PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 Acquisition Support and Grants, Office of Acquisitions & Grant Services (HFA–500), Food and Drug Administration, 5630 Fishers Lane, rm. 2139, Rockville, MD 20852, 301–827–7175. 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/. SUPPLEMENTARY INFORMATION: I. Funding Opportunity Description RFA–FD–009–007 Catalog of Federal Domestic Assistance Number 93.103 A. Background The development of pediatric medical devices currently lags 5 to 10 years behind the development of devices for adults. Children differ from adults in terms of their size, growth, development, and body chemistry, adding to the challenges of pediatric device development. There currently exists a great need for medical devices designed specifically with children in mind. Such needs include the original development of pediatric medical devices, as well as the specific adaptation of existing adult devices for children. Thus, as part of the 2007 Food and Drug Administration Amendments Act (FDAAA) legislation, Congress passed the Pediatric Medical Device Safety and Improvement Act of 2007. Section 305 of FDAAA requires the Secretary of Health and Human Services to provide demonstration grants or contracts to nonprofit consortia to promote pediatric device development. B. Research Objectives The goal of FDA’s PDCGP is to promote pediatric device development by providing grants to nonprofit consortia. 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 nonFederal resources; (4) Assessing the scientific and medical merit of proposed pediatric device projects; and (5) Providing assistance and advice as needed on business development, E:\FR\FM\04MYN1.SGM 04MYN1 Federal Register / Vol. 74, No. 84 / Monday, May 4, 2009 / Notices personnel training, prototype development, post-marketing needs, and other activities. C. Eligibility Information Dated: April 29, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–10329 Filed 5–1–09; 8:45 am] 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 the Department of Health and Human Services (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. BILLING CODE 4160–01–S II. Award Information/Funds Available ACTION: 30-Day Notice of information collection under review: Form N–300, Application to File Declaration of Intention; OMB Control No. 1615–0078. A. Award Amount The estimated amount of funds available for support of 1 to 4 consortia awarded as a result of this announcement is $2 million for fiscal year 2009. 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 the financial plans of FDA provide support for this program, awards under 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 $2,000,000 in total costs (direct costs plus indirect costs) per year for up to 2 years. tjames on PRODPC75 with NOTICES III. How to Submit a Paper Application 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/. 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 Central Contractor Registration These steps can be found at https:// www07.grants.gov/applicants/ organization_registration.jsp. Submit paper applications by express mail to Camille Peake. (See the FOR FURTHER INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT section.) VerDate Nov<24>2008 15:26 May 01, 2009 Jkt 217001 DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services Agency Information Collection Activities: Form N–300, Extension of a Currently Approved Information Collection; Comment Request The Department of Homeland Security, U.S. Citizenship and Immigration Services (USCIS) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection was previously published in the Federal Register on February 11, 2009, at 74 FR 6915 allowing for a 60-day public comment period. USCIS did not receive any comments for this information collection. The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until June 3, 2009. This process is conducted in accordance with 5 CFR 1320.10. Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the Department of Homeland Security (DHS), and to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), USCIS Desk Officer. Comments may be submitted to: USCIS, Chief, Regulatory Products Division, Clearance Office, 111 Massachusetts Avenue, Washington, DC 20529–2210. Comments may also be submitted to DHS via facsimile to 202– 272–8352 or via e-mail at rfs.regs@dhs.gov, and to the OMB USCIS Desk Officer via facsimile at 202–395– 6974 or via e-mail at oira_submission@omb.eop.gov. When submitting comments by e-mail please make sure to add OMB Control Number 1615–0078. Written comments and suggestions from the public and PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 20489 affected agencies should address one or more of the following four points: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of This Information Collection (1) Type of Information Collection: Extension of a currently approved information collection. (2) Title of the Form/Collection: Application to File Declaration of Intention. (3) Agency form number, if any, and the applicable component of the Department of Homeland Security sponsoring the collection: Form N–300. U.S. Citizenship and Immigration Services. (4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals or Households. This form will be used by permanent residents to file a declaration of intention to become a citizen of the United States. This collection is also used to satisfy documentary requirements for those seeking to work in certain occupations or professions, or to obtain various licenses. (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: 433 responses at 45 minutes (.75) per response. (6) An estimate of the total public burden (in hours) associated with the collection: 325 annual burden hours. If you need a copy of the proposed information collection instrument with instructions, or additional information, please visit the Web site at: https:// www.regulations.gov/search/index.jsp. If additional information is required contact: USCIS, Regulatory Products Division, 111 Massachusetts Avenue, Washington, DC 20529–2210, (202) 272– 8377. E:\FR\FM\04MYN1.SGM 04MYN1

Agencies

[Federal Register Volume 74, Number 84 (Monday, May 4, 2009)]
[Notices]
[Pages 20488-20489]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-10329]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0199]


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 Grant Program 
(PDCGP). The goal of the PDCGP is to promote pediatric device 
development by providing grants to nonprofit consortia whose business 
model and approach to device development will either result in, or 
substantially contribute to, market approval of medical devices 
designed specifically for use in children. Although administered by the 
OOPD, this grant program is intended to encompass devices that could be 
used in all pediatric conditions or 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 15, 2009.
    2. The anticipated start date is September 2009.
    3. The opening date is May 1, 2009.
    4. The expiration date is June 16, 2009.

FOR FURTHER INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT:
    Linda C. Ulrich or Debra Y. Lewis, Pediatric Device Consortia 
Grants Program, Office of Orphan Products Development (HF-35), Food and 
Drug Administration, 5600 Fishers Lane, rm. 6A-55, Rockville, MD 20857, 
301-827-3666.
    Camille Peake, Division of Acquisition Support and Grants, Office 
of Acquisitions & Grant Services (HFA-500), Food and Drug 
Administration, 5630 Fishers Lane, rm. 2139, Rockville, MD 20852, 301-
827-7175.
    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/.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

RFA-FD-009-007
Catalog of Federal Domestic Assistance Number 93.103

A. Background

    The development of pediatric medical devices currently lags 5 to 10 
years behind the development of devices for adults. Children differ 
from adults in terms of their size, growth, development, and body 
chemistry, adding to the challenges of pediatric device development. 
There currently exists a great need for medical devices designed 
specifically with children in mind. Such needs include the original 
development of pediatric medical devices, as well as the specific 
adaptation of existing adult devices for children. Thus, as part of the 
2007 Food and Drug Administration Amendments Act (FDAAA) legislation, 
Congress passed the Pediatric Medical Device Safety and Improvement Act 
of 2007. Section 305 of FDAAA requires the Secretary of Health and 
Human Services to provide demonstration grants or contracts to 
nonprofit consortia to promote pediatric device development.

B. Research Objectives

    The goal of FDA's PDCGP is to promote pediatric device development 
by providing grants to nonprofit consortia. 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,

[[Page 20489]]

personnel training, prototype development, post-marketing needs, and 
other activities.

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 the Department of Health and 
Human Services (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 1 to 4 
consortia awarded as a result of this announcement is $2 million for 
fiscal year 2009. 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 the financial 
plans of FDA provide support for this program, awards under 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 $2,000,000 in 
total costs (direct costs plus indirect costs) per year for up to 2 
years.

III. How to Submit a Paper Application

    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/. 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 Central Contractor Registration
    These steps can be found at https://www07.grants.gov/applicants/organization_registration.jsp. Submit paper applications by express 
mail to Camille Peake. (See the FOR FURTHER INFORMATION AND ADDITIONAL 
REQUIREMENTS CONTACT section.)

    Dated: April 29, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-10329 Filed 5-1-09; 8:45 am]
BILLING CODE 4160-01-S
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