Office of Critical Path Programs-Critical Path Initiative, 39963-39964 [E9-19010]

Download as PDF 39963 Federal Register / Vol. 74, No. 152 / Monday, August 10, 2009 / Notices Average time response (Minutes) Frequency of response Number of respondents Study Questionnaire Annual hour burden 243 1 3/60 12.15 Subtotal ............................................................................................. ........................ ........................ ........................ 789.65 NCI validation and observational feeding study: Screener ................................................................................................... Reminder Telephone Call ......................................................................... Eating 3 meals .......................................................................................... Dietary Recall ........................................................................................... Demographics questionnaire .................................................................... 100 90 90 80 80 1 1 1 1 1 3/60 3/60 135/60 30/60 8/60 5.00 4.50 202.50 40.00 10.67 Subtotal ............................................................................................. ........................ ........................ ........................ 262.67 Total ................................................................................................... rmajette on DSK29S0YB1PROD with NOTICES Preference survey .................................................................................... ........................ ........................ ........................ 1,052.32 Request for Comments: Written comments and/or suggestions from the public and affected agencies should address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proposed performance of the functions of the agency, including whether the information may have practical utility; (2) The accuracy of the estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Direct Comments to OMB: 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 Attention: NIH Desk Officer, Office of Management and Budget, at OIRA_submission@omb.eop.gov or by fax to 202–395–6974. To request more information on the proposed project or to obtain a copy of the data collection plans, contact Frances E. Thompson, PhD, Project Officer, National Cancer Institute, NIH, EPN 4095A, 6130 Executive Boulevard MSC 7335, Bethesda, Maryland 20892–7335, or call non-toll-free number 301–594–4410, or FAX your request to 301–435–3710, or e-mail your request, including your address, to thompsof@mail.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. VerDate Nov<24>2008 15:09 Aug 07, 2009 Jkt 217001 Dated: July 31, 2009. Vivian Horovitch-Kelley, NCI Project Clearance Liaison, National Institutes of Health. [FR Doc. E9–19022 Filed 8–7–09; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0366] Food and Drug Administration, HHS. ACTION: Important dates are as follows: 1. The application due date is September 7, 2009. 2. The anticipated start date is in September 2009. 3. The opening date is August 10, 2009. 4. The expiration date is September 8, 2009. DATES: FOR FURTHER INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT: Nancy Stanisic, Office of Critical Path Programs (HF–18), rm. 14B45, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–1660. Gladys M. Bohler, Grants Management Specialist, Office of Frm 00049 Fmt 4703 Funding Opportunity Description Number: RFA FD–09–019 Catalog of Federal Domestic Assistance Number: 93.103 A. Background Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of Office of Critical Path Programs (OCPP). The goal of OCPP is to develop an administrative and scientific infrastructure to support the creation and execution of a series of projects under the FDA’s Critical Path Initiative. PO 00000 SUPPLEMENTARY INFORMATION: I. Funding Opportunity Description Office of Critical Path Programs— Critical Path Initiative AGENCY: Acquisitions and Grants Services (HFA–500), Food and Drug Administration, 5630 Fishers Lane, rm. 2105, Rockville, MD 20857, 301–827–7168. For more information on this funding opportunity announcement (FOA) and to obtain detailed requirements, please refer to the full FOA located at https:// www.fda.gov/oc/initiatives/criticalpath/ . Sfmt 4703 The Critical Path Initiative, launched by FDA in 2004, has the objective of helping modernize the development, evaluation, manufacture, and use of FDA-regulated products. Through nationwide collaboration with other Federal, academic, scientific, and industry organizations, the initiative seeks to develop new tools to facilitate innovation in FDA-regulated product development. Examples of tools include novel biomarkers, laboratory assays, genetic tests, and state-of-the art information technologies, etc. In this initiative, FDA plays the role of a facilitator in the creation of partnerships and collaborations to support specific scientific projects. B. Research Objectives FDA’s Office of the Commissioner is announcing its intent to accept and consider a single source application for the award of a Cooperative Agreement to the Critical Path Institute (C-Path). FDA anticipates providing up to $1.5 million (direct and indirect costs combined) during fiscal year (FY) 2009 to support research and related efforts of E:\FR\FM\10AUN1.SGM 10AUN1 39964 Federal Register / Vol. 74, No. 152 / Monday, August 10, 2009 / Notices identified projects that are part of the Critical Path Initiative. This Cooperative Agreement ensures substantial FDA involvement in this program, and will include, but will not be limited to, co-development of study priorities, protocols, decisionmaking, reports, and publications at specified program milestones related to performance. FDA will support research covered by this document under the authority of section 301 of the Public Health Service Act (42 U.S.C. 341). Administrative regulations found in 45 CFR parts 74 and/or 92 are applicable. C. Eligibility Information The following organization/institution is eligible to apply: Critical Path Institute. Competition is limited because of FDA’s ongoing collaboration with the University of Utah and the Critical Path Institute, in support of FDA’s Critical Path Initiative, and the combined ability of these parties to leverage existing databases, specimen repositories, clinical, and other technical expertise in support of this program. II. Award Information/Funds Available A. Award Amount It is anticipated that FDA will fund this Cooperative Agreement up to $1.5 million (direct and indirect costs) in FY 09 based on the quality of the application received and the availability of Federal funds. rmajette on DSK29S0YB1PROD with NOTICES B. Length of Support Funding beyond the first year (up to 5 years) will be noncompetitive and will depend on: (1) Satisfactory performance during the preceding year and (2) the availability of Federal fiscal year funds. 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://www.fda.gov/oc/ initiatives/criticalpath/. 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 • Step 3: Register With Electronic Research Administration (eRA) Commons Steps 1 and 2, in detail, can be found at https://www07.grants.gov/applicants/ organization_registration.jsp. Step 3, in detail, can be found at https:// VerDate Nov<24>2008 15:09 Aug 07, 2009 Jkt 217001 commons.era.nih.gov/commons/ registration/registrationInstructions.jsp. After you have followed these steps, submit paper applications to: Gladys M. Bohler (see FOR FURTHER INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT). Dated: August 4, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–19010 Filed 8–7–09; 8:45 am] BILLING CODE 4160–01–P 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. Dated: August 4, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–19080 Filed 8–7–09; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health DEPARTMENT OF HEALTH AND HUMAN SERVICES Clinical Center; Notice of Meeting 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 a meeting of the NIH Advisory Board for Clinical Research. The meeting will be open to the public as indicated below, 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. The meeting will be closed to the public in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended to discuss personnel matters, the disclosure of which would constitute a clearly unwarranted invasion of privacy. National Institute of Mental Health; Notice of Meeting Name of Committee: NIH Advisory Board for Clinical Research. Date: September 21, 2009. Open: 10 a.m. to 1:15 p.m. Agenda: To review the Clinical Center budget plans and updates on selected organizational initiatives. Place: National Institutes of Health, Building 10, 10 Center Drive, CRC Medical Board Room 4–2551, Bethesda, MD 20892. Closed: 1:15 p.m. to 2 p.m. Agenda: To review and evaluate to discuss personnel matters. Place: National Institutes of Health, Building 10, 10 Center Drive, CRC Medical Board Room 4–2551, Bethesda, MD 20892. Contact Person: Maureen E Gormley, Executive Secretary, Mark O. Hatfield, Clinical Research Center, National Institutes of Health, Building 10, Room 6–2551, Bethesda, MD 20892, (301) 496–2897. 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 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Advisory Mental Health Council. The meeting will be open to the public as indicated below, 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. 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 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. Name of Committee: National Advisory Mental Health Council. Date: September 24, 2009. Open: 10 a.m. to 12 p.m. Agenda: Presentation of NIMH Director’s report and discussion on NIMH program and policy issues. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Conference Room C/D/E, Rockville, MD 20852. Closed: 1 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Contact Person: Jane A. Steinberg, PhD, Director, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Blvd., E:\FR\FM\10AUN1.SGM 10AUN1

Agencies

[Federal Register Volume 74, Number 152 (Monday, August 10, 2009)]
[Notices]
[Pages 39963-39964]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19010]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0366]


 Office of Critical Path Programs--Critical Path Initiative

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 Office of Critical Path 
Programs (OCPP). The goal of OCPP is to develop an administrative and 
scientific infrastructure to support the creation and execution of a 
series of projects under the FDA's Critical Path Initiative.

DATES: Important dates are as follows:
    1. The application due date is September 7, 2009.
    2. The anticipated start date is in September 2009.
    3. The opening date is August 10, 2009.
    4. The expiration date is September 8, 2009.

FOR FURTHER INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT:
    Nancy Stanisic, Office of Critical Path Programs (HF-18), rm. 
14B45, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-1660.
    Gladys M. Bohler, Grants Management Specialist, Office of 
Acquisitions and Grants Services (HFA-500), Food and Drug 
Administration, 5630 Fishers Lane, rm. 2105, Rockville, MD 20857, 301-
827-7168.
    For more information on this funding opportunity announcement (FOA) 
and to obtain detailed requirements, please refer to the full FOA 
located at https://www.fda.gov/oc/initiatives/criticalpath/.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

Funding Opportunity Description Number: RFA FD-09-019
Catalog of Federal Domestic Assistance Number: 93.103

A. Background

    The Critical Path Initiative, launched by FDA in 2004, has the 
objective of helping modernize the development, evaluation, 
manufacture, and use of FDA-regulated products. Through nationwide 
collaboration with other Federal, academic, scientific, and industry 
organizations, the initiative seeks to develop new tools to facilitate 
innovation in FDA-regulated product development. Examples of tools 
include novel biomarkers, laboratory assays, genetic tests, and state-
of-the art information technologies, etc. In this initiative, FDA plays 
the role of a facilitator in the creation of partnerships and 
collaborations to support specific scientific projects.

B. Research Objectives

     FDA's Office of the Commissioner is announcing its intent to 
accept and consider a single source application for the award of a 
Cooperative Agreement to the Critical Path Institute (C-Path).
    FDA anticipates providing up to $1.5 million (direct and indirect 
costs combined) during fiscal year (FY) 2009 to support research and 
related efforts of

[[Page 39964]]

identified projects that are part of the Critical Path Initiative.
    This Cooperative Agreement ensures substantial FDA involvement in 
this program, and will include, but will not be limited to, co-
development of study priorities, protocols, decisionmaking, reports, 
and publications at specified program milestones related to 
performance. FDA will support research covered by this document under 
the authority of section 301 of the Public Health Service Act (42 
U.S.C. 341). Administrative regulations found in 45 CFR parts 74 and/or 
92 are applicable.

C. Eligibility Information

     The following organization/institution is eligible to apply: 
Critical Path Institute.
    Competition is limited because of FDA's ongoing collaboration with 
the University of Utah and the Critical Path Institute, in support of 
FDA's Critical Path Initiative, and the combined ability of these 
parties to leverage existing databases, specimen repositories, 
clinical, and other technical expertise in support of this program.

II. Award Information/Funds Available

A. Award Amount

    It is anticipated that FDA will fund this Cooperative Agreement up 
to $1.5 million (direct and indirect costs) in FY 09 based on the 
quality of the application received and the availability of Federal 
funds.

B. Length of Support

    Funding beyond the first year (up to 5 years) will be 
noncompetitive and will depend on: (1) Satisfactory performance during 
the preceding year and (2) the availability of Federal fiscal year 
funds.

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://www.fda.gov/oc/initiatives/criticalpath/. 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
     Step 3: Register With Electronic Research Administration 
(eRA) Commons
    Steps 1 and 2, in detail, can be found at https://www07.grants.gov/applicants/organization_registration.jsp. Step 3, in detail, can be 
found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed these steps, 
submit paper applications to: Gladys M. Bohler (see FOR FURTHER 
INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT).

    Dated: August 4, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-19010 Filed 8-7-09; 8:45 am]
BILLING CODE 4160-01-P
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