Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)

Components of Participating Organizations
National Cancer Institute (NCI) (http://www.cancer.gov)

Title: Etiology, Prevention, and Treatment of Hepatocellular Carcinoma (P01)

Announcement Type
This Funding Opportunity Announcement (FOA) is a reissue of PA-05-138.

Update: The following update relating to this announcement has been issued:

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, seehttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).

Program Announcement (PA) Number: PAR-08-245

Catalog of Federal Domestic Assistance Number(s)
93.393, 93.394, 93.395, 93.396

Key Dates
Release/Posted Date: August 19, 2008
Letters of Intent Receipt Date(s): September 22 2008; December 28, 2008; April 28, 2009; August 29, 2009; December 28, 2009; April 28, 2010; August 28, 2010; December 28, 2010; and April 30, 2011.
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Due Date(s): October 20, 2008; Jan 28, 2009; May 28, 2009; Sep 29, 2009; Jan 28, 2010; May 28, 2010; Sep 28, 2010; Jan 28, 2011; and May 31, 2011.
AIDS Application Due Date(s): Not applicable.
Peer Review Date(s): February/March 2009; June/July 2009; October/November 2009; February/March 2010; June/July 2010; October/November 2010; February/March 2011; June/July 2011; October/November 2011
Council Review Date(s): May 2009; October 2009; January 2010; May 2010; October 2010; January 2011; May 2011; October 2011; January 2012
Earliest Anticipated Start Date(s): July 2009; April 2010; July 2010; December 2010; April 2011; July 2011; December 2011; April 2012; July 2012
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date:  (Now Expired April 8, 2009 per issusance of PAR-09-147) Original Exp. Date: June 1, 2011

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt and Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing   
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Purpose

This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), invites grant applications that: (a) address the etiology and etiologic mechanisms of hepatocellular carcinoma (HCC); (b) propose development of animal models for HCC; (c) propose novel approaches to prevent HCC malignancy; (d) propose therapeutic or diagnostic tools for reliable prognostic indicators for HCC; and (e) develop therapeutic approaches to minimize morbidity and mortality associated with HCC.  The primary focus of the proposed projects must be on the basic biology, prevention, and/or treatment of liver cancer. Applications that are solely concerned with population studies and epidemiology are not appropriate for this FOA.

This FOA will use the NIH Program Project (P01) grant mechanism. Each Program Project application must consist of at least three component projects. The component projects must share a common central theme, focus, and/or overall objective.

Applications submitted in response to this FOA may propose interdisciplinary Program Projects that comprehensively address novel aspects of the biology of hepatocellular carcinoma, combined with the meaningful translation of basic research findings into clinical-relevant context. For these goals, it is essential that each proposed Program Project is based on appropriate substantive collaborative arrangements between basic and clinical scientists/translational researchers.

Related Funding Opportunity:

This FOA runs in parallel with two other FOA of similar scientific scope, PA-08-243 and PA-08-244 that encourage applications under the R21 and R01 mechanisms, respectively.

Background

Liver cancer, also referred to as hepatocellular carcinoma (HCC), is the most rapidly increasing type of cancer in the United States (U.S.). HCC accounts for at least 14,000 deaths in the U.S. annually, and it ranks eighth as a cause of cancer mortality in men. The rapid increase in rates of HCC incidence in the U.S. and other developed countries correlates with a similar trend in the prevalence of chronic infection with hepatitis C virus (HCV) since 1960. Approximately 75 percent of HCV-infected patients develop chronic hepatitis C, and at least one-third of these patients suffer from progressive hepatic fibrosis and cirrhosis. Within this patient population with liver cirrhosis, a small proportion develops HCC.

The overall increase in the incidence of HCC warrants efforts to prevent and more efficiently treat this disease. HCC is a highly malignant tumor type with average survival rates that are currently less than 1 year following diagnosis. One major difficulty is that most patients with HCC are diagnosed when the disease is already at an advanced stage, and the cancerous tissue cannot be surgically removed. Furthermore, because almost all patients have cirrhosis, neither chemotherapy nor major resections are well tolerated. Clearly, the ideal approach to better management of HCC is prevention, and, barring that, early detection methods combined with either local resection or ablation. Accordingly, the Trans-NIH Action Plan for Liver Disease Research (http://liverplan.niddk.nih.gov) identifies studies on the etiology of HCC and improvements in the detection, prevention, and treatment of HCC as high priorities for research on liver disease.

An increased understanding of the fundamental etiologic mechanisms that are involved in hepatocellular carcinoma is key to development of successful preventive and therapeutic modalities for HCC. It is essential to define the cellular and molecular bases of hepatocarcinogenesis and the processes and pathways involved in malignant transformation of hepatocytes. For example, such knowledge should: (a) greatly facilitate the identification of patients at risk; (b) prompt efforts to decrease risk factors; and (c) improve surveillance and early diagnosis through diagnostic imaging modalities. Possible benefits extend also to the clinical management of this disease. Research on alterations of gene and protein expression in the initiation of HCC should facilitate identification of potential molecular targets for novel therapeutic strategies. Development of animal models that can recapitulate all phases of the disease, will facilitate identification of diagnostic/prognostic biomarkers, allow for tumor imaging studies, and provide evaluation of preventive and therapeutic strategies.

Areas of HCC research warranting particular attention. Although various aspects of HCC deserve further exploration, the available information points to two areas as particularly relevant: (i) the connection between alcohol consumption and HCC and (ii) the role of viral infections in HCC.

Alcohol consumption and HCC. Excessive and chronic alcohol consumption is an important risk factor for HCC. Ethanol may promote the development of HCC through several mechanisms. First, ethanol, which is primarily metabolized in the liver by alcohol dehydrogenase and cytochrome P450 2E1 (CYP2E1), leads to the production and accumulation of acetaldehyde, a potent mutagen and carcinogen. Second, CYP2E1 can catalyze the conversion of various procarcinogens into carcinogens. Third, chronic ethanol consumption is associated with hepatic oxidative stress, which arises through CYP2E1 induction, lipid peroxidation, iron accumulation, and glutathione depletion. Fourth, the presence of HCC is associated with increased expression and function of inhibitory guanine nucleotide regulatory proteins (Gi proteins) and components of an extracellular signal-regulated kinase-mitogen activated protein kinase (ERK-MAPK) cascade. Stimulation of Gi-proteins activates ERK-MAPK cascade leading to enhanced cell mitogenesis. Furthermore, ethanol has been shown to increase the expression of Gi-proteins and enhance ERK-MAPK signaling and cell growth. Finally, chronic alcohol consumption may also promote the growth of HCC by causing hepatic depletion of s-adenosylmethionine, and induction of global DNA hypomethylation. Further studies are required to understand the underlying molecular mechanisms by which chronic alcohol consumption leads to the development of HCC.

Specific Research Objectives

This FOA encourages research activities in the broad areas of etiology and etiologic mechanism(s) of liver cancer, which include, but are not limited to: (a) identification of viral and host factors in initiation of HCC; (b) examination of the development of HCC in the sequelae of viral infection; (c) development of animal models and in vitro virus cultivation methods; (d) development of prevention and control strategies, including chemoprevention; (e) validation of markers; (f) preclinical or clinical trials of promising agents; and (g) imaging studies for diagnosis and intervention.

Research areas of interest include, but are not necessarily limited to, the following topics.

A) Research on the etiology of hepatocellular carcinoma:

B) Research on prevention and control of hepatocellular carcinoma:

C) Research on Treatment and Diagnosis of HCC:

Translational studies may exploit in the clinical context basic research advances in any of the above-listed areas or in other areas related to hepatocellular carcinoma research.

Although the listed research areas are of definite importance, applications in all areas related to hepatocellular carcinoma research with translational impact are encouraged. To be appropriate to this FOA, the overarching goal of the entire Program Project must have direct translational relevance to clinical oncology, including prevention, diagnosis, and therapy of malignant disease.

Applications that focus on the role of HIV/AIDS in HCC are not appropriate for this P01. Nonetheless, such projects may be appropriate for the other two R01 and R21 companion FOAs, PA-08-243, and PA-08-244.

Shared Resource Core(s) (optional)

In addition to individual research projects, the applicants may propose one or more Shared Resource Cores, if needed. Both administrative and research support cores are allowed. Each Shared Resource Core must be designed to provide support and enhance the productivity, cost-effectiveness, and/or research outcome of at least two research projects. New cores or existing cores may be proposed and existing cores may be augmented, if necessary.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This FOA will use the NIH Program Project Grant (P01) grant award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

2. Funds Available

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 the NCI provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

NIH grants policies as described in the NOT-OD-05-004.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Whereas Foreign institutions are not eligible to apply, they can be involved in Program Projects proposed by eligible Domestic institutions under subcontractual arrangements, if appropriate.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Applicants may submit a resubmission application, but such application must include an Introduction addressing issues raised in the previous critique (Summary Statement).

Applicants may submit a renewal application.

Applicants may submit more than one application, provided that each application is scientifically distinct.

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

Please note that special instructions for formatting the multicomponent program project (P01) applications are available on an NCI web site for P01 applications (see http://deainfo.nci.nih.gov/awards/P01.pdf.)

ORGANIZATION OF THE APPLICATION

For all P01 applications submitted in response to this FOA, the standard PHS 398 instructions are modified. In particular, Research Plan (Items 2-5 as per Revision 11/07 of the PHS 398 Table of Contents, previously known as “Sections A-D”) is altered to follow the NCI P01 Guidelines (see http://deainfo.nci.nih.gov/awards/P01.pdf, for “SPECIAL INSTRUCTIONS for PREPARATION of PROGRAM PROJECT APPLICATIONS“).

Applicants must follow the instructions in these Guidelines and obey page limitations  in the preparation of the following main application components A-H (as defined in the Guidelines, hyperlink text):

  1. Face Page
  2. Description, Performance Sites and Key Personnel
  3. Table of Contents
  4. Overall Budget for Program Project
  5. Biographical Sketches and Other Research Support Information for all investigators, starting with Principal Investigator followed by Project Directors
  6. Program Narrative: Overall Program Project (12 pages)
  7. Individual Research Projects (25 pages, each research project)
  8. Shared Resource Cores (if applicable) (10 pages, each)

Note: Each P01 applicant must propose at least three individual (albeit connected) research projects pertinent to a single unifying research theme. These projects can be a combination of either basic or translational research. 

Regarding other items of the PHS398 Research Plan and Appendix materials, follow standard PHS 398 instructions.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs 

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new item of the research plan (item 14 in the November 2007 release of PHS 398 Table of Content), entitled “Multiple PD/PI Leadership Plan” must be included.  A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. 

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Note 1: During the funding period, all awardees will be required to participate in periodic (annual) joint meetings to be organized by the NCI to share recent results and progress. Appropriate travel funds must be budgeted for the participation in these meetings of the PIs and Project Leaders.

Note 2: If applicants propose to have an External Advisory Board, they must be prepared to identify non-affiliated experts as potential appointees.  The applicants should describe the desired scientific profiles of such external advisors.  However, in order not to adversely affect the process of peer review of the applications, names of such individuals must not be provided in the application.  Moreover, the applicants must not contact these individuals unless their application is selected for funding after the completion of the peer review process.

Additional information is available in the PHS 398 grant application instructions.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): September 22, 2008; December 28, 2008; April 28, 2009; August 29, 2009; December 28, 2009; April 28, 2010; August 28, 2010; December 28, 2010; and April 30, 2011.
Application Due Date(s): October 20, 2008; Jan 28, 2009; May 28, 2009; Sep 29, 2009; Jan 28, 2010; May 28, 2010; Sep 28, 2010; Jan 28, 2011; and May 31, 2011.
AIDS Application Due Date(s): Not applicable.
Peer Review Date(s): February/March 2009; June/July 2009; October/November 2009; February/March 2010; June/July 2010; October/November 2010; February/March 2011; June/July 2011; October/November 2011
Council Review Date(s): May 2009; October 2009; January 2010; May 2010; October 2010; January 2011; May 2011; October 2011; January 2012
Earliest Anticipated Start Date(s): July 2009; April 2010; July 2010; December 2010; April 2011; July 2011; December 2011; April 2012; July 2012

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Elizabeth Read-Connole, Ph.D.
Division of Cancer Biology
National Cancer Institute (NCI)
National Institutes of Health (NIH)
6130 Executive Boulevard, EPN Suite 5000, MSC 7398
Bethesda, MD 20892-7398 (for U.S. Postal Service express or regular mail)
Telephone: (301) 496-6085
Fax: (301) 496-2025
E-mail: bconnole@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix materials must be sent to:

Referral Officer
Program Coordination and Referral Branch
Office of Referral, Review, and Program Coordination
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8040, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
Telephone: 301-496-8580
Fax: 301-402-0275
Email: ncirefof@dea.nci.nih.gov

3.C. Application Processing

Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.

Upon receipt applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.)

6. Other Submission Requirements and Information

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year

Applicants requesting $500,000 or more in direct costs for any year (excluding consortium F&A costs) must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as plans are being developed for the study;

2) Obtain agreement from the IC staff that the IC will accept the application for consideration for award; and,

3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.

This policy applies to all new, renewal, revision, or resubmission applications. See NOT-OD-02-004, October 16, 2001.

During the funding period, all awardees of the program on Etiology, Prevention, and Treatment of Hepatocellular Carcinoma (R01, R21, and P01) will be required to participate in periodic (annual) joint meetings to be organized by the NCI to share recent results and progress. Applications should include meeting attendance costs for the Principal Investigators in the budget.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application.  (See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance, research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)

 (b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information


1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications that are complete will be evaluated for scientific and technical merit by (an) appropriate scientific review group convened by the National Cancer Institute and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.

As part of the scientific peer review, all applications will:

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, and weighted as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?

Innovation:  Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?   

Investigators: Are the PD/PI(s) and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the PD/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)? 

Environment:  Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?  

In addition to the standard NIH-wide criteria, the following FOA-specific criteria will be used to evaluate specific aspects/components of the P01 application. The overall application will be evaluated as an integrated research effort focused on a central theme. Individual research projects (minimum 3 for this FOA), supporting cores (if applicable), and the administrative structure are collectively considered.

The review criteria are as follows:

A. Criteria for Overall Program Organization, Interaction, and Capability

Significance: What is the potential of the overall program to advance knowledge related to human hepatocellular carcinoma (HCC)? Will the proposed Program Project, if successful, use the novel findings in basic research on HCC to generate applications of direct translational relevance to clinical oncology, including prevention, diagnosis, and therapy of malignant disease?

Approach: What is the overall adequacy and quality of the experimental approaches proposed in the projects? What is the adequacy of services provided by the cores (if proposed), and the overall design of the P01? Does the proposed overall approach appropriately balance efforts towards new discoveries in the biology of HCC and translation of basic research findings into clinical practice?

Innovation: To what degree does the overall program apply novel concepts and innovative approaches that advance basic understanding of HCC and use this progress in translational context?

Investigators: Are the qualifications of the Principal Investigator(s) and other senior scientists appropriate for the main theme of the entire program? Are their expertise and experience in hepatocellular carcinoma research complementary and adequate for the overall goal of the program? Are there appropriate collaborative arrangements in place between basic and translational researchers? Is the lead PI qualified and able to lead the P01 scientifically and coordinate all P01 activities? Do the lead PI and other PIs (if designated) provide effective scientific and administrative leadership, as demonstrated by selection of individual projects for scientific excellence and thematic relatedness? If the multiple PIs option is used, how well does the leadership plan define the responsibilities of the individual PIs? 

Environment:  Is there evidence of sufficient institutional support for the Program Project? Is there evidence that the proposed lines of authority, the decision-making process, and the administrative structure will result in effective management of the Project? What are the plans for the evaluation of progress? If internal/external Advisory Committees are included in the plans, are these plans and the desired expertise of the advisory committees adequate?

Integration: Is there evidence of scientific and administrative integration of the proposed Program Project around the central theme of exploring advances in hepatocellular carcinoma research for translational applications? Is there evidence of coordination, interrelationships, and synergy among the individual research projects and core components? Are there clear advantages or “value added” by conducting the proposed research as a Program Project rather than through separate research efforts? Are the mechanisms proposed for regular communication and coordination among investigators, and for quality control of the research adequate? How well do the translational or clinical project(s) interface with the basic research proposed?

B. Criteria for Individual Research Projects:  The relationship and contributions of each research component and core to the overall theme of the program project will be discussed and evaluated. Although projects not recommended for inclusion in the program automatically are removed from consideration as part of the overall program project, such projects will reflect on the leadership capabilities of the Principal Investigator and shall be considered in the overall merit. The individual projects will be evaluated based on the following criteria:

Significance: Does this project address an important problem in the area of hepatocellular carcinoma biology that is exploitable in translational sense? How will scientific knowledge and/or clinical practice related to HCC be advanced? What will be the effect of these studies on the concepts, methods, and technologies related to treatment and/or prevention of HCC? Do the proposed basic hepatocellular carcinoma biology studies (if proposed in a given project) have potential to provide new molecular or cellular targets for early cancer detection, prognosis and/or preventive and therapeutic interventions? Will the translational efforts (if proposed in a given project) have a significant impact on clinical practice?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Do the researchers focus on the unique characteristics of HCC and their “niche” or microenvironment, in order to develop and validate new targets for prevention and/or therapy?

Innovation: Is the project original and innovative? For example: Does the project centered on basic aspects of HCC biology challenge existing paradigms; address an innovative hypothesis or critical barrier to progress in the field? Does the project centered on translational applications of stem cell biology develop or employ novel concepts, approaches or methodologies, tools, or technologies to address unmet needs relevant to clinical practice? 

Investigators: Is the investigators’ expertise appropriate and sufficiently matched to the profiles of individual projects (i.e., basic versus translational research versus combination of both)? Are there appropriate substantive collaborative arrangements in place as needed for individual projects? Is the leadership plan at the project level (e.g., regarding responsibilities of the multiple PIs if this option is used) well defined? 

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements?

C. Criteria for Shared Resource Core(s) (IF APPLICABLE):  Each Shared Resource Core must provide essential functions or services for at least two projects. The merit of each core will be assessed based on the following criteria:

Does the Shared Resource Core match well the needs of the overall program? Does it provide essential facilities or services for two or more scored research project components? Is each Shared Resource Core unique and not duplicative of any other existing and available Cores (e.g., if P01 originates from an institution supported by an NCI Cancer Center Support Grant, P30)? Is adequate justification provided for the usefulness of the Shared Resource Cores to the various research projects? What is the relationship of the Shared Resource Core to the central focus of the overall program? What quality control processes are in place for facilities or services provided by the Shared Resource Cores (including procedures, techniques, and quality control)? What are the criteria for prioritization and usage? Is the Shared Resources Core budget appropriate? What are the qualifications, competence, and commitment of the Shared Resource Core leaders and other key personnel?

D. Progress (for competing continuation projects only). 

Are the overall progress and achievements specific to the application and relevant to translational research since the previous competitive review? Are the justifications for adding new projects and/or cores and/or deleting previous components appropriate and acceptable? Does progress made during the previous funding period for competing continuation applications demonstrate an acceptable level of integration among the P01 subprojects? Have the applicants addressed any difficulties in achieving the previously proposed specific aims? Are the new research goals logical extensions for the project? Is there clear evidence that such a project reached its anticipated human application(s) during the current funding period? Will the continuation of the project lead to new translational findings? Is there sufficient evidence provided that the investigative team, especially the project co-leaders, established a productive working relationship during the current performance period? Is their productivity documented by published or submitted manuscripts describing their previous findings?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the rating:

Resubmission Applications (formerly “revised/amended” applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

NCI's Guidelines for the Program Project grant application are located on the NCI web site at http://deainfo.nci.nih.gov/awards/P01.pdf. Please note that “Integration of Effort” is an additional required review criterion used in the peer review of P01 applications that have primary assignment to the NCI.

2.C. Resource Sharing Plan(s)   

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NOA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

stewardship role in awards, as described below

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Elizabeth Read-Connole, Ph.D.
Division of Cancer Biology
National Cancer Institute (NCI)
National Institutes of Health (NIH)
6130 Executive Boulevard, EPN Suite 5000, MSC 7398
Bethesda, MD 20892-7398 (for U.S. Postal Service express or regular mail)
Telephone: (301) 496-6085
Fax: (301) 496-2025
E-mail: bconnole@mail.nih.gov

Asad Umar, Ph.D.
Division of Cancer Prevention
National Cancer Institute (NCI)
National Institutes of Health (NIH)
6130 Executive Boulevard, EPN Room 2141, MSC 7317
Bethesda, MD 20892-7317 (for U.S. Postal Service express or regular mail)
Telephone: (301) 594-2684
Fax: (301) 435-6344
E-mail: au17z@mail.nih.gov

Heng Xie, M.D., M.P.H., Ph.D.
Division of Cancer Therapy and Diagnosis
National Cancer Institute (NCI)
National Institutes of Health (NIH)
6130 Executive Boulevard, EPN Room 7009, MSC 7432
Bethesda, MD 20892-7432 (for U.S. Postal Service express or regular mail)
Telephone: (301) 496-8866 or (301) 496-6512
Fax: (301) 480-4663
E-mail: XieHe@mail.nih.gov

2. Peer Review Contacts:

Referral Officer
Program Coordination and Referral Branch
Office of Referral, Review, and Program Coordination
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8040, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier service)
Telephone: 301-496-3428
Fax: 301-402-0275
Email: ncirefof@dea.nci.nih.gov

3. Financial or Grants Management Contacts:

Leslie Hickman
Grants Management Specialist
National Cancer Institute
Fairview Center Building, Suite 300
1003 West 7th Street
Frederick, MD 21701-4106
Telephone: (301) 846-1013
Fax: (301) 451-5391
E-mail: HickmanL@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html), investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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