and Human Services (HHS)
EXPIRED
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 PAR-08-245.
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-09-147
Catalog of Federal Domestic
Assistance Number(s)
93.393, 93.394, 93.395, 93.396
Key Dates
Release/Posted Date: April 8, 2009
Letters of Intent Receipt Date(s): April 28, 2009; August 29, 2009; December 28, 2009; April 28, 2010; August 28, 2010; December 28, 2010; and April 27, 2011.
Application Due Date(s): May 28, 2009; September 29, 2009; January 28, 2010; May 28, 2010; September 28, 2010; January 28, 2011; and May 27, 2011.
AIDS Application Due Date(s): Not applicable.
Peer Review Date(s): 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): January 2010; May 2010; October 2010; January 2011; May 2011; October 2011; January 2012
Earliest Anticipated Start Date(s): April 2010; July 2010; December 2010; April 2011; July 2011; December 2011; April 2012
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: May 28, 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.
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: (a) the connection between alcohol consumption and HCC and (b) 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 the 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 FOA. Nonetheless, such projects may be appropriate for the R01 and R21 HCC 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.
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 NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Facilities
and Administrative (F&A) costs requested by consortium participants are not
included in the direct cost limitation. See NOT-OD-05-004.
Section III. Eligibility Information
1. Eligible Applicants
1.A.
Eligible Institutions
The following organizations/institutions are eligible to apply:
Although foreign institutions are not eligible to apply, they may 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. 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
Number of Applications.
Applicants may submit more than one application, provided that each application
is scientifically distinct.
Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009, official submission due date (and any other due dates for FY2010 funding and beyond), all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1). See the new NIH policy on resubmission (amended) applications (NOT-OD-09-003 and NOT-OD-09-016). Original new and competing renewal applications that were submitted for due dates prior to January 25, 2009, will be permitted two resubmissions (amendments A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.
Original new and competing renewal applications that were first submitted prior to January 25, 2009 will be permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.
Renewals. Applicants may submit a renewal application.
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)
710-0267, Email: [email protected].
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.
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 such as SO or IAR 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 programs proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed program.
Supplemental Instructions for the Preparation of Multi-Project Applications.
For all P01 applications submitted in response to this FOA, the standard PHS 398 grant application instructions are modified as summarized below, and as described in more detail in the Guidelines for NCI P01s (go to http://deainfo.nci.nih.gov/awards/P01.pdf. for SPECIAL INSTRUCTIONS for PREPARATION of PROGRAM PROJECT APPLICATIONS). These additional instructions are required because the PHS Form 398 is designed primarily for individual freestanding research project grant applications, and does not have specific instructions for multi-project applications.
Form Page 1 - Face Page: Include the number and
title of this FOA in item/line 2 of the PHS 398 application face page.
Form Page 2 - Description, Performance Sites, and Key
Personnel: Under Description, state the proposed program?s broad,
long-term objectives, specific aims, and the significance to the field of
cancer research. Define the relevance of each proposed project and shared
resource core to the overall theme and goals of the program. List all
performance sites and all Key Personnel and Other Significant Contributors
for the entire P01, beginning with the PI/PD(s) and then listing all other
Key Personnel alphabetically. Include all project and core leaders,
co-leaders, co-investigators, and consultants and consortium collaborators
(if applicable and if these individuals will devote measurable effort to the
project).
Form Page 3 - Table of Contents: Modify the PHS
398 Form Page 3 to enable reviewers to find each component of the
application easily. A sample Table of Contents is included as Appendix A in
the Guidelines for NCI P01s as an example of the format for the Table of
Contents and how the application should be organized (see
http://deainfo.nci.nih.gov/awards/P01.pdf).
Form Pages 4 and 5 Detailed Budget for Initial Budget
Period; Budget for Entire Proposed Period of Support: Prepare a
detailed composite budget for all requested support categories for the first
years using Form Page 4 and a summary budget for the entire proposed period
of support using Form Page 5 of the PHS 398 application. If applicable,
provide additional budget pages pertaining to Consortium/Contractual
arrangements (following the standard PHS 398 instructions).
Biographical Sketches: Compile all biographical
sketches after the Overall Budget, starting with the PD(s)/PI(s) followed by
all other investigators in alphabetical order. Do not repeat biographical
sketches in the individual research projects or shared resources cores.
Overall Aims:
Summarize the the overall theme, goals, specific aims and expected
impact of the proposed program on one or more broad fields of cancer
research (limited to one page).
Overall Research Strategy:
Summarize the overall research strategy, including the overall
significance, innovation, approaches, preliminary studies and progress (for
competing renewal applications) of the program as a whole,. This section is
limited to 12 pages excluding references and the list of publications that
resulted from work in the program during the current funding period (for
renewal applications).
Additional details on the content of the Program Overview section
are provided in the Guidelines for NCI P01s (http://deainfo.nci.nih.gov/awards/P01.pdf)
Program Integration and Management:
Explain how the proposed projects and shared resource cores (if
proposed) will be coordinated and work together to address the overall goals
and aims of the program more effectively than if the projects were done
independently; Explain the plans for organizational and administrative
management of the overall program, and for coordination and communication
within the program. Explain the methods that will be used for
monitoring progress in the projects and effective use of the shared resource
cores. This section is limited to six pages.
Additional details on the content of the Program Integration and
Management section are provided in the Guidelines for NCI P01s (http://deainfo.nci.nih.gov/awards/P01.pdf)
Overall Program Environment:
The Overall Program Environment section should briefly summarize
the overall institutional environment, resources and commitments that are
relevant to effective implementation of the P01. Describe how the
proposed projects and shared resource cores will use the facilities and
resources available at the overall program level. Describe how the
program as a whole will benefit from any special equipment, laboratories,
patient populations, and collaborations.
Additional details on the content of the Overall Program
Environment section are provided in the Guidelines for NCI P01s (http://deainfo.nci.nih.gov/awards/P01.pdf).
Multiple PI Leadership Plan (if applicable). If the multiple
PDs/PIs option is used, the required section describing the Multiple PI
Leadership Plan (see SPECIAL INSTRUCTIONS below) should be inserted in the
application after the Overall Program Environment section. There is no page
limit for this section, but applicants should be specific and concise.
Individual Research Projects: Each P01 program project application
must include at least three individual (albeit connected) research projects
each of which is pertinent to the central theme of the program. Each
research project should be prepared according to the standard
PHS 398
instructions as modified in the Guidelines for NCI P01s (http://deainfo.nci.nih.gov/awards/P01.pdf:
Instead of the standard PHS 398 face page for each project, create a title
page that lists the project number, the title of the project, and the name
of the project leader. Do not repeat biographical sketches included at the
beginning of the application. Do not exceed 12 pages for Section 3, Research
Strategy, of the research plan. Each Project must have a single designated
Project Leader.
Shared Resource Cores: Applicants may propose one or more (as
needed) appropriate shared technical or administrative shared resources cores.
These shared resource cores must not duplicate analogous resources already established in
the applicant institutions (although supplemental funding to such existing
resources may be requested). Each shared resource core should be prepared
according to the standard
PHS 398
instructions as modified in the Guidelines for NCI P01s (http://deainfo.nci.nih.gov/awards/P01.pdf:
Instead of the standard PHS 398 face page for each shared resource core, create a title page
that lists the shared resource core number, the title of the shared resource core, and the name of the
shared resource core
director. Do not repeat biographical sketches included at the beginning of
the application. Do not exceed 12 pages for Item 3, Core Services Plan, of
each shared resource core. Each shared resource core must have a single designated Core
Director.
Appendix materials: Follow standard PHS 398 instructions for
preparation of Appendix materials.
SPECIAL INSTRUCTIONS
Multiple PD/PI Leadership Plan: For applications designating
multiple PDs/PIs the research plan section, 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.
Additional information is available in the
PHS 398
grant application instructions.
The Multiple PD/PI leadership plan should be placed immediately
following the overall Program Environment section as indicated above and in
the Guidelines for NCI P01s.
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): April 28, 2009; August 29, 2009; December 28, 2009; April 28, 2010; August 28, 2010; December 28, 2010; and April 27, 2011
Application Due Date(s): May 28,
2009; September 29, 2009; January 28, 2010; May 28, 2010; September 28, 2010; January 28, 2011; and May 27, 2011
AIDS
Application Due Date(s): Not applicable.
Peer Review Date(s): 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): January
2010; May 2010; October 2010; January 2011; May 2011; October 2011; January
2012
Earliest Anticipated Start Date(s): April
2010; July 2010; December 2010; April 2011; July 2011; December 2011; April
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: [email protected]
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 (for U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for non-USPS delivery)
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 copy of the application and all
appendix material 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 (for U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: 301-496-3428
Fax: 301-402-0275
Email: [email protected]
Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, it may be delayed in the review process or not reviewed.
Upon receipt, applications will be evaluated for completeness
by the 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/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)
6. Other Submission Requirements and Information
Budget Allocation for Annual Meetings. 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.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.
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. An application that does not observe the required page limitations may be delayed in the review process.
Submit the CD with all appendix materials in the package with the two copies of the application that is sent to the NCI Referral Office.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
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 mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).
Core Review Criteria
Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach. Are the overall strategy, methodology, and
analyses well-reasoned and appropriate to accomplish the specific aims of the
project? Are potential problems, alternative strategies, and benchmarks
for success presented? If the project is in the early stages of
development, will the strategy establish feasibility and will particularly
risky aspects be managed?
If the project involves clinical research, are the plans for 1) Protections for Human Subjects, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?
Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
In addition to the standard NIH criteria, the following criteria will be used to evaluate P01-specific components/aspects of the application. The overall application will be evaluated as an integrated research effort focused on a central theme. Individual research projects, supporting cores (if proposed), and Program as an Integrated Effort are collectively considered. The relationship and contributions of each research project and core to the overall theme of the program project will be discussed and evaluated. Although projects not recommended for inclusion in the program are not considered in scoring the overall program project, such projects may reflect on the leadership capabilities of the PD(s)/PI(s).
A. Review Criteria for the Overall Program as a Whole:
B. Review Criteria for Individual Research Projects:
C. Review 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 shared resource core will be assessed based on the following criteria:
D. Progress (for
renewal/competing continuation programs/projects/shared resource cores only)
Additional Review Criteria
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.
Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.
Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact score.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Resource Sharing Plans.
Reviewers will comment on whether the following Resource Sharing Plans, or the
rationale for not sharing the following types of resources, are reasonable: 1)
Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm);
2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html);
and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
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 ofAward (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/grants/policy/nihgps_2003/NIHGPS_Part4.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/grants/policy/nihgps_2003/NIHGPS_part9.htm).
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.
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: [email protected]
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: [email protected]
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: [email protected]
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:
[email protected]
Section VIII. Other Information
Required
Federal Citations
Vertebrate Animals:
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 impact/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/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, Minorities, and Children:
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-09-116.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.
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 investigators 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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