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)
National Institute of Diabetes and Digestive
and Kidney Diseases (NIDDK), (http://www.niddk.nih.gov/)
(NIDDK not participating as of 11/9/2006, per NOT-DK-06-021)
National
Institute of Biomedical Imaging and Biotechnology (NIBIB), (http://www.nibib.nih.gov/)
National
Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov/)
Title: Etiology, Prevention,
and Treatment of Hepatocellular Carcinoma (R21)
Announcement Type
This is a
reissue of PA-05-137, which was previously released July
13, 2005.
Update: The following update relating to this announcement has been issued:
NOTICE: Applications submitted in response to this FOA for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least 4 weeks prior to the grant submission date. See Section IV.
Two steps are required for on time submission:
1) The application must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the submission/receipt date (see Key Dates below); and
2) Applicants
must complete a verification step in the eRA Commons within 2 business days
of notification from NIH. Note: Since e-mail can be unreliable, it is the
responsibility of the applicant to periodically check on their application
status in the Commons.
Program Announcement (PA)
Number: PA-06-295
Catalog of Federal
Domestic Assistance Number(s)
93.393, 93.394, 93.395, 93.396, 93.848, 93.286,
93.273
Key Dates
Release/Posted Date: March 29, 2006
Opening Date: May 2, 2006 (earliest date an application may be
submitted to Grants.gov).
Letters of Intent Receipt Date(s): Not
applicable.
Application Submission Date(s):
Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Receipt Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council Review Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest Anticipated Start Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Additional Information To Be Available Date
(URL Activation Date): Not applicable.
Expiration Date: July 2, 2008 (now September 8, 2008 per NOT-OD-07-093)
.
Due Dates for E.O. 12372
Not Applicable.
Additional Overview
Content
Executive Summary
The National Cancer Institute (NCI), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Biomedical Imaging and Biotechnology (NIBIB), and the National Institute on Alcohol Abuse and Alcoholism (NIAAA) are interested in receiving grant applications that address the etiology and etiologic mechanisms of hepatocellular carcinoma (HCC) and development of animal models, novel approaches to prevent this malignancy, and therapeutic or diagnostic studies aimed at establishing reliable prognostic indicators for disease progression and/or minimizing morbidity and mortality associated with this malignancy.
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. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, 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
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
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
1. Research Objectives
Purpose and background
The NCI, NIDDK, NIBIB, and NIAAA are interested in receiving grant
applications that address the etiology and etiologic mechanisms of
hepatocellular carcinoma (HCC) and development of animal models, novel
approaches to prevent this malignancy, and therapeutic or diagnostic studies
aimed at establishing reliable prognostic indicators for disease progression
and/or minimizing morbidity and mortality associated with this malignancy.
Since the main thrust of this FOA is the basic biology, prevention, and
treatment of liver cancer, applications solely concerned with population
studies and epidemiology are not appropriate for this FOA.
Liver cancer is the most rapidly increasing type of cancer in the United States, accounting for at least 14,000 deaths yearly and ranking eighth as a cause
of cancer mortality in men. HCC is one of the few cancers that is increasing in
frequency and in mortality in the United States. The rapid increases in rates
of HCC incidence in the United States and in other countries of the developed
world correlate with similar increases in the prevalence of chronic infection
with hepatitis C virus (HCV) in those same countries increases in frequency
that occurred in the 1960s and 1970s. Chronicity occurs in approximately 75
percent of people acutely infected with HCV, and, of the patients who develop
chronic hepatitis C, approximately one third develop progressive ?brosis
and cirrhosis. Long-term heavy alcohol consumption is also a risk factor for
liver cirrhosis. Once cirrhosis is present, HCC develops in 1 percent to 4
percent of patients yearly.
The increase in incidence of HCC in the developed world has not been matched by
improvements in survival for this cancer. HCC remains a highly malignant tumor,
with average survival rates after the onset of symptoms of less than 1 year.
The major difficulty is that most patients with HCC present when the disease is
at an advanced stage, by which time the tumor is no longer amenable to surgical
therapy. Furthermore, almost all patients have cirrhosis, so chemotherapies or
major resections are not well tolerated. Clearly, the most practical approach
to better management of HCC is prevention and, barring that, early detection
combined with local resection or ablation.
An appreciation of the significance of this major public health problem led the
National Cancer Institute (NCI), the National Institute for Diabetes and
Digestive and Kidney Diseases (NIDDK), the National Institute for Biomedical
Imaging and Bioengineering (NIBIB), the Department of Veterans Affairs (VA),
and the Fogarty International Center (FIC) to co-sponsor a workshop on
Hepatocellular Carcinoma: Screening, Diagnosis and Management on April 1-3,
2004, at the National Institutes of Health. The results of this meeting have
been published, and the participants indicated that there is clearly a need to
promote research to understand the fundamental biology and etiology of HCC in order to: identify targets for development of vaccines; develop small molecule inhibitors
or other preventive approaches; better identify and quantitate the risk of
developing cancer; and develop new treatment modalities to minimize or
eliminate the burden of cancer in those at risk. In report language, both
Houses of Congress urged the NCI to work with NIDDK to respond to the
recommendations for research activities from the workshop.
Elucidation of the etiology and improvement in means of detection, prevention,
and treatment of hepatocellular carcinoma were areas considered to be high
priority for liver disease research as delineated in the recently published
Trans-NIH Action Plan for Liver Disease Research (http://liverplan.niddk.nih.gov/).
Several of the areas of focus in this program announcement are discussed in
detail in this Action Plan which outlines specific research goals of highest
priority for progress in the understanding and management of this malignancy. NCI has also issued another separate funding opportunity (PA-05-138; http://grants.nih.gov/grants/guide/pa-files/PA-05-138.html)
that covers most of the same areas of scientific research, but involves use of
the P01 (program project) grant mechanism instead.
An increased understanding of fundamental etiologic mechanisms involved in
hepatocellular carcinoma is key to successful preventive and therapeutic
modalities for this lethal human malignancy. Better understanding of the
pathway(s) that lead to the development of HCC would help all aspects of
clinical management of this tumor, including: identifying patients at risk;
decreasing risk factors; surveillance; early diagnosis; diagnostic imaging; and
therapy, both locally ablative and systemic. In particular, determining the
involvement of cancer genes in transformation, promotion, and alteration in the
normal pattern of cell growth regulation is key to an understanding of hepatic
carcinogenesis and should provide insights into possible future therapies by
identifying potential molecular targets for therapy. Development of animal
models that recapitulate all phases of the disease will facilitate
identification of markers for prognosis and diagnosis, imaging studies, and
evaluation of preventive (e.g., vaccine) and therapeutic (e.g., small molecule)
approaches. An important goal for future research is to de?ne the
cellular and molecular basis of hepatocarcinogenesis and the processes and
pathways involved in malignant transformation of hepatocytes.
Chronic alcohol consumption is a major cause of cirrhosis, which is a risk
factor for HCC. Ethanol may promote the development of HCC through various
mechanisms. Ethanol is primarily metabolized in the liver by alcohol
dehydrogenase and cytochrome P450 2E1 (CYP2E1) leading to the production of
acetaldehyde, which has been found to be mutagenic and carcinogenic in animal
studies. CYP2E1 can also catalyze conversion of various procarcinogens into
carcinogens. Chronic ethanol consumption is associated with oxidative stress
which has been linked to carcinogenesis. In the liver, alcohol-associated
oxidative stress may arise through CYP2E1 induction, lipid peroxidation, iron
accumulation, and glutathione depletion. 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. Alcohol consumption
may also promote the growth of HCC by causing hepatic depletion of
s-adenosylmethionine and associated 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.
Research activities are encouraged in the broad areas of etiology and etiologic
mechanism(s) of liver cancer, including: identification of viral and host
factors; development of animal models and in vitro viral cultivation methods;
development of prevention and control strategies, including chemoprevention,
validation of markers, and clinical trials of promising agents; and conduct of
treatment and diagnosis research, including imaging studies.
Research areas of interest include, but are not necessarily limited to, the
following topics.
A) Research on the etiology of hepatocellular carcinoma, including:
B) Research on prevention and control of hepatocellular carcinoma, including:
C) Research on Treatment and Diagnosis of HCC, including:
See Section VIII, Other Information - Required Federal Citations for policies related to this announcement.
1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an) application(s) if your
organization has any of the following characteristics:
1.B.
Eligible Individuals
Any individual with the skills, knowledge, and
resources necessary to carry out the proposed research as the Project
Director/Principal Investigator (PD/PI) is invited to work with his/her
organization 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.
2. Cost Sharing or
Matching
Not applicable. This program does not require
cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special
Eligibility Criteria
Applicants may submit more
than one application, provided each application is scientifically distinct.
Section
IV. Application and Submission Information
To download a SF424 (R&R) Application Package and SF424 (R&R)
SBIR/STTR Application Guide for completing the SF424 (R&R) forms for this
FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure
they are registered in the eRA Commons.
Several additional separate actions are required before an applicant
institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started.
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration
process could take 4 weeks or more. Therefore, applicants should immediately
check with their business official to determine whether their institution is
already registered in both Grants.gov and
the Commons. The NIH will
accept electronic applications only from organizations that have completed all
necessary registrations.
1. Request Application
Information
Applicants must download the SF424 (R&R)
application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package directly attached to a specific FOA can be used.
You will not be able to use any other SF424 (R&R) forms (e.g., sample
forms, forms from another FOA), although some of the "Attachment"
files may be useable for more than one FOA.
For further assistance, contact GrantsInfo; Telephone:
301-710-0267, E-mail: [email protected].
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of
Application Submission
Prepare all applications using the SF424 (R&R) application forms and in
accordance with the SF424 (R&R) Application Guide
(MS
Word or PDF).
The SF424 (R&R) Application Guide is critical to submitting a
complete and accurate application to NIH. There are fields within the SF424
(R&R) application components that, although not marked as mandatory, are
required by NIH (e.g., the Credential log-in field of the Research &
Related Senior/Key Person Profile component must contain the PD/PI’s assigned
eRA Commons User ID). Agency-specific instructions for such fields are
clearly identified in the Application Guide. For additional information, see
Tips and Tools for Navigating Electronic Submission on the front page of Electronic
Submission of Grant Applications.
The SF424 (R &R) application is comprised of data arranged in
separate components. Some components are required, others are optional. The
forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and
optional. A completed application in response to this FOA will include the
following components:
Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site
Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget
Optional Components:
PHS398 Cover Letter File
Note: While both budget components are included in the
SF424 (R&R) forms package, the NIH R21 uses ONLY the PHS 398 Modular
Budget. (Do not use the detailed Research & Related Budget.)
Foreign Organizations:
Several special provisions apply to applications
submitted by foreign organizations:
Proposed research should provide a
unique research opportunity not available in the United States.
3. Submission Dates
and Times
See Section IV.3.A for details.
3.A. Submission, Review,
and Anticipated Start Dates
Opening Date: May 2, 2006 (earliest date an application may be
submitted to Grants.gov).
Letters of Intent Receipt Date(s): Not
applicable.
Application Submission Date(s):
Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Receipt Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council Review Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest Anticipated Start Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
3.A.1.
Letter of Intent
A letter of intent is
not required for the funding opportunity.
3.B. Sending an
Application to the NIH
To submit an application in response to this FOA,
applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted electronically.
PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C. Application Processing
Applications may be submitted on
or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization) on the application
submission/receipt date(s). (See Section IV.3.A. for
all dates.) If an application is not
submitted by the receipt date(s) and time, the application may be delayed in
the review process or not reviewed.
Upon receipt, applications will be transferred
from Grants.gov to the NIH Electronic Research Administration process for
validation. Both the PD/PI and the SO for the organization must verify the
submission via Commons within 2 business days of notification of the NIH validation.
Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH. Incomplete applications
will not be reviewed.
There will be an acknowledgement of receipt of
applications from Grants.gov and the Commons. Information related to the
assignment of an application to a Scientific Review Group is also in the Commons.
The NIH will not accept any
application in response to this FOA 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. This does not preclude the
submission of an application already reviewed with substantial changes, but
such application must include an Introduction addressing the previous
critique. Note such an application is considered a "resubmission" for
the SF424 (R&R).
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.
6. Other
Submission Requirements
The NIH requires the PD/PI to fill in
his/her Commons User ID in the PROFILE Project Director/Principal
Investigator section, Credential log-in field of the Research & Related
Senior/Key Person Profile component. The applicant organization must include
its DUNS number in its Organization Profile in the eRA Commons. This DUNS
number must match the DUNS number provided at CCR registration with Grants.gov.
For additional information, see Tips and Tools for Navigating Electronic
Submission on the front page of Electronic
Submission of Grant Applications.
Renewal (formerly competing
continuation or Type 2 ) applications are not permitted.
All application instructions outlined in the SF424
(R&R) application are to be followed, with the following requirements for
R21 applications:
Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
Plan
for Sharing Research Data
Not applicable.
Sharing Research
Resources
NIH policy requires that grant awardee
recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after
publication (see the NIH
Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each Non-Competing Grant
Progress Report (PHS 2590). See Section VI.3.,
Reporting.
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 submitted for this funding
opportunity will be assigned to the NIH ICs on the basis of established PHS
referral guidelines.
Appropriate scientific review groups convened in
accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm)
will evaluate applications for scientific and technical merit.
Applications that are complete will be evaluated
for scientific and technical merit by an appropriate review group convened by the NIH Center for Scientific
Review in accordance with the review
criteria stated below.
As part of the initial merit 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
NIH R21 exploratory/developmental grant is a mechanism for supporting novel
scientific ideas or new model systems, tools, or technologies that have the
potential to significantly advance our knowledge or the status of
health-related research. Because the Research Plan is limited to 15 pages, an
exploratory/developmental grant application need not have extensive background
material or preliminary information as one might normally expect in an R01
application. Accordingly, reviewers will focus their evaluation on the
conceptual framework, the level of innovation, and the potential to
significantly advance our knowledge or understanding. Reviewers will place less
emphasis on methodological details and certain indicators traditionally used in
evaluating the scientific merit of R01 applications, including supportive
preliminary data. Appropriate justification for the proposed work can be
provided through literature citations, data from other sources, or, when
available, from investigator-generated data. Preliminary data are not required
for R21 applications; however, they may be included if available.
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, weighting them 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 high 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?
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 investigators appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the experience
level of the PD/PI and other researchers? Does the investigative team bring
complementary and integrated expertise to the project (if applicable)?
Environment: Does the scientific environment 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?
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 priority score:
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 item 6 of the
Research Plan component of the SF424 (R&R).
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 item 7 of the Research Plan component of the SF424
(R&R).
Care and Use of Vertebrate
Animals in Research: If vertebrate
animals are to be used in the project, the five items described under item 11
of the Research Plan component of the SF424 (R&R) 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 and
Period of Support:
The reasonableness of the proposed budget and the appropriateness of the
requested period of support in relation to the proposed research may be
assessed by the reviewers. Is the effort listed for the PD/PI appropriate for
the work proposed? Is each budget category realistic and justified in terms of
the aims and methods?
2.C. Sharing
Research Data
Not applicable.
2.D. Sharing
Research Resources
NIH policy requires that grant awardee recipients make
unique research resources readily available for research purposes to qualified
individuals within the scientific community after publication (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
Program staff will be responsible for the
administrative review of the plan for sharing research resources.
The adequacy of the resources sharing plan and any related data sharing plans
will be considered by Program staff of the funding organization when making
recommendations about funding applications. The effectiveness of the resource
sharing will be evaluated as part of the administrative review of each Non-Competing Grant
Progress Report (PHS 2590), See Section VI.3.,
Reporting.
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 NIH 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.
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
e-mail notification from the awarding component to the grantee business
official.
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 Section
IV.5., Funding Restrictions.
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 and Part
II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions
for Specific Types of Grants, Grantees, and Activities.
3. Reporting
When multiple years are involved, awardees will be
required to submit the Non-Competing Grant
Progress Report (PHS 2590) annually and financial statements as required in
the NIH
Grants Policy Statement.
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:
John Cole, Ph.D.
Division of Cancer Biology
National Cancer Institute
National Institutes of Health
6130 Executive Boulevard, Suite 5000, MSC 7398
Bethesda,
MD 20892-7398 (for U.S. Postal
Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-1718
FAX: (301) 496-2025
E-mail: [email protected]
Asad Umar, D.V.M., Ph.D.
Division of Cancer Prevention
National Cancer Institute
National Institutes of Health
6130 Executive Boulevard, Room 2141, MSC 7317
Bethesda,
MD 20892-7317 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 594-2684
FAX: (301) 435-6344
E-mail: [email protected]
Heng Xie, M.D., M.P.H., Ph.D.
Division of Cancer Therapy and Diagnosis
National Cancer Institute
National Institutes of Health
6130 Executive Boulevard, Room 7009, MSC 7432
Bethesda,
MD 20892-7432 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Phone: 301-496-8866 or
301-496-6512
Fax: 301-480-4663
E-mail: [email protected]
Edward Doo, Ph.D.
Liver Diseases Research Program
Division of Digestive Diseases and Nutrition
National Institute of Diabetes, Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Boulevard, Room 651, MSC 5450
Bethesda, MD 20892-5450
Phone: 301-451-4524
Fax: 301-480-8300
E-mail: [email protected]
Alan McLaughlin, Ph.D.
Program Director
Division of Applied Science and Technology
National Institute of Biomedical Imaging and Bioengineering
National Institutes of Health
6707 Democracy Boulevard, Suite 200, MSC 5469
Bethesda, MD 20892-5469
Phone: (301) 496-9321
Fax: (301) 480-4973
Email: [email protected]
Vishnudutt Purohit, Ph.D.
Program Director
Division of Metabolism and Health Effects
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health
5635 Fishers Lane, Room 2035, MSC 9304
Bethesda, MD 20892 -9304
Telephone: (301) 443-2689
Fax: (301) 594-0673
E-mail: [email protected]
2. Peer
Review Contacts:
Not applicable.
3. Financial or
Grants Management Contacts:
For NCI:
Eileen Natoli
Office of Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, EPS Room 243, MSC 7150
Bethesda,
MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: ( 301) 496-8791
FAX: (301) 496-8601
E-mail: [email protected]
For NIDDK:
Florence Danshes
NIDDK-EP-GMB
2 Democracy Plaza
6707 Democracy Blvd., Room 734, MSC 5450
Bethesda, MD 20892-5450
Telephone: 301-594-8861
E-mail: [email protected]
For NIAAA:
Judy S. Fox
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism/NIH
5635 Fishers Lane, Room 3023, MSC 9304
Bethesda, MD 20892-9304
Phone: 301-443-4704
FAX: 301-443-3891
E-mail: [email protected]
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); and 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 institutional
review board (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 scientific
merit or the priority score.
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.
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 at 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.
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 SF424 (R&R); 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:
NIH-funded investigators are requested to submit to
the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts
resulting from: (1) currently funded NIH research projects; or (2) previously
supported NIH research projects if they are accepted for publication on or
after May 2, 2005. The NIH Public Access Policy applies to all research grant
and career development award mechanisms, cooperative agreements, contracts,
Institutional and Individual Ruth L. Kirschstein National Research Service
Awards, as well as NIH intramural research studies. The Policy applies to
peer-reviewed, original research publications that have been supported in whole
or in part with direct costs from NIH, but it does not apply to book chapters,
editorials, reviews, or conference proceedings. Publications resulting from
non-NIH-supported research projects should not be submitted.
For more information about the Policy or the
submission process, please visit the NIH Public Access Policy web site at http://PublicAccess.nih.gov/ and
view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_manual.htm).
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 Web site (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. Unless otherwise specified in
an NIH solicitation, Internet addresses (URLs) should not be used to provide
information necessary to 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 or Health Systems Agency review. 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 percent of their time (at least 20 hours per week based on a
40-hour week) for 2 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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