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, (http://www.cancer.gov)
Title: Pilot Studies in Pancreatic
Cancer (R21)
Announcement Type
This is a reissue of PA-05-116, which
was previously released on May 26, 2005.
Update: The following update relating to this announcement has been issued:
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (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-06-303
Catalog of Federal
Domestic Assistance Number(s)
93.393, 93.394,
93.395, 93.396, 93.399
Key Dates
Release/Posted
Date: March 31,
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://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Receipt Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm#review.
Council Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm#review.
Earliest Anticipated Start Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#review.
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
This funding opportunity is
intended to promote innovative research across multiple disciplines for better
understanding of the biology, etiology, detection, prevention, and treatment of
pancreatic cancer.
Examples of appropriate research areas include, but are not limited to:
Identification of genetic aberrations (e.g., mutations, epigenetic changes,
etc.) or combinations of aberrations alterations that initiate or promote
pancreatic cancer; development of experimental models for human pancreatic
cancer to facilitate the understanding of molecular carcinogenesis, to help to
identify promising molecular targets, and to test new preventive/therapeutic
strategies; exploration of molecular pathways using human cell lines and/or
tissues to identify possible novel targets for prevention or therapeutic
development; identification of markers for early detection of cancer; conduct
of preclinical studies to identify candidate chemopreventive drug(s) and
dietary factors for prevention and to characterize the molecular mechanism(s) of
the agent's activity; conduct of small exploratory clinical trials with a
potential chemopreventive agent (e.g., a farnesyltransferase inhibitor or a
statin) assessing response via endoscopic ultrasound or another similar
technology; development of early-stage clinical trials in pancreatic cancer
prevention and therapy; assessment of any associations of tumor pathophysiology
on tumor development, progression, and preventive/therapeutic response; conduct
of exploratory studies to identify and evaluate biomarkers (with associated
assay development) to determine prognosis and predict response to therapy in
pancreatic cancer; evaluation of combination therapies for pancreatic cancer;
Identification of new' environmental exposures (e.g., adverse energy balance)
that may contribute to pancreatic cancer development, including adverse energy
balance; assessment of the impact of pancreatic cancer on health-related
quality of life of patients and their caregivers; and conduct of pilot
surveillance studies and generation of survivorship registries.
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. 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
Section I. Funding Opportunity Description
1. Research Objectives
Purpose and Background
The Division of Cancer Control and
Population Sciences (DCCPS), Division of Cancer Biology (DCB), Division of
Cancer Prevention (DCP), and Division of Cancer Treatment and Diagnosis (DCTD)
of the National Cancer Institute (NCI) invite Exploratory/Developmental Grant
(R21) applications relating to the biology, etiology, detection, prevention,
and treatment of pancreatic cancer. These are short-term awards intended to
provide support for pilot projects, testing of new techniques, and/or
development of innovative projects that could provide a basis for more extended
research.
According to a recent estimate, there would be 31,860 new cases of pancreatic
cancer and 31,270 deaths from this disease in 2004. Pancreatic cancer is a
highly lethal disease marked by pain, anorexia, sleep problems, and weight
loss. Most pancreatic cancers are adenocarcinomas, arising in the pancreatic
ductal system, and have the worst prognosis of all the major malignancies. Due
to its aggressiveness and our inability to detect pancreatic cancer at an early
stage, the disease is often far advanced in patients by the time the diagnosis
is established. The 5-year relative survival rate for all stages is
approximately 4 percent. Conventional treatment approaches such as
chemotherapy, radiation surgery, or combinations of these modalities have had
little impact on the course of this disease in patients. It is clear that a
better understanding of the etiology, and biology, of pancreatic cancer is
urgently needed to effectively diagnose, prevent, and treat this malignancy.
The incidence of pancreatic cancer varies with age, gender, and race. Whereas
pancreatic cancer is rare in people under age 25, and quite uncommon in those
under age 45, over 70 percent of pancreatic cancer cases occur in people 60-80
years old. Although pancreatic cancer is more prevalent in industrialized
countries, the highest incidence in men has been reported among the New Zealand
Maoris. In the U.S., incidence and mortality rates for pancreatic cancer are 50
percent higher in African Americans than in whites. Rates for Native Hawaiians
are slightly higher than those in whites, whereas the rates for Hispanics and
Asian Americans are generally lower. Due to the short lifespan after pancreatic
cancer diagnosis, data gathered thus far only relate to pancreatic cancer
incidence, and no data are available on its prevalence. Such data are not
sufficient to describe racial associations with the etiology, progression, or
prevention of the disease.
Tobacco use is clearly the most established preventable risk factor for
pancreatic cancer. Research has shown that tobacco use increases an
individual's risk of developing pancreatic cancer by about 25 percent. However,
the underlying mechanism by which tobacco use contributes to the development of
pancreatic cancer remains illusive. Similarly, the data linking pancreatic
cancer with industrial exposure to formaldehyde, pesticides, aluminum, and
other potential carcinogens are missing. Initial studies investigating a causal
relationship between industrial exposures and pancreatic cancer relied heavily
on employment records, job titles, union memberships, death certificates, etc.
However, these findings have been inconsistent, possibly because of misclassification
of exposures in the studies. Therefore, future studies need to focus not only
on better defining and assessing the exposure and end points of each study, but
also on standardizing the data collecting process and refining the statistical
methods used.
It has been estimated that about 10 percent of pancreatic cancer occurs in a
familial form and may be linked to six genetic syndromes or variants: p16 mutations
and hereditary melanoma; BRCA2 mutations; hereditary nonpolyposis
colorectal cancer; hereditary pancreatitis; Peutz-Jeghers syndrome; and ataxia
telangiectasia. However, it is likely that yet unrecognized susceptibility
genes and gene-environment interactions predispose a subset of the population
to pancreatic cancer.
The purpose of this funding opportunity announcement is to promote innovative
research across multiple disciplines to better understand the etiology of
pancreatic cancer and to promote its early detection, prevention, and
treatment. Specific topics of interest include, but are not limited to, the
following:
Applicants are encouraged to
propose other topics that may help us understand the etiology of pancreatic
cancer and provide opportunities to prevent and treat pancreatic cancer.
See Section VIII, Other
Information - Required Federal Citations for policies related to this
announcement.
1. Mechanism of Support
This FOA will use the NIH Exploratory/Developmental Research Grant (R21) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses just-in-time concepts. It also uses the modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, Modular Budget Component, of the Application Guide).
Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation ) applications will not be accepted. Up to two resubmissions (formerly revisions/amendments") of a previously reviewed exploratory/developmental grant application may be submitted. See NOT-OD-03-041, which was published in the NIH Guide on May 7, 2003.
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 NIH Institutes and Centers (ICs) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project; direct costs are limited to $275,000 over an R21 2-year period, with no more than $200,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined 2-year award period. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this Program Announcement funding opportunity.
Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, which was published in the NIH Guide.
Section III. Eligibility Information
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
Research & Related
Subaward Budget Attachment(s) Form
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
Letter of Intent Receipt Date: Not applicable.
Application Submission
Date(s): Standard dates apply,
please see: http://grants.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.
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
award if such costs: are necessary to conduct the project, and 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 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 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.
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 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.
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:
For cancer control, epidemiology, and
survivorship, contact:
Mukesh Verma, Ph.D.
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, EPN Room 5104 , MSC 7324
Bethesda,
MD 20892-7328 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 594-7344
FAX: (301) 402-4279
E-mail: [email protected]
For cancer biology and models,
contact:
Judy Mietz, Ph.D.
Division of Cancer Biology
National Cancer Institute
6130 Executive Boulevard, EPN Room 5028, MSC 7391
Bethesda,
MD 20892-7328 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-9326
FAX: (301) 496-1224
E-mail: [email protected]
For cancer etiology, contact:
Mary Ellen Perry, Ph.D.
Division of Cancer Biology
National Cancer Institute
6130 Executive Boulevard, EPN Room 5034, MSC 7396
Bethesda,
MD 20892-7328 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-7028
FAX: (301) 402-5034
E-mail: [email protected]
For cancer exogenous factors including
diet, and cancer prevention contact:
Sharon Ross, Ph.D.
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard, EPN Room 3160, MSC 7328
Bethesda,
MD 20892-7328 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-8573
FAX: (301) 480-3925
E-mail: [email protected]
For cancer diagnosis and
treatment contact:
Claudio Dansky Ullmann, M.D.
Division of
Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive
Boulevard, EPN Room 7009, MSC 7432
Bethesda, Maryland 20892-7432
Telephone: 301-435-9065 (Direct)
Telephone: 301-496-8866 (Office)
Fax:
301-480-4663
E-mail: [email protected]
For translational research scientific
discussion only, and not for grant referral, contact:
Ivan Ding, Ph.D.
Office of Centers, Training and Resources
Specialized Centers of Research Excellence
National Cancer Institute
6116 Executive Boulevard, Room 7036
Bethesda,
MD 20892-7328 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-8528
FAX: (301) 402-5319
E-mail: [email protected]
2. Peer
Review Contacts:
Referral
Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-7328 (for
U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496 -3428
FAX: (301) 402-0275
E-mail: [email protected]
3. Financial or
Grants Management Contacts:
Crystal
Wolfrey
Office of Grants Administration
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) 496-8634
Fax: (301) 496-8601
E-mail: [email protected]
Section VIII. Other Information
Required Federal
Citations
Use of Animals in Research:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and Use of
Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects Protection:
Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(Phase I); efficacy studies (Phase II); 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 IRB rules, as well as local, State, and
Federal laws and regulations, including the Privacy Rule. Reviewers will
consider the data sharing plan, but will not factor the plan into the
determination of the scientific merit or the priority score.
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 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, healthcare, 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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