and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Cancer Institute (NCI), (http://www.cancer.gov)
Title: Quick-Trials
for Novel Cancer Therapies: Exploratory Grants (R21)
Announcement Type
This is a reissue of PAR-04-155,
which was previously released August 31, 2004.
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.
Program Announcement (PA) Number: PAR-06-451
Catalog of Federal Domestic Assistance Number(s)
93.393, 93.394, 93.395
Key Dates
Release/Posted Date: June 9, 2006
Opening Date: June 9, 2006 (earliest date an application
may be submitted to Grants.gov).
Letters of Intent Receipt Date(s): Not applicable.
NOTE: On-time submission requires that applications be successfully
submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization).
Application Submission Date(s): August 9, 2006; December
9, 2006; April 9, 2007; July 9, 2007; November 9, 2007.
Peer Review Date(s): November
2006; March 2007; July 2007; November 2007; March 2008.
Council Review Date(s): February
2007; June 2007; October 2007; February 2008; June 2008.
Earliest Anticipated Start Date(s): April 2007; July 2007; December 2007; April 2008; July
2008.
Additional Information To Be Available Date (URL Activation
Date): Not applicable.
Expiration Date: November 19, 2007 (Changed from December 10, 2007 per PAR-08-025)
Additional Overview Content
Executive Summary
Continuing progress in basic cancer research and drug development has
led to discoveries of new agents or approaches for molecular targeting in
novel cancer therapies. These new agents or approaches suppress tumor growth
through multiple mechanisms, such as: cell cycle control; activation of tumor
suppressor genes; essential signal pathway blockage; tumor vaccines; tumor
microenvironment modification; etc. Rapid translation of these exciting discoveries
into clinical practice requires timely support to accommodate the special
needs of novel cancer therapy development. This funding opportunity announcement
(FOA) is intended to provide investigators with rapid access to support for
pilot, Phase I, and Phase II cancer clinical trials as well as support for
patient monitoring and laboratory studies linked to a cancer clinical trial.
Phase III trials are not excluded, but such trials generally require greater
resources and duration than available from an R21 grant award. Applications
that do not propose a cancer clinical trial or patient monitoring or laboratory
studies linked to a cancer clinical trial may be returned to applicants without
being reviewed.
The focus of this QUICK-TRIAL FOA is on translational research in new agent
development to ensure the timely exploitation of new cancer therapeutic approaches,
including the development of new cancer prevention agents.
This FOA is aimed at providing a new approach in the grant application process
by offering a rapid turnaround from application submission to funding. Features
of this initiative include a modular grant application and award process,
inclusion of the clinical protocol within the grant application, and an accelerated
peer review with the goal of issuing new awards within 6 months of application
receipt. Inclusion of the complete clinical protocol within the grant application
is intended to simplify the application process by eliminating the need to
duplicate protocol details in the Research Plan section and to insure proper
peer review of the application. In addition, QUICK-TRIAL applications do not
require extensive preliminary data in the grant application and support exploratory
translational and clinical research studies involving cancer prevention, chemotherapy,
and rapid development and application of novel clinical cancer therapies,
including image-guided therapeutic procedures.
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. Submitting an Application
Electronically 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
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
Advances in the understanding of molecular cancer genetics, basic cancer
biology, and the development of powerful technologies, such as microarray,
proteomics, and bioinformatics, have led to the identification of many new
molecular targets and pathways in cancer cells. These discoveries have created
new frontiers for novel molecular cancer prevention and treatment leading
to the development of molecular medicine in cancer therapy. In addition, these
novel targets and pathways have presented excellent translational research
opportunities for revolutionizing cancer drug development and bringing more
effective molecular cancer therapies and cancer prevention strategies into
clinical practice.
Novel approaches or agents for inhibiting tumor growth either directly or
by impacting the tumor microenvironment are ready to be tested in the clinic
with new tools and laboratory analyses that allow investigators to ascertain
how specific targets are affected by therapy. These agents include new classes
of cytotoxic agents, agents, or approaches that act via immune-stimulatory
effects, agents that stimulate apoptosis, inhibit angiogenesis and metastasis,
or alter tumor cell signaling pathways, and agents targeted specifically to
novel cancer cell targets. New clinical therapeutic trials may employ drugs/agents,
biologics, radiation, heat, or surgery used as single agents/modalities or
in combination for the treatment of early and advanced disease. In addition,
clinical trials of therapies for cancer treatment, including, but not limited
to: herbal therapies; dietary supplements; bioactive food components; or unconventional
pharmacological and biological interventions (e.g., antineoplastons, Coley's
toxin, enzyme therapies, etc.); will be considered. Another relevant area
of investigation is the use of anatomical and molecular image guidance for
targeted treatment with ablative techniques or delivery of chemotherapeutic
agents. At present, there are few funding mechanisms targeted to stimulate
the translation of promising and potentially relevant advances in new prevention
or therapeutic agent development from the laboratory into the clinical setting.
Quite frequently, the initial stages of clinical investigation are the most
difficult to accomplish. They are resource intensive, and, to be done well,
they require laboratory, pharmacology, and other resource support, as well
as substantial personnel effort, none of which is supported by traditional
health benefit programs. Nonetheless, these early studies tend to fare poorly
in competition for conventional grant support precisely because they are preliminary
and cannot serve as the definitive tests of new approaches. Even when funding
is received, the review and award cycle may introduce a year or more of delay.
Except where there is an industrial sponsor with a particular commitment to
development of an agent, it may take a long time for a promising approach
to get through the initial phase of demonstrating feasibility and interest,
or it may never be tested in more than one or two diseases.
This FOA will continue to support scientific, technological, clinical, and
logistical needs in novel cancer therapy development. In addition, this FOA
will complement the Rapid Access to Intervention Development (RAID) program http://dtp.nci.nih.gov/docs/raid/raid_index.html by providing an initiative with accelerated peer review and funding to support
the clinical and laboratory costs of early clinical testing to ensure the
timely development of new therapeutic approaches.
See Section VIII, Other Information - Required Federal Citations for policies related to this announcement.
Section II. Award Information
1. Mechanism of Support
This FOA will use the NIH 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; 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.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
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.
The most current Grants Policy Statement can
be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.
3. Other-Special Eligibility Criteria
A pplicants may submit more
than one application, provided each application is scientifically distinct. However, the NIH will not accept similar grant applications
with essentially the same research focus from the same applicant organization.
Section IV.
Application and Submission Information
PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH Electronic Research Administration (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 numbers and CCR registrations 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 organization/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 Modular Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
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 special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
3. Submission Dates and Times
See Section IV.3.A for
details.
3.A. Submission, Review, and
Anticipated Start Dates
Opening Date: June 8, 2006 (earliest date an application may
be submitted to Grants.gov).
Application Submission Date(s): August 9, 2006; December 9, 2006;
April 9, 2007; August 9, 2007; December 9, 2007.
Peer Review Date(s): November
2006; March 2007; July 2007; November 2007; March 2008.
Council Review Date(s): February
2007; June 2007; October 2007; February 2008; June 2008.
Earliest Anticipated Start Date(s): April 2007; July 2007; December 2007; April 2008; July 2008.
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.
3.B. Submitting
an Application Electronically 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.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have 2 business days to view the application image.
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 or competing renewal 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 Guide (MS Word or PDF) 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.
Plan for 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 sharing
research resources plan 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 U.S. Public Health
Service (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.
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 percent 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 sharing
research resources plan 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.
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:
Dr. Roy Wu
Clinical
Grants & Contracts Branch
Cancer Therapy Evaluation Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive Boulevard, EPN Room 7009,
MSC 7432
Bethesda, MD 20892-7432 (for U.S. Postal Service express or regular
mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: 301-496-8866
Fax: 301-480-4663
E-mail: [email protected]
2. Peer Review Contacts:
Not applicable.
3. Financial or Grants Management Contacts:
Ms. Amy Connolly
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) 496-8786
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 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.
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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