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 Institute of
Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov/)
National
Eye Institute (NEI) (http://www.nei.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), (http://www.niams.nih.gov/)
National
Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov/)
National
Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov/)
Title: Countermeasures Against Chemical
Threats (CounterACT) Advanced Development Cooperative Agreements (U01)
Announcement Type
New
Update: The following update relating to this announacement has been issued:
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(s) of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Address to Request Application
Information
2. Content and Form of Application
Submission
3. Submission Dates and Times
A. Receipt and Review and
Anticipated Start Dates
1. Letter of
Intent
B. Sending an Application to
the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
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
A. Cooperative Agreement Terms
and Conditions of Award
1. Principal
Investigator Rights and Responsibilities
2. NIH
Responsibilities
3. Collaborative
Responsibilities
4. Arbitration
Process
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
The purpose of this research program is to support advanced development cooperative agreement (U01) projects to develop safe and effective medical countermeasures against chemical threat agents. Chemical threat agents are toxic chemicals that could be used in a terrorist attack against civilians, or chemicals that could be released at toxic levels by accident or natural disaster. This announcement will support previous and ongoing research within the CounterACT Network by translating basic research findings into clinical interventions.
Background
The NIH has developed a comprehensive CounterACT Research Network that includes Research Centers of Excellence, individual U01 research projects, SBIRs, contracts and other programs (see http://www.ninds.nih.gov/funding/research/counterterrorism/index.htm). The network conducts basic, translational, and clinical research aimed at the discovery and/or identification of better therapeutic and diagnostic medical countermeasures against chemical threat agents and their movement through the regulatory process. The overarching goal of this research program is to enhance our medical response capabilities during an emergency. The CounterACT Advanced Development U01 program described in this RFA is part of this overall larger effort, and is designed to support investigator-initiated individual research projects. To ensure that research is highly focused on the development of new and improved countermeasures and their timely advancement through the regulatory process, CounterACT research projects will be funded as cooperative agreement U01s with substantial involvement by NIH staff. Each CounterACT U01 will be part of the CounterACT Research Network which will facilitate interactions with other researchers in the field as well as regulatory and public health organizations. The CounterACT U01 principal investigator and collaborators will be members of the research network. The CounterACT program at NIH is part of the larger biodefense program coordinated by the National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov/) that includes biological and radiation/nuclear threats.
Objectives
The primary objective of the CounterACT Advanced Development U01 program is to develop medical countermeasures against chemical threat agents. The civilian chemical threat spectrum now includes chemical warfare agents, toxic industrial chemicals, toxins and other chemicals. Categories of higher priority chemical threats that will be supported by this CounterACT Advanced Development FOA program include:
Unlike the previous CounterACT FOAs, research on sulfur mustard will not be supported. Applicants are urged to contact the program officials listed in this RFA to determine whether their proposed threat agent or countermeasure is of high enough programmatic priority to be considered for funding under the CounterACT U01 program.
Scope of Research
The CounterACT advanced development U01 program will only support translational research that is clearly relevant to the development of new or improved therapeutic drugs that will enhance our medical response capabilities during an emergency. New medical countermeasures that have no practical use during a mass casualty situation will not be considered under this program. Drugs that are only effective if given prior to chemical agent exposure (pre-treatment), or those that must be given within a very short period (1-15 minutes) after exposure will not be supported. Research areas that will be supported under this program include:
The highest priority will be given to projects that have already identified a lead compound, or will do so within the three-year project period. Lead compounds are biologically active compounds or hits where affinity, potency, and selectivity have been established. High priority will also be given to research that is clearly aimed at rapid screening for candidate therapeutics, such as studies that develop and validate efficacy screens using the appropriate controls. Validation includes a demonstration of the model s predictive value for screening compounds for the desired therapeutic effect. Several other areas of research will be given higher priority in this announcement in order to fill research gaps within the overall program.
The highest priority will also be given to research that is relevant to specific populations who are particularly vulnerable, including the young, the elderly, and individuals with pre-existing medical conditions. Clinical research, including trials, will be supported but will depend on the nature and scope of the proposed project. All applicants are strongly encouraged to confer with NIH staff and with staff at the U.S. Food and Drug Administration (FDA) as soon as an appropriate product candidate or medical approach is identified. Information on FDA processes, requirements, and contacts can be found at the following web sites: http://www.fda.gov/cder/about/ smallbiz/default.htm; http://www.fda.gov/cber/manufacturer.htm; and http://www.fda.gov/cdrh/devadvice.
Some examples of research projects that could be supported within this Advanced Development U01 program are listed below. This list only presents some examples of research that could be supported by this FOA. Investigators are encouraged to contact the program officials listed in this FOA to determine if their proposed research will be responsive. Research may include but is not limited to:
Special Biosafety Certification
Special biosafety certifications may be required to conduct research with some chemical threat agents, e.g. nerve agents. Therefore when applicable, applicants will be encouraged to collaborate with laboratories that are certified to work with restricted chemical agents, such as the NIH-supported facility at the US Army Medical Research Institute of Chemical Defense. Applicants are encouraged to contact the NINDS program official listed in this RFA for further information on working with restricted chemical agents.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism(s) of Support
This funding opportunity
will use the Research
Project Cooperative Agreement (U01) award mechanism(s).
As an applicant, you
will be solely responsible for planning, directing, and executing the proposed
project.
This funding opportunity
uses the just-in-time budget concepts. It also uses the non-modular budget
format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
A detailed categorical budget for the "Initial Budget Period" and the
"Entire Proposed Period of Support" is to be submitted with the
application.
The NIH U01 is a cooperative agreement
award mechanism. In the cooperative agreement mechanism, the Principal
Investigator retains the primary responsibility and dominant role for planning,
directing, and executing the proposed project, with NIH staff being
substantially involved as a partner with the Principal Investigator, as
described under the Section VI. 2. Administrative
Requirements, "Cooperative Agreement Terms and Conditions of
Award".
2. Funds Available
The NIH CounterACT Program intends to commit
approximately $2.5
million dollars in FY08 to fund 4-6 new and/or competing
continuation grants in response to this RFA. An applicant may request a project
period of up to three years and a budget for
direct costs up to $500,000 dollars per year.
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 IC(s) provide support for this program, awards
pursuant to this funding opportunity are contingent upon the availability of
funds and the receipt of a sufficient number of meritorious applications.
Facilities and
administrative 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 is invited to work with their institution to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support.
2. Cost Sharing or Matching
Not applicable
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
Milestones
This RFA supports translational research (see Section 1). Since the need for new and improved medical countermeasures is time-sensitive, priority will be given to those projects that are translational in nature, with a new therapy that has already been identified and needs further development. Each CounterACT U01 application must include a clearly stated project timeline that includes practical achievable goals and project milestones. Milestones toward therapeutic intervention are not a description of specific aims and experiments, but rather are discreet goals that create go/no-go decision points in the project that include quantitative success criteria. Some awards may be contingent upon pre-award negotiations between the applicant and the NIH where milestones are reviewed and refined. Progress towards proposed milestones will be a major factor in the review and approval/disapproval of Type 5 non-competing annual applications.
If a specific new therapy has not yet been identified, the proposed translational research should demonstrate a clear path towards identification of a lead compound by the end of the three-year project period. Lead compounds are biologically active compounds or hits where affinity, potency, and selectivity have been established. If the project goals are related to model development, then the model(s) should be fully developed and validated by the end of the three-year project period. Validation includes a demonstration of the model’s predictive value for screening compounds for the desired therapeutic effect. The proposal should describe in detail how the proposed research will lead to the development of a validated model and/or lead compound, and it should present milestones related to achieving that goal.
All collaborators, consultants, or subcontractors must be identified, no matter when during the conduct of the activity the proposed interaction occurs. It is not required that an IND or IDE is achieved during the first project period, but the plan to complete preclinical development should be presented in the application. Since translational research is intrinsically interdisciplinary, this plan will often involve cooperation among basic researchers and clinicians, and may include the participation of private-sector companies and voluntary organizations.
Section IV. Application and Submission Information
1. Address to Request Application Information
The PHS 398 application
instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
710-0267, Email: [email protected].
Telecommunications for
the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms. Applications must have a D&B Data Universal Numbering System
(DUNS) number as the universal identifier when applying for Federal grants or
cooperative agreements. The D&B number can be obtained by calling (866)
705-5711 or through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and number of this funding opportunity must
be typed on line 2 of the face page of the application form and the YES box
must be checked.
3. Submission Dates and Times
Applications must be
received on or before the receipt date described below (Section
IV.3.A). Submission times N/A.
3.A.
Receipt, Review and Anticipated Start Dates
Letters of Intent
Receipt Date: November 9, 2007
Application
Receipt Date: December 10, 2007
Peer Review
Date(s): April-May 2008
Council Review
Date: August 2008
Earliest
Anticipated Start Date: September 30, 2008
3.A.1. Letter of Intent
Prospective applicants
are asked to submit a letter of intent that includes the following information:
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
The letter of intent
is to be sent by the date listed at the beginning of this document.
The letter of intent
should be sent to:
David A. Jett, Ph.D.
Technology Development
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard
NSC, Room 2177, MSC 9527
Bethesda, MD 20892
Telephone: (301) 496-6035
FAX: (301) 402-1501
Email: [email protected]
3.B. Sending an
Application to the NIH
Applications must be
prepared using the research grant applications found in the PHS 398
instructions for preparing a research grant application. Submit a signed,
typewritten original of the application, including the checklist, and three signed photocopies in one
package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries of
applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of
submission, two additional copies of the application and all copies of the
appendix material must be sent to:
Chief, Scientific Review
Branch
National Institute of Neurological Disorders and Stroke
Institute or Center
6001 Executive Boulevard
NSC, Room 3201, MSC 9529
Bethesda, MD 20892
Telephone: (301) 496-9223
FAX: (301) 402-0182
Email: [email protected]
Using the RFA
Label: The RFA label available in the PHS 398 application instructions must be affixed
to the bottom of the face page of the application. Type the RFA number on the
label. Failure to use this label could result in delayed processing of the
application such that it may not reach the review committee in time for review.
In addition, the RFA title and number must be typed on line 2 of the face page
of the application form and the YES box must be marked. The RFA label is also
available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.
3.C. Application
Processing
Applications must be received on or before the
application receipt date(s) described above (Section IV.3.A.).
If an application is received after that date, it will be returned to the
applicant without review. Upon receipt, applications will be evaluated for
completeness by the CSR and responsiveness by the appropriate IC. Incomplete and non-responsive
applications will not be reviewed.
The NIH will not
accept any application in response to this funding opportunity that is
essentially the same as one currently pending initial review, unless the
applicant withdraws the pending application. However, when a previously
unfunded application, originally submitted as an investigator-initiated
application, is to be submitted in response to a funding opportunity, it is to be
prepared as a NEW application. That is, the application for the funding
opportunity must not include an Introduction describing the changes and
improvements made, and the text must not be marked to indicate the changes from
the previous unfunded version of the application.
Information on the status of an application should be
checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is not
subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The Grants Policy Statement can
be found at http://grants.nih.gov/grants/policy/policy.htm.
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 continuation 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 or competing continuation award.
The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
The
overall program is designed for optimal research flexibility, synergy, and
efficiency, with the goal of rapidly developing effective countermeasures for
clinical use. When appropriate, and in accordance with NIH policies (http://grants.nih.gov/grants/policy/data_sharing and http://www.ott.nih.gov/policy/rt_guide_final.html),
awardees will be expected to collaborate; share novel reagents, assays, and
animal models; and share both positive and negative results that would help
guide the research and development activities of other CounterACT
awardees. These activities will be facilitated by annual meetings of
CounterACT investigators. Budgets should include cost for travel to one
annual meeting of CounterACT investigators.
Plan for Sharing Research
Data
The precise content of
the data-sharing plan will vary, depending on the data being collected and how
the investigator is planning to share the data. Applicants who are planning to
share data may wish to describe briefly the expected schedule for data sharing,
the format of the final dataset, the documentation to be provided, whether or
not any analytic tools also will be provided, whether or not a data-sharing
agreement will be required and, if so, a brief description of such an agreement
(including the criteria for deciding who can receive the data and whether or
not any conditions will be placed on their use), and the mode of data sharing
(e.g., under their own auspices by mailing a disk or posting data on their
institutional or personal website, through a data archive or enclave).
Investigators choosing to share under their own auspices may wish to enter into
a data-sharing agreement. References to data sharing may also be appropriate in
other sections of the application.
All applicants must
include a plan for sharing research data in their application. The data sharing
policy is available at http://grants.nih.gov/grants/policy/data_sharing.
All investigators responding to this funding opportunity should include a
description of how final research data will be shared, or explain why data
sharing is not possible.
The reasonableness of
the data sharing plan or the rationale for not sharing research data will be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
Sharing Research Resources
NIH policy expects that
grant recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after
publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and 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, http://grants.nih.gov/grants/funding/2590/2590.htm).
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.
The following will be
considered in making funding decisions:
2. Review and Selection Process
Applications that are
complete and responsive to the RFA will be evaluated for scientific and
technical merit by an appropriate peer review group convened by NINDS in accordance with the review
criteria stated below.
As part of the initial
merit review, all applications will:
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 principal investigator 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?
In addition to the above criteria, the following items will
be considered in the determination of scientific merit and the priority score:
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 the Research Plan, Section E on
Human Subjects in the PHS Form 398).
Inclusion
of Women, Minorities and Children in Research: The adequacy of plans to
include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated (see the Research Plan, Section E on Human Subjects in
the PHS Form 398).
Care and
Use of Vertebrate Animals in Research: If vertebrate animals are to
be used in the project, the five items described under Section F of the PHS
Form 398 research grant application instructions will be assessed.
Biohazards: If materials or procedures
are proposed that are potentially hazardous to research personnel and/or the
environment, determine if the proposed protection is adequate.
2.B. Additional Review
Considerations
Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
2.C. Sharing Research Data
Data Sharing Plan: The reasonableness of the
data sharing plan or the rationale for not sharing research data will be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
The presence of a data sharing plan will be part of the terms and conditions of
the award. The funding organization will be responsible for monitoring the data
sharing policy.
Program staff will be responsible for the administrative
review of the plan for sharing research data.
2.D.
Sharing Research Resources
NIH policy expects that
grant recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after
publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). 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 will be considered by Program staff of the funding
organization when making recommendations about funding applications. Program
staff may negotiate modifications of the data and resource sharing plans with
the awardee before recommending funding of an application. The final version of
the data and resource sharing plans negotiated by both will become a condition
of the award of the grant. 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 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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice
of Award (NoA) will be provided to the applicant organization. The NoA
signed by the grants management officer is the authorizing document. Once all
administrative and programmatic issues have been resolved, the NoA will
be generated via email notification from the awarding component to the grantee
business official (designated in item 12 on the Application Face Page). If a
grantee is not email enabled, a hard copy of the NoA will be mailed to the business
official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.
2. Administrative and National
Policy Requirements
All NIH grant and
cooperative agreement awards include the NIH Grants Policy Statement as part of
the NoA. For these terms of award, see the NIH Grants Policy Statement Part II:
Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
The following Terms and
Conditions will be incorporated into the award statement and will be provided
to the Principal Investigator as well as to the appropriate institutional
official, at the time of award.
2.A. Cooperative Agreement
Terms and Conditions of Award
The following special
terms of award are in addition to, and not in lieu of, otherwise applicable OMB
administrative guidelines, HHS grant administration regulations at 45 CFR Parts
74 and 92 (Part 92 is applicable when State and local Governments are eligible
to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for
this program will be the cooperative agreement (U01), an "assistance"
mechanism (rather than an "acquisition" mechanism), in which
substantial NIH programmatic involvement with the awardees is anticipated
during the performance of the activities. Under the cooperative agreement, the
NIH purpose is to support and stimulate the recipients' activities by
involvement in and otherwise working jointly with the award recipients in a
partnership role; it is not to assume direction, prime responsibility, or a
dominant role in the activities. Consistent with this concept, the dominant role
and prime responsibility resides with the awardees for the project as a whole,
although specific tasks and activities may be shared among the awardees and the
NIH as defined below.
2.A.1. Principal
Investigator Rights and Responsibilities
The Principal Investigator will have the primary responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies.
Awardees are responsible for identifying specific milestones toward development of medical countermeasures that will be achieved during the project period.
Awardees agree to participate in the overall coordination of NIH research efforts to develop medical countermeasures against chemical threats. This participation may include collaboration and consultation with other CounterACT research awardees, and the sharing of information, data, and research materials.
Awardees
will retain custody of and have primary rights to the data and software
developed under these awards, subject to Government rights of access consistent
with current HHS, PHS, and NIH policies.
2.A.2. NIH
Responsibilities
An
NIH Project Scientist will have substantial programmatic involvement that is
above and beyond the normal stewardship role in awards, as described below.
Each project will have the support of one or more Project
Scientists from NIH program staff who are assigned an administrative role for
the countermeasure(s) being studied and have expertise in the implementation of
the CounterACT research program.
The NIH Project Scientists will have substantial scientific-programmatic involvement during conduct of this activity, through technical assistance, advice, and coordination above and beyond normal program stewardship for grants.
NIH Project Scientists will be responsible for assessing the progress of the projects toward the accomplishment of specified milestones, and for recommending if further funds should be released to the project.
The NIH Project Scientists will facilitate the establishment of contacts and collaborations between awardees of the CounterACT research program and other persons or organizations whose participation will assist with the accomplishment of project goals. These persons or organizations may include the FDA, disease voluntary organizations, pharmaceutical companies, or research organizations that can provide essential services on contract.
An important part of the CounterACT research program is the coordination of research efforts across different funding mechanisms and research structures, and coordination among efforts aimed at different countermeasures. NIH Project Scientists will have the primary responsibility for this overall coordination.
In addition, an NIH Program Official will be responsible for normal stewardship of the award.
2.A.3. Collaborative Responsibilities
Not Applicable
2.A.4. Arbitration
Process
Any disagreements that
may arise in scientific or programmatic matters (within the scope of the award)
between award recipients and the NIH may be brought to arbitration. An
Arbitration Panel composed of three members will be convened. It will have
three members: a designee of the Steering Committee chosen without NIH staff
voting, one NIH designee, and a third designee with expertise in the relevant
area who is chosen by the other two; in the case of individual disagreement,
the first member may be chosen by the individual awardee. This special
arbitration procedure in no way affects the awardee's right to appeal an
adverse action that is otherwise appealable in accordance with PHS regulations
42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
3. Reporting
Awardees will be
required to submit the PHS Non-Competing Grant Progress Report, Form 2590
annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
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:
Primary
contact for questions concerning the overall CounterACT program or for
questions related to the mission of NINDS and its role in the CounterACT
program:
David
A. Jett, Ph.D.
Technology
Development
National
Institute of Neurological Disorders and Stroke
6001
Executive Boulevard
NSC, Room
2177, MSC 9527
Bethesda, MD 20892
Telephone:
(301) 496-6035
FAX:
(301) 402-1501
Email: [email protected]
For questions related to the mission of NEI and its role in the CounterACT program:
Michael
D. Oberdorfer, Ph.D.
Div. of
Extramural Research
National
Eye Institute
5635
Fishers LN.,
MSC 9300
Suite 1300
Bethesda, MD 20892-9300
Telephone:
(301) 451-2020
FAX:
(301) 402-0528
Email: [email protected]
For questions related to the mission of NIAID and its role in the CounterACT program:
Ernest
T. Takafuji, M.D., M.P.H.
Asst.
Director for Biodefense Research
National Institute of Allergy and Infectious Diseases
6610 Rockledge
Dr.
Rm. 4091
Bethesda, MD 20892
Telephone:
(301) 451-4416
FAX:
(301) 480-1432
Email: [email protected]
For questions related to the mission of NIAMS and its role in the CounterACT program:
Carl
C. Baker, M.D. Ph.D.
Program
Director, Skin Diseases Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National
Institutes of Health
One Democracy Plaza
6701
Democracy Blvd., Room 888
Bethesda, Maryland 20892-4872
Telephone:
301-594-5017
FAX:
301-480-4543
Email: [email protected]
For questions related to the mission of NIEHS and its role in the CounterACT program:
Elizabeth
A. Maull, Ph.D.
Program
Administrator, Susceptibility and Population Health Branch
National
Institute of Environmental Health Sciences
P.O. Box 12233, MD EC21
Research
Triangle Park,
NC 27709
Telephone:
(919) 316-4668
FAX:
(919) 316-4606
Email: [email protected]
For questions related to the mission of NIGMS and its role in the CounterACT program:
Richard
T. Okita, Ph.D.
Division
of Pharmacology, Physiology, & Biological Chemistry
National Institute of General Medical Sciences
45 Center
Drive
Room
2AS-49A
Bethesda, MD 20892-6200
Telephone:
(301) 594-3827
FAX:
(301) 480-2802
Email: [email protected]
2. Peer Review Contacts:
Chief, Scientific Review
Branch
National
Institute of Neurological Disorders and Stroke
6001
Executive Boulevard
NSC, Room
3201, MSC 9529
Bethesda, MD 20892
Telephone:
(301) 496-9223
FAX:
(301) 402-0182
Email: [email protected]
3. Financial or Grants Management Contacts:
Denise Chatman
Grants
Management Specialist
National
Institute of Neurological Disorders and Stroke
NSC 3269
6001
Executive Blvd.
Bethesda, MD 20892
Telephone:
(301) 496-3993
FAX:
(301) 402-0219
Email: [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);
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 new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses, as
appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children
as Participants in Clinical Research:
The NIH maintains a
policy that children (i.e., individuals under the age of 21) must be included
in all clinical research, conducted or supported by the NIH, unless there are
scientific and ethical reasons not to include them.
All investigators proposing research involving human
subjects should read the "NIH Policy and Guidelines" on the inclusion
of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on
the Protection of Human Subject Participants:
NIH policy requires
education on the protection of human subject participants for all investigators
submitting NIH applications for research involving human subjects and
individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem
Cells (hESC):
Criteria for federal
funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the application
as appropriate, the official NIH identifier(s) for the hESC line(s)to be used
in the proposed research. Applications that do not provide this information
will be returned without review.
NIH Public Access
Policy:
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
website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text and
a set of decision tools on "Am I a covered entity?" Information on
the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant
Applications or Appendices:
All applications and proposals
for NIH funding must be self-contained within specified page limitations. For
publications listed in the appendix and/or Progress report, internet addresses
(URLs) must be used for publicly accessible on-line journal
articles. Unless otherwise specified in this solicitation, Internet
addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation
to view the Internet sites. Furthermore, we caution reviewers that their
anonymity may be compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health
Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This RFA 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% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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