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
This FOA is developed as an NIH Roadmap initiative (http://nihroadmap.nih.gov). All NIH Institutes
and Centers participate in Roadmap initiatives. The FOA will be
administered by the National Institute of General Medical Sciences (NIGMS/NIH),
(http://www.nigms.nih.gov) on behalf of
the NIH.
Title: Pilot-Scale
Libraries (PSL) for High-Throughput Screening (P41)
Announcement Type
This is a reissuance of RFA-RM-06-003.
Request For Applications (RFA) Number: RFA-RM-09-007
Catalog of Federal Domestic Assistance Number(s)
93.310
Key Dates
Release Date: May 27, 2009
Letters of Intent Receipt Date: September 4, 2009
Application Receipt
Date: October 1, 2009
Peer Review Date(s): February-March 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July
1, 2010
Additional Information To Be Available Date (Url
Activation Date): N/A
Expiration Date: October
2, 2009
Due Dates
for E.O. 12372
Not
Applicable
Additional
Overview Content
Executive Summary
Table of Contents
Part I
Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism(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, Review and Anticipated
Start Dates
1.
Letter of Intent
B. Sending an Application to
the NIH
C. Application Processing
D. Application Assignment
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. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Background
The NIH Roadmap, overseen by the NIH Office of Strategic Coordination within the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI; http://dpcpsi.nih.gov/), is a series of initiatives designed to address roadblocks to research and to transform the way biomedical research is conducted by overcoming specific hurdles or filling defined knowledge gaps. Roadmap programs span all areas of health and disease research and boundaries of NIH Institutes and Centers (ICs). These are programs that might not otherwise be supported by the NIH ICs because of their scope or because they are inherently risky. Roadmap Programs are expected to have exceptionally high potential to transform the manner in which biomedical research is conducted. They are also expected to be short term, 5–10 year programs. This “incubator space” time frame is intended to allow the major roadblocks that were defined for each program to be overcome, thereby stimulating further research conducted through the ICs.
The ultimate goal is to enable the rapid transformation of new scientific knowledge into tangible benefits for public health (http://nihroadmap.nih.gov/). The Molecular Libraries and Imaging Initiative (MLI) (http://nihroadmap.nih.gov/molecularlibraries/) is a component of the “New Pathways to Discovery” theme of the Roadmap (http://nihroadmap.nih.gov/newpathways/). The MLI will be known as the Molecular Libraries Program (MLP) in the production (i.e., post-pilot) phase.
The last decade has witnessed major breakthroughs in the identification of genes, gene products, metabolic pathways, and signaling pathways, as well as progress in miniaturization and robotics, enabling the development of high-throughput, mechanism-based biological assays. The new assays have, in turn, facilitated the discovery of small molecules with powerful physiological effects. While high-throughput screening (HTS) of small-molecule libraries is a standard approach in the pharmaceutical industry, the goal of the MLP is to facilitate the use of HTS and chemical libraries within the academic and nonprofit community. The MLP is producing research tools (including novel small-molecule modulators of biological function) for the study of fundamental biology. It also yields large amounts of data, in a publicly-accessible format, enabling scientists to test hypotheses that correlate biological function with specific regions of chemical structure space. (http://www.nature.com/horizon/chemicalspace/index.html).
This particular FOA is part of the Chemical Diversity Technology Development effort, which is a major component of the MLP. Other components of the MLP include:
1) the Molecular Libraries Probe Production Centers Network (MLPCN), which provides innovative HTS capacity for implementing assays that are submitted by the research community. The MLPCN also conducts medicinal chemistry to optimize these molecules as biological probes (http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-08-005.html).
2) the NIH Molecular Libraries Small-Molecule Repository (MLSMR; http://mlsmr.glpg.com/MLSMR_HomePage/identify.html; http://grants.nih.gov/grants/guide/notice-files/NOT-RM-04-003.html), which maintains a collection of approximately 300,000 compounds obtained from both commercial and academic sources. The MLSMR distributes these compounds to the MLPCN centers for HTS. Ultimately, the compound collection will include up to 500,000 chemically and functionally diverse small organic molecules.
3) PubChem: a publicly accessible database that provides information on the biological activities of small molecules, including the compounds in the MLSMR and the biological data generated by the MLPCN (http://pubchem.ncbi.nlm.nih.gov/).
4) the development of related technologies, including HTS instrumentation and cheminformatics.
The MLP effort differs from HTS efforts in private industry and others in academic settings in several ways. First, the express purpose of this NIH program is the identification of a large number of compounds for use as probes to study cellular processes. This involves screening a greater diversity of small molecules in assays encompassing a broader range of novel biological targets and phenotypes, as well as exploring novel biological activities of marketed or investigational drugs. Second, the biological screening data, assay protocols, and a certain amount of chemical data for compounds tested in the MLPCN (see below) are publicly accessible via the PubChem database. Data-sharing with the larger scientific community represents a new paradigm that leverages the MLP’s investment and empowers the scientific community broadly. Third, the MLP facilitates, but does not engage in, the much more difficult and expensive process of drug development. The MLP complements private sector drug development efforts by contributing to the identification and validation of novel drug targets, as well as small molecule classes with potential for development into therapeutics. The benefits to public health, especially for rare or marginalized disorders, are evident.
Objectives of the Project
The goal of this FOA is to solicit applications for chemical library generation, in order to increase the diversity, the uniqueness, and the overall value of the collection in the MLSMR.
The pilot-scale libraries (PSLs) generated under this FOA will be submitted to the MLSMR and then to the MLPCN for HTS evaluation. When a PSL compound exhibits an encouraging pattern of biological activity, a decision may be made to more fully explore the pertinent region of chemical structure space. It is likely that grantees under this initiative will be given the opportunity to participate in followup studies of compounds that they submit that show up as “actives” in HTS.
Since the goal of the MLP is to identify novel small molecule effectors of biological function, it is crucial that library designs be driven primarily by biological considerations rather than by chemical methodologies. Furthermore, since the goal is to identify effectors of truly novel biological phenotypes and mechanisms, it is important that the compounds produced under this FOA represent chemotypes that are distinct from what is available commercially and from those that are already in the MLSMR. The applicant must describe procedures that will be used to assess the uniqueness of the proposed libraries.
In contrast to the NIGMS Centers of Excellence in Chemical Methodologies and Library Development (CMLD; http://www.nigms.nih.gov/Initiatives/CMLD), the focus of this FOA is on the generation and provision to NIH of novel libraries rather than on methodology development.
Approaches Being Sought to Achieve the Objectives
This FOA does not specify the means by which the libraries are to be assembled. In fact, various approaches may be envisioned, including: 1) high-throughput (HT) synthesis (often referred to as combinatorial chemistry, combichem, or diversity-oriented synthesis); 2) isolation and purification of discreet compounds from living organisms (natural products; NPs), including compounds isolated from their natural sources, as well as NPs and their analogs made through pathway engineering or semisynthesis; and 3) target-oriented synthesis (including the synthesis of analogs of a NP or other lead compound).
A particularly high priority for the MLP is to obtain chemical neighbors of high-value synthetic molecules that are known to be biologically active. This includes marketed drugs as well as drugs that have demonstrated biological activity in human clinical trials or animal models but that have not been approved for therapeutic use.
Most NPs have evolved to serve roles such as chemical defense or signaling, thus enhancing the survival of the organisms that produce them. As NPs are inherently biologically active, it is not surprising that a great number of approved drugs are themselves NPs, are derived from NPs, or were inspired by NPs.
Libraries of NPs will be an especially rich source of bioactive small molecules with broad utility as probes of biological mechanisms. Furthermore, new source organisms may elaborate novel structural classes of NPs with unprecedented bioactivities. Libraries of such compounds should be especially valuable for HTS by the MLPCN, and for this reason, obtaining libraries of NPs and their congeners is a high priority for the NIH.
NPs may be isolated directly from their natural sources. However, some NPs can be produced by engineered organisms, including heterologous hosts. Similarly, by genetic manipulation, biosynthetic pathways may be adapted so as to yield NP analogs.
A prime motivation for the synthesis of complex molecules is the investigation of biological activities. Accordingly, many synthetic strategies are devised so as to be short (i.e., relatively few reaction steps), efficient (i.e., high-yielding and highly specific), and readily adaptable to the synthesis of key analogs. Potential applicants under this FOA should note that it is the desire of the NIH to obtain substantial numbers of novel small molecules via this FOA. Additionally, the ease of resupply and ready access to analogs are important considerations.
Experts have estimated that chemical diversity space may encompass 10^60 small-molecule structures (i.e., molecular weights up to 500). By comparison, fewer than 10^8 small-molecules have ever been synthesized or isolated from natural sources. Given the tiny fraction of chemical diversity space that thus far has been probed for biological activity, it is important that library design be underpinned by a strong biological rationale. For synthetic libraries designed de novo, applicants should describe the process by which regions of chemical diversity space will be selected for study, as well as the general rationale for library design. Structural complexity or synthetic accessibility, per se, will not suffice in the absence of a compelling biological rationale. For synthetic libraries, the biological rationale must be supported by objective criteria such as computational modeling or preliminary biological screening of representative or related molecules. Supporting data need not have been generated by the applicant but may come from the literature or collaborators’ laboratories.
Note that PubChem or other chemical databases may be useful for gauging the need for libraries representing particular regions of chemical diversity space. The applicant must discuss the specific approach to be used for assessing the uniqueness of proposed libraries. While libraries submitted in response to this initiative need not be “drug-like” in the usual sense (since the goal of the MLP is not drug discovery), chemical stability under both HTS and storage conditions is very important. Also, compounds with inherently reactive functional groups e.g., potent alkylating or acylating agents (see http://mlsmr.glpg.com/MLSMR_HomePage/pdf/MLSMR_Excluded_Functionality_Filters_200605121510.pdf) as well as compounds that are prone to nonspecific aggregation (see, for example, J. Med. Chem. 2003, 46, 4265-4272) are undesirable. The applicant should state specific criteria by which undesirable compounds will be excluded.
Ordinarily, providers of synthetic libraries should plan to submit multiple focused libraries over the lifetime of the PSL grant. Each library must exhibit a balance between “depth” and “breadth” of structural variation. Enough thoughtfully chosen analogs must be included to allow establishment of a meaningful structure-activity relationship (SAR). Ordinarily, ca. 20 compounds in a given series should be sufficient.
NIH is not specifying the total number of compounds to be submitted over the course of the project. As is the case for library size, in certain cases—for example, natural products from rare organisms, where there is a high probability of discovering unprecedented chemical structures and bioactivities, but great effort may be required to produce and isolate these compounds—smaller numbers may be adequate.
The MLSMR will accept only discrete, well characterized compounds. While racemates are acceptable, mixtures (including mixtures of diastereomers) cannot be accepted. This is due to the additional effort that would be required to deconvolute HTS hits (i.e., identify which component of a mixture is responsible for a hit) as well as the challenges of carrying out routine quality control in the MLSMR (see below).
Compounds submitted to the MLSMR may not have intellectual property restrictions that would hinder the distribution and use of the compounds by the MLPCN.
A high premium will be placed on analytical purity. Applicants should state specifications for acceptable levels of purity (ordinarily, at least 90%) and should describe analytical as well as preparative methods. Unless a compelling justification is provided, preparative chromatographic purification (or purification by another method that will remove chromatographic baseline impurities) of all samples is required.
In order to streamline the process of sample acceptance into the MLSMR and distribution to the screening centers, PSL grantees will be required to submit up-to-date analytical data to document the structures and the purities of the samples that they submit. Analytical data must be submitted along with the samples and must have been obtained in the 90 day period prior to sample submission.
The MLSMR will perform analytical chemistry/quality control (QC) on all compounds entering the collection and periodically will perform QC on a representative sampling of compounds already in the collection. Detailed sample submission and QC procedures are provided on the MLSMR website (http://mlsmr.glpg.com/MLSMR_HomePage/submitcompounds.html). Commercial solvents (dichloroethane, methanol, DMSO, etc.) are used by the MLSMR without any additional purification. Solvent specifications may be obtained from the MLSMR.
The QC process will be discussed with the compound provider and all details must be finalized before the MLSMR begins sample processing. Optional procedures (e.g., solubility testing, HPLC conditions, MS ionization mode) must be specified to the MLSMR at this time.
Applicants should indicate in their proposals whether any aspects of the MLSMR QC process are likely to be incompatible with the proposed libraries and, where possible, should discuss appropriate, alternative analysis methods.
Compounds in the MLSMR will be subjected to a large number of HTS and followup assays. Thus, unless there is a compelling justification to the contrary, each compound must be supplied in a quantity of no less than 20 mg. When HTS assay results call for it, additional quantities and/or analogs may be needed. To this end, compounds submitted to the MLSMR must be accompanied by documentation indicating their origin, including synthesis, isolation, and/or derivatization protocols.
Analogs of synthetic compounds may be substantially easier to make than analogs of NPs. However, since NPs have evolved for their biological activity, it is likely that minimal SAR optimization will be required to generate useful biological probes. For this reason, the ease of generating analogs will not be a major factor in the evaluation of NP libraries.
In order to optimize the use of medicinal chemistry resources within the MLP, PSL grantees should expect to be asked to participate in the optimization of compounds that they provide to the MLSMR. The MLP will benefit from the experience and skills of the PSL grantees, and the grantees will have the opportunity to participate in a larger scientific undertaking, with joint publication a likely outcome.
NIH is not specifying the number of libraries to be submitted each year by a PSL grantee. An applicant should provide a clear and well-justified estimate of the total number of compounds and the number of unique libraries to be submitted to the MLSMR each year. These estimates will provide a basis for evaluation of the grant application as well as a benchmark for evaluating the actual output of each grantee. It is likely that libraries submitted to the MLSMR by grantees under this FOA will be accepted into the NIH small-molecule collection; however, this may not always be the case. For example, if a new library falls largely in a region of chemical diversity space that already is adequately represented in the collection, then it is unlikely that the new library will be accepted.
Applicants must discuss their proposed methodologies and strategies for the generation of high-quality libraries. The following are examples of topics that should be addressed:
Project Oversight
As part of the larger Molecular Libraries and Imaging Roadmap Initiative, projects funded under this FOA are subject to oversight and evaluation of each aspect of the effort.
The Molecular Diversity Project Team is the operational governing body for this initiative. It includes NIH staff from various Institutes and Centers who are actively involved in the management and implementation of this Roadmap initiative. The Project Team reports to the Molecular Libraries and Imaging Implementation Group (MLIIG).
While it is likely that libraries submitted under this FOA will be accepted into the MLSMR, NIH may decline to include certain compounds or libraries at its own discretion. Also, compounds may be eliminated from the collection if they are deemed expendable or if they are found to have properties that are incompatible with HTS.
Grantees under this FOA will be expected to use a Material Transfer Agreement (MTA) approved by the NIH MLPCN Project Team for transfer of compounds and any associated materials to the MLSMR for screening in assays selected for implementation within the MLPCN centers (https://mli.nih.gov/mli/mlpcn/documents-definitions/?dl_id=673).
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism of Support
This funding opportunity
will use the P41 award mechanism(s).
The Project
Director/Principal Investigator (PD/PI) will be solely responsible for
planning, directing, and executing the proposed project.
This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
2. Funds
Available
The
estimated amount of funds available for support of approximately six new and/or
competing renewal grants awarded
as a result of this announcement is $2.5 million for
fiscal year 2010. Future year amounts
will depend on annual appropriations. An applicant may request a project
period of up to three years and a budget for direct costs up to $250,000
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.
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.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
The following
organizations/institutions are eligible to apply:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
2. Cost Sharing or Matching
This
program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
Number of
Applications. Applicants may submit more than one application, provided they are
scientifically distinct.
Resubmissions. Applicants may submit a resubmission application, but such
application must include an Introduction addressing the previous peer review
critique (Summary Statement). Beginning with
applications intended for the January 25, 2009 official submission due date,
all original new applications (i.e., never submitted) and competing renewal
applications will be permitted only a single amendment (A1). See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-016.html. Original new and competing renewal
applications that were submitted prior to January 25, 2009 will be permitted
two amendments (A1 and A2). For these “grandfathered”
applications, NIH expects that any A2 will be submitted no later than January
7, 2011, and NIH will not accept A2 applications after that date.
Renewals. Renewal applications are permitted in response to this FOA
Section IV. Application and Submission Information
1. Address to
Request Application Information
The PHS 398 application
instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY
301-451-5936.
2. Content and Form of Application Submission
Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms. Applications must have a D&B Data Universal Numbering System
(DUNS) number as the universal identifier when applying for Federal grants or
cooperative agreements. The D&B number can be obtained by calling (866)
705-5711 or through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and
number of this funding opportunity must be typed in item (box) 2 only of the
face page of the application form and the YES box must be checked.
Applications
From Federal Agencies
The requests from federal agencies,
including the NIH intramural program, will not include any salary and related
fringe benefits for career, career conditional or other federal employees
(civilian or uniformed service) with permanent appointments under existing
position ceilings or any costs related to administrative or facilities support
(equivalent to Facilities and Administrative costs).
In general, the budget requests will be limited to the incremental costs
required for carrying out the proposed work. These costs may include salary
for staff to be specifically hired under a temporary appointment for the
project, consultant costs, equipment, supplies, travel, and other items
typically listed under Other Expenses. While support for extramural
collaborators may be requested in a separate grant application, funds can be
requested for services by an external investigator or contractor as a
subcontract/consortium including the applicable indirect (F&A costs) of the
contractor/collaborating institution.
Justification must be provided for all requested support and for the Federal
employees who will be committed to the project although no funds are requested
in the application.
Applicants should indicate the number of person-months devoted to the project,
even if no funds are requested for salary and fringe benefits.
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.
All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Additional information is available in the PHS 398 grant application instructions.
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: September 4, 2009
Application Receipt Date: October
1, 2009
Peer Review Date(s): February-March
2010
Council Review Date: May 2010.
Earliest
Anticipated Start Date: July 1, 2010
3.A.1.
Letter of Intent
Prospective
applicants are asked to submit a letter of intent that includes the following
information:
Although a letter of
intent is not required, is not binding, and does not enter into the review of a
subsequent application, the information that it contains allows IC staff to
estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed
in Section IV.3.A.
The letter of intent
should be sent to:
John
M. Schwab, Ph.D.
Division of Pharmacology, Physiology, and Biological Chemistry
National Institute of General Medical Sciences
45 Center Drive, Room 2As.43A
MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-3827
FAX: (301) 480-2802
Email: [email protected]
3.B. Sending an
Application to the NIH
Applications must be
prepared using the forms found in the PHS 398 instructions for preparing a
research grant application. Submit a signed, typewritten original of the
application, including the checklist, and five 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).
3.C. Application
Processing
Applications must be received on or before the
application receipt date) described above (Section
IV.3.A.). If an application is received after that date, the application
may be delayed in the review process or not reviewed. Upon receipt,
applications will be evaluated for completeness by the CSR and for
responsiveness by the reviewing Institute Incomplete and/or non-responsive
applications will not be reviewed.
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 that such an application is considered a "resubmission" for the SF424 (R&R).
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 NIH Grants
Policy Statement.
Pre-award costs
are allowable. A grantee may, at its own risk and without NIH prior approval,
incur obligations and expenditures to cover costs up to 90 days before the
beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the
project, and 2) would be allowable under the grant, if awarded, without NIH
prior approval. If specific expenditures would otherwise require prior
approval, the grantee must obtain NIH approval before incurring the cost. NIH
prior approval is required for any costs to be incurred more than 90 days
before the beginning date of the initial budget period of a new or
renewal award.
The incurrence
of pre-award costs in anticipation of a competing or non-competing award
imposes no obligation on NIH either to make the award or to increase the amount
of the approved budget if an award is made for less than the amount anticipated
and is inadequate to cover the pre-award costs incurred. NIH expects the
grantee to be fully aware that pre-award costs result in borrowing against
future support and that such borrowing must not impair the grantee's ability to
accomplish the project objectives in the approved time frame or in any way
adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)
6. Other Submission Requirements
It is likely that grantees under this FOA will be invited to
attend one meeting per year of the MLPCN Steering Committee, for discussions
among PSL grantees as well as with MLPCN personnel. Applicants are
advised to include appropriate travel costs in their budgets.
Research Plan Page Limitations
As per the PHS 398 instructions (http://grants.nih.gov/grants/funding/phs398/phs398.html),
Research Plan Sections 2-5 may be up to 25 pages in length.
Appendix Materials
All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
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.
It is NIH's understanding that the utility of the resources and data generated
by the MLP will be maximized if they are treated as community resources and
made broadly available. To this end, and consistent with achieving the
goals of the MLP, NIH expects that (1) protocols for obtaining all libraries
and individual compounds that are submitted to the NIH under this FOA (via
synthesis, biosynthesis, or isolation from biological sources) will be made
readily available by publication in the scholarly literature and/or by posting
on the PSL grantee’s publicly accessible website; (2) data derived from
biological screening of these compounds by the MLPCN will be made readily
available and accessible via the PubChem database; and (3) molecular structures
will be uploaded to PubChem by the MLSMR immediately upon acceptance of samples
into the MLSMR.
It is NIH’s expectation that access to the MLPCN’s HTS data (via
PubChem) will spur efforts to develop second-generation compounds with
practical value, such as more advanced tools for biological investigation, or
drug leads. Optimized, second generation compounds that are pursued
independent of this FOA would not be subject to any special IP
considerations. NIH recognizes that under the Bayh-Dole Act, awardees
have the right to elect title to subject inventions and seek appropriate IP
protection, and NIH would encourage appropriate intellectual property (IP)
protection of compounds at those later stages of development.
Data sharing and IP plans should take all of the above considerations into
account, consistent with achieving the programmatic goals of the MLP.
Applicants should provide clear explanations and rationales for their plans,
especially for any proposed plan that involves principles differing from those
described in this FOA.
Section V.
Application Review Information
1. Criteria
Only the review
criteria described below will be considered in the review process.
2. Review and Selection Process
Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIH Center for Scientific Review (CSR) in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.
As part of the scientific peer review, all applications will:
The following will be considered in making funding decisions:
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Overall Impact. Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).
Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? How likely are the proposed strategies to result in the discovery of small molecules with novel and significant bioactivities?
Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Are the proposed compounds novel, and does the applicant provide adequate evidence for their novelty?
Approach. Are the overall strategy, methodology, and analyses well-reasoned
and appropriate to accomplish the specific aims of the project? Are
potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development,
will the strategy establish feasibility and will particularly risky aspects be
managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed? Will the proposed approach afford compounds in acceptable
quantities (at least 20 mg/compound) and acceptable purities (ordinarily, at
least 90%)? Are the proposed analytical methodologies adequate for
demonstrating the quality (i.e., identity and purity) of the compounds to be
submitted to the NIH? Is there an adequate plan to ensure that compounds
submitted to the NIH will be physically and chemically compatible with
high-throughput screening? Are issues of resupply dealt with
adequately? Do the proposed libraries have a sufficient diversity of
chemical handles to enable the exploration of structure-activity
relationships? If not, are there compelling biological considerations
that make these libraries particularly desirable? Will a substantial
number of unique libraries and new compounds be provided, and is the
applicant’s estimate well justified? Will library design be based
upon a sound and insightful rationale? Are the proposed methods for
sample handling and storage sound and adequate? Is there an acceptable
plan to ensure that the proposed libraries will be unique and will not
duplicate structures or structure types already present in the MLSMR?
Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Additional Review Criteria. As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.
Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.
Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Additional Review Considerations. As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact score.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Select Agent Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
3. Anticipated Announcement and Award
Dates
Applicants may expect to learn about the outcome of their
applications, whether successful or unsuccessful, by no later than August 1,
2010. Grants will be awarded in July or August 2010.
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.
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).
3. Reporting
Awardees will be
required to submit the Non-Competing
Continuation Grant Progress Report (PHS 2590) annually and financial
statements as required in the NIH Grants
Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research, peer review, and financial or grants management
issues:
1. Scientific/Research Contacts:
John M. Schwab, Ph.D.
Division
of Pharmacology, Physiology, and Biological Chemistry
National Institute of General Medical Sciences
45 Center
Drive, Room
2As.43A, MSC 6200
Bethesda, MD 20892-6200
Telephone:
(301) 594-3827
FAX:
(301) 480-2802
Email: [email protected]
2. Peer Review Contacts:
John L. Bowers, Ph.D.
Chief,
Biological Chemistry and Macromolecular Biophysics (BCMB) IRG
Center
for Scientific Review
National
Institutes of Health
6701
Rockledge Drive MSC 7806
Bethesda, Maryland 20892-7806
Express/Overnight
Mail:
6701
Rockledge Drive, Room 4170
Bethesda, Maryland 20817-7806
Telephone:
(301) 435-1725
FAX:
(301) 480-2327
Email: [email protected]
3. Financial or Grants Management Contacts:
Ms. Lisa Moeller
Grants
Management Office
National Institute of General Medical Sciences
National
Institutes of Health
45 Center
Drive, Room
2AN.50C,MSC 6200
Bethesda, MD 20892-6200
Telephone:
(301) 594-3914
FAX:
(301) 480-5601
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.
Policy
for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/
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.
NIH Public Access Policy Requirement:
In
accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html)
investigators must submit or have submitted for them their final, peer-reviewed
manuscripts that arise from NIH funds and are accepted for publication as of
April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly
available no later than 12 months after publication. As of May 27, 2008,
investigators must include the PubMed Central reference number when citing an
article in NIH applications, proposals, and progress reports that fall under
the policy, and was authored or co-authored by the investigator or arose from
the investigator’s NIH award. For more information, see the Public
Access webpage at http://publicaccess.nih.gov/.
Standards
for Privacy of Individually Identifiable Health Information:
The Department
of Health and Human Services (DHHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the DHHS
Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH
Grant Applications or Appendices:
All
applications and proposals for NIH funding must be self-contained within
specified page limitations. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution
reviewers that their anonymity may be compromised when they directly access an
Internet site.
Healthy
People 2010:
The Public
Health Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.
Authority and
Regulations:
This
program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order
12372. Awards are made under the authorization of Sections 301 and 405 of the
Public Health Service Act as amended (42 USC 241 and 284) and under Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the
terms and conditions, cost principles, and other considerations described in
the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly
encourages all grant recipients to provide a smoke-free workplace and
discourage the use of all tobacco products. In addition, Public Law 103-227,
the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in
some cases, any portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development services are
provided to children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.
Loan
Repayment Programs:
NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP awardees
must commit at least 50% of their time (at least 20 hours per week based on a
40 hour week) for two years to the research. For further information, please
see: http://www.lrp.nih.gov.
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NIH Funding Opportunities and Notices
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