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 General Medical Sciences (NIGMS), (http://www.nigms.nih.gov/)
Title: Drug Docking and Screening Data Resource (U01)
Announcement Type
New
Update: The following update relating to this announcement 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
Background
Computational screening of large databases of organic molecules against the three-dimensional structures of biological target proteins has the potential to provide rapid and accurate prediction of the binding modes and affinities of potential drug molecules, increasing the efficiency and speed of drug development. Computational screening has had notable successes and is widely used in drug discovery efforts, but the technique suffers from high failure rates and inconsistent predictive power. A crucial need is rapid, automated, quantitative prediction of binding affinities from the structures of ligands and their target proteins. The initial motivation for this proposal was a wide-spread sense that the field has reached a plateau and needs a spur to further development. [For example, see: Leach, A. R., Shoichet, B. K., Peishoff, C. E., Prediction of Protein-Ligand Interactions. Docking and Scoring: Successes and Gaps in J. Med. Chem. (Perspective) (2006) 49: 5851-5855]
At a meeting among academic and industrial computational chemists and NIH staff in Bethesda, MD in August 2005 (Report of the NIGMS Workshop on Challenges in Docking and Virtual Screening), a key need was identified--common datasets suitable for development and comparison of ligand-protein docking and screening software. Surprisingly, adequate datasets do not exist in the public domain. The Research Collaboratory for Structural Bioinformatics Protein Data Bank (PDB), for instance, archives tens of thousands of protein structures, but rarely contains data on series of analogous ligands bound to a single target. Affinities for a significant number of protein-ligand pairs in a organized series under comparable conditions, in conjunction with structural information, are typically not available in the public literature. Carefully designed datasets of high resolution three-dimensional structures and experimental ligand affinities are needed in order to decompose molecular interaction potentials into component terms that can lead to more reliable docking predictions. Such datasets will also be invaluable for unbiased comparison of docking/screening methods.
In a follow-on meeting on February 24, 2006, it was determined that the nucleus of the needed datasets exists, albeit in isolated or incomplete states, among industrial groups and in academic laboratories across the country. There was strong support among both the industrial and the academic participants for a government effort that would result in the collection, curation, and public release of additional high-quality datasets combining matched structural, affinity, and other physical-chemical information for multiple ligand complexes of a variety of typical drug target proteins. The community also felt strongly that, in order to be optimally useful, these benchmarking sets would need to be extended by generation of novel data on new ligands, to test potentially relevant physical interactions and to allow for blinded community benchmarking exercises.
A number of large databases already serve the needs of the computational docking and screening field. The Drug Docking and Screening Data Resource (hereafter, the Data Resource) to be created will not duplicate databases and tools that have already been created, such as the PDB. The Data Resource is expected to complement the functions of the PDB and other relevant resources and to make seamless connections to them, while avoiding duplication of effort whenever possible.
Objectives
The unique goal of the Data Resource is to increase the public availability of high quality experimental datasets required for development, validation and benchmarking of computer software for drug docking to protein targets and to provide a platform for evaluation of docking and screening software. The main functions of the Data Resource include:
The Data Resource project team will identify, collect, and evaluate datasets submitted by public and private contributors for quality, completeness and utility. The intention is to populate the Data Resource database with existing data insofar as possible. Data will be solicited and collected from public and private sources, including but not limited to those pharmaceutical industry and academic groups that participated in the preliminary workshops. The Data Resource will provide any needed additional preparation to contributed data, and will generate additional experimental results, when necessary, to maximize the usefulness of the datasets for the development and evaluation of in silico docking software.
Activities expected to be required include refinement of pre-existing x-ray crystallographic data; expression and purification of known target proteins using existing protocols; determination of additional x-ray crystallographic structures of targets with identified ligands, as well as with new compounds deemed likely to provide novel information; synthesis and/or purchase of such ligands; experimental determination or redetermination of binding affinities for series of ligands to generate complete and consistent datasets; and determination of other physical properties of drug-like molecules that are potentially of high value for the prediction of ligand affinity.
The Data Resource will organize existing and newly generated data in a database optimized for the design and testing of computer-based methods for drug binding affinity prediction and in formats that are in wide use by the docking and screening software development community. Data should be made available via a well-designed and freely accessible web-based interface. The web-based interface should permit facile upload of the appropriate experimental data by contributors and have sufficient capacity to allow multiple community users to download the complete data on a regular basis.
The Data Resource should permit and facilitate performance evaluation of docking and screening methods and software by users. In addition, the Data Resource should organize and promote community benchmarking exercises, including by the periodic generation of test sets of temporarily unreleased matched affinity data and protein ligand complex structures.
Within the term of this award, the Data Resource is intended to be limited in scope, to provide a test bed for hypotheses about improving computational methods, rather than to support massive data mining efforts. Although the exact extent of the Data Resource cannot be predicted, it is anticipated that approximately 8-12 datasets would be received, assembled, curated, completed with experimental data and released to the public each year, where a dataset comprises binding affinity data for 10-50 analogous compounds per target protein, with high resolution structural data for at least one third of these. Ideally, several series of differing chemotypes for each target will be made available.
In addition to the main functions enumerated above, there are other requirements for the Drug Docking and Screening Data Resource.
The Data Resource must interconnect to various other resources. The resources of the National Center for Biotechnology Information (NCBI) and the PDB are widely used by the docking and screening software research and development community; existing development platforms are designed to utilize these resources. To avoid unnecessary duplication and to establish interoperability with existing resources, the applicant is expected to have plans to utilize the NCBI, the PDB, and other resources. All three-dimensional atomic coordinates and diffraction data contributed to and generated by the Data Resource must be deposited in the PDB and released promptly (except for occasional temporary delays, which should be publicly announced, to allow blind testing of prediction programs).
The applicant must present plans to sustain and maintain the operability of the Data Resource, including provisions for expected growth, personnel changes, and disaster recovery.
The Data Resource will provide long-term support to the research community. At the end of the initial funding period, the NIGMS may consider re-announcing the program for open competition. The successful applicant to the current RFA must present plans for architecture design and software development practice that will make the entire Resource and its components transferable to other groups for continued maintenance and further development. All products developed with support of this program must be made readily transferable to successors, consistent with achieving the goals of this program and applicable NIH policies. Applicants must state explicitly in the application their policy on continued availability of the contents of the Data Resource.
The applicant must have plans to communicate and promote to the scientific community the resources provided by the Data Resource, and to solicit suggestions and advice from the research community. This should be implemented by establishing an external Advisory Board, as well as by other means proposed by the applicant.
Milestones
The applicant should present detailed timelines and milestones in the application describing how to implement all the specific aims.
Data contributed to the Data Resource (as enhanced by the Data Resource where appropriate) or generated by the Data Resource must be made publicly available as soon as practicable. Software developed by the Data Resource must be freely available to all biomedical researchers and educators for research purposes. Unique resources generated by the Resource must be shared with the scientific community
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 U01 award
mechanism.
As
an applicant, you will have primary responsibility for planning, directing, and
executing the proposed project.
This
funding opportunity uses just-in-time concepts. It 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". At the end of the
initial funding period, the NIGMS may consider re-announcing the program for
open competition.
2. Funds Available
The NIGMS intends
to commit approximately $1.0 million (total costs) in FY 2008 to fund one new cooperative agreement in response to this
RFA. An applicant may request a project period of up to five years. The anticipated earliest start date is September 30,
2008.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible
Institutions
You
may submit applications if your organization is domestic and 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
Cost sharing or
matching is not required.
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
An applicant may
submit one application in response to this RFA.
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
Letter
of Intent Receipt Date: February 19, 2008
Application
Receipt Date: March 18, 2008
Peer
Review Date: July 2008
Council Review Date: October 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:
Janna
P. Wehrle, Ph.D.
Division of Cell Biology and Biophysics
National Institute of General Medical Sciences,
NIH
45 Center Drive, Room 2As.19K, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-5950
FAX: (301) 480-2004
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:
Helen R. Sunshine,
Ph.D.
Office of Scientific Review
National Institute of General Medical Sciences, NIH
45 Center Drive, Room 3An.12F, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-2881
FAX: (301) 480-8506
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 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 NIGMS. 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
Participant Affiliations:
Applications must include a separate sheet that lists 1) all participants of the application, including consultants and collaborators; 2) all the institutional affiliations for each participant; 3) their roles on the project; and 4) the percent effort listed separately for each role.
Page Limit:
The page limit for the Research Plan section of the application is 25 pages. Please note that there is no requirement to submit the maximum number of pages; instead, concise, articulate applications are desired.
Budget:
The budget of total costs for the first year, including direct costs, consortium/contractual costs, and all facilities and administrative costs is up to $1.0 million. Annual cost of living increases in subsequent years should not exceed 3%. The budget should include funds for organizing annual Data Resource Advisory Board meetings.
Drug Docking and Screening Data Resource Advisory Board:
The Data Resource will be expected to have an Advisory Board (4-6 people) drawn from experts in computational chemistry and biology, drug design and development, computer science, and other relevant areas. These advisors will meet annually to review progress and provide community feedback and guidance on Data Resource development and maintenance. The Data Resource Advisory Board will:
The membership of the Advisory Board will be determined by the NIGMS Project Scientist in collaboration with the Data Resource Principal Investigator following the announcement of the award (see Section VI.2A3). While a description of the Board’s activities should be included in the application, potential members of the Board should not be named in the application or contacted or selected before an award is made.
Plan for Sharing Research
Data
NIGMS
is committed to making all data provided to and newly generated by the Data
Resource freely available for use by the entire research community and, therefore, released into the public domain. Applicants
must include a explicit plan for sharing research data in their
application. In addition to any other data sharing mechanisms proposed by
the applicant, coordinates for all three-dimensional structures of proteins and
protein-ligand complexes must be deposited in the PDB. The data sharing policy
is available at http://grants.nih.gov/grants/policy/data_sharing.
The scientific review group will comment, as appropriate, on the plans for sharing research data. Since dissemination of results is a critical aspect of the Data Resource, evidence of the commitment to the sharing of research data and resources and to effective management of intellectual property issues will be part of the scientific merit review, as well as an important factor in the Institute’s decision to make an award. Furthermore, these plans, after negotiation with the applicant when necessary, will be made a condition of the award. The NIGMS will closely monitor the grantee’s activities with respect to public release of data.
The effectiveness of the data 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.
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
addressing how unique research resources contributed to or generated by the
Data Resource will be shared with the community.
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 NIGMS 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?
Environment: Does the
scientific environment in which the work will be done contribute to the
probability of success? Do the proposed studies benefit from unique features of
the scientific environment, or subject populations, or employ useful
collaborative arrangements? Is there evidence of institutional support?
2.A. Additional
Review Criteria
Not
applicable.
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 plans will be assessed by the reviewers and will be a factor in the
determination of scientific merit or the priority score. Data sharing is
required and dissemination is a critical aspect and fundamental purpose of
theis funding opportunity. Thus there should be evidence of a genuine
commitment on the part of the project leadership to the sharing of data.
In addition, the data sharing plan will be subject to review by the NIGMS.
The final data sharing plan agreed to by the awardee and the NIGMS will be part
of the terms and conditions of the award. The NIGMS will be responsible for
monitoring the data sharing policy and practice throughout the award
period. Evaluation of annual progress reports will include assessment of
the effectiveness of sharing of 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. The reasonableness of the research resources-sharing plan
will be assessed by the reviewers and reviewers will factor the proposed
research resources-sharing plan into the determination of scientific merit and
the priority score.
In addition to
evaluation during the review process, t he 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
The
earliest anticipated award date will be September 30, 2008.
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 (PI) will have the primary responsibility for designing and directing the development and maintenance of the Data Resource. The PI is also responsible for setting milestones for the project, ensuring compliance with NIGMS policies and requirements, and submitting annual progress reports to the NIGMS. The PI will:
Data and materials
deposited by public and private organizations and individuals will remain the
property of the depositors. Awardees will have primary rights to the data
and resources generated by the Data Resource and to software developed to
manage the Data Resource under these awards, subject to
Government rights of access consistent with current HHS, PHS, and NIH policies
and subject to the terms and conditions of the award.
2.A.2. NIH Responsibilities
A NIGMS Project
Scientist will have substantial programmatic involvement that is above and
beyond the normal stewardship role in grants. The Project Scientist will
be a member of the NIGMS extramural staff who will have substantial scientific
involvement during the conduct of the project through technical assistance,
advice, and coordination. He/She will assist in the interaction between
the Data Resource and the NIH. The NIGMS Project Scientist will
facilitate communication with the private sector and academic scientific
communities to promote data donation to the Data Resource and to facilitate
utilization of the Data Resource for the improvement and evaluation of drug
docking and screen methods.
Additionally, an NIGMS Program Director will be responsible for normal stewardship of the award and will be named in the award notice.
2.A.3. Collaborative Responsibilities
The PI and the NIGMS Project Scientist will be jointly responsible for selecting an Advisory Board for the project, and for ensuring, via input from the Advisory Board and other sources, that the needs of the docking and screening software development community are being met. The Advisory Board will meet annually to review progress and provide community feedback and guidance on Data Resource development and maintenance. The Data Resource Advisory Board will be responsible for examining and commenting on dataset selection policy and on progress toward milestones; providing input from the scientific community and promote communications; providing advice to the P(I)s and the NIGMS Project Scientist about meeting the goals of the project and about future directions; and raising issues for consideration by the Principal Investigator and the NIGMS Project Scientist.
The PI and the NIGMS Project Scientist will be jointly responsible for approving all Data and Material Transfer Agreements negotiated by the Data Resource. No Data or Material Transfer Agreements can be implemented by the awardee on behalf of the Data Resource without the approval of the NIGMS.
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 will be convened composed of three members: a
designee of the Advisory 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
The progress of the
Drug Docking and Screening Data Resource project will be reviewed annually by
the Data Resource Advisory Board and the assigned NIGMS Program Director.
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.
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:
Janna P. Wehrle,
Ph.D.
Division of Cell Biology and Biophysics
National Institute of
General Medical Sciences, NIH
45 Center Drive, Room 2As.19K, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-5950
FAX: (301) 480-2002
Email: [email protected]
2. Peer Review Contacts:
Helen R. Sunshine,
Ph.D.
Office of Scientific Review
National Institute of General Medical Sciences
45 Center Drive, Room
3An.12F, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-2881
FAX: (301) 480-8506
Email: [email protected]
3. Financial or Grants Management Contacts:
E.C. Melvin
Division of Extramural Activities
National Institute of General Medical Sciences
45 Center Drive, Room 2An.32E, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-3912
FAX: (301) 480-2554
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
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.
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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