Part I Overview Information


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: Molecular Probes for Microscopy of Cells (R01)

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants.gov. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html). Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant application.

Announcement Type
New

Update: The following update relating to this announcement has been issued:


Program Announcement (PA) Number: PAR-06-288

Catalog of Federal Domestic Assistance Number(s):
93.859

Key Dates
Release Date: March 29, 2006
Letter of Intent Receipt Date(s): April 25 and July 29
Application Receipt Date(s): May 25 and August 29
Peer Review Date(s): September/October and February/March
Council Review Date(s) : January and May
Earliest Anticipated Start Date(s):  April 1 and July 1
Expiration Date: February 23, 2007

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 and 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

The purpose of this initiative is to evaluate promising but unproven enabling technologies for the routine detection by microscopy of single molecules and single molecular events inside cells.  Applications are invited for (1) feasibility studies for new classes of high-signal output molecular imaging probes; (2) evaluation of general purpose methods for the delivery and specific targeting of externally administered imaging probes without disturbing cellular physiology; and (3) basic research on underlying fundamental photophysical phenomena relevant to improving the spectral properties of fluorescent probes.

This initiative is intended only for the evaluation of possible new enabling technologies of high potential impact but unproven feasibility.  Responding projects are not required to deliver a working technology in a single project period, but should address clearly defined questions about the capabilities and feasibility of the possible new technology.  Applicants are invited to initiate work on unexplored, poorly understood topics but should set well-defined goals.  Review of applications will focus on significance, innovation, rationale, strategy, and the qualifications of the investigators. 

Individuals and interdisciplinary teams are invited to apply.  Since a key goal is to bring fresh perspectives and ideas to bear on imaging technology, investigators who are established in other research fields are especially encouraged to apply.  Applicants need not have preliminary results or an active program in imaging technology, but should have a track record of innovation.

For the development of technologies for which proof of principle has already been achieved and/or extensive preliminary data are already available, or for the refinement of established technologies, investigators should seek other means of support, for example, a Bioengineering Research Grant (BRG) or Partnership (BRP).

Background

The long term goal of this announcement is to develop new technologies for the routine detection by microscopy of single molecules and single molecule events inside cells with minimal disturbance of normal cellular physiology.  This goal requires both molecular probes with high signal output and the supporting technologies for their specific targeting and non-disruptive delivery.

Over the last decade, use of green fluorescent protein (GFP) fusion proteins to observe protein dynamics in living cells by fluorescence microscopy has made a vast range of biological processes amenable to investigation.  More recently, sensors based on fluorescent resonance energy transfer (FRET) have extended the capabilities of light microscopy to report on molecular transitions and interactions in living cells.

The genetic encoding of fluorescence offers many advantages for specific targeting and delivery.  GFP labeling often does not interfere with normal cellular physiology.  However, the spectral properties of GFP are inadequate for routine single molecule imaging.   Routine single-molecule reporting of all classes of molecular events in living cells will require fluorescent probes capable of producing 20-1000 times more signal (number of photons emitted before bleaching) than GFP.

Externally administered probes based on organic and inorganic compounds and materials (dyes and nanoparticles like quantum dots) offer advantages for diagnostic and high-throughput research applications.  Nanoparticles can deliver outstanding spectral performance (high signal over lifetime and multichannel capability), but to realize their potential as practical tools, they must be supported by better packaging, delivery, and targeting technologies.

The ideal molecular probe technology would offer absolute specificity (like genetically-encoded GFP tags), high signal output and narrow bandwidth (like nanoparticles), advantageous photophysical properties (e.g., no bleaching or blinking), modularity (interchangeable contrast and targeting moieties), minimal size, deliverability (access to all cell types and compartments, comparable to that achievable with GFP), and physiological neutrality (non-cytotoxic, biochemically inert).  Although it may not be practical to realize all these characteristics in a single probe technology at this time, it should be possible to achieve major improvements over existing probe classes in one or several of these performance categories.

Objectives

This initiative addresses technological barriers to imaging the locations, states, interactions, reactions, and proximities of single macromolecules in cells: (1) achieving probe signal output sufficient for single molecule sensitivity;  (2) designing probes whose size and surface properties do not interfere with normal cellular physiology or with targeting;  (3) specific targeting of molecular probes to subcellular targets and (4) non-disruptive delivery of probes into living cells.   The goal is to develop high-output probes and general purpose targeting and delivery strategies that interfere minimally with normal cellular functions and can be adapted to a wide range of intracellular targets. 

The objectives of this initiative include the following examples but are not limited to: 

This Program Announcement has special application instructions and restrictions, altered review emphasis, and special award criteria.  Their purpose is to level the playing field for applications that pursue new directions and high-risk goals.  The Research Plan is limited to 10  pages.  The purpose of this page restriction is to focus the attention of applicants and reviewers on the significance of the questions being asked, rationale and general research strategy, and the qualifications of the investigators.  The page limits are sufficient only to explicitly define objectives and outline a well-founded and -designed general research strategy.  By design, the page limits are insufficient for a complete predefined research agenda that anticipates all contingencies that may arise in the course of a project.  Unpublished preliminary data shall not be included in the application.  The purpose of this restriction is to make it possible for applicants to initiate new lines of research without a large prior investment of funds and effort.  The objective of this funding opportunity to broaden the scope of imaging research and to recruit skilled investigators from other areas into the field, not to increase funding for research that is already underway.  Responsiveness to the goals of the initiative will be an award criterion.

Potential applicants are strongly encouraged to discuss their ideas with the Institute Scientific/Research contacts listed in Section VII to see if they fit within the goals of this initiative, and to send a letter of intent prior to submission.

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 NIH R01 award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for non-modular research grant applications.

2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with 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 programs.

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/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

None

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) 435-0714, Email: GrantsInfo@nih.gov.

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.

All PHS 398 requirements should be followed, with the exception of items affected by the following instructions.

Describe the theoretical and conceptual underpinnings of the proposed approach.  The strategy should be justified by reference to published research, which may (but need not) be from the applicant's own laboratory.  Unpublished experimental results may not be included or cited anywhere in the application. 

Strategies should be robust enough to justify the full requested period of support.  For example, the later stages of the project should not depend on make-or-break approaches that may fail feasibility tests early in the project period, leaving no viable alternative plan for the remaining period of support. 

In view of the long-term nature and anticipated difficulty of the goals, significant risks are expected and acceptable.  Nevertheless, potential difficulties and feasibility issues must be identified and addressed in the research plan.  Where specific solutions to them cannot yet be identified (as will often be the case), more general strategies may be proposed.

Applicants should describe their expertise and technical qualifications to undertake the work.  It is not necessary that the investigators demonstrate prior hands-on experience with every technique and experiment, but the research team should document relevant experience and adequate expertise.  The research plan should describe any collaborative arrangements needed to bridge gaps in expertise.

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

Proposed research should provide a unique research opportunity not available in the U.S.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Dates: April 25 and July 29
Application Receipt Dates: May 25 and August 29
Peer Review Dates: October/November and February/March
Council Review Dates: January and May
Earliest Anticipated Start Dates: April 1 and July 1

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:

James F. Deatherage, Ph.D.
Division of Cell Biology and Biophysics
National Institute of General Medical Sciences
Building 45, Room 2AS.13J, MSC6200
Bethesda MD 20892-6200
Telephone: (301) 594-0828
Email: deatherj@nigms.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application 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(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by CSR.  Incomplete 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. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

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/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements

Supplementary scientific information and updates may not be submitted after the application receipt date, unless specifically requested by the SRA.  Unpublished experimental results may not be included or cited anywhere in the application, supporting materials, or updates.

Specific Instructions for Modular Grant applications.

Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year.

Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:

  1. Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;
  2. Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and,
  3. Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.

This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy requires that grant awardee 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/archive/archive/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to ICs on the basis of established PHS referral guidelines.

Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.

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. 

In planning their projects and preparing their applications, applicants should take note of the questions in the review criteria that follow.

1. 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, and technologies, treatments, services, or preventative interventions that drive this field?

Under the Significance criterion for this funding opportunity, reviewers will be asked to answer the following questions:  If successful, would this proposed research make an important advance towards achieving single molecule imaging under physiological conditions inside cells?  For fluorescent probes, does the research strategy have the potential to achieve at least 20-fold improvement over existing methods, such as those using GFP? 

2. Approach.  Are the conceptual or clinical framework, design, methods, and analyses adequately developed, and are the conceptual framework, rationale, and general strategy well integrated, well reasoned, and appropriate to the aims of the project?  Does the applicant acknowledge potential problem areas and consider alternative tactics?

Most applications that are responsive to the goals of this funding opportunity will be of unproven feasibility and high risk.  In this context, reviewers will be asked to evaluate:  Is the rationale for exploring this area sound?  Are the objectives clearly defined?  Is the strategy promising?  Do the potential benefits justify the risks?  Since exploratory work is invited, and page limits are too short for experimental details, in most cases it will not be practical for applicants to set out a predefined research sequence that anticipates every contingency that might arise in the course of the research. Nevertheless, are the major classes of difficulties addressed?  

3. 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? 

The Innovation criterion is critical for this funding opportunity, which is specifically intended only for the exploration and invention of unproven new enabling technologies, and not for the refinement of existing technology.  Reviewers will be asked to identify what the project offers beyond the steady improvement and extension of established technologies currently underway in the applicants' or others' laboratories.  Reviewers will also be asked to assess innovation in the composition of the project team.  Do the investigators bring new perspectives and skills to the field? 

4. Investigators . Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Since investigators new to the field have been encouraged to apply for this funding opportunity, applicants need not have an active research program on the problem.  Reviewers will be asked to evaluate:  Can the investigator(s) be relied upon to design well-founded research approaches and execute them effectively?  Do they have a record of innovation and achievement on difficult problems in related areas?  Does their history suggest that they will be resourceful enough to solve the kinds of problems expected to arise in the course of the research?   Will they be able to master the techniques that will be needed?

5. Environment . Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement (http://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm#availofrr and http://ott.od.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 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

For applications received in May and August and reviewed at the January and May Councils, the earliest start dates are April 1 and July 1.

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/archive/grants/policy/nihgps_2003/index.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 notice of grant award. 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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.htm).

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually:
http://grants.nih.gov/grants/funding/2590/2590.htm and financial statements as required in the NIH Grants Policy Statement. 

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.  Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

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:  

Direct your questions about photophysical studies and fluorescent probe development to:

Catherine Lewis, Ph.D.
Division of Cell Biology and Biophysics
National Institute of General Medical Sciences
Building 45, Room 2AS-13C, MSC6200
Bethesda, MD  20892-6200
Telephone:  (301) 594-0828
Email: lewisc@nigms.nih.gov

Direct your questions about targeting and delivery and probes for electron and X-ray microscopy to:

James F. Deatherage, Ph.D.
Division of Cell Biology and Biophysics
National Institute of General Medical Sciences
Building 45, Room 2AS.13J, MSC6200
Bethesda MD 20892-6200
Telephone: (301) 594-3828
Email: deatherj@nigms.nih.gov

2. Peer Review Contacts:

Sally Ann Amero, Ph.D.
Chief, Bioengineering Sciences and Technologies (BST) IRG
Center for Scientific Review
6701 Rockledge Drive, Room 4190, MSC 7849
Bethesda, Maryland, 20892
Telephone:  (301) 435-1159
Email:  ameros@csr.nih.gov

3. Financial or Grants Management Contacts:

Grace Olascoaga
Grants Management
National Institute of General Medical Sciences
Building 45, Room 2AN.32E, MSC6200
Bethesda, MD  20892-6200
Telephone:  (301)594-5520
Email: olascoag@nigms.nih.gov

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.

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, 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).

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA 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.


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NIH Funding Opportunities and Notices


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