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 Cancer Institute (NCI), (http://www.cancer.gov/)
National Center for Research Resources (NCRR), (http://www.ncrr.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov/)
National Institute on Aging (NIA) (http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), (http://www.niams.nih.gov)
National Institute of Biomedical Imaging and Bioengineering (NIBIB), (http://www.nibib.nih.gov/)
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov/)

Title: Biomedical Research on the International Space Station (BioMed-ISS) (UH2/UH3)

Announcement Type

New

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

Program Announcement (PA) Number: PAR- 09-120

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

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.389, 93.838, 93.837, 93.839, 93.866, 93.846, 93.286, 93.209, 93.853

Key Dates
Release/Posted Date: March 17, 2009
Opening Date: August 30, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): August 31, 2009, 2010, 2011
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): September 30, 2009, 2010, 2011
Peer Review Date(s): Feb/Mar, 2010, 2011, 2012
Council Review Date(s): May, 2010, 2011, 2012
Earliest Anticipated Start Date(s): July 1, 2010, 2011, 2012
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: October 1, 2011

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 of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

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
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 Contacts
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 National Aeronautics and Space Administration Authorization Act of 2005 (P.L.109-155) established the U.S. portion of the International Space Station (ISS) as a National Laboratory to be made available for use by the U.S. public and private entities. The accompanying Senate Report (109-108) emphasized that a primary justification for support of the ISS is its scientific and research potential. Recognizing that the ISS will be capable of hosting a wide range of scientific research that can only be undertaken in a microgravity environment, the authors of P.L.109-155 specifically noted that the ISS resources should be applied to microgravity research that is not related directly to NASA human exploration efforts. The designation as a National Laboratory underscores the significance and importance that the United States places on the scientific potential of the ISS for biomedical research. When completed in 2010, the ISS will have a variety of multidisciplinary laboratory facilities and equipment available to support National Laboratory operations. A list of laboratory equipment (including incubators, refrigerators, freezers, and centrifuges) is available at http://www.nasa.gov/mission_pages/station/science/experiments/Discipline.html.

In accord with the September 2007 Memorandum of Understanding, the NIH and NASA are cooperating to facilitate biomedical research on the ISS for a better understanding of human physiology and human health. The NIH uses this FOA to publicize the availability of the ISS as a National Laboratory and to announce the NIH BioMed-ISS program encouraging applications for biomedical research on the molecular or cellular level that will use the unique microgravity and radiation environment and resources available on the ISS to test innovative hypotheses for the potential benefit of human health on Earth. NASA will provide access to the NASA/US on-orbit facilities, data processing capabilities, and crew time, without charge, for experiments funded under this FOA. NASA will facilitate, when possible, access to other commercial and International Partner on-orbit facilities. NASA also will transport the NIH-funded experiments to the ISS and provide on orbit resources within the available capacity and without additional cost to the NIH or the grantee institution.

Using extreme conditions to investigate life processes affords opportunities for discovery and development. For example, using elevated cell culture temperatures brought new concepts to cell biology leading to the discovery of heat shock proteins and of the refined stress-response suites observed in gene expression. Studies of Thermophilus aquaticus isolated from marine thermal vents resulted in Taq polymerase so critical to our advances in molecular genetics. As we proceed into the 21st century, the microgravity of space affords a new opportunity to observe life processes. Earths gravitational force has been constant for the 4.8 billion years of evolving life. In the short time we have studied microgravity, it is apparent that the effects of gravity on terrestrial life alter gene expression, inhibit locomotion, promote differentiation, and facilitate tissue morphogenesis. Novel responses to microgravity have been observed in bacteria, yeast, plants, lower animals, and human cells. For example, mammalian cells tend to become spherical, alter their signal transduction pathways, and produce secretory products. In summary, most cells survive the transition to lower gravity, and many adapt. Thus, microgravity is a probe into life processes, just as other physical stresses, with the prospect of revealing novel mechanisms that are fundamental to cell processes, to disease, and to the adaptation of living systems to changes in physical forces. It affords a new tool to investigate the influences of various forces on life as it is manifest in structural and functional process in cells, tissues, and organ systems.

The NIH intends to fund investigator-initiated, meritorious applications to support biomedical research on the ISS in order to better understand and improve human health on Earth, including but not limited to the following emphases.

The National Cancer Institute (NCI) is interested in applications aligned with its mission of reducing the burden of cancer. Applications most appropriate for NCI will be those cellular and molecular biological studies that have the potential to improve our understanding, management and treatment of the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients. Cellular- and molecular-based research may involve but not be limited to:

The National Heart, Lung and Blood Institute (NHLBI) is interested in applications that have the potential to improve our understanding, management and treatment of the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases and sleep disorders. Cellular-based research would in general be conducted in heart, lung, or blood cells. Research topics of interest to NHLBI include, but are not limited to:

The National Institute on Aging (NIA) is interested in applications applying the unique environment of the ISS to questions relevant to the aging cell and organism. Examples are, but not limited to, effects of microgravity and space radiation upon:

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is interested in applications that utilize the unique environment of the ISS to better characterize the effect of ethanol on cellular function. The ionizing radiation and microgravity of the space station environment could be expected to influence the molecular and cellular responses to ethanol. Applications are encouraged for those studies that will justifiably employ these factors to advance our understanding of the mechanisms of response to alcohol.

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is interested in applications aligned with its mission of reducing the burden of arthritis and musculoskeletal and skin diseases. Applications most appropriate for NIAMS will propose cellular- or molecular- based studies that have the potential to improve our understanding of diseases or conditions within the NIAMS mission or may lead to prevention or treatment strategies to reduce the burden associated with them.

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) is interested in applications aligned with its mission of improving human health by leading the development and accelerating the application of new biomedical imaging and bioengineering technologies to fundamentally improve the detection, treatment, and prevention of disease. Research topics of interest to NIBIB for the purposes of this announcement include, but are not limited to:

More information on NIBIB interests and Scientific Program Areas can be found at: http://www.nibib.nih.gov/Research/ProgramAreas.

The National Institute of Child Health and Human Development (NICHD) is interested in applications aligned with its mission to ensure that every person is born healthy and wanted, that women suffer no harmful effects from reproductive processes, and that all children have the chance to achieve their full potential for healthy and productive lives, free from disease or disability, and to ensure the health, productivity, independence, and well-being of all people through optimal rehabilitation.

The National Institute of Neurological Disorders and Stroke (NINDS) is interested in applications aligned with its mission of reducing the burden of neurological disorders and diseases. Submission of a letter of intent is strongly encouraged. Applications most appropriate for NINDS will be those that have the potential to improve our understanding, management and treatment of neurological diseases as they are manifest on Earth. Research topics of interest to NINDS include, but are not limited to:

Applications to the BioMed-ISS program should propose innovative biomedical research on a molecular or cellular level that is consistent with one of the participating NIH IC missions, is relevant to improving health of humans on Earth, and could be refined such that implementation on the ISS is feasible. Space-related studies fitting the mission of NASA sponsored research programs such as human adaptation to the space environment or human health countermeasures to prevent the adverse effects of the microgravity environment are not appropriate for this FOA. In vitro and tissue culture experiments that make use of existing ISS resources and require a minimal amount of astronaut intervention are strongly encouraged. Prospective applicants who are interested in learning about experiments that have been conducted on the ISS are encouraged to visit http://www.nasa.gov/mission_pages/station/science/experiments/Expedition.html.

The ISS provides a unique environment in which to do science but there are special requirements and constraints that investigators must consider before submitting an application. Implementing/adapting experiments on Earth into feasible experiments on the ISS is a complicated process. All prospective applicants are expected to identify an implementation partner with expertise in preparing experiments for transportation to and implementation on the ISS and work with them for the duration of the grant. The costs of this partnership must be included in the proposed budgets of the application (for both UH2 and UH3 phases as necessary). To facilitate this process, NASA is supporting this NIH announcement by serving as a clearinghouse for information on space flight implementation. A special website is being maintained to support the solicitation at http://www.nasa.gov/mission_pages/station/science/nlab/nlab_proposal.html. NASA and NIH will also coordinate a pre-application meeting for technical interchange to be conducted in person or via teleconference with a goal to provide information to all prospective investigators about hardware/equipment already developed for use on the ISS, as well as to provide opportunities to meet with implementation partners with experience flying the hardware in space. The pre-application meeting is to held on June 16, 2009 in Houston, Texas. Although attendance at this meeting is not required, it is the most efficient way for investigators not familiar with the ISS research equipment to match their needs to existing hardware capabilities and to be introduced to the implementing organizations familiar with spaceflight. However, NASA and NIH personnel cannot make specific recommendations on implementation to individual applicants. A matrix of all queries from prospective investigators and responses from NASA will be maintained at the above website. After the pre-application meeting, additional questions about implementation not answered by the meeting minutes or website may be sent (in written form only) to the ISS Payloads Office at pdl.helpdesk@msfc.nasa.gov. In order to ensure all information provided by NASA is available to all prospective investigators, queries to NASA must be submitted in writing and will become part of the publicly distributed question and answer matrix.

Consultation with NIH Program Staff: Due to the unique requirements of the program, prospective applicants should consult with NIH program staff as plans for applications are being developed. Pre-application consultation should be done with adequate lead time before the application receipt date in order for applicants to have sufficient time to consider advice from NIH program staff.This early contact will provide an opportunity to clarify the applicant's understanding of the BioMed-ISS program goals and guidelines, including the scope of projects within the program and the requirement that project objectives be milestone-driven. The ISS provides a unique environment in which to do science but there are special requirements and constraints that investigators must consider before submitting an application. Failure to understand and meet the requirements for integrating an experiment into the work flow for the ISS is likely to make an application non-fundable.

Identification of Implementation Partners: Implementation partners are companies or organizations that have the expertise and equipment appropriate for conducting different types of experiments on the ISS or in space; provide hardware, integration and operations services; and mostly handle the engineering, safety, documentation and standard agreements aspects of conducting experiments on the ISS. They work closely with NASA to implement scientific experiments on the ISS and provide services to allow the investigators to focus on their own scientific expertise. Applicants should contact prospective implementation partners while developing their application and should include the implementation cost as part of the budget. All prospective applicants are expected to identify an implementation partner with expertise in preparing experiments for transportation to and implementation on the ISS and work with them for the duration of the grant. The costs for this partnership must be included in the proposed budgets of the application. To facilitate this process, NASA is supporting this NIH FOA by serving as a clearinghouse for information on space flight implementation (http://www.nasa.gov/mission_pages/station/science/nlab/nlab_proposal.html) and information about implementation partners with experience refining experiments such that they can be conducted on the ISS. However, NASA and NIH personnel cannot make specific recommendations on implementation partners to individual applicants. Therefore, applicants are encouraged to participate, either in person or via teleconferencing, in the pre-application meeting described below.

Pre-Application Meeting: The NIH and NASA anticipate holding a pre-application meeting for the BioMed-ISS program on June 16, 2009 in Houston, Texas. All prospective applicants may participate in this meeting in person or through a teleconference. This meeting will provide information on hardware/equipment already developed for use on the ISS, and opportunities to meet with hardware developers and potential implementation partners. Although attendance at this meeting is not required, it is the most efficient way for investigators not familiar with ISS research equipment to match their needs to existing hardware capabilities and the implementing organizations familiar with spaceflight. NIH program and review staff and NASA advisors also will explain the goals and objectives for the BioMed-ISS program and answer questions from the attendees. Prospective applicants are urged to monitor the NIH Guide for Grants and Contracts regarding a Notice for the date and time of the meeting (http://grants.nih.gov/grants/guide/index.html).

After the pre-application meeting, additional questions about implementation not answered by the meeting minutes or website may be sent (in written form only) to the ISS Payloads Office at pdl.helpdesk@msfc.nasa.gov. To ensure all information provided by NASA is available to all prospective investigators, queries to NASA must be submitted in writing and will become part of the publicly distributed question and answer matrix. A matrix of all queries from prospective investigators and responses from NASA will be maintained at the above website.

Resubmission Applications: Due to the unique requirements of this program, prospective investigators are highly encouraged to submit new applications rather than to resubmit applications. Investigators are encouraged to contact NIH program staff before choosing to submit any application to this program.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism of Support

This FOA will use the NIH two-phased Exploratory/Developmental cooperative agreement UH2/UH3 award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed BioMed-ISS project. The transition from the UH2 feasibility phase and eligibility for award of the UH3 ISS experimental phase will be determined by NIH program staff based on NIH IC program priorities, successful completion of scientific milestones, ISS feasibility, and the availability of funds. For the BioMed-ISS program, the UH2 phase must include one to three clear, well-defined, measurable goals (objective and quantifiable milestones) that can be used to judge the success of the proposed research, as well as a credible developmental research plan for the UH3 phase. The application must have a section labeled "Milestones" which must include: (1) one to three well-defined, objective, quantifiable, scientific milestones for completion of the UH2 phase, (2) a discussion of the suitability of the proposed milestones for assessing success in the UH2 phase, and (3) a discussion of the implications of successful completion of these milestones for the proposed UH3 study.

Under this FOA, applicants will submit for only the combined UH2/UH3 cooperative agreement. Separate UH2 and UH3 applications will not be accepted.

This FOA uses Just-in-Time information concepts (see SF424 (R&R) Application Guide). It uses the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm).

U.S. applicants requesting more than $250,000 in annual direct costs must complete and submit budget requests using the Research & Related Budget component.

This funding opportunity will use an NIH cooperative agreement award mechanism. In the cooperative agreement mechanism, the PD(s)/PI(s) retain(s) 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 PD(s)/PI(s), as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

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.

Funding to the BioMed-ISS program will be based on NIH IC program priorities, scientific and technical merit, and the availability of funds. The total BioMed-ISS project period for an application in response to this FOA may not exceed two years for the UH2 phase and five years for a combined UH2/UH3 application. For applicants proposing molecular- or cellular-based studies, the UH2 phase may not exceed $150,000 direct costs per year, including technical consulting cost of the implementation partner for the applicant; the UH3 phase for such experiments is anticipated to require up to $300,000 in direct costs per year, including all of the necessary implementation cost for pre-, during-, and post-flight support.

Funding of the UH3 phase will be based on NIH IC program priorities, the availability of funds, ISS feasibility, and successful completion of scientific milestones within the UH2 phase, as determined by NIH program staff in the context of peer review recommendations and advice from NASA. It is strongly recommended that applicants communicate with NIH program staff at an early stage of the application process to discuss programmatic suitability of the proposed project. Refer to Agency Contacts: Scientific/Research for further contact information for NIH staff.

Facilities and Administrative (F&A) 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(s) with the skills, knowledge, and resources necessary to carry out the Earth-based component of the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

More than one PD/PI (i.e., 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 and 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 electronic Research Administration (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 grant 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. When considering the multiple PD/PI option, 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 that each application is scientifically distinct.

Resubmission: are allowed but due to the special requirements of this program, applicants are highly encouraged to submit new applications. Investigators are encouraged to contact NIH program staff before choosing to submit any application to this program

Renewal: Renewal applications may not be submitted for this FOA.

Section IV. Application and Submission Information

Registration:
Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered ?on-time? (see 3.C.1 for more information about on-time submission).

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Both the PD(s)/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo -- Telephone 301-710-0267, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PIs assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Research & Related Budget

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered in the Project Director/Principal Investigator Contact Information section of the SF424 (R&R) Cover component.All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI.Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission.The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component.Failure to include this data field will cause the application to be rejected.

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 of the Research Plan in the SF424 (R&R), 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 (NoA).

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component.All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form.See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review and Anticipated Start Dates
Opening Date: August 30, 2009 (Earliest date an application may be submitted to Grants.gov)
Letter of Intent Receipt Date(s): August 31, 2009, 2010, 2011.
Application Due Date(s): September 30, 2009, 2010, 2011
Peer Review Date(s): Feb/Mar, 2010, 2011, 2012
Council Review Date(s): May, 2010, 2011, 2012
Earliest Anticipated Start Date(s): July 1, 2010, 2011, 2012

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:

Dr. Xibin Wang
Division of Musculoskeletal Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Democracy 1, Democracy Plaza
6701 Democracy Blvd, Suite 800
Bethesda, MD 20892-4892
Telephone: (301) 594-5055
Fax: (301) 480-1284
Email: wangx1@mail.nih.gov

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time(of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed. Applications to the BioMed-ISS program will also be evaluated for their relevance to the NIH IC missions in this FOA by scientific program staff from the participating NIH ICs. Applications that are not relevant to the participating NIH ICs will not be reviewed. It is therefore very important for perspective applicants to contact the appropriate NIH Staff listed under Agency Contacts: Scientific/Research
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or 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 and Information

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

PHS398 Research Plan Component Sections

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

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 (excluding consortium F&A costs) must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as plans are being developed for the study;

2) Obtain agreement from the IC staff that the IC will accept the 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 new, renewal, revision, or resubmission applications. See NOT-OD-02-004, October 16, 2001.

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations. An application that does not comply with 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 and further the advancement of the 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 the 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 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 (e.g., 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 (go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.)

NASA encourages the widest practical dissemination of research results at any time during the course of the investigation.

Special Instructions

Any project funded under the BioMed-ISS program that uses ISS resources will be consistent with participating NIH IC interests listed under Research Objectives and will be relevant to potentially improving human health on Earth. The NIH expects prospective researchers to develop their hypotheses, technologies, or methodologies and design experiments, and provide a cogent rationale as to why the unique environment of the ISS is essential for their studies. Consistent with the NIH mission, applicants should explain how the knowledge gained from their ISS-based experiments could potentially be applied to extend healthy life and reduce the burdens of illness and disability on Earth. Applications to the BioMed-ISS program should propose molecular- and cellular-based innovative biomedical research with practical feasibility to be carried out on the ISS. Applicants are encouraged to include in the cover letter that they have spoken with the appropriate participating NIH Institute.

In a BioMed-ISS application, the UH2/UH3 must be submitted as a single application and should be clearly organized into two phases (UH2 and UH3). To clearly distinguish between the two phases, applicants should specify separate UH2 and UH3 information in each subsection of the PHS 398 Research Plan as appropriate.

In preparing a BioMed-ISS application, investigators should consider the fact that applications will be assigned a single impact/priority score for both UH2 and UH3 phases. Thus, clarity and completeness of the BioMed-ISS application with regard to specific goals and the feasibility of milestones are critical. Milestones should be sufficiently scientifically rigorous to be valid for assessing progress in the UH2 phase, and will reflect the scientific judgment and experience of the applicant.

PHS 398 Research Plan: For applications submitted for this FOA, the following should be included:

Specific Aims: Applicants should address the scientific questions to be answered, what specifically will be done during the proposed funding periods, and how the proposed research is relevant to the mission of a participating NIH IC. Specific aims should be scientifically appropriate for the relevant phases of the BioMed-ISS project. Include separate aims for both the UH2 and UH3 Phase in this attachment and clearly label them as UH2 specific aims and UH3 specific aims.

Significance: Applicants should address why the proposed BioMed-ISS research is important, explain how it potentially impacts improving human health and reducing the burdens of illness and disability on Earth, and elaborate on the innovative nature of the proposed BioMed-ISS research. They should clarify how the proposed fundamental research, technologies, or approaches will enhance and direct the current and/or future Earth-based research. And, they should clearly identify how the BioMed-ISS project, if successful, would result in an improved understanding of human physiology and human health on Earth. Applicants should also describe why the conditions on the ISS are required for these experiments and why the conditions cannot be simulated on Earth.

Preliminary Studies for New Applications and Progress Report for Renewal and Revision Applications: Applicants should focus on how the unique environment of the ISS may be useful for their research and should be able to answer the question how the reduction of gravity or the unique radiation environment on the ISS further the research aims and long term goals. Applicants should also address what has been done to demonstrate the feasibility of the proposed research. Their narrative should demonstrate creative thinking and knowledge of the field to reinforce the feasibility of the application.

Approach: Applicants should address how the specific aims will be accomplished, the practical feasibility of conducting the proposed experiments on the ISS, and their strategy for packaging their experiments for the ISS. Prospective applicants who are interested in learning about experiments that have been conducted on the ISS and the ISS available equipment are encouraged to visit (http://www.nasa.gov/mission_pages/station/science/experiments/Expedition.html and http://www.nasa.gov/mission_pages/station/science/experiments/Discipline.html, and participate in the Pre-Application Meeting as described in this FOA. Applicants who require assistance in identifying an implementation partner to assist them in preparing their experiments for space are welcome to contact the NASAs ISS Payloads Office at pdl.helpdesk@msfc.nasa.gov after the pre-application meeting described in section III, 3. Other-Special Eligibility Criteria.

This attachment should include 3 separate major divisions UH2 phase, Milestones (to be achieved at the end of the UH2), and a UH3 phase.

Applications must include a specific heading in the Approach attachment labeled Milestones.Milestones should be well described, quantifiable, and scientifically justified and not simply a restatement of the specific aims. A discussion of the milestones relative to the success of the UH2 phase, as well as implications for successful completion of milestones in the UH3 phase should be included. Applications lacking this information will likely be non-competitive.

All other sections should be completed as normal. The eRA system will insert headers, footers, and page numbers and create the Table of Contents prior to posting the assembled grant application image in eRA Commons. There is a 30-page limit for the entire Research Strategy. Specific Aims has an additional one page.

For funded BioMed-ISS applications, completion of the UH2 milestones will prompt an Institute-expedited review that will determine whether or not the UH3 should be awarded. The release of UH3 funds will be based on NIH IC program priorities, the availability of funds, ISS feasibility, and successful completion of milestones. The expedited review may result in additional negotiations prior to award.

Budget form: All applicants are required to use the detailed Research & Related Budget component, regardless of the amount of annual direct costs requested.

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 on the basis of established PHS referral guidelines to the ICs for funding consideration.

Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIBIB and 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:

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

The 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/priority 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? Will conducting this research on the ISS lead to new insights or refinements of the field and further work on Earth? Does it provide better understanding of human physiology and human health on Earth and benefit human health on Earth?

Investigators. 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? Do the PD/PIs have experience designing experiments collaboratively with other institutions/organizations? Is the implementation partner appropriate and a well integrated part of the research team?

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? Does the use of the ISS significantly add to the innovation of this research?

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) Protections 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? Is the use of the ISS environment appropriate to this area of research? Are the proposed milestones well-defined, quantitative, and appropriate for assessing the success in the UH2 phase of the application? Is it clear how the UH3 phase of the study will develop and expand once the UH2 milestones are achieved?

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.

Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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/priority 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 Agents 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

Not Applicable

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., Funding Restrictions.

Awardees will be expected to define a set of concrete, objective and quantifiable project-specific milestones consistent with achieving the goals of the program.

The negotiated milestones will become a condition of the award. Completion of the UH2 milestones will prompt an Institute-expedited review that will determine whether or not the UH3 should be awarded. The release of UH3 funds will be based on NIH IC program priorities, the availability of funds, ISS feasibility, and successful completion of milestones.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

With respect to the placement of any article on the ISS, liability is governed by Article 16 of the 1998 ISS Intergovernmental Agreement requiring cross waivers of liability, as implemented by 14 CFR Part 1266.

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 U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) 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, 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 PD(s)/PI(s) will have the primary responsibility for all aspects of the research and coordination with implementation partners and NASA. These responsibilities include conducting the research, assuring quality and integrity of data, analyzing and interpreting data, preparing publications, and dissemination of research findings. The PI will agree to accept close coordination, cooperation, and participation of NIH Program staff in those aspects of scientific and technical management of the project as described under "NIH Program Staff Responsibilities."

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

2. A.2. NIH Responsibilities

Scientific Program Staff from NIH funding institute will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned program staff may also serve as the NIH Project Scientist.

An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

NIH Project Scientists will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination. However, the role of NIH Project Scientists will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be made by the PI and NIH Project Scientists will be given the opportunity to offer input to this process.

The Project Scientist may:

The Project Scientists adhere to stringent NIH ethics rules and financial disclosure reporting to eliminate overt and perceived conflict of interest; Project Scientist are prohibited from observing scientific review of competing applications from an investigator with whom they have published in the last three years; recommendations from Project Scientist about budgetary requests (e.g., carryover, administrative supplements, no-cost extensions) are reviewed by other NIH program staff without any perceived conflict of interest and approved by their supervisors (e.g., Branch Chiefs, Division Director, and Institute Director); recommendations made by Project Scientist in annual progress reports are reviewed by grant management specialists; Project Scientists will not seek lead authorship on any publications and will obtain approval from their supervisors to participate in any writing group.

Progress will be administratively reviewed prior to issuance of the second phase (UH3) of the award. The NIH funding institute reserves the right to terminate or curtail an individual award.

2.A.3. Collaborative Responsibilities

Due to the special nature of transporting to and conducting experiments on the ISS, collaboration may be required for BioMed-ISS experiments funded by different NIH institutes. The PIs will agree to such an arrangement when necessary.

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, 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.

In addition to annual progress report, awardees may be required to submit an interim progress report in the UH2 phase. This report serves the purpose of communicating the UH2 phases progress between NIH program staff and the PI. If work is progressing well ahead of schedule, the PI may request an earlier transition date so to allow sufficient time for the NIH program staff to initiate the transition process. If the work is progressing well behind schedule, the PI may request a no-cost extension. As part of good program management, the NIH program staff may also request information essential to an assessment of the effectiveness of this Program. Awardees will agree to share these reports with NASA.

UH2 to UH3 Transition Request: Completion of the UH2 milestones will prompt an Institute-expedited review that will determine whether or not the UH3 should be awarded. Request for the transition should be submitted to the NIH at least 6 months prior to the completion of the UH2 phase. The release of UH3 funds will be based on NIH IC program priorities, the availability of funds, ISS feasibility, and successful completion of milestones

Grantee Meetings: Principal Investigators may be required to attend an annual BioMed-ISS meeting organized by the NIH and NASA. Investigators may include travel to this meeting as part of the budget request and state a willingness to participate in this meeting. The meeting will also serve as a training opportunity for prospective applicants.

Pre- and Post-Flight Reporting: The awardees are required to provide a description of research objectives for each manifested payload on the ISS. 30 days after flight completion, the awardees are required to provide an Operational Report consisting of hardware performance during operations on the ISS while conducting the research, and including details such as anomalies and functional performance achieved v. planned. In their annual progress report, awardees are expected to provide a list of scientific publications, commercial development, patents, and products that result from ISS research. Awardees will share these reports with NASA in order to contribute to the body of information about experiments in space and the utility of the ISS.

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.

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 (program), peer review, and financial or grants management issues:

1. Scientific/Research Contact(s):

For National Cancer Institute:

J. Milburn Jessup, M.D.
National Cancer Institute
NIH, DHHS
EPN 6040, 6130 Executive Boulevard
Rockville, MD 20892
Tel: 301-435-9010
Fax: 301-402-7819
Email: jessupj@mail.nih.gov

For National Center for Research Resources:

Amy L. Swain, Ph.D.
National Center for Research Resources
NIH, DHHS
6701 Democracy Blvd., Room 964
Bethesda, MD 20892-4874
Tel: 301-435-0752
Fax: 301-480-3659
E-mail: SwainA@mail.nih.gov

For National Heart, Lung, and Blood Institute:

Andrea L Harabin, Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
NIH, DHHS
6701 Rockledge Drive, Suite 10042
Bethesda, MD 20892-7952
Tel: 301-435-0222
Email: harabin@nih.gov

George J. Papanicalaou, Ph.D.
Division of Prevention and Population Sciences
National Heart, Lung, and Blood Institute
NIH, DHHS
6701 Rockledge Dr., Room 10018
Bethesda, Maryland 20892-7936
Tel: 301-435-0453
Email: gjp@nhlbi.nih.gov

For National Institute on Aging:

Bradley Wise, Ph.D.
National Institute on Aging
NIH, DHHS
Gateway Building, Suite 350
7201 Wisconsin Avenue, MSC 9205
Bethesda, MD 20892
Tel: 301-496-9350
Email: wiseb@nia.nih.gov

For National Institute on Alcohol Abuse and Alcoholism:

Sam Zakhari, Ph.D.
Division of Metabolism and Health Effects
National Institute on Alcohol Abuse and Alcoholism
NIH, DHHS
5635 Fishers Lane, Room 2031
Bethesda, MD 20892-9304
Tel: 301-443-0799
Fax: 301-594-0673
Email: szakhari@mail.nih.gov

For National Institute of Arthritis and Musculoskeletal and Skin Diseases:

Fei Wang, PhD
National Institute of Arthritis and Musculoskeletal and Skin Diseases
NIH, DHHS
6701 Democracy Blvd, Suite 800
Bethesda, MD 20872-4872
Tel: 301-594-5055
Fax: 301-480-4543
Email: wangf@mail.nih.gov

For National Institute of Biomedical Imaging and Bioengineering

Rosemarie Hunziker, Ph.D.
National Institute of Biomedical Imaging and Bioengineering
NIH, DHHS
6707 Democracy Boulevard, Suite 200
Bethesda, MD 20892
Tel: 301-451-1629
Email: hunzikerr@mail.nih.gov

For National Institute of Child Health and Human Development

Florence Haseltine, Ph.D., M.D.
Director of the Center for Population Research
6100 Executive Boulevard, 6100/8B07D
Rockville, MD 20892-7510
Tel: 301-496-1101
Fax: 301-496-0962
E-mail: fhaseltine@nih.gov

For National Institute of Neurological Disorders and Stroke:

Merrill M. Mitler, Ph.D.
National Institute of Neurological Disorders and Stroke
NIH, DHHS
Neuroscience Center, Room 2116
6001 Executive Boulevard
Bethesda, MD 20892
Tel: 301-496-9964
Fax: 301-402-2060
Email: mitlerm@ninds.nih.gov

2. Peer Review Contact(s):

David T. George, Ph.D.
National Institute of Biomedical Imaging and Bioengineering
NIH, DHHS
6707 Democracy Blvd, Suite 920, Room 956
Bethesda, MD 20892-5469
Tel: 301-496-8633
Fax: 301-480-0675
Email: GeorgeD@nih.gov

3. Financial/Grants Management Contact(s):

Andrew Jones
National Institute of Arthritis and Musculoskeletal and Skin Diseases
NIH, DHHS
6701 Democracy Blvd, Suite 800
Bethesda, Maryland 20892-4872
Tel: 301-435-0610
Fax: 301-480-5450
E-mail: jonesan@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

Vertebrate Animals:
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 (45 CFR 46) 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 institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the impact/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/

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. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal 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.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women, Minorities, and Children:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; 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-09-116.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, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicines PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). 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 (HHS) 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 HHS 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) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles.Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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:
As noted above, liability with respect to the placement of any article on the ISS is governed by Article 16 of the 1998 ISS Intergovernmental Agreement requiring cross waivers of liability, as implemented by 14 CFR Part 1266. Separate launch services or payload integration agreements, as appropriate, may be required prior to flight.

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 Part 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 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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