Exploratory/Developmental Research Grant (R21) / Research Project Grant (R01) focused on Extracellular Matrix and Aging Skin

Exploratory/Developmental Research Grant (R21) / Research Project Grant (R01) focused on Extracellular Matrix and Aging Skin is sponsored by National Institutes of Health (NIH). This funding opportunity solicits grant applications for basic research projects to investigate how changes in the extracellular matrix with age affect the function of tissues, including the skin.

Expired PA-06-242: Aging Musculoskeletal and Skin Extracellular Matrix (R21) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Participating Organizations National Institutes of Health (NIH), ( http://www.

nih. gov ) Components of Participating Organizations National Institute on Aging (NIA),( http://www. nia.

nih. gov ) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), ( http://www. niams.

nih. gov/ ) National Institute of Child Health and Human Development (NICHD), ( http://www. nichd.

nih. gov ) Title: Aging Musculoskeletal and Skin Extracellular Matrix (R21) This is a reissue of PA-03-167 which was previously released September 4, 2003. Update: The following update relating to this announcement has been issued: October 10, 2007 - Expiration Date adjusted to accommodate recent changes to standing submission deadlines, per NOT-OD-07-093.

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 SF424 (R&R) Application Guide. APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT. must be read in conjunction with the application guidelines provided with this announcement in Grants.

gov/Apply for Grants(hereafter called Grants. gov/Apply). registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date.

See Section Two steps are required for on time submission: The application must be submitted to Grants. gov by 5:00 p. m.

local time (of the applicant institution/organization) on the submission date (see Key Dates Applicants must complete a verification step in the eRA Commons within two business days of notification from NIH.

Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application Program Announcement (PA) Number: PA-06-242 Catalog of Federal Domestic Assistance Number date an application may be submitted to Grants. gov) Intent Receipt Date(s): Not applicable Submission Date(s): Standard dates apply, please see http://grants1. nih.

gov/grants/funding/submissionschedule. htm Peer Review Date(s): http://grants1. nih.

gov/grants/funding/submissionschedule. htm#reviewandaward . Review Date(s): http://grants1.

nih. gov/grants/funding/submissionschedule. htm#reviewandaward Earliest Anticipated Start Date: http://grants1.

nih. gov/grants/funding/submissionschedule. htm#reviewandaward .

To Be Available Date (URL Activation Date): Not Applicable Expiration Date: March 2, 2009, unless reissued (now May 8, 2009 per NOT-OD-07-093 ) objective of this funding opportunity announcement (FOA) is to solicit grant applications for basic research projects to investigate how changes in the extracellular matrix with age affect the function of the tissues of the musculoskeletal system and skin.

Projects are encouraged that determine how cellular aging processes lead to altered matrix production and maintenance, and how aging-related altered matrix composition and organization affect the function of these tissues.

funding opportunity utilizes the NIH R21 Exploratory/Developmental Research Grant award mechanism and runs in parallel with a program announcement of identical scientific scope that utilizes the traditional research project grant (R01) mechanism ( PA-03-167 ) . number of awards made under this solicitation will depend on the overall scientific merit of the applications and the availability of funds.

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.

The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications Period and Award Levels: The applicant may request a project period of up to two years with a combined budget for direct costs of up to $275,000 for the Eligible organizations: For profit organizations; Non-profit organizations; Public or private institutions, such as universities, colleges, hospitals and laboratories; Units of State government; Units of local government; Eligible institutions of the Federal government; Domestic institutions; and Foreign institutions.

Eligible Project Directors/Principal Investigators (PD/PIs): 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 support.

may submit more than one application, provided they are scientifically See Section IV. 1 for application materials. The SF424 (R&R) Application Guide for this FOA is located at these Web sites: http://grants1.

nih. gov/grants/funding/424/SF424_RR_Guide_General_Ver2. doc http://grants1.

nih. gov/grants/funding/424/SF424_RR_Guide_General_Ver2. pdf information on SF424 (R&R) Application and Electronic Submission, see the Application and Electronic Submission Information: http://grants.

nih. gov/grants/funding/424/index. htm information on Electronic Submission of Grant Applications: http://era.

nih. gov/ElectronicReceipt/ Telecommunications for the hearing impaired is available at: TTY 301-451-5936 Part I Overview Information II Full Text of Announcement I. Funding Opportunity Description III.

Eligibility Information IV. Application and Submission Information of Application Submission Submission, Review and Anticipated Start Dates Sending an Application to the NIH V. Application Review Information Additional Review Criteria Additional Review Considerations Sharing Research Resources Announcement and Award Dates VI.

Award Administration Information and National Policy Requirements Scientific/Research Contact(s) Section VIII. Other Information - Required Federal - Full Text of Announcement Section I. Funding Opportunity elderly frequently experience problems associated with the musculoskeletal system and skin that affect their quality of life.

Some of these problems, for example, muscle weakness, are due to changes in tissue that is thought to be unavoidably linked to aging. Other problems are due to disease processes or accumulation of disabling conditions for which the elderly are particularly susceptible, likely due to changes in the diseased tissue with age and/or changes in tissues upon which the diseased tissue depends.

and bone are classified as connective tissues and are composed largely of extracellular matrix. The structural support these tissues give to the body depends on the matrix composition and structure; that composition and structure being a result of activity of the resident cells (chondrocytes, osteoblasts, osteocytes, and osteoclasts).

Reciprocally, the matrix and the mechanical and biochemical processes it is subject to, affect the cells. Muscle and skin are not connective tissue, but each depends on connective tissue for function: the dermis and subcutaneous fat in the case of skin, and the endo- peri- and epimesium layers and tendons in the case of muscle.

The interaction of the epidermis and the muscle fibers with their associated connective tissue and, in particular, the extracellular matrix, is fundamental to the function of these tissues. In most of these tissues there is evidence of increased turnover of extracellular matrix with age as well as changes in composition of the matrix with age.

Paradoxically, however, the matrix can become increasingly insoluble, less digestible and more cross-linked with age. Because these tissues depend on matrix for function and cell viability, these aging-associated changes in matrix are likely key to altered integrity and function of the musculoskeletal tissues and skin in the elderly.

needs to be done to understand the changes that take place in extracellular matrix composition and structure with age, why those changes occur and the mechanisms by which they result in altered tissue function. Changes occur in both collagenous and non-collagenous proteins, and post-translational modifications may be different in aged vs. younger tissues.

Important post-translational modifications may include glycosylation, phosphorylation and sulfation, as well as glycation and formation of cross-linkages. Some of these modifications play specific roles in specific tissues and have been shown to change with age.

Furthermore, there is evidence that the extracellular matrix acts as a reservoir of humoral factors such as hormones and growth factors, and mediates cell interactions with these factors. Thus, changes in matrix composition with age could lead to altered local balances or effects of these factors.

extracellular matrix is involved in normal tissue function on a number of levels, including regulation of cell fate, growth and function within the tissue. The matrix is a mediator of signals for cell proliferation and differentiation, and for apoptosis. Cell adhesion to extracellular matrix, may, in and of itself, help prevent apoptosis.

The extracellular matrix may have an influence on vascular function and neurological function, and the converse may also be true. Work in cancer shows that the matrix influences angiogenesis. Thus, matrix influences on blood vessels and nerves in aging tissues of the musculoskeletal system and skin may be important to understand, as vascular and neural function change.

Because stem cells may play a role in maintaining cell numbers and function and in healing of aging tissues, it is also important to understand how the matrix microenvironment of these tissues affects recruitment, differentiation, and functional integration of stem cells. structural support lent by the matrix is critical to the structure and function of tissues of the musculo-skeletal system and skin.

The extracellular matrix is the medium through which mechano-transduction takes place, which is vital to the health of cartilage, bone and muscle.

Furthermore, the ability to generate force (in the case of muscle) or respond to forces with appropriate structure (in the case of cartilage, skin and bone) is inherent in the arrangement of the the musculoskeletal system, and to some degree where there is mechanical action on skin, the health of the tissue is dependent on interaction with associated tissues, notably through the extracellular matrix.

These interactions can be endocrine, paracrine, or mechanical. In some cases, changes in one tissue may result in changes in the extracellular matrix and resulting tissue health of another associated tissue.

For example, in osteoarthritis changes occur in the quality and quantity of cartilage matrix, and the underlying bone is also affected, but it is unclear how these may on several tissues may need to be integrated to investigate tissue interactions as they affect, and are affected by, altered extracellular matrix with age.

Research is needed on interdependent aging changes in bone, skin, muscle, and cartilage, and the role of extracellular matrix in these changes. The biomechanical and biochemical signals from these tissues and how the extracellular matrix mediates these effects may be critical to our understanding of interdependent changes in tissues with age.

FOA is intended to encourage basic research into aging effects on extracellular matrix and how those changes in extracellular matrix composition and organization contribute to the altered function seen with aging in the musculoskeletal system and skin.

While some descriptive work may be justified to document changes that take place in extracellular matrix with age, studies are especially encouraged to investigate the mechanisms whereby aging leads to these changes and by which altered matrix affects cell and tissue function. The following examples illustrate areas of research that are of interest, but serve as examples only, and are not exclusive.

Basic biology studies on aging that use animal models or human tissues are of interest. However, clinical studies in humans, beyond collection of tissues or cells for in vitro use, are outside the scope of this FOA.

The mechanisms by which altered composition of the matrix seen with age affects mechanotransduction and the response of cells to loading Effect of age-related changes in matrix structure/function on the susceptibility of cells to altered apoptosis Effect of age-related changes in matrix structure/function on cell Interactions between cells and matrix that lead to characteristic alterations in cell or tissue morphology and function with age.

For example, thinning of epidermis or change in fiber type in muscle. How cell senescence affects matrix synthesis, secretion, assembly, or turnover How altered matrix composition or structure may predispose tissues to diseases commonly associated with aging, such as Paget's disease or osteoarthritis.

How alterations in matrix composition or structure with age affect normal tissue repair or cell turnover, including involvement of stem cells in these How the changing extracellular matrix environment with age affects the local bioavailability of growth factors or hormones that influence tissue health and Mechanisms by which changes in one tissue, lead to altered structure and function in another tissue.

For example, how muscle weakness of sarcopenia affects the structure and integrity of the associated bone. Such interaction could be effected through mechanotransduction, through soluble factors such as IL-6, or through other mechanisms.

How alterations in activity levels or function affect matrix structure and function, particular in the context of disabling conditions; this may include studies of muscle atrophy and contractures or osteoporosis. See Section VIII, Other Information - Required Federal Citations , for policies related to this announcement. This funding opportunity will use the NIH Exploratory/Developmental Research Grant (R21) award mechanism(s).

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation ) applications will not be accepted. Up to two resubmissions (formerly revisions/amendments") of a previously reviewed exploratory/developmental grant application may be submitted .

See NOT-OD-03-041 , May 7, 2003. This funding opportunity uses just-in-time concepts. It also uses the modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement .

Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5. 4, Modular Budget Component, of the Application Guide).

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 NIA, NIAMS, and NICHD 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 The total project period for an application submitted in response to this funding opportunity may not exceed 2 years.

Direct costs are limited to $275,000 over the two years of the R21 award, with no more than $200,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period. For example, the applicant may request $100,000 in the first year and $175,000 in the second year.

The request should be tailored to the needs of the project. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this Program Announcement funding opportunity. Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation .

See NOT-OD-05-004 . III. Eligibility Information 1.

A. Eligible Institutions application(s) if your organization has any of the following characteristics: Public or private institutions, such as universities, colleges, hospitals, and laboratories Units of State government Units of local government Eligible agencies of the Federal skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. 2. Cost Sharing or Matching This program does not require cost sharing as defined in the current NIH 3.

Other-Special Eligibility Criteria IV. Application and Submission Information Instructions for Submission via Grants. gov To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, 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: Grants.

gov ( http://www. grants. gov/GetStarted ) eRA Commons ( http://era.

nih. gov/ElectronicReceipt/preparing. htm ) PD/PIs should work with their institutions/organizations to make sure they are registered in the NIH Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as 1) Organizational/Institutional Registration in Grants. gov/Get organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants. gov registration process.

organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration. also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.

Direct questions regarding Grants. gov registration to: Grants. gov Customer Support Business Hours: M-F 7:00 a.

m. - 9:00 p. m.

Eastern Time 2) Organizational/Institutional Registration in the eRA Commons To find out if an organization is already Commons-registered, see the " List of Grantee Organizations Registered in NIH eRA Commons. Direct questions regarding the Commons registration to: Phone: 301-402-7469 or 866-504-9552 (Toll Free) Business hours M-F 7:00 a. m.

8:00 p. m. Eastern Time 3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users The individual designated as the PD/PI on the application must also be registered in the NIH eRA Commons.

It is not necessary for PDs/PIs to register with Grants. gov. The PD/PI must hold a PD/PI account in the Commons and must be affiliated with the applicant organization. This account cannot have any other role attached to it other This registration/affiliation must be done by the Signing Official (SO) or their designee who is already registered in the Commons.

Both the PD/PI and SO need separate accounts in the NIH eRA Commons since both are required to verify Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization.

Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the 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 institution is already registered in both Grants. gov and the Commons .

The NIH will accept electronic applications only from organizations that have completed all 1. Request Application Information must download the SF424 (R&R) application forms and 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. assistance contact GrantsInfo, Telephone 301-710-0267, Email: [email protected] .

for the hearing impaired: TTY 301-451-5936. Content and Form of Application Submission using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide ( MS Word or PDF ). SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH.

There are fields within the SF424 (R&R) application components that, 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/PI’s assigned eRA Commons User ID ). Agency-specific instructions for such fields are clearly identified in the Application Guide.

For additional information, see Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.

gov/ APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the Research & Related Project/Performance Site Locations & Related Other Project Information & Related Senior/Key Person Subaward Budget Attachment(s) Form Note: While both budget components are included in the SF424 (R&R) forms package, the NIH R21 uses ONLY the PHS 398 Modular Budget.

(Do not use the detailed Research & Related Budget.) special provisions apply to applications submitted by foreign organizations: Charge back of customs and import fees is not Format: Every effort should be made to comply with the format specifications which are based upon a standard U.S. paper size of 8. 5 x 11 within each PDF.

Funds for up to 8% administrative costs (excluding equipment) may be requested. See NOT-OD-01-028 , Organizations must comply with Federal/NIH policies on human subjects, animals, and biohazards. Organizations must comply with Federal/NIH biosafety and biosecurity regulations.

See Section VI. 2. , Administrative and National Security Requirements.

Proposed research should provide a unique research opportunity not available in the United States. 3. Submission Dates and Times See Section IV.

3. A for details. Submission, Review, and Anticipated Start Dates Date(s): Standard dates apply, please see http://grants.

nih. gov/grants/funding/submissionschedule. htm for details Peer Review Date(s): Standard dates apply, please see http://grants.

nih. gov/grants/funding/submissionschedule. htm for details Council Review Date(s): Standard dates apply, please see http://grants.

nih. gov/grants/funding/submissionschedule. htm for details Earliest Anticipated Start Date: Standard dates apply, please see http://grants.

nih. gov/grants/funding/submissionschedule. htm for details not required for this funding opportunity.

in response to this FOA, applicants should access this FOA via http://www. grants. gov/Apply and follow steps 1-4.

Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT Applications may be submitted to Grants. gov on or after the opening date and must be submitted no later than 5:00 p.

m. local time (of the applicant institution/organization) on the application submission date(s). (See Section IV.

3. A. for all dates.)

If an application is not submitted by the submission date(s) and time, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be transferred from Grants. gov to the NIH Electronic Research Administration process for validation.

Both the PD/PI and the Signing Official for the organization must verify the submission via Commons within 2 business days of notification of the NIH validation. Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH.

Incomplete applications will not be The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed.

This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note that such an application is considered a "resubmission" for the SF424 (R&R). There will be an acknowledgement of receipt of applications from Grants.

gov and the Commons . Information related to the assignment of an application to a Scientific Review Group is also in the Commons . 4.

Intergovernmental Review This initiative is not subject to intergovernmental review . 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 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 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 the NIH Grants Policy Statement . 6.

Other Submission Requirements The NIH requires the PD/PI 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. 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 Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications . Renewal (formerly competing continuation or Type 2 ) applications are not permitted. Specific Instructions for Modular Grant applications.

Applications requesting direct costs in each year of $250,000 or less (excluding consortium F&A costs), must be submitted in a modular budget format using the Modular Budget Component provided in the SF424 (R&R) Application Package and Instructions Guide (see specifically Section 5. 4). 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. Application Characteristics All application instructions outlined in the SF424 (R&R) application are to be followed, with the following requirements for R21 applications: R21 applications will use the modular budget format and "Just-in-Time" concepts, with direct costs requested in $25,000 modules, up to the total direct costs limitation of $275,000 over an R21 two-year period.

No more than $200,000 in direct costs will be allowed in any Items 2-5 of the Research Plan of the R21 application may not exceed 15 pages, including tables, graphs, figures, diagrams, and charts . Introduction (required for a resubmission application) is limited to one page.

Preliminary data are not required but may be included if each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits.

All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a . pdf extension must be used. materials should be limited, as is consistent with the exploratory nature of the R21 mechanism.

The following materials may be included in the Appendix: publications, manuscripts ( accepted for publication), abstracts, patents, or other printed materials directly relevant to this project. Do not include manuscripts submitted for publication. press: Include only a publication list with a link to the on-line journal article or the PubMed Central (PMC) submission identification number.

Do not include the entire article. accepted for publication but not yet published: The entire article may be submitted electronically as a PDF attachment. published but an online journal link is not available: The entire article may be submitted electronically as a PDF attachment.

Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents. Graphic images of gels, micrographs, etc. provided that the image (may be reduced in size) is also included within the 15-page limit of Items 2-5 of the Research Plan.

No images may be included in the Appendix that are not also represented within the Research Plan Do not use the Appendix to circumvent the page limitations of the Research Plan. An application that does not observe these limitations may be delayed in the review process. for Sharing Research Data 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 must include a plan for sharing research data in their application.

The data sharing policy is available at http://grants. nih. gov/grants/policy/data_sharing .

All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources NIH policy 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/grants/policy/nihgps_2003/NIHGPS_Part7.

htm#_Toc54600131 ). 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.

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. Section V. Application Review Information 1.

Criteria ( Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025 ). criteria described below will be considered in the review process. 2.

Review and Selection Process submitted for this funding opportunity will be assigned to the ICs on the basis of established NIH 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.

initial merit review, all applications will: selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score. second level of review by an appropriate national advisory council or board following will be considered in making funding decisions: merit of the