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
This FOA is developed as a part of the NIH-wide Genes, Environment, and Health Initiative (GEI). All NIH Institutes and Centers participate in NIH-wide initiatives. This FOA will be administered by NHGRI (http://www.genome.gov) on behalf of the NIH (http://www.nih.gov).

Title: Comparing Design Approaches for Sequencing Disease-Associated Regions found in Genome-Wide Association Studies (U01)

Announcement Type
New

Request For Applications (RFA) Number: RFA-HG-09-014

Catalog of Federal Domestic Assistance Number(s)
93.172

Key Dates
Release Date: October 6, 2009
Letter of Intent Receipt Date: November 12, 2009
Application Receipt Date: December 11, 2009
Peer Review Date(s): March 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 2010
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: December 12, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

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

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Sequencing Center Responsibilities
4. Collaborative Responsibilities
5. Arbitration Process
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Background

Genome-wide association studies (GWAS), in which hundreds of thousands of SNPs across the genome are genotyped in hundreds or thousands of well-phenotyped samples, have identified many gene regions that are associated with common diseases and other traits. Most of the common SNPs with moderate to large effects on disease risk will have been included in the identified association regions, either directly or by imputation from other data sets. SNPs of common to moderate frequency with large to moderate allelic effects may also have been included in the association regions; the larger the GWAS sample size the more likely they would have been found.

However, most successful GWA studies account for only a small amount of the heritability of the disease studied; additional genetic contributions remain to be found. It has been proposed that the low amount of explained variance results, in part, because only a fraction of the contributing variants are detected in GWA studies, and that rare variants and structural variants, which can be hard to detect in GWA studies as currently carried out, contribute significantly to disease risk. The research problem then becomes one of comprehensively identifying all of the variants that contribute to disease risk, including the structural variants and rare SNPs.

With the recent increase in sequencing capability and reduction in cost, it is now possible to follow up a GWA study by sequencing the disease-associated regions in many samples to identify comprehensively the variants in those regions. Sequencing will find variants that are poorly imputed, such as SNPs with low LD, rare SNPs, copy-number variants, insertions, deletions, and inversions. Sequencing will also allow determination of their frequencies, LD patterns, and disease associations. The sequence data can then be used to help prioritize sets of candidates for subsequent functional studies to identify the causal variants.

A number of design strategies could be used for the follow-up sequencing studies. For example, sequencing could focus only on the exons in the disease-associated regions to attempt to identify the genes and coding sequence variants that contribute to the risk. Alternatively, entire disease-associated regions could be sequenced to find both non-coding and coding variants. The samples chosen for sequencing could include only ones from individuals with extreme phenotypes, to maximize the genetic signal, or could include ones from individuals from across the range of the phenotype distribution, to allow the discovery of variants that may not cause extreme phenotypes. Samples could come from one or multiple populations, and could include ones with particular haplotypes or ones that contributed strongly to the GWAS signal. Rare variants are an important subset of interest, so the sample sizes need to be large. Since the genetic architectures of various diseases and traits differ, it is likely that different strategies will be required for different types of diseases or GWAS signals. Currently it is not clear under which conditions particular strategies would be most useful or how to choose a particular design strategy in a specific instance.

Scope

This FOA solicits research proposals to participate in a systematic process to generate data sets that can be used to learn how to design sequencing follow-up to GWA studies. The research groups supported by this FOA will help develop a broad design strategy that will be used to sequence entire GWAS association regions in many samples; this strategy will be used for all the GWAS follow-up studies supported by this program. The samples will include ones spanning the range of phenotypes, the range of haplotypes, and multiple populations when possible, to capture the comprehensive patterns of variation in those regions.

The resulting data sets will allow the participating research groups to find the sets of variants most associated with the diseases or traits studied and to choose the variants that will be studied further (but not supported by this FOA), such as by typing the newly discovered variants in the complete set of samples and doing functional studies. The participating research groups will also use the data sets to compare various specific design strategies for how well they identify the variants that should be studied further. The sequence data sets will be made available to the research community when they are generated, so that other groups can also use the sequencing results for the diseases studied and for evaluating sequencing strategies for GWA studies.

This initiative is being supported by the NHGRI and the trans-NIH Genes, Environment, and Health Initiative (GEI), which is a four-year, NIH-wide program to identify major genetic susceptibility factors for diseases of substantial public health importance and to develop technologies for measuring environmental exposures. GEI is a multi-component program involving several related solicitations.

All completed GWA studies with replicated disease associations are eligible for this program, whether they have been supported by NIH (by GEI or other Institutes or Centers) or by other funding agencies. Since the broad aim of this program is to evaluate strategies for sequencing follow-up to GWA studies, complete genotype, phenotype, and exposure data sets must be deposited in dbGaP (or another NIH database with similar broad access). Applicants are strongly encouraged to submit these data by the time of the application; they will be required to submit these data before an award is made. Genotyping studies that have replicated the results of previous GWA studies in other sets of samples in particular regions, rather than doing genome-wide genotyping, are eligible, as long as their genotype, phenotype, and exposure data and the data of the initial studies are in dbGaP or a similar NIH database. This will allow researchers to examine the complete GWAS data sets to compare the design strategies.

Awards under this program will provide up to $150,000 direct costs (with a maximum of $250,000 total costs) per award to each GWAS group for providing the samples, designing the sequencing studies, analyzing the sequence data set for their GWA study, and evaluating the various design strategies. The awards will be for one year, starting in late summer 2010.

Funds will not be provided under this program to GWA groups for sequencing. NHGRI will support the production of the sequence data with the capacity at one to three of its large-scale sequencing centers (http://www.genome.gov/10001691). These centers will also contribute expertise and will participate in designing and interpreting these studies.

Funds will not be provided under this program for genotyping, submitting phenotype or exposure data to dbGaP, or functional studies. Other ICs or funders may support these activities.

To make the resulting sequence data sets as useful as possible for comparing design strategies, the funded groups (including analysis experts) whose studies are chosen will work closely in a consortium with each other, with the sequencers, and with NIH program staff to develop required common approaches. Before sequence production starts, the consortium will develop a broad design strategy that encompasses the various specific strategies to be compared. The consortium will decide on uniform criteria for

a. which association peaks in each GWA study will be sequenced, based on their significance and other factors such as additional genetic information;

b. the extent of sequencing needed in each peak region, based on the patterns of LD and genomic elements in those regions;

c. which samples get sequenced, based on including samples spanning the range of phenotypes and populations, with possible consideration of factors such as which samples and haplotypes contributed to the association signal. To find rare variants, it is anticipated that thousands of samples from each study will need to be sequenced.

Funded groups will need to provide at least 5 micrograms of DNA for each sample; tens to hundreds of micrograms per sample would be preferable.

The sequencing to be provided under this program will be roughly 3 Tb total over the three studies. Assuming that each study uses the same amount of capacity, each study could look at, for example, 4,000 samples in 11 regions of 0.9 Mb each at 25X coverage, or 10,000 samples in 5 regions of 0.8 Mb each at 25X. Standard design criteria for choosing regions and samples will be developed by the consortium, so the amount of sequencing provided for each study will vary depending on the number and breadth of the association signals and features of the samples.

All of the NHGRI policies for sequence data release, access, and publication (http://www.genome.gov/Pages/Research/SequenceMapsBAC/MedicalSequencing/MEDSEQPOLICIES-03.12.2008.pdf) are applicable to the awards made under this FOA. Specifically, it is expected that the sequence data generated in conjunction with the funded applications will be deposited rapidly after their production (i.e., on a weekly basis) into the Short Read Archive at NCBI for access through dbGaP or similar NIH database. Other investigators are free to use these sequence data for their own purposes, including submission of publications once the original depositors have published the first analysis of the data. Also of relevance are the NIH-wide GWAS policies (http://grants.nih.gov/grants/gwas/) that similarly require rapid data deposition and make the data available for use, but allow the specification that users of the data other than the GWAS investigators who provided the samples and their collaborators will have to respect a moratorium on submission of publication of results using these data for a period of no longer than one year. Because this FOA funds the sequencing of samples that were genotyped under those GWAS policies, NHGRI is open to negotiation of similar moratorium terms for the sequence data produced under this FOA. NIH is developing policies for sequence data release and these will also apply as appropriate.

When the sequencing centers produce the sequence data, each funded GWAS group will analyze the data from its study, including the variants identified by the sequencing that were not predicted well by imputation based on the GWAS genotype data. Groups will be able to describe the comprehensive patterns of variation and association in the disease-associated regions, including rare variants, variants with low LD, structural variants, haplotypes, and the association relations among the variants, phenotypes, and sample subcategories such as exposure classes. These analyses should lead to the identification of a set of variants that would be candidates for subsequent study, such as genotyping in the entire GWAS cohort and functional analyses (although such studies are beyond the scope of this FOA).

The groups participating in this project will also work together as a consortium to develop and carry out common analyses to compare the various design strategies, by choosing subsets of the data in each study according to each of those strategies (such as looking at entire regions and only at exons, looking at samples with the range of phenotypes and only at samples from the extremes of the phenotype distribution, looking at samples from only one and from multiple populations if available, and by choosing the samples based on haplotype, contribution to the GWAS signal, and by other criteria). By doing this for several diseases or traits with evidence for diverse genetic architectures, the program should provide an underlying large data set that is broadly available to researchers to use to examine the conditions when particular strategies would be appropriate. The consortium will produce a joint summary of the results found in these comparisons for later sequencing projects to build on. The analyzed and complete data sets will also be released according to NHGRI policies, to allow others in the scientific community to perform similar comparisons of design strategies.

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

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

Plans beyond the current funding opportunity are indefinite.

2. Funds Available

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

GEI includes the potential for an allocation of funds to the NIH Intramural Research Program, if such applications are among the most meritorious. The awards to intramural scientists will be limited to the incremental costs required for participation. These awards will not include salary or fringe benefits for federal employees with permanent appointments or costs related to administrative or facilities support (equivalent to F&A costs).

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

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Investigators from the NIH Intramural Research Program are eligible to participate in the NIH-wide Genes, Environment, and Health Initiative (GEI), including this FOA. Expanding this program to include intramural investigators will help GEI meet its goals of including the most highly scientifically meritorious projects, accessing diverse population samples, and ensuring programmatic balance across disease areas. It will also assist in meeting goals for enhancing intramural-extramural collaborations as outlined in the 2003 Institute of Medicine Report, Enhancing the Vitality of the National Institutes of Health. Applications from intramural investigators will be competitively reviewed.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided they are scientifically distinct.

Resubmissions. Resubmission applications are not permitted in response to this FOA.

Renewals. Renewal applications are not permitted in response to this FOA.

Section IV. Application and Submission Information

1. Address to Request Application Information

The most current PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

Foreign Organizations (Non-domestic (non-U.S.) Entity)

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.

Applications from foreign organizations must:

In addition, for applications from foreign organizations:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: November 12, 2009
Application Receipt Date: December 11, 2009
Peer Review Date: March 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 2010

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Lisa D. Brooks, Ph.D.
Program Director, Genetic Variation Program
NHGRI
(301) 435-5544
lisa.brooks@nih.gov (e-mail the letter of intent)

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Rudy Pozzatti, Ph.D.
Scientific Review Branch
NHGRI
Suite 4076
5635 Fishers Lane
Bethesda, MD 20892-930 5 (U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier service, non-USPS service)
(301) 496-7531
rp7s@nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at 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: 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 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

Investigators and their major analysts will be required to attend two meetings of the program consortium in the Bethesda, Maryland area, so applicants should include these costs in the budget.

Awardees must agree to the Cooperative Agreement Terms and Conditions of Award in Section VI.2.A Award Administration Information .

In place of sections 2-5, applications should use this 12-page format:

1. Significance of the disease or trait (up to 1/2 page)

Explain the significance of the disease or trait for population health and biomedical research, and any special features that make this disease or trait particularly compelling for this program.

2. The study population (up to 1.5 pages)

Explain what GWA study or follow-up genotyping study is proposed to be used, the populations and ethnicities of the participants and their numbers, and the phenotype and exposure data that are available. A large set of phenotype and exposure data may be valuable for analyses, if appropriate for the disease or trait being studied.

Note that applicants are strongly encouraged to have the genotype, phenotype, and any exposure data for the GWA study and any follow-up genotyping studies be in dbGaP or a similar NIH database by the application deadline; an award will be made only after all these data are in the database.

For this program, it will be particularly valuable to have many samples available (at least a few thousand) for choosing the set of samples for the sequencing, with a diversity of populations across the set of studies.

Provide information on the amount of DNA available for the samples, and how the amounts were estimated. At least 5 micrograms of DNA is needed for each sample; tens to hundreds of micrograms per sample is preferable.

3. Breadth of consent and process for data access (up to 1/2 page)

Explain the types of studies that the consent conditions allow, especially whether all studies are allowed or only ones relating to particular diseases or traits. This program aims to provide a data set that can be used to explore how design strategies compare for identifying which variants to study further; thus participant consent for a broad range of biomedical uses is best, although studies with more limited consents will be considered. Explain whether the samples are available to other researchers for additional studies.

Indicate whether the GWAS genotype, phenotype, and exposure data are already in dbGaP or a similar NIH database, or explain how the study is ready to provide those data quickly if an award were to be made. Explain briefly how researchers will be able to obtain access to the GWAS genotype, phenotype, exposure, and sequence data in dbGaP or a similar NIH database (i.e., which Data Access Committee must provide approval and any conditions that researchers must meet).

All the samples in a proposed study must have been properly consented for release of data to dbGaP or a similar NIH database. Consent forms must be provided in an appendix, as well as a brief description of any elements of the consent process that resulted in conditions on uses of the samples. Since the GWAS genotype data should already be in the database, it is anticipated that the consent forms will be adequate, but NHGRI staff will look at the consent forms prior to application or after the applications are received, to ensure that the consents are consistent with the release of the sequence data in the database. IRB approval (or the equivalent) for such data release will be required before the awards are made.

4. Evidence for a genetic component and summary of GWAS results (up to 2 pages)

Provide the evidence for a genetic contribution to the disease or trait, and what is known about its genetic architecture. Include the results of the initial GWA study and replication studies, in the same or different populations. Include any information on gene by environment interactions that would require taking into account exposure measures in the data set. If a replication study is proposed for this program, make clear which GWA study has data in dbGaP (or a similar NIH database) to allow analysis of a complete genotype, phenotype, exposure, and sequence data set.

5. Suggested sequencing study design (up to 3 pages)

Propose criteria for choosing GWAS association peaks for sequencing and the extent of sequencing around those peaks. Discuss criteria for choosing the samples to be sequenced, including the phenotype variables that would allow choosing extreme as well as intermediate phenotypes, and factors such as population and haplotype. If the disease or trait proposed for study is qualitative (presence or absence) rather than quantitative, are related data available, such as age of onset, that would allow choosing samples with a stronger genetic component?

List the chromosome regions, including their size, proposed for sequencing in this program and the basis for their choice. Include the calculation of how much sequencing would be needed for the proposed study using these criteria. Discuss the quality of the sequence data that will be needed.

Applicants need to describe all features of the proposed strategy to allow the reviewers to evaluate the applicant group’s expertise. Note that the final experimental design, however, will be decided on by the consortium group of PIs, sequencers, and NIH program staff. The actual amount of sequencing may be more or less than proposed, based on the criteria agreed on by the group and the capacity available.

6. Suggested analysis of the sequence data (up to 4.5 pages)

Explain how the data will be analyzed, both for identifying variants for further study in the specific GWA study proposed for use and for comparing the various possible design strategies. Indicate who will have major responsibility for these analyses. Include any special features of the proposed GWA study. Discuss how the power of the analyses relates to the sample size.

Note that analysis expertise--for the design of the experiment, for the analysis of the sequence data set for each study, and for the comparison of the design strategies--is a critical component of this application. Thus GWA study investigators are encouraged to include collaborations as needed with experts in sequence analysis. Provide examples of prior collaborations with broad release of results.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations of the Research Strategy component. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Specific Instructions for Foreign Applications

All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.

Section V. Application Review Information

1. Criteria

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

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NHGRI 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:

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? How significant is the disease or trait and how important would the proposed data be for providing insight into its biology? Would this GWAS study make an important contribution to an evaluation of design strategies for sequencing follow-up to GWA studies?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the investigators show expertise in the design and analyses of the sequencing studies? Do the investigators have experience in working cooperatively with others and sharing data and methods in a timely manner?

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?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Is the evidence for the association peaks replicated and convincing? Is a sufficiently large number of samples available for consideration for sequencing under a broad range of design strategies? Do the samples come from multiple populations or ethnic groups? How rich are the associated phenotype and environmental exposure data sets? Are the data in dbGaP or a similar NIH database, or is there evidence that the applicants will be able to provide the data quickly?

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.

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).

Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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

It is anticipated that applications will be reviewed in early 2010 and that awards will be made in the summer of 2010.

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2.A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for defining the details for the project within the guidelines of this FOA and for performing the scientific activities. The P.I. will agree to accept close coordination, cooperation, and participation of NIH staff in those aspects of scientific and technical management of the project as described under "NIH Program Staff Responsibilities".

The P.I. of a GWAS sequencing study design research group will:

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 HHS, PHS, and NIH policies.

2.A.2. NIH Responsibilities

The NIH Program Director is a scientist of the NHGRI extramural staff who will provide normal stewardship of the award and, in addition, will have substantial scientific and programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination. However, the role of NIH staff will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be reached by consensus of the participants and that NIH staff will be given the opportunity to offer input to this process. The NIH Program Director will participate as a member of the Steering Committee and will have one vote. The NIH Program Director will have the following substantial involvement:

2.A.3. Sequencing Center Responsibilities

The P.I. of a large-scale sequencing center will:

2.A.4. Collaborative Responsibilities

The Steering Committee will serve as the main governing board of this program. It will include the P.I. of each award in the program, a representative from each sequencing center, a representative from dbGaP, and additional members, including the NHGRI Program Director and any others agreed on by the rest of the Steering Committee. Other government staff may attend the Steering Committee calls and meetings if their expertise is required for specific discussions.

The Steering Committee will coordinate the development of the overall study design, including the choice of samples to sequence and the sequencing strategy, and will allocate the sequencing capacity to each GWA study according to this sequencing strategy. It will coordinate the development of the general strategies for the analysis of the sequence data in a GWA study and for the comparisons of the alternative design strategies within and across the GWA studies. It will ensure that the sequence data are deposited in the Short Read Archive and dbGaP and that the analysis results for the individual GWA studies and the comparisons of alternative design strategies are released broadly in standard and coordinated ways.

To address particular issues, the Steering Committee may establish groups as needed, which would include representatives from the grantees and the funding agencies, and possibly other experts. Each awardee P.I. will have one vote on the Steering Committee. Awardees will be required to accept and implement the common guidelines, procedures, and policies approved by the Steering Committee.

2.A.5. Dispute Resolution

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. A Dispute Resolution 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 dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts

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

1. Scientific/Research Contacts:

Lisa D. Brooks, Ph.D.
Program Director, Genetic Variation Program
NHGRI
5635 Fishers Lane, Suite 4076
Bethesda, MD 20892-9305
(301) 435-5544
(301) 480-2770 fax
Email: lisa.brooks@nih.gov

2. Peer Review Contacts:

Rudy Pozzatti, Ph.D.
Scientific Review Branch
NHGRI
5635 Fishers Lane, Suite 4076
Bethesda, MD 20892-930 6 (U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier service, non-USPS service)
(301) 402-0838
(301) 435-1580 fax
Email: rp7s@nih.gov

3. Financial or Grants Management Contacts:

Ms. Cheryl Chick
Grants Administration Branch
NHGRI
5635 Fishers Lane, Suite 4076
Bethesda, MD 20892-9306
(301) 435-7858
(301) 402-1951
Email:chickc@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the 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/.

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

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.

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