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Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Canadian Institutes of Health Research (CIHR), (http://www.cihr-irsc.gc.ca/e/193.html)
Health Research Board, Ireland (HRB), (http://www.hrb.ie)
Southwest Autism Research & Resource Center (SARRC), (http://www.autismcenter.org/)
Cure Autism Now (CAN), (http://canfoundation.org/)
National Alliance for Autism Research (NAAR), (http://www.naar.org/)

Components of Participating Organizations
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov)
National Institute for Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD), (http://www.nidcd.nih.gov)
National Institute of Child Health & Human Development (NICHD), (http://www.nichd.nih.gov)
National Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov)
Institute of Neurosciences, Mental Health and Addiction (INMHA), (http://www.cihr-irsc.gc.ca/e/8602.html)
Institute of Human Development, Child and Youth Health (IHDCYH), (http://www.cihr-irsc.gc.ca/e/8688.html)
Institute of Genetics (IG), (http://www.cihr-irsc.gc.ca/e/13147.html)

Title: Identifying Autism Susceptibility Genes

Announcement Type
 New

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

Request fo Applications (RFA) Number: RFA-MH-05-007

Catalog of Federal Domestic Assistance Number(s)
 93.242, 93.865, 93.853, 93.173, 93.113

Key Dates
 Release Date: December 13, 2004
Letters Of Intent Receipt Date(s): March 19, 2005
Application Receipt Dates(s): April 19, 2005
Peer Review Date(s): July 2005
Council Review Date(s): September/October 2005
Earliest Anticipated Start Date: September 30, 2005
Additional Information To Be Available Date (URL Activation Date): March 1, 2005
Expiration Date: April 20, 2005

Due Dates for E.O. 12372
Not applicable.

Additional Overview Content

Executive Summary

The goal of this Request for Applications (RFA) is to solicit applications to identify specific genes and gene variants in localized chromosomal regions that confer susceptibility to autism. Fine mapping of disease loci, or quantitative trait loci (QTLs), is expected to occur in very large datasets of pre-existing samples that have high statistical power for fine mapping autism susceptibility loci. In order to improve the probability of obtaining biologically and clinically meaningful associations between genotypes and disease outcomes, this initiative will not be limited to fine-scale mapping of a disease locus but will proceed to the next level of positional identification of strong candidate genes via assessment of the functional significance of the autism - associated genetic variants. Such assessments should include approaches based on computational biology, comparative and evolutionary genomics, as well as experimental evidence from relevant in vitro or animal model studies designed to probe the effect of genetic variants on gene expression, splicing or function.Applications are encouraged to focus on complex modes of inheritance that include multiple risk factors, e.g., environmental, multigenic and epigenetic effects. New data collection activities will not be supported. Data - and biomaterials, if possible - analyzed in projects supported under this RFA can be included in a data management and cell repository facility maintained under the NIMH Human Genetics Initiative (http://nimhgenetics.org) and broadly distributed to the scientific community.

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
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
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Merit Review Criteria
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement
Section I. Funding Opportunity Description

1. Research Objectives

Autism is a complex neurodevelopmental disorder with early childhood onset and a reported prevalence that ranges from 1 in 400 to 1 in 1,000 in the United States. There is strong evidence from twin and families studies for the impact of genetic variation on the etiology of autism. However, autism's mode of inheritance is complex and no simple genetic model seems to fit its familial transmission. An explanation for this inheritance pattern posits that susceptibility is produced by environmental factors and multiple loci of small to intermediate effect, some of which have independent additive influences and others of which act epistatically.

A variety of research designs have been applied to enhance our understanding of the genetic basis of autism. Researchers have: studied specific genes for association based on biological reasoning about the etiology of autism; identified candidate genomic regions by linkage studies; searched for chromosomal damage using cytogenetic studies; considered neurotransmitter pathways implicated in therapeutic action; and evaluated the disease and genetic loci in light of the etiologies of other neurodevelopmental disorders e.g., tuberous sclerosis, Rett syndrome and Fragile X syndrome - which share phenotypic characteristics in common with autism. Chromosome 15 has been a focus of genetic studies because cytogenetic abnormalities within 15q13-14 are found in a small fraction of the autism population. Multiple candidate gene association studies and whole-genome scans also have been conducted. Although suggestive evidence for linkage between DNA markers and given autism phenotypes has been reported on 17 of the 22 autosomes and at various locations on the X chromosome, only a few regions appear to be supported by independent studies. Specific susceptibility loci have not been convincingly identified.

NIMH, NINDS, NIDCD, NICHD, CAN and NAAR previously have initiated activities to encourage the sharing of research resources. Such activities, including establishment of CAN's Autism Genetic Resource Exchange (http://www.familyagre.org/), the NIMH Autism Genetics Initiative (http://nimhgenetics.org/), and the NAAR-initiated Autism Genome Project (http://www.naar.org/news/render_pr.asp?intNewsItemID=176), have permitted the assembly of large data sets that are expected to have adequate statistical power for the detection of autism susceptibility loci. Ongoing work is now focused on the conduction and analysis of genome scans of over 1,000 pedigrees in these data sets.

Such efforts are expected to result within the next year in the identification of several candidate genomic regions. Now is therefore an opportune time to plan the next generation of autism genetic studies, in which investigators will move from initial chromosomal localization to gene identification. This will require the generation of fine maps of implicated chromosomal regions to the level of the gene and the variants within those genes. Fine mapping in such large regions that may contain hundreds of plausible candidate genes will be the next major challenge in dissecting the genetic basis of autism.

This initiative is intended to support state-of-the-art research conducted in very large data sets of adequate power for the detection of autism susceptibility genes (quantitative trait loci (QTLs)), where candidate genomic regions have been or will be identified. Applications are solicited to fine map genes and gene variants to chromosomal regions and then to demonstrate that variation in the genes is associated with autism. This RFA also solicits applications that aim to identify in autism heritable changes that do not depend on changes in a DNA sequence. Such epigenetic mechanisms e.g., DNA methylation, changes in chromatin configuration, imprinting, and changes in protein conformation - that regulate gene expression but do not involve alterations in the genetic code itself could play a very important etiological role in autism.

It is expected that successful applications will exclusively focus on analyses in large pre-existing data sets, and will not include new data collection activities. In order to improve the probability of obtaining biologically and clinically meaningful associations between genotypes and disease outcomes, this initiative will not be limited to fine-scale mapping of a disease locus but will proceed to the next level of positional identification of strong candidate genes via assessment of the functional significance of the autism - associated genetic variants. Such assessments should include approaches based on computational biology, comparative and evolutionary genomics, as well as experimental evidence from relevant in vitro or animal model studies designed to probe the effect of genetic variants on gene expression, splicing or function. Applicants are encouraged to focus on complex modes of inheritance that include multiple risk factors, e.g., environmental, multigenic and epigenetic effects. The types of projects supported by this initiative include but are not limited to:

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

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH Research Project Grant (R01) and the Collaborative R01 for Clinical and Services Studies of Mental Disorders and AIDS (http://grants.nih.gov/grants/guide/pa-files/PA-01-123.html) award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

NIH (NIMH, NINDS, NIDCD, NICHD, NIEHS), CIHR (INMHA, IHDCYH, IG), HRB, SARRC, CAN and NAAR intend to commit approximately $4,295,000 dollars in FY 2005 to fund 2 3 new grants in response to this RFA. Individual yearly commitments are as follows: NIMH, $500,000; NINDS, $500,000; NIDCD, $100,000; NICHD, $100,000; NIEHS, $200,000; INMHA, $75,000; IHDCYH, $75,000; IG, $75,000; HRB, $1,250,000 ( 1,000,000); SARRC, $20,000; CAN, $100,000; and NAAR, $1,300,000. An applicant may request a project period of up to 5 years. 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) and other sponsors 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. The anticipated start date for new awards will be September 30, 2005.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

There is no limit to the number of applications an applicant may submit under the announcement. Applications submitted by Irish-based research teams may include research associates in Northern Ireland.

1.B. Eligible Individuals

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

2. Cost Sharing
Cost sharing is not required.

3. Other-Special Eligibility Criteria
 Not applicable.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].

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

2. Content and Form of Application Submission

Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (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/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

See Section VI.2 Administrative and National Policy Requirements for additional information.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times
Applications must be received on or before the receipt date of April 19, 2005. Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: March 19, 2005
Application Receipt Date(s): April 19, 2005
Peer Review Date: July 2005
Council Review Date: September/October 2005
Earliest Anticipated Start Date: September 30, 2005

3.A.1. Letter of Intent

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

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

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Steven O. Moldin, Ph.D.
Division of Neuroscience & Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7191, MSC 9643
Bethesda, MD 20892-9643
Telephone: (301) 443-2037
FAX: (301) 443-2037
Email: [email protected]

3.B. Sending an Application to NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 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)

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

Jean Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892-9609
Telephone: (301) 443-3367
FAX: (301) 443-4720
Email: [email protected]

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date listed in the heading of this funding opportunity. If an application is received after that date, it will be returned to the applicant without review. Applications will be evaluated for completeness by CSR.

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.

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIMH. Incomplete applications will not be reviewed.

If the application is not responsive to the RFA, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (See also Section VI.3. Reporting)

6. Other Submission Requirements

Because the applications may be co-funded by NIH, CIHR, HRB, SARRC, CAN and NAAR, all applicants should submit a brief letter to NIH indicating that the application and the summary statements for such applications can be shared with CIHR, HRB, SARRC, CAN and NAAR. Letters of authorization should be prepared by the principal investigator and co-signed by the official signing for the applicant organization. This letter may be combined with the Letter of Intent (see below) or may be submitted as a cover letter accompanying the application

Upon initiation of this program, NIH, CIHR, HRB, SARRC, CAN and NAAR plan to sponsor periodic meetings to encourage exchange of information among investigators, to foster collaborative efforts among program grantees, and to identify resources that would enhance the productivity of grantees. For this purpose, applicants should request travel funds for a two-day meeting each project year in the metropolitan DC area. Applicants should also include a statement in their applications indicating their willingness to participate in such meetings.

Plan for Sharing Research Data

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

All 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 sharing is not possible.

The 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.

The sharing of biomaterials, data, and software in a timely manner has been an essential element in the rapid progress that has been made in the genetic analysis of human diseases. To address the joint interests of the government in the availability of, and access to, the results of publicly funded research and in the opportunity for economic development based on these results, NIH requires applicants who respond to this RFA to develop and propose detailed plans for data sharing. It is expected that analyses to be conducted in projects supported under this RFA will occur in pre-existing data sets. Data sharing plans are expected to minimally include all clinical, diagnostic and genotyping data. If biomaterials (e.g., DNA and cell lines) from subjects to be analyzed in an application submitted in response to this RFA currently are not being broadly shared with the international scientific community, investigators are encouraged to include those biomaterials in their data sharing plan. This likely would require re-consenting of subjects, cell line shipments, and potentially re-drawing blood for cell line immortalization. The cost of such activities which will be a relatively minor activity compared to the main scientific focus of project - may be included in the submitted application's budget.

The dissemination of data and biomaterials via individual laboratories and Web sites is not sufficient, as it would force interested investigators to have to search several different data collections to make use of the results of this initiative. In addition, differences in protocols across projects for creating databases may make it impossible for researchers to combine information for integrated genetic analyses. It is preferable that data and biomaterials from subjects analyzed in grants funded under this RFA should be placed in common, public cell repositories and databases that are widely accessible by investigators in the international scientific community. An NIMH-supported data management facility and cell repository the NIMH Center for Collaborative Genetic Studies on Mental Disorders (http://nimhgenetics.org) - is such a community resource. Information regarding access procedures and policies utilized in the NIMH Human Genetics Initiative can be found at http://nimhgenetics.org. Further information is available from the NIMH staff contact for scientific/research issues listed below.

It is expected that the investigator's data sharing plan will specify the following elements: (1) the creation of comprehensive and verified databases that contain all clinical, diagnostic, and genotypic information; (2) if possible, the availability of high-quality cell lines, from which DNA will be extracted and stored; (3) mechanisms by which all databases and any biomaterials (DNA samples and cell lines, if applicable) are widely distributed to qualified investigators in the scientific community; (4) a protocol for wide dissemination of these data and applicable biomaterials; (5) a timetable for distribution; and (6) an assurance that data and applicable biomaterials are disseminated in a manner comparable to pre-existing protocols and procedures for distributing such data and biomaterials in the NIMH Human Genetics Initiative (see http://nimhgenetics.org).

After extensive discussion with mental health and human genetics researchers and advocacy members, the Genetics Workgroup of the National Advisory Mental Health Council (NAMHC) recommended that NIMH should draft a policy that provides for the sharing of genetic materials after a 12- to 18-month proprietary period (see http://www.nimh.nih.gov/publicat/nimhgenetics.pdf). Adherence with the time frame recommended by the NAMHC's Genetics Workgroup is highly desirable. This is expected to result in all data being released to the scientific community no later than the end of the award period, even if a competing renewal application is submitted. More rapid sharing is strongly encouraged. Requests for exemptions or extensions will require compelling justification and will be fully evaluated through peer review and by program staff.

NIMH, in consultation with NIH's Office of the General Counsel, the National Human Genome Research Institute's Ethical, Legal, and Social Implications Research Program and the Department of Health and Human Services' Office for Human Research Protections, has developed a model consent form for use in human genetic research at http://zork.wustl.edu/nimh/NIMH_initiative/NIMH_initiative_link.html. This may then serve as a template that is subject to modification and/or approval by local institutional review boards. It is expected that the applicant's approved consent form address the following:

NIMH will review consent forms and IRB approvals for all projects prior to funding under this RFA.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the international scientific community after publication. NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131. Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

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

Section V. Application Review Information

1. Criteria

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

The following will be considered in making funding decisions:

2. Review and Selection Process

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIMH. Incomplete applications will not be reviewed.

If the application is not responsive to the RFA, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle.

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIMH in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? Is there a high likelihood of success that the study will identify a gene(s) producing susceptibility to autism? Is there a high likelihood of success that the study will identify specific functional variants and result in the positional cloning of an autism susceptibility gene(s)?

Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?

Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

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

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See also Section VIII - Other Information.

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See also Section VIII-Other Information.

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed.

2.B. Additional Review Considerations

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

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data 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. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy. Program staff will be responsible for the administrative review of the plan for sharing research data.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the international scientific community after publication. NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://www.ott.nih.gov/policy/rt_guide_final.html. Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible. Program staff will be responsible for the administrative review of the plan for sharing research data.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the Principal Investigator before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report. (PHS 2590). See Section VI.3. Reporting.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The notice of award signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

The notice of grant award will be sent via email to the administrative official whose name is listed in Block 12 on the Face Page of the Form PHS 398.

2. Administrative and National Policy Requirements

All NIH Grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General http://grants.nih.gov/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
Not applicable.

3. Reporting

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

Section VII. Agency Contacts

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

1. Scientific/Research Contacts:

Steven O. Moldin, Ph.D.
Division of Neuroscience & Basic Behavioral Science
National Institute of Mental Health
6001 Executive Blvd., Room 7191, MSC 9643
Bethesda, MD 20892-9643
Telephone: (301) 443-2037
FAX: (301) 443-2037
Email: [email protected]

Laura A. Mamounas, Ph.D.
Neurogenetics and Development Program
National Institute of Neurological Disorders & Stroke
6001 Executive Blvd., Room 2132, MSC 9525
Bethesda, MD 20892-9525
Telephone: (301) 496-5745
FAX: (301) 402-1501
Email: [email protected]

Judith A. Cooper, Ph.D.
Division of Scientific Programs
6120 Executive Blvd., Suite 400-C, MSC 7180
Bethesda MD 20892-7180
Telephone: (301) 496-5061
FAX: (301) 402-6251
Email: [email protected]

Alice Kau, Ph.D.
Center for Developmental Biology and
Perinatal Medicine
National Institute of Child Health & Human Development
6100 Executive Blvd., Rm. 4B09, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-1383
FAX: (301) 496-3791
Email: [email protected]

Cindy P. Lawler, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-23
Research Triangle Park, NC 27709-2233
Telephone: (919) 316-4671
FAX: (919) 541-5064
Email: [email protected]

2. Peer Review Contacts:

Jean Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892-9609
Telephone: (301) 443-3367
FAX: (301) 443-4720
Email: [email protected]

3. Financial or Grants Management Contacts:

Bonnie J. Jackson
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6117, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-3483
FAX: (301) 443-6885
Email: [email protected]

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.

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

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

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/guide/notice-files/NOT-OD-04-042.html). 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 that is available at 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-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see 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. Applications that do not provide this information will be returned without review.

Public 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 public 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 PA 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.

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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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

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

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

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