November 2007 Contents

1. Message from the NIMH Director
2. New Announcements about Funding Opportunities
   • NIMH-Administered Requests for Applications
   • NIMH-Collaborative Requests for Applications
   • NIMH Program Announcements
   • NIH Roadmap Initiatives
   • NIH Neuroscience Blueprint Initiatives
3. Future Research Directions
   • National Advisory Mental Health Council Concept Clearances for Potential New Research Initiatives
   • Upcoming NIMH Co-Sponsored Meeting
   • Summaries of NIMH-Sponsored Scientific Meetings
4. Update on Electronic Submission of Grant Applications
5. Recent NIMH News Releases

I. Message from the NIMH Director

As NIMH enters Fiscal Year (FY) 2008, I would like to review the current status of the FY 2008 budget, as well as the strategies we have implemented over the past few years to maintain funding levels in the post-doubling era and highlight their success.

The FY 2008 President’s Budget Request for the NIH was submitted to Congress in February 2007. The request for NIMH is approximately $1,405 million, an increase of $927 thousand or slightly less than 0.1 percent over the FY 2007 funding level approved by Congress. In June, both houses of Congress recommended increases to NIMH’s FY 2008 budget: an increase of $20 million from the House and $31 million from the Senate over the FY 2008 President’s Budget. The next steps involve reconciling these proposals between the House and the Senate. Until the budget proposal is finalized and is signed by the President, the NIH as a whole is currently operating at FY 2007 levels on a Continuing Resolution.

In FY 2007, Congress approved the reallocation of Roadmap funds and established a Common Fund in the NIH Office of the Director, which funded the Roadmap initiatives entirely. This returned nearly $17 million to NIMH and allowed us, in combination with other strategies already in place, to maintain the number of new and competing RPG’s at FY 2000-2004 levels, as well as new Principal Investigators at 5-year historical averages.

So what does all this mean for NIMH funding in FY 2008? Essentially, the proposed budget increase for NIMH will remain below inflation, as it has for the past three years, and may even be considered to be decreasing as inflation has climbed as high as 4.5 percent over that same time. Despite this outlook, many of the strategies NIMH has put in place since 2004 are allowing us to keep the success rate above 20 percent and continue funding the number of new competing applications at levels near 2003-2004 averages. This means that approximately 20 percent of all competing RPG applications will receive funding, but that 20 percent is not defined solely by percentile order or a strict payline.

In general, NIMH assumes that research applications that fall below the 20th percentile are scientifically meritorious and that sufficient funds are available to support up to three-fourths of these new and competing research applications. However, NIMH no longer funds applications according to a strict payline. Instead, Council and program staff may selectively recommend payment of grants that fall in this range, as well as beyond, based on: 1) Institute and division priorities; 2) balance in the existing research portfolio; 3) new investigator status; and 4) availability of funds. (For example, new R01 investigators were paid beyond the 20th percentile in FY 2007.) Additional priorities include: first time grantees applying for their first renewal with the goal of avoiding serious attrition or closure of new laboratories; and, established grantees with insufficient other support with the goal of avoiding the loss of outstanding laboratories.

To further guide NIMH in prioritizing budgetary resources, NIMH is undertaking a strategic planning process that enables us to generate research in the next decade that will profoundly transform the treatment, recovery, and prevention of mental disorders, paving the way toward cures. We plan to make the draft plan available for public comment in the fall 2007.

And lastly, you may be aware that NIH launched, as a major public-private partnership, the Biomarkers Consortium in October 2006 with a goal to search for and validate new biomarkers that accelerate the delivery of successful new technologies, medicines, and therapies for prevention, early detection, diagnosis, and treatment of disease. Neuroscience is included in the initial areas of activity. The Consortium is open to proposals regarding biomarker discovery, development, and qualification. If interested in applying for Biomarkers Consortium funding on neuroscience-related proposals, please contact Dr. Linda Brady at NIMH so we can facilitate the submission process.

II. New Announcements about Funding Opportunities

Each week, NIH electronically distributes the NIH GUIDE, a listing of all NIH Funding Opportunity Announcements (FOAs), which include requests for applications (RFAs), program announcements (PAs), and important notices for the scientific community. Below are samples of FOAs in which NIMH participates. The Research Funding page on the NIMH Web site has links to listings of all NIMH FOAs and other resources.

Note: You can subscribe to regular weekly e-mails of the NIH GUIDE.

NIMH-Administered Requests for Applications

Methods of Statistical Analysis of DNA Sequence Data for Studies Relating Variation to Disease

NIMH seeks applications related to the development of novel methods of statistical analysis of DNA sequence data in studies that aim to relate genetic variation to disease. Areas of interest include, but are not limited to, designing sequencing studies and statistical methods for relating the variation to phenotype; assessing the significance of the associations; incorporating population genetic factors such as population history, admixture, and natural selection; and finding sets of variants that may include functional variants.

Release Date: June 21, 2007; Expiration Date: January 9, 2008

• NIH GUIDE version of the R01 announcement (RFA-MH-08-040)

Prefrontal Cortical Influences on Brain Systems Supporting Complex Mental Function

This FOA solicits grant applications that propose to use novel electrophysiological, molecular, genetic and/or imaging techniques in animals to examine the fundamental mechanisms by which regions in the mature and developing prefrontal cortex interact with other cortical and sub cortical systems to give rise to sophisticated behavior and complex mental function (e.g., cognition, emotion, reward, motivation). This FOA seeks applications employing sophisticated approaches that enable precise spatio-temporal manipulation of circuits to better understand how the prefrontal cortex influences the function of these brain networks and their development. It is expected that applications will use non-human primates where the anatomical and functional homology of the prefrontal cortex with humans has been relatively well established. The use of rodents to develop novel approaches to manipulate prefrontal circuitry and examine associated complex behaviors will be considered if these techniques have the clear potential for near-term translation to non-human primates.

Release Date: October 17, 2007; Expiration Date: January 12, 2008

• NIH GUIDE version of the R01 announcement (RFA-MH-08-110)
• NIH GUIDE version of the R21 announcement (RFA-MH-08-111)

Center for Genomic Studies on Mental Disorders (U24)

The NIMH seeks to continue, enhance, and enrich research resources in the NIMH Human Genetics Initiative for free and open sharing with the scientific community. NIMH seeks Research Resource Center applications (U24) under this Funding Opportunity Announcement (FOA). The long-term objective of data sharing and research resource enrichment under this FOA is to accelerate gene discovery in mental disorders. It is expected that the Center will be comprised of a team of investigators with expertise in molecular biology, computer and information sciences, statistical genetics and psychiatric genetics. It is expected that this effort will involve activities at multiple institutions that are strategically and functionally coordinated such that the Center will function as a single, national resource. A new critical feature of the Center will be the establishment of a genomic cyberinfrastructure that represents the coordinated aggregate of software, hardware and other technologies, as well as human expertise, required to support current and future discoveries in the genetics of mental disorders. This cyberinfrastructure will integrate relevant and often disparate genetic and genomic resources to provide a useful, usable, and enabling framework for human genetic research and gene discovery in mental disorders that will be characterized by broad access and “end-to-end” coordination.

Release Date: October 23, 2007; Expiration Date: January 12, 2008

• NIH GUIDE version of the U24 announcement (RFA-MH-08-100)

Programs of Excellence in Scientifically Validated Behavioral Treatment

This R25 funding opportunity supports the development of curricula in science-based behavioral interventions for the addictive and mental disorders. For the purposes of this announcement, “behavioral interventions” refers to various learning-based psychotherapies, including, for example, cognitive, interpersonal, reinforcement, and skills training procedures. The goals in establishing the Programs of Excellence Award are to recognize and enhance clinical training programs that teach and develop research-based clinical practices and to provide a model for clinician education nationwide. Hallmarks of Programs of Excellence will be greater integration of science and practice than in the pre-award training program and immediate improvements in the competence of graduates to work in the area of psychotherapy treatment practice and innovation. In addition, curricula developed with the support of these R25 awards should be made publicly available so that the awardee programs can serve as models for other training programs.

Release Date: October 19, 2007; Expiration Date: January 18, 2008

• NIH GUIDE version of the R25 announcement (RFA-MH-08-080)

Adapting Basic Cognitive Measures for Clinical Assessment of Schizophrenia

The goal of this FOA is to support the adaptation and optimization of experimental cognitive measures for use in treatment trials of schizophrenia. Only tasks from experimental cognitive science and cognitive neuroscience traditions with (1) good construct validity and (2) evidence of impaired task performance in schizophrenia or theoretical relevance to cognitive domains implicated in schizophrenia symptomatology should be selected for further instrument development. Stages of measurement development covered in this initiative include standardization of cognitive task design and administration, adapting testing procedures so they are tolerated by persons with schizophrenia, testing the psychometric properties of adapted measures, and ensuring that modifications to experimental tasks do not compromise initial construct validity.

Release Date: October 16, 2007; Expiration Date: January 31, 2008

• NIH GUIDE version of the R01 announcement (RFA-MH-08-090)

Basic and Translational Research Opportunities in the Social Neuroscience of Mental Health

NIMH and the National Institute on Aging invite applications that examine the neurobiological bases of social behavior — including its genetic, developmental, cognitive and affective components — at either the basic or translational levels of analysis. It is anticipated that findings derived from these approaches will ultimately aid in understanding of the causes or disease courses of mental disorders, or will add to the knowledge base necessary for developing appropriate biomarkers or identifying key endophenotypes that will further advance the understanding of the causes and treatments of mental disorders across the developmental lifespan.

Release Date: August 8, 2007; Expiration Date: October 21, 2008

• NIH GUIDE version of the R01 announcement (RFA-MH-08-070)

Prevention of Trauma Related Adjustment and Mental Disorders in High-Risk Occupations

NIMH invites applications that will contribute directly to the goal of establishing empirically-demonstrated methods of preventing the development of trauma-related disorders among high trauma exposure occupational groups, for example, civilian employees and military personnel who regularly encounter traumatic situations. From a scientific perspective, occupations that involve exposure to trauma at higher than average frequency present unique opportunities for testing the effectiveness of preventive interventions designed to minimize posttraumatic adjustment disorders. From a public health and national security perspective, attending to the mental and behavioral health of individuals and groups who respond to emergencies, provide disaster relief, defend national interests, participate in peacekeeping missions, and maintain a civil society can be viewed as strengthening our national infrastructure. This RFA is being issued under the R01 and R34 mechanisms.

Release Date: April 12, 2007; Expiration Date: November 22, 2008

• NIH GUIDE version of the R01 announcement (RFA-MH-08-010)
• NIH GUIDE version of the R34 announcement (RFA-MH-08-011)

NIMH-Collaborative Requests for Applications

Epidemiologic Investigation of Putative Causal Genetic Variants Coordinating Center

The purpose of FOA is to provide support for a Coordinating Center to serve as a centralized resource to facilitate and support the investigation, in well-characterized population studies, of genetic variants identified as potentially causally associated with complex diseases in genomewide association and other genetic studies. It is the aim of this announcement to promote widespread sharing of the resulting population-based descriptive and association data to accelerate the understanding of genes related to complex diseases.

Release Date: August 17, 2007; Expiration Date: November 20, 2007

• NIH GUIDE version of the U01 announcement (RFA-HG-07-015)

Microbicide Innovation Program (MIP III)

The purpose of the Microbicide Innovation Program (MIP III) is to support novel and underexplored strategies in the field of topical microbicides. This broadly based program will support research and development of microbicides with the ultimate goal of facilitating technology or methodology design and development that can advance the field as a whole.

Release Date: August 17, 2007; Expiration Date: November 21, 2007

• NIH GUIDE version of the R21/R33 announcement (RFA-AI-07-034)

International Cooperative Biodiversity Groups (ICBG)

NIH, along with the National Science Foundation, the US Department of Agriculture, and the US Department of Energy, invite applications for the establishment or continuation of ICBGs to address the interdependence of biodiversity exploration for potential applications in health, agriculture, and energy, with investments in research capacity that support sustainable use of these resources, the knowledge to conserve them and equitable partnership frameworks among research and development organizations in the United States and low- and middle-income countries. This competition of the ICBG program includes several changes from past RFAs, including an increased emphasis on microbial and marine organisms, changes in target health areas, greater involvement of funded consortia with government contract resources, greater use of molecular and genomic tools, new data dissemination resources, and the opportunity to integrate energy or agriculture-related discovery research into projects.

Release Date: September 5, 2007; Expiration Date: December 5, 2007

• NIH GUIDE version of the U01 announcement (RFA-TW-08-003)

Collaborative Research to Explore New Uses for Existing Radioligands

NIDA, NIA, NINDS, and NIMH, are seeking applications to increase the use of established positron emission tomography (PET) or single photon emission tomography (SPECT) radioligands by reducing barriers to wider distribution, and by expanding their utility to the research on diseases or organs not previously studied with these radioligands. Radioligands are small molecules that have been tagged with a radioactive tracer that will appear in certain imaging scans, such as PET or SPECT. Applications are expected to propose multi-institutional collaborations between investigators who have the capacity for routine production of a given radioligand for human use and investigators who lack access to the radioligand but wish to demonstrate the feasibility of an innovative use for the radioligand in a novel patient population.

Release Date: August 8, 2007; Expiration Date: January 29, 2008

• NIH GUIDE version of the R21/R33 announcement (RFA-DA-08-001)

NIMH Program Announcements

Since the beginning of July 2007, NIMH has published several program announcements highlighting areas of research interest, which span topics in genetics, basic neuroscience, behavioral science, translational research, interventions, and mental health services research. The NIMH Web site has a full listing of these program announcements.

NIH Roadmap Initiatives

The NIH Roadmap is a set of transdisciplinary initiatives that seek to transform all of biomedical research and accelerate its discoveries. All NIH Institutes, including NIMH, participate in the Roadmap, and funding opportunities are open to all investigators.

Roadmap 1.5 Human Microbiome Project

The NIH Roadmap-funded Human Microbiome Project (HMP) has awarded FY 2007 funds to initiate the construction of a data resource for the HMP. These funds support one-year efforts to

• Sequence the genomes of 200 microbes that have been isolated from the human body;
• Recruit a set of healthy donors and obtain samples from a set of body regions (see report from HMP sampling workshop for recommendations on recruitment and sampling strategies); and
• Perform initial 16S rDNA gene metagenomic sequence analyses to estimate the complexity of the microbiota at these sites.

A total of $8.2 million in FY2007 was awarded to the sequencing centers at The Baylor College of Medicine, The Broad Institute, The J. Craig Venter Institute, and Washington University. The initial data being generated through this funding will provide a valuable resource to aid in the analysis of metagenomic sequence data to be produced in the next phase of the HMP. All data generated through this project will be rapidly released into public databases. NIH intends to release a solicitation in FY2008 to support the additional activity that will be necessary to generate the full HMP reference data set.

The Director’s Pioneer Awards were announced in September. These awards provide $2.5 million in direct costs over 5 years. Of the 12 awards made, eight were related to mental health or neuroscience. The New Innovators Awards were also announced. These awards are targeted to more junior researchers and provide $1.5 million in direct costs over 5 years. Of the 29 New Innovator Awards made, nine were related to mental health or neuroscience. See the list of award recipients.

The NIH Roadmap for Medical Research has funded nine Interdisciplinary Research Consortia as a means of integrating aspects of different disciplines to address health challenges that have been resistant to traditional research approaches. Several of these focus on areas of science important for NIMH priorities, including a phenomics center at UCLA led by Dr. Robert Bilder and one focusing on neurotherapeutics at UC Davis led by Dr. Paul Hagerman.

Institutional Clinical and Translational Science Award

The ever increasing complexities involved in conducting clinical research are making it more difficult to translate new knowledge to the clinic, and back again to the bench. These challenges limit professional interest in the field and hamper the clinical research enterprise at a time when it should be expanding. The purpose of this Roadmap initiative is to assist institutions in creating an academic home for clinical and translational science that has the resources to advance a cadre of well-trained multi-disciplinary investigators with access to innovative research tools and information technologies to promote the application of new knowledge and techniques to patient care. In September, the Roadmap Clinical and Translational Science Awards were made, adding 12 new centers to this clinical research network bringing it to a total of 24 centers.

NIH is still accepting applications for the next round of CTSA awards.

Release Date: March 22, 2007; Expiration Date: November 8, 2007

• NIH GUIDE version of this announcement (RFA-RM-07-007)

NIH Neuroscience Blueprint Initiatives

The Neuroscience Blueprint is a framework to enhance cooperative activities among 15 NIH Institutes and Centers that support research on the nervous system. The Blueprint aims to develop research tools, resources, and training and to make them available to the neuroscience community.

FY 2009 Initiative

Neuroplasticity Workshop Team

Team Leaders: Chiiko Asanuma, NIMH and Nancy Pilotte, NIDA — The Blueprint Neuroplasticity Workshop was held August 29-31, 2007 to get input from the extramural community about neurodevelopment initiatives. A workshop report will be made available soon.

FY 2008 Initiatives

Neurodevelopment Workshop Team

Team leaders: Beth-Anne Sieber and Bob Riddle, NINDS — To seek input from the extramural community on neurodevelopment initiative topics for FY 2008, the Blueprint workshop on Neurodevelopment was held November 13-15, 2006. The workshop report is available on the Blueprint Web site.

Blueprint Resources Antibody Initiative for Neurodevelopment (BRAINdev)

Team leaders: Bob Riddle, Randy Stewart, NINDS — Improved availability and NIH distribution of validated monoclonal antibodies for neurodevelopmental markers was a clear priority for many of the workshop participants. The working group has been developing plans for the implementation of two related mAB initiatives and a Request for Information (RFI). The NIH Blueprint will create and distribute approximately 150 high quality monoclonal antibodies via BRAINdev over the next three year period. Dr. Trimmer from the University of California will direct this work at NeuroMab through an extension of his NINDS/NIMH U24 cooperative research resource agreement. An RFI has been published in the NIH Guide requesting input about which antibodies should be produced.

Blueprint Stem Cell Workshop Team

Team Leaders: Barry Davis and Buck Wong, NIDCD — A workshop held June 28-29, 2007 generated many interesting ideas. Participants identified the following five needs: 1) validated methodology to identify neural developmental stages, 2) improved methods to genetically modify hESC lines for neural development, 3) efficient neural functional assays, 4) improved culture conditions for scale-up through neural developmental stages, and 5) effective targeted differentiation of hESCs into neuronal or glial cell types. The project team will explore options for FY 2008, 2009 and 2010, including the possibility of supplementing the BRAINdev Antibody initiative in FY 2008. A summary of the workshop can be found on the Blueprint Web site.

Blueprint Informatics Team

Team leader: Greg Farber, NCRR — The Biomedical Informatics Research Network (BIRN) is cyberarchitecture allowing investigators to virtually pool their data and share common resources freely. NIH has published two program announcements: the ontology announcement (PAR-07-425) and the tool and data federation announcement (PAR-07-426).

III. Future Research Directions

National Advisory Mental Health Council (NAMHC) Concept Clearances for Potential New Research Initiatives

This listing of potential future initiatives is meant to provide the earliest possible alert to the field of our research interests and of potential upcoming announcements to solicit that research. While NIMH plans to proceed with these initiatives, their publication and timing are not certain and depend on sufficient funding. The titles and brief descriptions are consistent with the information available at the time of concept clearance. The resultant FOAs may differ from the concepts in the final wording of their titles or other aspects.

To send questions about a specific concept, follow the “Submit Comments” link at the bottom of the description.

• Adapting Basic Cognitive Measures for Clinical Assessment of Schizophrenia
• Developing Innovative Approaches to Personalizing Mental Health Care
• Developing State Mental Health Services Research “Laboratories” for Policy Relevant Studies
• NIMH Career Opportunities in Research (COR) Honors Undergraduate Research Training Grant (T34)
• Programs of Excellence in Scientifically Validated Psychosocial Treatment

Related Information

• Past NAMHC Meetings (contains links to agendas, minutes, and Director’s Reports)
• A listing of recent NAMHC-approved concepts

Upcoming NIMH Co-Sponsored Meetings

NIMH is co-sponsoring NCDEU 2008: New Research Approaches for Mental Health Interventions, May 27-30, 2008 in Phoenix, Arizona, where presenters will focus on the most important developments in psychopharmacologic clinical research. See the NCDEU Web page for information about submissions and the new features for the 2008 meeting.

Summaries of NIMH-Sponsored Scientific Meetings

Research workshops and scientific meetings are some of the best forums in which to identify research gaps and to stimulate new areas of mental health research. Below are brief descriptions of meetings that NIMH has sponsored over the past several months. You should send questions about a specific meeting to the program contact listed in the description.

• NIH Conference on Building the Science of Dissemination and Implementation in the Service of Public Health
• Roundtable on Mood Disorders and Hormonal Transitions
• NIMH Annual International Research Conference on the Role of Families in Preventing and Adapting to HIV/AIDS
• Cognition and Stress: Advances in Basic and Translational Research
• Enhancing the Impact of Mental Health Services Research
• Mental Health Consideration in Secondary HIV Prevention
• NeuroAIDS in Asia and the Pacific Rim
• Novel Methods for Examining Prefrontal Interactions with Cortical and Subcortical Systems that Support Complex Mental Function
• Third Annual Meeting of the Developing Centers for the Intervention and Prevention of Suicide
• Are Endophenotypes for Genetic Studies of Suicidal Behavior within Reach?
• Child and Adolescent Onset Schizophrenia: Research Challenges and Opportunities

IV. Update on Electronic Submission of Grant Applications

The change to electronic submission for grant programs originally targeted to transition after May 2007 has been delayed; these include applications for Career Development (K), Fellowship (F), Training & Development (T&D), and complex mechanisms grants. Although all agencies were expected to transition to the new Adobe-based forms by the end of fiscal year 2007, Grants.gov has extended the deadline into 2008.

The U.S. Department of Health and Human Services Public Health Service Grants.gov Application Guide SF424 (R&R) and the corresponding Grants.gov SBIR/STTR Application Guide have been updated to include additional guidance on dealing with sub-award budgets, recent policy change to exclude federal holidays from the two day application viewing window, and suggested clarifications from the applicant community (see summary of changes). NIH welcomes feedback on the Application Guide. Email the NIH Electronic Submission team.

For more information, see the Electronic Submission Web site. You can also subscribe to the NIH Electronic Receipt Listserv to receive periodic updates on the electronic grant application program.

V. Recent NIMH News Releases

• Institute of Medicine (IOM) of the National Academies Announces New Members (October 22, 2007)
• Stress: Brain Yields Clues About Why Some Succumb While Others Prevail (October 18, 2007)
• How Schizophrenia Develops: Major Clues Discovered (October 17, 2007)
• Depressed Adolescents Respond Best to Combination Treatment (October 1, 2007)
• Genes Linked to Suicidal Thinking During Antidepressant Treatment (September 27, 2007)
• Workplace Depression Screening, Outreach and Enhanced Treatment Improves Productivity, Lowers Employer Costs (September 26, 2007)
• NIH Director Invests in Innovation, New Investigators (September 18, 2007)
• Manic Phase of Bipolar Disorder Benefits from Breast Cancer Medication (September 12, 2007)
• Global Survey Reveals Significant Gap in Meeting World's Mental Health Care Needs (September 6, 2007)
• Rates of Bipolar Diagnosis in Youth Rapidly Climbing, Treatment Patterns Similar to Adults (September 3, 2007)
• Gene Triggers Obsessive Compulsive Disorder-Like Syndrome in Mice (August 22, 2007)
• Success or Failure of Antidepressant Citalopram Predicted by Gene Variation (August 1, 2007)
• Faster-Acting Antidepressants Closer to Becoming a Reality (July 24, 2007)
• Improvement Following ADHD Treatment Sustained in Most Children (July 20, 2007)
• Violence in Schizophrenia Patients More Likely Among Those with Childhood Conduct Problems (July 2, 2007)

Please help us spread the word about the results of NIMH funding by acknowledging our support of your research, for example, in journal articles (citing your NIMH award by number when possible) and other communications. NIMH has two primary methods of getting the word out:

• Press releases — promoted through distribution to major media; posted on the NIMH Web site
• Science updates — highlight recently published findings; also posted on the NIMH Web site

These are all also distributed to the public through the NIMH ListServ, which now has more than 20,000 subscribers.

If you have a manuscript accepted for publication that describes an especially significant finding, please contact your NIMH program director to discuss the possibility of a news release or other forms of dissemination.

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