NOT-DC-11-001: NIDCD and NIMH Announce Availability of Funds for Competitive Revision Applications for Targeted Research on Non-Verbal School-Aged Children with Autism (R01, R34 and P50)

NIDCD and NIMH Announce Availability of Funds for Competitive Revision Applications for Targeted Research on Non-Verbal School-Aged Children with Autism (R01, R34 and P50)

Notice Number: NOT-DC-11-001

Key Dates
Release Date: August 20, 2010
Application Due Date: October 22, 2010
Earliest Anticipated Start Date: July 1, 2011

Issued by
National Institute on Deafness and Other Communication Disorders (NIDCD), http://www.nidcd.nih.gov
National Institute of Mental Health (NIMH), http://www.nimh.nih.gov

Purpose

The National Institute on Deafness and Other Communication Disorders (NIDCD) and the National Institute of Mental Health (NIMH) announce the opportunity for investigators and United States institutions/organizations with active NIDCD or NIMH-supportedR01, R34 and P50 grants to submit revision applications (formerly termed competitive supplements) to support an expansion of the scope or research protocol to develop preliminary investigations into the characterization and/or treatment of non-verbal school-aged children with autism.

Background

In April 2010, the NIH convened a multidisciplinary workshop to discuss the state of the empirical knowledge about the substantial subgroup of children with autism who have not developed functional verbal language by five years of age. The discussants reviewed the current state of scientific knowledge, critical gaps in our knowledge, and identified research opportunities that could be garnered to address knowledge gaps. A series of presentations, and group discussions, addressed the three major foci of the workshop.

Who are these children? What do we know about their developmental trajectories?
How can we assess their skills and knowledge across different domains, with special reference to those abilities relevant to language acquisition (e.g., verbal comprehension, sensory and motor skills, apraxia)?
What treatments/interventions are effective in improving spoken language and communication in these children (augmentative and non-augmentative methods)?

A number of research needs and opportunities were identified. There is a need for novel methods for assessing cognition and language comprehension in non-speaking children with ASD, using a range of neural and behavioral approaches. Studies are needed to elucidate the underlying mechanisms that explain why some children do not acquire spoken language by school-age, in spite of exposure to evidence-based interventions. Potential areas of investigation include oral-motor skills, auditory/speech processing, social attention mechanisms, and fundamental impairments in intentional communication. Comprehensive treatment studies focusing on non-speaking school-aged children with ASD should address active ingredients of the intervention and moderators of treatment response. An extensive summary of the workshop is available at: http://www.nidcd.nih.gov/funding/programs/10autism/detail and potential applicants are encouraged to review the summary.

Scope and Objectives of the Competive Revision

A competitive revision of up to a maximum 2 years duration (the project period of the competitive revision may not extend beyond that of the parent award) will be limited to currently active NIDCD and NIMH projects that focus on clinical aspects of autism. These parent projects should already have the capability of recruitment within this population.
The goal of this competitive revision is to develop preliminary investigations into the characterization and/or treatment of non-verbal school-aged children with autism and include the one of the following only:

Characterize the population: Given the paucity of attention to this population, this is a logical first step. We need to better understand this diverse population, the range of phenotypic profiles, and the varying trajectories of development. Two options are available:
1. Collect new data, e.g., expand existing assessment protocols for a fuller profile of behavioral/cognitive phenotypes; pilot test physiological methods (e.g., functional imaging, electrophysiology, magnetoencephalography, eye tracking) to measure implicit knowledge or response to intervention.
2. Analyze existing data, e.g., propose additional analyses of existing proprietary data. Also of interest are applications proposing to analyze data in public-access data repositories, such as the National Database for Autism Research (NDAR) (http://ndar.nih.gov)

Conduct treatment pilot studies: This population is often excluded in clinical treatment studies or clinical trials, despite evidence that lack of language by age 5 is considered a strong prognostic indicator of poorer outcome. Addition of school-aged non-verbal children to ongoing treatment studies would be informative. In addition, pilot studies are encouraged of adapted/novel treatments for nonverbal children who fail to make language gains (non-responders) in the parent study.

Eligibility

This notice calls for competitive revision applications to active NIDCD and NIMH Research Grants funded under R01, R34 and P50 grant mechanisms.

To be eligible, the parent award on which the revision application is based must be active at the time of the proposed start date of the revision. Also, the project period of the competitive revision may not extend beyond that of the parent award. Therefore, the revision application’s project end date must be equal to or earlier than the parent award’s project end date. If a no-cost extension is needed to complete the work to be proposed in the revision, the no-cost extension must be in place before the application is submitted. Note no-cost extension notifications cannot be submitted in the Commons until 90 days before the project end date and a request for an early no-cost extension will not be considered. Thus the requested budget period may be limited for some applications.

The proposed studies must address characterization of and/or treatment for non-verbal school-aged children with autism, as described above.

All revision applications must be submitted by the sponsoring institution of the PD/PI (or Contact PD/PI for multi-PD/PI grants) listed on the parent grant. Only one revision request may be submitted per NIDCD- or NIMH-funded parent grant.

NIDCD and NIMH encourage the participation of individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals with disabilities and individuals from disadvantaged backgrounds.

Budget and Funding Information

The NIDCD and NIMH intend to commit up to $3 million in total costs in FY 2011 to fund up to 8-12 competitive revisions in response to this announcement.
Applicants must submit a budget using the same budget format as was used for the parent award.

An applicant may request a budget of up to $200,000 per year for direct costs associated with the proposed new work. The maximum duration of each award will be limited to two years. Facilities and Administrative (F&A) costs will be paid at the full, negotiated rate. Applicants should provide a detailed budget justification for personnel costs, supplies, and other expenses.

Although the budget plans of the NIDCD and NIMH provide support for this program, awards pursuant to this solicitation are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Application Review Process

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.

For funding considerations, revision applications will be assigned to NIDCD or NIMH, wherever the parent grant was funded. Applications that are complete will be evaluated for scientific and technical merit by a scientific review group convened by NIDCD, in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below. Applications deemed to be non-responsive by Institute staff will be withdrawn and not reviewed. Applicants will be notified regarding the review outcome.

As part of the scientific peer review, all applications will:

Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit, generally the top half of applications under review, will be discussed and assigned an overall impact/priority score;
Receive a written critique; and
Receive a second level of review by the appropriate national advisory council or board.

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 standard review criteria, and additional review criteria (as applicable for the project proposed). The review committee will consider the overall scientific merit of the new work proposed, the appropriateness of the match between the parent project and the proposed work, and the likelihood for the project to achieve the goals noted in the Purpose section.

When reviewing a revision application, the committee will consider the scientific merit of the new work proposed and the appropriateness of the proposed expansion of the scope of the project. If the revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident. Additionally, the committee will consider the feasibility of accomplishing the specific aims of the revision application within the requested project period.

Scored Review Criteria. The standard review criteria for research grant applications and cooperative agreements will be used by reviewers for evaluating the scientific and technical merit of all applications as outlined in this Notice: NOT-OD-09-025.

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; Inclusion of Women, Children, and Minorities; Vertebrate Animals; and Biohazards.
Additional criteria also include:

Has the application demonstrated the availability or feasibility of recruitment?
Is there a clear plan for how the results of the information gleaned from the proposed pilot study will be used to inform the development of a larger, more definitive study?
Does the application demonstrate that the combined expertise of the proposed research team is adequate to ensure successful completion of the study, including expertise with the study population and with the proposed methods?

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; Select Agent Research; and Resource Sharing Plans.

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

Selection Process

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

Scientific and technical merit of the proposed project as determined by scientific peer review.
Availability of funds.
Translational impact and relevance of the proposed project to program priorities.
Programmatic balance

Award Notices

If the application is considered 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.

Terms of Award

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

The resource sharing plan will become part of the terms and conditions of the award.

In order to advance the goal of widespread data sharing among ASD researchers, investigators funded under this Notice who are collecting data from humans are expected to share those data via the National Database for Autism Research (NDAR, http://ndar.nih.gov). Established by the NIH, NDAR is a secure bioinformatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research data, tools, and supporting documentation. NDAR links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technology. Investigators funded under this Notice are expected to use these technologies to submit data to NDAR. To accomplish this objective, it will be important to formulate a) an enrollment strategy that will obtain the information necessary to generate a GUID for each participant, and b) a budget strategy that will cover the costs of data submission. The NDAR web site provides two tools to help investigators develop appropriate strategies: 1) the NDAR Data Sharing Checklist (http://ndar.nih.gov/ndarpublicweb/Documents/NDAR_Data-Sharing_Checklist_10152009.pdf) -- A list of critical steps in the data submission process, including informed consent language and GUID generation; and 2) the NDAR Data Submission Planning Cost and Effort Model (http://ndar.nih.gov/ndarpublicweb/Documents/NDAR_Data_Submission_Costs.xls) -- A customizable Excel worksheet that includes tasks and hours for the Principal Investigator and Data Manager. Investigators are expected to certify the quality of all data generated by grants funded under this Notice prior to submission to NDAR and to review their data for accuracy after submission. Submission of descriptive data is expected semi-annually (every January 15 and July 15); submission of all other experimental data is expected after the primary objectives of the grant have been met (the primary objectives of a grant will be determined in consultation with the investigator’s Program Officer prior to award). The NDAR Data Sharing Policy is available for review on the NDAR web site (http://ndar.nih.gov/ndarpublicweb/policies.go). NDAR staff will work with investigators to help them submit data types other than phenotypic, genetic, or imaging. For answers to frequently asked questions and how to contact the NDAR Manager, please see: http://ndar.nih.gov.
A Program Official from one or more of the participating NIH Institutes and Centers will be assigned to each funded application and will assume responsibility for normal stewardship of the awards.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. All awardees will have to specifically report on the awarded revision as part of the annual progress report of the parent grant.

How to Apply

The receipt date for revision applications is October 22, 2010.

Active NIMH and NIDCD P50 grants focused on autism will submit paper applications, using the NIDCD FOA for P50s (http://grants.nih.gov/grants/guide/pa-files/PAR-10-047.html). All other applicants interested in applying for revision support must submit the application electronically through Grants.gov, using the Funding Opportunity Announcement (FOA) that was used for the parent grant. Or, if this FOA is no longer active, use the Parent FOA that matches the program (activity code) of the award. The Parent FOA for the R01 activity code is http://grants.nih.gov/grants/guide/pa-files/PA-10-067.html.

This Notice should be mentioned in the cover letter.

For ALL applications:
Follow the instructions as noted below. Note: Font size restrictions apply as designated within the applicable SF424 (R&R) Application or the PHS398 application instructions. The current NIH guideline on page limitations should be followed.

Include a Cover Letter and cite the Notice Number (NOT-DC-11-001) and title [ NIDCD and NIMH Announces Availability of Funds for Competitive Revision Applications for Targeted Research on Non-Verbal School-Aged Children with Autism (R01, R34 and P50) ] in the first sentence.
When submitting a Competitive Revision application, the Descriptive Title of the Project (item 11 of the SF424 R&R cover) needs to be an exact match (including punctuation and spacing) of the parent project title.
Provide a one-page Introduction that describes the nature of the revision and how it relates to the scope of the specific aims, research design, and methods of the current grant. Use Item 2.1, Introduction to application, of the PHS 398 Research Plan component to provide this information.
The body of the application should contain sufficient information from the original grant application to allow evaluation of the proposed revision in relation to the expertise and approach of the original application.
Applicants must submit a budget using the same budget format as was used for the parent award. Any budgetary changes for the remainder of the project period of the current grant must be discussed in the Budget Justification.
Include the following additional information in the revision application:
1. Specific Aims. Summarize the activities that were included in the parent grant that encompass those proposed in the revision request. This section should include a description of the revision’s specific aims. Describe the relationship of the revision request to the parent grant and the impact that the proposed work will have on the research field(s) involved.
  The Specific Aims attachment is limited to one page.
2. Research Strategy. The research strategy section, limited to 12 pages, should discuss planned studies for characterization and/or treatment with this population, including research design and methods and data analysis
3. Budget. The budget format must be the same as that of the parent grant. Budget for the revision with a justification that details the items requested, including Facilities and Administrative costs and a justification for all personnel and their role in this project. The budget provided for the revision application must match the budget provided in the parent application. For instance, if the parent application was submitted using the Modular budget component, then the revision application must also use the Modular budget component.
4. Biographical Sketch for PD/PI and all new Senior/Key Personnel (those who are additions on the revision project). You will need to include an updated biographical Sketch for the PD/PI and new Senior/Key Personnel, using the forms, which are available as MS Word (http://grants.nih.gov/grants/funding/phs398/biosketch.doc) or PDF (http://grants.nih.gov/grants/funding/phs398/biosketch.pdf). There is no need to repeat information previously provided for other Senior/Key Personnel. The Biosketch attachment is limited to 4 pages.
5. Human Subjects/Vertebrate Animal documentation (if applicable). Include a current Human Subjects/IRB or Vertebrate Animals/IACUC approval letter, if available. Otherwise, this will be required at the time of funding. All appropriate IRB and IACUC approvals must be in place prior to a revision award being made. Any differences in the involvement or use of human subjects or specimens, or use of vertebrate animals, between the administrative revision activity and the parent grant should be noted. When appropriate, details should be provided on the protection of human subjects and inclusion of women, children, and minorities. Additional guidance on Human Subjects Research and Vertebrate Animals is provided under Part II of the PHS 398 instructions (http://grants.nih.gov/grants/funding/phs398/phs398.html).
  
  For electronic applications: Use the SF424 (R&R) Application Guide available at: ttp://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerB.doc (MS Word [3.5 MB]) or http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerB.pdf(PDF [4.5 MB]).

Inquiries

Applicants are encouraged to discuss their plans for responding to this Notice with the NIDCD or NIMH Program Directors who oversee the parent grant associated with the competitive revision request.

Dr. Judith Cooper
Deputy Director, NIDCD
Phone: 301 496 5061
Email:[email protected]

Dr. Lisa Gilotty
Chief, Research Program on Autism Spectrum Disorders, NIMH
Phone: 301 443 3825
Email: [email protected]