Expired RFA-DC-07-003: NIDCD Short-Term Enhancement Award for Research Careers in Language and Autism (K18)

Department of Health
and Human Services (HHS)

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EXPIRED

Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Institute on Deafness and Other Communication Disorders (NIDCD/NIH), (http://www.nidcd.nih.gov)

Title: NIDCD Short-Term Enhancement Award for Research Careers in Language and Autism (K18)

Announcement Type
New

Request For Applications (RFA) Number: RFA-DC-07-003

Catalog of Federal Domestic Assistance Number(s)
93.173

Key Dates
Release Date: December 22, 2005
Letters of Intent Receipt Date(s): April 24, 2006
Application Receipt Dates(s): May 24, 2006
Peer Review Date(s): October 2006
Council Review Date(s): January 2007
Earliest Anticipated Start Date: April 1, 2007
Additional Information To Be Available Date (Url Activation Date):
Expiration Date: May 25, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

This program will provide a short-term mentored career development and enhancement training experience in patient-oriented research of six months, typically over a sabbatical year or apportioned over two successive three-month summer periods, to established investigators in language/communication disorders research or autism research to acquire new research capabilities within the sister research domain for which support is being provided. The desired outcome is to facilitate research collaborations focusing on the intersection of these two research domains that will lead to new research programs competitive for NIH funding.
The estimated annual funds (total costs) available for the program is expected to be approximately $300,000. The actual amount may vary depending on the response to the RFA and the availability of funds. The total project period for an application submitted in response to this RFA is up to two years.
Up to four new awards are anticipated.
This program uses the K18 award mechanism.
Eligible organizations include domestic for-profit or non-profit institutions/organizations, or public or private institutions, such as universities, colleges, hospitals and laboratories. Foreign institutions are not eligible to apply.
Eligible principal investigators include doctoral-level investigators in language/communication disorders research or in autism research holding the rank of Associate Professor or Professor, or the equivalent in nonacademic settings, with evidence or documentation of research grant funding in one of the two areas.
Each applicant may submit only one application per review round.
See Section IV.1 for application materials.
Telecommunications for the hearing impaired is available at: TTY 301-451-5936

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt 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
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
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 prevalent neurodevelopmental disorder characterized by deficits in verbal and nonverbal communication, aberrant social interactions and stereotyped or rigid behaviors. Since communication deficits are at the core of the autistic syndrome, a body of research is developing focused on the characterization of symptoms and profiles of communicatively impaired autistic children, as well as on potentially effective interventions. However, important research needs remain, including: characterizing the developmental trajectories of verbal autistic children, identifying factors contributing to lack of progress in language acquisition, and evidence of language treatment efficacy with subgroups of autistic children, to name only a few. Researchers in child language disorders tackle many of the same issues with that population, but have historically remained apart from autism researchers. In recognition of the value in combining approaches, building on research findings of mutual value, and increasing research and research training on communication in autism, the National Institute on Deafness and Other Communication Disorders (NIDCD) joined with the National Alliance for Autism Research to cosponsor two Autism, Language and Communication Research Workshops in 2004. These organizations share a strong commitment to nurture a cadre of researchers who can further our understanding and improve the communication competencies of individuals with autism, particularly those who are nonverbal or minimally verbal.

One of the recommendations of the Workshop participants focused on the compelling need to provide concentrated research career development, or retooling, opportunities to established investigators within these research domains. Investigators in language/communication disorders and investigators in autism would thereby be prepared to forge research collaborations with one another, leading to a full-scale research program addressing language and other communication disorders in autism that will be competitive for funding through the National Institutes of Health (NIH) investigator-initiated R01 research grant. Because of the demands upon investigators at the midcareer stage, it is difficult for individuals seeking to retool in other disciplines and research domains to accomplish this goal, even during semester- or year-long sabbatical leave from their academic posts. While the NIH National Research Service Award (NRSA) Senior Fellowship (F33) may be utilized to meet such a need, its utility is limited. The NRSA provides primarily stipend support, rather than research support, and its stipend level may not provide sufficient support for many established investigators, particularly those within medical school settings. Furthermore, the NRSA requires a full-time commitment over a period of at least nine months, an untenable condition for many established scientists within academic settings.

The purpose of this initiative is to offer established investigators in language disorders research or those in autism research a short-term, six-month mentored career development and enhancement training experience, typically over a sabbatical year or apportioned over two successive three-month summer semesters, to acquire new research capabilities in the sister discipline. During this period, applicants shall devote their full-time (100%) effort to the research career development program. This research training experience shall involve patient-oriented research and take place in a host laboratory, whether within their own institution or elsewhere, under the mentorship of a well-qualified expert in the sister discipline enlisted by the applicant investigator. Patient-oriented research is defined by the NIH as research conducted with human subjects (or on material of human origin, such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. This area of research includes: mechanisms of human disease, therapeutic interventions and development of new technologies. The research career development program should be well-tailored to the individual needs and experience level of the applicant. The short duration of the career development and enhancement experience, when partitioned into two three-month periods separated in time, would enable awardees to hold their ongoing research grants (principal investigators of NIH research grants may hold their grants during absences of up to three months) and academic responsibilities as they retool in the new scientific discipline. The first phase of this program would provide didactic (e.g., directed study, short courses, seminar series, journal clubs) and/or laboratory-based training in the new discipline, techniques or technologies, and provide opportunities for intensive interactions with clinical populations. In the second three-month phase, the awardee shall conduct a small-scale research project in the host laboratory. Under appropriate circumstances, and with a stated justification in the application, this research project, or portion thereof (e.g., data analysis), may be conducted in the applicant’s laboratory. The applicant may propose, and justify within the application, variations on this phased approach tailored to individual needs, as long as an aggregate of six months of research career development is incorporated in the program.

This award is not renewable, nor may it be transferred to another individual. Due to the short-term nature of the award, it may not be transferred to another institution/organization.

The desired outcome of the NIDCD Short-Term Enhancement Award for Research Careers in Language and Autism is to provide established researchers in language/communication disorders or in autism research with new scientific knowledge and research capabilities to forge substantive collaborative research programs focusing on the intersection of these two domains that will lead to NIH investigator-initiated R01 grant applications and exploratory/developmental R21 applications.

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 uses the NIH K18 award mechanism. As an applicant, the candidate and his/her mentor will be jointly responsible for planning, directing and executing the proposed project and career development and enhancement activities.

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 (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

The salary amount provided by the NIDCD K18 Program shall be prorated based on the candidate’s full-time, 12-month salary level and the support period requested, up to the maximum legislated salary level (currently set at $181,100). The aggregate period of support shall be six months, either as a contiguous period within one Federal Fiscal Year (FY) (October 1-September 30), or partitioned over two successive years (typically summers). This program will also provide up to $40,000 Direct Costs across the total award performance period for research development support to cover career enhancement training expenses, such as tuition and fees for short-courses, consultant fees, and travel to scientific meetings, and research-related costs, primarily supplies and technical services. Facilities and administrative costs, which were formerly called indirect costs, will be reimbursed at eight percent of modified total direct costs.

The candidate s institution may supplement the salary received from the K18 award up to a level consistent with the institution’s salary scale. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the conduct of the K18 program.

K18 award recipients apportioning the six-month career development program into two three-month components separated in time may hold independent research awards, either Federal or private, concurrently with this award. However, the aggregate salary support derived from all Federal sources or awards may not exceed the maximum legislated salary rate and the total percentage effort cannot exceed 100 percent. Given the full-time commitment required by the K18 award, it is intended to provide the awardee with the full Federal contribution of salary support during the K18 award period. K18 award recipients may not derive any salary from their R01 or other research grant during the active period of the K18 award.

NIDCD intends to commit approximately $300,000 in FY 2007 to fund up to four new grants in response to this RFA. An applicant may request a project period spanning up to two years, with support limited to a total of six months.

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

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

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:

For-profit organizations
Non-profit organizations
Public or private institutions, such as universities, colleges, hospitals, and laboratories
Domestic Institutions

Foreign institutions are not eligible to apply.

1.B. Eligible Individuals

Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are 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.

This award is intended for investigators holding a research or health professional doctorate who are at the academic rank of Associate Professor or Professor, or the equivalent in a non-academic setting, who have an established record of independent, peer-reviewed Federal or private research grant funding for research in language or other communication disorders or in autism. Active research support at the time of K18 application or award is not required. The career development program proposed must directly address these research domains.

Applicants must identify one or more mentors with extensive research experience and an active, funded research program in the sister research domain or discipline, who is well-qualified and willing to sponsor the training experiences. During the short-term periods of active research career development, applicants will be required to spend their full-time professional effort on the K18 award.

At the time of award, applicants must be citizens or noncitizen nationals of the United States, or must have been lawfully admitted to the United States for permanent residence (i.e., in possession of a currently valid Alien Registration Receipt Card I-551, or other legal verification of such statues). Noncitizen nationals are generally persons born in outlying territories of the United States (e.g., American Samoa and Swain’s Island). Individuals on temporary or student visas are not eligible.

2. Cost Sharing or Matching

Cost sharing is not required.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

Applicants for this program may not concurrently apply for any other PHS award that duplicates the provisions of this award. An unsuccessful application responding to this initiative for one receipt date may be submitted as a new or revised application on a subsequent receipt date of this RFA.

Each short-term career enhancement program must be tailored to meet the individual needs of the candidate. The candidate and mentor are jointly responsible for the preparation of the career enhancement plan. The sponsoring institution must demonstrate a commitment to provide the environment and resources needed for the candidate to perform the activities included in the career enhancement program that maximize the use of relevant research and educational resources and propose qualified faculty in language and autism research as mentors.

If the host laboratory is not within the applicant institution, a Resources Format page (PHS 398) must be included in the application.

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

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

NIDCD Short-Term Enhancement Award for Research Careers in Language and Autism; RFA-DC-07-003.

See also Section VI.2 for additional information.

SUPPLEMENTAL INSTRUCTIONS for Career Development awards are located in the PHS 398, Section III, starting on page 44.

Note that new and revised applications responding to this announcement must include at least three sealed letters of reference following the instructions and using the CDA Reference Guidelines Format Page found in Section III of the PHS 398 application, attached to the face page of the original application. Applications submitted without the required number of reference letters will be considered incomplete and will be returned without review.

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: April 24, 2006
Application Receipt Date(s): May 24, 2006
Peer Review Date: October 2006
Council Review Date: January 2007
Earliest Anticipated Start Date: April 1, 2007

3.A.1. Letter of Intent

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

Descriptive title of proposed research
Name, address, and telephone number of the Principal Investigator
Name(s) of proposed mentor(s)
Participating institutions
Number and title of this funding opportunity

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:

Chief, Scientific Review Branch
Division of Extramural Activities
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, MSC 7180
Executive Plaza South, Room 400C
Bethesda, MD 20892-7180 (20852 for express/courier service)
Telephone: (301) 496-8683
FAX: (301) 402-6250
Email: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a career development grant application, 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)

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

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

Chief, Scientific Review Branch
Division of Extramural Activities
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, MSC 7180
Executive Plaza South, Room 400C
Bethesda, MD 20892 (20852 for express/courier service)
Telephone: (301) 496-8683
FAX: (301) 402-6250
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(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NIDCD. Incomplete and non-responsive applications will not be reviewed.

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

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 NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

Salary Support: The salary requested for the candidate must be consistent with both the established salary structure for full-time staff appointments and with salaries actually provided by the sponsoring institution from its own funds to other staff members of equivalent qualifications, rank and responsibilities in the applicable department. The candidate is required to devote 100% effort to this career enhancement program for a cumulative period of six months within a two-year period.

Research Development Support: The research development support costs must be justified and be consistent with the stage of development of the candidate and the proportion of time spent in research or career enhancement activities. Salary for ancillary personnel support, such as mentors, secretarial and administrative assistants is not allowed.

The K18 is not renewable, nor may it be transferred to another individual. Due to the short-term nature of the award, it may not be transferred to another institution.

6. Other Submission Requirements

Using the Supplemental Instructions in the PHS 398 for Research Career Awards (Instructions, Part III, starting on page 44), the following information must be included in the application.

CANDIDATE

Describe the candidate’s commitment to a health-related research scientist career in the domains of language/communication disorders and autism research.
Discuss the candidate’s research efforts and accomplishments in health-related research to this point as an independent investigator in his/her research career, including publications, prior research interests and experience and history of research support.
Discuss the candidate’s objectives and long-term career plans, and how these relate to the proposed activities on the career enhancement award.
Present evidence of the candidate’s potential to enhance/augment his research career through this career enhancement award.
Include a statement that the candidate will commit full-time effort to the short-term career enhancement program and related activities. Include a description of the candidate’s professional responsibilities and show their relationship to the proposed activities of the career enhancement award.
Present evidence of the candidate’s ability to interact and collaborate with other scientists.

CAREER ENHANCEMENT PLAN

Provide details of the career enhancement plan, tailoring it to the candidate’s goals, prior experience and career level, as well as the intent of the K18 award.
Develop a systematic plan and associated timeline: 1) that shows a logical progression from the candidate’s prior research and training experiences to the training and research experiences that will occur during the K18 award period and subsequently; 2) that will justify the need for further career development, as proposed, in view of the candidate’s future research goals; and 3) that will utilize the relevant research and educational resources of the host institution.
The candidate and the mentor are jointly responsible for the preparation of the career enhancement plan. A timeline for the phasing of the training and research phases of the K18 program should be included.
The didactic and the research phases of the plan must be designed to develop the necessary knowledge and research skills in relevant to the career goals of the candidate.

RESEARCH PLAN

A small-scale/pilot research project that is consistent with the candidate’s level of research development and the objectives of his/her career enhancement plan shall be provided, if it has been formulated in advance. If it is to be developed during the didactic phase of the K18 program, the steps to be taken to formulate the project must be described.

Organize the research plan as indicated in the Form PHS 398, following instructions for the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, and Research Design and Methods, to the extent possible and appropriate. The candidate should consult with the mentor regarding the development of this section.

TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH

Describe a plan for training in the responsible conduct of research or describe the training that has already been completed within the last three years that is relevant to the proposed career enhancement experience. The candidate must have completed this training by the time the K18 award begins. No award will be issued until confirmation is provided that this requirement has been completed.

STATEMENT(S) BY MENTOR(S)/CONSULTANT(S)/COLLABORATOR(S)

Candidates must name a primary mentor who, together with the applicant, is responsible for the planning, direction and execution of the program. Candidates may also nominate co-mentors, as appropriate to the goals of the program.
The mentor should be recognized as an accomplished investigator in the language and autism research areas and have a track record of success in training independent investigators.
Where feasible, women, individuals from diverse racial and ethnic groups and individuals with disabilities should be involved as mentors to serve as role models.
The application must include a statement from the mentor providing: 1) information on his/her research qualifications and previous experience as a research mentor; and 2) a mentoring plan describing the content and nature of the mentoring that will occur during the proposed award period.
Similar information must be provided by any co-mentor, if more than one mentor is proposed. The respective areas of expertise and responsibility of the primary mentor and co-mentor(s) should be described.
The mentor must agree to provide annual evaluations of the candidate’s progress for the duration of the award, as required in the annual progress report, PHS 2590 (see Section VI.3 Reporting).

Consultant(s)/Collaborator(s): Signed statements must be provided by each consultant/collaborator confirming his/her participation in the project and describing specific roles. Collaborators and consultants generally do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate areas of expertise in the proposed areas of consulting/collaboration.

ENVIRONMENT AND INSTITUTIONAL COMMITMENT TO THE CANDIDATE

The sponsoring institution must define and document a strong, well-established language/communication disorders and/or autism research and training program related to the candidate’s area of interest, including a research environment with staff capable of productive collaboration with the candidate. The sponsoring institution must provide a statement of commitment to meeting the conditions of this award.

Describe the resources and facilities that will be available to the candidate.
Describe how the research environment of the host laboratory and institution is particularly suited for the advanced development of the candidate’s research career and the pursuit of the proposed research plan. A Resources Format page is required if the host laboratory is not within the applicant institution.
In a clear statement, the candidate’s institution must provide assurances that during the active period of K18 award the candidate will be released from administrative, teaching, and/or clinical duties and able to devote one-hundred percent of his/her effort to the research career enhancement program. In addition, the institution must demonstrate a commitment to the enhancement of the candidate s career development.
Candidates who will be using the resources within a General Clinical Research Center (GCRC) during the course of the award should include a letter of agreement from either the GCRC program director or the principal investigator with the application.

LETTERS OF REFERENCE

Include with the application three sealed letters of reference from well-established scientists addressing the above areas and any other evidence that the candidate has a high potential for successfully augmenting his/her research program. The mentor(s) may also submit letters of reference, but these letters will be considered independently of the three required reference letters. All sealed letters of reference should be attached to the face page of the application.

BUDGET FOR ENTIRE PROPOSED PERIOD OF SUPPORT

Within the direct cost limitations for research development support, provide a detailed description, with justification, for all equipment, supplies and personnel that will be used to help achieve the career development and research objectives of this award.

Plan for Sharing Research Data
Not Applicable

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (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, http://grants.nih.gov/grants/funding/2590/2590.htm). 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.

2. Review and Selection Process

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 NIDCD in accordance with the review criteria stated below.

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

Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
Receive a written critique.
Receive a second level of review by the National Deafness and Other Communication Disorders Advisory Council.

The following will be considered in making funding decisions:

Scientific merit of the proposed project as determined by peer review
Relevance of program priorities
Availability of funds

The goals of NIH-supported career development programs are to help ensure that diverse pools of highly trained scientists are available in adequate numbers and in appropriate research numbers to address the Nation’s biomedical, behavioral, and clinical research needs. 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.

Candidate

Career Development Plan
Research Plan
Training in the Responsible Conduct of Research
Appropriateness of and statement by the Mentor, Co-Mentor(s), Consultant(s), and Collaborator(s)
Environment and Institutional Commitment to the Candidate

The application does not need to be strong in all categories to receive a high priority score. These criteria are listed in logical order and not in order of priority.

CANDIDATE

Quality of the candidate’s record as an independent and productive researcher, including ongoing and previous research support and publication output;
Commitment to meeting the program’s research career enhancement objectives;
Potential to become an outstanding investigator, teacher, resource person and leader in the intersect of language/communication disorders and autism;
Quality of the letters of reference of three well-established scientists submitted on behalf of the candidate; and
Letters of reference submitted by the mentor/co-mentor(s) will be considered independent of and in addition to the three reference letters.

CAREER ENHANCEMENT/DEVELOPMENT PLAN

Likelihood that the plan will contribute substantially to the scientific development of the candidate in redirecting their research program in a new trajectory, based on;

Appropriateness of the content, goals, scope and phasing of the career enhancement plan, when considered in the context of prior training/research experience and the stated training and research objectives;
Documentation of and commitment to devote 100% effort to the career enhancement award plan; and
Likelihood that the proposed experience will prepare the candidate to forge a substantive collaborative research program focusing on the intersection of language/communication disorders and autism research that will lead to the submission of an investigator-initiated R01 grant application or exploratory/developmental R21 grant application.

RESEARCH PLAN

Some candidates may have a fairly well developed research plan at the time of application, while others will need the first phase of the K18 program in order to develop and refine their research plan. Candidates in the former group shall provide a fundamentally sound and feasible research plan, while those in the latter group shall provide a plan for developing this.

Appropriateness of the research plan to developing or in enhancing research skills, as described in the career development plan, to develop a collaborative research program in the new research trajectory that will lead to an NIH research grant (e.g., R01, R21); and
Scientific and technical merit of the research question, design and methodology, if appropriate.

TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH

Quality and appropriateness of the proposed training in the responsible conduct of research.

STATEMENTS BY MENTOR/CO-MENTOR(S), CONSULTANT(S), and COLLABORATOR(S)

Appropriateness of the mentor’s research qualifications in the area of the proposed research;
Previous experience in fostering the development of independent investigators in the areas of language and autism research.
Quality and extent of the mentor’s proposed role(s) in providing guidance and advice to the candidate;
History of research productivity and peer-reviewed support; and
Strength of the mentor’s statement.

ENVIRONMENT AND INSTITUTIONAL COMMITMENT

Clear commitment of the candidate’s institution to ensure that one-hundred percent of the candidate’s effort will be dedicated to the research career enhancement plan during the active period of the award;
Strength of the institutional commitment to the candidate s career development in the new research trajectory; and
Quality and appropriateness of research facilities and training opportunities available to the candidate at the sponsoring institution.

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to 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 the Research Plan, Section E on Human Subjects in the PHS Form 398).

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 the Research Plan, Section E on Human Subjects in the PHS Form 398).

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

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

2.C. Sharing Research Data
A data sharing plan is not required.

2.D. Sharing Research Resources

NIH policy requires that grant award recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr 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.

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 awardee 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.

3. Anticipated Announcement and Award Dates
Not applicable

Section VI. Award Administration Information

1. Award Notices

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 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 (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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

2. Administrative and National Policy Requirements

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

Evaluation: In carrying out its stewardship of human resource-related programs, the NIH may begin requesting information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified that they may be contacted after completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

This award may not be transferred to another individual and, due to the short-term nature and purpose, is not transferable to another institution.

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 (following the instructions for Research Career Development applications) annually, if applicable, (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Both the Annual (when applicable) and Final Progress Report for this short-term career enhancement award should include the following information:

A demonstration of the scientific progress toward the aims of the career enhancement program;
A description of the career enhancement and research-related activities undertaken during the funding period;
A list of accomplishments, such as publication, scientific presentations, new collaborations, inventions, or project-generated resources made during the funding period;
A statement from the awardee regarding the value of the enhancement award in relation to his/her professional goals as a researcher in the area of language/communication disorders and autism; and
An evaluation statement of the awardee’s progress by the mentor, following the PHS 2590 application instructions (Item J. Sponsor’s Report).

A final progress report, invention statement and Financial Status Report are required when an award is terminated.

Section VII. Agency Contacts

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

1. Scientific/Research Contacts:

Daniel A. Sklare, Ph.D.
Research Training Officer
Division of Scientific Programs
National Institutes on Deafness and Other Communication Disorders
Executive Plaza South, Room 400C
6120 Executive Boulevard, MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 496-1804
FAX: (301) 402-6251
Email: [email protected]

2. Peer Review Contacts:

Melissa Stick, Ph.D., M.P.H.
Chief, Scientific Review Branch
Division of Extramural Activities
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400C
6120 Executive Boulevard, MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 496-8683
FAX: (301) 402-6250
Email: [email protected]

3. Financial or Grants Management Contacts:

Christopher Myers
Chief, Grants Management Branch
Division of Extramural Activities
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400C
6120 Executive Boulevard, MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 402-0909
FAX: (301) 402-1758
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

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).

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

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

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

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

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 funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

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.

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

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices