RFA-DC-03-004: IDENTIFICATION AND CLASSIFICATION OF CHILDHOOD SPEECH-SOUND ACQUISITION DISORDERS OF UNKNOWN ORIGIN

IDENTIFICATION AND CLASSIFICATION OF CHILDHOOD SPEECH-SOUND ACQUISITION DISORDERS OF UNKNOWN ORIGIN RELEASE DATE: March 10, 2003 RFA: DC-03-004 National Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.173 LETTER OF INTENT RECEIPT DATE: June 19, 2003 APPLICATION RECEIPT DATE: July 17, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute on Deafness and Other Communication Disorders (NIDCD) conducts and supports biomedical and behavioral research and research training in normal and disordered processes of speech production and perception. The purpose of this RFA is to solicit applications from multidisciplinary teams to investigate the identification and assessment of childhood speech-sound acquisition disorders of unknown origin. RESEARCH OBJECTIVES Background Speech-sound acquisition disorders are common childhood communication disorders, with estimates ranging from 3% to as high as 10% in preschool and school-age children. Children who exhibit speech sound acquisition disorders produce speech sounds less accurately than their same-age peers. They do so in the absence of coexisting conditions such as congenital hearing loss or mental retardation. Using a conservative prevalence estimate of 4%, at least 1.5 million children under the age of nine demonstrate a clinically significant speech-sound acquisition disorder of unknown origin. Research studies have linked delayed and/or disordered speech in children to decreased overall communication skills with consequences reported in psychosocial, educational, and vocational development and success. Historically, speech-sound acquisition disorders of unknown origin were classified as "functional." More recently, these disorders have been termed "developmental phonologic disorders," or "phonologic/articulatory disorders," terms that highlight the links to other domains of language. Evidence is mounting for the existence of several etiological subtypes of speech sound acquisition disorders of unknown origin in children. Recent reports from family and twin studies have suggested a genetic component. One childhood speech disorder of unknown origin has been characterized as a disorder in speech motor planning and/or programming and is termed "developmental apraxia of speech" or "childhood apraxia of speech." Questions remain as to the validity of the construct of developmental apraxia of speech and the precise criteria for its diagnosis. Its behavioral and neurologic markers remain undetermined, as do the factors which differentiate it from other subtypes of speech-sound acquisition disorders. Currently, there is a need for a widely accepted etiological classification system to identify and classify childhood speech-sound acquisition disorders. Empirical data and a coherent theory are lacking and are still needed to better guide clinical management of all children with such disorders. Research Needs NIDCD requests applications with potential significance and relevance to the clinical assessment of children with speech-sound acquisition disorders of unknown origin. Examples of research studies that would be responsive to this RFA include (but are not limited to) the following: The identification of factors that place children at risk for developing speech-sound acquisition disorders; The exploration of genetic factors associated with the development of speech-sound acquisition disorders; The identification of appropriate techniques for the differential diagnoses and classification of the subgroups of children with speech- sound acquisition disorders; The development, evaluation and standardization of evaluation procedures for childhood speech-sound acquisition disorders based on theoretical models; The development of a taxonomy that can delineate the various subgroups of children with speech-sound acquisition disorders; The use of neuroimaging to characterize the various subtypes of childhood speech-sound acquisition disorders; Longitudinal studies that will provide detailed information about the natural history and course of development of the various subtypes of childhood speech-sound acquisition disorders. MECHANISM OF SUPPORT This RFA will use NIH Research Project Grant (R01) and the Exploratory/Developmental Research Grant (R21) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is April 2004. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. Use of R21 or R01 mechanism Typically, the R21 is used for support of creative, novel, and/or high risk/high payoff approaches that could produce innovative advances in this field. This includes feasibility studies, protocol planning, and the incorporation of new disciplines and technologies. The R21 provides the means to acquire the necessary preliminary information, to attract talented new investigators from related disciplines, and to foster the development of interdisciplinary, inter-institutional collaborative efforts among investigators with diverse training and expertise. R21 awards are non-renewable, and may not be used to supplement an ongoing project. The R01 mechanism is recommended for applications based on significant published and/or preliminary data. Applicants are strongly encouraged to contact the scientific program director listed below under INQUIRIES to discuss which mechanism (R21 or R01) would be most suitable for the proposed research project. This RFA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see https://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non-modular research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at https://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE The NIDCD intends to commit approximately $1.5 million in FY 04 for applications responding to this RFA. For R01s, an applicant may request a project period of up to five years. Because of the exploratory/developmental nature of the R21, applicants submitting an R21 may only request a budget for direct costs of up to $125,000 per year for a maximum of three years. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary within the defined parameters. Although the financial plans of the NIDCD provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Applications in response to this RFA must include children with speech- sound acquisition disorders. The Principal Investigator may submit only one application in response to this RFA. This RFA is intended to provide information relevant to the clinical management of children with speech sound acquisition disorders of unknown origin and not disorders coexisting with conditions such as mental retardation, pervasive developmental disorders, autism, etc. Whenever feasible, participants from multicultural and with diverse dialectal backgrounds should be included. Additionally, a multidisciplinary research approach with expertise in speech-sound acquisition must be evident. Applicants awarded grants in response to this RFA may be required to come to the metro Washington DC area (or other location to be determined by the NIDCD) annually to share their findings with other recipients of the RFA, therefore annual travel for up to two individuals from the research team should be included as part of the overall requested budget. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA 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: o Direct your questions about scientific/research issues to: Lana Shekim, Ph.D. Program Director, Voice & Speech Program Division of Extramural Research National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, EPS Room 400C, MSC 7180 Bethesda, MD 20892-7180 Telephone: 301-496-5061 Fax: 301-402-6251 Email: shekiml@nidcd.nih.gov o Direct your questions about peer review issues to: Craig Jordan, Ph.D. Chief, Scientific Review Branch Division of Extramural Research National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, EPS Room 400C, MSC 7180 Bethesda, MD 20892-7180 Telephone: 301-496-8683 Fax: 301-402-6250 Email: jordanc@nih.gov o Direct your questions about financial or grants management matters to: Ms. Sara Stone Chief, Grants Management Branch Division of Extramural Research National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, EPS Room 400B, MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 402-0909 Fax: (301) 402-1758 Email: stones@nidcd.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA 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 June 19th 2003 to: Lana Shekim, Ph.D. Program Director, Voice & Speech Program Division of Extramural Research National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, EPS Room 400C, MSC 7180 Bethesda, MD 20892-7180 Telephone: 301-496-5061 Fax: 301-402-6251 Email: shekiml@nidcd.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. ADDITIONAL R21 INSTRUCTIONS: All application instructions in the PHS 398 research grant application instructions and forms (rev. 5/2001) apply to the R21 with the exception of the following modifications: 1. R21 applications may request up to five (5) $25,000 modules for a maximum direct cost of $125,000 per year for up to a maximum of three (3) years. 2. The Research Plan for the R21 application may not exceed 10 pages. All tables and figures (color and black and white) must be included within the 10-page limit. However, to aid reviewers, original color figures should be included in the appendices if the data cannot be adequately evaluated when scanned/copied in black and white (see APPLICATION SUBMISSION.) The R21 applications are limited to 5 publications in the appendix. Appendix materials must be sent with two copies of the application to the NIDCD SCIENTIFIC REVIEW BRANCH, DIVISION OF EXTRAMURAL RESEARCH, whose address is below. Appendices should not be sent to the Center for Scientific Review (CSR). SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at https://grants.nih.gov/grants/funding/phs398/phs398.html includes step- by-step guidance for preparing modular grants. Additional information on modular grants is available at https://grants.nih.gov/grants/funding/modular/modular.htm. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form 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: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: 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 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application and any appendices must be sent to: Craig Jordan, Ph.D. Chief, Scientific Review Branch Division of Extramural Research National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, EPS Room 400C, MSC 7180 Bethesda, MD 20892-7180 Telephone: 301-496-8683 Fax: 301-402-6250 Email: jordanc@nih.gov APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. The Center for Scientific Review (CSR) will not accept any application in response to this RFA 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 an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and for responsiveness by the NIDCD. Incomplete applications will be returned to the applicant without further consideration. In addition, if an R01 application is not responsive to the RFA, NIH staff may contact the applicant to determine whether to return the R01 application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. R21 applications that are not responsive to this RFA will be returned. 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 the NIDCD, in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Deafness and Other Communication Disorders Advisory Council. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: 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. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. o ADDITIONAL REVIEW CRITERIA: For the R01 applications only, the potential impact on the clinical management of children with speech-sound acquisition disorders. For the R21 applications, the likelihood that the exploratory grant will lead to an R01 submission. 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 criteria included in the section on Federal Citations, below). 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. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: June 19, 2003 Application Receipt Date: July 17, 2003 Peer Review Date: October/November 2003 Council Review: January 2004 Earliest Anticipated Start Date: April 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. 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 risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: https://grants.nih.gov/grants/guide/notice-files/not98-084.html). 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 - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://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 RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at https://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 proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at https://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 https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. 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 RFA 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 No. 93.173, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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