INTERVENTION STRATEGIES FOLLOWING IDENTIFICATION OF NEONATAL HEARING IMPAIRMENT Release Date: October 30, 1998 PA NUMBER: PAS-99-011 P.T. National Institute on Deafness and Other Communication Disorders Letter of Intent Receipt Dates: Jan 15, 1999, May 14, 1999, Sep 15, 1999 Application Receipt Dates: Feb 18, 1999, Jun 18, 1999, Oct 18, 1999 PURPOSE The National Institute on Deafness and Other Communication Disorders (NIDCD) invites research grant applications that address intervention strategies following identification of neonatal hearing impairment. Areas of interest include, but are not limited to: hardware (e.g., hearing aids, cochlear implants and other sensory aids); behavioral treatment programs; development of outcome measures to determine the benefit of intervention strategies; and, studies on the efficacy of intervention. Up to five awards may be made under this solicitation subject to the scientific quality of the applications received and the availability of funds. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), Intervention Strategies Following Identification of Neonatal Hearing Impairment, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2000" at http://www.crisny.org/health/us/health7.html. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, and units of State or local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This PA will use the NIH research project (R01) mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PA may not exceed five years. The earliest date of award is January 1, 2000. This PA is a one-time solicitation with three specified receipt dates in 1999. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and will be reviewed according to the customary NIH peer review procedures. FUNDS AVAILABLE Research grant applications submitted in response to this PA will compete for approximately $1 million in direct costs that will be made available for the first year of support. It is anticipated that up to five awards will be made. The number of awards will depend on the overall scientific merit of the applications and the availability of funds in Fiscal Year 2000. RESEARCH OBJECTIVES Background The early identification of children with hearing impairment is an important public health objective, with as many as 33 children per day born with significant hearing impairment in the United States. The consequences of a late diagnosis of hearing impairment are delays in spoken language and literacy. Without appropriate and timely intervention, early childhood hearing impairment interferes with the development of oral/aural communication, impedes academic performance, and results in harmful long-term vocational consequences. In 1993, an NIH Consensus Development Conference on Early Identification of Hearing Impairment in Infants and Young Children recommended universal screening of all infants for hearing impairment. This recommendation set the stage for the tremendous growth in universal newborn hearing screening programs over the last five years. Many states now screen all live births and others are introducing and passing legislation in support of this endeavor. In the near future approximately 19 states will screen all newborns for hearing impairment before discharge from the hospital, and this number will likely increase rapidly in the next decade. It has long been recognized that a necessary sequel to the identification of hearing loss in an infant or child is the implementation of intervention strategies that, to the extent possible, mitigate the effects of the disability. There is clear evidence that infants begin speech and language acquisition early in the neonatal period, and furthermore, that perturbations in that normal process produce lasting deficits. While an exact "critical period" for the effects of hearing loss on speech and language development is unknown, the first six months of life are critically important. As neonatal hearing screening is implemented throughout the United States, new and improved intervention strategies are needed. In March of 1998, the NIDCD convened a Working Group on Early Identification of Hearing Impairment to provide advice on the most pressing research questions regarding diagnostic and intervention strategies following neonatal hearing screening, taking into account the age of identification and the degrees of hearing impairment that are being identified in neonatal hearing screening programs. Current studies indicate that approximately 10-20 percent of the infants identified through neonatal hearing screening have profound hearing impairment. Thus, the majority of the identified infants have lesser degrees of hearing impairment, for which treatment outcomes are virtually nonexistent. Intervention strategies for neonatal hearing impairment typically have not begun until the child is at least six months of age and often not until the child is 2 years or older. These strategies typically involve the fitting of some form of hardware (e.g., hearing aids, cochlear implants, vibrotactile devices, FM auditory and other assistive devices, or some combination of these devices) and a behavioral treatment program [e.g., a home or clinic-based program to facilitate speech, language (manual and/or aural/oral) and auditory skill development]. Hearing aids are the most commonly employed assistive device for most levels of sensorineural hearing impairment and are, in most instances, fitted only after the hearing impairment is well-characterized. For profound hearing impairment, cochlear implants are becoming more commonly used as the age limits for implantation are lowered; vibrotactile and other assistive devices are less commonly used but remain an important option in the intervention process. Currently, the rationale for the selection and fitting of these sensory aids on infants and young children remains elusive since there is little information based on research to guide clinicians on the fitting of hardware in neonates and young children. In addition to fitting hardware (e.g., hearing aids, cochlear implants or other assistive devices), behavioral treatment programs are often initiated to mitigate the effects of hearing impairment on the communicative, educational, and social development of the child. These programs are varied, with some emphasizing a combination of signed and spoken language, while others focus on the development of oral and auditory communication only. Clearly, the degree of hearing impairment, as well as many other factors, impacts the decision of what type behavioral treatment program a given child is enrolled in. There have been few well-controlled studies of the efficacy of such treatment programs, and these focused predominantly on individuals who are either deaf or have profound hearing impairment and who were usually identified after the neonatal period. Since the majority of children identified through neonatal hearing screening programs have lesser degrees of hearing impairment, there is a critical need for information to guide clinicians in answering the questions of when and how to intervene in this population. Scope The focus of this PA is on intervention strategies for infants and very young children who have been identified as having a hearing impairment. Applications are encouraged that address relevant issues including, but not limited to: hardware (hearing aids, cochlear implants and other sensory aids); behavioral treatment programs; development of outcome measures to determine the benefit of intervention strategies; and, studies on the efficacy of intervention. The majority of children with hearing impairment identified by neonatal hearing screening have degrees of hearing impairment less than profound. Thus, research programs should take into account both the age of identification and the degree of hearing impairment identified in neonatal hearing screening programs, thereby optimizing the management of the entire spectrum of infants with hearing impairment. Applications that address one or more of the following research topics are encouraged: o Selection and fitting of hearing aids and cochlear implants for infants and young children (e.g., comparison of available prescriptive methods and strategies, development of new methods and strategies). o The comparative benefits of other, less frequently used hardware, such as assistive listening devices and vibrotactile devices, used alone or in conjunction with hearing aids or cochlear implants. o Development of outcome measures for determining the benefit of various device fitting strategies in infants and young children, allowing for the effects of age and maturation, the type of technology and signal processing strategy in use, and the type, degree, configuration, and etiology of hearing impairment. o Consideration of practical issues relating to hearing aid and cochlear implant utilization, such as ergonomics and changes in auditory structures occurring with maturation (e.g., rapid growth of the pinna in infants affects the proper fit of earmolds, often resulting in acoustic feedback). o Development of intervention models based on a "best fit" between the intervention and a constellation of subject and environmental factors, such as degree of hearing impairment, age at diagnosis and intervention, family environment, socioeconomic status, intervention type (e.g., center-based/home- based; family-centered/child-centered), culture, skill and accessibility of the provider. o Studies identifying and characterizing the components of effective intervention strategies and determining the commonalties among successful programs. o Development of appropriate outcome measures to determine the efficacy of intervention programs for infants with hearing impairment. Issues to be addressed include family and parent-child interactions, baseline measures (benchmarks of development that constitute "appropriate" development), as well as age-specific and function-specific measures. o Studies of the efficacy of intervention strategies, including child- and family-focused outcomes. o Long-term effects of intervention strategies and devices (e.g., hearing aids, cochlear implants, assistive listening systems, tactile devices, combinations of these), including issues related to plasticity and short-and long-term sensory deprivation. It is expected that all applications in response to this PA will propose research involving human subjects. Rapid integration of new techniques and laboratory-research findings into clinical or habilitative/rehabilitative programs remains a high priority for all research needs as outlined in this document. Translational research will facilitate the rapid and efficient integration of research findings into clinical practice. Thus, priority will be given to applications with a translational component or that are clinically applicable by design. SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research protocols involving human subjects, unless a clear and compelling rationale and justification is provided 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 10.1-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994, available on the web at the following URL address: http://www.nih.gov/grants/guide/notice-files/not94-105.html. NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://www.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, address, and telephone number of the Principal Investigator, names of other key personnel and, if applicable, participating institutions, and the number and title of the PA. There are three dates for submitting applications in response to this solicitation. Each date is preceded by a due date for submitting a letter of intent, January 15, 1999, May 14, 1999, and September 15, 1999, respectively. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NIDCD staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to: Chief, Scientific Review Branch National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, EPS 400C Bethesda, MD 20892 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-8693 APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda MD 20892-7910, telephone 301/710-0267, E- mail: GrantsInfo@nih.gov, and from the program administrator listed under INQUIRIES. Applicants planning to submit an application requesting $500,000 or more in direct costs for any year must contact the Institute program staff before submitting the application (i.e., as plans for the study are being developed). Furthermore, the applicant must obtain agreement from the program staff listed under INQUIRIES that the NIDCD will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute or Center who agreed to accept assignment of the application. Refer to the NIH Guide for Grants and Contracts, March 20, 1998, at http://www.nih.gov/grants/guide/notice- files/not98-030.html. The number and title of the PA ("Intervention Strategies Following Identification of Neonatal Hearing Impairment") must be typed on line 2 of the face page of the application form and the YES box must be marked. 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 must be sent to: Chief, Scientific Review Branch National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, EPS 400C Bethesda, MD 20892 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-8693 The Center for Scientific Review (CSR) will not accept any application in response to this PA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by NIDCD staff. Incomplete applications will be returned to the applicant without further consideration. Those judged non-responsive will be referred back to the CSR for review in an appropriate CSR Study Section. Applications that are complete and responsive to the PA will be evaluated for scientific and technical merit by the NIDCD Scientific Review Branch in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and 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 review, comments on the following aspects of the application will be made 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 the assignment of the overall score, weighing them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities, and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o 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. AWARD CRITERIA The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and programmatic priorities as determined by the National Deafness and Other Communication Disorders Advisory Council. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic and scientific issues may be directed to: Amy M. Donahue, Ph.D. Division of Human Communication National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, EPS 400C Bethesda, MD 20892 Telephone: (301) 402-3458 FAX: (301) 402-6251 Email: Amy_Donahue@nih.gov Direct inquiries regarding fiscal matters to: Ms. Sherry Dennison Grants Management Branch National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, EPS 400C Bethesda, MD 20892 Telephone: (301) 402-0909 Fax: (301) 402-1758 E-mail: Sherry_Dennison@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.173. Awards are made under the authority of the Public Health Service Act, Title IV, Part A (Public Law 78-410 as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-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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