AUDITORY/PERCEPTUAL PROCESSING BY INFANTS WITH HEARING LOSS: ISSUES IN CLINICAL ASSESSMENT AND MANAGEMENT RELEASE DATE: June 13, 2002 RFA: DC-02-004 National Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov/) LETTER OF INTENT RECEIPT DATES: October 1, 2002 and June 1, 2003 APPLICATION RECEIPT DATES: October 17, 2002 and June 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 purpose of this request for applications (RFA) is to support multidisciplinary research addressing auditory/perceptual processing in infants with hearing loss. As many as 33 children with significant hearing impairment are born every day in the United States and newborn hearing screening is now mandated in over 30 states. A new population of infants, i.e. those who have been identified with hearing impairment at a few weeks of age, has rapidly emerged. These infants require clinical decisions regarding assessment and management at ages much younger than previously encountered. Yet there are no tools or techniques that are sufficiently sensitive or developed for measuring/evaluating progress or benefit of various habilitative strategies in these infants. There is little information available on the auditory/perceptual processing abilities of infants with hearing loss. Information is lacking regarding suprathreshold auditory behaviors, perception of complex sounds, acquisition and organization of information necessary for language acquisition, multimodal perceptual processes, and cognitive factors such as learning and memory. Research that characterizes auditory/perceptual performance in infants with hearing loss is needed to guide clinicians as they evaluate and monitor an infant's auditory and linguistic development in order to identify optimal intervention strategies. Such investigations hold great promise for the refinement of clinical assessment and management tools for these pressing issues in this unique population. RESEARCH OBJECTIVES Background As many as 33 children with significant hearing impairment are born every day in the United States. Without appropriate and timely intervention, early childhood hearing impairment interferes with the development of oral/aural communication, impedes academic performance, and limits long-term vocational opportunities. NIDCD has a long- standing interest in the early identification of hearing impairment. Much has happened since the 1993 NIH Consensus Conference, Early Identification of Hearing Impairment in Infants and Young Children, which recommended hearing screening of all newborns prior to hospital discharge. Newborn hearing screening is now mandated in over 30 states and current estimates suggest that 65% of all newborns are screened for hearing loss prior to hospital discharge. The identification of infants with hearing loss has caused the emergence of new questions. Prior to newborn hearing screening programs, intervention for neonatal hearing impairment typically was not begun until the child was at least twelve months of age and most often not until the child was two years or older. These strategies typically involve the fitting of some form of assistive/prosthetic device (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 being used more commonly as the age limits for implantation have been lowered; vibrotactile and other assistive devices are less commonly used but remain important options in the intervention process. In addition to fitting 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. The degree of hearing impairment, as well as many other factors, influences the decision regarding the type of behavioral treatment program in which a given child is enrolled. NIDCD has an established "Working Group on the Early Identification of Hearing Impairment". These established scientists have relevant and varied expertise, and they have met several times over the last few years. In the course of the third meeting, held in September 2000, a list of seven research priorities relevant to the early identification of hearing impairment was established. The minutes from that meeting, from which this RFA evolved, can be found at: http://www.nidcd.nih.gov/funding/programs/hb/earlyid_00.asp There is now a cohort of infants who have been identified with hearing impairment by a few weeks of age. There are numerous questions regarding intervention and management. Decisions regarding the type and effectiveness of various early intervention/management strategies are being made at ages much younger than previously encountered and the decision-making is difficult in the absence of data to guide those decisions. Important clinical decisions about the fitting of hearing aids and cochlear implants are being made regarding habilitation of these infants. Yet measurement tools and techniques that are sufficiently sensitive or refined for measuring/evaluating progress or benefit of various habilitative strategies in these infants do not exist. There is no empirical database to guide decisions and the proactive approach to intervention does not allow for "wait and see" management. Further, the time window in which the decision-making must occur is extremely short and the decisions are critical, such as whether a 12 month-old with profound hearing loss should continue wearing a hearing aid or undergo cochlear implantation. Furthermore, if that infant is implanted, what are the auditory, linguistic, behavioral, and social cues that will signal a clinician to shift from a current strategy that is not working to a modified habilitation strategy, before that child is characterized a few years later as a "poor user" and critical windows for learning have passed? There are almost no data to guide clinicians in their search of the optimal intervention strategy for these newly identified hearing impaired infants as they monitor and evaluate an infant's auditory and linguistic development. Large unexplained individual differences in both performance and outcome also contribute to this difficult clinical scenario. Auditory perception begins in utero; well before infants begin to speak, their brains have been actively processing environmental auditory information to construct the speech and language of their native tongue. Animal research, in both single and multimodal experiments, has clearly demonstrated the impact of the sensory experience in the prenatal and postnatal period on the development of specific neural, behavioral and perceptual processes. Similarly, there is a large body of research on human infants' auditory and visual processing capabilities, as well as their multimodal processing abilities. Such experiments have demonstrated the impact of the sensory experience on developing perceptual processes and that perceptual systems influence one another in development. For example, infants can utilize information that is redundant across two sensory modalities and further, the response to one stimulus can be altered by the presence of another stimulus in a differing perceptual modality. As the natural infant environment is one of simultaneous and dynamic multimodal stimulation, these issues are of fundamental importance in understanding infant development. Traditional clinical research on hearing impairment has focused primarily on audition and the acquisition of speech and language; however, current measurement and evaluation tools are not appropriate for the preverbal infant with hearing impairment, who has both an altered sensory system (in most instances both prenatally and postnatally) as well as altered environmental inputs during development. In order to assess and manage the hearing impaired infant as a "whole child" there is an urgent need for multidisciplinary investigations of auditory/perceptual processing abilities in this population. Such investigations go beyond audition and speech/language in isolation, and include behavioral, psychological and cognitive development, such as multimodal integration, attention, memory and learning and require collaborations among many disciplines (including, but not limited to, audiology, speech-language pathology, linguistics, developmental psychology, cognitive psychology, pediatrics and otolaryngology). These investigations require the utilization of the research base on the development of human infant sensory and perceptual processing when developing and designing an assessment and treatment regimen for the infant with hearing impairment. This RFA seeks to bring together researchers for multidisciplinary investigations on auditory/perceptual processing in the infant with hearing impairment. Such investigations hold great promise for the betterment of clinical assessment and management tools for this unique population. Research Needs This RFA is intended to address pressing clinical issues. Applications of a solely theoretical/conceptual nature should not be submitted in response to this RFA and should be submitted as a traditional investigator-initiated application using standard NIH receipt dates. NIDCD will only accept applications with potential significance and relevance to the clinical assessment and management of infants/young children with hearing impairment. Research needs, many of which are multidisciplinary, include: Characterizing auditory/perceptual system capabilities of infants with varying degrees of hearing loss, with the long-term goal of determining appropriate/optimal habilitative strategies (both technical and behavioral) leading to the development of communication skills. Developing new or enhanced techniques and methods for examining supra- threshold auditory/linguistic/perceptual abilities for complex signals (speech), such as new uses of habituation and preferential looking/listening paradigms. Investigating multimodal perception in infants with hearing impairment. Utilization of multimodal perception to design novel habilitative strategies with the goal of increasing the acquisition of linguistic and auditory function in infants with hearing loss. Considering the effects of hearing impairment on the hierarchy of the acoustic-linguistic processes underlying normal development of language (e.g., acoustic, phonetic/phonological, lexical, and semantic). Devising objective and subjective tools/methods to determine/evaluate auditory/linguistic development in infants with hearing loss (including infants with multiple disabilities and infants from varying ethnic backgrounds). Determining the role of parental report, and its applicability to clinical decision making, is especially important. Understanding individual variability by examining contributing factors, such as, auditory status, age of onset/identification/intervention, etiology, cognitive status, physical status, parent/infant interaction, and social context. In addition, there is a need to compare infants with similar experiences/developmental profiles and degree of hearing impairment to each other. It is of benefit to study children across the full spectrum of performance (both low and high performers). Examining ways to determine the appropriateness of various types of technologies and approaches to habilitation, the need for a change in technology or intervention strategy, and/or candidacy for cochlear implantation for individual infants with hearing loss. This involves the ability of infants to modify perceptual learning strategies or acquire new strategies with changes in technology/programming schemes. Both absolute performance and the rate of change, whether positive or negative, need to be understood. Generating baseline data in infants with impaired hearing (normal hearing infants may be used for control/comparison data), describing the developmental stages of speech perception and production, particularly the trajectory of their rate of acquisition. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) R21 (EXPLORATORY/DEVELOPMENTAL GRANT) and R01 (INVESTIGATOR INITIATED RESEARCH GRANT) 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 with two receipt dates: October 17, 2002 and June 17, 2003. Beyond those dates, 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 dates are July 1, 2003 and April 1, 2004. Applications submitted for the first submission date may be revised and resubmitted for the second submission date. Use of the R21 or R01 mechanism Generally, applicants proposing exploratory/feasibility studies with limited preliminary data should use the R21 mechanism, while applicants proposing more extensive projects based on significant published and preliminary results should use the R01 mechanism. In addition, applicants are strongly encouraged to contact the scientific Program Officer 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. FUNDS AVAILABLE The NIDCD intends to commit approximately $750,000 in FY 2003 and $750,000 in FY 2004 to fund 3 to 5 new R21 and 3 to 5 new R01 grants in response to this RFA. Because of the exploratory 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 (3) years. R01 applicants may request a project period of up to five (5) years. Because the nature and scope of the research proposed are expected to vary for both R21s and R01s, it is anticipated that the size of each R21 and R01 award will vary. Additional specific application instructions, budget considerations and review criteria for the R21 and the R01 can be found below under APPLICATION PROCEDURES and REVIEW CONSIDERATIONS. 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 meritorious applications. At this time, it is not expected that this RFA will be reissued. ELIGIBLE INSTITUTIONS You may submit (an) application(s) 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 infants/children less than 3 years of age with hearing impairment as part of the subject population. This RFA is intended to provide information relevant to the clinical management of infants/children with permanent sensorineural hearing loss of varying degrees. Additionally, a multidisciplinary research approach must be evident (including, but not limited to, audiology, speech, language, linguistics, developmental psychoacoustics, developmental psychology, cognitive psychology, pediatrics, and otolaryngology). Multi-center applications are encouraged. Applicants awarded grants in response to this RFA may be required to come to Washington, DC (or other location to be determined by the NIDCD/NICHD) annually to share their findings with other recipients of the RFA. Annual travel costs for up to 2 individuals from the awardee institution 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: Dr. Amy M. Donahue Chief, Hearing and Balance/Vestibular Sciences Section 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: 301-402-3458 Fax: 301-402-6251 Email: amy_donahue@nih.gov o Direct your questions about peer review issues to: Dr. Craig Jordan 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 Institute staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by October 1, 2002 for the October 17, 2002 receipt date and by June 1, 2003 for the June 17, 2003 receipt date to the scientific program officer listed above under INQUIRIES. 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 APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) apply to the R21 with 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. Tables and Figures (color and black and white) must be included within the 10-page limit. However, to aid reviewers, duplicate original color figures should be included in the appendices if the data cannot be adequately evaluated when copied in black and white (see APPLICATION SUBMISSION.) Appendices must be sent to the NIDCD SCIENTIFIC REVIEW BRANCH, DIVISION OF EXTRAMURAL RESEARCH, whose address is below. Appendices should not be sent to 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, in addition to all appendices, must be sent to: CHIEF, SCIENTIFIC REVIEW BRANCH DIVISION OF EXTRAMURAL RESEARCH NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS 6120 EXECUTIVE BOULEVARD, ROOM 400-C, MSC 7180 BETHESDA, MD 20892-7180 ROCKVILLE, MD 20852 (for express/courier service) 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. 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. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and for responsiveness by the NIDCD. Incomplete and unresponsive applications will be returned to the applicant without further consideration. 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 NDCD 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? Is there evidence of a multidisciplinary research approach/research team? (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, specifically, the inclusion of infants/young children with hearing loss. 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. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: October 1, 2002 June 1, 2003 Application Receipt Date: October 17, 2002 June 17, 2003 Peer Review Date: January, 2003 October 2003 Council Review: May 2003 January 2004 Earliest Anticipated Start Date: July 1, 2003 April 1, 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 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 AMENDMENT "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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