BEHAVIORAL THERAPIES DEVELOPMENT PROGRAM RELEASE DATE: May 19, 2003 PA NUMBER: PA-03-126 (See addendum, NOT-DA-05-008) July 14, 2006 - This PA has been reissued and now is divided into separate FOAs for R01 (PA-06-486), R21 (PA-06-487)and R03 (PA-06-488) funding mechanisms. March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through using the electronic SF424 (R&R) application. This announcement will stay active for only the May 1, 2006 AIDS and AIDS-related application submission date for these mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms expires on the date indicated below. Other mechanisms relating to this announcement will continue to be accepted using paper PHS 398 applications until the stated expiration date below, or transition to electronic application submission. Parent R03 (PA-06-180) and R21 (PA-06-181) funding opportunity announcements have been issued for the submission date of June 1, 2006 and submission dates for AIDS and non-AIDS applications thereafter. Applications relating to R33 and R34 activities must be in response to NIH Institute/Center (IC)-specific announcements. EXPIRATION DATE for R03 and R21 Non-AIDS Applications: March 2, 2006 EXPIRATION DATE for R03 and R21 AIDS and AIDS-Related Applications: May 2, 2006 EXPIRATION DATE for All R01 Applications: May 30, 2006, unless reissued. National Institute on Drug Abuse (NIDA) ( National Institute on Alcoholism and Alcohol Abuse (NIAAA) ( CATALOG OF FEDERAL DOMESTIC ASSISTNACE NUMBER: 93.279 and 93.273 THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanisms of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE The National Institute on Drug Abuse (NIDA) and the National Institute on Alcohol Abuse and Alcoholism (NIAAA) are seeking research grant applications on the development of behavioral treatments for drug and alcohol abuse and dependence. This program announcement (PA) reaffirms NIDA's and NIAAA's continued and ongoing commitment to major programs of research on behavioral therapies. The term "behavioral therapies" is used here in a broad sense and includes various forms of psychotherapy, behavior therapy, cognitive therapy, family therapy, couples and marital therapy, group therapy, skills training, counseling, and other rehabilitative therapies. Behavioral therapy research has been conceptualized, for the purposes of this initiative, to consist of three stages. Stage I, or early therapy development, involves research on the development, refinement, and pilot testing of behavioral interventions. Stage I includes research on the translation of basic behavioral, cognitive, and neuroscience research into novel behavioral therapies. Stage II involves the efficacy testing of therapies that show promise. Stage III is research aimed at determining if and how efficacious behavioral therapies may be transported to community settings, including primary care sites. Stage III includes research examining methods of training therapists and counselors to administer new behavioral therapies. All three stages may focus not just on the development of efficacious treatments themselves, but also on how and why behavioral treatments work. This program announcement replaces in it’s entirety PA-03-066, published in the NIH Guide, February 3,2006 at Applicants interested in the organization, management, and economics of drug abuse treatment services, and the effects of these factors on the quality, cost, access to, effectiveness, and outcomes of care for drug abuse and addictive disorders are referred to the program announcement "Drug Abuse Health Services Research" RESEARCH OBJECTIVES Background and Rationale. Behavioral therapies are frequently the only treatments available to drug-dependent individuals. Even where medications are available, behavioral therapies can be an integral component of treatment, and may enhance adherence to medications. In addition, behavioral treatments may be an important alternative for those unable to take medication. Recognizing the importance of behavioral therapies, NIDA has been supporting research in this area through the Behavioral Therapies Development Program (BTDP). The BTDP is intended to promote all of the necessary stages of behavioral therapy research so that new and more efficacious behavioral therapies are developed as advancements in basic science (e.g., cognitive neuroscience, affective neuroscience and behavioral science) are made, and so that efficacious behavioral therapies may be effectively transported to the community treatment provider. It is NIDA's intention to support scientifically-sound and clinically-relevant behavioral treatment research that will have a meaningful impact on improving the efficacy of drug abuse/dependence treatment. Research indicates that many behavioral therapies for drug abuse and dependence are efficacious. However, no therapy has been shown to be completely efficacious for every individual. For many individuals, engagement and retention in treatment and relapse during and following treatment remain concerns. NIDA has undertaken the Behavioral Therapies Development Program with the goal of addressing these concerns and substantially improving, for each individual, the efficacy of behavioral therapies for drug abuse and dependence. For alcohol abuse and dependence, most of the treatments available in the U.S. also have been behavioral in nature. A large number of clinical trials conducted over the past 15 years have demonstrated effectiveness for several types of behavioral therapies, including cognitive behavioral therapy, motivational enhancement therapy, marital family therapy, brief interventions, and the community reinforcement approach. Although progress has been made in a broad range of behavioral interventions to treat alcohol abuse and dependence, many alcoholics do not respond adequately to currently available behavioral therapies. The purpose of this PA is to develop new innovative behavioral therapies or modify existing treatments to improve their effectiveness and devise ways to improve the engagement, retention, adherence, and outcome of alcoholism treatment across various populations of alcohol dependent and abuse subjects. NIDA's Behavioral Therapies Development Program delineates three stages of behavioral treatment research. Stage I, the earliest stage of behavioral therapy development research, is viewed as an iterative process involving: (1) identifying promising clinical, behavioral, affective and cognitive scientific findings relevant to behavioral treatment; (2) generating and formulating new behavioral treatments or modifying existing treatments; (3) operationally defining and standardizing principles and techniques of the therapies in manuals; and (4) pilot testing and refining the therapies. Stage I also involves testing the theory and/or hypotheses upon which the new or modified treatment is based to gain knowledge about moderators, mediators, and mechanisms of behavior change. Stage II research consists of efficacy testing of promising therapies identified in Stage I. Stage II may also involve studies examining the components of therapies, studies of the mechanism of action of efficacious therapies, studies examining the dose-response of therapies, and studies examining individual differences in response to the therapies. Stage II also involves the replication, at other sites, of efficacy studies with positive results. Stage III research is aimed at understanding if and how an efficacious therapy may be transported to the community. One question relevant to Stage III research is the degree to which a therapy maintains its potency when it is administered within community-based treatment programs. Another question relevant to Stage III research is the question of how therapists and counselors can be trained to administer a new therapy effectively. Thus, Stage III research may involve developing training procedures and techniques to help teach therapists and counselors how to utilize new therapies, and testing the utility of these procedures and techniques. In sum, Stage III research involves highly controlled research on behavioral treatments in community settings, such as randomized clinical trials of efficacious treatments, research on how to train therapists to make a treatment able to work in the community, and the examination of the mechanism of action of treatments and/or training procedures. Although Stage III involves studying the efficacy of behavioral treatments in community settings and how to train community therapists to administer efficacious behavioral treatments, research on the development or modification of a therapy for use in a community setting is considered to be Stage I research. It is NIDA's and NIAAA's objective to ensure sufficient emphasis and support for all stages of behavioral therapy research, so that scientific knowledge can readily be incorporated into newer and more efficacious behavioral interventions, and so that therapies can be effectively transported from research to the community. This PA is intended to promote this objective by encouraging research grant applications in any one of the three stages of behavioral therapy research. SPECIFIC AREAS OF INTEREST This PA is intended to support all types of research on behavioral therapies for drug and alcohol abuse and addiction. This includes, but is not limited to, behavioral therapy research on: o Therapies to treat abuse or addiction to understudied drugs including, but not limited to, marijuana, methamphetamine, MDMA and other club drugs, sedative-hypnotics, prescription drugs, inhalants, and hallucinogens, appetite suppressants and other supplements promoted for weight loss or physical enhancement, as well as more commonly studied drugs including, but not limited to, heroin, cocaine, and nicotine. o Therapies for smoking cessation, including therapies specifically for youth and young adults, that can be utilized alone or in conjunction with nicotine replacement therapies and/or medications. o New and innovative therapies to treat drug and/or alcohol use disorder that can be based on promising findings from basic behavioral and cognitive research, interventions found effective in changing other problematic behaviors, and theory-driven models of behavioral sciences. o Therapies to treat patients with a comorbid drug abuse and/or alcohol use disorders. o Therapeutic interventions that can be added to enhance an existing behavioral therapy. o Active components/mechanism(s) of action of behavioral therapies. o Identify and evaluate factors that mediate or moderate treatment efficacy. o Therapies to be utilized in conjunction with medications, to optimize the efficacy of drug/alcohol addiction treatment. Optimal combinations and sequencing of behavioral and pharmacological treatments need to be established. o Behavioral interventions to increase compliance with medication regimens. o Therapies to enhance the engagement and retention of patients in treatment. o Therapies that manage precipitants of relapse. Relapse to drinking or drug use is common after treatment. Patients have identified multiple precipitants of relapse including stress, social pressure, insomnia, anger, depression, anxiety, and environmental cues associated with prior drinking or substance use experiences. Behavioral techniques to enable patients to manage these precipitants without resorting to drinking or drug use are needed. o Therapies for after-care or long-term treatment of drug and alcohol abuse and dependence. o Behavioral therapies in group settings. Group therapies are the most commonly used approach in the treatment of alcohol and drug abuse and dependence. Research has been limited in this area, particularly on how group therapy compares with individual counseling. Behavioral dynamics and modeling of group sessions and evaluation of its effectiveness with subtypes of alcoholics or drug addicts in diverse treatment settings need to be investigated. Research from social psychology would be informative for studying group therapy. o HIV and other infectious disease risk-reduction interventions that can be implemented in conjunction with other therapeutic interventions. o Therapies for individuals with co-occurring drug or alcohol abuse and dependence and mental or other health disorders, including HIV/AIDS and hepatitis. o Therapies that address the unique needs and perspectives of women, minorities, families, couples, specific cultural groups, children, early or pre-adolescents, adolescents, the elderly, and persons with disabilities, such as the deaf. o Therapies for use in primary care, criminal and juvenile justice, welfare system, workplace settings, and for health care professionals. o Outreach therapies to out-of-treatment drug users to enhance their motivation and facilitate their entry and retention in treatment, including outreach approaches in primary care settings. o Adequate "dosage" of specific types of behavioral therapies for particular individuals and determination of minimally effective "dosages". o Treatments administered or assisted by technological devices and software applications such as computers, the Internet, expert systems models, telephone, pagers, or hand-held computers. o Alternative or complementary interventions as sole treatments or as adjunctive strategies to enhance the therapeutic potency of existing drug and alcohol abuse treatments. Stage I, Stage II, and Stage III grant applications are encouraged in these and other areas of behavioral therapy research for drug and alcohol abuse and addiction. Applicants are encouraged to include, and if necessary develop, measures of mediators of behavior change and mechanism of action of behavioral interventions in all three Stages. If this is not appropriate for a particular application, applicants are encouraged to address and justify why this will not be done. Additional information regarding Stages I, II, and III is provided below. Stage I Research. Investigators are encouraged to submit applications to develop new or to modify existing individual, group or family behavioral therapies for drug and alcohol abuse or dependence, and to pre- or pilot-test the therapies. Applications are encouraged to develop therapies that have a strong theoretical basis or logical rationale and are based on new developments in the behavioral and/or cognitive sciences. Applications based on modifications of existing efficacious treatments for use in other populations, cultures, or settings, especially for groups and settings for which few efficacious treatments exist, are encouraged. Modifications of treatments are encouraged to make them easier to administer in community treatment settings while retaining a beneficial effect, thus improving the likelihood they will be accepted by community practitioners. Applicants are encouraged to explicitly describe the theoretical basis for the proposed therapy, the scientific basis for the therapy being proposed, and the population for whom it is intended. A general description of the nature of the therapy/intervention being proposed and the plans for manualization of this therapy/intervention are also encouraged. If proposing a behavioral intervention that is supplemental to a manualized therapy, applicants are requested to include a copy of this therapy manual in their appendix materials, following the instructions for appendices in the PHS 398 application kit. Applicants are also encouraged to propose testing of the hypothesized effects of the therapy, and should incorporate, as appropriate, the development of measures of these effects in their applications. Where adequate measures do not exist, applicants may propose the development of measures of therapist competence and adherence, process measures, and instruments measuring the integrity and fidelity of the therapy. In the development of a new therapy for drug and alcohol dependence, a broad range of issues relevant to efficacy and safety are raised. Since pre- or pilot-testing is considered an integral part of the therapy development process, applicants are encouraged to describe the nature of any pre- or pilot-testing intended. Depending upon the scientific question being asked, a variety of research designs may be appropriate for Stage I research, including single case designs, random assignment of clinics to condition, and studies involving random assignment of subjects to condition. Although one goal of a Stage I project is to proceed to Stage II, another goal is to obtain scientific knowledge about behavioral processes that lead to behavior change. Therefore, testing of the theories and hypotheses upon which the novel behavioral treatment is based is a critical part of Stage I. Because the early therapy development process is an inherently exploratory process, immediate movement from Stage I to Stage II is not always possible or desirable. For example, an investigator may not be able to conduct a pilot study warranting movement to Stage II because of feedback necessitating changes in the therapeutic intervention during the pilot. In this case, although the Stage I investigator may not have acquired the pilot data to warrant a larger-scale Stage II efficacy study, the Stage I investigation may have produced valuable scientific information about behavior change that could lead to another successful Stage I study. Stage I may be conceptualized as having multiple phases. Early Stage I, or "Stage Ia" can be viewed as the most exploratory part of the Stage I process, in which the critical therapy development groundwork is laid. Late Stage I or "Stage Ib," although still exploratory, can be viewed as the phase of Stage I in which a pilot study is conducted that determines effect size, and is compelling enough to warrant progression to Stage II. Where scientifically warranted, it is acceptable to submit competing continuation applications of Stage I research when further development is indicated. Stage II Research. Stage II research establishes the efficacy of behavioral therapies or therapy components shown to be promising in Stage I. Stage II research examines if therapies work, but also examines why therapies work, and for whom therapies work. Such research may examine any type of behavioral therapy for drug and alcohol abuse or addiction, including behavioral therapies that are used in conjunction with medications. Proceeding to Stage II presumes that promising pilot data exist. That is, when proposing a Stage II study, investigators are encouraged to provide evidence that the new therapy shows promise in some way (such as in terms of a reduction in drug and/or alcohol use, dropout rate, or psychiatric symptoms). If evidence of promise does not exist, or such evidence is not strong enough to warrant progression to Stage II, applicants are encouraged to reconsider a Stage II submission. That is, they are encouraged to consider either ceasing the therapy development work or submitting a Stage I application. Investigators who believe that significant modification of the therapy is needed before it can be tested in another population are referred to the section of this PA entitled, "Stage I Research." As in Stage I, in Stage II research designs are determined by the research questions. In general, Stage II research asks if a therapy is efficacious, but also asks for whom the therapy is efficacious, and under what conditions and in what amount. The most common research design for Stage II research is the randomized, controlled clinical trial. However, there may be circumstances in which other types of research designs may be appropriate and scientifically justifiable. Knowing the effective components of a therapy can greatly aid in improving the quality of that therapy. Research designs used to determine the effective components or combination of components in drug and alcohol dependence behavioral therapies are encouraged. It is recognized that for many research questions asked in the behavioral therapy field, no perfect research design may exist. Where there is more than one way to answer a proposed research question, investigators are urged to state their theoretical, ethical, and practical reasons for choosing one control group or one research design over another. Progression to Stage III may occur when a behavioral therapy has been proven to be efficacious for a particular population of individuals. It should also be noted that information gathered in Stage II (or in Stage III) may lead an investigator back to Stage I. This may occur when a therapy is shown to be efficacious for a substantial majority of the population, but for some individuals it is ineffective, and the investigator believes a new therapy can be developed for these individuals through modification of the existing therapy, based upon information gathered in the Stage II study. Stage III Research. Where a behavioral therapy has been shown to be efficacious in Stage II research, investigators may propose to carry out a study to address the therapy's transportability to a community treatment setting. Stage III research addresses not only if a therapy can be transported, but also how and for whom a therapy may be transported to the community. Thus, Stage III research may sometimes be used to address issues of generalizability to different settings and patient populations more broadly representative of those in the community. Such research may test the acceptability of the therapy to patients, counselors, and therapists in the community. Stage III research is expected to maintain the integrity of the efficacious treatment examined during Stage II trials. Stage III research may also address questions about the amount or dosage of therapy required and the type and amount of training for clinical practitioners to deliver the behavioral treatment. One of many potential Stage III research paradigms is a randomized clinical trial conducted in a community setting. However, such a randomized clinical trial cannot be conducted adequately unless therapists are trained to competently administer the therapy. This raises the research question of how to train previously trained therapists and counselors to effectively utilize new therapies. Hence, Stage III also consists of another research area: the training of therapists. This includes research on the development of procedures and techniques to train therapists to administer new therapies. Conceptually, such research is analogous to a Stage I research, in the sense that a new behavioral intervention is under development. In this case, however, the new behavioral intervention is not a behavioral therapy, but a procedure or technique to help therapists administer new therapies. The investigator might, for example, develop the training procedure, pilot the procedure in the community clinic, refine the procedure, and ultimately test the training procedure in comparison with another training procedure and/or a "training as usual" condition (analogous to Stage II). Research on the refinement or modification of therapy to facilitate implementation in the community setting is considered Stage I research. HIV Considerations. It should be noted that if a subject is identified as being at risk for HIV acquisition and/or transmission, HIV testing and counseling should be offered to the subject in accordance with current guidelines. Wherever possible and appropriate, investigators are encouraged to collect data on the effect of their behavioral therapy on AIDS risk behaviors, including data on the route of drug administration and sexual behaviors that may place individuals at risk for HIV transmission. Also, as appropriate, investigators should offer risk-reduction counseling and collect data on the effect of their therapy on the acquisition/transmission of HIV/AIDS and other infectious diseases, such as Hepatitis C, associated with drug use. MECHANISMS OF SUPPORT This PA will use the National Institutes of Health (NIH) research project grant (R01), exploratory/developmental grant (R21), and small grant (R03) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Applicants are strongly encouraged to read the R21 and R03 announcements, which specify the goals and guidelines for each program at and This PA uses just-in-time concepts. It also uses the modular budgeting format (see Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at 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 o Faith-based or community-based organizations 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. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA 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: Direct your questions about scientific/research issues to: Lisa Onken, Ph.D. Division of Treatment Research and Development National Institute on Drug Abuse/NIH/DHHS 6001 Executive Blvd., MSC 9551 Bethesda, Maryland 20892-9551 Telephone: 301-443-2235 Fax: 301-443-8694 E-mail: Raye Litten, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism/NIH/DHHS Willco Building, Suite 505 6000 Executive Blvd., MSC-7003 Bethesda, MD 20892-7003 Telephone: 301-443-0636 Fax: 301-443-8774 Email: Direct your questions about financial or grants management matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse/NIH/DHSS 6001 Executive Blvd., MSC 9541 Rockville, MD 20892-9541 Telephone: 301-443-6710 Fax: 301-594-6849 E-mail: GF6S@NIH.GOV Judy Fox Grants Management Branch National Institute on Alcohol Abuse and Alcoholism/NIH/DHHS 6000 Executive Blvd., MSC 7003 Bethesda, MD 20892-7003 Telephone: 301-443-4704 Email: For any of the above addresses use Rockville, MD 20852 instead of Bethesda, MD, for express or courier services. 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 in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at Application deadlines are also indicated in the PHS 398 application kit. 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 includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five 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) APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at The 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. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. 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. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures ( will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o 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 o Receive a second level review by the appropriate national advisory council or board 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. 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? 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? 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? 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)? 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, the following items will be considered in the determination of scientific merit and the priority score: PROTECTIONS 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 included in the section on Federal Citations, below.) ADDITIONAL CONSIDERATIONS BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program 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 these 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 Phases 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: 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 (; a complete copy of the updated Guidelines are available at 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 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 HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at and at Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG ABUSE: Researchers funded by NIDA who are conducting research in community outreach settings, clinical, hospital settings, or clinical laboratories and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing service for persons at risk for HIV infection including injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners. For more information see NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS: The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Home Page at under the Funding, or may be obtained by calling (301) 443-2755. 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 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. 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). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website ( 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 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 AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at, 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 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 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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