and Human Services (HHS)
EXPIRED
CROSS-DISCIPLINARY TRANSLATIONAL RESEARCH AT NIH RELEASE DATE: June 9, 2004 PA NUMBER: PA-04-109 Update: The following update relating to this announcement has been issued: December 7, 2006 - The R01 portion of this funding opportunity has been replaced by PA-07-109, which now uses the electronic SF424 (R&R) application for February 5, 2007 submission dates and beyond. 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 Grants.gov 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. Replacement R03 (PA-06-322) and R21 (PA-06-321) funding opportunity announcements
have been issued for the submission date of June 1, 2006 and submission dates for
AIDS and non-AIDS applications thereafter. 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 R01 Non-AIDS Applications: November 2, 2006 EXPIRATION DATE for R01 AIDS and AIDS-Related Applications: January 3, 2007 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATION: National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) National Cancer Institute (NCI) (http://www.nci.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.279 (NIDA), 93.399 (NCI) 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 OF THIS PA The National Institute on Drug Abuse (NIDA) is committed to translating research findings into practice. As part of its mission, NIDA facilitates the translation of basic or clinical research discoveries in the field of drug abuse research into new clinical and research tools, medications, and behavioral therapies. The purpose of this PA is to foster research that will have a practical impact on the treatment and prevention of drug abuse through the development of new research technologies that are based on existing basic and/or clinical research knowledge, and technology transfer knowledge. RESEARCH OBJECTIVES The scope of this program announcement includes a range of activities designed to extend basic or clinical research findings to yield a knowledge base for the development of novel, efficacious drug abuse prevention or treatment interventions. It is envisioned that the research conducted under this PA will primarily use laboratory studies with human volunteers. However, it is possible that preclinical research studies may be relevant to the objective of this PA and, as such, may be a logical component of the work plan of an application. For example, studies with animal models might be relevant to the discovery of more details regarding the mode of action of a clinically used medication, knowledge that, in turn, would allow development of more specific medications. Medications development research, per se, is not the focus of this PA. Background: Significant progress has been made in the development of drug abuse prevention and treatment interventions. Nonetheless, many youth continue to experiment with and become addicted to drugs such as marijuana, cocaine, heroin, nicotine and amphetamine. Drug abuse public health concerns tend to be of a persistent nature. Part of the persistence of drug abuse is the result of social barriers to treatment, such as the stigma attached to replacement therapies (e.g., methadone) that inhibit treatment- seeking behavior. For others, current prevention or treatment options are ineffective: drug dependence occurs among experimental drug abusers as their drug abuse behaviors escalate, or abstinence is short-lived as drug abusers relapse to drug abuse. A key requirement for the development of successful prevention or treatment strategies is the characterization of new assays, models, tools, and technologies. Basic behavioral and cognitive research may also guide the development of new treatment and prevention interventions. A great deal of basic science knowledge exists, but has not yet been fully exploited in prevention or treatment strategies. For example, many science- based prevention programs have proven efficacious for significant numbers of youth, yet more research is needed to elucidate reasons why some individuals are non-responsive to such programs. Differences in neurocognitive processes may contribute to differential ability to process prevention related information, and this needs to be explored. As recent years have seen an explosion of fundamental insights in the basic sciences, translating this knowledge into practical advances has become a priority for NIDA. As such, the purpose of this announcement is to foster research that furthers the translation of existing knowledge into treatment and treatment practice, or research that, in and of itself, will readily translate to clinical research or practice. This PA is intended to encourage projects that provide tools and resources that serve as platforms for the development of effective prevention and treatment strategies. Collaboration of basic and applied investigators or between clinical and health services investigators working towards a common goal may produce new perspectives, insights and approaches to improving drug abuse prevention and treatment. Behavioral research, for example, has demonstrated the profound role that conditioned cues play in drug addiction, and has shown that drug- taking behavior is modified by environmental and situational factors. The neurochemical systems mediating some of these effects have been identified. As a second example, cognitive science suggests an influence of higher-order mental processes in decision-making expectancies and memories of drug use. Research on neurocognitive processing and decision-making, particularly among adolescents and young adults who may be at high risk for drug use onset or drug dependency may contribute to the development or refinement of intervention material. Outcomes from treatment and basic research also suggest that there may be gender differences in responses to interventions that could be examined from a neuroscience perspective. As a third example, health services research on technology transfer suggests that there are financial, organizational, and management factors that may help to explain differences in the rates and processes of uptake (i.e., exposure, adoption, implementation, sustained use) of new, efficacious drug abuse prevention and treatment technologies among community-based programs. Collaborations between basic and applied researchers with diverse fields of interest, or between clinical and health services researchers (e.g., health economists, industrial/organizational psychologists, public health experts), may aid in the development of innovative approaches to drug abuse treatment or prevention and to the delivery of services to those individuals who need them. Applications responsive to this PA will include such collaborations. Goals of such projects include, but are not limited to: o Laboratory studies with human volunteers that are designed to discover whether neurochemical or related mechanisms observed in preclinical science can serve as important targets for the treatment of drug addiction are needed. Agents to be tested might interact with the primary drug effects (e.g., reinforcement, craving, tolerance, withdrawal, etc.) and/or secondary drug effects (e.g., conditioned reinforcement, cue-induced craving, decision-making, etc.). Demographic factors, such as gender and age, could be examined as moderators of identified effects. o Laboratory studies, especially phase I clinical studies, with human volunteers that evaluate drugs that are currently being used to treat non-addiction disorders, but whose preclinical effects indicate possible utility for treating drug abuse are needed. Demographic factors, such as gender and age, could be examined as moderators of identified effects. o Studies that develop and evaluate new assessment or measurement tools designed to measure various aspects of the addictive state, including initiation, the transition from use to addiction, dependency, craving, withdrawal or relapse are needed. These tools will be important for further characterizing this disorder and evaluating treatment outcomes. o Discovery and evaluation of animal models that permit further evaluation of candidate therapeutics, such as using animals that have been modified genetically, chemically, or through any intervention, that captures critical features of drug abuse are needed. This may include individual vulnerability to drugs of abuse, development of addiction, withdrawal, or relapse. o Research that focuses on non-drug interventions that specifically address the role of conditioned reinforcement, craving, and relapse, as well as consciousness and higher-order mental processes (e.g., decision-making) are needed. This approach is envisioned to go beyond the contingency management and cognitive behavioral treatments that have already been translated and are currently used in clinical setting. It is anticipated that these types of interventions will be used in combination with existing addiction treatments to improve clinical outcomes. Demographic factors, such as gender and age, could be examined as moderators of identified effects. o Studies that assess the effectiveness and utility of using established basic behavioral and cognitive assessment paradigms (e.g., measures of implicit cognition, inter-temporal choice, semantic networks) in treatment intervention and in predicting treatment outcomes and relapse are needed. This is envisioned to go beyond cognitive assessments that have already been translated and are currently used in clinical setting. For more extensive development of behavioral therapies, please see PA-03-126 (http://grants.nih.gov/grants/guide/pa-files/PA-03-126.html ) o Development and testing of clinical tools for screening, assessment, diagnosis, and treatment matching to improve the targeting of treatment services, based on human laboratory studies of individual, social, and environmental factors, as well as studies of services characteristics. o Development and testing of innovative prevention and treatment services that can be used in a wide variety of non-specialty health care settings to address drug abuse using untapped findings on cognitive factors such as decision-making, automatic vs. controlled thinking, affective mediators and modulators of cognition. o Development of models of longitudinal care including medications, behavioral therapies, social services, and education for defined populations, based on clinical research of long-term patterns of drug use (e.g., cycles involving experimental use, escalation, abuse, dependence, withdrawal, abstinence, relapse) and long-term patterns of response to prevention and treatment (e.g., time to relapse, triggers for relapse, response to social support for abstinence) for these defined populations. o Studies looking at the utility in the prevention and treatment of drug abuse of approaches, technologies and strategies that have been developed for other clinical conditions. For example, virtual reality technologies are being used with success for some clinical conditions (e.g. phobias, eating disorders), but not for drug abuse prevention or treatment. Research examining how these types of treatments might be used to prevent or treat drug abuse is sought. o Using discoveries from the basic biological (e.g. neurobiological), psychological (e.g. emotional, behavioral, cognitive, and developmental) and social (e.g. social learning, peer network, and communications) sciences for developing and testing innovative drug abuse prevention interventions. o Development and testing of innovative methods for studying adolescent decision-making related to drug use and sexual risk behaviors that will apply more readily to real world settings. MECHANISMS OF SUPPORT This PA will use the National Institutes of Health (NIH) research project grant (R01), small grant (R03) (PA-03-108: NIH SMALL RESEARCH GRANT PROGRAM (R03)), and exploratory/developmental (R21) (PA-03-107: NIH EXPLORATORY/DEVELOPMENTAL RESEARCH GRANT AWARD (R21)) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Collaborations within and between research institutions are encouraged. This PA uses just-in-time concepts. It also uses the modular budgeting format (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non-modular research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. 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 institutions/organizations 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 two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: Dr. Allison L. Chausmer Division of Basic Neuroscience and Behavioral Research National Institute on Drug Abuse, NIH, DHHS 6001 Executive Boulevard, Room 4282, MSC 9555 Bethesda, MD 20892-9555 Rockville, MD 20852 (for express/courier service) Telephone: 301-402-5088 FAX: 301-594-6043 Email: [email protected] Dr. Jacqueline Stoddard Tobacco Control Research Branch National Cancer Institute, NIH, DHHS 6130 Executive Boulevard, Suite 440 Bethesda, Maryland 20892-7337 Rockville, Maryland 20852 (for express/courier service) Telephone: 301-496-0274 FAX: 301-496-8675 Email: [email protected] o Direct your questions about financial or grants management matters to: Dr. Gary Fleming Chief, Grants Management Branch National Institute on Drug Abuse, NIH, DHHS 6101 Executive Boulevard, Room 270, MSC 8403 Bethesda, Maryland 20892-8403 Rockville, MD 20852 (for express/courier service) Telephone: 301-443-6710 Fax: 301-594-6849 E-mail: [email protected] Ms. Crystal Wolfrey Grants Administration Branch National Cancer Institute, NIH, DHHS 6120 Executive Boulevard, Suite 243 Bethesda, MD 20892-7340 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-8634 Fax: (301) 496-8601 E-mail: [email protected] SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected]. The title and number of this program announcement must be typed on line 2 of the face page of the application form and the YES box must be checked. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. 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 http://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 http://grants.nih.gov/grants/funding/modular/modular.htm. 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 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 IC staff that IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member in 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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. 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 received by or mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. 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. Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: 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 written critique o Receive a second level review by an 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. 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. o Significance o Approach o Innovation o Investigator o Environment 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, 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 this study address an important problem? If the aims of your 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? 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? 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? 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 to that of other researchers (if any)? 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below) http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). ADDITIONAL REVIEW CONSIDERATIONS BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. Sharing Research Data Applicants requesting more than $500,000 in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. (http://grants.nih.gov/grants/policy/data_sharing ) 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 http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase II), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMB) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. 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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN 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. 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 http://grants.nih.gov/grants/funding/children/children.htm. 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 http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html. 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 www.nida.nih.gov under the Funding, or may be obtained by calling (301) 443-2755. 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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, 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. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this 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). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.279, 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)(or other authorizations) and administered under NIH grants policies described at http://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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