RFA-DA-04-010: TARGETED INTEGRATIVE RESEARCH IN DRUG ABUSE AND HIV/AIDS IN PREGNANCY

Department of Health
and Human Services (HHS)

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TARGETED INTEGRATIVE RESEARCH IN DRUG ABUSE AND HIV/AIDS IN PREGNANCY RELEASE DATE: December 23, 2003 RFA NUMBER: RFA-DA-04-010 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.279 LETTER OF INTENT RECEIPT DATE: February 17, 2004 APPLICATION RECEIPT DATE: March 17, 2004 THIS REQUEST FOR APPLICATIONS (RFA) CONTAINS THE FOLLOWING INFORMATION: o Purpose of this RFA o Research Objectives o Mechanisms 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 Supplementary Instructions o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute on Drug Abuse (NIDA) invites targeted integrative research on epidemiological, prevention, and treatment service approaches that focus on drug abuse, HIV/AIDS and other medical consequences of drug abuse, specifically relevant to pregnant women and females of childbearing age. Pregnancy is a clinical and psychosocial phenomenon that presents public health, clinical care and drug treatment services with challenges for effective drug abuse prevention and treatment services. Pregnancy also poses challenges to the overall health care, including therapies for HIV/AIDS and other medical consequences of drug abuse. Research and clinical experience have given rise to a burgeoning knowledge base about important gender differences in addiction treatment for females. However, among drug abusing pregnant females of childbearing age, patterns of drug use and effects of use from various drugs have not been adequately characterized or addressed. This is particularly true of emerging and re-emerging drugs of abuse such as ecstasy and methamphetamine. Substance using females who are pregnant often have inadequate or no prenatal care, have greater infant morbidity and mortality in the postnatal period, and significant deficiencies in child health care utilization. In addition the new mother is likely to have significantly lower levels of maternal postpartum visits, primary care visits, contraceptive use and, most importantly, exposure to prevention intervention strategies. Studies are sought that target pregnant and postpartum drug-using females as they move through the health care and drug abuse services continuum, and on overall health outcomes specific to this population. A key focus of these studies with respect to this population is integration and application of knowledge and models of care that can blend for improved outcomes targeting drug abuse (consequences, epidemiology, prevention intervention and treatment approaches) and clinical care (therapeutics, diagnostic tools). Specifically, NIDA seeks innovative research that targets, integrates and informs scientific knowledge on unique aspects of clinical care, prevention interventions, and drug abuse treatment for drug-using pregnant females and females of childbearing age. Applicants are encouraged to compare models of care addressing certain of the many factors involving this population, such as medical, behavioral, social and service system issues. Results of these studies are expected to inform the development and design of models of care for pregnant females and females of childbearing age that blend significant components to create optimal outcomes. Studies could for example investigate integrative strategies for intervention, treatment, prevention with clinical care and pre- or post-natal service approaches that best target this population over the health care, drug abuse and behavioral risk continuum. RESEARCH OBJECTIVES Background Over the years NIDA initiatives have reflected the changing scientific and clinical landscape and thus provide resources for timely investigations of issues as they related to drug abuse, HIV/AIDS and other medical consequences of drug abuse and pregnancy. Research and clinical experience have shown important differences in addiction treatment for women. Reframing theoretical questions, conceptual frameworks, assessment technique modifications, and new treatment approaches are some of the general attributes of female- centered or gender-specific models of care. Characteristics of these models include empowerment approaches, training and supervision protocols for treatment staff, increased flexibility in treatment planning and program structure, peer counseling and therapeutic relationships and comprehensive integrated services (e.g. GED, vocational counseling, nutrition, child care) oriented toward special needs of women. Of interest are programmatic activities that include spiritual and culturally relevant traditions, attention to exposure to interpersonal violence and physical and sexual abuse and primary care giving roles traditionally for females. Over the last decade perspectives have evolved on the conduct of research involving females of childbearing potential and those who are pregnant. Maternal-fetal physiology is understood as representing bi- directional interactions with the placenta as an interposed modulating organ system. Along with the advancements in basic science, new methods for clinical assessment of maternal and fetal physiologic events such as ultrasonography are available to be applied in research settings. Often an attenuation of all substance use occurs with pregnancy but there are differentials with respect to age, pregnancy history and the substance being used. Data from the 2002 National Survey on Drug Use and Health (formerly known as the National Household Survey on Drug Abuse) reports the past month prevalence of any illicit drug use, cigarette smoking, and marijuana and binge alcohol use to be higher among 18-25 year old pregnant women as compared to 26-44 year old pregnant women. Additional analyses performed on the NPHS data reveal that an association exists between report of illicit drug use in the index pregnancy and a higher order number of previous pregnancies after controlling for age. This same relationship holds for tobacco use. A research network is currently funded by NIDA to explore developmental outcomes of infants prenatally exposed to methamphetamine but there is limited research on methamphetamine use and pregnancy. In the United States, hospital delivery is virtually universal and almost all women have some interface with the medical care system prior to labor and delivery. Pregnancy has been characterized as an opportune time for screening and detection of drug use, initiation of behavior change and acceptability of clinical interventions. However, considerable variability exists among populations and participation in prenatal care or experience with drug abuse treatment. It is well documented that substance-abusing women have a high likelihood of inadequate prenatal care. In a prospective cohort analysis of 6673 women delivering in the District of Columbia, mothers with illicit drug exposure in pregnancy were significantly more likely to begin prenatal care later and to have fewer prenatal visits. The highest risk for prematurity, a 12-fold increased risk, occurred in infants born to mothers with no prenatal care and illicit drug use. The impact of illicit drug use, frequency of use or specific drug of abuse on maternal health and variations of effects are not well addressed in drug treatment interventions. Elevated risk estimates have been observed for syphilis, gonorrhea, pregnancy-related hypertensive disorders, chorioamnionitis, asthma and postpartum hemorrhage. Substance-abusing women who become pregnant and have inadequate or no prenatal care have greater infant morbidity and mortality in the postnatal period with significant deficiency in the pattern of child health care utilization. Equally significant by some standards are lower levels of maternal postpartum visits, primary care visits, and adoption of effective contraception for family planning. There is virtually no information on health or drug use outcomes for substance-abusing women who do not complete a pregnancy, either voluntarily or secondary to pregnancy complications such as miscarriage or ectopic pregnancy. Controversies persist regarding detoxification and the use of pharmacotherapies as part of drug abuse treatment and the treatment of co-occurring disorders in pregnant and lactating women. In addition, the availability of drug treatment for pregnant and newly parenting women is very limited. Many prenatal care programs are designed to provide for the multiple needs of the pregnant woman and her family such as psychological, social, vocational and legal services in addition to medical care. However, in most locations the inclusion of drug treatment into these comprehensive programs is also limited. Women residing in rural areas are particularly limited in treatment options. A limited number of studies in pregnant women have been undertaken to evaluate the office-based model of opiate substitution therapy with buprenorphine. The circumscribed duration of clinical obstetrical care may be at odds with the necessity of remaining in drug treatment for an adequate period of time to reach the threshold for recovery. Severity of addiction related problems and prior treatment experience have been both positively and negatively associated with involvement in drug treatment during pregnancy. Lack of coordination after delivery for the provision of aftercare predicts poorer prognosis for recovery. Multiple studies have demonstrated the lack of durability and sustainability beyond six months of abstinence or drug use reduction achieved during pregnancy. Gender and racial and ethnic diversity in relapse prevention needs has been reported but not specifically explored in relation to pregnancy. Community level prescription and proscription of certain behaviors in pregnancy are an important influence on pregnancy outcome and function outside of the clinical services realm. Peer group deviance, licit and illicit substance use by a male partner, significant other or family member, familial social support and mandated treatment are factors that have been described to influence acceptance of and compliance with drug treatment by pregnant women. Knowledge, attitudes and practices within the health care provider community have an influence on prenatal care and drug treatment. Substance-abusing women who become pregnant are stigmatized and many clinicians have limited knowledge of the nature of addiction and its medical consequences. There are specialty differences in screening, assessment and referral of women for substance use. Surveys have reported attitudes on the part of perinatal providers that do not foster reciprocal approaches to optimizing maternal and fetal/infant health outcomes. Negative attitudes coupled with the intensity of high-risk perinatal care may create dissonance for health care providers who are presented with a woman actively using drugs who also seeks to have a parenting and mothering role. Finally, one of the most significant individual and public health consequences of drug use: acquisition and transmission of HIV infection and other infectious diseases, has added a new dimension to drug abuse treatment in pregnancy. Among AIDS cases diagnosed in women and adolescent girls through 2001, injection drug use was the exposure category in 32 percent. Heterosexual transmission by way of sex with an injection drug user accounted for 16 percent of cases. Over fifty percent of all cases are classified as other exposure/not identified and sex with men of other or unspecified risk. Research is emerging on the indirect role of injection and non-injection drug use as facilitators of sexual risk behaviors. The heterosexual transmission category is now the predominant exposure category in the Midwest, South and West as compared to the Northeast. There has been a significant decline in the incidence of perinatal transmission of the HIV virus since the adoption of the results of ACTG 076 (using zidovidine) and other protocols. There are emerging issues in the provision of antiretroviral therapy to women of childbearing potential, as more women become candidates for indicated antiretroviral therapy as well as prophylaxis. There is evidence that women, who use illicit drugs during pregnancy, as well as tobacco and alcohol, are significantly less likely to receive prophylactic antiretroviral regimens. Substance- abusing women with limited prenatal health care contribute to the residual risk for maternal to child transmission in the United States. Areas of Research Interest Applicants are encouraged to propose targeted integrative research addressing females of childbearing age and unique aspects of drug abuse, HIV/AIDS and other medical consequences of drug abuse and pregnancy. Multidisciplinary approaches are encouraged as appropriate, derived from the clinical, behavioral, biomedical, and social sciences and utilizing both qualitative and quantitative measures and methodology. Focal issue areas include epidemiology, prevention, behavioral and other interventions, drug treatment, clinical care and services. Research proposals that address any of the following are encouraged: o Variations in conceptual models of gender-based drug abuse treatment and its applicability and transferability across the continuum of care provided to substance-abusing pregnant females and females of child bearing age. Examples of potential variables involved in models of care may include: Factors associated with prevention, intervention, treatment strategies as integrated into clinical care including, as appropriate, consideration of those receiving prenatal care late in pregnancy, intermittently or not at all and possibly involving issues such as detoxification, lactation, drug interactions, continued drug use, abstinence, provider practices, access and utilization of care, associations between entry into prenatal and other care and initiation into drug treatment and continuation in such services. o Epidemiology studies on incidence and prevalence of HIV acquisition and care throughout the preconception, pregnancy and postpartum cycle in drug abusing females. o Drug use trends and use patterns in drug-using pregnant women and females of child bearing age who have or are at risk for HIV/AIDS; for example, use of emerging drugs of abuse and nontherapeutic use of prescription drugs, including issues such as pharmacotherapy, drug interactions, pain management, comorbidity. MECHANISM OF SUPPORT This RFA will use the NIH research project (R01) and the exploratory/developmental (R21) award mechanisms (http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html). As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 30, 2004. Applications that are not funded in the competition described in this RFA may be submitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. This RFA uses just-in-time concepts. It also uses the modular budgeting as well as the non-modular budgeting formats (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 budget format. Otherwise follow the instructions for non-modular budget 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. FUNDS AVAILABLE NIDA intends to commit approximately $1,500,000 in FY 2004 to fund 2-5 new and/or competitive continuation grants in response to this RFA. For the R01, an applicant may request a project period of up to 5 years. For the R21, the project period is 2 years and up to $275,000 in direct costs for the two-year period (http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html). Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of NIDA provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit (an) application(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 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: J.C. Comolli, B.S.N., M.B.A. Center on AIDS and Other Medical Consequences of Drug Abuse National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 5194, MSC 9593 Bethesda, MD 20892-9593 Telephone: (301) 402-0630 Fax: (301) 594-6566 or (301) 480-4544 Email: Jcomolli@nida.nih.gov o Direct your questions about peer review issues to: Teresa Levitin, Ph.D. Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6101 Executive Boulevard, Suite 220, MSC 8401 Bethesda, Maryland 20892-8401 Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: tlevitin@mail.nih.gov o 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/DHHS 6101 Executive Boulevard, Suite 242, MSC 8403 Bethesda, MD 20892-8403 Telephone: (301) 443-6710 FAX: (301) 594-6849 Email: gf6s@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 Key areas of proposed research including major methodologies 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 NIDA staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Director Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6101 Executive Boulevard, Suite 220, MSC 8401 Bethesda, MD 20892-8401 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: tlevitin@mail.nih.gov 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 document 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: GrantsInfo@nih.gov. 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. 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: http://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/DHHS 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to: Director Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6101 Executive Boulevard, Suite 220, MSC 8401 Bethesda, MD 20892-8401 Rockville, MD 20852 (for express/courier service) APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignments within 8 weeks. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfounded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIDA. Incomplete applications will not be reviewed. If the application is not responsive to the RFA, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. 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 NIDA in accordance with the review criteria stated below. As part of the initial merit review, all applications will: 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 written critique o Receive a second level review by the National Advisory Council on Drug Abuse 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 evaluate the 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 the following criteria in assigning the 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, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Please assess the extent to which the study aims are consistent with the goals of the RFA. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? Does the study address an important problem consistent with the goals of this RFA? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Is the investigator appropriately trained and well- suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? 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: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). ADDITIONAL REVIEW CONSIDERATIONS Sharing Research Data Applicants requesting more than $500,000 in direct costs in any year of the proposed research must 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. (See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm.) 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: February 17, 2004 Application Receipt Date: March 17, 2004 Peer Review Date: July/August 2004 Council Review: September 2004 Earliest Anticipated Start Date: September 30, 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against 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 SAFETY AND 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 (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking more than $500,000 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. 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 http://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 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). 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 (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. 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 http://www.nida.nih.gov under the Funding, or may be obtained by calling (301) 443-2755. 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 at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284 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 http://grants.nih.gov/grants/policy/policy.htm. 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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