ACCEPTABILITY RESEARCH FOR HIV/STD PREVENTION Release Date: February 1, 2000 RFA: HD-00-005 National Institute of Child Health and Human Development National Institute for Mental Health Letter of Intent Receipt Date: April 10, 2000 Application Receipt Date: May 12, 2000 THIS RFA USES THE MODULAR GRANT AND JUST-IN-TIME CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. PURPOSE This Request for Applications (RFA) invites research leading to an improved understanding of the acceptability of methods for the prevention of HIV and/or other STDs. The ultimate goal of the research is to gain insight into the acceptability of new prevention methods, including microbicidal methods currently undergoing development and testing. Studies may examine the acceptability of specific products or classes of products, the processes and factors that influence acceptability in various populations, strategies to improve the acceptability of new products, and the development of improved methods for studying acceptability. It is hoped that such research will be useful in improving the methods, improving clinical trial design, and improving users" experiences with the methods. The National Institute of Mental Health (NIMH) is also interested in supporting applications on the identification of behavioral and social factors that encourage or discourage the initiation and maintenance of microbicide use and on the development of microbicides as alternative prevention strategies for HIV infection. 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 several priority areas. Potential applicants may obtain "Healthy People 2010" at http://odphp.osophs.dhhs.gov/pubs/hp2000. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01) mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed five years. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The earliest anticipated award date is September 29, 2000. For all applications requesting up to $250,000 direct costs per year, specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST IN TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on modular grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. Applications that request more than $250,000 in any year must use the standard PHS398 (rev. 4/98) application instructions. FUNDS AVAILABLE The NICHD intends to commit approximately $2 million total costs (direct plus Facilities and Administrative [F & A] costs) in FY 2000 to fund four to six new grants in response to this RFA. The NIMH intends to commit approximately $500,000 total costs in FY 2000 to fund one to two new grants. An applicant may request a project period of up to five years, and any applicant considering the submission of a budget request that exceeds $500,000 in direct costs in any year is strongly encouraged to contact program staff listed under INQUIRIES prior to submission. Because the nature and scope of the research proposed may vary, it is anticipated that the size of awards also will vary. Although the financial plans of the NICHD and NIMH 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. RESEARCH OBJECTIVES Background This RFA calls for research on the potential acceptability of new methods for HIV/STD protection. In the past several years, researchers and women’s health advocates have detailed the urgent need for the development of microbicides and other female-controlled methods that can prevent the spread of HIV and other STDs (Potts, 1994, Roddy, 1998). As of April 1998, there were 54 compounds and products in preclinical and clinical stages of development for possible use as microbicides (Alliance for Microbicide Development, 1998). New disease-prevention methods for men, including new forms of condoms and chemical barriers, also are needed and under development. Future products and approaches may take a wide variety of forms. They may not all consist of products for vaginal use. There is interest in research targeting modalities such as gene therapies that alter permissiveness, monoclonal antibodies, natural product inhibitors, vaccines to stimulate local protection, agents that interfere with membrane fusion and attachment, cell adhesion factors, hormone or other receptors, and angiogenesis. There is, however, little work that can provide estimates of how a new method will be integrated into the "calculus of conscious choice" that individuals are purported to use when deciding upon protection. For the purposes of this RFA, "acceptability" is defined as the probability that a method will be used in a defined population. This moves beyond an older definition of acceptability as a "quality which makes an object, person, event or idea attractive, satisfactory, pleasing or welcome" (Marshall, 1977). Method characteristics, user characteristics, partner characteristics, external influences such as the service delivery system and marketing, and the socio- cultural context in which the potential users live, all work together to determine the actual initiation and the continued use of a method. Actual use produces both feedback to the user and information into the socio-cultural context for other likely users. The goal of this RFA is to stimulate research to inform the development and dissemination of effective methods for disease protection that are acceptable to those whose sexual behavior places them in need of protection. Research on acceptability of methods is different from research about the methods" safety and efficacy. That which makes a product "acceptable" is typically more subjective and context-specific. A demonstrably effective and safe product may find no market, or may encounter other, more subjective, obstacles to its actual adoption and use (c.f. IUDs in the U.S.). Users may be willing to accept a lower efficacy for a product that they can use covertly, or to accept an undesirable texture or unpleasant side effects for a product that works extremely well. Sometimes, people feel forced to choose the "least worst alternative" (UNDP, 1995, Severy, 1998). The actual product, its viscosity, color, smell, taste, application method, quantity necessary for efficacious use, and duration of effectiveness may influence acceptability. Other aspects of the product, such as its actual or perceived effect on sexual pleasure, may have an impact. Finally, there are many parties besides the person using the product who can have opinions that could influence adoption and continued use. These include partners or potential partners, friends and family, health care providers, health system managers, and manufacturers of products. The sexual beliefs, practices, and norms of a group may influence acceptability at the individual level as well. The relative influence of these various parties and factors may vary among cultures, as well as among potential users of different ages and relationship statuses (Hardy et al., 1998). Past research on acceptability has typically followed one of several models, appropriate to different stages of product development and introduction. Hypothetical product acceptability studies determine potential user responses to a product that is not yet developed and/or proven safe for use in the target population. In some cases, these studies may employ existing products that are similar to the product under study. Often, in such research women are asked to make hypothetical trade-offs between many features of a product, a number of which (such as effectiveness) are unknown. This type of research provides the opportunity for early input from potential users about a new method, however, survey or focus group research asking individuals to evaluate their probable use of a hypothetical method generally has not been successful in predicting actual use of a method. Another common model of acceptability research is to embed behavioral studies within the clinical trials used to evaluate the safety and efficacy of new products. This approach can provide valuable information about users actual experience with a method. However, findings from such efforts are limited in their capacity to address use of a product in the larger population, once it is approved. Selection bias into clinical trials, and the participant "buy-in" that may develop as a result of intensive follow up, skew the ability of such studies to predict acceptability outside the experimental situation. A third model, often referred to as post-marketing research, tracks the adoption and use of a method in actual population settings, studying how the interplay of the individual user, product characteristics, the health system, and the larger social and cultural setting influences use. This model offers the advantages of generalization to larger populations, but suffers from the obvious disadvantage that it cannot be done before an approved product is available. An extension of this model studies diffusion processes within populations and potentially could lead to improved communication strategies tied to the introduction of new methods. Although each of these models of acceptability research is flawed in some ways, research designs that combine models in creative ways may yield more robust results about the acceptability of new products and the factors that influence acceptability. Approaches to the improvement of models for acceptability research might include strengthening the attention to user perspectives and/or to provider perspectives about users, combining qualitative and quantitative methods, and using existing products to model products-in-development. Studies of acceptability also should attend to the full range of factors that influence the ultimate, consistent, and continued use of a product, including the motivation of the individual and the couple to avoid unwanted consequences of their sexual behavior, the context in which the individual or couple are living, and the medical/health care service delivery they expect to encounter in their daily lives. The placement and timing of acceptability studies within the development of new methods need further efforts to adequately address these issues. Research Scope This RFA invites research that will contribute to an improved understanding of the acceptability of methods to prevent HIV and other STDs. The ultimate goal of the research is to gain insight into the acceptability of new prevention methods, including microbicidal methods currently undergoing development and testing. Studies may examine acceptability directly, through acceptability studies on new methods in development or testing, or indirectly, through studies of the acceptability of potential methods using existing methods as models. The choice of models for potential methods must be theoretically informed, but may include contraceptive methods as well as existing STD/AIDS prevention methods, such as the female condom. The inclusion of methodological sub-studies aimed at improving measurement and research design in acceptability research may be appropriate in the context of a study addressing one of the other questions posed under this RFA. Topics of particular interest include, but are not limited to: 1. Studies of the acceptability of specific products or classes of products, and the product characteristics that influence acceptability among various populations, especially adolescents and young adults, as well as persons with severe mental illness. o Expansion of our understanding of the acceptability of method delivery systems (e.g., insertion, ingestion, injection) and formulations (e.g., gel, film, foam) in different cultures and populations. o Examination of the extent to which dual protection against pregnancy and disease enhances or deters acceptability of any new method. 2. Studies of the processes and factors that influence acceptability in various populations. o Exploration of health care providers" understandings of acceptability and the impact of health care delivery approaches on acceptability. o Improvement of our understanding concerning how and when external factors (e.g., friends, family, community, media) influence the acceptability of methods, and how, when, and with whom individuals communicate about methods and method use. o How individuals and couples make tradeoffs among factors such as efficacy, side effects, mechanics of use, etc. in making choices about use and continued use. o Calibration of the influence of individuals" past history of contraceptive and prophylaxis use upon their acceptance of new methods o Examination of individual behavioral characteristics (e.g., attitudes, cognitive and decision making influences, belief in invulnerability), psychosexual factors (e.g., sexual experience, perception of control over sexual behavior or health), psychosocial characteristics (e.g., family environment, peer use, cultural values), and cultural or contextual factors (e.g., gender rules and roles, perceived sociosexual climate in which personal and public contraceptive health care decisions are made) that influence microbicide acceptance and use 3. Research leading to strategies to improve the acceptability of new products. o Exploration of the types of messages and delivery modalities most effective for different groups to facilitate their understanding, acceptance and use of methods. o Expansion of how messages concerning the risk of exposure to disease and negative outcomes are understood and balanced against desires for pleasure or pleasing a partner. 4. Development of improved methods for studying acceptability. o Development of better measures of hypothetical acceptability and testing them against actual use. This could include the design and testing of questions concerning acceptability included within Phase III clinical trials o Measurement issues related to self-report of sexual behaviors and use of methods. o Development and testing of measures of couple acceptability in situations where clandestine use is either not an option or not desired. o Gender/race/age/ethnicity/cultural differences in responding to questions that deal with hypothetical constructs and choices, as well as such differences in actual acceptability of a given product. Applications may propose research designs that encompass any or all of the models described under Background, or may propose new models for research. Applications may propose research in the context of clinical trials, general clinical or population samples, or a combination of these. Acceptability research is properly not the concern of Phase I clinical trials, where the safety of the product is tested among a highly select group. However, Phase II and Phase III trials may, in some cases, be appropriate locations for such work. Proposed methodologies should be appropriate to the questions under study, and may consist of qualitative or quantitative approaches or a mix. Qualitative research may be particularly appropriate for some questions, especially those requiring exploration of sensitive and complex issues. Such research could reveal user perspectives on the salient attributes of new products and attitudes towards the health delivery system. In all cases, strict attention must be paid to the ethical considerations related to the potential for respondents" exposure to any possible negative consequences of participation in research. Collaborations among clinical trial investigators, product developers, service providers, and social and behavioral science researchers are strongly encouraged. Selected References: Alliance for Microbicide Development. 8701 Georgia Avenue, Suite 804, Silver Spring, MD, 20910. DeZoysa, I., Elias C.J., Bentley, M. 1998. Ethical challenges in efficacy trials of vaginal microbicides for HIV Prevention. American Journal of Public Health, 88:571-575. Forrest, J.E., Frost J.J. 1999. Women"s interest in vaginal microbicides. Family Planning Perspectives. 31(1):16-24. Gross, M., Buchbinder, S.P., Celum, C., Heagerty, P., Seage, G.R. 1998. Rectal microbicides for U.S. gay men: Are clinical trials needed? Are they feasible? Sexually Transmitted Diseases. 25:296-302. Hardy, E., De Padua, K.S., Jiminez, A.L., Zaneveld, L.J.D. 1998. Women"s preferences for vaginal microbicidal contraceptives I, II. Contraception. 58:233-249. Heise, L., McCrory, E., Wood, S. 1998. Ethical Dilemmas in the Clinical Testing of Microbicides: A Report on a Symposium. NY: International Women"s Health Coalition. Mastroianni, F., Donaldson, P.J., Kane, T.K. (eds.) 1990. Developing New Contraceptives: Obstacles and Opportunities. Washington DC: National Academy Press. Potts, M. 1994. The urgent need for a vaginal microbicide in the prevention of HIV transmission (editorial) American Journal of Public Health. 84(6):890- 891. Roddy, R.E., Schultz, K.F., Cates, W. 1998. Microbicides, meta-analysis, and the N-9 question: Where"s the research? Sexually Transmitted Diseases. 25(3):151-153. Rosenthal, S.L., Cohen, S.S., Stanberry, L.R. 1998. Topical microbicides: Current status and research considerations for adolescent girls. Sexually Transmitted Diseases. 25(7):368-377. Severy, L.J. 1999. Acceptability as a critical component of clinical trials. Advances in Population. V3:103.122. Jessica Kingsley Publishers, Ltd. UNDP/UNFPA/WHO/World Bank Special Program of Research, Development and Research Training in Human Reproduction. 1995. Women"s and men"s perspectives on fertility regulation methods and services. Report of a meeting, Geneva, 29 November 1 December. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the Federal Register of March 28, 1994 (FR 59 14508- 14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994, available at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and/or 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," published in the NIH Guide for Grants and Contracts, March 6, 1998, and available at: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the 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 NICHD staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Susan Newcomer at the address listed under INQUIRIES by April 10, 2000. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research, on the Internet at http://grants.nih.gov/grants/funding/phs398/phs398.html, and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-710-0267, E-mail: Grantsinfo@nih.gov. Application Instructions The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in- time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers, and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD: Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT: Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION: Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form Page. Under Personnel, list key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus F & A) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH: The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm. - Complete the educational block at the top of the Form Page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years, - List selected peer-reviewed publications, with full citations. o CHECKLIST: This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. The applicant should provide the name and telephone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following initial review. Submission Instructions The RFA label available in the PHS 398 (rev. 4/98) application form must be stapled to the bottom of the face page of the application and must display the RFA number HD-00-003. A sample RFA label is available at http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Please note this is in the pdf format. 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. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package, to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA MD 20892-7710 BETHESDA MD 20817 (for express/courier service) At the time of submission, two additional copies of the application should be sent to: Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E03, MSC 7510 Bethesda MD 20892-7510 Rockville MD 20852 (for express/courier service) Applications must be received by May 12, 2000. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness to this RFA by NICHD and NIMH staff. Incomplete applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NICHD in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the National Advisory Council of NICHD or NIMH. 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 their written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative, but is essential to move a field forward. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications also will be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects also will be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. The scientific review group also will examine the provisions for the protection of human subjects and the safety of the research environment. Schedule Letter of Intent Receipt Date: April 10, 2000 Application Receipt Date: May 12, 2000 Council Review: September 2000 Earliest Anticipated Start Date: September 29, 2000 AWARD CRITERIA Awards will be made based on scientific merit as determined by peer review, on programmatic priorities, and on the availability of funds. INQUIRIES Written, E-mail, and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding NICHD programmatic issues to: Susan F. Newcomer, Ph.D. Demographic and Behavioral Science Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B07 Bethesda, MD 20892 Telephone: (301) 435-6981 FAX: (301) 496-0962 E-mail: sn19y@nih.gov Direct inquiries regarding NIMH programmatic matters to: David M. Stoff, Ph.D. Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6210, MSC 9619 Bethesda, MD 20892-9619 Telephone: (301) 443-4625 FAX: (301) 443-9719 E-mail: dstoff@nih.gov Direct inquiries regarding NICHD fiscal matters to: Michael Loewe Grants Management Office National Institute of Child Health and Human Development Building 61E, Room 8A17K Bethesda, MD 20892 Telephone: (301) 496-5481 FAX: (301) 402-0915 E-mail: loewem@nih.gov Direct inquiries regarding NIMH fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-2805 FAX: (301) 443-6885 E-mail: Diana_Trunnell@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.864, 93.121, and 93.242. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under NIH grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices



NIH Office of Extramural Research Logo
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®



Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.