STUDIES OF THE ETHICAL, LEGAL, AND SOCIAL IMPLICATIONS (ELSI) OF HUMAN GENETIC VARIATION RESEARCH FOR INDIVIDUALS AND DIVERSE RACIAL AND ETHNIC GROUPS Release Date: November 15, 2001 RFA: RFA-HG-02-003 National Human Genome Research Institute National Institute on Aging National Institute on Deafness and Other Communication Disorders National Institute of Dental and Craniofacial Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse National Institute of Environmental Health Sciences National Institute of General Medical Sciences National Institute of Nursing Research Fogarty International Center Letter of Intent Receipt Date: March 1, 2002 Application Receipt Date: July 10, 2002 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS REQUESTING LESS THAN $250,000 PER YEAR IN ALL YEARS. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html. PURPOSE Human genetic variation research, especially as it relates to risk factors for common, complex disorders, is leading to increased knowledge regarding variation among individuals and how this variation may contribute to the health status of individuals. It is also leading to more knowledge about variation within and among different racial and ethnic groups (to the extent that such groups can reasonably be identified) and how this variation may contribute to the aggregate health status of those groups. The NHGRI"s new initiative to develop a haplotype map of the human genome will make it possible to conduct this type of research (in particular, disease gene association studies) more quickly and efficiently than ever before, resulting in an even more rapid proliferation of this new information. Information regarding variation within and among groups, in particular, will increasingly be generated, because the map will facilitate the conduct of association studies in selected populations where certain diseases are more or less prevalent. While the ultimate goal of studies aimed at relating human genetic variation to disease risk is the improvement of human health, concerns have been raised that the findings of some genetic variation research may be misunderstood. Concerns have also been raised that such findings, if interpreted incorrectly and misused, will exacerbate, rather than ameliorate, already-existing health disparities among racial, ethnic, and socio-economic groups. The NHGRI, through its Ethical, Legal, and Social Implications (ELSI) Research Program, proposes a new initiative to encourage additional research on the ELSI implications of genetic variation research for both individuals and for diverse population groups. This builds on an earlier initiative in the same general area. See http://www.nhgri.nih.gov/Grant_info/Funding/RFA-HG-99-002.html. 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 Request for Applications (RFA), Studies Of The Ethical, Legal, And Social Implications (ELSI) Of Human Genetic Variation Research For Individuals And Diverse Racial And Ethnic Groups, 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/. 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. Faith-based organizations are eligible to apply for these grants. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Participation in the program by investigators at minority institutions is strongly encouraged. Investigators from foreign institutions should review the standard NIH criteria for funding foreign applications (see AWARD CRITERIA below) before preparing an application. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) regular research project grant (R01) and small research project grant (R03) award mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an R01 application submitted in response to this RFA may not exceed 3 years, the total project period for an R03 may not exceed 2 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 anticipated award date is March 1, 2003. FUNDS AVAILABLE The participating NIH institutes intend to commit approximately $4,500,000 in FY 2003 to fund 10-15 new grants in response to this RFA. An applicant for an R01 may request a project period of up to 3 years and a budget for direct costs of up to $500,000 per year, an applicant for an R03 may request a project period of up to 2 years and a budget for direct costs of up to $50,000 per year. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of the participating Institutes and Centers (IC) 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. At this time, it is not known whether this RFA will be reissued. RESEARCH OBJECTIVES Background While it is believed that virtually all disorders have a genetic component, the extent to which genetic factors, as distinct from other biological and non-biological factors, influence the increased or decreased risk of individuals for common, complex disorders remains uncertain. Genetic variation research will help us better understand the contribution that genetics makes to such disorders. However, we currently have few data about how individuals, health professionals, or various societal decision makers are likely to interpret, understand, and use the findings of such research. In addition, little is understood about how people are likely to react to information suggesting the possibility of group differences with respect to individual genetic risk for common, complex disorders. Some have argued that genetic variation research will enable people to be grouped in new, positive ways, so that health care will become increasingly tailored to genetic risk status. This, it is argued, could have positive results over time, not only for the health of individuals, but also for reducing health disparities among groups. For example, pharmacogenomics research aimed at determining the proportion of individuals in various population groups who have genotypes that make them more or less responsive to particular drugs could result in better-targeted drug therapies. This, in turn, could lead to measurable improvements in drug response and decreases in the incidence of adverse or toxic reactions in members of those groups. On the other hand, concerns have been raised that genetic variation research, to the extent that it may lead to an overemphasis on individual and group differences, may tend to reinforce existing patterns of racial, ethnic, and socio-economic stratification, both in health care and in other societal areas. These reinforced patterns, in turn, could over time lead to an actual worsening of the health status of individuals and of health disparities among groups. For example, misinterpretations of the findings of genetic variation research could increase the tendency of some to view genetics in an overly deterministic manner when assigning causality for common, complex disorders, creating a climate in which important non-genetic factors are ignored and societal resources are diverted from addressing crucial environmental, behavioral, or social concerns. Diagnoses of certain disorders could more often be delayed or even missed in patients who have not been identified as members of "high risk" racial or ethnic groups, as has happened in the past with such disorders as cystic fibrosis and sickle cell anemia. Other concerns relate to the potential for stigmatization and for racial and ethnic categories to be "reified" as well-defined biological constructs both of which could further affect both individual and group health status, even if only indirectly. Research Scope Examples of the types of topics that would be appropriate for applications submitted under this initiative include but are not limited to the following: 1. How will individuals understand and use genetic information that suggests the possibility of a meaningful association between their genotype and increased or decreased risk for a particular common, complex disorder (or between their genotype and increased or decreased responsiveness to a particular medication or susceptibility to a potentially hazardous environmental substance)? How will genetic information that suggests the possibility of differences in frequencies among groups of the genetic variants that contribute to these traits be understood and used? o Do perceptions, interpretations, or concerns about causality, or about group differences, differ between persons with the disorder and unaffected persons? o Do perceptions, interpretations, or concerns about causality, or about group differences, differ among individuals from different racial, ethnic, or socio- economic groups? o Do perceptions, interpretations, or concerns about causality, or about group differences, differ depending on the nature of the disorder, or on whether the non-genetic factors involved are environmental, behavioral or social in nature? o Do perceptions, interpretations, or concerns about causality, or about group differences, vary as a function of age? o What effect, if any, will the knowledge that one is at increased or decreased genetic risk for a particular disorder have on perceived health status and on individual health behaviors? How are these effects modified by such factors as age, gender, or socio-economic status? o What effect, if any, will the knowledge that a particular group has a higher proportion of individuals at increased or decreased genetic risk for a particular disorder have on the perceived health status or health behaviors of members of that group (including the willingness of group members to be screened, adhere to health interventions, and utilize other health services)? 2. How will genetic information that suggests the possibility of group differences in the prevalence of a genotype associated with increased or decreased risk for a particular common, complex disorder (or increased or decreased responsiveness to a particular medication or susceptibility to a potentially hazardous environmental substance) be understood and used by health professionals? How will it be understood and used by various other societal decision makers (e.g., insurance companies, pharmaceutical companies, employers, health care policymakers, environmental policymakers, educational institutions, courts, adoption agencies, the military)? How will this information differentially affect individual decision-making over the life course (e.g., insurance, retirement age, savings)? How will this information affect public and institutional policy for the aged (e.g., Social Security, Medicare, retirement benefits), or for individuals with disabilities? What long-term effect, if any, will the use of this information have on health disparities among groups? 3. In reporting the results of human genetic variation research, how do investigators assign causality when a particular disorder is associated with both genetic and non-genetic (environmental, behavioral, or social) risk factors? How do the media assign causality when reporting on such studies? What are the ethical obligations of investigators when they report the findings of disease gene association research involving common, complex disorders? What are the ethical obligations of the media when they report on such studies? 4. How do investigators define and describe the groups with whom they conduct human genetic variation research? How do the media describe those groups when reporting on such studies? What are the ethical obligations of investigators when they define and describe the groups with whom they conduct genetic variation research? What are the ethical obligations of the media when they report on such studies? 5. What new problems arise for individuals and groups when genetic variation data are incorporated into social survey research? (See Cells and Surveys: Should Biological Measures be Included in Social Science Research? Washington, DC: National Academy Press, 2001, available at http://www.nap.edu.) How will individuals and groups perceive the risks and benefits of participating in these surveys? How can these surveys be used to study the factors motivating participation? 6. How are the statements that "all human beings are 99.9% genetically the same" and "there is no biological basis for precise racial categorizations" understood by individuals who self-identify as members of particular racial, ethnic, or socio-economic groups? How do such statements affect how groups define themselves or are defined by others? What is the impact of such statements on individual conceptions of self and group identity? 7. In broad terms, what is likely to be the long-term impact of genetic variation research on the health status of individuals and on health disparities among groups? SPECIAL REQUIREMENTS To allow researchers to compare findings on issues common to all the projects, to reduce duplication of effort, and to promote sharing of information, grantee workshops will be arranged on an annual basis in the Bethesda area. The initial meeting will take place shortly after the grants are funded. Funds for travel to these meetings for up to two investigators (the PI and one other) per year should be included in the requested budget. 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 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 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 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: 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. 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. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following web site: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. 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 RFA 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. 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 the RFA in response to which the application may be submitted. 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 IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by March 1, 2002 to: Jean E. McEwen, J.D., Ph.D. ELSI Research Program National Human Genome Research Institute Building 31, Room B2B07 31 Center Drive, MSC 2033 National Institutes of Health Bethesda, MD 20892-2033 TEL: (301) 402-4997 FAX: (301) 402-1950 E-mail: jm522n@nih.gov APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html must be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable format. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. For R01 applications, the Research Plan section should not exceed a total of 25 pages, for R03 applications, the Research Plan section should not exceed a total of 10 pages. All R03 applications, and any R01 application that requests $250,000 or less per year in direct costs, must use the modular grant application instructions. Complete instructions and information on Modular Grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS 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 NIH staff. The research grant application form PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants, with modular budget instructions provided in Section C of the application instructions. 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. 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 must be sent to: Rudy Pozzatti, Ph.D. Office of Scientific Review National Human Genome Research Institute 31 Center Drive, Room B2B37 Bethesda, MD 20892-2033 Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NHGRI. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NHGRI in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and 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, assigned a priority score, and receive a second level review by the appropriate Institute or Center Advisory Council Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of 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 method? 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 will also 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 will also 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. Schedule Letter of Intent Receipt Date: March 1, 2002 Application Receipt Date: July 10, 2002 Peer Review Date: Fall 2002 Council Review: January 2003 Earliest Anticipated Start Date: March 1, 2003 AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: scientific merit of the proposed project as determined by peer review, availability of funds, and program priority. In order for the NIH to fund applications from foreign institutions, the application must meet the following three criteria: (1) The proposed project must have special relevance to the mission and objectives of the awarding organization and have the potential to advance knowledge that will benefit the United States, (2) The project must present special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries which are not readily available in the United States or which provide augmentation of existing U.S. resources, and (3) The foreign grant application must be in the upper half of the research grant priority scores. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or answer questions from potential applicants is welcome. Direct inquiries regarding review issues to: Rudy Pozzatti, Ph.D. Office of Scientific Review National Human Genome Research Institute 31 Center Drive, Room B2B37 Bethesda, MD 20892-2033 TEL: (301) 402-0838 FAX: (301) 435-1580 E-mail: rp7s@nih.gov Direct inquiries regarding programmatic issues to: Jean E. McEwen, J.D., Ph.D. ELSI Research Program National Human Genome Research Institute Building 31, Room B2B07 31 Center Drive, MSC 2033 National Institutes of Health Bethesda, MD 20892-2033 TEL: (301) 402-4997 FAX: (301) 402-1950 E-mail: jm522n@nih.gov Barbara Sina, Ph.D. Division of International Training and Research Fogarty International Center 31 Center Drive, Room B2C39, MSC 2220 Bethesda, MD 20892-2220 TEL: (301) 402-9467 FAX: (301) 402-0779 Email: barbara_sina@nih.gov Jennifer Harris, Ph.D. Behavioral and Social Research Program National Institute on Aging 7201 Wisconsin Avenue, Suite 533, MSC 9205 Bethesda, MD 20892-9205 TEL: (301) 496-3138 FAX: (301) 402-0051 Email: jh475o@nih.gov Amy M. Donahue, Ph.D. Chief, Hearing and Balance/Vestibular Section National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard EPS 400C Rockville, MD 20892 TEL: (301) 402-3458 FAX: (301) 402-6251 Email: amy_donahue@nih.gov Patricia S. Bryant, Ph.D. Director, Behavior, Health Promotion, and Environment Program National Institute of Dental and Craniofacial Research Building 45, Room 4AN-24 45 Center Drive, MSC 6402 Bethesda, MD 20892-6402 TEL: (301) 594-2095 FAX: (301) 480-8318 Email: pb36q@nih.gov Rebekah S. Rasooly, Ph.D. Program Director, Genetics and Genomics Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Two Democracy Plaza 6707 Democracy Blvd., MSC 5458 Bethesda, MD 20892-5458 TEL: (301) 594-6007 FAX: (301) 480-3510 Email: rr185i@nih.gov Jonathan D. Pollock, Ph.D. Division of Neuroscience and Behavioral Research National Institute on Drug Abuse 6001 Executive Boulevard, Room 4284, MSC 9555 Bethesda, MD 20892-9555 TEL: (301) 443-6300 FAX: (301) 594-6043 Email: jp183r@nih.gov Shobha Srinivasan, Ph.D. Scientific Program Administrator Chemical Exposures and Molecular Biology Branch Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-21 111 T.W. Alexander Drive RTP, NC 27709 TEL: (919) 541-2506 FAX: (919) 316-4606 Email: sriniva2@niehs.nih.gov Rochelle M. Long, Ph.D. Chief, Pharmacological & Physiological Sciences Branch Pharmacology, Physiology, & Biological Chemistry Division National Institute of General Medical Sciences 45 Center Drive, Room 2AS.49H Bethesda, MD 20892-6200 TEL: (301) 594-1826 FAX: (301) 480-2802 Email: longr@nigms.nih.gov Hilary D. Sigmon, Ph.D., R.N. Program Director National Institute of Nursing Research Building 45, Room 3AN12 45 Center Drive, MSC 6300 Bethesda, MD 20892-6300 TEL: (301) 594-5970 FAX: (301) 480-8260 Email: hilary_sigmon@nih.gov Direct inquiries regarding fiscal matters to: Jean Cahill Grants Administration Branch Division of Extramural Research National Human Genome Research Institute Building 31, Room B2B34 31 Center Drive, MSC 2031 Bethesda, MD 20892-2031 TEL: (301) 435-7858 FAX: (301) 402-1951 E-mail: jc166o@nih.gov Bruce Butrum Office of the Director Fogarty International Center 31 Center Drive, Rom B2C39, MSC 2220 Bethesda, MD 20892-2220 TEL: (301) 496-1670 FAX: (301) 402-0779 Email: butrumb@mail.nih.gov Linda Whipp Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212, MSC 9205 Bethesda, MD 20892 TEL: (301) 496-1472 FAX: (301) 402-3672 Email: lw17m@nih.gov Sherry F. Dabney Grants Management Officer National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard EPS 400B Rockville, Maryland 20892 TEL: (301) 402-0909 FAX: (301) 402-1758 Email: sd63u@nih.gov Martin R. Rubinstein Chief, Office of Grants Management National Institute of Dental and Craniofacial Research Building 45, Room 4AN-44A 45 Center Drive, MSC 6402 Bethesda, MD 20892-6402 TEL: (301) 594-4800 FAX: (301) 480-8301 Email: mr49c@nih.gov Donna Huggins Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 711, MSC 5456 Bethesda, MD 20892-5456 TEL: (301) 594-8848 FAX: (301) 480-3504 Email: dh48v@nih.gov Gary Fleming, J.D., M.A. Grants Management Branch Office of Planning and Resource Management National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 TEL: (301) 443-6710 FAX: (301) 594-6847 Email: gf6s@nih.gov Dorothy Duke Chief, Grants Management Branch Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-24 111 T.W. Alexander Drive Research Triangle Park, NC 27709 TEL: (919) 541-2749 FAX: (919) 541-2860 Email: duke3@niehs.nih.gov Antoinette Holland Grants Administration Branch National Institute of General Medical Sciences Building 45, Room 2AN.50B Bethesda, MD 20892-6200 TEL: (301) 594-5132 FAX: (301) 480-3423 Email: hollanda@nigms.nih.gov Cindy McDermott Grants Management Officer National Institute of Nursing Research Building 45, Room 3AN12 45 Center Drive, MSC 6300 Bethesda, MD 20892-6300 TEL: (301) 594-6869 FAX: (301) 480-8260 Email: mcdermoc@mail.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.172 (NHGRI), No. 93.989 (FIC), No. 93.866 (NIA), No. 93.847 (NIDCD), No. 93.121 (NIDCR), No. 93-849 (NIDDK), No. 93.279 (NIDA), Nos. 93.113, 93.115 (NIEHS), No. 93.390 (NIGMS), and No. 93.361 (NINR). Awards are made under authorization of sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 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, and 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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