RFA-AI-03-045: NIAID ENHANCEMENT AWARDS FOR UNDERREPRESENTED MINORITY SCIENTISTS

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NIAID ENHANCEMENT AWARDS FOR UNDERREPRESENTED MINORITY SCIENTISTS RELEASE DATE: July 10, 2003 RFA: AI-03-045 National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov) CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: No. 93.855, Immunology, Allergy, and Transplantation Research No. 93.856, Microbiology and Infectious Diseases Research LETTER OF INTENT RECEIPT DATE: January 16, 2004 APPLICATION RECEIPT DATE: February 19, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of the RFA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), invites applications from underrepresented minority investigators who are in the early stages of their scientific careers (assistant professor or junior level faculty) to establish basic or clinical research programs in the areas of allergy, immunology, transplantation, microbiology, and infectious diseases, including AIDS. This Request for Applications reflects NIAID's continued commitment to the development of a cadre of talented underrepresented minority scientists. Full participation and engagement of the junior investigator must be accomplished throughout the research process. While the previous RFA (AI-94-027 - http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-94-027.html) supported research in the area of AIDS only, the present RFA includes all the scientific areas encompassed in the scientific mission of the NIAID. RESEARCH OBJECTIVES The NIAID is committed to increasing the number of underrepresented minority investigators in all fields encompassed by its scientific mission. Historically, the NIAID has supported a variety of programs for underrepresented minorities in biomedical research, encompassing high school through postdoctoral training. Although these programs have demonstrated success in specific areas, only a few underrepresented minority investigators have become well established in biomedical research. The goals of the present RFA are: (1) to increase the number of underrepresented minority investigators capable of performing independent competitive research in the areas encompassed by the NIAID's scientific mission, and (2) to enhance the long-term research skills and potential of these individuals. A list of research areas that are considered relevant for this RFA follows. This list is not all-inclusive, and prospective applicants are encouraged to discuss program relevance issues with the program staff cited under INQUIRIES. The scope of acceptable areas of research includes basic and clinical research. The following are examples of research within the scope of this program announcement: o Immune-Mediated Diseases- Basic Immunology, immune tolerance, transplantation, asthma and allergic diseases, autoimmune diseases, genetically-determined immunodeficiencies, immunologic basis of human vaccines, and infectious etiologies of chronic immune-mediated diseases. o Acquired Immunodeficiency Syndrome (AIDS)- Epidemiology, pathogenesis, treatment, HIV vaccines, and non-vaccine prevention strategies. o Emerging Infectious Diseases and Global Health- Microbiology and vector biology, diagnosis and detection, treatment, drug and insecticide resistance, and global health. o Bio-Defense Research- programs to investigate pathogen biology, host response, microbial genomic sequencing, and proteomics; programs to identify potential vaccines, diagnostics, and immunotherapy targets; initiatives to evaluate biodefense therapies and diagnostics o Vaccines- Vaccine discovery, design and development, pathogens associated with emerging and re-emerging global health problems, overcoming obstacles to vaccines for pathogens of high public health importance, and newly identified areas of vaccine need. Specific research questions of the highest priority are contained in the current NIAID Strategic Plan. The plan is available on-line at http://www.niaid.nih.gov/strategicplan2000/default.htm. Please contact program staff listed under INQUIRIES for additional information. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01) award. The total requested project period for an application submitted in response to this RFA may not exceed four years for an R01. The applicant 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. Applications that are not funded in the competition described in this RFA may be resubmitted 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 format (see http://grants.nih.gov/grants/funding/modular/modular.htm. Specifically, if the investigator is submitting an application with direct costs in each year of $250,000 or less, us the modular format. 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 The NIAID intends to commit approximately $1M in FY 2004 to fund 3 to 5 new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to four (4) years and a budget for direct costs of up to $250,000 per year. 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 the NIAID 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 The applicant may submit (an) application(s) if their 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 Domestic o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Underrepresented minority investigators who are identified as such by their own domestic private or public institutions are encouraged to submit applications. Underrepresented minority refers to racial and ethnic minority groups that usually include African Americans, Hispanics, Native Americans, Alaska Natives, Hawaiian Islanders, Asian and Pacific Islanders. Applicants should be at the assistant professor level of their careers. Applicant institutions must have sufficient research infrastructure and a core of investigators already conducting basic, behavioral, clinical or epidemiological biomedical research. Foreign institutions are ineligible for this program. Participants in NIH programs for underrepresented minorities, such as the Research Supplements for Underrepresented Minorities (RSUM), Minority Biomedical Research Support (MBRS), Minority Access to Research Careers (MARC), and Research Centers in Minority Institutions (RCMI) are encouraged to apply. Scientists who have previously been Principal Investigators on NIH grants (R01 grants or equivalent) or similar awards from other funding agencies or organizations are not eligible for this award. Underrepresented minority scientists supported under a previous RFA AI-94-027 funded by NIAID are not eligible to apply. NIAID staff listed under INQUIRIES should be consulted for details concerning eligibility requirements. SPECIAL REQUIREMENTS Applicants are required to have available a recognized expert in the area of proposed research for guidance and consultation. It is expected that this expert will assist the applicant in the design and conduct of his/her research. It is not necessary that the expert be at the same institution as the applicant, but he/she should be within a reasonable proximity to be available for guidance and consultation. When clinical studies or trials are a component of the research proposed, NIAID policy requires that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. An UPDATED NIAID policy was published in the NIH Guide on July 8, 2002 and is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html. The full policy including terms and conditions of award is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf. WHERE TO SEND INQUIRIES We encourage Inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquires may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct questions about scientific/research issues to: Milton J. Hern ndez, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room Number 2133, MSC-7610 6700B Rockledge Drive Bethesda, MD 20892-7610 Bethesda, MD 20817-7610 (for express/courier service) Telephone:(301) 496-8697 FAX: (301) 496-8729 Email: mh35c@nih.gov Paula S. Strickland, Ph.D., MPH Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room Number 2139, MSC-7610 6700B Rockledge Drive Bethesda, MD 20892-7610 Bethesda, MD 20817-7610 (for express/courier service) Telephone:(301) 435-8563 FAX: (301) 402-0369 Email: ps30f@nih.gov Opendra Sharma, Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases Room Number 4136, MSC-7620 6700B Rockledge Drive Bethesda, MD 20892-7620 Bethesda, MD 20817-7620 (for express/courier service) Telephone:(301) 496-8378 FAX: (301) 402-3211 Email: os4g@nih.gov Lawrence J. Prograis, M.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Room Number 5134, MSC-7640 6700B Rockledge Drive Bethesda, MD 20892-7640 Bethesda, MD 20817-7640 (for express/courier service) Telephone:(301) 496-1886 FAX: (301) 402-2571 Email: lp13r@nih.gov Robert L. Quackenbush, Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Room Number 6050, MSC-7630 6610 Rockledge Drive Bethesda, MD 20892-7630 Bethesda, MD 20817-7630 (for express/courier service) Telephone:(301) 402-0443 FAX: (301) 480-3617 Email: rq1i@nih.gov o Direct questions about peer review issues to: Gary S. Madonna, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room Number 2149, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 Bethesda, MD 20817-7616 (for express/courier service) Telephone:(301) 496-3528 FAX: (301) 402-2638 Email: gm12w@nih.gov o Direct questions about financial or grant management matters to: Barbara Huffman Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room Number 2132, MSC-7610 6700B Rockledge Drive Bethesda, MD 20892-7610 Bethesda, MD 20817-7610 (for express/courier service) Telephone: (301) 496-3821 FAX: (301) 496-8729 Email: bh23q@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 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 IC 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: Gary S. Madonna, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room Number 2149, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 Bethesda, MD 20817-7616 (for express/courier service) Telephone:(301) 496-3528 FAX: (301) 402-2638 Email: gm12w@nih.gov SUBMITTING AN APPLICATION In October of 2003, there will be a one-day PRE-APPLICATION MEETING in the Washington, DC metropolitan area to provide potential applicants with background information and to answer questions. Applicants are encouraged to attend this meeting before submitting an application. Information about the meeting date, agenda, and a summary of the meeting results will be made available via the NIAID Internet site at http://www.niaid.nih.gov. For additional information about the Pre-Application Meeting call the NIAID Office of Special Populations and Research Training at 301 496-8697. Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: 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 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 exact copies of the grant application and all five sets of any appendix material must be sent to: Gary S. Madonna, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room Number 2149, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 Bethesda, MD 20817-7616 (for express/courier service) APPLICATION PROCESSING: 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. However, when a previously unfunded 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. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIAID. 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 NIAID in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Advisory Allergy and Infectious Diseases 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: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. 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. 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? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the application will also be reviewed with respect to the following: The applicant's plans and the availability of a recognized expert in the area of the proposed research for council and advice as attested to by a letter of agreement. 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 will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL CONSIDERATIONS DATA SHARING: The adequacy of the proposed plan to share data. 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: January 16, 2004 Application Receipt Date: February 19, 2004 Peer Review Date: May, 2004 Council Review: June, 2004 Earliest Anticipated Start Date: August, 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). 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. This policy announcement is 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. RECOMBINANT DNA AND HUMAN GENE TRANSFER RESEARCH: The National Institutes of Health Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) apply to NIH-funded and non-NIH-funded gene transfer projects that are conducted at or sponsored by an institution that receives NIH support for recombinant DNA research. As defined by the NIH Guidelines, recombinant DNA molecules are either: (1) molecules which are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell; or (2) DNA molecules that result from the replication of those described in (1). The NIH Guidelines set forth principles and standards for safe and ethical conduct of recombinant DNA research and apply to both basic and clinical research studies. Specific guidance for the conduct of human gene transfer studies appears in the appendix of the document (Appendix M.) The NIH Guidelines should be carefully reviewed to ensure compliance with all other requirements for the conduct of projects involving recombinant DNA research and human gene transfer. Failure to comply with the NIH Guidelines may result in suspension, limitation, or termination of NIH funds for recombinant DNA research at the organization or a requirement for NIH prior approval of any or all recombinant DNA projects at the organization. A copy of the NIH Guidelines is posted at the following URL: http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html and may be obtained from the NIH Office of Biotechnology Activities, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892, 301-496-9838. 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 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 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. 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. 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 Catalogue of Federal Domestic Assistance at http://www.cfda.gov/ in the following citations: No. 93.855, Immunology, Allergy, and Transplantation Research and No. 93.856, Microbiology and Infectious Diseases Research. 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 NIH Grants Policy Statement is available at http://grants.nih.gov/grants/policy/policy.htm. This document includes general information about the grant application and review process; information on the terms and conditions that apply to NIH Grants and cooperative agreements; and a listing of pertinent offices and officials at the NIH. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. 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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