IMMUNE SYSTEM DEVELOPMENT AND THE GENESIS OF ASTHMA RELEASE DATE: July 25, 2003 RFA: AI-03-041 National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov) National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov) CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: No. 93.855, Immunology, Allergy, and Transplantation Research No. 93.856, Microbiology and Infectious Diseases Research No. 93.838, Lung Diseases Research LETTER OF INTENT RECEIPT DATE: October 21, 2003 APPLICATION RECEIPT DATE: November 21, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA A considerable body of evidence suggests that abnormal function of the immune system is central to the pathogenesis of asthma, and recent studies indicate that the events that set the stage for the development of the asthma phenotype may occur during gestation and infancy. The purpose of this RFA is to stimulate research on immune function in early life in order to define the cellular and molecular mechanisms underlying the development of asthma and to use this new information to devise strategies for the effective prevention or reversal of the disease without compromising the integrity of the immune system. Although some aspects of the developing immune system are well understood, much remains to be learned about functional capabilities and molecular regulation at the early stages of immune development. With new technologies, it is now feasible to conduct definitive studies in this area of research. Identification of the cellular and molecular processes involved in the onset of asthma will provide the basis for developing immune-based treatment and prevention strategies that are not hampered by the limitations of current therapies. RESEARCH OBJECTIVES Approximately 20 million Americans have physician-diagnosed asthma, and more than 12 million have had an asthma attack within the past year. Asthma results in more than 130 million days of restricted activity, approximately 500,000 hospitalizations, and nearly 5000 deaths each year in the U.S. The morbidity and mortality associated with asthma are disproportionately high among children, particularly those who reside in the inner city. African Americans are hospitalized for asthma three times more often than other Americans, and African Americans and Hispanic Americans living in inner cities are two to six times more likely to die from asthma. Although the mortality associated with asthma is relatively low, the economic burden is high, with an estimated cost for asthma in the U.S. of $12.7 billion in 1998. In spite of recent advances in understanding the mechanisms underlying asthma and improvements in medications used to treat the disease, the adverse impact on public health continues to grow. For example, the prevalence of asthma has increased by more than 80% in all age and ethnic groups over the past two decades. The management of asthma is complex, and adequate control is difficult to maintain because patients are required to comply with daily, multi-drug regimens. Severe asthma poses a greater problem, even with an optimal management plan. In addition, many of the drugs currently used to treat asthma have a number of undesirable side effects, and, in some cases, overuse can actually lead to worsening of the disease. Research during the past two decades has significantly improved our appreciation of the role of airway inflammation and immune dysfunction in the pathogenesis of asthma and has led to the identification of the cells and molecules involved, but this knowledge has yet to be translated into the clinical arena. Consequently, it is important to consider new approaches to dealing with the growing asthma epidemic. Results of recent studies suggesting that the origins of asthma occur early in life coupled with new technologies that have the potential to elucidate the bases of complex biological problems provide the opportunity to focus on the cellular and molecular immune mechanisms that lead to the onset of asthma and disease progression. Research in this important area should yield vital new information required to devise novel immune-based therapies as well as rational strategies for disease prevention. Epidemiological studies have identified a number of environmental risk factors associated with the development of asthma (or pathophysiological precursors of asthma such as repeated wheeze), including viral infections and exposure to cockroach allergen or tobacco smoke. It is thought that during infancy and, perhaps, during gestation these environmental factors affect immune system development and prime genetically susceptible individuals for the later expression of asthma, usually by age five or six. The mechanisms leading to priming are poorly understood but may involve the persistence after birth of the Th2 phenotype, which is characteristic of the intrauterine environment. It is of interest that other factors, such as endotoxin, farm animals or furry pets, appear to protect against the development of asthma, perhaps by stimulating regulatory T cells and/or establishing a favorable Th1/Th2 balance. Collectively, these findings suggest that early life changes in immune function induced by environmental factors determine whether an individual is likely to develop asthma or is protected against the disease. If this hypothesis is correct, it should be possible to devise strategies that block the onset of asthma or slow the progression of the disease by targeting specific immune processes involved in establishing the asthma phenotype. This will require a better understanding of the cellular and molecular mechanisms involved in early life changes in immune function that contribute to the development of asthma. Certain aspects of the developing immune system have been well characterized, including the ontogeny of B and T cell repertoires, but little is known about the regulation of immune function during the early stages of development, particularly with respect to priming for the expression of asthma. This includes the temporal characteristics of priming, whether the process is reversible, the applicability of the Th1/Th2 paradigm to humans, the cellular and molecular basis of the protection provided by certain environmental factors and interactions between the innate and adaptive elements of the developing immune system. Innovative research in these important areas is essential to further elucidate the cellular and molecular mechanisms involved in the development and progression of asthma. This will require a variety of approaches, including birth cohort studies incorporating informative mechanistic investigations. Recent advances in technology ranging from genomic and proteomic tools to high-resolution imaging and non-invasive methods for measuring lung function in infants should facilitate such studies. Depending on study design, outcomes could include the development of asthma or early life surrogate markers that are strongly associated with the later development of asthma, such as frequent wheezing. Although the emphasis of this RFA is research in humans, projects involving animal models will be considered responsive if they are justified on the basis of technical feasibility and relevance to human asthma. Hypothesis driven, mechanistic studies on how the developing immune system affects susceptibility to, or protects against, asthma development are the focus of this RFA. Long-term epidemiological studies without accompanying mechanistic studies are not appropriate for this RFA. Examples of research areas to be supported under this RFA include, but are not limited to: early cellular and molecular markers of asthma onset and progression; factors that regulate the processing and presentation of aeroallergens in the infant lung and the effect of early exposures on the developing lung; the effect of timing, dose and route of antigen exposure on determination of susceptibility to asthma; mechanisms involved in the initiation and amplification of aeroallergen-specific IgE synthesis; regulation of primary B and T cell responses; role of the innate immune system and tolerance in determining susceptibility to asthma; immune-mediated mechanisms of protection against the development of asthma; effects of maternal and environmental asthma risk factors on immune function early in life; and translational research focused on new immune-based therapies and asthma prevention strategies, including proof of concept studies in humans. MECHANISM OF SUPPORT This RFA will use the NIH individual research project grant (R01) award. The total requested project period for an application submitted in response to this RFA may not exceed five 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. The anticipated award date is July 2004. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt for NEW applications described in the instructions to the PHS 398 application. This RFA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see https://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if an investigator is submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non-modular research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at https://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE The participating ICs intend to commit approximately $ 5.6 million in FY 2004 to fund 8 to 12 new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to five years. 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 vary. Although the financial plans of the ICs 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 the institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS 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: https://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. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct questions about scientific/research issues to: Ken Adams, Ph.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Room 3103, MSC-6601 6610 Rockledge Drive Bethesda, MD 20892-6601 Telephone: (301) 496-8973 FAX: (301) 402-8179 Email: ka93x@nih.gov Patricia Noel, Ph.D. Division of Lung Diseases National Heart, Lung, and Blood Institute Room 10222, MSC-7952 6701 Rockledge Drive, MSC-7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0202 FAX: (301) 480-3557 Email: pn61t@nih.gov o Direct questions about peer review issues to: Edward W. Schroder, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 3136 MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 Telephone: (301) 435-8537 FAX: (301) 402-2638 Email: es170m@nih.gov o Direct questions about financial or grants management matters to: Ann Devine Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2118, MSC-7614 6700-B Rockledge Drive Bethesda, MD 20892-7614 Telephone: (301) 402-5601 Email: ad22x@nih.gov Ephraim A. Johnson Division of Extramural Affairs National Heart, Lung, and Blood Institute Suite 7044, MSC-7926 6701 Rockledge Drive Bethesda, MD 20892-7926 Telephone: (301) 594-9529 FAX: (301) 480-3310 Email: ej47e@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: Edward W. Schroder, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 3136, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 Telephone: (301) 435-8537 FAX: (301) 402-2638 Email: es170m@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at https://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. SUPPLEMENTAL INSTRUCTIONS 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 https://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 https://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: https://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: Edward W. Schroder, Ph.D. Review Processing Unit, Room 3136 Scientific Review Program, DEA/NIAID/NIH/DHHS 6700-B Rockledge Drive, MSC-7616 Bethesda, MD 20892-7616 Bethesda, MD 20817 (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 the ICs. 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 and/or the National Heart, Lung, and Blood 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: 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 following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below) INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). 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: October 21, 2003 Application Receipt Date: November 21, 2003 Peer Review Date: March 2004 Council Review: May 2004 Earliest Anticipated Start Date: July 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 Programmatic priorities. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 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: https://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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://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 https://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 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at https://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 https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance at http://www.cfda.gov/ in the following citations: No. 93.855, Immunology, Allergy, and Transplantation Research, No. 93.856, Microbiology and Infectious Diseases Research, and No. 93.838, Lung 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 https://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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