CENTERS FOR REDUCING ASTHMA DISPARITIES Release Date: October 4, 2001 RFA: RFA-HL-02-006 National Heart, Lung, and Blood Institute (http://www.nhlbi.nih.gov) Letter of Intent Receipt Date: February 11, 2002 Application Receipt Date: March 12, 2002 PURPOSE The objective of this program is to promote partnerships (to be called Centers) between a minority serving institution (MSI) that may not have a strong research program and a research intensive institution (RII) that has a track record of NIH-supported research and patient care. The purpose of the partnership is to conduct collaborative research on asthma disparities (i.e. greater prevalence of asthma, higher rates of morbidity due to asthma, and lesser access or use of quality medical care among minorities and poor). The National Heart, Lung, and Blood Institute (NHLBI) invites research grant applications from each component of a Center to collaborate to a) conduct research on the causes for and correction of disparities in asthma among racial/ethnic and other population groups in U.S., at the MSI and the RI, that is complementary to one another; and b) provide reciprocal training, thereby enhancing the research opportunities and enriching the cultural sensitivity and asthma research capabilities, at both institutions. For the purpose of this solicitation, minority serving institutions (MSIs) are graduate or medical schools with more than 50 percent enrollment of minority students (African Americans, Hispanics, Native Americans, Alaskan Natives, Native Hawaiians, Pacific Islanders), or medical centers which serve a significant proportion of patients of minority or economically disadvantaged groups. Research intensive institutions (RIIs) are universities, medical school, or medical centers with documented accomplishments in research. Research intensive institutions that serve a significant number of minorities or poor are considered RII's, not MSI's, for the purposes of this solicitation. 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), Centers for Reducing Asthma Disparities, 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 for-profit and non-profit organizations; public and private institutions such as graduate schools, health professional colleges, universities and medical centers, that meet the definitions for MSI and RII provided in the RFA. Applications will be accepted only from MSIs and RIIs that enter into bilateral agreements and establish themselves as Centers for Reducing Asthma Disparities. Separate applications are submitted by each partner in the Center, but the applications will provide the same Research Plan (with identical parts A to G of Form PHS 398-Rev. 5/01). The common Research Plan, which has 40 page limit, must have at least six specific aims (four research-specific aims plus two training- specific aims), with each institution serving as the lead performance site for two research-specific aims and one training-specific aim. It is expected that the research and training program at one component of the Center will complement the program at the other, and performed as a collaborative effort and that the Principal Investigator from one component of the Center will name investigators from the second component as consultants (or collaborating investigators). Each of the two applications should identify the component institutions of the Center, delineate the research and training activities to be performed at each of the components, and explain how these activities complement each other. Although the Research/Training Plan section of the applications from each institution will be identical, they will have different Face Pages, Budgets, Biographical Sketches, Other Support and Resources. Because of the expected complementary and interrelated nature of this common research effort, the separate applications from each Center for Reducing Asthma Disparities will be packaged together for the Review Group, reviewed as a single program, and assigned the same priority score. A successful Center will receive two separate awards, one to the MSI and the second to the RII. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The administrative and funding instrument used for this program is a cooperative agreement (U01), an assistance mechanism (rather than an acquisition mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardees is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships and governance of the studies to be funded under cooperative agreement(s) are discussed later in this document under the section "Terms and Conditions of Award". The total project period for an application submitted in response to this RFA may not exceed 5 years. Applications from each partnership should clearly identify the institutions constituting the Center and the investigators in each institution who will serve respectively as the Principal Investigator and consultant (or co-principal Investigator) of each grant. The two applications from each partnership will be treated as a single program for review purposes. Although they will receive separate grant awards, if successful, they will be treated as a single entity i.e., a Center for Reducing Disparities in Asthma-- in post award monitoring, for submission of progress reports, and other RFA- related activities. This RFA is a one-time solicitation with a single deadline for receipt of applications. 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 September 30, 2002. FUNDS AVAILABLE The NHLBI intends to commit $ 3.6 million/year in total costs for this 5 year program beginning in fiscal year 2002, to fund two or three Centers (four or six separate grant awards) under this RFA. There is a maximum total of $1.2 million per Center per year. Each of the two applications within a Center can request up to $600,000 in total costs per year, of which up to $100,000 per application should be earmarked for training activities. 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 NHLBI 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. PROGRAM OBJECTIVES Background Asthma is a serious chronic condition affecting over 14 million Americans. Despite improved understanding of the pathophysiology of asthma, morbidity from asthma continues to rise, with disproportionate burden of disease occurring among the economically disadvantaged and minority populations. African Americans are three times more likely to be hospitalized and four times more likely to die from asthma. Morbidity and mortality from asthma is also high in U.S. Hispanic populations, particularly from Puerto Rico. What causes these disparities is unclear. Among the factors implicated as causes for asthma disparities are genetic variations (e.g., beta two adrenergic receptor polymorphisms), psychosocial factors, stress, smoking, dietary habits, infections, allergens, socioeconomic status, culture-related health practices, and inadequate access to care. It is generally believed that interactions among these factors, rather than any one factor by itself, cause the disproportionate occurrence and burden of asthma in certain population groups. Scope of Research and Training Goals of the Program This RFA is designed to stimulate minority serving institutions and research intensive institutions to generate bilateral partnerships ("Centers for Reducing Asthma Disparities") to conduct collaborative research on the causes and corrections for the disproportionate burden of asthma in U.S. minority and disadvantaged populations, and also to provide culturally sensitive, reciprocal training programs that will serve to enhance and enrich the research potential and asthma management capabilities at the collaborating institutions. Required Components in Each Application The two applications from each Center should include an identical "Research Plan" which covers in no more than 40 pages, both research and training aims (see "Eligibility Requirements"). A wide range of research areas (e.g. pathophysiologic mechanisms, pharmacogenetics, clinical trials, complementary medicine, patient and health care provider education) would be responsive to this RFA directed at understanding and reducing asthma disparities. A few topics illustrative of these areas are provided below. These are only examples and applicants are encouraged to propose others. A. Research 1. Examine the Contributions, Roles and Mechanisms of Risk Factors in Asthma Disparities Studies are needed on how the postulated risk factors (e.g. interactions between environmental exposures and biological/genetic factors, genetic polymorphisms, psychosocial factors, stress, depression, discrimination; socioeconomic status (SES); cultural beliefs and practices; personal behaviors/lifestyle including personal perceptions of risk and health care seeking behaviors; physical environmental exposures such as smoke, allergens, housing; social environment including maternal depression, multiple care givers, family and community environment), alone or in combination, might produce asthma disparities. Also needed are mechanistic studies to identify pathophysiologic pathways for disparate health outcomes. 2. Develop and Evaluate Interventions to Prevent or Decrease Disparities There are numerous research questions regarding the development and evaluation of strategies to reduce asthma disparities. An important consideration is how the community can be involved in research and intervention. o Evaluation and modification of current therapeutic regimens and patient education strategies: Are different medical regimens needed for different groups or will a single regimen be appropriate for all groups? Do medical regimens and educational programs need to be culturally adapted and how? How can existing strategies proven effective in one group be efficiently adapted and made culturally relevant to another group? What strategies are needed to change behavior, especially at early ages (prenatal), to address environmental and psychosocial exposures? How can complementary and alternative medicines be integrated into asthma care? o Medical care issues: How can medical practice be redesigned to be responsive to the needs of a high risk community? To adapt to the circumstances of chronic disease, do we need system-wide change or individual provider change? What are the most effective pathways for disseminating asthma clinical practice guidelines? Should interventions go to all providers or just "early adopters"? What is the role of choice among alternative interventions in increasing dissemination and adoption of best medical care practices? Should asthma programs be offered separately from or in conjunction with care for other chronic diseases? 3. Examine the Effect of Different Factors of Health Care Seeking Behavior on Morbidity Research is needed to address questions related to the factors that promote appropriate health care seeking behavior among minority and disadvantaged populations. Where services are available, what are the reasons for the underutilization or inappropriate use of services? What are the key issues that affect participation in care? (e.g., differing cultural perceptions of risk, prioritization of illness, skills in using resources appropriately, and related issues that determine health care seeking behaviors); What provider/medical practice attributes are best suited to promoting appropriate health care seeking and adherence behaviors among minorities and disadvantaged populations? What approaches are needed to develop partnerships between hospital/medical system - based programs and community organizations (e.g., schools, homeless shelters)? 4. Identify and Validate Outcomes Measures Research is needed to identify the most suitable instruments for measuring outcomes, especially those related to reducing disparities; to understand how to tailor outcome measures and process measures (e.g., measuring implementation activities) to multi-cultural settings; and on the use of common outcome measures to promote sharing data and comparing studies (e. g., quality of life measures to use in different communities). Measures to assess cost effectiveness of outcomes, the social impact of disease, and the social value of interventions in minority communities are also needed. B. Training A goal of this RFA is to encourage reciprocal training between the MSI and the RII to enhance asthma research capabilities and enrich the cultural sensitivity of asthma research projects and interventions at both institutions. The training activities within a Center would include training on asthma care issues as well as issues related to conducting research. The training program should represent true collaborations across the institutions. For example, new training programs might provide graduate students in the MSIs the opportunity to fulfill research requirements in the RII with mentoring by RII investigators; clinical research training programs for RII students could include rotations at the MSI that focus on dealing with cross-cultural issues. Successful activities may lead to more extensive training projects such as competitive applications for NIH training grants. Proposals for the training component in each application should include the following elements: o Designation of key personnel who will lead the training activities at each institution in the Center and description of the organizational structure to insure collaboration. o Plans for a training core to accomplish the cross-institution training objectives of the RFA that is comprised of courses, seminars, mentoring projects or other training methods. o Plans for training students, investigators and other personnel on issues and problems associated with asthma disparities in minority populations. o MSI's plans to help stimulate research programs in the RII that focus on reducing asthma disparities, provide training for the Center researchers and staff on cultural sensitivity and methods to promote community participation in the research. o RII's plans to help the MSI build its resources, research capacity, and skills to conduct research that merits independent grant support. This should include seminars or mentoring for administrative personnel as well as researchers to include issues related to research grant administration and dealing with grant awarding institutions such as NIH. o Plans to sustain the partnership and help investigators at the MSI and the RII generate collaborative investigator-initiated research proposals and continue reciprocal training opportunities. o Plans of the partnership to develop Career development programs to expand the scientific cadre of investigators dedicated to research on asthma in minority populations. SPECIAL REQUIREMENTS: TERMS AND CONDITIONS OF AWARDS The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator as well as the institutional official at the time of the award. These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administrative Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS and NIH Grant administration policy statements. 1. Awardee Rights and Responsibilities Awardees have primary authorities and responsibilities to define objectives and approaches, to plan and conduct the research activities, and to analyze and publish results, interpretations and conclusions of their studies. Awardees will retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. Awardees should attend an annual meeting at Bethesda, Maryland for the purpose of discussing progress and exchanging ideas. 2. NHLBI Staff Responsibilities The dominant role and prime responsibility for the Center activities reside with the awardees for the project as a whole, although specific tasks and activities in carrying out the programs will be shared among the awardees and the NHLBI Program Administrator. The Program Administrator will be an Extramural official with responsibility for administering the grant. The NHLBI reserves the right to terminate or curtail the study (or an individual award) for lack of scientific progress, failure to adhere to policies of the NHLBI under the U01 mechanism, or failure of the partnerships to evolve within the intent and purpose of this initiative. The NHLBI Program Administrator's scientific-programmatic involvement during the conduct of this activity that is expected to be above and beyond that normally exercised in the administration of a traditional R01 research grant. The expanded programmatic involvement will provide technical assistance, support, coordination, and momentum to help accomplish the goal of creating effective research partnerships and will include: o working closely with individual investigators and partners to facilitate collaborations, including coordinating regularly scheduled conference calls (at least quarterly) with principal investigators to discuss progress and approaches to address any problems, o assisting the partnership efforts by facilitating access to fiscal and intellectual resources provided by NHLBI, NIH, and federal funding agencies, o providing assistance in reviewing and commenting on all major transitional changes of an individual partner's activities prior to implementation to assure consistency with the goals of the RFA, o coordinating activities with other ongoing studies supported by NHLBI to avoid duplication of efforts and encourage sharing and collaboration in the development of new interventions to reduce disparities in asthma, o linking the approaches developed from these partnerships to other Centers funded by the RFA to ensure that information is shared and utilized on the widest basis possible, o helping re-direct program efforts within the peer reviewed scope of work, including modifying projects/programs when they are not making sufficient or timely progress, and o organizing an annual meeting among RFA participants. 3. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the NHLBI may be brought to arbitration. An arbitration panel will be composed of four members B one selected by each of the individual awardees in the Center, a third member selected by NHLBI, and the fourth member selected by the three prior selected members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete copy of the updated Guidelines are available at https://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. NIH POLICY AND GUIDELINES ON THE 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 clear and compelling scientific and ethical reasons not to include them. This policy applies to all initial (Type 1 and Type 2) 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: https://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 website: https://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: https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm Applicants may wish to place data collected under this RFA (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. LETTER OF INTENT Prospective Principal Investigators of the components of each Center are asked to submit a joint letter of intent that includes a descriptive title of the proposed research, the names, addresses, and telephone numbers of the Principal Investigators, the names of the participating institutions, the identities of other key personnel and the number and title of this RFA in response to which the applications 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 Dr. Deborah Beebe (see address listed under Inquiries below) by February 11, 2002. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) available at https://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable PDF format. Beginning January 10,2002, the NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301-710-0267, Email: GrantsInfo@nih.gov. Each institution within a proposed Center for Reducing Disparities in Asthma should submit a separate application with a cover letter that clearly delineates the proposed partnership and includes a letter of commitment to the Center that describes the bilateral agreement (see "Eligibility Requirements"). The "Research Plan" in the application that will cover both the research and training aims (see "Eligibility Requirements") must be limited to 40 pages. The research section of the plan should include, for each of the 4 proposed research aims, a specific description of the research approach proposed to address the aim; the description should includes the elements of parts A-G of Form PHS 398-Rev 5/01. The Research Plan should also include an explanation of how the four aims relate to and complement each other, a timeline that describes how the four aims will be addressed over the five year grant period. The training section of the plan should include the elements described in the "Training" section of this RFA. If the application proposes clinical trials, plans for data safety monitoring must be included. Applicants should describe the organizational structures and procedures they will employ to ensure the safety of participants and the validity and integrity of the data; for a statement of issues and concerns, see "NIH Policy for Data and Safety Monitoring," NIH guide to Grants and Contracts, Release Date: June 10, 1998, https://grants.nih.gov/grants/guide/notice-files/not98-084.html. At the time of the award, applicants should be prepared to make adjustments to their procedures based upon NHLBI policy. Travel funds for a two-day meeting each year, most likely to be held in Bethesda, Maryland, must be included in the budget calculation. The Principal Investigators at the RIIs and MSIs must include a statement indicating their willingness to participate in these meetings. Applicants are encouraged to contact the program officials listed under INQUIRIES for further information. 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. 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 as well as all five collated sets of Appendix material must be sent to Dr. Deborah Beebe at the address listed under Inquiries. 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 also 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. Principal investigators should not send supplementary material without first contacting the Scientific Review Administrator (SRA). The SRA will be identified in the letter sent to you indicating that your application has been received. If you do not receive such a letter within three weeks after submitting the application, contact Dr. Deborah Beebe at the address listed under Inquiries. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NHLBI. 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 NHLBI in accordance with the review criteria stated below. Because of their interrelatedness, the applications from each institution comprising a Center will be reviewed as a single program and assigned the same priority score. 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 NHLBI Advisory Council. Review Criteria o Significance, novelty, and feasibility of the proposed research and training aims to accomplish the goals of understanding the causes of asthma disparities and correcting them o Originality and innovativeness of the approaches, methods, and analyses proposed o Quality and complementary relationship of the research aims (at least two at each Center component; four per Center) and their potential to elucidate and correct asthma disparities o Quality and complementary relationship of the training aims (at least one at each Center component; two per Center) and their potential to enrich the research potential and asthma management capabilities of the trainees o Quality of the collaborative arrangements for the formation of the Center and assignment of responsibilities for conducting the research/training proposed o Qualifications, expertise, and demonstrated ability of the investigators in the two institutions comprising the Center to work collaboratively toward accomplishing the research and training goals of the RFA o Quality of the institutional environments to allow meaningful collaborations toward accomplishing the goals of the RFA o Documentation that each Center has access to minority populations willing to participate in the proposed research o The reasonableness of the proposed budget and duration in relation to the proposed research. 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 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: February 11, 2002 Application Receipt Date: March, 12, 2002 Peer Review: July, 2002 Awards: September 30, 2002 AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or answer questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Ms. Virginia Taggart, M.P.H. Division of Lung Diseases National Heart, Lung, and Blood Institute Rockledge 2, Suite 10018, MSC 7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0202 FAX: (301) 480-3557 Email: taggartv@nih.gov Direct inquiries regarding review issues, send letter of intent, and two copies of the application to: Deborah Beebe, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Dr., Room 7178 (MSC 7924) Bethesda, MD 20892-7924 Telephone: (301) 435-0270 Fax: (301) 480-3541 Email: db57j@nih.gov Direct inquiries regarding fiscal matters to: Raymond Zimmerman Grants Operations Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7154, MSC 7926 Bethesda, Maryland 20892-7926 Telephone: (301) 435-0171 FAX: (301) 480-3310 E-mail: rv7g@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.233, 93.242, 93.361, 93.837, 93.838, and 93.839. 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 recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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