NHLBI MINORITY INSTITUTION RESEARCH SCIENTIST DEVELOPMENT AWARD (K01) RELEASE DATE: March 14, 2003 RFA: HL-03-012 National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.233, 93.837, 93.838, 93.839 LETTER OF INTENT RECEIPT DATE: May 22, 2003 APPLICATION RECEIPT DATE: June 23, 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 The NHLBI Minority Institution Research Scientist Development Award is a five- year award made to a minority institution on behalf of a candidate with an appropriate mentor (at the same institution or at a collaborating research center) who is recognized as an accomplished investigator. It is open to candidates having faculty appointments and holding a Ph.D., M.D., D.V.M., D.O., or equivalent professional degree who wish to develop research capabilities in research areas relevant to the mission of the NHLBI. A "hands-on" research experience is required for the candidate for the duration of the award with 100% effort during summer and/or off quarter periods and at least 25% effort during the academic year. The award also requires that at least one and a maximum of two students participate on the project as research assistants. RESEARCH OBJECTIVES Important NHLBI program goals are to enhance the institution's science infrastructure, to provide "hands-on" research opportunities for underrepresented minority students at the applicant institutions, and to develop the research career and teaching skills of the candidate. By developing these capabilities, the candidate will be better able to prepare and direct his/her students to pursue advanced degrees and, ultimately careers in biomedical and behavioral research, thereby increasing the pool of well- trained biomedical and behavioral investigators in cardiovascular, pulmonary, hematologic, and sleep disorders research. Because it is important to sustain the candidate's research program following the initial period, recipients may reapply for an additional five years of support. One competing renewal award is allowed. More than one candidate from each institution may apply. At the end of the period of K01 support, it is anticipated that the awardee will be prepared to apply for other types of NIH support such as the Research Project Grant (R01), Academic Research Enhancement Award (AREA, R15), Exploratory/Development Grant (R21) or Minority Biomedical Research Support Program (MBRS, S06.) MECHANISM OF SUPPORT This RFA will use the NHLBI Minority Institution Research Scientist Development Award (K01) mechanism of support. Responsibility for the planning, direction, and execution of the proposed training project will be solely that of the applicant. The total project period for an application submitted in response to this RFA must be at least three but not more than five years and the applicant may reapply for an additional five years of support. The anticipated award date is April 1, 2004. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for the entire program is expected to be approximately $400,000 in Fiscal Year 2004 (October 1, 2003-September 30, 2004). The actual amount may vary, depending on the response to the RFA and availability of funds. Three new awards are anticipated. Loan Repayment Program (LRP): Awardees under this program may be eligible to apply for the NIH Extramural Loan Repayment Program. Information regarding the eligibility requirements and benefits for the program may be obtained through the LRP website at http://www.lrp.nih.gov/. ELIGIBLE INSTITUTIONS The Institution must be a domestic college or university with student enrollment drawn substantially from minority ethnic groups (including African Americans/Blacks, Hispanics, American Indians, Alaska Natives, and non-Asian Pacific Islanders). It must have the ongoing staff and facilities required for the proposed program. Foreign institutions are not eligible to apply. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Candidates for this award are minority school faculty members who: 1) are citizens of the United States, non-citizen nationals or permanent residents by the time of the award; 2) have a doctoral degree, such as the Ph.D., M.D., D.O., D.V.M., or an equivalent, in a biomedical or behavioral science; 3) wish to receive specialized training in cardiovascular, pulmonary, hematologic, or sleep disorders research; 4) have the background and potential to benefit from the training; and 5) are committed to providing research opportunities for underrepresented minority students at their institution. The candidate is responsible for tracking and reporting on the progress of the students for up to five years after they complete their undergraduate education. Guidelines for Special Leave: K01 Award recipients may take leave to train at another institution, take a leave of absence during the award period, or train at a lower level of effort for a longer period of time. K01 Award recipients should review a document describing the Special Leave Guidelines for Recipients of Mentored Career Awards at http://www.nhlbi.nih.gov/funding/training/redbook/sl_guide.htm which summaries NIH and NHLBI policies for these situations. SPECIAL REQUIREMENTS Mentor at Same or Collaborating Research Center Each candidate must also identify and complete arrangements with a mentor (at the same institution or at a collaborating research center) who is recognized as an accomplished investigator in the proposed research area and who will provide guidance for the candidate's development and research plan. Arrangements with mentors at institutions at a distance from the applicant institution will be considered, but approaches for ensuring close and active involvement of a distant mentor must be clearly outlined in the application. Plans for intensive training of the candidate and his/her student(s) during the summer period (2 - 3 months) and during the academic year should be developed with the mentor. The establishment of a viable mentoring plan is essential to the success of the candidate and the student. The commitment of the mentor and the mentor's department chair to both the summer and academic year training periods must be documented in the application. A mentoring plan that describes the candidate=s interaction with the mentor and his/her staff, how it will enhance the candidate=s research capabilities and teaching skills, and steps to assist the candidate and student(s) advance their career goals must be delineated in the application. The mentor must provide an annual evaluation of the candidate=s career development. This evaluation is to be included as part of the annual progress report if an award is made. Student Research Assistants Student research assistants are underrepresented minority students enrolled at the applicant institution who: 1) are citizens of the United States, noncitizen nationals, or permanent residents (i.e. in possession of a currently valid Alien Registration Receipt Card I-551, or some other legal verification of such status) at the time of application; 2) have declared a major or concentration in a biomedical, mathematical, computer, or behavioral science; 3) have an overall B grade average; 4) have the potential and desire to pursue an advanced degree in the biomedical, mathematical, computer, or behavioral sciences; and 5) wish to receive research training in areas relevant to cardiovascular, pulmonary, hematologic, or sleep disorders research. At least one and a maximum of two students may participate on the project simultaneously as research assistants. Students are expected to participate in the program for a minimum of two years. The candidate should identify and list in the application the student(s) proposed for the first two-year period; provide a brief summary of their interest in biomedical, mathematical, computer or behavioral science; and describe any previous research or laboratory experience of the students. The candidate should describe a mentoring plan stating how (s)he and the mentor will foster student interest in graduate school in behavioral or biomedical research and a career in scientific research in areas related to heart, lung, blood, or sleep disorders. For the purpose of this announcement, underrepresented minority students are defined as individuals belonging to a particular ethnic or racial group that has been determined by the applicant institution to be underrepresented in biomedical or behavioral research. Nationally, NHLBI considers African American/Black, Hispanic, American Indian, Alaska Native, and non-Asian Pacific Islander students to be underrepresented. Provisions Of The Award Salary The awardee (candidate at the minority institution) will receive salary support up to a maximum of $75,000 per year plus fringe benefits for five years. These funds must be used to support the awardee. The level of support will be based upon the awardee's actual salary and must be consistent with the established salary structure of the minority institution for persons of equivalent qualifications, experience, and rank. The actual salary level will be determined by the amount of effort devoted to this program. Awardees must commit 100% effort during summer and/or off-quarter periods and at least 25% of effort during the academic year. Supplementation of the awardee's salary from non-Federal sources is permissible. Supplementation of the awardee's salary from other Federal funds is not allowed unless explicitly authorized by both the program from which funds are derived and the NHLBI. In no case may other NIH funds be used to supplement the salary of the awardee. In addition to salary support for the awardee, support for up to 5% of the mentor's salary plus fringe benefits during the summer experience may also be requested. If funds are to be transferred to the mentor's institution for the mentor's salary, arrangements for the transfer of funds and the conduct of activities should be formalized in a subcontract agreement with the mentor's institution. The mentor=s salary should not be included in the research and development costs. A maximum of $8.50 per hour plus fringe benefits may be requested for the student research assistant(s). Level of support and hours worked during the academic year should reflect the institution's policy for student work-study programs. Students must commit 100% effort during the summer and off-quarter periods and at least 25% effort during the academic year. Research and Development Costs Up to $36,000 per year beyond that requested for the awardee's, mentor's, and student(s)' salaries will be provided for research support. Details regarding the apportionment of these funds between the minority institution and the mentor's institution must be worked out with the mentor, agreed to by representatives of both institutions, and included as part of the agreement submitted as part of the application. These research support funds may be used for: o Personnel: support for technical personnel. o Equipment: limited to specialized research equipment essential to the proposed program. In accordance with PHS policy, title to such equipment will vest with the grantee institution. o Supplies: consumable supplies essential to the proposed program. o Travel: essential to the proposed program. o Other: publication costs, computer costs, or other costs necessary for the research program. Facilities and Administrative (F & A) Costs F & A costs will be provided at a rate of 8% of the total direct costs of each award, exclusive of equipment. The F & A cost rate on an agreement with the mentor's institution may not exceed 8%. Concurrent Applications NHLBI Minority Institution Research Scientist Development Award applications may not be submitted or awarded concurrently with other NIH Career Development Award applications, such as the Independent Scientist Award, Mentored Clinical Scientist Development Award, Academic Award, Research Project Grant, or Mentored Patient-Oriented Research Career Development Award. Subsequent Applications for NIH Research Support During the later years of the NHLBI Minority Institution Research Scientist Development Award (K01), incumbents are encouraged to apply for independent research support (e.g., R01, etc.). K01 recipients who are successful in obtaining subsequent NIH research grant support may not receive salary support from the research grant for the duration of the K01 award except under certain circumstances and with prior NHLBI approval. After the conclusion or termination of the K01 award, salary support should transfer to the research grant. K01 recipients who apply for subsequent research grant support are encouraged to include salary and all other research needs in the research grant application for the period following completion of the K01. Alternatively, recipients of research grant awards may terminate the K01 prior to the start of the research grant. Training in the Responsible Conduct of Research (RCR): Candidates must describe plans to receive instruction in the responsible conduct of research. The Public Health Service policy on RCR (http://ori.hhs.gov/policies/RCR_Policy.shtml#rcr) describes nine core instructional areas that comprise RCR: data acquisition, management, sharing, and ownership; mentor/trainee responsibilities; publication practices and responsible authorship; peer review; collaborative science; human subjects; research involving animals; research misconduct; and conflict of interest and commitment. Plans for RCR training must describe the proposed subject matter, format, frequency and duration of instruction. This description should include an explicit statement that the candidate has taken or will take the course, and when. No award will be made if an application lacks this component. See the NIH website http://www.nih.gov/sigs/bioethics for resources and information on this topic. 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: programmatic, review and financial or grants management issues: o Direct your questions about programmatic issues to: Traci Heath Mondoro, Ph.D. Division of Blood Diseases and Resources (responding for all NHLBI programmatic Divisions) National Heart, Lung, and Blood Institute National Institutes of Health 6701 Rockledge Drive, MSC 7950 Bethesda, Maryland 20892-7950 Telephone: (301) 435-0052 FAX: (301) 480-0868 Email: mondorot@nhlbi.nih.gov o Direct your questions about review issues to: Anne Clark, Ph.D. Chief, Review Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute National Institutes of Health Two Rockledge Center, Room 7214 6701 Rockledge Drive, MSC 7924 Bethesda, MD 20892-7924 Bethesda, MD 20817 (for express mail) Telephone: (301) 435-0270 FAX: (301) 480-0730 Email: clarka@nhlbi.nih.gov o Direct your questions about financial or grants management matters to: Ms. Marsha D. Mathis Grants Management Specialist Division of Extramural Affairs National Heart, Lung, and Blood Institute National Institutes of Health 6701 Rockledge Drive, Room 7158, MSC 7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0170 FAX: (301) 480-3310 Email: mathism@nhlbi.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o A 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 NHLBI staff to estimate the potential review workload and plan for the review. The letter of intent is to be sent to Dr. Anne Clark at the address listed under WHERE TO SEND INQUIRIES by May 22, 2003. 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. Refer to K section. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. 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 (NHLBI MINORITY INSTITUTION RESEARCH SCIENTIST DEVELOPMENT AWARD) and number (HL-03-012) 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 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) All grant applications submitted to the Center For Scientific Review (CSR) must come via United States Postal Service or a recognized delivery/courier service. Individuals may not personally deliver packages to the building on Rockledge Drive. For further information please see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html. At the time of submission, two additional copies of the application and all five collated sets of the appendix material must be sent to Dr. Anne Clark at the address listed under WHERE TO SEND INQUIRIES. APPLICATION PROCESSING: Applications must be received by June 23, 2003. If an application is received after that date, it will be returned to the applicant without review. 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. 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. PEER REVIEW PROCESS 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 a Special Emphasis Panel in the Division of Extramural Affairs, NHLBI, 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 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 and assigned a priority score o Receive a second level review by the National Heart, Lung, and Blood Advisory Council. REVIEW CRITERIA The following criteria will be considered in the evaluation of the proposed NHLBI Minority Institution Research Scientist Development Award program: o Candidate -- The candidate's overall qualification as demonstrated by academic record and research performance, potential for a career as an independent researcher, potential to mentor undergraduate and graduate students, commitment toward pursuit of an academic research career and toward the enhancement of the scientific program at the minority institution, and commitment to the career development of minority students. o Candidate's Career Development Plan -- The quality of the research career development plan, based on the candidate's past research experience, training, and career goals, as demonstrated by such things as relevance of the proposed didactic training, structure of interaction with mentor, attendance at scientific meetings, and participation in journal clubs and research seminars. o Student's Development Plan B The quality of the student career development plan as demonstrated by such things as exposure to research opportunities to attend/present at scientific meetings, interaction with mentor, and participation in journal clubs and research seminars. o Research Project -- Scientific merit of the proposed research project and its appropriateness as a vehicle for developing the candidate's and student(s)' research skills. o Keeping Students in Research Careers -- The candidate=s record and an outline of future plans for involving students in research and guiding them to science graduate programs and careers in academic, biomedical and behavioral research, and plans for tracking students. o Mentor(s) -- The mentor's accomplishments in the scientific research area(s) proposed, plans for mentoring the candidate and students, experience and record in training investigators, and commitment for the duration of the project. A curriculum vitae with relevant publications and a list of current and pending research support must be included for all mentors. Mentors should also include a list of current and past research trainees (not more than the last 10 years) with information on their current positions. o Environment -- The applicant institution's ability to provide adequate facilities, resources, and opportunities necessary for the candidate's and student(s)' training, and the institutional commitment to the candidate and student(s). If the mentor(s)' institution is different from the applicant, the quality and extent of interaction of the faculty in the basic and clinical sciences, and the quality of the research and research training programs at the mentor's institution will be considered. o Institutional commitment -- The institution's commitment to the development of the candidate and student(s). ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, if your research involves human subjects your application will also be reviewed with respect to the following: 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 section 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. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research and career development activities. Training in the Responsible Conduct of Research: Every predoctoral and postdoctoral NRSA trainee supported by an institutional research training grant must receive instruction in the responsible conduct of research. (For more information on this provision, see the NIH Guide for Grants and Contracts, Volume 21, Number 43, November 27, 1992, see https://grants.nih.gov/grants/guide/notice-files/not92-236.html. Applications must include a description of a program to provide formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and will be returned to the applicant without review. o Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects. Within the context of training in scientific integrity, it is also beneficial to discuss the relationship and the specific responsibilities of the institution and the graduate students or postdoctorates appointed to the program. o Plans must address the subject matter of the instruction, the format of the instruction, the degree of faculty participation, trainee attendance, and the frequency of instruction. o The rationale for the proposed plan of instruction must be provided. o Program reports on the type of instruction provided, topics covered, and other relevant information, such as attendance by trainees and faculty participation, must be included in future competing continuation and noncompeting applications. The NIH encourages institutions to provide instruction in the responsible conduct of research to all graduate students, postdoctorates, and research staff regardless of their source of support. NIH initial review groups will assess the applicant's plans on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction. The plan will be discussed after the overall determination of merit, so that the review panel's evaluation of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. Staff within the NIH awarding component will judge the acceptability of the revised plan. Following initial review, the NHLBI Advisory Council provides a second level of review. The Council will consider the assessment of the scientific and educational merit of the research training grant application as well the plan for instruction in the responsible conduct of research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: May 22, 2003 Application Receipt Date: June 23, 2003 Peer Review Date: October/November 2003 Council Review: February 2004 Earliest Anticipated Start Date: April 1, 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific and career development merit (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. MONITORING PLAN AND DATA SAFETY AND 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 "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. You will find this policy announcement 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. 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 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. 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 Catalog of Federal Domestic Assistance No. 93.233, 93.837, 93.838, and 93.839 and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 described at https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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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