PAUL CALABRESI AWARD FOR CLINICAL ONCOLOGY (K12) RELEASE DATE: April 23, 2004 PA NUMBER: PAR-04-096 (Reissued as PAR-06-449) EXPIRATION DATE: June 2, 2006, (Change in receipt and expiration dates, see NOT-CA-05-025) Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Cancer Institute (NCI) (http://www.nci.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.398 LETTER OF INTENT RECEIPT DATE: June 1, 2004, May 2, 2005 APPLICATION RECEIPT DATE: July 1, 2004, June 1, 2005 This Program Announcement (PA) replaces PAR-03-083, Clinical Oncology Research Career Development Program, which was published in the NIH Guide on March 20, 2003. THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanisms of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Eligible Candidates o Special Requirements o Where to Send Inquiries o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Additional Review Criteria o Additional Review Considerations o Award Criteria o Required Federal Citations PURPOSE This PA announces the replacement of the NCI Institutional Clinical Oncology Research Career Development (K12) Program (PAR-03-083 at http://grants.nih.gov/grants/guide/pa-files/PAR-03-083.html) with the Paul Calabresi Award for Clinical Oncology (K12) or PCACO. The purpose of the PCACO is to increase the number of medical doctors (M.D.'s, D.O.'s), and doctorally-degreed nurses (Ph.D.’s or equivalents) and basic scientists (Ph.D.’s D.V.M. s, or equivalents) who are highly-motivated and trained to: 1) perform clinical oncology therapeutic research that develops and tests scientific hypotheses based on fundamental and clinical research findings; 2) design and test hypothesis-based, clinical therapeutic protocols and adjunct biological analyses and for clinician candidates to administer all phases (i.e., pilot/Phase I, Phase II, and Phase III) of cancer therapeutic clinical trials, and (3) conduct cancer therapeutic research in team research settings in which basic and clinical scientists collaborate and interact to expedite the translation of basic research discoveries into patient-oriented therapeutic cancer research. The PCACO is not intended to train laboratory-based scientists whose research will emphasize the use of animal or other model systems. For the purposes of this award, and in agreement with the recommendations of the NIH Director’s Panel on Clinical Research, (http://www.nih.gov/news/crp/97report/index.htm), patient-oriented research is defined as research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator directly interacts with human subjects. This area of research includes 1) mechanisms of human disease; 2) therapeutic interventions; 3) clinical trials, and; 4) the development of new technologies. Studies falling under Exemption 4 for human subjects research are not included in this definition. The NCI has named this award in honor of the late Dr. Paul Calabresi, who was a pioneer in the pharmacological treatment of cancer and early translational research. It recognizes him for his humanity, dedication to his patients, mentorship of young clinical oncologists, contributions to understanding and curing of cancer, untiring efforts to promote and develop the field of clinical oncology, and ceaseless service to the National Cancer Institute including his participation in the strategic development of the Nation’s War on Cancer. Most of all, this award is intended to symbolize the quality and excellence of the physician scientists and the non-clinician translational researchers that NCI hopes will become critical contributors to the future elimination of death and suffering from cancer. Individuals with medical degrees seeking a career development experience exclusively in laboratory-based research should refer to the NIH Mentored Clinical Scientist Career Development Award or K08 at the following website: http://grants.nih.gov/grants/guide/pa-files/PA-00-003.html. Individuals with medical degrees interested in patient- oriented research should refer to the NIH Mentored Patient-Oriented Research Career Development Award or K23 at the following website: http://grants.nih.gov/grants/guide/pa-files/PA-00-004.html. Postdoctoral individuals (e.g., Ph.D. s) trained in laboratory-based research, who wish to change direction and focus their research careers on human cancer, should refer to the NCI Howard Temin Award or K01 at the following website: http://grants.nih.gov/grants/guide/pa-files/PAR-03-104.html. RESEARCH OBJECTIVES Background In 1991, the NCI recognized the need for establishing formal training programs that would prepare the next generation of clinical scientists to participate more effectively in translational research. The NCI embarked on a pilot program initiative that would prepare clinical oncologists to be effective scientific partners with basic/behavioral scientists in the movement of discoveries in the laboratory into patient research settings or in the reverse process of taking observations in the clinic back into a laboratory research setting. These well-trained clinical oncology researchers would be expected to communicate, interact, and collaborate with basic/behavioral scientists in the design and implementation of clinical trials that were hypothesis driven and based on an understanding of biological mechanisms. This pilot program initiative was implemented through two successive RFAs in 1992 and 1997. The initial pilot Program was highly successful and generated considerable interest in the cancer research community. It therefore became clear that NCI objectives would be better served by making this grant mechanism open to investigator-initiated applications on a regular basis using a Program Announcement (PA). As a result, in 1998 the NCI established the Institutional Clinical Oncology Research Career Development Program (K12) as an ongoing PA with a once-a-year submission date. In 1999, the NCI extended eligibility for an appointment to an NCI K12 grant to include doctorally-prepared Oncology Registered Nurses, in recognition of the critical role of nursing in general and oncology nursing in particular in clinical cancer research and care. Finally, in view of the continuing commitment of the NCI to increase the participation of individuals from underrepresented minority groups in biomedical and behavioral research and the critical need for more underrepresented minorities in clinical oncology research, the PA was reissued in 2003 and required that all competing applications for the Institutional Clinical Oncology Career Development Program(K12) Grant include a specific plan to recruit and retain underrepresented minorities as trainees. The focus of this Program has always been the career development of medical doctors in translational therapeutic research. To this end, the Program specifically required that clinical candidates obtain a basic research experience as a means of increasing their ability to collaborate and communicate with basic scientists successfully in the translational research process. It is now clear that the translational therapeutic research of the future will require both dedicated clinician scientists and basic scientists working in team research settings. The NCI Paul Calabresi Award in Clinical Oncology (K12) changes the Program from supporting only clinician scientists to one that can support both clinician scientists and basic scientists as a cohort in order to further enhance career development that emphasizes basic/clinical scientific interactions and team research concepts. The NCI Paul Calabresi Award in Clinical Oncology (K12) is consistent with the objective of the NIH Roadmap Initiative to build a strong clinical research infrastructure and increase interactions between basic and clinical scientists. Program objectives The objectives of the Paul Calabresi Award for Clinical Oncology are to: o Encourage medical doctors to dedicate their careers to the design and conduct of hypothesis-based clinical therapeutic research; o Encourage basic research scientists to dedicate their careers to patient-oriented, clinical therapeutic research; and o Develop a cadre of medical doctors and basic science researchers who know how to work effectively in collaborative, team research settings. MECHANISM OF SUPPORT This PA will use the NIH Mentored Clinical Scientist Development Program Award or K12 grant mechanism. Planning, direction, and/or execution of the program will be the responsibility of the Program Leader/Principal Investigator (PI) and the Advisory Committee on behalf of the applicant institution. Applicants must request 5 years of support. Awards are renewable. Awards will be administered under the NIH grants policy as stated in the National Institutes of Health Grants Policy Statement (Revised, 12/03) and described on http://grants.nih.gov./grants/policy/nihgps_2003/index.htm. However, the K12 award, as administered by the National Cancer Institute, is not subject to the Just-in-time application procedures or to the Streamlined Noncompeting Application Process (SNAP). The K12 remains under Expanded Authorities except that carryover of funds from one Fiscal Year to the next requires approval by the NCI. ELIGIBLE INSTITUTIONS You may submit an application if your 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 Domestic institutions/organizations o Foreign institutions are not eligible to apply INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS The Program Leader is the Principal Investigator. The Program Leader must be an established investigator in patient-oriented research and must be able to provide both administrative and scientific leadership to the Program. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. ELIGIBLE CANDIDATES Clinician Candidates (required): All clinician candidates or trainees must currently be physicians holding the M.D. or D.O. degrees, or be nurses with a Ph.D. degree; and must have completed the necessary clinical training (i.e., completed residency and are board eligible) to engage in clinical oncology research. Basic Science Candidates (encouraged but optional): All basic science candidates must have doctoral-level degrees (e.g., Ph.D., D.V.M.) or the equivalent, a minimum of 2 years of postdoctoral research training, and a total basic research experience that is clearly preparatory (e.g., experience with animal models or preclinical research) for devoting a career to human therapeutic cancer research. All Clinician and Basic Science Candidates must satisfy the following: They must be committed to a minimum of 75 percent full-time professional effort conducting research and engaging in activities directly related to research career development, which includes all relevant didactic activities during the period of the award. They must be citizens or non-citizen nationals of the United States, or must have been lawfully admitted to the United States for permanent residence (i.e., in possession of a currently valid Alien Registration Receipt Card I- 551, or other legal verification of such status). Non- citizen nationals are generally persons born in outlying possessions of the United States (i.e., American Samoa and Swains Island). Individuals on temporary visas are not eligible. Candidates may be former or current principal investigators on NIH Small Grants (R03) or Development and Innovation Grants (R21 or non-NIH equivalents to these grants/awards. Candidates may not be current or former principal investigators on an NCI K01 (Temin Award),an NCI K07 or an NIH K08 grant, NIH Research Project Grants (R01, R29) and subproject leaders on Program Project Grants (P01) and Center Grants (P50), or non-NIH equivalents to these grants/awards. Candidates may also not be current or former principal investigators on an NIH K23 grant, an NCI K22 grant or non-NIH equivalent grants/awards. However, clinician candidates appointed to a K12 grant are encouraged to apply for these grants/awards. SPECIAL REQUIREMENTS Special NCI Programmatic Requirements o Where there already exists an active Ruth L. Kirschstein (T32) National Research Service Award (NRSA) or other institutional career development program (e.g., K12s, K30s, General Clinical Research Core (GCRC) Scholars Program) overlap between these programs must be eliminated and/or the NCI Paul Calabresi Award for Clinical Oncology (K12) structured in a way to complement and take advantage of these other career development/training programs. This may require merging components of other programs with the NCI K12 or linking curriculum programs (e.g., K30) with the core requirements of the NCI K12. o Institution: The institution must have substantial support for peer- reviewed basic and clinical research and faculty qualified in patient- oriented therapeutic research , translational research and basic cancer research to serve as mentors in the proposed Program. Institutions require NCI approval to submit an application if another NCI K12 exists at the institution. o Environment: The research environment should be one in which there are active basic/clinical research collaborations that exemplify a dynamic two-way exchange of information and ideas between basic and clinical scientists. o Program: 1. Program Management: The PI must use an Advisory Committee (AC) to provide an oversight function and annual evaluation of the Program as a whole. The committee's responsibilities should include but are not limited to: selecting clinician, nurse and basic candidates (Note: basic candidates are encouraged as part of these Programs but they are optional), assigning preceptors, approving each candidate's career development plan, evaluating each candidate's progress, authorizing the termination of a candidate who is not performing, monitoring the overall effectiveness of the program and recommending mid-course changes when needed. A detailed description of the committee's composition, function, and frequency of meetings should be provided. Plans for an annual evaluation of the program by the AC should be described, and annual written reports from the AC are required that describe the progress (e.g., success of candidates in achieving core didactic and research requirements) of the Program, evaluate its effectiveness (e.g., recruitment methods, effectiveness of mentors, effectiveness and appropriateness of curriculum), and provide recommendations for improvements. This annual report must also address the recruitment and retention of underrepresented minorities in the Program (see 7 below). 2. The Program may be completely devoted to clinician candidates. If basic candidates are included (and this is encouraged), the ratio of clinician candidates to basic candidates must not go below 2:1 at any time. 3. The Program must involve clinical mentors and candidates representing at least two clinical oncology disciplines such as medical oncology, surgical oncology, radiation oncology, pediatric oncology, gynecologic oncology and oncology nursing. Clinical candidates from non-oncology medical subspecialties may also be represented in the Programs. However, these subspecialties should have direct relevance to cancer (e.g., thoracic surgery, pulmonology) and the individualized career development plans developed for these candidates must be focused on clinical oncology research. 4. Appointees to the Program must be designated Paul Calabresi Scholars. 5. The Program must motivate and train candidates to: 1) perform clinical oncology therapeutic research that develops and tests scientific hypotheses based on fundamental and clinical research findings; 2) design and test hypothesis-based clinical therapeutic protocols and adjunct biological analyses and for clinician candidates to administer all phases (i.e., pilot/Phase I, Phase II, and Phase III) of cancer therapeutic clinical trials, and (3) conduct cancer therapeutic research in team research settings in which basic and clinical scientists collaborate and interact to expedite the translation of basic research discoveries into patient-oriented therapeutic cancer research. 6. Programs should have the flexibility to accommodate candidates with different levels of research experience and competence. (See number 9 below regarding Core Requirements. ) 7. A specific plan must be provided to recruit and retain individuals from underrepresented and disadvantaged groups in the Program. In addition, all future Non-competing Grant Progress Reports must include a separate section in the annual written report of the AC (see 1 above) that reports on the recruitment and retention of individuals from underrepresented and disadvantaged groups during the previous award period and makes recommendations for altering the plan, as necessary, to improve its effectiveness. 8. Appointments of candidates to the program should be for a minimum of TWO years. As long as a K12 has been renewed, individual CLINICIAN candidates can be supported for up to 7 years. All candidates must be able to commit a minimum of 75 percent of a full-time professional effort to the Program. The remaining 25 percent can be divided among other clinical and teaching activities only if they are consistent with the Program goals (i.e., the candidates development into effective scientists as either independent clinical investigators and/or clinician/basic co-leaders able to assemble and manage effective therapeutic research teams). 9. The Program should include specific Core Requirements that each candidate is expected to complete in order to meet the Program's training objectives. All candidates graduating from the program must complete all of these requirements either directly in this Program or through a combination of past training experience and work conducted in this Program. These requirements should include the following: a. A DIDACTIC CORE REQUIREMENT(e.g., formal courses in clinical trial design, biostatistics, informed consent, Institutional Review Boards, data safety and monitoring, lecture series, seminars, and journal clubs) based on the experience and needs of each candidate. The requirements for this core component should be the same for all candidates whether or not they have clinician or basic research backgrounds. b. A CLINICAL RESEARCH CORE REQUIREMENT that provides "hands-on" experience (e.g., protocol development; preparation of IRB applications; administration of clinical trials including patient accrual, analysis of outcomes) in all aspects of Phase I, Phase II and where possible Phase III clinical trials. Except for the administration of treatment to patients, this component should be the same for all candidates whether or not they have clinical backgrounds or basic research backgrounds. Basic science candidates are expected to be full partners with clinicians and become equally proficient in the design and the evaluation of results from translational, therapeutic clinical trials. c. A BASIC RESEARCH CORE REQUIREMENT that provides a hands-on research experience for CLINICIAN candidates for up to 2 years that results in a peer-reviewed publication(s) and that clearly serves as a tool for ensuring that these candidates are fully prepared to communicate, coordinate and collaborate with basic scientists in the conduct of hypothesis-driven cancer therapeutic research. Ideally, this experience should be linked to the core clinical research component. Although the submission of applications by candidates for investigator- initiated research project grants is encouraged, the core requirements cannot mandate candidates receipt of an investigator-initiated research project grant. The expectation of the NCI is that clinician and basic science candidates will enter the Program with different levels of experience that already satisfy many of the Didactic, Clinical Research, and Basic Research Core Requirements. Thus, individual candidates will need to complete only those additional didactic and research experiences that help them meet all of the core requirements of the Program and are likely to be supported by the Program for different periods of time. 10. All candidates are expected to receive either some formal degree (e.g., Masters in Clinical Research) or special certification in clinical research from the parent institution. 11. If basic science candidates are included in the Program, special efforts must be made to treat the clinician and basic science candidates as a COHORT with regard to sharing, presenting and discussing their research and training experiences. Special Administrative Requirements o Special Leave: Leave of a trainee to another institution, including a foreign laboratory, may be permitted if directly related to the purpose of the award. Only local, institutional approval is required if such leave does not exceed 3 months. For longer periods up to 1 year, prior written approval of NCI staff is required. To obtain prior approval, the trainee must submit a letter to the NCI Grants Administration Branch with a copy to the NCI Program Director describing the plan, countersigned by his or her department head and the appropriate institutional official. A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made for the leave and for the return of the trainee to the Program. Support from the award will continue during such leave. Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NCI and will be granted only in unusual situations. Support from other sources is permissible during the period of leave. Parental leave will be granted consistent with the policies of the grantee institution. o Termination: When a grantee institution plans to terminate an award, the NCI must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The NIH may discontinue an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, the Director of the NIH shall notify the grantee institution and career award recipients in writing of this determination, the reasons therefore, the effective date, and the right to appeal the decision. o Change of Institution: The Paul Calabresi Award for Clinical Oncology (K12) cannot be transferred from one institution to another. o Change of PI: If the PI moves to another institution or resigns from the position, support of the award may be continued with NCI prior approval provided: 1. The current PI or the awardee institution has submitted a written request for change of PI, countersigned by the appropriate institutional business official, to the NCI Grants Administration Branch with a copy to the NCI Program Director describing the reasons for the change; the biosketch of the proposed new PI, including a complete listing of active research grant support, is provided; the information in the request establishes that the specific aims of the original peer reviewed career development program to be conducted under the direction of the new PI will remain unchanged; and that the new PI has the appropriate research and administrative expertise to lead the program; and 2. The request is submitted far enough in advance of the requested effective date to allow the necessary time for review. o Changes of Program: Awards are made to a specific institution for a specific program under the guidance of a particular PI. Changes in any of these parameters requires prior approval by the NCI. A scientific rationale must be provided for any proposed changes in the aims of the original peer reviewed program. The new program will be evaluated by NCI staff to ensure that the program remains within the scope of the original peer reviewed research program. If the new program does not satisfy this requirement, support could be withheld or the award could be suspended or terminated. Budget and Related Issues o Allowable costs: 1. Direct cost caps: If an application is to support only clinician candidates, it must not exceed $750,000 in direct costs per annum. If an application is to support both clinician candidates and basic science candidates, it must not exceed $1,050,000 in direct costs per annum, AND the ratio of clinician candidates to basic candidates supported by the Program cannot go below 2:1 at any time. 2. Candidate Salary: The NCI will provide support for each candidate position up to $75,000 salary and associated fringe benefits per annum based on a full-time professional 12-month effort commensurate with the applicant institution’s salary structure for persons of equivalent qualifications, experience, and rank. The institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. Because the salary amount provided by this award is based on the full- time institutional salary, no other PHS funds may be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K12. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. 3. Research and Development Support: No more than $30,000 per individual candidate can be provided for the following types of expenses: (a) research expenses, such as supplies, equipment and technical personnel; (b) tuition, fees and books related to career development; (c) travel to research meetings or training; and (d) statistical services including personnel and computer time. These costs must be specifically documented for each individual candidate and must be specifically and directly related to the candidate's research activities. They cannot be pooled and used for advertising, recruiting, or other programs unrelated or indirectly related to the research activities of individual candidates or trainees. It is expected that the K12 trainees will be working in a funded research environment and that support provided by the K12 grant will augment existing research support to include the trainee. 4. Other Costs: This category is capped at $50,000. Up to 10 percent of the Principal Investigator/Program Leader’s salary plus fringe benefits will be provided for leadership, management, coordination and evaluation of the Program, in accordance with the percent effort commitment to the Program. Some partial salary plus fringe benefits may be provided for a dedicated administrator. Minimal costs can be allocated for advertising and recruitment in order to attract the best candidates nationally. 5. Facilities and Administrative Costs: These costs, which were formerly called indirect costs, will be reimbursed at 8 percent of modified total direct costs. 6. Other Income: Fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and research-related activities of this award may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods: The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution. The funds may be used for health-related research purposes. The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks should be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Office of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment. Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, honoraria from other institutions for lectures or seminars, and fees resulting from clinical practice, professional consultation or other comparable activities, provided these activities remain incidental, are not required by the research and research-related activities of this award, and provided that the retention of such pay is consistent with the policies and practices of the grantee institution. Funds budgeted in an NIH-supported research or research training grant for the salaries and/or fringe benefits of individuals, but freed as a result of a K12 award, may not be rebudgeted and may not be used for any other purpose without prior NIH approval. 7. Carryover of unobligated balances: Although the K12 is subject to Expanded Authorities, the carryover of funds from one budget period to the next requires prior written approval by NCI. Special Reporting Requirements o The K12 grant, as administered by the NCI, is not subject to the Streamlined Noncompeting Application Process (SNAP). In general, this means that all reporting of budgetary information and program progress are provided in greater detail in an annual progress report. o Progress Reports: An Annual Progress Report for the grant is required. This report should provide information about changes in the Program, an evaluation of the Program made by the Advisory Committee, and a description of the research and career progress of each candidate. These Annual Reports will be closely monitored by NCI staff to ensure that the grant is achieving the goals of the K12 initiative. Progress reports are submitted using the Form PHS 2590, which can be obtained at the following website address: http://grants.nih.gov/grants/funding/2590/2590.htm. The procedure for obtaining the face page for the application is described on the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-066.html. Since the Form PHS 2590 does not apply easily to the K12 grant, adapt the application for continuation to contain the following information: 1. Appropriate face page (Form Page 1) as instructed in the Form PHS 2590; 2. A budget page (Form Page 2) that provides the salary and fringe benefits for each candidate or trainee by name or by position if no individual is filling the position at the time of the application. Provide all other budgetary information (e.g., supplies, travel, technical help) by trainee name or by the position broken out specifically for each candidate and/or trainee up to the $30,000 limit; 3. A brief description of the Objectives and Goals of the Program; and 4. A brief summary listing by name delineating which faculty, mentors, and Advisory Committee members have left the Program and which new individuals have been added or are taking their places. Include for each person their degree and department affiliation (or equivalent). 5. Biographical sketches of i. New Faculty ii. New Mentors iii. New Advisory Committee (AC) Members iv. New Trainees The biosketches for each trainee should include any Board Eligibilities or Certifications. The biosketches for new faculty/mentors/AC members should include a listing of all active research grant support for which they are the PI or co-investigator. 6. Progress of Individual Trainees: For each trainee, provide the start date (month/year) of the appointment to the Program and the cumulative number of years supported by the K12 grant; the names of the basic and clinical research mentors; and a brief paragraph for each candidate or trainee describing progress toward satisfying the Didactic, Clinical Research, and Basic Research Core Requirements of the Program and the projected timetable for completing the remaining Core Requirements. The individual reports should also include: 1) A list of publications for the trainee resulting from their work in the Program; and 2) Descriptive titles of clinical trials developed and/or implemented by each trainee and resulting from their work in the program, identifying the role of the trainee in each of the trials. 7. A separately attached report from the AC summarizing the actions of the AC during the last year, evaluating the performance of individual candidates and the Program as a whole in meeting its objectives and the intent of the NCI, evaluating the effectiveness of recruitment strategies, and providing recommendations for improving the Program (e.g., new mentors, changes in Core Requirements, changes in recruitment strategies etc.) should be included. A special section should be devoted to evaluating the required plan for recruiting and retaining underrepresented minorities with recommendations for changing the plan to improve its effectiveness. 8. Evaluation: In carrying out its stewardship of human resource related programs, the NCI may request information essential to an assessment of the effectiveness of this program. Accordingly, recipients (PI's, individual candidates/trainees) are hereby notified, that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. 9. A final progress report, invention statement, and Financial Status Report are required upon either completion of an award or relinquishment of an award. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA 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 your questions about scientific/research issues to: Lester S. Gorelic, Ph.D. Cancer Training Branch National Cancer Institute 6116 Executive Boulevard, Suite 7025, MSC 8346 Bethesda, MD 20892-7390 Rockville, MD 20852 (express/courier service) Telephone: (301) 496-8580 Fax: (301) 402-4472 Email: gorelicl@mail.nih.gov o Direct your questions about peer review issues to: Referral Officer National Cancer Institute Division of Extramural Activities 6116 Executive Boulevard, Room 8041, MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (express/courier service) Telephone: (301) 496-3428 Fax: (301) 402-0275 Email: ncirefof@dea.nci.nih.gov o Direct your questions about financial or grants management matters to: Ms. Kimery Griffin Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, EPS Room 243, MSC 7150 Bethesda, MD 20892-7150 Rockville, MD 20852 (express/courier service) Telephone: 301-496-3196 Fax: 301-496-8601 Email: griffink3@mail.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; and o Number and title of this PA. 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 NCI 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: Lester S. Gorelic, Ph.D. Cancer Training Branch National Cancer Institute 6116 Executive Boulevard, Suite 7025, MSC 8346 Bethesda, MD 20892-7390 Rockville, MD 20852 (express/courier service) Telephone: (301) 496-8580 Fax: (301) 402-4472 Email: gorelicl@mail.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001)updated 9/9/03. Applicants are advised that these instructions are provided under the section titled "Table of Contents" following the tables providing individual PHS Form 398 pages. Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the website at http://www.dunnandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 Form. The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance, contact GrantsInfo, Telephone: (301) 710-0267, Email: GrantsInfo@nih.gov. The title and number of this program announcement must be typed on line 2 of the face of the application form and the YES box must be checked. SUPPLEMENTARY INSTRUCTIONS The instructions in the Form PHS 398 do not fully apply to the special needs of this grant application. Therefore, follow the modified instructions below in preparing an application for an NCI Paul Calabresi Clinical Oncology Award (K12). These instructions have been adapted to accommodate the Form PHS 398 and the special needs of the K12 grant: 1. Face Page: Use Form Page 1 of the Form PHS 398. On Line 1, include the title that best represents the nature of the training program. On Line 2, provide the number of this Program Announcement beginning with PAR-04-096, and the title "Paul Calabresi Clinical Oncology Award" of the Program Announcement. The Program Leader will be the principal investigator (PI) of the grant application. 2. The Description/ Performance site(s)/ Key personnel (Form Page 2 of Form PHS 398): Complete as directed in the Form PHS 398. The information provided should include the P.I., Advisory Committee members, mentors, and other faculty participating in the program. 3. Table of Contents to be organized as follows: Section I. Basic Administrative Information: 1. Face Page 2. Description/Key Personnel 3. Table of Contents 4. Statement of Commitment 5. Detailed Budget Page for the initial budget period. 6. Budget for Entire Proposed Period of Support 7. Biographical Sketches (not to exceed two pages per individual) a. Principal Investigator b. Advisory Committee Members c. Mentors, Other Faculty d. Trainees (if available) 8. Research Base/Resources and Facilities Section II. Specialized Information 1. Career Development/Training Plan (There is no page limit, but it is suggested that applicants be as clear and brief as possible; tables should be included in the text, not as appendices) a. Introduction to Revised Application (when applicable, not to exceed 3 pages) b. Purpose and Objectives c. Research Environment d. Description of Didactic, Clinical Research, and Basic Research Core Requirements 2. Program Management a. Principal Investigator b. General Recruitment Strategies c. Recruitment of underrepresented minorities d. Evaluation Plan 3. Advisory Committee 4. Individual Training Plans 5. Human Subjects 6. Vertebrate Animals 7. Checklist 8. Appendices Detailed instructions for Table of Contents Section I: Item 4. Statement of Commitment: This statement should guarantee that all candidates participating in this Program Announcement will commit a minimum of 75 percent of a full-time professional effort to research and research career development. Item 5. Detailed Budget for the Initial Budget Period: Provide detailed budget information with regard to salary and fringe benefits, supplies, travel etc. specified for each trainee by name or by position, if there is no one available to fill the position. Note that there is an upper limit of salary of $75,000 plus fringe benefits, an upper limit for other costs of $30,000 per trainee; and a required minimum 75 percent effort. Item 7. Biographical Sketches: Provide biographical sketches using the Biographical Sketch Format Page of the Form PHS 398. Group the biosketches into the following five sections: (1) PI; (2) K12 Advisory Committee Members; (3) Mentors; (4) Other Faculty; and (5) Trainees (when available). Item 8. Research Base/Resources and Facilities: (Suggested tabular formats for this information can be found under "Summary Information on Program" at http://cancertraining.nci.nih.gov/research/clinical/k12full.html#app. This should include support from other training programs that relate to this application (e.g., other K12 Awards, K30 Awards, T32 Awards, R25T Awards). Detailed instructions for Table of Contents Section II. Item 1. Part b. Purpose and Objectives: Briefly describe the background, purpose and objectives of this career development Program. This description should identify two or more clinical oncology disciplines represented in the Program and a discussion of the strategies to be used to ensure that the representation in each discipline in the mentor population and the trainee population will satisfy the intent of this NCI requirement. The description should clearly show how the purpose and objectives of the Program will meet the broader objectives and intent of the NCI to prepare clinician and where appropriate basic candidates who can design and implement all phases of clinical trials and who can effectively work together in team research settings in patient-oriented therapeutic cancer research. Item 1. Part c. Research Environment: Research Base: Describe the existing funded laboratory and patient- oriented research activities and the interactive nature of the research environment that will meet and sustain needs of this Program. Include in this description the number and types of early to late phase clinical therapeutic clinical trials being conducted in the institution, the general range of activities in these trials and, wherever present, the hypothesis-based translational nature of these activities. Resources and Facilities: Describe the research infrastructure, patient populations, facilities, etc., that are available and accessible to this Program. Mentors: Describe the pertinent research experience and track record in training cancer clinician scientists (and, for combined clinician-basic scientist programs, translational cancer researchers) of each mentor participating in the Program. Item 1. Part d. Description of Didactic Clinical Research Core Requirements: Describe separately the core didactic, core clinical research, and core basic research experiences that each clinician and basic candidate must complete to satisfy the overall Core Requirements of the Program. If there are existing institutional K30 or GCRC Scholar programs, explain how the K12 Program will link with and make use of these programs to meet the objectives of the K12 core didactic component. Using specific, real, or hypothetical examples, describe how individualized trainee career development plans will be developed that take into account past experiences and competencies before providing new experiences and skills by the Program. Describe the official degree or certification that candidates will receive FROM THE INSTITUTION after completing the Didactic, Clinical Research, and Basic Research Core Requirements. Item 2. Part a. Principal Investigator: Describe the qualifications and role of the PI to provide scientific and administrative leadership and coordination of the Program. Item 2. Part b. General Recruitment Strategies: Describe the selection criteria for clinician candidates and, where appropriate, basic candidates recruited to this Program. Describe the various strategies that will be used to ensure that the different clinical oncology disciplines represented by the Program are included and to ensure an adequate candidate pool. Address the nature of any other competing institutional Programs that might limit the number of candidates and describe the strategies for addressing this competition. Item 2. Part c: Recruitment of Underrepresented Minorities: Describe strategies for recruitment of individuals from underrepresented groups and from groups that may have been disadvantaged because of disability, economic, educational or any other circumstance that has inhibited their ability to pursue a career in health-related research and how these strategies will be implemented. For the purpose of the K12 an individual is from an underrepresented group if he or she belongs to a particular ethnic and racial group that has been determined by the grantee institution to be underrepresented in cancer-related biomedical, behavioral, clinical or social sciences research. Item 2. Part d: Evaluation Plan: Describe the plans for ongoing evaluation of the trainees, mentors, PI, Advisory Committee (AC) and the overall program. Provide criteria that will be used for this evaluation and describe how the results of the evaluation will be used. Section II. Item 3. Advisory Committee (AC): Describe how the AC will function in providing oversight of the development, implementation, and evaluation of recruitment strategies in the recruitment and selection of candidates; in the evaluation of special curricula and/or links to curricula developed through a K30 grant (if present); in the monitoring and evaluation of each candidate's progress with recommendations for changes in the training plan, if necessary, or termination of a candidate who is not making adequate progress; and in monitoring and evaluation of the overall effectiveness of the Program. Section II. Item 4. Individual Training Plans: Provide brief summaries/examples of individual training plans that the Program will employ or has been able to achieve (for competing renewal applications) in preparing clinician and (if relevant) Ph.D. candidates to design, implement, and participate in patient-oriented, therapeutic research and collaborate effectively with each other in translating basic science discoveries into therapeutic clinical trials. If relevant to your K12 program, provide examples of plans for short-term (2 years) appointments. Section II. Item 5. Human Subjects: Follow the instructions in Form PHS 398. If an award is made, human subjects may not be involved and appointees may not participate in human subjects related research until a certification of the date of IRB approval or a designation of an exemption has been submitted to the NCI and accepted. If a clinical trial will be involved, the PI will need to follow current NIH and NCI policies on providing information on data and safety monitoring. Refer to the following website for information on NCI policies on data and safety monitoring for training awards: http://www.cancer.gov/clinicaltrials/conducting/dsm-guidelines/page4. A detailed plan for data and safety monitoring (D&SM) is not required at the time of application. The application must, however, document an existing procedure for D&SM of clinical trials at the sponsoring institution. At the time an award is offered, applicants must contact NCI staff for specific instructions on how to fully comply with the requirements for D&SM. Section II. Item 6. Vertebrate Animals: Follow the instructions in Form PHS 398. If an award is made, vertebrate animals may not be involved until a certification of the date of IUCAC approval has been submitted to the NCI and accepted. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted by the receipt dates listed at the beginning of this program announcement. 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 (CSR) 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 and all five copies of the appendices must be sent to: Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8041, MSC-8329 Rockville, MD 20852 (express courier) Bethesda MD 20892-8329 Appendices should be comprised of single-sided, unbound materials, with separators between documents. APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE WILL NO LONGER BE ACCEPTED. This policy does not apply to courier deliveries (i.e., FEDEX, UPS, DHL, etc.) (http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html). This policy is similar to and consistent with the policy for applications addressed to Centers for Scientific Review as published as a Notice in the NIH Guide at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html. APPLICATION PROCESSING: Applications must be received on or before the receipt date on the first page of this PA. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an unfunded version application already reviewed, but such application must include an Introduction addressing the previous critique. 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 NCI. Incomplete and/or non-responsive applications will not be reviewed. Applications that are complete and responsive to the PAR will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities of the NCI in accordance with the review criteria stated below. As part of the initial merit review, all applications will: As part of the initial merit review, all applications will: 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 written critique o Receive a second level review by the National Cancer Advisory Board. 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 evaluate applications in order to judge the likelihood that the proposed Program will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application's overall score, weighting them as appropriate for each application. o Principal Investigator o Advisory Committee o Program/ Core Requirements o Environment o Mentors o Candidates o Institutional Commitment o Integration with other programs The application does not need to be strong in all categories to deserve a high priority score. These criteria are listed in logical order and not in order of priority PRINCIPAL INVESTIGATOR: Qualifications (and track record for competing renewal applications) of the PI to provide both scientific and administrative leadership of the Program. ADVISORY COMMITTEE: Quality (and track record for competing renewal applications) of the Advisory Committee and appropriateness for performing its critical functions in recruitment of candidates, assignment of mentors, establishment and monitoring of individual training plans, and evaluating and making mid-course corrections for the Program. Additionally, for competing renewal applications, adequacy of addressing any concerns expressed in the Summary Statement for the prior 5 year award. PROGRAM/CORE REQUIREMENTS: Overall merit of the Program (and track record for competing renewal applications). Appropriateness and adequacy of the Didactic Core Requirements, Basic Research Core Requirements, and Clinical Core Requirements including the end points for completion of the K12 appointment, to train patient-oriented clinical and basic research scientists who can work effectively with each other in a translational, team research setting, in the design and conduct of all phases (e.g., Phase I, Phase II, and Phase III) of hypothesis-driven, therapeutic cancer clinical trials and adjunct biological analyses. ENVIRONMENT: Quality, sufficiency, and interactiveness of the basic and clinical research of the institution to provide the environment necessary for the Program to meet its goals and objectives. MENTORS: Experience and quality of the mentors to ensure a successful outcome of the Program. CANDIDATES: Adequacy of the plans for (and track record for competing renewal applications) recruiting high quality trainees, to ensure a supply of high quality trainees for the Program representing at least two oncology disciplines. Adequacy of the plans (and track record for competing renewal applications) for recruiting basic science candidates with prior basic research experience that is clearly preparatory (e.g., experience with animal models or preclinical research) for devoting a career to human therapeutic cancer research. Adequacy of the specific measures proposed or taken (for competing renewal applications) to recruit underrepresented minority candidates to the Program. This does not include Continuing Umbrella of Research Experiences (CURE) supplements to the K12 program. INSTITUTIONAL COMMITMENT: The strength of the institution's commitment to the Program, especially with regard to ensuring that each candidate will have protected time to commit 75 percent of a full-time professional effort to research career development. INTEGRATION WITH OTHER PROGRAMS: The degree to which this program is effectively integrated with other existing training and career development programs to avoid duplication and achieve maximum complementarily. 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 will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below.) CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section G of the PHS 398 research grant application instructions (rev. 5/2001) updated 9/9/2003 will be assessed. ADDITIONAL REVIEW CONSIDERATIONS BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed objectives of the K12 Program. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review; o Availability of funds; and o Relevance to program priorities. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. See http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase II), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (See NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998; at http://grants.nih.gov/grants/guide/notice-files/not98-084.html.) Clinical trials supported or performed by NCI require special considerations. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the principal investigator/project manager or NCI program staff or a Data and Safety Monitoring Board (DSMB). These monitoring activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB). For details about the Policy for the NCI for Data and Safety Monitoring of Clinical, trials see; http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. For Phase I and II clinical trials, investigators must submit a general description of the data and safety monitoring plan as part of the research application. For additional information, see NIH Guide Notice on "Further Guidance on a Data and Safety Monitoring for Phase I and II Trials" for additional information at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. Information concerning essential elements of data safety monitoring plans for clinical trials funded by the NCI is available at http://www.cancer.gov/clinical_trials/. 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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by NIH, unless there are clear and compelling scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy And Guidelines" on the inclusion of children as participants in research involving human subjects that is available at: http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS: NIH policy requires education on the protection of human subjects 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, dated June 5, 2000, at http://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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description, and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this 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). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. 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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