NCCAM INTERNATIONAL POSTDOCTORAL FELLOWSHIP RELEASE DATE: January 6, 2003 PA NUMBER: PA-03-050 APPLICATION RECEIPT DATES: April 5, 2003; December 5, 2003; December 5, 2004; December 5, 2005 EXPIRATION DATE: December 6, 2005 National Center for Complementary and Alternative Medicine (NCCAM) (http://www.nccam.nih.gov) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose o Mechanism(s) of Support o Eligibility Requirements o Eligible Sponsoring Institutions o Allowable Costs o Salary Supplementation, Compensation, and Other Income o Taxes o Leave Policies o Other Special Requirements o Where To Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations o Supplemental Application Instructions PURPOSE This program announcement has several interrelated goals. The main goal is to support training of foreign scientists in rigorous scientific research methodology at a clinical or basic research facility in the United States. The purpose of this training is to prepare these scientists to successfully conduct high-quality research in complementary and alternative medicine (CAM) when they return to their home countries. NCCAM defines CAM as medical or health-related therapies practiced in the United States but not presently considered an integral part of conventional medicine in the United States (from NCCAM Five-Year Strategic Plan 2001-2005: http://nccam.nih.gov/about/plans/fiveyear/index.htm). As stated in NCCAM's strategic plan, CAM can be divided into five major domains. These domains are alternative medical systems, mind-body interventions, biologically based therapies, manipulative and body-based methods, and energy therapies. This NCCAM International Postdoctoral Fellowship specifically focuses on the domain of alternative medical systems, defined as complete systems of theory and practice that have evolved independently of, and often prior to, conventional biomedical approaches. Many of these alternative medical systems are actually traditional medical systems practiced in, as well as originating in, cultures throughout the world. Examples include, but are not limited to, traditional oriental medical systems, Ayurvedic medicine, Unani, and homeopathy. Fellows may focus their research on whole alternative medical systems common to or originating in their home country, or components of such systems. Components of such systems could include, but are not limited to acupuncture, herbal medicine, or forms of meditation. Through this international training initiative, NCCAM aims to increase the number and improve the quality of research and the competitiveness of its international research grant applications; to foster lasting collaborations between United States scientists and foreign scientists interested in CAM research; to build CAM research capacity and infrastructure in other countries; and, most importantly, to promote research in alternative medical systems or components of such systems by foreign scientists who reside in the countries where these medical systems originated and/or are practiced. MECHANISM OF SUPPORT This International Postdoctoral Fellowship is supported through the F05 mechanism, which is designed to "provide collaborative research opportunities for qualified non-immigrant alien scientists who hold a doctoral degree or its equivalent in one of the biomedical or behavioral sciences." The proposed postdoctoral training must be within the broad scope of biomedical, behavioral, or clinical research as it relates to alternative medical systems or components of such systems, and must offer an opportunity to enhance the fellow's understanding of the health-related sciences and extend his/her potential for a productive research career. Fellowship awardees are required to pursue their research training on a full-time basis, devoting at least 40 hours per week to the training program while at the U.S. research site. Research clinicians must devote full-time to their proposed research training and must restrict clinical duties within their full-time research training experience to activities that are directly related to the research training experience. This fellowship may not be used to support studies leading to the N.D., D.C., M.D., D.O., D.D.S., D.V.M., or other similar health-professional degrees. Neither may this award be used to support the clinical years of residency training. However, NCCAM recognizes the critical importance of training clinicians to become researchers and encourages them to apply. Moreover, for those who have a health professional degree, the proposed training may be used to satisfy a portion of the degree requirements for a master's degree, a doctoral degree or any other advanced research degree program. Women, minorities, and individuals with disabilities are encouraged to apply. ELIGIBILITY REQUIREMENTS VISA REQUIREMENTS: Foreign nationals who apply for the fellowship must have a visa that permits training or employment in the United States at the time that an award is made. One of the following visas is acceptable: o J-1 (exchange visitor) o F-1 (Student for post-completion practice training after award of doctoral degree) o H-1B (nonimmigrant worker in a specialty occupation) o 0-1 (extraordinary ability in the sciences) CITIZENSHIP: Non-immigrant alien scientists are eligible for this award. U.S. citizens, non-citizen nationals, or persons with U.S. permanent resident status are not eligible for this award. Individuals in the latter three categories should consult the training information on the NCCAM website for descriptions of other fellowship and career development awards for which they may be eligible (http://nccam.nih.gov/training/). DEGREE REQUIREMENTS: Before this fellowship award can be activated, the individual must have received a Ph.D., M.D., D.O., D.C., D.D.S., D.V.M., O.D., O.M.D, D.P.M., Sc.D., Eng.D., Dr.P.H., D.N.S., N.D., Pharm.D., D.S.W., Psy.D., or equivalent foreign degree in one of the biomedical or behavioral sciences from an accredited U.S. or foreign institution. The applicant must provide a photocopy of his/her diploma (and translation if not in English) or a letter from a university dean or registrar stating when the degree was awarded. Certification by an authorized official of the degree-granting institution that all degree requirements have been met is also acceptable. Scientists at all career levels who meet the degree requirements must also meet the following additional requirement. The applicant must have at least 4 years of relevant experience beyond the doctoral degree (or equivalent foreign degree) at the time the award is issued. Relevant experience may include research (including industrial research), teaching, internship, residency, clinical duties, or other time spent in full-time studies in a health-related field beyond the qualifying degree. DURATION OF SUPPORT: Individuals may receive a minimum of 1 year and up to 3 years of support to conduct research at a basic or clinical research facility within the United States (referred to as the U.S. Sponsoring Institution). During this support period, the fellow may spend up to one- fourth of the time per year at the institution in his/her home country (also referred to as the Foreign Institution) to which he/she plans to return to continue this research. This time at the Foreign Institution must be devoted totally to furthering the CAM research collaboration initiated at the U.S. Sponsoring Institution, and not to other responsibilities at the Foreign Institution such as teaching or clinical duties. Acceptable activities at the Foreign Institution could involve planning activities for setting up infrastructure so that clinical and/or basic research can continue upon return. SPONSOR: Before submitting a fellowship application, the applicant must identify a sponsoring institution in the United States and a research scientist at that institution who will serve as a sponsor (also called mentor or supervisor) and will supervise the training and research experience during the 1 to 3 years the applicant is supported through NCCAM by the U.S. Sponsoring Institution. The applicant's U.S. sponsor should be an active independent investigator in the area of the proposed research who will directly supervise the candidate's research. The sponsor does not necessarily need to be an expert in CAM research. However, his/her research expertise must be relevant to the CAM research that the applicant wishes to pursue. For example, an applicant who wishes to explore the effect on the immune system of a particular alternative medical system or component of such system, may chose a sponsor who has expertise in immunology and not CAM, as long as the sponsor agrees to support the applicant's research and continue a collaboration after the fellow returns to the Foreign Institution. The sponsor must document the availability of research support and facilities for high-quality research training at the U.S. Sponsoring Institution. In addition, the sponsor must demonstrate a commitment to continue a collaboration with the fellow once he/she returns to the Foreign Institution. A collaboration plan should be described in the section "Training Plan, Environment, Research Facilities," which is Item 34 in the sponsor's portion of the fellowship application. ELIGIBLE SPONSORING INSTITUTIONS U.S. SPONSORING INSTITUTION REQUIREMENTS: The U.S. Sponsoring Institution may be anyone of the following. o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of state and local governments o Eligible agencies and laboratories of the Federal government, including NIH intramural laboratories. FOREIGN INSTITUTION REQUIREMENTS: No application will be accepted without an accompanying letter from the Foreign Institution to which the applicant plans to return. This letter should be sent in the same package with the copies of the completed application. This letter must be signed by the appropriate institutional business official, by the appropriate academic official (such as a university dean responsible for the applicant's appointment), and co-signed by the applicant. It must contain the following information: 1) The title and description of the applicant's appointment at this institution; 2) the guaranteed duration of the appointment; 3) a description of the research facilities/equipment at the institution, including a description of the research facilities/equipment available to the applicant. Applicants for this NCCAM International Postdoctoral Fellowship must have a guaranteed appointment of no less than 4 years at the institution in their home country to which they plan to return. This guaranteed appointment must be documented in the letter from this institution described above. ALLOWABLE COSTS STIPEND: This fellowship award provides a stipend to the postdoctoral fellowship awardee to help defray living expenses during the research training experience at the U.S. Sponsoring Institution. The awards are not provided as a condition of employment with either the Federal government or the U.S. Sponsoring Institution. NCCAM will provide stipend support in addition to an institutional allowance, described below, to enable the awardee to participate as a postdoctoral research fellow on a research project funded by the sponsor through the U.S. Sponsoring Institution. Examples of funding support by the sponsor through the U.S. Sponsoring Institution include NIH research grant awards, awards from another Federal funding agency, or grant awards from private foundations. The fellowship awardee's requested stipend must be in accordance with the salary structure of the U.S. Sponsoring Institution, consistent with the level of effort, which is 100 percent effort based on a 40 hour week, and may not exceed the maximum National Research Service Award (NRSA) yearly stipend level based on years of postdoctoral experience. While this is not an NRSA fellowship, NRSA stipend levels will be used as a guide. Amounts requested above current NRSA stipend levels must be justified. The NRSA stipend schedule is updated nearly every year and applicants are advised to check for the posting of the current stipend schedule on the NIH website at http://grants.nih.gov/training/nrsa.htm. NCCAM will adjust awards on the anniversary date of the fellowship award to ensure consistency with the stipend schedule in effect at that time. TUITION AND FEES: NCCAM will offset the combined cost of tuition and fees at the following rate: 100 percent of all costs up to $3,000 and 60 percent of costs above $3,000. Costs associated with tuition and fees are allowable only if they are required for specific courses in support of the research training experience of the fellow at the U.S. Sponsoring Institution. Tuition and fees for courses must be requested from and approved by NCCAM. A full description of the tuition policy is contained within the NRSA section of the Grants Policy Statement at http://grants.nih.gov/grants/policy/policy.htm. INSTITUTIONAL ALLOWANCE AT THE U.S. SPONSORING INSTITUTION: NCCAM will provide an institutional allowance of $10,000 per 12-month period to nonprofit U.S. Sponsoring Institutions to help defray such awardee expenses as research supplies, equipment, health insurance (either self-only or family as appropriate), and travel to scientific meetings and/or the Foreign Institution. NCCAM will provide an institutional allowance of up to $8,000 for fellows sponsored by for-profit U.S. institutions or Federal laboratories. This allowance may be used for expenses associated with travel to scientific meetings and/or the Foreign Institution, health insurance, and books. These institutional allowances are intended to cover training-related expenses for the individual awardee. The allowance is not available until the fellow officially activates the award and must be used during the 1 to 3 years that the applicant is training at the U.S. Sponsoring Institution. If an individual fellow is enrolled or engaged in training for less than 6 months for any given award year, only one-half of that year's allowance may be charged to the grant. The Notice of Research Fellowship Award will be revised and the balance must be refunded to NCCAM. OTHER TRAINING COSTS: Additional funds may be requested by the U.S. Sponsoring Institution for accommodations for fellows who are disabled, as defined by the Americans With Disabilities Act. The funds requested for costs of this nature must be reasonable in relationship to the total dollars awarded under the fellowship and must be directly related to the approved research training experience. Such additional funds shall be provided only for circumstances that are fully justified and explained by the U.S. Sponsoring Institution. INSTITUTIONAL ALLOWANCE AT THE FOREIGN INSTITUTION: One of NCCAM's goals in issuing the NCCAM International Postdoctoral Fellowship is to increase the number and improve the quality of research and competitiveness of its international research grant applications; and at the same time, foster lasting collaborations between U.S. scientists and scientists from other countries interested in CAM research in alternative medical systems. To these ends, after successful completion of training at the U.S. Sponsoring Institution, NCCAM will provide the Foreign Institution, through a change in institution mechanism, with up to $32,000 per year for 2 years. This amount will not be released until the awardee returns to the Foreign Institution immediately after his/her training in the United States. These funds are to be used only by the awardee to support ongoing research initiated at the U.S. Sponsoring Institution in order to continue the collaborative research training effort and to enhance the applicant's ability to apply for an NCCAM regular research grant (R01) or exploratory/developmental grant (R21) in collaboration with the U.S. sponsor. These funds are limited to personnel costs, purchase of supplies and equipment, and travel. The plans for use of these funds at the Foreign Institution will be reviewed and approved by NCCAM before they are released. FACILITIES AND ADMINISTRATIVE COSTS: F&A (indirect) to the U.S. Sponsoring Institution: F&A costs are not allowed for the U.S. Sponsoring Institution. FACILITIES AND ADMINISTRATIVE COSTS: F&A (indirect) to the Foreign Institution: F& A costs of eight percent can be requested by the Foreign Institution. However, the F&A costs must be included as part of the $32,000 per year provided by NCCAM. More information about F&A costs for foreign and international organizations can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html SALARY SUPPLEMENTATION, COMPENSATION, AND OTHER INCOME The U.S. Sponsoring Institution is allowed to provide funds to the fellow in addition to the stipend and institutional allowance paid by NCCAM while the fellow is training at the U.S. institution. Such additional amounts may be in the form of augmented salary (supplementation). Supplementation should not require additional effort from the fellow. DHHS funds may not be used for supplementation under any circumstances. Additionally, no funds from other Federal agencies may be used for supplementation unless specifically authorized by the NIH and the other Federal Agency. The U.S. Sponsoring Institution may not provide funds in addition to the stipend in the form of compensation, such as salary or tuition remission for services provided, such as teaching. The fellow should spend 100 percent effort on activities related to this research training award and not be required to perform additional paid services while at the U.S. Sponsoring Institution. CONCURRENT AWARDS: The NCCAM International Postdoctoral Fellowship may not be held concurrently with another U.S. federally sponsored fellowship or similar Federal award that provides a stipend/salary or otherwise duplicates provisions of this award. TAXES All fellowship awardees must pay U.S. income taxes, unless they are exempted by an income tax treaty between the United States and their country of residence (for tax purposes). Although the tax assessment differs according to stipend/salary level (higher levels are taxed at higher rates), fellowship awardees can expect to pay at least 20 percent of their stipend/salary in U.S. Federal income tax. (Those that are exempt due to a tax treaty may have to pay taxes to their home country, depending on the country/treaty). All fellows, including those exempt from U.S. Federal tax, must pay state income taxes, depending on their state of residence. Individuals holding an H-1B or 0-1 visa also must pay Social Security tax. Employees who hold J-1 status will begin to pay Social Security tax at the start of their third calendar year in the United States. LEAVE POLICIES In general, during the years of support at the U.S. Sponsoring Institution, fellows may receive a stipend during the normal periods of vacation and holidays observed by individuals in comparable training positions at the sponsoring institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and research training and is not considered to be a vacation or holiday. Fellows may receive stipend for up to 15 calendar days of sick leave per year. A period of terminal leave is not permitted and payment may not be made from fellowship funds for leave not taken. Fellows requiring periods of time away from their research training experience longer than specified here must seek approval from the NIH awarding component for an unpaid leave of absence. OTHER SPECIAL REQUIREMENTS CERTIFICATION AND REPORTING PROCEDURES: No application will be accepted without the applicant signing the certification block on the face page of the application. When support ends, the fellow must submit a letter of termination to the NIH. LETTER FROM THE FOREIGN INSTITUTION: As described under Eligibility Requirements, no application will be accepted without an accompanying letter from the Foreign Institution to which the applicant plans to return. This letter must be signed by the appropriate institutional business official, by the appropriate academic official (such as a university dean responsible for the applicant's appointment), and co-signed by the applicant. It must contain the following information: 1) The title and description of the applicant's appointment at this institution; 2) the guaranteed duration of the appointment; 3) a description of the research facilities/equipment at the institution, including a description of the research facilities/equipment available to the applicant. Applicants for this NCCAM International Postdoctoral Fellowship must have a guaranteed appointment of no less than 4 years at the Foreign Institution to which they plan to return. This guaranteed appointment must be documented in the letter from this institution described above. POLICY OF THE NCCAM ON QUALITY OF NATURAL PRODUCTS: Applicants must follow NCCAM's policy on the quality of natural products in research described on the NCCAM website http://nccam.nih.gov/research/policies/naturalproducts.htm NCCAM CLINICAL RESEARCH REQUIREMENTS: In addition to the clinical research requirements listed below under REQUIRED FEDERAL CITATIONS, clinical research performed as part of this NCCAM International Postdoctoral Fellowship must conform to the NCCAM TERMS OF AWARDS FOR CLINICAL TRIALS found at http://www.nccam.nih.gov/research/policies/terms-of-awards.htm. INVENTIONS AND PUBLICATIONS: Fellowships made primarily for educational purposes are exempted from the PHS invention requirements. F05 awards will not contain any provision giving PHS rights to inventions made by the awardee. DATA SHARING: It is the policy of the DHHS that the results and accomplishments of all funded activities should be made available to the public. This policy also applies to individuals supported by individual postdoctoral fellowships. The U.S. Sponsoring Institution should place no restrictions on the publication of results in a timely manner. COPYRIGHTS: Except as otherwise provided in the terms and conditions of the award, the recipient is free to arrange for copyright without approval when publications, data, or other copyrightable works are developed in the course of work under a PHS grant-supported project or activity. Any such copyrighted or copyrightable works shall be subject to a royalty-free, nonexclusive, and irrevocable license to the U.S. Government to reproduce, publish, or otherwise use them, and to authorize others to do so for Federal Government purposes. WHERE TO SEND INQUIRIES As indicated above, applicants are strongly encouraged to contact the individuals designated below, in advance of preparing an application, for additional information concerning the areas of research, receipt dates, and other types of pre-application instructions. Nancy J. Pearson, Ph.D. Program Officer National Center for Complementary and Alternative Medicine Two Democracy Plaza, Suite 401 6707 Democracy Boulevard MSC 5475 Bethesda, MD 20892-5475 (0vernight express use 20817) Telephone: 301-594-0519 Email: pearsonn@mail.nih.gov Direct questions about NCCAM financial or grants management matters to: Marc Pitts, M.B.A. Grants Management Specialist National Center for Complementary and Alternative Medicine Two Democracy Plaza, Suite 401 6707 Democracy Boulevard MSC 5475 Bethesda, MD 20892-5475 (Overnight express use 20817) Telephone: (301) 594-9095 Fax: (301) 480-3621 Email: pittsm@mail.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 416-1 application. The PHS 416- 1 is available at http://grants.nih.gov/grants/forms.htm in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. APPLICATIONS MUST INCLUDE AT LEAST THREE SEALED LETTERS OF REFERENCE. THESE LETTERS MUST BE IN ENGLISH. APPLICATIONS WITHOUT AT LEAST THREE LETTERS OF REFERENCE MAY BE RETURNED OR DELAYED IN REVIEW. The PHS 416-1 application is used for several different types of fellowship awards. Therefore, not all statements in the PHS 416-1 form may be applicable to the NCCAM International Postdoctoral Fellowship Award. Supplemental application instructions are given at the end of this Program Announcement to assist applicants in completing the PHS 416-1 application. Please contact the NCCAM program official listed under WHERE TO SEND INQUIRIES if you have questions specific to the NCCAM International Postdoctoral Fellowship when completing the application form. The applicant should identify the number of this Program Announcement in Item 3 of the application. INSTRUCTIONS IN THE RESPONSIBLE CONDUCT OF RESEARCH: Applications must include the candidate's plans for obtaining instruction in the responsible conduct of research, including the rationale, subject matter, appropriateness, format, frequency and duration of instruction. The amount and nature of faculty participation must be described. No award will be made if an application lacks this component. CONCURRENT APPLICATIONS: An individual may not have more than one individual fellowship or comparable application pending review or award at the NIH or other DHHS agencies at the same time. APPLICATION RECEIPT DATES AND REVIEW SCHEDULE: The NCCAM International Postdoctoral Fellowship applications will undergo a review process that takes between 5 and 8 months. The receipt dates are as follows: Application Receipt Dates: Apr 5, 2003 Dec 5, 2003,2004,2005 Initial Review Dates: Jun/Jul Feb/Mar Secondary Review Dates: Sep/Oct May/June Range of Likely Start Dates:December July Submit a signed, typewritten original of the application (including the Checklist, Personal Data form, AT LEAST THREE SEALED REFERENCE LETTERS in English, and all other required materials) and one (1) exact, clear, single- sided photocopies of the signed application, 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 mail/courier service) All applications submitted to the Center for Scientific Review 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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html A copy of the application should also be sent to: Martin Goldrosen, Ph.D. Director, Office of Scientific Review National Center for Complementary and Alternative Medicine Two Democracy Plaza, Suite 401 National Institutes of Health 6707 Democracy Boulevard MSC 5475 Bethesda, MD 20892-5475 Bethesda, MD 20817 (for express mail/courier service) PEER REVIEW PROCESS Complete applications will be assigned to NCCAM for potential funding and to a suitable Scientific Review Group (SRG) for review. Applicants will be notified by mail of their application's assignment to NCCAM and assignment to an appropriate SRG. Applications receive two sequential levels of review. The first level is an assessment of the merit of the research training by an SRG, composed primarily of non-government scientists selected for their competence in research and research training in a scientific area related to the application. After the SRG meeting, the Scientific Review Administrator (SRA), a designated Federal official, who coordinates the review of applications for the SRG, prepares a written summary of the review of each application and forwards it to the appropriate NCCAM Staff. The second level of review is conducted by the National Advisory Council for Complementary and Alternative Medicine. REVIEW CRITERIA The review criteria will focus on five main components: o Candidate: An assessment of the candidate's previous academic and research performance and the potential to become an important contributor to biomedical, behavioral, or clinical science related to complementary and alternative medicine. o Sponsor and Training Environment at the U.S. Sponsoring Institution: An assessment of the quality of the training environment at the U.S. Sponsoring Institution, including qualifications of the sponsor as a mentor for the proposed research training experience. o Research Proposal: The merit of the scientific proposal and its relationship to the candidate's career plans to continue research in alternative medical systems or components of such systems. An assessment of whether the number of years requested (a minimum of 1 and up to 3 years) is an appropriate amount of time for the candidate to develop the skills necessary to continue this collaborative research once he/she returns to the Foreign Institution. o Training Potential: An assessment of the overall value of the proposed fellowship experience as it relates to the candidate's research training needs and the extent to which this training experience will allow the candidate to continue research, in collaboration with the U.S. sponsor, in his/her home country after the fellowship in the United States is ended. o Other Review Criteria: An assessment of the Foreign Institution's ability to support the candidate's continued research in collaboration with the U.S. sponsor, once the NCCAM supported training at the U.S. Sponsoring Institution has ended. This should be based on the candidate's and sponsor's description of plans for continuing research collaboration and on the letter sent by the Foreign Institution that should include: 1) The title and description of the applicant's appointment at this institution; 2) the guaranteed duration of the appointment; 3) a description of the research facilities/equipment at the institution, including a description of the research facilities/equipment available to the applicant. NOTIFICATION: Shortly after the SRG meeting, each applicant will be notified by mail of the SRG recommendation and the name and phone number of the NCCAM program official responsible for the application. When the NCCAM program official receives the written summary of the review, prepared by the SRA after the review meeting, a copy will be forwarded to the applicant. Following the second-level review, the NCCAM program officer will notify each applicant of the final disposition of the application. Any questions on SRG recommendations and funding possibilities should be directed to the appropriate NCCAM program officer, not the Scientific Review Administrator of the SRG. AWARD CRITERIA NCCAM staff use the following criteria in making awards: o Eligibility of the applicant; o The SRG recommendation of the overall merit of the application; o The relevance of the application to the NCCAM's research and research training priorities and program balance, including investment in international research; and o The availability of funds. ACTIVATION: No funds may be disbursed until the fellow has started training under the award and a letter of activation has been submitted to the NIH. An awardee has up to 6 months from the issue date on the award notice to activate the award. Under unusual circumstances, NCCAM may grant an extension of the activation period upon receipt of a specific request from the fellow. REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: NIH specifically requires the establishment of Data and Safety Monitoring Boards (DSMBs) for multi-site clinical trials involving interventions that entail potential risk to the participants, and generally for Phase III clinical trials. Although Phase I and Phase II clinical trials may also use DSMBs, smaller clinical trials may not require this oversight format, and alternative monitoring plans may be appropriate. A detailed Data and Safety Monitoring Plan must be submitted to the applicant's IRB and subsequently to the NIH funding Institute or Center for approval prior to the accrual of human subjects. For further information see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. For individual fellowships, the Institute/Center funding the fellowship will request the necessary information prior to issuing the award. Further information is available at http://grants.nih.gov/grants/policy/hs_educ_faq.htm. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this 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. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS This NCCAM International Fellowship award is described in the Catalog of Federal Domestic Assistance No. 485D (NCCAM). Awards are made under authorization of Sections 307 and 402 of the Public Health Service Act as amended and administered under NIH grants policies and Federal Regulations 42 CFR 63a. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and 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. SUPPLEMENTAL APPLICATION INSTRUCTIONS Below are instructions related to information requested in numbered items in the PHS 416-1 application where the information is specific for the NCCAM International Postdoctoral Fellowship Award. PART I Applicant Item 2. Level of Fellowship: Postdoctoral Item 3. Program Announcement/Request for Applications: Enter the PA number of this announcement: NCCAM International Postdoctoral Fellowship Item 23: Scholastic Performance: For applicants who have received their doctoral degree or equivalent within the past 7 years, follow the instructions for postdoctoral applicants. For applicants who received their doctoral degree or equivalent more than 7 years ago, omit this item. Item 30d: Sponsor and Institution: Parts (1) and (2) refer to the U.S. Sponsoring Institution. In part (3) briefly describe the plans for continuing the collaborative research at the Foreign Institution that was initiated at the U.S. Sponsoring Institution (two pages maximum length). PART II - Sponsor and Sponsoring Institution Officials Item 34: In addition to the requested description of the training plan for the applicant at the U.S. Sponsoring Institution, the U.S. sponsor should also describe the plan for future research collaboration with the awardee once he/she returns to the Foreign Institution.


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