Notice of Availability of Administrative Supplements forU.S. - China Biomedical Collaborative Research on Cancer, Allergy, Immunology, and Infectious Diseases including HIV/AIDS and its Co-morbidities
Notice Number: NOT-CA-11-003
Release Date: February 4, 2011Optional Letters of Intent Due: March 14, 2011Supplement Application Due: April 14, 2011Award Date: September 30, 2011
National Cancer Institute (NCI)National Institute of Allergy and Infectious Diseases (NIAID)
The National Institutes of Health (NIH) of the United States (U.S.) Department of Health and Human Services (HHS) supports international collaborative biomedical research to advance science and expand biomedical knowledge. Scientific cooperation between the U.S. and the People’s Republic of China was initiated over 30 years ago and has grown rapidly in recent years. Recognizing that enhanced cooperative biomedical research would be of mutual benefit to the U.S. and China, the NIH Director and the President of the National Natural Science Foundation of China (NSFC) signed a Memorandum of Understanding (MOU) in October 2010.
NIH and NSFC further signed an Implementing Arrangement (IA) in December 2010 to develop a new U.S.-China Program for Biomedical Research Cooperation. A Joint Working Group (JWG), made up of a specified number of members from both NIH and NSFC, will develop strategic plans for collaboration and facilitate the expedited review and clearance of proposed bilateral projects. Both the NIH and NSFC have allocated funds to support joint activities pursued under this program.
This Notice announces an opportunity for eligible NIH grantees to request administrative supplement support (additional funds to a grant or cooperative agreement for unexpected administrative expenses within the approved projectscope) for their eligible active grants to enhance ongoing research efforts through collaborations with Chinese scientists under the new U.S.-China Program for Biomedical Research Cooperation. Based on the merit of the requests received and the availability of funds, the NIH may award up to $3,000,000 (total costs) in FY2011 for this effort, and the NSFC has pledged to provide complementary funding to support the Chinese co-investigators involved in the research collaborations.
U.S. and Chinese collaborating investigators (referred to as co-investigators in this announcement) should work together to submit corresponding applications in response to this announcement to NIH and NSFC. By sending an application in to NIH, the applicant in turn agrees to provide directly a complete copy of the application to their Chinese counterpart. The NIH will not consider for funding any application that has not met this sharing requirement. Potential U.S. applicants concerned about confidentiality or proprietary information should take this requirement into account before deciding what information to submit in their application to NIH. Applications from U.S. co-investigators will be submitted in response to this funding announcement and reviewed administratively at NIH. NSFC will publish a corresponding funding announcement (in Chinese) for Chinese co-investigators to apply for funding under the joint U.S.-China Program in Biomedical Research Cooperation (see http://www.nsfc.gov.cn/Portal0/InfoModule_396/More.htm). Applications from Chinese co-investigators will be reviewed in parallel by NSFC using selection factors that are harmonized with NIH selection factors. Chinese applicants will also be required to submit as part of their applications a copy of the NIH application provided by their U.S. collaborator. Therefore, it is expected that the Chinese collaborator will contact the U.S. PD/PI and request copies of their application in response to this announcement for submission. This application will also be reviewed confidentially during the NSFC review process. Funding decisions will be made by NIH and NSFC in consultation with the JWG and with consideration of the research priorities of both countries.
Under this program, the NIH will support meritorious administrative supplements to existing NCI and NIAID grants as well as any NIH grants in the area of HIV/AIDS and its co-morbidities. These grants must have at least one year of active funding remaining at the time of the administrative supplement award on September 30, 2011. Funding under this program can be used to support new, previously unforeseen research opportunities enhancing existing grants through collaboration between U.S. and Chinese scientists. The proposed research must be within the peer-reviewed scope of the NIH-supported parent grant. NSFC will provide complementary funds as new research grants to scientists who are current or former NSFC grantees to support the Chinese co-investigators for these collaborative projects.
The intent of this initiative is to foster, stimulate, and/or expand collaborative basic, translational, and applied research between eligible NIH grantees and eligible Chinese researchers in the areas of cancer, allergy, immunology, and infectious diseases including HIV/AIDS and its co-morbidities.
Basic, translational, behavioral, clinical, preventive, or epidemiological research may be proposed under this program. Clinical trials of drugs, biologics or diagnostics will NOT be supported through this program. Examples of research areas that are responsive to this announcement include, but are not limited to:
§ Studies on the pathobiology of cancers in China or the U.S.
§ Studies of rare tumors where there is a benefit to U.S.-China cooperation to identify sufficient numbers of cases for study
§ Infection-associated cancers, including HIV-associated malignancies
§ Several areas of basic cancer research, including:
· Cancer genomics, including epigenomic, transcriptomic, proteomic and metabolomic studies
· Systems biology and structural biology
· Cancer nanotechnology
· Cancer cell and tumor biology
· Cancer stem cells
· Microenvironment and metastasis, tumor immunology and immunotherapy, and cancer etiology
· Cancer and inflammation
· Cancer epidemiology and population science studies, including investigations of infectious agents, nutrition, energy balance, environmental and occupational exposures and personal susceptibility factors that may affect cancer risk;
· Studies of traditional Chinese medicine (TCM) to 1) identify novel therapeutics in the pharmacopeia of traditional medical systems as defined by the World Health Organization (http://www.who.int/medicines/areas/traditional/definitions/en/index.html); 2) use of complementary approaches to improve the therapeutic ratio of standard and investigational anti-cancer therapies; or 3) conduct research on lifestyle modifications (e.g. diet, exercise, mind-body approaches) and their effect on cancer outcomes (e.g. response to conventional cancer therapy, survival)
In allergy, immunology, and infectious diseases:
§ HIV/AIDS and its co-morbidities including , but not limited to, co-infections, AIDS-defining and non-AIDS defining malignancies, and complications associated with long-term HIV disease and antiretroviral therapy (ART), including tuberculosis, hepatitis C and hepatitis B, metabolic disorders, cardiovascular disease, conditions associated with aging, and neurologic and neurocognitive disorders.
§ Asthma and allergic diseases, including the role of environmental pollutants, infections and allergens.
§ Basic immunology and immunity studies.
§ Emerging or re-emerging infectious diseases of national and global priority including:
· Zoonotic diseases, including leptospirosis, brucellosis, melioidosis, rickettsioses;
· Leprosy and Buruli ulcer;
· Viral pathogens, especially enterovirus 71;
· Respiratory diseases, including tuberculosis, influenza, Neisseria meningitidis, and Streptococcus pneumoniae;
· Sexually transmitted infections: bacterial vaginosis, Haemophilus ducreyi and trichomoniasis;
· Parasitic diseases and vectors;
· Hepatitis E in pregnant women;
· NIAID Category A, B, and C priority pathogens (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/CatA.htm, especially Enterotoxigenic Escherichia coli, Shigella, hantaviruses, dengue, Rift Valley fever, Japanese encephalitis virus and West Nile virus).
Budget and Funding Information
Up to $3,000,000 (total costs) will be available in Fiscal Year 2011.
Administrative supplements will be limited to 25 percent of the Institute Advisory Council-approved direct costs for the current budget year of the project or $100,000 direct costs, whichever is less. Awards will be for one year and the existing grant must have at least one (1) year of active funding remaining at the time that the supplement is awarded on September 30, 2011.
NSFC will provide complementary funds (approximately 300,000 Renminbi (Chinese currency) per project) for the Chinese co-investigators to engage in these projects. Five percent of the NSFC total award amounts can be used for indirect costs by Chinese institutions.
To be eligible, the parent NIH grant must be active, and the research proposed in the supplement must be accomplished within the remaining time of the award. The proposed supplement must be within the general scope of the peer-reviewed activities and aims approved within the parent grant. Current NCI or NIAID grantees funded in cancer, allergy, immunology, infectious diseases, and HIV/AIDS and its co-morbidities with at least one (1) year of active funding remaining as of September 30, 2011, are eligible to apply. Grantees at other NIH institutes funded in the area of HIV/AIDS and its co-morbidities are also eligible. Funding under this program will support collaborative research projects only and cannot be used to support research infrastructure. Funding under this program can be used to support new, previously unforeseen research opportunities enhancing existing grants through collaboration between U.S. and Chinese scientists. The proposed research must be within the peer-reviewed scope of the NIH-supported parent grant. . Applicants must propose to work with Chinese scientists who are current or former NSFC grantees. NSFC has additional eligibility requirements for Chinese co-investigators to apply for NSFC funding under this program which are described in detail in the corresponding NSFC funding announcement published on its website atwww.nsfc.gov.cn(only in Chinese). Applications are only responsive to this announcement if the Chinese co-investigator submits a corresponding application to NSFC. The NIH grant mechanisms eligible under this announcement are: active R01; P01; U01; U19; U54; P30 (as pilot projects to the Developmental Core with no additional funding to infrastructure); and P50 awards.
IMPORTANT: The research proposed by the NIH grantee in the administrative supplement request must be within the original scope of the NIH-supported parent grant. The funding mechanism being used to support this program, i.e., administrative supplements, can be used to cover increased cost associated with achieving certain new research objectives as long as they are within the original scope of the parent grant.
Eligible Chinese co-investigators may propose a new project in the corresponding application to NSFC, as NSFC will grant new, 1-year awards under the jointly funded program.
Applicants are encouraged to ensure that each administrative supplement request includes two budgets: one requesting NIH funding (for expenses on the U.S. side) and one budget requesting NSFC funding (for expenses on the Chinese side in Chinese currency). Both the U.S. and Chinese applications should include the same title for the collaborative project written in English.
Letters of Interest (Only for U.S. Investigators)
Letters of Interest (LOIs) are optional and non-binding. Before submitting an LOI, U.S. applicants are strongly encouraged to discuss the feasibility of their research application with the program officer or project scientist of the parent grant. LOIs should be no longer than two pages and should include the following information:
§ Name of NIH-funded Principal Investigator, grantee institution, title of grant, grant number of parent grant, names and address of Chinese collaborator and affiliated Chinese institution; and
§ Brief summary of the intended project.
LOIs should be sent by e-mail to:
For NCI:Bryan BakerE-mail:firstname.lastname@example.org
For NIAID:Maggie WellsE-mail:email@example.com
For administrative supplement requests to other NIH Institutes and Centers in the area of HIV/AIDS and its co-morbidities:
Robert W. Eisinger, Ph.D.E-mail:firstname.lastname@example.org
LOIs may be submitted at any time, but must be received at the NIH no later than 5:00PM Eastern Time on March 14, 2011.
Submitting an Administrative Supplement Request
To be considered for an administrative supplement, the request must be signed by the Authorized Organizational Representative/Signing Official (AOR/SO) and the PD/PI of the application, and must describe the need for additional funding and categorical costs.
Please note that Chinese co-investigators will be required to submit the contents of the entire NIH application to NSFC (in addition to the NSFC application) for review. This application copy will also be confidentially reviewed during the Chinese review. It is expected that the Chinese collaborator will contact the U.S. PD/PI and request copies of their application for submission.
Applicants are strongly encouraged to submit requests electronically as an attachment in pdf format via email; however, the signature of the Authorized Organizational Representative (AOR) must be clearly visible. Administrative supplement requests may be submitted at any time, but must be received by no later than 5:00PM Eastern Time on April 14, 2011.
As an alternative, requests can be submitted via CD to be mailed to the point of contact listed below (with the signature of the Authorized Organizational Representative [AOR] clearly visible in the application) and must be postmarked no later than April 7, 2011.
Late submissions will not be considered.
The contact information for submission is:
For NCI:Bryan BakerOffice of Grants AdministrationNational Cancer Institute6120 Executive Boulevard, EPS Suite T-44, MSC 7111Bethesda, MD 20892-7111 (for U.S. Postal Service regular and express mailRockville, MD 20852 (for non-U.S. Postal Service delivery)Telephone: (301) 496-9356E-mail:email@example.com
For NIAID:Maggie C. WellsGrants Management SpecialistNational Institute of Allergy and Infectious Diseases6700B Rockledge Drive, Room 2250, MSC 7614Bethesda, MD 20892-7614Telephone: (301) 594-9847Fax: (301) 493-0597E-mail:firstname.lastname@example.org
For applications to Other NIH Institutes and Centers in the area of HIV/AIDS and its co-morbidities:
Robert W. Eisinger, Ph.D.Director of Scientific and Program Operationsand Chair, Therapeutics Coordinating CommitteeOffice of AIDS ResearchNational Institutes of Health5635 Fishers Lane, Room 4015, MSC 9310Bethesda, Maryland 20892-9310Telephone: (301)-496-0358Fax: (301)402-8638E-mail:email@example.com
Requests should be submitted on thePHS398 Application Guideforms (font size and other formatting rules apply as designated in the instructions), as indicated below. Include only the following elements:
Cover Letter, which cites this Notice and contains the following information:
§ Project Director/Principal Investigator (PD/PI) name;
§ Parent NIH grant number and title;
§ Title of the U.S-China collaboration project;
§ Amount of the requested supplement;
§ Name and title of the institutional official;
§ Phone numbers, email addresses, and delivery addresses for both the PD/PI and institutional official; and
§ Signature of the authorized organizational representative/institutional official.
PHS 398 Form Page 1 (Face page)
§ The title of the project should be the title of the parent award.
§ This Notice should be cited in Box 2, and the “yes” box should be checked.
§ The Project Director/Principal Investigator (PD/PI) must be the same as the PD/PI on the parent award. For Multiple PD/PI parent awards, the Contact PD/PI must be the PD/PI listed on the supplement request, and the supplement cannot change the Multiple PD/PI team.
§ The remaining items on the face page should be filled out in accordance with the PHS 398 application instructions.
PHS 398 Form Page 2
§ Note: The project “summary” is that of the administrative supplement, not the parent grant. The name of the U.S.-China collaboration project should be included at the beginning of the project summary section. An identical title (in English) should be included in the corresponding application to NSFC.
A brief application describing the project that is being proposed in collaboration with the Chinese co-investigator, containing:
§ A research plan that does not exceed five pages (excluding bibliography and references) including:
· Brief description of the scope of the overall project on which the supplemental request is based;
· Relationship of the supplement request to the parent grant and the anticipated contribution of the requested supplement;
· Specific aims; and
· Research strategy, including research design, methods, and data analysis.
Other required components of the application (submitted in addition to the research plan) are:
§ Letter of confirmation co-written and co-signed by the U.S. and Chinese co-investigators, and including the Authorized Organizational Representative (AOR) signature. The first section of the letter of confirmation should describe specific responsibilities of the U.S. PD/PI and Chinese partner. This letter should detail available resources, including which collaborative partner is contributing which resources, and a plan for how resources will be shared (e.g., individual contributions of specific reagents, patient samples, compounds, and access to populations for epidemiologic studies). The second part of the letter of confirmation should address the benefit of U.S.-China collaboration for this project, explaining why there is a need for international collaboration, what is the synergy between the collaborating groups, and how the project will achieve intellectual balance between the respective partners (three-page limit).
§ Biographical sketches for all new key personnel who are additions on the supplemental project (two-page limit for each biographical sketch).
§ Roles of key staff (three-page limit)
§ A discussion of future plans for expanding, extending, or otherwise continuing the research jointly prepared with the Chinese partner(s) (one-page limit).
§ Budget for the supplement with a justification that details the items requested, including personnel, travel, and Facilities and Administrative (F&A) costs. The applicant is encouraged that each application includes two budgets: one requesting NIH funding (for expenses on the U.S. side) and one budget requesting NSFC funding (for expenses on the Chinese side in Chinese currency [Renminbi]).
§ Human subjects/vertebrate animal documentation (if applicable).
§ Include a current Human Subjects/Institutional Review Board (IRB) or Vertebrate Animals/Institutional Animal Care and Use Committee (IACUC) approval letter, if available. Otherwise, this will be required at the time of funding. All appropriate IRB and IACUC approvals must be in place prior to a supplement award being made.
§ Any differences in the involvement or use of human subjects or specimens, or use of vertebrate animals, between the administrative supplement activity and the parent grant should be noted.
§ When appropriate, details should be provided on the protection of human subjects and inclusion of women, children, and minorities. Additional guidance on Human Subjects Research and Vertebrate Animals is provided under Part II of the PHS 398 instructions.
§ The grantee institution must show evidence of compliance with U.S. and Chinese regulations for the conduct of research involving human subjects. Additional information can be found at the HHS Office for Human Research Protections website athttp://www.hhs.gov/ohrp.
§ PHS 398 Checklist Form.
Administrative supplement requests will be evaluated administratively by NIH Staff. Selection factors will include the following:
§ Relevance of the proposed activities to the parent grant;
§ Adequate progress of the parent grant appropriate to the current stage of the project;
§ Appropriate and well-described plan to accomplish the goals within the timeframe proposed; and
§ Expertise of the research team proposed to conduct and achieve the goals the supplemental study.
Reviewers also will examine the appropriateness of the budgets in consideration of the study proposed and the research environment for the scientific projects.
Additional selection factors include:
Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If submitters are Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? Do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation. Does the proposed research challenge and seek to shift current understanding or clinical practice paradigms by utilizing novel theoretical concepts, approaches, or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach. Are the overall strategies, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?If the project involves research in human populations, are the plans for: 1) protection of human subjects from research risks; and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Inquiries and discussion of plans for responding to this Notice are strongly encouraged.
For NCI:Geraldina Dominguez, Ph.D.Office of HIV and AIDS MalignancyNational Cancer Institute31 Center Drive, Room 3A33, MSC 2440Bethesda, MD 20852-2440Telephone: (301) 496-3204Fax: (301) 480-4137E-mail:firstname.lastname@example.org
Julie A. Schneider, Ph.D.Program Director, Office of China Cancer ProgramsU.S. Embassy BeijingNo. 55 An Jia Lou LuBeijing 100600 P.R. ChinaTelephone: 8610-8531-3986E-mail:email@example.com
For NIAID:Gayle Bernabe, M.P.H.Regional Program OfficerOffice of Global Research (OGR)National Institute of Allergy and Infectious DiseasesNational Institutes of Health6610 Rockledge Drive, Room 5211Bethesda, MD 20892-6613 (20817 for express delivery)Telephone: (301) 451-1018Fax: (301) 480-2954E-mail:firstname.lastname@example.org
Ray Chen, M.D., M.S.P.H.Medical OfficerOffice of Global ResearchNational Institute of Allergy and Infectious DiseasesNational Institutes of HealthU.S. Embassy BeijingNo. 55 An Jia Lou LuBeijing 100600 P.R. ChinaE-mail:email@example.com
Lara R. Miller, M.S.Program OfficerBasic Immunology BranchNational Institute of Allergy and Infectious DiseasesNational Institutes of Health6610 Rockledge Drive, Room 6307, MSC 6601Bethesda, MD 20892-6601 (20817 for express delivery)Telephone: (301) 496-7551Fax: (301) 480-2381E-mail:firstname.lastname@example.org
For applications to other NIH Institutes and Centers in the area of HIV/AIDS and its co-morbidities: