Request for Proposals (RFP)Indo-U.S. Joint Program on HIV/AIDS and STI Prevention Research

Collaboration Awards, 2018Proposal Deadline:

Monday July 2, 2018 (12:00) U.S. Eastern Standard Time (EST)

Monday, July 2, 2018 (21:30) Indian Standard Time (IST)

Table of ContentsI. COMPETITION SNAPSHOT........................................................................................................................... 2

II. BACKGROUND............................................................................................................................................. 3

III. SCOPE AND PURPOSE............................................................................................................................... 3

IV. ELIGIBILITY................................................................................................................................................. 6

V. REVIEW OF PROPOSALS............................................................................................................................ 8

Evaluation Criteria........................................................................................................................................ 8

VI. PROPOSAL PREPARATION AND SUBMISSION.......................................................................................9

A. Proposal Submission........................................................................................................................... 9

B. CRDF Global and ICMR Policies and Applicant Resources............................................................10

C. Proposal Formatting........................................................................................................................... 10

D. Proposal Elements (required unless otherwise noted)...................................................................10

PROPOSAL DOCUMENT (APPENDIX A)...............................................................................................10

ADDITIONAL SUPPORTING DOCUMENTATION...................................................................................13

VII. ALLOWABLE COSTS............................................................................................................................... 13

A. U.S. Sub-Team Expenses................................................................................................................... 14

B. Indian Sub-Team Expenses...............................................................................................................15

VIII. CRDF GLOBAL and ICMR EXPECTATIONS OF GRANTEES...............................................................16

IX. ADDITIONAL INFORMATION AND SUPPORT.........................................................................................16

X. PROGRAM SUPPORT INFORMATION......................................................................................................16

APPENDIX A: PROPOSAL DOCUMENT FORMS AND TEMPLATES.......................................................17

APPENDIX B: CHECKLIST OF ITEMS REQUIRED FOR PROPOSAL SUBMISSION...............................37

APPENDIX C: REPORTING FORMAT........................................................................................................39

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I. COMPETITION SNAPSHOT

Program Focus Expand the pool of researchers engaged in Indo-U.S. HIV/AIDS research collaboration, and provide institutional training and mentorship opportunity for early-career scientists.

Eligible Applicant(s) Joint teams of U.S. and Indian researchers, that include an early-career investigator1 from India.

Competition Opens Thursday, March 1, 2018 (23:00) U.S. Eastern Standard Time (EST)

Friday, March 2, 2018 (09:30) Indian Standard Time (IST)

Submission Opens Monday, April 2, 2018 (23:00) U.S. Eastern Standard Time (EST)

Tuesday, April 3, 2018 (08:30) Indian Standard Time (IST)

Submission Deadline Monday July 2, 2018 (12:00) U.S. Eastern Standard Time (EST)

Monday, July 2 , 2018 (21:30) Indian Standard Time (IST)

Announcement of Results

Friday, March 1, 2019 (23:00) U.S. Eastern Standard Time (EST)

Saturday, March 2, 2019 (09:30) Indian Standard Time (IST)

Eligible Research Scope

HIV Transmission, Prevention, and Treatment, and HIV-associated comorbidities, coinfections, and complications.

Project Duration Up to three years

Award Amounts Each project up to $240,000 (USD) total for up to three years of support

Complete Competition RFP and Proposal Forms

A Word version of proposal forms and templates is available for download:

http://www.crdfglobal.org/funding-opportunities/2018-IndoUSJointProgram

Per ICMR guidelines, Indian applicants may need to submit additional documentation. More information available in Section VI.

How to Apply Proposals must be submitted through both portals listed below:

CRDF Global’s Electronic Proposal Submission (EPS) portal: https://eps.crdfglobal.org/2018-IndoUSJointProgram

ICMR’s Electronic Project Proposal Management (e-PPMS) portal: http://icmrextramural.in/ICMR/

More information available in Section VI.

Program Contact Sheila Ribeiro, CRDF Global, sribeiro@crdfglobal.org

Dr. Manjula Singh, ICMR, hivcall2018@gmail.com

1 An early-career investigator is a scientist who is early in his or her research career (within 10 years of completing PhD, MD or other qualified health professional degree).

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II. BACKGROUNDIndia has many unique scientific opportunities. Key and vulnerable populations allow for unique research opportunities in prevention and treatment of HIV and HIV-associated comorbidities, coinfections, and complications. Unique research opportunities also include significant clinical data that can answer research questions. Of particular interest is research that will inform HIV prevention, treatment, and adherence priorities in order to achieve the UNAIDS 90-90-90 target set for India. The Indian Council of Medical Research (ICMR) and U.S. National Institutes of Health (NIH) have a longstanding and productive engagement, which has fostered significant research collaborations between U.S. and Indian HIV investigators. Since 2016, the Indo-U.S. Joint Program on HIV/AIDS and STI Prevention Research (Joint Program) has contributed additional evidence about the evolving HIV/AIDS epidemic, and helped guide Indian, U.S. and global HIV prevention efforts. The Joint Program aims to expand the pool of researchers engaged in Indo-U.S. HIV/AIDS research cooperation. It focuses on fostering new research collaborations and supports training and mentorship for early-career researchers in India and the U.S.

Proposals are requested from U.S. and India based investigators working jointly in the field of HIV transmission, prevention, and treatment, and HIV-associated comorbidities, coinfections, and complications for the 2018 Indo-U.S. Joint Program on HIV/AIDS and STI Prevention Research (Joint Program) Collaborative Awards. Under this engagement, U.S. investigators will receive funding from the NIH, through CRDF Global, and Indian investigators will receive funding from ICMR.

NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. Discoveries have led to new ways to treat, diagnose, and prevent illness. NIH plays a key role in the expansion of biomedical knowledge. NIH-funded research leads to tens of thousands of new scientific findings every year. These fundamental advances and technological developments expand our understanding of health and living systems, and form the building blocks required for translational and clinical advances to occur. NIH also fosters the generation of new knowledge within the scientific community by supporting training within the research workforce. For more information visit http://www.nih.gov/.

The Indian Council of Medical Research (ICMR), New Delhi, the apex body in India for the formulation, coordination and promotion of biomedical research, is one of the oldest medical research bodies in the world. The ICMR has always attempted to address itself to the growing demands of scientific advances in biomedical research on the one hand, and to the need of finding practical solutions to the health problems of the country, on the other. For more information visit http://www.icmr.nic.in/.

CRDF Global is an independent nonprofit organization that promotes international scientific and technical collaboration through grants, technical resources, training, and services. CRDF Global’s Research Partnerships (RP) competitions enable cross-border collaboration and the strengthening of international research through the implementation of peer-reviewed research grant competitions. Research partnerships open avenues for new research directions and foster new collaborative opportunities for U.S. and non-U.S. scientists. For more information visit http://www.crdfglobal.org.

III. SCOPE AND PURPOSEInvestigators from the India and U.S. are invited to jointly apply for funding for collaborative research projects focused on the areas of research listed below and other related topics:

1) Reducing the incidence of HIV/AIDS: HIV transmission and prevention

Studies to develop and test innovative HIV prevention strategies in the Indian context to reduce HIV infection and transmission in vulnerable and at-risk populations, including children and adolescents.

Studies to develop and evaluate interventions to address factors at multiple levels (community, clinic, family, and individual level) that lead to loss to follow-up in PMTCT, among mothers, infant/babies, and subsequently, among children in HIV care.

Studies to better understand and increase adoption of and adherence to biomedical prevention methods among pregnant women, women planning pregnancy and those most at-risk for HIV infection, (e.g., MSM, transgender, IDU, and FSW).

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Research to understand social determinants (e.g., stigma) and to address the socioecological factors that can facilitate or impede optimal access to and use of effective HIV prevention strategies, including HIV status disclosure.

Studies to better understand how to reduce the impact of domestic violence, migration, and/or HIV risk behaviors on HIV transmission.

Integrated treatment/prevention approaches for HIV and associated coinfections and comorbidities, including implementation science research to determine scalable, sustainable and cost-effective prevention strategies.

Studies to understand host factors, including microbiome and genetic determinants, of HIV transmission, infection, and persistence.

2) Next generation therapies: HIV/AIDS treatment and care continuum

Development of diagnostic biomarkers or low-cost, rapid, assays for HIV or TB, including diagnosis of drug resistance.

Enhance Seek, Test, Treat, and Retain models for care and prevention among vulnerable and at-risk groups (e.g., users of alcohol or drugs), with focus on both individual components in the cascade as well as strategies to improve linkage of these cascade components.

3) Develop a cure for HIV infection

Characterization and comparison of persistent HIV reservoirs among different populations of ART-treated individuals with undetectable viral load.

Developing novel strategies to target and eliminate HIV reservoirs that could lead toward a cure or sustained remission of HIV infection, including studies of viral persistence, latency, reactivation, and eradication.

4) Prevention and treatment of HIV-associated comorbidities, coinfections, and complications

a) Tuberculosiso Studies to address co-infection HIV/TB in pregnant women. Studying the identification of

biomarkers for prevention, diagnosis, and treatment.o Discovery or development of immune biomarkers that predict TB disease risk or protection

from TB in TB/HIV co-infected populations

b) Hepatitiso Utilization of new/enhanced therapeutics for HIV-related co-morbidities such as HCV and their

impact on disease outcomes

c) Cancero Addressing the biological differences of tumors from HIV-positive patients to similar tumors in

HIV-negative patients o Studies focused on the pathogenicity and natural history of malignancies and cancer

treatment outcomes of HIV positive personso Studies to understand the burden of HPV associated malignancies in MSM and other key

populationso Studies to better understand the knowledge about HPV associated malignancies, other

diseases, and HPV vaccine in MSM and other key populations

d) Neurologico Studying the effect of HIV subtype on CNS reservoir establishment, HIV persistence, and

response to viral reactivation strategies for HIV eradication studieso Studying the role of viral and host genetic and epigenetic factors in the pathophysiology of

HIV-associated neurocognitive disorders (HAND). Understanding the role of viral and host transcriptional regulation (including viral protein modifications, histone modifications, changes in chromatin structure, and non-coding RNA) in HIV neuropathogenesis, and the interaction of environmental factors

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o Studying mechanisms involved in CNS manifestations of HIV-associated immune reconstitution inflammatory syndromes, particularly in the setting of opportunistic and coinfections

e) Drug and Alcohol Use and Abuseo Understand and model the impact of drug and alcohol use (and related comorbidities) on

characteristics of the HIV/AIDS epidemic in India, including social and behavioral factors which affect utilization of HIV testing, treatment, retention, adherence, and risk reduction counseling

f) Mental Healtho Studies to improve our understanding of the complex interplay between mental health, stress,

trauma, and other psychosocial comorbidities commonly associated with HIV, and to characterize the biological, behavioral, emotional, cognitive, and social pathways through which these factors lead to poor HIV-related prevention and treatment outcomes, with the goal of identifying modifiable intervention targets.

o Intervention research to develop and test novel interventions that integrate mental health with HIV prevention or HIV treatment-related interventions.

o Studies to understand the impact and interventions that integrate mental health into care and treatment of children and adolescents infected with HIV

While clinical trials of medical countermeasures will not be supported through this call, clinical and population-science research proposals are encouraged, and applications that include the planning and establishment of the infrastructure for clinical trials and longitudinal cohort studies are welcome. Such applications should include descriptions of the aims of the planned trial or cohort, source population, strategies for the recruitment of human subjects, management of ethical review and monitoring, statistical considerations, plans for research staff training and strengthening research infrastructure, and potential sources for supporting the trial.

At the time of submission, U.S. and India PIs should apply to their institutional review boards (IRBs)/institutional ethics committees (IECs) for necessary bioethics approvals from all involved institutions. Proof of IRB approval must be provided to ICMR (http://icmrextramural.in/ICMR/) and CRDF Global no later than Sunday, October 14, 2018 (23:59) EST. The primary goals and objectives of the initiative are to:

Support scientific and administrative skills building for outstanding Indian and U.S. scientists who are early in their research careers (within 10 years of completing their PhD, MD or other qualified health professional degree), have some research experience and are interested in conducting collaborative HIV/AIDS research in India.

Engage mentoring expertise in India and in the U.S. for these investigators who are in the early stages of their careers with the goal of providing training, enhancing career development, and fostering long-lasting scientific research partnerships between India and the U.S.

Enhance the HIV/AIDS research environment in India through India-U.S. partnerships. Conduct well-designed HIV/AIDS research projects, that respond to Indian public health priorities, are

considered high priority by NIH, and advance global knowledge about prevention and treatment of HIV and the most significant HIV co-infections and co-morbidities.

At least four awards will be made, each not to exceed $240,000USD in total budget (U.S. sub-team budget + Indian sub-team budget) for up to three years. Each proposal must have a budget submitted for the U.S. sub-team and a separate budget submitted for the Indian sub-team. The Indian sub-team budget may not exceed $120,000 total for three years, using the exchange rate at time of submission. ICMR will administer funds to the Indian sub-team and CRDF Global will administer funds, provided by NIH, to the U.S. sub-team.

Duration and start date of the project Each awarded project is to be carried out jointly between the collaborative sub-teams. The start

date of the project per sub team shall be the date an award agreement enters into force (i.e. is signed with CRDF Global or ICMR).

Awards are anticipated to be active on March 1, 2019. CRDF Global (for NIH) and ICMR will coordinate respective sub-team award execution dates as close as possible. Sub-team finalists may not begin any

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project activities or incur any project expenses associated with the awards until an award agreement or other required documentation has been signed with their respective awarding agencies. CRDF Global awards start date is subject to change, pending timely submission by U.S. PIs of requested documentation as required by U.S. government (USG) grant regulations.

Research timeline must be prepared in terms of semi-annual segments, per the Milestone Plan. See sample plan included in Appendix A.

Annual Reports summarizing joint achievements must be submitted to CRDF Global and ICMR using the annual report format available in Appendix A.

The duration of the project must be no more than 36 months from the date an award agreement enters into force (i.e. is signed with CRDF Global or ICMR).

ICMR and CRDF Global will address all program-related inquiries, and serve as the point of contact for the RFP and communicate all results to applicants from India and U.S. respectively. CRDF Global will receive full proposals from applicants and will coordinate a technical peer review of proposals using a jointly constituted Indo-US panel of experts. Following this review, the program sponsors will collectively determine meritorious proposals to receive awards administered through CRDF Global (U.S. sub-teams) and ICMR (Indian sub-teams).

Applicants must submit proposal to CRDF Global’s portal site (https://eps.crdfglobal.org/2018-IndoUSJointProgram ) and to ICMR website for Health Ministry’s Screening Committee (HMSC) review. Applicants must assure that all additional documents required by ICMR and identified at the ICMR site (http://icmrextramural.in/ICMR/app_srv/icmr/gl/jsp/docReportHMSC.jsp) are completed.

IV. ELIGIBILITYThe application will be peer reviewed by a joint Indo-U.S. panel of experts administered by CRDF Global.For-profit companies are not eligible to apply for support through this RFP.

To be eligible for award, the application should be submitted to both CRDF Global and ICMR. Once the entire proposal has been finalized, it should only be submitted ONE time by ONE U.S. PI on the CRDF Global site and ONE time by ONE Indian PI on the ICMR site. The Indian applicant should submit the application to ICMR and include any additional documentation required on the ICMR website.

All proposals must meet each of the following eligibility criteria:

1) Each proposal must include at least one Principal Investigator (PI) that is an early-career2 investigator from India. Each proposal must include at least two mentors, one Indian mentor and one U.S. mentor. Proposals may also include an early-career investigator from the U.S. as a Co-PI. Co-PIs will share overall responsibility for the project and coordinating all project participants and institutions. The institution at which each PI is employed will serve as the individual team’s Principal Institution 3 designated on the proposal. Additional investigators and institutions may be included as secondary collaborators on each individual team at the discretion of the PIs.

2) Each PI must: Possess the degree of Ph.D., M.D., or the equivalent research experience Demonstrate scientific capacity and research experience Be employed at an institution that can serve as the Principal Institution on the award.

3) On each application there must be an early-career researcher from India.  The Indo-U.S. team composition could include: Early-career investigator in India partnered with experienced investigators in India and the U.S., or Early-career investigators in India and the U.S. partnered with experienced investigators in India and

the U.S.

2 An early-career investigator is a scientist who is early in his or her research career (within 10 years of completing PhD, MD or other qualified health professional degree).3 “Principal Institution” is a corporation, partnership, association, institution or other organization that receives assistance under the award Agreement and is responsible for carrying out the project as specified in the approved proposal.

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4) Both the Indian and U.S. sub-team budgets should demonstrate clear focus towards accomplishing the research plan and the development plan of the early-career researchers.

5) All projects must focus on basic, clinical or translational research targeting one or more of the following fields of topical areas listed in Section III , and identify which topical areas are being addressed.

6) Each proposal is evaluated independently and therefore should not be part of, nor depend on the success of other proposals submitted to this program.

7) The application must include a scientific research plan that: Strengthens interaction or collaboration engaging Indian and U.S. scientists with HIV/AIDS

research expertise and an interest in HIV/AIDS prevention and treatment of HIV and the most significant HIV-associated co-infections and co-morbidities.

Identifies the approach, objectives, milestones, and measurements of success that will be used in the project.

Includes study methodology clearly stated for each objective. Includes a monitoring and evaluation plan. Identifies the anticipated results/expected outcome of the project and how they address the

evaluation criteria listed in Section V. Demonstrates how the Indian and U.S. PIs will coordinate project implementation and assess

progress at regular intervals.

8) Each proposal must include a joint scientific research plan, including activities of Co-PIs and mentors.

9) The proposal narrative must include a training and mentorship plan that: Identifies the scientific and administrative skills of the early-career researcher that will be

developed. Identifies the milestones that will be achieved by the early-career researcher to develop the

scientific and administrative skills. Identifies an evaluation strategy to assess the early-career researcher’s progress towards

achieving the scientific and administrative skills, including the level of skills developed.

10) The application should either include a training and mentorship plan for each early-career researcher or a joint training and mentorship plan that incorporates the training and mentorship plan for all early-career researchers named in the proposal.

11) Each collaborative team can submit only one proposal for this competition. Individuals serving as PIs are NOT permitted to serve as team members on other proposals submitted to this program. Interested applicants are advised to submit the strongest application they can for this program.

12) U.S. SUB-TEAM ONLY : The U.S. PI and participants on the U.S. team may be foreign nationals (U.S. permanent residents or visa holders),but must reside in the U.S. for at least 50% of the award period. Graduate students on the U.S. team may be foreign nationals, but they must be enrolled in an accredited degree program at a U.S. institution during the period of their participation in the project. Scientists employed by the U.S. federal government may apply for this program, however the U.S. PI and affiliated federal agency are not permitted to receive funding under this Program. All award funds are intended to support the non-federal U.S. institutions and investigators or Indian sub-team(s). See Section VII.A Allowable Costs for more information.

13) INDIA SUB-TEAM ONLY : The Indian PI and participants on the Indian team must have regular employment in the universities, medical colleges, postgraduate institutions, recognized research and development laboratories or NGOs (documentary evidence of the recognition should be enclosed with the application). See Section VII.B Allowable Costs for more information

CRDF Global and ICMR reserve the right to restrict the participation of any individual or institution in its programs. CRDF Global and ICMR comply with all U.S. and Indian laws respectively and regulations pertaining to export control and the participation of foreign nationals or institutions in its activities. It is the policy of CRDF Global not to conduct any transactions with U.S. restricted entities without appropriate authorization from the U.S. Government.

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Any applicants as India sub-team must read and understand the conditions of ICMR for this program. Please refer to the information at the following URL: http://icmrextramural.in/ICMR/ http://icmrextramural.in/ICMR/app_srv/icmr/gl/jsp/docReportHMSC.jsp

For research ideas that require resources not provided by this program or in areas outside the scope of this program, interested applicants are encouraged to review other NIH, ICMR, and CRDF Global funding opportunities. Specific funding opportunities are available at:

NIH: https://grants.nih.gov/funding/index.htm ICMR: http://icmrextramural.in/ICMR/ CRDF Global: http://www.crdfglobal.org/grants/funding-opportunities

V. REVIEW OF PROPOSALSAll proposals and information contained therein will remain confidential prior to the award and will be screened for eligibility and completeness upon receipt by CRDF Global. Peer based panel review will take place through an Indo-U.S. joint scientific panel of experts appointed by CRDF Global and approved by NIH and ICMR. The panel will use the evaluation criteria described below in reaching its decisions. The panel will rank proposals by the evaluation criteria and assign an overall rating to each proposal, as well as a funding recommendation. CRDF Global will share these recommendations with NIH and ICMR, for a joint decision on selection of finalists.

CRDF Global and ICMR will announce awards via e-mail by Friday, March 1, 2019 (23:00) U.S. Eastern Standard Time (EST) [i.e. Saturday, March 2, 2019 (09:30) Indian Standard Time (IST)] . All awards are subject to the availability of funding from program sponsors. All decisions by CRDF Global, NIH, and ICMR are final.

Evaluation CriteriaCRDF Global panels of external reviewers will use the following criteria in the evaluation of proposals for this program.

1. Scientific Research Plan: How well the individual elements of the plan fit with the overall project goals.

2. Training and Mentorship Plan: How well the individual elements of the plan fit with the overall project goals.

3. Technical Merit: The technical soundness of the proposed work, the project’s management plan, and adequacy of the resources available, both technical and financial.

4. Research Impact: The probability that the project will result in new knowledge in one or more high-priority HIV research areas, or have a positive impact on population health in India and/or globally. A secondary consideration is that the project builds on the unique HIV research opportunities that India has to offer, including the study of social, cultural, and genetic determinants of the epidemic.

5. Personnel Capacity and Collaborative Benefits: The expertise of the investigators and other participants, including the strengths and weaknesses of each partner, as well as the balance of the collaboration and distribution of partnership benefits.

6. Personnel Development: The balance of activities that will directly contribute to the development of the early-career investigator(s) scientific and administrative skills. Proposals are encouraged to prioritize resources to accomplish primarily scientific research and the development the scientific and administrative skills of the early-career investigator(s).

7. Benefit to Education and Infrastructure: Appraisal of the project’s training and mentoring plans that target early-career researchers. Proposed activity should include the provision of career enhancing

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opportunities for personnel, the sharing of equipment and resources among all institutions involved, technology transfer, and the project’s long-term positive impact on the research environment and capacity, particularly in India.

VI. PROPOSAL PREPARATION AND SUBMISSIONOnly proposals submitted according to the instructions, and which follow the formatting and include all of the required elements listed below will be reviewed.

A. Proposal SubmissionAll proposals must be submitted electronically to CRDF through CRDF Global’s Electronic Proposal Submission (EPS) site: https://proposals.crdfglobal.org/USJCMSP and to ICMR’s web based Submission, Processing & Management for Project Proposals (e-PPMS) site: http://icmrextramural.in/ICMR/

EPS website will be active on:

Monday, April 2, 2018 (23:00) U.S. Eastern Standard Time (EST)

Tuesday, April 3, 2018 (08:30) Indian Standard Time (IST)

Note: Submission through the EPS website does not require previous registration. .

All submissions must be completed no later than:

Monday, July 2, 2018 (12:00) U.S. Eastern Standard Time (EST)

Monday, July 2, 2018 (21:30) Indian Standard Time (IST)

The Indian and U.S. team should jointly develop the proposal and provide written evidence of the concurrence of the Indian and U.S. Institute Leadership Representative. Once the entire proposal has been finalized, it should only be submitted ONE time by ONE U.S. PI on the CRDF Global site and ONE time by ONE Indian PI on the ICMR site.

At the conclusion of the electronic submission process, the collaborating PIs will receive a confirmation message from CRDF Global and ICMR. A copy of CRDF message will also be sent to Institute Leadership Representatives identified in the proposal. Further instructions on Electronic Proposal Submission (EPS) are available at the above EPS site.

Proposal application materials submitted to CRDF Global and ICMR must be prepared in English and compiled in the following separate document files for submission to the CRDF Global Electronic Proposal Submission (EPS) and ICMR’s electronic site . Acceptable file formats are MS Word (.doc) or Adobe Acrobat (.pdf).

The EPS site does not allow you to save partial submissions. Applicants must have all documents ready before beginning submission process.

Required:1. The research team must submit the completed proposal document including all applicable proposal

elements specified in Section VI.

2. The research team must submit any additional ICMR required documentation (additional documentation specified at: http://icmrextramural.in/ICMR/app_srv/icmr/gl/jsp/docReportHMSC.jsp)

3. Curriculum Vitae (CV) documents for all team participants, compiled into a single document.

4. Supporting documents for proposals involving human and/or animal subject research as required by CRDF Global and ICMR.

For questions on CRDF Global’s EPS process, contact CRDF Global point of contact listed in Section X.

For questions about ICMR’s e-PPMS process, contact ICMR point of contact listed in Section X.

Applications that do not complete submission through CRDF Global's EPS and ICMR’s e-PPMS site will be considered ineligible.

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B. CRDF Global and ICMR Policies and Applicant Resources

Before writing the proposal applicants should review all documents and policies on the CRDF Global Applicant Resources page and on the ICMR links below:

http://icmrextramural.in/ICMR/ http://icmrextramural.in/ICMR/app_srv/icmr/gl/formats/registrationHMSC.pdf http://icmrextramural.in/ICMR/app_srv/icmr/gl/jsp/docReportHMSC.jsp.

C. Proposal Formatting Typed One-inch margins on ALL sides

Single-spaced Font size of no less than Arial 10pt (Times New Roman 10pt font is not acceptable)*

*A font size of less than 10 points may be used for mathematical formulas or equations, figure, table or diagram captions and when using a Symbol font to insert Greek letters or special characters. PIs are cautioned, however, that the text must still be readable.

D. Proposal Elements (required unless otherwise noted)Detailed information for all necessary elements of a proposal is listed below. Appendices may not be included. Any proposal submitted without ALL required information, including signatures and forms, may be disqualified and removed from the competition. Applicants are encouraged to carefully review proposals prior to submission to ensure accuracy and completeness. Decisions by CRDF Global and the program sponsors are final and cannot be appealed.

Applicants are required to follow instructions and use the electronic forms and templates downloadable as a Word Document on:

CRDF Global website: http://www.crdfglobal.org/funding-opportunities/2018-IndoUSJointProgram

ICMR website: http://icmrextramural.in/ICMR/app_srv/icmr/gl/jsp/docReportHMSC.jsp

PROPOSAL DOCUMENT (APPENDIX A) The following sections must be compiled into a single proposal document with pages numbered consecutively, and submitted to both CRDF Global and ICMR portal sites.

A.1.Cover Sheet One per proposal including

Project title and basic information about the project Information about the Indian and U.S. PIs, including name, current designation, contact details,

and current international research projects under each PI. Information about the Indian and U.S. Institute Leadership Representative (individual who would

be responsible for negotiating contractual and financial terms in the case of an award.)

This information must also be entered during CRDF Global’s EPS process.

Note: CRDF Global requires that Form A.1 be signed by both the Indian and U.S. Institution Leadership Representative. Please include a scanned copy of the signed document.

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A.2: Project AbstractOne concise paragraph summarizing all relevant aspects of the project, with special attention to its objectives, methods, potential results and the importance of the objectives and application of the work in the context of US, Indian and global HIV/AIDS research priorities. (No more than 350 words).

A.3: Project NarrativeTen pages maximum including any graphs, diagrams, and photos. PIs are cautioned that the Project Narrative must be self-contained, and that URLs providing information related to the proposal should not be used. CRDF Global expects strict adherence to the rules of proper scholarship and attribution. The responsibility for proper scholarship and attribution rests with the authors of a proposal; all parts of the proposal should be prepared with equal care for this concern. All contributing authors, including any PIs and sub-team participants, should be named and acknowledged at the bottom of the Project Narrative section. Example: Contributing Authors: NAME (Indian team researcher), NAME (U.S. team researcher)

The following must be described in the Project Narrative: The approach, objectives, milestones, and measurements of success that will be used Study methodology clearly stated for each objective. A clearly defined project timeline, noting all project tasks and goals to be accomplished. A brief monitoring and evaluation plan How the individual and combined competencies of the sub-team participants will enable the

project to be carried out, and what relevant prior work has been carried out by member’s sub-teams

A summary of the objectives of the training and mentorship plans Describe any preliminary work completed by the Investigator that is relevant to this application

(e.g. selection of subjects, standardization of methods, data analysis plan etc.) The anticipated results/expected outcome of the project and how they address the CRDF Global

evaluation criteria listed in Section V How the project compares to current research conducted in the topic area and a relevant

bibliography of related research Facilities, equipment, and other resources available at the U.S. and Indian institutes directly

applicable to the project including those from secondary collaborators. This should address the adequacy of the resources available to perform the effort proposed. The description should be written narratively and not include any financial information

Requested equipment to be utilized in the project along with justification How the Indian and U.S. PIs will coordinate project implementation and assess progress at

regular intervals. Each project must involve significant and substantive cooperation between the Indian sub-team and U.S. sub-team.

All proposed travel (international and within India) to be funded under the project must be described in terms of its purpose and duration.

Confirmation that the PI will control all the administrative/research/data analysis and publication activities

If applicable, a brief description of how research will contribute to the achievement of the UNAIDS 90-90-90 goals.

Any linkage to other relevant projects (ad-hoc, task force or collaborative).

Note: Patentable ideas, trade secrets, privileged or confidential commercial or financial information, disclosure of which may harm the proposer, should be included in the proposals only when such information is necessary to convey an understanding of the proposed project. Such information must be clearly marked in the proposal and appropriately labeled as:

"The following is (proprietary or confidential) information that (name of proposing organization) requests not be released to persons outside of CRDF Global, except for purposes of review and evaluation."

A.4: References CitedReference information for the Project Narrative. Each reference must include the names of all authors (in the same sequence in which they appear in the publication), the article and journal title, book title, volume number, page numbers, and year of publication. Identify the website address if the document is available

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electronically. While there is no page limitation for the References Cited, this section must only include bibliographic citations and not be used to provide parenthetical information outside of the Project Narrative.

A.5: Project Milestone PlanOne Project Milestone Plan per proposal, describing specific milestones to be accomplished by the sub-teams during project implementation. A sample Milestone Plan is included in Appendix A.

Note: the following when preparing the Milestone Plan:

Milestones are discrete activities that allow the grantee to achieve the overall objectives described in the project narrative. Milestones should reflect realistic accomplishments that can be verified by CRDF Global and ICMR staff. Examples of such milestones include, but are not limited to: sample collection, data analysis, trainings, or travel for a specific task under the proposed project.

Milestones must be verifiable through submission of documentation or other deliverables (e.g. photos, purchase orders, training materials, reports, or other tangible proof that the activities occurred).

Each milestone should be clearly described and include a corresponding deliverable. The amount of funding requested (on a semi-annual basis) should be included in the Milestone Plan.

A.6: Sub-Team Key Participant Data Form One form for each additional participant on the Indian sub-team and U.S. sub-team, including researchers/engineers, technical/scientific support staff, graduate and undergraduate students, administrative/clerical support staff, and secondary collaborators.

Note:□ Form A.6 is for additional team participants only; the sub-team PIs do not need to complete this

form with their own information.□ For planned graduate students not yet identified, complete the form as “Planned Graduate

Student” indicating, at a minimum, the anticipated institution and level of education.□ Each form should be accompanied by the Curricula Vitae (CV) for the sub-team participant. All

CVs are to be compiled and submitted in a separate document. See section on CVs on page 13.

A.7: Project Sub-Team BudgetOne for each sub-team involved. Each budget should cover the entire award period. PIs should refer to “Allowed Costs” in Section VII

U.S. sub-team use Form A.7.i India sub-team use Form A.7.ii

A.8: Budget NarrativeOne for each sub-team involved explaining all budget items in the corresponding Project Sub-Team Budget.

U.S. sub-team use Form A.8.i. India sub-team use Form A.8.ii

A.9: Project Budget Overview One for each team. Convert all amounts to USD. PIs should refer to “Allowed Costs” in Section VII

A.10: Statement of Other Sources of Support of Key Personnel (if applicable)One for each PI listing current and pending sources of support for all their research projects, excluding those that are already included under the “COST-SHARING FROM NON-CRDF SOURCES” section in the Budget. PIs with grants from U.S. Government sources, such as NIH or NSF, should indicate the grant number, duration of the award, and level of effort. If this proposal has also been submitted to another organization, please indicate this information clearly on the form. Should a PI have no other sources of support, check the box marked “None” at the top of Form A.10, and include this page with the proposal.

A.11: PI Partnership Justification and Terms Agreement StatementEach PI must provide a signed statement on institutional letterhead certifying her or his agreement to the collaboration. One for each U.S. and Indian PI participating on a proposal certifying his or her agreement to

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the collaboration. The statement must be on institutional letterhead and submitted as a signed scanned copy. PIs should use the Partnership Statement template that is included herein.

A.12 Plagiarism Policy and Standards AgreementA CRDF Global plagiarism policy and standards document that is included herein, submitted as a signed scanned copy by each of the Indian and U.S. PI.

CRDF Global will not provide funding to an application in which plagiarism exists.

Plagiarism is defined as the incorporation of published writing or another person’s original writing into your document without clear formatting and accurate attribution of the source. Academic writing such as a funding proposal must be original work, written by the stated applicant(s).A.13 Institutional Data Form: This document is a CRDF Global requirement for U.S. institutions only.

A.14 Format of Summary Sheet for New Project Proposals Involving Foreign Collaboration/Assistance:This is an ICMR requirement. This document should be completed by Indian sub-team and submitted to ICMR only.

A.15 Material Transfer Agreement: This is an ICMR requirement. A Material Transfer Agreement (MTA) must be signed for any anticipated sharing of biological material between the Indian and US labs. The MTA form can also be accessed at the ICMR website at http://icmrextramural.in/ICMR/app_srv/icmr/gl/jsp/docReportHMSC.jsp. This document should be completed and submitted to ICMR only.

ADDITIONAL SUPPORTING DOCUMENTATIONThe following documents should be prepared and uploaded separately from the main proposal file:A. Curricula Vitae (CV) - RequiredOne for each Team (should include U.S. and Indian PIs and all Team Participants) compiled in one file.

Each CV should include the individual’s name, title, educational background, current and previous institutional affiliations with dates, area of expertise, and his or her scientific publications of relevance to the project. Please visit the Resource guides and templates for writing a Curriculum Vitae (CV) page on the CRDF Global website for assistance. Please ensure you have provided a full CV for each team member listed in the Sub-Team Key Participant Data form in the main proposal file.

PI CVs should be no more than five (5) pages Team member CVs should be no more than two (2) pages

B. Special Documentation (as applicable) Human/Animal Subjects Research: ICMR and CRDF Global are committed to ensuring that projects

involving human or animal subjects are protected from research risks in conformance with NIH/ICMR/CRDF Global policies. All projects recommended for award that involve human or animal subjects will undergo review by the CRDF Global Bioethics Review Committee (BRC) and Indian Bioethics Committees prior to award request.

o For more information about CRDF Global’s Human/Animal Subjects Research Policies, please visit the Guidelines for Proposals Involving Human and/or Animal Subject Research.

o For information on ICMR policies, please consult http://www.icmr.nic.in/guidelines/ICMR_Ethical_Guidelines_2017.pdf

U.S. and India PIs should apply to their institutional review boards (IRBs)/institutional ethics committees (IECs) at the time of submission to obtain necessary bioethics approvals from all involved institutions. Applicants are required to submit proof of their institution’s IRB approval by no later than Sunday, October 14, 2018 (23:59) EST.

Please see Appendix B for a checklist of proposal submission requirements.

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Please refer to the ICMR site (http://icmrextramural.in/ICMR/app_srv/icmr/gl/jsp/docReportHMSC.jsp) to make sure that all ICMR requirements are complete and submitted through the e-PPMS portal site.

CRDF Global reserves the right to request additional detail from U.S. institutions, if necessary to proceed with award selection.

VII. ALLOWABLE COSTSThe maximum total award is up to $240,000 U.S. Dollars (USD) disbursed over three years. The sub-teams budget allocation percentages must total 100%.

In the case of an award, a project budget may be subject to revision by CRDF Global and ICMR staff.CRDF Global will support a portion of the team project budget using NIH funds, and ICMR will support a portion of the team project budget using ICMR funds. NIH and ICMR will jointly review and approve funding allocations for the Indian and U.S. sub-teams. The total grant budget of $240,000 may be allocated such that $120,000 in the Indian budget is supported by ICMR, and of the $120,000 supported by CRDF, some portion of the project activities of the Indian sub-team may be supported through the US budget.

In accordance with the provisions of US government regulation 2 CFR 200 - Uniform Administrative Requirements, Cost Principles, and Audit Requirements For Federal Awards, non-federal entities that expend federal awards of $750,000.00 or more in a year, during the non-federal entity’s fiscal year must have a single or program-specific audit conducted for that year.

A. U.S. Sub-Team Expenses CRDF Global will support expenses requested by the U.S. sub-teams from universities and non-profits with the exception of large-scale equipment purchases. U.S. federal government agencies and U.S. teams from for-profit companies are not permitted to receive funding under this program. These expenses and their amounts should be described in the Budget and in the Budget Narrative (see forms provided in Appendix A).

CRDF Global will distribute support to the U.S. team as a fixed obligation grant with payment schedule tied to milestones. U.S. teams should refer to the instructions below for submitting all documentation necessary to execute grants:

1) Milestone Plan. The Project Milestone Plan should identify and describe specific milestones to be accomplished by the U.S. team during project implementation. CRDF Global staff and external peer reviewers will evaluate the plan to ensure that milestones are directly relevant to the overall research project; can be delivered in accordance with the timeline; and can be supported by appropriate documentation.

2) Budget. U.S. teams must also submit a line-item project budget using the form provided in Appendix A. If selected for an award, CRDF Global staff may request additional information or supporting documentation before finalizing an award agreement.

Funding may be requested for the following expenses:a) Labor;

b) Equipment, Supplies and Services: Equipment is defined as an article of non-expendable, tangible personal property having a useful life of more than one year and an acquisition cost of $5,000 or greater. Awardees will have to submit proof of fair and open bidding for any purchases above $3,500.

c) Travel: International travel is allowed under this solicitation, but must be justified within the project narrative and must significantly contribute to the research outcomes. Meals and incidentals (M&IE) and lodging per diem rates at no more than U.S government rates For travel in the U.S visit http://www.gsa.gov/portal/category/21287For non-U.S. travel visit https://aoprals.state.gov/content.asp?content_id=184&menu_id=78

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Applicants may use project funds to cover the cost of visa fees. If traveling to India as a U.S. citizen: plan your budget and timeline appropriately to control for the time involved in the procurement of an Indian visa. Travelers must comply with Fly America regulations

d) Institutional Support: Applicants may request indirect costs (IDC) on all direct costs except for equipment (over $5,000), capital expenditures, rent, student tuition, participant support costs and sub-awardees expenses (after the first $25,000). Total direct costs minus these items is considered the “modified total direct cost” (MTDC) amount for which the IDC rate should be applied. Institutions with a Negotiated Indirect Cost Rates Agreement (NICRA) may request up to their approved NICRA rate. If an institute requests IDCs at their NICRA rate, documentation for these rates should be provided in the budget narrative. Institutions without a NICRA and who wish to request IDCS should request 10% of MTDC. IDCs combined with the total direct costs cannot exceed the funding total allowed to request. Below are helpful calculations:

IDC $ = IDC% x MTDC $

Maximum Total Sub-Team budget = total direct costs $ (including MTDC) + IDCs $

Budget items should be clearly listed individually – items listed generally as “supplies” or “services” will NOT be accepted.

Each line item should be calculated based on actual costs – you should include receipts, quotes, or website links to support calculations for equipment, supplies, and services in the budget narrative.

Justification/support for labor, travel, and indirect/administrative costs should be provided in the budget narrative.

B. Indian Sub-Team Expenses

Total grant support for the Indian sub-team expenses as submitted in the Indian sub-team budget may not exceed 50% of the total award funds requested.

ICMR will support expenses for the Indian sub-teams from universities, non-profits, and government institutions in India with the exception of large-scale equipment purchases.

Indian sub-teams should refer to the instructions below for submitting all documentation necessary to execute grants:

Milestone Plan: The Team Project Milestone Plan should identify and describe specific milestones to be accomplished by the India sub-team during project implementation. ICMR will evaluate the plan to ensure that milestones are directly relevant to the overall research project; can be delivered in accordance with the timeline; and can be supported by appropriate documentation.

Budget. India sub-teams must also submit a line-item project Budget and Budget Narrative (see Appendix A for the required forms). If selected for an award, ICMR staff may request additional information or supporting documentation before finalizing an award agreement. India project budgets should be calculated in accordance with the following guidelines:

i. Funding may be requested for the following expenses:

(Direct costs + Indirect costs = Total Maximum Requested.)

Major Category

Definition

Direct Costs Goods

Non-Recurring

Recurring

Costs for purchasing new equipment

Supplies, kits, reagents, consumables, stationery, materials related to the project

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Travel Expenses for travel by the R&D PI or research unit members and by invited persons.

Personnel Annual salaries for research staff etc. employed for R&D objectives

Indirect Costs *(Overhead charges)

Indirect costs are 5% of direct cost, excluding travel and equipment costs, paid by ICMR as required costs for managing the research grant.

* Any product costing more than INR 25000/- requires detailed breakup

ii. ICMR grants allow advance payment up to 100% of the total amount requested for each year.

iii. Budget items should be listed individually – items listed generally as “supplies” or “services” will NOT be accepted.

iv. Each line item should be calculated based on actual costs – you should include receipts, quotes, or website links to support calculations for equipment, supplies, and services in the budget narrative.

v. Justification/support for personnel and services, travel, and other costs should be provided in the budget narrative.

VIII. CRDF GLOBAL and ICMR EXPECTATIONS OF GRANTEESAwardees from this competition will be expected to:

Submit semi-annual progress reports and one final project report to CRDF Global, all jointly prepared by the Indian and U.S. sub-teams utilizing the format provided in Appendix C, including a summary of major achievements.

Adhere to respective CRDF Global (for U.S. sub-team) or ICMR (for Indian sub-team) award agreement terms.

Submit invoices and applicable financial back-up for all project expenses to CRDF Global or ICMR, as applicable.

IX. ADDITIONAL INFORMATION AND SUPPORTFor information on sponsor organization award administration policies, please review the following websites:

CRDF Global Policies for U.S. and Indian sub-teams:

Grant Funding Opportunities: http://www.crdfglobal.org/grants/funding-opportunities Information for Applicants: http://www.crdfglobal.org/grants/information-applicants Information for Awardees: http://www.crdfglobal.org/grants/information-awardees Research Partnership Forms: http://www.crdfglobal.org/grants/forms

ICMR Policies for Indian sub-teams:

ICMR: http://icmrextramural.in/ICMR/app_srv/icmr/gl/formats/detailedProposalEMR.doc

X. PROGRAM SUPPORT INFORMATIONFor further information about this program, please contact the relevant point of contact listed below. Inquiries by e-mail are strongly encouraged and will result in prompt response.

Sheila Ribeiro, MS, PSMProgram ManagerCRDF Global

Dr. Manjula SinghDDG/Scientist EICMR

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E-mail: sribeiro@crdfglobal.org E-mail: hivcall2018@gmail.com

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APPENDIX A: PROPOSAL DOCUMENT FORMS AND TEMPLATESA.1. COVER SHEET

Complete for each applicable U.S. sub-team and Indian sub-team GENERAL PROJECT INFORMATION

Project Title (not to exceed 25 words)

Projected Length of Project (Months)

Research CategorizationResearch Area Sub-Research Area Research Focus

Research involves use of Human/Animal subjects Human Animal None

India Principal Investigator (PI) – If applicable

Last Name (surname)

First Name (Given)

Middle (Patronymic)

Position/Title

Institute Name

Complete Mailing Address (building #, street, city, postal code)

Institution type University/Academic Research Institution Non-profit/non-

governmental Government Other____________________________

PI E-Mail Alternative E-mail (optional)

Telephone # Gender Male Female

Highest Degree Earned/ Field of Degree Year Awarded

(Must Check One) Indian Citizen Permanent Resident Non- citizen with legal visa status

Name of Institution Director E-mail

Institutional Director Address Telephone #

Total number of Indian team members, including Indian PI and graduate students

SIGNATURES Scanned, signed copies of this cover sheet are required for applicants

Indian Principal Investigator Signature Date

Indian Institution Leadership Representative Signature Date

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U.S. Principal Investigator (PI) – If applicable

Last Name (surname)

First Name (Given)

Middle (Patronymic)

Position/Title

Institute Name

Complete Mailing Address (building #, street, city, postal code)

Institution type University/Academic Research Institution Non-profit/non-

governmental Government Other____________________________

PI E-Mail Alternative E-mail (optional)

Telephone # Gender Male Female

Highest Degree Earned/ Field of Degree Year Awarded

(Must Check One) U.S. Citizen Permanent Resident Non- citizen with legal visa status

Name of Institution Director E-mail

Institutional Director Address Telephone #

Total number of Indian team members, including Indian PI and graduate students

SIGNATURES Scanned, signed copies of this cover sheet are required for applicants

U.S. Principal Investigator Signature Date

U.S. Institution Leadership Representative Signature Date

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A.2. PROJECT ABSTRACTAbstract should not exceed 350 words

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A.3. PROJECT NARRATIVENarrative should not exceed 5 pages. Text should be Arial font size 10 within 1-inch margins

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A.4. REFERENCES CITEDThis section must only include bibliographic citations and not be used to provide parenthetical information

outside of the Project Narrative.

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A.5. PROJECT MILESTONE PLAN (Sample)Copy template to complete. Text in red is an example. Information should match the proposal Project Narrative and Project Budget. Rows should be added based on the award length (not to exceed three year period of performance, as determined by ICMR, CRDF Global and NIH.

First Semi-Annual Reporting Period Responsible TeamMark all that apply

Milestone: Description: Associated Deliverable(s): U.S. INDIAN

Training for five participants

The project team will receive training in GIS technologies/methods used for disease surveillance.

Copies of all training materials, including power point slides, hand-outs; photographs, and video footage of the training NO YES

Total Amount Requested for this Reporting Period: $30,000 $10,000 $20,000

Second Semi-Annual Reporting PeriodMilestone: Description: Associated Deliverable(s) U.S. INDIAN

Completion of data analysis

Team X will conduct analysis on data collected at field site

Final Report

YES YES

Total Amount Requested for this Reporting Period: $10,000 $5,000 $5,000

Rows should be added based on the award length (not to exceed three year period of performance), as determined by ICMR, CRDF Global and NIH.

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A.6. SUB-TEAM KEY PARTICIPANT DATAComplete ONE for each U.S. sub-team and Indian sub-team participant involved.Please copy this page as necessary.

TEAM MEMBER INFORMATION Indian Sub-Team Participant U.S. Sub-Team Participant

Last Name (Surname)

First Name (Given)

Middle (Patronymic)

Current Position

Institution NameComplete Mailing Address

E-mail Address Telephone #

Highest Degree/ Year Awarded Gender Male Female

Classification on Project (please check one):

Researcher/Engineer Technical/Scientific Support Student Administrative

Description of project role (responsibilities, expertise, level of effort on project):

TEAM MEMBER INFORMATION Indian Sub-Team Participant U.S. Sub-Team Participant

Last Name (surname)

First Name (Given)

Middle (Patronymic)

Current Position

Institution NameComplete Mailing Address

E-mail Address Telephone #

Highest Degree/ Year Awarded Gender Male Female

Classification on Project (please check one):

Researcher/Engineer Technical/Scientific Support Student Administrative

Description of project role (responsibilities, expertise, level of effort on project):

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A.7.i. PROJECT SUB-TEAM BUDGET (U.S.)

For “Allowable Costs” please refer to Section VII Convert all amounts to USD. Total Project Cost (U.S. + Indian sub-teams) must not exceed $240,000 USD

Team: U.S. sub-team Total U.S. sub-team Cost: Primary ParticipantsIndividual Financial Support (IFS)Participant Name (Add rows if necessary.) Hourly Rate Total person

hours4 # of Days $ USD

1        2        3        TOTAL IFS  Equipment, Supplies, & Services (ESS)Item (Add rows if necessary.) Units Unit Cost $ USD

1       2       3       TOTAL ESS  Travel (Totals only, describe purpose and per person costs in detail in Budget Narrative.)  $ USDDomestic Transportation   Domestic Per Diem  International Transportation  International Living Allowance/Per Diem  Other Travel Expenses (e.g. visa fees, conference registration fees, etc.)  TOTAL TRAVEL  TOTAL PRIMARY PARTICIPANT DIRECT EXPENSESInstitutional Support (IS) of Primary Participant NICRA approved rate or de minimus rate if no NICRA.  Secondary Collaborators (within individual team)Individual Financial Support (IFS)Participant Name (Add rows if necessary.) Hourly Rate # Hours per

Day # of Days $ USD

1        2        TOTAL IFSEquipment, Supplies, & Services (ESS)Item (Add rows if necessary.) Units Unit Cost $ USD

1       2       TOTAL ESS  Travel (Totals only, describe purpose and per person costs in detail in Budget Narrative.) $ USDDomestic Transportation   Domestic Per Diem  International Transportation  International Living Allowance/Per Diem  Other Travel Expenses (e.g. visa fees, conference registration fees, etc.)  TOTAL TRAVEL  TOTAL SECONDARY COLLABORATOR DIRECT EXPENSESInstitutional Support (IS) of Secondary CollaboratorsNICRA approved rate or de minimus rate if no NICRA.   TOTAL OF PRIMARY PARTICIPANT AND SECONDARY COLLABORATOR DIRECT EXPENSESSUB-TEAM SUBTOTAL (Total of direct expenses and IS)  TOTAL COST-SHARING FROM NON-CRDF Global SOURCES(Including for-profit contributions. Describe in detail in Budget Narrative)  

4 "Person-hours" = estimated total number of hours devoted to the project throughout the duration of the project.

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A.7.ii. PROJECT SUB-TEAM BUDGET (India) For “Allowable Costs” please refer to Section VII and ICMR website

http://icmrextramural.in/ICMR/app_srv/icmr/gl/formats/detailedProposalEMR.doc Convert all amounts to USD Total Project Cost (U.S. + Indian sub-teams) must not exceed $240,000 USD

Total Indian sub-team budget should not exceed $120,000 USD

Justification for each of the mentioned items must be submitted separately.A detailed breakup needs to be provided for any recurring contingency costing more than INR 25,000/-

Team: Indian sub-team Total Indian sub-team Cost:

Staff Salary Participant Name (Add rows if necessary.)

Position as per ICMR guidelines Year 1 Year 2 Year 3 Total $ USD

1        2        3        

TOTAL Staff Salary  Contingency (Recurring)Item (Add rows if necessary.) Year 1 Year 2 Year 3 Total $ USD

1       2       3       

TOTAL Contingency (Recurring)  Contingency (Non-recurring)Item (Add rows if necessary.) Year 1 Year 2 Year 3 Total $ USD

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TOTAL Contigency (Non-recurring)Training and Workshops (Add rows if necessary.) Year 1 Year 2 Year 3 Total $ USD

1        2        

TOTAL Training and WorkshopsTravel (Local)(Add rows if necessary.) Year 1 Year 2 Year 3 Total $ USD

1       2       

TOTAL Travel (Local)  Travel (International)(Add rows if necessary.) Year 1 Year 2 Year 3 Total $ USD

1       2       

TOTAL Travel (Local)  Indirect Costs@5% of total budget except on contingency non-recurring and travel costs.

Year 1 Year 2 Year 3 Total $ USD

      TOTAL Indirect Costs  

GRAND TOTAL (Staff salary, All contigencies, Training & workshops, Travel, Indirect costs)

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A.8.i. BUDGET NARRATIVE (U.S.)Complete ONE for U.S. sub-team; include Secondary Collaborative costs explanation within each budget category.

Describe and justify the expenses included in each line item, e.g. the purpose and duration of each travel, the number of travelers, destinations, and how costs were determined. If a line item doesn’t apply to your budget, please insert N/A for “not applicable” in the space provided.

Team: U.S. Sub-Team

Individual Financial Support (IFS) Describe the level of effort projected for the PI and other team participants – the time to be devoted by team member to the project and their hourly rate, and a total number of person-hours.

Equipment, Supplies and Services (ESS) List and justify in detail, requested equipment items with a value over $1,000, and all equipment, supplies and services with per unit costs. Explain the necessity of the ESS to the project, and how these items will be used in the proposal.

Travel Explain the need for travel - how the travel will benefit the project’s aims - and your calculations of travel costs for domestic and foreign travel. Break down by airfare, hotel, per diem, etc.

Institutional Support (IS) Calculate an allowance for institutional costs of % of the total individual team direct expenses. E.g. Total Team Budget ÷ (1+ IS%) = Direct Costs maximum. Modified Direct Total Costs + Institutional Support = Total Maximum Requested.

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A.8.ii. BUDGET NARRATIVE (India)Complete ONE for each Indian sub-team involved; include Secondary Collaborative costs explanation within each budget category.Describe and justify the expenses included in each line item, e.g. the purpose and duration of each travel, the number of travelers, destinations, and how costs were determined. If a line item doesn’t apply to your budget, please insert N/A for “not applicable” in the space provided.

Team: Indian Sub-Team

Contingencies (recurring and non-recurring) List and justify in detail, requested goods items with a value over INR 25,000, and all goods with per unit costs. Explain the necessity of the goods to the project, and how these items will be used in the proposal.

Travel Explain the need for travel - how the travel will benefit the project’s aims - and your calculations of travel costs for domestic and foreign travel. Break down by airfare, hotel, per diem, etc.

Personnel The staff recruited should be as per the ICMR approved positions. The justification for each of the project staff needs to be provided linking their role with achievements of study objectives.

OthersList and justify in detail, requested other items with per unit costs. Explain the necessity of the other items to the project, and how these items will be used in the proposal.

Indirect CostCalculate an indirect costs 5% of the total team direct expenses except on travel and non-recurring budgetE.g. Total Team Budget ÷ (1+ Indirect Costs 5 %) = Direct Costs maximum. Direct costs + Indirect Costs = Total Maximum Requested.

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A.9. PROJECT BUDGETComplete for each Team. Please refer to Section VII “Allowable Costs.” Convert all amounts to USD

Team Composition: U.S. Sub-Team Indian Sub-Team

＊Total Project Cost Allowed: $240,000 USD Maximum＊Team Budget Allocation

Team Budget Allocation U.S. Sub-Team (Up to $120,000) Indian Sub-Team(Up to $120,000)

U.S. Sub-Team’s SUBTOTAL (Total of direct expenses and Institutional Support) % of the Team Total Budget

$ USD %

Indian Sub-Team’s SUBTOTAL (Total of direct expenses and Indirect Cost) % of the Team Total Budget

$ USD %

TEAM TOTAL BUDGET (Total of all involved Sub-Team’s Subtotals) Not to exceed $240,000

$ USD TOTAL COST-SHARING FROM NON-CRDF & ICMR SOURCES (Including for-profit contributions. Describe in detail in Budget Narrative)

$ USD

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A.10. OTHER SOURCES OF SUPPORT OF KEY PERSONNEL (For PIs. Please copy this page as necessary.)

“None” – Check here if no other sources of support. List names of Principal Investigators below.

PI Name

Support Current Pending Submission Planned in Near Future

Project/Proposal Title

Source of SupportLevel of Effort (%)

Award Amount Period Covered

Location of Research

PI Name

Support Current Pending Submission Planned in Near Future

Project/Proposal Title

Source of SupportLevel of Effort (%)

Award Amount Period Covered

Location of Research

PI Name

Support Current Pending Submission Planned in Near Future

Project/Proposal Title

Source of SupportLevel of Effort (%)

Award Amount Period Covered

Location of Research

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A.11. Principal Investigator Partnership Statement

Please complete using this Template/Sample. Please use Institute Letterhead. Document must be signed and scanned.

[INSTITUTE LETTER HEAD]

Re: [Full Proposal Title]

I, [Principal Investigator (PI) Name], hereby acknowledge that I have submitted a proposal to Indo-U.S. Joint Program on HIV/AIDS and STI Prevention Research Collaboration Awards, 2018 jointly with [collaborating PI Name(s)] of [collaborating PI institution name].

If awarded, I undertake this research in good faith and will uphold my portion of the collaborative work as proposed in the submission.

I attest that the information contained in this proposal is truthful and that it has been prepared with the full knowledge and consent of [Institutional Leadership Representative Name], leadership representative of [Institution].

I affirm that I have read and understand CRDF Global’s policies and standards outlined within the Indo-U.S. Joint Program on HIV/AIDS and STI Prevention Research Collaboration Awards, 2018 RFP, including CRDF Global’s Plagiarism Policy5. I agree to adhere to CRDF Global’s Plagiarism Policy, and understand that CRDF Global will not provide funding to an application in which plagiarism exists. If plagiarism is detected, penalties may be imposed up to and including my exclusion from this funding opportunity and barring my participation in future funding opportunities.

__________________________________________________ __________________ Principal Investigator Signature Date

5 For more information, please see CRDF Global's Plagiarism Policy

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A.12. Plagiarism Policy and Standards AgreementProvide a copy signed by EACH sub-team PI on the proposal.

CRDF Global will not provide funding to an application in which plagiarism exists.

All applications for funding submitted to CRDF Global will be thoroughly screened for plagiarism against a large number of sources including published research papers, books, conference abstracts, and websites.

When plagiarism is detected, the program within CRDF Global that is overseeing the funding opportunity will determine the specific action to be taken. Action taken may include, but is not limited to a) informing the applicant that plagiarism has been discovered; b) excluding the applicant from the funding opportunity; c) informing the applicant’s institution; d) informing reviewers; e) informing organizations collaborating with CRDF Global on the funding opportunity; f) barring the applicant from participation in future funding opportunities.

StandardsDefinition: Plagiarism is the incorporation of published writing or another person’s original writing into your document without clear formatting and accurate attribution of the source. Academic writing such as a funding proposal must be original work, written by the stated applicant(s). Any text derived from another published source, or from an author not listed in the proposal, must be formatted to clearly indicate that it is not original writing of the applicant(s), and the correct citation to the original source must be given. Proper formatting is either the use of quotation marks around all of the borrowed text or indentation of the borrowed text to clearly set it off from your own writing.

Examples of plagiarism include, but are not limited to, the following cases. Using your own previously published text in the proposal without proper formatting and attribution. This is a

common error. Even if you wrote the text, you cannot reuse text that you have published in any publicly available form, such as in a research paper, on a website, or in a conference abstract. Even your own previously published text must be formatted and a correct citation to the source must be given.

Making minor alterations to previously published text and presenting it without proper formatting and citation. Simply changing some of the words within previously published text does not make it your original writing. To avoid plagiarism, the writing must be your original words, sentence structure, and organization. This is another common error.

Presenting the original writing of another person, even if it hasn't been previously published, as the work of the applicant(s). If someone contributes writing to your proposal, that person must be one of the listed participants (principal investigator or named team member) in the proposal. Even if another person agrees to write text for your proposal and agrees not to be named in the proposal, the use of that person’s writing as if it is your own is plagiarism.

Copying a sentence or obviously unique phrases from another source without formatting and attribution. Stealing a little bit is still stealing. If the text is clearly recognizable as derived from a previously published source then it must be formatted with proper attribution.

Giving the correct attribution (citation) at the end of copied text but not formatting the text to clearly indicate that it is taken from the cited source. In the sciences and engineering, it is not sufficient to simply give the citation if the text is from another source it must be clearly formatted to show that.

I affirm that I have read and understand the above policy and standards for plagiarism, and I agree to adhere to them.

____________________________________ ______________________PI Signature Date

____________________________________ PI Name

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A.13. Institutional Data FormThis is a CRDF Global requirement. Only U.S. sub-team needs to complete.

Institution Name:Institutional Website:Type of Organization: ☐ International Organization ☐ Government ☐ Corporation ☐ University

DUNS Number Organizations must have a DUNS number to receive federal funding. For help applying for a DUNS number and more guidance on completing this form, please click here.

US Organizations OnlyTIN/EIN

Small Business Designations ☐ Small Business ☐WOSB ☐ SDB ☐ HUB-Zone ☐ VOSB ☐ SDVOSB ☐ N/AFinancial Controls, Audits, & Bioethics

Did your organization expend more than US $750,000.00 in U.S. Government Federal Funding (Grants, Contracts, Subgrants, Subcontracts) in the previous fiscal year? If yes, please provide a copy of your single audit report, which is required under 2 CFR 200.

☐ Yes ☐ No

Have you been audited in the past 3 years? If yes, please send a copy of the report. ☐ Yes ☐ No Were there any material or significant findings in the audit report? ☐ Yes ☐ No Has your organization ever had a grant or contract terminated for cause? ☐ Yes ☐ No Does your organization utilize a financial manual to authorize expenses? ☐ Yes ☐ No Does your organization utilize an accounting system to track expenses? ☐ Yes ☐ No Does your organization have an ethics policy? ☐ Yes ☐ No Does your organization have a timekeeping system for labor such as timesheets? ☐ Yes ☐ No Does your project involve: ☐ Human Subjects ☐ Animal Subjects ☐ Recombinant DNA ☐ N/AOHRP IRB#

OHRP FWA#: AAALAC Accreditation: ☐ Yes ☐ No

Executive/Management Reporting RequirementsCRDF Global may be required to publicly report the names and total compensation of the five most highly compensated individuals at the awardees’ institution. If you meet any of the criteria below, you are exempt from this requirement. Please find and check any applicable exemption:

1. In the previous tax year, institutional gross income from all sources was LESS than $300,000. ☐ Exempt

2. The institution received LESS than 80 percent of its annual gross revenues in U.S. federal funding (Contracts, Grants, Subgrants, Subcontracts or Loans).

☐ Exempt

3. The institution received LESS than $25,000,0000 in annual gross revenues from U.S. federal funding sources (Contracts, Grants, Subgrants, Subcontracts or Loans).

☐ Exempt

4. Executive compensation is publicly reported under section 13(a) or 15(d) of the Security Exchange Act or section 6104 of the Internal Revenue Code.

☐ Exempt

I do not meet any of the exemptions above. I will provide the names and total compensation of the five most highly compensated executives. Click here for more information.

☐ Not Exempt

Past PerformancePlease list any applicable grants or contracts received from outside organizations. Successful completion is

defined as zero suspensions or terminations for cause, audit findings or other discrepancies. Funding Source Total Funding Successful Completion? Type of Project

World Bank Ex. 50,000USD ☐ Yes ☐ No Research Grant☐ Yes ☐ No ☐ Yes ☐ No

The information requested above must be provided in full and signed by an authorized institutional signatory, certifying that the information is true to the best of their knowledge. CRDF Global cannot proceed with an award to the institute without this information.

Signature Name and Title Date

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A.14. Format of Summary Sheet for New Project Proposals Involving Foreign Collaboration/Assistance,

This is an ICMR requirement. This document should be completed by Indian sub-team only.

1. Title of Project:

2. Name of Indian Institution(s):

3. (a) Name of Indian Principal Investigator(s) and Co-Investigator(s) with designation, address and Tel. No. / e-mail address:

(b) List of ongoing International projects being undertaken by the Indian PI (Title/ Funding Agency /Duration):(i)Clinical trials:(ii)Observational studies:(iii)Other projects:

4. Name and address of International Agency with which collaboration is proposed:

5. Name of foreign collaborating scientist(s) with designation, address and Tel. / e-mail address:

6. Source of Funds(i) Foreign funding agency:(ii) ICMR under bilateral programme/MoU (in response to Call for Proposals)

7. Duration of the project:

8. (a) Budget in Indian currency:Item Total budget

(INR)Budget for Indian Investigator (INR)

StaffEquipmentContingency (including chemicals, reagents etc.)Travel (including manpower training)MiscellaneousTOTAL

(b) Please indicate the reference (page no.) in the enclosed project proposal where full justification for the budget allocated to the Indian Investigator is mentioned:

(c) Year wise break up of exchange of scientists/ technicians with duration of each

visit

(i) Number of visits (both ways):

(ii) Duration of visits:

9. Objectives of the project:

10. Expected outcomes/Implications for Indian National Health Programmes or Priorities:

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11. (a) Justification for Indian Investigator for collaboration/ financial assistance from the foreign funding agency:

(b) Justification for foreign Investigator collaboration with an Indian Investigator/ institution:

12. Does the collaborating Indian agency or Institution have personnel with the requisite qualifications and equipment to concurrently conduct and monitor the progress of the research?

13. Who will control activities (Indian PI/Foreign PI/both) in India during the execution of the project?

(i) Financial/Administrative control:(ii) Technical aspects:(iii) In-country research:(iv) Data analysis:(v) Publications/Presentations (those including Indian data):

14. a) What will be the likely places to be visited within the country by the foreign coll26. aborator(s)?

b) Will the project involve visits of foreigners to sensitive areas in the country? If so, please specify the concerned Ministry, GoI from which the clearance has/will be obtained.

15. Does the project involve employment or stationing of foreigners in India, if so how many and where?

16. Does the proposal envisage transfer of any biological material including cultures, organisms, antigens, anti-sera or entomological specimens? If so, specify the purpose and quantity of the biological material (Enclose a duly signed Material Transfer Agreement in prescribed format).

17. Does the proposal envisage the possibility of import / gift of equipment, chemicals etc from the collaborating agencies to the Indian group? Has the clearance been obtained from the appropriate GoI authorities/Ministry?

18. Are there any special precautions /safety necessary in the project with reference to use of radio-active materials, recombinant DNA/genetic engineering work, environmental pollution, cytotoxicity to plants, animals and humans. If yes, has the clearance been obtained from the appropriate GoI authorities/Ministry?

19. Will the research be conducted in accordance not only with the country’s own environmental standards, but with international environmental standards as well?

20. Does the proposal confine itself to experimental work in the laboratory?

21. Does the project involve field trials / testing? If so, please indicate reference (Page no.) of the details in the enclosed project proposal.

22. Specify the ethical issues involved, if any. Enclose a copy of the Institutional Ethics Committee approval by an IEC constituted as per the ICMR ethical guidelines for biomedical research on human subjects/animal experimentation.

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23. Do the terms of collaboration ensure that all data and materials collected/generated in India are owned by Indian PI? Has a Memorandum of Understanding been signed to this effect?

24. Is foreign assistance is being sought for analysis of the data or will the data will be held and analyzed entirely within India?

25. Will raw or analysed data collected during the project be shared with the foreign collaborative agencies? Briefly describe plans for data sharing, including removal of identifiers.

26. Is the data to be computerized and incorporated into computerized data banks abroad? If so, will measures be taken to suitably “sanitize” such data?

27. Is geographical information being collected/analyzed? If yes, please specify the source/geographical area.

28. Is there any project related information which could compromise security / sensitivity aspects of the country?

29. Do you think that the results of collaborative research could be commercially exploited? If so,i. Specify the Intellectual Property Rights (IPR) issues involved.

ii. How these issues have been addressed?

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A.15. ICMR MATERIAL TRANSFER AGREEMENTThis is an ICMR requirement.

This document should be completed by Indian sub-team only.

1. Title of the project along with the funding agency & date of approval by HMSC

2. Name and address of the Institution where material is to be sent:

3. Name and address of the Institution providing the bio-material:

4. Bio-material to be transferred:

5. Quantity to be transferred:

6. Purpose and need of transfer of the material:

7. Type of research/investigation to be carried out using the material:

8. Safety norms to be observed during transit:

9. Safety norms to be observed while working with the bio-material:

10. Any other relevant information pertaining to this bio-material:

This transfer is governed by the following conditions:

1. The bio-material would not be used for any future commercial purposes other than those stated above.

2. The collaborating Institution would be the only user of the bio-material.3. The bio-material would not be transferred to any other person/agency in any circumstances.4. No patent/intellectual property issues shall be filed on any product or process so developed

with this bio-material without the written consent of the collaborating scientists.5. The requesting Institution indemnifies the donor Institution from all damages that may occur

due to improper handling of the bio-material.6. The collaborating Institution shall provide a yearly report on the use of bio-material.7. Mutual agreement by collaborating scientists on publications, confidentiality etc. are to be

agreed to.8. The present MTA shall remain in force for the duration of the research proposal and can not be

transferred/assigned to any other Scientists or Institutions9. The guideline issues by the MOHFW, GOI vide O.M. No. L-190155397-IH (Pt) dated 19th Nov.,

1997 are to be followed for proposals involving transfer of human biological material for biomedical research purposes.

Signature: Signature:

(Indian Principal Investigator) (Foreign Principal Investigator)

Date:

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APPENDIX B: CHECKLIST OF ITEMS REQUIRED FOR PROPOSAL SUBMISSION

BEFORE submitting through CRDF Global’s Electronic Proposal Submission (EPS) site, please ensure you have the following documents/information prepared as specified and ready to upload from your computer.

1. Documents/Information combined into a SINGLE PDF, Word, or Rich Text file: General

Proposal topic and project plan are responsive to the RFP No more than one proposal is submitted by a PI Each sub-team has at least ONE early-career and female investigator included as a key participant

A.1. Cover Sheet All fields are completed Signed by Indian PI and Indian Institute Leadership Representative.

A.2. Project Abstract Does not exceed 350 words

A.3. Project Narrative All project criteria are addressed Text is within five (5) page limit Formatted properly (typed, single spaced, one inch margins, page numbers, font no smaller than Arial

10 pt) Authors names are included at end of section

A.4. References Cited A.5. Project Milestone Plan

Written based on the instructions in Section VI (Required Elements) and sample (Appendix C) Should include clear, discrete, verifiable milestones; deliverables must be associated with each

milestone A.6. Sub-Team Key Participant Data Form

All fields are completed for all participants (other than Project PIs) A.7.i. Sub-Team Budgets (U.S. Sub-Team)

Follows Allowable Costs guidelines One budget included for U.S. sub-team The U.S. budget does not exceed $120,000 USD Indirect costs are supported by NICRA

A.7.ii. Sub-Team Budget (India Sub-Team) Follows Allowable Costs guidelines One budget included for participating Indian sub-team Indirect costs (if applicable) for sub-team does not exceed XX% of direct costs

A.8.i. Budget Narrative (U.S. Sub-Team) One form included for each participating U.S. sub-team that describe all expense listed in respective

budgets Any equipment valued over $1,000 includes an additional detailed justification For travel expenses, all trips are justified with description of who is traveling, to where and for how long.

Airfare, lodging and per diem costs for each trip are clearly stated A.8.ii. Budget Narrative (India Sub-Team)

One form included for participating Indian sub-team that describe all expense listed in respective budgets

Any equipment valued over $1,000 includes an additional detailed justification For travel expenses, all trips are justified with description of who is traveling, to where and for how long.

Airfare, lodging and per diem costs for each trip are clearly stated A.9. Project Team Budget Overview

One budget included for each participating Indian and U.S. sub-team The U.S. and Indian budgets combined do not exceed $240,000 USD

A.10. Statement of Other Sources of Support of Key Personnel At least one (1) form is completed for each PI

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If no other support reported, the form is completed with the PI’s name and the “none” box checked at the top of the page

A.11. PI Partnership & Terms Agreement Statement One for each U.S. and Indian PI on the proposal Written based on provided template On institute letterhead and signed by PI

A.12. Plagiarism Policy and Standards Agreement Scanned copy of the Agreement signed by the Indian and U.S. PIs.

A.13. Institutional Data Form ( CRDF Global requirement for U.S. sub-team only) The form can be retrieved at http://www.crdfglobal.org/grants/institutional-data-form One for each U.S. Institution on the proposal

A.14. Format of Summary Sheet for New Project Proposals Involving Foreign Collaboration/Assistance (ICMR Requirement, For Indian sub-team only)

A.15. ICMR Material Transfer Agreement (ICMR Requirement, to be signed by US and Indian PI)

2. Additional Documents to be uploaded to website as SEPARATE files from the main proposal file: CV for U.S. & Indian PIs and all team participants

PI CVs no more than five (5) pages. Team participant CVs are not more than two (2) pages. Each form has a corresponding detailed CV compiled as a separate document which is submitted

separately from the proposal Special Documentation Requirements (if applicable)

Proposals involving Human and or Animal Subjects research only: For U.S. sub-teams only CRDF Global Protocol Summary Form for Human Subjects CRDF Global Protocol Summary Form for Animal Subjects

Proposals involving Human and or Animal Subjects research only: For Indian sub-teams only http://www.icmr.nic.in/guidelines/ICMR_Ethical_Guidelines_2017.pdf

Submission Requirements

□ CRDF Global Submission Requirements: All documents submitted to CRDF Global MUST be entered through the competition’s specific Electronic Proposal Submission (EPS) website; proposals sent as e-mail attachments will NOT be accepted.

□ The following documents to be uploaded to website as SEPARATE files:o Proposal combined into a SINGLE PDF or Word fileo CVs combined into a SINGLE PDF or Word fileo Human and/or Animal Subjects research documentation combined into a SINGLE PDF or Word file (as

applicable)□ ICMR Submission Requirements: All documents submitted to CRDF Global MUST be re-submitted to ICMR

through its e-PPMS website; proposals sent as e-mail attachments will NOT be accepted. Additionally ICMR requires the following additional documentation:

o ICMR Summary Sheeto Additional Documents for NGOs: The proposals to be submitted by Non-Governmental Organizations

(NGOs) should be accompanied with the following additional documents/justifications:  The annual reports, statement of accounts, achievements and their role in the project.  Justification for the budget with exact amount to be used under different heads with full

explanation.  The composition of the Institutional Ethics Committee as per the  ICMR ethics guidelines for

biomedical research on human subjects.

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APPENDIX C: REPORTING FORMAT Teams will use this format for both Semi-Annual Progress Reports and Final Project report.

1. Project title

2. PI (name & address)

3. Co-PI (name & address)

4. Date of start

5. Duration

6. Objectives of the proposal

7. Methodology

8. Interim modification of objectives/methodology (with justifications)

9. Summary on progress (during the period of report)

10. Detail of the results with interim analysis (both India and US)

11. Applied value of the project

12. Research work which remains to be done under the project

13. Any publications.

14. Any patents applied for

15. If additional budget or staff is required for the remaining part of the research work, please give justifications and details.

Signature:

Print Name:

Designation:

Date:

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