NOT-MH-12-001: Notice of Availability of Administrative Supplements for U.S.

Notice of Availability of Administrative Supplements for U.S. - Russia Collaborative HIV/AIDS Research

Notice Number: NOT-MH-12-001

Update: The following update relating to this announcement has been issued:

January 4, 2012 - See Notice NOT-MH-12-012. The purpose of this Notice is to further clarify four issues related to the intent of the supplement opportunity; Subcontracts, Application, Appendices, Foreign Clearance.
December 7, 2011 - See Notice NOT-MH-12-011. The purpose of this Notice is to further clarify the intent of the supplement opportunity described in this Notice.

Key Dates
Release Date: October 12, 2011
Receipt Date: January 15, 2012
Earliest Anticipated Start Date: July 1, 2012

Issued by
National Institute of Mental Health (NIMH)
National Cancer Institute (NCI)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
Fogarty International Center (FIC)

Purpose

The National Institutes of Health (NIH) supports international collaborative research and research training on HIV/AIDS and the exchange of scientific information by HIV/AIDS researchers around the world. Scientific cooperation during the global HIV/AIDS pandemic has been strengthened between the United States (U.S.) and Russia. Further cooperative research and capacity-building focused on HIV/AIDS would be of mutual benefit to the U.S. and Russia. Therefore, the U.S. Secretary of Health and Human Services (HHS) supports the efforts of the NIH and the Russian Foundation for Basic Research (RFBR), to advance a new extramural research initiative.

A recent agreement between the NIH and the RFBR seeks to facilitate and support collaborative research partnerships (CRPs) among researchers and institutions in the U.S. and Russia via administrative supplements to existing NIH grants. Supplement requests may be derived from existing collaborations with an established history of interaction, or from new partnerships developed in response to this Notice provided the proposed research is within scope of the approved research aims of the parent grant. The CRP must be based on an interactive relationship that maximizes the expertise of the individual U.S. and Russian research teams as well as the interaction between their parent institutions and granting agencies. It is expected that these awards will develop and mature, leading to joint programs to pursue HIV/AIDS prevention strategies/interventions beyond the scope of the proposed supplement request.

This Notice is for administrative supplements for projects on HIV/AIDS research in the following priority areas: the basic science of HIV, microbicides, vaccines, behavioral and social science research, HIV-related co-morbidities, and genomics.

The number of administrative supplements awarded will be based on the merit of the administrative supplement requests received and the availability of funds. The NIH and RFBR each plan to contribute funding for every project selected for funding. Administrative supplement requests should not exceed 1 year and should request no more than $100,000 U.S. dollars (direct costs) or 25 percent of the Council-approved direct costs for the current budget year of the project (the lower of these amounts is the maximum allowable) from the NIH and up to 500,000 rubles from the RFBR. Applications that exceed these limits will not be accepted.

Research and Capacity-Building Objectives

The intent of this Notice is to foster collaborative research and capacity-building between current NIH grantees and Russian researchers working on HIV/AIDS. Highest priority will be given to collaborative HIV projects that focus on the basic science of HIV (e.g., molecular biology and immunology), microbicides, vaccines, behavioral and social science research, infectious and non-infectious co-morbidities, and genomics. Specific co-morbidities of high interest include HIV/AIDS and cancer, tuberculosis (TB), and the intersection of injection and non-injection drug use, alcohol abuse, and mental health problems for individuals with HIV/AIDS. Applicants are also encouraged to integrate these important domains- for example, a study to examine behavioral/adherence facilitators of microbicide use, or studies regarding the basic science or genomics of HIV in the context of vaccine development.

It is anticipated that administrative supplements supported through this program will result in sufficient preliminary data to allow the researchers to compete successfully for new NIH grants (e.g., R01, R21, R03).

Examples of topic areas that may be supported include, but are not limited to:

Basic Science of HIV

Studies to develop and enhance a range of laboratory assays to evaluate vaccine-induced blood and mucosal human immune responses that may be protective
Studies of the genetic variability of HIV and of the host, at sites that are conducting or may conduct future HIV vaccine, microbicides, or treatment as prevention (pre-exposure prophylaxis) clinical trials
Studies of the biology of HIV transmission, including horizontal and vertical (perinatal) transmission

Microbicides

Studies to understand the effects of adherence to product, including the implications for product efficacy, effects on the risk for resistance during and after efficacy trials of ARV-based prevention strategies, differential effects by sex, population level impacts, etc.
Studies to expand the battery of reliable and valid assessment tools to inform biomedical HIV prevention-product acceptability (e.g., microbicides), measure risk taking, and assess adherence to study regimens and HIV prevention guidelines
Preclinical developmental studies of microbicides and other pre-exposure prophylaxis (PrEP) modalities
Studies focused on the safety, acceptability, pharmacokinetics, and pharmacogenomics of microbicides and other PrEP agents in adolescents and adults

Vaccines

Studies of immunogenic reagents in phase I/II studies -- to address specific scientific questions, designing studies clearly outside the critical pathway of product development, but important in forwarding vaccine discovery
Studies of the feasibility and acceptability of testing vaccines in specific populations at risk for HIV infection
Studies to improve the range of laboratory assays to evaluate vaccine-induced blood and mucosal human immune responses that may be protective
Studies to design a simple to use, rapid HIV point-of-care diagnostic device for use in resource-limited settings that can distinguish HIV-infected from seronegative vaccinated individuals, as well as identify acute infection
Studies of the behavioral and social aspects of vaccine interventions in preventing HIV infection

Behavioral and Social Science

Studies of individual and community-based strategies to improve access, engagement, and sustained participation of most at risk populations, including men who have sex with men, adolescents, female sex workers, and persons with mental health and substance abuse disorders, in HIV/AIDS behavioral and biomedical research
Studies designed to evaluate individual or community-based prevention outreach and interventions targeted to adolescents or adult men or women at risk for HIV through high- risk sexual behaviors, drug or alcohol use, and/or pre-existing mental disorders
Studies of innovative strategies to facilitate linkage to medical care after HIV-testing, and to promote treatment initiation and adherence, retention in HIV care and transmission risk reduction in pediatric, adolescent and adult populations
Studies of behavioral decision-making under conditions of uncertainty, partial efficacy, and preventive misconceptions about the efficacy of experimental products or the benefits of participation in clinical trials (for microbicides, PrEP, vaccines, other interventions)
Studies addressing prevention of mother-to-child HIV transmission, through pregnancy prevention, increasing HIV testing in antenatal settings, and/or use of antiretroviral prophylaxis to prevent transmission

Co-Morbidities

Tuberculosis

Studies of immunologic interaction between TB and HIV infection
Studies designed to identify biomarkers of TB activation, disease progression, and disease relapse in HIV/TB co-infected individuals
Risk factor studies for the development of drug resistance in HIV- infected individuals, and HIV/TB co-infected individuals
Studies of risk factors for TB transmission among HIV-infected individuals
Studies of treatment and clinical outcomes among HIV/TB co-infected pregnant woman and their infants
Studies to develop and test better models for pediatric TB diagnostics and management
Studies evaluating anti-HIV and anti-TB drug interactions and toxicities among children, pregnant women, and adults

Cancer

Studies on the interactions between HIV and oncogenic viruses such as Human Papilloma Virus (HPV), Epstein-Barr Virus (EBV), Kaposi’s Sarcoma-associated Herpes Virus, and Hepatitis B and C Virus (HBV and HCV) and cancer development
Systematic studies to collect information on incidence/prevalence and outcomes of HIV-associated malignancies
Studies aimed at elucidating epidemiological factors that impact the risks, and region specific patterns of HIV-associated malignancies, including viral, host, behavioral and other host genetic factors

Non-injection and Injection Drug Use, Alcohol Use and Abuse

Studies of the social and behavioral factors associated with drug and alcohol use which affect utilization of HIV testing and sexual and substance use risk reduction counseling in adolescents and adults; pilot interventions to increase access and utilization to testing and counseling
Studies of medical and behavioral treatment interventions for drug and/or alcohol abuse combined with biomedical treatment for HIV and associated co-morbidities such as HCV and TB
Studies of HIV prevention interventions targeting specific high-risk venues such as bars and clubs or other settings where adults or at-risk youth may congregate, as well as in medical settings concerned with the treatment of alcohol or drug use disorders
Studies of the role of drug abuse and alcoholism on the recruitment of individuals into user groups and/or stigma associated with drug and alcohol use in the context of HIV/AIDS
Studies of viral transmission/resistance patterns in context of drug/alcohol use

Genomics

Studies of the genomics/pharmacogenomics of HIV and HIV/TB co-infection
Studies using genetic, epigenetic and proteomic approaches to elucidate differences in histologically comparable malignancies in HIV-positive and HIV-negative individuals
Studies using genomic or proteomic technologies to identify or test surrogate safety, efficacy and/or behavioral correlates to measure the impact of the prevention strategy or alter its implementation
Studies of use of genomic, epigenomic or proteomic technologies to understand the impact of substance abuse on HIV transmission dynamics and pathogenesis

Budget and Funding Information

In FY2012, it is anticipated that funds will be available for up to 15 administrative supplements to eligible NIH research grants. Individual administrative supplements requests should not exceed $100,000 direct costs and are limited to 25 percent of the Council-approved direct costs for the current budget year of the project (the lower of these amounts is the maximum allowable). Awards will be for 1 year and the existing grant must have at least 1 year remaining at the time that the supplement is submitted.

Administrative supplements for funded R01, R21, P01, U01, and P30 grants will be allowed. For Fogarty grantees, only AIDS International Training and Research Program (AITRP) projects (D43 grants) in Russia are eligible. Administrative supplement requests will also be accepted to supplement projects in the AIDS Malignancy Consortium, AIDS Cancer Specimen Resource, Centers for AIDS Research (CFAR), and the HIV/AIDS Clinical Trial Networks.

These funds cannot be used to conduct a clinical study requiring an investigational new drug including a phase 0, I, II, and/or III clinical trial, delivery of treatment, screening efforts to identify new therapeutic compounds for the cancers or sexually transmitted infections - associated with HIV acquisition.

Eligibility

IMPORTANT INFORMATION FOR APPLICANTS: The research or capacity-building proposed by the NIH grantee in the collaboration must be within the original scientific scope of the NIH-supported grant project. Administrative supplements can be used to cover cost increases within the original scientific scope of the project, that result from making modifications to the project in order to take advantage of the proposed collaborations and activities that would increase the value of the project. Applicants must provide evidence of the ongoing or proposed scientific collaborations necessary to support the proposed activities.

Administrative supplements may be submitted at any time before, but no later than 5:00PM in the applicant’s local time zone on January 15, 2012. Supplemental funds will be awarded by September 30, 2012.

Concurrent to the NIH administrative review, the RFBR will engage in an administrative review of all applications submitted to RFBR. Funding decisions will be made jointly and will consider the research priorities of both countries. Requests for supplements must comply with NIH policies for the inclusion of women, minorities, and children in research involving human subjects.

Before any funds can be expended for in-country research activities in a foreign country, the grantee institution must show evidence of compliance with U.S. and Russian regulations for the conduct of research involving human subjects. Additional information can be found at the HHS Office for Human Research Protections website: http://www.hhs.gov/ohrp.

To be eligible the parent grant must be active, and the research proposed in the supplement must be accomplished within the current competitive segment. The proposed supplement must be within the general scope of the peer-reviewed activities and aims approved within the parent grant.

Submitting an Administrative Supplement Request

Application Procedure

The U.S. scientists apply for funding in accordance with the NIH rules and the Russian scientists in accordance with the RFBR rules. In addition to submitting their NIH supplement request, the NIH applicant should collaborate with their Russia counterpart, and assist in the preparation of the Russian application that is submitted in parallel to the RFBR call for applications. Applications are only eligible if both an NIH and RFBR application is submitted.

To apply for a supplement, applicants must submit the following:

A cover letter citing this NOTICE, NOT-MH-12-001, requesting an administrative supplement, and containing the following information:

Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) name (must be the same as the PD/PI of the parent grant)
Parent grant number and title
Amount of the requested supplement
Name and title of the institutional official
Phone, email, and address information for both the PD(s)/PI(s) and institutional official.
The cover letter must be signed by the authorized organizational representative/institutional official.

Page 1 of the PHS398 grant application form, citing "Administrative Supplements for U.S.-Russia Collaborative HIV/AIDS Research in Line 2. Applicants must complete Page 1, and also include the signatures of the NIH grant Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) and authorized institutional budget office official from the NIH grant. Note that:

The title of the project should be the title of the parent award.
This Notice should be cited in Box 2, and the yes box should be checked.
The PD(s)/PI(s) must be the same as the PD(s)/PI(s) on the parent award. For Multiple PD(s)/PI(s) parent awards, the Contact PD/PI must be the PD/PI listed on the supplement request, and the supplement cannot change the Multiple PD(s)/PI(s) team.
The remaining items on the face page should be filled out in accordance with the PHS 398 application instructions.
On PHS 398 Form Page 2, the project summary is that of the administrative supplement, not the parent grant.

An abstract (no more than one page)

Research plan (no more than 6 pages) that includes:

Scientific description: Specific Aims and appropriateness of the parent NIH grant as a basis for the supplemental application. For research projects, a rationale/justification for the research, a detailed description of the supplemental project, monitoring plans, and expected outcomes, including: subject population, methods, and data analysis.
Added value expected from the collaboration: Planned research collaboration (with a timeline and distribution of work and methods of implementation); responsibilitiesof both partners; consolidated budget of the joint research project along with the separate budgets from both partners (to include substantiated costs for salaries, researchers mobility, joint meetings, etc.); the project’s significance to researcher’s career development and to developments in the research environment; the expected outcome of the proposed project, scientifically as well as in terms of its relevance for society and industry; the ongoing activities and specific advantages of the Russian and American groups respectively which form the basis for the proposed joint project; and how the project is expected to help strengthen research cooperation between Russia and U.S. over the longer term.
Explanation of how the proposed activities are within scope of the parent grant.
Other items to include are:
Biographical Sketch for all new key personnel (those who are additions on the supplemental project)
Letter from Russian investigator(s) which provides supportive evidence of the collaboration necessary to support the proposed activities.
Human Subjects/ Vertebrate Animal documentation (if applicable).
Include a current Human Subjects/IRB or Vertebrate Animals/IACUC approval letter, if available. Otherwise, this will be required at the time of funding. All appropriate IRB and IACUC approvals must be in place prior to a supplement award being made.
Any differences in the involvement or use of human subjects or specimens, or use of vertebrate animals, between the administrative supplement activity and the parent grant should be noted.
When appropriate, details should be provided on the protection of human subjects and inclusion of women, children, and minorities. Additional guidance on Human Subjects Research and Vertebrate Animals is provided under Part II of the PHS 398 instructions.
PHS 398 Checklist Form

Submission of Applications

An email mailbox has been set up for the receipt of Administrative supplement applications. Applications must be submitted as an e-mail attachment(s) in pdf format to: [email protected].

Contact Brian Remortel at [email protected] for issues related to electronic submission.

To be considered for an administrative supplement, the request must be signed by the Authorized Organizational Representative/Signing Official (AOR/SO), and must describe the need for additional funding and the categorical costs.

Please note: Applications should NOT be sent to the NIH Center for Scientific Review (CSR).

Requests must be submitted on the PHS398 Application forms available at: https://grants.nih.gov/grants/funding/phs398/phs398.html (font size and other formatting rules apply as designated in the instructions).

Selection

Administrative supplement requests will be reviewed administratively by NIH Staff. Selection factors will include the following:

Responsiveness to the goals and scientific priorities of this initiative
Quality of the scientific approach
Appropriate and well-described plan to accomplish the goals within the timeframe proposed
Relevance of the proposed activities to the parent grant
Adequate progress of the parent grant appropriate to the current stage of the project
Expertise of the research team proposed to conduct and achieve the project goals

Inquiries

Inquiries and discussion of plans for responding to this Notice are strongly encouraged.

Direct inquiries regarding scientific, programmatic, and review matters to the appropriate Program Official listed below:

NCI
Geraldina Dominguez, Ph.D.
Office of HIV and AIDS Malignancy
National Cancer Institute (NCI)
31 Center Drive, Room 3A33, MSC 2440
Bethesda, MD 20852-2440
Telephone: (301) 496-3204
Email: [email protected]

NCI Basic Science Inquiries
Elizabeth Read-Connole, Ph.D.
Division of Cancer Biology
National Cancer Institute (NCI)
6130 Executive Boulevard. Suite 5016, MSC 7398
Bethesda, MD 20892-7398
Telephone: (301) 496-6085
Email: [email protected]

NIAAA
Kendall J. Bryant, Ph.D.
HIV/AIDS Coordinator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
5635 Fishers Lane, Room 2062, MSC 9301
Bethesda, MD, 20892-9304
Telephone: (301) 402-9389
Email: [email protected]

NIAID
Jon Warren, Ph.D.
Vaccine Research Program
Division of AIDS (VRP, DAIDS)
National Institute of Allergy and Infectious Diseases (NIAID)
6700-B Rockledge Drive, Room 5135
Bethesda, MD 20892-7628
Telephone: (301) 402-0633
Email: [email protected]

NICHD
Lynne M. Mofenson, M.D.
Center for Research for Mothers and Children
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 4B11E, MSC 7510
Rockville, MD 20852-7510
Telephone: (301) 435-6870
Email: [email protected]

NIDA
Katherine Davenny, PhD
Associate Director, AIDS Research Program
National Institute on Drug Abuse (NIDA)
6001 Executive Boulevard, Room 4215, MSC 9582
Bethesda, MD 20892-9582
Telephone: (301) 443-2146
Email: [email protected]

NIMH
Christopher M. Gordon, PhD
Secondary HIV Prevention and Translational Research Branch
National Institute of Mental Health (NIMH)
6001 Executive Boulevard, Room 6212, 9619
Bethesda, MD 20892-9619
Telephone: (301) 443-1613
Email: [email protected]

FIC
Marya Levintova, Ph.D.
International Health Program Officer for Russia, Eurasia and Arctic Affairs
Division of International Relations
Fogarty International Center (FIC)
31 Center Drive, Room B2C11, MSC 2220
Bethesda, MD 20891-2220
Telephone: (301) 496-4784
Email: [email protected]

Direct inquiries regarding administrative and fiscal matters to:

Rita Sisco
Division of Extramural Activities
National Institute of Mental Health (NIMH)
Telephone: (301) 443-2805
Email: [email protected]