US-INDIA funding opportunity for HIV Prevention Research

[Guest guest]

Department of Health and Human Services

Participating Organizations

National Institutes of Health (NIH), (http://www.nih.gov/)

Components of Participating Organizations

National Institute of Allergy and Infectious Diseases (NIAID),

(http://www.niaid.nih.gov)

National Cancer Institute (NCI), (www.nci.nih.gov)

National Heart Lung and Blood Institute (NHLBI), (www.nhlbi.nih.gov)

National Institute on Alcohol Abuse and Alcoholism (NIAAA), (www.niaaa.nih.gov)

National Institute of Child Health and Human Development (NICHD),

(http://www.nichd.nih.gov/)

National Institute on Drug Abuse (NIDA), (www.nida.nih.gov)

National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/ )

Title: U.S.-India Bilateral Collaborative Research Partnerships (CRP) on the

Prevention of HIV/AIDS (R21)

Announcement Type

New

NOTICE: Applications submitted in response to this Funding Opportunity

Announcement (FOA) for Federal assistance must be submitted electronically

through Grants.gov (http://www.grants.gov) using the SF424 Research and Related

(R & R) forms and the SF424 (R & R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included

with this announcement in Grants.gov/Apply for Grants (hereafter called

Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly

encouraged to start the process at least four weeks prior to the grant

submission date. See Section IV.

Request For Applications (RFA) Number: RFA-AI-07-031

For Assistance downloading this or any Grants.gov application package, please

contact Grants.gov Customer Support at http://grants.gov/CustomerSupport

Catalog of Federal Domestic Assistance Number(s)

93.242, 93.273, 93.279, 93.393, 93.394, 93.396, 93.855, 93.856, 93.865, 93.839

Key Dates

Release/Posted Date: July 18, 2007

Opening Date: August 18, 2007 (Earliest date an application may be submitted to

Grants.gov)

Letters of Intent Receipt Date(s): September 18, 2007

NOTE: On time submission requires that applications be successfully submitted to

Grants.gov no later than 5:00 p.m. local time (of the applicant

institution/organization).

Application Submission/Receipt Date(s): October 18, 2007

Peer Review Date(s): January 2008

Council Review Date(s): January 2008

Earliest Anticipated Start Date(s): April 2008

Additional Information To Be Available Date (Activation Date): Not Applicable

Expiration Date: October 19, 2007

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Purpose. This Funding Opportunity Announcement (FOA) solicits

Exploratory/Developmental (R21) applications from United States (U.S.)-funded

institutions with an Indian-institution partner to establish Collaborative

Research Partnerships (CRP) in the field of HIV/AIDS prevention with an emphasis

on topical microbicides as well as other modes of HIV/AIDS prevention. The

U.S.-India Bilateral CRP Program is designed to develop collaborations between

scientists and institutions in the U.S. and India to conduct high quality

HIV/AIDS prevention research of mutual interest and benefit to both countries

while developing the basis for future institutional and individual scientific

collaborations. This FOA will utilize the research capacity of the institutions

and scientists in both countries to advance the field of HIV/AIDS prevention and

develop preliminary data that may support a research proposal to test an

HIV/AIDS prevention program with public health significance.

Mechanism of Support. This FOA will utilize the R21 grant mechanism.

Funds Available and Anticipated Number of Awards. It is anticipated that $3

million will be available in FY 2008 to fund 8 to 10 new awards. The Indian

Council for Medical Research (ICMR) and/or other Indian Government research

funding organization plans to issue a similar call for applications to support

the Indian collaborators. Awards issued under this FOA are contingent upon the

availability of funds and the submission of a sufficient number of meritorious

applications.

Budget and Project Period. The total project period for an application

submitted in response to this funding opportunity may not exceed two years.

Direct costs are limited to $275,000 USD over an R21 two-year period, with no

more than $200,000 USD in direct costs in any single year.

Eligible Institutions/Organizations: Public/State Controlled Institutions of

Higher Education; Private Institutions of Higher Education; Nonprofits with

501©(3) IRS Status (other than Institutions of Higher Education); Nonprofits

without 501©(3) IRS status (other than Institutions of Higher Education);

Small Businesses; For-Profit Organizations (other than Small Businesses); State

Government; U.S. Territory or Possession; Indian/Native American Tribal

Government (Federally Recognized); Indian/Native American Tribal Government

(Other than Federally Recognized); Indian/Native American Tribally Designated

Organization; Non-domestic (non-U.S.) Entitity (Foreign Organization);

Hispanic-serving Institutions; Historically Black Colleges and Universities

(HBCUs); Tribally Controlled Colleges and Universities (TCCUs); Alaska Native

and Native Hawaiian Serving Institutions; Regional Organizations; Other(s):

Eligible agencies of the U.S. Federal Government; Faith-based or community based

organizations.

Eligible Project Directors/Principal Investigators (PDs/PIs): Individuals with

the skills, knowledge, and resources necessary to carry out the proposed

research are invited to work with their Institution to develop an application

for support. Individuals from underrepresented racial and ethnic groups as well

as individuals with disabilities are always encouraged to apply for NIH support.

Number of Applications. Applicants may submit more that one application provided

each application is scientifically distinct.

Renewals and Resubmissions: The R21 is not renewable.

Number of PDs/PIs: This FOA does not use the multiple PDs/PIs format. Each

application must list one U.S-funded investigator with a history of U.S. funding

as the PD/PI on the CRP, and one Indian investigator as a collaborating partner.

The NIH will make awards to the U.S. partner while the ICMR and/or other Indian

Government research funding organization will make awards to the Indian partner.

Application Materials. See Section IV.1 for application materials.

General Information. For general information on SF424 (R & R) materials.

Application and Electronic Submission, see these the following Web sites:

SF424 (R & R) Application and Electronic Submission Information:

http://grants.nih.gov/grants/funding/424/index.htm

General Information on Electronic Submission Information of Grant Applications:

http://era.nih.gov/ElectronicReceipt/

Hearing Impaired. Telecommunications for the hearing impaired is available at:

TTY 301-451-0088.

Initial merit review convened by the NIAID Division of Extramural Activities.

Applications are due October 18, 2007.

Table of Contents

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Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Section II. Award Information

1. Mechanism of Support

2. Funds Available

Section III. Eligibility Information

1. Eligible Applicants

A. Eligible Institutions

B. Eligible Individuals

2. Cost Sharing or Matching

3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information

1. Request Application Information

2. Content and Form of Application Submission

3. Submission Dates and Times

A. Submission, Review, and Anticipated Start Dates

1. Letter of Intent

B. Submitting an Application Electronically to the NIH

C. Application Processing

4. Intergovernmental Review

5. Funding Restrictions

6. Other Submission Requirements

Section V. Application Review Information

1. Criteria

2. Review and Selection Process

A. Additional Review Criteria

B. Additional Review Considerations

C. Sharing Research Data

D. Sharing Research Resources

3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information

1. Award Notices

2. Administrative and National Policy Requirements

3. Reporting

Section VII. Agency Contact(s)

1. Scientific/Research Contact(s)

2. Peer Review Contact(s)

3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

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Section I. Funding Opportunity Description

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1. Research Objectives

Purpose

The purpose of the U.S.-India Bilateral Collaborative Research Partnerships

(CRP) on the Prevention of HIV/AIDS is to support innovative and basic research

on strategies to prevent HIV infection and transmission that will advance the

field of HIV/AIDS prevention through the collaborative efforts of U.S. and

Indian investigators and their institutions.

Background

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

between the U.S. and India has been successfully conducted for over forty years

under a variety of bilateral agreements. Recognizing that continuing cooperative

research and research training focused on HIV/AIDS would be of mutual benefit to

the U.S. and India, the U.S. Secretary of Health and Human Services (HHS) and

the Indian Minister of Health and Family Welfare signed a “Joint Statement for

Collaboration on Prevention of Sexually Transmitted Diseases and

HIV/AIDS”(http://www3.niaid.nih.gov/research/resources/PDF/US-IndiaStatmnt_HIV_S\

TD.pdf) in June 2006.

The lead U.S. agency identified to implement activities under this Joint

Statement is the HHS, NIH, and the lead Indian agencies are the Indian Council

for Medical Research (ICMR) and the Department of Biotechnology (DBT). The Joint

Statement calls for the establishment of a Joint Working Group (JWG) to develop

strategic plans for collaboration and to facilitate the expedited review and

clearance of proposed bilateral projects. Both the U.S. Secretary of Health and

Human Services (HHS) and India, (Indian Minister of Health and Family Welfare)

have pledged funds to support joint activities pursued under this bilateral

program.

Collaborative Research Partnerships

A critical feature of this FOA is the establishment and support of CRPs among

researchers and institutions in the U.S. and India. Applications may be derived

from existing collaborations with an established history of interaction, or from

new partnerships developed in response to this FOA. The CRP must be based on an

interactive relationship that maximizes the expertise of the individual U.S. and

Indian research teams as well as the interaction between their parent

institutions and granting agencies. It is expected that the unique opportunity

available through the U.S.-India Collaborative Research Program will foster

collaborative partnerships that will develop and mature, leading to the

establishment of joint programs intended to pursue and develop HIV/AIDS

prevention strategies/interventions beyond the scope of the proposed R21

application.

Research Objectives and Scope

As the HIV pandemic has continued and more information is obtained on the role

of other microbes (i.e. viruses, bacteria, etc.), on the behavioral and social

interactions, epidemiological factors and co-morbidities associated with HIV

transmission, (e.g., mental health, substance abuse [alcohol and drugs], and

with HIV infection, [Kaposi’s sarcoma (KS)]) is obtained, it has become apparent

that controlling the HIV/AIDS pandemic will require the development of a

multi-faceted approach to prevention. Therefore this FOA supports not only

individual prevention strategies/interventions, but also combination prevention

strategies. A combination prevention strategy is defined as being composed of

multi-level or multi-modal prevention/intervention approaches to achieve the

stated goals of this FOA. Examples include the ethical considerations

associated with microbicide clinical trials; for instance, where an obligation

exists to both counsel and provide condoms, or to integrate prevention

strategies such as the use of a vaccine along with a microbicide.

Highest priority will be given to collaborative research projects that focus on

HIV prevention programs that test microbicides. Projects that develop and test

other prevention strategies also will be considered. Applications may include,

but are not limited to collaborations addressing the following aspects of

HIV/AIDS prevention:

Identification of behavioral, social, epidemiological and/or infectious disease

relationships that represent barriers to, and/or opportunities for

implementation of a microbicide-based prevention strategy or other prevention

strategy

Conduct of focused microbiological, epidemiological and behavioral and social

science interventions and testing that addresses the implementation and/or

understanding of the impact of a prevention strategy

Acquisition of knowledge that assists the operational aspects of developing and

testing microbicide and/or other HIV/AIDS prevention strategies or

interventions.

The R21 innovation grant mechanism does not allow for the conclusive and powered

testing of proposed single and combination prevention strategies in its short

duration. However, this mechanism does accommodate the performance of

incremental studies or interventions that can either support progression to more

comprehensive studies or provide evidence that the proposed intervention is not

effective. CRP applications should incorporate activities that can test and

pilot specific prevention interventions.

The proposed studies must take into account the time limit and budget imposed by

this mechanism (See Section 2: Award Information). It is expected that where

possible the proposed applications will be interactive with ongoing prevention

efforts in India and the U.S., and/or propose to integrate with existing Indian

government-supported prevention programs.

CRP interactions may include:

ongoing and proposed clinical trials not requiring an IND of microbicides or

other relevant interventions, i.e., diaphragm use, STI chemoprevention and/or

vaccine trials

secondary/supplemental studies to existing/ongoing intervention efforts or

clinical studies

integration with local, regional and/or national Indian government-supported

HIV/AIDS prevention efforts, such as family or individual health care counseling

and intervention efforts, including alcohol abuse and mental health programs

integration with existing epidemiological and AIDS/co-morbidity databases and

collection efforts, such as the NIH/NIAID-sponsored International

Epidemiological Database to Evaluate AIDS (IEDEA)

http://grants1.nih.gov/grants/guide/rfa-files/RFA-AI-05-014.html, cancer

registries, etc.

Applications may address key aspects using a broad range of study populations

including men and women that are at-risk for HIV/AIDS infection and uninfected

and HIV/STI-infected infants and children. Other specific at-risk populations

of interest include, but are not limited to:

Age defined groups such as pediatric, adolescent and/or geriatric populations

Couples, sexually active pairings and married couples, including married men

with multiple partners

injection and non-injection drug users

Alcohol abusers

Men who have sex with men (MSM)

Transgender populations

Breast feeding or mother-infant pairs at high risk

Occupationally defined populations such as commercial sex workers (CSWs),

long-haul truck drivers and migrant workers

Mentally ill individuals

Because this FOA represents a broad-based international collaborative program to

address HIV/AIDS prevention, applicants are encouraged to discuss the scope of

their proposed application and its responsiveness to the FOA with the relevant

Program contacts listed in Section VII.

Specific areas of interest for this FOA include studies that may address or be

focused within one or more of the following broad research areas:

1. Infectious Diseases and HIV/AIDS Co-morbidities

The development of safe, effective and acceptable prevention strategies,

including microbicides, must integrate efforts to understand how biochemical,

pharmacological and biophysical factors affecting susceptibility and progression

to HIV/AIDS disease interact with the implementation of any given prevention

strategy. Efforts in this area may also address biological issues that could

alter the potential effectiveness of interventional prevention strategies in

at-risk individuals or populations. Examples of potential approaches include:

integration of physical and in silico tools associated with medicinal chemistry

and formulation to assess a potential prevention intervention’s success and/or

failure

adaptation/engineering of hardware or software for prevention applications,

including data base strategies and modeling of the impact and potential success

of single and combination prevention strategies

use of in vivo animal models to test the proposed efficacy and safety of a

prevention strategy, such as of a microbicide formulation being prepared for

incorporation into a proposed intervention

elucidation of the role of innate and adaptive immune function in response to

the prevention strategy. This may include HIV, STI or other co-infection(s) in

HIV-infected individuals or individuals at high-risk for HIV acquisition

use of 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 on the role of STIs and co-morbidities as linked to HIV/AIDS

acquisition/progression and their effect(s) on prevention-based interventions.

Specific pathogens of interest include viruses such as Herpes Simplex Virus

(HSV), Human Papilloma Virus (HPV) and other AIDS-related oncogenic viruses;

STIs, bacteria associated with bacterial vaginosis; bacterial and parasitic

co-morbidity pathogens, such as multi-drug resistant TB strains (MDR and XDR)

and malaria. Studies may address the positive and negative effects of these

pathogens on the specific prevention intervention.

2. Behavioral and Social Sciences

Primary and secondary prevention strategies addressing behaviors of at-risk

persons or populations with the potential for scale-up to support larger

populations are critical to the development of effective and sustainable single

and combination prevention strategies. Examples of interventions and areas of

interest that could be tested and/or developed in response to this FOA include:

the factors associated with conversion of low prevalence HIV/STI areas to high

prevalence areas, as a result of cultural issues and policies

Impact of environmental/structural aspects on individual or group perceptions

and dynamics of HIV/AIDS risk

the uptake and sustainability of Voluntary Counseling and Testing (VCT), STI

testing and other prevention modalities by at-risk populations

multi-level, multi-modal structural interventions that address behavioral and

social dynamics that can successfully impact the design of individual and

population prevention approaches

interventions to support HIV treatment adherence, particularly in the context of

hospitals and public health clinics in the U.S. and India

integration and linkage of HIV prevention/intervention with HIV treatment

efforts, including delivery of primary care to individuals recently diagnosed

with HIV/AIDS

examination of the impact of HIV stigma, discrimination, intimate partner

violence and/or history of abuse or trauma on risk behavior

examination of the rates of co-occurring mental illness and drug or alcohol

abuse among people living with HIV, as well as studies to develop

multi-component interventions that address co-occurring disorders (may include

alcohol use disorders (AUDS) or other recognized substance abuse syndromes and

their impact on increased incidence of infection.

3. Epidemiology (Behavioral and Population)

Applications proposing behavioral and population epidemiology may include

assessment and evaluation of the scope of the Indian HIV/AIDS epidemic. Local,

regional and national incidence and/or prevalence of HIV and STIs associated

with HIV acquisition and HIV/AIDS co-morbidities in the Indian population will

have a significant impact on the success or failure of proposed prevention

efforts. Specific examples of interest include, but are not limited to:

assessment(s) of HIV and STI incidence in preparation for use of single or

combination prevention strategies on a local, regional and national scale

assessment of risk, incidence and local and regional patterns of HIV-related

malignancies in India, such as Kaposi’s Sarcoma in HIV-infected individuals and

the seroprevalence of Kaposi's Sarcoma-associated Herpes Virus (KSHV) in India

assessment of the distribution of STIs (i.e., HPV subtypes, HSV serotypes, etc.)

in HIV-infected and HIV-uninfected at-risk populations and HIV clades in

infected populations

assessment of the effect of prevention strategies and interventions on existing

or projected incidence rates, including the effect efficacious vaccines (i.e.,

HPV) have on HIV, STI and co-morbidity incidence and prevalence in HIV-infected

individuals

post-trial behavioral surveillance that tracks the impact of new products on

perceived susceptibility/vulnerability to HIV infection, social norms, and

adherence to risk reduction guidelines.

4. Alcohol Abuse and Alcoholism

This area of interest within the FOA includes the use and abuse of alcohol as it

may directly or indirectly (through alterations in risk behaviors) alter and/or

promote the acquisition and/or progression of HIV/AIDS, STIs associated with HIV

acquisition and HIV/AIDS co-morbidities. Examples of intervention/research of

interest to this FOA include:

interventions targeting specific drinking settings such as bars and clubs, and

medical settings concerned with the treatment of AUDs

the influence of alcohol use on individual behaviors and group dynamics, as well

as its effect(s) on non-abusers

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

approaches designed to develop and provide pilot individual and community-based

HIV/AIDS intervention strategies for increased access, engagement, and sustained

participation through enhanced recruitment, retention and adherence to

prevention and treatment interventions of alcohol abusers in both behavioral and

biomedical research protocols

interventions to increase access to and the utilization of HIV testing combined

with sexual and alcohol use risk-reduction and counseling

the biological effects of alcohol abuse on individuals and populations who are

at risk for HIV/AIDS infection, acquisition of co-infection and HIV/AIDS

co-morbidities.

5. Drug Use and Abuse

This area of interest within the FOA includes the use and abuse of both

injection and non-injection drugs, that may be classified as legal or illegal,

depending upon local, regional or national laws. These substances may directly

or indirectly (e.g., through alteration in both sexual and substance use risk

behaviors) alter acquisition, transmission and/or progression of HIV/AIDS, STIs

associated with HIV acquisition, and HIV/AIDS-associated co-morbidities.

Examples of intervention research of interest include:

development of improved outreach strategies for drug users to increase access

and utilization of HIV testing combined with sexual and drug use risk reduction

counseling

development and assessment of individual and community-based prevention outreach

and intervention strategies to effectively reach women at risk for infection

through drug use and high–risk sex

identification of social and behavioral factors among drug users that influence

recruitment, retention and adherence to prevention and treatment interventions,

including therapeutics and microbicides

development of strategies to increase access, engagement, and sustained

participation of drug users in both behavioral and biomedical research protocols

enhancement of efforts to evaluate new and existing treatment and prevention

regimens among drug users in clinical trials, and the conduct of research on

factors that will improve trial participation and adherence

development of integrated biomedical and behavioral interventions, including

pharmacologic and behavioral treatment for drug abuse combined with HIV

treatment and treatment and care for other co-morbidities associated with drug

use (hepatitis, TB)

approaches to improve combined treatment and prevention, such as integration of

drug abuse prevention into HIV treatment settings

strategies to improve engagement in and initiation of HIV treatment, and to

sustain adherence

research on the acceptability and use of biomedical interventions such as

microbicides relative to and in combination with other behavioral, preventive

and therapeutic interventions among drug users.

6. Prevention of Mother-To-Child Transmission (MTCT)

Effective interventions to prevent mother-to-child transmission of HIV that are

applicable in resource-limited settings are now available. However,

implementation of these strategies has been slow. Limitations include lack of

access to antenatal care, lack of antenatal HIV counseling and testing, lack of

more effective regimens (e.g., single dose nevirapine plus short course

zidovudine), home delivery (emphasizing evaluation of innovative methods for

providing single-dose nevirapine), and breastfeeding. Examples of prevention

strategies include:

examination of methodologies to incorporate HIV counseling and testing into

antenatal clinic settings, including community-based strategies

examination of infant feeding issues in India within the context of proven

interventions to prevent mother-to-child transmission

development of demonstration projects designed to identify effective approaches

for screening and identifying HIV-infected pregnant women for treatment and

antiretroviral prophylaxis for their personal health prior to initiation of

therapy

development of innovative methods to provide antiretroviral prophylaxis for

preventing mother-to-child transmission, particularly in rural settings or

settings with high home delivery frequency (e.g., use of traditional birth

attendants to provide counseling and prophylaxis)

evaluation of the effectiveness of infant feeding counseling. This may involve

effectiveness of counseling women who exclusively breast feed, and/or the impact

of replacement feeding on infant morbidity and mortality.

Applications in the following areas will NOT be considered responsive and will

be returned without review:

clinical studies requiring an IND, including Phase 0 (Exploratory), Phase I,

Phase II and Phase III clinical trials. Non-IND studies to assess behavioral,

social and/or epidemiological parameters associated with HIV, STI co-infection

and HIV/AIDS co-morbidities are responsive as long as there is no clinical

intervention.

applications proposing development of new vaccines or vaccine vectors (HIV or

other viruses). Studies that provide supplemental or additional analysis,

including studies that assess safety, efficacy and acceptability parameters of

the vaccine-target population when associated with an ongoing vaccine trial(s)

are responsive.

proposed development and/or incremental modification of: a microbicide-based

prevention strategy derived primarily from a detergent, surfactant, non-specific

membrane active agent; over-the-counter products (OTC); non-specific female/male

vaginal and/or rectal health products as a single or combination prevention

strategy.

applications proposing random or bulk screening (high through-put screening) of

compound libraries or collections for potential anti-microbials, including HIV,

STIs associated with HIV acquisition and/or pathogens associated with HIV/AIDS

co-morbidities.

screening efforts to identify new therapeutics for the cancers or

STIs-associated with HIV acquisition.

applications proposing or involving delivery of treatment (i.e., drugs,

formulations, health foods, vitamins, Ayurvedic medicines or formulations) to

individuals or populations for HIV/AIDS, opportunistic infections (OIs),

co-infections or co-morbidities.

See Section VIII, Other Information - Required Federal Citations, for policies

related to this announcement.

Section II. Award Information

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1. Mechanism of Support

This Funding Opportunity Announcement (FOA) will use the NIH R21

Exploratory/Developmental grant award mechanism. The applicant will be solely

responsible for planning, directing, and executing the proposed project.

This FOA uses just-in-time concepts. For the R21, applicants must complete and

submit detailed budget requests using the SF424 Research and Related (R & R)

Budget component provided in the SF424 (R & R) Application Package and SF424 (R & R)

Application Guide (see specifically Section 4.7, “R & R Budget Component,” of the

Application Guide). Modular budgets are not permitted for this funding

opportunity.

Exploratory/developmental grant support is for new projects only; competing

renewal (formerly " competing continuation " ) and resubmission applications will

not be accepted.

2. Funds Available

Because the nature and scope of the proposed research will vary from application

to application, it is anticipated that the size and duration of each award will

also vary. Although the financial plans of the NIH Institutes and Centers (ICs)

and Indian partners provide support for this program, awards pursuant to this

funding opportunity are contingent upon the availability of funds and the

submission of a sufficient number of meritorious applications.

The total project period for an application submitted in response to this

funding opportunity may not exceed two years. Although the size of award may

vary with the scope of research proposed, it is expected that applications will

stay within the budgetary guidelines for an exploratory/developmental project.

Direct costs are limited to $275,000 USD over an R21 two-year period, with no

more than $200,000 USD in direct costs in any single year.

The participating institutes intend to commit approximately 3 million total

dollars in FY2008 to fund 8 to 10 applications.

NIH grant policies described in the NIH Grants Policy Statement

http://grants.nih.gov/grants/policy/nihgps_2003/index.htm will apply to the

applications submitted and awards made in response to this FOA.

F & A costs requested by consortium participants are not included in the direct

cost limitation; see NOT-OD-05-004, November 2, 2004.

Section III. Eligibility Information

---------------------------------

1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application(s) if your institution has any of the following

characteristics:

Public/State Controlled Institution of Higher Education

Private Institution of Higher Education

Hispanic-serving Institution

Historically Black Colleges and Universities (HBCUs)

Tribally Controlled Colleges and Universities (TCCUs)

Alaska Native and Native Hawaiian Serving Institutions

Nonprofit with 501©(3) IRS Status (Other than Institution of Higher Education)

Nonprofit without 501©(3) IRS Status (Other than Institution of Higher

Education)

Non-domestic (non-U.S.) Entity

Small Business

For-Profit Organization (Other than Small Business)

State Government

Regional Organization

U.S. Territory or Possession

Indian/Native American Tribal Government (Federally Recognized)

Indian/Native American Tribal Government (Other than Federally Recognized)

Indian/Native American Tribally Designated Organization

Other(s): Eligible agencies of the Federal government; Faith-based or community

based organizations.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out

the proposed research as the Project Director/Principal Investigator (PD/PI) is

invited to work with his/her organization to develop an application for support

Individuals from underrepresented racial and ethnic groups as well as

individuals with disabilities are always encouraged to apply for NIH support.

The PD/PI must be from a U.S.-funded institution and must collaborate with an

Indian investigator at an Indian institution and possessing complementary

expertise.

Investigators not qualifying for the U.S.-India Bilateral CRP are encouraged to

apply for the NIH-wide R21 exploratory/developmental research grant program (see

http://grants2.nih.gov/grants/guide/pa-files/PA-06-181.html), or other

announcements.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants

Policy Statement.

3. Other-Special Eligibility Criteria

Applicants may submit more than one application, provided each application is

scientifically distinct.

Section IV. Application and Submission Information

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To download a SF424 (R & R) Application Package and SF424 (R & R) Application Guide

for completing the SF424 (R & R) forms for this FOA, link to

http://www.grants.gov/Apply/ and follow the directions provided on that Web

site.

A one-time registration is required for institutions/organizations at both:

Grants.gov (http://www.grants.gov/GetStarted) and

eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

PDs/PIs should work with their institutions/organizations to make sure they are

registered in the eRA Commons.

Several additional separate actions are required before an applicant

institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Started

Your organization will need to obtain a Data Universal Number System (DUNS)

Number and register with the Central Contractor Registration (CCR) as part of

the Grants.gov registration process.

If your organization does not have a Taxpayer Identification Number (TIN) or

Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN

is necessary for CCR registration.

The CCR also validates the EIN against Internal Revenue Service records, a step

that will take an additional one to two business days.

Direct questions regarding Grants.gov registration to:

Grants.gov Customer Support

Contact Center Phone: 800-518-4726

Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time

Email support@...

2) Organizational/Institutional Registration in the eRA Commons

To find out if an organization is already Commons-registered, see the " List of

Grantee Organizations Registered in NIH eRA Commons.”

Direct questions regarding the Commons registration to:

eRA Commons Help Desk

Phone: 301-402-7469 or 866-504-9552 (Toll Free)

TTY: 301-451-5939

Business hours: M-F 7:00 a.m. – 8:00 p.m. Eastern Time

Email commons@...

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA

Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

The individual designated as the PD/PI on the application must also be

registered in the NIH eRA Commons.

The PD/PI must hold a PD/PI account in the Commons. Applicants should not share

a Commons account for both an Authorized Organization Representative/Signing

Official (AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role

and an Internet Assisted Review (IAR) role, both roles should exist under one

Commons account.

This registration/affiliation must be done by the AOR/SO or their designee who

is already registered in the Commons.

Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since

both are authorized to view the application image.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and

CCR registration, that particular DUNS number and CCR registration are for the

individual reviewer only. These are different than any DUNS number and CCR

registration used by an applicant organization. Individual DUNS and CCR

registration should be used only for the purposes of personal reimbursement and

should not be used on any grant applications submitted to the Federal

Government.

Several of the steps of the registration process could take four weeks or more.

Therefore, applicants should immediately check with their business official to

determine whether their organization/institution is already registered in both

Grants.gov and the Commons. The NIH will accept electronic applications only

from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R & R) application forms and SF424 (R & R)

Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used.

You will not be able to use any other SF424 (R & R) forms (e.g., sample forms,

forms from another FOA), although some of the " Attachment " files may be useable

for more than one FOA.

For further assistance, contact GrantsInfo: Telephone 301-435-0714, Email:

GrantsInfo@....

Telecommunications for the hearing impaired: TTY 301-451-0088.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R & R) application forms and in

accordance with the SF424 (R & R) Application Guide.

(http://grants.nih.gov/grants/funding/424/index.htm).

The SF424 (R & R) Application Guide is critical to submitting a complete and

accurate application to NIH. There are fields within the SF424 (R & R)

application components that, although not marked as mandatory, are required by

NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key

Person Profile” component must contain the PD/PI’s assigned eRA Commons User

ID). Agency-specific instructions for such fields are clearly identified in the

Application Guide. For additional information, see “Frequently Asked Questions –

Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R & R) application is comprised of data arranged in separate

components. Some components are required, others are optional. The forms package

associated with this FOA in Grants.gov/APPLY will include all applicable

components, required and optional. A completed application in response to this

FOA will include the following components:

Required Components:

SF424 (R & R) (Cover component)

Research & Related Project/Performance Site Locations

Research & Related Other Project Information

Research & Related Senior/Key Person

Research & Related Budget

PHS398 Cover Page Supplement

PHS398 Research Plan

PHS398 Checklist

Optional Components:

PHS398 Cover Letter File

Research & Related Subaward Budget Attachment(s) Form

Note: While both budget components are included in the SF424 (R & R) forms

package, this FOA for which all applications must include a foreign component

uses ONLY the Research & Related Budget. (Do not use the PHS398 Modular Budget.)

Foreign Organizations

NIH policies concerning grants to foreign (non-U.S.) organizations can be found

in the in the NIH Grants Policy Statement at:

http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.

Application from foreign organizations must:

Request budgets in U.S. dollars.

Prepare detailed budgets for all applications (that is, complete the Research &

Related Budget component of the SF424 (R & R) applications forms- not the PHS398

Modular Budget component). See NOT-OD-06-096, August 23, 2006.

Charge back of customs and import fees is not allowed.

Format: Every effort should be made to comply with the format specifications,

which are based upon a standard U.S. paper size of 8.5” x 11” within each PDF.

Funds for up to 8% administrative costs (excluding equipment) may be requested.

See NOT-OD-01-028, March 29, 2001.

Organizations must comply with Federal/NIH policies on human subjects, animals,

and biohazards.

Organizations must comply with Federal/NIH biosafety and biosecurity

regulations. See Section VI.2., “Administrative and National Policy

Requirements.”

SPECIAL INSTRUCTIONS

Applications Involving Multiple Institutions

When multiple institutions are involved, one institution must be designated as

the prime institution and funding for the other institution(s) must be requested

via a subcontract to be administered by the prime institution. When submitting a

detailed budget, the prime institution should submit its budget using the

Research & Related Budget component. All other institutions should have their

individual budgets attached separately to the Research & Related Subaward Budget

Attachment(s) Form. See Section 4.8 of the SF424 (R & R) Application Guide for

further instruction regarding the use of the subaward budget form.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates

Opening Date: August 18, 2007 (Earliest date an application may be submitted

to Grants.gov)

Letters of Intent Receipt Date(s): September 18, 2007

NOTE: On time submission requires that applications be successfully submitted to

Grants.gov no later than 5:00 p.m. local time (of the applicant

institution/organization).

Application Submission/Receipt Date(s): October 18, 2007

Peer Review Date(s): January 2008

Council Review Date(s): January 2008

Earliest Anticipated Start Date(s): April 2008

3.A.1. Letter of Intent

Prospective applicants are asked to submit a Letter of Intent that includes the

following information:

Descriptive title of proposed research

Name, address, and telephone number of the PD/PI.

Names of other key personnel

Participating institutions

Number and title of this funding opportunity

Although a LOI is not required, is not binding, and does not enter into the

review of a subsequent application, the information that it contains allows IC

staff to estimate the potential review workload and plan the review.

The LOI is to be sent by the date listed in Section IV.3.A,

The LOI should be sent to:

Sujata Vijh, Ph.D.

Division of Extramural Activities

National Institute of Allergy and Infectious Diseases

Room 3118, MSC-7616

6700-B Rockledge Drive

Bethesda, MD 20892-7616

FedEx Zip: 20817-7616

Tel: (301) 594-0985

Fax: (301) 480-2408

Email: vijhs@...

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this

FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications

must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be

successfully received by Grants.gov no later than 5:00 p.m. local time (of the

applicant institution/organization) on the application submission/receipt

date(s). (See Section IV.3.A. for all dates.) If an application is not

submitted by the receipt date(s) and time, the application may be delayed in the

review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov,

any errors have been addressed, and the assembled application has been created

in the eRA Commons, the PD/PI and the Authorized Organization

Representative/Signing Official (AOR/SO) have two business days to view the

application image.

If everything is acceptable, no further action is necessary. The application

will automatically move forward for processing by the Division of Receipt and

Referral, Center for Scientific Review, NIH, after two business days.

Prior to the submission deadline, the AOR/SO can “Reject” the assembled

application and submit a changed/corrected application within the two-day

viewing window. This option should be used if the AOR/SO determines that

warnings should be addressed. Reminder: warnings do not stop further application

processing. If an application submission results in warnings (but no errors) it

will automatically move forward after two business days if no action is taken.

Please remember that some warnings may not be applicable or may need to be

addressed after application submission.

If the two-day window falls after the submission deadline, the AOR/SO will have

the option to “Reject” the application if, due to an eRA Commons or Grants.gov

system issue, the application does not correctly reflect the submitted

application package (e.g., some part of the application was lost or didn’t

transfer correctly during the submission process). The AOR/SO should first

contact the eRA Commons Helpdesk to confirm the system error, document the

issue, and determine the best course of action. NIH will not penalize the

applicant for an eRA Commons or Grants.gov system issue.

If the AOR/SO chooses to “Reject” the image after the submission deadline for a

reason other than an eRA Commons or Grants.gov system failure, a

changed/corrected application still can be submitted, but it will be subject to

the NIH late policy guidelines and may not be accepted. The reason for this

delay should be explained in the cover letter attachment.

Both the AOR/SO and PD/PI will receive e-mail notifications when the application

is rejected or the application automatically moves forward in the process after

two days.

Upon receipt, applications will be evaluated for completeness by the Center for

Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and

the Commons. Information related to the assignment of an application to a

Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant

to check periodically on their application status in the Commons.

The NIH will not accept any application in response to this funding opportunity

that is essentially the same as one currently pending initial review, unless the

applicant withdraws the pending application. However, when a previously

unfunded application, originally submitted as an investigator-initiated

application, is to be submitted in response to a funding opportunity, it is to

be prepared as a NEW application, That is, the application for the funding

opportunity must not include an Introduction describing the changes and

improvements made, and text must not be marked to indicate changes from the

previous unfunded version of the application.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and

other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH

prior approval, incur obligations and expenditures to cover costs up to 90 days

before the beginning date of the initial budget period of a new award if such

costs: are necessary to conduct the project, and would be allowable under the

grant, if awarded, without NIH prior approval. If specific expenditures would

otherwise require prior approval, the grantee must obtain NIH approval before

incurring the cost. NIH prior approval is required for any costs to be incurred

more than 90 days before the beginning date of the initial budget period of a

new award.

The incurrence of pre-award costs in anticipation of a competing or

non-competing award imposes no obligation on NIH either to make the award or to

increase the amount of the approved budget if an award is made for less than the

amount anticipated and is inadequate to cover the pre-award costs incurred. NIH

expects the grantee to be fully aware that pre-award costs result in borrowing

against future support and that such borrowing must not impair the grantee's

ability to accomplish the project objectives in the approved time frame or in

any way adversely affect the conduct of the project. See the NIH Grants Policy

Statement.

6. Other Submission Requirements

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD/PI to fill in his/her Commons User ID in the “PROFILE –

Project Director/Principal Investigator” section, “Credential” log-in field of

the “Research & Related Senior/Key Person Profile” component. The applicant

organization must include its DUNS number in its Organization Profile in the eRA

Commons. This DUNS number must match the DUNS number provided at CCR

registration with Grants.gov. For additional information, see “Registration FAQs

– Important Tips -- Electronic Submission of Grant Applications.”

Organizational DUNS

The applicant organization must include its DUNS number in its Organization

Profile in the eRA Commons. This DUNS number must match the DUNS number provided

at CCR registration with Grants.gov. For additional information, see “Frequently

Asked Questions-Applications Guide, Electronic Submission of Grant

Applications.”

Research Plan Component Sections

While each section of the Research Plan component needs to be uploaded

separately as a PDF attachment, applicants are encouraged to construct the

Research Plan component as a single document, separating sections into distinct

PDF attachments just before uploading the files. This approach will enable

applicants to better monitor formatting requirements such as page limits. All

attachments must be provided to NIH in PDF format, filenames must be included

with no spaces or special characters, and a .pdf extension must be used.

All application instructions outlined in the SF424 (R & R) Application Guide are

to be followed, incorporating “Just-in-Time” information concepts and with the

following requirements for applications:

Supplementary Instructions

Total direct costs are limited to $275,000 USD over a 2-year period. No more

than $200,000 USD in direct costs will be allowed in any single year of the R21.

The NIH modular budget concept is NOT to be used. Even though the budget for the

R21 phase is limited, applications must present the detailed SF424 (R & R) Budget

forms for all years. The budget justification must include information about

where the funds will be utilized.

Preliminary data are not required for an R21 application but they may be

included.

Items 2-5 of the Research Plan of the R21 application may not exceed 15 pages,

including tables, graphs, figures, diagrams, and charts.

There should be a single Research Plan for the combined efforts of the two

organizations. Item 2, Specific Aims, must identify which partner of the

collaboration (U.S., India, or jointly) will be responsible for accomplishment

for each proposed specific aim. Item 5, Research Design and Methods, should

provide a complete description of the research, demonstrating the integration of

the two researcher’s efforts.

Applicants are required to provide a Collaboration Plan. This plan must be no

more than 3 pages. The Collaboration Plan is NOT included in the 15-page limit

of the Research Plan. The Collaborative Plan must be included as an attachment

to the Research & Related Other Project Information form under item 11 “Other

Attachments.” The Collaboration Plan should include a discussion on how the

collaboration will be established and maintained by the U.S. and Indian partners

including well-defined and identifiable responsibilities for the PD/PI and

Indian collaborator. Describe resources available, including which collaborative

partner is contributing the resources, a plan for how resources will be shared,

and detail how the coordination will benefit HIV/AIDS prevention science.

Individual contributions of specific reagents, i.e., patient samples, compounds

and access to populations for epidemiological and behavioral studies should be

identified. The governance and organizational structure of the collaboration

should be described, including communication plans, process for making decisions

on scientific direction, and procedures for resolving conflicts. Contingency

plans should also be included for setbacks and delays.

In preparing the R21 application, investigators should consider the fact that

the application will be assigned a single priority score. Thus, clarity and

completeness of the application with regard to specific goals and the proposed

interactions of the U.S. and India collaborators are critical. A poorly

developed collaboration strategy that is not sufficient for assessing the

potential for a successful R21 research effort will reflect poorly on the

scientific merit of the application.

Appendix Materials

NIH has published new limitations on grant application appendix materials to

encourage applications to be as concise as possible while containing the

information needed for expert scientific review. See

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html .

Applicants must follow the specific instructions on Appendix materials as

described in the SF424 (R & R) Application Guide (See

http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations of the Research Plan

component. An application that does not observe the relevant policies and

procedures may be delayed in the review process.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data

being collected and how the investigators are planning to share the data.

Applicants who are planning to share data may wish to describe briefly the

expected schedule for data sharing, the format of the final dataset, the

documentation to be provided, whether or not any analytic tools also will be

provided, whether or not a data-sharing agreement will be required and, if so, a

brief description of such an agreement (including the criteria for deciding who

can receive the data and whether or not any conditions will be placed on their

use), and the mode of data sharing (e.g., under their own auspices by mailing a

disk or posting data on their institutional or personal website, through a data

archive or enclave). Investigators choosing to share under their own auspices

may wish to enter into a data-sharing agreement. References to data sharing may

also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their

application. The data sharing policy is available at

http://grants.nih.gov/grants/policy/data_sharing. All investigators responding

to this funding opportunity should include a description of how final research

data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing

research data will be assessed by the reviewers. However, reviewers will not

factor the proposed data sharing plan into the determination of scientific merit

or the priority score.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily

available for research purposes to qualified individuals within the scientific

community after publication (See the NIH Grants Policy Statement

http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).

Investigators responding to this funding opportunity should include a sharing

research resources plan addressing how unique research resources will be shared

or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans

will be considered by Program staff of the funding organization when making

recommendations about funding applications. The effectiveness of the resource

sharing will be evaluated as part of the administrative review of each

Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., “Reporting.”

Section V. Application Review Information

------------------------------------------

1. Criteria

Only the review criteria described below will be considered in the review

process.

2. Review and Selection Process

Applications that are complete will be evaluated for scientific and technical

merit by an appropriate review group convened by NIH in accordance with the

review criteria stated below.

As part of the initial merit review, all applications will:

Undergo a selection process in which only those applications deemed to have the

highest scientific merit, generally the top half of applications under review,

will be discussed and assigned a priority score;

Receive a written critique;

Receive a second level of review by the National Advisory Allergy and Infectious

Diseases Council.

Applications submitted in response to this funding opportunity will compete for

available funds with all other recommended applications. The following will be

considered in making funding decisions:

Scientific merit of the proposed project as determined by NIH peer review;

Availability of funds;

Relevance to NIH program priorities;

Relevance to U.S. and Indian program priorities as evaluated by the Joint

Working Group Convened under the U.S.-India Joint Statement cited above in

Section I.1. “Research Objectives.”

The goals of NIH supported research are to advance our understanding of

biological systems, to improve the control of disease, and to enhance health. In

their written critiques, reviewers will be asked to comment on each of the

following criteria in order to judge the likelihood that the proposed research

will have a substantial impact on the pursuit of these goals. Each of these

criteria will be addressed and considered in assigning the overall score,

weighting them as appropriate for each application.

Significance

Approach

Innovation

Investigator

Environment

Significance: Does this study address an important scientific health problem? If

the aims of the application are achieved, how will scientific knowledge or

clinical practice be advanced? What will be the effect of these studies on the

concepts, methods, technologies, treatments, services, or preventative

interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and

analyses adequately developed, well integrated, well reasoned, and appropriate

to the aims of the project? Does the applicant acknowledge potential problem

areas and consider alternative tactics? Is the proposed collaborative team

positioned to accomplish the proposed research, and does the collaboration of

U.S.-funded investigators and Indian investigators add significantly to the

approach being proposed?

Innovation: Is the project original and innovative? For example: does the

project challenge existing paradigms or clinical practice; address an innovative

hypothesis or critical barrier to progress in the field? Does the project

develop or employ novel concepts, approaches, methodologies, tools, or

technologies in the area of HIV/AIDS prevention?

Investigators: Are the PD/PI(s) and other key personnel appropriately trained

and well suited to carry out this work? Is the work proposed appropriate to the

experience level of the principal investigator and other researchers? Does the

PD/PI(s) and investigative team bring complementary and integrated expertise to

the project (if applicable)?

Environment: Do(es) the scientific environment(s) in which the work will be done

contribute to the probability of success? Do the proposed studies benefit from

unique features of the scientific environment, or subject populations, or employ

useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be

considered in the determination of scientific merit and the priority score:

Collaborative Plan: Is the collaborative plan well-defined with identifiable

responsibilities for the U.S. and India partners? Is a plan for management of

the collaboration presented, as well as descriptions of what each participant

proposes to supply to the collaborative partnership? Is there a clear and well

thought out advantage to bringing the U.S. and Indian partners together in a

collaborative partnership and is it clear how coordination will contribute to

advances in prevention science?

Protection of Human Subjects from Research Risk: The involvement of human

subjects and protections from research risk relating to their participation in

the proposed research will be assessed. See the “Human Subjects Sections” of the

PHS398 Research Plan component of the SF424 (R & R).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans

to include subjects from both genders, all racial and ethnic groups (and

subgroups), and children as appropriate for the scientific goals of the research

will be assessed. Plans for the recruitment and retention of subjects will also

be evaluated. See the “Human Subjects Sections” of the PHS398 Research Plan

component of the SF424 (R & R).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be

used in the project, the adequacy of the plans for their care and use will be

assessed. See the “Other Research Plan Sections” of the PHS398 Research Plan

component of the SF424 (R & R).

Biohazards: If materials or procedures are proposed that are potentially

hazardous to research personnel and/or the environment, determine if the

proposed protection is adequate.

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the

appropriateness of the requested period of support in relation to the proposed

research may be assessed by the reviewers. The priority score should not be

affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale

for not sharing research data will be assessed by the reviewers. However,

reviewers will not factor the proposed data sharing plan into the determination

of scientific merit or the priority score. The presence of a data sharing plan

will be part of the terms and conditions of the award. The funding organization

will be responsible for monitoring the data sharing

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily

available for research purposes to qualified individuals within the scientific

community after publication (See the NIH Grants Policy Statement

http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).

Investigators responding to this funding opportunity should include a sharing

research resources plan addressing how unique research resources will be shared

or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for

sharing research resources.

The adequacy of the resources sharing plan and any related data sharing plans

will be considered by Program staff of the funding organization when making

recommendations about funding applications. The effectiveness of the resource

sharing will be evaluated as part of the administrative review of each

Non-Competing Grant Progress Report (PHS 2590), See Section VI.3., “Reporting.”

Model Organism Sharing Plan: Reviewers are asked to assess the sharing plan in

an administrative note. The sharing plan itself should be discussed after the

application is scored. Whether a sharing plan is reasonable can be determined by

the reviewers on a case-by-case basis, taking into consideration the organism,

the timeline, the applicant’s decision to distribute the resource or deposit it

in a repository, and other relevant considerations.

3. Anticipated Announcement and Award Dates

Not Applicable.

Section VI. Award Administration Information

-------------------------------------------------

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to

access his/her Summary Statement (written critique) via the NIH eRA Commons.

If the application is under consideration for funding, NIH will request

" just-in-time " information from the applicant. For details, applicants may refer

to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant

Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to

the applicant organization. The NoA signed by the grants management officer is

the authorizing document. Once all administrative and programmatic issues have

been resolved, the NoA will be generated via email notification from the

awarding component to the grantee business official.

Selection of an application for award is not an authorization to begin

performance. Any costs incurred before receipt of the NoA are at the recipient's

risk. These costs may be reimbursed only to the extent considered allowable

pre-award costs. See Section IV.5., “Funding Restrictions.”

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy

Statement as part of the NoA. For these terms of award, see the NIH Grants

Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A:

General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms

and Conditions for Specific Types of Grants, Grantees, and Activities.

3. Reporting

When multiple years are involved, awardees will be required to submit the

Non-Competing Grant Progress Report (PHS 2590) annually and financial statements

as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

-----------------------------------------------

We encourage your inquiries concerning this funding opportunity and welcome the

opportunity to answer questions from potential applicants. Inquiries may fall

into three areas: scientific/research, peer review, and financial or grants

management issues:

1. Scientific/Research Contacts:

Direct inquiries regarding scientific, programmatic, and review matters to the

appropriate Program Official listed below:

NCI

Kishor Bhatia, Ph.D., MRCPath

Office of AIDS Malignancy Program

National Cancer Institute

Room 6114, MSC-7204

6120 Executive Boulevard

Bethesda, MD 20892-7204 (for U.S. Postal Service regular or express mail)

Rockville, MD 20852 (for FedEx, UPS and other courier services)

Telephone: (301) 496-4995

Fax: (301) 480-4137

E-mail: bhatiak@...

NHLBI

Cheryl L. Mc, M.D.

AIDS Coordinator

National Heart, Lung, and Blood Institute

Room 8114, MSC-7940

6701 Rockledge Drive

Bethesda, MD 20892-7940 (For courier services use Zip 20817)

Telephone: (301) 435-0560

Fax: (301) 480-2858

E-mail: mcdonalc@...

NIAAA

Kendall , Ph.D.

HIV/AIDS Research

National Institute on Alcohol Abuse and Alcoholism

Room 2069, MSC 9304

5635 Fishers Lane

Rockville, MD 20892-9304

Telephone: (301) 402-9389

Fax: (301) 443-8614

E-mail: kbryant@...

NIAID

Jim A. Turpin, Ph.D.

Division of AIDS

National Institute of Allergy and Infectious Diseases

Room 5114, MSC-7628

6700B Rockledge Drive

Bethesda, MD 20892-7628

Phone: (301) 451-2732

Fax: (301) 496-8530

Email: jturpin@...

NICHD

Danuta Krotoski, Ph.D.

National Institute of Child Health and Human Development

Room 2A01, MSC 7510

6100 Executive Boulevard

Bethesda, MD 20892-7510

Phone: (301) 435-7566

Fax: (301) 435-0009

E-mail: krotoskd@...

NIDA

Davenny, M.P.H.

AIDS Research Program

National Institute on Drug Abuse

Room 4215, MSC 9581

6001 Executive Boulevard

Bethesda, MD 20892-9581

Telephone: (301) 443-2146

Fax: (301) 443-9127

E-mail: kdavenny@...

NIMH

Willo Pequenat, Ph.D.

Division of Mental Disorders

National Institute of Mental Health

Room 6219B, MSC-9619

6001 Executive Boulevard

Bethesda, MD 20892-9619

Telephone: (301) 443-1187

Fax: (301) 443-9719

E-mail: wpequegn@...

2. Peer Review Contacts:

Sujata Vijh, Ph.D.

Division of Extramural Activities

National Institute of Allergy and Infectious Diseases

Room 3118, MSC-7616

6700-B Rockledge Drive

Bethesda, MD 20892-7616

FedEx Zip: 20817-7616

Tel: (301) 594-0985

Fax: (301) 480-2408

Email: vijhs@...

3. Financial or Grants Management Contacts:

Chatman

Division of Extramural Activities

National Institute of Allergy and Infectious Diseases

Room 2241, MSC-76146700-B Rockledge Drive

Bethesda, MD 20892 (express zip 20817)

Direct Line: (301) 402-6580

GMP: (301) 496-7075

Fax: (301) 493-0597

E-mail: chatmank@...

Section VIII. Other Information

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Required Federal Citations

Use of Animals in Research:

Recipients of PHS support for activities involving live, vertebrate animals must

comply with PHS Policy on Humane Care and Use of Laboratory Animals

(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as

mandated by the Health Research Extension Act of 1985

(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal

Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as

applicable.

Human Subjects Protection:

Federal regulations (45 CFR 46) require that applications and proposals

involving human subjects must be evaluated with reference to the risks to the

subjects, the adequacy of protection against these risks, the potential benefits

of the research to the subjects and others, and the importance of the knowledge

gained or to be gained

(http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:

Data and safety monitoring is required for all types of clinical trials,

including physiologic toxicity and dose-finding studies (phase I); efficacy

studies (Phase II); efficacy, effectiveness and comparative trials (Phase III).

Monitoring should be commensurate with risk. The establishment of data and

safety monitoring boards (DSMBs) is required for multi-site clinical trials

involving interventions that entail potential risks to the participants (“NIH

Policy for Data and Safety Monitoring,” NIH Guide for Grants and Contracts,

http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:

Investigators submitting an NIH application seeking $500,000 or more in direct

costs in any single year are expected to include a plan for data sharing or

state why this is not possible

(http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to

institutional policies and local IRB rules, as well as local, State and Federal

laws and regulations, including the Privacy Rule. Reviewers will consider the

data sharing plan but will not factor the plan into the determination of the

scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:

The Office of Management and Budget (OMB) Circular A-110 has been revised to

provide access to research data through the Freedom of Information Act (FOIA)

under some circumstances. Data that are (1) first produced in a project that is

supported in whole or in part with Federal funds and (2) cited publicly and

officially by a Federal agency in support of an action that has the force and

effect of law (i.e., a regulation) may be accessed through FOIA. It is important

for applicants to understand the basic scope of this amendment. NIH has provided

guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this funding opportunity in a

public archive, which can provide protections for the data and manage the

distribution for an indefinite period of time. If so, the application should

include a description of the archiving plan in the study design and include

information about this in the budget justification section of the application.

In addition, applicants should think about how to structure informed consent

statements and other human subjects procedures given the potential for wider use

of data collected under this award.

Sharing of Model Organisms:

NIH is committed to support efforts that encourage sharing of important research

resources including the sharing of model organisms for biomedical research (see

http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time

the NIH recognizes the rights of grantees and contractors to elect and retain

title to subject inventions developed with Federal funding pursuant to the Bayh

Dole Act (see the NIH Grants Policy Statement). Beginning October 1, 2004, all

investigators submitting an NIH application or contract proposal are expected to

include in the application/proposal a description of a specific plan for sharing

and distributing unique model organism research resources generated using NIH

funding or state why such sharing is restricted or not possible. This will

permit other researchers to benefit from the resources developed with public

funding. The inclusion of a model organism sharing plan is not subject to a cost

threshold in any year and is expected to be included in all applications where

the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:

It is the policy of the NIH that women and members of minority groups and their

sub-populations must be included in all NIH-supported clinical research projects

unless a clear and compelling justification is provided indicating that

inclusion is inappropriate with respect to the health of the subjects or the

purpose of the research. This policy results from the NIH Revitalization Act of

1993 (Section 492B of Public Law 103-43). All investigators proposing clinical

research should read the " NIH Guidelines for Inclusion of Women and Minorities

as Subjects in Clinical Research”

(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete

copy of the updated Guidelines is available at

http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.

The amended policy incorporates: the use of an NIH definition of clinical

research; updated racial and ethnic categories in compliance with the new OMB

standards; clarification of language governing NIH-defined Phase III clinical

trials consistent with the SF424 (R & R) application; and updated roles and

responsibilities of NIH staff and the extramural community. The policy continues

to require for all NIH-defined Phase III clinical trials that: a) all

applications or proposals and/or protocols must provide a description of plans

to conduct analyses, as appropriate, to address differences by sex/gender and/or

racial/ethnic groups, including subgroups if applicable; and investigators

must report annual accrual and progress in conducting analyses, as appropriate,

by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:

The NIH maintains a policy that children (i.e., individuals under the age of 21)

must be included in all clinical research, conducted or supported by the NIH,

unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the

" NIH Policy and Guidelines " on the inclusion of children as participants in

research involving human subjects

(http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:

NIH policy requires education on the protection of human subject participants

for all investigators submitting NIH applications for research involving human

subjects and individuals designated as key personnel. The policy is available at

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):

Criteria for federal funding of research on hESCs can be found at

http://stemcells.nih.gov/index.asp and at

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only

research using hESC lines that are registered in the NIH Human Embryonic Stem

Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is

the responsibility of the applicant to provide in the project description and

elsewhere in the application as appropriate, the official NIH identifier(s) for

the hESC line(s) to be used in the proposed research. Applications that do not

provide this information will be returned without review.

NIH Public Access Policy:

NIH-funded investigators are requested to submit to the NIH manuscript

submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an

electronic version of the author's final manuscript upon acceptance for

publication, resulting from research supported in whole or in part with direct

costs from NIH. The author's final manuscript is defined as the final version

accepted for journal publication, and includes all modifications from the

publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently

funded NIH research projects or 2) previously supported NIH research projects if

they are accepted for publication on or after May 2, 2005. The NIH Public Access

Policy applies to all research grant and career development award mechanisms,

cooperative agreements, contracts, Institutional and Individual Ruth L.

Kirschstein National Research Service Awards, as well as NIH intramural research

studies. The Policy applies to peer-reviewed, original research publications

that have been supported in whole or in part with direct costs from NIH, but it

does not apply to book chapters, editorials, reviews, or conference proceedings.

Publications resulting from non-NIH-supported research projects should not be

submitted.

For more information about the Policy or the submission process, please visit

the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view

the Policy or other Resources and Tools, including the Authors' Manual.

Standards for Privacy of Individually Identifiable Health Information:

The Department of Health and Human Services (HHS) issued final modification to

the " Standards for Privacy of Individually Identifiable Health Information " , the

" Privacy Rule " , on August 14, 2002. The Privacy Rule is a federal regulation

under the Health Insurance Portability and Accountability Act (HIPAA) of 1996

that governs the protection of individually identifiable health information, and

is administered and enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with

the researcher and his/her institution. The OCR website

(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a

complete Regulation Text and a set of decision tools on " Am I a covered entity? "

Information on the impact of the HIPAA Privacy Rule on NIH processes involving

the review, funding, and progress monitoring of grants, cooperative agreements,

and research contracts can be found at

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:

All applications and proposals for NIH funding must be self-contained within

specified page limitations. For publications listed in the appendix and/or

Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission

identification numbers must be used for publicly accessible on-line journal

articles. Publicly accessible on-line journal articles or PMC

articles/manuscripts accepted for publication that are directly relevant to the

project may be included only as URLs or PMC submission identification numbers

accompanying the full reference in either the Bibliography & References Cited

section, the Progress Report Publication List section, or the Biographical

Sketch section of the NIH grant application. A URL or PMC submission

identification number citation may be repeated in each of these sections as

appropriate. There is no limit to the number of URLs or PMC submission

identification numbers that can be cited.

Healthy People 2010:

The Public Health Service (PHS) is committed to achieving the health promotion

and disease prevention objectives of " Healthy People 2010, " a PHS-led national

activity for setting priority areas. This FOA is related to one or more of the

priority areas. Potential applicants may obtain a copy of " Healthy People 2010 "

at http://www.health.gov/healthypeople.

Authority and Regulations:

This program is described in the Catalog of Federal Domestic Assistance in the

following citations: 93.242, 93.273, 93.279, 93.393, 93.394, 93.396, 93.855,

93.856, 93.865, and 93.839, and is not subject to the intergovernmental review

requirements of Executive Order 12372 or Health Systems Agency review. Awards

are made under the authorization of Sections 301 and 405 of the Public Health

Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR

Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and

conditions, cost principles, and other considerations described in the NIH

Grants Policy Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free

workplace and discourage the use of all tobacco products. In addition, Public

Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain

facilities (or in some cases, any portion of a facility) in which regular or

routine education, library, day care, health care, or early childhood

development services are provided to children. This is consistent with the PHS

mission to protect and advance the physical and mental health of the American

people.

Loan Repayment Programs:

NIH encourages applications for educational loan repayment from qualified health

professionals who have made a commitment to pursue a research career involving

clinical, pediatric, contraception, infertility, and health disparities related

areas. The LRP is an important component of NIH's efforts to recruit and retain

the next generation of researchers by providing the means for developing a

research career unfettered by the burden of student loan debt. Note that an NIH

grant is not required for eligibility and concurrent career award and LRP

applications are encouraged. The periods of career award and LRP award may

overlap providing the LRP recipient with the required commitment of time and

effort, as LRP awardees must commit at least 50% of their time (at least 20

hours per week based on a 40 hour week) for two years to the research. For

further information, please see: http://www.lrp.nih.gov.

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Department of Health and Human Services

National Institutes of Health (NIH)

9000 Rockville Pike

Bethesda, land 20892

_____________________________

Usha Sharma PhD MPH

Division of AIDS,

Prevention Sciences Program

National Institute of Allergy and Infectious Diseases,

Room 5117, 6700 B Rockledge Drive

Bethesda, MD 20892-7628

Ph. 301-451-3441

Fax 301-496-8530

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