Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Center for Complementary and Alternative Medicine (NCCAM)

Funding Opportunity Title

Improving Adherence to Treatment Regimens for HIV-Positive Adolescents and Young Adults (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

  • December 20, 2011 - See Notice NOT-HD-12-005. This Notice is to inform potential applicants that the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is clarifying and correcting information relating to “Award Budget”.

Funding Opportunity Announcement (FOA) Number

RFA-HD-12-206

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.865, 93.213

FOA Purpose

The purpose of this funding opportunity announcement (FOA) is to stimulate research projects that will develop, implement, and evaluate new or adapted interventions to improve adherence to medical and/or behavioral regimens for HIV-positive adolescents (11-21 years) and young adults (21-24 years).   Applicants may investigate individual, family, social, political, and/or contextual factors that influence adherence, and may develop new or refine existing measures of adherence, in the process of developing efficacious or effective adherence interventions.

Key Dates
Posted Date

October 28, 2011

Open Date (Earliest Submission Date)

January 21, 2012

Letter of Intent Due Date

January 21, 2012

Application Due Date(s)

February 21, 2012, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June/July 2012

Advisory Council Review

August 2012

Earliest Start Date(s)

September 2012

Expiration Date

February 22, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of this funding opportunity announcement (FOA) is to stimulate research projects that will develop, implement, and evaluate new or adapted interventions to improve adherence to medical and/or behavioral regimens for HIV-positive adolescents (11-21 years) and young adults (21-24 years).  Applicants may investigate individual, family, social, political, and/or contextual factors that influence adherence, and may develop new or refine existing measures of adherence, in the process of developing efficacious or effective adherence interventions.

Goal

The goal of this initiative is to prevent or slow the transmission of HIV and to improve health outcomes in HIV-positive adolescents and young adults.  This will be facilitated by inviting research projects that will develop, implement, and evaluate new or adapted interventions to improve adherence to medical and/or behavioral treatment regimens for these populations.

Background

According to the United States Agency for International Development, there were 33.4 million people living with human immunodeficiency virus (HIV) in the world in 2008, 2.7 million newly infected individuals, and 2 million AIDS-related deaths.   There were more than 23,000 adolescents and young adults (13-24 years of age) living with HIV/AIDS in the United States in 2007.  As the HIV epidemic continues and a vaccine remains elusive, millions of people survive with HIV as a chronic condition and must adhere to a daily regimen of antiretroviral medications to prevent the progression of HIV to full blown acquired immunodeficiency syndrome (AIDS).  In 2003, the World Health Organization (WHO) labeled poor adherence to prescription medications and treatments a “worldwide problem of striking magnitude.” 

The WHO defined adherence as “the extent to which a person’s behavior ---taking medication, following a diet, and/or executing lifestyle changes, correspond with agreed recommendations from a health care provider.”  Nonadherence is the discrepancy between prescribed treatment and what is actually taken or acted upon.  A person may be nonadherent for a variety of reasons such as failing to purchase the prescribed medication, skipping doses occasionally or for prolonged periods, or taking incorrect doses or at incorrect times.  Nonadherence can be intentional due to medication costs, unpleasant side effects, availability of alternative treatments, or personal beliefs, or unintentional and secondary to forgetfulness, poor health literacy, limited availability of medicine, or other reasons.

Adolescence is a time of tremendous biological, cognitive, and psychosocial change and pubertal development.  Recent research indicates that the juvenile brain is still maturing in the teen years and that reasoning and judgment are developing well into the early to mid 20s.  During adolescence, individuals are striving for autonomy, feeling the pull of peer pressure and the decreasing influence of parents and family, and assuming self management responsibility for medications.  A developmental perspective is needed for adherence research in adolescents and young adults due to the considerable variation in the age and rate at which individuals undergo physical and neurobehavioral changes. Likewise, different messages about healthy lifestyles and adherence to medical and behavioral regimens may be needed for adolescents who acquired HIV perinatally versus behaviorally.

There is an expanding literature on adherence to antiretroviral medication in adults and an increasing number of descriptive studies on adherence in HIV-positive youth.  We are learning more about how health, behavioral, and social influences affect adherence in young people and their families.  There remains a paucity of research identifying effective, developmentally appropriate interventions to improve adherence to medication and behavioral recommendations in adolescents and young adults.  Gaps also exist in the dissemination of effective adherence interventions. Too often ignored are behavioral recommendations issued to protect adolescents and young adults from acquiring HIV, to prevent them from spreading HIV, to facilitate the use of healthcare services, and to assist them in maintaining their health. Some examples of behavioral recommendations include the following: know your HIV status by being tested, follow up with testing results, link to and follow up with health care providers, limit the number of sexual partners, and avoid unprotected sexual activity and the sharing of drug injection equipment with a person infected with HIV.

Establishing and maintaining excellent adherence to antiretroviral medication is necessary for viral suppression and the prevention of viral resistance.  Suboptimal adherence is strongly associated with treatment failure including increased viral resistance, limited future treatment options, increased risk of HIV transmission to others, and increased mortality.  After CD4 counts, adherence to antiretroviral medication has been called the next best predictor of progression to AIDS and death.  Improving adherence to antiretroviral medication can reduce the risk of disease symptoms, progression of functional impairments, medical complications, co-morbidities, and health care utilization. Adherence is a potentially alterable factor that can improve life expectancy, quality of life, and healthcare costs.  Enhancing adherence to behavioral recommendations has the potential to reduce HIV transmission by improving personal self-efficacy regarding abstinence, sexual behavior negotiation skills, and condom use, and by increasing knowledge of HIV/AIDS routes of disease transmission and of myths surrounding HIV.

Acceptable standards for adherence vary by the condition being treated with 80 percent adherence being acceptable in some diseases but 95 percent or higher being necessary when treating HIV.  Despite its importance, adherence rates may be only 50 to 70 percent or less in patients with HIV.  Some factors that contribute to the variability in adherence rates for chronic disease regimens in pediatric populations include the disease and its severity, recommended regimen, adherence measure being used, and the classification criteria for adherence.  In the absence of a single gold standard for adherence, clinicians and researchers use a variety of objective and subjective measures including drug assays, electronic monitors, pill counts, direct observations, patient reports and provider estimates.  It is important to note that sub-therapeutic drug assays may reflect conditions other than poor adherence such as inadequate dosing, drug interactions, and pharmacokinetic variations in drug metabolism.

Research Scope

This FOA invites applications from investigators with diverse scientific training and interests to develop, implement, and systematically evaluate interventions to improve adherence to medical and/or behavioral regimens in HIV-positive adolescents and young adults.  Research efforts directed at individual, family, social, and contextual factors that predict and/or influence adherence are welcome in conjunction with the development of interventions to improve adherence.     

Relevant topics of study involving adherence to medical and behavioral regimens in HIV-positive adolescents and young adults may include but are not limited to the following:           

·       Studies to understand the effects of age, developmental status, gender, gender identity, race, ethnicity, and culture on adherence;

Studies to evaluate the usefulness of integrative care models that incorporate mind/body interventions or other complementary and alternative medicine approaches in improving adherence to HIV-related behavioral recommendations.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NICHD intends to commit approximately $2,500,000 in total costs in FY 2012 to fund approximately three to six new awards.

NCCAM intends to commit approximately  $400,000 in total costs in FY 2012.

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.  Future year amounts will depend on annual appropriations.  

Award Budget

Application budgets are limited to a total cost amount of $499,999 in FY 2012 and must reflect the actual needs of the proposed project.

Award Project Period

Scope of the proposed project should determine the project period. The maximum period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

Although a letter of intent 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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent to:

Lynne Haverkos, MD, MPH
Program Director, Pediatric Behavior and Health Promotion
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health
6100 Executive Boulevard, Room 4B05G, MSC 7510
Bethesda, MD.  20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301-435-6881
Email: lh179r@nih.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies; GWAS) as provided in the SF424 (R&R) Application Guide.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Foreign Institutions

Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

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 only as described in the NIH Grants Policy Statement.   

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD(s)/PI(s) Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Grantee Meeting Required.  Principal Investigators (PI(s)) or Program Directors (PD(s)) are required to attend a one-day meeting with other PI and/or PD from projects funded under this FOA, and with NIH staff in the Washington, D.C. area each year.  At this workshop, PI(s) and/or PD(s) will be asked to share research designs, proposed measurement strategies, and barriers encountered.  Requests for travel funds for these meetings should be included in the application budget. 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?       

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.   

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by NICHD, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned  to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.      

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Lynne Haverkos, MD, MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6881
Email: lh179r@nih.gov

Carol Pontzer, PhD
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: 301-435-6286
Email: pontzerc@mail.nih.gov  

Peer Review Contact(s)

Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-451-3415
Email: duperes@mail.nih.gov

Financial/Grants Management Contact(s)

Bryan Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.