Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

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

Funding Opportunity Title

NIH/PEPFAR Collaboration for Implementation Science (Admin Supp)

Activity Code

Administrative Supplement

Additional funds may be awarded as supplements to parent awards using the following Activity Code(s):

Administrative supplement requests must be submitted on paper for the following activity codes:

P01 Research Program Projects
P30 Center Core Grants
P50 Specialized Center
P60 Comprehensive Center
P2C Resource-Related Research Multi-Component Projects and Centers
PM1 Program Project or Center with Complex Structure
S06 Research-Related Programs
U10 Cooperative Clinical Research – Cooperative Agreements
U19 Research Program – Cooperative Agreements
U54 Specialized Center- Cooperative Agreements
UC2 High Impact Research and Research Infrastructure Cooperative Agreement Programs
UM1 Multi-Component Research Project Cooperative Agreements

Administrative supplement requests may be submitted electronically for the following activity codes:

D43 International Training Grants in Epidemiology
DP5/UP5 Early Independence Award/Cooperative Agreement
DP7 NIH Director’s Workforce Innovation Award
G08 Resources Project Grant (NLM)
K01 Research Scientist Development Award - Research & Training
K02 Research Scientist Development Award – Research
RC4 High Impact Research and Research Infrastructure Programs – Multi-Yr Funding
RM1 Research Project with Complex Structure
R01 Research Project Grant
R03 Small Grant Program
R18 Research Demonstration and Disseminations Projects
R24 Resource-Related Research Projects
R25 Education Projects
R37 Method to Extend Research in Time (MERIT) Award
S10 Biomedical Research Support Shared Instrumentation Grants
S11 Minority Biomedical Research Support Thematic Project Grants
S21 Research and Institutional Resources Health Disparities Endowment Grants – Capacity Building
SC1 Research-Enhancement Award
SC3 Research Continuance Award
U01 Research Project – Cooperative Agreements
U18 Research Demonstration – Cooperative Agreements
U2R International Training Cooperative Agreement
U24 Resource-Related Research Projects – Cooperative Agreements
UC4 High Impact Research and Research Infrastructure - Cooperative Agreement Programs
UH2 Exploratory/Developmental Cooperative Agreement Phase I
UH2/UH3 Phase Innovation Awards Cooperative Agreement
UH3 Exploratory/Developmental Cooperative Agreement Phase II
UL1 Linked Specialized Center Cooperative Agreement
UH2 Exploratory/Developmental Cooperative Agreement Phase I
UH2/UH3 Phase Innovation Awards Cooperative Agreement
UH3 Exploratory/Developmental Cooperative Agreement Phase II
UL1 Linked Specialized Center Cooperative Agreement

Announcement Type

Reissue of NOT-AI-10-023

Related Notices

NOT-AI-13-061

  • January 31, 2014 - NIH and AHRQ Extend Due Dates for Applications Due Jan 31-Feb 3 to Feb 4. See Notice NOT-OD-14-047.
  • December 13, 2013 - See Notice NOT-AI-14-017. Notice of Revised Application Due Date.

Funding Opportunity Announcement (FOA) Number

PA-14-024

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.855; 93.856; 93.394; 93.393; 93.395; 93.396; 93.397; 93.398; 93.399; 93.273; 93.865; 93.279; 93.847; 93.279; 93.242; 93.989  

Funding Opportunity Purpose

The National Institute of Allergy and Infectious Diseases (NIAID), with the NIH Institutes and Centers (ICs) named above, in collaboration with the President’s Emergency Plan for AIDS Relief (PEPFAR), is encouraging applications for implementation science projects that will provide results to directly inform PEPFAR programs in order to increase their impact, efficiency, and sustainability.  The research projects must be limited no more than one year in duration.  

Key Dates
Posted Date

December 10, 2013

Open Date (Earliest Submission Date)

December 21, 2013

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

(Extended to February 4, 2014 per NOT-OD-14-047 (previously January 31, 2014 per NOT-AI-14-017), Originally January 21, 2014, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

(Extended to January 31, 2014 per NOT-AI-14-017), Originally January 21, 2014, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Scientific Merit Review

Not Applicable

Advisory Council Review

Not Applicable

Earliest Start Date

April 2014

Expiration Date

(Now Expiring February 1, 2014 per NOT-AI-14-017), Originally January 22, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide or PHS 398 Application Guide, as appropriate) 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


Background

The President's Emergency Plan for AIDS Relief (PEPFAR) was initiated 10 years ago and quickly rolled out HIV/AIDS prevention, care, and treatment programs as an emergency response to the devastating epidemic in resource-limited countries.  Following the rapid scale-up, PEPFAR programs are steadily moving from the provision of emergency services to assisting in the development of sustainable programs to prevent and treat HIV and related illnesses and which can be integrated into public health systems.  Implementation science research is needed to inform approaches and investments for public health programming and policy making and to ultimately increase the chances of reversing the global AIDS epidemic. 

Implementation science is a relatively new, interdisciplinary area of health care research which focuses on the application of interventions that have already been proven as efficacious in controlled conditions, and includes investigations in the acceptability, coverage, and fidelity of services; service delivery systems, barriers to service delivery and strategies to overcome these barriers; cost-effectiveness outcomes and impact on health systems and/or the community.  The aim of this type of research is to provide evidence based approaches to health care delivery and to improve the benefits and sustainability of health-related programs. 

A rigorous implementation science research agenda is needed for PEPFAR to understand the effectiveness of combinations of proven prevention interventions brought to scale; to improve many aspects of program delivery; to determine the effects of integrating HIV care into primary care programs; and to increase the public health impact of proven HIV/AIDS modalities in prevention, treatment, and care.

Objectives

The intent of this Funding Opportunity Announcement (FOA) is to encourage implementation science research of relevance to PEPFAR programs that will focus on the multiple challenges being encountered by many programs in resource-limited countries when they attempt to deploy effective prevention, treatment, and integrated interventions against HIV/AIDS.  Studies should reflect the needs and priorities of the countries or regions in which they are to be conducted, but also produce results that are quantifiable and applicable to diverse circumstances and geographic areas.   Another objective is to incorporate capacity building and/or local investigators in the proposed work.

Projects will be awarded that apply accepted implementation science methodology while building in-country research capacity and that focus on one or more of the specific areas of research detailed in this notice.  Current grantees are encouraged to develop partnerships with local researchers and researchers from other disciplines that can best address the research question.  Collaborations are encouraged and may combine expertise in anthropology, business and public administration, clinical decision-making, data management, economics, epidemiology and statistical methods, individual and systems-level behavioral change, information science, learning theory, engineering, marketing and/or organizational and management theory.  Due to the limited time frame, secondary analyses of existing data sets or pilot projects of innovative approaches are also encouraged.

Specific Research Areas

The specific research areas below were developed through discussions with PEPFAR field staff, United States Government agency headquarters staff involved in PEPFAR programming, the PEPFAR Scientific Advisory Board, the NIH and the Office of the Global AIDS Coordinator (OGAC).

I. Implementation Science for Treatment Programs:

II. Metrics for Quality of Care

III. Identification/Diagnosis and/or Prevention of Tuberculosis (TB) Disease

IV. Linkage of non-HIV services with HIV care

V. Focus on Key Affected Populations (KAP) (FY 2014 PEPFAR Technical Considerations note that “Key Populations are persons who are affected by punitive laws, regulations and policies, stigmatized and marginalized, and disproportionately affected by HIV. This includes men who have sex with men (MSM) and transgender persons [TG], people who inject drugs [PWID], and sex workers [SWs]):

VI. Focus on Adolescents

VII. Training and Health Systems:

VIII. Mother-to-Child Transmission and Maternal Health:

The proposed research must fall within the scope of work of the parent grant and, once awarded, will be managed according to the rules and regulations of the NIH institute through which the project is funded.  The application may not include initiation of a new research site for this study.

Section II. Award Information
Funding Instrument

The funding instrument will be the same as the parent award. 

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

Non-competing Administrative Supplements

Funds Available and Anticipated Number of Awards

The Office of the Global AIDS Coordinator, through NIH, intends to commit a total of $7 million in FY14 to fund approximately 14-20 awards.  This will be divided into two categories: $5 million for awards addressing the topic areas in category I-VII above, the remaining $2 million is designated specifically for PMTCT projects addressing the topic areas in category VIII above.

Award Budget

Application budgets are limited to no more than $500,000 total costs (Direct and Indirect), and must reflect the actual needs of the proposed project. Note that ICs may further limit application budgets for specific activity codes or programs and applicants should contact the Program Contact listed in this announcement for their awarding IC.

The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives, as long as the research objectives are within the original scope of the project, or the cost increases are for unanticipated expenses within the original scope of the project. Any cost increases need to result from making modifications to the project that would increase or preserve the overall impact of the project consistent with its originally approved objectives and purposes.

Award Project Period

The project and budget periods must be within the currently approved project period for the existing parent award and may not exceed 12 months.

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

All organizations administering an eligible parent award may apply for a supplement under this announcement.

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

This announcement is for supplements to existing projects. To be eligible, the parent award must be active and the research proposed in the supplement must be accomplished within the competitive segment. The proposed supplement must be to provide for an increase in costs due to unforeseen circumstances. All additional costs must be within the scope of the peer reviewed and approved project.

IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project.

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

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Individual(s) must hold an active grant or cooperative agreement, and the research proposed in the supplement must be accomplished within the competitive segment of the active award. Individuals are invited to work with their organizations to develop applications for support.

For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award. Do not use this administrative supplement application to add, delete, or change the PDs/PIs listed on the parent award. Visit the Multiple Program Director/Principal Investigator Policy in the SF424 (R&R) Application Guide for more information.

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 is sufficiently distinct from any other administrative supplement currently under consideration by the awarding NIH Institute or Center.  

Other Eligibility Requirements

This opportunity for an administrative supplement will be limited to investigators with current grant funding from one the participating NIH Institutes or Centers for research and research training conducted at sites in low resource countries.

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants are required to prepare applications according to the current application forms in accordance with the Application Guide.
For electronic submissions, applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this announcement, or use the eRA Commons streamlined submission process.

2. Content and Form of Application Submission

All forms should be completed for the supplemental activities only and should not reflect funding or activities for the previously awarded parent award.

It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide or PHS 398 Application Guide, as appropriate) 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.

Page Limitations

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

Application Submission

Electronic submission of request for administrative supplements is only available for single-project activity codes for which competing applications are submitted electronically. Visit the list of single-project Activity Codes Processed Electronically by eRA to determine if the single-project activity code of the parent award has transitioned to electronic submission.  Submission of requests for administrative supplements is for all other activity codes must use paper.

If the administrative supplement may be submitted electronically, then you may either (A) submit using the SF424 (R&R) Application Forms and Grants.gov/Apply, (B) submit using the streamlined submission process of eRA Commons, or (C) submit using the paper-based PHS 398 Application forms and the PHS 398 Application Guide.

Instructions for Submissions using Grants.gov/Apply for electronic-based submissions

For single project grants with activity codes that have transitioned to electronic submission using the SF424 (R&R) application forms, administrative supplement requests may be submitted electronically as a Revision application type on the R&R Cover Component. Prepare applications using the SF424 (R&R) application forms associated with this announcement. Please note that some components marked optional in the application package are required for submission of applications for this announcement. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate required and optional components.

Special Instructions for Streamlined Submissions using the eRA Commons for electronic-based submissions

NIH now offers a streamlined system through the eRA Commons for submitting administrative supplements. Login to the eRA Commons, identify the parent award, and prepare an administrative supplement request. A User’s Guide for submitting through this system is available.

Include the Research Strategy and any other required documentation (described below) as a PDF file using the “Add Other Attachments” function.  Budget information should be entered for the grantee institution in the fields provided. There is no template or form available for subaward information; instead, all subaward information should be included as a separate attachment showing the funds requested (by budget period) using the same categories provided for the grantee institution. Also include a budget justification for the subawardee institution in the same file.

Instructions for Submissions using the PHS 398 Application Forms (for paper-based submissions)

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. The grantee institution, on behalf of the PD/PI of the parent award, must submit the request for supplemental funds directly to the awarding component that supports the parent award. Submit a signed, typewritten original of the application, including the checklist, and two signed photocopies in one package to the appropriate Institute or Center below:

Melanie C. Bacon, RN, MPH
Division of Acquired Immune Deficiency Syndrome
National Institute of Allergy and Infectious Diseases (NIAID)
6700B Rockledge Drive, Rm. 4201
Bethesda, MD  20814
Telephone:  301-451-2747
Email:  mbacon@niaid.nih.gov 

Joshua Rosenthal, Ph.D.
Division of International Training and Research
Fogarty International Center (FIC)
31 Center Drive, Building 31, B2C39, MSC 2220
Bethesda, MD 20892-2220
Telephone:  301-496-1653
Email:  joshua.rosenthal@nih.gov

Geraldina Dominguez, Ph.D.
Office of HIV and AIDS Malignancy
National Cancer Institute (NCI)
31 Center Drive, Building 31, Room3A/33
Bethesda, MD  20892-2440
Telephone:  301-496-3204
Fax:  301-480-4137
Email:  domingug@mail.nih.gov 

Lynne M. Mofenson, M.D.
Pediatric, Adolescent and Maternal AIDS Branch
Center for Research for Mothers and Children
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health
6100 Executive Boulevard, Room 4B11
Rockville, MD 20852
Telephone:  301-435-6870
Email:  Lynne.Mofenson@nih.hhs.gov 

Katherine Davenny, Ph.D.
AIDS Research Program
National Institute on Drug Abuse (NIDA)
6001 Executive Blvd., Room 4215
Bethesda, MD   20892
Telephone:  301.443.2146
Email: kd25h@nih.gov

Chris Gordon, Ph.D.
Division of AIDS and Health and Behavior Research
National Institute of Mental Health (NIMH)
6001 Executive Boulevard, Room 6199, MSC 9619
Bethesda, MD  20892-9619
Telephone:  301-443-1613
Email:  cgordon1@mail.nih.gov  

Kendall J. Bryant, Ph.D.
Coordinator, Alcohol and HIV/AIDS
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
5635 Fishers Lane, Rm 2069 
Rockville MD 20892-7003
Telephone: 301-402-9389
Email:  kbryant@mail.nih.gov

Paul L Kimmel, MD, MACP, FASN
Division of Kidney Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 611
Bethesda MD 20892-5458
Telephone: 301-594-1409
Email: KimmelP@extra.niddk.nih.gov 

On the face page of the application form, note that your application is in response to a specific program announcement, and enter the title and number of this announcement.  Text for the application should be limited to 5 pages.  Tables or graphs conveying preliminary data may be included in an appendix and, along with the bibliography, will not be included in the page count. 

PHS 398 Research Plan (Research Plan)

All instructions in the Application Guide must be followed for all Research Plan sections applicable to the proposed supplement activities. At a minimum, the Research Strategy section should be completed and must include a summary or abstract of the funded parent award or project. Other sections should also be included if they are being changed by the proposed supplement activities.

Research Strategy: Applications must identify the relevance of their question to PEPFAR program implementation. 

Letters of Support: A letter of support must be provided by the authorized organizational official for each collaborating institution, where data will be collected or study protocols will be implemented. 

Project/Performance Site Locations (Project/Performance Sites)

All instructions in the Application Guide must be followed, with the following additional instructions:

Senior/Key Personnel Form

All instructions in the Application Guide must be followed, with the following additional instructions:

R&R Detailed Budget Form (for use with electronic submissions)

All budgets should be submitted using the R&R Detailed Budget form, regardless of the form used for the parent award, and should only include funds requested for the additional supplement activities.

Note that some ICs may have policies in place that further limit administrative supplements.

Budget for the Entire Proposed Period of Support (for use with paper-based submissions)

A proposed budget should be submitted using the PHS 398 budget forms, in accordance with the PHS 398 Application Guide, and should only include funds requested for the additional supplement activities.

Other Project Information (for use with electronic submissions); Appendix (use with paper-based submissions)

All instructions in the Application Guide must be followed, with the following additional instructions:

Other Attachments (for electronic submission): If applicable, include documentation that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects’ involvement is planned for the supplement component.

The filename provided for each “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.

Planned Enrollment Report (for use with electronic submissions)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

Foreign Institutions

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications as described above. 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 before the due date in the eRA Commons to ensure accurate and successful submission.

For electronic application submission, information on the submission process and a definition of on-time submission are provided in the SF424(R&R) Application Guide.

For paper-based application submission, information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS 398 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 using the instructions specified above

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:
For applications submitted electronically on the SF424 (R&R) Application forms, 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/PI 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 System for Award Management (SAM). Additional information may be found in the Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and/or responsiveness by the awarding Institute or Center. Applications that are incomplete and/or nonresponsive will not be reviewed.

>Potential applicants are strongly encouraged to contact the Program Officer for the parent grant prior to submitting applications.  Clarifications of any questions regarding NIH and PEPFAR priorities and how these may fit with their currently funded research can be discussed at that time. The Program Officer should be notified when the application is submitted. If the Program Officer is out of the office and not available to receive your notice of application, you may submit it to the Program Officer listed on this announcement for the NIH IC through which the parent award is funded.    

Post Submission Materials

Not Applicable

Section V. Application Review Information


1. Criteria

Administrative Supplements do not receive peer review. Instead, the administrative criteria described below will be considered in the administrative evaluation process.

The staff of the NIH awarding component will evaluate requests for a supplement to determine its overall merit. The following general criteria will be used:

Budget and Period of Support

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

Overall Impact

Funding will be based on the applicant's responsiveness to the aims of this announcement, the ability to incorporate capacity building and/or local investigators in the proposed work, the scientific strengths of the proposal and generalizability of results across PEPFAR programs, and the ability and quality of the proposed supplement activities to address the priority research questions identified in this announcement within the scope of the parent award.

The criteria below will be used as applicable to the Administrative Supplements proposed:

Supplements to research awards or research centers:

Supplements to fellowship awards:

Supplements to career development awards:

Supplements to institutional training (and institutional career development) awards:

Supplements to shared instrumentation or resource awards:

In addition, each of the following criteria will be evaluated as applicable for the proposed supplement.

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, NIH staff 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, NIH staff 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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed.  For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

NIH Staff 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

NIH Staff 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.

2. Review and Selection Process

Administrative supplement requests will undergo an administrative evaluation by NIH staff, but not a full peer review. Applications submitted for this funding opportunity will be assigned to the awarding component for the parent award and will be administratively evaluated using the criteria shown above.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. This may be as an NoA for the supplemental activities only; alternatively, it may be as either a revision to the current year NoA or included as part of a future year NoA. 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, SAM 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

Any supplements to Cooperative Agreements will be subject to the same Cooperative Agreement terms and conditions as the parent award.

President’s Emergency Plan for AIDS Relief (PEPFAR) Program PEPFAR Agreements

Special terms and conditions concerning prostitution and sex trafficking apply to all grants awarded under the U.S. President’s Emergency Plan for AIDs Relief (PEPFAR) program.  These are:

a. The U.S. Government is opposed to prostitution and related activities, which are inherently harmful and dehumanizing, and contribute to the phenomenon of trafficking in persons. None of the funds made available under this agreement may be used to promote or advocate the legalization or practice of prostitution or sex trafficking. Nothing in the preceding sentence shall be construed to preclude the provision to individuals of palliative care, treatment, or post-exposure pharmaceutical prophylaxis, and necessary pharmaceuticals and commodities, including test kits, condoms, and, when proven effective, microbicides.

b. The following definitions apply for purposes of this provision:

c. The Grantee must insert this provision, which is a standard provision, in all subawards or subcontracts.

d. This provision includes express terms and conditions of the award and any violation of it is grounds for unilateral termination of the award by NIH prior to the end of its term.

PEPFAR Agreements Between the U.S. Government and Foreign Non-Governmental Organizations (NGOs)

Additional requirements regarding the opposition to prostitution and sex trafficking apply to grants awarded under PEPFAR and issued to foreign Non-Governmental Organizations (NGOs).  The terms and conditions for such agreements with foreign NGOs are:

a. The U.S. Government is opposed to prostitution and related activities, which are inherently harmful and dehumanizing, and contribute to the phenomenon of trafficking in persons. None of the funds made available under this agreement may be used to promote or advocate the legalization or practice of prostitution or sex trafficking. Nothing in the preceding sentence shall be construed to preclude the provision to individuals of palliative care, treatment, or post-exposure pharmaceutical prophylaxis, and necessary pharmaceuticals and commodities, including test kits, condoms, and, when proven effective, microbicides.

b. (1)  Except as provided in (b)(2) and (b)(3), by accepting this award or any subaward, a non-governmental organization or public international organization awardee/subawardee agrees that it is opposed to the practices of prostitution and sex trafficking because of the psychological and physical risks they pose for women, men, and children.  Any enforcement of this clause is subject to Alliance for Open Society International v. USAID, 05 Civ. 8209 (S.D.N.Y., orders filed on June 29, 2006 and August 8, 2008) (orders granting preliminary injunction) for the term of the Orders. 

The lists of members of GHC and InterAction can be found at: http:/transition.usaid.gov/business/business_opportunities/cib/pdf/GlobalHealthMemberlist.pdf.

(2) The following organizations are exempt from (b)(1): the Global Fund to Fight AIDS, Tuberculosis and Malaria; the World Health Organization; the International AIDS Vaccine Initiative; and any United Nations agency.

(3) Contractors and subcontractors are exempt from (b)(1) if the contract or subcontract is for commercial items and services as defined in FAR 2.101, such as pharmaceuticals, medical supplies, logistics support, data management, and freight forwarding.

(4) Notwithstanding section (b)(3), not exempt from (b)(1) are recipients, subrecipients, contractors, and subcontractors that implement HIV/AIDS programs under this assistance award, any subaward, or procurement contract or subcontract by:

(i) Providing supplies or services directly to the final populations receiving such supplies or services in host countries;

(ii) Providing technical assistance and training directly to host country individuals or entities on the provision of supplies or services to the final populations receiving such supplies and services; or

(iii) Providing the types of services listed in FAR 37.203(b)(1)-(6) that involve giving advice about substantive policies of a recipient, giving advice regarding the activities referenced in (i) and (ii), or making decisions or functioning in a recipient’s chain of command (e.g., providing managerial or supervisory services approving financial transactions, personnel actions).

c. The following definitions apply for purposes of this provision:

d. The recipient shall insert this provision, which is a standard provision, in all subawards, procurement contracts or subcontracts.

e. This provision includes express terms and conditions of the award and any violation of it shall be grounds for unilateral termination of the award by NIH prior to the end of its term.

3. Reporting

Reporting requirements will be specified in the terms and conditions of award as applicable to the supplemental activities. In most non-competing continuation applications, the progress report and budget for the supplement must be included with, but clearly delineated from, the progress report and budget for the parent award. The progress report must include information about the activities supported by the supplement even if support for future years is not requested. Continuation of support for the supplement activities in the remaining years of the competitive segment of the grant will depend upon satisfactory review by the NIH awarding component of progress for both the parent award and the supplement project, the research proposed for the next budget period, and the appropriateness of the proposed budget for the proposed effort. This information is submitted with the  Non-Competing Grant Progress Report, PHS 2590 or RPPR, and financial statements as required 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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
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

Scientific/Research Contact(s)

Melanie C. Bacon, RN, MPH
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone:  301-451-2747
Email:  mbacon@niaid.nih.gov  

Joshua Rosenthal, Ph.D.
Fogarty International Center (FIC)
Telephone:  301-496-1653
Email:  joshua.rosenthal@nih.gov

Geraldina Dominguez, Ph.D.
National Cancer Institute (NCI)
Telephone:  301-496-3204
Fax:  301-480-4137
Email:  domingug@mail.nih.gov  

Lynne M. Mofenson, M.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone:  301-435-6870
Email:  Lynne.Mofenson@nih.hhs.gov  

Katherine Davenny, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone:  301.443.2146
Email: kd25h@nih.gov

Chris Gordon, Ph.D.
National Institute of Mental Health (NIMH)
Telephone:  301-443-1613
Email:  cgordon1@mail.nih.gov   

Kendall J. Bryant, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-402-9389
Email:  kbryant@mail.nih.gov

Paul L Kimmel, MD, MACP, FASN
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-1409 or 594 7717
Email: KimmelP@EXTRA.NIDDK.NIH.GOV 

Peer Review Contact(s)

Not Applicable

Financial/Grants Management Contact(s)

Ann Devine
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-402-5601
Email: paullj@mail.nih.gov  

Bruce Butrum
Fogarty International Center, NIH
Telephone: 301-496-1670
Email: butrumb@nih.gov  

Alice Wong
National Cancer Institute (NCI) 
Telephone:  301-496-7800
Email: wongalice@mail.nih.gov  

Mario Martinez, MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-4024078
Email: martinem@mail.nih.gov  

Jane Z. Lin
National Institute of Mental Health (NIMH)
Telephone: 301-443-2229
Email: linja2@mail.nih.gov  

Carol Alderson
National Institute on Drug Abuse (NIDA)
Telephone:  (301) 933-6196
Email: aldersoc@nida.nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov

Diana Ly
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone:  301-594-9249
Email: dianaly@niddk.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.


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