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 Cancer Institute (NCI) National Eye Institute (NEI) National Institute of Environmental Health Sciences (NIEHS) Fogarty International Center (FIC) Office of Behavioral and Social Sciences Research (OBSSR) Office of Research on Women’s Health (ORWH)
Funding Opportunity Title	Administrative Supplements for Health Impacts of Household Air Pollution on Women’s Health and Child Survival (Admin Supp)
Activity Code	Administrative Supplement Additional funds may be awarded as supplements to parent awards using the following Activity Code(s): P01 Research Program Projects P20 Exploratory Grants P30 Center Core Grants P50 Specialized Center R24 Resource-Related Research Projects U10 Cooperative Clinical Research Cooperative Agreements U19 Research Program Cooperative Agreements U54 Specialized Center- Cooperative Agreements UM1 Multi-Component Research Project Cooperative Agreements D43 International Training Grants in Epidemiology K01 Research Scientist Development Award - Research & Training K02 Research Scientist Development Award Research K23 Mentored Patient-Oriented Research Career Development Award R01 Research Project Grant R15 Academic Research Enhancement Award (AREA) R21 Exploratory/Developmental Research Grant Award R25 Education Projects R33 Exploratory/Developmental Grants Phase II R34 Clinical Trial Planning Grant Program R37 Method to Extend Research in Time (MERIT) Award U01 Research Project Cooperative Agreements
Announcement Type	New
Related Notices	None
Funding Opportunity Announcement (FOA) Number	PA-12-202
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.865, 93.399, 93.867, 93.113, 93.989
Funding Opportunity Purpose	The NIH announces an opportunity to request an administrative supplement to NIH-funded research and training that would support research into the health impacts of household air pollution (HAP) from the incomplete combustion of biomass or solid fuels used for cooking, heating or lighting. The purpose of this administrative supplement is to provide opportunities for teams with current programs in lower and middle income countries (LMIC) to conduct research or research training on the relationship between exposure to HAP and the risk for adverse health effects to women and children including but not limited to risks for asthma, cardiovascular diseases, cancer, infections, ocular diseases, burns and scalds, pregnancy outcomes, acute lower respiratory tract infection (ALRI) or impaired growth and development in infants and children, and social and behavioral aspects of stove adoption and reduction in HAP exposures.

Posted Date	June 11, 2012
Open Date (Earliest Submission Date)	June 11 2012
Letter of Intent Due Date	Not Applicable
Application Due Date(s)	July 16, 2012, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	Not Applicable
Advisory Council Review	Not Applicable
Earliest Start Date(s)	September 1, 2012
Expiration Date	July 17, 2012
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Application Guide (SF 424 (R&R) Application Guide or PHS398 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.

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

The NIH announces an opportunity to request an administrative supplement to NIH-funded research and training that would support research into the health impacts of household air pollution (HAP) from the incomplete combustion of biomass or solid fuels used for cooking, heating or lighting. The purpose of this administrative supplement is to provide opportunities for teams with current programs in lower and middle income countries (LMIC) to conduct research or research training on the relationship between exposure to HAP and the risk for adverse health effects to women and children including but not limited to risks for asthma, cardiovascular diseases, cancer, infections, ocular diseases, burns and scalds, pregnancy outcomes, acute lower respiratory tract infection (ALRI) or impaired growth and development in infants and children, and social and behavioral aspects of stove adoption and reduction in HAP exposures.

The goal of this program is to provide administrative supplements to currently funded NIH investigators interested in understanding and preventing the adverse health outcomes of HAP to women and children. This research opportunity is timely as a result of the recent formation of the Global Alliance for Clean Cookstoves, a public-private partnership within the United Nations Foundation that is promoting the global distribution of more advanced cookstoves to improve health (http://cleancookstoves.org).

This program augments the NIH commitment to the Global Alliance and to its mission to use advanced stoves and fuels to reduce HAP and to improve human health, by providing administrative supplements to existing NIH grants relevant to this topic. Eligible parent grants should include studies in LMIC where HAP exists in urban or rural settings but the original research or research training focus can be diverse. Examples of such parent grants may include studies of adverse pregnancy outcomes, women’s or children s health, cardiovascular diseases, cancer, ALRI and other respiratory diseases, ocular disorders or household-related burns or scalds; health impacts of outdoor air pollution or environmental tobacco smoke; birth cohorts studying prevalence of disease or interventions; social and behavioral studies of health-related household activities such as water or sanitation practices; application of evaluation methods that can assess health impacts in large non-randomized cookstove implementation programs; field application of novel technology such as personal exposure monitors or biomarkers relevant to the purpose of the supplement; studies of children at risk for disease in early life (asthma, child development including impaired learning or cognition, malaria, tuberculosis, HIV/AIDS etc) as well as other diseases or conditions related to pregnancy or early life risks.

Examples of research skills, experience and priorities that would be responsive to this announcement include but are not limited to:

• Demonstrating existing research experience in the developing country setting with strong preference for in-country research partners including investigators (one of whom may be co-principal investigator) and familiarity with community engagement in conduct of research of health outcomes in such settings, and particularly impact of HAP or related exposures;
• Providing detailed information on how exposures will be assessed; if novel exposure technologies to be used, the application should include strategies for validation of these technologies for accuracy and reproducibility in field use with assessment of HAP exposure levels;
• Providing a rationale for the measures of selected health outcomes;
• Providing a plan to evaluate the possible impact of potential confounders/effect modifiers including but not limited to other combustion-sources of pollution, access to or utilization of health care, nutritional status, and socio-economic status;
• If an intervention is proposed, addressing critical issues such as how to measure successful adoption of new technology such as advanced stoves or fuels, any proposed training in use of new technologies or social/behavioral changes needed to minimize exposures;
• If use of biomarkers is proposed, demonstrating the relationship between measured biomarkers and exposure and/or health outcomes;
• Providing a plan for research training that would build capacity to conduct studies such as those mentioned above.

The research or research training proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project. 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 they are within the original scope of the project. Any cost increases need to result from making modifications to the project in order to take advantage of opportunities that would increase the value of the project consistent with its originally approved objectives and purposes.

Funding Instrument	The funding instrument will be the same as the parent award. Grant or Cooperative Agreement
Application Types Allowed	Non-competing Administrative Supplements
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
Award Budget	NIH participating ICs intend to commit up to $1.2M in FY2012 to fund up to 8 to 10 awards. Requested amounts must reflect actual needs of the proposed project. An applicant must request a project period of 1 year only. The budget requests may be for $50,000 to $200,000 total costs (i.e., DC +_F&A). The budget can include salary support in addition to other justified expenses, such as travel and supplies, for the proposed research or research training recognizing that the research site is likely in a developing country. The requested salary and fringe benefits must be in accordance with the salary structure of the grantee institution for individuals in comparable positions, consistent with the level of effort. Applicants are strongly encouraged to include travel support for an investigator from their research team to attend the NIH Training Course on Health Impacts of Household Air Pollution scheduled for October 10-12, 2012 on the NIH campus. An award issued under this FOA is contingent upon adequate progress on the parent grant during the current project period, the availability of funds, and the receipt of a sufficient number of meritorious applications. Although the financial plans of the NIH provide support for this program, administrative supplement awards pursuant to this initiative are contingent upon the availability of funds and the receipt of a sufficient number of meritorious requests. 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.

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.

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

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

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..

Current NIH awardees with NIH grants pertinent to health outcomes of women’s health and child survival from HAP may apply for an administrative supplement provided the following conditions are met:

• The topic of the administrative supplement must be related to the focus of research or training proposed and conducted under the original NIH award (parent award);
• Efforts proposed and funds requested in the administrative supplement application must expand on the original study design and be relevant to women’s health and child health risks from HAP;
• The parent award must remain active during the entire funding period of this supplement; and
• The Principal Investigator(s) for the supplement must be the Principal Investigator(s) of the parent award.

Applicants are strongly encouraged to contact the Scientific/Research Contact listed at the end of this FOA to discuss a potential supplement application.

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.

Applicant organizations must complete the following registrations as described in the 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.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov (required for all electronic application submissions)
• eRA Commons

All Program Directors/Principal Investigators (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 4-6 weeks prior to the application due date.

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 PD/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 PD/PIs listed on the parent award. Visit the Multiple Program Director/Principal Investigator Policy in the SF424 (R&R) Application Guide for more information.

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

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.

Since applications in response to this announcement will only receive administrative review by the awarding Institute or Center, and will not receive a peer review, the NIH policy on resubmissions will not apply. However, applications not accepted by the Institute or Center for review, or not funded by the Institute or Center, should not be submitted again without either responding to any written concerns or contacting the awarding Institute or Center for instructions first.

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.

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 PHS398 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.

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

The page limit for the Research Strategy section of the administrative supplements submitted in response to this FOA is limited to six pages.

The process for submitting an application varies depending on whether the activity code of the parent award requires electronic submission (as of the submission date of the supplement application). Visit the list of Activity Codes Processed Electronically by eRA to determine if the activity code of the parent award has transitioned to electronic submission.

• If the parent award’s activity code has not transitioned to electronic submission, then you must use the PHS398 Application Forms and follow the PHS398 Application Guide.
• If the parent award’s activity code has transitioned to electronic submission, then you may either (A) electronically submit using the SF424 (R&R) Application Forms and Grants.gov/Apply, (B) electronically submit using the streamlined submission process of eRA Commons, or (C) submit using the paper-based PHS398 Application forms and the PHS398 Application Guide.

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

For grants with activity codes that have transitioned to electronic submission using the SF424 (R&R) application forms, administrative supplement requests may be submitted electronically. 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.

Include the Specific Aims, Research Strategy and Cover Letter (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 PHS398 Application Forms (for paper-based submissions)

Applications must be prepared using the PHS398 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 applicable Scientific/Research or Financial/Grants Management Contacts listed below under Section VII. Agency Contacts.

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.

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.

Applicants should include the following components of the Research Plan in the application for the Administrative Supplement:

• Specific Aims of the project submitted as an Administrative Supplement (not to exceed one page). Discuss scope of the overall (parent) project and contributions of the requested project to the goals and aims of the parent.
• Research Strategy of the project submitted as an Administrative Supplement (not to exceed 6 pages' Within the Research Strategy, applicants should address the following items:
• Detailed research or research training design, approach, methods and data analyses for the proposed project.
• Expected outcomes and relationship to parent specific aims; and
• Timeline and milestones to be accomplished;

Cover Letter (for use with electronic and paper-based applications)

Include acover Letter which cites this FOA and the following:

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

PHS Form Page 1 Face page (for use with paper-based applications)

• The title of the project should be the title of the parent award.
• This FOA should be cited in Box 2, and the yes box should be checked.
• The Program Director(s)/Principal Investigator(s) must be the same as the PI on the parent award. For Multiple PI parent awards, the Contact PI must be the PI listed on the supplement request, and the supplement cannot change the Multiple PI team.
• The remaining items on the face page should be filled out in accordance with the PHS 398 application instructions.

PHS Form Page 2 (for use with paper-based applications)

• Note: The project summary is that of the administrative supplement, not the parent grant.

Include the primary site where the proposed supplement activities will be performed. If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.

List the PD/PI as the first person (regardless of their role on the supplement activities). List any other Senior/Key Personnel who are being added through this supplement, or for whom additional funds are being requested through this supplement; include a biographical sketch for each. Follow all instructions in the Application Guide.

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.

A proposed budget should be submitted using the PHS398 budget forms, in accordance with the PHS398 Application Guide, and should only include funds requested for the additional supplement activities.

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

IACUC Documentation and IRB Documentation (Uploaded via the Other Attachments Section for electronic submissions)

• 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.

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

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 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 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, iinformation on the process of receipt and determining if your application is considered on-time is described in detail in the PHS398 Application Guide.

This initiative is not subject to intergovernmental review.

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.

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 Central Contractor Registration (CCR). Additional information may be found in the Application Guide.

See more tips for avoiding common errors.

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

Not Applicable.

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

NIH staff will consider the ability of the proposed supplement activities to increase or preserve the parent award’s overall impact within the original scope of award:

• Will the administrative supplement increase or preserve the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved?
• Will the administrative supplement increase or preserve the likelihood for the candidate to maintain a strong research program?
• Will the administrative supplement increase or preserve the likelihood for the program to exert a sustained, powerful influence on the research field(s) involved?
• Will the administrative supplement increase or preserve the potential benefit of the instrument requested for the overall research community and its potential impact on NIH-funded research?

Administrative supplement requests will be reviewed at NIH by Program and Grants Management Staff affiliated with the Institutes and Centers funding the parent grant, in addition to other Institute, Center and Office program staff with expertise related to the studies proposed.

Selection factors will include the following:

• Relevance of the proposed research or training to the parent grant;
• Scientific merit of the proposed research or training;
• Adequate progress of the parent grant appropriate to the current state of the project;
• Appropriate timelines to accomplish stated goals of the proposed supplemental research or training activity.
• Appropriateness of the research or training team members if additional expertise is required within the proposed project.

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, NIH staff 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

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.

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.

Not Applicable.

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, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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.

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. This information is submitted with the PHS Non-Competing Grant Progress Report, Form 2590, 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.

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

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: [email protected]

Eugene G. Hayunga, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6856
Email: [email protected]

Britt C. Reid, D.D.S, Ph.D.
National Cancer Institute (NCI)
Telephone: 301-435-4914
Email: [email protected]

Houmam Araj, Ph.D.
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: [email protected]

Kimberly A. Gray, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0293
Email: [email protected]

Christine Jessup, PhD
Fogarty International Center (FIC)
Telephone: 301-496-1653
Email: [email protected]

William Elwood, Ph.D.
Office of Behavioral and Social Sciences Research (OBSSR)
Telephone: 301-402-0116
Email: [email protected]

Susan E. Maier, Ph.D.
Office of Research on Women’s Health (ORWH)
Telephone: 301-435-1573
Email: [email protected]

Not Applicable.

Bryan Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: [email protected]

Mr. William Darby
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: [email protected]

Ms. Dorothy Duke
National Institute of Environmental Health Sciences (NEIHS)
Telephone: 919-541-2749
Email: [email protected]

Mr. Bruce Butrum
Fogarty International Center (FIC)
Telephone: 301-496-1670
Email: [email protected]

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.

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.