Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	NIH Basic Behavioral and Social Science Opportunity Network (OppNet http://oppnet.nih.gov/) and its member Institutes, Centers and Offices: National Cancer Institute (NCI) National Eye Institute (NEI) National Heart, Lung, and Blood Institute (NHLBI) National Human Genome Research Institute (NHGRI) National Institute on Aging (NIA) National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Institute of Allergy and Infectious Diseases (NIAID) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) National Institute of Biomedical Imaging and Bioengineering (NIBIB) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute on Deafness and Other Communication Disorders (NIDCD) National Institute of Dental and Craniofacial Research (NIDCR) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institute on Drug Abuse (NIDA) National Institute of Environmental Health Sciences (NIEHS) National Institute of General Medical Sciences (NIGMS) National Institute of Mental Health (NIMH) National Institute of Neurological Disorders and Stroke (NINDS) National Institute of Nursing Research (NINR) National Institute on Minority Health and Health Disparities (NIMHD) National Library of Medicine (NLM) Fogarty International Center (FIC) National Center for Complementary and Alternative Medicine (NCCAM) National Center for Advancing Translational Sciences (NCATS) Office of Behavioral and Social Sciences Research (OBSSR) Office of Dietary Supplements (ODS) Office of Research on Women’s Health (ORWH)
Funding Opportunity Title	Limited Competition: Revision Applications for Basic Social and Behavioral Research on the Social, Cultural, Biological, and Psychological Mechanisms of Stigma (R01)
Activity Code	R01 Research Project Grant
Announcement Type	New
Related Notices	August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.
Funding Opportunity Announcement (FOA) Number	RFA-MD-13-005
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.113, 93.121, 93.142, 93.143, 93.172,93.173, 93.213, 93.233, 93.242, 93.273 ,93.279 ,93.286 ,93.307, 93.350,  93.361, 93.389,93.393, 93.394, 93.395,93.396, 93.399, 93.837, 93.838, 93.846, 93.847, 93.853, 93.855, 93.856, 93.859, 93.865, 93.866, 93.867, 93.879, 93.989
Funding Opportunity Purpose	This Funding Opportunity Announcement (FOA), issued as part of the NIH Basic Behavioral and Social Sciences Opportunity Network (OppNet), encourages revision applications to incorporate basic research on behavioral and social mechanisms underlying stigma into active R01 research projects. For this initiative, projects may focus on stigma processes and mechanisms from the perspective of stigmatized individuals or groups and/or of individuals or groups holding stigmatizing beliefs. Projects may examine stigma in the context of specific health conditions; however, the focus of the work must be on the underlying mechanisms of stigma rather than on condition-specific manifestations of stigma.

Posted Date	March 20, 2013
Open Date (Earliest Submission Date)	July 2, 2013
Letter of Intent Due Date(s)	July 2, 2013
Application Due Date(s)	August 2, 2013, 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)	August 2, 2013
Scientific Merit Review	October/November, 2013
Advisory Council Review	January, 2014
Earliest Start Date	April, 2014
Expiration Date	August 3, 2013
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (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.

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

OppNet is a trans-NIH initiative that funds activities to build the collective body of knowledge about the nature of behavior and social systems, and that deepen our understanding of basic mechanisms of behavioral and social processes. All 24 NIH Institutes and Centers that fund research and four Program Offices within the NIH Office of the Director (ICOs) co-fund and co-manage OppNet. All OppNet initiatives invite investigators to propose innovative research that will advance a targeted domain of basic social and behavioral sciences and produce knowledge and/or tools of potential relevance to multiple domains of health- and life course-related research. 

Applicants should understand that NIMHD, the NIH Institute or Center (IC) that made this FOA available to the public, is not necessarily the NIH IC that ultimately will manage a funded OppNet project. For this FOA, revision applications will automatically be assigned to the NIH IC that supports the parent R01 award.

For more information about OppNet and all its funding opportunities, visit http://oppnet.nih.gov. 

OppNet uses the NIH definition of basic behavioral and social science research (b-BSSR) (http://obssr.od.nih.gov/about_obssr/BSSR_CC/BSSR_definition/definition.aspx) to determine application responsiveness. Consequently, OppNet strongly encourages prospective investigators to consult this definition, OppNet s answers to frequently asked questions about b-BSSR (http://oppnet.nih.gov/about-faqs.asp), and the Scientific/Research Contacts section of this FOA for individuals with expertise in the research subject matter and the OppNet initiative.

Stigma remains a significant public health problem in the US and globally, particularly in low and middle income countries. Stigma has been shown to interfere with seeking and receiving appropriate health care, limit social and occupational opportunities, contribute to depression and other psychiatric disorders, and lower the quality of life of individuals with stigmatized statuses. A large body of research has been conducted on stigma, including a number of studies funded by the NIH. However, much of the existing stigma research, whether exploratory, descriptive or intervention-based, has focused on manifestations of stigma related to specific diseases, conditions, or populations (e.g., the unique features of stigma associated with HIV/AIDS, mental illness or lesbian, gay, bisexual, transgender and intersex (LGBTI) population). This focus may prevent an understanding of the underlying psychological and physiological mechanisms driving the development of stigmatizing attitudes and the experience of stigma and obscure important commonalities or differences across stigmatized health conditions and other stigmatized statuses, such as those associated with race/ethnicity, sexual orientation, or religious affiliation.

This gap in research poses a number of challenges for understanding stigma and developing effective interventions to prevent or reduce the experience of stigma or buffer against its effects. Without knowledge of shared underlying features of the development of stigmatizing attitudes or the experiencing of a stigmatized identity, researchers may adopt intervention models or strategies developed in the context of specific health conditions that do not fully address the complex psychological and physiological underpinnings of stigma. For example, little is known about the commonalities among stigma, social isolation, and stress, or about the potential for positive affect or social support to attenuate the experience of stigma. Additionally, disease-focused stigma research may lead to duplicated efforts, in that research aiming to understand and address stigma may not leverage relevant existing work done with other health conditions or stigmatized statuses.

The purpose of this FOA is to support projects that elucidate mechanisms underlying stigma that are relevant across health conditions or stigmatized statuses. An additional goal is to encourage applied stigma researchers to incorporate mechanistic components into their research and for b-BSSR investigators to incorporate stigma into studies of related phenomena.

Applications should clearly specify how the proposed research will address the underlying mechanisms through which stigma develops and/or is maintained, heightened, or diminished. Applications should also articulate how the findings generated will be relevant across different health conditions and/or other stigmatized statuses.

Examination of stigma mechanisms may occur at the individual level, including the study of behavioral factors such as cognition, memory, language, perception, personality, emotion, motivation, and others; or at the group level, including the study of social variables such as the structure and dynamics of small groups (e.g. couples, families, work groups, etc.); institutions and organizations (e.g. schools, religious organizations, etc.); communities (defined by geography or common interest); and larger demographic, political, economic, and cultural systems. Stigma mechanisms may also be examined through biopsychosocial research on the interactions of biological factors with behavioral or social variables and how they affect each other. Projects may focus on stigma processes from the perspective of stigmatized individuals or groups and/or of individuals or groups holding stigmatizing beliefs. Projects may include populations that are stigmatized based on health conditions and/or social characteristics; however, the focus of the project must be on the underlying mechanisms of stigma rather than on condition- or population-specific manifestations of stigma.

Projects may use a variety of approaches to uncover and explore stigma processes and mechanisms, including but not limited to the following:

• Experimental manipulation of stigma in laboratory, internet-based, or other controlled environments. This may include alteration of stigma experiences or stigmatizing attitudes in individuals with pre-existing stigmatized identities/stigmatizing attitudes OR induction of stigma experiences or stigmatizing attitudes in individuals without such pre-existing identities/attitudes.
• Laboratory-based studies involving assessment of cognitive, perceptual, psychophysiological, or neurological processes in descriptive or intervention studies.
• Animal models that offer a plausible analog to the social context of stigma in humans.
• Survey and interview research to examine stigma processes across different health conditions or other stigmatized statuses OR in individuals with multiple stigmatized identities.

Two types of active NIH-funded research projects are ideally poised to incorporate b-BSSR on stigma into their ongoing work: 1) applied stigma research that can accommodate exploration of stigma mechanisms, and 2) b-BSSR on related phenomena, such social cognition, social perception, social isolation, attitude formation, self-perception, and individual and group identity formation. However, grantees doing other types of basic and applied research projects that can feasibly incorporate research on stigma mechanisms are also encouraged to apply. Collaborations between b- BSSR investigators and applied stigma researchers are particularly encouraged.

Areas of specific interest include but are not limited to exploration or examination of the following:

• Social, cultural, biological, and psychological mechanisms that contribute to the experience of felt and enacted stigma or that underlie the development of stigmatizing attitudes.
• Mechanisms through which external or societal stigma develops into internalized stigma.
• Neurological, physiological, genetic/epigenetic, and psychological mechanisms through which felt or enacted health-related stigma affects health or the impact of health interventions.
• Neurological, physiological, and psychological processes involved in the development or expression of stigmatizing attitudes or behaviors.
• Neurological, physiological, and psychological processes that underlie changes in felt stigma experiences or stigmatizing attitudes in response to stigma interventions.
• Social, cultural, biological, or psychological phenomena that may attenuate the experience of stigma in response to perceived discrimination.
• The association between the experience of stigma and other psychological phenomena, such as stress or other affective states, resilience, self and group identity formation, and social isolation.
• Developmental course or changes in the experience of stigma and underlying neurological and physiological mechanisms.
• The nature of experiencing multiple stigmatized identities, including conditions under which this psychological experience is interactive or compounded.

This FOA targets b-BSSR approaches to understanding stigma. Many types of research have implications for understanding behavior and social processes or use behavioral and social factors as outcome variables. However, if the research lacks a major and explicit focus on the understanding of basic behavioral or social mechanisms or processes, it is not considered b-BSSR. The following are examples of research activities would NOT be considered responsive to this b-BSSR FOA unless they also included an exploration of mechanistic factors:

• Formative or qualitative research only.
• The inclusion of stigma as an additional predictor or outcome variable.
• The inclusion of biological or physiological factors as additional stigma outcomes.
• Documentation of disease-, condition-, or population-specific manifestations of stigma.
• Prospective or descriptive epidemiology of stigma or comparison of levels of stigma across different diseases, conditions, or populations.

In addition, b-BSSR does not address disease outcomes per se. Therefore, applications including an intervention component will be considered responsive only if they include a plan to examine the basic behavioral or social mechanism(s) through which the intervention impacts stigma and/or stigma impacts intervention effects.

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	Revision The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	OppNet intends to fund an estimated 6-7 awards, corresponding to a total of approximately $1.0 million in fiscal year 2014.
Award Budget	Direct costs requested for this revision may not exceed $100,000 per year, not including consortia F&A.
Award Project Period	Applicants may request support for up to one year, not to exceed the currently awarded parent project period. If a no-cost extension is needed on the parent grant to incorporate the project period of the revision, the no-cost extension must be in place before the revision application is submitted.

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.

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
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

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)

Only institutions that have an active R01 award issued by an NIH Institute or Center are eligible for this FOA.

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

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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.

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 PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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 application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

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.

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.

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:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Jennifer Alvidrez, PhD
Electronic Communication is preferred:  [email protected].

The subject line should begin with OppNet Stigma Revision RFA.

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

The forms package associated with this FOA includes all applicable components, required 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.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All R01 revision applications must have the same Program Director(s)/Principal Investigator(s) (PD(s)/PI(s) as the parent R01 grant.

All instructions in the SF424 (R&R) Application Guide must be followed.

All applications must use the same budget format (detailed or modular) as the parent grant. The requested budget may exceed the funding period for the parent grant. If a no-cost extension is needed on the parent grant to incorporate the project period of the revision, the no-cost extension must be in place before the revision application is submitted.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

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

Introduction to Application: Describe the nature of the revision and how it will influence the Specific Aims, research design, and methods of the current grant.

Specific Aims: Specific Aims for the revision application are required.

Research Strategy: Include a progress report as part of the Research Strategy.

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

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 to 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date 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.

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 electronically following the instructions described in the SF424 (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 SF424(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. See Section III of this FOA for information on registration requirements.

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. 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.

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

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.

Reviewers will provide an overall impact 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).

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/PI, 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?

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 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

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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 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.

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

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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.

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, SAM 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

Not Applicable

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) 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.

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

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

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]

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

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

Jennifer Alvidrez, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-9567
Email: [email protected]

Rebecca Ferrer, PhD
National Cancer Institute (NCI)
Telephone: 301-594-0437
Email: [email protected]

Enid Light, PhD
National Institute of Mental Health (NIMH)
Telephone: 301-443-3599
Email: [email protected]

Kathleen Michels, PhD
Fogarty International Center (FIC)
Telephone: 301-435-6031
Email: [email protected]

For more information about NIH’s OppNet initiative, contact:

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

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Priscilla Grant, JD
National Institute on Minority Health & Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: [email protected]

Applicants are encouraged to direct financial/budget questions to the Financial/Grants Management contact(s) identified in the NoA of the parent grant.

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.