Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
New
NOT-OD-19-128, Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research
NOT-OD-19-137, Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research
RFA AA 20-004, U24 Resource-Related Research Projects – Cooperative Agreements
RFA AA-20-005, U24 Resource-Related Research Projects – Cooperative Agreements
93.273
This Funding Opportunity Announcement (FOA) solicits research cooperative agreements as part of the Neurobiology of Adolescent Drinking in Adulthood (NADIA) consortium to elucidate persistent changes in complex brain function-behavior relationships following adolescent alcohol exposure. The purpose of this FOA is to support collaborative research projects (U01) focusing on research efforts across different research institutions investigating the consequences of repeated adolescent alcohol exposure on brain maturation and adult abilities. Since NIAAA is interested in supporting experimental studies on the effects of controlled alcohol doses and exposure periods, this initiative is limited to animal studies only.
September 23, 2019
November 18, 2019
December 18, 2019, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.
No late applications will be accepted in response to this FOA
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
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.
Not Applicable
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.
Purpose
The purpose of this Funding Opportunity Announcement (FOA) is to support the Neurobiology of Adolescent Drinking in Adulthood (NADIA) consortium. The overarching goal of the NADIA consortium is to elucidate the mechanisms mediating persistent neurobiological pathology and behavior caused by adolescent alcohol exposure. This FOA solicits collaborative research projects (U01) from multiple research institutions focused on investigating repeated adolescent alcohol exposure and its effects on brain maturation and adult abilities. In this initiative, NIAAA is interested in supporting experimental studies of the mechanisms of pathology produced by controlled alcohol doses and exposure periods. Therefore, this initiative is limited to animal studies only. Applications for administrative and resources cores, both under the U24 mechanism, should be submitted in response to the companion FOAs: RFA-AA 20-004 and RFA AA-20-005, respectively.
Background
Adolescent alcohol abuse is common, with the highest rate of hazardous drinking occurring between the ages of 19 to 25. People ages 12 through 20 drink 11 percent of all alcohol consumed in the United States. In 2015, 7.7 million young people reported that they drank alcohol beyond “just a few sips” in the past month. While 5.1 million young people reported binge drink at least once in the past month, 1.3 million reported binge drinking on 5 or more days over the past month. Although, the percentage of teens who drink decreased by one-third in the past decade, it is still a very high consumption to have serious long-term consequences. Drinking during adolescence greatly increases the lifelong risk of alcohol use disorders due to impaired cognition, decision-making skills and increased negative emotional states associated with dysregulated stress responses. During adolescence, the brain undergoes growth and remodeling that focuses responses and improves cognitive efficiency through changes in neurogenesis, synaptic remodeling, as well as changes in neurotransmitter and hormone levels. The high levels of neuroplasticity during adolescence allow optimization of brain function through adaptation to training and other experiences. Morphological changes in brain development during adolescence contribute to global intelligence (IQ), executive function, including refinement of reasoning, goal and priority setting, attention-impulse control, information processing efficiency, responses to reward, stress and the negative emotional states, and control over violence. The adolescent brain has critical periods of cortical development that are defined by adaptive changes causing persistent changes in brain structure and function. The emergence of many phobias, compulsive, and psychotic disorders as well as alcohol use disorders starts between the ages of 10-25 years, emphasizing the potential of adolescence as a vulnerable period. For example, recent data from National Consortium on Alcohol and Neurodevelopment in Adolescence (NCANDA) show accelerated frontal cortical gray matter trajectory and executive dysfunction in adolescent alcohol users that is related to risk for alcohol use and poor sleep quality. Thus, it is important to understand the mechanisms for the long-term neurobehavioral consequences of alcohol exposure during this period of brain maturation. The projects of the Consortium will investigate the neurobiology of adolescent alcohol exposure with the special focus on the molecular, cellular and circuit mechanisms underlying behavior changes.
Goals and Objectives
NIAAA recognizes that innovation, synergy, and conceptual advances arise from interactions across scientific disciplines, methodologies, and levels of analysis. Therefore, this FOA intends to provide support for a consortium with integrated research projects focused on the persistent brain and behavioral functional changes following adolescent alcohol exposure. It is anticipated that clusters of research projects within a consortium will address a mutual scientific objective, but will differ in emphasis, approaches and the research questions addressed. To ensure integration within the NADIA consortium, the proposed U01 research project applications should use resources and the technologies provided by one or more resource core facilities if proposed, use standardized methodologies across projects when appropriate, and demonstrate coordinated effort with other research projects addressing different levels of analysis. By fostering integration, the NAIDA consortium will significantly escalate the acquisition of knowledge and the translation of research findings to the human condition.
Areas of research appropriate to this announcement include, but are not limited to:
Organization of the NADIA Consortium:
The NADIA Consortium will consist of a cluster of integrated cooperative agreement research projects (U01s) and resource-related research projects (U24s). The research projects (U01s) will focus on the common theme of persistent changes in brain after adolescent alcohol use and will have collaborative studies with other U01 projects within the Consortium. The use of standardized methodology among various research projects and sharing of technical expertise is expected. The consortium will include one administrative unit (U24) led by the Consortium Coordinator. The consortium may also include research resource cores (U24), as applicable, to provide service to individual research projects cooperative agreement (U01) described in this FOA.
Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. Fostering diversity by addressing underrepresentation in the scientific research workforce is a key component of the NIH/NIAAA strategy to identify, develop, support and maintain the quality of our scientific workforce. Therefore, applicants are strongly encouraged to include as research staff and key contributors, investigators who are underrepresented in biomedical research including individuals of diverse racial/ethnic, gender, rural and low income backgrounds
In order to support NADIA consortium, NIAAA solicits the submission of one set of linked applications consisting of multiple U01s (RFA-AA-20-003, this FOA), one application for the Administrative Resource U24 (RFA-AA-20-004) and at least one application for the Research Resource U24 (RFA-AA-20-005), as follows:
Human subjects' research and HIV/AIDS-related research applications will be considered nonresponsive to this FOA.
Renewal (from RFA-AA-15-004)
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
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NIAAA intends to commit $4.2M in FY 2020 to fund 8 awards to grant applications responding to this FOA and the companion FOAs,
RFA-AA-20-004, RFA-AA-20-005. Future year amounts will depend on annual appropriations.
The scope of the proposed project should determine the project period. The maximum project period is 5 years.
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
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. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. 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.
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.
Multiple PDs/PIs are allowed on any single application. Because the FOA already supports a team approach between groups of experts across sites and collaborating applications, the designation of multiple PDs/PIs on a single application may be less likely to apply. PD(s)/PI(s) from each linked application should not be designated as multiple PDs/PIs on each application of a collaborative set.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
This FOA only accepts applications that are part of a collaborative set of multiple applications. A set must contain not more than 8 Research Projects U01 (RFA-AA-003, this FOA), not more than 1 Administrative Resource U24 (RFA-AA-20-004), and at least 1 Research Resource (RFA-AA-20-005).
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Abraham Bautista, Ph.D.
National Institute on Alcohol Abuse and Alcoholism
Telephone: (301) 443-9737
Email: [email protected]
Descriptive Title of Applicant's Project: To allow NIH to identify a group of applications as a related set of collaborative applications, the titles for each application in the set must have the following format: a “1/N” indicator + Identical Title (e.g., “1/3”, where the 1/3 means this is site 1 of 3 sites in the set. The other sites will be labeled 2/3, etc.) Titles may not exceed 200 characters in length, including the tag, e.g., 1/3, at the beginning of the title.
Cover Letter Attachment: The Cover Letter is one pdf file only. The following collaborative information is required in the Cover Letter: a listing of all the applications that are a part of the set of collaborative applications being submitted, including for each: 1) the PD/PI(s) name(s), 2) the Title (including the tag, e.g., “1/3”), and 3) the Applicant Institution. Each site should submit an identical listing.
All instructions in the SF424 (R&R) Application Guide must be followed.
Research Strategy: The application from each site must contain a Research Strategy that clearly describes those aspects of the project that are common to all sites of the collaboration. All variations in the Research Strategy between sites, no matter how minor, should be highlighted in a subsection of the Research Strategy with the heading "Elements Unique to This Site." In this subsection, PD(s)/PI(s) should describe, for example, how the research site has a unique role in the collaboration, such as data coordination, statistical analyses, (etc). Each individual U01 Research Project application should include in the Approach section a description of their interactions with various other components of the consortium.
Coordination and integration of linked applications: PD(s)/PI(s) should describe coordination, integration, synergy, and mutual reinforcement between the individual research projects and resources, as well as scientific and administrative integration of the proposed program. In addition, PD(s)/PI(s) should describe the advantages or value added by conducting the proposed research as a consortium rather than through separate research efforts, such as thematic cohesion to the consortium, and scientific justification of the interrelationship of individual research projects and resources.
The following modifications also apply:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
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.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.
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 and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
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 and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Each application of a collaborative set must be complete, compliant, and responsive. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
In order to expedite review, applicants are requested to notify the NIAAA Referral Office by email at bautista@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? 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?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?
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?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project ? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
Specific to this FOA: Is there a clear description of how this project interacts with other components of the consortium? Is it synergistic with other consortium components or provide any unique opportunity?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
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?
Coordination and integration of linked applications
Do the linked applications show evidence of coordination, integration, synergy, and mutual reinforcement between the individual research projects and resources? Is there evidence of scientific and administrative integration of the proposed program? Are there clear advantages or value added by conducting the proposed research as a consortium rather than through separate research efforts? Is there thematic cohesion to the consortium? Is the interrelationship of individual research projects and resources clear and scientifically well-justified?
For research that involves human subjects but does not involve one of the 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 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 Guidelines for the Review of Human Subjects.
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 individuals of all ages (including children and older adults) 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.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
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.
Not Applicable
For Renewals, the committee will consider the progress made in the last funding period.
Not Applicable
Not Applicable
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).
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) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
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 National Institute on Alcohol Abuse and Alcoholism, 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.
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 national Advisory Council on Alcohol Abuse and Alcoholism. The following will be considered in making funding decisions:
Information regarding the disposition of applications is available 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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
The PD/PI will have the primary responsibility for:
NIAAA Project Scientist is a designated NIAAA Program Staff, who will have substantial programmatic involvement, as described below and will be named in the Notice of Award (NoA).
NIAAA Program Staff designated as the Program Official/Director will be responsible for the normal scientific and programmatic stewardship of the awards and will be named in the summary statement and the Notice of Award (NoA). NIAAA Program Official/Director may recommend withholding of support, suspension, or termination of the award for lack of adherence to required policies and/or procedures, and lack of adherence to the goals of the FOA.
NIAAA Program Staff may not have dual role as the Project Scientist and Program Official/Director.
Areas of Joint Responsibility include:
The PD(s)/PI(s) and the NIAAA Project Scientist will participate in regularly scheduled monthly Steering Committee meetings to coordinate implementation and evaluation of the ongoing projects. The Steering Committee will consist of a minimum of one member from each participating site and the NIAAA Project Scientist. Every participating site and the NIAAA Project Scientist will each have a single vote on the Steering Committee. All Steering Committee decisions and recommendations that require voting, will be based on a majority vote.
Additionally, the PIs and the NIAAA Project Scientist will participate in a yearly meeting to present major findings, to plan collaborative efforts, to assist in analysis, interpretation, and dissemination of scientific findings.
Dispute Resolution Process:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the awardee, an NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
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.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Antonio Noronha, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-7722
Email: [email protected]
Soundar Regunathan, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phone: 301-443-1192
Email:[email protected]
Ranga Srinivas, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-451-2067
Email: [email protected]
Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: [email protected]