Notice of Special Interest: Availability of Administrative Supplements and Competitive Revision Supplements on Coronavirus Disease 2019 (COVID-19) within the Mission of NIAAA
Release Date: April 16, 2020
First Available Due Date: May 15, 2020
Expiration Date: April 16, 2021
PA-18-591 Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
PA-18-935 Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional)
NOT-OD-20-118 Guide Notice of Information Highlighting Harmonization and Data Sharing Expectations for Supplement and Revision Projects Addressing Social, Behavioral, Economic and Health Impacts of the COVID-19 Public Health Emergency
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
The impact of the COVID-19 pandemic on the nation is vast, especially on health and well-being. Research suggests that alcohol consumption tends to increase during times of duress and uncertainty such as disasters and other traumatic events, and as such alcohol is often misused to cope with stress, anxiety, and other uncomfortable emotions. In addition, the misuse of alcohol to cope with the stress as a result of physical distancing and other policy measures, and a lack of access to supportive social networks and treatment for people with pre-existing alcohol use disorder (AUD) are significant concerns during the pandemic. These outcomes are particularly challenging with respect to COVID-19 because alcohol misuse can interfere with normal immune system function and elevate susceptibility to viral infections of the respiratory system. Alcohol-associated damage to the liver, heart, and other organs may also complicate health outcomes in individuals with COVID-19. These myriad physical and behavioral health outcomes related to alcohol and COVID-19 present a range of urgent research needs and opportunities.
Research is needed to understand the potentially complex relationships between alcohol consumption and COVID-19 related-outcomes to enhance the nation’s response to the current pandemic. The outcomes include overt pathophysiology and the impact of social and policy measures on COVID-19 outcomes. Such studies also will help to lay the groundwork for responding to future public health emergencies. This NOSI encourages applications, in the form of urgent competitive revisions and administrative supplements to existing grants and cooperative agreements, to assess the impact of alcohol as a biological contributor to COVID-19 outcomes, to assess behavioral, social, and economic consequences of the pandemic and to assess the responses that the pandemic has provoked as they relate to alcohol consumption and related outcomes.
NIAAA is encouraging research in the following areas, including those that capitalize on existing research cohorts, to investigate urgent research questions of significance to the COVID-19 pandemic within the general population and among underserved populations, such as racial, ethnic and gender minorities, individuals with low socioeconomic status, and those who are incarcerated or homeless.
Questions that may be addressed under this NOSI include, but are not limited to:
- Are individuals who engage in high-risk drinking behaviors or with AUD more likely to engage in behaviors that increase risks for infection or transmission of SARS-CoV-2, the virus that causes COVID-19?
- What is the influence of alcohol drinking history, patterns, amount, and duration on susceptibility to SARS-CoV-2 infection and COVID-19 prevalence, progression, and outcomes? Are people living with HIV differentially affected? Are racial, ethnic and gender minorities and those of low socioeconomic background, or pregnant women or individuals with underlying conditions differentially affected?
- What are the common mechanisms of alcohol-associated Acute Respiratory Distress Syndrome (ARDS) and COVID-19-related ARDS? Are there mechanistic synergies or distinctions that can be exploited to manage COVID-19 progression?
- What are the broad physiological and pathological mechanisms mediating the impact of alcohol use and misuse on SARS-CoV2 infection and COVID-19 progression and complications? In immune compromised persons, or persons with other underlying co-morbid conditions, what additional physiological factors mediate the impact of alcohol misuse on SARS-CoVo2 infection and COVID-19 progression and outcomes?
- Does alcohol misuse mediate multi-organ or multi-system disruption, including neuroinflammation, to alter the severity and progression of COVID-19?
- Does COVID-19-related systemic inflammation accompanied by concomitant alcohol use exacerbate the neuroinflammation associated with AUD?
- Is SARS-CoV-2 neuroinvasive, similar to some other coronaviruses? How does alcohol impact the susceptibility and consequences of neurobiological manifestations of coronaviruses?
- Do the COVID-19 pandemic and the personal, social, policy, and economic responses and consequences impact stress and emotional regulation, thereby exacerbating the social isolation that increases the risk of alcohol misuse, potentially leading to harmful consequences of high-risk drinking behavior to self and others? What is the impact of social distancing on AUD treatment, recovery, relapse risk, and management of withdrawal? How do demographic, socio-cultural, and/or geographic differences affect recovery for individuals with AUD?
- How does the system-level shift towards COVID-19 impact access to primary and specialty health care for AUD and co-occurring mental health conditions? What are the systems-level challenges (policy, practice, financing) to rapid deployment of emergency mental health/AUD services during the pandemic?
- What workforce development and deployment strategies are needed to address emerging challenges in mental health/AUD treatment during the pandemic?
Application and Submission Information
Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.
- PA-18-591 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
- PA-18-935 - Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional) is intended to provide funds for NIH grantees applying to expand the scope of their active grant.
- The funding instrument, or activity code, will be the same as the parent award.
All instructions in the SF424 (R&R) Application Guide, PA-18-591, and PA-18-935 must be followed, with the following additions:
- The Research Strategy section of the application is limited to 6 pages.
- The award project period of the submission must not exceed two years and must reflect the needs of the project.
- Application budgets are generally limited to no more than $100,000 direct costs per year. Should the proposed research require a higher budget, the applicant should consult with the program official assigned to the parent award. Permission to exceed $100,000 must be acquired from NIAAA’s Office of Extramural Activities prior to submission. The PI must include a strong justification for the larger budget in the supplement application. The proposed budget must reflect the actual needs of the proposed project.
- The parent award must be active when the supplemental application is submitted regardless of the time remaining on the current project. If the project is not active at the time that the application is submitted (e.g., entered into a no-cost extension), the application will be withdrawn”.
- Applications will be accepted on a rolling basis through April 15, 2021 by 5:00 PM local time of the applicant organization. This NOSI expires on April, 16, 2021.
- All applications (including those for multi-project activity codes) must be submitted electronically using a single-project application form package:
Administrative supplement applications to PA-18-591 must use the application form package with the Competition ID that contains “FORMS-E-ADMINSUPP”. This FOA will be reissued with application form packages containing “FORMS-F-ADMINSUPP” on May 25, 2020. Submissions to PA-18-591 must be completed by June 25, 2020 (see NOT-OD-20-026 for details.) Submissions to the reissued FOA will be accepted on or after May 25, 2020 through the expiration date of this Notice. In addition, the process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.
Competitive revision applications to PA-18-935 must use the application form package with the Competition ID of “NOT-DA-20-047-FORMS-E." This FOA will be reissued with a “NOT-AA-20-011-FORMS-F” package on May 25, 2020. Submissions to PA-18-935 must be completed by June 25, 2020. Submissions to the reissued FOA will be accepted on or after May 25, 2020 through the expiration date of this Notice.
- IMPORTANT: For funding consideration, all applicants must designate “NOT-AA-20-011” (without quotation marks) in the Agency Routing Identifier field (Box 4b) of the SF424 (R&R)
- Form. Applications without this information in Box 4b will not be considered for this initiative.
- Investigators planning to submit an application in response to the NOSI are strongly encouraged to contact the program officer listed below to discuss the proposed project in the context of the parent award.
Applications nonresponsive to terms of this NOSI will be not be considered for the NOSI initiative.
Please direct all inquiries to:
Kathy Jung, PhD.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)