Notice Number: NOT-AT-20-011

Key Dates
Release Date: April 10, 2020

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-20-077, Reminder: FORMS-F Grant Application Forms & Instructions Must be Used for Due Dates On or After May 25, 2020- New Grant Application Instructions Now Available

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

Issued by
National Center for Complementary and Integrative Health (NCCIH)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP) New participating organization as of 05/29/2020 for due dates on/after 05/29/2020

Purpose

NCCIH is issuing this Notice of Special Interest (NOSI) to highlight the urgent need for research on the 2019 Novel Coronavirus (2019-nCoV, also known as COVID-19). Topics of specific interest for this NOSI include research on stress management strategies, including mind and body approaches, that individuals may engage in remotely to address stressors related to social distancing, as well as to address recovery and recurrence of symptoms during and after COVID-19 infections.

Background

As of March 27, 2020, more than 500,000 cases of COVID-19 and 20,000 deaths have been reported worldwide, with more than 65,000 cases and 1,000 deaths in the United States. There are now reported cases in every state, and widespread social distancing, self-quarantine, and/or shelter-in-place measures are in place (www.coronavirus.gov). While these measures are critical to slow the spread of COVID-19, they may have a negative impact on symptoms of stress, anxiety, and depression. Anxiety about uncertainty of virus exposure and stress from social isolation are features of the current pandemic that may have unwanted consequences of their own and possibly add to the morbidity and mortality of COVID-19 virus infection.

As people across the United States respond to the COVID-19 pandemic, opportunities exist to conduct critical research on the usefulness and impact of stress management techniques to address emotional resilience to this unique public health crisis, as well as possibly influence symptom severity during and after COVID-19. There is some indication that stress management approaches, such as mindfulness training or exercise, may reduce severity of viral infections; however, additional research is needed to understand whether these strategies may impact the immune response to COVID-19 specifically (e.g., the severity of infection, duration of infection, or postinfection symptoms).

Interventions that can be remotely delivered, including phone delivery, app-based approaches, video delivery, web-based platforms, wearable devices, and/or new technologies, are uniquely well suited to the current social situation of this pandemic.

Research Objectives

To better understand the impact of stress management strategies in the context of the COVID-19 pandemic, NCCIH is encouraging the submission of applications for Administrative Supplements or Competitive Revisions to active grants. Applicants should propose research that can be completed remotely, without any in-person contact between study staff and research participants. Interventions proposed for study should already be fully developed and ready for immediate testing. Areas of research interest include but are not limited to the following:

• Research on the impact of remotely delivered stress management strategies (e.g., mindfulness-based stress reduction (MBSR), yoga, meditation, guided imagery, hypnosis, social support) on stress, anxiety, and depressive symptoms among at-risk populations (e.g., older adults, immunocompromised people), worried well populations, vulnerable and diverse populations (e.g., individuals with HIV, opioid and/or alcohol use disorder populations, or underserved/rural populations and other health disparity populations*), individuals who test positive for COVID-19, and/or individuals recovering from COVID-19 infection
• Research on the impact of remotely delivered stress management strategies on COVID-19 infection outcomes (illness severity and duration, immune response to the virus, longer term health outcomes)
• Longer term follow up of randomized trials to examine whether prior training in stress management strategies is associated with improved mental or physical health outcomes during the present pandemic, resilience to COVID-19 infection, or symptom severity
• Research on stress management for pediatric populations, and studies using family- or system-level interventions that can be done under current physical distancing recommendations
• Use of ongoing longitudinal research studies to understand utilization of stress management techniques in the broad context of the COVID-19 pandemic (e.g., social distancing, school closures, food insecurity, unemployment, family loss, underlying health conditions), as well as the impact of these techniques and potential individual differences in response to stress management.

NCCIH intends to fund up to three awards in response to this NOSI. Priority will be given to studies that have the potential to produce highly impactful results and use a rigorous study design to address a testable hypothesis.

The National Institute on Aging (NIA) will accept applications for supplements and revisions to NIA-supported projects that fall within the scope of this announcement and are relevant to the mission and strategic priorities of the NIA. Applications are encouraged that address the specific needs and circumstances of midlife and older adults, including, but not limited to, individuals with Mild Cognitive Impairment (MCI), Alzheimer’s disease and Alzheimer’s disease related dementias (AD/ADRD) and their healthcare providers and caregivers.

*NIH-designated health disparity populations include racial and ethnic minorities (Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asians, Native Hawaiians and other Pacific Islanders), sexual and gender minorities, socioeconomically disadvantaged populations, and under-served rural populations.

Application and Submission Information

Applications in response to this NOSI must be submitted using one of the following targeted funding opportunities or subsequent reissued equivalent:

• 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.
• PA-18-591 Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) is intended to provide funds for NIH grantees where the work proposed in the supplement is fully within the scope of the ongoing grant.
• The funding instrument, or activity code, will be the same as that of the parent award.

To be eligible for either an Administrative Supplement or Urgent Competitive Revision, the parent award on which the supplement or revision application is based must:

• Be an active award (i.e., not be in an extension period) at the time the supplement or revision is awarded
• Have sufficient time left to complete the studies proposed after the supplement or revision has been awarded within the existing project period
• Have IRB approval to conduct the proposed work prior to award and be allowed to start the proposed work during the period of the pandemic (no delayed-start studies will be supported).

When developing applications in response to this NOSI, all instructions in the SF424 (R&R) Application Guide 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 2 years.
• The parent award must be active when the application is submitted. The project and budget periods must be within the currently approved project period for the existing parent award.
• Applications will be accepted on a rolling basis through October 6, 2020 by 5:00 p.m. local time of the applicant organization. This NOSI expires on October 7, 2020.
• All applications must be submitted electronically using a single-project application form package:

  • Administrative supplement applications toPA-18-591must 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 toPA-18-591must be completed by June 25, 2020 (seeNOT-OD-20-026for 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-AT-20-011-FORMS-E. This FOA will be reissued with a NOT-AT-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-AT-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 this NOSI are strongly encouraged to contact the program officers listed below to discuss the proposed project in the context of the parent award.

Applications nonresponsive to the terms of this NOSI will be not be considered for the NOSI initiative.

Inquiries

Please direct all inquiries to:

Lanay M. Mudd, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-9346
Email: [email protected]

Della White, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-827-6358
Email: [email protected]

Lisa Onken Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3131
Email: [email protected]?

Laura Kwako Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-451-8507
Email: [email protected]