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Grants to USA, Canada, and International Nonprofits, For-Profits, Agencies, and IHEs to Improve Drug Safety and Effectiveness for Mothers and Children

Translational Research in Maternal and Pediatric Pharmacology and Therapeutics (R01 Clinical Trial Optional)


GrantWatch ID#

Funding Source
National Institute of Mental Health (NIMH)
CFDA Number: 93.242
Funding or PIN Number: PAR-20-299
Array ( [0] => American Samoa (USA); [1] => Guam (USA); [2] => Puerto Rico (USA); [3] => Virgin Islands (USA); [4] => Northern Mariana Islands (USA); )

Geographic Focus
USA Territories: American Samoa (USA);   Guam (USA);   Puerto Rico (USA);   Virgin Islands (USA);   Northern Mariana Islands (USA);
USA Compact Free Associations:The Federated States of Micronesia (USA)   Marshall Islands (USA)   Republic of Palau (USA)
International, Israel and Canada.

Important Dates
LOI Date: 03/12/23
Deadline: 04/11/23 5:00 PM Local Time Save

Grant Description
Grants to USA, Canada, and International nonprofit and for-profit organizations, agencies, IHEs, FBOs, CBOs, and Native American tribal entities for research to improve drug safety and effectiveness for mothers and children. Applicants are advised that required registrations may take over six weeks to complete.

The purpose of this funding opportunity announcement (FOA) is to encourage applications that will perform basic, translational and clinical research to (1) advance the understanding of underlying mechanisms of drug action; (2) discover and develop novel therapeutics; (3) enhance the usage of existing drugs or drug repurposing for safer and more effective treatment for pregnant women, lactating women, neonates and children. The overall goal is to improve drug safety and efficacy for maternal and pediatric precision therapeutics.

NIMH Area of Interest: The NIMH is specifically interested in clinical studies supporting the establishment of pharmacodynamic (PD) markers of psychopharmacologic drugs in pediatric populations. For instance, a study using an EEG measure that would change in proportion to an administered drug dose (a CNS PD marker of drug action) would be of interest. It is expected studies include dose ranging PK/PD measures. Age-dependent effects would be of interest as well as the inclusion of comparator drugs. Using the EEG PD example, it is likely that the EEG measures reflecting drug action would be different in grade school children vs adults.

For examples of topics, see


  • City or township governments
  • County governments
  • For profit organizations other than small businesses
  • Independent school districts
  • Indian housing authorities
  • Native American tribal governments (Federally recognized)
  • Native American tribal organizations (other than Federally recognized tribal governments)
  • Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
  • Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
  • Private institutions of higher education
  • Public and State controlled institutions of higher education
  • Public housing authorities/Indian housing authorities
  • Others (see text field entitled "Additional Eligibility Criteria" for clarification)
  • Small businesses
  • Special district governments
  • State governments

Additional Eligibility Criteria
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.

For further eligibility information, see

The following types of applications will not be considered responsive to this FOA and will be withdrawn:
- Mechanistic research on understanding normal biology or disease etiology/progression except for research focusing on developmental pharmacology.
- Studies that do not address research projects in either maternal or pediatric pharmacology.
- Projects that focus on medicinal chemistry or protein engineering without an integrated plan to evaluate the validity of the therapeutic for health-related outcomes within the mission of the NICHD.
- Projects that focus on cancer therapy or cancer drug development

Pre-Application Information
Letter of Intent Due Date(s): 30 days prior to application receipt date. 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.

December 10, 2020, April 9, 2021, August 10, 2021, December 10, 2021, April 11, 2022, August 10, 2022, December 9, 2022, April 11, 2023. All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early.

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application.

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.
- Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number.
-System for Award Management (SAM) – Applicants must complete and maintain an active registration.
- eRA Commons

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

View this opportunity on


Application Guide:

Term of Contract
Earliest Start Date: July 2021, December 2021, April 2022, July 2022, December 2022, April 2023, July 2023. The maximum project period is 5 years.

Contact Information
The letter of intent should be sent to:
Zhaoxia Ren, M.D., Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Phone: 301-402-9340

There are several options available to submit your application:

1. Apply Online Using ASSIST:

2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to and to track your application. Check with your institutional officials regarding availability.

3. Use Workspace to prepare and submit your application and to track your application.

Scientific/Research Contact:
Margaret C. Grabb, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-7123

Financial/Grants Management Contact:
Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811

Peer Review Contact:
Elaine Sierra-Rivera, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-1043

Financial/Grants Management Contact:
Bryan Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975

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