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Grants to USA, Canada, and International Agencies, For-Profits, IHEs, and Nonprofits for Exploratory Biomedical Research

Translational Research in Maternal and Pediatric Pharmacology and Therapeutics (R21 Clinical Trial Optional)


GrantWatch ID#

Funding Source
U.S. Department of Health and Human Services (HHS) - National Institutes of Health (NIH)
CFDA Number: 93.313, 93.865
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: 03/10/23
Deadline: 04/11/23 Save

Grant Description
Grants to USA, Canada, and International agencies, for-profits, IHEs, and nonprofits for new research to develop better pharmaceuticals for children and pregnant women. Applicants are advised that required registrations may take several weeks to complete. Funding is intended for the investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research.

The objectives of this funding opportunity announcement (FOA) are to support 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 medications in pregnant and lactating women and children. The overall goal is to improve safe and effective precision therapeutics for pregnant and lactating women and for neonates and children.

Proposed research activities should also align with the OPPTB’s research priorities to expand the knowledge in pharmacokinetics, pharmacodynamics, pharmacogenomics, biomarkers, new drug development and drug repurposing for the treatment of maternal and pediatric diseases.

Knowledge deficits in maternal and pediatric pharmacology may require interaction between disciplines, in which case a multiple integrated and interactive research team to address interrelated research areas are encouraged.

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

For the purpose of this FOA, maternal and pediatric therapeutics is defined to encompass:

  • Therapeutic treatment of obstetric and breastfeeding conditions;
  • Physiological changes that occur in a woman’s body during pregnancy, the post-partum period, and during lactation that impact the distribution or effects of administered therapeutics;
  • Passage of drug from mother to fetus during pregnancy and to child during breastfeeding, including the effects of those drugs on the fetus or child;
  • Therapeutic treatment of pediatric disease, particularly where there are unique pediatric conditions or pharmacodynamic differences from adult disease;
  • Physiological changes that occur across the entire spectrum of pediatric development from birth through adolescence that impact the distribution or effects of administered therapeutics.

Applications that apply scientific discoveries generated from the basic science laboratory and preclinical studies to clinical studies/trials in maternal and/or pediatric populations are appropriate for this FOA.


  • City or township governments
  • County governments
  • For profit organizations other than small businesses
  • Independent school districts
  • 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
Eligible Applicants:
- Higher Education Institutions
- Nonprofits Other Than Institutions of Higher Education
- For-Profit Organizations
- Local Governments
- Federal Governments
- 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)

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.

Pre-Application Information
Key Dates:
- Posted Date: September 11, 2020
- Open Date (Earliest Submission Date): November 10, 2020
- Letter of Intent Due Date(s): 30 days prior to application receipt date
- Application Due Date(s): December 10, 2020; April 9, 2021; August 10, 2021; December 10, 2021; April 11, 2022; August 10, 2022; December 9, 2022
- Scientific Merit Review: March 2021, July 2021, November 2021, March 2022, July 2022, November 2022, March 2023
- Advisory Council Review: May 2021, October 2021, January 2022, May 2022, October 2022, January 2023, May 2023
- Earliest Start Date: July 2021, December 2021, April 2022, July 2022, December 2022, April 2023, July 2023
- Expiration Date: December 10, 2022

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.

All applications are due 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.

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

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)
- System for Award Management (SAM)
- eRA Commons

View this opportunity on

For a list of relevant application documents, go to the Package tab (press Preview) on the link above.

Estimated Size of Grant
The combined budget for direct costs for the two-year project period may not exceed $275,000. No more than $200,000 in direct costs may be requested in any single year.

Term of Contract
The scope of the proposed project should determine the project period. The maximum project period is 2 years.

Contact Information
Apply online:

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

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