Notice of Special Interest: Availability of Administrative Supplements to Advance Safe and Effective Therapeutics in Pregnant and Lactating Women and Children

NIH Notice Number: NOT-HD-20-003

Key Dates
Release Date: March 25, 2020
First Available Due Date: June 01, 2020
Expiration Date: June 02, 2020

Related Announcements
PA-18-591 Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

Issued by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Human Genome Research Institute (NHGRI)
National Institute of General Medical Sciences (NIGMS)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Minority Health and Health Disparities (NIMHD)

Purpose

This Notice of Special Interest (NOSI) calls for research that can ultimately advance safe and effective therapeutics in pregnant or lactating women, neonates, or infants. The purpose of this NOSI is to provide seed funds to support current and prospective investigators to generate preliminary data, collect samples, or develop robust models or analytic tools for future novel research of the NICHD's Obstetric and Pediatric Pharmacology and Therapeutics Branch's program priorities (https://www.nichd.nih.gov/about/org/der/branches/opptb).

Background

Physiological changes during pregnancy resulting in altered maternal drug metabolism have impacted efficacy and safety of therapeutics in pregnant women. Pregnancy induced hormonal, immunologic, or metabolic changes may also influence and alter drug disposition. Despite research efforts that have been focusing on pharmacokinetics of medications used in pregnant women in the past decade, knowledge gaps exist in understanding how pregnancy influences drug disposition and the underlying mechanisms as well as roles of placental drug transporters. Moreover, there is a dearth of research in understanding the safety and effectiveness of therapeutics in lactating women.

Administrative supplements will primarily provide support to stimulate the scientific community in conducting research in pregnant or lactating women. As knowledge gaps also exist in the understanding of pediatric ontogeny influencing pharmacokinetics, pharmacodynamics and dosing, funds will be also available to research addressing the gaps in knowledge specifically in neonates and infants.

Research Objectives

This NOSI informs current NIH awardees that NICHD is interested in administrative supplement applications to currently funded projects supported by NICHD and investigators who are currently funded by other participating NIH ICs if interested in expanding or moving into obstetric or pediatric pharmacology and therapeutics research.

Interested applicants are encouraged to expand efforts from their parent grants to address research topics relevant to NICHD’s strategic plan Theme Five on advancing safe and effective therapeutics for pregnant and lactating women and children which is outlined in the link: https://www.nichd.nih.gov/sites/default/files/2019-09/NICHD_Strategic_Plan.pdf

Example of topics include, but are not limited to, the following:

  • Leveraging existing resources and integrative data analyses (e.g., biobanks, EHRs, etc.) to assess safety, effects, and clinical outcomes of therapeutics in pregnant or lactating women to discover/identify novel therapeutic potentials for diseases and conditions in these populations;
  • Biomarkers to detect/predict adverse pregnancy outcomes for preventing and reducing maternal morbidity and mortality;
  • Pharmacogenomic, metabolomic, or microbiome approaches to precision therapeutics in pregnant or lactating women or neonates;
  • Innovative strategies to accelerate ongoing studies (e.g., incorporate new analytical or technical approaches, add additional study sites to augment patient enrollments, etc.);
  • Studies of ontogeny of drug metabolizing enzymes, transporters, and/or receptors in neonates and infants;
  • In silico models to assess potential targets and toxicities of novel therapeutic strategies for pregnant or lactating women;
  • Collection and banking of biospecimens from humans (i.e., cord blood, placenta, breast milk) for future therapeutics research.

While not a research area per se, the inclusion of underserved and understudied populations in research studies is encouraged. These populations include racial and ethnic minority groups, underserved rural populations, people of less privileged socioeconomic status, along with groups subject to discrimination who have poorer health outcomes often attributed to being socially disadvantage

IC-Specific Information

National Institute of General Medical Sciences: NIGMS will support studies focused in drug disposition. Work proposed in supplements must fall within the scope of the aims of the NIGMS grant to be supplemented. Investigators are encouraged to contact their NIGMS Scientific Program Officer for the grant to be supplemented before preparing an application, to discuss the relevance of the proposed research to the parent grant and to the Institute's research priorities. NIGMS grantees must hold an active R01 or Maximizing Investigators' Research Award (MIRA) (R35) award at the time of the award.

National Human Genome Research Institute: NHGRI shares interest and expresses support for any of the current NHGRI awardees who qualifies to submit administrative supplement requests under NOT-HD-20-003.

National Institute on Minority Health and Health Disparities: NIMHD welcomes applications that focus on clinical and translational research studies in pregnant or lactating women and infants/children of minority and health disparity populations (African Americans, Hispanics, American Indians, Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, and rural populations). Studies are not limited to early detection, prevention, and treatment to reduce maternal and infant morbidity and mortality, and may include identification of genetic ancestral markers, pharmacokinetic and pharmacodynamic biomarkers of drug efficacy, drug-drug interactions and drug-diet interactions, microbial profiling and validation studies.

National Institute of Neurological Disorders and Stroke: NINDS is interested in research relevant to its mission to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. In addition to the general areas of interest listed above, areas of interest specific to NINDS include but are not limited to advancing safe and effective therapeutics for neurological disorders in pregnant or lactating women, neonates, or infants. Human subjects research with either newly enrolled participants or experiments using newly-acquired specimens for the purposes of this NOSI is considered to be out of scope.

Award Budget

Supplement budget requests are limited to no more than the amount of the current parent award and cannot exceed $200,000 in direct costs, exclusive of Facilities and Administrative costs on sub-awards. Requests must reflect the actual needs of the proposed project. Requests are for one year of support only. It is anticipated that 10-12 awards will be made, subject to availability of funds at NICHD.

The earliest anticipated start date is August 1, 2020.

Eligible Individuals (Program Director/Principal Investigator)

To be eligible, individual(s) must hold an active NIH grant at the time of the award. Awards in No-Cost Extension (NCE) are not eligible. For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award.

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)

All instructions in the SF424 (R&R) Application Guide and PA-18-591 must be followed, with the following additions:

  • Application Due Date – June 1, 2020, by 5:00 PM local time of applicant organization.
  • For funding consideration, applicants must include “NOT-HD-20-003” (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.
  • Requests may be for one year of support only.
  • The Research Strategy section of the application is limited to 6 pages.
  • The process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.

It is strongly recommended that the applicants contact both (1) their respective program officer(s) at the Institute supporting the parent award to confirm ahead of time that the supplement falls within scope of the parent award and (2) Dr. Aaron Pawlyk (pawlykac@mail.nih.gov) to confirm the proposed request fits within the scientific scope of this Notice. Further, applicants are strongly encouraged to notify the program contact at the Institute supporting the parent award (See Table of IC-Specific Information, Requirements and Staff Contacts) that a request has been submitted in response to this FOA in order to facilitate efficient processing of the request.

Administrative Review Process

NICHD will conduct administrative reviews of submitted applications and will support the most meritorious applications submitted for consideration, pending availability of funds.

Criteria:

  1. Is the work proposed within the scope of the active award?
  2. Is the work proposed focused on activities that will ultimately lead to advancing safe and effective therapeutics for pregnant or lactating women, neonates, or infants?
  3. Is the work likely to stimulate additional activity leading to progress towards safe and effective therapeutics for pregnant or lactating women, neonates, or infants?

Inquiries

Please direct all inquiries to:

Aaron C. Pawlyk, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
E-mail: pawlykac@mail.nih.gov

 

 

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