Reproductive health is a fundamental aspect of overall human health and wellbeing, but research on reproductive health is not always integrated into large and/or longitudinal studies of other systems. For the purposes of this notice, reproductive health includes fertility/infertility and gynecologic or andrologic health for those attempting to conceive, not attempting to conceive, or actively preventing pregnancy. Reflecting the importance of research in these areas, NICHD has laid out Promoting Gynecologic, Andrologic, and Reproductive Health as a major theme of the new NICHD Strategic Plan 2020.

The ultimate goal of this NOSI is to improve human reproductive health by supporting the addition of reproductive health components to ongoing large and/or longitudinal studies that have not previously collected data or specimens relevant to reproductive health on a large-scale basis. It is anticipated that this mechanism will allow the collection of data and biospecimens from large and/or long-running studies that will enable researchers to address reproductive questions that would otherwise require independent cohorts.

These components may include new survey questions, measures, or protocols to support the collection of relevant biological data or specimens that can be used for future analyses of reproductive health outcomes. The addition of these components to ongoing projects is expected to encourage interdisciplinary collaborations between the investigators of the ongoing studies and reproductive health researchers, expanding the potential scientific insight and investigational toolkit available to these projects and the field.

This initiative requires that the projects address topics or questions that are directly relevant to the NICHD Strategic Plan 2020 and one or more of the research interests of the following branches at NICHD (description of the mission and high priority areas for each participating branch are linked, below) and that address the:

• Gynecologic Health and Disease Branch
• Contraception Research Branch
• Fertility and Infertility Branch
• Population Dynamics Branch

Funding priority will be given to supplement applications whose parent award does not currently include a reproductive health aim. Projects that examine reproductive health questions in diverse populations in order to address health disparities are encouraged. In addition, all applications should include 1) a reproductive health expert as key personnel with a project management plan similar to an MPI leadership plan and 2) a data and resource sharing plan.

Projects of high priority for this FOA include, but are not limited to:

• Determinants and risk factors, including genetic determinants, of reproductive health and disease;
• Early exposures and conditions, including those experienced prenatally and or by prior generations, that influence reproductive health, development, or risk of disease in later life, including later in childhood, adolescence, and young adulthood;
• Long-term effects of interventions aimed at addressing conditions related to reproductive health, including both the long-term effects on the targeted condition itself and other health-related outcomes;
• Natural history studies of disorders or conditions that may inform biomarker discovery or development of treatments or interventions;
• Identifying biomarkers of disease or injury progression, functional impairment, treatment response, and functional recovery;

Projects of lower priority for this FOA include, but are not limited to:

• Studies that solely or predominately focus on reproductive oncology
• Studies that focus on post-implantation pregnancy and parturition

Applications that propose supplemental data collection in on-going studies should clearly address the following: study progress, including enrollment, to date, the anticipated number of data points that can be captured with the proposed supplemental assessments, and a plan for how the proposed reproductive health data will be analyzed.

Applications that propose new measures and assessment of reproductive outcomes should:

• propose assessment measures and strategies that can facilitate integration and sharing of data.
• provide the rationale for the selection of constructs and corresponding assessment instruments, the time periods assessed, and the assessment schedule for administration.
• where appropriate, consider opportunities for later follow-up of reproductive events through self-report and/or medical records through informed consent

Applications that propose collection of new or additional biospecimens should include a biospecimen resource sharing plan that addresses the following:

• The type of specimens that will be collected and the anticipated number of specimens/aliquots
• Ownership and storage of the biospecimens
• Plans for sharing the biospecimens
• Ownership and storage of the clinical data linked to these samples
• How decisions about future use of the specimens will be made
• Whether there will be residual specimens after the aims of the project(s) are met

Biospecimens that might be collected under this FOA could include saliva, blood, semen, endometrial biopsy, cervical mucus, and menstrual effluent, among other sample types. The biospecimen sharing plans will be used in the review and prioritization of received applications.

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(s) June 1, 2020, May 1, 2020, May 1, 2021, May 1, 2022, by 5:00 PM local time of applicant organization.
• For funding consideration, applicants must include NOT-HD-20-008 (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.
• The Research Strategy section of the application is limited to 6 pages.
• Only electronic submissions will be accepted for this funding opportunity. Use one of the methods described in PA-18-591. Paper submissions and applications submitted as attachments will be returned.
• The process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.
• Indicate the title of this Notice, Ancillary reproductive health projects to existing large and/or longitudinal studies , in the abstract.
• Applicants are strongly encouraged to notify the program contact at the Institute supporting the parent award that a request has been submitted in response to this FOA in order to facilitate efficient processing of the request.

Eligibility: The scope of this FOA is limited to parent awards focused on clinical research (human subjects research, clinical trials not required). Studies of model systems will be considered non-responsive. Administrative supplements can be sought through all non-training grant mechanisms, including small business innovation research and technology transfer applications. Parent awards focused on reproductive health will not be eligible for this administrative supplement.

Award Duration: Award duration is, at minimum, one year and limited to the remaining duration of the parent award. Active awards with project end dates in FY 2021 or later are eligible. The award may not be in terminal no cost extension or going into no cost extension in FY2020. Please note that a few ICs limit no cost extensions in a non-competing year of an award. For that reason, it is important to contact staff at the Institute supporting the award when planning the duration of the supplement request.

Award Budget: Total costs for a supplement application cannot exceed $250,000.

Institute-, Center-, and Office-specific Instructions

NIMHD is interested in projects that focus on one or more NIH-designated U.S. health disparity populations, which include Blacks or African Americans, Hispanics or Latinos, American Indians and Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities. Comparison groups may be included as appropriate for the research questions posed.

Review Process

NICHD will conduct administrative reviews of all supplement applications based on initial review from their parent award IC. NICHD will make funds available for at least two awards from across all participating ICs.

Criteria:

1. Is the work proposed focused on reproductive health as defined by this notice?
2. Is the work likely to stimulate progress in reproductive health?
3. Is the parent award progressing satisfactorily/according to planned timeline and milestones?