National Centers for Translational Research in Reproduction and Infertility (NCTRI) (P50 Clinical Trial Optional) is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). This program aims to re-compete the National Centers for Translational Research in Reproduction and Infertility, which are designed to foster multidisciplinary interactions among scientists to establish high-quality translational research programs in reproductive sciences.

Expired RFA-HD-24-010: National Centers for Translational Research in Reproduction and Infertility (NCTRI) (P50 Clinical Trial Optional) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) Funding Opportunity Title National Centers for Translational Research in Reproduction and Infertility (NCTRI) (P50 Clinical Trial Optional) October 3, 2023 - Notice of Change to RFA-HD-24-010 "National Centers for Translational Research in Reproduction and Infertility (NCTRI) (P50 Clinical Trial Optional)".

See Notice NOT-HD-23-026 August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Notice of Funding Opportunity (NOFO) Number Companion Notice of Funding Opportunity See Section III. 3.

Additional Information on Eligibility . Assistance Listing Number(s) Notice of Funding Opportunity Purpose The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), through the Fertility and Infertility (FI) Branch, provides funding for a limited number of research centers in the reproductive sciences.

These centers provide an arena for multidisciplinary interactions among basic and clinical scientists interested in establishing high quality translational research programs in these scientific areas. The purpose of this NOFO is to announce the re-competition of the National Centers for Translational Research in Reproduction and Infertility (NCTRI).

The NCTRI will be administered through the Specialized Research Center (P50) award mechanism. These centers will form a national network that facilitates and accelerates bidirectional knowledge transfer between the laboratory and clinic with the ultimate goal of improving human reproductive health through research excellence and innovation.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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.

Required Application Instructions It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), through the Fertility and Infertility (FI) Branch, provides funding for a limited number of research centers in the reproductive sciences.

These centers provide an arena for multidisciplinary interactions among basic and clinical scientists interested in establishing high quality translational research programs in this scientific area. The centers also serve as national resources for the training and career development of young scientists electing to pursue biomedical research careers in reproduction and infertility.

Finally, center investigators develop and participate in community outreach and education efforts to increase awareness and convey the importance and implications of their research activities to the general public. Accordingly, the purpose of this Notice of Funding Opportunity (NOFO) is to announce the re-competition of the National Centers for Translational Research in Reproduction and Infertility (NCTRI).

The NCTRI will be administered through the Specialized Research Center (P50) award mechanism. These centers will form a national network that facilitates and accelerates bidirectional knowledge transfer between the laboratory and clinic with the goal of improving human reproductive health through research excellence and innovation.

One of the most basic of human drives - reproduction - is frustrated or denied by the occurrence of infertility in couples desiring children. According to data from the National Survey of Family Growth, between 2011-2015, 6. 7 percent of married women between the ages of 15-44 were infertile (12 months or longer without birth control and without a pregnancy).

While this represents a decline from the prevalence of 7. 4 percent reported in 2002, about 11% of married women had impaired fecundity, i.e., the biological capacity to reproduce, in 2010 compared to 8. 5% of married women in 1982.

This trend likely is indicative of the delay in childbearing found in the couple population base in which significant age-related increases in infertility and subfecundity have been reported. Physician office visits for infertility services have markedly increased over four-fold between 1968 and 2015 in the U.S. (>2,000,000 visits annually).

It is estimated that 12 percent of American women aged 15-44 receive infertility services at some point during their lifetime. Of the infertile couples seeking treatment for infertility, it has been estimated that up to one half will be unsuccessful in achieving their desired outcome. This increase in medical assistance has led to a rise in infertility service costs to more than several billion dollars annually.

In couples struggling with infertility, approximately one third of infertility is attributable to the male partner, one third is attributed to the female partner, and one third attributed to either both partners or unknown factors. For male factor infertility, the pathophysiology is either not understood at all or, at best, poorly understood. The prognosis for male infertility treatment outcomes is extremely poor at present.

Indeed, whereas 80 percent of infertile women can be successfully treated, male infertility can be treated in only 10-20 percent of cases.

While intracytoplasmic sperm injection and other assisted reproductive technologies have enabled otherwise infertile men (and women) to have children, these technologies do not address the underlying causes of infertility, which could be passed down to future generations, and may also be linked to other health problems that will negatively impact the life of the child.

Female infertility is more likely to be successfully treated, yet the sociologic and economic consequences of female infertility can still be devastating.

Uterine leiomyomatas, polycystic ovary syndrome (PCOS), premature ovarian insufficiency (POI), idiopathic hypogonadotropic hypogonadism (IHH) and endometriosis all can negatively impact infertility, but the pathogenesis and etiology of these debilitating conditions are poorly understood. Data now firmly support the contribution of genetics in both male and female infertility.

In males, there is considerable evidence from animal studies that mutations in over 100 separate genes result in infertility. More limited studies in humans show that several inherited diseases associated with abnormal sperm morphology and function are likely polygenic.

Similarly, it is estimated that 15-20 percent of human pregnancies are chromosomally abnormal as a result of division errors during oocyte meiosis or early embryonic cleavage. Such errors are not only the leading cause of birth defects but may be the most important factor contributing to human infertility.

It is becoming increasing apparent that, in addition to genetic contributions, non-genetic factors are involved in infertility and diseases of reproductive health, e.g., PCOS, endometriosis, and male infertility. These non-genetic factors, collectively referred to as epigenetic mechanisms, include DNA methylation, RNA modifications, post-translational histone modifications, and non-coding RNAs (microRNAs, long non-coding RNAs).

Unlike alterations to the DNA that are fixed , epigenetic mechanisms are bidirectional, e.g., a histone may alternate between being acetylated or not depending on the transcriptional state of its associated gene. These epigenetic mechanisms are responsible for how the genome interacts with the environment and changes in the epigenome are sporadic and differ from cell-to-cell.

This heterogeneity makes analyses difficult, although techniques now exist that permit the epigenome to be interrogated at the single cell level. Recent scientific breakthroughs have allowed for unprecedented access to researchers studying the complexities of biological systems.

The explosion of 'omics technologies has allowed for a better characterization and quantification of the biological molecules that translate into the structure and function of a cell, organ, system, or organism. These advances have also allowed for many of these 'omics technologies to be more affordable, a necessary advancement for the advent of a more personalized approach to healthcare.

The rise of 'omics technologies has led to single-cell 'omics that is, the use of these powerful technologies on individual cells.

The combination of genetic factors such as genomics, transcriptomics, and proteomics, along with non-genetic factors such as epigenomics, metabolomics, and microbiomics could conceivably be used to better understand reproductive health and to better predict (i.e., establishment of biomarkers) diseases and disorders that impact fertility.

The advent of multiomic approaches also has the potential to elucidate the relationship between fertility and overall health. Multiple studies suggest that infertility is not necessarily a unique disease of the reproductive axis, but is often physiologically and/or genetically linked with other diseases and conditions.

Although it is well-established that many chronic diseases and conditions can impair fertility, less is known about the extent to which fertility status can act as a biomarker for overall health. Recent epidemiologic studies demonstrate a link between fertility status and various somatic diseases and disorders and suggest that fertility status can be a window into overall health.

The findings include both male and female reproductive function, and their association with cancer, as well as conditions of the cardiovascular, metabolic, and the immune systems. Validation of the premise that fertility status can be a window into overall health would provide a valuable opportunity to affect future health during fertility evaluation, allowing early intervention in serious, chronic somatic diseases and conditions.

The FI Branch recognizes that the interactive needs of basic and clinical research necessary to address the above and related problems may be so complex that they cannot be solved by individual investigators working alone.

Therefore, it is the intention of the branch, contingent upon the availability of funds, to continue supporting multi-component reproduction and infertility research programs that focus on topics of high priority and significance that are critically important to the mission of the FI Branch and NICHD, and that address important reproductive health concerns of the American public.

A major objective of the NCTRI is to support specialized translational reproductive research programs of high quality, and to facilitate and accelerate bidirectional transfer of knowledge between the laboratory and clinic. This process of translating research between the laboratory and clinic is a continuum that encompasses all aspects of knowledge transfer from non-human animal models to humans.

This knowledge transfer is bidirectional, i.e., from humans back to animal models to answer biological questions identified in humans. The ultimate goal of supporting translational research through the NCTRI is to improve human reproductive health.

This NOFO is specifically designed to stimulate the reproductive sciences research community to organize and maintain research-based centers of outstanding quality that, serving as national research resources, form a centers program that fosters communication, innovation and high-quality reproduction and infertility research.

To facilitate networking and collaboration, investigators will have opportunities to participate in various Research Focus Groups, comprised of investigators from multiple centers who have similar research interests in various aspects of reproductive health. The NCTRI is comprised of research-based center grants designed to support interactive groups of research projects and supporting core service facilities.

The research activities included in these center grants must comprise, by definition, a multidisciplinary approach to biomedical problems addressing the specific research topic areas discussed in this NOFO. These centers may have more than one focus or emphasis, but all the research projects involved must address one or more of the specific research areas of reproduction supported by the FI Branch.

Furthermore, the objectives of this Program require that at least one of the research projects be entirely or predominantly clinical, and that all basic science projects be linked to the clinical project(s) of the center.

The topics listed below identify areas where research at the basic/clinical interface is deemed essential to the potential development of new leads or approaches to fertility regulation, as well as of diagnostic tools and procedures for the detection and effective management of reproductive disorders that impact on reproductive competence.

Reproductive Developmental Biology: origins and maintenance of male and female gametogenesis from fertilization to adulthood. Reproductive Tract Biology and Physiology: the proper formation and function of the male and female reproductive tracts. Reproductive Endocrinology and Neuroendocrinology: mechanisms of hormone synthesis, secretion, regulation, and action in the context of reproduction.

Reproductive Medicine: etiology, pathophysiology, prevention, and management of male or female infertility (including fertility preservation). Fertility Status as a Biomarker for Future Health: the linkage between fertility status and overall fitness. Studies of disadvantaged populations or understanding the impact of race, ethnicity or socioeconomic status on the topics listed above.

For this NOFO, applications that address the 'omic (e.g., genomic, epigenomic, proteomic, metabolomic) bases of reproductive health and fertility will be strongly encouraged. Particular emphasis will be on applications that go beyond correlative studies to address possible causality and contributions of variants to inherited reproductive health.

Although applications that are responsive to the scientific mission areas of the FI Branch will be accepted, meritorious applications addressing the 'omic bases of reproductive health will receive priority in making funding decisions. These 'omics technologies would include, but are not limited to genomics, transcriptomics, proteomics, epigenomics, metabolomics, metallomics, and microbiomics.

Centers will be allowed only two renewals (15 years of total NCTRI support) in which the same biological question is being investigated. Because this list of topics is not meant to be all-inclusive, prospective applicants preparing either a new or renewal center grant application are encouraged to discuss program relevance issues with the Scientific/Research Contact indicated in Section VII. Agency Contacts.

Non-Responsive Applications Studies in the following areas are beyond the scope of this NOFO and will be considered non-responsive: Reproductive oncology, reproductive toxicology, reproductive epidemiology, post-implantation pregnancy and parturition and other areas that are out-of-scope of research supported by the FI Branch.

Further, applications proposing research activities focused exclusively on basic research or applications or components thereof proposing large scale clinical trial research will not be considered responsive to this NOFO. See Section VIII. Other Information for award authorities and regulations.

See Section VIII. Other Information for award authorities and regulations. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed Renewal (Only two renewals allowed) The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Only those application types listed here are allowed for this NOFO. Optional: Accepting applications that either propose or do not propose clinical trial(s). Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards NICHD intends to commit $3. 41 million in FY 2024 to fund two awards. Application budgets may request a budget for direct costs of no more than $1.

1 million/year. The scope of the proposed project should determine the project period. The maximum project period is 4 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO. Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. 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. The NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registration; all registrations must be in place by time of submission.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants. gov Applicants must have an active SAM registration in order to complete the Grants.

gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019 .

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement . 3.

Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2. 3.

7. 4 Submission of Resubmission Application . This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application. An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2. 3.

9. 4 Similar, Essentially Identical, or Identical Applications ). Section IV.

Application and Submission Information 1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO.

See the administrative office for instructions if planning to use an institutional system-to-system solution. 2. Content and Form of Application Submission It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide , except where instructed in this notice of funding opportunity to do otherwise and where instructions in the Application Guide are directly related to the Grants.

gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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. By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Component Type for Submission Instructions for the Submission of Multi-Component Applications The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing a multi-component application. When preparing the application, use Component Type Overall . All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall) PHS 398 Cover Page Supplement (Overall) Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component. Research & Related Other Project Information (Overall) Follow standard instructions.

Project/Performance Site Locations (Overall) A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall) Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application. A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover. A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component. Specific Aims: Include Specific Aims for the overall P50 project. Research Strategy: Describe the major themes of the overall Center, its goals and objectives, background information and the overall importance of the research to the theme of this program.

Explain the strategy for achieving the goals defined for the overall program and how each Research Project and Core relate to that strategy. Explain how the different aspects of the organization, including key personnel, will coordinate and communicate, why they are essential to accomplishing the overall goal of the research, and how the combined resources create an overall program that is more than the sum of its parts.

Describe how organization of the center will contribute to cohesiveness and synergy among the research projects and core components as they relate to the common theme of the Center. Include all necessary tables, graphs, figures, diagrams and charts in this section.

In addition, provide the following information: History, Purpose, and Objectives of the Program Discuss the overall program's objectives and general plans for the proposed grant period, including research grant history (as a P50 and/or U54 center) with yearly funding level, if appropriate.

Administration, Organization, and Operation Include information on the support and commitment of the parent institution for the program, the authority and responsibilities of the PD(s)/PI(s). Describe organizational framework and provide an organizational chart. Discuss the proposed research program, highlighting its central theme.

Description of Assurances and Collaborative Agreements Provide an overview and rationale for any collaborative and cooperative endeavors or subcontracts. Letters of Support for these arrangements are included as described below.

Progress Report for Renewal Applications Describe how the activities of the center have contributed to the translational goals of the program, defined as bidirectional knowledge transfer from basic (both animal and other laboratory model systems) to clinical and from clinical to basic (animal and other laboratory model systems).

Letters of Support: Include letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants. Letters of support for the overall Center should be included with the Overall Component. Letters of support for individual Research Projects or Cores should be included with those components of the application.

For program activities to be conducted off site, i.e., at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the off-site institutional officials, must be submitted with the application . Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply: All applications, regardless of the amount of direct costs requested for any one year, must include a Resource Sharing Plan. The Resource Sharing Plan will be considered during peer review and by program staff as award decisions are being made as appropriate and consistent with achieving the goals of the program.

It is expected that the results of NICHD-funded research will be shared with the wider scientific community in a timely manner. Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. Awardees are strongly encouraged to deposit large-scale, human genetic data in the database for Genotype and Phenotype dbGaP ( https://www. ncbi.

nlm. nih. gov/gap ).

For other data and biospecimens from human genetic or non-genetic studies, awardees are encouraged to use the NICHD Data and Specimen Hub DASH ( https://dash. nichd. nih.

gov/ ) or other equivalent broad-sharing data and/or biospecimen repositories. The following resource describing Common Data Elements may be helpful during the planning phases of a project when considering ways to optimize data collection in order to facilitate broad data sharing: https://www. nlm.

nih. gov/cde/ Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall) When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions: If you answered Yes to the question Are Human Subjects Involved?

on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components.

To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed.

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed. PHS Assignment Request Form (Overall) All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application, use Component Type Admin Core. All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted. Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component. SF424 (R&R) Cover (Administrative Core) Complete only the following fields: Type of Applicant (optional) Descriptive Title of Applicant’s Project Proposed Project Start/Ending Dates PHS 398 Cover Page Supplement (Administrative Core) Enter Human Embryonic Stem Cells in each relevant