Opportunity Information: Apply for PAR 16 061
Apply for PAR 16 061
- The HHS-NIH11 in the food and nutrition, health, income security and social services sector is offering a public funding opportunity titled "Natural History of Disorders Identifiable by Screening of Newborns (R01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847, 93.865,.
- This funding opportunity was created on Dec 11, 2015 and posted on Dec 11, 2015.
- Applicants must submit their applications by May 08, 2019. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, 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, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:
Natural History of Disorders Identifiable by Screening of Newborns (R01), funding opportunity number PAR 16-061, is a discretionary NIH grant program under HHS (listed as HHS-NIH11) that supports research aimed at building a much clearer, evidence-based picture of how certain diseases unfold over time when they are detected early through newborn screening. The central goal is to fund studies that map the natural history of disorders that are already screened for in newborns, as well as disorders that could plausibly benefit from being identified through screening. The emphasis is on producing clinically useful knowledge that helps the field understand what happens to infants and children with these conditions from the earliest detectable stages onward, including how symptoms emerge, how complications develop, and how outcomes vary across individuals.
A core idea behind the announcement is that newborn screening can identify babies before symptoms appear, but early identification is only truly helpful when clinicians and families have a strong understanding of what to expect and when to expect it. This FOA highlights natural history data as a foundational requirement for making appropriate medical decisions after a positive screen. By carefully defining the sequence and timing of symptom onset and disease progression, funded projects are expected to generate resources that improve clinical care and decision-making. In practical terms, that means characterizing early signs, intermediate milestones, and later complications; documenting variability in progression; and clarifying which findings are most predictive of meaningful health outcomes.
The announcement also underscores the importance of explaining why children with the same screened disorder can experience very different courses. For some conditions, genotype-phenotype correlations may be strong enough to help predict clinical trajectory based on specific genetic variants. For others, the FOA points to the value of identifying modifying influences, including additional genetic factors, epigenetic changes, or environmental contributors that shape severity and outcomes. This reflects an interest not only in describing the course of disease, but in understanding the sources of heterogeneity that can affect prognosis, management strategies, and counseling for families.
The FOA frames comprehensive natural history datasets as enabling several concrete advances for the field. First, better natural history knowledge supports more accurate diagnosis, which is especially important when screening detects biochemical or molecular signals that can represent a spectrum from severe disease to milder or uncertain phenotypes. Second, it improves understanding of genetic and clinical heterogeneity and the full range of phenotypic expression, helping clinicians distinguish subtypes and anticipate different needs. Third, it can help identify underlying mechanisms linked to the basic biological defect, providing a stronger scientific basis for targeted therapies or improved clinical protocols. Fourth, by revealing when and how complications arise, natural history studies can inform strategies to prevent, manage, and treat symptoms, including guiding the timing of interventions and the selection of meaningful clinical endpoints. Fifth, the work is intended to strengthen the support available to children and families by improving predictive information, counseling, and long-term planning based on real-world trajectories rather than limited case reports.
From an administrative standpoint, this is an R01 research grant mechanism. Eligible applicants are broad and include state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding higher education institutions when specified); for-profit organizations other than small businesses; small businesses; and additional applicants as allowed under the FOA’s eligibility clarifications. The program is associated with CFDA numbers 93.847 and 93.865. The opportunity was posted and created on December 11, 2015, with an original and current closing date listed as May 08, 2019. The source data does not specify an award ceiling or expected number of awards in the fields provided.
Overall, PAR 16-061 is designed to push the field beyond detection and into actionable understanding: turning early newborn screening results into clearer diagnoses, better prognostic tools, more informed intervention strategies, and stronger guidance for families, grounded in rigorous, longitudinal knowledge of how these disorders naturally develop and vary over time.
Frequently Asked Questions (FAQs)
What is the name of this funding opportunity?
The opportunity is titled Natural History of Disorders Identifiable by Screening of Newborns (R01).
What is the funding opportunity number?
The funding opportunity number is PAR 16-061.
Which federal agency sponsors this grant?
This is a discretionary NIH grant program under HHS, listed as HHS-NIH11.
What type of grant mechanism is being used?
This opportunity uses the R01 research project grant mechanism.
What is the main purpose of this FOA?
The central purpose is to fund research that builds a clearer, evidence-based understanding of the natural history of certain disorders that are identified early through newborn screening, including how disease features emerge over time and how outcomes differ across individuals.
What does "natural history" mean in the context of this announcement?
In this FOA, natural history refers to mapping how a disorder unfolds over time from the earliest detectable stages onward. This includes the sequence and timing of symptom onset, intermediate milestones, later complications, and the overall pattern of progression and variability across patients.
Which disorders are in scope for this grant program?
The FOA supports studies of (1) disorders that are already screened for in newborns and (2) disorders that could plausibly benefit from being identified through newborn screening.
Why is natural history research emphasized for newborn screening conditions?
The FOA emphasizes that newborn screening can identify infants before symptoms appear, but early identification is most useful when clinicians and families have strong, evidence-based expectations about what may happen and when. Natural history data are presented as foundational for making appropriate medical decisions after a positive screen.
What kinds of clinically useful outputs is this FOA aiming to generate?
The FOA aims to generate knowledge and resources that improve clinical care and decision-making, such as clearer characterization of early signs, intermediate milestones, later complications, and which findings best predict meaningful health outcomes.
What aspects of disease progression are applicants expected to characterize?
Projects are expected to carefully define the sequence and timing of symptom onset and progression, including early signs, intermediate milestones, later complications, and variability in course among children with the same screened disorder.
Does the FOA address why children with the same disorder can have different outcomes?
Yes. A major focus is understanding heterogeneity in disease course. The FOA highlights potential explanations such as genotype-phenotype correlations and modifying influences including additional genetic factors, epigenetic changes, or environmental contributors that shape severity and outcomes.
How does this FOA connect natural history data to better diagnosis?
The FOA explains that natural history knowledge can support more accurate diagnosis, particularly when screening detects biochemical or molecular signals that may represent a spectrum from severe disease to milder or uncertain phenotypes.
How can the proposed research help clinicians and families after a positive newborn screen?
By defining when symptoms and complications tend to arise and how outcomes vary, natural history studies can strengthen predictive information, improve counseling, and support long-term planning based on real-world trajectories rather than limited case reports.
How does the FOA describe the value of studying genetic and clinical heterogeneity?
The FOA describes comprehensive natural history datasets as improving understanding of genetic and clinical heterogeneity and the full range of phenotypic expression, helping clinicians distinguish subtypes and anticipate different clinical needs.
Does this FOA aim to inform treatment timing and clinical endpoints?
Yes. The FOA states that by revealing when and how complications arise, natural history studies can inform strategies to prevent, manage, and treat symptoms, including guiding the timing of interventions and the selection of meaningful clinical endpoints.
Is the FOA limited to describing disease courses, or does it also include understanding mechanisms?
It includes both. Alongside describing disease progression, the FOA notes that natural history data can help identify underlying mechanisms linked to the basic biological defect, supporting a stronger scientific basis for targeted therapies or improved clinical protocols.
Who is eligible to apply for this opportunity?
Eligibility is broad and includes: state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding higher education institutions when specified); for-profit organizations other than small businesses; small businesses; and additional applicants as allowed under the FOA's eligibility clarifications.
Are small businesses eligible?
Yes. Small businesses are included among the eligible applicant types listed.
Are for-profit organizations eligible?
Yes. For-profit organizations other than small businesses are included, and small businesses are also explicitly included.
Are tribal governments and tribal organizations eligible?
Yes. Federally recognized Native American tribal governments and other tribal organizations are listed as eligible applicants.
Are government entities eligible?
Yes. State, county, and local governments, as well as special district governments and independent school districts, are listed as eligible.
What CFDA numbers are associated with this opportunity?
The program is associated with CFDA numbers 93.847 and 93.865.
When was this opportunity posted?
The opportunity was posted and created on December 11, 2015.
What is the closing date listed for this opportunity?
The original and current closing date listed is May 08, 2019.
Does the provided information include an award ceiling?
No. The source data does not specify an award ceiling in the fields provided.
Does the provided information state how many awards are expected?
No. The source data does not list an expected number of awards in the fields provided.
What is the overall intended impact of PAR 16-061?
The overall intent is to move the field beyond detection and into actionable understanding by turning early newborn screening results into clearer diagnoses, better prognostic tools, more informed intervention strategies, and stronger guidance for families grounded in rigorous longitudinal evidence.
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