Opportunity Information: Apply for RFA HD 13 010

  • The National Institutes of Health in the health income security and social services sector is offering a public funding opportunity titled "Genomic Sequencing and Newborn Screening Disorders (U19)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865 Child Health and Human Development Extramural Research.
  • This funding opportunity was created on Aug 9, 2012 and posted on Aug 9, 2012.
  • Applicants must submit their applications by Nov 19, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $25,000,000.00 to eligible and selected applicants.
  • Each selected applicant is eligible to receive up to $1,250,000.00 in funding.
  • Eligible applicants include: Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments State governments Small businesses Independent school districts Special district governments Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities For profit organizations other than small businesses.
  • Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) 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 not allowed.
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Opportunity Summary:

The Genomic Sequencing and Newborn Screening Disorders (U19) funding opportunity (RFA-HD-13-010) was a National Institutes of Health cooperative agreement program led by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) in partnership with the National Human Genome Research Institute (NHGRI). Its central purpose was to support research that examines what it would realistically mean to use genomic sequence information during the newborn period, especially in the context of or alongside traditional newborn screening programs. The announcement emphasized not just the potential benefits, but also the practical, ethical, clinical, and public health challenges that arise when genomic sequencing is introduced at the very start of life, when decisions may affect the child and family for years.

The opportunity was designed to stimulate coordinated, multi-project research focused on newborn screening-relevant questions. Awards used the U19 mechanism, meaning applicants were expected to propose an integrated set of component projects (the solicitation specifies three component projects) that together could address different but connected aspects of genomic sequencing in newborns. Because it was a cooperative agreement rather than a standard grant, the NIH anticipated having substantial scientific involvement in the program’s direction, coordination, and oversight, reflecting the complexity and sensitivity of the topic and the need for harmonized approaches across projects.

From a funding and administrative standpoint, the program was posted on August 9, 2012, with an application due date of November 19, 2012, and an estimated total program funding level of $25,000,000. The award ceiling listed was $1,250,000. There was no cost-sharing or matching requirement. The CFDA listing associated with the opportunity was 93.865 (Child Health and Human Development Extramural Research), situating it within NIH’s broader child health research portfolio while also explicitly incorporating genomics expertise through NHGRI.

Eligibility was broad across U.S.-based organizations and governments, including public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (with small businesses explicitly listed), and a range of governmental entities (state, county, city/township, special districts, and independent school districts). The announcement also included several mission-relevant institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), tribal governments and tribal organizations, faith-based or community-based organizations, regional organizations, and eligible federal agencies, as well as U.S. territories or possessions. Foreign institutions were not eligible, and foreign components of U.S. organizations were not allowed, consistent with the statement that foreign components (as defined by NIH policy) were not permitted.

In practical terms, the program can be understood as an NIH effort to push beyond the technical ability to generate genomic data and instead rigorously study how such data could be responsibly used in newborn screening contexts. That includes understanding implications for clinical decision-making and follow-up, communication of results to parents, management of uncertain or incidental findings, alignment with public health screening goals, and the broader societal considerations that come with sequencing at birth. The full announcement and details were provided through the NIH grants guide page linked in the opportunity, and NIH’s Office of Extramural Research (OER) provided contact support for access or technical linking issues.

Frequently Asked Questions (FAQs): Genomic Sequencing and Newborn Screening Disorders (U19) - RFA-HD-13-010

What is the Genomic Sequencing and Newborn Screening Disorders (U19) funding opportunity?

This was a National Institutes of Health (NIH) cooperative agreement program (U19) described under the funding opportunity announcement RFA-HD-13-010. It supported research on what it would realistically mean to use genomic sequence information during the newborn period, particularly in the context of or alongside traditional newborn screening programs.

Which NIH institutes led and partnered on this program?

The program was led by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) in partnership with the National Human Genome Research Institute (NHGRI).

What was the main purpose of the program?

The central purpose was to support research that examines real-world use of genomic sequencing at birth, including potential benefits as well as practical, ethical, clinical, and public health challenges that can arise when sequencing is introduced at the very start of life.

Why did the announcement emphasize challenges as well as benefits?

The opportunity specifically highlighted that decisions made based on genomic information in the newborn period can affect the child and family for years. Because of that, the program emphasized studying not only promise and utility, but also the complexities of responsible implementation.

What kinds of issues was the research expected to address?

Based on the announcement description, research areas included how genomic data could be used responsibly in newborn screening contexts, implications for clinical decision-making and follow-up, communication of results to parents, management of uncertain or incidental findings, alignment with public health screening goals, and broader societal considerations related to sequencing at birth.

What does it mean that this was a U19 mechanism?

The U19 mechanism is a multi-project research structure. In this solicitation, applicants were expected to propose an integrated set of component projects, specified as three component projects, that together addressed connected aspects of genomic sequencing in newborns.

How was a cooperative agreement different from a standard grant for this opportunity?

This was a cooperative agreement, meaning NIH anticipated substantial scientific involvement in the program's direction, coordination, and oversight. The announcement framed this as reflecting the complexity and sensitivity of newborn genomic sequencing and the need for harmonized approaches across projects.

When was the opportunity posted and when were applications due?

The program was posted on August 9, 2012. The application due date was November 19, 2012.

How much funding was available under the program?

The estimated total program funding level described was $25,000,000.

What was the award ceiling listed for this opportunity?

The award ceiling listed in the opportunity information was $1,250,000.

Was cost-sharing or matching required?

No. The opportunity stated there was no cost-sharing or matching requirement.

What CFDA number was associated with this opportunity?

The CFDA listing associated with the opportunity was 93.865, labeled as Child Health and Human Development Extramural Research.

Who was eligible to apply?

Eligibility was broad across U.S.-based organizations and governments. It included public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (with small businesses explicitly listed), and governmental entities such as state, county, city/township, special districts, and independent school districts.

Were mission-relevant institution types explicitly included?

Yes. The opportunity listed a range of institution types including Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), tribal governments and tribal organizations, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

Were foreign institutions eligible to apply?

No. Foreign institutions were not eligible under the opportunity.

Were foreign components of U.S. organizations allowed?

No. The opportunity stated that foreign components (as defined by NIH policy) were not permitted.

What was the overall program goal in practical terms?

In practical terms, the program aimed to move beyond the technical ability to generate genomic data and instead rigorously study how genomic sequence information could be used responsibly in newborn screening settings, including how it fits with traditional screening programs and public health goals.

Where were the full announcement details provided?

The full announcement and details were provided through the NIH grants guide page linked in the opportunity information.

Who provided help for access or technical linking issues related to the announcement?

NIH's Office of Extramural Research (OER) provided contact support for access or technical linking issues.

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