Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Heart, Lung, and Blood Institute (NHLBI)
Funding Opportunity Title	Safe and Effective Instruments and Devices for Use in the Neonatal Intensive Care Units (STTR) [R41]
Activity Code	R41 Small Business Technology Transfer (STTR) Grant - Phase I only
Announcement Type	Reissue of RFA-HD-10-013
Related Notices	January 23, 2013 - This RFA has been reissued as PAR-13-090.
Funding Opportunity Announcement (FOA) Number	RFA-HD-12-193
Companion FOA	RFA-HD-12-192, R43 Small Business Innovation Research (SBIR) Grant - Phase I only
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.865, 93.839
FOA Purpose	The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Heart, Lung, and Blood Institute (NHLBI) invite Small Business Technology Transfer (STTR) grant applications from small business concerns (SBCs) to propose research to develop new devices and instruments, and/or improve existing devices and instruments, to monitor and treat newborn infants and small children safely and efficaciously.

Posted Date	June 14, 2011
Open Date (Earliest Submission Date)	August 19, 2011
Letter of Intent Due Date	August 19, 2011
Application Due Date(s)	September 19, 2011, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable.
Scientific Merit Review	February/March 2012
Advisory Council Review	May 2012
Earliest Start Date(s)	July 2012
Expiration Date	September 20, 2011
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) SBIR/STTR Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) 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 the Announcement
Section I. 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

1. Research Objectives

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Heart, Lung, and Blood Institute (NHLBI) invite Small Business Technology Transfer (STTR) grant applications from small business concerns (SBCs) to propose research to develop new devices and instruments, and/or improve existing devices and instruments, to monitor and treat newborn infants and small children safely and efficaciously.

Devices and instruments developed for use in sick infants should be based on sound bioengineering principles. They also need to be tested for safety, efficacy, and accuracy of functioning. Despite major advances in biotechnology, research and development (R&D) efforts directed at introducing new and innovative pediatric devices and instruments (or improving existing ones) for use in newborn infants and small children have been limited. This may be due, in part, to infrequent collaboration between the clinical and bioengineering scientific communities for R&D in basic and translational efforts to develop or improve pediatric devices and instruments.

One objective of this FOA is, therefore, to foster such collaboration between clinical and bioengineering research communities in the field of pediatric device development. It is anticipated that through rigorous collaborative R&D efforts, safe and effective instruments and devices can be developed for use in newborn infants and small children.

Successful R&D in this area requires close and innovative collaboration and partnership between scientists from different specialties, especially from SBCs and clinical fields, as has been underscored by scientists participating in two different NICHD-sponsored workshops. Summaries from these workshops have been published in Pediatrics 2005, volume 115:468-74; and Biomed. Instrum. Technol. 2009, Sep-Oct; volume 43:408-18. These publications provide additional scientific background information for this FOA.

Optimizing care for small children and infants in all clinical circumstances, including in neonatal intensive care units (NICUs), is an important component of the NICHD mission. This FOA invites SBCs to propose innovative research that can lead to development of non-invasive, or minimally invasive instruments, devices, and monitors that improve assessment, monitoring, and treatment of newborn infants and small children requiring routine as well as intensive care treatments.

Although advanced technological support remains the backbone of NICUs, much of the equipment, instruments, and devices used are miniaturized versions of those used for older age group patients. With few exceptions, it is rare to find instruments and devices that have been developed with rigorous evaluations of efficacy and safety specifically in newborn infants and small children. This gap in R&D is particularly striking when one considers the revolutions that are taking place in biotechnology and bioengineering sciences and their application to medicine elsewhere. Some of these include: genetic and proteomic-based biotechnology; microfluidics; nanotechnology; laser and optical imaging; and signal processing, such as adopting advanced mathematical computations for analyzing biological signals. Thus, there is an urgent need for R&D in improving existing devices and instruments and introducing new devices and instruments while optimizing their utility and safety in the neonatal intensive care setting.

The focus of this FOA is primarily targeted at introducing or improving instruments and devices for monitoring and treating sick newborn infants and small children. Many existing monitoring systems and treatment paradigms require invasive procedures. For example, indwelling intra-arterial catheters are needed for continuous measurement of systemic blood pressure and for obtaining blood samples for the analyses of blood gas and acid base status and biochemical monitoring. Intravenous catheters are threaded via a peripheral vein into the great veins near the heart for providing fluid and nutritional support. Gastric tubes are used for gavage feeding. Endotracheal tubes and nasal prongs are essential components for providing assisted ventilation and continuous positive airway pressure support, respectively.

While these devices are life saving, there are potential adverse consequences from their routine use in large cohorts of subjects. Any device that needs an invasive procedure for its introduction can cause pain and suffering at a vulnerable period in life. Long-term indwelling catheters and devices also have a potential to add to the burden of morbidity. Examples include: accidental dislodging and hemorrhage; ventilator-associated pneumonia; microbial colonization within and around the walls of indwelling catheters and tubes, enhancing the risk of bacterial and fungal sepsis; thrombus formation in and around the tubes and catheters that can lead to venous obstruction or embolization to distant organs such as the brain or extremities; and catheter migration into the heart, causing perforation and cardiac tamponade. It is estimated that catheter-associated infections alone account for a huge burden of morbidity, with millions of dollars added to health care costs each year.

This FOA aims to stimulate improvement in the existing devices and instruments being used in the neonatal ICU, and/or encourage the introduction of new and innovative technologies into the NICU setting. The new and improved instruments and devices developed as a result will reduce the burden of morbidity and mortality associated with such devices, as well as provide a means for the clinical community to monitor key physiological and pathological processes while treating complex disorders in newborn infants. The FOA intends to bridge the gap between the biomedical academic community and bioengineering researchers from SBCs and promote collaborative partnership. By providing set-aside funds for researcher-initiated grants (R41), it is anticipated that a set of instruments and devices that are effective, risk-free, and marketable will be developed.

The proposed studies need to establish the accuracy and safety of the device under varied clinical conditions. Studies may range from concept to developmental phases, with the goal of developing accurate devices that can be marketed, and used in regular clinical settings in sick newborn infants of varying gestational age, postnatal age, and illness severity. The major topic areas for the R&D efforts to be supported under this FOA include, but are not limited to:

Cardiovascular : Non-invasive or minimally invasive devices, instruments, or methods for assessing and supporting a variety of cardiovascular functions, including improved methods for measuring and monitoring systemic blood pressure such as advanced mathematical computations for analyzing cardiac pulse wave forms; devices to measure and monitor cardiac output and global tissue oxygen delivery; improved methods of assessing blood volume and tissue perfusion; devices for use in cardiac surgery; interventional catheterization; and electrophysiology technologies for neonates and small children.

Pulmonary: Improved or non-invasive devices and instruments to measure pulmonary function (e.g., pulmonary arterial pressures, gas exchange, airway pressure, lung volume, ventilation/perfusion ratios, PCO2 and PO2); improved systems for respiratory support with reduced air-leaks; non-invasive ventilation; interfaces for nasal continuous positive airway pressure (CPAP) that do not affect musculoskeletal development; synchronized ventilation; improved methods of patient-triggered ventilation and pulmonary perfusion; automated inspired oxygen control; airway secretion clearance devices (including but not limited to applications for cystic fibrosis children); improved aerosol delivery systems targeting small airways for use in newborn infants and small children on and off of ventilatory support; improved oxygen cannula tubing for infants during transportation; and diaphragm pacers for use in rapidly growing infants and children.

Hematologic: Non-invasive or minimally invasive methods for testing hemostasis that provide results in a timely manner using small quantities of blood; for evaluating global hemostasis in very small infants, and in those requiring extra-corporeal membrane oxygenation (ECMO); for monitoring the efficiency of either continuous or discontinuous dialysis treatments (e.g., for optimizing management of retained fluids); and improved age and size-specific blood pumps to deliver small volumes of blood products.

Brain: Non-invasive or minimally invasive devices, instruments, and methods for assessing a variety of cerebrovascular functions, including methods for assessing global and regional cerebral blood and cerebrospinal flow, oxygen extraction, utilization of nutritional substrates, and autoregulation of cerebral blood flow; devices and technologies to objectively assess pain in neonates and infants, and to evaluate the adequacy of analgesic therapies; devices for measuring the wavelengths and irradiance from commercial neonatal phototherapy units; devices and technologies to measure free components of indirect-bilirubin concentrations in the serum, to enable more accurate prediction of neurological injury from severe neonatal hyperbilirubinemia; and optical imaging of the developing brain for assessing cerebrovascular structural and functional status.

Metabolic: Devices, instruments, and methods for assessing a variety of metabolic substrates, including sensors for non-invasive or minimally invasive measurement of blood metabolic chemicals, such as glucose, ketone bodies, and lactate/pyruvate, that are sensitive at the low plasma concentrations seen in the neonatal period; micro-infusion pumps to optimize insulin administration and glucose control in neonates, infants, and small children; technologies to monitor kidney function or injury, or to improve indwelling urinary or dialysis catheters used in neonates, infants, and small children; and sensors for the assessment of other blood chemical parameters (e.g., serum sodium, potassium, and chloride).

Infections: Devices, instruments, and methods for assessing and treating neonatal infections, including innovative technologies for improving the quality of invasive catheters and tubes used during the evaluation and care of newborn infants and small children. The catheters and their component systems may include IV tubes, indwelling catheters (venous, arterial, umbilical, percutaneous), connector-hubs, and syringes. Examples of other tubes include endotracheal tubes, oral or naso-gastric tubes, suction catheters, and chest-tubes and other catheters used for drainage purposes. The proposals need to focus on methods to improve the performance quality of such tubes, catheters, and accessories that ultimately lead to reduced microbial colonization and reduced incidence of health-care and device-associated sepsis, reduced thrombogenic properties, and/or prevention of other device-associated complications. Proposals may also include studies to improve the accuracy and speed of bacterial and fungal septicemia diagnoses, rapid identification of pathogenic microbial organisms, and assessment of antimicrobial resistance/susceptibility characteristics utilizing small volumes of blood and/or other biological fluids.

Hearing, speech, and swallowing functions: Devices and instruments for assessment and preservation of hearing (e.g., improved auditory brainstem response technologies to provide continuous monitoring and effective noise cancellation to reduce incubator noise) and speech/swallowing functions (e.g., improved oro-cutaneous stimulation devices and improved therapeutic devices to facilitate oral motor development and sucking capacity in premature infants and in infants with developmental/intellectual disabilities).

Funding Instrument	Grant
Application Types Allowed	New (Phase I) Resubmission (Phase I) The OER Glossary and the SF424 (R&R) SBIR/STTR Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
Award Budget	Budgets up to $250,000 total costs per year for Phase I may be requested.
Award Project Period	Duration of up to 2 years for Phase I may be requested.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria:

1. Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor;

2. Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there can be no more than 49 percent participation by foreign business entities in the joint venture;

3. Is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, except in the case of a joint venture, where each entity to the venture must be 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States; and;

4. Has, including its affiliates, not more than 500 employees.

SBCs must also meet the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both. Business concerns include, but are not limited to, any individual (sole proprietorship) partnership, corporation, joint venture, association, or cooperative. The SF424 (R&R) SBIR/STTR Application Guide should be referenced for detailed eligibility information.

Applicant organizations must complete the following registrations as described in the SF424 (R&R) SBIR/STTR Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For the STTR program, the PDs/PIs may be employed with the SBC or the single, partnering non-profit research institution as long as s/he has a formal appointment with or commitment to the applicant SBC, which is characterized by an official relationship between the SBC and that individual. Each PD/PI must commit a minimum of 1.2 person months (10 percent) effort to the project. Such a relationship does not necessarily involve a salary or other form of remuneration.

The SF424 (R&R) SBIR/STTR Application Guide should be referenced for specific details on eligibility requirements. For institutions/organizations proposing multiple PDs/PIs, see Multiple Principal Investigators section of the SF424 (R&R) SBIR/STTR Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process, or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and any other HHS funding opportunity, including the SBIR and STTR Parent announcements.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF424 (R&R) SBIR/STTR Application Guide.

A Phase I awardee may submit a Phase II application either before or after expiration of the Phase I budget period, unless the awardee elects to submit a Phase I and Phase II application concurrently under the Fast-Track procedure. To maintain eligibility to seek Phase II support, a Phase I awardee should submit a Phase II application within the first six due dates following the expiration of the Phase I budget period.

In Phase I and Phase II, at least 40% of the work must be performed by the small business concern and at least 30% of the work must be performed by the single, partnering research institution. The basis for determining the percentage of work to be performed by each of the cooperative parties will be the total of direct and F&A/indirect costs attributable to each party, unless otherwise described and justified in Consortium/Contractual Arrangements of the PHS398 Research Plan component of the SF424 (R&R) application forms.

A small business concern may subcontract a portion of its STTR award to a Federally Funded Research and Development Center (FFRDC), either in its capacity as the Research Institution or as a participant in the STTR project in another capacity. However, STTR funds may not be used to pay for laboratory resources of non-FFRDCs, and no STTR funds may be used to pay for subcontracting any portion of the STTR award back to the issuing agency or to any other Federal government unit unless a waiver is granted by the Small Business Administration.

The basis for determining the percentage of work to be performed by each of the cooperative parties in Phase I or Phase II will be the total of the requested costs attributable to each party, unless otherwise described and justified in Consortium/Contractual Arrangements of the PHS398 Research Plan component of SF424 (R&R) application forms.

Additional details are contained in the SF424 (R&R) SBIR/STTR Application Guide.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) SBIR/STTR Application Guide, except where instructed in this funding opportunity announcement to do otherwise. 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 research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

Tonse N. K. Raju, MD
Pregnancy and Perinatology Branch (PPB)
Center for Developmental Biology and Perinatal Medicine (CDBPM)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 4B03
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301- 402-1872
Fax: 301-496-6790
Email: [email protected]

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) SBIR/STTR Application Guide to ensure you complete all appropriate optional components.

All page limitations described in the SF424 (R&R) SBIR/STTR Application Guide and the Table of Page Limits must be followed.

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed, with the following additional instructions:

Resource Sharing Plans

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the SF424 (R&R) SBIR/STTR Application Guide.

Appendix

Do not use the appendix to circumvent page limits. Note that Phase I SBIR/STTR Appendix materials are not permitted, unless requested specifically by NIH SBIR/STTR.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) SBIR/STTR Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) SBIR/STTR Application Instructions. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:

All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) SBIR/STTR Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by the NICHD. Applications that are incomplete and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the proposed project have commercial potential to lead to a marketable product, process or service? (In the case of Phase II, Fast-Track, and Phase II Competing Renewals, does the Commercialization Plan demonstrate a high probability of commercialization?)

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangement?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

Not Applicable.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review (CSR) , in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a committee process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review), will be discussed and assigned an overall impact/priority score.
• Will receive a written critique.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Child Health and Human Development Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

NIH requires that SBIR/STTR grantees submit the following reports within 90 days of the end of the grant budget period unless the grantee is under an extension.

• Expenditure data portion of the Federal Financial Report
• Final Invention Statement and Certification (HHS 568)
• Annual Invention Utilization Reports
• Final Cash Transaction Report (PSC 272)
• Phase II Data Collection Requirement for Government Tech-Net Database

Failure to submit timely final reports may affect future funding to the organization or awards with the same PD/PI.

For details about each specific required report, see the section on Award Guidelines, Reporting Requirements, and Other Considerations, in the SF424 (R&R) SBIR/STTR Application Guide.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

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Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Tonse N. K. Raju, MD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301- 402-1872
Email: [email protected]

Dr. Carol Blaisdell, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0219
Email: [email protected]

John Firrell Ph.D.
Scientific Review Officer
Surgical Sciences, Biomedical Imaging and Bioengineering IRG Center for Scientific Review National Institutes of Health
6701 Rockledge Dr, Room 5118
Bethesda, MD 20892
Phone: (301) 435-2598
Fax (301) 480-2241
[email protected]

Ted Williams
Grants Management Specialist
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 EXECUTIVE BLVD, RM 8A17L, MSC 7510
Bethesda, 20892-7510
Phone: 301-435-6996
Fax: 301-451-5510
E-mail: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.

The STTR Program is mandated by the Small Business Reauthorization Act of 1997 (P.L. 105-135), and reauthorizing legislation, Small Business Technology Transfer Program Reauthorization Act of 2001 (P.L. 107-50). The basic design of the NIH STTR Program is in accordance with the Small Business Administration (SBA) STTR Policy Directive.