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Child Health and Human Development Extramural Research

NICHD Eunice Kennedy Shriver National Institute of Child Health and Human Development
Number: 93.865
Agency: Department of Health and Human Services
Office: National Institutes of Health

Program Information 

Program Number/Title (010):
93.865 Child Health and Human Development Extramural Research
Federal Agency (030):
National Institutes of Health, Department of Health and Human Services
Authorization (040):
Public Health Service Act, Section 301, 448 and 487, as amended, Public Laws 78-410 and 99-158, as amended, 42 U.S.C. 241; 42 U.S.C. 285g; 42 U.S.C. 288; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564, Public Law 113-76.
Objectives (050):
To conduct and support laboratory research, clinical trials, and studies with people that explore health processes. NICHD researchers examine growth and development, biologic and reproductive functions, behavior patterns, and population dynamics to protect and maintain the health of all people. To examine the impact of disabilities, diseases, and defects on the lives of individuals. With this information, the NICHD hopes to restore, increase, and maximize the capabilities of people affected by disease and injury. To sponsor training programs for scientists, doctors, and researchers to ensure that NICHD research can continue. By training these professionals in the latest research methods and technologies, the NICHD will be able to conduct its research and make health research progress until all children, adults, families, and populations enjoy good health.

The mission of the NICHD is to ensure that every person is born healthy and wanted, that women suffer no harmful effects from reproductive processes, and that all children have the chance to achieve their full potential for healthy and productive lives, free from disease or disability, and to ensure the health, productivity, independence, and well-being of all people through optimal rehabilitation.
Types of Assistance (060):
PROJECT GRANTS
Uses and Use Restrictions (070):
Grantee agrees to administer the grant in accordance with the regulations and policies governing the research grant programs of the Public Health Service as stated in the terms and conditions on the application for the grant. National Research Service Awards: Awarded to individuals for full-time research training in specified behavioral and biomedical shortage areas. Awardees may utilize some of their time in academic and clinical duties if such work is closely related to their research training. Awards may be made to institutions to enable them to make NRS awards to individuals selected by them. Each individual awardee is obligated upon termination of the award to comply with certain service and payback provisions. SBIR Phase I grants (of approximately 6-months' duration) are to establish the technical merit and feasibility of a proposed research effort that may lead to a commercial product or process. Phase II grants are for the continuation of the research initiated in Phase I and which are likely to result in commercial products or processes. STTR Phase I grants (normally of 1- year duration) are to determine the scientific, technical, and commercial merit and feasibility of the proposed cooperative effort that has potential for commercial application. Phase II funding is based on results of research initiated in Phase I and scientific and technical merit and commercial potential on Phase II application.
Eligibility Requirements (080)
Applicant Eligibility (081):
Universities, colleges, medical, dental and nursing schools, schools of public health, laboratories, hospitals, State and local health departments, other public or private institutions, both nonprofit and for-profit, and individuals. National Research Service Award: Support is provided for academic and research training only, in health and health-related areas that are periodically specified by the National Institutes of Health. Individuals with a professional or scientific degree are eligible (M.D., Ph.D., D.D.S., D.O., D.V.M., Sc.D., D.Eng., or equivalent domestic or foreign degree). Predoctoral research training grants to institutions are also supported. Proposed study must result in biomedical or behavioral research training in a specified shortage area and which may offer opportunity to research health scientists, research clinicians, etc., to broaden their scientific background or to extend their potential for research in health-related areas. Applicants must be citizens of the United States or be admitted to the United Ss for permanent residency; they also must be nominated and sponsored by a public or private institution having staff and facilities suitable to the proposed research training. Domestic nonprofit organizations may apply for the institutional NRS grant. SBIR: SBIR grants can be awarded only to domestic small businesses (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed, and have no more than 500 employees). Primary employment (more than one- half time) of the principal investigator must be with the small business at the time of award and during the conduct of the proposed project. In both Phase I and Phase II, the research must be performed in the U.S. or its possessions. To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council. STTR grants can be awarded only to domestic small business concerns (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed and have no more that 500 employees) which "partner" with a research institution in cooperative research and development. At least 40 percent of the project is to be performed by the small business concern and at least 30 percent by the research institution. In both Phase I and Phase II, the research must be performed in the U.S. and its possessions. To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council.
Beneficiary Eligibility (082):
Any nonprofit or for-profit organization, company, or institution engaged in biomedical or biobehavioral research.
Credentials/Documentation (083):
Applicants should submit electronically via Grants.gov as directed in the relevant NIH Funding Opportunity Announcement. All required forms specified in the application kit are to be completed by the applicant and submitted with the application package. National Research Service Award: Individual Award: The applicant's academic record, research experience, citizenship, and institution sponsorship should be documented in the application. Institutional Award: the applicant organization must show the objectives, methodology, and resources for the research training program, the qualifications and experience of directing staff, the criteria to be used in selecting individuals for awards, and a detailed budget and justification for the amount of grant funds requested. For-profit organizations' costs are determined in accordance with 48 CFR, Subpart 31.2 of the Federal Acquisition Regulations. For other grantees, costs will be determined by HHS Regulations, 45 CFR, Part 74, Subpart Q. For SBIR and STTR grants, applicant organization (small business concern) must present in a research plan an idea that has potential for commercialization and furnish evidence that scientific competence, experimental methods, facilities, equipment, and funds requested are appropriate to carry out the plan. OMB Circular No. A-87 applies to this program.
Application and Award Process (090)
Preapplication Coordination (091):
Preapplication coordination is not applicable. Environmental impact information is not required for this program. This program is excluded from coverage under E.O. 12372.
Application Procedures (092):
This program is excluded from coverage under OMB Circular No. A-102. OMB Circular No. A-110 applies to this program. National Research Service Award: Prior to formal application, an individual must arrange for acceptance at a sponsoring institution by a sponsor who will supervise the training. Individuals must be sponsored by a domestic or foreign institution. SBIR/STTR: Same as for grants (above). Applications are submitted electronically via Grants.gov following the general guidance provided at: http://grants.nih.gov/grants/forms.htm and the specific instructions for the respective Funding Opportunities Announcement which may be found at: http://grants.nih.gov/grants/guide/index.html?CFID=50541572&CFTOKEN=87322295&jsessionid=f630f3b44e23db8088b9e5e5224596361271
Award Procedure (093):
Each application receives a dual scientific review by non-NIH scientists. Awards are issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). National Research Service Awards: Applications are reviewed for scientific merit by an appropriate study section committee or by an institute review committee. If recommended for approval and a decision is made to make an award, a formal award notice will be sent to the applicant and sponsor. Institutional Awards are issued by the Eunice Kenney Shriver National Institute of Child Health and Human Development (NICHD). All accepted SBIR/STTR applications are evaluated for scientific and technical merit by an appropriate scientific peer review panel and by a national advisory council or board. All applications receiving a priority score compete for the available SBIR/STTR set-aside funds on the basis of scientific and technical merit and the commercial potential of the proposed research, program relevance, and program balance among the areas of research.
Deadlines (094):
Contact the headquarters or regional office, as appropriate, for application deadlines.
Range of Approval/Disapproval Time (095):
> 180 Days. From 6 to 9 months: National Research Service Awards: From 6 to 9 months. SBIR/STTR: approximately 6 months.
Appeals (096):
A principal investigator (P.I.) may question the substantive or procedural aspects of the review of his/her application by communicating with the staff of the Institute. A description of the NIH Peer Review Appeal procedures is available on the NIH web site at: http://public.csr.nih.gov/ApplicantResources/InitialReviewResultsAppeals/Pages/default.aspx.
Renewals (097):
> 180 Days. Renewal applications are accepted, as described in the relevant Funding Opportunity Announcement (FOA) found at: http://grants.nih.gov/grants/guide/index.html?CFID=50541572&CFTOKEN=87322295&jsessionid=f630f3b44e23db8088b9e5e5224596361271. National Research Service Awards: awards may be made for 1, 2, or 3 years. No individual may receive NIH fellowship support at the postdoctoral level for more than 3 years. Institutional Awards may be renewed.
Assistance Consideration (100)
Formula and Matching Requirements (101):
This program has no statutory formula.
This program has no matching requirements.
This program does not have MOE requirements.
Length and Time Phasing of Assistance (102):
Awards are usually made annually with no project period to exceed 5 years in length. National Research Service Awards: From 1 to 3 years. SBIR: Phase I awards are generally for 6 months; Phase II awards normally may not exceed 2 years. STTR Phase I awards are generally for 1 year; Phase II awards normally may not exceed 2 years. See the following for information on how assistance is awarded/released: Each year, submitted progress reports for awarded grants are reviewed, and if satisfactory progress is demonstrated, a Notice of Grant Award is issued.
Post Assistance Requirements (110)
Reports (111):
NIH requires that grantees periodically submit financial and progress reports. Other required reports may include annual invention utilization reports, lobbying disclosures, conflict of interest reports, audit reports, reports to the appropriate payment points (in accordance with instructions received from the payment office), and specialized programmatic reports. Grantees also are expected to publish the results of research in peer-reviewed journals and to provide information to the public on the objectives, methodology, and findings of their NIH-supported research activities, as specified in Administrative Requirements—Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Research Resources.

The GMO is the official receipt point for most required reports. However, NIH has centralized the submission of annual progress reports; details are provided below. In addition, electronic submission through the eRA Commons is required for some annual progress reports and available for all closeout documents (final grant progress reports, final invention statements and certifications, and final financial status reports). When a paper non-competing continuation progress report is submitted, only a signed original is required; no copies are required. Submission of these reports to an address other than the centralized one may result in delays in processing of the non-competing continuation award or the submission being considered delinquent. FFRs must be electronically submitted to OFM (see Financial Reports below) through the eRA Commons eFFR feature unless otherwise indicated in the award’s terms and conditions.

Grantees are allowed a specified period of time to submit required financial and final progress reports (see 45 CFR parts 74.51 and 74.52, 92.40 and 92.41, and the discussion in this subsection). Failure to submit complete, accurate, and timely reports may indicate the need for closer monitoring by NIH or may result in possible award delays or enforcement actions, including withholding, removal of certain NIH Standard Terms of Award, or conversion to a reimbursement payment method (also see Administrative Requirements—Enforcement Actions). The schedule for submission of the non-competing continuation progress report is discussed in the next subsection. The FFR has a dedicated section to report Federal cash receipts and disbursements. For domestic grantees this information is submitted quarterly directly to the PMS using the web-based tool. Quarterly reports are due 30 days following the end of each calendar quarter. The reporting period for this report continues to be based on the calendar quarter. Questions concerning the requirements for this quarterly financial report should be directed to the PMS.

For awards issued to foreign institutions after October 1, 2012, even though payment is now through PMS, the requirement for quarterly cash reporting does not apply. These awards are now administered in PMS using subaccounts and payments will be specific to each grant at the time the grantee draws funds. Progress reports usually are required annually as part of the non-competing continuation award process. NIH may require these reports more frequently. The “Non-Competing Continuation Progress Report” (PHS 2590) or equivalent documentation (e.g., Research Performance Progress Report [RPPR]) must be submitted to, and approved by, NIH to non-competitively fund each additional budget period within a previously approved project period (competitive segment). Except for awards subject to SNAP, the progress report includes an updated budget in addition to other required information.

NIH continues to transition to using the RPPR for progress reporting. The RPPR is a federal wide format for the submission of required annual or other interim performance reporting on grant and cooperative agreement awards. The transition to RPPR will be implemented in phases through a module in the eRA Commons. The RPPR is now required for all SNAP and fellowship awards. The PHS 2590 non-competing continuation progress report is currently required for all other NIH awards; however, the RPPR will eventually replace the PHS 2590 paper progress report. Reports of expenditures are required as documentation of the financial status of grants according to the official accounting records of the grantee organization. NIH requires all financial expenditure reports to be submitted using the Federal Financial Report (FFR) system located in the eRA Commons. This includes all initial FFRs being prepared for submission and any revised FSR/FFRs being submitted or re-submitted to NIH. The eRA Commons Federal Financial Report (FFR) system allows participants to view information on currently due and late expenditure reports and to submit these reports electronically to NIH. Paper expenditure reports are not accepted. Expenditure data submitted to NIH is initially reviewed and accepted by OFM. NIH IC grants management staff also review these expenditure reports.

Except for awards under SNAP and awards that require more frequent reporting, the FFR is required on an annual basis. An annual FFR is required for awards to foreign organizations made prior to October 1, 2012 and Federal institutions made prior to October 1, 2013, whether or not they are under SNAP. When required on an annual basis, the report must be submitted for each budget period no later than 90 days after the end of the calendar quarter in which the budget period ended. The reporting period for an annual FFR will be that of the budget period for the particular grant; however, the actual submission date is based on the calendar quarter. Failure to submit timely reports may affect future funding. The report also must cover any authorized extension in time of the budget period. If more frequent reporting is required, the NoA will specify both the frequency and due date.

In lieu of the annual FFR expenditure data, NIH will monitor the financial aspects of grants under SNAP by using the information submitted directly to PMS. The GMO may review the report for patterns of cash expenditures, including accelerated or delayed drawdowns, and to assess whether performance or financial management problems exist. For these SNAP awards, FFR expenditure data is required only at the end of a competitive segment. It must be submitted within 90 days after the end of the competitive segment and must report on the cumulative support awarded for the entire segment. An FFR must be submitted at this time whether or not a competing continuation award is made. If no further award is made, this report will serve as the final FFR. The grantee institution is required to submit a progress report on an annual basis for each grant award, which includes monitoring of performance.
Audits (112):
In accordance with the provisions of OMB Circular No. A-133 (Revised, June 27, 2003), "Audits of States, Local Governments, and Non-Profit Organizations," nonfederal entities that expend financial assistance of $500,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $500,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in Circular No. A-133. In addition, grants and cooperative agreements are subject to inspection and audits by DHHS and other Federal officials.
Records (113):
Expenditures and other financial records must be retained for 3 years from the day on which the grantee submits the last expenditure report for the report period.
Financial Information (120)
Obligations (122):
(Project Grants) FY 13 $874,250,000; FY 14 est $901,095,000; and FY 15 est $893,833,000 - PROJECT GRANTS (non-SBIR/STTR and SBIR/STTR combined): FY 2013 actual $874,250,000; FY 2014 estimate $901,095,000; FY 2015 estimate $893,833,000.
Range and Average of Financial Assistance (123):
For research project grants, fiscal year 2014, range is $50,000 to $5,000,000; average is $448,292. Individual research fellowship awards: Basic stipend (first year beyond the doctoral degree) of $43,680. The sponsoring institution will be provided, on application, with an allowance of up to $7,850 per year to help defray the cost of training. No dependency allowances. SBIR: Average Phase I awards are for approximately $205,389; Phase II awards may be made for amounts up to $1,243,361.
Program Accomplishments (130):
Fiscal Year 2013: Fiscal year 2013 competing and noncompeting research project grants actuals were 1,579. Of this number, 88 were SBIR/STTR awards. There were 47 research centers awarded. 525 other research grants were awarded. Actual institutional training awards were 577 in fiscal year 2013. The individual training awarded for fiscal year 2013 was 79. Fiscal Year 2014: Fiscal year 2014 competing and noncompeting research project grants estimates are 1,530. Of this number, 88 are expected to be SBIR/STTR awards. Approximately 52 research centers will be awarded. A planned 508 other research grants are anticipated to be awarded. Projected institutional training awards are 564 in fiscal year 2014. The individual training award are projected for fiscal year 2014 to be 85. Fiscal Year 2015: Fiscal year 2015 competing and noncompeting research project grants estimates are 1,500. Of this number, 90 are expected to be SBIR/STTR awards. Approximately 50 research centers will be awarded. A planned 476 other research grants are anticipated to be awarded. Projected institutional training awards are 557 in fiscal year 2015. The individual training award are projected for fiscal year 2015 to be 87.
Regulations, Guidelines, and Literature (140):
42 CFR 52; 42 CFR 66; 45 CFR 74; 45 CFR 92; NIH Grants Policy Statement, (Rev.) March 1, 2001, available on the NIH website at http://grants.nih.gov/grants/policy/nihgps_2001/; NIH Guide to Grants and Contracts, available on the NIH website at http://grants.nih.gov/grants/guide/. Grants will be available under the authority of and administered in accordance with the NIH Grants Policy Statement and Federal regulations at 42 CFR 52 and 42 USC 241; Omnibus Solicitation of the Public Health Service for Small Business Innovation Research (SBIR) Grant and Cooperative Agreement Applications. Omnibus Solicitation of the National Institutes of Health for Small Business Technology Transfer (STTR) Grant Applications.
Information Contacts (150)
Regional or Local Office (151) :
None.
Headquarters Office (152):
Eugene G. Hayunga, 6100 Executive Blvd., Room 2C01, Bethesda, Maryland 20892-7510 Email: ehayunga@mail.nih.gov Phone: (301) 496-6856.
Website Address (153):
http://www.nichd.nih.gov/Pages/index.aspx
Examples of Funded Projects (170):
Fiscal Year 2013: DEVELOPMENTAL BIOLOGY
Research in developmental biology increases knowledge about how individuals develop and the origins of various diseases and conditions. Recently, NICHD-funded scientists found that women with epilepsy who took the prescription drug topiramate during their first trimester to prevent seizures were at a slightly increased risk of having babies with cleft lip. Intramural scientists recently used next-generation gene sequencing techniques to discover in an animal model new brain regions, once thought to be inert, which appear to be active in the pineal gland, which controls the body’s 24-hour cycle and is integral to development. Advances in genetics and systems biology will shed new light on human development, and provide critical underpinnings for emerging fields such as regenerative medicine.

DEVELOPMENTAL ORIGINS OF HEALTH AND DISEASE
Complex interactions among biological and external factors, starting before conception, can influence health across the life course, and even across generations. NICHD researchers discovered a genetic pathway common to the rapid growth of healthy fetuses and the uncontrolled cell division of cancer, shedding light on both normal development and the genetic bases of common cancers. Understanding the developmental origins of health and disease will benefit from interdisciplinary and global studies and, ultimately, can be applied to prevent, treat, or even reverse chronic conditions such as obesity, diabetes, and cognitive deterioration.

PREGNANCY AND PREGNANCY OUTCOMES
Achieving a better understanding of pregnancy processes and fetal development can pave the way for predicting and preventing poor pregnancy outcomes as well as improving lifelong health for both women and infants. A new NICHD-funded study reported that pregnant women’s exposure to the flu was associated with a nearly four-fold increased risk that their children would develop bipolar disorder in adulthood. This information may encourage and increase the use of prevention strategies, such as the flu vaccine. Another study found that women who develop gestational diabetes during pregnancy can greatly decrease their risk of developing type 2 diabetes later in life by maintaining a healthy diet in the years following pregnancy. Targeted areas for future research include obtaining further understanding of how to promote healthy pregnancies and unraveling the complex causes of stillbirth and prematurity.

REPRODUCTION
Reproductive health is an essential element of personal well-being across the lifespan, and necessary to ensuring the health of future generations. NICHD-supported research found that the hormone progestin, often given as a first step in infertility treatment for polycystic ovary syndrome, unexpectedly decreased the odds of conception and giving birth. Scientists advance our understanding of what works in clinical practice, while identifying potential new diagnostic and therapeutic targets for managing critical aspects of women’s and men’s reproductive health.

BEHAVIOR AND COGNITION
Human behaviors can promote positive health outcomes or increase the risk of adverse ones. NICHD-funded researchers found that when the mind is at rest, the electrical signals by which brain cells communicate appear to travel in reverse, wiping out unimportant information, while sensitizing cells for future learning. NICHD research found that children who failed to acquire a particular math skill, number system knowledge, in first grade scored well behind their peers by seventh grade, pointing the way for targeted intervention when it matters most. In another study, seven-month old babies who were later diagnosed with autism took slightly longer to shift their gaze than babies who developed normally, which may provide an early clue to differences in their brain structure. Future basic and translational research that combines neuropsychological, behavioral, and social science perspectives will increase knowledge about the mechanisms that underlie typical and atypical behavior and cognition.

PLASTICITY AND REHABILITATION
Plasticity, adaptive or maladaptive change at the cellular, tissue, organ, or system levels, is at the core of human development and rehabilitation. NICHD researchers have identified proteins in an animal model that help fuse early-stage cells and eventually develop into muscle cells. This finding has implications for understanding how to repair and rehabilitate muscle tissue and how specialized cells (osteoclasts) repair and maintain bones. The ongoing challenge for scientists will be to generate additional knowledge about the mechanisms of plasticity, and translate this knowledge into interventions that can help individuals remodel, maintain, or enhance functioning.

POPULATION DYNAMICS
Individuals, families, and communities are all critical units through which population-level factors interact with genetic and environmental variables, influencing individual health across the lifespan. A NICHD study demonstrated that the stresses of poverty were shown to lead to impaired learning ability in children. Another study, a landmark collaboration among NICHD, other NIH Institutes and Centers, federal agencies, and private foundations, demonstrated that providing specialized housing vouchers that enabled low-income women and children to move from impoverished neighborhoods to those with relatively few poor residents reduced extreme obesity and diabetes over time. Over the next decade, cutting edge data collection and analytic methods could assess biological, physical, and social processes in diverse families and communities to inform the development of effective population-based interventions to improve health and reduce health disparities.

CONDUCT OF SCIENCE
In the coming years, biomedical and biobehavioral researchers will need to work as transdisciplinary teams, manage massive amounts of data, and acquire new and diverse skill sets. The very breadth of NICHD’s mission requires us to create and support such teams to translate and implement our research advances into actions that improve the health of women, families, and individuals with disabilities. Fiscal Year 2014: FY 2014: Understanding developmental change is at the heart of the NICHD mission. NICHD research touches the life of every person, starting with basic studies to understand the fundamental mechanisms that transform a single cell into a fully formed and healthy individual. NICHD clinical studies help improve the lifelong health and well-being of children, women, those with disabilities, families, and communities. The Institute’s broad range of research spans developmental biology, reproductive health, pregnancy, pediatric/adolescent development, pediatric trauma, intellectual disability, demography and behavior, and rehabilitation research.

Within an essentially flat budget, NICHD intends to continue its focus on the highest priority research and the most scientifically meritorious projects. NICHD’s core research has yielded an array of life-saving advances over the past 50 years. For instance, based on NICHD’s ollaborative research, HIV transmission from infected mother to fetus and infant has dropped from 25 percent to less than 1 percent in the United States. Likewise, the incidence of aemophilus influenzae type B, once the leading cause of acquired intellectual and developmental disability in the United States, has been virtually eliminated, dropping by more
than 99 percent. Building upon its compelling mission and strong science foundation, NICHD
will continue to explore emerging opportunities in a wide array of scientific disciplines, thus
moving forward key areas of interest to the NIH.

Regardless of past accomplishments, one fact remains: funding and other constraints have forced NICHD to cut back on activities and postpone important new research, impeding NICHD’s ability to capitalize fully and quickly on critical scientific opportunities that could improve the health of women, children, and families worldwide. Fiscal Year 2015: FY 2015: Program Directions and Changes -- Over the past two years, NICHD has begun to transform its “Scientific Vision: The Next Decade” into a living document and guide. However, to continue funding the investigator-initiated research that is central to its mission, NICHD will be able to expand work in only a few of the many promising areas that the document highlights. With very limited funds for new initiatives, NICHD will focus on funding a few additional grants in three areas: 1) creating new ways to study the workings arguably the most understudied human organ -- the placenta -- and its impact on fetal, maternal, and lifelong health; 2) the science needed to improve contraceptive options for both men and women; and 3) the long-term implications of assisted reproductive technologies. These topics represent significant research gaps unique to NICHD’s mission and ones unlikely to be funded through other public or private research investments.

This past year, NICHD worked with two Blue Ribbon Panels. One reviewed the science and organization of NICHD’s Division of Intramural Research (DIR); the other reviewed the science and organization of medical rehabilitation research across the NIH, particularly the National Center for Medical Rehabilitation Research (NCMRR) at NICHD. The final report of the DIR Blue Ribbon Panel focused on how to maintain essential intramural research in the face of significant resource cuts. The NCMRR report offered ways to reshape and reinvigorate rehabilitation research. NICHD will begin implementing the most important recommendations of each report by reorganizing its intramural programs and by strengthening collaboration in rehabilitation research across NIH.

For the past few years, NICHD has continued to make decisions that represent difficult tradeoffs. By maintaining and extending support for research training and career development grants and for the Small Business Innovation Research program, NICHD has continued to protect the next generation of researchers and the program that helps small business commercialize research innovations. To accomplish this, however, NICHD had to cut other grant mechanisms and significantly restrict the number of other new grants funded. Similarly, NICHD acted to preserve and help rebuild some of the research infrastructure lost in Hurricane Sandy, honoring all relevant requests, but at reduced levels.

Despite such tradeoffs, the nation continues to enjoy strong returns from NICHD’s research investments, which ultimately improve clinical care and save lives. For example, NICHD research showed that the biology underlying early developmental growth holds promise for addressing cancer and other conditions. Researchers have long known that some of the genes that promote rapid growth in prenatal and early postnatal life are reactivated in cancer cells. NICHD researchers identified a molecular on-off switch that controls some of these genes. This finding may help scientists understand the complex genetic choreography responsible for normal growth and identify some of the earliest origins of disease to help prevent certain cancers.

Recently, NICHD-supported researchers discovered possible new biomarkers for stillbirth and preeclampsia. This precision testing represents a first step to help scientists identify earlier, and eventually prevent, these life-threatening conditions. NICHD-supported researchers also helped to develop a wireless, implanted sensor to broaden the range of precision-oriented brain research. The sensor permits more natural studies of brain activity in moving subjects, a major step toward cord-free control of advanced prosthetics, powered by human thought, which could change the lives of those with physical disabilities.

Today’s far-reaching technological and computational capabilities also offer unprecedented opportunities to connect researchers with each other, industry partners, and the public. NICHD established the first national Down syndrome registry, a Web-based registry that serves as a national resource for people with Down syndrome and their families, researchers, and health care providers. Although nationally based data resources can accelerate scientific progress, they must be used with great care. Recently, NICHD announced that it will co-fund new studies to understand how genomics, newborn screening technologies, and the collection and use of related data influence parental decision-making and physician behavior.

Advances that improve clinical practice and public health rely on basic research that provides new insights into long-standing health challenges. NICHD-supported researchers discovered that cells of the placenta secrete tiny, balloon-like structures called vesicles. Absorbed by other cells, the vesicles program the recipient cells to ward off viral infections. One day, researchers hope to transfer this innate virus-fighting ability to other organs and tissues. This exciting finding also illustrates the potential of conducting research on the placenta. Data increasingly suggest that the placenta, which changes over time, has a huge impact on the lifelong health of both baby and mother. Yet the mechanisms that underlie these protective or harmful outcomes remain a mystery. The great challenge lies in finding non-invasive and safe ways to study the human placenta in real time, to give researchers and clinicians their first window into the forces that shape health over time. Being able to move forward in this and other exciting areas of developmental science, without jeopardizing the success of programs that NICHD has spent more than a half century building, is at the core of the difficult tradeoffs that we have made and continue to face. NICHD will persist in making difficult choices, focusing on areas that few others can or will pursue and that hold the most promise to improve the health of children, women, those with disabilities, families, and communities.
Criteria for Selecting Proposals (180):
The major elements in evaluating proposals include assessments of the significance of the proposed research; approach; innovation; investigators; and environment. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific and technical merit of the proposed approach for achieving the Phase II objectives; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation originality, or societal importance of the proposed research; (5) the potential of the proposed research for commercial application; (6) the reasonableness of the budget requested for the work proposed; (7) the adequacy and suitability of the facilities and research environment; and (8) where applicable, the adequacy of (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment.