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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 113-6.
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. Only Phase I awardees are eligible to receive Phase II support. 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 the most recent revision of research grant application form to the Center for Scientific Review, National Institutes of Health, Bethesda, MD 20892, using either PHS Form 398 or electronic submission via Grants.gov as directed in the relevant NIH Funding Opportunity Announcement. NIH is in the process of converting to electronic submission of grant applications through Grants.gov, using the SF-424 (Research and Related (R&R)) family of forms. Information on the transition plan and on registering for electronic submission is available at http://grants.nih.gov/grants/gide/notice-files/NOT-OD-05-067.html. Updates regarding the transition process may be viewed at http://era.nih.gov/ElectronicReceipt/. 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. Grant forms PHS 6246-1 and PHS 6246-2 are used to apply for SBIR Phase I and Phase II, respectively. Grant forms PHS 6246-3 and PHS 6246-4 are used to apply for STTR Phase I and Phase II, respectively. 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. The standard application forms, as furnished by PHS and required by 45 CFR, Part 92, must be used for 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). NRSA applications, may be obtained at http://www.grants.nih.gov/grants/funding/416/phs416.htm; e-mail: grantsinfo@nih.gov. Completed applications should be submitted to the Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892-7710, or electronically via Grants.gov. The SBIR and STTR Grant Solicitations and SBIR Contract Solicitation may be obtained electronically through the NIH's "Small Business Funding Opportunities" home page at www.nih.gov/grants/funding/sbir.htm on the World Wide Web. A limited number of hard copies of these publications are produced. Subject to availability, they may be obtained by contacting the NIH support services contractor: Telephone: (301) 206-9385; Fax: (301) 206-9722; E-mail: a2y@cu.nih.gov. The Solicitation includes application forms, which, upon completion, should be submitted to the Center for Scientific Review, National Institutes of Health, Bethesda, MD 20892. Small Business Technology Transfer (STTR) program uses same procedure as SBIR immediately above.
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://grants.nih.gov/grants/guide/notice-files/not97-232.html.
Renewals (097):
> 180 Days. Renewal applications are accepted, except for small grants. 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):
Program reports are not applicable. The grantee institution is required to submit a SF 272 - Federal Cash Transactions Report - on a quarterly basis. The grantee institution is required to submit a progress report on an annual basis for each grant award. A Financial Status Report (FSR) is due either annually or at the end of the project period, depending on the type of grant. 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 12 $930,940,000; FY 13 est $874,024,000; and FY 14 est $945,732,000 - SBIR/STTR: FY 2012 actual $31,445,000; FY 2013 estimate $30,604,000; FY 2014 estimate $34,609,000.

1. Do you create a separate obligation record for each funding stream? Each grant award is a separate obligation record.

2. In which cases do you answer yes to the question, “Is this obligation for salaries and expenses?” Salaries and expenses are included in the grantees budget request and are separate from federal salaries and expenses.

3. What is the source of the data for the actual obligations and estimated obligations? Do these figures include assistance funds only or do they also include program office funds to implement the programs? The source of data is NIH’s Accounting system for actual obligations and the most current President’s Budget request for estimated obligations. The figures represent project grants; small business innovation and technology transfer research; and Ruth L. Kirschstein National Research Service Awards (NRSA) only.

4. In which cases, do you use the “not separately identifiable” for the estimates? N/A

5. If the program is a revolving fund or has no-year or multiple-year obligations, in which year(s) do you enter the obligation (e.g., all funds obligated in the initial year, as funds are obligated to grantees, or other)? If applicable, NICHD would enter obligations in the actual year incurred.

6. What information do you typically include in the “additional information” textbox? Program updates.
Range and Average of Financial Assistance (123):
For research project grants, fiscal year 2013, range is $50,000 to $5,000,000; average is $433,433. Individual research fellowship awards: Basic stipend (first year beyond the doctoral degree) of $41,500. The sponsoring institution will be provided, on application, with an allowance of up to $8,860 per year to help defray the cost of training. No dependency allowances. SBIR: Average Phase I awards are for approximately $100,000; Phase II awards may be made for amounts up to $760,000.
Program Accomplishments (130):
Fiscal Year 2013: No Current Data Available Fiscal Year 2014: Fiscal year 2014 competing and noncompeting research project grants estimates are 1,618. Of this number, 89 are expected to be SBIR/STTR awards. Approximately 54 research centers will be awarded. 504 other research grants are anticipated to be awarded. Projected institutional training awards are 591 in fiscal year 2014. The individual training award are projected for fiscal year 2014 to be 82. Fiscal Year 2015: No Current Data Available
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.
Examples of Funded Projects (170):
Fiscal Year 2013: No Current Data Available Fiscal Year 2014: This past year, the NICHD celebrated its 50th anniversary. Beyond celebrating past accomplishments, this milestone inspired the Institute, along with its many stakeholders, to identify compelling scientific opportunities for the next decade. The Institute’s future research must build upon its strong foundation of scientific advances, from better understanding of the basic mechanisms that transform cells into healthy and effectively functioning individuals, to clinical studies that improve the health and well-being of women, families, and individuals with disabilities.
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 2015: No Current Data Available
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.