Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Agency for Health Care Research Quality (AHRQ), (http://www.ahrq.gov)
Centers for Disease Control and Prevention (CDC), (http://www.cdc.gov)
Health Resources and Services Administration (HRSA), (http://www.hrsa.gov)

Components of Participating Organizations
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov)
National Institute of Biomedical Imaging and Bioengineering, (NIBIB), (http://www.nibib.nih.gov)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov)
National Institute of Nursing Research (NINR), (http://www.ninr.nih.gov/)
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov)
National Institute for Occupational Safety and Health (NIOSH), (http://www.cdc.gov/niosh/homepage.html)
Maternal and Child Health Bureau (MCHB), (http://www.mchb.hrsa.gov)

Title: Research on Emergency Medical Services for Children

Announcement Type
This Program Announcement (PA) replaces PA-01-044, which was previously released January 25, 2001.

Update: The following update relating to this announcement has been issued:

Program Announcement (PA) Number: PA-05-081

Catalog of Federal Domestic Assistance Number(s)
93.226, 93.262, 93.110, 93.273, 93.286, 93.865, 93.242, 93.361

Key Dates
Release Date: March 30, 2005
For NIH, AHRQ and NIOSH
Letters of Intent Receipt Date(s): Not applicable
Application Receipt Dates(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Peer Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Council Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Earliest Anticipated Start Date: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date for Non-AIDS Applications: November 2, 2006
Expiration Date for AIDS and AIDS-Related Applications: January 3, 2007

For HRSA/MCHB
Letters of Intent Receipt Date(s): Not applicable
Application Receipt Dates(s): Approximately March 1 and August 15 of each year, check with HRSA program staff (see below) to verify dates
Peer Review Date(s): June 2005-2007 and October/November, 2005-2007
Council Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Earliest Anticipated Start Date: September 1 for March applicants and January 1 for August applicants
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: August 16, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

  Section I. Funding Opportunity Description
    1. Research Objectives

  Section II. Award Information
    1. Mechanism(s) of Support
    2. Funds Available

  Section III. Eligibility Information
    1. Eligible Applicants
      A. Eligible Institutions
      B. Eligible Individuals
    2.Cost Sharing or Matching
    3. Other - Special Eligibility Criteria

  Section IV. Application and Submission Information
    1. Address to Request Application Information
    2. Content and Form of Application Submission
    3. Submission Dates and Times
      A. Receipt and Review and Anticipated Start Dates
        1. Letter of Intent
      B. Sending an Application to the NIH
      C. Application Processing
    4. Intergovernmental Review
    5. Funding Restrictions
    6. Other Submission Requirements

  Section V. Application Review Information
    1. Criteria
    2. Review and Selection Process
   A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
  3. Anticipated Announcement and Award Dates

  Section VI. Award Administration Information
  1. Award Notices
  2. Administrative and National Policy Requirements
    A. Cooperative Agreement Terms and Conditions of Award
      1. Principal Investigator Rights and Responsibilities
      2. NIH Responsibilities
      3. Collaborative Responsibilities
      4. Arbitration Process
  3. Reporting

  Section VII. Agency Contact(s)
    1. Scientific/Research Contact(s)
    2. Peer Review Contact(s)
    3. Financial/ Grants Management Contact(s)

  Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description

1. Research Objectives

The goal of this PA is to improve the quality and increase the quantity of EMSC research to be conducted in the United States in FY 2005 and beyond. Specifically, this PA seeks to inform prospective applicants regarding grant opportunities available to conduct EMSC research under the sponsorship of a group of Federal agencies, and to broadly describe the areas where research is invited. Each sponsoring agency has further delineated specific issues/questions as illustrative of topics of research interest and will provide additional information to prospective applicants upon request.

Background In 1993, the Institute of Medicine (IOM) published a study of EMSC that recommended a dramatic increase in research addressing various aspects of children's emergency care. Subsequently, the Maternal and Child Health Bureau of the Health Resources and Services Administration and the Agency for Healthcare Research and Quality jointly issued an RFA and funded projects addressing this topic, as did the Centers for Disease Control and Prevention. As of fiscal year 2000, all states, the District of Columbia, and most Territories have received grant support to address issues related to the 1993 IOM study findings at some time since the EMSC Program was established by federal legislation in 1984. States used these funds to identify specific pediatric EMS needs and make changes to their regional EMS systems.

However, even with these successes, the extent of EMSC research continued to be minimal compared to the need. In 1997, a multi-disciplinary group representing several professional organizations met to prioritize the research needs in children's emergency services and again affirmed the need for a national commitment to research in this area. In 1998, the Ambulatory Pediatrics Association developed a set of recommendations designed to encourage EMSC research. The 1999 IOM report, “Reducing the Burden of Injury”(http://books.nap.edu/catalog/6321.html), recommends that additional funding for surveillance, research, and program evaluation in injury research for children and adults be supported by a variety of federal agencies. In 1999, an expert panel of EMSC researchers prioritized conditions for EMS outcomes. This publication reported relief of discomfort as the central outcome parameter EMS professionals identified as having the most potential impact in top quartile conditions. In 2001, a National ESM Research Agenda was published after being commissioned by the National Highway Traffic Safety Administration and the Maternal and Child Health Bureau. It detailed the need for a national investment in the EMS research infrastructure to help facilitate the accumulation of essential evidence of the effectiveness of EMS practice. It also called for funding to train new researchers and to support the development of effective pre-hospital treatments for the diseases that drive the design of the EMS system, including injury and sudden cardiac arrest.

This PA therefore responds to a need that has been clearly identified in the last decade. The sponsoring institutes/agencies are jointly issuing this PA because EMSC involves many agencies in its consequences, prevention, management, treatment, and control. This document is intended to go beyond what any single organization would be likely to accomplish individually, since EMSC requires visibility and multi-disciplinary approaches to effectively address the complicated and interwoven nature of the issues. Significant differences between the health care needs of children and adults mean that the dramatic changes now affecting the organization, financing, and delivery of health services may have differing effects on children than on adults. Children are different from adults in their patterns of use of health services, in their distinctive developmental vulnerabilities and strengths, and in their dependence on others for access to care and financial resources. The same is true in children's emergency care. Research in emergency medical services for children is essential to validate the clinical merit of care that is given, to identify better kinds of care, to devise better ways to deliver that care, and to learn where best to direct prevention activities. The use, costs, quality, accessibility, delivery, organization, financing, and outcomes of physical and mental health care services must be evaluated to increase understanding of the structure, processes, and effects of health services for both individual children and populations of children.

Priority EMSC-Related Program Areas by Agency Overall, seven broad areas of research on emergency medical services for children have been identified by recent national meetings, conferences, reports and symposia: (1) clinical aspects of emergencies and emergency care; (2) indices of the severity of injury and illness; (3) patient outcomes and outcome measures; (4) costs and cost-effectiveness; (5) system organization, configuration, and operation; (6) effective approaches to education and training, including re-training and skill retention; and (7) prevention. Each agency has priority areas of scientific investigation, with some illustrative lists represented below.

Agency for Healthcare Research and Quality (AHRQ) AHRQ seeks to support research to better understand and improve the outcomes of health care and, in particular, what works, for whom, when, and at what cost.  In terms of pediatric emergencies, AHRQ interests include, but are not limited to, studies that: 

For more detailed information on the Agency's priority interests for extramural grants for research, demonstration, and evaluation projects, applicants are strongly encouraged to consult the following program announcement: “AHRQ Health Services Research," PA-00-111, published in the NIH Guide on June 22, 2000 (http://grants.nih.gov/grants/guide/pa-files/PA-00-111.html). AHRQ encourages research applications that will use data from the Medical Expenditure Panel Survey (MEPS), the Healthcare Cost and Utilization Project (HCUP), and other AHRQ data as referenced in this announcement.

National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC) NIOSH supports research to identify and investigate the relationships between hazardous working conditions and associated occupational diseases and injuries; to develop more sensitive means of evaluating hazards at work sites, as well as methods for measuring early markers of adverse health effects and injuries; to develop new protective equipment, engineering control technology, and work practices to reduce the risks of occupational hazards; and to evaluate the technical feasibility or application of a new or improved occupational safety and health procedure, method, technique, or system. The research identified in this announcement relates to the following five priority areas in the National Occupational Research Agenda (NORA): traumatic injuries; special populations at risk; health services research; social and economic consequences of workplace injuries and illnesses; and intervention effectiveness research. Information about NORA is available through the NIOSH Home Page: http://www.cdc.gov/niosh/nora/. Topics of research that are appropriate for this program announcement include, but are not limited to, the following and should address occupational hazards associated with agriculture, construction, service and other industries:

Maternal and Child Health Bureau (MCHB), Health Resources and Services Administration (HRSA)
The research supported by MCHB is guided by a multi-year research agenda comprising strategic research issues of relevance to MCH service delivery and care, and consistent with the MCHB Mission and Strategic Plan. The MCHB Strategic Research Issues: Fiscal Years (FY) 2004 - 2009 are available to the public on the MCHB web page at: http://www.mchb.hrsa.gov/research. Addressing one of the four strategic research issues is a review criterion worth up to 10 points in the overall score of an application.

National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH) NIAAA supports a research program on all aspects of alcohol abuse and alcoholism. This broad mission includes both alcohol-related epidemiological and health services research. Research on services for children and adolescents with alcohol use problems (underage drinkers) encourages the interdisciplinary study of the structures, processes, and outcomes of medical, alcohol treatment, and mental health service delivery for alcohol-affected and alcohol-exposed youth. Programs of research on quality of care, the organization of systems of care, economics, and methods development are among the areas of emphasis. NIAAA is especially interested in studies that examine the appropriateness and effectiveness of specialized services for children and adolescents in need of emergency medical care in terms of their mental and physical health outcomes. With special attention to issues related to alcohol use, abuse, and addiction, NIAAA encourages studies on a wide range of EMSC-related topics, including but not limited to:

National Institute of Biomedical Imaging and Bioengineering (NIBIB), NIH NIBIB is interested in expanding the availability of bioengineering and imaging technologies that are related to emergency medical services for children. Emergency services often involve the diagnosis and localization of injury and disease by medical imaging (x-ray, ultrasound, CT, and others). Examples of biomedical engineering technologies that can improve emergency services for children include, but are not limited to, pediatric medical devices, point-of-care diagnostic technologies, biosensors, and tissue engineering.

National Institute of Child Health and Human Development (NICHD), NIH
The NICHD conducts and supports laboratory, clinical, and epidemiological research on a variety of topics to assure that every individual is born healthy, is born wanted, and has the opportunity to fulfill his or her potential for a healthy life unhampered by disease or disability. The following are examples of topics of interest to the NICHD:

National Institute of Mental Health (NIMH), NIH The NIMH has an active grant program on child and adolescent mental health services research. Programs of research on quality of care, the organization of systems of care, dissemination and implementation, economics, and methods development are among the areas of emphasis in health services research. NIMH is especially interested in studies that examine the quality and appropriateness of services for children and adolescents with mental health problems who are seen for emergency medical care, as well as the impact of the delivery of emergency care on mental health sequelae for children. NIMH is also interested in studies of the mental health consequences of traumatic events and the development and testing of interventions to assist victims and survivors. Knowledge is sought regarding the spectrum of responses to trauma and the influence that different stressor parameters (e.g., setting, frequency, controllability, severity) may have for pathological sequelae, treatment alternatives, and preventive options. Examples of relevant research topics include, but are not limited to, studies that:

National Institute of Nursing Research (NINR), NIH The NINR supports clinical and basic research to establish a scientific basis for the care of individuals across the life span--from management of patients during illness and recovery to the reduction of risks for disease and disability and the promotion of healthy lifestyles. The research mission of NINR is available at http://www.ninr.nih.gov/research/diversity/mission.html. For the purposes of this PA, NINR is interested in EMSC-related clinical nursing research, particularly in the areas of clinical assessment of disaster emergencies, brain injury, and asthma, as illustrated in the following examples:

Disaster Emergencies

Traumatic Brain Injury (TBI) Asthma

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the investigator-initiated Research Project Grant award mechanism known as "R01" at AHRQ, CDC, and NIH, and as "field-initiated" award at HRSA/MCHB. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Applicants are encouraged to contact the agency listed under INQUIRIES that matches their research interest, and to seek guidance on other potential grant mechanisms that are applicable to each agency.

This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for non-modular research grant applications.

HRSA/MCHB and AHRQ do not use the modular budget format and HRSA/MCHB caps its awards at $300,000 per year in total costs.

2. Funds Available

No set-aside of funds will be made to exclusively cover the support of scientifically meritorious applications under this PA. Applications will compete for funds with all other scientifically meritorious applications generated by each agency through their investigator-initiated research programs. The total project period for an application submitted in response to this PA may not exceed five years, three years for applications submitted to AHRQ.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) to the NIH if your organization has any of the following characteristics:

AHRQ

For AHRQ, applications may be submitted by domestic and foreign, public and private nonprofit organizations including universities, clinics, units of State and local governments, firms, and foundations. Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible. Applications may be from a single institution or may include arrangements with one or more institutions (for example, consortia, clinical trials cooperative group) if appropriate.

HRSA/MCHB

Applications submitted to the HRSA/MCHB may be submitted by domestic non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, and units of State and local governments. Applications may be from a single institution or may include arrangements with one or more institutions (for example, consortia, clinical trials cooperative group) if appropriate. For MCHB, eligibility is restricted to public or nonprofit institutions of higher learning and public or private nonprofit agencies engaged in research or in programs relating to maternal and child health and/or services for children with special health care needs, and if otherwise eligible, faith-based and community organizations are eligible to apply.

NIOSH/CDC and NIH

For applications assigned to the NIOSH, NIAAA, NIBIB, NICHD, NIMH, or NINR, applications may be submitted by domestic and foreign, non-profit and for-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, and units of State and local governments, and eligible agencies of the Federal Government and federally recognized Indian tribal governments, Indian tribes, or Indian tribal organizations. Applications may be from a single institution or may include arrangements with one or more institutions (for example, consortia, clinical trials cooperative group) if appropriate.  

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution 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 programs.

2. Cost Sharing or Matching

Not applicable

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria
Not applicable

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

AHRQ, NIH, and NIOSH: Applications must be mailed on or before the receipt date described below (Section IV.3.A). Submission times N/A.

For MCHB applications, the receipt dates are March and August of each year.

3.A. Receipt, Review and Anticipated Start Dates

For NIH, AHRQ and NIOSH
Letters of Intent Receipt Date(s): Not applicable
Application Receipt Dates(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Peer Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Council Review Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Earliest Anticipated Start Date: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: July 2, 2008

For HRSA/MCHB
Letters of Intent Receipt Date(s): Not applicable
Application Receipt Dates(s): Approximately March 1 and August 15 of each year, check with HRSA program staff (see below) to verify dates
Peer Review Date(s): June 2005-2007 and October/November, 2005-2007
http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Earliest Anticipated Start Date: September 1 for March applicants and January 1 for August applicants
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: August 16, 2008

3.A.1. Letter of Intent
Not applicable

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Sending an Application t o HRSA/MCHB

Applications must be prepared using the PHS 398 research grant application instructions and forms and the HRSA/MCHB Research Program Application guidance, which can be downloaded at: http://www.mchb.hrsa.gov/research. Please submit one (1) original and two (2) unbound copies of the application to:

HRSA Grants Application Center
Attention: MCHB Research Program
CFDA #93.110
901 Russell Avenue, Suite 450
Gaithersburg, MD 20879
Telephone: 1-877-477-2123
Email: hrsagac@hrsa.gov

3.C. Application Processing

Applications must be submitted on or before the dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm. Upon receipt, applications will be evaluated for completeness by CSR.

The NIH and AHRQ will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (see also Section VI.3. Reporting).

6. Other Submission Requirements

Specific Instructions for Modular Grant applications (This applies only for NIH and NIOSH. HRSA/MCHB and AHRQ do not use the modular budget format.)

Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year (See below for HRSA requirement.)

Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;

2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and,

3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.

This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

HRSA/MCHB caps its awards at $300,000 per year in total costs.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources
Not applicable

Section V. Application Review Information

1. Criteria
Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

This review and selection process applies for NIH, NIOSH, and AHRQ. Review criteria for HRSA/MCHB are listed below.

Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.

Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.

As part of the initial merit review, all applications will:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

2. Approach. Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

3. Innovation. Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

4. Investigators. Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

HRSA/MCHB applications are evaluated based on seven review criteria:

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources
Not applicable

3. Anticipated Announcement and Award Dates
Not applicable

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document.

Once all administrative and programmatic issues have been resolved, the NGA will be generated via e-mail notification from the awarding component to the grantee business official (designated on the Face Page of the Form PHS 398). If a grantee is not e-mail enabled, a hard copy of the Notice of Grant Award will be mailed to the business official.

HRSA/MCHB applicants will receive a summary statement of the review of their application. Once funding decisions are made, applicants will also receive a notice informing them of the outcome of their application. Applicant organizations that are selected for funding will receive a notice of award from the HRSA Division of Grants Management Operations.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

All applicants are strongly encouraged to contact the appropriate agency representatives listed below to verify eligibility, inquire about funding mechanisms or otherwise clarify any part of this program announcement as it pertains to that agency.

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Lynne Haverkos M.D., M.P.H.
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B05G, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 435-6881
FAX: (301) 480-0230
Email: haverkol@mail.nih.gov

Carol Nicholson, M.S., M.D.
National Center for Medical Rehabilitation Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 2A03, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 435-6843
FAX: (301) 402-0832
Email: nicholca@mail.nih.gov

Pamela Owens, Ph.D.
Center for Delivery, Organization, and Markets
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1438
FAX: (301) 427-1430
Email: powens@ahrq.gov

Bridgette E. Garrett, Ph.D.
Office of Extramural Programs
National Institute for Occupational Safety and Health
Executive Park Building 24, Room 1423, MS E-74
1600 Clifton Road, N.E.
Atlanta, GA 30333
Telephone: (404) 498-2508
FAX: (404) 498-2571
Email: bgarrett@cdc.gov

Rita Haggerty
Public Health Analyst
Maternal and Child Health Bureau
5600 Fishers Lane
Parklawn Building, Room 18A-55
Rockville, MD 20857
Telephone: (301) 443-3146
FAX: (301) 443-4842
Email: RHaggerty@hrsa.gov

Hae Young Park, M.P.H.
Public Health Analyst
Maternal and Child Health Bureau
5600 Fishers Lane
Parklawn Building Room, 18A-55
Rockville, MD 20857
Telephone: (301) 443- 2127
FAX: (301) 443-4842
Email: hpark@hrsa.gov

Harold Perl, Ph.D.
Division of Treatment and Recovery Research
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2039
Bethesda, MD 20892-9304
Rockville, MD 20852-1705 (for express/courier service)
Telephone: (301) 443-0788
FAX: (301) 443-8774
Email: hperl@mail.nih.gov

John Haller, Ph.D.
Division of Applied Science and Technology
National Institute of Biomedical Imaging And Bioengineering
6707 Democracy Blvd.
Bethesda, MD 20892
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 451-4780
Fax: (301) (301) 480-4973
Email: hallerj@mail.nih.gov

Heather L. Ringeisen, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7146
Bethesda, MD 20892-9631
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-7227
FAX: (301) 443-4045
Email: hringeis@mail.nih.gov

Farris Tuma, Sc.D.
Division of Adult Translation Research
National Institute of Mental Health
6001 Executive Boulevard, Room 6200
Bethesda, MD 20892-9617
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-5944
FAX: (301) 480-4415
Email: ftuma@nih.gov

Karen Huss, DNSc
Office of Extramural Programs
National Institute of Nursing Research
6701 Democracy Boulevard, Room 718
One Democracy Plaza
Bethesda, MD 20892-4870
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Phone: (301) 594-5970
Fax: (301) 480-8260
Email: hussk@mail.nih.gov

2. Peer Review Contacts:
Not Applicable

3. Financial or Grants Management Contacts:

Kimberly Chatman
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8A07F, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 435-7002
FAX: (301) 451-5510
Email: chatmank@mail.nih.gov

Marc Milton Pitts
Grants Management Branch
Agency for Healthcare Research and Quality
OPART/GM
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1704
FAX: (301) 427-1462
Email: mpitts@ahrq.gov

David Staudt
Grants Management Branch
Centers for Disease Control and Prevention
626 Cochrans Mill Road
Pittsburgh, Pennsylvania 15236-0070
Telephone: (412) 386-6459
FAX: (412) 386-6429
Email: david.staudt@cdc.hhs.gov

James L. King
Grants Management Branch
Health Resources and Services Administration
5600 Fishers Lane
Parklawn Building, Room 11A-16Rockville, MD 20857
Telephone: (301) 443-1123
FAX: (301) 443-6686
Email: jking@hrsa.gov

Bruce A. Holmes
Grants Management Branch
HRSA Division of Grants Management Operations
5600 Fishers Lane, Room 11A-16
Rockville, Maryland 20857
Telephone: (301) 443-0752
Email: bholmes@hrsa.gov

Judy S. Fox (Formerly, Simons)
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3023
Bethesda, MD 20892-9304
Rockville, MD 20857 (for express/courier service; non-USPS service)
Telephone: (301) 443-4704
FAX: (301) 443-3891
Email: jsimons@willco.niaaa.nih.gov

Aaron Nicholas
Grants Management Branch
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard, Suite 900
Bethesda, MD 20892-5469
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 451-4791
FAX: (301) 496-8521
Email: nicholaa@mail.nih.gov

Joy R. Knipple
Grants Management Branch
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6131
Bethesda, MD 20892-9605
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-8811
FAX: (301) 443-6885
Email: jk173r@nih.gov

Lawrence Haller
Office of Grants/Contract Management
National Institute of Nursing Research
6701 Democracy Boulevard, Room 710
Bethesda, MD 20892-4870
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 402-1878
FAX: (301) 451-5652
Email: hallerl@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Applicants for research funding from NIAAA should review the NIAAA-specific Guidelines for Data and Safety Monitoring Plans http://www.niaaa.nih.gov/extramural/guidelines.htm.

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

Public Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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