RESEARCH ON EMERGENCY MEDICAL SERVICES FOR CHILDREN

Release Date:  January 25, 2001

PA NUMBER:  PA-01-044

Maternal and Child Health Bureau, HRSA
Agency for Healthcare Research and Quality
National Institute for Occupational Safety and Health, CDC
National Heart, Lung, and Blood Institute, NIH
National Institute of Child Health and Human Development, NIH
National Institute on Drug Abuse, NIH
National Institute of Mental Health, NIH
National Institute of Nursing Research, NIH

PURPOSE

This multi-agency announcement is designed to improve the quality and quantity 
of research related to emergency medical services for children (EMSC).  The 
types of research included under the term EMSC are: prevention research to 
reduce the need for emergency care; clinical research to ensure that children 
receive high quality and appropriate medical, nursing and mental health care 
in an emergency; health systems research, from pre-hospital care, to the 
emergency department, to inpatient care and return to the community; cost-
effectiveness analyses; and methodological studies to improve the quality of 
research conducted.  A goal is to reduce morbidity and mortality in children 
through improved care delivery.  Research specific to minority and inner city 
and rural populations is encouraged. 

This Program Announcement (PA) expires three years from the Release Date shown 
directly above, unless reissued.

Former NIMH Program Announcement PA-93-075, “Research on Emergency Mental 
Health Services for Children and Adolescents,” which was published in 1993, is 
no longer active.

RESEARCH OBJECTIVES

The goal of this PA is to improve the quality and increase the quantity of 
EMSC research to be conducted in the U.S. in FY 2001 and beyond.  
Specifically, this PA seeks to inform prospective applicants regarding grant 
support opportunities available to conduct EMSC research under the sponsorship 
of a group of Federal agencies, and to broadly describe the areas where 
research is warranted.  Each sponsoring agency has further delineated specific 
issues/questions as illustrative of what topics they are interested in 
investigating and will make more detailed information available to prospective 
applicants upon request. 

Background

In 1993, the Institute of Medicine 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.  However, the 
extent of this 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” (online at 
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. 

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 would include studies that:

o  Support improvements in health outcomes.  For example, studies of the 
effect of pediatric hospitals versus trauma centers with a pediatric 
commitment on the outcomes for children with severe trauma and studies 
(including clinical trials), comparing effectiveness and costs of diagnostic 
or treatment alternatives. 

o  Strengthen quality measurement and improvement and improve patient safety.  
For example, research to develop valid and reliable measures of the process 
and outcomes of pediatric emergency care; use of quality measures in programs 
of quality improvement; studies to show the benefits and costs of improved 
coding and classifications (e.g., E-codes) of the causes of injury requiring 
emergency treatments; studies to predict and reduce medical errors; and 
studies of ways to disseminate and broadly implement quality improvement 
mechanisms that have proven successful in studies of single settings.

o  Identify strategies to improve access, foster appropriate use, and reduce 
unnecessary expenditures.  For example, the effects of managed care on 
utilization of emergency care for children; differentials in access to 
emergency care by children related to non-medical factors such as ethnicity or 
payment source; or effects on children of demand management strategies 
designed to control emergency care utilization.

Applicants are strongly encouraged to consult PA-00-111,“AHRQ Health Services 
Research,” published in the NIH Guide on June 22, 2000 and available at: 
http://grants.nih.gov/grants/guide/pa-files/PA-00-111.html for more detailed 
information on the Agency’s priority interests for extramural grants for 
research, demonstration, and evaluation projects.  

National Institute for Occupational Safety and Health (NIOSH), 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 PA 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/norhmpg.html

Topics of research that are appropriate for this PA include, but are not 
limited to, the following and should address occupational hazards associated 
with agriculture, construction, service and other industries:  

o  Evaluation of the effectiveness of training programs to prevent childhood 
occupational injuries for example programs that are targeted to 
owners/operators, workers, family members and care-givers;

o  Development and evaluation of community-based programs to enhance the 
safety and well-being of children who may be exposed as bystanders;

o  Identification of skills, procedures and equipment needed by pre-hospital 
providers in responding to childhood occupational trauma, and how differences 
in care lead to different outcomes;

o  Development and evaluation of approaches for using emergency departments to 
introduce effective emergency management strategies that improve skills of 
workers and family members in handling injuries to children.

o  Development and evaluation of “first on the scene” training specific to 
childhood agricultural trauma for farm owners/operators, farm workers, family 
members, and care-givers;

Maternal and Child Health Bureau (MCHB), HRSA - The research supported by MCHB 
is guided by a multi-year research agenda comprised of 11 areas of 
programmatic interest.  Each area is further defined by a list of research 
issues/questions, from which MCHB has selected a sub-set of 15 
issues/questions for "priority" consideration during FY 2000-2003.  The 
"priority" consideration consists of a 0.5 adjustment to the funding score 
assigned to an application when recommended for approval by the MCHB Research 
Study Section.  The issues/questions remaining under the 11 broadly demarcated 
areas are also of programmatic importance.  Applications addressing this 
larger list will be accepted for review and considered for funding, but will 
not be given the special funding consideration.

These lists of issues/questions within each of the 11 areas of programmatic 
importance are not exhaustive, however.  Thus issues/questions representing 
applicants' own interests would qualify for non-priority consideration, as 
long as they are congruent with the implied meaning of the 11 broad 
programmatic areas of interest.  Examples of EMSC-related priority and non-
priority issues/questions found in the MCHB research agenda are presented 
below.

Priority:
o  Study the extent to which children who need emergency medical services 
receive them, with particular attention to care received (or not received) in 
hospital emergency departments (EDs).

Nonpriority:
o  Conduct studies on the economic consequences of pediatric trauma or severe 
illness for families and geo-political units.

o  Study the processes involved in the evaluation and management of minor head 
trauma, including indications for CT scans, observation and admission.

The full research agenda is available on the MCHB Web Page at: 
http://www.mchb.hrsa.gov/grants/default.htm.
 
National Heart, Lung, and Blood Institute (NHLBI), NIH - The NHLBI provides 
leadership for national programs in diseases of the heart, blood vessels, 
lungs, and blood.  It plans and supports, through extramural research grants 
and contracts, an integrated program that includes basic and clinical 
investigations; clinical trials; and demonstration and education projects 
relating to causes, diagnosis, treatment, and prevention of diseases.  Because 
emergency department visits and hospitalizations for asthma have risen over 
the last 10 years, especially among young children and minority and 
economically disadvantaged populations, NHLBI is encouraging grant 
applications that will study ways to reverse this trend.  Grant applications 
are encouraged that cover such topics as:

o  Demonstration and education studies to develop and evaluate programs using 
the emergency department to introduce effective asthma management strategies 
that improve patient and family skills in handling exacerbations and prevent 
future needs for emergency care;

o  Demonstration and education studies that develop program models for 
promoting successful referral from the emergency department to long-term 
sources of asthma care;

o  Epidemiological studies to identify risk factors for emergency department 
visits, or for near fatal exacerbations of asthma;

o  Clinical studies to identify optimal treatments for acute exacerbations of 
asthma in children, especially infants and young children.

o  Interdisciplinary clinical and mechanistic studies to evaluate varying 
patterns of patient responses to therapy among children with different asthma 
phenotypes.

National Institute for 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 NICHD has a variety of 
EMSC research interests.  With a particular focus on the biobehavioral factors 
involved, these research interests include:

o  Childhood injuries, including the surveillance of injuries, the mechanisms, 
risk factors, etiologies, environmental influences, interventions and 
preventions.

o  The care of suicidal children and adolescents.

o  The outcomes of emergency care for children acutely ill secondary to 
infection, trauma, or acute exacerbation of chronic illness.

o  The biobehavioral aspects of pain, stress, and coping with illness or 
injury in situations of emergency care.

o  Training programs for researchers interested in prevention of childhood 
injuries.

o  Behavioral factors involved in risk-taking behaviors with subsequent need 
for emergency medical services (drug, alcohol, or inhalant abuse, injurious 
behavior, pelvic inflammatory disease, tubal pregnancy, etc.)

The National Center for Medical Rehabilitation Research (NCMRR), a component 
of NICHD, strives to foster development of scientific knowledge needed to 
enhance the health, productivity, independence, and quality of life of persons 
with disabilities, including disabilities which occur secondary to trauma.  
The Center is interested in research on emergency medical services for 
children with disabilities, and in interventions that have implications for 
rehabilitation in areas such as, but not limited to:
o  Orthopedic injuries
o  Traumatic brain injury 
o  Spinal cord injury 

National Institute on Drug Abuse (NIDA), NIH - NIDA supports a research grant 
program on health services designed for children and adolescents with drug-use 
problems and encourages interdisciplinary study of the structures, processes 
and outcomes of the delivery of medical and mental health services for drug-
affected youth.  NIDA 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 illicit 
drug use, abuse and addiction, NIDA encourages studies on a wide range of 
service-related topics, including but not limited to:

o  Emergency service availability, access and utilization, linkages to primary 
care, social services, case management systems and follow-up programs designed 
for children and/or youth who are actively or passively exposed to drugs-of-
abuse;

o  Emergency services delivery and the economics of specialized pediatric 
care;

o  Prevention intervention and family-oriented treatment for drug-exposed 
children and adolescents to reduce the need for emergency care;

o  Emergency medical and mental health services developmentally appropriate 
for children and youth affected by drug use and co-occurring disorders;

o  Screening (e.g., biological and self-report measures) and comprehensive 
assessment tools developmentally appropriate and suitable for use in emergency 
medical service settings;

o  Psychosocial and behavioral determinants of parental/guardian adherence to 
medical staff recommendations made at the time of the emergency service.

National Institute of Mental Health (NIMH), NIH - NIMH has an active grant 
program on mental health services for children and adolescents.  Programs of 
research on quality of care, the organization of systems of care, 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.  
Studies also encouraged will: 

o  Examine aspects of service delivery (that is, intake, assessment, referral, 
case management, medical staff communication style, follow-up care, etc.) and 
its impact.  

o  Focus on the quality or effectiveness of family involvement in aftercare. 

o  Examine costs, organizational climate, or structural features of emergency 
departments that affect the quality, outcomes, or delivery of services.

o  Examine the mental health effects of violence and trauma on children and 
youth, including prevention and treatment.

o  Explore factors affecting access to mental health services by children with 
emergency medical conditions (for example, risk-taking behavior, suicide 
attempts, depression, life-threatening substance abuse, victims of violence) 
presenting to the emergency department. 

o  Develop methodologies aimed at measuring post-traumatic stress in young 
children. 

o  Develop strategies for resolving methodological and ethical problems in 
EMSC research, including issues related to informed consent, breaking of 
confidentiality, and selection of appropriate comparison groups.

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.nih.gov/ninr/a_mission.html.  For the purposes of this PA, NINR is 
interested in EMSC-related clinical nursing research, particularly in the 
areas of brain injury and asthma, as illustrated in the following examples:

Traumatic Brain Injury (TBI) 
o  Identify and test emergency room and ICU nursing interventions to reduce 
intracranial pressure and brain ischemia; to relieve severe pain; to prevent 
muscle atrophy and kidney failure; and to treat acute lung injury, fever, and 
seizures; to improve ICU pediatric nursing procedures such as suctioning 
techniques, nutritional therapies, and positioning techniques.

o  Identify and test rehabilitative nursing interventions to prevent 
motor/sensory loss to be performed immediately upon hospital admission. 

o  Identify and test ways to engage parents and caregivers in rehabilitative 
care of children and adolescents diagnosed with TBI immediately upon hospital 
admission.

Asthma
o  Validate optimum nursing therapies to improve the accuracy of cues to 
prevent asthma attacks; to alleviate adverse psychological consequences (such 
as fear) of shortness of breath and wheezing, in children and care providers; 
and to monitor adherence/compliance to therapy.  

o  Evaluate asthma teaching plans used with adults to assess appropriate uses 
with children.  

o  Develop home-based tele-health technologies with special appeal to children 
with emphasis on flow charts, decision trees, or algorithms.

SPECIAL REQUIREMENTS FOR AHRQ APPLICATIONS

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 is referenced in the “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).  
  
Data Privacy

Pursuant to section 924(c) of the Public Health Service Act (42 USC 299c-
3(c)), information obtained in the course of any AHRQ-study that identifies an 
individual or entity must be treated as confidential in accordance with any 
promises made or implied regarding the possible uses and purposes of the data 
collection.  In the Human Subjects section of the application, applicants must 
describe procedures for ensuring the confidentiality of such  identifying 
information.  The description of the procedures should include a discussion of 
who will be permitted access to the information, both raw data and machine 
readable files, and how personal identifiers and other identifying or 
identifiable data will be restricted and safeguarded.

The grantee should ensure that computer systems containing confidential data 
have a level and scope of security that equals or exceeds those established by 
the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix 
III - Security of Federal Automated Information Systems.  The National 
Institute of Standards and Technology (NIST) has published several 
implementation guides for this circular.  They are: An Introduction to 
Computer Security: The NIST Handbook; Generally Accepted Principals and 
Practices for Securing Information Technology Systems; and Guide for 
Developing Security Plans for Information Technology Systems.  The circular 
and guides are available on the web at 
http://csrc.nist.gov/publications/nistpubs/800-12/handbook.pdf.     

The application of these confidentiality and security standards to 
subcontractors and vendors should be addressed as necessary.

Rights in Data

AHRQ grantees may copyright or seek patents, as appropriate, for final and 
interim products and materials including, but not limited to, methodological 
tools, measures, software with documentation, literature searches, and 
analyses, which are developed in whole or in part with AHRQ funds.  Such 
copyrights and patents are subject to a worldwide irrevocable Federal 
government license to use and permit others to use these products and 
materials for government purposes.  In accordance with its legislative 
dissemination mandate, AHRQ purposes may include, subject to statutory 
confidentiality protections, making research materials, data bases, results, 
and algorithms available for verification or replication by other researchers; 
and subject to AHRQ budget constraints, final products may be made available 
to the health care community and the public by AHRQ or its agents, if such 
distribution would significantly increase access to a product and thereby 
produce public health benefits.  Ordinarily, to accomplish distribution, AHRQ 
publicizes research findings but relies on grantees to publish research 
results in peer-reviewed journals and to market grant-supported products.

Important legal rights and requirements applicable to AHRQ grantees are set 
out or referenced in the AHRQ grants regulation at 42 CFR Part 67, Subpart A 
(Available in libraries and from the GPO’s website at:  
http://www.access.gpo.gov/nara/cfr/index.html.

MECHANISM OF SUPPORT

This PA will use the investigator-initiated research project grant award 
mechanism known as "R01" at AHRQ, CDC, and NIH, and as "field-initiated" at 
MCHB/HRSA.  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. 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. Responsibility 
for the planning, direction, and execution of the proposed project will be 
solely that of the applicant.  The total project period for an application 
submitted in response to this PA may not exceed five years.  Because the 
nature and scope of the research proposed in response to this PA will vary, it 
is anticipated that the size and length of the awards will also vary.

For applications assigned to the NIOSH, NHLBI, NICHD, NIDA, NIMH, or NINR, 
specific application instructions have been modified to reflect “MODULAR 
GRANT” AND “JUST-IN-TIME” streamlining efforts being examined by the NIH. 
Complete and detailed instructions and information on Modular Grant 
applications can be found at 
http://grants.nih.gov/grants/funding/modular/modular.htm

ELIGIBILITY REQUIREMENTS

ALL APPLICANTS ARE STRONGLY ENCOURAGED TO CONTACT THE APPROPRIATE AGENCY 
REPRESENTATIVES LISTED UNDER INQUIRIES TO VERIFY ELIGIBILITY, INQUIRE ABOUT 
FUNDING MECHANISMS OR OTHERWISE CLARIFY ANY PART OF THIS PROGRAM ANNOUNCEMENT 
AS IT PERTAINS TO THAT AGENCY.

A.  MCHB/HRSA

Applications submitted to the MCHB/HRSA 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.  Racial/ethnic minority individuals, women, and persons 
with disabilities are encouraged to apply as principal investigators.  

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.  Only these entities may apply to 
MCHB for grants, contracts or cooperative agreements.

B.  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.  Racial/ethnic 
minority individuals, women and persons with disabilities are encouraged to 
apply as principal investigators.

AHRQ also encourages new investigators (as defined in the PHS 398 application 
instructions) to apply as Principal Investigators.  Organizations described in 
Section 501(c)4 of the Internal Revenue Code that engage in lobbying are not 
eligible to receive grant or cooperative agreement awards.

B.  NIOSH/CDC, and NIH

For applications assigned to the NIOSH, NHLBI, NICHD, NIDA, 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.  Racial/ethnic minority individuals, women, and persons 
with disabilities are encouraged to apply as principal investigators. 

INQUIRIES

Copies of the PA are available from:

AHRQ Publications Clearinghouse
P.O. Box 8547
Silver Spring, MD 20907-8547
Telephone: 1 (800) 358-9295 
TDD Service: 1 (888) 586-6340

The PA is also available on the AHRQ website at:  http://www.ahrq.gov/fund/ as 
well as on the NIH Guide website at:  
http://grants.nih.gov/grants/guide/index.html, and through the AHRQ InstantFAX 
at (301) 594-2800.  To use InstantFAX, you must call from a facsimile (FAX) 
machine with a telephone handset.  Follow the voice prompt to obtain a copy of 
the table of contents, which has the document order number (not the same as the 
RFA number).  The PA will be sent at the end of the ordering process.  AHRQ 
InstantFAX operates 24 hours a day, 7 days a week.  For comments or problems 
concerning AHRQ InstantFax, please call (301) 594-6344.

Inquiries regarding agency- or institute-specific scientific (including 
eligibility), fiscal, or grants management issues should be directed to the 
individuals listed on the following website:  
http://www.nimh.nih.gov/grants/emschildcontacts.cfm Inquiries regarding 
agency- or institute-specific scientific (including eligibility), fiscal, or 
grants management issues should be directed to the individuals listed on the 
following website:  
http://www.nimh.nih.gov/grants/index.cfm

APPLICATION PROCEDURES

Applications are to be submitted on the research grant application form PHS 
398 (rev. 4/98) and will be accepted at the standard application deadlines as 
indicated in the application kit.  Application kits are available at most 
institutional offices of sponsored research and may be obtained from the 
Division of Extramural Outreach and Information Resources, National Institutes 
of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 
301/435-0714, email: GrantsInfo@nih.gov.

The title and number of this Program Announcement must be typed on line 2 of 
the face page of the application form and the YES box must be marked.

A.  MCHB/HRSA

Further guidance on HRSA application procedures may be obtained at 
http://www.mchb.hrsa.gov/html/grantguidances.html#forms or Grants Management 
Officer, MCHB, HRSA Grants Application Center, 1815 N. Fort Myers Drive, Suite 
300, Arlington, VA  22209, Telephone: 1 (877) 477-2123, Email: 
hrsagac@hrsa.gov.

For a HRSA application, mail the application per MCHB guidance directions to:

GRANTS MANAGEMENT OFFICER, MCHB
HRSA GRANTS APPLICATION CENTER
1815 N. FORT MYERS DRIVE
SUITE 300
ARLINGTON, VA  22209 

B.  AHRQ

For AHRQ, State and local government applicants may use PHS 5161-1, 
Application for Federal Assistance (rev. 5/96), and follow those requirements 
for copy submission.  These AHRQ applicants can find copies of the PA and 
application kits from AHRQ Publications Clearinghouse, P.O. Box 8547, Silver 
Spring, MD 20907-8547, Telephone: 1 (800) 358-9295, TDD Service: 1 (888) 586-
6340.

AHRQ is not using the Modular Grant Application and Award process.  Applicants 
for funding from AHRQ should prepare applications according to instructions 
provided in form PHS 398 (rev. 4/98).

Questions regarding HCFA data for AHRQ applications should be directed to the 
program official listed under INQUIRIES.

For an AHRQ application, 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
BETHESDA, MD 20817 (for express/courier service)

C.  CDC and NIH

Applications submitted to NIOSH, NHLBI, NICHD, NIDA, NIMH, and NINR will use 
the "modular grant" and "just-in-time" concepts.  The following modifications 
to the standard instructions must be used in preparing applications in 
response to this PA.

Applicants planning to submit a grant application requesting $500,000 or more
in direct costs for any year are required to discuss their eligibility with 
the program staff contact listed at the end of this program announcement 
before submitting the application.  Furthermore, the applicant must obtain 
agreement from program staff that the agency/institute will accept the 
application for consideration of award.  Finally, the applicant must identify, 
in a cover letter sent with the application, the program staff member who 
agreed to accept assignment of the application.  This policy requires an 
applicant to obtain agreement for acceptance of both any such application and 
any subsequent amendment.  Refer to the NIH Guide for Grants and Contracts, 
March 20, 1998, which is available at
http://grants.nih.gov/grants/guide/notice-files/not98-030.html 

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets.  Only 
limited budgetary information is required under this approach.  The just-in-
time concept allows applicants to submit certain information only when there 
is a possibility for an award.  It is anticipated that these changes will 
reduce the administrative burden for the applicants, reviewers and Institute 
staff.  The research grant application form PHS 398 (rev. 4/98) is to be used 
in applying for these grants, with the modifications noted below.

BUDGET INSTRUCTIONS

Modular Grant applications will request direct costs in $25,000 modules, up to 
a total direct cost request of $250,000 per year.  (Applications that request 
more than $250,000 Direct Costs in any year must follow the traditional PHS 
398 application instructions.)  The Total Direct Costs must be requested in 
accordance with the program guidelines and the modifications made to the 
standard PHS 398 application instructions described below:

PHS 398

o  FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in 
$25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total 
Direct plus Facilities and Administrative (F&A) costs] for the initial budget 
period Items 8a and 8b should be completed indicating the Direct and Total 
Costs for the entire proposed period of support.

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 
of the PHS 398.  It is not required and will not be accepted with the 
application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the 
categorical budget table on Form Page 5 of the PHS 398.  It is not required 
and will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative 
page. (See  http://grants.nih.gov/grants/funding/modular/modular.htm for 
sample pages.)  At the top of the page, enter the total direct costs requested 
for each year.  This is not a Form page.

o  Under Personnel, list all project personnel, including their names, percent 
of effort, and roles on the project.  No individual salary information should 
be provided.  However, the applicant should use the NIH appropriation 
language, salary cap and the NIH policy for graduate student compensation in 
developing the budget request.

For Consortium/Contractual costs, provide an estimate of total costs (direct 
plus facilities and administrative) for each year, each rounded to the nearest 
$1,000.  List the individuals/organizations with whom consortium or 
contractual arrangements have been made, the percent effort of key personnel, 
and the role on the project.  Indicate whether the collaborating institution 
is foreign or domestic.  The total cost for a consortium/contractual 
arrangement is included in the overall requested modular direct cost amount.  
Include the Letter of Intent to establish a consortium.

Provide an additional narrative budget justification for any variation in the 
number of modules requested.

o  BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by  
reviewers in the assessment of each individual's qualifications for a specific 
role in the proposed project, as well as to evaluate the overall 
qualifications of the research team.  A biographical sketch is required for 
all key personnel, following the instructions below. No more than three pages 
may be used for each person.  A sample biographical sketch may be viewed at:  
http://grants.nih.gov/grants/funding/modular/modular.htm
- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research projects ongoing or completed during the last three years.
- List selected peer-reviewed publications, with full citations;

o  CHECKLIST - This page should be completed and submitted with the 
application.  If the F&A rate agreement has been established, indicate the 
type of agreement and the date.  All appropriate exclusions must be applied  
in the calculation of the F&A costs for the initial budget period and all 
future budget years.

o  The applicant should provide the name and phone number of the individual to 
contact concerning fiscal and administrative issues if additional information 
is necessary following the initial review. 

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
BETHESDA, MD 20817 (for express/courier service)

REVIEW CONSIDERATIONS 

Applications will be assigned prior to review on the basis of established PHS 
referral guidelines.  Applications will be evaluated for scientific and 
technical merit by an appropriate scientific review group convened by NIH or 
the appropriate institute or agency in accordance with standard PHS peer 
review procedures.  As part of the initial merit review, all applications will 
receive a written critique and undergo a process in which only those 
applications deemed to have the highest scientific merit, generally the top 
half of applications under review, will be discussed and assigned a priority 
score.  NIH and CDC applications will receive a second level review by the 
appropriate national advisory council, secondary review committee or board.

Review Criteria

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  The 
reviewers will comment on the following aspects of the application in their 
written critiques 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 by the reviewers in assigning the 
overall score weighting them as appropriate for each application.  Note that 
the application does not need to be strong in all categories to be judged 
likely to have a 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 be advanced?  
What will be the effect of these studies on the concepts and methods that 
drive the field? 

(2) Approach: Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics? Are measures used that are appropriate to the phenomenon 
under investigation?  If reliability and validity characteristics are not yet 
known for a particular assessment procedure, does the application contain 
specific plans for establishing these features?  If an analysis of secondary 
data is proposed, how are concepts operationalized, and how are limitations of 
the data addressed?

(3) Innovation: Does the project employ novel concepts, approaches, or 
methods?  Are the aims original and innovative?  Does the project challenge 
existing paradigms or develop new methodologies or technologies? 

(4) Investigator: Is the investigator 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 and/or staff members?

(5) Environment: Does the scientific environment in which the work will be 
done contribute to the probability of success?  How adequate are the 
facilities and resources available to the applicant to perform the project?  
Do the proposed experiments take advantage of unique features of the 
scientific environment or employ useful collaborative arrangements?  Is there 
evidence of institutional support, including documentation of cooperation from 
project collaborators, where applicable?

In addition to the above criteria, all applications will also be reviewed with 
respect to the following:

o  The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research. Plans for the recruitment and retention of subjects will also be 
evaluated.  (For example, do plans for implementing interventions or programs 
(if any) include procedures for: establishing and maintaining the necessary 
community relations, training and supervising staff, insuring implementation 
fidelity, securing ongoing access to the subject population pool, recruiting a 
representative sample of the target population, recruiting minorities for the 
staff of the research intervention, and monitoring subject participation over 
time?)

o  The reasonableness of the proposed budget and duration in relation to the 
proposed research.

o  The adequacy of the proposed protection for humans, animals, or the 
environment, to the extent they may be adversely affected by the project 
proposed in the application.  (For example, what provisions have been made for 
the protection of experimental subjects and the safety of the research 
environments?  How does the applicant plan to handle issues of confidentiality 
and compliance with mandated reporting requirements?)

AWARD CRITERIA

Applications will compete for available funds with all other recommended 
applications.  The following will be considered in making funding decisions: 
Quality of the proposed project as determined by peer review, availability of 
funds, and program priority.

For AHRQ, to receive an award, applicants must agree to submit an original and 
2 copies of an abstract, executive summary, and full report of the research 
results in the format prescribed by AHRQ no later than 90 days after the end 
of the project period. The executive summary should be sent at the same time 
on a computer disk which specifies on the label the format used (WP5.1 or 
WP6.0 are preferable).

In the case of AHRQ and MCHB/HRSA awards, applicants must agree to notify the 
funding agency immediately when a manuscript based on research supported by 
the grant is accepted for publication, and to provide the expected date of 
publication as soon as it is known.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

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 biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are 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 research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.  The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to 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) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.  To the 
extent possible, AHRQ requires adherence to these NIH Guidelines.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

AHRQ and NIOSH encourage investigators to consider including children in study 
populations, as appropriate.  It is the policy of NIH that children (i.e., 
individuals under the age of 21) must be included in all human subjects 
research, conducted or supported by the NIH, unless there are scientific and 
ethical reasons not to include them. This policy applies to all initial (Type 
1) applications submitted for receipt dates after October 1, 1998.  

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" that was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address:  http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES. Program staff may also provide additional relevant 
information concerning the policy.

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.  Reviewers are cautioned 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, Research on Emergency Medical 
Services for Children, is related to several 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 Nos. 
93.110RS (MCHB), 93.226 (AHRQ), 93.262 (NIOSH), 93.838 (NHLBI), 93.865 and 
93.929 (NICHD), 93.278 (NIDA), 93.242 (NIMH), and 93.361 (NINR).

AHRQ
Awards are made under authorization of Title IX of the Public Health Service 
Act, amended (42 USC 299-299c-7 as amended by P.L. 106-129 (1999).  Awards are 
administered under the PHS Grants Policy Statement and Federal Regulations 42 
CFR 67, Subpart A, and 45 CFR Parts 74 and 92.  This program is not subject to 
the intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.

NIOSH/CDC
This program is authorized under the Public Health Service Act, as amended, 
Section 301(a) [42 U.S.C. 241(a)], and the Occupational Safety and Health Act 
of 1970, Section 20(a) [29 U.S.C. 669(a)].  The applicable program regulation 
is 42 CFR Part 52.  

MCHB/HRSA
Authorization:  Title V of the Social Security Act, 42 U.S.C. 701.  
Eligibility:  42 CFR Part 51a.3

NIH
Awards are made under authorization of the Public Health Service Act, Title 
IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 
285) and administered under NIH grants policies and Federal Regulations 42 CFR 
52 and 45 CFR Parts 74 and 92.  This program is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.

LOBBYING RESTRICTIONS

Applicants should be aware of restrictions on the use of HHS funds for 
lobbying of Federal or State legislative bodies.  Under the provisions of 31 
U.S.C. Section 1352, recipients (and their sub-tier contractors) are 
prohibited from using appropriated Federal funds (other than profits from a 
Federal contract) for lobbying congress or any Federal agency in connection 
with the award of a particular contract, grant, cooperative agreement, or 
loan.  This includes grants/cooperative agreements that, in whole or in part, 
involve conferences for which Federal funds cannot be used directly or 
indirectly to encourage participants to lobby or to instruct participants on 
how to lobby.

In addition, no part of CDC appropriated funds shall be used, other than for 
normal and recognized executive-legislative relationships, for publicity or 
propaganda purposes, for the preparation, distribution, or use of any kit, 
pamphlet, booklet, publication, radio, television, or video presentation 
designed to support or defeat legislation pending before the Congress or any 
State or local legislature, except in presentation to the Congress or any 
State or local legislature itself.  No part of the appropriated funds shall be 
used to pay the salary or expenses of any grant or contract recipient, or 
agent acting for such recipient, related to any activity designed to influence 
legislation or appropriations pending before the Congress or any State or 
local legislature.

SMOKE-FREE WORKPLACE

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the non-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, and 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.