PRENATAL ALCOHOL EXPOSURE AMONG HIGH-RISK POPULATIONS: RELATIONSHIP TO SUDDEN 
INFANT DEATH SYNDROME

RELEASE DATE:  November 18, 2002  
 
RFA:  HD-03-004
 
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)
 
LETTER OF INTENT RECEIPT DATE:  February 17,2003 

APPLICATION RECEIPT DATE:  March 17,2003 

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

The National Institute of Child Health and Human Development (NICHD) and the 
National Institute on Alcohol Abuse and Alcoholism (NIAAA) invite cooperative 
agreement applications for the development of community-linked studies to 
investigate the role of prenatal alcohol exposure in the risk for sudden 
infant death syndrome (SIDS) and adverse pregnancy outcomes such as 
stillbirth and fetal alcohol syndrome (FAS), and how they may be inter-
related.  The investigators will work collaboratively under cooperative 
agreements with NICHD and NIAAA over a three-year period to plan and pilot 
multidisciplinary investigations using common protocols, within communities 
at high risk for prenatal maternal alcohol consumption.  The long-term goals 
of this initiative are to decrease fetal and infant mortality and improve 
child health in these communities.  

RESEARCH OBJECTIVES

Background, Nature, and Scope of the Research Problem
 
Sudden infant death syndrome (SIDS) and adverse alcohol-related birth 
outcomes such as fetal alcohol syndrome (FAS) affect all human cultures and 
ethnic groups.  Rates for SIDS and FAS vary across populations and each is 
influenced by unique factors.  Epidemiological evidence increasingly 
suggests, however, that elevated rates of SIDS and FAS may co-occur among 
populations in which excessive alcohol consumption by pregnant women is 
common.  Studies in some American Indian communities provide an example of 
the co-risk for FAS and SIDS.

Epidemiological data indicate that in the U.S., the rates for FAS appear to 
be the highest for American Indian and Alaskan Native populations.  Excessive 
alcohol consumption, typically associated with alcohol dependence 
(alcoholism), is an essential factor in the development of FAS.  It is 
important to note that the rates of abstention from alcohol use by American 
Indian communities are greater than for the general U.S. population, for both 
men and women.  However, American Indian women who do consume alcohol tend to 
be young, of child-bearing age, and to drink in a heavy episodic manner 
(binge drinking pattern) that would result in high blood alcohol levels, a 
risk factor for FAS and for other alcohol-related fetal effects.  For 
example, in some Northern Plains communities researchers have found that 60 
percent of pregnant women use or abuse alcohol, with binge drinking being the 
most common pattern.  Similarly, a recent survey of an American Indian 
community found that slightly more than half of all women between the ages of 
16 and 34 were current drinkers with binge drinking or intermittent heavy 
drinking as the typical consumption pattern.

As a consequence, despite high abstention rates by the population in general, 
the prevalence of FAS in the U.S. Plains and Plateau American Indian cultures 
is nine per 1,000 among children ages one through four.  This is well above 
the apparent North American FAS prevalence of two to three cases per 1,000 
children.  It is also important to note that the true magnitude of alcohol-
derived problems in the fetus is likely greater than these numbers as the 
reported FAS prevalence does not include early or late fetal loss, or other 
expressions of fetal alcohol syndrome spectrum disorder such as other 
alcohol-related birth defects (ARBD) or alcohol-related neurodevelopmental 
disorders (ARND). 

While the rate of SIDS has declined nationally, the disparity in SIDS rates 
among racial/ethnic groups is growing.  According to 1999 period linked 
files, the rate of SIDS was 1.3/1000 live births among blacks, 0.56/1000 
among whites, 0.37/1000 among Hispanics, and 0.31/1000 among Asian/Pacific 
Islanders.  Among American Indians and Alaskan Natives, SIDS is the leading 
cause of overall infant mortality, with a rate of 1.47/1000 live births, 
which is almost three times that of whites.  While some of the disparity may 
be due differences in the sleep environment of the infants and the adoption 
of the back sleep position to reduce SIDS risk, recent studies indicate that 
other risk factors may be contributing significantly to the disparity.  These 
risk factors include maternal cigarette smoking, and alcohol abuse, which 
might adversely affect the maturing fetus directly or through nutritional, 
inflammatory, and other chemical mediators.  

With respect to SIDS, the Aberdeen Area Infant Mortality Study, conducted 
recently among Northern Plains cultures by NICHD, IHS, CDC, and the Aberdeen 
Area Tribal Chairman's Health Board, found a six-fold increased risk for SIDS 
among children born to mothers who binged during the periconceptional period 
or the first trimester of pregnancy.  Neurochemical analyses of brainstems of 
SIDS victims revealed deficits in serotinergic receptors in the arcuate 
nucleus –- findings similar to those seen in SIDS victims from other 
communities and racial and ethnic groups. 

Such studies suggest that harmful drinking patterns, and the risks to the 
developing fetus, are greatest during the early first trimester, or 
periconceptional period, a time when many women may not know that they are 
pregnant.  Therefore, if these findings can be confirmed and generalized to 
the general population, they would have broad epidemiologic implications.
  
The purpose of this solicitation is to support collaborative, 
multidisciplinary investigations using protocols with shared elements, within 
populations in which there is a high risk for alcohol use and abuse by women 
during pregnancy.  The solicitation is intended to blend the expertise of 
investigators working on FAS, SIDS, and adverse pregnancy outcomes with 
active participation from members of the affected communities.  The RFA 
solicits research proposals that explore the role of prenatal alcohol 
exposure in the risk for SIDS and adverse pregnancy outcomes, such as 
stillbirth and FAS, and study how they may be inter-related.  The RFA 
specifically requests the use of methodologies in epidemiology, physiology, 
pathology, and the neurosciences to decipher the complex relationship between 
alcohol use and abuse during pregnancy, and their effect on the fetus at 
large.

Scientific Knowledge to be Achieved through Research Supported by the RFA 

Because little is known about the complex interactions between prenatal 
alcohol exposure, other adverse health behaviors and social environment and 
their effects on fetal development in relation to poor pregnancy outcome and 
SIDS, research supported through this RFA may shed light on this important 
area of developmental biology.  The RFA-funded studies may also uncover how 
and why alcohol adversely affects the fetus during the critical phases of 
organogenesis, how it affects maternal health during pregnancy and lactation, 
and how it might adversely influence the long-term neurodevelopmental outcome 
of the infant.  The knowledge obtained may help public health programs to 
implement preventive strategies for SIDS and alcohol-related fetal disorders. 
 
Objectives of this Research Program

This research program is designed to:

o  Investigate the association of alcohol consumption in pregnancy and after 
delivery in fetal death and SIDS. 

o  Explore the biochemical, physiological, and neurodevelopmental mechanisms 
associated with alcohol-related adverse pregnancy outcome in the subject 
population.

o  Discover social and behavioral variables affecting alcohol use and abuse 
by women during pregnancy and lactation, especially in certain ethnic 
segments of our population, and show how such information may lead to 
implementing remedial programs. 

The following Specific Objectives for Phase I are listed below:

o  Establish functional community partnerships to conduct research on 
prenatal alcohol consumption and poor pregnancy outcomes and SIDS.  These 
links would form the basis for clinical and epidemiological studies to 
address the main objectives of the RFA.  These links also should be able to 
develop epidemiological and clinical protocols exploring social factors and 
family dynamics responsible for alcohol use and abuse during pregnancy and 
lactation, and other related issues; 

o  Formalize the collaborative structure and operations between and among the 
investigative teams (see below);

o  Develop a set of testable hypotheses; 

o  Develop core study protocol supplemented by site specific research;

o  Develop plans for data acquisition and analysis; 

o  Pilot core protocol;

o  Produce a report summarizing the achievements and analyzing pilot data and 
protocol testing results toward these objectives, and an assessment of the 
feasibility of proceeding to Phase II, which will be study implementation and 
analysis. 

Research Approaches and Project Organization

To facilitate the participation of groups with highest expertise in each of 
the various components of the larger research objectives, this RFA has been 
designed to include three component types, which will work collaboratively as 
a team.  Potential applicants may apply to be a Comprehensive Clinical Site 
(CCS), or a Developmental Biology and Pathology Center (DBPC), or the Data 
Coordinating Analysis Center (DCAC).  Applicants must meet the Special 
Requirements noted for each of the individual components (see below). 

The three components of the collaborative structure are as follows:

o  Comprehensive Clinical Sites (CCS) 
 
The applicant organization for the CCS should be able to conduct clinical, 
epidemiological, and physiological studies that address the association 
between alcohol consumption and risk for stillbirth and SIDS.  Based on their 
links to high-risk communities, the CCS should be able to design and 
implement a broad range of clinical, biological, and epidemiological studies. 
These studies should address clinical epidemiology of alcohol abuse and its 
relation to stillbirth and SIDS, and study the social, demographic, and 
family support structures and their relationship to alcohol abuse during 
pregnancy and lactation.  To accomplish these goals, women prior to or during 
the early periods of pregnancy may have to be enrolled, and studied through 
pregnancy and early childrearing periods.  The sites should also be able to 
address related biological measures of alcohol effects on the mother, the 
fetus, and the infant in order to understand the mechanisms and identify 
pregnancies and infants at risk.  Because the objective is to be able to 
study the largest possible segment of at-risk populations, the applicant 
organization should have either an existing collaborative arrangement or 
should be able to develop such partnerships within a reasonable timeframe, 
with the communities in which the studies will take place.  It is possible 
for an applicant organization to link with more than one community. It is the 
intention to have more than one CCS. 
 
o  Developmental Biology and Pathology Center (DBPC)   
 
The DBPC should be able to conduct basic and applied research related to 
molecular and biological aspects of alcohol-related injury to the brain and 
other vital organs, including the placenta in the subject population.  The 
applicant organization should be able to perform diagnostic procedures, 
design studies on neurobiology of alcohol injury, and study the pathological 
processes operating such injuries.  Studies may include the adverse 
influences on the developing brain, as well as alcohol-nutrition-and fetal 
growth interactions.  
 
One of main functions of the DBPC is to conduct biochemical and 
neuropathology studies utilizing the biological materials from the study 
subjects enrolled at the CCS.  The materials may include fluid samples from 
the mother, the placenta, fetal tissues, and in the case of SIDS victims, 
pathological materials from the Medical Examiners'(ME) offices obtained at 
autopsy.  It is possible that some of the expertise for these studies will 
also be available at the CCS, so it is expected that there will be scientific 
as well as operational collaboration between the DBPC and the CCS.  To enable 
accomplishing the broad range of comprehensive research goals related to 
developmental biology and neurobiology issues, up to two awards may be made 
for a DBPC.    

o  Data Coordinating and Analysis Center (DCAC)  
 
The DCAC applicant will collaborate with all component groups in developing 
policies for data collection, developing data collection tools and data 
management procedures, and guidelines for interim analyses.  The DCAC will 
also conduct data analyses, share them with the investigators, and integrate 
them with the overall research teams.  There will be a single DCAC award.

Phase I to Phase II Transition
 
During Phase I, all awardees representing the three components will work 
together to develop a comprehensive set of proposals for pilot testing.  It 
is anticipated that Year 01 will be devoted to protocol development and Years 
02-03 to piloting the protocol and data analysis.  Only those applicants who 
are successful in receiving Phase I support will be eligible to compete for 
participation in Phase II.
  
A Steering Committee will be assembled from among Phase I awardees.  In the 
planning phase, the Steering Committee will provide a forum to share program 
activities and potential directions for Phase II.  The Committee will consist 
of the Principal Investigators and Co-Principal Investigators of all awarded 
grants, and NIH staff.  Each awardee, NICHD, and NIAAA, will have one vote on 
the Steering Committee.  The Steering Committee will be charged with the task 
of combining multiple perspectives and research agendas across sites into a 
coherent plan of action.  Applicants should request funds to attend four 
meetings in the Washington D.C. Area for the purpose of protocol development 
and information sharing in the first year. 

MECHANISM OF SUPPORT
 
This RFA will use the National Institutes of Health (NIH) Cooperative 
Research Project Grant (U01) award mechanism.  As an applicant you will be 
solely responsible for planning, directing, and executing the proposed 
project.  This RFA is a one-time solicitation.  NICHD and NIAAA may create a 
future opportunity (Phase II) to implement the plan of action created by the 
collaboration established by this RFA.  The anticipated award date is 
September 2003.  

The NIH U01 is a cooperative agreement award mechanism in which the Principal 
Investigator retains the primary responsibility and dominant role for 
planning, directing, and executing the proposed project, with NIH staff being 
substantially involved as a partner with the Principal Investigator, as 
described under the section "Cooperative Agreement Terms and Conditions of 
Award."     

Only applicants who are successful in receiving Phase I support will be 
eligible for participation in the Phase II competition.
 
FUNDS AVAILABLE 
 
NICHD intends to commit approximately $800,000 in total costs and NIAAA 
intends to commit $800,000 in total costs [Direct plus Facilities and 
Administrative (F & A) costs] in FY 2003 to fund five to eight awards in 
response to this RFA:  most of these would be for Comprehensive Clinical 
Sites applications, up to two for the Developmental Biology and Pathology 
Center, and one for the Data Analysis and Coordinating Center.  Applicants 
should request a project period of three years.  An applicant for a clinical 
site may request a base budget (see Budget Preparation, below) of $125,000 
direct costs for the first year.  An applicant for a DBPC may request a base 
budget (see Budget Preparation, below) of up to $125,000 direct costs for the 
first year of the project.  An applicant for the DCAC may request a budget 
(see Budget Preparation, below) of up to $200,000 direct costs for the first 
year of the project.  Because the nature and scope of the proposed research 
will vary from application to application, it is anticipated that the size of 
each award will also vary.  Although the financial plans of the NICHD and 
NIAAA provide support for this program, awards pursuant to this RFA are 
contingent upon the availability of funds and the receipt of a sufficient 
number of meritorious applications.  

ELIGIBLE INSTITUTIONS
 
You may submit an application if your institution has any of the following 
characteristics:

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments 
o Eligible agencies of the Federal government  
o Domestic or foreign
o Faith-based or community-based organizations 

Institutions applying to be a Comprehensive Clinical Site are not barred from 
applying to be the Data Coordinating and Analysis Center or a Developmental 
Biology and Pathology Center provided that independence of functions is 
demonstrated.  Therefore, a separate application is required for the 
Comprehensive Clinical Site, the Data Coordinating and Analysis Center and 
Developmental biology and Pathology Center.  An institution may apply to be 
the Data Coordinating and Analysis Center or a Developmental Biology and 
Pathology Center only.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

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.   

SPECIAL REQUIREMENTS

Minimum Applicant Requirements 

(1) For Comprehensive Clinical Site Applicants: 

o  A documented link between the community(s) with a high risk for alcohol 
use and abuse by women during pregnancy, and the applicant organization.  

o  Documentation of a high prevalence of alcohol-related fetal effects and/or 
risk drinking for adverse pregnancy outcomes (see Fetal Alcohol Syndrome: 
Diagnosis, Epidemiology, Prevention, and Treatment, Institute of Medicine, 
National Academy Press, 1996) within the community (communities, if a 
consortium).

o  A demonstrated willingness to work with the community leaders to allow 
clinical studies to be performed and ensure that human subject protection 
issues are addressed. 

o  Clinical site applicants may be a consortium of sites.

o  Clinical sites should have a catchment of at least 2,000 births among the 
index communities per year, with more being preferred.  The applicant must 
demonstrate that a large majority of the population receives prenatal care 
within the catchment population.

o  Clinical Sites should have experience in multi-center research 
investigations.

o  Clinical sites should have relevant experience in the screening and 
identification of at-risk maternal drinking.
 
o  The following expertise should be part of the research team:  obstetrics, 
pediatrics, and epidemiology.  There should also be a dedicated research 
nurse/community outreach worker.

o  Clinical sites should have the abilities to conduct epidemiological and 
physiological studies relevant to the main research questions. 

o  The site should have a relationship with the Medical Examiner/coroner 
system that serves the patient community.

o  The site should have experience in community outreach to pregnant women 
and in working with community clinics, hospitals, and other organizations 
that provide support to pregnant women.

o  The investigators should be prepared to meet as a Steering Committee about 
four times in the first year to develop protocols and three times per year 
thereafter.

o  The investigators should be prepared to work collaboratively with the 
NICHD, NIAAA, and the Data Coordinating and Analysis Center to achieve the 
goals of this solicitation.

o  Departmental and institutional commitments to collaborative research 
should be clearly documented by providing letters to the Principal 
Investigator that should accompany the application.

o  The applicant must exhibit a preparedness to pursue capitation of 
particular operational costs of the protocol (see Budget Preparation). 

(2) For Developmental Biology and Pathology Center Applicants:

o  Expertise in pediatric neuropathology and in the evaluation of the 
architecture of the developing brain and its abnormalities including, but not 
limited to, studies related to neurotransmitters and analyses of molecular, 
cellular, and structural deficits.  

o  Expertise in perinatal and pediatric pathology.  This expertise would 
enhance the work related to autopsy studies on SIDS victims, stillbirths, 
placenta, and other organs. 

o  Demonstrated prior experience in conducting experimental and clinical 
research. 

o  The investigators should be prepared to meet as a Steering Committee about 
four times in the first year to develop protocols and three times per year 
thereafter.

o  The investigators should be prepared to work collaboratively with the 
NICHD, NIAAA, and the Data Coordinating and Analysis Center to achieve the 
goals of this solicitation.

o  Departmental and institutional commitments to collaborative research 
should be clearly documented by providing letters to the Principal 
Investigator that should accompany the application.

o  The applicant must exhibit a preparedness to pursue capitation of 
particular operational costs of the protocol (see Budget Preparation).

(3) For Data Coordinating and Analysis Center Applicants: 

o  The applicant must have demonstrated prior experience as a coordinating 
and statistical center in multi-center clinical and epidemiological studies. 

o  The Principal Investigator, with other staff, must have appropriate 
biostatistical, data collection, data management, and coordination expertise 
and capability.  The applicant must have the ability to assist in designing 
protocols, study manuals, and data collection systems. 

o  The applicant must have experience in developing and maintaining a quality 
control system, and should demonstrate experience in monitoring quality 
assurance of data.

o  The applicant must have experience in data monitoring, patient tracking 
systems, and coordination. 

o  The Data Coordinating and Analysis Center will report quarterly to the 
NIAAA, NICHD, and to the Steering Committee prior to/at each meeting 
regarding accumulated data and clinical unit performance.  The applicant 
should document the ability to meet such reporting deadlines. 

o  The investigators should be prepared to meet as a Steering Committee about 
four times in the first year to develop protocols and three times per year 
thereafter.

o  The applicant must be prepared to assist the NICHD in securing services of 
research sub-specialties to supplement the expertise of members of the 
Steering Committee.

o  The applicant must be prepared to cooperate with the other awardees, 
NIAAA, and NICHD in all design, collection, and analysis functions.

Data Collection and Sharing

It is anticipated that one site will serve as a Data Coordinating and 
Analysis Center for the entire team of researchers in this program through 
both Phase I and II.  The awardees will develop plans for the activities of 
the DCAC and address issues related to human subject protection including 
confidentiality and community needs, and data sharing with investigators 
outside of the awardees.  There will be central data collection, management, 
and analysis for this study.  

The Data Coordinating and Analysis Center, in collaboration with the Steering 
Committee, will develop and implement plans to create a database that is 
accessible to the public within a year of study completion. 

Because the data elements and study design will be developed after award, the 
data-sharing plan will not be reviewed at the time of application.  It will 
be reviewed after award by the Steering Committee, NIAAA, and NICHD, and in 
the peer review of Phase II applications.

Cooperative Agreement Terms and Conditions of Award 

Cooperative agreements are assistance mechanisms and are subject to the same 
administrative requirements as grants.  The special Terms and Conditions of 
Award are in addition to, not in lieu of, otherwise applicable OMB 
administrative guidelines, HHS, PHS, and NIH grant regulations, policies, and 
procedures, with particular emphasis on HHS regulations at 42 CFR Part 74 and 
92.  Facilities and Administrative cost (indirect cost) award procedures will 
apply to cooperative agreement awards in the same manner as for grants. 
Business management aspects of these awards will be administered by the NIAAA 
and NICHD Grants Management Branch in accordance with HHS, PHS, and NIH grant 
administration requirements. 

The cooperative agreement funding mechanism will require collaboration among 
the NIAAA and NICHD Project Scientists and the Principal Investigators.  The 
NIAAA and NICHD Project Scientists will coordinate the activities of the 
awardees, and will facilitate communication and the exchange of information 
as specified below.

1.  The Primary Rights and Responsibilities of the Awardees

All awardees will agree to accept the participatory and cooperative nature of 
the group process.  All awardees are required to submit annual progress 
reports to NIAAA and NICHD, as appropriate, and to provide study and site 
performance information as stipulated by NIAAA and NICHD.

The Principal Investigator of each CCS will play an important role in the 
design of the Phase I plan of action.  Each Principal Investigator will have 
primary responsibility for work that establishes a community link at their 
site and to gather preliminary information necessary to prepare their site 
for Phase II studies.  The awardees will retain custody of, and primary 
rights to their data developed under this award, subject to Government rights 
of access, consistent with current HHS, PHS, and NIH policies.  

Each investigator will have the right to publish based on the work of their 
individual research programs, according to the publication policies developed 
by the Steering Committee.  

All awardees will:

o  Work cooperatively with other CCS, DBPC, and DCAC awardees to develop 
hypotheses and study protocols.

o  Carry out pilot studies developed by the Steering Committee. 
 
o  Present research concepts, plans, progress, and results to the Steering 
Committee.

o  Publish and disseminate results of both independent and shared research. 
When joint protocols are completed, publish in collaboration with other 
involved sites.

o  Collaborate with other awardees and the NIH.

o  Obtain local institutional review board (IRB) approval of all study 
protocols implemented at U.S. or foreign sites and comply with both IRB and  
Steering Committee policies and procedures.

o  Attend and participate in all Steering Committee meetings.  

In addition, the Comprehensive Clinical Sites specifically will:

o  Develop active community links at their site to sustain the development 
and conduct of study protocols in Phase I and Phase II.

In addition, the Development Biology and Pathology Center specifically will:

o  Be responsible for the storage and cataloguing of biologic materials from 
the enrolled subjects;

o  Be responsible for conducting standardized diagnostic and research 
procedures on biologic materials form the enrolled subjects;

In addition, the Data Coordinating Analysis Center specifically will:

o  Be responsible for central data collection, quality control, management, 
and analysis;

o  Be responsible for contracting with consultants to the Steering Committee 
on an as needed basis.
  
2.  NIAAA and NICHD Responsibilities

NIAAA and NICHD Project Scientists

The NIH Project Scientists will be staff from the Pregnancy and Perinatology 
Branch, NICHD, and the NIAAA, who will have substantial involvement above and 
beyond the normal program stewardship of the award.  The Project Scientist is 
a partner within the  research team representing the government's interest in 
the substantive work of the research team.  The primary role of the Project 
Scientists is to facilitate the work of the awardees and the Steering 
Committee.  

He/she will: 

o  Assist in all functions of the Steering Committee, including:  reviewing 
and commenting on each stage of the program before subsequent stages are  
started; recommending the options of adding, modifying or terminating aspects 
of the program.

o  Recommend consultants for appointment to the Steering Committee on an as 
needed basis.

o  Assist with accomplishing the objectives of Phase I.

o  Assist in the analysis, interpretation, and reporting of findings in the 
scientific literature and other media to the community at large and the 
public policy community within the Federal government.

NIAAA and NICHD Project Officers

NIAAA and NICHD will appoint a Project Officer, apart from the Project 
Scientists, who will:

o  Have the option to withhold support to a participating institution if 
technical performance requirements, such as compliance with the protocol, are 
not met.

o  Carry out continuous review of all activities to ensure objectives are 
being met.

o  Exercise the normal stewardship responsibilities of an NIH Program 
Officer.

3.  Collaborative Responsibilities

Steering Committee

The overall guidance and management of the research team will be provided by 
a Steering Committee.

Steering Committee responsibilities will include planning and implementation 
of the cooperative aspects of the study.  The Steering Committee will consist 
of the Principal Investigator and Co-Principal Investigator from each 
participating awardee institution and the NIH Project Scientists.  Each 
awardee, NICHD, and NIAAA will each have one vote.  An outside chairperson, 
who is not participating as a Principal Investigator, will be selected by 
NICHD and NIAAA.

The Steering Committee will:  

o  Plan the design and implementation of the plan of action for Phase II.

o  Participate in decision-making regarding gathering preliminary information 
at the participating sites and operationalizing key constructs regarding the 
community and other environmental factors at participating sites.

o  Formulate publication policy and appoint a Publication Subcommittee, as 
judged necessary by the Steering Committee.  Publish results, conclusions, 
and interpretations of the cooperative planning activity.  Due publication 
credit will be given to all work done cooperatively.

o  Agree to accept the coordinating role of the committee and the cooperative 
nature of the group process.

Data Safety and Monitoring Committee 

A Data Safety and Monitoring Committee (DSMC) will be established by NIAAA 
and NICHD, and will advise the Steering Committee on research design issues, 
data quality and analysis, and ethical and human subject issues.  

4.  Arbitration Procedures

When agreement between an awardee and NIH staff cannot be reached on 
programmatic and scientific-technical issues that may arise after the award, 
an arbitration panel will be formed.  The panel will consist of one person 
selected by the Principal Investigators, one person selected by the NIAAA and 
NICHD staff, and a third person selected by these two members.  The decision 
of the arbitration panel, by majority vote, will be binding.  These special 
arbitration procedures in no way affect the awardees right to appeal an 
adverse action in accordance with PHS regulations at 42 CFR Part 50, Subpart 
D, and HHS regulations at 45 CFR Part 16. 

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA 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:

o Direct your questions about scientific/research issues to: 

Marian Willinger, Ph.D.
Pregnancy and Perinatology Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B03, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6896
FAX:  (301) 496-3790
Email:  mw75q@nih.gov

Or 

Tonse N.K. Raju, M.D.
Pregnancy and Perinatology Branch 
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B03D, MSC 7510
Bethesda, MD 20892-7510
Telephone:  (301) 402-1872
FAX:  (301) 496-3790 
Email:  rajut@mail.nih.gov 

Or

Deidra Roach, M.D.
Office of Collaborative Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 302, MSC 7003
Bethesda, MD   20892-7003
Telephone:  (301) 443-5820
FAX:  (301) 480-2358
Email:  droach@willco.niaaa.nih.gov

o Direct your questions about peer review issues to:

Eugene G. Hayunga, Ph.D.
Chief, Extramural Project Review Branch
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Room 409, MSC 7003
Bethesda MD 20892-7003
Telephone:  (301) 443-4375
FAX:  (301) 443-6077
Email:  hayungae@mail.nih.gov

o Direct your questions about financial or grants management matters to:

Chris Myers
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17K, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6996
FAX:  (301) 402-0915
Email:  myresc@mail.nih.gov

Judy Fox Simons
Chief, Grants Management Branch
Office of Planning and Resource Management
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 504, MSC 7003
Bethesda, MD 20892-7003
Telephone:  (301) 443-4704 
FAX:  (301) 443-3891 
Email:  jsimons@willco.niaaa.nih.gov

LETTER OF INTENT
 
Prospective applicants are asked to submit a letter of intent that includes 
the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

Although a letter of intent is not required, is not binding, and does not 
enter into the review of a subsequent application, the information that it 
contains allows NIAAA and NICHD staff to estimate the potential review 
workload and plan the review.
 
The letter of intent is to be sent by the date listed at the beginning of 
this document.  The letter of intent should be sent to:

Marian Willinger, Ph.D.
Pregnancy and Perinatology Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B03, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6896
FAX:  (301) 496-3790
E-mail:  mw75q@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

SUPPLEMENTAL INSTRUCTIONS: 

Comprehensive Clinical Sites

Please provide the following in your application:

(1) Patient population

o  Descriptions of catchment populations (size and demographic 
characteristics) to include the number of births per year overall and within 
racial/ethnic groups;

o  Documented fetal deaths (20 weeks or greater gestation)and infant 
mortality rates, SIDS rate overall and within racial/ethnic groups 1995-1999;

o  Documentation of rates of prenatal alcohol exposure in the catchment 
population;

(2) Staffing and procedures

o  Descriptions of the staff and programs in place for the recruitment and 
evaluation of families and infants at risk within the community, for 
counseling and support as might be clinically needed.

o  Demonstrated capacity to conduct obstetric, pediatric, and social and 
behavioral research; documentation of the formation of an interdisciplinary 
team combining appropriate biomedical, social, and behavioral expertise to 
include their expertise and strengths to achieve the objectives of the RFA.

o  A description of special areas of expertise among your applicant team that 
would benefit this multi-center cooperative study of the relationship between 
prenatal alcohol exposure and adverse pregnancy and infant outcomes.  Such 
strengths would represent state-of-the-art scientific capabilities that might 
be shared or made available to the Steering Committee, to expand the 
scientific productivity of the research beyond what it might be otherwise.  
Capabilities in areas such as genetics, comprehensive pediatric and 
developmental follow-up program, abilities to carry out advanced neuroimaging 
studies such as MRI, FMRI.

o  Evidence of a working relationship with the index community(s). 

(3) Sample Study

The Research Methods section of the application should include a description 
of one sample research study that will lead to assessment of relationship 
between alcohol consumption during pregnancy and rates of stillbirths and 
SIDS.  The sample research study will serve as a starting point for 
deliberations within the Steering Committee and will enable reviewers to 
evaluate the substantive approaches that the site is best equipped to 
perform.  Investigators will not be expected to perform these studies at 
their site during Phase I, nor is it likely that the study as submitted would 
be conducted.  The sample study should be designed based on a theoretical 
total catchment of the CCS of about 40,000 pregnancies and deliveries over 
four years of enrollment among 4-5 CCS, a SIDS rate of 1.5/1000 live births, 
and stillbirth rate of 5/1000 stillbirths plus live births.  The description 
should include specific aims and hypotheses regarding the role alcohol in 
adverse pregnancy and infant outcome and the study design to achieve these 
specific aims. It should not be a complete protocol and should not exceed 
seven pages.  

(4) Intent to Participate

o  There must be a clearly expressed intent to participate in a cooperative 
manner with the DBPC, DCAC, and the NIH in all aspects of collaborative 
research as outlined in this RFA.

Developmental Biology and Pathology Center

Please provide the following in your application:

(1) Research Experience

o  Description of previous research experience in areas related to objectives 
of this RFA to include developmental neuroscience, neuropathology, perinatal 
pathology, molecular and biochemical studies of alcohol effects in humans. 

o  Description of applicant's perception of their role in the study. 

(2) Sample Research Study

The Research Methods section of the application should include descriptions 
of one sample research study that will lead to an understanding of 
relationship between alcohol consumption during pregnancy and rates of still 
births and SIDS.  The sample research study will serve as a starting point 
for deliberations within the Steering Committee and will enable reviewers to 
evaluate the substantive approaches that the site is best equipped to 
perform.  Investigators will not be expected to perform these studies at 
their site during Phase I, nor is it likely that the study as submitted would 
be conducted.  The sample study should be designed based on a theoretical 
total catchment of the CCS of about 40,000 pregnancies and deliveries per 
year over four years of enrollment among 4-5 CCS, a SIDS rate of 1.5/1000 
live births, and stillbirth rate of 5/1000 stillbirths plus live births.  The 
description should include specific aims and hypotheses regarding the role 
alcohol in adverse pregnancy and infant outcome; elements of the system to 
obtain biological and autopsy specimens; and research and diagnostic 
approaches to meet the objectives of the specific aims. It should not be a 
complete protocol and should not exceed seven pages.  

(3) Intent to Participate

o  There must be a clearly expressed intent to participate in a cooperative 
manner with the CCS, the DCAC, and the NIH in all aspects of collaborative 
research as outlined in this RFA.

Data Coordinating and Analysis Center

Please provide the following in your application:

(1) Research Experience

o  Description of previous experience in managing multi-center clinical 
research studies. 

o  Description of applicant's perception of their role in the study. 

(2) Staffing and Procedures

o  Description of staff and computing, data processing, and analytic 
capability. 

o  A plan detailing methods of data receipt, quality control, analysis and 
reporting, including communication with clinical and administrative 
personnel.  This plan should be based on the assumption that there will be a 
patient tracking system, and a database that will include information from 
maternal interview, medical records, specialized clinical studies, and 
specialized laboratory studies (e.g., pathology, genetics, neurochemistry). 

(3) Intent to Participate

o  There must be a clearly expressed intent to participate in a cooperative 
manner with the CCS, DBPC, and the NIH in all aspects of the collaborative 
research as outlined in this RFA.

Budget Preparation

Comprehensive Clinical Sites:

The first-year budget at the time of application will be limited to a BASE 
BUDGET with maximum allowances as follows:

o Principal Investigator/Co-Principal Investigator(s):  up to a total of 30 
percent effort

o Research Nurse Coordinator/outreach worker:  50 percent effort

o Data Entry Clerk:  50 percent effort

o Supplies and Small Equipment (itemized and justified):  Not to Exceed 
$4,500

o Travel (a maximum of 12 person trips to Bethesda):  as appropriate

o Other costs (itemized and individually justified):  Not to Exceed $2,500

When an application has been reviewed and is being considered for funding, 
the applicant will be required to complete the budgets based on capitation 
funding.  Each Clinical Site will be given base costs (listed above) in 
addition to a flat fee per subject.  When protocol development is near 
completion, a final per-subject rate will be determined, which will include 
costs, which cannot be estimated at this time, such as pathology and 
laboratory tests.
 
After protocol development, the individual member sites will be required to 
project subject enrollment during a specified time frame.  Taking this 
information into account, NICHD will determine the capitation level and make 
an award.  Continuation and level of funding for future years will be based 
on the number of subjects successfully enrolled and completed.  

Future years' budgets should be limited to base budget costs, with an annual 
increment of base salary and travel not to exceed three percent.  The maximum 
amount available for equipment, supplies and other costs will not increase.  
Federal agencies shall use negotiated rates for F&A costs in effect at the 
time of the initial award throughout each competitive segment of the project.  
Award levels for sponsored agreements may not be adjusted in future years as 
a result of changes in negotiated rates.

Developmental Biology and Pathology Center:

The first-year budget at the time of application will be limited to a BASE 
BUDGET with maximum allowances as follows:

o Principal Investigator/Co-Principal Investigator(s):  up to a total of 30 
percent effort

o Research Technician:  50 percent effort

o Supplies and Small Equipment (itemized and justified):  Not to Exceed 
$10,000

o Travel (a maximum of 12 person trips to Bethesda):  as appropriate

o Other costs (itemized and individually justified):  Not to Exceed $2,500

When an application has been reviewed and is being considered for funding, 
the applicant will be required to complete a budget based on operational 
costs.  The DBPC will be given base costs (listed above) in addition to 
operational costs.  When protocol development is near completion, operational 
costs will be determined, which will include costs, which cannot be estimated 
at this time, such as those related to the storage and processing of biologic 
samples. 

Taking subject enrollment estimates into account, NICHD will determine the 
level of operational costs and make an award.  Continuation and level of 
funding for future years will be based on the number of subjects successfully 
enrolled and completed.  

Future years' budgets should be limited to base budget costs, with an annual 
increment of base salary and travel costs not to exceed three percent.  The 
maximum amount available for supplies and other costs not increase.  Federal 
agencies shall use negotiated rates for F&A costs in effect at the time of 
the initial award throughout each competitive segment of the project.  Award 
levels for sponsored agreements may not be adjusted in future years as a 
result of changes in negotiated rates.

Data Coordinating and Analysis Center:

The first-year budget at the time of application will be limited to a BASE 
BUDGET with maximum allowances as follows:

o Principal Investigator/Biostatistician team:  up to 100 percent effort 

o Programmer/Systems Analyst:  50 percent effort 

o Study Coordinator/Administrative Assistant:  50 percent effort

o Travel (a total of 12 person trips to Bethesda):  as appropriate

o Consultants for protocol development and one meeting of the DSMC:  $10,000

o Supplies and small equipment:  $10,000

When an application has been reviewed and is being considered for funding, 
the applicant will be required to complete a budget based on operational 
costs.  The data center will be given base costs (listed above) in addition 
to operational costs.  When protocol development is near completion, 
operational costs will be determined, which will include costs, which cannot 
be estimated at this time, such as data entry and management, quality control 
costs, software, printing and duplication of forms, distribution and storage 
of forms, and service contracts, logistic support to the study, report 
generation, and data analysis.  Taking subject enrollment estimates into 
account, NICHD will determine the level of operational costs and make an 
award.  Continuation and level of funding for future years will be based on 
the number of subjects successfully enrolled and completed.  

Future years' budgets should be limited to base budget costs, with an annual 
increment of base salary and travel costs not to exceed three percent.  The 
maximum amount available for supplies and other costs not increase.  Federal 
agencies shall use negotiated rates for F&A costs in effect at the time of 
the initial award throughout each competitive segment of the project.  Award 
levels for sponsored agreements may not be adjusted in future years as a 
result of changes in negotiated rates.

USING THE RFA LABEL:  The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  Failure to use this label 
could result in delayed processing of the application such that it may not 
reach the review committee in time for review.  In addition, the RFA title 
and number must be typed on line 2 of the face page of the application form 
and the YES box must be marked. The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of 
the application, including the Checklist, and three 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)
 
At the time of submission, two additional copies of the application must be 
sent to:

Extramural Project Review Branch
ATTN: HD-03-004
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Room 409, MSC 7003
Bethesda MD 20892-7003
Rockville MD 20852 (for express/courier service)

APPLICATION PROCESSING:  Applications must be received by the application 
receipt date listed in the heading of this RFA.  If an application is 
received after that date, it will be returned to the applicant without 
review.
 
The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed.  This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must 
include an Introduction addressing the previous critique.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NICHD and NIAAA.  Incomplete and/or non-responsive 
applications will be returned to the applicant without further consideration.

Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by the NICHD and NIAAA in accordance with the review criteria stated 
below.  

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

o Receive a written critique
o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications under 
review, will be discussed and assigned a priority score.
o Receive a second level review by the National Advisory Child Health and 
Human Development Council and the National Advisory Alcohol Abuse and 
Alcoholism Council.
 
REVIEW CRITERIA

Criteria for Review of Comprehensive Clinical Site (CCS) and Developmental 
Biology and Pathology Center (DBPC) Applications

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following 
aspects of your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 
goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these criteria 
in assigning your application's overall score, weighting them as appropriate 
for each application.  Your 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, you may propose to carry out 
important work that by its nature is not innovative but is essential to move 
a field forward.

SIGNIFICANCE:  Does research proposed address an important problem? If the 
aims of the sample studies are achieved, how do they advance scientific 
knowledge and improve the public health?  What will be the effect of these 
studies on the concepts or methods that drive this field? 

APPROACH:  Are the conceptual framework, design, methods, and analytic plans 
outlined in the sample studies appropriate to the aims of the research 
objectives as outlined in the RFA?  Are the sample studies feasible in the 
context of the community served by your application.  Do you acknowledge 
potential problem areas and consider alternative tactics?

INNOVATION:  Does your project employ novel concepts? Do the sample studies 
employ novel approaches or methods? Does your project challenge existing 
paradigms or develop new methodologies or technologies?

INVESTIGATOR:  Are you appropriately trained and well suited to carry out 
this work?  Is the work proposed appropriate to your experience level as the 
Principal Investigator and to that of other researchers (if any)?  Is an 
appropriate multidisciplinary team assembled to carry out the work? 

ENVIRONMENT:  Does the scientific and community environment in which the work 
will be done contribute to the probability of success?  Do the proposed 
approaches take advantage of unique features of the scientific and community 
environment and employ useful collaborative arrangements?  Is there evidence 
of institutional support?

Criteria for Review of Data Coordinating and Analysis Center (DCAC) 
Applications

o  Qualifications, Experience, and Commitment of Key Personnel:  Scientific 
and administrative abilities of the Principal Investigator and other team 
members; experience of the Principal Investigator and other key personnel in 
statistical data management, quality control, study coordination, and 
administrative aspects. 

o  Protocols and Procedures:  Quality of past performance and proposed plans 
for study coordination, data collection, analysis and monitoring. 

o  Facilities and Management:  Evidence of satisfactory facilities and 
supporting environment, including space and equipment for work proposed (any 
new equipment requested under this award must be adequately justified); 
evidence of institutional support for participation in a long-term 
collaborative project. 

OTHER REVIEW CRITERIA:  

Other Criteria for Review of Comprehensive Clinical Site (CCS) Applications

o Adequacy of documentation of the patient population as outlined in 
supplemental instructions;

o Adequacy of ability to implement clinical, biological, or epidemiological 
studies, based upon links to high-risk communities.

o Ability to address related biological measures of alcohol effect on the 
mother, the fetus, and the infant.

o Adequacy of existing collaborative arrangements with communities in which 
the studies will take place, or plans to develop such arrangements.

Other Criteria for Review of Developmental Biology and Pathology Center 
(DBPC) Applications

o Ability to design studies on neurobiology of alcohol injury and the 
pathological processes operating such injuries.

o Adequacy of plans to store and examine samples from the mother, the 
placenta, fetal tissues, and/or materials obtained at autopsy.

o Adequacy of plans for scientific and operational collaboration between the 
DBPC and CCS.

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, your 
application will also be reviewed with respect to the following:

o PROTECTIONS:  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.

o INCLUSION:  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.  Plans for the recruitment and 
retention of subjects will also be evaluated. (See Inclusion Criteria 
included in the section on Federal Citations, below.)

o BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  February 17,2003
Application Receipt Date:  March 17,2003
Peer Review Date:  June/July 2003  
Council Review:  August/September 2003
Earliest Anticipated Start Date:  September 2003

AWARD CRITERIA

Criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review). The combined expertise of 
all sites will play a role in the selection of grants for award.  

o Availability of funds

o Programmatic priorities to include geographic and subpopulation diversity.  

REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD:  Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html.  

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 AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
(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 RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy 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 is available at 
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 proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

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 RFA 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.

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 
RFA 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 Nos. 93.864, 93.865, and 93.891, and is not 
subject to the intergovernmental review requirements of Executive Order 12372 
or Health Systems Agency review.  Awards are made under authorization of 
Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 
and 284) and administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92.  

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.

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