RESEARCH INTO MECHANISMS OF FETAL GROWTH RESTRICTION

RELEASE DATE:  April 7, 2003 

RFA:  HD-03-018

National Institute of Child Health and Human Development (NICHD)
 (http://www.nichd.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:  93.865  

LETTER OF INTENT RECEIPT DATE:  June 23, 2003

APPLICATION RECEIPT DATE:  July 23, 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) invites 
research grant applications to investigate the mechanisms of fetal growth 
restriction.  The aim of this initiative is to stimulate research into the 
mechanisms of fetal growth restriction and to gain a better understanding of 
the factors that regulate fetal growth during pregnancy.

RESEARCH OBJECTIVES

Background

Fetal growth restriction (FGR) results in significant perinatal 
complications, including fetal death, prematurity, neonatal death, fetal 
compromise in labor, neonatal morbidity, induction of labor, and cesarean 
delivery.  Studies have shown that nearly half of non-malformed stillborn 
fetuses were growth restricted.  Neonates with FGR who survive are at 
increased risk for neonatal morbidity and mortality.  The incidence of fetal 
growth restriction is estimated to be approximately five percent in the 
general obstetric population.  However, the incidence varies depending on the 
population under examination (including racial and geographic location).  In 
assessing perinatal outcome by weight, infants who weigh less than 2,500 
grams (five pounds, eight ounces) at term have a perinatal mortality rate 
that is five to 30 times greater than that of infants whose birth weights are 
at the 50th percentile.  The mortality rate is 70 to 100 times higher in 
infants who weigh less than 1,500 grams (three pounds, five ounces). 
Perinatal asphyxia involving multiple organ systems is one of the most 
significant problems in growth-restricted infants.  Despite expert neonatal 
care, a significant proportion of these children suffer impairments (often 
neurological) in childhood.  In addition, there is evidence to suggest that 
chronic diseases (such as hypertension, ischaemic heart disease, and 
diabetes) of later adult life are more common in individuals born suffering 
from fetal growth restriction.  Inadequate fetal growth may occur in the 
absence of recognized causal factors such as maternal hypertension, smoking 
or inadequate nutrition.  It may be associated with intrauterine fetal demise 
or immediate neonatal and long-term consequences for the infant.  In most 
cases, the reasons for poor fetal growth are not known.  Known associations 
with fetal growth restriction include fetal chromosomal, Mendelian or 
congenital structural abnormalities; placental factors such as placental 
mosaicism and abnormal placentation; and maternal factors including 
hypertension/preeclampsia, antiphospholipid antibody syndrome (APS), and 
inherited thrombophilia.  In addition, extrinsic factors such as altitude, 
infectious agents, nutritional deficits, and toxins (cigarette smoking, 
alcohol, illicit drugs) may result in fetal growth restriction.  Currently, 
the management of under-grown fetuses is empirical, aimed primarily at 
selection of safest time for delivery.  There are no effective treatments to 
prevent or reverse fetal growth restriction.  Further research into the 
mechanisms that control normal fetal growth will lead to our understanding of 
and prevention of situations of abnormal fetal growth.  Providing the best 
possible environment for the fetus would not only ensure adequate fetal 
growth and health in the newborn period, but also protect against the 
development of diseases in adult life.
 
Scientific Knowledge to be Achieved Through Research Supported by the RFA 

The aim of this initiative is to stimulate research into the mechanisms of 
fetal growth restriction and to gain a better understanding of the factors 
that regulate fetal growth during pregnancy. 
 
Objectives of this Research Program

The major objectives of this RFA are the identification and characterization 
of the mechanisms of fetal growth; to clarify how these mechanisms are 
altered in fetal growth restriction; and to develop noninvasive methods to 
detect the abnormalities.  The following are some examples of research topics 
that are responsive to this RFA, but they are not to be viewed as exclusive 
or restrictive:

o Identification of the cellular and molecular mechanisms that result in 
fetal growth restriction such as studies dealing with apoptosis, oxidative 
stress, abnormal cytokine milieu, etc.

o Elucidation of the mechanisms by which confined placental mosaicism (CPM) 
and uniparental disomy (UPD) result in abnormal fetal growth.  Examples 
include studies on the role of imprinted genes, gene dosage, and cis and 
trans regulatory factors responsible for mediating the effects of CPM and UDP 
on fetal growth.

o Identification and characterization of novel genes and DNA polymorphisms 
involved in fetal growth. 

o Characterization of normal and abnormal placentation resulting in normal 
and growth restricted fetuses.

o Characterization of the placenta, its blood flow, and its attachment to the 
uterus during pregnancy that result in fetal growth restriction.

o Identification and characterization of marker molecule(s) such as growth 
factors or cytokines that are associated with fetal growth restriction.

o Comparative study of animal and human tissues to determine applicability of 
information obtained in the animal to human in terms of a mechanism, molecule 
or process identified.

o Evaluation of the role of the fetus and its potential self-regulation of 
fetal growth.

o Identification of the mechanisms underlying known maternal factors 
including chronic diseases (e.g., hypertension, diabetes), environmental 
factors such as toxins of abuse (smoking, alcohol), and environmental 
exposures. 

o Investigation of the differential effects of abnormal fetal growth on 
specific organ maturation and development.

In addition to the above, potential applicants are encouraged to utilize 
characterized mutant mice with phenotypes of abnormal fetal growth that are 
being produced at NIH-funded mutagenesis facilities such as the mouse 
mutagenesis and phenotyping facilities at Baylor College of Medicine, at 
Jackson Laboratories or the Tennessee Mouse Genome Consortium.  This RFA will 
provide an excellent opportunity for researchers to exploit these rich 
genomic and genetic resources.

MECHANISM OF SUPPORT

This RFA will use the NIH Program Project Grant (P01) and Research Project 
Grant (R01) award mechanisms.  The complex and multivariate nature of this 
research goal necessitates the use of both individual-investigator research 
studies (R01) and integrated, multidisciplinary, and multi-site approaches 
involving expertise in a number of disciplines (PO1).  NICHD Program Project 
Guidelines may be obtained at: 
http://www.nichd.nih.gov/funding/mechanism/p01_guide.cfm.  As an applicant you will 
be solely responsible for planning, directing, and executing the proposed 
project.  This RFA is a one-time solicitation.  Future unsolicited, competing 
continuation applications based on this project will compete with all 
investigator-initiated applications and will be reviewed according to the 
customary peer review procedures.  The anticipated award date is April 01, 
2004.  Applications that are not funded in the competition described in this 
RFA may be resubmitted as NEW investigator-initiated applications using the 
standard receipt dates for NEW applications described in the instructions to 
the PHS 398 application.

FUNDS AVAILABLE

The NICHD intends to commit approximately $2.5 million total costs [Direct 
plus Facilities and Administrative (F and A) costs] in FY 2004 to support 
three to five new and/or competing continuation grants in response to this 
RFA.  An applicant for an R01 may request a project period of up to five 
years and a budget for DIRECT costs of up to $350,000 per year.  An applicant 
for a P01 may request a project period of up to five years and a budget for 
TOTAL costs of up to $750,000 per year.  Because the nature and scope of the 
proposed research will vary from application to application, it is 
anticipated that the size and duration of each award will also vary.  
Although the financial plans of the NICHD 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  

Foreign institutions are only eligible to apply for RO1 grants.

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

Principal Investigators from projects funded through this RFA will be 
expected to attend an annual NICHD meeting to share findings, research 
approaches, and core instrumentation.  Application budget requests should 
include funds to support travel to the Washington DC area for a two-day 
meeting in each year of the grant.  In addition, following the award of 
grants resulting from this RFA, the funded investigators and NICHD will 
develop an informal communication collaboration to provide ongoing 
information and advice relevant to critical issues and trends in the field at 
large to supplement the aforementioned formal annual meetings.

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:  

John Ilekis, Ph.D.
Pregnancy and Perinatology Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 4B03, MSC 7510 
Bethesda, MD  20892-7510
Telephone:  (301) 496-5575
FAX:  (301) 496-3790
Email:  ilekisj@mail.nih.gov 

o Direct your questions about peer review issues to:  

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Telephone:  (301) 496-1485
FAX:  (301) 402-4104
Email:  stretchr@mail.nih.gov 

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

Kathy Hancock
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8A17, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-5482
FAX:  (301) 402-0915
Email:  kh246t@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 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:  

John Ilekis, Ph.D.
Pregnancy and Perinatology Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 4B03, MSC 7510
Bethesda, MD  20892-7510
Telephone: (301) 496-5575
FAX:  (301) 496-3790
Email:  ilekisj@mail.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:  Applications for the Program Project Grant (P01) 
should be prepared in a manner consistent with the information presented in 
the NICHD Program Project Guidelines, available from the contact listed under 
WHERE TO SEND INQUIRIES, above, and at 
http://www.nichd.nih.gov/funding/mechanism/p01_guide.cfm.

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:  

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)

APPLICATION PROCESSING:  Applications must be received on or before 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.

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within eight weeks.
 
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.  
However, when a previously unfunded application, originally submitted as an 
investigator-initiated application, is to be submitted in response to an RFA, 
it is to be prepared as a NEW application.  That is the application for the 
RFA must not include an Introduction describing the changes and improvements 
made, and the text must not be marked to indicate the changes.  While the 
investigator may still benefit from the previous review, the RFA application 
is not to state explicitly how. 

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NICHD.  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 NICHD 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.

REVIEW CRITERIA

REVIEW CRITERIA FOR P01 APPLICATIONS:

The scientific and technical merit peer review of Program Project (P01) 
applications focuses on three areas:  (1) review of the component research 
subprojects; (2) review of the core units; and (3) review of the overall 
program as an integrated effort.  P01 applications submitted in response to 
this RFA will be evaluated according to the review criteria described in the 
NICHD P01 Guidelines, available at:  
http://www.nichd.nih.gov/funding/mechanism/p01_guide.cfm.

REVIEW CRITERIA FOR R01 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 the 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 the application's overall score, weighting them as appropriate 
for each application.  The application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score.  For example, an investigator may propose to 
carry out important work that by its nature is not innovative but is 
essential to move a field forward.

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 or methods that 
drive this field?

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?

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?

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 (if any)?

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

ADDITIONAL CRITERIA/CONSIDERATIONS APPLYING TO P01 AND R01 APPLICATIONS

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

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK:  The involvement of human 
subjects and protections from research risk relating to their participation 
in the proposed research will be assessed. (See criteria included in the 
section on Federal Citations, below.)
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH:  The adequacy of 
plans to include subjects from both genders, all racial and ethnic groups 
(and subgroups), and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will also be 
evaluated. (See Inclusion Criteria in the sections on Federal Citations, 
below.)

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH:  If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.  

ADDITIONAL CONSIDERATIONS 

DATA SHARING:  The adequacy of the proposed plan to share data.
 
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:  June 23, 2003
Application Receipt Date:  July 23, 2003
Peer Review Date:  October/November 2003
Council Review:  January 2004
Earliest Anticipated Start Date:  April 01, 2004

AWARD CRITERIA

Criteria that will be used to make award decisions include: 

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities

REQUIRED FEDERAL CITATIONS

HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained.

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 "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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to 
the "Standards for Privacy of Individually Identifiable Health Information", 
the "Privacy Rule," on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified 
under the Rule as "covered entities") must do so by April 14, 2003  (with the 
exception of small health plans which have an extra year to comply).  

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

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

HEALTHY PEOPLE 2010:  The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting priority areas.  This 
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 at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm. 

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

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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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