MENTAL RETARDATION AND DEVELOPMENTAL DISABILITIES RESEARCH CENTERS 2004

RELEASE DATE:  September 8, 2003

RFA Number:  RFA-HD-03-027

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATIONS:

National Institutes of Health (NIH)
 (http://www.nih.gov)

COMPONENTS OF PARTICIPATING ORGANIZATIONS:

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

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.865

LETTER OF INTENT RECEIPT DATE:  November 19, 2003

APPLICATION RECEIPT DATE:  December 19, 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), through 
the Mental Retardation and Developmental Disabilities (MRDD) Branch, Center 
for Developmental Biology and Perinatal Medicine (CDBPM), invites Center Core 
Grant (P30) applications to advance diagnosis, prevention, treatment, and 
amelioration of mental retardation and developmental disabilities.  

This Request for Applications (RFA) seeks applications from institutions that 
meet the qualifications for a program of MRDD research.  The primary 
objective of the NICHD Mental Retardation and Developmental Disabilities 
Research Centers (MRDDRC) Program is to provide core support and facilities 
for cohesive, interdisciplinary research and research training.  Funds for 
the research projects using these core facilities come from independent 
sources including Federal, State, and private organizations.  

RESEARCH OBJECTIVES

Background

For more than 35 years, NICHD has provided support for MRDDRCs through Center 
Core grants (P30) that facilitate program coordination and support central 
research facilities, administration, and development of a limited number of 
new research programs.  A major goal of the NICHD MRDDRC Program is to 
support research that leads to prevention and/or amelioration of MRDD.  The 
degree of impairment associated with MRDD varies with the cause.  Moderate 
and more severe MRDD often results from problems that produce profound 
alterations in brain development and/or function.  Diminished intellectual 
and adaptive capacity often can be traced to defective genes, teratogenic 
agents, toxic substances, infections, nutritional deficits, accidents, 
maternal conditions, and other factors causing brain damage.  A larger 
proportion of cases of MRDD is related to environmental or social conditions 
and disorders of unknown etiology.  Several MRDD syndromes have been 
identified and new ones are being discovered.  Each requires fundamental 
research into the underlying processes, as well as studies designed to meet 
the unique needs of the affected children.  Therefore, one of the missions of 
the MRDD Branch is to support research on the etiology, pathophysiology, 
epidemiology, diagnosis and evaluation, prevention, and treatment or 
amelioration of MRDD.  Research conducted in the MRDDRCs will cover a broad 
spectrum of scientific approaches ranging from laboratory research on 
fundamental processes of normal and abnormal development to clinical and 
behavioral research in which persons with MRDD are studied.  

It is thought that major solutions to the problems of MRDD may emerge from 
multidisciplinary, collaborative, and integrated approaches involving 
biomedical, behavioral, and biobehavioral sciences in the MRDDRCs.  Thus, 
NICHD encourages cooperation among the Centers, including and their 
integration into a network.  Administrative and scientific organization 
within a Center and across the network of MRDDRCs should enhance 
opportunities for breakthroughs.

Research Scope

The intent of MRDDRC Center Core Grants is to bring together scientists from 
a variety of disciplines to work within a Center on the common problems of 
MRDD.  Consequently, applications for MRDDRC Core Grants (P30) should include 
investigators studying a range of topics in basic and clinical or applied 
research.  NICHD encourages, but does not require, applicants to include both 
biomedical and behavioral components among the topics addressed within their 
Center.  Center grant applications must include among these topics at least 
five of the following, focused specifically on MRDD.  This list of topics is 
not comprehensive, nor are the examples exhaustive.

1.  Developmental and neurobiological studies to define the molecular and 
cellular bases of MRDD and to facilitate development of specific hypotheses 
about basic abnormalities that underlie these conditions.

2.  Studies of cellular and molecular aspects of brain development: 
differentiation, synapse formation and modification, plasticity, trophic 
factors, and neurotransmitter function and modulation.

3.  Applied clinical and experimental studies of inborn errors of metabolism 
relevant to MRDD that involve pathophysiology of cellular and subcellular 
organelles.  

4.  Development of novel and innovative technologies for pre- and post-natal 
diagnosis of common and rare causes of MRDD; investigation and therapy of 
conditions associated with MRDD.

5.  Studies of the genetic and epigenetic basis of MRDD by molecular genetic, 
genomic, and proteomic approaches.

6.  Studies of the pathways by which genotype affects the development, 
function, and dysfunction of the nervous system, particularly with respect to 
cognition and behavior. 

7.  Creation and characterization of animals that, through genetic 
alteration, model specific important aspects of MRDD by clear 
neurodevelopmental, pathophysiological, genetic, and/or functional homology 
and their use to test existing and develop new medications that are safe and 
effective for individuals with MRDD.

8.  Prenatal therapy of genetic and structural defects using nutritional, 
pharmacological, surgical, and other techniques.  

9.  Genetic, molecular, behavioral, and biobehavioral research and 
therapeutic approaches to the MR syndromes, such as Down, Fragile X and Rett. 
   
10.  Studies of physical environmental factors in the etiology, treatment, 
and prevention of MRDD, such as heavy metals (e.g., lead and mercury) and 
toxic wastes (e.g., hydrocarbons and polycarbonates or PCBs) and their 
effects on morphogenesis and function that contribute to MRDD.  Areas of 
interest include developmental and behavioral teratology, neuroimmunological 
toxicology, and conditions such as fetal alcohol syndrome.

11.  Studies of the effects of malnutrition (protein, caloric, micronutrient) 
on intellectual, behavioral, social, and physical development; 
intergenerational effects of malnutrition.

12.  Studies of psychopharmacology, including medication use and development; 
cellular and molecular mechanisms, pharmacokinetics, behavioral effects; 
rational drug development (e.g., combinatorial chemistry, pharmacogenomics); 
medication use and treatment efficacy in different subpopulations of MRDD; 
dual diagnoses.

13.  Clinical trials for the treatment, amelioration, and/or prevention of 
MRDD.

14.  Studies of infectious diseases in the etiology, treatment, and 
prevention of MRDD; neuropathological, neurological, behavioral, and 
intellectual consequences of AIDS in children.

15.  Studies that develop and test novel methods and measures for screening 
and diagnosis, and/or identify children and infants at risk; validation of 
emerging technologies (e.g., microarrays, proteomics, microanalysis of 
analyates, biomolecule sensing, mass spectrometry, functional imaging) for 
screening and diagnosis.

16.  Studies that develop methods to better define clinical phenotypes, 
including sources of variability, in MRDD, with particular focus on 
characteristic components of behavior and cognition; measurement tools to 
assess cognitive and behavioral development; tests that highlight abilities 
and disabilities, including tests for specific subpopulations (e.g., specific 
inborn errors of metabolism and syndromes such as Down, Fragile X, Prader-
Willi, and Williams).

17.  Studies involving early interventions (biological, behavioral, 
educational, environmental) for infants born at risk for MRDD; research into 
the strategies for early intervention; follow-up of high-risk infants and 
children whose risk is due to biomedical conditions such as low birth weight 
and/or conditions of environmental deprivation; studies of 
intergenerational effects and outcomes for children whose parents have 
conditions associated with MRDD; effects of teen pregnancy on at-risk infant 
outcome. 

18.  Predictive and developmental studies of perinatal problems associated 
with MRDD; developmental studies of low birth weight, including infants who 
are small for gestational age, preterm, medically fragile, and neonatally 
sick (such as those who experience hypoxic or ischemic insults).

19.  Neurodevelopmental and longitudinal studies that characterize the 
neuropathogenesis and inherent variability in MRDD to develop specific 
hypotheses about the initial (primary) abnormality, and to address the degree 
to which phenotypic variation impacts upon postnatal brain development. 

20.  Studies to follow the developmental trajectories of different brain 
functions and their influence on developing cognitive and motor skills; such 
studies might use techniques of imaging, electrophysiology, pharmacology, 
molecular biology, and behavioral science.

21.  Studies of psychological processes in MRDD, including attention, 
cognition, information processing, perception, motor development, 
neuropsychology, and affective, social, motivational, and personality 
factors.

22.  Studies of autism and autism spectrum disorders:  screening and 
diagnosis, etiology, neurobiology, genetics, pathophysiology, developmental 
course, using medical, biological, and pharmacological approaches; behavioral 
and pharmacological interventions.

23.  Studies involving manipulations of interaction between behavior and 
environment of individuals with MRDD throughout the life-span to reduce 
behavior problems or to facilitate vocational training, social and self-help 
skills, and learning; use of social support networks; parent-child, sibling, 
peers, and family interactions over the life-span.

24.  Studies that examine and evaluate residential, educational, and 
vocational settings of individuals with MRDD throughout the life span.

25.  Studies of learning disabilities, dyslexia, and attention deficit 
hyperactivity disorder.

26.  Studies of language and communication in MRDD populations.

27.  Studies of socio-ecological processes:  individuals with MRDD from 
various cultural and ethnic groups in multiple settings (naturalistic 
observation); ethnographic research, life history reporting, and systematic 
observation of specific activities.

28.  Studies of hyperaggressive, destructive, and self-injurious behavior in 
humans and animal models, including pharmacological and behavioral 
treatments; stereotypic behaviors; lack of adherence of mentally retarded 
individuals in family and educational settings.

29.  Studies of the epidemiology of MRDD:  analytic and case-control studies 
of etiology; incidence and prevalence; follow-up over the life span for 
outcomes.

30.  Studies that examine and evaluate behavior, life styles, health needs, 
and health disparities of affected individuals that could affect mortality 
and morbidity throughout the life span.

31.  Studies that develop and utilize assistive devices (e.g., computer 
software, hand-held devices, and touch screen computers) to help individuals 
with MRDD to learn and communicate.

MECHANISM OF SUPPORT

This RFA will use the NIH Center Core Grant (P30) award mechanism.  As an 
applicant you will be solely responsible for planning, directing, and 
executing the proposed project.  Applicants must prepare the application in a 
manner consistent with the guidelines presented in the "NICHD P30 CENTER CORE 
GRANT GUIDELINES" (http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm).  The 
anticipated award date is July 1, 2004.  At this time, it is not known if 
this RFA will be reissued.

FUNDS AVAILABLE

The NICHD intends to commit approximately $4.5 million in total costs [Direct 
plus Facilities and Administrative (F & A) costs] in FY 2004 to support up to 
three new and/or competing continuation grants in response to this RFA.  An 
applicant may request a project period of up to five years.  Applicants for a 
new P30 Center may request a budget for direct costs of up to $750,000 in the 
first year.  Applicants for competing continuations from existing P30 Centers 
may request a budget for initial year direct costs of up to 20 percent above 
the level of the last year of the Type 5 award, or $750,000 in direct costs, 
whichever is greater.  Budget increments for subsequent years will be limited 
to three percent.  Budgets for new and renewal applications will be 
stringently reviewed within these guidelines.  Applications with budget 
requests exceeding these guidelines will be administratively withdrawn by 
NICHD and returned to the applicant.  The cost of a proposed Center will be a 
material consideration in the selection of applications for funding.  
 
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 institutions/organizations

Foreign institutions are not eligible to apply.

For the purpose of this RFA, the NICHD will support no more than one MRDDRC 
grant (P30) per institution.  To be eligible for an award, the proposed 
Center must provide core support for a minimum of 10 projects funded from 
non-university sources.  Additional eligibility criteria for the P30 are 
listed in the NICHD P30 CENTER CORE GRANT GUIDELINES at: 
http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm.

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 his/her 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

o The MRDDRC Director should be a scientist or science administrator who can 
provide effective scientific and administrative leadership.  The Director 
will be responsible for the organization and operation of the MRDDRC and for 
communication with the NICHD on scientific and operational matters.  She/he 
should be able to integrate and synthesize the proposed research and, 
thereby, serve as an example to other investigators.  Scientific personnel 
and institutional resources must be available to provide a strong research 
base in the specified fields.  In addition, the institution and pertinent 
departments must show a strong commitment to the Center's support.  Dedicated 
space and/or equipment, staff recruitment, investigators' salaries or other 
financial support for the proposed Center exemplify such commitment.

o Applications for P30 MRDDRC grants must propose a program consisting of 
cores to be accessed by grants that propose research addressing at least five 
of the topics relevant to the mission of the MRDD Branch outlined above.  The 
program should consist of at least 10 externally funded research projects 
grouped according to relevant topics.  These projects must be of high quality 
and provide a multidisciplinary approach to the problem(s) under 
investigation.  Each project is to be summarized in accordance with the NICHD 
P30 CENTER CORE GRANT GUIDELINES 
(http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm). Projects funded under 
initiatives unrelated to this RFA (such as Fragile X Research Centers, 
Centers for Programs of Excellence in Autism, Rare Disease Research Centers, 
and traditional P01s) may be counted in the 10 externally funded research 
projects. 

o An MRDDRC must contain an Administrative Core and may contain one or more 
additional core units.  A minimum of three federally funded research 
projects, at least one of which is NIH-funded, must utilize each core unit.  
These projects must be related to MRDD and at least one must be funded by 
NICHD, exclusive of research contracts, training grants, interagency 
agreements, and NIH-supplemental projects funded by other agencies.  

o Subprojects within a Program Project (P01) will be considered as individual 
projects comparable to an R01.  Those projects located at institutions that 
do not do not already have an MRDDRC must receive NICHD prior approval to 
access core facilities.  

o The applicant must provide a detailed description of each Core unit 
proposed as part of the Center, with detailed budget and budget 
justification.  Budgetary items allowable for Administrative Core Units 
include salaries and support for a limited number of administrative and 
clerical personnel; administrative support services, travel to one Center 
Directors' meeting to discuss scientific advancements of the Centers 
annually; and travel to one Center Directors' and administrators' meeting 
annually to confer with other NICHD Center Directors. 

o The applicant must name a scientist to be responsible for each Core unit 
proposed.  The description of each Core unit proposed should include a 
rationale, indicating how the Core will support the research effort in an 
efficient and cost-effective manner.  Budgetary items allowable for other 
Cores include salaries and support for core staff; supplies (including 
animals); scientific equipment; computer facilities and services; travel for 
technical or administrative staff for technical training or to maintain 
operation of the core unit; and consultations services.  

o The applicant institution must provide facilities for the primary needs of 
the MRDDRC Program.  These facilities should require no more than modest 
alteration and/or renovation.  No funds for new construction will be 
provided.

o As a major goal, the MRDDRC Program promotes 1) interdisciplinary 
collaboration among scientists, 2) data sharing, 3) integration of large sets 
of data, and 4) synthesis of knowledge about MRDD that will lead to 
amelioration and prevention.  Each Center application should address a 
specific plan for achieving this goal.   

o Another goal of the MRDDRC Program is to attract scientists to MRDD 
research.  Where appropriate, the applicant may request up to five years' 
support for "New Program Development" for direct research support of one or 
more projects.  This support should not exceed a total of $100,000 per year, 
or 10 percent of total direct costs, whichever is less.  Applicants may use 
such funds to attract new investigators to the Center, to develop a new area 
or program of research, or to facilitate the development of new research 
programs of newly trained investigators or investigators new to MRDD 
research.  Description of New Program Development projects should compare to 
R01 research grant applications in detail and development.  Each such project 
may provide support for no more than two years to any one investigator.

o A major goal of the NICHD is to promote active collaboration among MRDDRCs. 
To accomplish this goal, successful applicants will participate in the 
collaborative efforts of established Centers' programs.  In planning the 
program, applicants should consider potential collaborative studies and 
projects that they may propose for the MRDDRCs network.  The Administrative 
Core should budget for interactive functioning including meetings to develop 
common protocols, databases, and communications and informatics technologies.

o Starting with the October 1, 2003 receipt date, investigators submitting an 
NIH application seeking $500,000 or more in direct costs in any single year 
are expected to include a plan for data sharing or state why sharing is not 
possible.  For more information on data sharing, please see website 
https://grants.nih.gov/grants/policy/data_sharing/.  The reasonableness of the 
data sharing plan or the rationale for not sharing research data will be 
assessed by the reviewers.  However, reviewers will not factor the proposed 
data-sharing plan into the determination of scientific merit or priority 
score. 

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:  

Ljubisa Vitkovic, Ph.D.
Mental Retardation and Developmental Disabilities Branch
National Institute of Child Health and Human Development
6700 Executive Boulevard, Room 4B-09, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1383
FAX:  (301) 496-3791
Email:  vitkovil@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:  

Dianna Bailey
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-5482
FAX:  (301) 402-0915
Email:  dn11r@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:  

Ljubisa Vitkovic, Ph.D.
Mental Retardation and Developmental Disabilities Branch
National Institute of Child Health and Human Development 
6700 Executive Boulevard, Room 4B-09, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1383
FAX:  (301) 496-3791
Email:  vitkovil@mail.nih.gov 

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a DUN and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at http://www.dunandbradstreet.com. The DUNS number should 
be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document 
is available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an 
interactive format.  For further assistance contact GrantsInfo, Telephone 
(301) 710-0267, Email: GrantsInfo@nih.gov.

SUPPLEMENTARY INSTRUCTIONS:  Supplemental instructions for application 
preparation can be found in the NICHD P30 CENTER CORE GRANT GUIDELINES 
(http://www.nichd.nih.gov/funding/mechanism/p30_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: 
https://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 from the 
previous unfunded version of the application.  

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 the NICHD in accordance with the review criteria stated below.  
No site visits are planned in the review of these applications; all 
information required for evaluation must be contained in the application.  As 
part of the initial merit review, all applications will: 

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 written critique
o Receive a second level review by the National Advisory Child Health and 
Human Development Council.

REVIEW CRITERIA

All applications responding to this RFA will be evaluated according to the 
review criteria for Core units, New Program Development projects, and the 
overall center as outlined in the NICHD P30 CENTER CORE GRANT GUIDELINES 
(http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm).

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 REVIEW CONSIDERATIONS

Sharing Research Data

Applicants requesting more than $500,000 in direct costs in any year of the 
proposed research must include a data-sharing plan in their application.  The 
reasonableness of the data-sharing plan or the rationale for not sharing 
research data will be assessed by the reviewers.  However, reviewers will not 
factor the proposed data-sharing plan into the determination of scientific 
merit or priority score. 

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:  November 19, 2003
Application Receipt Date:  December 19, 2003
Peer Review Date:  March 2004
Council Review:  June 2004
Earliest Anticipated Start Date:  July 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
o Cost-effectiveness of the core facilities
o Cost of the Center

REQUIRED FEDERAL CITATIONS

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

DATA AND SAFETY MONITORING PLAN:  Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II); efficacy, 
effectiveness and comparative trials (phase III).  The establishment of data 
and safety monitoring boards (DSMBs) is required for multi-site clinical 
trials involving interventions that entail potential risk to the 
participants.   (NIH Policy for Data and Safety Monitoring, NIH Guide for 
Grants and Contracts, June 12, 1998:  
https://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

SHARING RESEARCH DATA:  Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking $500,000 or more in 
direct costs in any single year are expected to include a plan for data 
sharing or state why this is not possible  
(https://grants.nih.gov/grants/policy/data_sharing).  Investigators should 
seek guidance from their institutions, on issues related to institutional 
policies, local IRB rules, as well as local, state and Federal laws and 
regulations, including the Privacy Rule.  Reviewers will consider the data- 
sharing plan, but will not factor the plan into the determination of the 
scientific merit or the priority score.

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH:  It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of 
the research.  This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43).

All investigators proposing clinical research should read the "NIH Guidelines 
for Inclusion of Women and Minorities as Subjects in Clinical Research - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts 
on October 9, 2001 
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines is available at 
https://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 
https://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 
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

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

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:  The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
https://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 
https://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 

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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	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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