MENTAL RETARDATION AND DEVELOPMENTAL DISABILITIES RESEARCH CENTERS 

RELEASE DATE:  September 3, 2004

RFA NUMBER:  RFA-HD-04-024 (This RFA has been reissued, see RFA-HD-05-030) 

EXPIRATION DATE:  December 22, 2004

Department of Health and Human Services (DHHS)
 
PARTICIPATING ORGANIZATION:

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

COMPONENT OF PARTICIPATING ORGANIZATION:
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 21, 2004
APPLICATION RECEIPT DATE: December 21, 2004  

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 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. 
NICHD strongly encourages translation of basic research observations into 
patient-oriented protocols whose ultimate aims are to validate the mechanistic 
basis of MRDD in humans and to develop new approaches for the prevention, 
diagnosis, and treatment of MRDD. Consequently, applications for MRDDRC Center 
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 in MRDD, 
including sources of variability, 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, 
peer, 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 to 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.

Applications must be prepared in a manner consistent with the guidelines 
presented in the "NICHD P30 CENTER CORE GRANT GUIDELINES" (by 
http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm).  The anticipated award 
date is July 1, 2005. At this time, it is not known if this RFA will be 
reissued. 

This program does not require cost sharing as defined in the current NIH 
Grants Policy Statement at 
http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.  

FUNDS AVAILABLE

The NICHD intends to commit approximately $4.3 million in total costs [Direct 
plus Facilities and Administrative (F & A) costs] in FY 2005 to support up to 
four new and/or competing continuation grants in response to this RFA.  An 
applicant for a new grant may request a project period of five years and 
budget for direct cost of up to $750,000 per year.  An applicant for a 
competing continuation may request a project period of five years and a budget 
for initial year direct costs of $750,000 or the amount representing an 
increase of 10 percent above the direct costs awarded in the final non-
competing (Type 5) year, 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 without 
review. 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 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
o 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.   

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.

SPECIAL REQUIREMENTS

o 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 among the 10 externally funded research 
projects.

o An MRDDRC must contain an Administrative Core and a minimum of two 
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 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. 

o Budgetary items allowable for Administrative Core Units include salaries and 
support for a limited number of administrative and clerical personnel; 
administrative support services, when not covered by institutional Facilities 
and Administrative (F & A) charges; 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 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 consultant 
services.

o The applicant must name a scientist to be responsible for each Core unit 
proposed. The description of each Core unit should include a rationale, 
indicating how the Core will support the research effort in an efficient and 
cost-effective manner. Cores should integrate with or buy in to existing 
institutional resources rather than duplicate them. Core support to individual 
investigators should not overlap with support already available to them from 
other sources. 

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/information sharing and integration, 
3) synthesis of knowledge about MRDD, and 4) translational research that will 
lead to amelioration and prevention. Each Center application should present 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 direct costs 
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, to facilitate the development of new research 
programs of newly trained investigators or investigators new to MRDD research, 
or to facilitate use of a Core at one Center by investigators affiliated with 
another Center that lacks that kind of Core. 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 MRDDRC network. The Administrative Core 
should budget for interactive functioning including meetings to develop common 
protocols, databases, and communications and informatics technologies.

o 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 http://grants.nih.gov/grants/policy/data_sharing/. 
The reviewers will assess the reasonableness of the data sharing plan or the 
rationale for not sharing research data. 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
6100 Executive Boulevard, 4B09E, MSC 7510
Bethesda, MD  20892-7510
Telephone: (301) 402-1822
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, 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:  

Chris Robey
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8A17, MSC 7510
Bethesda, MD  20892-7510
Telephone: (301) 435-6996
FAX: (301) 480-4783
Email: robeyj@mail.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
6100 Executive Boulevard, 4B09E, MSC 7510
Rockville, MD 20852 (for express/courier service)
Bethesda, MD  20892-7510
Telephone: (301) 402-1822
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 
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.
 
SUPPLEMENTARY INSTRUCTIONS:  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: 
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 and all 
copies of the appendix material must be sent to:  

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, 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.  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

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). 

In addition to the review criteria applied to new applications, review of 
competing continuation (renewal) applications (type 2) will evaluate the 
progress made by a Center in the previous funding period. The reviewers will 
evaluate productivity of investigators affiliated with a Center by the number 
and impact of their publications that acknowledge support by the Center grant.

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 will be assessed.  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 

SHARING RESEARCH DATA:  Applicants requesting $500,000 or more 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 21, 2004
Application Receipt Date:  December 21, 2004
Peer Review Date:  March/April 2005
Council Review:  June 2005
Earliest Anticipated Start Date:  July 01, 2005

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

ANIMAL WELFARE PROTECTION:  Recipients of PHS support for activities involving 
live, vertebrate animals must comply with PHS Policy on Humane Care and Use of 
Laboratory Animals 
(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as 
mandated by the Health Research Extension Act of 1985 
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA 
Animal Welfare Regulations 
(http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable.

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: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

SHARING RESEARCH DATA:  Investigators submitting an NIH application seeking 
$500,000 or more in direct costs in any single year are expected to include a 
plan for data sharing or state why this is not possible 
(http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek 
guidance from their institutions on issues related to institutional policies, 
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 
(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.  

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.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on 
hESCs can be found at http://stemcells.nih.gov/index.asp and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (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 
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). 

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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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