POPULATION RESEARCH INFRASTRUCTURE PROGRAM

RELEASE DATE:  August 20, 2003

RFA Number:  RFA-HD-03-026  

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

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.864

LETTER OF INTENT RECEIPT DATE:  October 21, 2003

APPLICATION RECEIPT DATE:  November 21, 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 Demographic and Behavioral Sciences Branch (DBSB), Center for Population 
Research (CPR), invites applications for infrastructure grants in support of 
population research relevant to the DBSB mission.  Applicants may request 
funds to support infrastructure development and/or research designed to:  (1) 
enhance the quality and quantity of population research conducted at an 
institution; and (2) develop new research capabilities to advance population 
research through innovative approaches.  A central goal of this program is to 
facilitate interdisciplinary collaboration and innovation in population 
research while providing essential and cost-effective core services in 
support of the development, conduct, and translation of population research 
based in centers or comparable administrative units.  

This announcement invites applications for two types of award:  for full-
fledged Research Infrastructure Awards and for Developmental Awards.  
Developmental Awards are intended to support the development and demonstrate 
the feasibility of programs that have high potential for advancing population 
research, but have not yet fully developed the necessary resources and 
mechanisms to be competitive for a Research Infrastructure Award.

RESEARCH OBJECTIVES

Background

The Demographic and Behavioral Sciences Branch (DBSB) is one of three 
programs in the Center for Population Research of the NICHD.  The mission of 
the Branch is to foster research on the processes that determine population 
size, growth, composition, and distribution, and on the determinants and 
consequences of those processes.  This mission translates into a research 
portfolio that looks intensively at the demographic processes of fertility, 
mortality, and migration and at their broad interrelationships with larger 
social, economic, and cultural processes.  Areas of supported research 
include fertility and family planning, sexually transmitted disease, family 
and household demography, mortality and health, population movement, 
population and environment, and population composition and change.  Research 
supported by the Branch uses a broad spectrum of scientific approaches in the 
clinical, behavioral, and social sciences.

During the years 1972-2000, NICHD provided infrastructure support for 
population research through the Center Core Grant (P30) and Specialized 
Research Center Grant (P50) mechanisms.  In 1999, DBSB undertook a 
comprehensive review of this program to determine whether its structure and 
guidelines best served the future needs of population research.  A report 
summarizing the results of this review is available at 
http://www.nichd.nih.gov/about/cpr/dbs/pubs/report.pdf and from the program 
contact named under WHERE TO SEND INQUIRIES, below.  As a result of the 
review, DBSB is phasing out the P30 and P50 mechanisms in favor of the R24 
and R21 mechanisms. 

Objectives and Scope

The primary purposes of the Population Research Infrastructure Program are to 
provide resources to support and advance research that will improve 
understanding of the antecedents and consequences of population structure and 
change, facilitate interdisciplinary collaboration among investigators 
conducting population-related research, and promote innovative approaches to 
population research questions.  An additional goal is to facilitate 
interaction among scientists in locations throughout the United States that 
contributes to the integration and coordination of population research. 

The Infrastructure Grant retains some of the characteristics of traditional 
P30 and P50 grants.  It funds infrastructure to support a portfolio of 
population research housed in or coordinated by a center or other research 
unit (hereafter, "research unit" or "unit") at an institution.  However, it 
is designed to move beyond the traditional center grant mechanism to allow 
institutions to aggressively pursue scientific opportunities appearing at the 
boundaries between traditional population research and allied fields, and to 
facilitate partnerships among diverse scientists and institutions.  The 
Infrastructure Grant allows units to use funds to address not only the core 
support needs of existing projects, but to develop new directions and 
approaches to population research.  It asks applicants to design and propose 
infrastructure programs that will advance the interdisciplinary reach, 
innovation, and impact of their research programs, in addition to serving the 
existing needs of researchers.  It also allows the development of 
infrastructure that broadly serves the field of population research by 
translating and/or disseminating research findings and resources.

Institutions that have not held a P30, P50, or R24 grant related to 
population research in the three years prior to the application receipt date 
may, at their option, request to be considered for a R21 Developmental Award.  
This award is intended to support the development of research units that have 
high potential for advancing population research.  The award provides such 
units the opportunity to further develop the mechanisms and resources 
required to support and facilitate significant new contributions to the 
field, continue to build a substantial interdisciplinary portfolio of 
population research, and demonstrate their feasibility as full-fledged 
population research units.  Applicants for Developmental Awards are expected 
to demonstrate the potential for becoming competitive for an R24 
Infrastructure Award within three to five years.

Applicants responding to this RFA must articulate a clear vision for their 
research unit and its current and future contributions to population 
research.  Applicants must identify the signature population-related themes 
of the unit and these must be relevant to the DBSB mission.  Signature themes 
are defined as research topics that exemplify the applicant program's most 
significant current and/or anticipated contributions to population research.  
The themes should reflect major strengths of the program and need not 
encompass all research topics covered by program researchers.  Applicants 
must also articulate a vision for the potential future contributions of the 
program.

A description of the DBSB mission is available at 
http://www.nichd.nih.gov/about/cpr/dbs/dbs.htm.  Illustrative examples of 
population research topics that fall within the DBSB mission are listed 
below.  Applicants are encouraged to consult with program staff listed under 
WHERE TO SEND INQUIRIES to determine the relevance of other topics to the 
DBSB mission. 

1. Research on the antecedents and consequences of changes in population 
size, structure, and composition, including the documentation, analysis, 
and/or projection of population composition with respect to demographic, 
economic, social, and geographic characteristics; economic and social 
mobility; the relationship of economic, social, and cultural factors to 
population change; and the interrelationship between population and the 
physical environment.

2. Research on families and households, including studies of the determinants 
of trends in marriage, divorce, and cohabitation; the formation of and 
changes in household structures, fatherhood, patterns of child support and 
visitation with absent parents; the use of child care services; the 
relationship between changing fertility and family patterns and the well-
being of children; intergenerational demography; and the implications of 
welfare and health policies on families.

3.  Fertility research, including research on individual, social, economic, 
and cultural determinants and consequences of fertility and fertility trends, 
on the interrelationship between fertility patterns and education, work, 
union formation and dissolution, family structure, and health; and on 
contraceptive use, abortion, and sexual behavior. 

4.  Research on population movement and distribution, including studies of 
the determinants and consequences of international and internal migration and 
residential mobility, assimilation and adaptation of migrants; migrant 
selectivity; residential segregation; and spatial demography.

5. Demographic aspects of health, morbidity, disability, and mortality, 
including research on infant mortality and low birth weight; health 
disparities; research that relates demographic and social processes to 
mortality and health across the life course; and the health and well-being of 
children (see http://www.nichd.nih.gov/cpr/dbs/dbsb_mission.htm for more 
information).

6. Behavioral research on the sexual transmission of HIV, including 
demographic studies of sexual behaviors related to HIV transmission; studies 
of the interrelationships between social, institutional, economic, and 
cultural contexts and sexual behavior; studies of the interrelationships 
among pregnancy, pregnancy prevention, and HIV prevention; theoretically 
grounded intervention studies within these areas; and related methodological 
studies (see https://grants.nih.gov/grants/guide/pa-files/PAS-00-136.html).

Infrastructure Support - R24 Research Infrastructure Awards 

R24 applicants may request support in the following categories:  (1) Research 
Support Cores; (2) Developmental Infrastructure; (3) Research Projects; and 
(4) Public Infrastructure.  Applicants are not expected to request support in 
all or even most of the categories; rather, they should request types and 
levels of support that best suit their needs and objectives.  The NICHD 
expects that the amount and allocation of infrastructure support that 
applicants request will vary substantially. 

The first three categories of infrastructure support are intended to advance 
the scientific program of the applicant research unit.  For these categories, 
applicants must justify the types and amounts of support requested in terms 
of:  (1) the scope, objectives, and current and potential impact of the 
applicant's research program; (2) the potential contribution of requested 
infrastructure to advancing the research program; and (3) the cost-
effectiveness of the requested support.  Applicants are expected to define 
guidelines for determining the eligibility of researchers and research 
projects to access resources provided under this program, and guidelines and 
procedures for allocating such resources.  No restrictions on access (e.g., 
by students, investigators lacking research support, investigators in fields 
other than population research) are imposed under this announcement.  
However, applicants must demonstrate that their proposed guidelines and 
procedures for controlling access to core resources are consistent with the 
goal of effectively advancing the scientific program of the unit and the 
goals of this RFA.

Definitions of Infrastructure Support Categories:

1. Research Support Cores provide shared resources that support the 
applicant's research program.  Examples include: 

o  Administrative Core, providing for coordination of research, editorial 
services, and/or assistance with grant application development and fiscal 
management of grants.

o  Computing Core, providing equipment and/or services supporting shared 
computing needs. 

o  Information Core, providing support for retrieving information, materials, 
and data commonly used in population research.  

o  Methodology Support Cores, providing support for specific methodologies 
employed in population research (e.g., GIS, statistical methods, biomarkers, 
survey methodologies).

Research Support cores should be designed to advance the applicant's research 
program while providing essential, cost-effective services to support on-
going research activities.  Cores should be designed to facilitate and 
promote innovation in the science conducted by program researchers in 
addition to responding to researcher needs.  Equipment and support services 
that are specific to individual research projects or researchers are not 
allowable, except in the context of individual research projects that may be 
proposed in response to this RFA. 

2. Developmental Infrastructure refers to activities that promote the 
development of new research capabilities.  Such activities may lead to 
outcomes such as innovative projects and approaches, new interdisciplinary 
collaborations, the scientific development of junior researchers, or the 
integration of experienced researchers from other fields into population 
research.  Examples of potential developmental infrastructure activities 
include:

o  Seed grant programs, providing funds for the development of new research 
projects.  Institutions proposing seed grant programs must develop guidelines 
and eligibility requirements appropriate to the goals of this RFA, and 
procedures and policies for administration of the program.  Issues that may 
be addressed include (but need not be limited to):  (1) priorities for 
allocating funds (e.g., junior researchers, specified areas of research, 
interdisciplinary work, etc.); (2) procedures for reviewing applications; (3) 
requirements for leveraging funds or preparing research proposals to continue 
or expand the research project; (4) size of awards; (5) length of award 
periods; (6) number of awards permitted to an individual researcher; (7) 
mentoring arrangements; and (8) support for the program from the parent 
institution or other funding sources.

o  Faculty development, providing for partial salary support or other support 
for the recruitment of new faculty in scientific areas critical to the 
development of innovative and/or interdisciplinary research directions.  
Support for any one individual may not exceed three years in duration.  

o  Activities that foster the development of new core services.  For example, 
applicants may propose to hire consultants to assist with the design of GIS 
services, or conduct pilot studies to evaluate the cost-effectiveness of 
alternative modes of core service delivery. 

o  Workshops, conferences, seminar series, and visiting scholar programs that 
lay the groundwork for new substantive work or foster new research 
collaborations.

3.  Research Projects proposed for R24 support must be of R01 quality, must 
directly address and advance the program's central scientific objectives and 
signature population-related themes, and should emphasize innovative, 
interdisciplinary, and/or cross-cutting elements.  Institutions are 
encouraged to consider R01 and other research grant mechanisms for the 
support of research projects that do not explicitly meet these criteria.

4.  Public Infrastructure activities differ from the first three categories 
of infrastructure support in that they are not solely intended to advance the 
research program at the applicant institution, but are primarily directed 
instead at significant external audiences.  These audiences may include (but 
are not limited to) the broad community of population researchers or 
communities concerned with public policy or health or social programs.  

o Illustrative examples of activities benefiting the broader scientific 
community include:  supporting and disseminating databases of high relevance 
to population research; developing and disseminating multidisciplinary 
bibliographic databases; and providing infrastructure for data sharing.  

o Illustrative examples of activities benefiting policy or program audiences 
include the development of tools for effectively communicating population 
research findings to relevant audiences and innovative strategies for 
translating basic research findings for application to programs designed to 
improve health and well-being.  

Applicants are encouraged to request funds for public infrastructure 
activities only when they can justify:  (1) that these activities will 
significantly advance the field of population research and/or benefit policy 
or practice communities; (2) that the proposed activity does not duplicate 
existing resources or services; and (3) that the proposed activity is cost-
effective.  They should also address the time frame during which the 
resource(s) or service(s) will be needed, and the short- and long-term plans 
for supporting them.  This plan should address, as applicable, expectations 
for NICHD support, support from the institution and other sources of support, 
and plans for charging users and managing program income.

Applicants may propose to cooperate with other institutions in undertaking 
any of the above-mentioned infrastructure activities.  Cooperative activities 
may include the development of research partnerships involving scientists in 
the applicant's program and colleagues in other institutions, and/or joint 
ventures with other institutions to provide research, developmental, or 
public infrastructure services.  Proposed research partnerships must be 
justified in terms of the scientific advances to be gained through 
collaboration across institutions relative to those likely to emerge from 
within-institution partnerships.  Examples of allowable activities include 
travel for project development and coordination and use of research support 
core, seed project, and research project funds.  Applicants also may propose 
cooperative research support, developmental, or public infrastructure 
services in which the applicant and a Population Center or similar unit in 
another institution participate in joint funding and administration of a 
common service or resource.  Examples might include a shared library, data 
archive or outreach effort.  Partners in a cooperative venture need not be 
another funded applicant or Center.  Applicants must clearly describe the 
rights and responsibilities of each proposed partner in the funding, 
administration, and use of shared resources.

Infrastructure Support - R21 Developmental Awards 

R21 applicants may request support in only two categories:  (1) Research 
Support Cores and (2) Developmental Infrastructure.  Although applicants may 
not request support for R01-like research projects, they may request support 
for developmental activities, using a seed grant or similar mechanism (see 
description under Developmental Infrastructure, above).  Specific guidelines 
for these categories are provided above under "Infrastructure Support - R24 
Research Infrastructure Awards."  Applicants must justify the types and 
amounts of support requested in terms of:  (1) the scope, objectives, and 
current and potential impact of the applicant's research program; (2) the 
potential of the requested infrastructure to develop the resources and 
mechanisms required to build a substantial interdisciplinary portfolio of 
population research and facilitate significant new contributions to the 
field; and (3) the cost-effectiveness of the requested support.  All other 
guidelines pertaining to infrastructure requests for R24 Research 
Infrastructure Awards apply also to R21 awards.

MECHANISM OF SUPPORT

This RFA will use the NIH Exploratory/Developmental Grant (R21) and the 
Resource-Related Research Project (R24) award mechanisms.  A table 
summarizing the differences between the R21 and R24 mechanisms as applied to 
this RFA is available at: 
http://www.nichd.nih.gov/RFA/HD-03-026/HD-03-026.htm.  NICHD expects to issue 
an RFA annually to solicit applications for this program; applications may be 
submitted only in response to an RFA.  As an applicant you will be solely 
responsible for planning, directing, and executing the proposed project.  The 
anticipated award date is July 01, 2004.  

This RFA uses just-in-time concepts.  It also uses the modular as well as the 
non-modular budgeting formats (see 
https://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, if 
you are submitting an application with direct costs in each year of $250,000 
or less, use the modular format.  Otherwise follow the instructions for non-
modular research grant applications.  This program does not require cost 
sharing as defined in the current NIH Grants Policy Statement at 
https://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm.

FUNDS AVAILABLE

The NICHD intends to commit approximately $2.5 million in total costs [Direct 
plus Facilities and Administrative (F & 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 R21 may request a project period of up to five years and a 
budget for direct costs of up to $150,000 per year (including F & A costs on 
subcontracts). An applicant for an R24 Research Infrastructure Award should 
request a project period of five years and should request support appropriate 
to the size and impact of their scientific portfolio and to the goals of 
their infrastructure program.  As a general rule, NICHD expects direct cost 
budget requests for R24 applications to average approximately $15,000 for 
each researcher in the program who can provide evidence of research activity 
directly relevant to the DBSB mission in two or more of the following 
categories:  (1) externally funded research grants or contracts in the past 
three years; (2) publications in peer-reviewed journals during the past three 
years; and (3) papers in preparation and future plans for research. See 
ELIGIBLE INSTITUTIONS, below, for further information on these categories of 
research activity.  Requests may vary from the guideline provided above as 
justified by evidence of exceptionally high impact or productivity or special 
features of the proposed infrastructure program.  Applicants may request 
additional funds beyond those suggested by the guideline for Public 
Infrastructure activities (see RESEARCH OBJECTIVES, above). Applicants are 
encouraged to discuss budget requests with program staff listed under WHERE 
TO SEND INQUIRES, below, prior to submission.
 
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 Faith-based or community-based organizations 
o Domestic institutions

Foreign institutions are not eligible to apply.

Applicant institutions must have an established research center or other 
administrative unit (referred to as the "research unit" or "unit") that 
serves as a focal point for or coordinates population research across the 
institution.  This unit must have a defined governance structure.  

The research conducted at the unit should reflect scientific benefits and 
cost-efficiencies resulting from cooperation and interaction among a pool of 
scientists with shared interests in population research.  Applicants should 
have in place (or propose in their applications) effective mechanisms for 
fostering the development of an intellectual community that bridges 
investigators from different disciplines and different projects and promotes 
innovation in population research.  

To be eligible to apply, the unit must have at least three researchers who 
can present evidence of research activity related to the mission of DBSB in 
all three of the following categories:  (1) externally funded research grants 
or contracts in the past three years; (2) publications in peer-reviewed 
journals during the past three years; (3) papers in preparation and future 
plans for research.  The "past three years" refers to the 36-month period 
preceding the application submission date for this RFA.  "Externally funded" 
means funding is received from sources outside the institution; it may 
include funding from NIH, NSF, other federal agencies, state and local 
governments, and private foundations.  Include only projects on which the 
individual has served as Principal Investigator or had substantial 
involvement, comparable to that indicated by identification of an 
investigator as "key personnel" on an NIH-funded grant.

Note that the criterion used for unit eligibility above (at least three 
researchers with evidence of research activity in all three categories) 
differs from the criteria used to define guidelines for requested budgets 
under FUNDS AVAILABLE and to define page limitations under the Application 
Guidelines at http://www.nichd.nih.gov/RFA/HD-03-026/HD-03-026.htm.  In each 
of the latter two cases, the criterion of an "active researcher" is evidence 
of research activity in at least two of the three categories defined above.  

If your institution has held a P30, P50, or R24 grant related to population 
research in the three years prior to the application date, you may not apply 
for an R21 Developmental Award.  Developmental awards are nonrenewable and 
institutions may not simultaneously hold a Developmental Award and a Research 
Infrastructure Award.

Potential applicants are strongly encouraged to contact staff listed under 
WHERE TO SEND INQUIRIES, below, to discuss eligibility prior to submission of 
an application.

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 Principal Investigator should be a scientist or science administrator who 
can provide effective administrative and scientific leadership.

SPECIAL REQUIREMENTS

Because the Infrastructure Program is expected to enhance the unit's 
competitiveness for NIH funding, the institution and pertinent departments 
are expected to show a strong commitment to the unit by providing additional 
infrastructure support at a level appropriate to the resources of the 
institution and the scope of the proposed program activities.  Such 
commitment may be demonstrated by the provision of dedicated space, faculty 
appointments in subject areas relevant to the goals of the unit's research 
program, salary support for investigators or core staff, dedicated equipment, 
or other financial support for the proposed program. Applicants are 
encouraged to consult with program staff listed under WHERE TO SEND INQUIRIES 
to discuss this requirement.  
  
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:  

Dr. Christine Bachrach
Chief, Demographic and Behavioral Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8B07, MSC 7510
Bethesda, MD  20892-7510
Telephone: (301) 496-9485
FAX:    (301) 496-0962
Email:  cbachrach@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:  

Dr. Christine Bachrach
Chief, Demographic and Behavioral Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8B07, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-9485
FAX:  (301) 496-0962
Email:  cbachrach@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 
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.  

SUPPLEMENTAL INSTRUCTIONS:  Applications for Research Infrastructure Awards 
(R24) and Developmental Awards (R21) should be prepared according to the 
Application Guidelines available at 
http://www.nichd.nih.gov/RFA/HD-03-026/HD-03-026.htm 
and from program staff listed under WHERE TO SEND INQUIRIES.  
All instructions and guidelines accompanying the PHS 398 are to 
be followed, with the exception of the sections modified by these guidelines.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:  Applications 
requesting up to $250,000 per year in direct costs must be submitted in a 
modular grant format.  The modular grant format simplifies the preparation of 
the budget in these applications by limiting the level of budgetary detail.  
Applicants request direct costs in $25,000 modules.  Section C of the 
research grant application instructions for the PHS 398 (rev. 5/2001) at 
https://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at 
https://grants.nih.gov/grants/funding/modular/modular.htm.

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.  

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 National Institute of Child Health and Human Development 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. 

Applicants should anticipate that no site visit will be conducted and ensure 
that their applications are complete at the time of submission.

REVIEW CRITERIA

Reviewers will evaluate each application for overall scientific merit 
according to the criteria provided below.  Separate criteria are provided for 
judging the overall merit of R24 Research Infrastructure Awards and R21 
Developmental Awards.  Reviewers will also evaluate the merit of proposed 
Infrastructure Support Components.  

The size and scope of applicant programs are not a review criterion under 
either the R24 or R21 mechanism.  NICHD believes that investments of 
infrastructure resources in small centers of excellence with focused 
scientific programs may be highly cost-efficient for the field.  Reviewers 
are encouraged to take the number of researchers involved in a program into 
account in applying the review criteria below, particularly when evaluating 
current and potential program impact.  While both larger and smaller programs 
are expected to demonstrate research activity of high quality, programs with 
fewer researchers would not be expected to demonstrate the same quantity of 
research productivity and program impact as programs with a greater number of 
researchers.

Overall Program - R24 Research Infrastructure Awards:

Three primary criteria will be used to evaluate the overall scientific merit 
of an application for a Research Infrastructure Award:  

1) Quality of the research program and its impact on the field:  reviewers 
will consider the significance, innovation, and quality of current and recent 
contributions of program scientists.  Considering both the applicant's 
signature population-related themes and other relevant research, have these 
contributions produced new knowledge and/or new approaches to research that 
have significantly expanded, improved or altered the content, methods, and 
direction of population research? Reviewers may consider the impact of large-
scale projects that benefit the field broadly, creation of interdisciplinary 
collaborations, training and mentoring of junior researchers, scientific 
leadership of program personnel, and translational activities to improve 
clinical practice, public intervention programs, and public policy 
formulation.  The number of researchers involved in the program will be taken 
into account in evaluating impact.   

2) The potential future contributions of the applicant's program to 
population research:  Reviewers will base their assessment of potential on 
such factors as the current trajectory of research productivity, innovation, 
and accomplishments; the applicant's vision for the potential future 
contributions of the program; the plan for advancing the scientific program; 
and the applicant's success in contributing to the development of junior 
researchers.

3) The applicant program's success in creating an active intellectual 
community that encourages synergy and intellectual exchange among population 
researchers and advances innovative and/or interdisciplinary research.
 
Applicants proposing only Public Infrastructure activities will be judged on 
the basis of the secondary criteria below and the detailed review criteria 
listed below under "Public Infrastructure."

Three secondary criteria will also be used to assess the overall scientific 
merit of applications:

1) Quality and potential impact of proposed infrastructure program:  
Reviewers will examine the overall quality, scientific merit, and innovation 
of the activities to be supported. Reviewers will consider the likelihood, 
based on existing capabilities and proposed activities, that the proposed 
program will enhance population research, promote new research directions, 
facilitate interactions across disciplines and substantive areas of study, or 
advance theoretical or technical approaches. For infrastructure components 
benefiting audiences outside the population research community, reviewers 
will assess potential impact in terms of improving the accessibility of 
population research to significant audiences and enhancing the appropriate 
application of research findings to activities that improve health and well-
being.

2) Research competence of key personnel:  reviewers will consider the 
capability and scientific credentials of the Principal Investigator to direct 
the Program and maintain high standards of research collaboration; the 
specific technical qualifications of core directors; and the scientific 
accomplishments of all participating investigators.

3) Institutional commitment and environment:  reviewers will assess the 
nature and level of resource commitment from the institution in which the 
center is housed and any cooperating institutions, taking into account the 
institutional context.  Reviewers also will consider the academic and 
physical environment as it bears on research opportunities, space, equipment, 
and the potential for interaction with scientists from various departments, 
institutions or disciplines.

Overall Program - R21 Developmental Award:

One primary criterion will be used to evaluate the overall scientific merit 
of an application for a Developmental Award:  

The potential future contributions of the applicant program to population 
research: reviewers will base their assessment of potential on such factors 
as the current level and trajectory of research productivity, innovation, 
quality and significance; the significance of the applicant's central 
scientific objectives and signature population-related themes and the plan 
for advancing them; the program's plan for encouraging synergy and 
interaction among population researchers; and the applicant's success in 
contributing to the development of junior researchers.  Applicants rated 
favorably on this criterion will have high potential for becoming competitive 
for an R24 Infrastructure Award within three to five years.

Three secondary criteria will also be used to assess the overall scientific 
merit of applications:

1) Quality and potential impact of proposed infrastructure program:  
reviewers will examine the overall quality, scientific merit, and innovation 
of the activities to be supported.  Reviewers will consider the likelihood, 
based on existing capabilities and proposed activities, that the proposed 
program will develop the resources and mechanisms required to build a 
substantial interdisciplinary portfolio of population research and facilitate 
significant new contributions to the field.

2) Research competence of key personnel:  reviewers will consider the 
capability and scientific credentials of the Principal Investigator to direct 
the program and maintain high standards of research collaboration; the 
specific technical qualifications of core directors; and the scientific 
accomplishments of all participating investigators.

3) Institutional commitment and environment:  reviewers will assess the 
nature and level of resource commitment from the institution in which the 
center is housed and any cooperating institutions, taking into account the 
institutional context.  Reviewers also will consider the academic and 
physical environment as it bears on research opportunities, space, equipment, 
and the potential for interaction with scientists from various departments, 
institutions or disciplines.

Infrastructure Support Components:

For both R21 and R24 applications, each individual element of the proposed 
infrastructure program will be evaluated separately based on the criteria 
below.

Research Support Cores 

o Potential or actual contribution of the proposed core to advancing research 
within the applicant unit, by: enhancing the productivity of the existing 
scientific program; fostering new scientific advances; facilitating 
interactions across disciplines and substantive areas of study; and/or 
advancing theoretical or technical approaches. 

o Appropriateness to the size and characteristics of the applicant's existing 
research program and the vision for the potential future contributions.

o Qualifications, experience, and commitment to the program of the 
investigators responsible for the cores or activities and their ability to 
devote the required time and effort to the program; and

o Cost-effectiveness of services or activities and appropriateness of cost-
sharing arrangements with the institution, relevant departments, and other 
external infrastructure support programs.

Developmental Infrastructure

o Potential of the proposed activity to advance research within the 
applicant's unit by stimulating innovation in population research and/or 
fostering the development of junior researchers.

o Appropriateness to the size and characteristics of the applicant's existing 
research program and the vision for the potential future contributions.

o Qualifications, experience, and commitment to the program of the 
investigators responsible for the activities and their ability to devote the 
required time and effort to the program; and

o Cost-effectiveness of services or activities and appropriateness of cost-
sharing arrangements with the institution, relevant departments, and other 
external infrastructure support programs.

o For seed grant programs proposed under "Developmental Infrastructure," the 
appropriateness and quality of procedures and policies for administering the 
program, such as guidelines for reviewing applications, priorities for 
allocating funds, requirements for leveraging funds, and size and length of 
awards, and other program guidelines.  Upon renewal, seed grant programs will 
be reviewed for their success in developing funded research projects relevant 
to the mission of DBSB.

Research Projects (R24 only):

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?  

Each proposed research project will also be evaluated with respect to:

o The contribution of the project to advancing the unit's signature 
population-related themes and the extent to which it embodies innovative, 
collaborative, and/or cross-cutting elements of the unit.

Public Infrastructure (R24 only):

Public infrastructure components will be evaluated according to the following 
criteria:

o For activities intended to benefit the research community, the value and 
significance of the proposed activity for population researchers and its 
potential for promoting interdisciplinary and/or innovative population 
research.

o For activities directed to policy, program, or other audiences, the 
significance of the proposed activity and its potential for improving the 
accessibility of population research to significant audiences and enhancing 
the appropriate application of research findings to activities that improve 
health and well-being. 

o Appropriateness of the targeted audiences and the adequacy of the plans for 
disseminating the proposed activities, resources, or services to these 
audiences.

o Cost-effectiveness of services or activities and appropriateness of  the 
short- and long-term plans for supporting them (including cost-sharing 
arrangements).

o Qualifications, experience, and commitment to the program of the 
investigators responsible for the cores or activities and their ability to 
devote the required time and effort to the program.

Applications proposing to undertake any infrastructure activity in 
cooperation with another institution will be evaluated for the value added by 
the involvement of other institutions and the appropriateness and adequacy of 
plans for the sharing of rights and responsibilities among proposed partners 
with respect to the funding, administration, and use of shared resources.

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.)

ADDITIONAL CONSIDERATIONS

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:  October 21, 2003
Application Receipt Date:  November 21, 2003
Peer Review Date:  February/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 Relevance of the applicant's research program to the DBSB mission.

Within applications recommended for funding, specific infrastructure 
components may be funded selectively.

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

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: https://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 
(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.

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.  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 
https://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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