RELEASE DATE:  August 11, 2004

PA NUMBER:  PAR-04-138  

March 2, 2006 (NOT-OD-06-046) – Effective with the June 1, 2006 submission date, 
all R03, R21, R33 and R34 applications must be submitted through using 
the electronic SF424 (R&R) application. This announcement will stay active for 
only the May 1, 2006 AIDS and AIDS-related application submission date. The 
non-AIDS portion of this funding opportunity expires on the date indicated below. 
A replacement R21 (PAR-06-362) funding opportunity announcement has been issued 
for the submission date of June 1, 2006 and submission dates for AIDS and 
non-AIDS applications thereafter.

EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006 

Department of Health and Human Services (DHHS)

National Institutes of Health (NIH)

National Institute of Child Health and Human Development (NICHD) 


                              November 23, 2005
                              November 22, 2006  


o Purpose of this PA
o Research Objectives
o Mechanism of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations


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 developmental infrastructure grants 
in support of population research relevant to the DBSB mission. Applicants may 
request funds to support infrastructure development 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 is one of two announcements inviting applications under the Population 
Research Infrastructure Program. This announcement invites applications for 
Developmental Infrastructure Awards. A separate announcement, RFA-HD-04-022, 
invites applications for Research Infrastructure Awards. A table summarizing 
the differences between the Research Infrastructure Award and the 
Developmental Infrastructure Award is available at: 

Developmental Infrastructure 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 full-fledged Research 
Infrastructure Award. 


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 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.  This announcement uses the R21 mechanism.  A corresponding 
announcement (RFA-HD-04-022) uses the R24 mechanism.

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. 

The Developmental Infrastructure 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 a 
Population Research Infrastructure Program Award (R24) within three to five 

Applicants 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.

Population Research Topics:

A description of the DBSB mission is available at  Illustrative examples of 
population research topics that fall within the DBSB mission include, but are 
not limited to, the list that follows. Applicants may consult with program 
staff listed under WHERE TO SEND INQUIRIES to discuss 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 for more 

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 

Infrastructure Support 

Applicants for the Developmental Infrastructure Award may request support in 
two categories: (1) Research Support Cores and (2) Developmental 
Infrastructure. Applicants are not required to request support in both 
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. 
For both categories of support, 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. 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 announcement.

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. 

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 

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 PA, 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 

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 or developmental 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.

This PA will use the NIH Exploratory/Developmental Grant (R21) award 
mechanism.  As an applicant you will be solely responsible for planning, 
directing, and executing the proposed project.

For this announcement, an applicant for an R21 award may request a project 
period of up to five years and a budget for direct costs of up to $150,000 per 
year.  Developmental Infrastructure Awards are not renewable.

This PA uses just-in-time concepts.  It also uses the modular budgeting format 
Specifically, if you are submitting an application with direct costs in each 
year of $250,000 or less, use the modular format.  This program does not 
require cost sharing as defined in the current NIH Grants Policy Statement at 


You may submit an application if your institution has any of the following 

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 
hold permanent (tenured or non-tenured) appointments with the applicant 
institution and 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. Because their association with the 
unit can be expected to be temporary, trainees, post-doctoral fellows, and 
visiting professors should not be counted toward this requirement. The "past 
three years" refers to the 36-month period preceding the application 
submission date for this announcement. "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 page limitations under the 
Application Guidelines at 
In latter case, 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 from NICHD related to 
population research in the three years prior to the application date, you may 
not apply for a Developmental Infrastructure Award. Developmental awards are 
nonrenewable and institutions may not simultaneously hold a Developmental 
Award and a Population Research Infrastructure Program Award.

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


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.


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 may consult with 
program staff listed under WHERE TO SEND INQUIRIES to discuss this 


We encourage your inquiries concerning this announcement and welcome the 
opportunity 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:  

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

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

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

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


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 D&B number can be obtained by calling (866) 705-5711 or 
through the web site at The D&B number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 
is available at in an 
interactive format.  For further assistance contact GrantsInfo, Telephone 
(301) 710-0267, Email:

SUPPLEMENTARY INSTRUCTIONS:  Applications for Infrastructure Development 
Awards (R21) should be prepared according to the Application Guidelines 
available at 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.

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 includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at

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, Room 5B01, MSC 7510
Bethesda, MD  20892-7510
Rockville, MD  20852 (for express/courier service)

APPLICATION PROCESSING: Applications must be mailed on or before the receipt 
dates listed in the heading of this PA. 

The CSR will not accept any application in response to this PA that is 
essentially the same as one currently pending initial review unless the 
applicant withdraws the pending application.  The CSR will not accept any 
application that is essentially the same as one already reviewed.  This does 
not preclude the submission of a substantial revision of an application 
already reviewed, but such application must include an Introduction addressing 
the previous critique.

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.


Applications submitted for this PA will be assigned to NICHD.  An appropriate 
scientific review group convened by the NICHD in accordance with the standard 
NIH peer review procedures ( will evaluate 
applications for scientific and technical merit.

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

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


Reviewers will evaluate each application for overall scientific merit 
according to the criteria provided below. Reviewers will also evaluate the 
merit of proposed Infrastructure Support Components. 

The size and scope of applicant programs are not a review criterion. 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 additional 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.


One primary criterion will be used to evaluate the overall scientific merit of 
an application for a Developmental Infrastructure 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 a Research 
Infrastructure Award within three to five years.

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

o 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.

o 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.

o 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 


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. In the review of a subsequent 
application for R24 funding, seed grant programs will be reviewed for their 
success in developing funded research projects relevant to the mission of 


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:

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.)

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.)


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


Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities
o Relevance of the applicant's research program to the DBSB mission.


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

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 
a complete copy of the updated Guidelines is available at  
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 

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 

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

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

Applicants may wish to place data collected under this PA 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.

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 
( 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 

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 PA is 
related to one or more of the priority areas. Potential applicants may obtain 
a copy of "Healthy People 2010" at 

AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal 
Domestic Assistance at 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    

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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NIH Funding Opportunities and Notices

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