SOCIAL AND DEMOGRAPHIC STUDIES OF RACE AND ETHNICITY IN THE UNITED STATES

RELEASE DATE:  January 16, 2003  

PA NUMBER:  PA-03-057

EXPIRATION DATE:  February 1, 2006, unless reissued.

National Institute of Child Health and Human Development (NICHD)
 (http://www.nichd.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI) 
 (http://www.nhlbi.nih.gov/)
National Human Genome Research Institute (NHGRI) 
 (http://www.genome.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 
 (http://www.niddk.nih.gov/)
National Institute of Mental Health (NIMH) 
 (http://www.nimh.nih.gov/)
National Institute on Aging (NIA) 
 (http://www.nia.nih.gov/)
National Institute on Drug Abuse (NIDA) 
 (http://www.nida.nih.gov/) 

THIS PROGRAM ANNOUNCEMENT CONTAINS THE FOLLOWING INFORMATION

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

PURPOSE OF THIS PA

The National Institute of Child Health and Human Development (NICHD), the 
National Heart, Lung and Blood Institute (NHLBI), the National Human Genome 
Research Institute (NHGRI), the National Institute of Diabetes and Digestive 
and Kidney Diseases (NIDDK), the National Institute of Mental Health (NIMH), 
the National Institute on Aging (NIA), and the National Institute on Drug 
Abuse (NIDA) invite qualified researchers to submit research grant 
applications on the demography and social science of race and ethnicity in 
the United States.  The goal of this program announcement is to encourage 
research that will improve understanding of race and ethnicity in social 
science and demographic research.  Demographic and social aspects of race and 
ethnicity include issues related to understanding how the changing 
composition and conceptualization of race and ethnicity are affecting the 
U.S. socially, economically, and demographically, including how increasing 
racial and ethnic diversity are affecting population health and health 
disparities; issues related to the development of racial and ethnic identity 
and to interactions between racial/ethnic identification and demographic, 
health, and other outcomes; and issues related to the measurement of race and 
ethnicity, including racial and ethnic self-identification.  Potential 
applicants are strongly encouraged to contact the Program Contact for 
Scientific/Research issues listed under WHERE TO SEND INQUIRIES, below.

RESEARCH OBJECTIVES

Since the 1960s, a series of policy changes have profoundly altered the 
racial and ethnic composition of the U.S.  One key change was the 1965 
amendments to the 1962 immigration law, which ended the immigration system 
that had favored immigrants from Europe, and resulted in increases in 
immigration from Asia and Central America.  Other policy changes also 
influenced the economic, social, and political opportunities available to 
racial and ethnic minority groups; these included the Civil Rights Act of 
1964, the 1965 Voting Rights Act, the Fair Housing Act of 1968, and the 
Supreme Court's 1967 ruling in Loving versus Virginia that ruled anti-
miscegenation laws unconstitutional.  Recent policy changes, such as the 
Personal Responsibility and Work Opportunities Reconciliation Act of 1996 
(PRWORA, often referred to as "Welfare Reform"), have also significantly 
affected racial and ethnic groups and immigrants.  Over the last four 
decades, the proportion of the U.S. population that is non-Hispanic white has 
declined, while the proportions that are Hispanic and Asian have risen 
substantially.  By 2000, Hispanics had surpassed blacks as the largest 
racial/ethnic minority group in the U.S.  The share of the population that 
reports being of more than one race or of mixed race in vital statistics 
registries and in social science surveys has also risen.

In response to these demographic changes, as well as to an heightened 
attention to racial and ethnic identity, the legacy of the civil rights 
movement, and recent advances in genetic research that call into question 
some commonly held beliefs about the biological basis for apparent racial and 
ethnic differences, Americans are grappling with how to best conceptualize 
race and ethnicity.  In 1997, the U.S. Office of Management and Budget (OMB) 
announced new standards for Federal data on race and ethnicity.  The 2000 
Census used these new standards, a system that allows for tabulation of 126 
racial and ethnic categories.  (See Section C. Conceptualizing, Measuring, 
and Modeling Race and Ethnicity, below, for a more detailed explanation of 
the OMB standards.) 

But while categorizing race and ethnicity becomes more detailed and exact, 
the meaning of these distinctions is becoming less certain.  Recent advances 
in our understanding of genetics made possible by the Human Genome Project 
show that while the frequency of certain genetic variants does vary to some 
extent among groups based on the groups' ancestral origins, no precise 
boundaries between identified racial groups can be drawn (Collins, 2001).  In 
May 2001, the editor of the New England Journal of Medicine declared "I 
maintain that attributing differences in a biologic end point to race is not 
only imprecise but also of no proven value in treating an individual patient 
...Race is a social construct, not a scientific classification" (Schwartz, 
2001).  The editors of the Archives of Pediatrics and Adolescent Medicine 
were particularly critical of past uses of race and ethnicity in medical 
research, stating that "[a]nalysis by race and ethnicity has become an 
analytical knee-jerk reflex."  Noting that the Human Genome Project has 
established "…there is a greater range of genetic differences within such 
groups as 'white' or 'black' than between groups," and that "[t]here is no 
biological or scientific basis for the term 'race' much less the categories 
commonly used to describe it," they asked authors not to use race and 
ethnicity "when there is no biological, scientific, or sociological reason 
for doing so," and further instructed authors not to use race as an 
explanatory variable when it is actually capturing socioeconomic variation 
(Rivara and Finberg, 2001).  

Race continues to be a key variable in most social science research.  Goals 
of this PA are to clarify what is captured by "race" and "ethnicity" in 
social science analysis, and to elaborate the complex social, cultural, and 
psychological processes that underlie racial and ethnic identification and 
its meaning in social science analysis.  This PA calls for research in three 
broad areas:  (a) causes and consequences of the changing racial and ethnic 
composition of U.S. society, including effects on population health and 
health disparities; (b) issues related to the development, maintenance, and 
consequences of racial and ethnic identity; and (c) developing and validating 
methods of conceptualizing, measuring, and modeling race and ethnicity.  
Illustrative examples of possible research topics are listed below each of 
these headings in the sections that follow. 

A.  Causes and Consequences of the Changing Racial and Ethnic Composition of 
U.S. Society

In the past 30 years the U.S. has become increasingly diverse.  The primary 
factor contributing to this diversity has been immigration; other influences 
are differential fertility among ethnic and racial groups and intermarriage.  
Social and economic factors influencing the trend may include changes in 
labor markets, economic restructuring, changing social and cultural attitudes 
and norms, and social policies that influence the opportunities for social 
and economic advancement of minority individuals.  The consequences of 
increasing diversity on the economic, social, and cultural fabric of the U.S. 
are still largely conjectural, and may ultimately depend on how communities, 
institutions, individuals, and social policy respond to the changes in our 
population.  Research can make a valuable contribution to understanding these 
consequences and how they may be moderated under different circumstances.
Examples of topics that address the changing racial and ethnic composition of 
U.S. society include, but are not limited to, the following:

o How are economic, social, and demographic factors and government policies 
affecting the racial and ethnic composition of the U.S.?   How are 
immigration and intermarriage affecting the racial and ethnic composition of 
the U.S.?  How can the racial and ethnic composition be expected to change in 
the future?  How do population projections change depending on how 
assumptions about immigration, intermarriage, and racial/ethnic 
identification and assignment are varied?

o What are the implications of racial and ethnic diversity for institutions, 
residential patterns, and individuals' experiences, attitudes, and outcomes?  
For example, how do schools manage diversity and how does diversity affect 
student achievement, student attachment to schools, and students' patterns of 
friendships?  How have these outcomes been affected by programs that have 
bused children to achieve racial integration of schools?  How have changes in 
the ethnic and racial diversity of workplaces, social organizations, and 
other institutions affected behavior, values, and attitudes?  What factors 
influence how institutions and communities respond to racial and ethnic 
diversity?  

o How and why have patterns of interracial and interethnic friendship, 
courtship, marriage, and childbearing changed in the U.S.? How have attitudes 
about interracial and interethnic friendship changed and how do attitudes 
vary across socioeconomic and demographic groups?  How has our notion of the 
family changed with increasing racial and ethnic diversity?

o How has increasing racial and ethnic diversity affected population health 
and health disparities?  How has increasing diversity in the population 
affected the health care system?  How has increasing diversity, including 
that resulting from immigration, affected social programs such as Medicare 
and Social Security, and policy reform?  Does the aging process differ for 
individuals of different racial/ethnic groups?  What are the moderators, 
mediators, and mechanisms that contribute to racial and ethnic variations in 
the burden of mental disorders as they occur across the life span and to 
racial and ethnic variations in the patterns of psychiatric diagnoses? 

B.  Development, Maintenance, and Consequences of Racial and Ethnic Identity

As the U.S. becomes ethnically and racially more diverse, and as the 
prevalence of interracial and interethnic unions and unions between 
immigrants and non-immigrants increases, issues related to how individuals 
acquire racial and ethnic identity and the consequences of racial and ethnic 
identity become increasingly important.  For instance, research suggests that 
interactions between racial/ethnic identity and socioeconomic status are 
complex and sometimes interdependent (Waters, 2000), and that racial identity 
among adolescents, especially mixed race adolescents, can be very fluid 
(Harris, 2000).  Examples of topics that address the development, 
maintenance, and consequences of racial and ethnic identity include, but are 
not limited to, the following:

o How are racial and ethnic identities formed?  How are racial and ethnic 
identity affected by socioeconomic status, by neighborhood, school, and other 
contexts, by the prevailing culture, and by the media?  What factors affect 
how parents assign a race to their children?  How do children learn to 
identify themselves and how fluid is this identification?  How do differences 
in self-identified race/ethnicity and race/ethnicity as perceived and 
assigned by others interact and how do they affect socioeconomic, health, and 
demographic outcomes? 

o How does racial/ethnic identity interact with immigration status?  How do 
immigrants to the U.S., especially those from nations with completely 
different methods of conceptualizing race and ethnicity, come to categorize 
themselves—-and others, including non-immigrants—-in the U.S. racial/ethnic 
pantheon?  What affects their racial/ethnic identity in the U.S., and how 
does their racial/ethnic identification affect and respond to their 
assimilation?  How does racial/ethnic identification change across 
generations?  How do socioeconomic, demographic, and cultural contexts affect 
racial/ethnic identification among immigrants and their descendants?  Even 
with its new complexity, does the U.S. scheme of categorizing race and 
ethnicity have salience for recent immigrant groups?

o How does racial/ethnic identity relate to socioeconomic and demographic 
outcomes?  For individuals with fluid racial/ethnic identity, such as 
immigrants and individuals of mixed race, do their socioeconomic status and 
demographic behavior affect how they identify themselves racially and 
ethnically? 

o Research suggests that how individuals with ancestors from more than one 
racial group identify themselves racially differs by age:  older mixed race 
individuals are more likely than mixed race younger individuals to identify 
themselves as belonging to only one racial group.  Are such findings the 
result of cohort effects or aging effects?  Within cohorts, among individuals 
with mixed racial/ethnic heritage, how does racial and ethnic self-identity 
change as individuals age?

o How does macro-level racial and ethnic composition affect individual's 
racial and ethnic identity and individual demographic behavior, health, and 
socioeconomic outcomes?  How does racial and ethnic identity change over the 
life course and what effect does it have on behavior, health, and 
socioeconomic status?

o How has the increasing diversity of the U.S. population affected the 
meanings given to racial and ethnic origins and identity and the role they 
play in organizing social life and economic opportunity?  How and why has 
this process varied across different regions, communities, and socioeconomic 
groups within our country?

C.  Conceptualizing, Measuring, and Modeling Race and Ethnicity 

In light of the new OMB standards on collecting and categorizing data on race 
and ethnicity, and questions about the salience of race from the biomedical 
community, there is a heightened focus on how demographic and other social 
science research can most appropriately integrate race and ethnicity.  Two 
important issues are:  (1) whether the racial and ethnic categories used to 
describe groups with shared identity, characteristics, and experiences are 
valid, and (2) how to develop models that elaborate the causal processes that 
explain why racial and ethnic differences in outcomes exist.

OMB's 1997 standards for classifying Federal data on race and ethnicity call 
for recording Hispanic status and race separately, expanding the number of 
racial categories to five, and allowing respondents to report that they 
belong to more than one racial group.  The five racial categories are 
American Indian or Alaska Native; Asian; Black or African American; Native 
Hawaiian or Other Pacific Islander; and White.  While the 1960 Census 
reported information on three race groups—-white, black, and "other"—-the 
2000 Census collected information that will allow for 126 racial/ethnic 
categories:  63 distinct racial categories with each category broken down 
into Hispanic and non-Hispanic.

Besides changing the racial and ethnic composition of the U.S. overall, 
immigration in the latter part of the 20th century has also changed the 
composition of racial/ethnic groups themselves.  While "Asians" once 
primarily included Japanese, Chinese, and Filipinos, this group now also 
encompasses large numbers of Southeast Asians, Koreans, and Indians and other 
South Asians.  In addition, Pacific Islanders such as Native Hawaiians, and 
persons with origins in the original peoples of Guam, Samoa, once included in 
an overall group called "Asian and Pacific Islanders," are now classified as 
a distinct category.  And while 40 years ago nearly all African 
Americans/Blacks were descendants of U.S. slaves, this group now also 
embraces increasing numbers of immigrants (and their descendents) from the 
Caribbean, whose ancestors also came to the New World as slaves, and from 
Africa.  Even the meaning of "white" has changed, as this group now includes 
small but increasing numbers of Middle Easterners and immigrants from the 
former Soviet bloc.  In relation to opportunity and achievement, there are 
some indications that these differences within racial/ethnic groups are as 
important as differences across racial/ethnic groups.  

Changing Federal standards for collecting information on race and ethnicity 
can result in some comparison problems.  Changing how data on race and 
ethnicity are collected could make it difficult to track changes in 
characteristics and outcomes for a given ethnic or racial group.  It also 
affects comparisons of racial and ethnic groups across data systems, that is, 
comparisons between the Federal data, that are based on the new data 
standards, and other data systems, such as some of those collected at the 
state and local level, that do not use the new data standards.

Examples of topics that address the conceptualization, measurement, and 
modeling of race and ethnicity include, but are not limited to, the 
following:

o Is the racial and ethnic classification scheme that is now being used in 
Federal data systems, including the 2000 Census—-five racial categories plus 
Hispanic and non-Hispanic as described above—-meaningful and appropriate for 
social science research?  Do these categories have different meanings across 
racial/ethnic groups and across cohorts?  How do the questions and categories 
used when collecting racial and ethnic data affect responses to race and 
ethnicity questions and to other questions?  In modeling socioeconomic, 
demographic, and health outcomes, are ethnic differences within racial groups 
more or less important than differences across the major groups?  

o When racial and ethnic differences in social, economic, demographic, and 
other outcomes are observed, what are the mechanisms explaining these 
differences?  How can possible explanations for racial and ethnic 
differences—-such as culture, racism, and social constraints—-be measured and 
tested?  Do socioeconomic and demographic processes differ for different 
racial and ethnic groups?  If these processes do differ, how should racial 
and ethnic differences be modeled in social science analysis?

o How can demographers and other social scientists conceptualize and analyze 
individuals of mixed race/ethnicity and how do the categories used affect the 
analysis?  How much are research findings determined by how race and 
ethnicity—-especially individuals of mixed race—-are defined?  Recent 
evidence suggests that the apparent trends in residential segregation depend 
entirely on how individuals of mixed race are categorized.  How does the 
racial/ethnic categorization scheme used affect other analyses?

References

Collins, Francis (2001).  Transcript of "2001 Genomics Short Course
Dr. Francis Collins: 'The Human Genome Project And Beyond' 8-7-2001" 
http://www.nhgri.nih.gov/DIR/VIP/ShortCourse01/SC_01collinsTranscript.html.

Harris, David R. (2000). "Demography's Race Problem," paper presented at the 
National Institute of Child Health and Human Development panel, "Visions of 
the Future: A Town Meeting on New Directions in Population Research," Annual 
Meeting of the Population Association of America, March 2000 
http://www.nichd.nih.gov/about/cpr/dbs/sp/harris.htm.

Rivara, Frederick P. and Laurence Finberg (2001).  "Use of the Terms Race and 
Ethnicity," Archives of Pediatrics and Adolescent Medicine, Volume 155, 
February 2001.

Schwartz, Robert S. (2001).  "Racial Profiling in Medical Research," The New 
England Journal of Medicine, Vol. 344, No. 18, May 3, 2001.

Waters, Mary C. (2000).  Black Identities:  West Indian Immigrant Dreams and 
American Realities, New York:  Russell Sage Foundation Books.

Relevant Research Links  

The Demographic and Behavioral Sciences Branch, Center for Population 
Research, NICHD, recently completed a long-range planning activity that 
culminated in a planning workshop in June 2001 and a report on the Branch's 
new strategic plan, "Goals and Opportunities, 2002-2006."  This strategic 
plan, which includes several recommendations about population research on 
race and ethnicity, can be found at 
http://www.nichd.nih.gov/publications/pubs/dbsb_plan.htm.  Other documents 
related to the long-range planning activity can be found at 
http://www.nichd.nih.gov/about/cpr/dbs/sp/index.htm.  The National Institute 
on Aging Strategic Plan to Address Health Disparities can be found at 
http://www.nia.nih.gov/AboutNIA/StrategicPlan/StrategicPlanHD/.

Potential applicants specifically concerned with methodological research 
related to behavioral and social science research on race and ethnicity 
should also see the program announcement "Methodology and Measurement in the 
Behavioral and Social Sciences" at
http://grants.nih.gov/grants/guide/pa-files/PA-02-072.html.

Potential applicants interested in basic social science research on the 
social and cultural constructs and processes used in health research, 
including race and ethnicity, should also see the program announcement 
"Social and Cultural Dimensions of Health" at 
http://grants.nih.gov/grants/guide/pa-files/PA-02-043.html.
 
MECHANISM OF SUPPORT

This PA will use the NIH research project grant (R01) award mechanism.  As an 
applicant, you will be solely responsible for planning, directing, and 
executing the proposed project.  The total project period for a research 
project grant (R01) application submitted in response to this PA may not 
exceed five years.  At the end of this five-year period, awardees may apply 
for a competing continuation.  

This PA uses just-in-time concepts.  It also uses the modular as well as the 
non-modular budgeting formats (see 
http://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.

ELIGIBLE INSTITUTIONS 

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

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign
o Faith-based or community-based organizations

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.   

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into two 
areas:  scientific/research and financial or grants management issues:

o Direct your questions about scientific/research issues to:

National Institute of Child Health and Human Development (NICHD)
Rebecca L. Clark, Ph.D.
Center for Population Research 
Demographic and Behavioral Sciences Branch
6100 Executive Boulevard, Room 8B07, MSC 7510
Bethesda, MD 20892-7510
Telephone:  (301) 496-1175
Fax:  (301) 496-0962
Email:  rclark@mail.nih.gov

National Heart, Lung and Blood Institute (NHLBI) 
Ebony Bookman, Ph.D.
Division of Epidemiology and Clinical Applications
6701 Rockledge Drive, Room 8166, MSC 7934
Bethesda, MD 20892-7934
Telephone:  (301) 435-0446
Fax:  (301) 480-1455
Email:  bookmane@nhlbi.nih.gov

National Human Genome Research Institute (NHGRI)
Jean E. McEwen, J.D., Ph.D.
Ethical, Legal, and Social Implications Research Program
31 Center Drive, Room B2B07, MSC 2033
Bethesda, MD 20892-2033 
Telephone:  (301) 402-4997
Fax:  (301) 402-1950
Email:  jm522n@nih.gov

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lawrence Agodoa, M.D.
Office of Minority Health Research Coordination
6707 Democracy Boulevard, Room 653, MSC 5454
Bethesda, MD 20892-5454
Telephone:  (301) 594-1932
Fax:  (301) 594-9358
Email:  la21j@nih.gov

National Institute of Mental Health (NIMH)
Cheryl A. Boyce, Ph.D.  
Developmental Psychopathology and Prevention Research Branch  
6001 Executive Boulevard, Room 6200, MSC 9617  
Bethesda, MD 20892-9617  
Rockville, MD 20852 for delivery  
Telephone:  (301) 443-0848
Fax:  (301) 480-4415 
Email:  cboyce@nih.gov 

National Institute on Aging (NIA) 
Georgeanne E. Patmios, M.A.
Behavioral and Social Research Program
7201 Wisconsin Avenue, Suite 533, MSC 9205
Bethesda, MD 20892-9205
Telephone:  (301) 496-3138
Fax:  (301) 402-0051
Email:  patmiosg@nia.nih.gov

National Institute on Drug Abuse (NIDA)
Yonette Thomas, Ph.D.
Division of Epidemiology, Services and Prevention Research 
Epidemiology Research Branch
6001 Executive Boulevard, Room 5174, MSC 9589
Bethesda, MD 20892-9589
Telephone:  (301) 402-1910
Fax:  (301) 480-2543
Email:  yt38e@nih.gov

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

National Institute of Child Health and Human Development
Kathy Hancock  
Grants Management Branch
6100 Executive Boulevard, Room 8A17G, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-5482
Fax:  (301) 402-0915
Email:  kh47d@nih.gov

National Heart, Lung and Blood Institute 
Holly Atherton
Grants Operations Branch
6701 Rockledge Drive, Room 7152, MSC 7926
Bethesda, MD 20892-7926
Telephone:  (301) 435-0177
Fax:  (301) 480-3310  
Email:  athertoh@nhlbi.nih.gov

National Human Genome Research Institute 
Jean Cahill
Grants Management Officer
31 Center Drive, Room B2B34, MSC 2031
Bethesda, MD 20892-2031
Telephone:  (301) 435-7858
Fax:  (301) 402-1951
Email:  jc166o@nih.gov

National Institute of Diabetes and Digestive and Kidney Diseases 
Trudy Hilliard
Grants Management Branch
2 Democracy Plaza, Room 717, MSC 5456
Bethesda, MD 20892-5456
Telephone:  (301) 594-8859
Fax:  (301) 480-4237
Email:  HilliardT@extra.niddk.nih.gov

National Institute of Mental Health 
Brian Albertini  
Grants Management Branch 
6001 Executive Boulevard, Room 6115, MSC 9605 
Bethesda, MD  20892-9605 
Telephone:  (301) 443- 0004  
Fax:  (301) 443- 0219  
Email:  ba18b@nih.gov 

National Institute on Aging
Traci Lafferty
Grants and Contracts Management Officer
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212, MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-1472
FAX:  (301) 402-3672
Email:  laffertt@nia.nih.gov 

National Institute on Drug Abuse 
Gary Fleming, J.D., M.A.
Grants Management Branch
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, Maryland 20892-9541
Telephone:  (301) 443-6710
Fax:  (301) 594-6849
Email:  gf6s@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov. 

APPLICATION RECEIPT DATES:  Applications submitted in response to this 
program announcement will be accepted at the standard application deadlines, 
which are available at http://grants.nih.gov/grants/dates.htm.  Application 
deadlines are also indicated in the PHS 398 application kit. 

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 
http://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 
http://grants.nih.gov/grants/funding/modular/modular.htm. 

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:  
Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIH staff member within one of NIH 
institutes or centers who has agreed to accept assignment of the application.   

Applicants requesting more than $500,000 must carry out the following steps:

1) Contact the IC program staff at least six weeks before submitting the 
application, i.e., as you are developing plans for the study; 

2) Obtain agreement from the IC staff that the IC will accept your 
application for consideration for award; and,

3) Identify, in a cover letter sent with the application, the staff member 
and IC who agreed to accept assignment of the application.

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types. Additional information on this 
policy is available in the NIH Guide for Grants and Contracts, October 19, 
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. 

SENDING AN APPLICATION TO THE NIH:  The title and number of the program 
announcement must be typed on line 2 of the face page of the application form 
and the YES box must be marked.

Submit a signed, typewritten original of the application, including the 
checklist, and five 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)

APPLICATION PROCESSING:  Applications must be received by or mailed on or 
before the receipt dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  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.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
convened in accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit.  

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

o Receive a written critique
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 second level review by the appropriate national advisory council 
or board.

REVIEW CRITERIA 

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 your 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 your application's overall score, weighting them as appropriate 
for each application.  Your 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, you may propose to carry out 
important work that by its nature is not innovative but is essential to move 
a field forward.

(1) 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? 

(2) 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? 

(3) INNOVATION:  Does the project employ novel concepts, approaches or 
method?  Are the aims original and innovative? Does the project challenge 
existing paradigms or develop new methodologies or technologies? 

(4) 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)? 

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

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, your 
application will also be reviewed with respect to the following:

PROTECTIONS:  The adequacy of the proposed protection for humans, animals, or 
the environment, to the extent they may be adversely affected by the project 
proposed in the application.

INCLUSION:  The adequacy of plans to include subjects from both genders, all 
racial and ethnic groups (and subgroups), and children as appropriate for the 
scientific goals of the research.  Plans for the recruitment and retention of 
subjects will also be evaluated.  (See Inclusion Criteria included in the 
section on Federal Citations, below.)

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

AWARD CRITERIA 

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

REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD:  Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

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

All investigators proposing clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_
2001.htm.  The amended policy incorporates: the use of an NIH definition
of clinical research; updated racial and ethnic categories in compliance with
the new OMB standards; clarification of language governing NIH-defined
Phase III clinical trials consistent with the new PHS Form 398; and updated
roles and responsibilities of NIH staff and the extramural community.  The
policy continues to require for all NIH-defined Phase III clinical trials
that: a) all applications or proposals and/or protocols must provide a
description of plans to conduct analyses, as appropriate, to address
differences by sex/gender and/or racial/ethnic groups, including subgroups if
applicable; and b) investigators must report annual accrual and progress in
conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:   
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them.  This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS:  NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:  The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this 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.

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 Program Announcement 
(PA) 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 Nos. 
93.864 (NICHD), 93.837 (NHLBI), 93.172 (NHGRI), 93.849 (NIDDK), 93.242 
(NIMH), 93.866 (NIA), and 93.279 (NIDA) and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under authorization of Sections 301 
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92. 

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

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

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