ROYBAL CENTERS FOR TRANSLATIONAL RESEARCH ON AGING

RELEASE DATE:  November 3, 2003

RFA Number:  RFA-AG-04-007 June 11, 2008  - This RFA has been reissued as (RFA-AG-09-008).

(see NOT-AG-04-001)

Department of Health and Human Services (DHHS)

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

COMPONENTS OF PARTICIPATING ORGANIZATIONS:
National Institute on Aging (NIA) 
 (http://www.nih.gov/nia/)

CATALOG OF FEDERAL DOMESTIC ASSISTANT NUMBER:   93.866 

LETTER OF INTENT RECEIPT DATE: December 22, 2003
APPLICATION RECEIPT DATE:  January 22, 2004 

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives 
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplementary Instructions
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 on Aging (NIA) invites applications from 
qualified institutions for Edward R. Roybal Centers for Translational 
Research in the Behavioral and Social Sciences.  

The long-range objectives of the Roybal Centers are to improve the 
health, quality of life, and productivity of middle-aged and older 
people, through: (1) facilitating the translation from the basic 
behavioral and social sciences (including human factors) to practical 
outcomes, including new technologies, for the benefit of the aged, and 
2) if possible also stimulating new "use-inspired" basic research in 
the behavioral and social sciences.  
 
By making research resources more accessible, a Roybal Center grant 
will provide the research infrastructure to:  (1) Stimulate ideas for 
new program development in the area of translational research in the 
social and behavioral sciences;  (2) Enhance the productivity of 
relevant basic research or existing projects through translation into 
viable new products or technologies;  (3) Facilitate acceleration in 
the development of new products or technologies to enhance the health 
and quality of life of older Americans; (4) Recruit new researchers to 
the area of translational research; (5) Develop innovative networks of 
researchers with interests in translational research;  (6) Assemble 
multidisciplinary teams to solve practical problems;  (7) Facilitate 
public-private partnerships including increased interaction and 
collaboration among academic researchers, and commercial interests or 
Governmental bodies;  (8) Facilitate and accelerate application through 
studies and analyses of the translational process itself.

Given the limited funding available, successful Centers are expected to 
encourage researchers at their institutions and elsewhere to pursue 
additional funding to further develop, test, and implement ideas 
piloted within these Centers.  Mechanisms for additional funding 
through NIH would include program projects (P01), research grants (R01, 
R21 and R03), and Small Business Innovative Research (SBIR) awards 
(R41, R43, R44).  (SBIR/STTR applications would be submitted from small 
businesses.)

RESEARCH OBJECTIVES

Background

NIA has long been the primary sponsor of research in the basic social 
and behavioral sciences on the processes of aging at both the 
individual and societal levels.  This long-term investment in research 
has generated a large body of knowledge about how people change over 
the adult life course (both physically and in such areas as cognition, 
motivation, personality, and memory), on the inter-relationships 
between older people and social institutions, and on the societal and 
economic impact of the changing age-composition of the population.  The 
Behavioral and Social Research (BSR) Program has supported research at 
both (i) the population level, on the antecedents and impact of 
changing social, demographic, economic, and health characteristics of 
the older population, and (ii) the individual level, on the bio-
psychosocial processes linking health and behavior, cognitive 
functioning, human factors, and integrative approaches to the study of 
social, psychological, contextual/environmental, genetic, and 
physiological influences on health and well-being over the life course.    

As recent years have seen an explosion of fundamental insights in the 
basic social and behavioral sciences, translating this knowledge into 
practical advances to benefit the health and well being of older 
Americans has increasingly become a priority for the NIA.  Feedback 
loops between basic and applied areas of social and behavioral science 
may accelerate the development of both. The underlying objective of 
this RFA is to strengthen the linkages (in both directions) between 
basic and applied research in order to accelerate the development of 
practical advances.  It is anticipated that Center investigators will 
use the Center resources to develop and pilot new and innovative ideas, 
and will then submit applications for P01s, R01s, or SBIRs to more 
fully implement ideas developed and piloted in the Roybal Centers. 
Investigators who have already effectively piloted their ideas should 
consider applying through these mechanisms.

A. Specific NIA Objectives

The theme of a proposed Roybal Center for the study of middle-aged and 
older people may be organized to examine:  

(a) Acceleration in the process of translating basic behavioral and 
social science research theories, methodologies, and findings about 
aging processes into practical outcomes and new technologies that would 
improve the lives of middle-aged and older people.  The end-point could 
be improvement in some indicator or indicators of functioning or well-
being in different environments, whether in the home, at work, or in 
spheres as diverse as health, communications, transportation, 
retirement planning and saving, etc.  The Center could also facilitate 
and accelerate application through studies and analyses of the 
translational process itself.  Life-span approaches to translational 
issues could be appropriate.  

(b) New "use-inspired basic research" as defined by Stokes (Pasteur's 
Quadrant: Basic Science and Technological Innovation, 1997).  Using the 
work of Pasteur as an example, Stokes argued that the most beneficial 
research is frequently motivated by considerations of use while 
simultaneously advancing basic understanding.  Such "use-inspired basic 
research" is distinguished from those studies that serve as theoretical 
exercises designed mainly to further the body of knowledge on a 
particular topic and from those that are "strictly applied research" 
that may be undertaken to solve a particular problem but not 
necessarily concerned with the advancement of scientific knowledge per 
se.  It may be that some areas of basic research advance most rapidly 
when there are feedback loops and interactions involving application to 
real world problems.

The focus on investigating a practical problem will require applicants 
to show familiarity with the practical domain or environment being 
investigated as well as with relevant aspects of aging research.  Such 
familiarity may be achieved by collaboration with specialists in the 
domain or community, or by prior experience in applying aging research 
successfully to this domain.  Because practical problems will likely 
benefit from cross-disciplinary attention, applications that reflect 
broad-based expertise are particularly encouraged. 

B. NIA's Behavioral and Social Research (BSR) Program's "Areas of 
Emphasis" 

The BSR Program is particularly interested in, but does not require, 
applications that address one or more of the "areas of emphasis."  
BSR's areas of emphasis include:

(a) Aging Minds 
(b) Increasing Health Expectancy 
(c) Health, Work, and Retirement 
(d) Intervention and Behavior Change 
(e) The Burden of Illness and the Efficiency of Health Systems
(f) Health Disparities
(g) Genetics, Behavior, and the Social Environment

C. Examples of Areas of Concentration

Below are examples of potential areas of concentration for proposed 
Centers. These ideas are intended to be illustrative only, as 
applications are welcome from all domains that would increase our 
understanding of the processes of technological innovation and 
translation of basic research to practical outcomes, in the areas of 
individual and population aging.  Applications are strongly encouraged 
to focus on a single topic.   
 
o  Being able to adapt one’s behavior to a new context frequently 
determines whether one will or will not perform a given task 
successfully.  By example, as adults grow older changes in speed of 
response to stimuli and increased length of time to learn new material 
are factors that could impinge on the ability to adapt.  Likewise, 
vision, speech and hearing can become impaired.  In addition, older 
adults often exhibit larger temporal variations in sensory, motor, and 
more abstract cognitive abilities than do younger and middle-aged 
adults.  Advances in technology provide the opportunity to construct 
devices that can augment the adaptive and functional capacity of older 
adult users (NAS/NRC, 2000; see also NAS/NRC, 2003 “Panel on Adaptive 
Aging: From Technology to Gerontology” early November 2003).  This line 
of research includes developing and testing various devices (e.g., 
miniaturized computers) to aid perception and processing of 
environmental information for activities such as walking, driving, and 
reading and viewing of computerized or electromechanical displays, so 
improving quality of life among the elderly.  The Center might also 
focus research on personalized and interactive interfaces.  Such a 
Center should integrate the social and behavioral sciences with 
engineering as well as contribute to theory building for broader 
applications. Alternatively, a Center could focus on enhancing health 
outcomes by means of enhanced caregiver interaction technologies, such 
as through mobile patient monitoring systems that alert healthcare 
providers or caregivers to problematic or changed patient status.  Auto 
regulatory systems, that is, devices that alert the user to change or 
adjust their behavior to maximize or enhance their health and 
functioning, could also be a Center focus.

o  With increasing age, adults face important decisions regarding their 
investments, retirement plans, mobility (e.g., motor vehicle 
operation), health, and living arrangements.  A "Center for Applied 
Decision-Making" could extrapolate existing knowledge, conceptual 
models, and research paradigms to the study of older adults' decision-
making skills and their effect on instrumental activities of daily 
living.  Related to this, another example might be a "Center for Health 
Communication, Literacy and Decision Making."  Research is needed to 
evaluate, and translate this research to practical interventions, how 
older adults read, comprehend and then possibly act on health-related 
information pertaining to long-term care and health insurance, media 
reports of medical research, treatment benefits and risks, and other 
medical or genetic risk information.  

o  A Center could stimulate research on various topics aimed at 
translating our basic understanding of the theories and principles of 
economics, psychology, and other behavioral and social science 
disciplines to improved interventions for older persons in the areas of  
work and retirement.  For example, a Center might focus on using 
behavioral economics and basic cognitive science to improve retirement 
planning, such as increasing the savings rate for retirement, whether 
through 401k plans or personal savings, or increasing participation in 
long term care insurance programs. The influence of employer/corporate 
behavior on such interventions might also be examined.  

o  A Center focusing on maintaining and accelerating the decline in 
disability in the older population might encourage research on adapting 
the principles of behavior change to design or modify health promotion 
programs or to address specific conditions affecting older people's 
functional status in terms of the activities of daily living.  Topics 
might include the improved management of chronic diseases, and 
treatment of conditions such as diabetes, hypertension, or glaucoma  -- 
that require the patient to strictly follow complicated regimens.  

o  A Center could develop the design and piloting needed to establish 
the  feasibility of a multi-level social and behavioral intervention 
designed to reduce disability in a set of target communities.  Such a 
center might seek to find the most cost-effective ways of applying what 
is known (best practices) about maximizing functioning and reducing 
disability at both the individual and social structural levels (e.g., 
NAS/NRC New Horizons in Health 2001).  Such a multi-factorial 
demonstration or feasibility study might also test the hypothesis that 
there are significant interactions between individual and social or 
economic levels.

o  Another Center could focus on behavioral medicine and analyze how 
genetic differences affect individual ability to modify behavior and 
how genes affect variation in responses to these behavioral changes.  
Questions of gene-environment covariation and age-related decrease in 
the ability to select stimulating and supportive environments are also 
relevant. 

o  A Center could use new understanding of the psychological, economic, 
social and neurological underpinnings of well-being and life 
satisfaction to design improved measures of well-being and quality of 
life for use in clinical trials, surveys, or as outcomes in behavioral 
or policy interventions. Such a Center might even begin to lay 
groundwork for the development of an experimental system of National 
Wellbeing Accounts.

o  A Center might focus on the development and application of  highly 
innovative models and methodologies from the behavioral and social 
sciences to the development of interventions and clinical trials, such 
as how best to increase compliance or show efficacy of pharmaceutical 
regimens, how to improve cognition and/or functional disability, or how 
to best define or track the cognitive and physical changes that result 
in a change in functional status. 

o  A Center might focus on translating basic research on cognitive and 
social psychology to improve the validity or quality of large scale 
surveys or longitudinal studies of the adult population that rely 
heavily on self report. 

o  Differing degrees of efficiency with which health systems  are 
organized, financed, and react to the needs of their populations, 
explain part of the widening gap in death rates between the rich and 
the poor, in nations and between countries, around the world (WHO, 
2000).  Such health system inefficiencies and consequent under 
utilization of resources have resulted in a high degree of inequality 
in the provision of services and in preventable disability.  A "Center 
on the Efficiency of Health Systems" could stimulate basic research to 
document how middle-aged and older adults are affected by these trends, 
linked with pilot projects to address how best to offer a safety net 
for those groups who are disproportionately affected by health system 
inefficiencies.  A related area might translate what has been learned 
about the geographic inefficiencies in the use of health care by the 
older population to improve the health of this population.

o  It is increasingly acknowledged that social and behavioral factors 
play a major role in the health of middle aged and older individuals.  
However, many attempts at carefully controlled interventions have 
either failed or met with only limited success.  A Center in this area 
might attempt to evaluate and screen such interventions and develop new 
and highly innovative approaches.

o  Large differences in health outcomes by socioeconomic status (SES) – 
less education and lower income and wealth -- have long been 
identified, but cannot be explained fully by traditional arguments, 
such as access to health care or poor health behaviors.  Recent 
research by Goldman and Smith (2002) examined differences in treatment 
adherence among patients with two illnesses, diabetes and HIV, and 
found, after controlling for other factors, more educated patients are  
more likely to adhere to therapy, and this adherence makes them 
experience improvements in their self-reported general health.  The 
ability to maintain a better health regimen is an important independent 
determinant of subsequent health outcomes. Differences associated with 
less education could be effectively overcome, resulting in improved 
compliance and improved health outcomes.  A Center in this area might 
develop a theory of SES differences in health-related risks and test 
the theory through multi-level practical interventions among lower SES 
patients. 

o A Center might develop and apply new methods of forecasting health 
and health expenditures to the adult and older population in order to 
assess how medical and behavioral interventions might affect Medicare, 
Medicaid, out of pocket, and health insurance expenditures.

D. Center Components

Each Center Grant (P30) must consist of: (a) a management and 
administrative core and (b) a pilot core. 

Although the Center grant is primarily designed to support a research 
Center at a specific institution, some Centers may wish to make 
research resources available to the larger scientific community or 
galvanize scientists at several academic institutions.  Consortium 
arrangements are permissible, provided that the applicant institution 
meets the eligibility requirements.  Centers are also encouraged to 
collaborate with other NIA-funded Centers, including the Resource 
Centers and Coordinating Center for Minority Aging Research (RCMAR) and 
the Demography Centers. Information about these Centers is available 
from the program staff listed under INQUIRIES.  

(a)  Management and Administrative Core 
 
The Management and Administrative Core is central to each Center.  
Activities
of the core should include:

o developing a strategic vision for the Center, coordinating all Center 
activities that fall within the Center's tactical framework; 

o monitoring pilot projects that are part of the Center, assessing 
their progress, and reassigning resources as needed during the course 
of the award; 

o encouraging and facilitating the development of networks among 
researchers, commercial interests, community interests, and 
Governmental entities; 

o encouraging the pursuit of additional financial and/or material 
resources to support and expand Center research, for example through 
collaborating with commercial interests and submitting small business 
and traditional research applications to NIH; pursuing additional 
resources for non-research support services to, for example, promote 
dissemination, marketing, and/or corporate sponsorship of product 
development;   

o maintaining any optional advisory committees that provide advice to 
the Principal Investigator on the overall direction and  functioning of 
the Center, including the individual pilot projects.  Members of the 
Advisory Committee should not be named in the application; instead 
areas of expertise should be listed.

o initiating and maintaining interactions with relevant community 
groups (e.g., community boards, businesses, health care facilities) in 
order to facilitate the conduct of the Center's pilot research 
projects.

o disseminating any practical outcomes generated by the Roybal Centers 
to the research community and general public

(b)  Pilot Core 
 
The Center application must request funds to initiate small-scale (in 
the range of $10,000 to $80,000 direct costs per year) pilot research 
that is consistent with the theme of the Center grant.  Such pilots 
could be implemented by both junior and established investigators at 
the Center institutions or at outside institutions or in association 
with academic and/or corporate partners.  It is expected that 
approximately three to five pilot projects will be funded annually.  
While pilot projects may be proposed for one to three years' duration, 
it is expected that most will be funded for one year.  The Center 
application must include examples of three pilot projects, and the 
description of each example should not exceed 4 pages. In addition, the 
application must describe a plan to develop, identify, review and 
monitor pilot projects in a manner consistent with the overall goals of 
the Center.

MECHANISM OF SUPPORT

This RFA will use the NIH Research and Development Core Center Grant 
(P30) award mechanism.  P30 grants support shared resources and 
facilities for a multidisciplinary research team or group of 
investigators focusing on a common research topic. As an applicant you 
will be solely responsible for planning, directing, and executing the 
proposed project. This RFA is a one-time solicitation.  Future 
unsolicited, competing-continuation applications based on this project 
will compete with all investigator-initiated applications and will be 
reviewed according to the customary peer review procedures. The 
anticipated award date is September 30, 2004. Applications that are not 
funded in the competition described in this RFA may be resubmitted as 
NEW investigator-initiated application using the standard receipt dates 
for NEW applications described in the instructions to the PHS 398 
application. 

This RFA uses just-in-time concepts.  It also uses the modular 
budgeting 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 budget format.  
Otherwise follow the instructions for non-modular budget research grant 
applications.  This program does not require cost sharing as defined in 
the current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.  

FUNDS AVAILABLE

The NIA intends to commit up to approximately $1.6 million in total 
costs in FY 2004 to fund approximately 4-6 new 5-year grants in 
response to this RFA.  NIA expects to fund Centers of different sizes.  
Although this program is provided for in the financial plans of the 
NIA, awards are contingent upon the availability of funds for this 
purpose and the receipt of a sufficient number of applications of 
outstanding scientific and technical merit.  Maximum allowable annual 
total costs are $360,000.  A 3% per annum inflation increase is 
allowable in subsequent years. 

The NIA appreciates the value of complementary funding from other 
public and private sources, including foundations and commercial and 
industrial concerns, for activities that will complement and expand 
those supported by the NIA.

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 or local governments
o Eligible agencies of the Federal government
o Faith-based or community-based organizations

Note that foreign organizations are not eligible to apply for P30 
grants. 

An Edward R. Roybal Center Grant (P30) requires relevant pre-existing 
research activity at the institution.  Ideally, applicant institutions 
will be able to draw from a substantial base of relevant research.  

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.  

SPECIAL REQUIREMENTS
 
Annual Meeting

Roybal Center Principal Investigators and Core leaders will be required 
to attend annual meetings in the first, second and third years of the 
project and the travel budget should therefore reflect appropriate 
allocation for this activity.  The meetings will be held at the NIH in 
Bethesda, MD, or at another site agreed to by the Principal 
Investigators and the NIA.  The purpose of the meetings is to have 
investigators working in the same general area share information about 
translational research methods and findings.  Applicants should include 
a statement in the application indicating a willingness to participate 
in such meetings and to cooperate with other researchers in the 
exchange of data, materials, and ideas.

Approval of Pilot Projects

NIA policy requires that the specific aims of any pilot project, in 
addition to the pilot project budget and Curriculum Vitae of the pilot 
investigator, must be submitted to the NIA Program Official for 
approval before funds may be expended.  

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:

Jeffrey W. Elias, Ph.D. 
Behavioral and Social Research Program
National Institute on Aging
Gateway Building, Suite 533
Bethesda, MD 20892-9205
Telephone: (301) 402-4156
E-mail:  eliasj@nia.nih.gov

o Direct your questions about peer review issues to:

Mary Nekola, Ph.D., Chief
Scientific Review Office
Gateway Building, Room 2C212
Bethesda, MD 20892-9205
Telephone: (301) 496-9666
E-mail: NekolaM@nia.nih.gov

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

Jean Richelsen
Grants and Contracts Management Office
Gateway Building, Room 2N212
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
E-mail: richelsj@nia.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 IC 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. Mary Nekola
Scientific Review Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2C212, MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-9666
FAX:  (301) 402-0066
Email: NekolaM@nia.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001). Applications must 
have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) 
number as the Universal Identifier when applying for Federal grants or 
cooperative agreements. The DUNS number can be obtained by calling 
(866) 705-5711 or through the web site at 
http://www.dunandbradstreet.com/. The DUNS number should be entered on 
line 11 of the face page of the PHS 398 form. The PHS 398 document is 
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in 
an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

SUPPLEMENTARY INSTRUCTIONS: Center applications must follow the 
application format and page limitations described in the NIA Program 
Project Guidelines available on the NIA Webpage at 
http://www.nia.nih.gov/ResearchInformation/FundingAndTraining/
ResearchSupport/P01Guidelines.htm .  
The following exceptions to these guidelines apply:  no pre-application 
permission is required; the eligibility requirements do not apply; the 
application receipt date is January 22, 2004; the instructions for 
amended and supplemental applications do not apply; and the applicable 
review criteria are listed in the RFA.  The Center application must 
follow the organization format described in the Guidelines with the 
exception of the pilot core. The Pilot Core component of the 
application should include examples of three pilot projects, and each 
example should not exceed 4 pages. The pilot core is limited in total 
to 14 pages.  In summary, there should be up to a 10 page introduction 
of the Center as a whole, plus up to 10 pages for the Management Core, 
and no more than 14 pages for the Pilot Core, to include description of 
the core and the pilot projects.  Bio-sketches should not be repeated 
for pilot projects, but should be consolidated in the bio-sketch 
section.  

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 
5/2001) application form must be affixed to the bottom of the face page 
of the application. Type the RFA number on the label.  Failure to use 
this label could result in delayed processing of the application such 
that it may not reach the review committee in time for review.  In 
addition, the RFA title and number must be typed on line 2 of the face 
page of the application form and the YES box must be marked.  The RFA 
label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten 
original of the application, including the Checklist, and three signed, 
photocopies, in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7701
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:

Mary Nekola, Ph.D. Chief
Scientific Review Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2C212, MSC 9205
Bethesda, MD  20892-9205
Telephone: (301) 496-9666
E-mail: NekolaM@nia.nih.gov

APPLICATION PROCESSING: Applications must be received by 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 8 weeks.
 
The Center for Scientific Review (CSR) will not accept any application 
in response to this RFA that is essentially the same as one currently 
pending initial review, unless the applicant withdraws the pending 
application.  However, when a previously unfunded application, 
originally submitted as an investigator-initiated application, is to be 
submitted in response to an RFA, it is to be prepared as a NEW 
application.  That is, the application for the RFA must not include an 
Introduction describing the changes and improvements made, and the text 
must not be marked to indicate the changes from the previous unfunded 
version of the application.  

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by NIA staff.  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 NIA in accordance with the review criteria 
stated below.  As part of the initial merit review, all applications 
will:

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

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 evaluate the 
application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals. The 
scientific review group will address and consider each of the following 
criteria in assigning the application’s overall score, weighting them 
as appropriate for each application.

A. Overall Center

o  Significance of the proposed mission or theme of the Center.  If the 
aims are achieved, how do they advance the translation of behavioral 
and social science research into practical advances to benefit the 
health and well being of older Americans or advance "use-inspired basic 
research"?

o  Considerable weight will be given to: (1)  significant on-going 
research activity that is relevant to the theme of the proposed Center 
and (2) that demonstrate the ability to translate a body of basic 
research into significant practical outcomes. 

o  Demonstrated potential to act as a conduit between basic behavioral 
and social science research and applied outcomes (in either or both 
directions).  This will be judged by evidence of past involvement in 
related research and the specific plans for seeking applied outcomes as 
described in the application.

o  The theoretically and empirically supported rationale for the 
particular approach to extending basic behavioral and social science 
research into applied areas, and the degree to which the proposed 
approach is innovative and employs novel concepts, approaches or 
methods.  Considerable weight will be given to the innovativeness of 
the approaches chosen.

o  Commitment as stated in the application to collaborate with 
commercial, non-profit or governmental interests to support and expand 
Center research.  Such commitment should be demonstrated by letters of 
support regarding new collaborations and/or evidence of past 
partnerships.  Proposed collaborative activities must increase the 
opportunities for research and translation.

o  Evidence of institutional support, such as commitment from the host 
institution to the research activity and availability of appropriate 
facilities for the research activities proposed.

o  Appropriateness of the budget for the Center. 

o  The leadership ability, relevant experience, scientific stature and 
the appropriateness of the time committement of the P.I.  A past 
history of applying basic behavioral and social research in a relevant 
area will be an important advantage.

o  The extent to which the scientific environment and proposed 
collaborative arrangements will lead to a successful interplay between 
basic and applied social and behavioral science.  
  
B.  Management and Administrative Core

o  The qualifications, responsibilities and effectiveness of senior 
leaders. Appropriateness of percent effort of senior leaders.

o  Appropriateness of the duties and percent efforts of administrative 
staff of the Center in terms of their qualifications and contributions 
to the specialized needs and conduct of the Center's theme.  Whether 
the administrative structure maximizes the Center's capability to take 
advantage of research opportunities.

C. Pilot Core

o  Quality, innovativeness and importance of the pilot studies .

o  Adequacy of the proposed process for developing, soliciting, 
reviewing, selecting, monitoring and evaluating pilot projects.

o  The qualifications, responsibilities and effectiveness of Pilot Core 
senior leaders.  

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

o 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).

o INCLUSION OF WOMEN AND MINORITIES IN RESEARCH: The adequacy of plans 
to include subjects from both genders and all racial and ethnic groups 
(and subgroups), 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).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals 
are to be used in the project, the five items described under Section f 
of the PHS 398 research grant application instructions (rev. 5/2001) 
will be assessed.  

ADDITIONAL REVIEW CONSIDERATIONS

o 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:  December 22, 2003
Application Receipt Date:  January 22, 2004
Peer Review Date:  June 2004
Council Review:  September 2004
Earliest Anticipated Start Date:  September 30, 2004

AWARD CRITERIA

Award 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

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

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

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 are 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.

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

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

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

Applicants may wish to place data collected under this 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.

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 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and 
proposals for NIH funding must be self-contained within specified page 
limitations. Unless otherwise specified in an NIH solicitation, 
Internet addresses (URLs) should not be used to provide information 
necessary to the review because reviewers are under no obligation to 
view the Internet sites.   Furthermore, we caution reviewers that their 
anonymity may be compromised when they directly access an Internet 
site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of 
"Healthy People 2010," a PHS-led national activity for setting priority 
areas. This RFA is related to one or more of the priority areas. 
Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.healthypeople.gov/.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject 
to the intergovernmental review requirements of Executive Order 12372 
or Health Systems Agency review.  Awards are made under the 
authorization of Sections 301 and 405 of the Public Health Service Act 
as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 
and 45 CFR Parts 74 and 92.  All awards are subject to the terms and 
conditions, cost principles, and other considerations described in the 
NIH Grants Policy Statement.  The NIH Grants Policy Statement can be 
found at http://grants.nih.gov/grants/policy/policy.htm 
 
The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and discourage the use of all tobacco products.  In 
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits 
smoking in certain facilities (or in some cases, any portion of a 
facility) in which regular or routine education, library, day care, 
health care, or early childhood development services are provided to 
children.  This is consistent with the PHS mission to protect and 
advance the physical and mental health of the American people.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

Department of Health and Human Services

National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892