THE NATIONAL INSTITUTE ON AGING MULTICENTER STUDY ON EXCEPTIONAL SURVIVAL IN 
FAMILIES (U01)

RELEASE DATE:  February 25, 2003

RFA:  AG-03-004

Update: The following update relating to this announcement has been issued:

July 29, 2009 - This RFA has been reissued as (RFA-AG-10-005).

National Institute on Aging (NIA)
 (http://www.nih.gov/nia/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:  93.866

LETTER OF INTENT RECEIPT DATE:  May 19, 2003

APPLICATION RECEIPT DATE:  June 24, 2003

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
o References

PURPOSE OF THIS RFA

The National Institute on Aging (NIA) invites applications for cooperative 
agreements (UO1s) to participate in the design and implementation of a 
Multicenter Study on Exceptional Survival in Families (ESF).  This study will 
determine the degree and patterns of familial transmission and aggregation of 
exceptional longevity and healthy survival to advanced age as characterized 
by a variety of phenotypic measures.  This Request for Applications (RFA) 
solicits proposals for: (1) Study Centers to design and implement the ESF 
study, and (2) a Data Management and Coordinating Center (DMCC) that will 
interact with the Study Centers, a Steering Committee, a Monitoring Board, 
and NIA staff by providing administrative, logistical, and data management 
support for the ESF Study.

Exceptional longevity (i.e., survival to extreme old age) is one of a set of 
favorable exceptional survival outcomes, including unusually long survival 
before the occurrence of significant morbidity ("health span") or disability 
(active life expectancy). This set of outcomes is referred to in this 
document as "exceptional survival" (ES). Understanding the factors that 
contribute to ES could lead to better understanding of contributors to long 
and healthy life in humans in general, not just the very old. In view of 
evidence that exceptional longevity is associated with other ES outcomes and 
shows a pattern of familial aggregation, information from exceptionally long-
lived families provides a starting point for identifying patterns of and 
appropriate measures for exceptional survival. Results of the ESF study will 
provide a better understanding of the degree and patterns of familial 
aggregation of ES outcomes. In addition, the data from the ESF study will 
provide a strong information-base on the characteristics of exceptionally 
long-lived families that will aid in identifying research strategies that are 
likely to be successful for future studies on factors contributing to 
exceptional survival.  

This is a one-time solicitation to support the Study Centers and the DMCC for 
5 years. The DMCC and a participating Study Center may be located at the same 
Institution, however each must be administratively and fiscally distinct from 
the other. 

RESEARCH OBJECTIVES

Background and Rationale

A primary public health objective of aging research is to identify ways to 
help people be as healthy as possible, as long as possible.  Elucidating the 
multiple potential genetic and environmental factors and their various 
interactions that contribute to long and healthy survival in the general 
population is a complex and daunting task. One approach to achieving this 
objective is to characterize groups of individuals with exceptionally 
favorable survival outcomes and to identify contributory factors that lead to 
them. One such outcome is exceptional longevity (EL) (i.e., survival to 
extreme old age). EL is among a group of positive survival outcomes worthy of 
study. Other exceptional survival outcomes include survival time in the 
absence of certain diseases ("health span") and disabilities (active life 
expectancy). Research has shown that individuals who live to extremely old 
ages tend to have maintained good health throughout most of their lives, 
suggesting that exceptionally long life is associated with exceptionally long 
healthy life (1). Thus collecting information on EL is a first step in 
identifying the kinds of information necessary to identify factors that may 
contribute to exceptional survival. 

There is increasing evidence that EL and other ES traits are clustered in 
families. Siblings of exceptionally old people have been found to have an 
increased chance of surviving to extremely old age than the average 
population, and the chance of surviving to exceptionally old age is 
especially high if the siblings come from families with many exceptionally 
long-lived members (2-3). Offspring of centenarians have been found to have 
lipid profiles associated with lower risk for cardiovascular disease (4). 

There is also evidence of a genetic basis for at least some of the familial 
clustering of EL.  Comparisons of the degree of association of exceptionally 
long life between sibling-pairs vs. less closely-related pairs have found 
that the pattern is consistent with effects of a small number of genes 
contributing to EL (5). Additionally, a genome-wide scan in exceptionally old 
sibling pairs indicated that a region on chromosome 4 is likely to contain at 
least one gene with significant effects on the likelihood of reaching 
exceptional old age (6).

Given that familial factors contribute to longevity and other ES traits, 
information from families with exceptionally long-lived individuals could 
lead to the identification of factors that contribute to unusually long and 
healthy life. In addition to information on long-lived probands and relatives 
in their generation, information on subsequent generations would be useful in 
identifying phenotypes expressed earlier in life that may contribute to 
exceptional survival, and factors contributing to these phenotypes. 

The design of studies to identify such factors in families would be aided by 
better knowledge of the patterns of transmission of EL and other exceptional 
survival traits within families, using tools such as segregation analysis and 
other approaches. Collecting and characterizing accurate pedigree 
information, detailed phenotypic information, and information on shared and 
non-shared environmental factors, is needed for such analyses. Based on this, 
subsequent studies to identify specific genetic, physiologic, and 
environmental contributors to EL and other exceptional survival traits can be 
done. 

Thus, studies on multiple generations in families with exceptionally long-
lived members comprise an appropriate target population for studying 
favorable survival outcomes. To account for the numerous environmental and 
other variations among these families, large numbers of them will likely be 
needed to identify the full range of contributory factors. However, though 
some families with significantly high proportions of family members living to 
extreme old ages have been identified, the number of such families that might 
be identified using different criteria for exceptional longevity (e.g., 
different ages, or different degrees of familial aggregation) is unknown, as 
is the yield rate of efforts to recruit members of such families for 
research.  Thus information on the prevalence and yield rate of families with 
clustering of EL using different definitions is crucial for decisions about 
feasible study designs and subsequent recruitment efforts for such studies. 

Further background on this topic is contained in recommendations from an NIA 
Advisory Panel on Exceptional Longevity (APEL).  (The report of the APEL can 
be found at (http://www.nia.nih.gov/research/meetings/apelreport.pdf.) 

Goals and Scope 

The primary goal of this RFA is to establish a study to determine the degree 
and patterns of familial aggregation and transmission of ES traits, 
specifically to: 

o Determine patterns of occurrence of exceptional longevity within families, 
using segregation analyses and other approaches to identify modes of 
transmission (e.g., Mendelian, polygenic, environmental) of EL among family 
members; 

o Test for familial aggregation of specific exceptional survival phenotypes 
in addition to longevity (e.g., exceptionally long survival without certain 
diseases or impairments),  and possible differences among families in 
patterns of extended survival (e.g., lower mortality risks at all ages vs. 
slower exponential rate of rise in mortality risk with age);   

Applications for Study Centers should include detailed plans, specifically 
to:

o Select a sampling frame based on geographic location (e.g., national or 
regional) or on descent (e.g., common ancestry) from which a representative 
sample of multigenerational families with exceptionally long-lived members 
can be drawn;

o Determine demographic characteristics of the sampling frame from which 
families are enrolled, in order to establish relative (percentile) degree of 
survivorship within the sampling frame; The use of population-based sampling 
frames is encouraged. 

o Develop an appropriate recruitment strategy, including methods of 
identifying, contacting and obtaining information from study subjects;

o Determine the yield rates of families with patterns of exceptional 
survival, using different definitions of exceptional survival (e.g., 
different age criteria, different family risk scores or other measures of 
familial aggregation of  exceptional survival, or different survival curve 
parameters), from the selected sampling frame and the selected recruitment 
strategy;

o Collect complete and verified pedigree information for exceptionally long-
lived probands, their parents, their siblings, and members of at least one 
subsequent generation; Methods for validation of ages and familial 
relationships must be included.
 
o Collect phenotypic information from family members; All plans must include 
the minimum set of phenotypic measures established by the NIA Panel on the 
Characterization of Participants in Studies of Exceptional Survival in Humans 
(explained below), in addition to other appropriate measures selected by the 
applicants.

o Collect information on environmental exposures, including shared and non-
shared exposures, (e.g. diet, lifestyle, etc.) from family members; 

o Develop and apply appropriate strategies to analyze the data collected to 
characterize familial aggregation and transmission of ES traits. 

o Obtain appropriate informed consent from family members for possible 
subsequent DNA and/or cell collection (including potential  future contact 
with family members for studies of exceptional survival patterns in younger 
generations as they transition to older age groups, to validate measures 
identified in the exceptionally long-lived probands); 

o Collect cells/DNA appropriate for establishment of lymphoblastoid cell 
lines, from exceptionally long-lived probands who may not be alive at a later 
date when genotype analyses will be designed and when DNA would be collected 
from other family members;  

o Develop a data sharing plan according to the specifications listed below 
under "Data sharing"; 

o Test and evaluate the successfulness of strategies for the identification 
and recruitment of families with exceptionally long-lived members, as well as 
methods for collection of phenotypic, genotypic and other data from such 
families.
 
o Demonstrate willingness to enter into a collaborative relationship with 
other investigators, who together will develop and use common protocols and 
analyze common data, based on the data collection and analyses plans 
submitted by successful applicants.

Participation in the ESF Study will be a complex and time-consuming 
undertaking. Applicants for Study Centers must have the necessary experience 
and expertise to conduct studies involving elderly and/or other hard-to-reach 
populations. Evidence of such experience must be provided in the application. 
Prospective Study Centers must have and document in the application, 
experience and expertise in the conduct of large population-based and/or 
family studies, and demonstrated access to a sufficient number of study 
subjects to accomplish their part of the ESF Study protocol. An appropriate 
time commitment is expected from the leadership (i.e., Principal Investigator 
and any Co-investigators) at each Study Center. A detailed description of the 
appropriate time commitment and how it will be maintained throughout the full 
project period, as well as evidence of time commitments from prior studies, 
must be provided in the application.  

Each applicant should propose the study design that s/he believes best 
addresses the objectives of the ESF Study and is most appropriate for their 
target population. Applicants should provide a detailed justification for the 
proposed study subject selection strategy including the rationale and 
criteria for selection, an estimate of the number of families in the target 
population, statistical power calculations showing the appropriate number of 
families needed for significant results, documentation of the ability to 
recruit sufficient numbers of families, and an estimate of the necessary time 
and effort needed for recruitment.

It is not the intent of this RFA to solicit elaborately detailed research 
plans for the implementation of the ESF Study. Applicants should provide 
sufficient details to determine the merits and feasibility of the proposed 
study design with the understanding that the final protocol will be developed 
collaboratively by the investigators and the NIA during the planning phase 
(Phase I) of the study described below under "Study Structure." 

The ESF DMCC will be responsible for organizational, informational, and data 
management and analyses functions for the ESF Study. Specifically it will 
work in collaboration with the ESF Study Centers and NIA program staff to:

o Coordinate, with the Steering Committee, the development of standardized 
data and biological sample collection, recruitment procedures, methods to 
validate familial relationships and ages all family members, and all 
standardized forms to be used for the operation of the study; A data entry 
system should be established along with a plan for data verification and 
maintenance. Prepare disseminate, and update an ESF Study Manual of 
Procedures (MOP), data collection forms, databases, and results reporting 
summaries of the ESF Study.   

o Provide or arrange for training of all ESF Study personnel, as needed, on 
data and biological sample collection, management and analysis, quality 
control, and quality assurance;

o Collaborate with ESF Study Centers (conditional on approval by the Steering 
Committee and NIA Project Official ) in data analysis both for internal use 
by the Study Centers and for publications;

o Provide the NIA Project Official, the Monitoring Board, and the Steering 
Committee with reports based on biostatistical and other analyses of issues 
relating to the data, or other needs that arise during the course of the 
study;

o Take initiative, with the Study Centers, in the development of data quality 
control procedures and information databases regarding the data and 
biological samples and analyses over the course of the ESF Study; 

o Coordinate and administer the establishment, operation, and quality control 
of a database and a repository for biological samples, and the establishment 
of lymphoblast cell lines from collected biological materials; This includes 
the development of procedures for assuring data quality control, procedures 
for transfer of data and biological samples to the database and the 
repository. The establishment of cell lines and a repository for biological 
samples may require the use of a contractor.  In such a situation, all NIH 
policies and procedures governing cooperative agreements must be adhered to.

o Maintain informed consent records and contact information of family members 
for potential follow-up contact and data collection;

o Prepare detailed reports in standardized formats on progress of subject 
recruitment and data collection for use by the Steering Committee, the 
Monitoring Board, and NIA Project Official; 

o Support the activities of the ESF Study Centers, the Steering Committee, 
and the Monitoring Board through provision of materials, documentation 
support, meeting planning and logistics, and conference call coordination; 
This includes attendance at Steering Committee, and Monitoring Board meetings 
to perform the functions listed above.

o Participate in all Steering Committee and Monitoring Board meetings and 
conference calls as needed;  

o Prepare and distribute minutes and action items from the Steering Committee 
and Monitoring Board meetings and conference calls, ESF site visits, and 
provide timelines for the completion of action items and updates on the 
status of action items as required; 

o Assist the NIA Project Official in written, telephone, and electronic 
communications with the study sites and with various committees as requested; 

o Establish databases that catalogue and disseminate information about all 
ESF Study publications; 

o Develop and maintain a public and private (secured, password-protected) ESF 
Study Web Page.

Applicants for the DMCC should address the potential requirements of the ESF 
Study by providing a description of projected tasks likely to be performed by 
the DMCC consistent with resources projected to be available for the ESF 
Study.

Plans for collection, handling, and analysis of data and biological samples 
consistent with the projected needs of the Study Centers should be addressed.  
Plans for ensuring data integrity and quality control should be addressed.

The application for the DMCC must describe the expertise of key scientific, 
technical and administrative personnel and include a mechanism for replacing 
key professional or technical personnel should the need arise. Any staffing 
changes must be approved by NIA. The Principal Investigator of the DMCC 
should have strong biostatistical expertise and experience in directing a 
coordinating center for large-scale collaborative multicenter studies or 
other large-scale epidemiological research project focusing on elderly 
populations and/or other hard-to-reach populations, involving multiple 
institutions. Such experience must be clearly documented in the application. 
Staff needs may be modified as the ESF Study progresses; however, adequate 
support staff should be designated to manage routine tasks as follows:

o The Principal Investigator of the DMCC will serve as the DMCC Director and 
should provide overall scientific and biostatistical guidance.

o A Deputy Director, qualified to fulfill the duties of the Director of the 
DMCC must be designated. 

o A Project Manager will attend to day-to-day details and communicate 
necessary information to Study Centers and/or to the other ESF Study 
organizational components, and to plan and coordinate project staff training;

o Biostatisticians and demographers will assist with data analysis;

o System analysts will help with developing and managing the database 
programs;

o Computer programmers will develop computer databases;

o Clerks and administrative assistants will help in administrative work and 
data entry.

Study Structure

The NIA ESF Study will be organized into several components including 2-4 
Study Centers, a Steering Committee, (the main decision-making body for the 
study), a Monitoring Board (a group of independent experts that will review 
research progress), a Data Management and Coordinating Center (responsible 
for organizational, informational, and data management and analyses functions 
for the study) and an NIA Project Official.

The NIA ESF Study will be conducted in three phases as follows:

Phase I: Protocol refinement (up to one year)

o Awarded Study Center investigators will meet in Bethesda, MD to develop a 
common protocol and organize recruitment strategies (e.g., geographical 
coverage, sampling techniques), and methods to validate familial 
relationships and ages of all family members, based on the plans submitted in 
the successful NIA ESF applications. All Study Centers will use the 
standardized protocol. Study Centers may be required to restructure their 
originally submitted budgets and scientific approaches, including recruiting 
from different sampling frames than initially proposed in the applications, 
to achieve broad geographical coverage and other specifications, based on 
study planning at the Post-Award meeting.

o The Steering Committee will develop standardized protocols for data 
collection and analytical approaches that will then be reviewed by the 
monitoring board before implementation.

Phase II: Implementation: Data Collection (up to three years)

o Collection of complete verified familial information, appropriate informed 
consent, phenotypic and genotypic data, and other information from family 
members as described in the "Goals and Scope" section above. 

o The Steering Committee will review the data collected and determine 
appropriate analytical approaches that will then be reviewed by the 
monitoring board before implementation.
 
Phase III: Implementation: Data Analysis and Reporting (up to one year)

o Analysis and reporting of data as described in the "Goals and Scope" 
section above. 

Organizational Components

1. Study Centers

A Study Center is the Institution that receives an Award for conducting the 
investigations under this RFA. There must be evidence of strong Institutional 
support for the Study Center and a stated willingness to participate in 
common aspects of study design, employ statistical and biological measures, 
and perform analyses as approved by the Steering Committee.

2. Steering Committee

A Steering Committee will serve as the main decision-making body for the 
study. The Steering Committee will have the overall responsibility for the 
development and finalization of standard definitions and protocols common to 
all Study Centers. The Principal Investigators of the Study Centers, the 
Principal Investigator of the DMCC, and the designated NIA Project Official 
will comprise the voting members of the Steering Committee. The study will 
proceed into the next phase only after approval by the Steering Committee of 
the common protocols, review and approval by the Monitoring Board, and 
acceptance by the NIA. The Steering Committee will meet every three to six 
months or as needed.

3. Monitoring Board

A Monitoring Board will be formed to advise the Study Centers by periodically 
reviewing their research progress and the safety of the study subjects, as 
well as resolve any serious conflicts over how the overall study should 
proceed. The Monitoring Board will be comprised of independent experts in 
relevant clinical, statistical, and bioethical fields. The Monitoring Board's 
approval will be required for the Study to transition from Phase I to Phase 
II and again from Phase II to Phase III. The Chairperson of the Steering 
Committee and the NIA Project Official will participate as non-voting members 
of this Monitoring Board.

4. Data Management and Coordinating Center

A Data Management and Coordinating Center will coordinate the decision making 
processes and administration of study-wide activities, and participate in 
development of common operating procedures and common protocols, organize and 
administer data collection and storage, and provide biostatistical support.  

MECHANISM OF SUPPORT

This RFA will use the NIH UO1 award mechanism. As an applicant you will be 
solely responsible for planning, directing, and executing the proposed 
project.  

The NIH UO1 is a cooperative agreement award mechanism in which the Principal 
Investigator retains the primary responsibility and dominant role for 
planning, directing, and executing the proposed project, with NIH staff being 
substantially involved as a partner with the Principal Investigator, as 
described under the section "Cooperative Agreement Terms and Conditions of 
Award".

This RFA is a one-time solicitation. The total project period for an 
application submitted in response to this RFA may not exceed five years. The 
anticipated award date is February 2004. 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. 

FUNDS AVAILABLE

The NIA intends to commit, in total first-year costs, $3,750,000 in FY2003 to 
fund 2-4 Study Centers (at a cost of $3,000,000) and one Data Management and 
Coordinating Center (DMCC) (at a cost of $750,000) in response to this RFA. 
An applicant for a Study Center or the DMCC may request a project period of 
up to five years.  For the Study Centers total costs may not exceed $750,000 
per year.  For the DMCC it is permissible to request funding for increments 
above $750,000 per year, not to exceed 4% per year for future years.  Because 
the nature and scope of the proposed research will vary from application to 
application, it is anticipated that the size and duration of each award will 
also vary.  
 
Applications requesting total cost budgets above these amounts in the first 
year will be deemed non-responsive to this RFA and returned to the applicant 
institution. Although the financial plans of NIA provide support for this 
program, awards pursuant to this RFA are contingent upon the availability of 
funds and the receipt of a sufficient number of meritorious applications.  At 
this time, it is not known if this RFA will be reissued.
 
 ELIGIBLE INSTITUTIONS
 
You may submit (an) application(s) 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 Institutions

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.  

Disciplines and expertise appropriate for the ESF Study include, but are not 
limited to, geneticists, epidemiologists, gerontologists, demographers, and 
statisticians. 

SPECIAL REQUIREMENTS

Under the terms of the cooperative agreement, the awardee defines the details 
of the project within the guidelines of the RFA, retains primary 
responsibility for the performance of the activity and for the analyses and 
publication of the results. The awardee agrees to accept assistance, close 
coordination and participation of the designated NIA Project Official in all 
aspects of the scientific and technical management of the project in 
accordance with the terms of this RFA. The NIH will have the option of 
halting the study, the individual Study Centers, or the DMCC if the program 
objectives are not being met, or have been met prior to the full 5-year 
period. The maximum duration of the proposed projects may not exceed five 
years. Variations in project length will be due to differences in time needed 
for subject recruitment and data collection.

All Study Centers must include the minimum set of phenotypic measures 
established by the NIA Panel on the Characterization of Participants in 
Studies of Exceptional Survival in Humans, and listed below, in addition to 
other appropriate measures selected by the Steering Committee. A report of 
this panel is available at 
http://www.nia.nih.gov/research/meetings/espreport.htm.

Minimal requirements for applicants for the ESF Study DMCC are:

o The applicant must have demonstrated prior experience as a coordinating 
center in multicenter studies. Evidence of previous experience in population- 
or family-based research focusing on, and data collection from, elderly 
and/or other hard-to-reach populations is required.

o The Principal Investigator and other staff, must have appropriate 
statistical data, (including biological samples) management, and coordination 
expertise.

o The applicant must have the willingness and ability to assist in designing 
protocols and the data collection system, including transmission via the 
Internet. 

o The applicant must demonstrate the willingness and ability to cooperate 
with the ESF Study Centers and NIA staff in all design, data collection and 
analysis functions. The applicant should provide a plan for developing a 
cooperative relationship among the ESF Study Centers and among the various 
ESF organizational components.

o The applicant must have an established data system for collection and 
statistical analysis of common data. 

Data Sharing 

Restricted availability of unique research resources, upon which further 
studies are dependent, can impede the advancement of research. The NIH is 
interested in ensuring that the research resources developed through this 
grant become readily available to the broader research community in a timely 
manner for further research, development, and application, in the expectation 
that this will lead to products and knowledge of benefit to the public 
health.  It is expected that resources to be shared will include all data and 
biological samples collected and all analyses techniques.

To address this interest in assuring research resources are accessible, NIH 
requires applicants who respond to this RFA to submit plans for: (1) sharing 
the research resources generated through the grant; and (2) addressing how 
they will exercise intellectual property rights, should any be generated 
through this grant, while making such research resources available to the 
broader scientific community.

The sharing of research resources plan and intellectual property plan must 
make unique research resources readily available for research purposes to 
qualified individuals within the scientific community in accordance with the 
NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps/) and 
the Principles and Guidelines for Recipients of NIH Research Grants and 
Contracts on Obtaining and Disseminating Biomedical Research Resources: Final 
Notice, December 1999 (http://www.ott.nih.gov/policy/rt_guide_final.html) and 
(http://ott.od.nih.gov/NewPages/64FR72090.pdf)).  These documents also define 
terms, parties, responsibilities, prescribe the order of disposition of 
rights, prescribe a chronology of reporting requirements, and delineate the 
basis for and extent of government actions to retain rights.  Patent rights 
clauses may be found at 37 CFR Part 401.14 and are accessible from the 
Interagency Edison web page, http://www.iedison.gov.

In the peer review of applications submitted in response to this RFA, 
reviewers will comment, as appropriate, on the adequacy and feasibility of 
the sharing of research resources plan and the intellectual property plan.  
Comments on the plans and any concerns will be presented in an administrative 
note in the Summary Statement.  These comments will not affect the priority 
score of the proposal. NIH program staff will consider the adequacy of the 
plans in determining whether to recommend an application for award.  The 
approved plans will become a condition of the grant award and Progress 
Reports must contain information on activities for the sharing of research 
resources and intellectual property.

Budget Preparation by Study Phase

Study Centers

Each applicant for a Study Center should submit adequately justified budgets 
for the entire anticipated project period. The budget for each phase of the 
ESF Study should be clearly delineated. Detailed budgets will vary according 
to policies of the applicant institution and specific needs identified in 
response to this RFA. Applicants should prepare individual budgets for each 
of the three planned study phases.

Phase I activities will require phasing-in staff at least six months prior to 
initiating study subject recruitment. Budgets should allow for three persons, 
including the Principal Investigator, to participate in at least three 
Steering Committee meetings during this phase.  

Detailed budget estimates for Phase II and Phase III should be based on the 
applicant's proposed plan. Budgets for Phases II and III will be modified 
based on the final protocol developed collaboratively during Phase I. 
However, applicants should budget for at least three persons, including the 
Principal Investigator, to participate in three Steering Committee Meetings 
during each year of Phases II and III. 

The initial Steering Committee Meeting will take place in Bethesda, MD. 
However, the location of the subsequent Steering Committee Meetings may 
change over the course of the full project period. Specific locations will be 
determined by the Steering Committee. All Steering Committee meetings should 
be assumed to last two days at a cost of $1200 per person. 

Data Management and Coordinating Center (DMCC)

The Phase I budget should include costs of establishing the DMCC staff, as 
required to carry out DMCC functions (including costs of training personnel 
of ESF Study Centers for management and analyses, and quality control and 
quality assurance of common data).  Phase I also will involve development of 
the protocols and manuals of operations by the study sites, in conjunction 
with the Steering Committee for the ESF Study and creation of a database. 
Budgets should include costs of organizing at least three "in person" 
Steering Committee meetings and for attendance of necessary DMCC staff to 
these meetings.

The Phase II budget should include projected data handling costs, reporting 
functions, meetings and other communications costs, and the projected expense 
of performing any interim analyses that may be requested by the Monitoring 
Board. The DMCC applicant also should address the potential requirements of 
the ESF study by budgeting for tasks to be performed for the development of a 
repository to store patient samples.  Applicants must include the costs of 
cell line establishment. The specific facilities and budgets to be supported 
through subcontracts will depend on the final protocol developed 
cooperatively by the Steering Committee. It should, however, be understood 
that the specific centralized facilities required and their final budgets 
will be determined following the design of the final study protocols and the 
writing of the manual of operations by the study sites and the Steering 
Committee.  Budgets should also include costs of organizing three Steering 
Committee meetings per year and providing for attendance of necessary DMCC 
staff.

The Phase III budget should be concerned with study close-out, data analyses, 
and reporting of results in collaboration with the Study Centers. Budgets 
should include the costs of organizing three meetings of the Steering 
Committee and providing for attendance of necessary DMCC staff.

The initial Steering Committee Meeting will take place in Bethesda, MD. 
However, the location of the subsequent Steering Committee Meetings may 
change over the course of the full project period. Specific locations will be 
determined by the Steering Committee. All Steering Committee meetings should 
be assumed to last two days at a cost of $1200 per person.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, 
otherwise applicable OMB administrative guidelines, HHS Grant Administration 
Regulations at 45 CFR Parts 74 and 92 and other HHS, PHS, and NIH Grant 
Administration policy statements.

The administrative and funding mechanism used for this program is a 
cooperative agreement (UO1), and assistance mechanism (rather than an 
acquisition mechanism) in which substantial NIH scientific and/or 
programmatic involvement with the awardees is anticipated during performance 
of the activity. Under the cooperative agreement, the NIH purpose is to 
support and/or stimulate the recipient's activity by working jointly with the 
award recipient in a partner role, but it is not to assume direction, prime 
responsibility or a dominant role in the activity. Consistent with this 
concept, the dominant role and prime responsibility for the activity resides 
with the awardees for the project as a whole, although specific tasks and 
activities in carrying out the collaborative aspects will be shared among the 
awardees and the designated NIA Project Official.

1. Awardee Responsibilities

Awardees will have primary authorities and responsibilities to define 
objectives and approaches, and for participant recruitment and follow-up, 
quality control, data analyses and interpretation, and for preparation of 
publications for their projects. Awardees at the Study Centers shall retain 
custody of, and primary rights to, the site-specific data developed under 
their award, subject to Government rights of access, consistent with current 
HHS, PHS, and NIH policies. In addition, awardees will engage in 
collaborative activities through participation in Steering Committee meetings 
and potential conference calls in the development and implementation of 
common measures across Study Centers. The Steering Committee will define the 
rules regarding access to, and publication of, findings from analyses of 
common data.

The Study Centers will work collaboratively to develop the study design, 
collect appropriate data and biological samples, and perform analyses for the 
ESF Study as approved by the Steering Committee. Study Center Principal 
Investigators will be expected to maintain close communications with the NIA 
Project Official and the DMCC.

The DMCC will be involved in collaborations with the NIA and the ESF Study 
Centers during all phases of the studies. The DMCC is responsible for working 
cooperatively with Study Centers and sponsoring organizations in a 
multicenter study and in overseeing the implementation of, and adherence to, 
a common protocol, as well as assuring quality control of the data collected. 
In addition to organizing and attending regular meetings, the DMCC will be 
expected to maintain close communications with the NIA Project Official and 
the Principal Investigators of the ESF Study Centers.

2. NIA Staff Responsibilities

The designated NIA Project Official will have substantial 
scientific/programmatic involvement during conduct of this activity, through 
technical assistance, advice and coordination above and beyond normal program 
stewardship of cooperative agreement awards, assisting in those aspects of 
the ESF Study described below. Awardees agree to accept assistance from the 
designated NIA Project Official, as follows:

o Participate in the monitoring of issues relating to recruitment, data 
collection, quality control, and analyses.

o Assist in the development and/or adjustment of study protocols.

o In conjunction with the Steering Committee, approves the transition of 
Study Centers from Phase I to Phase II and Phase II to Phase III. Prior to 
Phase II, after approval from the Monitoring Board, the NIA must accept 
(approval by the Director, NIA) the protocol before it can be implemented. 
The NIA reserves the right to terminate or curtail the study (or an 
individual award) in the event of substantial shortfall in participant 
recruitment, follow-up, data reporting, quality control, or other major 
breach of the protocol; if human subject safety or ethical issues dictate a 
premature termination; or if there is failure to develop or implement 
mutually agreeable protocols.

o The Project Official will be a voting member of the Steering Committee.

o Assistance in data analyses

o An NIA Program Director will be responsible for normal program stewardship.  
The Program Director may also serve as the Project Official.

3. Collaborative Responsibilities

A Steering Committee will serve as the main decision-making body for the 
shared aspects of the study. The Steering Committee will have the overall 
responsibility for developing and finalizing standard definitions and 
protocols common to all of the Study Centers. The Principal Investigators of 
the Study Centers, the Principal Investigators of the DMCC, and the 
designated NIA Project Official will comprise the voting members of the 
Steering Committee. Appropriate DMCC staff should also attend the Steering 
Committee Meetings. The study will proceed into the next phase only after 
approval of the Steering Committee of the common protocols, review and 
approval by the Monitoring Board, and acceptance by the NIA. The Steering 
Committee will meet every three to six months, or as needed.

A Monitoring Board will be formed to advise the Study Centers by periodically 
reviewing their research progress and the safety of the study subjects on a 
regular basis, and will resolve any serious conflicts over how the overall 
study should proceed. The Monitoring Board will be established by NIA staff 
and approved by the Director, NIA, and will be comprised of experts in 
relevant clinical, statistical, and bioethical fields. The Monitoring Board's 
approval will be required for study site transition from Phase I to Phase II 
and again from Phase II to Phase III. The Chairperson of the Steering 
Committee and the NIA Project Official will participate as non-voting members 
of this Monitoring Board.

4. Arbitration

Any disagreement that may arise on scientific/programmatic matters (within 
the scope of the UO1 award), between UO1 awardees and the NIA may be brought 
to arbitration. An arbitration panel will composed of three members: one 
selected by the Steering Committee (without NIH representatives voting) or by 
the individual UO1 awardee in the event of an individual disagreement; a 
second member selected by the NIA; and, a third member selected by the two 
prior selected members. For UO1 awardees, this special arbitration procedure 
will in no way affect the awardee's right to appeal an adverse action in 
accordance with PHS regulation at 42 CFR Part 50, Subpart D, and HHS 
regulations at 45 CFR Part 16.

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into three 
areas:  scientific/research, peer review, and financial or grants management 
issues:

o Direct your questions about scientific/research issues to:

Winifred K. Rossi, M.A.
Special Assistant for Planning
Geriatrics and Clinical Gerontology Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 3C3O7 MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-3836
Email:  rossiw@nia.nih.gov

o Direct your questions about peer review issues to: 

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

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

Ms. Linda Whipp
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212, MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-1472
FAX:  (301) 402-3672
Email:  whippl@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 project
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:

Mary Nekola, Ph.D.
Chief, Scientific Review
Scientific Review Office 
National Institute on Aging 
7201 Wisconsin Avenue, Room 2C212
Bethesda, MD  20892-9205
Telephone:  (301) 496-9666
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).  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.

SUPPLEMENTAL INSTRUCTIONS:
 
See additional instructions in the GOALS AND SCOPE and SPECIAL REQUIREMENTS 
sections of this RFA.

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

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the Checklist, and three signed, photocopies, in 
one package to:
 
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application must be 
sent to:

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

APPLICATION PROCESSING: Applications must be received on or before the 
application receipt date listed in the heading of this RFA.  If an 
application is received after that date, it will be returned to the applicant 
without review.

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 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.  While the 
investigator may still benefit from the previous review, the RFA application 
is not to state explicitly how.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NIA.  

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:

o Will receive a written critique
o May 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 May 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 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 an application's overall score, weighting them as appropriate 
for each application. An application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score.  For example, an applicant may propose to 
carry out important work that by its nature is not innovative but is 
essential to move a field forward.

Review Criteria for the Study Centers

(1) SIGNIFICANCE:  Does the proposed project address an important problem? If 
the aims of the application are achieved, how do they advance scientific 
knowledge?  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?  Is the potential sampling frame available to the investigator 
clearly outlined? Does the investigator provide realistic estimates of the 
number of study participants meeting the inclusion criteria for the study? 
Have sample size and power calculations been adequately addressed? What plans 
are presented to ensure high rates of participation and follow-up? What steps 
are planned for data quality control? How will missing follow-up data be 
handled? Are plans presented to ensure the complete, reliable, and timely 
transmission of study data to the DMCC? Does the investigator show knowledge 
of possible problems associated with the conduct of a multicenter population-
based study and of other potential issues relevant to the ESF Study? Are 
alternative tactics considered?

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

(4) INVESTIGATORS:  Is the Principal Investigator appropriately trained and 
well suited to carry out this work?  Is the work proposed appropriate to the 
applicant's experience level as the principal investigator and to that of 
other researchers (if any)? Is appropriate expertise in genetics, 
epidemiology, gerontology, demography, and statistics and/or similar fields 
represented within and documented for the study team? Are the Principal 
Investigator and other study team members experienced in working with elderly 
populations? Are the Principal Investigator and his/her co-investigators 
experienced in collaborating with other investigators in a multicenter study? 
Do the Principal Investigator and other members of the proposed study team 
possess experience in recruiting participants to long-term follow-up studies? 

(5) ENVIRONMENT:  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Does the proposed research 
plan 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, applications 
for the Study Centers will also be reviewed with respect to the following:

o COLLABORATION: Demonstration of willingness to enter into, and collaborate 
within, a network of investigators that will develop and use common protocols 
and analyze common data.

o SCIENTIFIC PLAN: The appropriateness and soundness of sampling and data 
collection strategies, familial structures sought, informed consent plans, 
validation methods, and management, and analyses. Are the sampling and data 
collection strategies appropriate? Are familial structures sought 
appropriate? Are the familial validation approaches appropriate?

o DATA SHARING: Reviewers will comment, as appropriate, on the adequacy and 
feasibility of sharing the research resources plan and the intellectual 
property plan.  Comments on the plans and any concerns will be presented in 
an administrative note in the Summary Statement.  These comments will not 
affect the priority score of the proposal.  NIH program staff will consider 
the adequacy of the plans in determining whether to recommend an application 
for award.  The approved plans will become a condition of the grant award and 
Progress Reports must contain information on activities for the sharing of 
research resources and intellectual property.

o 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.

o 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)

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

Review Criteria for the DMCC

The final design of the ESF Study protocol will be developed collaboratively 
by the Steering Committee, based on individual protocols proposed by awarded 
Study Centers. In assessing applications for the DMCC, the scientific review 
group will focus on whether the applicant recognizes the significance of the 
issues involved and has the knowledge necessary to contribute meaningfully to 
the final study design, including understanding the scientific, ethical, and 
practical issues underlying the ESF Study. 

(1) SIGNIFICANCE: Does the proposed approach for managing logistical and data 
coordination have scientific and technical merit? Are the proposed plans and 
experience related to data collection, management, editing, processing, 
analysis, and reporting adequate? Are the plans for coordination with the 
Study Center investigators adequate? Is the approach to developing a 
cooperative relationship among the Study Centers and among the various ESF 
organizational components adequate? Are the plans for exercising appropriate 
leadership in matters of study design, data acquisition, data management and 
data analysis demonstrated?

(2) APPROACH: Does the proposed plan demonstrate the ability to identify and 
enlist the cooperation of central facilities to carry out centralized support 
functions for the Study Centers?  Is the plan to develop and maintain a 
public and private (secured, password-protected) ESF Study Web Page adequate?

(3) INNOVATION: Does the DMCC applicant offer innovative ideas on how to 
achieve the goals of the ESF Study with regard to its design and 
administration? Does the proposal address problems that may arise during the 
study and provide innovative solutions to such problems?  

(4) INVESTIGATORS: Is the Principal Investigator appropriately trained in 
biostatistics? Does the Principal Investigator possess experience in 
directing a Coordinating Center for large-scale collaborative multicenter 
studies or other large-scale epidemiological research project focusing on 
elderly populations and involving multiple Study Centers? Does the 
application provide evidence of specific competence and relevant experience 
of professional, technical, and administrative staff pertinent to the 
operation of a Coordinating Center for multicenter studies?  Do the Principal 
Investigator and his/her co-investigators have prior experience collecting 
data and biological samples from multiple Study Centers, database 
development, data management, monitoring the data quality, and developing and 
utilizing statistical methods for analysis of data? Is there evidence of 
experience in, and willingness to, participate appropriately in a 
collaborative study as described in this RFA among within the study team? Are 
there adequate assurances that the DMCC personnel have experience in 
utilizing procedures that ensure the safety and confidentiality of study 
subject identity and data? 

(5) ENVIRONMENT: Has the application documented the adequacy of the proposed 
facility, technical hardware, and space for the DMCC?  Is there an 
appropriate organizational and administrative structure to the proposed DMCC?  
Is there evidence of institutional support and commitment, including adequate 
space, for the proposed program?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, applications 
for the DMCC will also be reviewed with respect to the following:

o COLLABORATION: Is there demonstration of willingness to enter into and 
collaborate within a network of investigators that will develop and use 
common protocols and analyze common data?

o SCIENTIFIC PLAN: Is there demonstration of understanding of the scientific, 
statistical, logistical and technical issues underlying multicenter studies, 
including issues related to collecting, handling, storage, and analysis of 
biological samples from elderly populations. Is there demonstration of 
leadership in statistics, data acquisition and management, data quality 
control, data analysis and multicenter coordination?  

o DATA SHARING: Reviewers will comment, as appropriate, on the adequacy and 
feasibility of sharing the research resources plan and the intellectual 
property plan.  Comments on the plans and any concerns will be presented in 
an administrative note in the Summary Statement.  These comments will not 
affect the priority score of the proposal.  NIH program staff will consider 
the adequacy of the plans in determining whether to recommend an application 
for award.  The approved plans will become a condition of the grant award and 
Progress Reports must contain information on activities for the sharing of 
research resources and intellectual property.

o 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.

o 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)

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:  May 19, 2003
Application Receipt Date:  June 24, 2003
Peer Review Date:  November 2003
Council Review:  January 2004
Earliest Anticipated Start Date:  February 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 

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 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.

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

Applicants may wish to place data collected under this RFA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

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

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

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.866, 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 recipients to provide a smoke-free 
workplace and to 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.

REFERENCES

(1) Hitt R, Young-Xu Y, Silver M, Perls T. Centenarians: the older you get, 
the healthier you have been [letter]. Lancet 1999; 354(9179):652.

(2) Perls TT, Bubrick E, Wager CG, Vijg J, Kruglyak L. Siblings of 
centenarians live longer. Lancet 1998 May 23;351(9115):1560

(3) Perls T, Shea-Drinkwater BA, Bowen-Flynn J, Ridge SB, Kang S, Joyce et 
al. Exceptional familial clustering for extreme longevity in humans. JAGS 
2000; 48: 1483-5.

(4) Barzilai N, Gabriely J, Gabriely M, Ienkowitz N, Sorkin JD. Offspring of 
centenarians have a favorable lipid profile. Journal of the American 
Geriatrics Society 2001; 49(1):1-4.

(5) Kerber R, O'Brien E, Smith K, Cawthon R. Familial excess longevity in 
Utah genealogies. J. Gerontol Biol Sci 2001; 56a: B1-B10. 

(6) Puca AA, Daly MJ, Brewster, Matise TC, Barrett J, Shea-Drinkwater M, et 
al. A genome-wide scan for linkage to human exceptional longevity identifies 
a locus on chromosome 4. PNAS 2001; 98(18) 10505-8.


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