COORDINATING CENTER FOR CALERIE (COMPREHENSIVE ASSESSMENT OF LONG-TERM EFFECTS 
OF REDUCING INTAKE OF ENERGY) STUDIES 

RELEASE DATE:  May 8, 2002
 
RFA:  AG-02-007
 
National Institute on Aging 
 (http://www.nih.gov/nia/)

LETTER OF INTENT RECEIPT DATE: June 12, 2002  

APPLICATION RECEIPT DATE:  July 12, 2002 

THIS RFA CONTAINS THE FOLLOWING INFORMATION

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

The National Institute on Aging (NIA) invites applications for a Cooperative 
Agreement (UO1) to establish a Coordinating Center (CC) for the CALERIE  
(Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy) 
studies. The three recently funded CALERIE sites (also UO1 studies) are 
exploratory controlled studies on the effects of sustained caloric 
restriction interventions on physiology, body composition, and risk factors 
for age-related pathologies in non-obese persons. Each of the three CALERIE 
sites will be conducting site-specific protocols, but standardized protocols 
will be followed for a Common Data Set of measures conducted at all the 
sites. The CALERIE CC will have responsibility for implementing and 
participating in processes for making and implementing CALERIE-wide 
decisions, participation in development of procedures related the Common Data 
Set, management and reporting of data, and participation in data analyses. 
The CC will interact with the CALERIE study sites, the CALERIE Steering 
Committee, the NIA Program Administrator, and the CALERIE Data and Safety 
Monitoring Board (DSMB). The period of support for the CALERIE CC will be 
seven years. Up to $700,000 in total (direct plus facilities and 
administrative (F&A) costs) costs) for the first year may be requested, with 
increments above this level of up to 4% per year for future years. 

RESEARCH OBJECTIVES

Background

The three funded CALERIE sites were selected from the responses to the RFA 
"Exploratory Studies of Sustained Caloric Restriction in Non-Obese Persons:  
Physiologic Effects and Comparisons/ Interactions with Physical Activity, that 
was issued by the National Institute on Aging (NIA) in October 13, 2000 (NIH 
Guide to Grants and Contracts 
(http://grants.nih.gov/grants/guide/rfa-files/RFA-AG-01-001.html).
Detailed information on the background and rationale for these studies may be 
found at the above address. Briefly, the CALERIE projects are funded under the 
Cooperative Agreement mechanism (UO1) and involve exploratory controlled human 
intervention studies on the effects of caloric restriction (CR) interventions 
on physiology, body composition, and risk factors for age-related pathologies in
non-obese persons. The primary goals of the CALERIE projects are: to gain 
knowledge about the effects in humans of sustained caloric restriction (CR) on
physiology, metabolism, body composition, risk factors for age-related 
pathologies, progression of age-related changes, and potential adverse effects; 
and to gain knowledge of similarities, differences and interactions between the 
effects of CR and physical activity (PA) on the above outcomes when employed 
in interventions to prevent weight gain. The endpoints of the CALERIE studies 
include energy intake and expenditure, physical activity, body composition, 
endocrine responses, insulin sensitivity/glucose metabolism, cardiovascular 
function, bone density, immune function, quality of life and potential 
adverse effects of CR. Study populations in the CALERIE studies will be 
nonobese, with a likely age range of 25-60 years. The expected duration of 
the CALERIE projects is seven years. They will be conducted in three phases 
as follows:

Phase 1: Protocol Refinement (up to 2 years). Phase I is primarily devoted to 
the development of recruitment strategies, determining feasibility and safety 
of the proposed CR interventions, as well as standardization of common 
measures and methodologies.  Approximately 190 subjects are expected to be 
studied in Phase 1. 

Phase 2: Protocol Implementation (at least two years). Activities under this 
phase include the conduct of intervention activities, continued screening and 
recruitment of subjects (if necessary), and preliminary data analysis. 
Approximately 300 subjects (100 per site) are expected to be studied in Phase 
2. 

Phase 3: Data analysis and reporting (approximately one year). Each of the 
three CALERIE sites will be conducting site-specific protocols, in addition 
to standardized protocols that will collect common measures across the sites 
(Common Data Set). It is expected that information in the Common Data Set 
will be used in studies involving comparisons among sites, and/or studies 
that require aggregation of data from multiple sites. 

The other organizational components of the CALERIE studies with which the CC 
will interact are: the study sites; the Steering Committee, which is the main 
decision-making body; subcommittees that report to the Steering Committee; 
the Data and Safety Monitoring Board (DSMB), which will oversee progress of 
the studies and monitor the safety of human subjects; and, the NIA Program 
Administrator for the CALERIE projects. The Principal Investigator (PI) of 
the CALERIE CC will participate as a voting member of the Steering Committee.  

This RFA is to establish a Coordinating Center (CC) for the CALERIE studies 
to provide coordination, and organizational and analytical support. Overall 
the activities requested for the CC consist of organizational, informational, 
and data management and analysis functions for activities of the CALERIE 
Steering Committee, subcommittees, and DSMB. 

Specifically, the CC will work in collaboration with the CALERIE study sites 
and NIA program staff to:

1. Coordinate with the CALERIE Steering Committee the selection of the 
common data collection protocols, and standardized forms, and the data 
entry system for the creation and maintenance the Common Data Set for 
measurements to be done in common by two or all three of the CALERIE 
sites. Prepare, disseminate, and update the CALERIE Common Data Set 
Manual of Procedures (MOP), data collection forms, databases, and 
results reporting summaries for the CALERIE sites, and maintain and 
verify for correctness the resulting Common Data Set.

2. Provide or arrange for training to all CALERIE site personnel as needed 
on data management and analysis, and quality control and quality 
assurance.

3. Collaborate with the CALERIE study sites (conditional on approval by 
the Steering Committee and NIA Program Administrator) in the analysis 
of common data both for internal use by the study sites and for 
publications. 

4. Provide the NIA Program Administrator, the DSMB, and the Steering 
Committee with reports based on statistical and other analyses of 
issues related to the Common Data Set, or other needs arising during 
the course of studies.

5. Coordinate the logistics for the establishment and operation of a 
common laboratory for doubly labeled water analyses, and participate 
with the study sites in the development of data quality control 
procedures, and information databases regarding these samples and 
analyses over the course of the CALERIE studies. 

6. Coordinate logistics for the establishment, operation, and quality 
control of laboratory assays for the Common Data Set, and a repository 
for biological specimens from the CALERIE study sites, including 
development of procedures for monitoring samples to be sent, assuring 
assay quality, data quality control, procedures for transfer of 
specimens to the repository, and related databases. 

7. Prepare detailed reports in standardized formats on progress of study-
specific recruitment, protocol completion, compliance, and adverse 
events, for use by the Steering Committee, DSMB, and NIA Program 
Administrator. 

8. Prepare a list of all CALERIE site-specific data items including the 
equipment, test batteries, and assessment techniques that are used. 

9. Monitor adherence of CALERIE components to NIH and NIA policies on 
transmission of information on adverse events, and maintain a database 
on adverse events and responses to them. 

10. Support the activities of the CALERIE sites, the CALERIE Steering 
Committee, and the CALERIE DSMB through provision of materials, 
documentation support, meeting planning and logistics, and conference 
call coordination. This includes attendance at Steering Committee, 
subcommittee, and DSMB meetings to perform the functions listed above.

11. Participate in all CALERIE Steering Committee and DSMB meetings 
and conference calls, and CALERIE Subcommittee conference calls as 
needed.  

12. Prepare and distribute the minutes and action items from the 
CALERIE Steering Committee (SC) and DSMB meetings and conference calls, 
CALERIE Site visits, and CALERIE Subcommittee meetings, and provide 
timelines for the completion of actions items and updates on the status 
of action items as required. 

13. Assist the NIA Program Administrator in written, telephone, and 
electronic communications with the study sites and with various 
committees as requested. 

14. Establish databases that catalogue and disseminate information 
about all CALERIE publications. 

15. Develop and maintain a public and private (secured, password-
protected) CALERIE Web page.

The three funded CALERIE sites and the NIA Program Administrator are 
preparing Manuals of Procedures and developing the Common Data Set. By the 
anticipated September 30, 2002 start date for the CC, some decisions 
regarding the Common Data Set and other CALERIE activities will have been 
made, and some protocols begun. However, it is anticipated that many issues 
and procedures regarding the Common Data Set and other aspects of CALERIE 
Phase 1 studies will still need to be addressed at that time, and will 
benefit from CC participation. The decision process for finalizing CALERIE 
Phase 2 study protocols will not begin until 2003 at the earliest. 

MECHANISM OF SUPPORT

This RFA will use the NIH  cooperative agreement (U01) award mechanism.  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, 2002.  

The NIH U01 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."  The total project period for an application submitted in response to 
the present RFA may not exceed seven years. 
 
FUNDS AVAILABLE 

For the initial year of funding the amount of funds requested for the CALERIE 
CC should not exceed $700,000 total cost (direct cost + F&A costs).  
Requested funding for increments above this level not to exceed 4% per year 
for future years is permissible.  The size of the proposed budget for each 
year should be appropriate for the Phase being conducted by the trials in 
that year. No more than one award will be made as a result of this RFA and 
funding of this award is contingent upon availability of funds.

ELIGIBLE INSTITUTIONS 

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

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

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 

1. Minimal requirements for potential applicants for the CALERIE Coordinating 
Center are as follows:

o The applicant must have demonstrated prior experience as a coordinating 
center in multicenter studies. Previous experience with dietary or physical 
activity interventions, obesity and/or metabolic studies is mandatory.

o The Principal Investigator, with other staff, must have appropriate 
biostatistical, data management and coordination expertise.

o The applicant must have the 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 CALERIE sites and NIA staff in all design, data collection and 
analysis functions. The applicant should provide a plan for developing a 
cooperative relationship among the CALERIE sites and between the various 
CALERIE organizational components.

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

2. Collaboration of Coordinating Center with CALERIE Organizational 
Components

o  The CC will be involved in collaborations with the NIA and the CALERIE 
study sites during all phases of the studies. Thus, the applicant is expected 
to demonstrate experience in working cooperatively with clinical sites and 
sponsoring organizations in a multi-site trial 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 CC will be expected to maintain close 
communications with the NIA Program Administrator and the Principal 
Investigators of the CALERIE study sites.

o  Steering Committee.  The primary governing body of the study will be the 
Steering Committee, which will have responsibility for overall study design 
and policy decisions (described in more detail under Terms and Conditions). 
The Principal Investigator of the CC will be a voting member of the Steering 
Committee.

o  Data and Safety Monitoring Committee (DSMB).  An independent committee 
will be 
established by NIA staff and approved by the Director, NIA, to review the 
progress of the study on a regular basis (described in more detail under 
Terms and Conditions).
 
o  NIA Program Administrator.   The NIA Program administrator function will 
be to assist the components as appropriate in all aspects of the CALERIE 
studies (described in more detail under Terms and Conditions).

3. 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 instrument used for this program is a 
cooperative agreement (UO1), an 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 Program administrator.

1. Awardee Responsibilities

The Coordinating Center awardee agrees to work cooperatively with the CALERIE 
study sites and will have the primary responsibility for developing and 
implementing systems necessary for communications between the various CALERIE 
organizational components. The Coordinating Center will facilitate the design 
and refinement of all protocols, manuals of operation, and forms. Awardees at 
the study sites 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. The Steering 
Committee will define the rules regarding access to and publication of 
findings from analysis of common data.

2.  Staff Responsibilities

The designated NIA Program Administrator will have substantial 
scientific/programmatic involvement during conduct of this activity, through 
technical assistance, advice and coordination above and beyond normal program 
stewardship of grants. The awardee agrees to accept assistance from the 
designated NIA Program Administrator, as described 
below: 

o  Participate in the monitoring of issues relating to recruitment, 
treatment, follow-up, quality control, and adherence to protocols.

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

o  In conjunction with the Steering Committee, approve the transition of 
study sites from Phase 2 to Phase 3. 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 breech 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 collaborative 
protocols. 

o  Assistance in data analyses

3. Collaborative Responsibilities

The Steering Committee (SC), comprised of each of the Principal Investigators 
of the CALERIE study sites, the Principal Investigator of the Coordinating 
Center, and the NIA Program Administrator, will have primary responsibility 
for developing and finalizing standard definitions/laboratory measures common 
to the protocols of the study sites. Each member of the Steering Committee 
will have one vote, and all major scientific decisions will be determined by 
majority vote of the Steering Committee. A Chairperson for the SC has been 
chosen from among the Principal Investigators of the CALERIE study sites.  
Subcommittees appointed by the Steering Committee and comprised of the 
Principal Investigators and appropriate staff from the study sites, the 
Coordinating Center will be involved in design of the protocol and the manual 
of operations, and in ongoing functions of the CALERIE studies such as 
consideration of potential ancillary studies and preparation of publications. 
The SC will meet every three to six months, or as dictated by the needs of 
the CALERIE studies.

The DSMB will advise the study sites 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 DSMB will be 
comprised of experts in relevant medical, statistical and bioethical fields. 
The DSMB's approval will be required before initiation of Phase 1 study 
protocols, and before transition to Phase 2. The Chairperson of the Steering 
Committee and the NIA Program Administrator will participate as non-voting 
members of this Board. 

4.  Arbitration

Any disagreement that may arise on scientific/programmatic matters (within 
the scope of the U01 award), between U01 awardees and the NIA may be brought 
to arbitration.  An arbitration panel will be composed of three members: one 
selected by the Steering Committee (without NIH representatives voting) or by 
the individual U01 awardee in the event of an individual disagreement; a 
second member selected by the NIA; and, the third member selected by the two 
prior selected members. For U01 awardees, this special arbitration procedure 
will in no way affect the awardee's right to appeal an adverse action in 
accordance with PHS regulations 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

Direct inquiries regarding programmatic issues to:

Charles Hollingsworth, Dr. P.H.
Branch Chief, Clinical Trials Branch
Geriatrics and Clinical Gerontology Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 3E-327 MSC 9205
Bethesda, MD  20892-9205
Express Mail Zip Code: 20814
Telephone:  301/435-3047;  FAX:  301/402-1784
E-mail: hollinc@nia.nih.gov

Direct inquiries regarding peer review issues to:

Mary Nekola, Ph.D.
Chief, Scientific Review Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2C-212
Bethesda, Maryland 20892-9205
Express Mail Zip Code:  20814
Telephone:  301/496-9666; FAX:  301/402-0066
E-mail:  nekolam@nia.nih.gov

Direct inquiries regarding financial or grants management matters to:

Cynthia Riddick
Grants Management Specialist
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N-212
Bethesda, Maryland  20892-9205
Express Mail Zip Code:  20814
Telephone:  301/496-1472; FAX:  301/402-3672
E-mail: riddickc@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: 

Chief of Review
Chief, Scientific Review Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2C-212
Bethesda, Maryland 20892-9205
Telephone:  301/496-9666 
FAX:  301/402-0066
E-mail:  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:

Applicants for the Coordinating Center should address the potential 
requirements of the CALERIE studies by providing a description of projected 
tasks likely to be performed by the CC and the centralized facilities, 
consistent with resources projected to be available for the CALERIE studies.

Plans for collection and handling of data and samples consistent with the 
projected needs of the study sites should be discussed.  Plans for ensuring 
data integrity and quality control should be discussed.

Personnel: The application for CC 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. 
The Principal Investigator of the Coordinating Center should be a 
biostatistician or other professional with experience in directing a 
coordinating center for large-scale collaborative multi-site clinical studies 
or other large-scale epidemiological research project involving multiple 
institutions. Staff needs may be modified as the CALERIE studies progress; 
however, adequate support staff should be designated to manage routine tasks:

o PI of the Coordinating Center should provide overall scientific and 
biostatistical guidance.

o Project Manager to attend to day-to-day details and communicate necessary 
information to study sites and/or to the other CALERIE organizational 
components. Staff 
training is also a responsibility of the Project Manager.

o Statisticians to help in data analysis.

o System analysts to help with developing and managing the database 
programs.

o Computer programmers to develop computer database.

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

Budget:  The budgets for the Coordinating Center application should be based 
on the applicant's best judgment of activities likely to be involved during 
the different Phases of the CALERIE studies. The Coordinating Center also 
will be responsible for organizing meetings of the Data and Safety Monitoring 
Board (DSMB) at least twice a year and for supporting the travel of these 
individuals to meeting sites and their lodging. These costs should be 
included in the budget.

The Phase 1 budget (Year 1) should include costs of establishing the 
Coordinating Center staff, as required to carry out the Coordinating Center's 
functions (including costs of training personnel of CALERIE sites for 
management and analyses, and quality control and quality assurance of common 
data).  Phase 1 also will involve development of the protocols and manuals of 
operations by the study sites, in conjunction with the Steering Committee for 
the CALERIE studies and creation of a database for the common measures 
between the study sites. Budgets should include costs of organizing at least 
three "in person" Steering Committee meetings and for attendance of necessary 
Coordinating Center staff to these meetings.

During Phase 2, the budgets 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 DSMB. The applicant also should address the potential requirements of the 
CALERIE studies by budgeting for tasks to be performed for the development of 
a repository to store patient samples.  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 Data 
Coordinating Center staff.

The Phase 3 budget should be concerned with study closeout, analysis of study 
data, and reporting of results in collaboration with the study sites.  
Budgets should include the costs of organizing three meetings of the Steering 
Committee and providing for attendance 
of necessary Coordinating Center staff.

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:

Chief of Review
Scientific Review Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2C212, MSC 9205
Bethesda, MD 20892-9205
 
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.

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 
should be complete at the time of submission. The Scientific Review Office 
(SRO), NIA, will determine whether late materials will be accepted. If late 
materials are accepted, they will be limited to three typed pages and the 
Scientific Review Administrator (SRA) in charge of the review must authorize 
submission.

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

(1) SIGNIFICANCE:  Does your study address an important problem? If the aims 
of your 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?

The final design of the protocols (site-specific and common) will be 
developed collaboratively by the CALERIE study sites and the Steering 
Committee. In assessing applications for the Coordinating Center, 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 design, including understanding of the 
scientific, ethical, and practical issues underlying the CALERIE studies.

(2) APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Do you acknowledge potential problem areas and consider alternative 
tactics?
Does the proposed approach in managing the logistical and data coordination 
have scientific and technical merit? Are the proposed plans and experience 
relating to data collection, management, editing, processing, analysis, and 
reporting adequate? Are the plans for coordination with the study site 
investigators adequate? Is the approach to developing a cooperative 
relationship among the study sites and between the various CALERIE 
organizational components adequate? Are the plans for exercising appropriate 
leadership in matters of study design, data acquisition, data management, and 
data analysis demonstrated?

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

Does the applicant for the Coordinating Center offer innovative ideas on how 
to achieve the goals of the CALERIE studies 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) INVESTIGATOR: Are you appropriately trained and well suited to carry out 
this work?  Is the work proposed appropriate to your experience level as the 
principal investigator and to that of other researchers (if any)?

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 multi-site studies?  Prior 
experience collecting data and patient specimens from multiple clinical 
sites, monitoring the data quality, and developing and utilizing statistical 
methods for analysis of data should be demonstrated. Is there evidence of 
experience in and willingness to participate appropriately in a collaborative 
study as described in this RFA? Are there adequate assurances that the 
Coordinating Center personnel have experience in utilizing procedures that 
insure the safety and confidentiality of medical records? 

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

Has the application documented the adequacy of the proposed facility, 
technical hardware, and space for the Coordinating Center?  Is there an 
appropriate organizational and administrative structure to the proposed 
Coordinating Center?  Evidence of institutional support and commitment for 
the proposed program should be provided.

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

o PROTECTIONS:  The CALERIE Coordinating Center will be setting up a 
repository of samples from human subjects.  Therefore, the Center must comply 
with current human subjects protection policies regarding potential patient 
identifier information that are associated with these stored samples.

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:    June 12, 2002
Application Receipt Date:         July 12, 2002
Peer Review Date:                 September 2002
Council Review:                   September 2002
Earliest Anticipated Start Date:  September 30, 2002

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

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.

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