PLANNING GRANTS FOR HIV/AIDS PREVENTION AND TREATMENT INTERVENTION IN 
MIDDLE-AGED AND OLDER POPULATIONS

Release Date:  January 8, 2001

RFA:  RFA-AG-01-004

National Institute on Aging
 (http://www.nih.gov/nia/)
National Institute on Mental Health
 (http://www.nimh.nih.gov/)

Letter of Intent Receipt Date:  February 23, 2001
Application Receipt Date:       March 26, 2001

THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  IT 
INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS 
THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA.

PURPOSE

The National Institute on Aging (NIA) and National Institute of Mental 
Health (NIMH) invites qualified researchers to submit applications for 
planning grants (R21) to assist in the design, testing and preliminary 
evaluation of prevention and treatment interventions for HIV/AIDS in the 
middle-aged and older population.  Effective strategies for AIDS 
prevention and treatment through behavior change interventions for the 
major populations at risk have been identified but not yet applied to 
the fifty plus population.  

This announcement solicits planning applications for one-time grants to 
support pilot and feasibility research important for 1) the 
implementation and evaluation of behavioral and primary social 
prevention interventions targeted toward the identification and 
reduction of risk factors or enhancement of protective factors 
associated with HIV/AIDS among middle-aged and older people, and/or 2) 
for the implementation and evaluation of effective secondary prevention 
interventions that address the needs of HIV-infected middle-aged and 
older people.   The R21 mechanism supports exploratory and open trial 
studies that will lead to the development of a phase 2 clinical trial 
testing the efficacy of different intervention approaches for this 
population.   While this RFA is intended to encourage innovation and 
high impact research upon which significant future research may be 
built, and while no preliminary data are expected to be described in 
the application, applications should make clear that the proposed 
research and/or development is scientifically sound, that the 
qualifications of the investigators are appropriate, and that resources 
available are adequate (see review criteria).

Because of the lack of randomized controlled studies in this 
population, there is a need for a planning phase to conduct preliminary 
research on the application and adaptation of previously successful HIV 
intervention strategies utilized in younger populations or those used 
to prevent or minimize other diseases/conditions among older adults.  
The planning grant application and review process is intended to 
provide a mechanism for initial peer review of the rationale and basic 
design of an intervention study which requires further development and 
testing before a full fledged study is appropriate.  This award 
mechanism is appropriate for interventions whose rationale and basic 
design are considered sufficiently meritorious, but where sufficient 
information is lacking to move directly to more formal efficacy trials.   
This planning grant is intended to provide support for the development 
of a refined study design, organizational plan, detailed intervention 
and assessment protocol, preliminary data collection and analysis, 
manual of procedures, and budget.  While the focus of this solicitation 
is on the application and testing of intervention techniques to the 
fifty plus population, additional information may also need to be 
gathered to understand older people’s unique risks as well as settings 
and situations that place this population at risk.

Applicants should be aware that the award of a Planning Grant does not 
guarantee NIA or NIMH acceptance of the full-scale clinical trial for 
peer review, nor subsequent funding of the trial following peer review.  
However, it is expected that the applicant will develop a full-scale 
clinical trial for submission to a public or private agency if the 
Clinical Trial Planning Grant is funded.

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 Request for 
Applications (RFA), PLANNING GRANTS FOR HIV/AIDS PREVENTION AND 
TREATMENT INTERVENTIONS, 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/. 

ELIGIBILITY REQUIREMENTS

Applications may be submitted by foreign and domestic for-profit and 
non-profit organizations, public and private, such as universities, 
colleges, hospitals, laboratories, units of state and local 
governments, and eligible agencies of the Federal government. 
Racial/ethnic minority individuals, women, and persons with 
disabilities are encouraged to apply as principal investigators.

MECHANISM OF SUPPORT

The mechanism of support will be the NIH Exploratory/Developmental 
Grant (R21).  The award cannot be renewed.  Applicants should note that 
the funding of a planning grant does not imply a commitment by the 
sponsoring organizations to fund the proposed full-scale study, nor 
even to accept a subsequent application for such a study. 

Specific application instructions have been modified to reflect 
"MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined 
by NIH. Complete and detailed instructions and information on Modular 
Grant applications can be found at: 
http://grants.nih.gov/grants/funding/modular/modular.htm

FUNDS AVAILABLE 

These planning grants will provide up to $150,000 in direct costs per 
year (with a total cost cap of $250,000 per year) for up to two years.  
The participating Institutes (NIA and NIMH) will contribute up to $1.6 
million in FY 2001 to fund a total of 5 to 7 meritorious applications 
that are relevant to the Institutes’ missions. Although the financial 
plans of the Institutes 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 applications of outstanding 
scientific and technical merit.

Direct costs will be awarded in modules of $25,000, less any overlap or 
other necessary administrative adjustments. Facilities and 
Administrative costs will be awarded at the negotiated rate.

RESEARCH OBJECTIVES

Background
 
HIV/AIDS prevention research has shown that interventions that target 
risk behaviors, improve knowledge, develop and practice skills, and 
support maintenance of behavior change can be effective in reducing the 
behaviors associated with the spread of HIV(NIH Consensus Development 
Conference Panel, Interventions to Prevent Risk behaviors. AIDS 2000, 
14 (suppl 2): 85-96).   Despite data showing that the proportion of 
adults fifty and older with HIV/AIDS has remained steady at 
approximately 10% since the beginning of the epidemic, interventions 
for primary and secondary prevention have been targeted to younger 
persons, generally neglecting older adults.  There is some suggestion 
that the HIV/AIDS caseload may be aging, due both to new treatments 
that improve survival for those already infected and to the growth in 
new cases among those over age 50.   For example, the rate of new AIDS 
cases is rising twice as fast in the older population compared with the 
younger population, particularly among specific older populations at 
risk, including men who have sex with men, substance users, and older 
women. The majority of older persons do not identify themselves as at 
risk, even those who engage in drug- or sex-related activities that 
increase the likelihood of contracting HIV.  Thus, it is not surprising 
that, compared to younger adults, older people know less about HIV 
infection and are often misinformed about HIV/AIDS risks, that symptoms 
are often attributed to other causes, including aging, that physicians 
often under-diagnose older people, and that there is a widening 
survival gap for older people with HIV/AIDS relative to their younger 
counterparts.

Research efforts are needed that apply and expand interventions with 
science-based effectiveness to the reduction of risk behaviors among 
middle-aged and older people and for improvement in the diagnosis and 
treatment of older adults with HIV/AIDS.  While the older population as 
a whole may be at relatively low risk of contracting HIV, findings show 
that practices engaged in by some groups of middle-aged and older 
adults may place them at risk of infection.  Due to delays attributable 
to both patient and health care provider factors, older persons come to 
medical attention at later stages and experience shorter post-diagnosis 
survival times and may be at special risk because of age-related and 
HIV-related immune changes.    Moreover, the presence of co-morbidities 
in older people may complicate adherence to and the effectiveness of 
HIV/AIDS drug treatments and may have important consequences such as 
the necessity for multiple therapies, increased disability, increased 
burden on clinical care and service delivery systems and increased 
associated costs.  

An intensified research effort is needed to understand the 
effectiveness of behavioral and social interventions aimed toward older 
people.   However, intervention efforts need to be informed and 
targeted  by current epidemiological information, both nationally and 
locally, on incidence and prevalence of HIV at older ages.  In order to 
translate research to practice, intervention research needs to build on 
existing basic knowledge of HIV, the unique aspects of aging with 
HIV/AIDS, and settings and situations in which older people are at 
risk.  The merits of individual, social and community level 
interventions for targeting specific behaviors and persons at risk need 
to be considered.  Other important intervention factors that may vary 
in effectiveness for older populations include type of intervention 
facilitator, setting in which the intervention is delivered, duration 
of the intervention, intervention delivery methods, incentives and 
compensation, as well as the specific content related to reducing risk 
behaviors.   Prevention programs must be initiated as early as 
feasible, must consider developmental level of target population, 
should be delivered at levels with maximum impact and must be based on 
long-term strategic planning.

Specific Objectives

HIV/AIDS is a public health problem affecting Americans of all ages. 
Research on preventing HIV/AIDS or its consequences in the middle and 
later years is increasingly important. Aging populations need to be 
integrated into ongoing prevention related studies, and researchers need 
to focus studies on how age interacts with other behavioral, social, and 
biological factors to affect the likelihood of middle-aged and older 
people contracting HIV, transmitting it to others, and living with 
HIV/AIDS.  Drawing on knowledge from the behavioral sciences about HIV 
transmission and its prevention in younger populations, the research 
objectives in this RFA focus on preliminary research and background 
documentation needed to design and implement intervention methods that 
may increase knowledge and perceived risk, improve skills related to 
risk reduction (such as needle-cleaning for injection drug users, or 
negotiating condom use), identify risk settings and situations (life 
transitions or crises), achieve earlier testing and diagnosis of 
HIV/AIDS and enhance delivery of, and adherence to, treatment and 
medical regimens among middle-aged and older adults.  The planning grant 
application should describe the conceptual basis for the proposed 
intervention study, the basic design characteristics, and preliminary 
information to be gathered in this initial feasibility phase.  

Specifically the application should include information on:
o   Study rationale and hypothesis.  Address significance of research 
area and the principal hypotheses to be tested.
o   Preliminary studies.  Outline of preliminary studies (including 
analyses of existing data) to guide selection of, and/or refine, 
intervention strategies targeted to middle aged and older populations.
o   Study design.  Outline the major design elements of preliminary 
studies to be conducted during this planning phase.  These might include 
topics such as sample size, identification of any control groups, and 
strategies for assuring recruitment and retention. 
o   Study population.  Specify who will be included in preliminary 
studies, including general eligibility and exclusionary criteria and the 
sources of recruitment.
o   Assessment and measurement. Outline covariate, mediating and outcome 
measures to be employed or pilot tested in this phase, strategies for 
assessment, and rationale for selection.
o   Intervention strategy. Describe the conceptual basis for the 
proposed intervention, outline the major intervention components and 
implementation plans; and discuss strategies for assuring treatment 
fidelity and adherence.
o   Data analytical approaches.  Outline methods for data management and 
analysis with attention to strategies for assuring data quality.
o   Future Directions.  Outline how the proposed research in this 
planning phase would lead to phase 2 efficacy studies which in turn 
would lead to phase 3 multi-site controlled trials and phase 4 
“effectiveness/dissemination” research.

In addition to characterizing proposed new intervention research, 
information should be included on organizational and logistical aspects 
of this planning process: 
o   Timeline.  Outline timeline and tasks to be accomplished during each 
year of the planning grant.
o   Personnel.  Identify participants in the planning process, their 
roles in the development of the plan, and their experience in related 
studies.
o   Liaison /Collaborations.  Describe other persons or other groups you 
will be interacting within the planning phase.
o   Manual of Operations.  Identify the study elements to be planned or 
refined if the planning grant is awarded.  Outline factors to be 
included in the draft Manual of Procedures that awardees are expected to 
produce at the end of the planning grant award period in order to move 
to the next stage of intervention research.
o   Human subjects protection.  Identify plans for establishing an 
external data and safety monitoring board for any randomized controlled 
studies to be initiated in the planning or future stages of this 
research. 
                           
In addition to addressing generic research design and methodological 
issues, the planning grant activities should indicate what information 
will be examined in relationship to factors that are specific to the 
design and implementation of effective prevention and treatment HIV/AIDS 
interventions among middle-aged and older adults.  The bullets 
underneath the four major categories described below illustrate the type 
of issues that might be included to indicate an understanding of the 
complexities involved in designing, testing and evaluating HIV/AIDS 
prevention and treatment interventions in this targeted population.

Population and social context characteristics:  The application should 
discuss population characteristics that may be unique to middle-aged and 
older people, or people at risk of HIV as they age and that will affect 
intervention responsiveness and outcomes. These include, for example:
o   Population diversity. This includes factors such as chronological 
age, gender, HIV serostatus and care status, and other biopsychosocial 
factors such as frailty or level of cognitive function. 
o   Social and cultural factors.  This includes factors that influence 
behaviors related to risk of HIV as well as access to and delivery of 
medical care such as socio-economic status, marital status, social 
networks, living arrangements, and cultural attitudes and expectations. 
o   Contexts, settings, and situations.   The context in which risk 
behaviors occur may vary by age. For example, research shows that older 
drug users are less likely than younger drug users to use illicit drugs 
in “shooting galleries”.
o   Life course events and experiences.    HIV risk may change as a 
function of life transitions and life course events, such as changing 
work or family relationships, separation or divorce, and death of a 
loved one or partner.

HIV/AIDS Knowledge, Skills, Attitudes and Behaviors. These factors 
define persons at risk as well as serve as major intermediary 
intervention outcomes. Factors to consider include:
o   Knowledge, skills, and attitudes.  Prevention interventions for 
older people need to consider knowledge of HIV transmission and AIDS 
among the targeted older population, as well as attitudes regarding 
adoption of safer sex- and drug-related behaviors.  For example, older 
women may lack the skills or confidence to negotiate safe-sex practices 
with their partners.  In addition, prevention efforts should address the 
issue of AIDS stigma.
o   Risk behaviors.  The type and frequency of risky activities or 
behaviors may also vary by age, or be modified by factors related to 
aging.  For example, there is evidence that older men in retirement 
communities have multiple female sex partners and do not perceive that 
their sexual behavior places them at risk.  Behavioral determinants and 
correlates of risky behavior may also be important to consider.
o   Adjustment to diagnosis and treatment.  Other factors to consider 
include the psychosocial needs of older HIV-infected individuals, with 
particular attention to coping with the chronic and fatal nature of the 
disease.

Intervention Characteristics:  The application should address factors in 
the actual design of optimal interventions.  For example, in what way 
will the proposed research be based on models of behavioral change and 
target the risk reduction needs of the specific population, use the most 
effective delivery techniques, and be linked to desired outcomes through 
appropriate methodology and measurement.   Of particular concern is the 
degree to which effective interventions and intervention strategies work 
for reducing HIV risk among middle-aged and older adults, or whether 
modifications related to aging are warranted. The following factors 
should be addressed in the application:

o   Consideration of covariates.  Several factors unique to an aging 
population may act as covariates in intervention effectiveness.  These 
include factors such as: comorbidity (medical, mental, psychiatric), 
functional status (social, cognitive, psychiatric), pharmacology 
(polypharmacy, interactions, side effects), the type and extent of risky 
behaviors (e.g., illegal drug use or unprotected sexual behaviors with 
high risk partners), etc.
o   Models of behavior change.   Researchers should also consider the 
multiplicity of factors that influence behavior change, and integrate 
biological, cognitive, psychological, and social perspectives to explain 
and predict the acquisition and maintenance of preventive HIV-related 
behaviors among middle- aged and older people.  Pathways of influence 
specifying mediators linking interventions to hypothesized outcomes 
should be delineated.
o   Specificity of content.  A plan for standardizing the treatment 
fidelity of interventions should be developed with attention to 
treatment adherence . Intervention intensity, duration and frequency 
should be addressed.
o   Delivery channels of the intervention:  The effectiveness of the 
intervention message may vary depending on how the intervention is 
delivered to participants and the particular delivery channel specified.  
It will be important to specify whether the intervention is delivered to 
individuals, couples, small or large groups, to a community, or to the 
general population.
o   Community advisory boards. A strategy for obtaining appropriate 
community input and participation should be outlined.

Measurement, Outcomes, and Evaluation:  This area focuses on the need to 
link our understanding of HIV-related behaviors and behavior change to 
the appropriate measurement of relevant outcomes for middle-aged and 
older adults.  Topics to consider include factors such as:
o   Attrition:  The ability to evaluate intervention effectiveness is 
affected by loss of intervention participants.  Thus, strategies for 
recruiting and retaining samples of middle-aged and older adults are 
needed .
o   Measurement selection:  Researchers should identify methods for 
obtaining accurate self-report of HIV-related behaviors and behavior 
change, considering the sensitivity of the information for many older 
persons, and the diversity of backgrounds, languages, and cultures.   
Researchers at this stage may not have final assessment batteries and 
can propose assessment for examining the reliability and validity of 
assessments as part of the design. 
o   Outcomes:  Factors affecting selection of study outcomes should be 
identified.  For example outcomes are likely to vary by targeted risk 
behavior as well as the type of intervention  (individual, social, 
community), setting (general population, clinic sample, retirement 
community, drug treatment facility), and the specific hypothesis being 
evaluated.  The use of biological outcomes may also be appropriate.   
The spectrum of outcome measures might also include cost-effectiveness 
factors, HIV-specific health outcomes and general health outcomes.

SPECIAL REQUIREMENTS

Awardees should budget for three trips a year for up to three 
investigators to Bethesda, Maryland in order to come and discuss common 
aspects of their protocol development with other awardees and share 
solutions to common problems in conducting intervention research in 
middle-aged and older populations.  Additionally investigators will be 
expected to participate in workgroups that will meet electronically and 
by phone between meetings to discuss issues common to the different 
intervention studies (e.g., recruitment and retention; developing 
strategies for cross site assessments; treatment fidelity). This 
planning phase should provide the necessary information to develop 
detailed protocols and a Manual of Procedures for subsequent Phase 2 
studies to be proposed by the investigative team.  The resultant Manual 
of Procedures is a key product of this planning phase and should be 
submitted in the final report.

Applicants for planning grants for human intervention studies should 
review the NIA document "Implementation of Policies for Human 
Intervention Studies". This is available in the "Grants and Contracts" 
section of the NIH Home Page 
(http://www.nih.gov/nia/funding/policy/humint.htm).  Persons without 
access to the NIH Home Page may obtain copies of the policy from: Office 
of Extramural Affairs, National Institute on Aging; Gateway Building, 
Suite 2C218; Bethesda, MD 20892-9205.  Phone (301) 496-9322).

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

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 
biomedical and behavioral research projects involving human subjects, 
unless a clear and compelling rationale and justification are 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 research involving human subjects should 
read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities 
as Subjects in Clinical Research," published in the NIH Guide for 
Grants and Contracts on August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a 
complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm:  
The revisions relate to NIH defined Phase III clinical trials and 
require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, 
and to conduct and report analyses, as appropriate, by sex/gender 
and/or racial/ethnic group differences.

Investigators also may obtain copies of these policies from the program 
staff listed under INQUIRIES. Program staff may also provide additional 
relevant information concerning the policy.


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.  Reviewers are cautioned that 
their anonymity may be compromised when they directly access an 
Internet site.

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that 
includes a descriptive title of the proposed research, the name, 
address, and telephone number of the Principal Investigator, the 
identities of other key personnel and participating institutions, and 
the number and title of the RFA in response to which the application 
may be submitted. 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 to the program staff listed under 
INQUIRIES by the letter of intent receipt date listed in the heading of 
this RFA.

 APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used 
in applying for these grants, with the modifications noted below.  
These forms are available at most institutional offices of sponsored 
research; from the Division of Extramural Outreach and Information 
Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 
7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: 
grantsinfo@nih.gov; and on the internet at: 
http://grants.nih.gov/grants/funding/phs398/phs398.html.

The RFA label available in the PHS 398 (rev. 4/98) 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 sample RFA label available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been 
modified to allow for this change.  Please note that this sample label 
is in pdf format.

The modular grant concept establishes specific modules in which direct 
costs may be requested as well as a maximum level for requested 
budgets. Only limited budgetary information is required under this 
approach. The just-in-time concept allows applicants to submit certain 
information only when there is a possibility for an award. It is 
anticipated that these changes will reduce the administrative burden 
for the applicants, reviewers and Institute staff. The research grant 
application form PHS 398 (rev. 4/98) is to be used in applying for 
these grants, with the modifications noted below.

BUDGET INSTRUCTIONS

Modular Grant applications will request direct costs in $25,000 
modules. The total direct costs must be requested in accordance with 
the program guidelines and the modifications made to the standard PHS 
398 application instructions described below:

PHS 398

o  FACE PAGE: Items 7a and 7b should be completed, indicating Direct 
Costs (in $25,000 increments up to $150,000 which is the direct cost 
cap of this RFA) and Total Costs [Modular Total Direct plus Facilities 
and Administrative (F&A) costs] for the initial budget period.  Items 
8a and 8b should be completed indicating the Direct and Total Costs for 
the entire proposed period of support.

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form 
Page 4 of the PHS 398.  It is not required and will not be accepted 
with the application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete 
the categorical budget table on Form Page 5 of the PHS 398.  It is not 
required and will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget 
Narrative page. (See 
http://grants.nih.gov/grants/funding/modular/modular.htm for sample 
pages.)  At the top of the page, enter the total direct costs requested 
for each year. This is not a Form page.

o  Under Personnel, list all project personnel, including their names, 
percent of effort, and roles on the project. No individual salary 
information should be provided. However, the applicant should use the 
current NIH appropriation language salary cap and the NIH policy for 
graduate student compensation in developing the budget request.

For Consortium/Contractual costs, provide an estimate of total costs 
(direct plus facilities and administrative) for each year, each rounded 
to the nearest $1,000.  List the individuals/organizations with whom 
consortium or contractual arrangements have been made, the percent 
effort of all personnel, and the role on the project.  Indicate whether 
the collaborating institution is foreign or domestic.  The total cost 
for a consortium/ contractual arrangement is included in the overall 
requested modular direct cost amount. Include the Letter of Intent to 
establish a consortium.

Provide an additional narrative budget justification for any variation 
in the number of modules requested.

o  BIOGRAPHICAL SKETCH - The Biographical Sketch provides information 
used by reviewers in the assessment of each individual's qualifications 
for a specific role in the proposed project, as well as to evaluate the 
overall qualifications of the research team.  A biographical sketch is 
required for all key personnel, following the instructions below. No 
more than three pages may be used for each person.  A sample 
biographical sketch may be viewed at: 
http://grants.nih.gov/grants/funding/modular/modular.htm

- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research projects ongoing or completed during the last three years;
- List selected peer-reviewed publications, with full citations.

o  CHECKLIST - This page should be completed and submitted with the 
application.  If the F&A rate agreement has been established, indicate 
the type of agreement and the date. All appropriate exclusions must be 
applied in the calculation of the F&A costs for the initial budget 
period and all future budget years.

o  The applicant should provide the name and phone number of the 
individual to contact concerning fiscal and administrative issues if 
additional information is necessary following the initial review.  

Submit a signed, typewritten original of the application 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, send two additional copies of the 
application to:

Mary Nekola, Ph.D.
Chief, Scientific Review
Scientific Review Office
National Institute on Aging
7201 Wisconsin Avenue, Room 2C212
Bethesda, MD  20892-9205

It is important to send these copies at the same time as the original 
and three copies are sent to the Center for Scientific Review. These 
copies are used to identify conflicts and to help ensure the 
appropriate and timely review of the application.

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.

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.  The CSR will not accept any application that is 
essentially the same as one already reviewed.  This does not preclude 
the submission of substantial revisions of applications already 
reviewed, but such applications must include an introduction addressing 
the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by CSR and 
for responsiveness by the NIA and NIMH.  Incomplete and/or 
nonresponsive 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 NIA and NIMH in accordance with the review 
criteria stated below. As part of the initial merit review, a process 
may be used by the initial review group in which applications receive a 
written critique and 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, assigned a priority 
score, and receive a  second level review by the National Advisory 
Council on Aging and the National Advisory Council on Mental Health.

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 the application in order to judge the likelihood 
that the proposed research will have a substantial impact on the 
pursuit of these goals.  Each of these criteria will be addressed and 
considered in assigning the overall score, weighting them as 
appropriate for each application.  Note that the 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 investigator may propose to carry out important work that by its 
nature is not innovative but is essential to move a field forward.

1.  Significance:  Does this study address an important problem?  If 
the aims of the application are achieved, how will scientific knowledge 
be advanced?  What will be the effect of these studies on the concepts 
or methods that drive this field?

2.  Approach:  Are the conceptual framework, design, methods, and 
analyses adequately developed, well-integrated, and appropriate to the 
aims of the project?  Does the applicant acknowledge potential problem 
areas and consider alternative tactics?

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

4.  Investigator:  Is the investigator appropriately trained and well 
suited to carry out this work?  Is the work proposed appropriate to the 
experience level of the principal investigator and other researchers 
(if any)?

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

o  The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research. Plans for the recruitment and retention of subjects will also 
be evaluated.

o  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.

The personnel category will be reviewed for appropriate staffing based 
on the requested percent effort.  The direct costs budget request will 
be reviewed for consistency with the proposed methods and specific 
aims.  Any budgetary adjustments recommended by the reviewers will be 
in $25,000 modules.  The duration of support will be reviewed to 
determine if it is appropriate to ensure successful completion of the 
requested scope of the project.

Several criteria specific to this RFA have been identified.  These 
include:
o   Demonstrate an understanding of the special needs of the HIV/AIDS 
and aging population and relevant research issues
o   Show knowledge of intervention research principles and processes in 
the proposed population
o   Likelihood that planning grant will yield findings upon which to 
build a subsequent clinical trial

Schedule:

Letter of Intent Receipt Date:  February 23, 2001
Application Receipt Date:       March 26, 2001
Date of Initial Review:         June 2001
Review by Advisory Council:     August 2001
Anticipated Award Date:         September 2001

AWARD CRITERIA

The following will be considered in making funding decisions:
o  Quality of the proposed project as determined by peer review
o  Availability of funds
o  Program priority and balance. 

Inquiries concerning this RFA are encouraged.  Additional information, 
including sample budget narratives and biographical sketch, may be 
found at this site: 
http://grants.nih.gov/grants/funding/modular/modular.htm.  The 
opportunity to clarify any issues or questions from potential 
applicants is welcome.  Email queries are preferred.

Further information about Institute priorities and procedures can be 
found on the Institute Home Pages: NIA (http://www.nih.gov/nia); NIMH 
(http://www.nimh.nih.gov/).

Direct inquiries regarding programmatic issues related to HIV/AIDS 
research focused on understanding the role of aging processes and aging 
populations in HIV/AIDS intervention research to:

Marcia Ory, Ph.D., M.P.H.
Behavioral and Social Research Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 533 MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 402-4156
FAX:  (301) 496-3136
Email:  Marcia_Ory@NIH.GOV

Direct inquiries regarding NIA fiscal matters to:

Carol Lander
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:  Carol_Lander@NIH.GOV

Direct inquiries regarding programmatic inquiries focused on mental 
health aspects of HIV intervention research to:

David M. Stoff, Ph.D.
HIV/AIDS and Mentally Ill Research Program
Center for Mental Health Research on AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6210, MSC 9619
Bethesda, MD 20892-0619
Telephone: (301) 443-4625
FAX: (301) 443-9719
Email: dstoff@nih.gov

Direct inquiries regarding NIMH fiscal matters to:
Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2805
FAX: (301) 443-6885
Email: Diana_Trunnell@nih.gov

AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance 
No. 93.866 (NIA) and No. 93.242 (NIMH).  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 and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  
This program is not subject to the intergovernmental review 
requirements of Executive Order 12372 or Health Systems Agency review

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

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