RELEASE DATE:  November 7, 2002

PA NUMBER:  PA-03-024 (see replacement PA-04-157)

Expiration Date:  This PA will expire on September 16, 2004 (per replacement PA-04-157).

National Cancer Institute (NCI)
National Institute of Alcohol Abuse and Alcoholism (NIAAA) 
National Institute on Drug Abuse (NIDA)
National Institute of Child Health and Human Development (NICHD) 
This Program Announcement (PA) replaces PA-00-086, which was published 
in the NIH Guide on April 6, 2000. 

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


The Division of Cancer Control and Population Sciences of the National 
Cancer Institute (NCI), the National Institute of Alcohol Abuse and 
Alcoholism (NIAAA), the National Institute on Drug Abuse (NIDA), and 
the National Institute of Child Health and Human Development (NICHD) 
invite grant applications for interdisciplinary studies to better 
understand the molecular epidemiology and role of cofactors in the 
etiology and pathogenesis of pre-neoplastic conditions and cancers 
occurring among persons infected with the human immunodeficiency virus 
(HIV), specifically those cancers associated with viruses such as human 
papillomavirus(HPV), Epstein Barr virus (EBV), human herpesvirus 
8/Kaposi sarcoma associated herpesvirus (HHV8/KSHV), and hepatitis 
viruses B and C.  The initiative will also include malignancies arising 
within the context of acquired immunosuppression from non-HIV sources, 
such as organ transplants, and include the oncogenic virus, HTLV.  
While the primary emphasis is on malignant outcomes, cofactors of 
interest include host genetic susceptibility and phenotype; gender 
differences; and the role of endogenous and exogenous hormones; 
temporal association of acquisition of the oncogenic virus relative to 
time of HIV acquisition; effect of circulating viral load on the 
oncogenic virus; and role of behavioral factors such as tobacco use, 
diet, illegal drug and medication use; and alcohol abuse.  It is 
expected that enhanced understanding of the molecular epidemiology of 
these tumors within the context of host immunodeficiency will yield 
information important to cancer control and prevention, including 
development of prophylactic vaccines, chemotherapeutic treatment 
modalities, and other biomedical and behavioral preventive 

The NIAAA is interested in alcohol intake as an agent provocateur in 
the development of cancers associated with HIV. Alcohol is associated 
with immunosuppression and it is thought that alcohol ingestion may 
predispose the individual to a more profound or accelerated course to 

The NIDA is interested primarily in epidemiological studies pertaining 
to use of illegal drugs and medications on the immune system, hepatitis 
viruses, HIV progression and oncogenesis.

The NICHD is interested in gender differences and the role of exogenous 
hormones as they apply to the immune system and modulation of oncogenic 


Infection by the human retrovirus, HIV, is a major public health 
problem throughout the world, particularly in the developing world.  
Retroviruses may be directly oncogenic, or may foster the development 
of human cancers indirectly through immune suppression and subsequent 
reactivation of previously latent human oncogenic viruses.  In 
addition, alcohol and illegal drug use may affect or accelerate these 
processes.  The young age at which most people in the world become 
infected with HIV coupled with time spent living in an immunodeficient 
state portends that malignancies will have a significant impact on 
years of potential life lost and quality of life.

The NCI, NIAAA, NIDA and NICHD have had a continuing interest in the 
study of the molecular epidemiology of pre-neoplastic conditions and 
cancers occurring among immunodeficient persons who may also be using 
illegal drugs or alcohol, and exogenous hormones.    Studies have 
revealed that prognosis for some AIDS-related malignancies have 
improved in the era of highly-active antiretroviral therapy (HAART). 
One of the most remarkable outcomes is the decline in Kaposi sarcoma. 
Systemic non-Hodgkin lymphoma appears to be declining as well but to a 
lesser degree. However other cancers, notably those associated with 
epithelial tissues (anogenital dysplasias and invasive cervical 
cancers) have not declined to a significant degree during the HAART 
era.  These cancers appear to persist and progress in HIV-infected 
individuals on HAART therapy, and/may be refractory to standard 
therapies.  Overall, the long-term efficacy of antiretroviral therapy 
on HIV progression and HIV/AIDS-associated malignancies is still being 

The cancers of interest in this PA are ones associated with concomitant 
infection with viruses that frequently confer latency, such as Epstein 
Barr virus (EBV), human herpesvirus 8/Kaposi sarcoma associated herpes 
virus (HHV8/KSHV), human papillomavirus (HPV), hepatitis B and C, and 
HTLV.  In each case, infection by the concomitant virus appears to be 
necessary, but not sufficient, for subsequent tumor development. The 
proposed scope of the PA also includes host immune suppression from 
other conditions such as organ transplantation. 
This PA seeks to encourage research on the molecular epidemiology of 
preneoplastic conditions among persons with acquired immunodeficiency 
throughout the world and comparative epidemiologic studies based in 
several geographic areas.  An interdisciplinary approach that links the 
expertise of basic scientists with that of epidemiologists, clinicians, 
and behavioral scientists in an etiologic study is strongly encouraged.  
Investigations may be conducted in adults or children. The areas of 
research listed below are not intended to be all-inclusive, but rather 
are designed to give the applicant some direction as to the types of 
research that the NIH is interested in stimulating.  The NCI is 
interested primarily in issues related to oncogenesis and cancer; the 
NIAAA is interested in the areas of research with a special emphasis on 
the impact of ethanol ingestion on oncogenesis and progression to AIDS; 
the NIDA is interested in the use of illegal drugs and medications on 
the immune system and oncogenesis; and the NICHD is interested in the 
role of endogenous hormones (as manifested by gender differences)in 
oncogenesis, the interaction of the viruses and the immune system, 
disease progression and the effect of exogenous hormones on the above.  

o The evaluation of HIV-associated malignancies in international 
settings of high HIV incidence and prevalence, including India, South 
East Asia, Eastern Europe, Central/South America, and Africa, that 
offer unique research opportunities

o The role of lifestyle factors such as alcohol, injectable drugs, 
tobacco, and nutrition in the pathogenesis of HIV/AIDS-associated pre-
neoplastic changes and malignancies  

o The incorporation of studies conducted through specimen bank programs 
for correlative research on HIV/AIDS associated malignancies

o The incidence and trends of cancers associated with long-term immune 
suppression in the era of HAART and HIV disease, and organ 

o The (treated) natural history of cancers and pre-neoplastic changes 
in situations where the temporality of observed events, including 
timing of first infection or reactivation of existing infection, may be 

o The interplay of routes of acquisition, especially the oral route, of 
the oncogenic virus and other cofactors on the molecular epidemiology 
and natural history of immunodeficiency associated pre-neoplastic and 
malignant processes

o The effect of endogenous hormones (gender differences) and exogenous 
hormones on the up or down regulation of HIV and oncogenic viruses, and 
what impact that may have of disease progression


This PA will use the National Institutes of Health (NIH) research 
project grant (R01) and competing supplements to existing NCI, NICHD, 
NIAAA and NIDA funded (R01) grants, as the award mechanism.  
Responsibility for the planning, direction, and execution of the 
proposed project will be solely that of the applicant.  The supplement 
must have the same Principal Investigator as the parent grant.  The 
total requested project period for an application submitted in response 
to the PA may not exceed five years. Competing supplements must not 
extend beyond the funding period of the parent grant; the parent grant 
must have at least one year remaining in its project period after award 
of the supplement.

This PA uses just-in-time concepts.  It also uses the modular as well 
as the non-modular budgeting formats (see  
Specifically, if you are submitting an application with direct costs 
in each year of $250,000 or less, use the modular format.  Otherwise 
follow the instructions for non-modular research grant applications.


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
o Faith-based or community-based organizations 


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. 


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

Direct both overall programmatic issues and inquiries with a primary 
scientific research focus on cancer to:
Vaurice Starks, B.S.
Division of Cancer Control and Population Sciences
National Cancer Institute
Executive Plaza North, Room 5103, MSC 7395
Bethesda, MD  20892-7395
Telephone:  (301) 402-9375
Fax: (301) 402-4279

Sandra L. Melnick, Dr.P.H.
Division of Cancer Control and Population Sciences
National Cancer Institute
Executive Plaza North, Room 5103, MSC 7395
Bethesda, MD 20892-7395
Fax:  (301) 402-4279

Direct inquiries regarding the AIDS & Cancer Specimen Bank 
collaborations to:

Jodi Black, Ph.D.
AIDS Malignancy Program
National Cancer Institute
Division of Cancer Treatment and Diagnosis
31 Center Drive
Room 3A44
Bethesda, MD 20892-2440
Telephone: (301) 402-6293 
Fax: (301) 496-0826 
Link to the specimen bank:

Direct inquiries regarding applications with a primary focus on alcohol 
abuse and alcoholism to:

Denise Anne Russo, Ph.D. 
Biomedical Research Branch
Division of Basic Research,
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Room 402 
Bethesda, MD 20892-6402
Telephone: (301)402-9403 
Fax: (301) 594-0673
Direct inquiries regarding use of illegal drugs and medications to:

Thomas F. Kresina, Ph.D.
Center on AIDS & Other Medical 
Consequences of Drug Abuse (CAMCODA) 
National Institute on Drug Abuse, NIH 
6001 Executive Blvd., Room 5098, MSC 9593 
Bethesda, MD 20892-5953 
Telephone: (301) 402-1913 
Fax: (301) 594-6566 

Direct inquires regarding gender differences and exogenous hormones to:

Patricia Reichelderfer, Ph.D. 
Contraception and Reproductive health branch
Center for Population Research
National Institute for Child health and Human Development
6100 Executive Blvd., Room 8B13D
Rockville, MD 20892
Telephone: (301) 435-6991
Fax: (301) 480-1972

Direct inquiries regarding fiscal matters to:
Ms. Crystal Wolfrey
Team Leader, DCCPS Team
Grants Administration Branch
National Cancer Institute
National Institutes of Health
6120 Executive Blvd., Suite 243
Bethesda, MD 20892
Phone:(301) 496-8634
Fax:  (301) 496-8601

Ms. Judy Simons
Chief, Grants Management Office
Office of Planning and Resource Management
National Institute on Alcohol Abuse and Alcoholism 
6000 Executive Boulevard, Suite 504, MSC 7003
Bethesda, MD 20892-7003
Telephone:  (301) 443-0915
Fax:  (301) 443-3891

Gary Flemming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Blvd., Room 3131, MSC 9541
Bethesda, MD 20892-9541
Telephone: (301) 443-6710
FAX: (301) 594-6847

Ms. Kathy Hancock
Lead Grants Management Specialist
National Institute of Child Health 
and Human Development
6100 Executive Blvd. Room 8A17M
Telephone: (301) 496-5482
Fax: (301) 402-0915


Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001).  The PHS 398 is 
available at in 
an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 710-0267, Email:

APPLICATION RECEIPT DATES: Applications submitted in response to this 
program announcement will be accepted at the standard AIDS-related and 
non-AIDS application deadlines, which are available at  Application deadlines are also 
indicated in the PHS 398 application kit.

requesting up to $250,000 per year in direct costs must be submitted in 
a modular grant format.  The modular grant format simplifies the 
preparation of the budget in these applications by limiting the level 
of budgetary detail.  Applicants request direct costs in $25,000 
modules.  Section C of the research grant application instructions for 
the PHS 398 (rev. 5/2001) at includes step-
by-step guidance for preparing modular grants.  Additional information 
on modular grants is available at

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

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

1)  Contact the NCI program staff at least 6 weeks before submitting 
the application, i.e., as you are developing plans for the study; 

2)  Obtain agreement from the NCI staff that the NCI will accept your 
application for consideration for award; and,
3)  Identify, in a cover letter sent with the application, the staff 
member from NCI who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), 
competing continuation (type 2), competing supplement, or any amended 
or revised version of these grant application types. Additional 
information on this policy is available in the NIH Guide for Grants and 
Contracts, October 19, 2001 at 

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten 
original of the application, including the checklist, and five signed 
photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING: Applications must be received by or mailed on 
or before the receipt dates described at  The CSR 
will not accept any application in response to this PA that is 
essentially the same as one currently pending initial review unless the 
applicant withdraws the pending application.  The CSR will not accept 
any application that is essentially the same as one already reviewed.  
This does not preclude the submission of a substantial revision of an 
application already reviewed, but such application must include an 
Introduction addressing the previous critique.


Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review 
group convened in accordance with the standard NIH peer review 
procedures ( will evaluate 
applications for scientific and technical merit.  

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

o  Receive a written critique
o  Undergo a 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 
o  Those that receive a priority score will undergo a second level 
review by the appropriate national advisory council or board.


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?

(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?

(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 

(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)?

(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?

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

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

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

DATA SHARING:  The adequacy of the proposed plan to share data.

BUDGET:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research. Foreign 
applications and domestic applications with international components 
may receive a flat rate of 8 per cent indirect costs.   

OTHER REVIEW CRITERIA:  Applications from foreign institutions will be 
evaluated and scored during the initial review process using the 
standard review criteria.  In addition, the following will be assessed 
as part of the subsequent review procedures and award decision:

o Whether the project presents special opportunities for furthering 
research programs through the use of unusual talent, resources, 
populations, or environmental conditions in other countries that are 
not readily available in the U.S. or that augment existing U.S. 

o Whether the proposed project has specific relevance to the mission 
and objectives of the National Institutes of Health and has the 
potential for significantly advancing the health sciences of the U.S. 

Research grant applications from foreign or international organizations 
may not be funded unless approved by the IC Advisory Council/Board. 


Applications submitted in response to a PA will compete for available 
funds with all other recommended applications.  The following will be 
considered in making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities


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 

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 
(; a 
complete copy of the updated Guidelines are available at
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 

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

All investigators proposing research involving human subjects should 
read the "NIH Policy and Guidelines" on the inclusion of children as 
participants in research involving human subjects that is available at  

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
files/NOT-OD-00-039.html.  A continuing education program in the 
protection of human participants in research in now available online 

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

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

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 

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 PA is related to the priority areas of cancers associated 
with acquired immunodeficiency.  Potential applicants may obtain a copy 
of "Healthy People 2010" at

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of 
Federal Domestic Assistance Nos. 93.393, 93.856, and 93.121, and is not 
subject to the intergovernmental review requirements of Executive Order 
12372 or Health Systems Agency review.  Awards are made under 
authorization Sections 301 and 405 of the Public Health Service Act 
amended (42 USC 241 and 284) and administered under NIH grants policies 
described at and under Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  

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

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

Office of Extramural Research (OER) - Home Page Office of Extramural
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Bethesda, Maryland 20892
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