RELEASE DATE:  October 20, 2003 

PA NUMBER:  PAR-04-011 (see addenda NOT-CA-04-021 and NOT-CA-04-001)

EXPIRATION DATE:  November 2, 2005, unless reissued. 

Department of Health and Human Services (DHHS)


National Institutes of Health (NIH) 

National Cancer Institute (NCI) 


LETTER OF INTENT RECEIPT DATE:  May 1, 2004; January 2, 2005; September 1, 2005  

                                                 October 1, 2005

November 1, 2005

This Program Announcement (PA) replaces PAS-02-009, which was published in 
the NIH Guide on October 11, 2001. 


o Purpose of the PA
o Research Objectives
o Mechanism of Support 
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 Award Criteria
o Receipt and Review Schedule
o Required Federal Citations


The Division of Cancer Control and Population Sciences (DCCPS) of the 
National Cancer Institute (NCI) announces special receipt dates for R01 grant 
applications from investigators intending to initiate, competitively 
supplement, or competitively renew population-based epidemiologic or 
survivorship cohort studies of human cancers.  The purpose of the Program 
Announcement (PA) is to coordinate the submission, review, and funding of 
population-based epidemiologic or survivorship cohort studies, and covers 
applications characterized by their cohort design and direct costs of 
$500,000 or more in any one study year.  This PA represents a continuation of 
previous NCI policy, in that the NCI does not accept unsolicited applications 
at these budget levels for population-based cohorts.  All usual NIH grants 
policies apply to these awards. 

Prospective population-based cohort studies are one of the mainstays of 
epidemiologic inquiry, and have the clear advantage over cross-sectional and 
case-control study designs of unbiased assessment of multiple pre-diagnostic 
exposures and the ability to assess multiple outcomes.  In the cohort design, 
information on the study factor is known for all subjects at the beginning of 
the follow-up period, and they are followed over time to determine who among 
them develop the disease(s) of interest.  Therefore, the study factor of 
interest, or exposure, is observed and measured before the disease is 
detected, making it likely that the study factor is related to disease 
development (i.e., is a risk factor) instead of being part of the disease 
process.  Also, it is much less likely that the presence or absence of the 
study factor of interest can differentially influence selection of study 
participants on the basis of disease outcome status.  Once a population-based 
cohort is established, and data and bio-specimens become available, it 
typically becomes an attractive infrastructure for additions or supplements 
to address new areas of scientific investigation.  Often the cohort is used 
to study other diseases in addition to cancer.

However, these types of population-based cohort studies are usually 
substantially more time-consuming and expensive than most cross-sectional and 
case-control approaches, and are usually less suitable for study of more 
uncommon outcomes unless very large numbers of subjects are followed.  Also, 
because study factor information must be observed at the outset of the study, 
a cohort study design limits opportunities for generating new etiologic 
hypotheses requiring information on other, unanticipated exposures.  

Rigorous scientific inquiry in gene-gene and gene-environment interactions 
has raised the awareness of the role of prospective population-based cohorts, 
with a concomitant increase in number, scale, and costs of the research 
grants.  Cohort studies have been tremendously useful tools, particularly in 
assessment of exposures and capture of multiple outcomes.  However, cohort 
research proposals are frequently submitted without full appreciation of the 
opportunities for research nested within existing cohorts.  Most new cohorts 
require the passage of years before accumulation of enough endpoints to 
analyze.  Existing cohorts include people who are well characterized, and 
likely already experiencing the impact of environmental exposures. Issues of 
key interest to the NCI with regard to these resources include continuity of 
funding, balance of important cohort characteristics, quality of design, 
rigor in exposure assessment, response and follow-up rates, bio-specimen 
collection and storage, bioinformatics, availability of bio-specimen 
resources to outside qualified investigators, and willingness to collaborate 
with other investigators in the establishment of research consortia.  
Potential applicants are encouraged to learn more about extramurally funded, 
large, population-based epidemiologic and survivorship cohort studies at the 
NCI at the following website:

Coordination of research infrastructure in the arena of population-based 
cohorts may be expected to yield new and expanded opportunities for study, as 
the biomedical resources are made available to outside investigators.  These 
large databases will afford the opportunity to study hypotheses that would be 
underpowered in smaller studies.  This is especially true in the study of 
gene-environment and gene-gene interactions, in which large numbers of study 
participants followed in a standardized fashion are required.  In addition, 
NCI coordination of population-based epidemiologic and survivorship cohorts 
will make it possible to identify gaps, whether in special populations, 
special cancers of high interest, or other special outcomes.

Applications pursuant to this PA are limited to population-based 
epidemiologic and survivorship cohort studies of human cancers.  

This PA covers population-based epidemiologic and survivorship cohort 
applications requesting $500,000 or more in direct costs (excluding third-
party facility and administrative, formerly indirect, costs) in any one 
project year.  Potential applicants are encouraged to become familiar with 
existing resources at the address listed above, 

Examples of applications that MUST be submitted under this solicitation 
include the following:

o applications for new population-based epidemiologic cohort studies of human 
cancers requesting $500,000 direct costs or more in any one project year

o applications for new survivorship cohorts of human cancers requesting 
$500,000 direct costs or more in any one project year

o applications for competitive supplements to an NCI-funded population-based 
epidemiologic or survivorship cohort study that would result in such study 
costing $500,000 direct costs or more in any one project year

o applications for competitive renewal (Type 2) of an NCI-funded population-
based epidemiologic or survivorship cohort study requesting $500,000 direct 
costs or more in any one project year

This solicitation specifically EXCLUDES the following:

o applications for new and existing epidemiologic cohort studies of HIV-
related malignancies, which will continue to be submitted and reviewed under 
existing NIH guidelines for AIDS-related research and under PA-03-024, 
Molecular Epidemiology of Cancers Associated with Acquired Immunodeficiency

o applications for new and existing epidemiologic cohort studies of 
individuals at high genetic risk for cancer

o applications for new and existing intervention studies, including 
randomized controlled trials

o administrative supplements, such as those resulting from unexpected loss of 
equipment or increase in costs of a test 


This PA will use the NIH investigator-initiated research project grants (R01) 
award mechanism(s).  As an applicant, you will be solely responsible for 
planning, directing, and executing the proposed project.  The total project 
period for an application submitted in response to the PA may not exceed FIVE 
years.  The earliest anticipated award date is April 2005.

Revisions of unsuccessful applications submitted under this PA will ONLY be 
accepted in response to future reissuances of this PA.  The next submission 
opportunity for competing continuations, supplements, and revisions is July 
1, 2004 .  Revised versions of unsuccessful applications may NOT be submitted 
under other mechanisms, including submission of revised applications to the 
NIH Center for Scientific Review (CSR) for standard R01 receipt dates not 
specified as submission opportunities in this PA.  NCI will not accept  
applications, including revisions, for population-based epidemiologic and 
survivorship cohorts costing $500,000 or more direct costs in any one study 
year that are not submitted in response to this PAR. Though the size of award 
may vary with the scope of research proposed, applications must stay within 
the NCI budgetary guidelines for R01 investigator-initiated competing 
projects.  Application for competitive renewal of existing cohorts (Type 2) 
will be limited to a 20 percent increase over the last non-competing (Type 5) 
year.  In cases where the last non-competing year budget was substantially 
lower than other previous years, and if the nature of the new research 
requires budget increases for one or more years above the 20 percent rule for 
the last non-competing year, applicants may cite the average yearly direct 
cost as a base for the new cap.  Applicants interested in this option are 
required to contact the NCI program director for the currently funded grant 
before submitting applications.  Requests for exceptions to the 20 percent 
cap on Type 2 applications will NOT be granted.  Further information on NCI 
policy in this area may be found at Letters of 
Intent are strongly recommended, and are due May 1, 2004 (for the first 
receipt date), January 2, 2005 (for the second receipt date), or September 1, 
2005 (for the third receipt date).  

This PA uses just-in-time concepts.  It also uses the non-modular budgeting 
formats (see  This 
program does not require cost sharing as defined in the current NIH Grants 
Policy Statement at  


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

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


Effective with the October 1, 2003, receipt date for NIH applications, NIH 
expects timely release and sharing of final research data for use by other 
researchers.  Grant applications must include a plan for data sharing, or 
state why data sharing is not possible.  Data sharing plans must be discussed 
with NIH Institute/Center staff for all applications submitted under this PA. 
Information on data sharing must be included in relevant sections of the 
grant application, including a data sharing plan at the end of the Research 
Plan, Budget and Budget Justification if asking for funds, and in Background 
and Significance sections if creating an important scientific resource.  
Institute/Center program staff will be responsible for assessing the 
appropriateness and adequacy of the data sharing plan, and program concerns 
must be resolved prior to making an award.  Reviewers will review the data 
sharing plan, but it will not be included in determinations of the scientific 
merit or priority score for an application.  Further information on the NIH 
data sharing requirements may be found at 


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

o Direct your questions about scientific/research issues to:

Sandra L. Melnick, Dr.P.H.
Division of Cancer Control and Population Sciences
National Cancer Institute
Executive Plaza North, Room 5100, MSC 7324
Bethesda, MD  20892-7324
Telephone:  (301) 435-4914
FAX:  (301) 402-4279

o Direct your inquiries regarding peer review issues to:

Denise Wiesch, Ph.D.
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 3150, MSC 7770
Bethesda, MD 20892-7770
Bethesda, MD 20817 (for express/courier service)
Telephone:  (301) 435-0684
Fax:  (301) 480-3962

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

Crystal Wolfrey
Division of Extramural Activities
National Cancer Institute
Executive Plaza South, Room 234, MSC 7150
Bethesda, MD  20892-7150
Telephone:  (301) 496-8634
FAX:  (301) 496-8601


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 PA

Although a letter of intent is not required, is strongly recommended, not 
binding, and does not enter into the review of a subsequent application, the 
information that it includes allows NCI 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:

Sandra L. Melnick, Dr.P.H.
Division of Cancer Control and Population Sciences
National Cancer Institute
Executive Plaza North, Room 5100, MSC 7324
Bethesda, MD  20892-7324
Telephone:  (301) 435-4914
FAX:  (301) 402-4279


Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a Dun and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 
398 document is available at in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 

The title, “Cohort Studies in Cancer Epidemiology,” and the number of the 
program announcement (PAR-04-011) must be typed on line 2 of the face page of 
the application form and the YES box must be marked.

APPLICATION RECEIPT DATES:  Applications submitted in response to this 
program announcement will be accepted by the receipt dates listed on the 
first page of this program announcement ONLY.

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 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 unfunded version of an application 
already reviewed, but such application must include an Introduction 
addressing the previous critique.  

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.


Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  Appropriate scientific review groups 
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 Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications under 
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the National Cancer Advisory 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 evaluate the application in 
order to judge the likelihood that the proposed research will have a 
substantial impact on the pursuit of these goals.  The scientific review 
group will address and consider each of these criteria in assigning the 
application’s overall score, weighting them as appropriate for each 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

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 

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?

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?

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

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)?

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?  

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score:

subjects and protections from research risk relating to their participation 
in the proposed research will be assessed. (See criteria included in the 
section on Federal Citations, below).

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 will be assessed.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the sections on 
Federal Citations, below).


Sharing Research Data 

Applicants requesting more than $500,000 in direct costs in any year of the 
proposed research are expected to include a data sharing plan in their 
application. The reasonableness of the data sharing plan or the rationale for 
not sharing research data will be assessed by the reviewers. However, 
reviewers will not factor the proposed data sharing plan into the 
determination of scientific merit or priority score. (See Federal Citation 

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


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

Because the nature and scope of the research proposed will vary, it is 
anticipated that the size of each award also will vary.  Other things being 
equal, cost and program relevance may be considered in making awards.  If 
several applications are of similarly high scientific and technical merit, 
preference for funding may be given to competitive continuation of existing 


Letter of Intent                                     May 1, 2004
New Applications                                     June 1, 2004
Competing Continuations, Supplements, and Revisions  July 1, 2004
Scientific Merit Review                              Oct-Nov, 2004
Advisory Council Review                              Jan-Feb, 2005
Earliest Anticipated Start Date                      April 2005

Letter of Intent                                     January 2, 2005
New Applications                                     February 1, 2005
Competing Continuations, Supplements, and Revisions  March 1, 2005
Scientific Merit Review                              June-July, 2005
Advisory Council Review                              Sept-Oct, 2005
Earliest Anticipated Start Date                      December 2005

Letter of Intent                                     September 1, 2005
New Applications                                     October 1, 2005
Competing Continuations, Supplements, and Revisions  November 1, 2005
Scientific Merit Review                              Feb-March, 2006
Advisory Council Review                              May-June, 2006
Earliest Anticipated Start Date                      July 2006


HUMAN SUBJECTS PROTECTION:  Federal regulations (45 CFR 46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained.


Starting with the October 1, 2003 receipt date, investigators submitting an 
NIH application seeking more than $500,000 or more in direct costs in any 
single year are expected to include a plan for data sharing or state why this 
is not possible. 

Investigators should seek guidance from their institutions, on issues related 
to institutional policies, local IRB rules, as well as local, state and 
Federal laws and regulations, including the Privacy Rule. Reviewers will 
consider the data sharing plan but will not factor the plan into the 
determination of the scientific merit or the priority score.

the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of 
the research. This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43).

All investigators proposing clinical research should read the "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
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 

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, 1998.

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 

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  A 
continuing education program in the protection of human participants in 
research is available online at:

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.

Department of Health and Human Services (DHHS) issued final modification to 
the “Standards for Privacy of Individually Identifiable Health Information”, 
the “Privacy Rule,” on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified 
under the Rule as “covered entities”) must do so by April 14, 2003 (with the 
exception of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
( provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on “Am I a covered 
entity?”  Information on the impact of the HIPAA Privacy Rule on NIH 
processes involving the review, funding, and progress monitoring of grants, 
cooperative agreements, and research contracts can be found at

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 PA 
is related to one or more of the priority areas. 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 at and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at 

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

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