RELEASE DATE:  October 20, 2003

PA NUMBER:  PA-04-012

March 2, 2006 (NOT-OD-06-046) – Effective with the June 1, 2006 submission
date, all R03, R21, R33 and R34 applications must be submitted through 
using the electronic SF424 (R&R) application. Accordingly, this funding 
opportunity relating expires on the date indicated below. Replacement R01 (PA-06-385) 
and R21 (PA-06-386) funding opportunity announcements have been issued for 
the submission date of June 1, 2006 and submission dates thereafter.

EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006 
EXPIRATION DATE for All R01 Applications: November 2, 2006. (Expiration
 date extended, see NOT-CA-05-026) 

Department of Health and Human Services (DHHS)


National Institutes of Health (NIH)
Agency for Health Research and Quality (AHRQ) 

National Cancer Institute (NCI)


This Program Announcement (PA) replaces PA-02-006, which was published in the 
NIH Guide on October 4, 2001. 


o Purpose of the PA
o Research Objectives
o Mechanisms 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


NCI and AHRQ invite investigator-initiated grant applications for research 
entailing the use of health claims data for cancer surveillance. Cancer 
surveillance may include assessment of patterns of care, quality and outcomes 
of care, and health disparities across the continuum of treatment.  Projects 
sought under this Program Announcement (PA) may focus on treatment and 
outcomes at the patient-specific level or include influences from the 
provider or broader health-system level.  In addition to studies of cancer 
treatment and outcomes, responses to this PA may also initiate analyses to 
expand understanding of the capability of and methods needed to use claims 
data for cancer surveillance. Health claims include secondary data sources 
such as the linked SEER-Medicare data 
(, databases with multiple 
payers such as the Healthcare Cost and Utilization Project (HCUP) database 
(, fee-for-service insurance bills for 
medical, rehabilitative, or other health care services, managed care 
encounter data, and discharge summaries.  

This PA relates to priority areas for NCI and AHRQ.  Projects under this PA 
may address two priorities, improving the quality of cancer care and reducing 
cancer-related health disparities, as identified by NCI in “The Nation's 
Investment in Cancer Research” (   AHRQ supports 
general health services and outcomes and effectiveness research for a wide 
range of clinical conditions, including cancer 



There is increasing interest in the collection and analysis of valid, 
accurate and reliable secondary data to assess screening, treatment and 
outcomes for specific disease entities.  For example, the 1998 Institute of 
Medicine report on Scientific Opportunities and Public Needs: Improving 
Priority Setting and Public Input at the NIH 
( recommends that, "In setting priorities, 
NIH should strengthen its analysis and use of health data, such as burdens 
and costs of diseases, and of data on the impact of research on the health of 
the public."  Increasing the use of these types of data to assess the quality 
of cancer care has also been identified as a priority by the Institute of 
Medicine (  Studies using 
claims-based data are usually population-based and have the potential to 
address a number of priority questions including disparities in health care 
based on demographic characteristics and the quality of cancer care.

Scope of Activity

Cancer is a heterogeneous chronic disease which requires innovation in 
treatment and care approaches.  This initiative supports research directed at 
the use of health claims data for cancer surveillance, including studies of 
cancer detection, treatment, and outcomes.  In addition, this initiative is 
directed towards studies that assess the utility of claims data for cancer 

Research topics that would be relevant to the studies of detection, treatment 
and outcomes include, but are not limited to the following examples:

1. Studies of the patterns of cancer for persons with specific 
cancers/stages.  This might include treatment during the peri-diagnostic 
period, use of adjuvant treatments, as well as long-term follow-up.
2. Disparities in the receipt in cancer care based on demographic and socio-
economic characteristics.
3. Determinants of the quality of care across the cancer continuum, e.g., 
training and volume of health care providers. 
4. Use of screening tests among the general population and rates of post-
diagnostic surveillance for persons with cancer. 
5. Differences in cancer screening and treatment based on insurance status- 
such as uninsured, managed care and fee-for-service, and the impact of carve-
out plans.
6. Intensity and types of services provided at the end of life.
7. Rates of short-term complications following cancer treatment.
8. Long-term complications for cancer survivors as sequellae to their cancer 

The types of projects dealing with detection, treatment, and outcomes that 
have been funded under earlier releases of this PA include:

o Understanding Racial Differences in Lung Cancer Treatment
o Colorectal Cancer Care Variation In Vulnerable Elderly
o Managed Care Penetration and Cancer Care
o Cancer Surveillance Using HMO Administrative Data
o The Non-cancer Care of Elderly Colorectal Cancer  Patients
o Use of Claims Data to Study Quality of Cancer Care
o Provider Specialty and Outcomes in Ovarian Cancer
o Cancer Care and Outcomes for Disabled Medicare Patients
o Patterns of Cancer Care at the End of Life

Some of the publications from prior issues of this PA that are related to 
detection, treatment and outcomes are as follows:

Bach PB, Cramer LD, Schrag D, Downey RJ, Gelfand SE, Begg CB. The influence 
of hospital volume on survival after resection for lung cancer.  N Engl J 
Med. 2001 Jul 19, 345(3):181-8. 

Du X, Goodwin JS.  Patterns of use of chemotherapy for breast cancer in older 
women: findings from Medicare claims data. J Clin Oncol. 2001 Mar 

Du XL, Osborne C, Goodwin JS. Population-based assessment of hospitalizations 
for toxicity from chemotherapy in older women with breast cancer. J Clin 
Oncol. 2002 Dec 15;20(24):4636-42. 

Earle CC. Influenza vaccination in elderly patients with advanced colorectal 
cancer. J Clin Oncol. 2003 Mar 15;21(6):1161-6.  

Earle CC, Burstein HJ, Winer EP, Weeks JC.  Quality of non-breast cancer 
health maintenance among elderly breast cancer survivors. J Clin Oncol. 2003 
Apr 15;21(8):1447-51. 

McCarthy EP, Burns RB, Ngo-Metzger Q, Davis RB, Phillips RS.  Hospice use 
among Medicare managed care and fee-for-service patients dying with cancer. 
JAMA. 2003 May 7;289(17):2238-45. 

McCarthy EP, Burns RB, Davis RB, Phillips RS. Barriers to hospice care among 
older patients dying with lung and colorectal cancer. J Clin Oncol. 2003 Feb 

Research topics that would be relevant to assessing the utility of claims 
data for cancer surveillance include, but are not limited to the following 

1. Use of claims data to assess the frequency and intensity of diagnostic 
2. Methods to distinguish screening vs. diagnostic procedures.
3. Methods to identify recurrences or metastases from claims data.
4. Assessment of the availability and completeness of encounter data from 
managed care settings.  
5. Use of claims data to measure adjuvant therapies.
6. Determination of whether health claims-based data systems can be used to 
track the emergence of new technologies for detecting, diagnosing, or 
treating cancer or pre-cancerous conditions.   
7. Use of health claims-based data systems to obtain additional information 
that is not routinely collected by cancer registries, including enhanced case 
8. Methods to measure comorbidity. 

The use of claims data to assess population-based cancer incidence and 
survival rates has been assessed in numerous earlier studies and is not a 
priority of this PA. 

The types of projects dealing with the utility of claims data for cancer 
surveillance  under earlier releases of this PA include:

o Evaluation Of Enteral Stent Placement Using Claims Data
o Evaluation Of Chemotherapy Claims For Breast Cancer
o Evaluating Mammography Claims Data
o Using Claims Data to Assess Cancer Incidence, Stage, and Treatment

Some of the publications from prior issues of this PA that are related to 
assessing the utility of claims data for cancer surveillance are as follows:           

Cooper GS, Yuan Z, Stange KC, Amini SB, Dennis LK, Rimm AA.  The utility of 
Medicare claims data for measuring cancer stage. Med Care. 1999 Jul;37 

Cooper GS, Yuan Z, Stange KC, Dennis LK, Amini SB, Rimm AA.  The sensitivity 
of Medicare claims data for case ascertainment of six common cancers.  Med 
Care. 1999 May;37(5):436-44. 

Freeman JL, Zhang D, Freeman DH, Goodwin JS. An approach to identifying 
incident breast cancer cases using Medicare claims data. J Clin Epidemiol. 
2000 Jun;53(6):605-14.

Freeman JL, Klabunde CN, Schussler N, Warren JL, Virnig BA, Cooper GS.  
Measuring breast, colorectal, and prostate cancer screening with medicare 
claims data.  Med Care. 2002 Aug;40(8 Suppl):IV-36-42.


This PA will use the NIH investigator-initiated research project grant (R01) 
and the exploratory/developmental grant (R21) award mechanism.  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 this PA may not exceed 5 years for an R01 
application and 2 years for an R21 application. 

For R21 submissions, applicants may request up to $100,000 direct costs (four 
budget modules) per year unless the application includes consortium costs, in 
which case the limit is $125,000 in direct costs (five budget modules) per 
year.  Applicants without extensive preliminary data or who wish to explore 
the utility of claims-based data to address a specific question are urged to 
submit applications for this PA using the exploratory/developmental grant 

This PA uses just-in-time concepts.  It also uses the modular budgeting 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 budget research grant applications.  This program does not require 
cost sharing as defined in the current NIH Grants Policy Statement at  

Since AHRQ study sections require complete budget information in their 
review, all applications reviewed by AHRQ study sections will be required to 
include detailed budget pages prior to the study section review.


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.  


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

o Direct your questions about scientific/research issues to:

Joan Warren, Ph.D.
Division of Cancer Control and Population Sciences
Applied Research Program
National Cancer Institute
Executive Plaza North, Room 4004
Bethesda, MD  20892
Telephone: (301) 496-5184
FAX:  (301) 435-3710

Bernard Friedman, Ph.D.
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD  20850
Telephone: (301) 427-1404
Email:  BFriedma@AHRQ.GOV

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

Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD  20892
Telephone:  (301) 496-8634
FAX:  (301) 496-8601

Mable Lam
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD  20850
Telephone: (301) 427-1448
Email:  mlam@AHRQ.GOV


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, “Cancer Surveillance Using Health Claims-Based Data System,” and 
the number of the program announcement (PA-04-012) must be type 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 at the standard 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 budget grant format.  The modular budget 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

Applications to NIH 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 

Applicants requesting more than $500,000 must carry out the following steps:
1. Contact the NIH/AHRQ 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 NIH/AHRQ staff that the NIH/AHRQ will accept 
your application for consideration for award; and,
3. Identify, in a cover letter sent with the application, the NIH/AHRQ staff 
member 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 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.  An appropriate scientific review group 
convened in accordance with the standard NIH peer review procedures 
( or AHRQ process will evaluate 
applications for scientific and technical merit.  

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

o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by an 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 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).

be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.  


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


HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) 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.

SHARING RESEARCH DATA:  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 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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS) - Government Made Easy

Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.