This PA will expire on October 2, 2003, unless reissued.

CANCER SURVEILLANCE USING HEALTH CLAIMS-BASED DATA SYSTEM

Release Date:  October 4, 2001

PA NUMBER:  PA-02-006 (see replacement PA-04-012)
 
National Cancer Institute
Agency for Health Care Quality and Research

This Program Announcement (PA) replaces PA-99-015, which was published in the 
NIH Guide on November 12, 1998.

THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  MODULAR 
INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS UP TO $250,000 PER 
YEAR. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 
(REVISION 5/2001) AVAILABLE AT 
http://grants.nih.gov/grants/funding/phs398/phs398.html.

Since AHRQ study sections require complete budget information in their 
review, all applications assigned, after initial submission, to AHRQ for 
review and funding considerations will be requested to submit detailed budget 
pages prior to the study section review.

PURPOSE
 
The Division of Cancer Control and Population Sciences (DCCPS), National 
Cancer Institute (NCI) and the Agency for Health Care Research and Quality 
(AHRQ) invite investigator-initiated grant applications for research 
entailing the use of health claims data for cancer surveillance, including 
cancer detection, treatment, and outcomes.   Health claims include secondary 
data sources such as the linked SEER-Medicare data, fee-for-service insurance 
bills for medical, rehabilitative, or other health care services, managed 
care encounter data, data bases with multiple payers such as the Healthcare 
Cost and Utilization Project (HCUP) data base and discharge summaries.  
Studies of cancer treatment may include assessment of patterns of care, 
quality and outcomes of care across the continuum of treatment and health 
disparities.  Projects funded under this PA may focus on determinants of 
treatment and outcomes at the patient-specific level or including influences 
from the provider or broader health-system.  In addition to studies of cancer 
incidence and treatment, responses to this program announcement (PA) may also 
initiate analyses to expand understanding of the capability of and methods 
needed to use claims data for cancer surveillance. 

This Program Announcement (PA) relates to the general health services and 
outcomes and effectiveness research supported by the AHRQ for a wide range of 
clinical conditions, including cancer.  For example, AHRQ is presently 
supporting research that supports improvements in health outcomes, 
strengthens quality measurement and improvement, identifies strategies to 
improve access, foster appropriate use, and reduce unnecessary expenditures, 
and promotes advances in health services research methodologies, especially 
cost-effectiveness analysis.  Related research priorities are described in 
AHRQ Health Services Research Program Announcement PA-00-111, which is 
available on the WEB at:  
http://grants.nih.gov/grants/guide/pa-files/PA-00-111.html.

RESEARCH OBJECTIVES

Background

There is increasing interest in the collection and analysis of valid, 
accurate and reliable data related to preventive, screening and treatment 
intervention related to 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 (See 
http://www.nap.edu/readingroom/books/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 
(http://search.nap.edu/html/enhancing_data_systems).  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 characterized by 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 
surveillance. 

Examples of research topics that could be relevant to the studies of 
detection, treatment and outcomes include but are not limited to:

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.  Use of screening tests among the general population and rates of post-
diagnostic surveillance for persons with cancer. 
3.  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.
4.  Intensity and types of services provided at the end of life.
5.  Rates of short-term complications following cancer treatment.
6.  Long-term complications for cancer survivors as sequellae to their cancer 
treatment.
7.  Disparities in the receipt in cancer care based on demographic and socio-
economic characteristics.
8.  Determinants of the quality of care across the cancer continuum, e.g. 
training and volume of health care providers. 

Examples of research topics that could be relevant to assessing the utility 
of claims data for surveillance include but are not limited to:

1.  Use of claims data to assess the frequency and intensity of diagnostic 
tests.
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.  Evaluation of the use of health claims-based data systems to identify 
environmental causes of cancer, such as cluster analysis of incidence in 
small areas.
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 
ascertainment.
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.

MECHANISM OF SUPPORT

Support of this program will be through the National Institutes of Health 
(NIH) research project grant (R01) or an exploratory/developmental grant 
(R21).  Applicants will be responsible for planning, direction and execution 
of the proposed project.  Awards will be administered under NIH grants policy 
as stated in the NIH Grants Policy Statement. 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. 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 mechanism. Investigators are 
encouraged to seek continued support after completing an exploratory/ 
developmental grant project through a research project grant (R01). 

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 direct costs (five budget modules) per year.

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

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. 

INQUIRIES
 
Inquiries are encouraged.  The opportunity to clarify any issues or questions 
from potential applicants is welcome.
 
Direct inquiries regarding programmatic issues to:

Joan Warren, Ph.D.
Applied Research Branch
National Cancer Institute
Executive Plaza North, Room 313
Bethesda, MD  20892
Telephone: (301) 496-5184
FAX: (301) 435-3710
Email:  jw227v@nih.gov

Bernard Friedman, Ph.D.
Agency for Healthcare Research and Quality
2101 East Jefferson Street, Suite 605
Rockville, MD  20852
Telephone: (301) 594-6819
Email:   BFriedma@AHCPR.GOV

Direct inquiries regarding fiscal 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
Email:  wolfreyc@mail.nih.gov

Mabel Lam
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 601
Rockville, MD  20852
Telephone: (301) 594-1447  X1165

APPLICATION PROCEDURES

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 NIH staff.  

The research grant application form PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in 
applying for these grants, with modular budget instructions beginning on page 
13 of the application instructions.  Applicants are permitted, however, to 
use the 4/1998 revision of the PHS 398 for scheduled application receipt 
dates until January 9, 2002.  If you are preparing an application using the 
4/1998 version, please refer to the step-by-step instructions for Modular 
Grants available at http://grants.nih.gov/grants/funding/modular/modular.htm. 
Although applicants are strongly encouraged to begin using the 5/2001 
revision of the PHS 398 as soon as possible, the NIH will continue to accept 
applications prepared using the 4/1998 revision until January 9, 2002. 
Beginning January 10, 2002, however, the NIH will return applications that 
are not submitted on the 5/2001 version.  For further assistance contact 
GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov.

Applicants planning to submit an investigator-initiated new (Type 1), 
competing continuation (Type 2), competing supplement, or any amended/revised 
version of the preceding grant application types requesting $500,000 or more 
in direct costs for any year are advised that he or she must contact the NCI 
program staff before submitting the application, i.e., as plans for the study 
are being developed.  Furthermore, the application must obtain agreement from 
the NCI staff that the NCI will accept the application for consideration for 
award.  Finally, the applicant must identify, in a cover letter sent with the 
application, the staff member and Institute or Center who agreed to accept 
assignment of the application. 

This policy requires an applicant to obtain agreement for acceptance of any 
such application and any such subsequent amendment.  Refer to the NIH Guide 
for Grants and Contracts, March 20, 1998 at  
http://grants.nih.gov/grants/guide/notice-files/not98-030.html

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

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 NIH staff.  The research grant application form PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in 
applying for these grants, with modular budget instructions provided in 
Section C of the application instructions.  Applicants are permitted, 
however, to use the 4/1998 revision of the PHS 398 for scheduled application 
receipt dates until January 9, 2002.  If you are preparing an application 
using the 4/1998 version, please refer to the step-by-step instructions for 
Modular Grants available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.  Additional 
information about Modular Grants is also available on this site.

The title and number of the program announcement must be typed on line 2 of 
the face page of the application form and the YES box must be marked.

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) 
 
REVIEW CONSIDERATIONS
 
Applications will be assigned based on established NIH referral guidelines.  
Applications will be evaluated for scientific and technical merit by an 
appropriate scientific review group convened in accordance with the standard 
NIH peer review procedures.  As part of the initial merit review, all 
applications will 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 applications under review, will be discussed, 
assigned a priority score, and receive a second level review by the 
appropriate national advisory council or board. 

Review Criteria
 
The five criteria to be used in the evaluation of grant applications are 
listed below.
 
The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  The 
reviewers will comment on the following aspects of the application in their 
written critiques 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 by the reviewers 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 a 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?

The initial review group will also examine: 

o  the appropriateness of proposed project budget and duration, 
o  the adequacy of plans to include both genders, minorities (and their 
subgroups), and children as appropriate for the scientific goals of the 
research and plans for the recruitment and retention of subjects, 
o  the provisions for the protection of human and animal subjects, 
o  the safety of the research environment,
o  the adequacy of the proposed plan to share data.  

AWARD CRITERIA
 
Award criteria that will be used to make award decisions include:

o  scientific merit (as determined by peer review)
o  availability of funds
o  programmatic priorities.

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 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 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 is 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.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS.

It is the policy of NIH 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 clear and compelling 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 was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html

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

REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

All investigators proposing research involving human subjects should read the 
NIH policy on education in the protection of human research participants now 
required for all investigators, which is published in the NIH Guide for 
Grants and Contracts, June 5, 2000 (Revised August 25, 2000), available at 
the following URL address:  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.  
A continuing education program in the protection 
of human participants in research is now available online at 
http://cme.nci.nih.gov/.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT

The Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.  
Applicants may wish to place data collected under this 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.

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.

REQUIREMENTS FOR SHARING RESEARCH RESOURCES

NIH policy requires that investigators make unique research resources readily 
available for research purposes to qualified individuals within the 
scientific community when they have been published.  All investigators should 
read the Guidelines available at the following url address:  
http://grants.nih.gov/grants/policy/nihgps_2001/part_iia_6.htm.  See also:  
NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps) and 
Sharing Biomedical Research Resources: Principles and Guidelines for 
Recipients of NIH Research Grants and Contracts: Final Notice, December 1999 
(http://www.nih.gov/od/ott/RTguide_final.htm).  It is expected that 
biomaterials and other patentable research resources (examples could be, but 
are not limited to, vectors, embryonic cell lines, mutant mice, etc.) 
produced in projects funded by this initiative will be made available and 
distributed to the broader scientific community.

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, Cancer 
Surveillance Using Health Claims-Based Data System, is related to priority 
area of cancer control.  Potential applicants may obtain a copy of "Healthy 
People 2010" at http://www.health.gov/healthypeople/.

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.399, Cancer Control Research, 93.121, Oral Health Research and 93.226.  
Awards are made under authorization of the Public Health Service Act, Title 
IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 
and 285) and administered under PHS grants policies and Federal Regulations 
42 CFR 52 and 67, Subpart A, and 45 CFR Part 74 and part 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 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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