NATIONAL DIGITAL MAMMOGRAPHY DEVELOPMENT GROUP

NIH GUIDE, Volume 21, Number 12, March 27, 1992



PA NUMBER:  PA-92-57



P.T. 34



Keywords:

  Diagnosis, Medical 

  Medical/Diagnostic Imaging 

  Computer Science 



National Cancer Institute



PURPOSE



The National Cancer Institute (NCI) through the Diagnostic Imaging

Research Branch (DIRB) of the Radiation Research Program seeks grant

applications through Interactive Research Project Grants (IRPGs) in

order to form a National Digital Mammography Development Group (NDMDG)

that will consist of six major components:  (1) software and hardware

for digital mammography; (2) image processing; (3) computer-aided

diagnosis; (4) telemammography; (5) pre-clinical and clinical

technology evaluation; and (6) Headquarters for the scientific

leadership (development of experimental design and data processing).

The objective of this program announcement (PA) is to establish a

multi- institutional, multi-disciplinary scientific group to facilitate

integrated development and evaluation of digital mammography and

related technologies, such as image processing, computer-aided

diagnosis (CAD), and tele-mammography, for improved breast cancer

imaging and characterization.



HEALTHY PEOPLE 2000



The Public Health Service (PHS) is committed to achieving the health

promotion and disease prevention objectives of "Healthy People 2000,"

a PHS-led national activity for setting priority areas.  This PA,

National Digital Mammography Development Group, is related to the

priority area of cancer.  Potential applicants may obtain a copy of

"Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0) or

"Healthy People 2000" (Summary Report:  Stock No. 017-001-00473-1)

through the Superintendent of Documents, Government Printing Office,

Washington, DC 20402-9325 (telephone 202-783-3238).



ELIGIBILITY REQUIREMENTS



Applications may be submitted by foreign and domestic, for-profit and

non-profit, public and private organizations, such as universities,

colleges, hospitals, laboratories, units of State and local

governments, and eligible agencies of the Federal Government.

Applications from minority individuals and women are encouraged.



MECHANISM OF SUPPORT



This program will be supported through the research project grant (R01)

mechanism.  The NCI encourages the coordinated submission of related

research project grant applications from investigators who want to

collaborate on a common cancer research theme but do not require

extensive shared physical resources or core functions.  A minimum of

three independent investigators with related research objectives are

encouraged to submit concurrent, collaborative, cross-referenced

individual research project grant applications (R01) that share a

common research focus.  Applications may be from either a single

institution or a consortium of institutions. Applications will be

reviewed independently for scientific merit.  Meritorious applications

will be considered for funding both as independent awards and in the

context of the overall proposed collaboration.



Applicants will be responsible for the planning, direction, and

execution of the proposed projects.  One Principal Investigator out of

the group MUST be identified as the "Program Coordinator," and must be

cited in all applications on page 2 of form PHS 398.  Individual

investigators may request funds for the time and effort contributed

toward the coordination of the overall research and for collaborative

resource activities.



Additional information about the interactive R01 mechanism may be found

in the NIH Guide for Grants and Contracts, January 10, 1992, in

Interactive Research Project Grants for Cancer, PA-92-29."



Awards will be administered in accordance with Public Health Service

Policy as described in the PHS Grant Policy Statement, DHHS.

Publication No. (OASH) 90-50,000 revised October 1, 1990.



RESEARCH OBJECTIVES



Background Information



The goal of this announcement is to stimulate research in the area of

digital mammography and related technologies to improve breast cancer

detection and staging.  The scope of the proposed research will

encompass technologic developments in digital mammography integrated

with basic research in critical avenues that can be opened by digital

mammography, such as image processing for improved lesion

visualization, computer-aided diagnosis (CAD) for enhanced image

interpretation and teleradiology, or electronic image transmission, as

a potential mechanism to bring world expertise to community hospitals.

To achieve the above-stated goals, the NDMDG will be established to

ensure comprehensive collaboration among industry (e.g., design of

receptor or display systems), the academic community, and the NCI for

an integrated, multi-component approach to digital mammography

development.  The NDMDG will be supported by the interactive program by

using the R01 funding mechanism (as described in the NIH Guide for

Grants and Contracts, January 10, 1992) and will consist of six major

components:  (1) digital mammography; (2) image processing; (3) CAD;

(4) teleradiology; (5) pre-clinical and clinical technology evaluation;

and (6) Headquarters for the scientific leadership (centralized

development of experimental design and data processing).



Research Goals and Scope



The major thrust of this initiative is to facilitate integrated

technologic development of digital mammographic systems.  This PA

encompasses a full range of studies from basic technology and

instrumentation development through pre-clinical and clinical

evaluation.  The research agenda for the NDMDG encompasses the

following goals:



o  To develop and evaluate new technologic advances to increase image

quality in digital mammography (e.g., spatial/contrast/time

resolution);



o  To develop and validate new digital imaging methodology (dynamic or

"real time" imaging);



o  To develop and validate new image processing techniques to increase

the sensitivity of the detection of lesions;



o  To develop and validate new algorithms, neural networks, and other

forms of machine intelligence for CAD; and



o  To develop and validate practical methods of data compression,

storage, and image transmission for telemammography.



STUDY POPULATIONS



SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH

POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL

RESEARCH STUDY POPULATIONS



NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical

research grants and cooperative agreements will be required to include

minorities and women in study populations so that research findings can

be of benefit to all persons at risk of the disease, disorder or

condition under study; special emphasis must be placed on the need for

inclusion of minorities and women in studies of diseases, disorders and

conditions which disproportionately affect them.  This policy is

intended to apply to males and females of all ages.  If women or

minorities are excluded or inadequately represented in clinical

research, particularly in proposed population-based studies, a clear

compelling rationale should be provided.



The following is a statement of NIH and ADAMHA policy regarding he

inclusion of women and minorities in study populations.  Applications

that are responsive to this PA will, by definition, meet the

requirement for inclusion of women,  However, the inclusion of racial

and ethnic minorities must be addressed in applications submitted

responding to this PA.



The composition of the proposed study population must be described in

terms of gender and racial/ethnic group, together with a rationale for

its choice.  In addition, gender and racial/ethnic issues should be

addressed in developing a research design and sample size appropriate

for the scientific objectives of the study.  This information must be

included in the form PHS 398 in Section 2, 1-4 of the Research Plan AND

summarized in Section 2, E, Human Subjects.



Applicants are urged to assess carefully the feasibility of including

the broadest possible representation of minority groups.  However, NIH

recognizes that it may not be feasible or appropriate in all research

projects to include representation of the full array of United States

racial/ethnic minority populations (i.e., Native Americans [including

American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks,

Hispanics).  The rationale for studies on single minority population

groups should be provided.



For the purpose of this policy, clinical research is defined as human

biomedical and behavioral studies of etiology, epidemiology, prevention

(and preventive strategies), diagnosis, or treatment of diseases,

disorders or conditions, including not but limited to clinical trials.



The usual NIH policies concerning research on human subjects also

apply.  Basic research or clinical studies in which human tissues

cannot be identified or linked to individuals are excluded.  However,

every effort should be made to include human tissues from women and

racial/ethnic minorities when it is important to apply the results of

the study broadly, and this should be addressed by applicants.



For foreign awards, the policy on inclusion of women applies fully;

since the definition of minority differs in other countries, the

applicant must discuss the relevance of research involving foreign

population groups to the United States' populations, including

minorities.



If the required information is not contained within the application,

the application will be returned.  Peer reviewers will address

specifically whether the research plan in the application conforms to

these policies.  If the representation of women or minorities in a

study design is inadequate to answer the scientific question(s)

addressed AND the justification for the selected study population is

inadequate, it will be considered a scientific weakness or deficiency

in the study design and will be reflected in assigning the priority

score to the application.



All applications for clinical research submitted to NIH are required to

address these policies.  NIH funding components will not award grants

or cooperative agreements that do not comply with these policies.



APPLICATION PROCEDURES



The research grant application form PHS 398 (rev. 9/91) is to be used

in applying for this program announcement.  These forms are available

at most institutional business offices, from the Office of Grants

Inquiries, Division of Research Grants, National Institutes of Health,

Westwood Building, Room 449, 5333 Westbard Avenue, Bethesda, MD 20892,

telephone (301) 496-7441, and from the NCI program director named

below.



The PA number and title must be typed on line 2a of the face page of

the application form.



The use of the IRPG mechanism must be mentioned briefly in form PHS

398, Sections 1-4 of the Research plan.  The goal of the collaborative

efforts MUST be identified in the specific aims of each application,

with the major rationale and explanation for the use of the IRPG

mechanism to be given in Section G, Consultants/ Collaborators.  A

complete list of applications in the IRPG must be provided in Section

G, and an indication of the specific collaborations to be established

for the individual application under consideration.



Requests for limited shared resources, if any, must be proportionally

budgeted in each application based on anticipated use, with a full

explanation given in the budget.  Personnel Time and Effort requests

for management of shared resources are allowable.  If consortium

arrangements between independent institutions are proposed that would

make transfer of funds for required new equipment impractical, the

entire equipment request may be budgeted by the responsible laboratory.

This must be clearly justified.



All PHS and NIH grants policies will apply to applications received in

response to this announcement.



If the applicant has an approved assurance covering the research

(multiple project assurance for human subjects/full assurance of

compliance for animal subjects), the applicant should provide with the

application certification of institutional review board (IRB) approval

if humans are involved and verification of the institutional animal

care and use committee (IACUC) approval if animals are involved.  These

reviews and approvals should occur PRIOR TO SUBMISSION of the

applications and the certifications and verifications should be

SUBMITTED WITH the applications.  If animals or humans will be subjects

of research at PERFORMANCE SITES OTHER THAN THE APPLICANT ORGANIZATION,

the applicants must identify, with the application, the assurance

status of each participant.



Submit a signed, typewritten original of the application, including the

Checklist, and five signed, exact photocopies, in one package to the

address below.  The photocopies must be clear and single sided.



DIVISION OF RESEARCH GRANTS

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**



REVIEW PROCEDURES



Applications will be assigned on the basis of established Public Health

Service referral guidelines.  Applications will be reviewed for

scientific and technical merit by study sections of the Division of

Research Grants, NIH in accordance with the standard NIH peer review

procedures.  Following scientific-technical review, the applications

will receive a second-level review by the appropriate national advisory

council.



AWARD CRITERIA



Applications will compete for available funds with all other approved

applications.  The following will be considered in making funding

decisions:



o  Quality of the proposed project as determined by peer review

o  Availability of funds

o  Program balance among research areas of the announcement



INQUIRIES



Written and telephone inquires concerning the objectives and scope of

this PA and inquiries about whether or not specific proposed research

would be responsive are encouraged and are to be directed to:



Faina Shtern, M.D.

Chief, Diagnostic Imaging Research Branch

Radiation Research Program

National Cancer Institute

Executive Plaza North, Suite 800

Bethesda, MD  20892

Telephone:  (301) 496-9531



Dr. Shtern welcomes the opportunity to clarify any issues or questions

from potential applicants.



Direct inquiries regarding programmatic issues to:



Joan Metcalfe

Grants Management Specialist

National Cancer Institute

Executive Plaza South, Room 242

Bethesda, MD  20892

Telephone:  (301) 496-7800, extension 28



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic Assistance

Number 93.395, Cancer Treatment Research.  Awards are made under the

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 Part 52 and 45 CFR Part 74.  This program is not subject to the

intergovernmental review requirements of Executive Order 12372 or

Health Systems Agency review.



.

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