FEDERAL TECHNOLOGY TRANSFER PROGRAM IN DIGITAL MAMMOGRAPHY

NIH GUIDE, Volume 22, Number 45, December 17, 1993



PA NUMBER:  PA-94-020



P.T. 34



Keywords:

  Technology Transfer 

  Medical/Diagnostic Imaging 



National Cancer Institute



PURPOSE



The National Cancer Institute (NCI) through the Diagnostic Imaging

Research Branch (DIRB) of the Radiation Research Program seeks

research grant applications from multidisciplinary research teams for

federal technology transfer in digital mammography including, but not

limited to, the following areas:  (1) digital detectors and display

systems; (2) novel algorithms for image processing and computer-aided

diagnosis; and (3) novel high performance, low cost networks for

telemammography.  This program was jointly developed with and will be

co-sponsored by the National Aeronautics and Space Agency (NASA), if

the grant applications are judged of programmatic interest to the

agency.



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 Program

Announcement, Federal Technology Transfer Program in Digital

Mammography, 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. 017-00100473-1) 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, public and

private, non-profit and for-profit organizations such as

universities, colleges, hospitals, laboratories, units of State and

local governments, and eligible agencies of the Federal government.

Foreign institutions are not eligible for the First Independent

Research Support and Transition (FIRST) (R29) awards.  Women and

minority investigators are encouraged to apply.



MECHANISM OF SUPPORT



This program will be supported by the individual research grant

(R01), the First Award (R29), and Program Project Grant (P01) Award

mechanisms.  Because the nature and scope of the research proposed in

response to this PA may vary, it is anticipated that the size of the

awards will vary.



RESEARCH OBJECTIVES



Background



Digital mammography is one of the most promising novel technologies

for early detection of breast cancer.  Digital images offer several

potential advantages in image quality compared to conventional

film-based systems, including improved image contrast and resolution

at a lower radiation dose, and offer the additional benefits of

computerized image enhancement and image analysis, computerized image

archiving, and the possibility of image transmission for analysis at

a distant site (teleradiology), which could bring world-class

expertise to community hospitals.  A Program Announcement entitled

"National Digital Mammography Development Group" (PA-92-57, NIH Guide

for Grants and Contracts, Vol. 21, No. 12, March 27, 1992) resulted

in the funding of a multi-disciplinary, international group

consisting of four academic centers and two industrial components

aimed at developing this technology.  We are convinced that the

development of all aspects of this technology will result in better

quality mammographic images, more reliable interpretation, and

greater dissemination of state-of-the-art screening to a greater

proportion of the U.S. population of women at risk, with a resultant

significant probability of saving lives.  As the recent data

indicate, digital mammography may be of particular potential benefit

in younger women with dense breast tissue.



Many of the tools of digital mammography, including digital detectors

and display systems for the generation of high- resolution,

high-contrast, large-field-of-view images and computer algorithms for

image enhancement and analysis have already been developed for space

and military applications.  As a result of the Diagnostic Imaging

Research Branch pursuit of the development of a Federal technology

transfer program in digital mammography, an interagency agreement

between the NCI and NASA was formalized in March 1992.  This resulted

in the establishment of the NCI - NASA Working Group in an effort to

apply the latest technologic advances in image acquisition,

processing, and transmission to digital mammography.  In July 1992,

the Working Group, in collaboration with academic experts from the

radiologic community, developed a program statement, which was

broadly disseminated to Federal and Federally-supported laboratories

in order to identify technologies critical for, and transferable to,

digital mammography.  Forty-three technologic proposals were received

in response to the program statement, and thirteen were selected by

peer review process for further evaluation at the May 1993 Digital

Mammography Technology Transfer Workshop held by the NCI - NASA

Working Group.  The conference faculty, composed of industrial and

academic experts, concluded that the proposed technologies may solve

some of the currently existing fundamental technologic difficulties

hindering the development of digital mammography as a practical tool.

Based on the recommendations of this Workshop, we propose a jointly

sponsored NCI - NASA Program Announcement in order to support the

transfer of promising technologies to digital mammography.



Objectives



The goals and scope of this joint NCI/NASA Program Announcement may

include, but are not limited to, the following:



1.  Dual use technology support.  Development, assessment, and

implementation of dual-use technology, wherein the proposed

technology will contribute to digital mammography as well as to image

generation, processing, and transmission, as required by NASA.



2.  Technology transfer support, wherein medical imaging

academic/industrial teams work cooperatively with a Federal

Laboratory and/or Federally-funded grantee or contractor to apply a

Federally developed or funded technology to digital mammography.



Examples of appropriate topics include, but are not limited to:



1.  development and testing of digital displays for high resolution

(e.g., 50-100 micrometers per pixel), high contrast (about 12-14

bits), large field of view visualization (4K by 4K, or 2K by 2K with

4K by 4K buffer) combined with practical rate of display and

luminescence;



2.  incorporation of the above described video display systems into

the development of computer workstations with practical user

interfaces, including multi-resolution, "region-of-interest" displays

and "bright light" display equivalents;



3.  development and implementation of novel x-ray detectors in

prototype digital mammographic systems;



4.  development and testing of novel high performance, low cost

digital networks for image transmission;



5) high speed image processing for pattern recognition or image

compression, testing of innovative computer algorithms for

computer-aided diagnosis and image processing using standardized

and/or pathologically confirmed mammographic image databases, image

compression algorithms that do not compromise data integrity;



It is expected that multi-disciplinary teams will be formed, with

participation of clinical radiologists as potential end-users of the

systems developed, medical physicists who can define the technical

requirements of the proposed equipment, and scientists from

Federally-supported laboratories and industry who developed relevant

imaging technologies for applications that may be other than digital

mammography (e.g., military, space, entertainment).  Participation of

medical imaging technology manufacturers in these projects will be

encouraged in order to stimulate early assessment of commercial

viability and to facilitate technology implementation.



STUDY POPULATIONS



SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH

POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL

RESEARCH STUDY POPULATIONS



NIH policy is that applicants for NIH clinical research grants and

cooperative agreements are 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 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 (rev. 9/91) in

Sections 1-4 of the Research Plan and summarized in Section 5, 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 but not limited to

clinical trials.



The usual 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 review will be deferred until the information is provided.



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 responding to this Program Announcement.  These forms are

available at most institutional offices of sponsored research and

from the Office of Grants Information, Division of Research Grants,

National Institutes of Health, Westwood Building, Room 449, Bethesda,

MD 20892, telephone (301) 710-0267.



The Program Announcement number and title must be typed on line 2a of

the face page of the application form.



Applications for the FIRST Award (R29) must include at least three

sealed letters of reference attached to the face page of the original

application.  FIRST Award (R29) applications submitted without the

required number of reference letters will be considered incomplete

and will be returned without review.



Submit a signed, typewritten original of the application, including

the Checklist, and five signed, exact, clear, and single-sided

photocopies in one package to:



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**



Applications will be accepted on the standard receipt dates listed in

the application kit.  If the application submitted in response to

this program announcement is substantially similar to a grant

application already submitted to the NIH for review, but not yet

reviewed, the applicant will be asked to withdraw either the pending

application or the new one.  Simultaneous submission of identical

applications will not be allowed, nor will essentially identical

applications be reviewed by different review committees.  Therefore,

an application cannot be submitted in response to this announcement

that is essentially identical to one that has already been reviewed.

This does not preclude the submission of substantial revisions of

applications already reviewed, but such applications must include an

introduction addressing the previous critique.



REVIEW CONSIDERATIONS



Applications will be assigned on the basis of established PHS

referral guidelines.  Applications will be reviewed for scientific

and technical merit 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 board or 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 Program Announcement and inquiries about whether or not specific

proposed research would be responsive are encouraged and may be

directed to:



Faina Shtern, M.D.

Radiation Research Program

National Cancer Institute

Executive Plaza North, Suite 800

Bethesda, MD  20892

Telephone:  (301) 496-9531



Direct inquiries regarding fiscal matters to:



Ms. Carolyn Mason

Grants Administration Branch

National Cancer Institute

Executive Plaza South 242

Bethesda, MD  20892

Telephone:  (301) 496-7800, ext. 59



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic

Assistance No. 93.395, Cancer Treatment Research.  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 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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