Release Date:  October 11, 2001 
PA NUMBER:  PA-02-011 

- This PA has been reissued, see PA-06-419
- Expiration date extended until reissue later in 2006,  see NOT-EB-06-006
- Expiration date extended, see NOT-EB-05-005
- See NOT-EB-04-003 and NOT-EB-04-003

Expiration Date: May 17, 2006, unless reissued.

National Institute of Biomedical Imaging and Bioengineering
National Cancer Institute
National Center for Research Resources
National Eye Institute
National Heart, Lung, and Blood Institute
National Human Genome Research Institute
National Institute on Aging
National Institute of Allergy and Infectious Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute of Child Health and Human Development
National Institute on Drug Abuse
National Institute on Deafness and Communication Disorders
National Institute of Dental and Craniofacial Research
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Environmental Health Sciences
National Institute of General Medical Sciences
National Institute of Mental Health
National Institute of Neurological Disorders and Stroke
National Institute of Nursing Research
National Library of Medicine



Participating Institutes and Centers (ICs) of the National Institutes of Health 
(NIH) invite applications for R01 awards to support Bioengineering Research 
Grants (BRGs) for basic and applied multi-disciplinary research that addresses 
important biological or medical research problems.  The BRGs support multi-
disciplinary research performed in a single laboratory or by a small number of 
investigators that applies an integrative, systems approach to develop knowledge 
and/or methods to prevent, detect, diagnose, or treat disease or to understand 
health and behavior.  A BRG application may propose hypothesis-driven, 
discovery-driven, developmental, or design-directed research at universities, 
national laboratories, medical schools, large or small businesses, or other 
public and private entities. 

On October 1, 200l, NIH issued a related program announcement (PA) PAR-02-010  
for Bioengineering Research Partnerships (BRPs).  The BRPs differ from the BRGs 
in that the BRP research will be performed by multi-disciplinary research teams 
from several laboratories or organizations and by several investigators.


Many of today"s biomedical problems are best addressed using a multi-
disciplinary approach that extends beyond the traditional biological and 
clinical sciences.   Principles and techniques in allied quantitative sciences 
such as physics, mathematics, chemistry, computer sciences, and engineering can 
be applied to effectively address biomedical problems.   Bioengineering 
integrates principles from a diversity of technical and biomedical fields, and 
the resulting multi-disciplinary research is providing new basic understandings, 
novel products, and innovative technologies that improve basic knowledge, human 
health, and quality of life.  Bioengineering also crosses the boundaries of  
scientific disciplines that are represented throughout academia, Federal 
laboratories, and industry.

Recognizing the importance of bioengineering in public health, the 
Bioengineering Consortium (BECON) was established in 1997 as a focus for  
bioengineering activities at the NIH.  To facilitate communication between the 
allied and biomedical disciplines and to provide input from the scientific 
community on research needs and directions, the BECON has held annual two-day 
symposia on emerging topics of interest related to bioengineering including 
bioengineering (1998), bioimaging, (1999), nanotechnology (2000), and reparative 
medicine (2001).   Summaries of the proceedings and recommendations of these 
symposia are available on the Internet at  

Discussions and recommendations of symposia participants aided the formulation 
of the BRP and BRG program announcements. Both the BRP and BRG PAs recognize 
that applications for bioengineering projects often focus on technology 
development rather than on proving or disproving scientific hypotheses.  
Therefore, the NIH review criteria for bioengineering applications submitted in 
response to these PAs have been modified to ensure that these proposals are 
evaluated appropriately and fairly.

In December 2000, the National Institute of Biomedical Imaging and 
Bioengineering (NIBIB) was established at the NIH with a mission to improve 
health by promoting fundamental discoveries, design and development, and 
translation and assessment of technological capabilities.  In support of this 
mission, the NIBIB funds research aimed at developing fundamental or cross-
cutting technologies that can be translated into several biomedical 
applications.  Studies involving technological application to a specific 
disease, organ system, or social issue will be considered by the appropriate NIH 
institute or center.


Applications for a BRG award should focus on an area of basic, applied, 
behavioral, or clinical research in bioengineering that supports the missions of 
the NIH institutes and centers and where progress is likely to make a 
significant contribution to improving human health.


The mechanism of support will be the NIH R01 research grant. Responsibility for 
the planning, direction, and execution of the proposed project will be solely 
that of the applicant.  The total requested project period for a competitively-
reviewed application may not exceed five years.


Applications may be submitted by domestic for-profit, non-profit, public, and 
private organizations.  Examples of eligible organizations include universities, 
colleges, hospitals, national laboratories, industrial research organizations, 
large or small businesses, units of state and local governments, eligible 
agencies of the Federal government, and faith-based organizations.  Foreign 
institutions are not eligible to apply.  Racial/ethnic minority individuals, 
women, and persons with disabilities are encouraged to apply as principal 


Applicants are strongly advised to personally contact the appropriate IC 
scientific program staff listed under INQUIRIES to discuss the relevance of 
their proposed work to the institute’s mission before preparing a BRG 
application.  Detailed information on research missions and programs for each 
NIH institute and center is available on the individual IC’s Web sites which can 
be accessed through the NIH Homepage at   

The PHS 398 research grant application instructions and forms (rev. 5/2001) at must be used in applying 
for these grants and will be accepted at the standard application deadlines 
( as indicated in the application kit.  
This version of the PHS 398 is available in an interactive, searchable format. 
Although applicants are 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 301/435-0714, 

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 Institute or 
Center (IC) program staff before submitting the application, i.e., as plans for 
the study are being developed.  Furthermore, the application must obtain 
agreement from the IC staff that the IC 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.  

Follow the PHS 398 instructions for "Preparing Your Application" with the 
following modifications and additions to the section titled “Research Plan”:

  A. Specific Aims – Applications submitted in response to this program 
announcement may be design-, problem, need-, or hypothesis-driven.  Thus, the 
application should state the hypotheses, designs, problems, and/or needs that 
will drive the proposed research.  Describe the specific aims in the appropriate 
area of bioengineering research and the goals for the first year and for the 
long term. Describe the expected applications of the bioengineering research 
that will improve human health. One page is recommended.

  B. Background and Significance - Briefly describe the area of 
bioengineering research that is the focus of the BRG.  Critically evaluate 
existing knowledge and approaches that have been or are being applied in the 
area and specifically describe how the proposed BRG approach will advance the 
field.  State concisely the importance and health relevance of the research 
proposed to achieve the Specific Aims.

  C. Preliminary Studies and Rationale - Preliminary studies that support 
the proposed research should be submitted with the application.

  D. Research Design and Methods - A BRG should focus on a significant area 
of bioengineering research where advances are likely to affect human health or 
health-related research.  If the proposed BRG research is closely related to 
ongoing research, explain how the research activities of the BRG will complement 
but not overlap the existing research.  Provide a tentative sequence or 
timetable for the project.  Include how the data will be collected, analyzed, or 
interpreted.  Applications should also include a plan for making available to 
the research community the technologies developed or enhanced by work supported 
by this program announcement.  Investigators are required to make unique 
research resources readily available for research purposes to qualified 
individuals within the scientific community when they have been published.  The 
intent of this policy is not to discourage, impede, or prohibit the organization 
that develops the unique research resources or intellectual property from 
commercializing the products.


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 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  Additional 
information about Modular Grants is also available on this site.

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


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 
for 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.


In accordance with NIH policy 
an applicant planning to submit a proposal that requests 
$500,000 or more in direct costs for any year must obtain approval to submit the 
application from scientific program staff at a research institute or center.  
This approval must be obtained at least six weeks before the application receipt 
deadline.  The applicant must identify the institute or center and the 
scientific program staff member who agreed to accept assignment of the 
application in the cover letter that transmits the proposal.  A list of 
scientific program contacts for each of the NIH IC’s is available on the 
Internet at
Applications exceeding $500,000 per year direct costs in any year that are 
submitted without this approval will be returned.


Submit a signed, typewritten original of the application, including the 
Checklist, and five signed photocopies in one package to:

ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)


The Center for Scientific Review (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 substantive revision of an 
application already reviewed, but such an application must include an 
introduction addressing the previous critique. 


Upon receipt, applications will be reviewed for completeness by CSR staff. 
Applications that are complete will be evaluated for scientific and technical 
merit by Scientific Review Groups of the CSR.  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) may be discussed, assigned 
a priority score, and receive a second-level review by the appropriate national 
advisory council or board. 


The NIH review criteria have been adapted to ensure that the BRG application is 
evaluated appropriately.  The score should reflect the overall impact that the 
BRG award could have on the selected area of bioengineering research based on 
consideration of the five criteria given below.  The emphasis on each criterion 
can vary from one application to another depending on the nature of the 
application and its relative strengths.  An application need not be strong in 
all categories to be judged likely to have major technical or scientific impact 
and thus deserve a high priority score.  For example, an investigative 
partnership may propose to perform important work that by its nature is not 
innovative but is essential to advance a field. 

A BRG may propose discovery-driven, developmental, non-hypothesis-driven, 
design-directed, or hypothesis-driven research at universities, national 
laboratories, medical schools, large or small businesses, or other public and 
private entities.  The review criteria include:

1. Significance.  If the specific aims of the project are achieved, will they 
provide significant advances in the selected area of bioengineering research? Is 
the research likely to have a significant impact on other areas of research? 
Will the technological advances have a significant impact on human health?

2. Approach. Are the engineering, scientific and clinical approaches and methods 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Does the application address potential problem areas and consider 
alternative strategies?  Is a timetable with adequate research milestones 
proposed?  Are appropriate specifications and evaluation procedures provided for 
assessing technological progress?  Is the plan for sharing or disseminating 
(through commercialization or other ways) technologies developed or enhanced 
under this program announcement adequate?

3. Innovation.  Does the BRG propose new approaches, explore new research 
paradigms, or represent new concepts that combine bioengineering, physical, and 
clinical sciences?  Will the proposed approaches or concepts solve current 
scientific or technical problems in novel ways?

4. Investigators.  Is the PI capable of coordinating and managing the proposed 
project? Are the investigators (partners) appropriately trained in their 
disciplines and capable of conducting the proposed interdisciplinary work? 

5. Environment.  Does the scientific and technological environment in which the 
work will be done contribute to the probability of success?  Does the proposed 
research take advantage of unique features of the scientific environment or 
employ useful collaborative arrangements within the partnership?  Is there 
evidence of institutional support?  


BRG applications will compete for available funds with all other recommended 
applications. Funding decisions will be based on the quality of the proposed 
research as determined by peer review, availability of funds, and the 
institute’s programmatic priority for the focus of the proposed research.


It is the policy of the NIH that women and members of minority groups and their 
subpopulations 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 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 
"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 ( 
Recent 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. 


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 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 on the Internet at 


NIH policy requires education on the protection of human subject participants 
for all investigators submitting NIH proposals for research involving human 
subjects.  This policy announcement is available in the NIH Guide for Grants an 
Contracts, June 5, 2000 (Revised August 25, 2000), available at: 


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:

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.


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 program announcement is related to one 
or more of the priority areas.  Potential applicants may obtain a copy of 
"Healthy People 2010" on the Internet at 


Inquiries concerning this PA are encouraged.  The opportunity to clarify any 
issues or questions from potential applicants is welcome.

Inquiries or contacts concerning institute-specific scientific or financial 
issues should be directed to the NIH BECON scientific or financial contacts 
listed at the following Web site:  

These scientific contacts can also be used to obtain permission to submit 
applications that request more the $500,000 of direct costs in any year.

Inquiries regarding general programmatic issues should be directed to:

Dr. Richard E. Swaja
National Institute of Biomedical Imaging and Bioengineering
31 Center Drive – Room 1B37
Bethesda, MD  20892-2077
TEL:  301-451-6771
FAX:  301-480-4515

Inquiries concerning review issues should be directed to:

Dr. Eileen Bradley
Center for Scientific Review
6701 Rockledge Drive
Bethesda, MD  20892
TEL:  301-435-1179
FAX:  301-480-2241	


This program is described in the Catalog of Federal Domestic Assistance Nos. 
93.394, 93.395, 93.396, 93.306, 93.867, 93.172, 93.837, 93.838, 93.839, 93.866, 
93.273, 93.855, 93.856, 93.846, 93.864, 93.865, 93.929, 93.279, 93.173, 93.121, 
93.847, 93.848, 93.849, 93.113, 93.821, 93.859, 93.862, 93.242, 93.853, 93.361, 
and 93.879.  Awards are made under authorization of Sections 301 and 405 of the 
Public Health Service Act as amended (42 USC 241 and 284) and administered under 
NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74 and 92.  
This program is not subject to the intergovernmental review requirements of 
Executive Order 12372 or Health Systems Agency review.

The NIH Grants Policy Statement is available at  This document includes general 
information about the grant application and review process, information on the 
terms and conditions that apply to NIH grants and cooperative agreements, and a 
listing of pertinent offices and officials at the NIH.

The PHS strongly encourages all grant and contract 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 

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

H H S Department of Health
and Human Services

  N I H National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892