BIOENGINEERING RESEARCH PARTNERSHIPS

RELEASE DATE:  November 18, 2003

PA NUMBER:  PAR-04-023 

Updates:

-June 12, 2006 (PAR-06-459) - This PAR has been replaced, see PAR-06-459
-Program contact information updated, see NOT-EB-06-002)
-New receipt dates and letter of intent dates available, see NOT-EB-04-005

EXPIRATION DATE:  May 23, 2006

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
 (http://www.nih.gov)

COMPONENTS OF PARTICIPATING ORGANIZATION:
National Institute of Biomedical Imaging and Bioengineering (NIBIB) 
 (http://www.nibib.nih.gov)
National Cancer Institute (NCI)
 (http://www.nci.nih.gov)
National Eye Institute (NEI)
 (http://www.nei.nih.gov)
National Heart, Lung, and Blood Institute (NHLBI)
 (http://www.nhlbi.nih.gov)
National Human Genome Research Institute (NHGRI)
 (http://www.nhgri.nih.gov)
National Institute on Aging (NIA)
 (http://www.nia.nih.gov)
National Institute of Allergy and Infectious Diseases (NIAID)  
 (http://www.niaid.nih.gov)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) 
 (http://www.niams.nih.gov)
National Institute of Child Health and Human Development (NICHD)  
 (http://www.nichd.nih.gov)
National Institute on Drug Abuse (NIDA)
 (http://www.nida.nih.gov)
National Institute on Deafness and Other Communication Disorders (NIDCD)  
 (http://www.nidcd.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR)  
 (http://www.nidcr.nih.gov)
National Institute of Environmental Health Sciences (NIEHS)  
 (http://www.niehs.nih.gov)
National Institute of General Medical Sciences (NIGMS) 
 (http://www.nigms.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS)  
 (http://www.ninds.nih.gov)
National Library of Medicine (NLM) 
 (http://www.nlm.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:  93.286, 93.287, 93.394, 
93.395, 93.396, 93.867, 93.172, 93.837, 93.838, 93.839, 93.866, 93.855, 
93.856, 93.846, 93.864, 93.865, 93.929, 93.279, 93.173, 93.121, 93.113, 
93.821, 93.859, 93.862, 93.853, and 93.879.  

LETTER OF INTENT RECEIPT DATES: November 20, 2004 (past); March 20, 2005; 
July 20, 2005; November 20, 2005; and March 20, 2006. 
(Letter of Intent Receipt Dates changed per NOT-EB-04-005)

APPLICATION RECEIPT DATES: January 20, 2005; May 20, 2005; 
September 20, 2005; January 20, 2006; and May 22, 2006. 
(Application Receipt Dates changed per NOT-EB-04-005)

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA  

Participating Institutes and Centers (ICs) of the National Institutes of 
Health (NIH) invite applications for R01 awards to support Bioengineering 
Research Partnerships (BRPs) for basic, applied, and translational multi-
disciplinary research that addresses important biological or medical research 
problems.  In the context of this program, a partnership is a multi-
disciplinary research team 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.  The partnership must include 
appropriate bioengineering or allied quantitative sciences in combination 
with biomedical and/or clinical components.  The Principal Investigator (PI) 
also serves as the project manager and must be capable of leading the 
proposed effort.  A BRP may propose design-directed, developmental, 
discovery-driven, or hypothesis-driven research at universities, national 
laboratories, medical schools, large or small businesses, or other public and 
private entities or combinations of these entities.   It is expected that a 
BRP will have a well-defined goal or deliverable that will be achieved based 
on objective milestones specified in the initial application.  
On October 11, 2001, the NIH issued a related program announcement (PA) 
PA-02-011 (http://grants.nih.gov/grants/guide/pa-files/PA-02-011.html) 
for Bioengineering Research Grants (BRGs).  The BRGs differ from the BRPs 
in that the research will be performed in a single laboratory, by a single 
investigator, or by a small group of investigators.  On January 16, 2003, the 
NIH issued another related program announcement PA-03-058 
(http://grants.nih.gov/grants/guide/pa-files/PA-03-058.html) for 
Exploratory/Developmental (R21) Bioengineering Research Grants (EBRG).   The 
EBRGs differ from the BRPs in that (1) the research will be performed in a 
single laboratory, by a single investigator, or by a small group of 
investigators and (2) the projects are high-risk/high-payoff in nature (R21 
mechanism) as compared to the R01-type grants supported by the BRP program.

RESEARCH OBJECTIVES

Many of today's biomedical problems are best addressed using a multi-
disciplinary approach that extends beyond the traditional biological and 
clinical sciences.  Bioengineering integrates principles from a diversity of 
technical and biomedical fields and crosses the boundaries of many scientific 
disciplines represented throughout academia, laboratories, and industry.  The 
creativity of interdisciplinary teams is resulting in new basic 
understandings, novel products, and innovative technologies for addressing 
biomedical problems.  

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), reparative medicine (2001), biosensors (2002), and 
team science (2003).   Summaries of the proceedings and recommendations of 
these symposia are available on the Internet at 
http://www.becon.nih.gov/becon_symposia.htm.  

Discussions and recommendations of symposia participants aided in the 
formulation of the BRP, BRG, and EBRG program announcements.  It is expected 
that some applications submitted in response to the BRP, BRG, and EBRG PAs 
will focus on technology development rather than on proving or disproving 
scientific hypotheses.  In support of this approach, NIH instructions to 
applicants and review criteria emphasize that a project may “…test a stated 
hypothesis, create a novel design, solve a specific problem, or develop new 
technology” (PHS 398 instructions for the research plan).

The primary objective of this program announcement is to encourage basic, 
applied, and translational bioengineering research that could make a 
significant contribution to improving human health.  Bioengineering 
integrates physical, engineering, and computational science principles for 
the study of biology, medicine, behavior, or health.  It advances fundamental 
concepts, creates knowledge from the molecular to the organ systems level, 
and develops innovative biologicals, materials, processes, implants, devices, 
and informatics approaches for the prevention, diagnosis, and treatment of 
disease, for patient rehabilitation, and for improving health.  Some BRP 
projects may propose research that could lead to a novel device as a product.  
Partnership with companies that have relevant expertise or that may 
eventually be involved in commercialization is appropriate under the BRP 
program.

A second objective is to encourage collaborations and partnerships among the 
allied quantitative and biomedical disciplines.  A BRP must bring together 
the necessary physical, engineering, and computational science expertise with 
biological or clinical expertise and resources to address a significant area 
of bioengineering research within the mission of the NIH.  In addition to the 
benefits to be derived from the research, the collaborations and partnerships 
can create opportunities for trans-disciplinary communication and training 
for a new generation of scientists capable of interacting across traditional 
technical boundaries. 
 
Applications for a BRP award should focus on an area of basic, applied, 
translational, behavioral, or clinical research in bioengineering that 
supports the missions of the participating NIH institutes and centers and 
where progress is likely to make a significant contribution to improving 
human health. Some NIH institutes and centers have indicated that they will 
only consider BRP applications in specific focus areas.  These institutes and 
focus areas are available at http://www.becon.nih.gov/becon_brpareas.htm.  

MECHANISM OF SUPPORT 

This PA uses the NIH R01 award mechanism.  As an applicant, you are solely 
responsible for planning, directing, and executing the proposed project.

This PA uses just-in-time concepts.  It also uses the modular budgeting as 
well as the non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, if 
you are submitting an application with direct costs in each year of $250,000 
or less, use the modular budget 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 
http://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm.  

The initial period of support of a BRP award may be up to five years.  The 
award may be competitively renewed for a total of up to ten years of NIH 
funding. 
 
Competing renewal and revised applications for BRP grants are to be received 
at the NIH on the same receipt dates as new BRP applications.

For new grants, the maximum total (direct plus facilities and administrative 
[F&A] costs) budget to be awarded in any year is $2 million.  The number of 
awards and level of support will depend on the number of applications of high 
scientific merit that are received and the availability of funds.  Funding in 
subsequent years will be contingent upon satisfactory progress during the 
preceding year(s) and the availability of funds.  Applicants are strongly 
encouraged to discuss budget requests with NIH scientific and financial 
contacts listed under WHERE TO SEND INQUIRIES prior to submission.   

Grantees have the authority to extend the duration of a BRP grant on a no-
cost basis.  This extension provides additional time to use funds that remain 
available at the end of the project period to continue pursuing the aims of 
the grant.  Grantees should notify the Grants Management Officer of the 
awarding institute or center of the no-cost extension as early as possible 
and before the expiration of the grant.

ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) if your institution has any of the 
following characteristics:

o Domestic for-profit or non-profit organizations 
o Domestic public or private institutions such as universities, colleges, 
hospitals, and national laboratories 
o Units of state and local governments
o Eligible agencies of the Federal government 
o Large or small businesses
o Faith-based or community-based organizations
o Foreign institutions are not eligible to apply as Principal Investigators.  
However, BRP collaborative projects may include work at a foreign site when 
the expertise at the foreign site is not present in the United States.  

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the leadership skills, knowledge, and resources necessary 
to carry out the proposed research and manage the overall effort 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 encouraged to apply for NIH programs.  

SPECIAL REQUIREMENTS

RESEARCH FOCUS AREAS: Applicants are strongly advised to contact IC 
scientific program staff listed under WHERE TO SEND INQUIRIES to discuss the 
relevance of their proposed work to the institute's mission before preparing 
a detailed research application.  Detailed information on research missions 
and programs for each NIH institute and center is available on the 
participating ICs Web sites, which are listed at the beginning of this 
announcement.  Some NIH institutes and centers have indicated that they may 
only want to consider BRP applications in specific focus areas.  As they are 
available, these institutes and focus areas will be posted at 
http://www.becon.nih.gov/becon_brpareas.htm. 

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING DIRECT COSTS OF $500,000 OR 
MORE PER YEAR:  Applicants requesting $500,000 or more in direct costs for 
any year must request permission to submit the application at least six weeks 
before the application receipt date. BRP applicants for projects with direct 
costs of $500,000 or more in any year must carry out the following steps:

1) At least six weeks before submitting the application (i.e., as you are 
developing plans for the study), contact a program staff member from an IC 
which may be appropriate for supporting the project based on its mission to 
request approval to submit the application.  A list of scientific program 
contacts for participating IC's is available on the Internet at 
http://www.nibib.nih.gov/Funding/Bioengineering/Contacts.

2) Obtain agreement from the IC staff member that the IC will accept your 
application for consideration for award, and,

3) Identify the staff member and IC who agreed to accept assignment of the 
application in the cover letter that transmits 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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

All applications that list direct costs of $500,000 or more per year must 
also have a data sharing plan.

LETTER OF INTENT: Prospective applicants are asked to submit a letter of 
intent that includes the following information:

o Number and title of this PA
o Descriptive title of the proposed research
o Name, address, telephone number, and e-mail address of the Principal 
Investigator
o List of participating institutions and key personnel

Although a letter of intent is not required, is not binding, and does not 
enter into the review of a subsequent application, the information that it 
contains allows NIH staff to estimate the potential review workload, plan the 
review, and evaluate programmatic impacts of the proposals.
 
The letter of intent is to be sent by the date listed at the beginning of 
this document.  The letter of intent should be sent to:

Dr. Richard E. Swaja
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard, Suite 200
Bethesda, MD  20892-5469
Telephone:  (301) 451-4779 
FAX:  (301) 480-4973
Email: swajar@nibib.nih.gov

BRP ORGANIZATIONAL STRUCTURE, LEADERSHIP, AND MANAGEMENT:  An organizational 
structure that clearly defines the partnership and relationships among the 
various components must be developed and described in the application.  The 
BRP size, structure, and mode of operation should match the needs and scope 
of the proposed research.  NIH policy requires that a single PI be designated 
on the face page of all applications.  While this individual is responsible 
for the scientific and technical aspects, as well as the proper conduct of 
the project, the structure of the BRP may involve more than one individual in 
developing the application and in making decisions concerning planning, 
management, staffing, and resource allocation.  In recognition of the 
essential intellectual and/or technical contributions of the lead scientists 
responsible for developing and implementing the goals of the proposal, the 
BRP organizational structure must include a “Leadership Statement” that 
specifies the roles of the individuals that provide major intellectual and/or 
technical contributions.  The PI has the responsibility and authority to use 
BRP funds in the most productive way to achieve the goals defined at the time 
of the award.  To accomplish these tasks, the PI in collaboration with other 
individuals identified in the “Leadership Statement” can adjust funding among 
BRP participants to support new partners or to reduce support to existing 
partners as needed.  The BRP should establish a Scientific Steering Group 
that consists of representatives from each of the partnering organizations 
and meets regularly to discuss project status, problems, and directions.  
Those individuals identified in the “Leadership Statement”, who together 
would have the intellectual and leadership responsibilities normally 
attributed to the PI, would likely be members of the Scientific Steering 
Group.

BRP PI MEETING:  BRP PIs will meet annually in Bethesda, Maryland, to share 
results, to ensure that the NIH has a coherent view of the advances in these 
fields, and to have an opportunity for collective problem solving among the 
PIs.  The cost of participating in this annual meeting should be included in 
the BRP budget.

WHERE TO SEND INQUIRIES

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

Inquiries or contacts concerning institute-specific scientific, grants 
management, or financial issues should be directed to the NIH BECON 
scientific or financial contacts listed at the following Web site: 
http://www.nibib.nih.gov/Funding/Bioengineering/Contacts.  The scientific contacts can 
also be used to obtain permission to submit applications that request 
$500,000 or more of direct costs in any year and to discuss specific research 
focus areas of interest to individual ICs.

Inquiries regarding general BRP programmatic issues should be directed to: 
(Contact information updated, see NOT-EB-06-002)
 
Dr. Henry Khachaturian
National Institute of Biomedical Imaging and Bioengineering/NIH/DHHS
6707 Democracy Boulevard, Suite 200
Bethesda , MD 20892-5469
TEL: 301-451-4792
FAX: 301-480-1614
E-mail: hk11b@nih.gov

Inquiries concerning peer review issues should be directed to:

Dr. Eileen Bradley
Center for Scientific Review/NIH/DHHS
6701 Rockledge Drive
Bethesda, MD  20892
TEL: 301-435-1179
FAX: 301-480-2241
E-mail: bradleye@csr.nih.gov

SUBMITTING AN APPLICATION

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 http://www.dunandbradstreet.com/. The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 
398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html 
in an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

APPLICATION PREPARATION INSTRUCTIONS:  Follow the PHS 398 instructions for 
"Preparing Your Application" with the following modifications and additions:

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.

1.  Page limitations for both new and competing continuation BRP applications 
have been increased to a maximum of 40 pages from the usual 25-page limit for 
sections A-D of the "Research Plan". This 40-page limit is an absolute 
maximum.  Applicants are encouraged to be concise and use fewer pages.

2.  Description page - In addition to the information requested on Form Page 
2, identify in the Description the name(s) of the institution(s) leading the 
BRP and other participating institutions.  The Description should clearly 
indicate the area(s) of bioengineering research that will be the focus of the 
BRP, the planned multi-disciplinary approach, and the specific objective of 
the project.

To provide recognition of the essential contributions of partners who provide 
significant intellectual leadership to the BRP project, applicants are 
strongly encouraged to include information about Lead Investigators in the 
abstract, which is a publicly accessible document.  Lead Investigators are 
those who provide essential scientific, engineering, technical, and visionary 
leadership to the effort.  In the past, applications might have listed such 
individuals as Key Personnel.  Include in the abstract the following 
information about each Lead Investigator:  name, institution if different 
from the applicant organization, and one sentence about the leadership role.  
The description of the roles of Lead Investigators should be provided in 
greater detail in the narrative for personnel in the budget section.

The Lead Investigators will usually include the Principal Investigator and a 
subset of the Key Personnel.  The following information is provided to 
clarify the roles of the various individuals who are to be named on this 
page.  NIH grants policy requires that each application designate a single 
Principal Investigator (PI) who (1) is responsible for the overall scientific 
and technical direction of the effort and (2) serves as the contact person 
with whom NIH staff will interact. Lead Investigators provide essential 
scientific, engineering, technical, and visionary leadership to the effort.  
Key Personnel are those individuals who contribute in a substantive way to 
the scientific or engineering development or execution of the project.

3.  An organization chart (OC) that clearly defines the partnership and 
relationships among its various components must be included with the 
application. A program plan (PP) should accompany the OC and list major tasks 
with a timeline of quantitative milestones for the entire project period.  
The structure and function of the Scientific Steering Group should be 
described in this section.  The OC and PP must not exceed one page each.  
This information should be included in the Research, Design, and Methods 
section of the application.

4.  BRP Budget Items - A separate budget for each partner at a 
subcontract/consortium institution, and when appropriate for clarity, for 
each partner within the grantee institution must be included.  Include a 
summary budget for all BRP participants with partners at non-grantee 
institutions shown as consortium arrangements.  It is understood that this is 
an initial budget, and that the PI has the responsibility to reallocate funds 
during the project to accomplish the BRP goals.

The NIH ICs will not provide annual support in excess of $2 million total 
cost for any year for new applications.  Direct cost inflationary increases 
following the first year may be included, but the maximum total cost request 
level of $2 million per year must be observed.

The PI is expected to devote a minimum of 25% effort to the BRP.  The percent 
effort requested for all personnel should be limited to time devoted 
specifically to BRP activities and not to other research projects.  
Information documenting the level of effort on BRP activities should be 
included in the application.  The need for all requested personnel costs 
should be thoroughly justified.  

There will be an annual BRP PI meeting at a date and location to be 
determined by NIH staff.  Applicants should include travel funds specifically 
for these meetings in the BRP budget request.  

Applicants may request and justify additional travel funds. Travel funds 
could be used to promote collaboration among BRP partners at different 
institutions or at a distant site, for travel of external advisors to the BRP 
site, and/or for BRP partners to attend scientific meetings essential to the 
progress of the project and for which other funds are not available.

Other expenses can be requested including costs necessary for the central 
administration and fiscal management of the BRP including relevant and 
reasonable costs for reprints, graphics, and publications.  Administrative 
support (a secretary or an administrative assistant) may be requested only 
for matters directly pertaining to the BRP.

With regard to projected funding by source, some BRP applicants may 
anticipate or receive commitments for significant funding from sources other 
than the NIH; e.g., from a collaborating company. In this case, applications 
should describe the source, annual amount, and use of the other funding.

5.  Resources - The application should describe the equipment and facilities 
available for the proposed BRP.

If the BRP entails an institutional commitment of resources across boundaries 
in the institution or anticipates the provision of institutional resources, 
letters from appropriate senior-level individuals describing their agreements 
to support those commitments must be included. 

Where appropriate, describe the shared facilities to be established including 
specific major research instruments and plans for the development of 
instruments.  Describe plans for maintaining and operating the facilities 
including staffing, provisions for user fees, and plans for ensuring access 
to outside users.  Distinguish between existing facilities and those still to 
be developed.

6. Research Plan

   A.  Specific Aims – A BRP may propose design-directed, developmental, 
discovery-driven, or hypothesis-driven research.  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 milestones for the project period.  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 BRP.  Critically evaluate 
existing knowledge and approaches that have been or are being applied in the 
area and specifically describe how the proposed BRP 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 described in the application.

   D.  Research Design and Methods - A BRP should focus on a systems approach 
for bioengineering research aimed at a significant advance in biology or 
medicine.  The research plan should be sufficiently long term (five to ten 
years) and comprehensive to justify organizing a BRP and adaptable enough to 
permit change as the research proceeds.   The integrative systems approach 
and its appropriateness for the proposed project should be described 
including plans for collecting, analyzing, and interpreting data.  A 
timetable of events including quantitative milestones or other evaluative 
criteria should be included. The contributions of each partner and how these 
will be integrated and organized to accomplish the specific aims of the 
project should be described.  Potential technical challenges and possible 
alternative approaches to achieve the aims of the project should be 
discussed.  Plans for enhancing the abilities and opportunities for 
investigators and trainees to work across disciplinary boundaries should also 
be included. If the proposed BRP research is closely related to ongoing 
research, explain how the research activities of the BRP will complement but 
not overlap the existing research.  

7.  Applications should include a plan for making available to the research 
community any technologies developed or enhanced by work conducted as part of 
the program announcement.  The plan should include ordering of authors and 
provision for publication/recognition of the contributions of each essential 
co-author.  This plan should be described in the Research Design and Methods 
section of the application.  Investigators using PHS funds are required to 
make unique research resources readily available for research purposes to 
qualified individuals within the scientific community when the results 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.  It is strongly 
encouraged that technology transfer officials from each participating 
organization be members of the BRP or the Scientific Steering Group.
 
APPLICATION RECEIPT DATES: New and competing renewal applications submitted 
in response to this program announcement will be accepted on January 21, 
2004; August 20, 2004; January 20, 2005; August 19, 2005; January 20, 2006; 
and August 22, 2006.  These are the dates that applications must be received 
at the NIH.

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/DHHS
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING: Applications must be received on or before the 
receipt dates described as listed on the first page of this announcement.  
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.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  Appropriate scientific review groups 
convened in accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit.  

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

o Possibly undergo a selection process in which only those applications 
deemed to have the highest scientific merit will be discussed and assigned a 
priority score
o Receive a written critique
o Receive a second level review by the appropriate national advisory council 
or board

REVIEW CRITERIA

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 discuss the following 
aspects of your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 
goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
 
The score should reflect the overall impact that the BRP 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 BRP may propose design-directed, developmental, discovery-driven, 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 BRP 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 BRP 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 technologies developed or enhanced under this 
program announcement adequate? Is the plan for technology transfer involving 
each partnering organization adequate? Does the application describe 
arrangements that facilitate the fruitful participation of a partner at a 
distant site?  If partnership with industry or small business is included, 
does this positively affect the research goals and technology dissemination?  

3. Innovation.  Does the BRP propose new approaches, explore new research 
paradigms, or represent new concepts that combine engineering, 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 BRP? Are the investigators (partners) appropriately trained in their 
disciplines and capable of conducting and contributing to the management of 
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?  Does the 
partnership create potential opportunities to foster trans-disciplinary 
communication and training across traditional scientific and technical 
boundaries?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

PARTNERSHIP AND LEADERSHIP:  Is the proposed partnership adequate for the 
research?  Is there evidence that the partnership will be effectively managed 
by the PI or project manager?  Is the partnership strategy well planned and 
documented?  Is there evidence that the partners from academia or industry 
can work together effectively, have an impact on achieving the research 
goals, and disseminate the developed technology?  

PROTECTIONS:  The adequacy of the proposed protection for humans, animals, or 
the environment, to the extent they may be adversely affected by the project 
proposed in the application.

INCLUSION:  The adequacy of 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.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria included in the 
section on Federal Citations, below)

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. 

TECHNOLOGY TRANSFER:  The adequacy of the proposed plan to integrate 
technology transfer from the partnering organizations.

BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

AWARD CRITERIA

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

REQUIRED FEDERAL CITATIONS 

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. 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

DATA AND SAFETY MONITORING PLAN:  Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II), efficacy, 
effectiveness and comparative trials (phase III). The establishment of data 
and safety monitoring boards (DSMBs) is required for multi-site clinical 
trials involving interventions that entail potential risk to the 
participants.  (NIH Policy for Data and Safety Monitoring, NIH Guide for 
Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  
  
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. 
http://grants.nih.gov/grants/policy/data_sharing . 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.

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 clinical research projects unless a 
clear and compelling 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 clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:  
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 
http://grants.nih.gov/grants/funding/children/children.htm. 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
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 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research 
on hESCs can be found at http://stemcells.nih.gov/index.asp and at  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide, in the project 
description and elsewhere in the application as appropriate, the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review.

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.  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 http://www.healthypeople.gov/.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ 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 
http://grants.nih.gov/grants/policy/policy.htm.

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.


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NIH Funding Opportunities and Notices


H H S Department of Health
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