NIH ERA SMALL BUSINESS FUNDING OPPORTUNITIES (ERA-SBIR)

RELEASE DATE:  January 29, 2002 (See Addendum NOT-RR-02-007)

RFA:  RFA-RR-02-004

PARTICIPATING INSTITUTES AND CENTERS (ICs):

National Center for Research Resources (NCRR)
 (http://www.ncrr.nih.gov)
National Institute of Allergy and Infectious Diseases (NIAID)
 (http://www.niaid.nih.gov)
National Institute of Alcoholism and Alcohol Abuse (NIAAA)
 (http://www.niaaa.nih.gov)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
 (http://www.nibib.nih.gov)
National Institute of Drug Abuse (NIDA)
 (http://www.nida.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 (http://www.niddk.nih.gov)

PUBLIC BRIEFING DATE:           March 4, 2002
LETTER OF INTENT RECEIPT DATE:  March 22, 2002
APPLICATION RECEIPT DATE:       April 17, 2002
AWARD DATE:                     September 2002

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Public Briefing
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to become Principal Investigators
o Special Requirements
o Where to send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

On behalf of the National Institutes of Health, the National Center for 
Research Resources (NCRR) invites applications for the development of 
commercial products and services supporting NIH Electronic Research 
Administration (eRA). These products and services should be useful to the 
thousands of institutions, organizations, and principal investigators that 
apply for and are awarded NIH grants and cooperative agreements and will use 
the eRA component, the NIH Commons, for creation and exchange of research and 
administrative information with the NIH. Detailed information about the NIH 
eRA, its components, and the status/plans for each can be found at:  
http://era.nih.gov/.

This RFA, eRA-SBIR, invites FAST-TRACK grant applications from organizations 
eligible for Small Business Innovation Research (SBIR) research and 
development grants. Grants awarded under this RFA will have the following 
special characteristics:

o award amounts and durations greater than those routinely allowed under the 
SBIR program;
o subcontracts for larger percentages of the research and development effort 
than is traditionally allowed in SBIR grants;
o research and development performed in collaboration with NIH's development 
and updating of the NIH's Electronic Research Administration (eRA) system;
o research and development timelines and milestones tied to the timelines and 
milestones for the NIH eRA development and implementation, as made available 
to grantee organizations on the eRA website;
o applications submitted for both phase I and Phase II grants (SBIR Fast-Track 
applications) so that there can be continuity of R&D efforts; and,
o awardee products/services that meet NIH eRA requirements and specifications 
certified by NIH for use by grantee organizations at the end of Phase II.

PUBLIC BRIEFING. 

On March 4, 2002, a briefing by NIH staff developing the NIH eRA (IMPAC II and 
the Commons) will be held from 10:00 am to 5:00 pm at the NIH in Room 1202, 
6700B Rockledge Drive, Rockville, MD. The purposes of this briefing will be to 
(1) provide up-to-date information on the status of and plans for the Commons 
and (2) answer questions that potential applicants may have. The briefing will 
be telecast and viewers will be able to call to have their questions answered. 
Further information on the briefing including how to log into the telecast 
will appear in the NIH Guide shortly.

RESEARCH OBJECTIVES

Background

Each year NIH invests billions of dollars -- about $13.5 billion in FY 2000 -- 
in grant awards to some 50,000 grantees worldwide. In addition, applicants 
submit approximately 47,000 competing research and research training 
applications each year. The administration associated with annual reports 
submitted by existing awardees, and well as applications for funding sets in 
motion intense, multi-step processes. This massive enterprise currently 
generates hundreds of millions of pieces of paper each year.

The paperless transfer of extramural research grant application and 
administrative data is NIH's vision for the 21st century. The Electronic 
Research Administration (eRA) at NIH is dedicated to making the research 
enterprise more effective and efficient through business process reengineering 
and the use of current technology. 

In responding to a congressional mandate requiring federal agencies to migrate 
from paper-based to electronic systems, the NIH has undertaken the eRA project 
to lower costs and administrative effort, expedite extramural grants 
processing, and provide better quality information to the NIH and the external 
grantee community. The eRA project is a collaborative endeavor of the full NIH 
community. Ultimately, all parties involved will conduct seamless, secure, 
interactive business in a fully electronic environment. 

eRA is NIH's infrastructure for conducting interactive electronic transactions 
for the receipt, review, monitoring, and administration of NIH grant awards to 
biomedical and behavioral investigators worldwide. eRA integrates two parallel 
systems, the NIH Commons and IMPAC II. The Commons enables communication with 
NIH's partners in the research community, whereas IMPAC II is used by NIH 
staff. In addition, the NIH Commons is designed to exchange data and 
transactions with other federal agencies through a trans-government electronic 
grants administration system, the Federal Commons (see 
http://www.fedcommons.gov/Docs/data.html).

In practical terms, eRA is a system comprised of modules (software 
applications) for each grants administration business area as well as cross-
functional processes. By mid FY2002, the following modules will be available 
on the NIH Commons:
o Registration and Accounts Administration
o Profiles (Organizational and Professional)
o Status
o Training Activities
o Invention Reports

By early FY2003, the NIH Commons will also include modules for the Non-
Competing Award process and for the Competitive Grant Application process.

As a gateway for the grantee organization community to engage in electronic 
research administration activities with the NIH, the magnitude of NIH awardees 
predicts the required capacity of the NIH Commons. In Fiscal Year 2000, NIH 
provided research support to more than 2500 institutions: universities, 
medical schools, research institutes, and for-profit and not-for-profit 
organizations. More than $1,000,000 was awarded to 663 institutions; more than 
$10,000,000 to 200 institutions; and more than $100,000,000 to 40 institutions. 

To undertake the grants business processes electronically, some awardee 
institutions plan to independently participate fully in the NIH Commons with 
development of internal applications for this purpose. Other institutions may 
wish to develop some applications and purchase others. Finally, some 
institutions may wish to use outside service providers to act as their agents 
for most or all interactions with the Commons.

Research Objectives

It is predicted that a large number of NIH grantee organizations will not 
independently develop all of the capabilities needed to interact fully with 
the NIH Commons. Therefore, a potential market exists for one or more 
companies to provide products and services to NIH grantee organizations.

The purpose of this RFA is to stimulate the development of applications and 
services that could be purchased by or licensed to these NIH grantee 
organizations so they can fully participate in the NIH Commons and to 
stimulate the small business community to augment the functionality of the 
commons to provide additional services to the NIH research applicant 
community. It is recognized that the funds available may not be the full 
amount needed for the development and testing of products and services. 
However, the potential market is large enough that applicant organizations 
should consider the use of internal resources to support this effort; further, 
potential applicants should see http://www.cfda.gov
for information about the grant related information plans for all federal 
agencies. Organizations that wish to develop applications and services 
without NIH financial support may do so NIH will work cooperatively with 
these organizations and will offer certification for products/services that 
meet compatibility requirements (see Certification below).

NIH has been a leader among federal research grant making agencies in the 
development of data standards for grant applications.  NIH was a key 
participant in the approval of the EDI Transaction Set 194 as an ANSI national 
standard.  Additionally, NIH has mapped the data requirements for a notice of 
grant award (NGA) to the EDI 850 Transaction Set. Since the development of 
these formats, these data standards have now been described in an XML DTD 
format for grant applications and notice of grant awards (see 
http://www.fedcommons.gov/Docs/data.html).  NIH intends to follow these data 
standards and will only certify software that is also compliant with these 
standards. NIH expects awardees to develop software including tools that 
enable grantees to:

o register with the Commons
o create and update Organizational and Individual (Professional) Profiles in a 
fully secure/authenticated session
o create and submit competing grant applications electronically in a fully 
secure/authenticated session
o obtain information about pending grant applications and awards in a fully 
secure/authenticated session
o submit applications for non-competing continuation grant awards in a fully 
secure/authenticated session
o provide required information on inventions developed with government funds 
in a fully secure/authenticated session

(NOTE: If the functions of the Commons expand, extension of the Phase II SBIR 
award with additional funds is possible.)

Certification

Successful completion of Phase II research and development will be NIH 
certification that the applications developed by the awardee, when used 
appropriately, will enable grantee institutions and NIH to communicate via the 
Commons. Certification could be given for applications that perform some, but 
not all, Commons functions.

MECHANISM OF SUPPORT

The administrative and funding mechanisms to be used to undertake this program 
will be the SBIR FAST TRACK.  Simultaneous submission of the Phase I and Phase 
II grant applications is required for applications in response to this RFA; 
simultaneous submissions are called FAST-TRACK APPLICATIONS.
 
FAST-TRACK APPLICATIONS. Information on the FAST-TRACK process may be found in 
Section VI-B of the PHS 398 at:  
https://grants.nih.gov/grants/funding/phs398/phs398.html.

To meet FAST-TRACK requirements, the Phase I SBIR application must include 
well defined quantifiable milestones that will be used to judge the 
feasibility of the proposed approach for development of applications and 
services to send and receive transactions to and from the NIH eRA system 
through the NIH Commons, as well as a credible plan for development and 
testing of the products and services in the Phase II application. These 
milestones must be linked to the timeline for NIH eRA activities available at:  
http://era.nih.gov/ProjectMgmt/implementation/index.cfm.

FAST-TRACK applications in response to this RFA are subject to the following 
cost and duration limits:

o Phase I grants. Unless approved before the submission of an application by 
the NIH Program Officer (see INQUIRIES below), the total requested budget may 
not exceed $500,000 and the duration of the Phase I award may not exceed 12 
months. At least 30% of the Phase I research and development effort (i.e., 30% 
or more of the proposed budget) must be carried out by the small 
business concern.

o Phase II grants. Unless approved before the submission of an application by 
the NIH Program Office, the total annual requested budget may not exceed 
$1,500,000; the duration (project period) of the Phase II award may not exceed 
four years. At least 25% of the Phase II research and development effort 
(i.e., 25% or more of the proposed budget) must be carried out by the small 
business concern.

FUNDS AVAILABLE 

The estimated total funds, direct and Facilities and Administrative (F&A) 
costs, available for the first year of support for all awards made under this 
RFA will be $1,500,000 in Fiscal Year 2002 and $3,000,000 annually in Fiscal 
Years 2003, 2004, 2005, and 2006. NIH plans to fund one to three Phase I 
awards in FY 2002 and one or two Phase II awards in FY 2003. The most 
promising of the Phase I awardees will be funded for Phase II. Although this 
program is provided for in the financial plans of the NIH, awards pursuant to 
this RFA are contingent upon the availability of funds for this purpose and 
the receipt of a sufficient number of applications of high scientific merit. 
Funding beyond the first and subsequent years of the grant will be contingent 
upon satisfactory progress during the preceding years and availability of funds.

ELIGIBILE INSTITUTIONS

Applicant organizations must meet the eligibility requirements for SBIR grants 
are found in Section I.D, SBIR/STTR PROGRAM ELIGIBILITY, at 
https://grants.nih.gov/grants/funding/sbirsttr1/index.pdf.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

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

SPECIAL REQUIREMENTS

There will be a  required series of meetings between the awardee(s) and the 
NIH eRA staff: (1) an initial two day meeting at NIH within 30 days of grant 
award to establish initial milestones; (2) annual two day meetings at NIH 
thereafter to share information, discuss progress and future directions, and 
revise milestones as necessary. In addition, applicants should request 
additional interactions as they deem necessary.

Terms and Conditions of Award 

The following terms and conditions will be incorporated into the award 
statement of each R43 and R44 grant awarded under RFA RR-02-004 and will be 
provided to the Principal Investigator, as well as the appropriate 
institutional official, at the time of award.  The following special terms of 
award are in addition to, and not in lieu of, otherwise applicable OMB 
administrative guidelines, DHHS grant administration regulations at 45 CFR 
Parts 74 and 92 [Part 92 are applicable when State and local Governments are 
eligible to apply], as are other DHHS, NIH, and NIH grant 
administration policies: 

(1) Principal Investigator (P.I.) Rights and Responsibilities: 

The P.I. will have the primary responsibility for developing the products and 
services within the guidelines of RFA RR-02-004 and for performing the 
research and development activities. The P.I. will agree to accept close 
coordination, cooperation, and participation of NIH staff and contractors in 
those aspects of technical management of the project as described under 
"NIH Responsibilities."

(2) NIH Responsibilities: 

The NIH Program Director and others working with the NIH eRA will have 
substantial involvement during the conduct of the R&D through technical 
assistance, advice and coordination. The Program Director will: 

o Participate in discussing priorities, timelines and milestones with the SBIR 
P.I. and staff.
o Serve as liaison to the NIH eRA staff to enable the SBIR P.I. and staff 
access to needed information about the Commons modules.
o Retain the option to recommend, with the advice of the Commons Advisory 
Panel, the withholding or reduction of support from any grantee that 
substantially fails to achieve agreed to milestones.

(3) Collaborative Responsibilities
 
The awardee and Program Director will be responsible for:

o Establishing project milestones.
o Delineating the specific access to NIH eRA staff and computer 
systems/applications needed by the awardee for timely development and testing 
of products and services
o Determining, during the Phase I award, the specific requirements for 
products and services to meet NIH Certification requirements
o Meetings between the awardee(s) and the NIH eRA staff: (a) an initial two 
day meeting at NIH within 30 days of grant award to establish initial 
milestones; (b) annual two day meetings at NIH thereafter to share 
information, discuss progress and future directions, and revise milestones 
as necessary.

(4) Commons Advisory Panel (CAP)

A Commons Advisory Panel (CAP) will be responsible for reviewing and 
evaluating awardee progress and making recommendations to the P.I. and NIH 
Program Director. The CAP will be composed of 3 to 5 experts in NIH grants and 
information technology from NIH grantee organizations. The membership of the 
CAP may be enlarged permanently, or on an ad hoc basis, as needed. The CAP 
will review awardee progress at the end of Phase I and make recommendations to 
the NIH Program Director for continuation to Phase II. The CAP will review 
progress annually during Phase II and make recommendations and, based on the 
results of tests of the awardee products and services, make recommendations to 
the NIH Program Director concerning certification of the awardee products 
and services.

(5) Milestones 

After consultation with the NIH Program Director, the awardee will define 
initial milestones for both Phase I and Phase II awards within 30 days of the 
time of the award and to update these milestones annually at the anniversary 
date. These will be made a condition of the award. In accord with the 
procedures described above, NIH may withhold or reduce funds for any project 
that substantially fails to meet its milestones or to maintain the state of 
the art. 

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA 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:

o Direct your questions about research and development issues to:

Mr. Jerry Stuck 
Commons Coordinator, NIH eRA 
Office of Extramural Research, OD
National Institutes of Health 
6705 Rockledge Drive, Suite 1040
Bethesda, MD  20892-7980
Telephone:  (301) 435-0690, ext. 615
Email:  js706d@nih.gov

(or)

Amy Swain, Ph.D.
Program Director
Division of Biomedical Technology
National Center for Research Resources
Rockledge 1, Room 6154
6705 Rockledge Drive
Bethesda, MD  20892
Telephone:  301-435-0755
FAX:  301-480-3659
Email:  as387d@nih.gov

o Direct your questions about peer review issues to:

Dr. Bill Bunnag
Center for Scientific Review, NIH
Rockledge II Building, Room 5124 MSC 7850
6701 Rockledge Drive
Bethesda, MD  20892-7850
Telephone:  (301) 435-1177
Email:  bb24c@nih.gov

o Direct your questions about financial or grants management matters to:

Bryan S. Clark, MBA
Office of Grants Management
National Center for Research Resources
Rockledge 1,  Room 6216
Bethesda, MD  20892
Telephone:  (301) 435-0845
FAX:  (301) 480-3777
Email:  clarkb@ncrr.nih.gov
 
LETTER OF INTENT
 
Prospective applicants are asked to submit a letter of intent that includes 
the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

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 IC staff to estimate the potential review workload and plan 
the review.
 
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:

Amy Swain, Ph.D.
Program Director
Division of Biomedical Technology
National Center for Research Resources
Rockledge 1, Room 6154
6705 Rockledge Drive
Bethesda, MD  20892
Telephone:  301-435-0755
FAX:  301-480-3659
Email:  as387d@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 
Email:  GrantsInfo@nih.gov.
 
URLS IN NIH GRANT APPLICATIONS OR APPENDICES

Because of the special nature of the products and services to be developed, 
APPLICANTS ARE ALLOWED TO PRESENT URLS IN THEIR APPLICATIONS. The URLs should 
be limited to links that provide information essential for staff and peer 
reviewers to assess the capabilities and experience of the applicant related 
to this RFA. In addition, or alternatively, the applicants may as an appendix 
to their application a CD with comparable information on directly relevant 
information capabilities and experience.
 
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  Failure to use this label 
could result in delayed processing of the application such that it may not 
reach the review committee in time for review.  In addition, the RFA title and 
number must be typed on line 2 of the face page of the application form and 
the YES box must be marked. The RFA label is also available at:  
https://grants.nih.gov/grants/funding/phs398/labels.pdf or 
https://grants.nih.gov/grants/funding/phs398/labels.doc.
 
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
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)
 
APPLICATION PROCESSING: Applications must be received by the application 
receipt date listed in the heading of this RFA.  If an application is received 
after that date, it will be returned to the applicant without review.
 
The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA 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 substantial 
revisions of applications already reviewed, but such applications must include 
an Introduction addressing the previous critique.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NCRR and OER/NIH.

Incomplete and/or non-responsive applications will be returned to the 
applicant without further consideration.

Applications that are complete and responsive to the RFA will be evaluated for 
scientific and technical merit by an appropriate peer review group convened by 
the Center for Scientific Review in accordance with the review criteria stated 
below.  As part of the initial merit review, all applications will:

o Receive a written critique
o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the NCRR National Advisory Council.
 
REVIEW CRITERIA

The review criteria for applications in response to this RFA will be the 
standard SBIR criteria found in Section VI of the PHS 398 (5/2001) at 
https://grants.nih.gov/grants/funding/phs398/phs398.html.

RECEIPT AND REVIEW SCHEDULE

Public Briefing Date:             March 4, 2002
Letter of Intent Receipt Date:    March 22, 2002
Application Receipt Date:         April 17, 2002
Peer Review Date:                 June 2002
Council Review:                   August/September 2002
Earliest Anticipated Start Date:  September 2002

AWARD CRITERIA

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

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
 
REQUIRED FEDERAL CITATIONS 
 
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 
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this RFA 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.

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 RFA is 
related to one or more of the priority areas. Potential applicants may obtain 
a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal 
Domestic Assistance No. 93.371 and is not subject to the intergovernmental 
review requirements of Executive Order 12372 or Health Systems Agency review.  
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 described at https://grants.nih.gov/grants/policy/policy.htm 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.

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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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