RELEASE DATE:  March 21, 2003  

PA NUMBER:  PA-03-085  (This PA has been reissued, see PA-06-029 and PA-06-030)

EXPIRATION DATE:  October 21, 2005

National Institute of Child Health and Human Development (NICHD)


APPLICATION RECEIPT DATES:  Applications submitted in response to this 
program announcement will be accepted at the standard application deadlines, 
April 1, August 1, December 1.

NOTICE:  This program announcement (PA) must be read in conjunction with the 
current Omnibus Solicitation of the National Institutes of Health, Centers 
for Disease Control and Prevention, and Food and Drug Administration for 
Small Business Innovation Research (SBIR) and Small Business Technology 
Transfer (STTR) Grant Applications.  The solicitation (see contains 
information about the SBIR and STTR programs, regulations governing the 
programs, and instructional information for submission.  All of the 
instructions within the current SBIR/STTR Omnibus Solicitation apply.


o Purpose of the PA
o Research Objectives
o Mechanisms of Support 
o Project Period and Amount of Award
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Receipt and Review Schedule
o Required Federal Citations


The purpose of this Program Announcement (PA) is to solicit from NICHD-
supported SBIR/STTR Phase II awardees, competing continuation applications 
that propose to continue the process of assessing and improving devices or 
conducting preclinical studies of drugs or devices that ultimately require:  
1) clinical evaluation, 2) approval of a Federal regulatory agency, and 3) 
continuing refinements to durable medical equipment (DME) designs such as 
cost reduction, testing for safety, durability, and reliability, and meeting 
or establishing standards.  Such products include, but are not limited to, 
devices, drugs, vaccines, medical implants, etc. related to the mission of 
the NICHD.



The SBIR/STTR programs were initiated as a means for government agencies to 
use small businesses to stimulate technological innovation and to help 
agencies meet their research and development (R and D) needs.  An additional 
provision of these programs is the expected commercialization of the product 
of the research.  Certain types of research require clinical evaluation and 
Federal regulatory approvals before Phase III of the small business research 
pathway can ever be realized.  A recipient of NICHD SBIR/STTR Phase I and 
Phase II awards normally receives no more than $1 million in support.  If the 
intended commercialized product is a medical device, drug or biologic, this 
amount often represents a small fraction of the funds necessary to complete 
the studies required for approval and licensing by the Food and Drug 
Administration (FDA) or other Federal agencies.  

Similarly, a recipient of NICHD SBIR/STTR Phase I and Phase II awards 
normally receives less than three years of support.  Yet, the process of 
moving promising new products from bench to bedside typically takes more than 
a decade.  The drug discovery timeline, for example, starts with 
identification of an agent or class of agents with particular activity, 
identification and optimization of lead compounds, and subsequent pre-
clinical testing of these compounds for safety and toxicity.  Those agents 
still considered viable after such rigorous scrutiny are then brought to 
human subjects for clinical evaluation of a variety of aspects of the agent, 
including safety, effectiveness, and dosage determination.  Similarly long 
timelines are needed for other products intended to understand, diagnose, 
prevent, or treat human health disorders (e.g., medical devices, vaccines).  

These are precisely the products with potential to contribute significantly 
to the economy of the nation and to the health of her people, despite the 
cost and the length of time required to move such products from the 
laboratory to the patient.  It is the intent of the SBIR/STTR Phase II 
competing continuation grants to support such research and development.  

Research Scope

The SBIR/STTR Phase II competing continuation would represent a continuation 
of support for research and development of such previous work funded by the 
original Phase II grant.  It is expected that promising results from a 
previous SBIR/STTR Phase I and Phase II grant will indicate the merit of 
further research and development.  Clinical investigations and Federal 
regulatory approvals will ultimately be required to realize the potential of 
the product being researched and developed.

Activities supported by a competing continuation of a Phase II SBIR/STTR 
grant may include an extension and expansion of preclinical research and 
development, clinical testing, and other scientific research and development 
activities needed to meet the requirements and expectations of Federal 
regulatory processes.  It is expected that some in vitro or in vivo studies 
would be carried out in Phase I or the initial Phase II grant.  A competing 
continuation Phase II award should not, however, be used to conduct very 
early stage research (e.g., identifying targets for drugs, initial 
identification of lead compounds, etc.).

Examples of research that would be considered responsive to this announcement 
are listed below for illustrative purposes and are not exclusive of other 
appropriate activities. Preclinical studies, including pharmacology and 
toxicology, and other clinical studies beyond those conducted under the NICHD 
Phase I (R41, R43) and initial NICHD Phase II (R42, R44) grants such as:  

o  innovative assistive devices and techniques to minimize residual 
disability and to impact on critical illness, physical behavior and cognitive 
development in childhood;

o  novel assays, kits, and devices to monitor fertility;

o  new and improved methods of fertility regulation, for men and for women, 
that are safe, effective, inexpensive, reversible, and acceptable;

o  new tools to monitor the state of various organ systems during therapy in 
pregnancy or infancy; and,

o  Evaluation of neuroimaging tools specific to brain development in 
pediatric populations or individuals with injuries.


This PA uses the NIH Small Business Innovation Research (R44) and Small 
Business Technology Transfer (R42) Phase II award mechanisms, which are set-
aside programs.  An NICHD SBIR/STTR Phase II competing continuation 
application must be in response to this PA, and the application will be 
accepted only as a competing continuation of a previously funded NICHD Phase 
II SBIR (R44) or STTR (R42) grant.  The previously funded NICHD Phase II 
grant need not have been submitted in response to any particular 
solicitation, but the application for the competing continuation must propose 
research and development that represents a logical extension of the 
previously supported Phase II research as described in this announcement.  As 
an applicant, you will be solely responsible for planning, directing, and 
executing the proposed project.  

This PA uses just in time concepts. Except as otherwise stated in this PA 
awards will be administered under NIH grants policy as stated in the NIH 
grants policy statement available at

Like a Phase I and initial Phase II grant, the competing continuation Phase 
II award will not support costs for legal consultation, marketing efforts, 
and the like.  


The SBIR/STTR Omnibus Solicitation indicates the statutory guidelines of 
funding support and project duration periods for SBIR and STTR Phase I and 
Phase II awards.  Awards in response to this solicitation are expected to 
average in the range of $150,000 to $300,000 total costs per year for up to 
three years.  The total costs may be higher in the initial years for some 
types of projects (e.g., testing of durable medical equipment) due to high 
research start-up costs (i.e., production of expensive test articles, safety 
and endurance testing, product/tooling rework and design refinement caused by 
test failures, etc.) and moderate during the remaining years of the award as 
the research is completed and the results are documented and published.  
Because the length of time and cost of drug discovery and development 
represent a long-term research and development commitment, a project period 
of up to three years and a budget not to exceed total costs of $900,000 
(including direct costs, Facilities and Administrative costs and fee/profit) 
will be considered under this PA if the time period and amount are well 

Consultant and Contractual Costs

The total amount of all consultant costs and contractual costs normally may 
not exceed 50 percent of the total costs requested for initial SBIR Phase II 
applications.  SBIR Phase II competing continuation grant applications 
submitted under this PA may exceed this guideline, however, when well 
justified and when those costs are necessary to support clinical studies or 
trials and related expenses.  Examples of well-founded reasons for exceeding 
this guideline include, but are not limited to, subcontracts to clinical 
research organizations to carry out aspects of clinical evaluation or 
subcontracts to assure compliance with Good Manufacturing Practices (GMPs) 
expectations of the FDA. 

For STTR Phase II applications, the small business must perform at least 30 
percent of the research/R and D and the partnering research institution must 
perform at least 40 percent of the proposed research/R and D.  


Eligibility requirements are described in the SBIR/STTR Omnibus Solicitation.  
Only small business concerns are eligible to submit applications.  A small 
business concern is one that, on the date of award for both Phase I and Phase 
II agreements, meets ALL of the criteria as described in the SBIR/STTR 
Omnibus Solicitation.  The competing continuation application must be a 
continuation of a previously funded NICHD Phase II (R44) SBIR or Phase II 
STTR (R42) grant focusing on research and development of a product or 
products ultimately requiring clinical testing and Federal regulatory 


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.  On an SBIR application, the Principal 
Investigator must have his/her primary employment (more than 50 percent) with 
the small business at the time of award and for the duration of the project. 
The PI on an STTR application may be employed with the small business concern 
or the participating non-profit research institution as long as s/he has a 
formal appointment with or commitment to the applicant small business 
concern, which is characterized by an official relationship between the small 
business concern and that individual. 


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

o Direct your questions about scientific/research issues to:

Louis A. Quatrano, Ph.D.
Program Director, Behavioral Science and Rehabilitation Engineering
National Center for Medical Rehabilitation Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 2A03, MSC 7510
Bethesda, MD 20892-7510
Telephone:  (301) 402-4221
FAX:  (301) 402-0832

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

Ms. Kathy Hancock
Grants Management Branch
National Institute of Child Health and Human Development
6001 Executive Boulevard, Room 8A17M, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-5482
FAX:  (301) 402-0915

The PHS 398 research grant application must be used for all SBIR/STTR Phase 
I, Phase II and Fast-Track applications (new and revised.)  The PHS 398 is 
available at  
Prepare your application in accordance with the SBIR/STTR Omnibus 
Solicitation and the PHS 398.  Helpful information on the preparation of the 
application can be obtained at:  The NIH will 
return applications that are not submitted using the PHS 398 grant 
application.  For further assistance contact GrantsInfo, Telephone: (301) 
710-0267, Email:  

The title and number of this PA must be typed on line 2 of the face page of 
the application.

All Phase II SBIR/STTR grant applications, including this competing 
continuation application, require a "Commercialization Plan," as described in 
item J on page 38 of the Phase II SBIR Instructions 
(  The Commercialization Plan 
is meant, in part, to demonstrate the commercial viability of the product 
researched and developed with SBIR support.  Since this Phase II competing 
continuation application mechanism supports a more advanced stage of research 
and development than the R44 Phase II mechanism, the Commercialization Plan 
should reflect more advanced plans and arrangements for commercialization 
than what might be submitted for an initial R44 application.

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)

Applications must be received by or mailed on or before the receipt dates 
described on the first page of this program announcement.  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 substantial revision 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 eight weeks.


Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
convened in accordance with the standard NIH peer review procedures 
( will evaluate applications for scientific 
and technical merit.

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

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


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 the 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

SIGNIFICANCE:  Does the proposed project have commercial potential to lead to 
a marketable product or process?  Does this study address an important 
problem?  What may be the anticipated commercial and societal benefits of the 
proposed activity?  If the aims of the application are achieved, how will 
scientific knowledge be advanced? Does the proposal lead to enabling 
technologies (e.g., instrumentation, software) for further discoveries?  Will 
the technology have a competitive advantage over existing/alternate 
technologies that can meet the market needs? 

APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Is the proposed plan a sound approach for establishing technical 
and commercial feasibility?  Does the applicant acknowledge potential problem 
areas and consider alternative strategies?  Are the milestones and evaluation 
procedures appropriate? 

INNOVATION:  Does the project challenge existing paradigms or employ novel 
technologies, approaches or methodologies?  Are the aims original and 

INVESTIGATORS:  Is the Principal Investigator capable of coordinating and 
managing the proposed SBIR/STTR?  Is the work proposed appropriate to the 
experience level of the Principal Investigator and other researchers, 
including consultants and subcontractors (if any)?  Are the relationships of 
the key personnel to the small business and to other institutions appropriate 
for the work proposed? 

ENVIRONMENT:  Is there sufficient access to resources (e.g., equipment, 
facilities)?  Does the scientific and technological environment in which the 
work will be done contribute to the probability of success?  Do the proposed 
experiments take advantage of unique features of the scientific environment 
or employ useful collaborative arrangements? 

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, the following 
items will be applied to ALL applications in the determination of scientific 
merit and the priority score:

o  Does the activity as proposed address issues related to Federal regulatory 
approval processes?
o  What will be the effect of these studies on the concepts or methods that 
drive this field?

subjects and protections from research risk relating to their participation 
in the proposed research will be assessed.  (See additional information and 
criteria included in the section on Federal Citations, below.)

Protection of Human Subjects from Research Risks - for all studies involving 
human subjects.  See instructions and "Guidance for Preparing the Human 
Subjects Research Section." 

o  If an exemption is claimed, is it appropriate for the work proposed?  If 
no exemption is claimed, are the applicant's responses to the six required 
points appropriate? 

o  Are human subjects placed at risk by the proposed study?  If so, are the 
risks reasonable in relation to the anticipated benefits to the subjects and 
others?  Are the risks reasonable in relation to the importance of the 
knowledge that reasonably may be expected to be gained? 

o  Are the plans proposed for the protection of human subjects adequate? 

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 additional information and Inclusion Criteria in the sections 
on Federal Citations, below.)

o  Inclusion of Women Plan - for clinical research only:  Does the applicant 
propose a plan for the inclusion of both genders that will provide their 
appropriate representation?  Does the applicant provide appropriate 
justification when representation is limited or absent?  Does the applicant 
propose appropriate and acceptable plans for recruitment/outreach and 
retention of study participants? 

o  Inclusion of Minorities Plan - for clinical research only:  Does the 
applicant propose a plan for the inclusion of minorities that will provide 
their appropriate representation?  Does the applicant provide appropriate 
justification when representation is limited or absent?  Does the applicant 
propose appropriate and acceptable plans for recruitment/outreach and 
retention of study participants? 

o  Inclusion of Children Plan - for all studies involving human subjects:  
Does the applicant describe an acceptable plan in which the representation of 
children of all ages (under the age of 21) is scientifically appropriate and 
recruitment/retention is addressed realistically?  If not, does the applicant 
provide an appropriate justification for their exclusion?

be used in the project, the required five items described under Vertebrate 
Animals (section f of the Research Plan instructions) will be assessed.  

o  If vertebrate animals are involved, are adequate plans proposed for their 
care and use? Are the applicant's responses to the five required points 
appropriate? Will the procedures be limited to those that are unavoidable in 
the conduct of scientifically sound research? 

ADDITIONAL CONSIDERATIONS:  The following items may be also be considered by 
reviewers but will not be included in the determination of scientific merit.

BUDGET:  The reasonableness of the proposed budget may be considered.
For all applications, is the percent effort listed for the PI appropriate for 
the work proposed?  Is the budget realistic and justified in terms of the 
aims and methods? 

PERIOD OF SUPPORT:  The appropriateness of the requested period of support in 
relation to the proposed research.


Applications submitted in response to a PA will compete for available funds 
with all other recommended SBIR and STTR 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




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.

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 "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 (
NOT-OD-02-001.html); a complete copy of the updated Guidelines is available 
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 

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 

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 

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for federal funding of research 
on hESCs can be found at and at  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see   
It is the responsibility of the applicant to provide 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 

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.

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 

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of 
Federal Domestic Assistance at 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
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) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
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