NCI COMPETING CONTINUATION SBIR/STTR PHASE II GRANTS FOR CANCER DIAGNOSIS, 
PREVENTION AND TREATMENT
 
RELEASE DATE:  January 5, 2004

PA NUMBER: PA-04-047 (This PA has been reissued, see PA-06-051 and PA-06-052) 

EXPIRATION DATE:  November 3, 2005 

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION: 
National Institutes of Health (NIH) 
 (http://www.nih.gov)
 
COMPONENT OF PARTICIPATING ORGANIZATION:  
National Cancer Institute (NCI/NIH) 
 (http://www.nci.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.393. 93,394, 93.395, 93.396, 
93.399 

LETTER OF INTENT RECEIPT DATES: March 1, July 1, November 1 of each year

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

THIS PA CONTAINS THE FOLLOWING INFORMATION:

o  Purpose of the PA
o  Research Objectives
o  Mechanism(s) 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  Letter of Intent
o  Submitting an Application
o  Supplementary Instructions
o  Peer Review Process
o  Review Criteria
o  Award Criteria
o  Receipt and Review Schedule 
o  Required Federal Citations

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 
http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf) or 
http://grants.nih.gov/grants/funding/sbirsttr1/index.doc (MS Word] 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 with the following exceptions: 

o Additional grant submission instructions    
o Additional review considerations    
o Extended project period and amount of award 

PURPOSE OF THE PA 

The Small Business Innovation Research (SBIR) and Small Business Technology 
Transfer (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&D) needs.  An additional provision of these 
programs is the expected commercialization of the research. Certain types of 
research require clinical evaluation and Federal regulatory approvals before the 
Phase III part of the small business research pathway can ever be realized.  A 
recipient of a NIH SBIR/STTR Phase I and Phase II award normally receives no more 
than $1 million. If the intended commercialized product is a medical device, drug, 
biologic or diagnostic assay, the $1 million 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 and for clinical 
evaluation.  

While a recipient of an NIH SBIR/STTR Phase I and Phase II award normally receives 
less than three years of support, the process of moving promising new products 
from bench to bedside typically may take more than a decade.  The drug discovery 
timeline, for example, starts with identification of an agent or class of agents 
with particular activities; 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 various aspects of the agent, including 
safety, toxicity, effectiveness, and dosage determination. Similarly, long 
timelines are required for other products intended to understand, diagnose, 
prevent, or treat human health disorders (e.g., medical devices, vaccines).  

Despite the cost and the length of time required to move such products from the 
laboratory to the patient, these are products with potential to contribute 
significantly to the economy of the nation and to the health of her people. The 
intent of the competing continuation SBIR/STTR Phase II grants is to support such 
research and development and its translation into the clinic.

The purpose of this Program Announcement (PA) is to solicit grant applications for 
the competing continuation of previously funded Phase II SBIR/STTR grants that 
propose to continue the process of developing products for commercialization that 
ultimately require: 1) approval of a Federal regulatory agency and 2) clinical 
evaluation up to "proof of principle" demonstration, generally only through a 
Phase II clinical trial.  Such products include, but are not limited to: drugs, 
vaccines, radioligands, biomarkers, medical implants or devices, imaging protocols 
proposed for clinical use, new software for instrument performance, and diagnostic 
or predictive assays applicable for cancer diagnosis, prevention, and treatment.  

RESEARCH OBJECTIVES 

The small business community has been very active in the innovative development 
and production of a variety of commercializable biomedical research and technology 
products since the inception of the SBIR and STTR programs in 1982 and 1992, 
respectively.  However, the progress made by the SBIR/STTR recipient businesses in 
translating their new discoveries and technologies into clinical benefit for the 
cancer patient may be hampered by the lengthy process and costs required before 
commercialization. As a way to alleviate some of these issues, this PA will 
provide competing continuation funds for up to 3 additional years to Phase II 
grantees that have developed promising anticancer agents or biologics, new 
diagnostic or treatment devices, or biological assays for diagnosis or treatment, 
etc.  These funds will help businesses to complete the necessary preclinical 
research and development needed for Investigational New Drug (IND) or 
Investigational Device Exemption (IDE) filing and other processes needed to meet 
the requirements and expectations of Federal regulatory agencies prior to clinical 
evaluation for safety, toxicity, and effectiveness. The products may include, but 
are not limited to: drugs, vaccines, radioligands, medical implants, imaging 
protocols proposed for clinical use, instrumentation software, medical devices, 
etc.

The competing continuation SBIR/STTR Phase II application should represent a 
continuation of support for research and development of the 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 and need for 
further research and development. Clinical investigations and Federal regulatory 
approvals will ultimately be required before the potential of the product being 
researched and developed can be translated into the clinic.

Activities supported by a competing continuation of an SBIR/STTR Phase II 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 agencies. It is 
expected that some in vitro or in vivo studies will have been carried out in Phase 
I or the initial Phase II grants. A competing continuation Phase II award should 
not, however, be used to conduct early stage research (e.g., identifying targets 
for drugs, identification of new and more effective compounds or potential 
diagnostic markers, initial device/software development, initial assay testing, 
etc.).

Listed below are examples of research that would be considered responsive to this 
program announcement. These are listed for illustrative purposes and are not 
exclusive of other appropriate activities. 

o  Preclinical studies, including pharmacology and toxicology, and other clinical 
studies beyond those conducted under the NCI Phase I (R41, R43) and initial NCI 
Phase II (R42, R44) grants.

o  Completion of studies as required by the Food and Drug Administration (FDA) for 
Investigational New Drug (IND), Investigational Device Exemption (IDE), 
Premarketing Approval (PMA), or Radioactive Drug Research Committee (RDRC) 
applications.  

o  Assessment of devices, including clinical laboratory assays and/or software 
with regard to performance standards related to the FDA approval process, 
including possible in vivo animal studies and clinical evaluation through Phase II 
trials only.

o  Safety and effectiveness studies of novel medical devices and/or software.

o  Biocompatibility studies of surface materials of putative medical implants.

o  Evaluation of imaging technologies for screening, diagnostic or therapeutic 
purposes.

o  Evaluation of novel genetic, proteomic, and epigenetic technologies for 
diagnostic or therapeutic purposes.

o  Clinical studies up through Phase II trials in normal and patient/disease 
populations in support of New Drug Application approval by the FDA.

o  Clinical studies in normal and patient/disease populations in support of Pre-
Market Approval for medical devices, diagnostic assays and/or instrumentation 
software by the FDA.

MECHANISM(S) OF SUPPORT 

This PA uses the SBIR and STTR mechanisms, which are set-aside programs. As an 
applicant, you will be solely responsible for planning, directing, and executing 
the proposed project. Future unsolicited, competing continuation applications 
based on this project will compete with all SBIR/STTR applications and will be 
reviewed according to the customary peer review procedures.

This PA uses just-in-time concepts. Applicants must follow the instructions for 
non-modular budget research grant application format and instructions as described 
in the current SBIR/STTR Omnibus Solicitation. Cost-sharing arrangements are 
encouraged because SBIR/STTR programs cannot support all activities that may be 
required to advance a project to feasibility demonstration in a clinical trial.

An NCI competing continuation SBIR/STTR Phase II application must be in response 
to this PA, and the application will only be accepted as a competing continuation 
of a previously funded NCI Phase II SBIR or STTR award or other NIH Phase II SBIR 
or STTR award that now has cancer relevance. The expectation is that, as a result 
of support from a previous SBIR/STTR Phase I (R43/R41) and Phase II (R44/R42) 
grant, promising results have been produced that indicate not only the merit of 
further research and development but also that clinical investigations and Federal 
regulatory approvals will ultimately be required to realize the potential of the 
product being researched and developed for translation into the clinic. 

The previously funded NIH Phase II grant need not have been submitted in response 
to any specific solicitation, but the application for the competing continuation 
must propose specific aims and development that represent a logical extension of 
the previously supported Phase II R44/R42 research that will be translated into 
the clinic.  Activities supported by a competing continuation SBIR/STTR Phase II 
grant may include expansion of preclinical development, clinical testing, and 
other scientific activities that would ultimately be necessary in meeting the 
requirements and expectations of Federal regulatory approval processes.

PROJECT PERIOD AND AMOUNT OF AWARD 

Because the length of time and cost of drug, device or assay/biomarker development 
represent a long- term research and development commitment, a maximum project 
period of up to three years and a budget not to exceed total costs of $750,000 per 
year (including direct costs, F & A and a fee/profit) will be considered under 
this PA if the time period and amount are well justified. However, for those Phase 
II applications that include support for expensive studies required for IND filing 
with the FDA and/or clinical trials up through only Phase II trials, applicants 
may request up to $1 million per year total costs if the time periods and amounts 
are well justified. 

ELIGIBLE INSTITUTIONS:

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 the Phase II agreement, meets ALL of 
the criteria as described in the SBIR/STTR Omnibus Solicitation.

The competing continuation application must be a continuation of an on-going or a 
previously completed Phase II (R44) SBIR or Phase II STTR (R42) grant submitted by 
an SBIR/STTR-eligible small business concern that focuses on research and 
development of a product or products ultimately requiring Federal regulatory 
approval and clinical testing before licensing.  To maintain eligibility to seek a 
competing continuation Phase II grant, a Phase II grantee organization should 
submit an application for the competing continuation Phase II grant within the 
first six receipt dates following the expiration of the initial Phase II award.  
Other eligibility requirements for a competing continuation Phase II grant are 
identical to those for the initial Phase II (R44/R42) applications and can be 
found 
at http://grants.nih.gov/grants/funding/sbirsttr2/PhaseII_SBIRSTTR.pdf (PDF) or 
http://grants.nih.gov/grants/funding/sbirsttr2/PhaseII_SBIRSTTR.doc (MS Word)

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry out 
the proposed continuing research is invited to work with his/her 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 by 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. 

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants. It is highly recommended that 
prospective competing continuation applicants first contact their respective Phase 
II Program Director at the various NCI programs to discuss their eligibility and 
qualification before beginning the process of putting together a competing 
continuation Phase II application in response to this PA.  Inquiries may fall into 
two areas:  scientific/research, and financial or grants management issues:

o Direct other questions about scientific/research issues to:

Rosemary S. L. Wong, Ph.D.
Radiotherapy Development Branch
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive Boulevard, EPN Room 6015A, MSC 7440
Bethesda, MD  20892-7440
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 496-9360
FAX:  301-480-5785
Email: rw26f@nih.gov

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

Mr. Ted Williams
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, EPS Room 243
Bethesda, MD  20892-1750
Telephone: (301) 496-8785
FAX: (301) 496-8601
Email: williate@mail.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 PA

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 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:

Rosemary S. L. Wong, Ph.D.
Radiotherapy Development Branch
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive Boulevard, EPN Room 6015A, MSC 7440
Bethesda, MD  20892-7440
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 496-9360
FAX:  301-480-5785
Email: rw26f@nih.gov

SUBMITTING AN APPLICATION

The PHS 398 research grant application must be used for these competing 
continuation SBIR/STTR Phase II applications (new and revised). Effective October 
1, 2003, 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 accessing 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 document is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html.  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: 
http://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf.  The NIH will return 
applications that are not submitted using the 5/2001 version of the PHS 398 
guidelines.  For further assistance contact GrantsInfo, Telephone: (301) 435-0714, 
Email:GrantsInfo@nih.gov. 

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

SUPPLEMENTARY INSTRUCTIONS:

CONSULTANT AND CONTRACTUAL COSTS

SBIR:  The total amount of all consultant costs and contractual costs normally may 
not exceed 50% of the total costs requested for initial SBIR Phase II 
applications. Competing continuation SBIR Phase II grant applications submitted 
under this PA may exceed this guideline, however, when well justified and when 
those costs are necessary to support required IND/IDE/PMA filing activities, 
clinical studies or trials, and related expenses not available at the awardee 
institution. 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). 

STTR:  By law, for STTR Phase II applications, the small business MUST perform at 
least 40% of the research/R&D and the partnering research institution MUST perform 
at least 30% of the proposed research/R&D.  

The content of the Research Plan in response to Items a-d is limited to 25 pages. 
Part of the Specific Aims (Item a) of the Research Plan should include a Gantt 
chart or equivalent representation of the tasks including the stages at which 
interaction with the regulatory agencies will occur.  In the Preliminary Studies 
section (Item c), include a Phase II Final Report that describes the 
accomplishments of the Phase II efforts that justify this request for competing 
continuation funds. Those applicants requesting funds for clinical evaluation must 
follow the instructions applicable for Human Subjects Research (Item e) as 
described in the SBIR/STTR Omnibus Solicitation.  

COMMERCIALIZATION PLAN

All Phase II grant applications, including these competing continuation Phase II 
applications, require a "Commercialization Plan" as described in Item j of the 
SBIR/STTR Phase II instructions at 
http://grants.nih.gov/grants/funding/phs398/instructions2/p1_specific
_instructions.htm#8_Appendix. The 
Commercialization Plan is meant in part to demonstrate the commercial viability of 
the product to be researched and developed with SBIR/STTR support.  Since this 
competing continuation Phase II application mechanism supports a more advanced 
stage of research and development activities relative to the original R44/R42 
Phase II mechanism, the Commercialization Plan should provide a timeline 
describing more advanced plans and arrangements for commercialization following 
the completion of the research, as well as Federal regulatory issues to be 
addressed with the competing continuation funds.  Part of a Commercialization Plan 
could be a clear indication of an arrangement (e.g., strategic alliance, letter of 
support) with another party through which the final stages of the work might be 
supported or carried out, including additional clinical trials, FDA submissions, 
drug manufacturing, and drug commercialization.  This example is meant for 
illustrative purposes; the details of any Commercialization Plan will depend upon 
the particular circumstances represented in a given 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 (FOR USPS EXPRESS or REGULAR MAIL)
Bethesda, MD  20817 (FOR EXPRESS/COURIER NON-USPS SERVICE)

APPLICATION PROCESSING:  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 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 that are complete 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 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 written critique
o Receive a second level review by an 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 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

ALL SBIR/STTR APPLICATIONS

1. 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? 
2. 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? 
3. Innovation:  Does the project challenge existing paradigms or employ novel 
technologies, approaches or methodologies? Are the aims original and innovative? 
4. 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? 
5. 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 review criteria, the following items will be applied to 
ALL Type 2 Competing Continuation Phase II 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  Did the applicant submit a concise Commercialization Plan that adequately 
addresses the specific areas described in Item j of the Phase II research plan?

O  Does the project carry a high degree of commercial potential as described in 
the Commercialization Plan?

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 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).
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 additional 
information and Inclusion Criteria in the sections on Federal Citations, below).

Human Subjects: 
1. Protection of Human Subjects from Research Risks - for all studies involving 
human subjects. See instructions and "Guidance for Preparing the Human Subjects 
Research Section.” 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? 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? Are the plans proposed 
for the protection of human subjects adequate? 

2. 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? 

3. 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? 

4. 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? 

5. Data and Safety Monitoring Plan – for clinical trials only.  Does the applicant 
describe a Data and Safety Monitoring Plan that defines the general structure of 
the monitoring entity and mechanisms for reporting Adverse Events to the NIH and 
the IRB? 

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be 
used in the project, the required five items described under Vertebrate Animals 
(section f of the Research Plan instructions) will be assessed. 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? 

BIOHAZARDS:  Is the use of materials or procedures that are potentially hazardous 
to research personnel and/or the environment proposed? Is the proposed protection 
adequate?

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

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. (See 
http://grants.nih.gov/grants/policy/data_sharing)

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, and is each budget category 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.

AWARD CRITERIA

Applications submitted in response to this PA will compete for available funds 
with all other submitted 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

RECEIPT AND REVIEW SCHEDULE  
See http://grants.nih.gov/grants/funding/sbirsttr_receipt_dates.htm 

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).  

Clinical trials supported or performed by NCI require special considerations.  The 
method and degree of monitoring should be commensurate with the degree of risk 
involved in participation and the size and complexity of the clinical trial.  
Monitoring exists on a continuum from monitoring by the principal 
investigator/project manager or NCI program staff or a Data and Safety Monitoring 
Board (DSMB).  These monitoring activities are distinct from the requirement for 
study review and approval by an Institutional review Board (IRB).  For details 
about the Policy for the NCI for Data and Safety Monitoring of Clinical trials 
see: http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.  For Phase I and II 
clinical trials, investigators must submit a general description of the data and 
safety monitoring plan as part of the research application.  See NIH Guide Notice 
on “Further Guidance on a Data and Safety Monitoring for Phase I and II Trials” 
for additional information: 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.  
Information concerning essential elements of data safety 
monitoring plans for clinical trials funded by the NCI is available: 
http://www.cancer.gov/clinical_trials/

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 "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.  
A continuing education program in the protection of human participants in 
research is available online at:  http://cme.nci.nih.gov/

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 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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The 
Department of Health and Human Services (DHHS) issued final modification to the” 
Standards for Privacy of Individually Identifiable Health Information”, the 
“Privacy Rule,” on August 14, 2002. The Privacy Rule is a federal regulation under 
the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that 
governs the protection of individually identifiable health information, and is 
administered and enforced by the DHHS Office for Civil Rights (OCR). Those who 
must comply with the Privacy Rule (classified under the Rule as “covered 
entities”) must do so by April 14, 2003 (with the exception of small health plans 
which have an extra year to comply).

Decisions about applicability and implementation of the Privacy Rule reside with 
the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) 
provides information on the Privacy Rule, including a complete Regulation Text and 
a set of decision tools on “Am I a covered entity?” Information on the impact of 
the HIPAA Privacy Rule on NIH processes involving the review, funding, and 
progress monitoring of grants, cooperative agreements, and research contracts can 
be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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.health.gov/healthypeople.

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.

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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