Release Date:  May 7, 2001 (see replacement PAR-03-074)

PA NUMBER:  PA-01-091

National Cancer Institute

Letter of Intent Receipt Dates:  June 6, 2001, March 6, 2002, October 8, 2002
Application Receipt Dates:       July 12, 2001, April 10, 2002, November 12, 2002
This Program Announcement (PA) replaces PAR-00-030, which was published in the 
NIH Guide, release date December 15, 1999.


Discovery and development of new drugs and biologicals for cancer treatment, 
including gene therapy and drug delivery approaches, normally involve lengthy 
and costly projects.  The multiple components of the overall process including 
discovery, efficacy testing, development of lead agents, toxicology and 
pharmacology, Investigational New Drug Application (IND) filing, and clinical 
evaluation, may require years and several million dollars.

The small business community is an active participant in the cancer therapy 
discovery effort.  Thus it is important that their innovative ideas be 
supported. The Small Business Innovation Research (SBIR) and Small Business 
Technology Transfer (STTR) programs were developed to support innovative 
research with a commercial intent by small businesses.  This PA provides a 
flexible system within the SBIR and STTR programs to accommodate the special 
needs of the complex discovery and development process, at least partially, 
from basic discovery through proof of principle demonstration in clinical 
trials.  It is hoped that this initiative will stimulate drug discovery 
research efforts in the small business community.
This PA must be read in conjunction with the OMNIBUS SOLICITATION OF THE 

All of the instructions within the OMNIBUS SOLICITATION apply with the 
following exceptions:

o  Special receipt dates
o  Initial review convened by the Division of Extramural Activities, National 
Cancer Institute (NCI)
o  Additional review considerations
o  More flexible time and budget specifications
o  No modular format.  Instructions for detailed budgets will be followed.

This PA will expire on November 13, 2002, unless reissued.  NIH Grants 
policies apply to these awards.


Recent advances in all branches of medical sciences provide new insight into 
the underlying mechanisms in malignancy and suggest new targets and approaches 
for therapy.  For example, key growth regulatory pathways and genes mutated in 
cancer cells are being identified, array technology for expression of 
thousands of genes as well as computer-assisted evaluation of data are 
available, new technologies in chemistry which allow facile synthesis of 
millions of new chemicals, and high resolution structures of important target 
proteins are becoming available. NCI has made approaches for drug discovery 
based on these directions a high priority: http://plan2002.cancer.gov/.  
Translation of these new discoveries and innovations into clinical benefit for 
the cancer patient is essential; however, the process is lengthy and costly.  
Following initial discovery and lead optimization, potential drugs must 
undergo a series of rigorous pre-clinical evaluations which may culminate in a 
clinical trial.  The actual procedures for this process vary somewhat with 
each agent to be tested, and, with innovative approaches often required for 
new agents, an extensive research effort may be necessary for successful 
development and eventual commercialization. The objective of this PA is to 
provide a flexible funding mechanism with regard to budgets and time of award 
to support the research activities required to enable small businesses to 
bring their innovative efforts for drug discovery and development to clinical 

Projects submitted in response to this PA should be focused on discovery and 
development of a specific agent or class of agents.  Applications devoted to 
topics relating more generally to drug discovery such as technology and model 
development without direct relevance to development of a specific agent are 
not appropriate.

Flexibility within the PA allows for projects to be presented at all stages of 
the drug discovery and development process.   Projects will be evaluated on 
OVERALL innovation, strength of the drug discovery approach, and probability 
of clinical success, with less emphasis on the nature of the specific stage 
proposed in the application.  This latter aspect is especially important if 
applications are focused on later stages of the drug discovery and evaluation 
process that may be more routine and often considered less innovative as 
stand-alone projects. 


Support for this PA is through the SBIR and STTR mechanisms which are set-
aside programs.  This PA is a one-time announcement which may be reissued.

Applications can be submitted for support as Phase I STTR (R41) or Phase I 
SBIR (R43) grants; Phase II STTR (R42) or Phase II SBIR (R44) grants; or the 
SBIR/STTR  FAST-TRACK option as described in the OMNIBUS SOLICITATION.  Phase 
II applications in response to this PA will only be accepted as competing 
continuations of previously funded NIH Phase I SBIR/STTR awards.  The Phase II 
proposal must be a logical extension of the Phase I research.

Information on the FAST-TRACK process and the OMNIBUS SOLICITATION is 
available at https://grants.nih.gov/grants/funding/sbirsttr1/index.pdf.


Eligibility requirements are described in the OMNIBUS SOLICITATION.  Any small 
business independently owned by United States citizens or permanent resident 
aliens and located in the United States may apply. 


Inquiries concerning this PA are encouraged.  The opportunity to clarify any 
issues or questions from potential applicants is welcome.  “Frequently Asked 
Questions” relating to this PA are available on the Developmental Therapeutics 
Program website: http://dtp.nci.nih.gov/, go to Grants and Contracts site: 

Direct inquiries regarding programmatic issues to: 
George S. Johnson, Ph.D.
Division of Cancer Treatment and Diagnosis
National Cancer Institute 
Executive Plaza North, Room 8152, MSC 7456
6130 Executive Blvd
Bethesda, MD  20892-7456
Telephone:  (301) 496-8783
FAX: (301) 402-5200
Email: johnsong@exchange.nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Kathleen Shino
National Cancer Institute 
Executive Plaza South, Room 243
6120 Executive Blvd
Bethesda, MD  20892-7150
Telephone:  (301) 846-1016
FAX: (301) 846-5720
Email: shinok@gab.nci.nih.gov

Direct inquiries regarding review matters to:

Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8109, MSC 8326
Bethesda, MD 20892-8326
Telephone: (301) 496 -3428
FAX: (301) 402-0275 
Email: tf12w@nih.gov


Prospective applicants are asked to submit, by the dates listed on the first 
page of this PA, a Letter of Intent that includes a descriptive title of the 
proposed research, the name, address, and telephone number of the Principal 
Investigator, the identities of other key personnel and participating 
institutions, and the number and title of the PA in response to which the 
application may be submitted.  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 NCI staff to estimate the potential 
review workload and plan the review.

NCI policy requires that all applicants requesting greater than $500,000 
direct costs in any one year must obtain approval from NCI Program staff prior 
to submission of the application.  If greater that $500,000 per year is 
requested, this fact must be clearly stated and approval requested in the 
Letter of Intent. 

The letter of intent is to be sent to Dr. George S. Johnson at the address 
listed under INQUIRIES by the Letter of Intent receipt dates.


Applications received in response to this PA are to be prepared as described 
in the OMNIBUS SOLICITATION for the SBIR and STTR programs.  The OMNIBUS 
SOLICITATION is available electronically through the NIH, Office of Extramural 
Research, Small Business Funding Opportunities web site: 
Helpful information for preparation of the application can be obtained at 

Applications will be accepted at the application receipt dates listed on the 
first page of this PA document.   THE TITLE AND NUMBER OF THIS PA MUST BE 
and Phase II applications must be submitted together for concurrent initial 
peer review.

If an application is received after one of the application receipt dates, it 
will be returned to the applicant without review.  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 review, unless the applicant 
withdraws the pending application. Revised applications may be submitted, but 
such applications must include an introduction addressing the previous 

The OMNIBUS SOLICITATION indicates the normal levels of support and period of 
time for SBIR and STTR Phase I and Phase II awards.  However, for this PA 
budgets up to $250,000 total costs per year (direct costs, indirect costs, and 
fixed fee) and time periods up to 2 years for Phase I and $650,000 total costs 
per year (direct costs, indirect costs, and fixed fee) and up to 4 years for 
Phase II can be requested.  The total duration of Phase I plus Phase II cannot 
exceed 5 years.  

A detailed budget with appropriate justification of all requested items should 
be provided in all applications.  SBIR Phase I applications will use “Budget 
for Phase I Direct Costs” (form page 3 of PHS 6246-1), and justify this 
request using “Budget Justification” form page 4 and PHS 62461. 

STTR Phase I applications will use “Budget of Applicant Organization for Phase 
I - Direct Costs Only” (form page 3 of PHS 6246-3) and justify this request 
using “Budget Justification” (form page 5).

Phase I SBIR and STTR applications requesting a duration of more than one year 
should follow the following procedures: Photocopy Form page 3, “Budget for 
Phase I - Direct Costs only”, and number it Form Page 3a “Phase I - 2nd year 
budget”. (This page will not be counted against the 25 page limit.); Provide 
the appropriate/requested information in the narrative justification (Form 
Page 4) for years 1 and 2; Indicate on the Phase I Face Page in Field 6, Dates 
of Project Period, the dates for the ENTIRE project period; Indicate on the 
Phase I Face Page in Field 7, the requested Direct Costs and Total Costs for 
the entire project period; The summary statement will reflect the recommended 
budget for the -01 and -02 years.
Applications can be submitted for Phase I or Phase II support, or as a 
combined Phase I and II (FAST-TRACK).  A Phase II application will be accepted 
only as continuation of a previously funded Phase I grant.  The Phase II 
proposal must be a logical extension of the Phase I research but not 
necessarily a Phase I project supported in response to this initiative.  All 
Phase II applications and FAST TRACK applications must include a succinct 
commercialization plan, hereafter referenced as a “Product Development Plan”.  
The Product Development Plan must be included as part of the Research Plan.  
(Note: It is no longer included as appendix material in FAST TRACK 
applications.)  Refer to Phase II grant application instructions for more 
specific details and instructions.
PHASE I:  Demonstration of feasibility for proceeding to the next step in the 
drug discovery and development process.  Applicants should emphasize 
innovative aspects of the agent or approach as well as the potential for 
clinical relevance. Applications should include a brief plan for development 
of the agents and clearly state how the proposed Phase I fits into this plan.

If two years of support are requested, the goals for the first year must be 
clearly stated.  Support for the second year will be contingent upon NCI 
programmatic evaluation to ensure that investigators have accomplished the 
proposed goals.
PHASE II: Continuing support for development of preclinical activities which 
may include establishment of proof of principle in clinical trials.  Support 
can be requested for preclinical developmental activities including 
pharmacology, formulation and toxicology.  Innovative aspects of the research 
necessary to complete the projects such as development of new in vivo 
evaluation  models which may require “surrogate endpoints” should be clearly 
described.  Support for clinical trial evaluation up to the point of 
establishing proof of principle (or through Phase II development) can be 
requested to commence following completion of the pre-clinical activities and 
approval of the IND by the FDA.  A brief plan for the clinical trial should be 
presented in the RESEARCH PLAN section.  Also, IN THE HUMAN SUBJECTS SECTION, 
Informed consent form(s) must be included.  NIH will treat as confidential any 
scientific, preclinical, clinical or formulation data and information that the 
sponsor deems to be proprietary and confidential.  For each trial, provide a 
Gender and Minority Inclusion Report in the format provided in the 398 form 
instructions: https://grants.nih.gov/grants/funding/phs398/phs398.html.

The goals and milestones for each year of support must be clearly presented.  
Support for years two to four, if requested, is dependent upon NCI 
Programmatic review of progress and achievement of the proposed goals.  For 
example, if a goal cannot be achieved such as identification of a more 
effective analog or demonstration of acceptable toxicity cannot be 
demonstrated, additional years may not be supported.

This PA encourages projects with aims focusing on later stages of drug 
development such as formulation and toxicology.  However, accomplishing these 
aims may likely require expertise not present in the applicant small business, 
and a sub-contract site within the award may be required.    Information on 
the drug development process is available: http://dtp.nci.nih.gov/  and 

FAST TRACK: Applications may be submitted for combined Phase I and Phase II, 
FAST TRACK consideration as described in the OMNIBUS SOLICITATION.  However, 
due to the complex nature of the drug development process, it is recommended 
that only well defined and more advanced projects be proposed for support 
through this mechanism.  

Phase I, FAST TRACK applications must specify clear, measurable milestones 
that should be achieved prior to Phase II funding.  Failure to provide such 
information in the Phase I application and/or sufficient detail in the Phase 
II application may be sufficient reason for the peer review committee to 
exclude the Phase II from consideration.  If so, the applicant may apply later 
for Phase II support.  Such applications will be reviewed by a standing Study 
Section of CSR or by a special review group convened in response to a re-
issuance of this PA, if applicable.

Special provisions described in this PA pertaining to Phase I and Phase II 
also apply to FAST TRACK applications.

FAST TRACK applications must include a succinct commercialization plan, 
hereafter referred to as a “Product Development Plan”.  The Product 
Development Plan must be included as part of the Research Plan.  (Note: It is 
no longer included as appendix material in FAST TRACK applications). Refer to 
Phase II grant application instructions for more specific details and  

Potential applicants are encouraged to contact program staff for guidance and 
to read the advice and information on the web sites.  However, responsibility 
for planning, direction, and execution of the proposed research will be solely 
that of the applicant.

The completed original application and three legible copies must be sent or 
delivered to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive
Room 1040 - MSC 7710
Bethesda, MD  20892-7710
(20817-7710 for express/courier service)

Two additional copies of the application must also be sent to:

Ms. Toby Friedberg
Referral Officer
National Cancer Institute
6116 Executive Boulevard, Room 8109, MSC 8236
Bethesda, MD 20892-8326
Rockville, MD 20852 (for express/courier service)
Telephone:    (301) 496-3428
FAX:    (301) 402-0275

Applications must be received by the receipt dates listed at the beginning of 
this PA.

Upon receipt, applications will be reviewed by CSR staff for completeness and 
by NCI program staff for adherence to the guidelines of this PA. Applications 
not adhering to instructions described above and those applications that are 
incomplete as determined by CSR or NCI program staff will be returned to the 
applicant without review.

Applications that are complete and adhere to the guidelines of the PA will be 
evaluated for scientific and technical merit and the documented ability of the 
investigators to meet the RESEARCH OBJECTIVES of this PA by a scientific 
review group convened by the NCI in accordance with the review criteria stated 
below.  As part of the initial merit review, all applications will receive a 
written critique and may undergo a process in which only those applications 
deemed to have the highest scientific merit, generally the top half of the 
applications, will be discussed, assigned a priority score, and receive a 
second level review by the National Cancer Advisory Board (NCAB).

Review Criteria:

Review criteria are described in the OMNIBUS SOLICITATION and are available 
at: https://grants.nih.gov/grants/funding/sbirsttr1/index.pdf.  

The goals of NIH-sponsored research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  
Within this framework, the specific goals of this PA include the discovery and 
development of new cancer therapies within the SBIR and STTR programs. In 
addition to the standard review criteria described in the OMNIBUS 
SOLICITATION, reviewers will comment on the following aspects of the 
application in their written critiques in order to judge the likelihood that 
the proposed research will have a substantial impact on the pursuit of these 
goals.  Each criterion will be addressed and considered by the reviewers in 
assigning the overall score weighting them as appropriate for each 
application.  Note that the application does not need to be strong in all 
categories to be judged highly meritorious.  For example, an investigator may 
propose a development or testing project which alone may not be highly 
innovative, but is required for successful development of an innovative and 
potentially important agent. 

Significance.  Does this study address an important problem?  If the aims of 
the application are achieved, how will scientific knowledge be advanced?  What 
will be the effect of these studies on the concepts or methods that drive this 
field?  What is the potential clinical relevance of the research and agents 

Approach.  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?  Is it likely that the drug or vaccine can be developed 
in a reasonable time frame?  Is the approach feasible and cost effective? For 
systems intended for clinical research, the following, additional criteria 
will be considered: to what degree is the analysis appropriate for clinical 
research and likely to have utility for the analysis of clinical specimens or 

Milestones.  Are the proposed feasibility goals in Phase I, if successful, 
appropriate and sufficient for transition to a Phase II?  

Innovation.   Does the project employ novel concepts, approaches, or methods?  
Are the aims original and innovative?  Does the project challenge existing 
paradigms?  Are the new drugs or vaccines proposed novel? 

Investigator.  Is the investigator appropriately trained and well suited to 
carry out this research?   

Environment.  Does the scientific 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?  Is there evidence of institutional support?

For FAST TRACK, the initial review group will evaluate the Phase I application 
for measurable goals to be achieved prior to initiating Phase II.  Failure to 
provide clear, measurable goals may be sufficient reason for the initial 
review group to judge the application non-competitive.  The review group may 
disapprove the Phase II component and then review and score the Phase I 

The initial review group will also examine: the adequacy of the proposed 
project budget and duration; the adequacy of plans to recruit and retain both 
genders, minorities and their sub-groups, and children as appropriate for the 
scientific goals of the research and plans for the recruitment and retention 
of subjects; the provisions for the protection of human and animal subjects; 
the safety of the research environment; and the Data and Safety Monitoring 


Applications will compete for available funds with all other approved SBIR and 
STTR applications.  A portion of the SBIR/STTR allotment will not be 
designated for this initiative. Funding decisions for Phase I or Phase II 
applications will be based on quality of the proposed project as determined by 
peer review, program priority, potential for clinical success, adequacy of the 
Data and Safety Monitoring Plan, and availability of funds.

FAST TRACK, Phase II applications may be funded following submission of the 
Phase I progress report and other documents necessary for continuation.  Phase 
II applications will be selected for funding based on the initial priority 
score, NCI’s assessment of the Phase I progress and determination that Phase I 
goals were achieved, the project’s potential for commercial success, and the 
availability of funds.


Letter of Intent Receipts:        June 6, 2001   March 6, 2002  October 8, 2002
Application Receipt:              July 12, 2001  April 10, 2002 Nov. 12, 2002
NCAB Review:                      Jan/Feb 2002   Sept/Oct 2002  May/June 2003
Earliest Anticipated Award Date:  April 2002     December 2002  July 2003

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 biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and 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 research involving human subjects should read the 
UPDATED "NIH Guidelines For Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000: 
A complete copy of the updated Guidelines is available at: 
https://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.   The 
revisions relate to NIH defined Phase III Clinical trials and require: a) all 
applications or proposals and/or protocols to provide a description of plans 
to conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and b) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and /or racial/ethnic group differences. 


It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by the 
NIH, unless there are clear and compelling scientific and ethical reasons not 
to include them.  This policy applies to all initial (Type 1) applications 
submitted for receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
“NIH Policy and Guidelines on the Inclusion of Children as Participants in 
Research Involving Human Subjects” that was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at 

All clinical trials supported or performed by NCI require some form of 
monitoring.  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 to 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 of 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 plan for Phase I 
and II Trials” for additional information: 


All investigators proposing research involving human subjects should read the 
policy published in the NIH Guide for Grants and Contracts, June 5, 2000 
(Revised August 25, 2000), available at  
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-036.html.  A 
continuing education program on the protection of human participants in 
research is now available online at: http://cme.nci.nih.gov/.  


All applications and proposals for NIH funding must be self-contained within 
specified page limitations.  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. Reviewers are cautioned that their 
anonymity may be compromised when they directly access an Internet site.


The Public Health Service (PHS) is committed to achieving the health promotion 
and disease prevention objectives of “Healthy People 2010", a PHS lead 
national activity for setting priority areas.  The PA, “Flexible System to 
Advance Innovative Research for Cancer Drug Discovery by Small Businesses 
(FLAIR)” is related to the priority area of cancer.  Potential applicants may 
obtain a copy of “Healthy People 2010" at http://www.health.gov/healthypeople/

This program is described in the Catalog of Federal Domestic Assistance No. 
93.395.  Awards are made under authorization of the Public Health Service Act, 
Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 
241 and 285) and administered under PHS grants policies and Federal 
Regulations 42 CFR 52 and 45 CFR Part 74 and part 92.  This program is not 
subject to the intergovernmental review requirements of Executive Order 12372 
or Health Systems Agency review. 

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the non-use of all tobacco products.  In 
addition, Public Law 103-227, the Pro- Children Act of 1994, prohibits smoking 
in certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.

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