This Program Announcement expires on December 7, 2004, unless reissued.

PHARMACOLOGIC AGENTS AND DRUGS FOR MENTAL DISORDERS (SBIR AWARD)

Release Date:  December 4, 2001

PA NUMBER:  PA-02-027 (This PA has been reissued, see PA-05-121)

National Institute of Mental Health
 (http://www.nimh.nih.gov/)

PURPOSE

Pharmacologic probes and therapeutics have allowed tremendous advances in 
understanding and treating mental disorders.  The complexity of the brain and 
of these diseases have, however, presented formidable challenges, and there 
remain many unexplored opportunities for new pharmacologic agents and drugs.  
This program announcement (PA) solicits Small Business Innovation Research 
(SBIR) grant applications that propose to develop novel pharmacologic agents 
for brain research related to mental disorders, including research aimed at 
discovering new drugs for these disorders.  Finally, this PA solicits SBIR 
grant applications that propose to take existing, promising compounds, 
through the next step of drug discovery and development. 

This PA must be read in conjunction with the Omnibus Solicitation of the NIH, 
CDC and FDA SBIR and STTR Grant Applications found at 
http://grants.nih.gov/grants/funding/sbir.htm, the instructions for Phase II 
Grant Applications found at 
http://grants.nih.gov/grants/funding/sbir2/index.htm, and the PHS 398 
instructions (http://grants.nih.gov/grants/funding/phs398/phs398.html).   
Except as noted below, all instructions and information in these documents 
also apply to applications submitted in response to this PA.

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, Pharmacologic 
Agents and Drugs for Mental Disorders (SBIR Award), 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/.

ELIGIBILITY REQUIREMENTS 

Eligibility requirements for Phase I and Phase II grants are found at 
http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf and 
http://grants.nih.gov/grants/funding/sbir2/index.htm, respectively. 

MECHANISM OF SUPPORT - PHASE I

Phase I applications in response to this PA will be funded as Phase I 
SBIR Grants (R43) with modifications as described below. Responsibility 
for the planning, direction, and execution of the proposed research 
will be solely that of the applicant.  Applications for Phase I grants 
should be prepared following the instructions at 
http://grants.nih.gov/grants/funding/phs398/phs398.html.

o  Project Period and Amount of Award.

Because the length of time and cost of drug discovery and development often 
exceed those routinely awarded for SBIR grants, a project period up to two 
years and a budget not to exceed a total cost of $250,000 per year (direct 
costs, indirect costs and fixed fee) will be considered under this PA if the 
time period and amount are well justified.  See section, BUDGET REQUESTS 
GREATER THAN $100,000 TOTAL COSTS, in 
http://grants.nih.gov/grants/funding/phs398/phs398.html for instructions on 
submitting a budget greater than $100,000.

o  Consultant and contractual costs.

The total amount of all consultant costs and contractual costs normally 
may not exceed 33% of the total costs requested for Phase I SBIR 
applications.  However, Phase I grant applications submitted under this PA 
may exceed this limit when well justified and those cost are necessary to 
support clinical studies or trials.

MECHANISM OF SUPPORT - PHASE II

Phase II applications in response to this PA will be awarded as Phase 
II SBIR grants (R44) with modifications as described below.  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 
previously funded Phase I award need not have been submitted in response to 
this PA, but the Phase II proposal must be a logical extension of the Phase I 
research.

Phase II applications should be prepared using instructions at 
http://grants.nih.gov/grants/funding/phs398/phs398.html.

o Project Period and Amount of Award.

Because the length of time and cost of drug discovery and development often 
exceed those routinely awarded for SBIR grants, a project period up to three 
years and a budget not to exceed total costs of $450,000 per year (direct 
costs, indirect costs and fixed fee) will be considered under this PA if the 
time period and amount are well justified.

o Consultant and contractual costs.

The total amount of all consultant costs and contractual costs normally 
may not exceed 50% of the total costs requested for Phase II SBIR 
applications.  However, Phase II grant applications submitted under this PA 
may exceed this limit when well justified and those costs are necessary to 
support clinical studies or trials.

MECHANISM OF SUPPORT-FAST TRACK

Applications for Fast Track SBIR grants should be prepared following 
the instructions for Phase I and Phase II applications at 
http://grants.nih.gov/grants/funding/phs398/phs398.html, and the additional 
instructions at http://grants.nih.gov/grants/funding/sbirsttr1/sbirsttrft-rs.pdf.

The total duration of Phase I and Phase II cannot exceed 5 years for fast 
track applications, and the budget levels described above for Phase I and 
Phase II applications apply.

RESEARCH OBJECTIVES 

Over the past two decades, neuroscience research has yielded knowledge of 
brain function that has been revolutionary in its scope and implications for 
understanding both healthy and disordered states of this most complex organ.  
Part of this new understanding has been identification of a large number of 
potential targets for intervening in disease processes such as schizophrenia, 
depression, bipolar disorder, and others.  In parallel to the development of 
new information about the brain, powerful technologies have been developed 
that allow these targets to be rapidly well-characterized.  Finally, new 
synthetic and analytic approaches in chemistry have made possible the 
manufacture of classes of agents and high throughput assessment of their 
properties.  Thus, the stage is set for a new thrust to discover and develop 
novel pharmacologic agents that might be used to probe and treat mental 
disorders.

The process of translating novel pharmacologic compounds to useful probes and 
treatments for disorders is long and expensive, starting with discovery of an 
agent or class of agents with particular activity, identifying lead 
compounds, optimizing them, and only then testing these in preclinical 
conditions for safety, toxicity, etc.  Those agents still considered viable 
are then brought to human subjects for clinical evaluation of a variety of 
aspects of the agent.  

In recent years, with the advent of biotechnology, small businesses have 
played an increasingly important role in drug discovery and development, 
typically, but not entirely, focusing their efforts on the earlier stages of 
this process.  This program announcement aims to support small businesses 
research and development of pharmacologic compounds for probing and treating 
psychiatric brain disorders.  

Although applications proposing research aimed primarily at identifying new 
targets are not considered appropriate for this initiative, the following 
objectives would make appropriate topics for proposed Phase I/Phase II 
projects.  This list is not meant to be all-inclusive.  

o  Characterization of already identified potential targets for intervention 

o  Lead compound identification/optimization, including research, development 
and syntheses of chemicals leading to agents with suitable bioactivity, 
binding affinity, biodistribution, bioavailability, pharmacokinetics, etc.

o  Pre-clinical studies, including initial pharmacology and toxicology 

o  Determination of toxicology/pathology (Food and Drug Administration (FDA) 
approvable) for submission of and Radioactive Drug Research Committee (RDRC) 
or Investigational New Drug (IND) application

o  IND application development and submission to the FDA prior to pilot human 
studies

o  Clinical studies in patient/disease population or experimental 
manipulations

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and 
their sub-populations must be included in all NIH-supported clinical research 
projects unless a clear and compelling justification is provided indicating 
that inclusion is inappropriate with respect to the health of the subjects or 
the purpose of the research. This policy results from the NIH Revitalization 
Act of 1993 (Section 492B of Public Law 103-43).

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

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

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 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 the following URL 
address:  http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

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.  This policy announcement is found in the NIH Guide for Grants and 
Contracts Announcement dated June 5, 2000, at the following website: 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.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.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

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.

APPLICATION PROCEDURES

Applicants should follow the instructions for SBIR Phase I, Phase II or 
fast-track submissions with the modifications as noted in this PA.

The original application and five single-sided copies must be mailed to 
the NIH Center for Scientific Review.  For purposes of identification 
and processing, the title and number of this PA must be shown in the 
appropriate place on the face page of the SBIR Phase I or Phase II 
applications.  Follow the mailing instructions in the Omnibus 
Solicitation for Phase I applications.  Follow the mailing instructions 
in the Phase II application package for Phase II applications.

Applicants are encouraged to contact the program staff listed under INQUIRIES 
with any questions regarding their proposed project and the goals of this PA.

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral 
guidelines.  Applications will be evaluated for scientific and technical 
merit by an appropriate scientific review group convened in accordance with 
the standard NIH peer review procedures.  As part of the initial merit 
review, all applications will receive a written critique and undergo a 
process in which only those applications deemed to have the highest 
scientific merit, generally the top half of applications under review, will 
be discussed, assigned a priority score, and receive a second level review by 
the appropriate national advisory council or board.

Review Criteria

Review criteria are described in Phase I and Phase II SBIR websites 
listed above.  The Phase I application should specify clear, measurable 
goals (milestones) that should be achieved prior to initiating Phase 
II.  Failure to provide clear, measurable goals may be sufficient 
reason for the study section to judge the application non-competitive.

AWARD CRITERIA

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

o  scientific merit (as determined by peer review)
o  availability of funds
o  programmatic priorities

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or questions 
from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Michael Huerta, Ph.D.
Division of Basic and Clinical Neuroscience Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7202, MSC 9645
Bethesda, MD  20892-9645
Rockville, MD  20852 (for express or courier service)
Telephone:  (301) 443-3563  
FAX:  (301) 443-1731
Email:  mhuerta@helix.nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Kathy Hancock
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17M
Bethesda, MD  20892-7510
Telephone:  (301) 496-5482
FAX:  (301) 402-0915
Email:  hancockk@mail.nih.gov

AUTHORITY AND REGULATIONS 

This program is described in the Catalog of Federal Domestic Assistance No. 
93.242 (NIMH).  Awards are made under authorization of sections 301 and 405 
of the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under NIH grants policies and Federal Regulations 42 CFR 52 and 
45 CFR Parts 74 and 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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