IMMUNOTHERAPY FOR ADDICTION TREATMENT:  SBIR/STTR INITIATIVE

RELEASE DATE:  December 30, 2002  

RFA NUMBER:  DA-03-015

National Institute on Drug Abuse (NIDA)
 (http://www.nida.nih.gov)

LETTER OF INTENT RECEIPT DATE:  March 24, 2003

APPLICATION RECEIPT DATE: April 23, 2003

THIS REQUEST FOR APPLICATIONS (RFA) CONTAINS THE FOLLOWING INFORMATION

o Purpose of this  RFA
o Research Objectives
o Mechanisms of Support
o Funds Available 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
? Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

NOTICE:   This Request for Application (RFA) 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
(see http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf).
The solicitation contains information about the SBIR and STTR programs,
regulations governing the programs, and instructional information for
submission. Applicants are required to use the PHS398 forms for all SBIR and
STTR submissions. Helpful information for advice and preparation of the
application can be obtained at: 
http://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf.  

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

o Special receipt dates    
o Initial review convened by the (insert IC) Division of Extramural      
Activities    
o Additional review considerations
 
The title and number of this RFA must be typed on line 2 of the face page of 
the application.

PURPOSE OF THIS RFA

This RFA encourages small businesses, or small businesses in collaboration 
with research institutions, to develop effective methods for the large-scale 
production and clinical testing of monoclonal antibodies or vaccines as 
therapeutic agents for drug or nicotine addiction and/or overdose.  Because 
the RFA is focused on the advanced phase development of these therapies, 
applicants should already have access to a new molecular entity (NME), either 
for active or passive immunization, which is in the advanced stages of 
preclinical development and is ready to begin the process for translation 
into clinical trials (large scale GMP production of the entity, toxicity 
testing, formulation development, stability testing and clinical evaluation).  
The small business should be conversant with the requirements for the 
Investigational New Drug (IND) filing of such an entity and should have 
access to a clinical site.  The clinical site could be a part of the small 
business, the research institution involved in the project, or a 
subcontractor site.

RESEARCH OBJECTIVES

Background

There has been a great deal of research in the past ten years on the 
production of monoclonal antibodies and vaccines for the treatment of drug 
and nicotine abuse.  Monoclonal antibodies have been reported as possible 
treatment agents through passive immunization for PCP, methamphetamine, MDMA, 
and cocaine overdose and may also serve to minimize abuse and prevent 
relapse.  New vaccines are being developed as therapies for drug or nicotine 
cessation and relapse prevention.  However, the transition of a new molecular 
entity, or NME (a term which is applied by the Food and Drug Administration 
to both new pharmaceutical and immunological agents) from the preclinical 
phase to the clinical phase of development requires large-scale production of 
the NME and toxicity testing.  The requirements are described in the most 
recent FDA Guidance for Industry documents for vaccines and monoclonal 
antibodies (http://www.fda.gov/cber/gdlns/cmcvacc.pdf and 
http://www.fda.gov/cber/gdlns/mab032901.pdf) and constitute a major 
commitment of resources. 

Recent advances in the production methods for monoclonal antibodies and 
vaccines have led to the discovery and preclinical development of new 
entities intended for the treatment of drug overdose and relapse prevention 
and cocaine and nicotine addiction. Although preclinical research on new 
therapies for active or passive immunization for substance abuse disorders 
has been reported in the literature, the need exists for the advanced phase 
development and validation of technologies for the bulk scale production of 
new monoclonal antibodies or vaccines in quantities large enough for clinical 
trials, and for the design and implementation of clinical trials using 
immunotherapy for treatment of substance abuse disorders.  

Major difficulties in the large-scale production of these types of NMEs arise 
from contaminants such as animal proteins and viruses, culture media 
constituents, and purification problems.  Alternative methods to antibody and 
immunoconjugate production, which minimize these problems or avoid them 
altogether, would provide faster and more efficient manufacture of the NME 
and involve less toxicity testing and therefore less time and expense to 
obtain a marketable product.

Current procedures such as the development of antibodies in bioreactors are 
costly and time-consuming, with potential for contamination and purification 
problems.  New developments in proteomics should facilitate a more rapid and 
efficient production method.  The testing of these products in human clinical 
trials will establish the proof-of-concept that active immunization is an 
effective way of preventing or controlling drug or nicotine addiction and/or 
relapse and that passive immunization will prevent the adverse health effects 
of drug overdoses caused by cocaine, methamphetamine, PCP, or MDMA abuse in 
emergency room overdose situations.

Objectives and Scope

The goal of this RFA is to facilitate the development of a monoclonal 
antibody or vaccine for a drug overdose and treatment indication, or drug or 
nicotine addiction treatment indication, respectively.  

New technologies are emerging for the large-scale and cost-effective 
production of monoclonals and vaccines, and it is reasonable to consider that 
these advances could be applied to their development.  The objective of this 
RFA is to provide the support necessary to successfully transition a NME for 
immunotherapy for drug or nicotine abuse from the preclinical to the clinical 
phase, through utilization of improved technology approaches, and to support 
the clinical safety and efficacy testing of the NME.  

Because the program is designed to provide support to bridge the critical 
translation of the NME from the laboratory into the clinic, this RFA is 
suitable for applicants who already have access to an NME for immunotherapy 
that has been adequately characterized in animal models, and is ready for 
clinical development.  

MECHANISMS OF SUPPORT

This RFA uses the SBIR (R43,R44) and STTR (R41,R42) mechanisms, which are 
set-aside programs. As an applicant, you will be solely responsible for 
planning, directing, and executing the proposed project. Future 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.  The anticipated award date is (insert month, date, year).

Applications may 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 SBIR/STTR 
SOLICITATION.  Phase II applications in response to this RFA will only be 
accepted as competing continuations of previously funded NIH Phase I 
SBIR/STTR awards.  The Phase II application must be a logical extension of 
the Phase I research but not necessarily a Phase I project supported in 
response to this RFA.  

Fast Track applications will benefit from expedited evaluation of progress 
following the Phase I feasibility study for transition to Phase II funding 
for expanded developmental work.

PROJECT PERIOD AND AMOUNT OF AWARD

The OMNIBUS SBIR/STTR SOLICITATION indicates the statutory guidelines of 
funding support and project duration periods for SBIR and STTR Phase I and 
Phase II awards. Because the duration and cost of research for the 
development of a new immunotherapeutic agent (large-scale production under 
Good Manufacturing Practices (GMP), toxicity testing needed to support 
initial human safety testing, and costs associated with the implementation 
and execution of safety and efficacy trials) is likely to exceed that 
routinely awarded for SBIR/STTR grants. However, a well-justified application 
under this RFA will be considered with a Phase I project period of up to 2 
years and a budget not to exceed $1,000,000 ($500,000 per year), and a Phase 
II project period of up to 3 years and a budget not to exceed $2,000,000 
(approximately $700,000 per year). Total costs include direct costs, F&A, and 
a fixed fee.  

FUNDS AVAILABLE

The NIDA intends to commit approximately $1,000,000 in FY 2003 to fund 2 new 
grants in response to this RFA under the SBIR/STTR set-aside funding 
mechanism.  Because the nature and scope of the research proposed may vary, 
it is anticipated that the size of each award will also vary.  Although the 
financial plans of NIDA provide support for this program, awards pursuant to 
this RFA are contingent upon the availability of funds and the receipt of a 
sufficient number of meritorious applications.  

ELIGIBLE INSTITUTIONS

Eligibility requirements are described in the OMNIBUS SBIR/STTR 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.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.  On an SBIR application, the principal 
investigator must have his/her primary employment (more than 50%) 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. 

Consultant and Contractual Costs

Because the resources required for the successful development of an 
immunotherapeutic agent are highly specialized, the total amount of 
consultant costs and contractual costs requested by applicants may exceed the 
statutory guidelines.  Requests in excess of the guidelines must be fully 
justified.

WHERE TO SEND INQUIRIES

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

o Direct your questions about scientific/research issues to:

Jamie Biswas, Ph.D.
Division of Treatment Research and Development
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 4123, MSC 9551
Bethesda, MD  20892-9551
Telephone:  (301) 443-8096
FAX:  (301) 443-9649
Email:  [email protected]

o Direct your questions about peer review issues to:

Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, Maryland 20892-9547
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: [email protected]

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

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3131
Bethesda, MD 20892-9541
Telephone:  (301) 443-6710
FAX:  (301) 594-6849
E-mail:  [email protected]

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent by that 
includes the following information:

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

Although a letter of intent is not required, is not binding, and does not 
affect the review of a subsequent application, the information that it 
contains allows NIDA 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 addressed to:

Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Blvd, Room 3158, MSC 9547
Bethesda, MD  20892-9551
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2755
FAX:  (301) 443-0538
Email:  [email protected]

SUBMITTING AN APPLICATION

The PHS 398 research grant application (rev. 5/2001) must be used for all 
Phase I, Phase II and Fast-Track applications (new and revised.)  
Instructions and forms are available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html.  Prepare your 
application in accordance with the SBIR/STTR Omnibus Solicitation and Chapter 
VI of the PHS 398. The NIH will return applications that are not submitted on 
the 5/2001 version of the PHS 398.  For further assistance contact 
GrantsInfo, Telephone: (301) 710-0267, Email:[email protected]. 

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  Failure to use this label 
could result in delayed processing of the application such that it may not 
reach the review committee in time for review.  In addition, the RFA title 
and number must be typed on line 2 of the face page of the application form 
and the YES box must be marked. The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of 
the application, including the checklist, and three 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)

At the time of submission, two additional copies of the application must be 
sent to:

Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Blvd., Room 3158, MSC 9547
Bethesda, MD 20892-9547
Rockville, MD  20852 (for express/courier service)

RECEIPT OF APPLICATIONS. Applications must be received by the receipt date 
listed on the first page of this announcement. 

The Center for Scientific Research (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review unless the applicant withdraws the pending application.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed. This does not preclude the submission of a substantial 
revision of an application already reviewed, but such application must 
include an Introduction addressing the previous critique.

PEER REVIEW PROCESS
 
Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by NIDA.  Incomplete and/or non-responsive applications will 
be returned to the applicant without further consideration. If the 
application is not responsive to the RFA, CSR staff may contact the applicant 
to determine whether to return the application to the applicant or submit it 
to compete with other applications submitted in response to the next 
available receipt date of the OMNIBUS SOLICITATION. An appropriate scientific 
review group 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 Receive a written critique 
o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Those that receive a priority score will undergo a second-level review by 
the 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 your 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 Milestones and Proof of Principle
o Innovation
o Investigator
o Environment

The scientific review group will address and consider each of these criteria 
in assigning your application's overall score, weighting them as appropriate 
for each application.  Your application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score.  For example, you may propose to carry out 
important work that by its nature is not innovative but is essential to move 
a field forward.

Review criteria are described in the NIH Omnibus Solicitation and available 
on the web at the following URL address:  
http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf 

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

SIGNIFICANCE:  Will the product arising from this research address a clinical 
need in the targeted patient population?

APPROACH:  Does the applicant have access to the new molecular entity (NME)?  
Does the applicant have access to a clinical site for clinical trials?  Has 
the applicant or applicant organization provided a Data and Safety Monitoring 
Plan for the clinical studies?

INNOVATION:  Will the production of the proposed monoclonal antibody or 
vaccine utilize an innovative method, or methods, which will allow for the 
reasonably cost effective and efficient large scale production of the 
immunotherapeutic agent?  Is the product expected to improve the treatment of 
substance abuse and its consequences?

INVESTIGATOR:  Is the PI knowledgeable in FDA requirements for 
Investigational New Drug (IND) filing?  Does the applicant have experience in 
the development and clinical testing of immunotherapies?

ENVIRONMENT:  Has the site experience in producing entities under Good 
Manufacturing Practices (GMP)?  Is the facility set up for the large scale 
GMP manufacture, purifications, and formulation of a therapeutic entity?

PROTECTIONS:  The adequacy of the proposed protection for humans, animals, or 
the environment, to the extent they may be adversely affected by the project 
proposed in the application.

INCLUSION:  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 Inclusion Criteria included in the 
section on Federal Citations, below)

BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  March 24, 2003
Application Receipt Date:  April 23, 2003
Peer Review Date:  June/July/August 2003
Council Review:  September 2003
Earliest Anticipated Start Date:  September 30, 2003

AWARD CRITERIA

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

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities

Phase II applications will be selected for funding based on the following:

o Quality of the proposed project as determined by peer review
o Assessment of Phase I progress 
o Determination that the Phase I goals were achieved
o The project's potential for commercial success 
o Availability of funds

Fast Track Phase II applications may be funded following submission of:

o The Phase I progress report 
o Other documents necessary for continuation  

REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components 
involving Phases I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

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 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:  
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. 

HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG 
ABUSE:  Researchers funded by NIDA who are conducting research in community 
outreach settings, clinical, hospital settings, or clinical laboratories and 
have ongoing contact with clients at risk for HIV infection, are strongly 
encouraged to provide HIV risk reduction education and counseling.  HIV 
counseling should include offering HIV testing available on-site or by 
referral to other HIV testing services.  Persons at risk for HIV infection 
including injecting drug users, crack cocaine users, and sexually active drug 
users and their sexual partners.  For more information see 
http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html.

NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE 
ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS:  The National Advisory Council on 
Drug Abuse recognizes the importance of research involving the administration 
of drugs to human subjects and has developed guidelines relevant to such 
research.   Potential applicants are encouraged to obtain and review these 
recommendations of Council before submitting an application that will 
administer compounds to human subjects.  The guidelines are available on 
NIDA's Home Page at www.nida.nih.gov  under the Funding, or may be obtained 
by calling (301) 443-2755.

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.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research 
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm 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 RFA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

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

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.279 and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under authorization of Sections 301 
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92.

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

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