TRANSLATING TOBACCO ADDICTION RESEARCH TO TREATMENT

RELEASE DATE:  December 10, 2002

RFA:  DA-03-010

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 APPLICAIONS (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
o 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

PURPOSE OF THIS RFA

The National Institute on Drug Abuse (NIDA) is committed to the translation 
of research findings into practice.  The purpose of this initiative is to 
support research designed to translate existing knowledge about the targets, 
mechanisms and processes of nicotine addiction into treatments immediately 
applicable or demonstrably exportable to the treatment of tobacco addiction 
in humans.  It is envisioned that the research will be conducted using 
laboratory studies with human volunteers, or Stage I style clinical studies.  
However, it is possible that basic research studies may be relevant to the 
objective of this RFA and, as such, may be one logical component of the work 
plan of an application.  For example, studies with animal models might be 
relevant to the discovery of more details regarding the mode of action of a 
clinically used medication, knowledge that, in turn, would allow development 
of more specific medications.   For such applications the applicant will need 
to provide a compelling rational that the basic research, if successful will, 
in fact, have direct impact on clinical research, with direct application to 
treatment interventions. Notwithstanding the importance of the further 
discovery of the targets, mechanisms and processes of drug addiction, such 
research itself is not the focus of this RFA.  The purpose of this 
announcement is to foster research that translates existing knowledge into 
treatment and treatment practice, or research that, in and of itself, will 
readily translate to clinical research or practice.

RESEARCH OBJECTIVES

Background and Rationale

Significant progress has been made in the treatment of tobacco addiction, and 
as a result, there are several medications available as the first line 
treatments of choice. Similarly, behavioral approaches have been shown to 
produce a treatment response.  However, a significant number of tobacco users 
remain addicted, many of whom are unable to quit their use of tobacco 
products even when assisted by current treatment approaches.

There are at present real opportunities to develop new treatment approaches 
by building on contemporary advances in our understanding of the biological 
substrates and behavioral mechanisms of nicotine and tobacco addiction.  For 
example, contemporary discoveries from the field of neuroscience have 
challenged concepts of the neurochemical substrates that might underlie 
general addictive processes, and have provided a broad range of alternative 
candidate systems for exploration as treatment targets for drugs including 
nicotine, and in some cases, for nicotine specifically.  Behavioral research 
has demonstrated the profound role that conditioned cues play in drug 
addiction, and has shown that drug-taking behavior is modified by 
environmental and situational factors.  The neurochemical systems mediating 
some of these effects have been identified.  As another example, cognitive 
science suggests an influence of higher-order mental processes in decision-
making expectancies and memories of drug use.  Epidemiological studies of the 
onset of tobacco dependence show clearly that treatment interventions 
targeting adolescents and young adults are needed; understanding decision-
making and information processing in this population may contribute to the 
development of successful interventions in this case.  Outcomes of current 
treatments and basic research suggest that gender-based approaches are also 
required, and existing science provides some clues with which to develop 
them.  Nicotine and tobacco addiction offer unique opportunities to the 
translational scientist to advance treatment approaches.  This RFA invites 
researchers from diverse disciplines to synthesize knowledge from basic 
research findings into a cogent plan for study that will produce findings 
directly applicable to the creation of new treatments for tobacco dependence.

Areas of Interest

This announcement focuses exclusively on the support of translational studies 
that are based solidly on existing knowledge of the mechanisms and processes 
of tobacco and nicotine addiction or related areas. The applicant will need 
to clearly present the existing evidence and appropriate background that 
justifies building on, translating and applying this body of work to the 
proposed translational studies.  It is expected that studies will primarily 
involve volunteers in laboratory-based or Stage I style experiments.  (For 
greater detail about Stage I behavioral treatment research, please see the 
Behavioral Therapies Development Program Announcement at 
http://grants.nih.gov/grants/guide/pa-files/PA-99-107.html.)  However, as 
noted above, experiments with cells, tissues or animals may be required to 
clarify mechanisms of existing medications/treatments in ways that directly 
contribute to making improvements in them.

This initiative does not support research to expand the basic science base of 
nicotine and tobacco addiction per se.  Researchers interested in conducting 
studies of this kind are encouraged to contact NIDA staff to discuss other 
support and opportunities for them at NIH.  

Illustrative examples of research described below serve as a guide and are 
not meant to subsume all research topics that would be appropriate under this 
announcement.

o Testing pharmacological interventions that are logically based on targets 
that have been identified in basic research studies.  These interventions 
could have utility in reducing use, ameliorating withdrawal symptoms or 
attenuating cravings in tobacco users. For example, several neurochemical 
systems (including glutamatergic, noradrenergic and GABAergic) have been 
identified as playing a role in the reinforcement of nicotine self-
administration in animals and/or in neuronal and synaptic processes 
associated with nicotine addiction.  Studies might examine the efficacy of 
agents that target these neurochemical systems in smokers or other tobacco 
users;

o Similarly, developing and testing new behavioral approaches to treatment. 
For example, conditioning factors play a prominent role in tobacco addiction 
as they do for other drug use, and their role in treatment has been examined 
in some contexts and with certain drugs.  However, it may be possible to 
develop effective ways to extinguish conditioned stimuli associated with 
tobacco use, and thereby reduce relapse.  Indeed, treatment studies are 
needed that will explore ways to extinguish the multiplicity of cues 
associated with tobacco use as well as with the context specificity of 
extinction. In addition, the nature of tobacco use and nicotine addiction, 
and the availability of nicotine replacement therapies may contribute to 
success in this area;

o Development and validation of treatments applicable to particular 
population groups.  There is a considerable body of research showing gender 
differences relevant to the treatment of nicotine dependence, including 
differences in the control of smoking by non-nicotine factors, differences in 
the effectiveness of nicotine replacement therapies and other 
pharmacotherapies, differences in cessation rates and relapse rates, and 
issues specific to females such as menstrual cycle and weight control 
concerns.  Such research points to the need for new gender-sensitive and 
gender-specific treatment research and approaches.  A second example centers 
on the treatment of smokers with co-occurring mental illness that predispose 
them to engage in sustained, heavy use of tobacco products. For example, 
research has shown that tobacco use is prevalent in individuals with 
depression and schizophrenia.  New approaches with medications and new 
behavioral strategies may improve the effectiveness of treatment in such 
populations.

o Approaches based on employing existing nicotine replacement therapies in 
new ways to affect sustained reduction of smoking behavior or a sustained 
attenuation of relapse;

o Applying the knowledge of cognitive neuroscience to relapse prevention.  
Examples in this area include developing methods to improve the decision-
making skills of nicotine-dependent individuals, applying knowledge about 
cognitive development to processes such as attitude formation that may 
influence relapse and its prevention, and applying knowledge of the role of 
context in accessing knowledge;

o Certain clinical observations may require greater exploration with basic 
research studies to improve efficacy, or to discover mechanisms of action 
that would be valuable to the further development of treatments.  For 
example, discovery of the pharmacological profile of bupropion might identify 
elements that would support the development of new medications;

o Applying new technologies to tobacco cessation, withdrawal management, and 
relapse prevention, where the use of such technologies is justified by our 
understanding of tobacco addiction.  For example, a new nicotine delivery 
system might be more useful as a cigarette substitute, or the application of 
virtual reality approaches might facilitate the extinction of tobacco-related 
cues;

o Assess the effectiveness and utility of using established basic behavioral 
and cognitive assessment paradigms (e.g., measures of implicit cognition, 
inter-temporal choice, semantic networks) in treatment intervention and in 
predicting treatment outcomes and relapse.

MECHANISMS OF SUPPORT

This RFA will use NIH research project grant (R01), the small grant (R03), 
and the exploratory/developmental grant (R21) award mechanisms.  As an 
applicant you will be solely responsible for planning, directing, and 
executing the proposed project.  This RFA is a one-time solicitation.  Future 
unsolicited, competing-continuation applications based on this project will 
compete with all investigator-initiated applications and will be reviewed 
according to the customary peer review procedures. The anticipated award date 
is September 30, 2003.

This RFA uses just-in-time concepts.  It also uses the modular as well as the 
non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, if 
you are submitting an application with direct costs in each year of $250,000 
or less, use the modular format.  Otherwise follow the instructions for non-
modular research grant applications.

FUNDS AVAILABLE

NIDA intends to commit approximately $2,000,000 in FY 2003 to fund 7 to 10 
new grants in response to this RFA. An applicant may request a project period 
of up to five years for the R01 and a budget for direct costs of up to 
$250,000 per year. For R03 applications, the project period cannot exceed 2 
years and $50,000 in direct costs in each of those years, and the application 
research plan (items a-d) cannot exceed 10 pages.  Foreign applicants are not 
eligible for the R03 mechanism.  For 21 applications, the project period 
cannot exceed 3 years and $100,000 in direct costs in each of those years.

Because the nature and scope of the proposed research will vary from 
application to application, it is anticipated that the size and duration 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. At this time, it is not known if this RFA will be reissued.

ELIGIBLE INSTITUTIONS
 
You may submit (an) application(s) if your institution has any of the 
following characteristics:

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign
o Faith-based or community-based organizations

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.   

WHERE TO SEND INQUIRIES

We encourage 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:

William A. Corrigall, Ph.D.
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 4282, MSC 9555
Bethesda, MD 20892-9555
Telephone:  (301) 435-1324
Fax:  (301) 594-6043
Email:  wcorriga@nida.nih.gov

Lisa Onken, Ph.D.
Division of Treatment Research and Development
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 4241, MSC 9551
Bethesda, MD 20892-9551
Telephone:  (301) 443-2235
Fax:  (301) 443-6814
Email:  lonken@nida.nih.gov 

o Direct your questions about peer review matters to:

Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Telephone: (301) 443-2755
Email: tlevitin@mail.nih.gov

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

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3131 MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
E-mail:  gfleming@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 RFA 

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 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 sent to:

Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2755
Fax:  (301) 443-0538
Email:  tlevitin@mail.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting 
up to $250,000 per year in direct costs must be submitted in a modular grant 
format.  The modular grant format simplifies the preparation of the budget in 
these applications by limiting the level of budgetary detail.  Applicants 
request direct costs in $25,000 modules.  Section C of the research grant 
application instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

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/DHHS
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
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Rockville, MD  (for express/courier service)
Telephone: (301) 443-2755
Fax:  (301) 443-0538

APPLICATION PROCESSING: Applications must be received by the application 
receipt date listed in the heading of this RFA.  If an application is 
received after that date, it will be returned to the applicant without 
review.
 
The Center for Scientific Review (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 substantial 
revisions of applications already reviewed, but such applications 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.

Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by NIDA in accordance with the review criteria stated below.  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 the applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the National Advisory Council on Drug 
Abuse

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 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.

(1) SIGNIFICANCE:  Does your study address an important problem? If the aims 
of your application are achieved, how do they advance scientific knowledge?  
What will be the effect of these studies on the concepts or methods that 
drive this field?

(2) APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Do you acknowledge potential problem areas and consider alternative 
tactics?

(3) INNOVATION:  Does your project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does your project challenge 
existing paradigms or develop new methodologies or technologies?

(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out 
this work?  Is the work proposed appropriate to your experience level as the 
principal investigator and to that of other researchers (if any)?

(5) ENVIRONMENT:  Does the scientific environment in which your 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?

(6) RELEVANCE:  The relevance of the proposed work to the purpose of the RFA.

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

o 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.

o 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)

o 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 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 (as determined by peer review)
o Availability of funds
o Programmatic priorities.
 
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. 

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. 

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 service for 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.

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.

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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