CHRONIC STRESS AND ITS RELATION TO DRUG ABUSE AND ADDICTION

RELEASE DATE:  September 16, 2002

RFA:  DA-03-004

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

LETTER OF INTENT RECEIPT DATE:  November 19, 2002
APPLICATION RECEIPT DATE:  December 19, 2002

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
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 encouraging research on 
adaptive changes within the brain brought about by chronic stress or repeated 
stressors and their functional relevance to drug use, abuse, and addictive 
processes.  The relationship between drugs of abuse such as cocaine and 
heroin, activation of the hypothalamo-pituitary-adrenal (HPA) axis, and 
neural substrates subserving cognitive or behavioral processes under 
conditions of chronic stress is complex, but studies of these relationships 
may provide clues as to how drugs of abuse can produce persistent changes in 
the brain that in turn modulate behavioral processes, including drug-seeking 
and drug-taking behavior.    

Much of the preclinical literature in the area of stress and drug use has 
focused on endocrine measurements and behavior in acutely stressed animals.  
NIDA-supported research emphasizes the role of acute stress in relapse, 
evaluates endocrine parameters following an acute stressor, or employs acute 
footshock as a stressor to maintain or reinstate drug-seeking behaviors in 
preclinical models.  Few studies evaluate the effects of chronic stressors on 
neurobiological substrates, or combines the effects of stress on the 
neurobiology and associated behaviors related to drug use.  Even fewer 
evaluate the effects of chronic or repeated stress during early development 
on drug-directed behaviors in adulthood.  The purpose of this request for 
applications (RFA) is to encourage investigations into the neural and 
behavioral consequences of exposure to physiologically relevant chronic or 
repeated stressors that can increase our understanding of drug abuse and 
addiction.  As drugs of abuse themselves or repeated withdrawal from drugs 
can also be stressors, studies examining the effects of these variables on 
stress systems and drug abuse relevant behavioral or cognitive measures are 
encouraged, however, studies focusing solely on alcohol will not be 
considered responsive to this RFA.  Both studies using chronic or repeated 
stress manipulations in animals, and human laboratory-based investigations 
that propose to study individuals who are or continue to be chronically 
stressed are encouraged.  Study of the neural and behavioral adaptive changes 
that occur in individuals chronically exposed to stress, the duration of 
those changes, and their relationship to drug seeking behavior and relapse to 
drug use are also of interest. Preclinical applications employing footshock, 
learned helplessness, or other physically debilitating experimental paradigms 
as stressors, will not be considered responsive to this RFA because data 
obtained under such conditions are subject to multiple interpretations.

RESEARCH OBJECTIVES

The goal of the research areas outlined below is to understand the 
neurobiological mechanisms that underlie the interaction between stress and 
drug abuse and lead to behavioral change in all phases of the addictive 
process.  "Stress" refers to both a physiological state of heightened 
arousal/vigilance/discomfort often accompanied by activation of the HPA, and 
to stimuli that can provoke that physiological state.  Individuals under 
chronic stress can experience a progressive sensitization in their subsequent 
response to stress, and undergo pronounced physiological changes that are 
typified by dysregulation of important bodily systems leading to serious 
illnesses such hypertension and diabetes. These altered physiological states 
in turn influence subsequent adaptive responding in the face of additional 
stress.  In fact, stress is often associated clinically with chronic drug use 
and is recognized as a major factor contributing to the relapse to drug use 
in abstinent individuals.  Parallel findings in the preclinical literature 
also indicate that stress may enhance the vulnerability to acquire, maintain 
and relapse to drug-taking behavior.  

Data obtained from some animal models of chronic stress and from humans 
experiencing repeated stress document that neural adaptations in brain 
regions associated with the rewarding effects of drugs of abuse occur in 
response to chronic or repeated exposure to stress.  Recent evidence also 
suggests that different types of stressors may affect specific components of 
brain circuitry in regions of the brain that serve as substrates of reward, 
stress, cognitive processes, motor systems, and autonomic regulation.  
Examples of such findings come from animal models of maternal separation, 
studies on dominant and submissive members of social hierarchies, and 
reactivity to novelty as a predictive factor for the acquisition and 
maintenance of drug self-administration. Chronic stress induces behavioral 
and neurobiological cross-sensitization to some drugs of abuse. Chronic 
stress has also been shown to decrease cells within the hippocampus in 
animals and decrease its volume in humans.  The hippocampus is a structure 
implicated in learning and memory, and this cell loss may be related to the 
persistence of drug-taking behavior.  While deficits are most often reported 
in response to chronic or repeated stress, adaptation to stress also includes 
an allostatic process, which represents an organism"s attempt to regain 
homeostasis, and suggests that certain compensatory adaptations occur in 
response to chronic or repeated stress.  However, few reports document this 
effect, or its relationship to drug abuse, and further work in this area is 
encouraged.  

NIDA would like to promote and support research in the area of chronic or 
repeated stress on adaptations within the neural circuits involved in all 
aspects of drug abuse as well as the individual components of the circuits, 
and determine the functional impact of such alterations, particularly on drug 
seeking behavior and relapse to drug abuse.  To that end, research topics 
that would be considered responsive to this RFA may include (but are not 
limited to) the following:

o Development of objective measures of chronic and repeated stressors in 
preclinical studies. 

o Studies that manipulate stress as an experimental variable or as an outcome 
variable interacting with or influencing drug abuse-relevant behavioral or 
cognitive assessments.

o Studies that examine the interaction of components of neural circuitry 
underlying both reward and stress, investigations of compensatory 
neuroadaptations brought about by stress and their reversal are also 
encouraged.  Variables of interest might include alterations in the elements 
of reward circuits as a result of chronic stress and repeated exposure to 
drugs of abuse, neuroadaptive and behavioral responses to novelty, complexity 
or change in the environment, or changes in gene expression as a function of 
chronic stress and exposure to abused drugs.  The persistence of such 
neuroadaptations is also of interest.

o Studies of how drug exposure may affect response to repeated exposure to 
stressors.  

o Development of animal models of chronic or repeated stress and examination 
of neuroadaptations in macro- and micro-circuits in the brain produced as a 
result of chronic or repeated exposure to stressful stimuli, including their 
consequence for behavioral or cognitive phenomena relevant to understanding 
drug abuse and addiction. These might include studies of graded (incremental) 
levels of physical and psychological stressors and examining cumulative or 
synergistic effects on one or more outcomes.  Stressful stimuli such as 
restraint, exposure to cold, and socially-induced stress such as early 
maternal separation or aggression or other manipulations that may mimic 
stressful experiences likely to be encountered by humans are suitable 
candidates for study.  

o Assessment of cognitive abilities, changes in behavioral repertoire, 
including choice behaviors in chronically stressed animals or humans who are 
or have been subjected to chronic stress.  Cognitive abilities of interest 
may include, but are not limited to, tasks that assess "executive function," 
learning and memory, or tasks designed to assess choices between drugs of 
abuse, or between drugs and other natural rewards.  It is also of interest to 
determine the consequences of and subsequent response to additional stressful 
situations or adverse events, stress manipulations, or availability of drugs 
after chronic stress, and stress plus drug exposure.

o Cognitive and behavioral studies of humans with HIV-AIDS who are exposed to 
or experience chronic or repeated stress are also encouraged.   For example, 
studies of the positive or negative influence of acute stress against the 
baseline of chronic stress may be useful in identifying variables (cognitive, 
behavioral, neurobiological or immunological) that affect response to 
behavioral or pharmacological treatment.

o Studies on the consequences of repeated exposure to stressors in concert 
with abused substances on the immune system, especially in the brain are also 
encouraged.  These may include studies of the effects of chronic stress on 
cytokines in the brain, and the effects of cytokines on the regulatory 
elements of neurotransmission (receptors, transporters, signal transduction 
factors, etc.).  

o Studies of individual differences in neurobiological and hormonal responses 
to acute drug challenges in the chronically stressed subject are also of 
interest.  Such studies might also include pharmacological dose-response 
studies to determine the sensitivity of the stressed individual to treatment 
aimed at blocking drug-induced or cue-induced reinstatement of drug-taking 
behavior or its neurobiological correlates.  Differential responses to acute 
challenges in chronically stressed individuals might help differentiate the 
likelihood of an individual"s response to stress and drugs.  These might be 
reflected, for example, in the relative proportions of adrenal steroids 
released upon challenge with a stressor.

o Imaging studies in animals and humans to delineate stress pathways and 
their activity in living brains.  These might include the study of 
environmental cues for stress or drug-taking, or the effects of a 
pharmacological intervention on the activity of a so-called "stress circuit."  

o Studies of the effects of early (developmental) stress in animal models or 
in human subjects on sensitization of the CNS to psychoactive substances.  
Such studies may also include examination of early stress on adult behaviors 
and neuroadaptations that are specifically associated with the increased 
probability of drug seeking, such as impulsivity, and aggression 
(vulnerability).

o Pharmacological modification of stress responses and its consequences on 
drug-related behaviors.

o Studies that explore the role(s) of gender in chronically or repeatedly 
stressed individuals on any of the research areas noted thus far. 
  
MECHANISMS OF SUPPORT
 
This RFA will use the National Institutes of Health (NIH) research project 
(R01), NIDA small grant (R03) and NIDA exploratory/developmental (R21) award 
mechanisms.  The total project period for an R01 application submitted in 
response to this RFA may not exceed 5 years.  For R21 applications, the 
project period cannot exceed 3 years and $100,000 in direct costs in each of 
those years.  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.  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 July 2002.  

This RFA uses just-in-time concepts.  It also uses the modular budgeting 
format. (see http://grants.nih.gov/grants/funding/modular/modular.htm).   

FUNDS AVAILABLE 

NIDA intends to commit approximately $2.5 million in FY 2003 to fund 7 to 12 
new and/or competitive continuation grants in response to this RFA. For the 
R01 mechanism, an applicant may request a project period of up to four years 
and a budget for direct costs of up to $200,000 per year for all years.  For 
the R03 mechanism, an applicant may request up to $50,000 in direct costs in 
each of the 2 years.  For an R21 mechanism, an applicant may request up to 
$100,000 in direct costs in each of the 3 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

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 preclinical scientific/research issues to:

Nancy Pilotte, Ph.D.
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4282, MSC 9555
Bethesda, MD  20892-9555
Telephone:  301-443-6975
Email:  npilotte@mail.nih.gov

o Direct your questions about human laboratory-based scientific/research 
issues to:

Minda Lynch, Ph.D.
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4282, MSC 9555
Bethesda, MD  20892-9555
Telephone:  301-445-1322
Email:  mlynch1@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
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, Maryland 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
6001 Executive Boulevard, Room 3131 MSC 9541
Bethesda, Maryland  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 IC 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
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, Maryland 20892-9547
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2755
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) 710-0267, 
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
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, Maryland 20892-9547
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2755

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?

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 DATA SHARING:  The adequacy of the proposed plan to share data.
 
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:     November 19, 2002
Application Receipt Date:          December 19, 2002
Peer Review Date:                  February/March 2003
Council Review:                    May 2003
Earliest Anticipated Start Date:   July 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 Phase 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. 

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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