CROSS-DISCIPLINARY TRANSLATIONAL RESEARCH AT NIH

RELEASE DATE:  June 9, 2004

PA NUMBER:  PA-04-109  

EXPIRATION DATE:  May 31, 2007 unless reissued.

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:  
National Institutes of Health (NIH) 
 (http://www.nih.gov)

COMPONENTS OF PARTICIPATING ORGANIZATION:
National Institute on Drug Abuse (NIDA)  
 (http://www.nida.nih.gov)
National Cancer Institute (NCI) 
 (http://www.nci.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:  93.279 (NIDA), 93.399 (NCI)

THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanisms of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA

The National Institute on Drug Abuse (NIDA) is committed to 
translating research findings into practice.  As part of its 
mission, NIDA facilitates the translation of basic or clinical 
research discoveries in the field of drug abuse research into new 
clinical and research tools, medications, and behavioral 
therapies.  The purpose of this PA is to foster research that will 
have a practical impact on the treatment and prevention of drug 
abuse through the development of new research technologies that 
are based on existing basic and/or clinical research knowledge, 
and technology transfer knowledge.

RESEARCH OBJECTIVES

The scope of this program announcement includes a range of 
activities designed to extend basic or clinical research findings 
to yield a knowledge base for the development of novel, 
efficacious drug abuse prevention or treatment interventions.  It 
is envisioned that the research conducted under this PA will 
primarily use laboratory studies with human volunteers.  However, 
it is possible that preclinical research studies may be relevant 
to the objective of this PA and, as such, may be a 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.  Medications development research, per 
se, is not the focus of this PA.

Background:

Significant progress has been made in the development of drug 
abuse prevention and treatment interventions.  Nonetheless, many 
youth continue to experiment with and become addicted to drugs 
such as marijuana, cocaine, heroin, nicotine and amphetamine.  
Drug abuse public health concerns tend to be of a persistent 
nature.  Part of the persistence of drug abuse is the result of 
social barriers to treatment, such as the stigma attached to 
replacement therapies (e.g., methadone) that inhibit treatment-
seeking behavior.  For others, current prevention or treatment 
options are ineffective:  drug dependence occurs among 
experimental drug abusers as their drug abuse behaviors escalate, 
or abstinence is short-lived as drug abusers relapse to drug 
abuse.  A key requirement for the development of successful 
prevention or treatment strategies is the characterization of new 
assays, models, tools, and technologies.  Basic behavioral and 
cognitive research may also guide the development of new treatment 
and prevention interventions.  A great deal of basic science 
knowledge exists, but has not yet been fully exploited in 
prevention or treatment strategies.  For example, many science-
based prevention programs have proven efficacious for significant 
numbers of youth, yet more research is needed to elucidate reasons 
why some individuals are non-responsive to such programs. 
Differences in neurocognitive processes may contribute to 
differential ability to process prevention related information, 
and this needs to be explored.

As recent years have seen an explosion of fundamental insights in 
the basic sciences, translating this knowledge into practical 
advances has become a priority for NIDA.  As such, the purpose of 
this announcement is to foster research that furthers the 
translation of existing knowledge into treatment and treatment 
practice, or research that, in and of itself, will readily 
translate to clinical research or practice.  This PA is intended 
to encourage projects that provide tools and resources that serve 
as platforms for the development of effective prevention and 
treatment strategies.  

Collaboration of basic and applied investigators or between 
clinical and health services investigators working towards a 
common goal may produce new perspectives, insights and approaches 
to improving drug abuse prevention and treatment.  Behavioral 
research, for example, 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 a second example, cognitive 
science suggests an influence of higher-order mental processes in 
decision-making expectancies and memories of drug use.  Research 
on neurocognitive processing and decision-making, particularly 
among adolescents and young adults who may be at high risk for 
drug use onset or drug dependency may contribute to the 
development or refinement of intervention material.  Outcomes from 
treatment and basic research also suggest that there may be gender 
differences in responses to interventions that could be examined 
from a neuroscience perspective.  As a third example, health 
services research on technology transfer suggests that there are 
financial, organizational, and management factors that may help to 
explain differences in the rates and processes of uptake (i.e., 
exposure, adoption, implementation, sustained use) of new, 
efficacious drug abuse prevention and treatment technologies among 
community-based programs.  Collaborations between basic and 
applied researchers with diverse fields of interest, or between 
clinical and health services researchers (e.g., health economists, 
industrial/organizational psychologists, public health experts), 
may aid in the development of innovative approaches to drug abuse 
treatment or prevention and to the delivery of services to those 
individuals who need them.  Applications responsive to this PA 
will include such collaborations.

Goals of such projects include, but are not limited to: 

o Laboratory studies with human volunteers that are designed to 
discover whether neurochemical or related mechanisms observed in 
preclinical science can serve as important targets for the 
treatment of drug addiction are needed.  Agents to be tested might 
interact with the primary drug effects (e.g., reinforcement, 
craving, tolerance, withdrawal, etc.) and/or secondary drug 
effects (e.g., conditioned reinforcement, cue-induced craving, 
decision-making, etc.).  Demographic factors, such as gender and 
age, could be examined as moderators of identified effects.  

o Laboratory studies, especially phase I clinical studies, with 
human volunteers that evaluate drugs that are currently being used 
to treat non-addiction disorders, but whose preclinical effects 
indicate possible utility for treating drug abuse are needed.  
Demographic factors, such as gender and age, could be examined as 
moderators of identified effects.  

o Studies that develop and evaluate new assessment or measurement 
tools designed to measure various aspects of the addictive state, 
including initiation, the transition from use to addiction, 
dependency, craving, withdrawal or relapse are needed.  These 
tools will be important for further characterizing this disorder 
and evaluating treatment outcomes.

o Discovery and evaluation of animal models that permit further 
evaluation of candidate therapeutics, such as using animals that 
have been modified genetically, chemically, or through any 
intervention, that captures critical features of drug abuse are 
needed.  This may include individual vulnerability to drugs of 
abuse, development of addiction, withdrawal, or relapse.  

o Research that focuses on non-drug interventions that 
specifically address the role of conditioned reinforcement, 
craving, and relapse, as well as consciousness and higher-order 
mental processes (e.g., decision-making) are needed.  This 
approach is envisioned to go beyond the contingency management and 
cognitive behavioral treatments that have already been translated 
and are currently used in clinical setting.  It is anticipated 
that these types of interventions will be used in combination with 
existing addiction treatments to improve clinical outcomes.  
Demographic factors, such as gender and age, could be examined as 
moderators of identified effects.  

o Studies that 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 are needed.  This is envisioned to 
go beyond cognitive assessments that have already been translated 
and are currently used in clinical setting.  For more extensive 
development of behavioral therapies, please see PA-03-126   
(http://grants.nih.gov/grants/guide/pa-files/PA-03-126.html )

o Development and testing of clinical tools for screening, 
assessment, diagnosis, and treatment matching to improve the 
targeting of treatment services, based on human laboratory studies 
of individual, social, and environmental factors, as well as 
studies of services characteristics.

o Development and testing of innovative prevention and treatment 
services that can be used in a wide variety of non-specialty 
health care settings to address drug abuse using untapped findings 
on cognitive factors such as decision-making, automatic vs. 
controlled thinking, affective mediators and modulators of 
cognition.

o Development of models of longitudinal care—including 
medications, behavioral therapies, social services, and education—
for defined populations, based on clinical research of long-term 
patterns of drug use (e.g., cycles involving experimental use, 
escalation, abuse, dependence, withdrawal, abstinence, relapse) 
and long-term patterns of response to prevention and treatment 
(e.g., time to relapse, triggers for relapse, response to social 
support for abstinence) for these defined populations.

o Studies looking at the utility in the prevention and treatment 
of drug abuse of approaches, technologies and strategies that have 
been developed for other clinical conditions.  For example, 
virtual reality technologies are being used with success for some 
clinical conditions (e.g. phobias, eating disorders), but not for 
drug abuse prevention or treatment.  Research examining how these 
types of treatments might be used to prevent or treat drug abuse 
is sought.    

o Using discoveries from the basic biological (e.g. 
neurobiological), psychological (e.g. emotional, behavioral, 
cognitive, and developmental) and social (e.g. social learning, 
peer network, and communications) sciences for developing and 
testing innovative drug abuse prevention interventions.

o Development and testing of innovative methods for studying 
adolescent decision-making related to drug use and sexual risk 
behaviors that will apply more readily to real world settings.
 
MECHANISMS OF SUPPORT 

This PA will use the National Institutes of Health (NIH) research 
project grant (R01), small grant (R03) (PA-03-108: NIH SMALL RESEARCH 
GRANT PROGRAM (R03)), and exploratory/developmental (R21) (PA-03-107: 
NIH EXPLORATORY/DEVELOPMENTAL RESEARCH GRANT AWARD (R21)) award 
mechanisms.  As an applicant, you will be solely responsible for 
planning, directing, and executing the proposed project.   
Collaborations within and between research institutions are encouraged.  

This PA uses just-in-time concepts.  It also uses the modular budgeting
format (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.  
This program does not require cost sharing as defined in the current 
NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.

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 institutions/organizations
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 your inquiries concerning this PA and welcome the 
opportunity to answer questions from potential applicants.  Inquiries 
may fall into two areas:  scientific/research and financial or grants 
management issues:

o Direct your questions about scientific/research issues to:

Dr. Allison L. Chausmer
Division of Basic Neuroscience and Behavioral Research
National Institute on Drug Abuse, NIH, DHHS
6001 Executive Boulevard, Room 4282, MSC 9555
Bethesda, MD 20892-9555
Rockville, MD  20852 (for express/courier service)
Telephone:   301-402-5088
FAX:   301-594-6043
Email:  achausme@nida.nih.gov

Dr. Jacqueline Stoddard
Tobacco Control Research Branch
National Cancer Institute, NIH, DHHS
6130 Executive Boulevard, Suite 440
Bethesda, Maryland  20892-7337
Rockville, Maryland 20852 (for express/courier service)
Telephone:  301-496-0274
FAX:  301-496-8675
Email:  stoddaja@mail.nih.gov

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

Dr. Gary Fleming
Chief, Grants Management Branch
National Institute on Drug Abuse, NIH, DHHS
6101 Executive Boulevard, Room 270, MSC 8403
Bethesda, Maryland  20892-8403
Rockville, MD 20852  (for express/courier service)
Telephone:  301-443-6710
Fax:  301-594-6849
E-mail:  GF6S@NIH.GOV

Ms. Crystal Wolfrey
Grants Administration Branch
National Cancer Institute, NIH, DHHS
6120 Executive Boulevard, Suite 243
Bethesda, MD  20892-7340
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 496-8634
Fax:  (301) 496-8601
E-mail: crystal.wolfrey@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001). Applications must 
have a Dun and Bradstreet (D&B;) Data Universal Numbering System (DUNS) 
number as the Universal Identifier when applying for Federal grants or 
cooperative agreements. The DUNS number can be obtained by calling 
(866) 705-5711 or through the web site at 
http://www.dunandbradstreet.com/. The DUNS number should be entered on 
line 11 of the face page of the PHS 398 form. 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.

The title and number of this program announcement must be typed on line 
2 of the face page of the application form and the YES box must be 
checked.

APPLICATION RECEIPT DATES: Applications submitted in response to this 
program announcement will be accepted at the standard application 
deadlines, which are available at 
http://grants.nih.gov/grants/dates.htm.  Application deadlines are also 
indicated in the PHS 398 application kit.

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.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER 
YEAR: Applications requesting $500,000 or more in direct costs for any 
year must include a cover letter identifying the NIH staff member 
within one of NIH institutes or centers who has agreed to accept 
assignment of the application.   

Applicants requesting more than $500,000 must carry out the following 
steps:

1) Contact IC program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study; 

2) Obtain agreement from IC staff that IC will accept your application 
for consideration for award; and,
  
3) Identify, in a cover letter sent with the application, the staff 
member in IC who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), 
competing continuation (type 2), competing supplement, or any amended 
or revised version of these grant application types. Additional 
information on this policy is available in the NIH Guide for Grants and 
Contracts, October 19, 2001 at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

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

APPLICATION PROCESSING: Applications must be received by or mailed on 
or before the receipt dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  The CSR 
will not accept any application in response to this PA 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.

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and 
funding assignment within 8 weeks.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  Appropriate scientific review 
groups 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 Undergo a selection 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 Receive a written critique
o Receive a second level review by an 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.  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.   

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The 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.

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

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

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

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

ENVIRONMENT:  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed 
experiments take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements?  Is there 
evidence of institutional support?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the 
following items will be considered in the determination of scientific 
merit and priority score:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of 
human subjects and protections from research risk relating to their 
participation in the proposed research will be assessed. (See criteria 
included in the section on Federal Citations, below) 
http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm.

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals 
are to be used in the project, the five items described under Section f 
of the PHS 398 research grant application instructions (rev. 5/2001) 
will be assessed.  
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 will be assessed.  Plans for the recruitment and 
retention of subjects will also be evaluated. (See Inclusion Criteria 
in the sections on Federal Citations, below).

ADDITIONAL REVIEW CONSIDERATIONS 

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

Sharing Research Data 

Applicants requesting more than $500,000 in direct costs in any year of 
the proposed research are expected to include a data sharing plan in 
their application. The reasonableness of the data sharing plan or the 
rationale for not sharing research data will be assessed by the 
reviewers. However, reviewers will not factor the proposed data sharing 
plan into the determination of scientific merit or priority score.
(http://grants.nih.gov/grants/policy/data_sharing )

AWARD CRITERIA

Applications submitted in response to a PA will compete for available 
funds with all other recommended applications.  The following will be 
considered in making funding decisions:  

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

REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated 
with reference to the risks to the subjects, the adequacy of protection 
against these risks, the potential benefits of the research to the 
subjects and others, and the importance of the knowledge gained or to 
be gained 
http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm.

DATA AND SAFETY MONITORING PLAN:  Data and safety monitoring is 
required for all types of clinical trials, including physiologic, 
toxicity, and dose-finding studies (phase I); efficacy studies (phase 
II), efficacy, effectiveness and comparative trials (phase III). The 
establishment of data and safety monitoring boards (DSMB) is required 
for multi-site clinical trials involving interventions that entail 
potential risk to the participants. (NIH Policy for Data and Safety 
Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

SHARING RESEARCH DATA:  Investigators submitting an NIH application 
seeking $500,000 or more in direct costs in any single year are 
expected to include a plan for data sharing or state why this is not 
possible. http://grants.nih.gov/grants/policy/data_sharing 
Investigators should seek guidance from their institutions, on issues 
related to institutional policies, local IRB rules, as well as local, 
state and Federal laws and regulations, including the Privacy Rule. 
Reviewers will consider the data sharing plan but will not factor the 
plan into the determination of the scientific merit or the priority 
score.

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. 

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 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.

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://stemcells.nih.gov/index.asp 
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, in the project description and elsewhere in the 
application as appropriate, 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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  
The Department of Health and Human Services (DHHS) issued final 
modification to the "Standards for Privacy of Individually Identifiable 
Health Information", the "Privacy Rule," on August 14, 2002.  The 
Privacy Rule is a federal regulation under the Health Insurance 
Portability and Accountability Act (HIPAA) of 1996 that governs the 
protection of individually identifiable health information, and is 
administered and enforced by the DHHS Office for Civil Rights (OCR).  

Decisions about applicability and implementation of the Privacy Rule 
reside with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule,
including a complete Regulation Text and a set of decision tools on "Am 
I a covered entity?"  Information on the impact of the HIPAA Privacy 
Rule on NIH processes involving the review, funding, and progress 
monitoring of grants, cooperative agreements, and research contracts 
can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and 
proposals for NIH funding must be self-contained within specified page 
limitations.  Unless otherwise specified in an NIH solicitation, 
Internet addresses (URLs) should not be used to provide information 
necessary to the review because reviewers are under no obligation to 
view the Internet sites.   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 PA 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)(or other authorizations) 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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

Department of Health and Human Services

National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892