RELEASE DATE:  August 26, 2004

PA Number:  PA-04-152  

December 7, 2006 - The R01 portion of this funding opportunity has been 
replaced by PA-07-112, which now uses the electronic SF424 (R&R) 
application for February 5, 2007 submission dates and beyond.

August 14, 2006 - This PA has been reissued as PA-06-525 (R21) and PA-06-524 (R03).

March 2, 2006 (NOT-OD-06-046) – Effective with the June 1, 2006 submission date, 
all R03, R21, R33 and R34 applications must be submitted through using 
the electronic SF424 (R&R) application. This announcement will stay active for 
only the May 1, 2006 AIDS and AIDS-related application submission date for these 
mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms 
expires on the date indicated below. Other mechanisms relating to this announcement 
will continue to be accepted using paper PHS 398 applications until the stated 
expiration date below, or transition to electronic application submission. Parent 
R03 (PA-06-180) and R21 (PA-06-181) funding opportunity announcements have been 
issued for the submission date of June 1, 2006 and submission dates for AIDS and 
non-AIDS applications thereafter. Applications relating to R33 and R34 activities 
must be in response to NIH Institute/Center (IC)-specific announcements.

EXPIRATION DATE for R03 and R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R03 and R21 AIDS and AIDS-Related Applications: May 2, 2006 
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007

Department of Health and Human Services (DHHS)

National Institutes of Health (NIH) 

National Institute on Drug Abuse (NIDA) 



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 Supplementary Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations


The purpose of this PA is to provide an optimally comprehensive, strategic, 
and balanced MDMA (3,4-methylenedioxymethamphetamine) research program, given 
the upsurge in MDMA abuse worldwide, including its abuse outside the rave 
scene.  Although researchers have made great strides in characterizing MDMA’s 
neural mechanisms and neurotoxicity, it is necessary now to focus on specific 
areas of MDMA research, across all research disciplines, urgently needing our 

For the purpose of this PA, the term “MDMA” is defined as 3,4-
methylenedioxymethamphetamine and its very close structural analogues, such 
as p-methoxyamphetamine (PMA), p-methoxymethamphetamine (PMMA), and 3,4-
methylenedioxy-N-ethyl-amphetamine (MDEA), insofar as they share specific 
subjective, discriminative stimulus, or toxicological properties with 3,4-
methylenedioxymethamphetamine; however, methamphetamine and other 
amphetamines that are characterized by neurotoxic effects on central 
dopaminergic systems in experimental animals are not included in this 
definition.  “Ecstasy” is defined as a preparation (usually a tablet) 
supposed by its users to contain MDMA.  


This PA is designed to increase the scope of NIDA’s MDMA research portfolio.  
Clinical and preclinical research is needed.  Research on racially and 
ethnically diverse populations in various social and cultural settings is 
encouraged.  Studies with adolescent subjects are especially encouraged.  
When appropriate, research should include males and females, address gender 
issues, contain sex/gender-based hypotheses, and perform a sex/gender 
analysis of the data.  

Epidemiology and Prevention:

Despite a decrease in MDMA use in 2002 and 2003, MDMA remains a prominent 
drug of abuse among youth.  In addition, (a) MDMA users often combine it, or 
use it in sequence with, other drugs, (b) emergency department mentions 
continue to raise cause for concern, (c) MDMA-related deaths have been 
reported, and (d) MDMA use has expanded beyond the context of rave/dance 
clubs to a broad range of settings and populations.  Furthermore, despite 
scientific evidence of short- and long-term deleterious consequences, such as 
effects on learning and memory, there appears to be a perception of MDMA as a 
benign or harmless drug.  Epidemiologic and prevention research is needed to 
better characterize and understand the extent and patterns of MDMA use, and 
to develop effective population-appropriate interventions to prevent the 
initiation or continuation of MDMA use.  Applications to test the 
effectiveness of interventions for the prevention of MDMA use are of great 
interest, including interventions that target youth and young adults.  These 
prevention interventions can take place in a variety of contexts (e.g., 
school, community, peer networks, clubs, Internet, concerts, etc.).
Examples of research that are encouraged by this PA are given below, and are 
not meant to be exclusive:

o Identify risk and protective factors for MDMA use in different populations.  
Examine the relevance of existing theories regarding drug abuse initiation 
and progression for youth and the use of MDMA.

o Identify the health, social and behavioral consequences experienced by MDMA 
users in different populations.  Determine whether MDMA can produce 
psychopathological deficits.  For example, is there a correlation between 
MDMA use and major depression or suicide?  Determine MDMA users’ perceptions 
of their need for treatment for problems they attribute to MDMA use.  To what 
extent do users perceive that use of MDMA has negative effects or impairs 
their lives (e.g., affects school or work attendance or performance)?  What 
are users’ perceptions regarding the addictive potential of MDMA?

o Examine how MDMA is used in combination or in sequence with other drugs, 
and for what reasons, in different populations.

o Analyze what substances drug dealers are representing as “ecstasy,” and how 
these substances relate to adverse consequences.

o Assess whether and how user expectations and factors in the social 
environment, i.e., the setting, the physical availability of the drug, and 
social norms regarding its use, influence the effects experienced by users. 

o Investigate MDMA-related knowledge, perceptions, attitudes and norms among 
MDMA users and non-users in different populations.  Determine sources of 
information about MDMA, and the effects and consequences of this information, 
and explore reasons for use and non-use of MDMA.

o Examine the roles of youth social networks and the Internet in the 
transmission and dissemination of information and misinformation about 
benefits, risks, effects, and consequences of MDMA use and MDMA use in 
combination with other drugs.  Assess how information is evaluated and 
utilized with respect to decisions pertaining to MDMA use and associated 

o Examine how and to what extent MDMA users undertake behaviors and 
activities in an effort to reduce consequences.  For example, within specific 
study populations (e.g., circuit party attendees, inner-city youth), what is 
the perception of availability of kits or services for testing “ecstasy,” and 
what proportion of users utilize these kits/services?  Are there drugs that 
are used specifically to counteract perceived negative consequences of MDMA 
use?  For example, what proportion of MDMA users takes selective serotonin 
reuptake inhibitor (SSRI) antidepressants as an attempt to decrease MDMA 
neurotoxicity or alleviate post-MDMA depression?

o Characterize the role and influence of the Internet on patterns and trends 
of MDMA abuse.

o Test the effectiveness of universal MDMA prevention interventions focused 
on entire populations (e.g., school and college-based programs, PSA media 
messages for youth, primary care intervention modules).

o Test selective interventions (e.g., peer-driven network approaches) focused 
on at-risk populations that may include individuals with other drug use 
experience, proximity to club drug use locations, or involvement with peers 
using MDMA.

o Implement and evaluate indicated interventions focused on individuals who 
have initiated MDMA use and/or alterations in the environment of MDMA use 
(e.g., intervention modules for the club scene; media approaches, especially 
through the Internet; emergency room interventions; peer-driven network 

HIV/AIDS and Other Medical Consequences:

o Conduct studies to understand HIV transmission and progression in MDMA 
users vs. non-MDMA users.  Are there differences between MDMA users and non-
users relative to behavioral risks for HIV and other infectious diseases?  
For example, do the pharmacological effects of MDMA (intoxication; feelings 
of empathy, self-confidence, and heightened perception) influence the 
likelihood of other risk behaviors, such as risky sex and use of other drugs 
and alcohol?

o Compare MDMA users and non-users to determine if, how, and to what extent 
the persisting effects of MDMA on the brain and behavior may influence 
potential neurotoxic and mental complications of HIV/AIDS.

o Characterize long-term differences in dental complications among MDMA users 
and non-users.

o Design and conduct case-control studies to compare the health and 
behavioral outcomes of infants and children of MDMA users and non-users, to 
examine how the lifestyles of MDMA users may affect the health of their 
offspring, and to characterize the extent and severity of anomalies among 
infants exposed to MDMA vs. those not exposed to MDMA.

Preclinical and Basic Clinical:

o Determine the extent to which, and the conditions under which, MDMA is 
reinforcing and addicting.  Studies employing choice procedures to examine 
relative reinforcement in comparison with other drugs of abuse or natural 
reinforcers are especially of interest.  Also of interest are long-term 
studies on changes in reinforcing efficacy of MDMA over repeated 
administration, including the neurobiological substrate changes responsible 
for these effects.

o Identify the behavioral, cognitive, psychological or biological risk 
factors contributing to MDMA abuse, addiction, acute toxicity, and persistent 
effects of MDMA.  For example, does a baseline of low serotonergic activity 
in the brain increase the vulnerability to abuse MDMA?  Does a history of 
mood disorder increase the likelihood or severity of persisting MDMA-induced 
depression?  Do physical or psychosocial stressors enhance the neurotoxicity 
of MDMA?  Are there gender differences in vulnerability to the effects of 
MDMA?  Is adolescence a risk factor?

o Characterize acute and chronic drug-drug interactions between MDMA and (a) 
drugs intentionally co-abused with MDMA, (b) substances other than MDMA in 
“ecstasy” tablets (or other “ecstasy” preparations), (c) selective serotonin 
reuptake inhibitors (SSRI’s) and other antidepressants.  Users of MDMA often 
take SSRI antidepressants in an attempt to prevent neurotoxicity and post-
MDMA depression; however, the interactions of SSRI’s and other 
antidepressants with MDMA have not been adequately characterized.  Examples 
of drugs in categories (a) and/or (b) include LSD, dextromethorphan, 
methamphetamine, PMA, ephedrine, cannabis, and ketamine.

o Characterize the acute and chronic cardiovascular and cerebrovascular 
effects of MDMA.

o Characterize the recovery from MDMA-induced neural damage over long 
durations, under various conditions (e.g., normal aging, stress, other 
ongoing pathology).

o Determine the consequences of chronic MDMA ingestion on pain perception.

o Determine which dosage parameters (e.g., cumulative lifetime dose, duration 
of MDMA abuse, peak plasma levels achieved, time since last dose, or 
frequency of use) contribute to the neurotoxicity of MDMA.

o Determine how different populations of glial cells react to the relatively 
specific neural injury induced by MDMA.

o Measure the persistent consequences of prenatal and neonatal exposure to 
MDMA, especially the effects of MDMA exposure during very early stages of 
brain development.  Determine the mechanism of action of MDMA in producing 
any such effects.  Measure the spontaneous recovery from MDMA-induced 
developmental deficits, as well as the effects of behavioral and 
environmental treatment interventions.  Characterize the pharmacokinetics of 
MDMA in the mother and fetus during early development.

o Determine the pharmacology and toxicology of metabolites of MDMA.

o Using animal models of long-term cognitive, emotional, sleep, sexual, 
neuroendocrine, and immunological consequences of MDMA abuse, determine the 
causes of these functional changes (e.g., are the functional deficits due to 
serotonin terminal loss?), examine possible treatments to restore function, 
and study the modifying effects of other drugs of abuse.

o Examine MDMA effects in animal behavioral models that mimic social 
situations of human abuse, and that are sensitive to the functional 
consequences of acute and repeated drug administration.

Basic Clinical:

o Assess the influence of alternate routes (i.e., other than oral) of MDMA 
administration – rectal, snorting, smoking, or injection – on the effects of 

o Develop more sensitive and specific methods for detecting serotonergic 
neurotoxicity in living humans, as well as methods that better define its 
functional consequences.

o Perform well-controlled post-mortem studies in MDMA users in order to 
quantitatively assess serotonergic and other neurotoxicity.

o Determine whether continued MDMA use causes progressive psychological or 
neurological impairments over time.  While scientific evidence has been 
obtained that MDMA can injure many of the brain’s serotonergic neurons, and 
that there are at least subtle (sub-clinical), persisting functional 
consequences associated with this neurotoxicity, it is not known whether more 
severe, pathological cognitive, psychological, and other functional (e.g., 
behavioral, sleep, temperature regulation, neuroendocrine, sexual function) 
deficits occur in some individuals, or whether the likelihood of more severe 
deficits changes with normal aging or other factors (e.g., stress, pre-
existing psychopathology).

o Determine whether MDMA intoxication, combined with various environmental 
stimuli, affects performance related to driving, operating machinery, etc.

o Determine the causes, characteristics, and consequences of post-MDMA 
negative moods (termed “midweek blues” and “terrible Tuesdays”).  For 
example, besides mood, what additional deficits (e.g., in cognition or sleep) 
occur in this post-acute interval, and are there individual or gender 
differences in vulnerability to this effect?  Do these effects worsen or 
abate with repeated MDMA use?

Treatment-Related Studies:

o Assess the degree to which there is a need for treatment of MDMA addiction 
or other persisting MDMA-induced deficits, such as learning and memory 
deficits.  Studies of treatment readiness in MDMA users are lacking.

o Develop and evaluate medical screening and assessment instruments for MDMA 
abuse and its consequences that clinicians can use in a variety of clinical 
settings, including  primary care, where MDMA users (typically adolescents 
and young adults) may normally be seen (perhaps because of the MDMA abusers' 
concerns regarding their MDMA abuse consequences).

o Assess spontaneous recovery from MDMA effects, during abstinence, in 

o Measure the benefits and risks of pharmacological treatments for persisting 
MDMA effects in humans.

o Using animal models, determine the effects of various experimental 
treatments on persisting effects of MDMA.

o Assess the degree to which people in treatment for other drugs of abuse use 

o Develop and evaluate new behavioral treatments, or adapt existing 
behavioral treatments that have shown efficacy in populations that abuse 
other drugs, for MDMA abuse (for detailed information, see the NIDA 
Behavioral Therapies Development Program Announcement, PA-03-066).

o Evaluate and develop pharmacotherapies or other types of therapies for 
reversal of acute MDMA intoxication or for prevention of  long-term 
neurotoxic effects of MDMA.

o Investigate possible gender, individual, or cultural differences (i.e., 
mediators or moderators) in treatment responses of MDMA abusers.

o Examine the unmet need for treatment services to address MDMA abuse, the 
barriers to the provision and receipt of treatment for MDMA abuse, and 
strategies for improving access to and utilization of treatment services by 
MDMA abusers.


This PA will use the NIH research grant (R01), small grant (R03)(PA-03-108: 
NIH SMALL RESEARCH GRANT PROGRAM (R03), and exploratory/developmental grant 
award mechanisms.  As an applicant, you will be solely responsible for 
planning, directing, and executing the proposed project.
This PA uses just-in-time concepts.  It also uses the modular budgeting 
format (see  
Specifically, if you are submitting an application with direct costs in each 
year of $250,000 or less, use the modular budget format.  This program does 
not require cost sharing as defined in the current NIH Grants Policy 
Statement at  


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 

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.


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:

Jerry Frankenheim, Ph.D.
Division of Basic Neuroscience and Behavioral Research (DBNBR)
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:  301-435-1312
Fax: 301-594-6043

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

Gary Fleming, J.D.
Chief, Grants Management Branch
National Institute on Drug Abuse
6101 Executive Boulevard, Room 270, MSC 8403
Bethesda, MD  20892-9605
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-6710
FAX:  (301) 594-6849


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 D&B number can be obtained by calling (866) 705-5711 or 
through the web site at The D&B number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 
398 is available at 
in an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 710-0267, Email:

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  Application 
deadlines are also indicated in the PHS 398 application kit.

requesting up to $250,000 per year in direct costs must be submitted in a 
modular budget grant format.  The modular budget 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 
includes step-by-step guidance for preparing modular grants.  Additional 
information on modular grants is available at

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 $500,000 or more 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 the IC will accept your         
application for consideration for award; and,
3) Identify, in a cover letter sent with the application, the staff member       
in the 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 

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 mailed on or before the receipt 
dates described at  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 unfunded version 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.


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 
( 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.


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 evaluate 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 the following criteria in assigning 
the application’s overall score, weighting them as appropriate for each 

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, an investigator may propose to carry out important work 
that by its nature is not innovative but is essential to move a field 

SIGNIFICANCE: Does this study address an important problem? If the aims of 
the 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 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 the 
priority score:

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).

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).

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.  


Sharing Research Data 

Applicants requesting $500,000 or more 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. 

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


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


ANIMAL WELFARE PROTECTION:  Recipients of PHS support for activities 
involving live, vertebrate animals must comply with PHS Policy on Humane Care 
and Use of Laboratory Animals 
(, as 
mandated by the Health Research Extension Act of 1985 
(, and the USDA 
Animal Welfare Regulations 
(, as applicable.

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.

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 (DSMBs) 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:  

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. 
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.

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 "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 
a complete copy of the updated Guidelines are available at  
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 

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 

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 

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

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research 
on hESCs can be found at and at  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see   
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 

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

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 under the Funding, or may be obtained by 
calling (301) 443-2755.

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

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.

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 
( 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

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

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at

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

Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS) - Government Made Easy

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