MEDICATIONS DEVELOPMENT FOR CANNABIS-RELATED DISORDER

RELEASE DATE:  December 1, 2003

RFA NUMBER:  RFA-DA-04-014 - (Reissued as RFA-DA-09-001)

Department of Health and Human Services (DHHS)

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

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

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:  93.279

LETTER OF INTENT RECEIPT DATE:        February 20, 2004
APPLICATION RECEIPT DATE:             March 23, 2004  

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 seeking grant 
applications focusing on the identification, evaluation and development 
of safe and effective pharmacological treatments for cannabis-related 
disorders (CRDs), such as cannabis abuse or dependence, and cannabis-
induced disorders (e.g., intoxication, delirium, psychotic disorder, 
and anxiety disorder), and their comorbidity with other medical and 
psychiatric disorders (e.g., depression), with special interest in the 
treatment of children and adolescents. Cannabis use includes marijuana, 
hashish, and other tetrahydrocannabinol (THC) containing substances. 

This RFA will support clinical trials to test potential medications in 
humans, and the preclinical development of new chemical entities (NCEs) 
for advancement to the clinical development stage.  Applications may 
focus on the pharmacotherapy of cannabis abuse and they may target one 
or various CRDs or clinical manifestations of the disorders.  For 
example, research may focus on marijuana dependence or specifically on 
marijuana withdrawal.  Clinical applications may include human 
laboratory studies to develop models for testing medications targeting 
single or multiple manifestations of the CRDs, and the interaction of 
cannabinoids with other medications, pharmacokinetic and/or 
pharmacodynamic studies of potentially therapeutic compounds.  
Preclinical applications may include pharmacological studies on NCEs 
leading to the identification of candidates for advanced preclinical or 
phase I/II IND covered clinical evaluation as potential 
pharmacotherapies for CRDs.

RESEARCH OBJECTIVES

Background

The treatment of CRDs is an issue of great public health concern.  
Currently, marijuana is the most commonly used illicit drug in the 
United States with recent estimates from SAMSHA of 14.6 million users 
in the past month, with particularly heavy use occurring in adolescent 
populations (over 20% of all high school seniors).  Approximately 2.4 
million people use marijuana for the first time every year and two 
thirds of them are between 12 and 17 years of age. In addition, of the 
3.5 million people who met criteria for past-year cannabis abuse or 
dependence in 2001, more than two thirds were between the ages of 12 
and 25 years.  An estimated 852,000 individuals reported marijuana as 
the specific substance for which they received their last or current 
treatment among persons who received treatments in the past year and 
approximately one half of those individuals were 25 years old or 
younger.  

Sufficient research has been carried out to confirm that the use of 
cannabis can produce serious physical and psychological consequences.  
The consequences of cannabis use may be due to the acute effects of the 
drug or due to the chronic exposure that may ultimately produce abuse 
or dependence.  The use of a large amount in a short period of time may 
induce hallucinations, delirium, and other perceptual manifestations 
compatible with a psychotic episode.  Chronic users of cannabis may 
experience difficulty in stopping or controlling drug use, develop 
tolerance to the subjective and cardiovascular effects, and eventually 
present withdrawal symptoms after sudden discontinuation of use. 

Long-term heavy use may also produce cognitive changes that affect 
memory and learning and, in predisposed individuals, induce psychosis 
and other perceptual phenomena, anxiety, depression and suicidal 
ideation.  In young people, cannabis use additionally seems to affect 
the normal development of adolescence, and is associated with poor 
school performance, early problems with the law, and the use of other 
drugs and alcohol. 

Among the medical problems, cannabis use has been associated with 
cardio-respiratory problems, such as aggravation of asthma, bronchitis, 
emphysema, hypertension and arrhythmias, and increased risk of sexually 
transmitted diseases. 

Given the extent of the use of cannabis in the general population and 
the medical and psychological consequences of its use, particularly the 
clinically significant psychosocial impairment, there is a great public 
health need to develop safe and effective therapeutic interventions. 
The need to develop treatments targeting adolescents and young adults 
is particularly relevant in view of their disproportionate use 
patterns. 

Unfortunately, there is currently no effective pharmacological 
treatment for CRDs and there is very limited research focused on the 
identification and development of medications to treat these disorders.  
Drug abuse treatment research as a whole has rarely focused on the 
treatment of CRDs.  One indicator is the fact that there are no 
published randomized controlled clinical trials to evaluate 
pharmacotherapies for CRD as the primary outcome.  

There are multiple reasons why it is timely to develop medications to 
treat CRDs.  First, there are newly marketed medications available 
whose mechanisms of actions may have potential therapeutic effects on 
the clinical manifestations of CRD.  Second, the recent discovery of an 
endogenous cannabinoid system with specific receptors and endogenous 
ligands, the availability of genetically engineered knockout mice that 
lack functional cannabinoid receptors to study genetic predispositions 
to the effects of cannabinoids, and the subsequent development of 
reliable preclinical models to study the rewarding and dependence-
producing effects of THC, all provide understanding of the basic 
therapeutic mechanisms. Lastly, there is the discovery and development 
of new chemical entities, some of them already being investigated at 
the clinical level, which target the cannabinoid system and have the 
potential for therapeutic benefit. All these factors are setting the 
stage for the development of medications to treat CRDs. 

Objectives and Scope

The goal of this RFA is to develop safe and effective medications for 
the treatment of CRDs.  Studies may focus on the treatment of 
marijuana, hashish or other cannabis derivatives. Medications studied 
under this RFA may aim to treat cannabis-use disorders, such as abuse 
and dependence, or cannabis-induced disorders, such as intoxication, 
delirium, psychosis, and anxiety.  They may also focus on the specific 
symptoms of the disorder such as withdrawal, craving or relapse, 
complications such as cognitive impairment, sleep disorders/disruption 
of normal rhythms or the clinical surrogates of their use such as 
depression and other mood disorders. 

Research topics of interest include but are not limited to: 

o   Development and testing of human laboratory models to evaluate the 
effects of medications on cannabinoid drug discrimination, conditioned 
place preference or aversion, self-administration, reward, tolerance, 
sensitization, craving, withdrawal, and physiological dependence. 

o   Human laboratory evaluation of medications that may affect the 
pathophysiological correlates of cannabis-use disorders such as self-
administration, reward, tolerance, withdrawal, craving, and 
physiological dependence. 

o   Design and implementation of FDA defined Phase I clinical trials to 
assess the medical safety and tolerability of medications when 
treating patients with CRDs. 

o   Interaction studies focused on the effects of medications to treat 
CRDs and the concurrent use of cannabis derivatives, including 
pharmacokinetic and/or pharmacodynamic studies.

o   Testing medications that may affect the interaction between 
cannabinoid, opioid and dopamine systems, and which may have 
therapeutic effect not only for CRDs but also for other medical 
conditions such as pain and other drug dependencies. 

o   Exploratory/developmental pilot studies to evaluate the preliminary 
efficacy of medications to treat single or multiple clinical 
manifestations of CRDs.

o   Randomized clinical trials, defined by FDA as Phase II, to evaluate 
the efficacy of new or already marketed medication for the treatment 
of single or multiple CRDs, or any of their clinical manifestations. 
For example, studies may focus on the treatment of marijuana 
dependence or marijuana withdrawal. 

o   Development of medications to block withdrawal symptoms. 

o   Studies focusing on the treatment of comorbid psychiatric conditions 
that may negatively affect the outcome of the disorders or their 
treatment. For example, studies may focus on treating the clinical 
depression associated with the use of cannabis. 

o   Studies focusing on interactions of medications developed for CRDs 
with those treating comorbid mental disorders.

o   Brain imaging studies to determine the effects of treatments on brain 
processes and to determine surrogate markers of treatment efficacy.

o   Clinical studies aimed at preventing or reducing the medical 
consequences of cannabis use, including HIV and other infections. 

o   Pharmacological testing of potential medications which would act as 
full agonists, partial agonists, or antagonists (or prodrugs whose 
metabolism would result in such desired activity).

o   Identification and testing of potential medications which would 
produce one or more of the following effects in pharmacological 
studies: a relatively long duration of action; mild reinforcement when 
compared to cannabinoids; and/or blockade of cannabinoid’s effects in 
behavioral assays and on cognitive, spatial/motor and/or 
learning/memory functions.

o   Design and synthesis of novel radioligands targeting the cannabinoid 
receptors for use as tools to study both the neurobiology of ligand-
receptor interaction as well as targets for treatments.

The rationale for choosing the medication(s) to be investigated can be 
based on a top-down approach, a bottom-up approach, or both approaches 
combined. The top-down approach would be the testing of marketed 
medications that are available for other indications and which may be 
promising candidates for the treatment of CRDs. For example, an FDA 
approved antidepressant may be chosen as a target medication. The 
bottom-up approach involves the identification and testing of new 
chemical entities that, because of their chemical characteristics and 
mechanism of action, could be candidates to be developed specifically 
for CRDs. 

The testing of combinations of medications is within the scope of this 
RFA. Medications may target one or more neurochemical mechanisms 
implicated in the physiopathology of CRDs by direct or indirect 
modulation of the systems, or by producing synergistic or antagonist 
effects.  

The treatment of CRDs usually requires a multidisciplinary approach, 
including behavioral treatment strategies. Therefore, it is expected 
that the medication treatment studies proposed under this RFA should 
have a behavioral intervention platform or propose the concurrent 
evaluation of medications and behavioral interventions in a 2X2 design. 

MECHANISM OF SUPPORT

This RFA will use the NIH research project (R01), the small grant (R03) 
and the exploratory/development (R21) 
(http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html) award 
mechanisms.  As an applicant you will be solely responsible for 
planning, directing, and executing the proposed project.  This RFA is a 
one-time solicitation.  Future unsolicited, competing-continuation 
applications based on this project will compete with all investigator-
initiated applications and will be reviewed according to the customary 
peer review procedures.  The anticipated award date is September 30, 
2004.  Applications that are not funded in the competition described in 
this RFA may be resubmitted as NEW investigator-initiated applications 
using the standard receipt dates for NEW applications described in the 
instructions to the PHS 398 application.

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

FUNDS AVAILABLE

NIDA intends to commit approximately $3 million in FY 2004 to fund 4-7 
new and/or competitive continuation grants in response to this RFA.  An 
applicant may request for the R01 a project period of up to 5 years and 
up to $400,000 in direct costs per year.  For the R03, the project 
period is 2 years and direct costs up to $50,000 for each of those 
years.  For the R21, the project period is 2 years and up to $275,000 
in direct costs for the two-year period.  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. 

The size of individual awards will vary as a function of the nature and 
scope of the research proposed.  It is anticipated that the upper limit 
of each award will be $400,000 in direct costs, and applications over 
this amount will not be accepted for review. Budget requests should be 
carefully justified and commensurate with the complexity of the 
project.

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 inquiries concerning this RFA and welcome the opportunity 
to answer questions from potential applicants. Inquiries may fall into 
three categories: Scientific/research, peer review, and financial or 
grant management issues:

o Direct your questions about scientific/research issues to:

Iv n D. Montoya, M.D., M.P.H.
Division of Treatment Research and Development
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4143, MSC 9551
Bethesda, MD  20892-9551
Phone: (301) 443-8639
Fax: (301) 443-2599
Email: [email protected]

o Direct your questions about peer review issues to:

Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Room 220, MSC 8401
Bethesda, MD  20892-8401
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  [email protected]

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

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Room 242, MSC 8403
Bethesda, MD  20892-8403
Telephone:  (301) 443-6710
FAX:  (301) 594-6847
Email:  [email protected]

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 Name of other key personnel
o Participating institutions
o Number and title of this RFA

Although a letter of intent is not required, is not binding, and does 
not enter into the review of a subsequent application, the information 
that it contains allows NIDA staff to estimate the potential review 
workload and plan the review. 

The letter of intent is to be sent by the date listed at the beginning 
of this document. The letter should be sent to:

Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Room 220, MSC 8401
Bethesda, MD  20892-8401
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  [email protected]

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 document 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: [email protected].

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

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 
5/2001) application form must be affixed to the bottom of the face page 
of the application.  Type the RFA number on the label.  Failure to use 
this label could result in delayed processing of the application such 
that it may not reach the review committee in time for review.  In 
addition, the RFA title and number must be typed on line 2 of the face 
page of the application form and the YES box must be marked. The RFA 
label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten 
original of the application, including the Checklist, and three signed, 
photocopies, in one package to:
 
Center For Scientific Review
National Institutes Of Health/DHHS
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application and 
all copies of the appendix material must be sent to:

Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD  20892-8401
Rockville, MD  20852 (for express/courier service)

APPLICATION PROCESSING: Applications must be received on or before 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.

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and 
funding assignments within 8 weeks.
 
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.  However, when a previously unfounded application, 
originally submitted as an investigator-initiated application, is to be 
submitted in response to an RFA, it is to be prepared as a NEW 
application.  That is, the application for the RFA must not include an 
Introduction describing the changes and improvements made, and the text 
must not be marked to indicate the changes from the previous unfunded 
version of the application.  

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by NIDA.  Incomplete and/or nonresponsive 
applications will not be reviewed. 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 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 written critique
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 evaluate the 
application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals. For the 
regular project applications (R01) 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 
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, an investigator may propose to carry out 
important work that by its nature is not innovative but is essential to 
move a field forward.

(1) SIGNIFICANCE:  Please assess the extent to which the study aims are 
consistent with the goals of the RFA.  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?  

(2) 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?

(3) 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?

(4) 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)?

(5) 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:  

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).

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.  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.

The R03 and R21 applications will be evaluated based on the review 
criteria specified in the respective R03 and R21 announcement. The 
applicants should read the appropriate announcement before preparing 
the application. They can be found at the following web addresses:
http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html and 
http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html, 
respectively.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:     February 20, 2004 
Application Receipt Date:          March 23, 2004
Peer Review Date:                  June/July 2004
Council Review:                    September 2004
Earliest Anticipated Start Date:   September 30, 2004

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 

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://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.

DATA SAFETY AND 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 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://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). 
Those who must comply with the Privacy Rule (classified under the Rule 
as  covered entities ) must do so by April 14, 2003 (with the exception 
of small health plans which have an extra year to comply).  

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.

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 
http://www.nida.nih.gov under the Funding, or may be obtained by calling 
(301) 443-2755.

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 at http://www.cfda.gov/ 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 http://grants.nih.gov/grants/policy/policy.htm.

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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