COLLABORATIVE CLINICAL TRIALS IN DRUG ABUSE

RELEASE DATE:  March 9, 2004

PA NUMBER:  PAR-04-073 February 23, 2007  - This PA has been reissued as (PAR-07-232).
 
EXPIRATION DATE:  October 14, 2006

January 3, 2007 - Effective with the February 5, 2007 submission date, 
all R01 applications must be submitted through Grants.gov using 
the electronic SF424 (R&R) application. Accordingly, the R01 portion 
of this funding opportunity expired on October 14, 2006.  Unsolicited 
or investigator-initiated R01 electronic SF424 (R&R) applications may 
be submitted through the Research Project Grant (Parent R01) announcement.

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

APPLICATION RECEIPT DATES: 
June 16, 2004; October 13, 2004; February 16, 2005
June 16, 2005; October 13, 2005; February 16, 2006
June 16, 2006; October 13, 2006; February 16, 2007

THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION:
 
o Purpose of the PA
o Research Objectives
o Mechanism of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
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

This is a reissuance of PAR-01-039, Collaborative Clinical Studies in 
Drug Abuse, published in the NIH Guide for Contracts and Grants, 
January 2, 2001 at http://grants.nih.gov/grants/guide/pa-files/PAR-01-039.html.
This new announcement replaces PAR-01-039 in its entirety.

The National Institute on Drug Abuse (NIDA) seeks to increase the 
collaboration of investigators at different sites in order to address 
critical issues in the treatment of substance-related disorders that 
require sample sizes greater than a single site can reasonably attain.  
The expectation for the collaborative effort is that there will be 
implementation of common clinical trials across different sites in 
order to study patient outcomes, patient factors, provider factors, 
setting characteristics, interactions of these, or other effects where 
pooled samples are appropriate and necessary for the hypotheses under 
consideration.

This announcement provides guidelines for the development, review, and 
funding of Collaborative Clinical Trials in Drug Abuse (CCTDA) 
projects.

RESEARCH OBJECTIVES

In order to draw valid conclusions from clinical trials of substance-
related disorders, in many cases a large sample size is needed, which 
frequently can only be obtained through collaboration across multiple 
study sites.  For some research questions, such as clinical trials of 
relatively infrequent behaviors, the required sample size effectively 
prohibits a single site from being able to recruit sufficient numbers. 
In other circumstances, even where the main hypotheses can be addressed 
with the sample available, interesting hypotheses about subpopulations 
(based on gender, ethnicity, drug use patterns, age, etc.), interaction 
effects, or ancillary questions (e.g., such as about therapist 
characteristics, patient matching to treatment, unexpected outcomes, 
etc.) can only be examined by studying large samples of subjects. 

Collaborative clinical trials allow multiple investigators to initiate 
and submit separate applications, each with a separate PI and applicant 
institution, that propose timely recruitment of an aggregate sample 
sufficient to address clinical concerns.  By allowing multiple sites to 
recruit, a sample that otherwise could not be recruited, or could not 
be recruited within a reasonable time frame, can be enrolled.  CCTDA 
seems ideally suited to foster the efficiency and creativity that can 
be obtained through investigator initiated research and, at the same 
time, allows multiple investigators to coordinate a focus on a 
particular clinical issue relevant to drug abuse.  

Examples of possible foci for a CCTDA are:

o Pharmacological treatments that may include new or already-marketed 
medications.  

o Large-scale clinical trials of psychopharmacological treatments, 
alone or in combination with behavioral therapies. 

o Clinical trials for relatively low prevalence conditions in drug 
abusing populations or conditions for which it is difficult to recruit 
subjects.

o Clinical trials involving neuroimaging studies of treatment effects 
that require multiple sites in order to study sufficient numbers of 
subjects of interest.

o Clinical trials powered to draw conclusions about the impact of 
interventions associated with gender; racial, ethnic, or linguistic 
group; sexual orientation; age; or other developmental variables.

o Clinical trials of other clinical issues in drug abuse (e.g., 
HIV/AIDS and other infectious diseases) that require multiple sites to 
ensure a sufficiently large sample to answer the question posed.

MECHANISM OF SUPPORT

This PA will use the NIH R01 award mechanism; no other mechanisms may 
be used.  The applicant will be solely responsible for planning, 
directing, and executing the proposed project. The total project period 
for an application submitted in response to this PA may not exceed 5 
years.

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 budget format.  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.  

ELIGIBILE 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 and foreign institutions/organizations 
 
The CCTDA requires more than one applicant organization, and each 
applicant organization must meet the eligibility requirements above.  
Multiple campuses of a single institution or university system are 
considered separate organizations for the purposes of eligibility to 
apply. 

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.   

SPECIAL REQUIREMENTS

One of the sites should be the coordinating site for the trial. The 
application for the coordinating site should explicitly state how it is 
going to fulfill its function and its interaction with the other sites. 
Similarly, the participating sites should describe their relationship 
with the coordinating site. Although a foreign institution may be a 
participating site, the coordinating site must be a domestic 
institution.

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 three areas:  scientific/research, peer review, and 
financial or grants management issues:

o Direct your questions about scientific/research issues to:

Ivan D. Montoya, M.D., M.P.H.
Division of Treatment Research and Development
National Institute on Drug Abuse
National Institutes of Health/DHHS
6001 Executive Boulevard, Room 4123, MSC 9551
Bethesda, MD  20892-9551
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-8639
Email:  imontoya@mail.nih.gov

o Direct your questions about peer review to:  

Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse
National Institutes of Health/DHHS
6101 Executive Boulevard, Room 220,  MSC 8401
Bethesda, MD  20892-9547
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-2755
Email:  tl25u@nih.gov

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

Gary Fleming, J.D., M.A.
Grants Management Branch
Office of Planning and Resource Management
National Institute on Drug Abuse
National Institutes of Health/DHHS
6101 Executive Boulevard, Room 242, MSC 8403
Bethesda, MD  20892-9541
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-6710
Email: gf6s@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: All applications (Type 1 and Type 2 or 
amended) submitted in response to this program announcement will be 
accepted at:  June 16, 2004; October 13, 2004; February 16, 2005; June 
16, 2005; October 13, 2005; February 16, 2006; June 16, 2006; October 
13, 2006 and February 16, 2007.  AIDS applications must comply with the 
standard AIDS receipt dates; the last AIDS receipt date for this PA 
will May 1, 2007.

Separate applications must be prepared by each applicant institution.  
Because the CCTDA is expected to address questions that are not 
addressable in single site clinical trials, competing continuation of 
single site clinical trials would not be appropriate.  

SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: 
Applications 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 
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 the 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 the 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 at 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 
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: All applications (Type 1 and Type 2, or 
amended) must be bundled together and mailed on or before the receipt 
dates of June 16, 2004; October 13, 2004; February 16, 2005; June 16, 
2005; October 13, 2005; February 16, 2006; June 16, 2006; October 13, 
2006 and February 16, 2007. AIDS applications must comply with the 
standard AIDS receipt dates; the last AIDS receipt date for this PA 
will be May 1, 2007.  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.

The application must be organized in accordance with standard PHS Form 
398 instructions, with the following modifications:

Each application in a CCTDA group should be essentially identical to 
the others, with the exception of expected differences in elements such 
as numbers of available subjects, resources and environment, budgetary 
requirements, and staff.

Each application must include an overview section that is no longer 
than 2 pages and constitutes the first pages of the RESEARCH PLAN 
section (i.e., immediately precedes the Specific Aims).  This overview 
should list the individual applicant organizations participating in the 
CCTDA and the Principal Investigator for each.  It should establish the 
need for applying as a CCTDA and justify the role for each applicant 
organization in the CCTDA. The investigators may also wish to identify 
one individual as the contact person for the group for the purposes of 
facilitating communication.  If so, that should be noted in the 
overview.

Sections A-D of the research plan should describe those aspects of the 
project that are common to all sites.  The research procedures and 
protocol should be presented in detail, along with description of the 
study population from which samples are drawn, the anticipated samples 
themselves, resources, plans for data analysis, and characteristics 
that support each site’s (i.e., not simply the applicant’s site) role 
in the project.  Where there are minor variations in plans, these 
should be noted in the text and then summarized in a separate 
subheading in Section D (which counts toward the 25 page limit) titled 
“ELEMENTS UNIQUE TO THIS SITE.”

The research plan should describe a feasible strategy for integration 
of research procedures, managerial and administrative responsibilities, 
and training across sites to ensure the integrity of the research 
effort.  The Principal Investigators may wish to designate a Steering 
Committee or other decision-making body.  If so, the biosketches of 
these individuals should be included.  If not, a feasible strategy for 
decision-making must be detailed.  

Plans for ensuring access to data by all sites, analytic resources, 
publication and authorship procedures, public use of data, 
dissemination of results, and means of arbitrating disagreements should 
be addressed. 

Any site that contracts out elements of the research should note this 
as an element unique to the site, both in the main body of the research 
plan and in the separate section on unique elements.  The nature, 
purpose, and oversight of the contractual arrangement should be fully 
described.

Revised submissions of CSDAs must include an introduction to the 
revision that highlights changes in the research plan and how delays in 
initiating the project will affect the work.  This is particularly 
important in cases where some but not all of the CCTDA sites have 
already begun work on a project.

All applications submitted as part of the CCTDA should be mailed 
together in one package, in order to assure that they are processed as 
CCTDA submissions.  All of the applications constituting the proposed 
CCTDA group must be submitted in a single package, whether or not the 
applications are from the same institution.  A cover letter must list 
the total number of applications submitted for the CCTDA group, clearly 
identifying each application and the principal investigator of each.  
For each component application in the CCTDA group, the original, five 
copies, and the appendix material must be bundled together and clearly 
identified

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.   Appropriate scientific review 
groups convened by NIDA 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 the National Advisory Council on 
Drug Abuse
  
REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  
In the written comments reviewers will be asked to discuss the 
following aspects of the application in order to judge the likelihood 
that the proposed research will have a substantial impact on the 
pursuit of these goals.  Each of these criteria will be addressed and 
considered in assigning the overall score, weighting them as 
appropriate for each application.  

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

Note that 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.
     
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 
method?  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?

RATIONALE AND FEASIBILITY OF THE COLLABORATION:  How well is the use of 
collaborating sites justified?  How necessary is collaboration to 
address the scientific issues?  How well does this application 
establish, through preliminary data or other means that other sites 
will be able to contribute to the study? 

MANAGEMENT PLANS:  How well developed and reasonable are the plans for 
coordination, decision-making, quality control, and arbitration?  In 
particular, how well have other administrative and managerial issues 
been addressed with respect to:

o the reliability and accuracy of the main administrative site's past 
performance and the potential of the main administrative site's future 
performance in clinical trials;

o the experience of the Principal Investigator and other key personnel 
in conducting clinical trials;

o the ability of the main administrative site to manage and analyze 
data for the clinical trial; and,

o  the appropriateness of the proposed procedures for data management, 
data storage, and analytical activities.

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

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).

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.  

ADDITIONAL REVIEW CONSIDERATIONS 

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

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

Funding decisions will also consider whether there are sufficient high 
quality collaborating sites for the CCTDA project. 

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 AND SAFETY MONITORING PLAN:  Data 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).

SHARING RESEARCH DATA:  Starting with the October 1, 2003 receipt date, 
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 "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.

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.

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.

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.healthypeople.gov/.

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.


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)
  USA.gov - Government Made Easy


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