DRUG ABUSE DISSERTATION RESEARCH:  EPIDEMIOLOGY, PREVENTION, TREATMENT, SERVICES, 
AND WOMEN AND GENDER DIFFERENCES

RELEASE DATE:  February 5, 2002
 
PA NUMBER:  PA-02-055 (This PA has been reissued, see PAR-05-083) 
                      (See change NOT-DA-03-002)


EXPIRATION DATE:  February 1, 2005

PARTICIPATING INSTITUTES AND CENTERS (ICs):

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

THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to send Inquiries
o Submitting an Application
o Special Requirements
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA

This PA replaces in its entirety PA-98-109, Drug Abuse Treatment and 
Services Dissertation Research, published in the NIH Guide September 
24, 1998 at:  http://www.nih.gov/grants/guide/pa-files/PA-98-109.html.

The National Institute on Drug Abuse (NIDA) announces the availability 
of small grants (R03) to support drug abuse doctoral dissertation 
research in epidemiology, prevention, treatment, services and women and 
gender differences where there is a significant need for new 
investigators.  Grant support is designed to aid the research of new 
investigators and to encourage doctoral candidates from a variety of 
academic disciplines and programs to conduct research in these areas of 
interest to NIDA.  It is hoped that this program will ultimately 
facilitate the entry of promising new investigators into the field of 
drug abuse research.

Women and Gender Differences

Historically, in drug abuse research, as in other fields of public 
health research, the research subjects have been almost exclusively 
male.  Accumulating drug abuse research, however, suggests that the 
antecedents, consequences, and mechanisms of drug abuse and addiction 
are not identical in males and females and that gender may be an 
important variable in maximizing treatment and prevention outcomes.  
Thus, through this dissertation award program, NIDA seeks to foster 
research on females and gender differences in all areas of drug abuse 
research. From basic cellular and genetics research to epidemology, 
prevention, treatment, and services research, investigators are 
encouraged to explore the possible importance of gender differences in 
their chosen area of study or to explore drug abuse issues specific 
to women.

Special Program Considerations for Recruiting Minority Researchers

The primary objective of this PA is to prepare qualified individuals 
for careers that can significantly impact the Nation's drug abuse 
research agenda.  Within the framework of this program's commitment to 
excellence in research and projected need for investigators in drug 
abuse research, special attention will be given to recruiting 
individuals from racial or ethnic groups underrepresented in the 
biomedical and behavioral sciences.  The following groups have been 
identified as underrepresented in biomedical and behavioral research 
nationally:  African Americans, Hispanic Americans, Native Americans, 
Alaskan Natives, and Pacific Islanders.  Use of the term "minority" in 
this announcement will refer to these groups.

RESEARCH OBJECTIVES

NIDA supports more than 85 percent of the world's research on the 
health aspects of drug abuse and addiction.  Research supported by NIDA 
encompasses basic, behavioral, and applied sciences related to the 
underlying mechanisms and health effects of drugs of abuse.  This grant 
initiative is to provide students with grant-in-aid to perform drug 
abuse dissertation research on a topic related to the study of 
epidemiology, prevention, treatment, services, and women and gender 
differences, and thereby increase the pool of highly talented drug 
abuse scientists.  

The descriptions below are examples of the research foci of this grant 
program and are provided to guide potential applicants to determine 
whether a given scientific topic may be appropriate for this 
initiative.  These descriptions are not intended to be comprehensive.  
In addition, given the complexity of drug abuse research, it is 
permitted to conduct the proposed dissertation research in conjunction 
with an ongoing research study or to use extant data.   Questions on 
the relevance of a particular research topic to NIDA's scientific 
mission and other questions about this PA should be addressed to the 
program contact listed under INQUIRIES.  Potential applicants are 
strongly encouraged to discuss their application with the appropriate 
program contact.

Epidemiology:  

Studies of multiple factors that influence drug use outcomes.  That is, 
studies that examine genetic, neurological, biomedical, familial, 
environmental, social, cultural, developmental psychopathological, 
psychological, their interactions, and mediating characteristics.

Studies of the underlying psychosocial mechanisms associated with the 
transition from lower to higher levels of drug involvement and from 
higher levels of drug involvement to dependence and addiction. 

Development and improvement of techniques for studying drug abuse, 
including enhancements in measurement, development of improved sampling 
procedures, and refinement of analytic methods.

Development of innovative approaches to identify both physical 
(ecological) and social environmental/contextual characteristics of 
local communities that influence drug use, emerging drug use patterns, 
and adverse drug-related outcomes. 

Delineation of the underlying dynamic causal mechanisms associated with 
drug use patterns and adverse drug-related outcomes by integrating 
individual and community level factors.

Studies of emerging trends (e.g., club drugs), including studies that 
relate these trends to influences such as changes in social attitudes, 
new drugs of abuse, new patterns of social interaction, new 
technologies, new drug trafficking patterns, and similar 
macro-level changes. 

Research on drug use and drug-related consequences among ethnic/racial 
minority groups and other underserved populations. This includes 
studies that uncover the basis for racial/ethnic disparities in drug 
use and social, behavioral, and health outcomes related to drug use.

Research to assess the impact of mental health interventions in 
childhood on subsequent drug abuse.  

Studies to assess the nature, scope, and consequences of drug-related 
crime including violent and nonviolent crime.  

Research to assess the impact of drug use on adverse behavioral, 
social, and health consequences (e.g., violence, educational 
attainment, HIV) as well as the role of adverse consequences on further 
drug involvement.

Prevention:

Studies to test the efficacy and effectiveness of drug prevention 
interventions for children with early psychiatric and behavioral disorders.

Studies on the efficacy of interventions for high-risk youth designed 
to prevent both the initiation and progression of drug use and early 
sexual risk behaviors that could lead to exposure to HIV infection 
and AIDS. 

Studies that examine organizational, management, and delivery factors 
related to the effective and efficient provision of prevention services.

Research on the efficacy of selective and indicated prevention 
interventions for adolescents and young adults at serious risk for 
increasing levels of drug abuse, dependence, and addiction.

Studies to examine the use of media and other new technologies in drug 
prevention interventions among all populations.

Studies to test the efficacy and effectiveness of new and innovative 
theory-based prevention approaches.

Research to identify and assess the processes through which components 
of research-based intervention strategies and programs account 
for effectiveness.

Studies that develop new methodologies appropriate for studying these 
complex aspects of prevention science.

Treatment:

Research on the development and/or testing of behavioral therapies for 
various populations of drug-addicted individuals, including but not 
limited to special populations and populations with comorbid 
mental disorders.

Research integrating behavioral therapies with pharmacotherapies to 
maximize efficacy.

Research using secondary analyses of existing behavioral treatment 
research data sets.

Research on psychometric analysis and instrument development for the 
clinical assessment of drug abuse and HIV risk.

Research on a behavioral treatment intervention aimed at testing a 
principle of behavior change.

Services: 

Studies to assess the impact of organizational factors on access to, 
use of, quality or outcomes of prevention and treatment services.

Research to measure the effectiveness, cost-effectiveness, and cost-
benefits of drug abuse prevention and treatment.

Drug abuse service delivery systems and models, such as continuity of 
care, or service linkage and integration models.

Studies that advance the adoption and implementation of drug abuse 
prevention and treatment interventions into the service delivery system.

Drug abuse treatment services for HIV seropositive patients and for 
those at risk of infection.

Studies focusing on management strategies (e.g., work team models, 
quality management) aimed at improving the adaptation and adoption of 
emerging or underutilized proven service delivery technologies.

Women and Gender Differences:
 
Gender differences in the basic behavioral, biological, and genetic 
mechanisms underlying drug abuse and addiction; and laboratory (both 
human and animal), clinical, and epidemiological studies of gender 
differences in the determinants of initiation, progression, and 
maintenance of drug use and addiction. 

Laboratory (both human and animal), field, and clinical research aimed 
at:  (1) identifying gender differences in the consequences of drug 
use, abuse, and addiction following acute use, chronic use, as well as 
residual effects following prolonged abstinence, and (2) examining 
drug-related consequences that are unique to females.

The application of gender-specific theories and empirical research on 
the origins, pathways, and risk and protective factors related to drug 
use, progression/transition, and maintenance, to the design, 
development, and testing of gender-sensitive prevention strategies and 
interventions to determine effectiveness and efficacy.

The development and testing of theoretically-based drug treatment 
approaches (including behavioral treatment and pharmacotherapies) that 
address gender-specific issues and the examination of gender-specific 
issues related to the effective and efficient delivery of drug abuse 
treatment services. 

Develop and evaluate gender-specific interventions directed at 
preventing HIV infection and treating HIV/AIDS among drug using 
populations.

For additional details about other areas of research supported by NIDA, 
please refer to the program announcements found at 
http://www.nida.nih.gov/ResFundslist.html.

MECHANISM OF SUPPORT

This PA will use the National Institutes of Health (NIH) R03 award 
mechanism.  Responsibility for the planning, direction, and execution 
of the proposed project will be solely that of the applicant.  The 
total project period for an application submitted in response to this 
PA may not exceed two years.

Grants to support dissertation research will provide no more than 
$50,000 in direct costs per year; they are awarded for up to two years 
and may be extended without additional funds for up to 12 months. 

This PA uses just-in-time concepts.  It also uses the modular budgeting 
format. (see https://grants.nih.gov/grants/funding/modular/modular.htm).   
Specifically, if you are submitting an application with direct costs in 
each year of $250,000 or less, use the modular format.

ELIGIBILE INSTITUTIONS

You may submit an application 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

The applicant institution must have staff and facilities available on 
site to provide a suitable environment for performing high-quality research.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

The applicant for a dissertation research grant must be enrolled in an 
accredited doctoral degree program in the behavioral, biomedical, or 
social sciences and must propose to conduct research in one of the 
areas specified in this Program Announcement.  The applicant must be a 
registered doctoral student in good standing.  Information on the 
student's academic standing as well as a commitment from the school to 
implement the study as proposed must be included in the application.  
The letter regarding the latter should be from the student's advisor 
and cosigned by the department chair, dean or program director. 

These awards support research training applied toward preparation of a 
dissertation and do not support study leading to the M.D., D.O., or 
D.D.S., or similar professional degrees unless they are part of a 
combined degree program (for the latter see: Individual Pre-doctoral 
National Research Award for M.D./Ph.D. Fellowships - PAR-96-003, which 
may be obtained from:  
https://grants.nih.gov/grants/guide/pa-files/PA-99-089.html).

The doctoral student must be a citizen or a non-citizen national of the 
United States or an individual who has been lawfully admitted for 
permanent residence (i.e., in possession of an Alien Registration 
Receipt Card) at the time of application.

An applicant who receives support for dissertation research under a 
grant from NIDA may not hold concurrently another federally sponsored 
fellowship or similar Federal award, such as a National Research 
Service Award (NRSA) that provides a stipend or otherwise duplicates 
provisions of this grant program.  A NIDA dissertation grant recipient 
may, however, accept concurrent educational remuneration from the 
Department of Veterans Affairs (VA) and loans from Federal funds.  
Receipt of non-Federal funds during the grant period is also allowable 
if it is in accordance with the sponsoring institution's policy and 
does not detract from or prolong the approved doctoral training program.

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the 
opportunity 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:

William J. Bukoski, Ph.D.
Office of the Director
Division of Epidemiology, Services, and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5153, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 402-1526
FAX:  (301) 443-2636
E-mail:  bb75h@nih.gov

o Direct inquiries regarding drug treatment to:

Melissa Racioppo, Ph.D.
Division of Treatment Research and Development
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4230, MSC 9551
Bethesda, MD  20892-9551
Telephone:  (301) 443-2261
E-mail:  mraciopp@nida.nih.gov

o Direct inquiries regarding research on women and gender differences 
to:

Cora Lee Wetherington, Ph.D.
Women & Gender Research Coordinator
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4282, MSC 9555
Bethesda, MD  20892-9555
Telephone:  301-435-1319
FAX:  301-594-6043
E-mail:  wetherington@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
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
FAX:  (301) 594-6847
Email:  gf6s@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001).  The PHS 398 is 
available at https://grants.nih.gov/grants/funding/phs398/phs398.html in 
an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 710-0267, Email:  GrantsInfo@nih.gov.

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

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

SPECIAL REQUIREMENTS 

Allowable Costs

Expenses usually allowed under PHS research grants will be covered by 
the NIDA dissertation research grant, but may not exceed $50,000 per 
year in direct costs.  An application that requests more than $50,000 
per year in direct costs will be returned to the applicant.  Allowable 
costs include the investigator's salary (not to exceed $18,156 for 12 
months full-time effort).  In developing the modular budget, applicants 
may also include costs for research assistants' salaries, and direct 
research project expenses, such as data processing, payments to 
subjects, supplies, and dissertation costs (e.g., printing and binding 
of the dissertation).  No tuition, alteration/renovations, contracting 
costs, or space rental are allowed on dissertation research grants.  
Indirect costs are limited to eight percent of requested direct costs, 
less equipment.

Level of Effort

Any level of effort by the investigator that is less than full time (40 
hours per week) must be fully justified, and the investigator's salary 
must be prorated accordingly.

Letter of Certification

A letter from the faculty committee or university official directly 
responsible for supervising the development and progress of the 
dissertation research must be submitted with the application.  The 
letter must:  (a) fully identify the members of the dissertation 
committee and certify their approval of the dissertation proposal; (b) 
certify that all requirements for the doctoral degree, except the 
dissertation and, if necessary, the clinical internship, are completed 
or will be completed by the time the grant award starts; (c) note that 
the university official or faculty committee expects the doctoral 
candidate to proceed with the approved project proposal with or without 
NIDA support; and (d) briefly describe the facilities and resources for 
the project and certify that they are adequate to conduct the 
proposed research.

Official Transcript

A copy of an official transcript of the applicant's graduate school 
record should be included with the application.

Statement of Career Goals

Applicants must provide a statement of career goals, including 
reference to their interest in the specific areas of research 
designated in this program announcement and a description of their 
intended career trajectory.  This information will be used by NIDA 
program staff to determine how the proposed study addresses 
program priorities.

Biographical Sketch of the Mentor

A four page biographical sketch of the mentor, normally the 
dissertation director, should be sent.  This should be on the 
biographical sketch form found in the form PHS 398.  The applicant 
should also include material on the mentor's previous, and active 
related research support.

Narrative of the Proposed Research Plan

The applicant must provide a narrative project description (not to 
exceed 10 pages in sections a-d of the Research Plan) that contains a 
detailed scientific and technical discussion of the following 
specific points:

a.  A description of the research project and what it is intended to 
be accomplished.

b.  A summary of related published research that addresses the 
identified problem(s).

c.  The questions to be answered or the hypotheses to be tested by 
the project.

d.  The methodological procedures to be followed and, whenever 
applicable, information on such matters as sampling procedures, 
including the size and composition of the population to be studied and 
the size and composition of the sample and control groups, as well as a 
description of the types and sources of data to be gathered, 
methodological problems to be encountered, specific statistical 
analyses to be used, and steps that will be taken to protect human 
subjects.

e.  The management of the project including a schedule of the main 
steps of the proposed investigation.

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten 
original of the application, including the checklist, and five signed 
photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING: Applications must be received by or mailed 
before the receipt dates described at 
https://grants.nih.gov/grants/funding/submissionschedule.htm.  The CSR 
will not accept any application in response to this PA that is 
essentially the same as one currently pending initial review unless the 
applicant withdraws the pending application.  The CSR will not accept 
any application that is essentially the same as one already reviewed.  
This does not preclude the submission of a substantial revision of an 
application already reviewed, but such application must include an 
Introduction addressing the previous critique.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review 
group convened in accordance with the standard NIH peer review 
procedures (http://www.csr.nih.gov/refrev.htm) will evaluate 
applications for scientific and technical merit.  

As part of the initial merit review, all applications will:

o Receive a written critique
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 second level review by the appropriate national advisory 
council or board
	
REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  
In the written comments, reviewers will be asked to discuss the 
following aspects of your application in order to judge the likelihood 
that the proposed research will have a substantial impact on the 
pursuit of these goals: 

o Significance
o Approach
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these 
criteria in assigning your application's overall score, weighting them 
as appropriate for each application.  Your application does not need to 
be strong in all categories to be judged likely to have major 
scientific impact and thus deserve a high priority score.  For example, 
you may propose to carry out important work that by its nature is not 
innovative but is essential to move a field forward.

(1) SIGNIFICANCE:  Does 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, your 
application will also be reviewed with respect to the following:

PROTECTIONS:  The adequacy of the proposed protection for humans, 
animals, or the environment, to the extent they may be adversely 
affected by the project proposed in the application.

INCLUSION:  The adequacy of plans to include subjects from both 
genders, all racial and ethnic groups (and subgroups), and children as 
appropriate for the scientific goals of the research.  Plans for the 
recruitment and retention of subjects will also be evaluated. (See 
Inclusion Criteria included in the section on Federal Citations, below)

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

REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research 
components involving Phase I and II clinical trials must include 
provisions for assessment of patient eligibility and status, rigorous 
data management, quality assurance, and auditing procedures.  In 
addition, it is NIH policy that all clinical trials require data and 
safety monitoring, with the method and degree of monitoring being 
commensurate with the risks (NIH Policy for Data Safety and Monitoring, 
NIH Guide for Grants and Contracts, June 12, 1998: 
https://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 
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines are available at 
https://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 
https://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 
https://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 
https://grants.nih.gov/grants/stem_cells.htm and at  
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  
Only research using hESC lines that are registered in the NIH Human 
Embryonic Stem Cell Registry will be eligible for Federal funding (see 
http://escr.nih.gov).   It is the responsibility of the applicant to 
provide the official NIH identifier(s)for the hESC line(s)to be used in 
the proposed research.  Applications that do not provide this 
information will be returned without review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: 
The Office of Management and Budget (OMB) Circular A-110 has been 
revised to provide public access to research data through the Freedom 
of Information Act (FOIA) under some circumstances.  Data that are (1) 
first produced in a project that is supported in whole or in part with 
Federal funds and (2) cited publicly and officially by a Federal agency 
in support of an action that has the force and effect of law (i.e., a 
regulation) may be accessed through FOIA.  It is important for 
applicants to understand the basic scope of this amendment.  NIH has 
provided guidance at 
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application 
should include a description of the archiving plan in the study design 
and include information about this in the budget justification section 
of the application. In addition, applicants should think about how to 
structure informed consent statements and other human subjects 
procedures given the potential for wider use of data collected under 
this award.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and 
proposals for NIH funding must be self-contained within specified page 
limitations. Unless otherwise specified in an NIH solicitation, 
Internet addresses (URLs) should not be used to provide information 
necessary to the review because reviewers are under no obligation to 
view the Internet sites.   Furthermore, we caution reviewers that their 
anonymity may be compromised when they directly access an Internet site.

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 services.  
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 
https://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.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of 
"Healthy People 2010," a PHS-led national activity for setting priority 
areas. This PA is related to one or more of the priority areas. 
Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.279, and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or 
Health Systems Agency review.  Awards are made under authorization of 
Sections 301 and 405 of the Public Health Service Act as amended (42 
USC 241 and 284 and administered under NIH grants policies described at 
https://grants.nih.gov/grants/policy/policy.htm and under Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.

The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and discourage the use of all tobacco products.  In 
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits 
smoking in certain facilities (or in some cases, any portion of a 
facility) in which regular or routine education, library, day care, 
health care, or early childhood development services are provided to 
children.  This is consistent with the PHS mission to protect and 
advance the physical and mental health of the American people.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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