SUPPLEMENTS FOR THE STUDY OF DRUG ABUSE AND HIV/AIDS
Release Date: February 10, 2000
PA Number: PAS-00-058
National Institute on Drug Abuse
THIS PROGRAM ANNOUNCEMENT (PA) USES THE MODULAR GRANT AND JUST-IN-TIME
CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION
INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO
THIS PA.
PURPOSE
The National Institute on Drug Abuse (NIDA) announces the availability of
funds to supplement existing federal research project grants for the study of
issues related to drug abuse and HIV/AIDS. Funding will be available through
competing supplements.
HEALTH PEOPLE 2010
The Public Health Services (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 Program Announcement
(PA), Supplements for the Study of Drug Abuse And HIV/AIDS, is related to
one or more of the priority areas. Potential applicants may obtain a copy of
Healthy People 2010, at http://odphp.osophs.dhhs.gov/pubs/hp2000.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic and foreign, for-profit and non-
profit organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of state and local governments, and eligible
agencies of the federal government. Racial/ethnic minority individuals,
women and persons with disabilities are encouraged to apply as principal
investigators.
MECHANISM OF SUPPORT
This PA will supplement the National Institutes of Health (NIH) research
project grant (R01) award mechanism only. 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 five years or the life of the parent grant (i.e.,
the grant being supplemented), whichever is less.
FUNDS AVAILABLE
NIDA will set aside $500,000 total cost for this program for FY 2000.
RESEARCH OBJECTIVES
Background
The HIV/AIDS epidemic has demonstrated an increasing association with drug
abuse, through transmission of HIV by contaminated drug injection equipment,
high-risk sexual behavior with an infected drug user, and perinatal exposure
of newborns from infected drug-abusing mothers.
With this Supplement Announcement, NIDA plans to continue to develop a strong
multidisciplinary research program in response to the complex challenges of
drug abuse and HIV/AIDS. The Supplement Program is designed to encourage and
enhance interactive, multidisciplinary collaborative projects involving
researchers with primary foci both within and outside the area of drug abuse.
Areas of Interest
In an effort to improve and expand its research on drug abuse-related aspects
of HIV/AIDS, NIDA will consider requests from current NIDA grantees and those
with grants from other NIH components to expand and/or enhance ongoing
research that includes drug use-related HIV/AIDS issues. The primary intent
of this Program is to encourage grantees who have not focused on drug use-
related HIV/AIDS issues to do so, thus recognizing that drug abuse/dependence
and HIV/AIDS are two diseases that often co-occur and interact and that they
must be prevented and treated together and in parallel. Projects that
currently focus solely on either AIDS-related or drug abuse issues are
encouraged to strengthen efforts in the complementary area. Thus, grantees
are encouraged to examine for HIV/AIDS relevance ongoing drug abuse research
projects that may not have been designed to examine AIDS-related issues.
Similarly, those doing AIDS research, but who have not investigated how drugs
of abuse may act within their area of investigation, are encouraged to think
about these issues and consider submitting an application.
Current areas of NIDA supported drug use research that are considered
HIV/AIDS related include those listed below, as well as crosscutting areas of
relevance, i.e., racial/ethnic factors, underrepresented or minority status,
socioeconomic and cultural factors, gender differences, and issues that are
unique to women and to men. For example, gender-related research has shown
that women"s HIV viral loads are not the same as men"s, raising the issue of
whether women may need earlier interventions with anti-viral therapies.
Another example may be a field such as genetics in which the rapid
development of knowledge, as well as technology (e.g., gene chip arrays,
quantitative trait locus analysis), may be broadly applicable to a number of
research areas. As relevant data emerge from laboratory, community-based, and
clinical HIV/AIDS research, investigators are urged to include these and
other crosscutting perspectives in their research designs and analyses, where
appropriate.
Natural History and Epidemiology
o International and/or national studies of the epidemiology and natural
history of infectious diseases commonly transmitted by drug injection and/or
sexual behavior and/or other behaviors associated with drug use (e.g.,
hepatitis A, B and C, Sexual Transmitted Diseases (STDs), Tuberculosis, and
HIV).
o Studies of interactions among chronic drug use and the treatment of HIV
and comorbid mental disorders and other infectious diseases, including
studies of health seeking behaviors.
o Studies of the incidence and prevalence of HIV infection and AIDS,
including monitoring the trends in HIV infection and AIDS-related diseases
among specific subpopulations such as adolescents, women, minorities, and
sexual partners and newborns/children of drug abusers.
o Research on the natural history of HIV/AIDS, including the natural history
of the dynamics of HIV and other blood-borne infectious disease transmission
in sexual and drug-using risk networks.
o Research on the transmission, incidence, prevalence, and natural history
of pharmacotherapy-resistant HIV/AIDS in drug-using populations.
o Research on the nature and extent of HIV risk behaviors and factors that
affect the propagation of HIV and other diseases in at-risk populations.
o Research to develop improved study protocols, research designs, interview
and measurement instruments, and biostatistical techniques to detect,
measure, and characterize HIV risk behaviors (drug use and unsafe sexual
practices) in adolescent and adult populations.
o Studies of the nature, extent, and progression of drug use and abuse,
which include assessment of knowledge and attitudes regarding HIV/AIDS and/or
the incidence, prevalence, and nature of drug-related HIV risk behaviors.
Etiology and Pathogenesis
o Studies to define interactions between drugs of abuse and the operation of
secondary messenger pathways effecting lymphocyte or monocyte function.
o Studies to define the role of drugs of abuse and related compounds or drug
abuse treatment medications on susceptibility, onset, and progression of HIV
disease, including studies to identify latent HIV infection and
pharmacotherapy-resistant HIV strains in drug abusing populations.
o Research on the pharmacokinetics and pharmacodynamics of drugs of abuse as
factors with an impact on susceptibility, onset, progression, and treatment
of HIV disease.
o Studies to further develop and utilize experimental models to study the
effects of drugs of abuse on the pathogenesis of central nervous system
lentivirus infections.
o Studies to investigate the role of drugs of abuse and related endogenous
substances and other biological and environmental factors in modulating HIV-
induced neuroAIDS.
o Studies to identify and elucidate the role of drug abuse on immune
susceptibility and the development and progression of AIDS-related
opportunistic infections, e.g., smoking drugs of abuse and bacterial
pneumonias.
o Studies of nutritional, metabolic, endocrine, and gastrointestinal
disorders and their underlying pathophysiology in HIV-infected drug abusers.
o Research on adulterants/contaminants of drugs of abuse and their roles in
the etiology, pathogenesis, and natural history of HIV/AIDS and associated
illness in drug abusers.
o Studies of the role of patterns of drug abuse in HIV/AIDS progression
among women, e.g., in perinatal transmission of HIV and the effects on the
fetal and neonate nervous system, immune system, and placenta.
o Studies of the effects of drugs of abuse and drug treatment medications on
immune function that may increase our knowledge of the immune dysfunction
characteristic of HIV infection.
o Studies of how drugs of abuse may modulate the immune system through the
hypothalamic-pituitary axis and other parts of the central nervous system.
o Basic and clinical research on neurobiologic, neurologic,
neuropsychological, and psychiatric consequences of drug abuse that have
relevance for understanding the natural history of HIV/AIDS-related dementia
in drug users.
o Studies of dual function receptor systems, e.g., opioid, with activation
receptors of immune cells and subsequent induction of immune cell responses,
including cytokine responses and other host factors.
Therapeutics
o Research to improve access to health services provided to and long-term
therapeutic strategies designed for HIV-infected drug users, their sexual
partners, and their children, including studies of:
a. Strategies to improve adherence with HIV medication regimens (e.g.,
simultaneous or co-located drug abuse and HIV treatment),
b. Recruitment and retention of HIV-infected drug users into drug abuse and
HIV/AIDS treatment,
c. Delivery of linked medical and drug abuse prevention and treatment
services through drug abuse treatment programs and/or other preventive and
health services delivery programs (e.g., mobile van services), and
d. Strategies to improve the methods in and adherence to disease prevention,
detection, and treatment programs (e.g., tuberculosis, hepatitis B and C,
STDs, and other infectious diseases).
o Evaluation of the safety, efficacy, and acceptability of new agents and
approaches, including alternative and complementary therapies (e.g.,
chemopreventive treatment with micro- and macronutrients such as vitamins and
trace elements), in the treatment of wasting syndrome, growth failure, and
other complications of HIV infection in drug users.
o Research that investigates interactions between approved and
investigational medications for drug addiction and HIV pharmacotherapies.
o Research on the development, dynamics, prevention, and treatment of
pharmacotherapy-resistant HIV strains in drug abusing populations.
o Research to test the feasibility of enhancing recruitment of HIV-infected
drug users, their sexual partners, and infants into HIV/AIDS-therapeutics
clinical trials, including very hard-to-reach risk groups and
underrepresented racial and ethnic minority subpopulations.
Vaccines
o Research on improving behavioral and/or biomedical methods to deliver HIV
and other infectious disease vaccines to adolescent and adult drug using
populations.
o Research to recruit injection and non-injection drug users at high risk of
HIV infection into clinical trials of vaccines, including developing specific
strategies to study children, adolescents, and adults.
o Investigation of how drugs of abuse may affect or modulate cofactors for
HIV transmission. Those cofactors include, for example, vaginal/cervical
epithelium changes during puberty, hormonal changes during pregnancy, and use
of contraceptives, hormonal replacement therapy, or steroids.
o Studies of the genital tract immune system and inflammatory activity that
might compromise integrity of the genital tract or inductive ability of
vaccines. Studies of drugs of abuse and genital mucosal inflammation induced
by drug use behaviors, which facilitate HIV transmission in injection and
non-injection drug users.
o In collaboration with institutions and communities being targeted, explore
behavioral and social issues and prevention activities that might have a
substantial impact on the design or conduct of a trial, including:
a. Evaluation of other biomedical and behavioral interventions that could
prove of benefit in decreasing the incidence of HIV infection in the
populations identified for future vaccine efficacy trials and assessment of
their potential impact on the evaluation of vaccine efficacy,
b. Conduct of behavioral research in populations at high risk for HIV
infection to determine, for example, appropriate risk-reduction interventions
and to estimate risk behavior and recruitment, adherence, and retention
strategies pertinent to the design and execution of a successful efficacy
trial, especially for populations that have been historically
underrepresented in clinical trials,
c. Determination of possible adverse social, economic, behavioral, or legal
consequences of participation in clinical trials and development of broadly
applicable strategies for mitigating potential harm,
d. Determination of optimal methods of achieving informed consent for vaccine
efficacy trials, and
e. Evaluation of ethical issues and challenges, and the behaviors and conduct
of health care workers, peer counselors, outreach workers, and prevention
scientists in performing drug use and HIV-related studies.
Behavioral and Social Sciences Research
o Research to develop, evaluate, and disseminate prevention strategies to
reduce the incidence of drug-use related HIV infection, including high risk
drug use-associated sexual behaviors (e.g., among adolescents, in perinatal
transmission in drug-abusing mothers, and in commercial sex work). Such
research may include, but is not limited to:
a. Community-based behavioral and social intervention studies to stop or
reduce the reuse and sharing of needles and unsafe sexual behaviors among
injection drug users, crack cocaine users, and methamphetamine users and
their sexual partners,
b. Behavioral studies on multicomponent prevention and intervention
strategies, such as improving compliance with barrier methods, vaccine
regimens, and HIV therapeutics,
c. Studies to develop and enhance prevention of HIV among high risk
adolescents and youth, including ethnographic and epidemiologic studies of
runaways and street children at risk for initiating drug use and injecting
drug use and/or for exchanging sex for money, drugs, or subsistence, and
d. Development of new or improved HIV-risk and drug-use risk screening
questionnaires that are developmentally appropriate for use with specific
target populations in diverse settings (e.g., among street youth and
adolescents, in communities of older adults, and among ethnic and cultural
subgroups) and that serve as valid and reliable predictors of immediate and
future exposure to HIV and other infectious diseases where preventive
interventions do not occur.
o Studies of the determinants and correlates of HIV risk behaviors and risk
behavior change among adolescents who have initiated or recently transitioned
to injecting drug use and who engage in unsafe sex in association with their
drug use.
o Studies of simultaneous and serial treatment interventions for drug
dependence and comorbid conditions that meet the following criteria:
a. Determines the efficacy or effectiveness of psychosocial and/or
pharmacological treatment interventions for drug dependence and have a high
probability of leading to reductions in transmission of infectious diseases
associated with drug use, e.g., HIV, viral hepatitis, and other medical
consequences of drug use and addiction (e.g., pneumonitis, osteomyelitis,
cutaneous abscesses and cellulitis, hypertension, bacterial endocarditis, and
diabetes mellitus),
b. Reduces the risks of acquiring or transmitting HIV and other blood-borne
infections among drug users who are in or out of drug treatment and at risk
for HIV or HIV seropositive,
c. Includes the assessment of drug use injection and non-injection practices
and/or sexual AIDS risk,
d. Evaluates HIV risk reduction counseling being provided either (1) during
the course of the study or (2) as part of the intervention under study.
o Studies of the impact of HIV/AIDS on the drug abuse treatment delivery
system and on the HIV/AIDS services provided within drug treatment programs,
including those provided under managed care.
o Studies of the cost, cost-benefit, and cost-effectiveness of interventions
to reduce HIV risk behaviors and prevent the transmission of HIV and other
blood-borne infections.
o Studies of the organization and management of services for HIV-positive
drug abusers, including studies of the barriers to service access and
utilization and strategies for overcoming them.
o Studies of the organization and management of drug use and medical
services provided by mobile care systems (e.g., vans) as a method for
improving the effectiveness of community-based outreach, prevention, and
health care access.
o Research to enhance the effectiveness of other community-based HIV
prevention interventions, such as studies to enhance entry and retention of
new initiates to injecting drug use, persons at risk of transitioning to
injecting drug use, and high-risk non-injecting drug users into drug abuse
treatment and prevention programs.
o Research to inform and improve our understanding of behavior change, the
maintenance of behavior change, and risk avoidance and relapse prevention
relative to the prevention of drug use-related HIV transmission.
Information Dissemination
o Research on mass media and other education strategies focused on AIDS and
drug abuse in children (ages 8-12), adolescents, adults, racial/ethnic
groups, and gender specific groups.
o Studies of HIV and drug use prevention strategies for community-based
organizations, health care service providers, practitioners, and other
clinical and public health professionals involved in HIV prevention, risk
reduction, and/or drug abuse and HIV/AIDS treatment that targets high risk
and hard-to-reach community populations.
Research Ethics
o Studies of the ethical, legal, and social interactions and resulting
issues related to research on HIV/AIDS and drug abuse in diverse settings
(i.e., the community, the street setting, or in the clinic). Investigators
are referred for general topic areas and more background information to the
program announcement: Research on Ethical Issues in Human Studies (PA-99-
079).
International Research Collaboration
o Research support for collaborative national and international research
with a focus on drug abuse-related links to HIV/AIDS. International
collaborative research may involve, for example, any of the above areas (e.g,
etiology and pathogenesis, natural history/epidemiology, vaccines, social and
behavioral sciences, information dissemination, research ethics).
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
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 biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification are provided 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 1983
(Section 492B of Public Law 103-43).
All investigators proposing research involving human subjects should read the
NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research, that were published in the Federal Register on March 28, 1994 (FR
59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No.
11, March 18, 1994 available on the web at the following URL address:
http://grants.nih.gov/grants/guide/notice-files/not94-100.html.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH that children (i.e., individuals under the age 21)
must be included in all human subjects research, conducted or supported by
the NIH unless there are scientific and ethical reasons not to include them.
All investigators proposing research involving human subjects should read the
NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects that was published in the NIH Guide for
Grants and Contract, March 6, 1998, and is available at the following
website: http://grants.nih.gov/grants/guide/notice-files/not98-024.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 before submitting an
application that will administer compounds to human subjects. The guidelines
are available on the NIDA Home Page at http://www.nida.nih.gov/, or may be
obtained by calling 301-443-2755.
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, clinics, 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
include injection drug users, crack cocaine users, and sexually active drug
users and their sexual partners.
SPECIAL REQUIREMENTS
Budget/Administrative Issues
NIDA will set aside $500,000 total costs into this program for FY 2000.
Applicants should request only what is necessary to do the proposed work and
should request no more than $100,000 in direct costs.
Competing supplements are provided for expansion of a project"s scope or the
research protocol. Supplements are treated as new applications for purposes
of the review requirements and competition for funds and are reviewed in
accordance with NIH standard procedures, i.e., peer review/council review.
Competing supplement requests should be submitted to the Center for
Scientific Review on the standard AIDS receipt date of May 1, 2000.
Applications submitted for the other NIH AIDS application receipt dates will
not be considered for these funds and will compete for funds with other
unsolicited applications.
Supplements may not exceed the stated life of the parent project. Parent
grants that would require or be in the status of no-additional-cost extension
during the supplement period will not be eligible for supplementation.
Supplements may not represent changes in the basic goals or intent of the
project. AIDS-related competing supplement requests to either non-AIDS or
AIDS-related grants will receive expedited review, according to Section 301
of the Public Health Service Act (42 USC241).
APPLICATION PROCEDURES
Supplement applications are to be submitted in the grant application form PHS
398 (rev. 4/98). Application kits are available at most institutional offices
of sponsored research and may be obtained from the Division of Extramural
Outreach and Information Resources, National Institutes of Health, 6701
Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301)435-0714,
E-mail: GrantsInfo@nih.gov. The kit contains detailed instructions on page
limits, appendix material, and other matters related to preparation and
submission of the application.
SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS
The modular grant concept establishes specific modules in which direct costs
may be requested, as well as a maximum level for requested budgets. Only
limited budgetary information is required under this approach. The
just-in-time concept allows applicants to submit certain information only
when there is a possibility for an award. It is anticipated that these
changes will reduce the administrative burden for the applicants, reviewers,
and Institute staff. The research grant application form PHS 398 (rev. 4/98)
is to be used in applying for these grants, with the modifications noted
below.
BUDGET INSTRUCTIONS
Applications will use the modular grant format, requesting direct costs in
$25,000 modules, up to a total direct cost request of $100,000 per year. The
total direct costs must be requested in accordance with the program
guidelines and the modifications made to the standard PHS 398 application
instructions described below:
PHS 398
FACE PAGE - Items 7a and 7b should be completed, indicating Direct Costs (in
$25,000 increments up to a maximum of $100,000) and Total Costs [Modular
Total Direct plus Facilities and Administrative (F&A) costs] for the initial
budget period. Items 8a and 8b should be completed indicating the Direct and
Total Costs for the entire proposed period of support.
DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4
of the PHS 398. It is not required and will not be accepted with the
application.
BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398. It is not required
and will not be accepted with the application.
NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative
page (see http://grants.nih.gov/grants/funding/modular/modular.htm for sample
pages). At the top of the page, enter the total Direct Costs requested for
each year. This is not a Form page.
Under Personnel, list key project personnel, including their names, percent
of effort, and role in the project. No individual salary information should
be provided. However, the applicant should use the NIH appropriation
language salary cap and the NIH policy for graduate student compensation in
developing the budget request.
For Consortium/Contractual costs, provide an estimate of total costs (Direct
plus F&A) for each year, each rounded to the nearest $1,000. List the
individuals/organizations with whom consortium or contractual arrangements
have been made, the percent effort of key personnel, and the role in the
project. Indicate whether the collaborating institution is foreign or
domestic. The total cost for a consortium/contractual arrangement is
included in the overall requested Modular Direct Cost amount. Include the
letter of intent to establish a consortium.
Provide an additional narrative budget justification for any variation in the
number of modules requested.
BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by
reviewers in the assessment of each individual"s qualifications for a
specific role in the proposed project, as well as to evaluate the overall
qualifications of the research team. A biographical sketch is required for
all key personnel, following the instructions below. No more than three
pages may be used for each person. A sample biographical sketch may be
viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm
- Complete the educational block at the top of the Form page,
- List position(s) and any honors,
- Provide information, including overall goals and responsibilities, on
research projects ongoing or completed during the last three years, and
- List selected peer-reviewed publications, with full citations.
CHECKLIST - This page should be completed and submitted with the application.
If the F&A rate agreement has been established, indicate the type of
agreement and the date. All appropriate exclusions must be applied in the
calculation of the F&A costs for the initial budget period and all future
budget years.
The applicant should provide the name and phone number of the individual to
contact concerning fiscal and administrative issues if additional information
is necessary following the initial review.
Submit a signed typewritten original of the application, including the
Checklist, and five signed photocopies 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)
As noted, to be eligible for consideration for these FY 2000 supplement
funds, competing supplement applications must be received by May 1, 2000.
REVIEW CONSIDERATIONS
Applications that are complete will be evaluated for scientific and technical
merit by an appropriate peer review group convened in accordance with the
standard peer review procedures. As part of the initial merit review, all
applications will receive a written critique and undergo a process in which
only those applications deemed to have the highest scientific merit,
generally the top half of applications under review, will be discussed,
assigned a priority score, and receive a second level review by the
appropriate national advisory council or board.
Review Criteria
The goals of NIH-supported research are to advance the 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. 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 the study on the concept 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 concept, 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?
In addition to the above criteria, in accordance with NIH policy, all
applications will also be
reviewed with respect to the following:
- The adequacy of plans to include genders, minorities and their subgroups,
and children as appropriate for the scientific goals of the research. Plans
for the recruitment and retention of subjects will also be evaluated.
- The reasonableness of the proposed budget and duration in relation to the
proposed research.
- The adequacy of the proposed protection for humans, animals, or the
environment, to the extent they may be adversely effected by the project
proposed in the application.
AWARD CRITERIA
Applications will compete for available funds with all other recommended
applications. The following will be considered in making funding decisions:
quality of the proposed project as determined by peer review, availability of
funds, and program priority.
INQUIRIES
Inquiries concerning this notice are encouraged. The opportunity to clarify
any issues or questions from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Sander G. Genser, M.D., M.P.H.
Center on AIDS and Other Medical Consequences of Drug Abuse
National Institute on Drug Abuse
6001 Executive Boulevard, Rm. 5198, MSC 9593
Bethesda, MD 20892-9593
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-1801
FAX: (301) 594-6566
Email: sg73f@nih.gov
Direct fiscal inquiries to:
Gary Fleming, J.D.
Chief, Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Rm. 3131, MSC 9541
Bethesda, MD 20892-9541
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: gf6s@nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.279. Awards are made under authorization of the Public Health Service
Act, as amended by Sections 301 and 405 (42 USC 241 and 284) and are
administered under NIH grants policies and Federal Regulations 42 CFR 52 and
45 CFR Part 74. This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and promote the non-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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