and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)
National Institute of Mental Health (NIMH),
(http://www.nimh.nih.gov)
Office of Dietary Supplements (ODS), (http://dietary-supplements.info.nih.gov/)
Title: Psychopharmacology Of Widely Available Psychoactive Natural Products (R03)
Announcement Type
This is a reissue of PA-04-084,
which was previously released April 2, 2004, and is now divided into
separate Funding Opportunity Announcements (FOAs) for the R03 and R01 grant
mechanisms.
Update: The following update relating to this announcement has been issued:
NOTICE: Applications submitted in response to this FOA for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply)
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Two steps are required for on time submission:
1) The application must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the submission/receipt date (see Key Dates below).
2) Applicants must complete a verification step in the eRA Commons within two business days of notification from NIH. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the Commons.
Program Announcement (PA) Number:
PA-06-323
Catalog of Federal Domestic Assistance Number(s)
93.279, 93.242
Key Dates
Release/Posted Date: April 5, 2006
Opening Date: May 2, 2006 (Earliest date an application may be submitted
to Grants.gov
Letters of Intent Receipt Date(s): Not Applicable
Application Submission/Receipt Date(s): Standard dates apply, please
see http://grants1.nih.gov/grants/funding/submissionschedule.htm.
AIDS Application Submission/Receipt Date(s): Please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council Review Date(s): Please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest Anticipated Start Date(s): See http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: May 8, 2007
Due Dates for E.O. 12372
Not Applicable.
Additional Overview Content
Executive Summary
This Funding Opportunity Announcement (FOA) will support research grant applications
that characterize the chemistry, psychopharmacology, and/or toxicology of
acute and chronic exposure to psychoactive natural products, as well as the
transition in the use of these products to licit or illicit drugs of abuse.
Table of Contents
Part I Overview
Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible
Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and Submission
Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated
Start Dates
1. Letter of Intent
B. Sending an Application to the
NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
In September 2003, the National Institute on Drug
Abuse (NIDA) and the Office of the Director’s Office of Dietary Supplements
(ODS) came together and supported a workshop entitled Psychoactive Botanical
Products. The presentations and ensuing discussion illustrated how little
the scientific community currently knows about the chemistry, biology, pharmacology,
and behavioral effects of psychoactive botanical (or natural) products and
thus this workshop served to identify gaps in our knowledge outlined in this
announcement. A summary for this workshop can be found at:
http://www.drugabuse.gov/whatsnew/meetings/psychoactivemtgsumm.html.
Under this Funding Opportunity Announcement (FOA), the NIDA, the ODS, and the National Institute of Mental Health (NIMH) invite research grant applications that characterize the chemistry, psychopharmacology, and/or toxicology of acute and chronic exposure to psychoactive natural products, as well as the transition in the use of these products to licit or illicit drugs of abuse. For the purposes of this FOA, psychoactive natural products are defined as fungus- or plant-derived products that are taken primarily for their effects on the central nervous system (e.g., stimulant, depressant, and/or hallucinogenic effects), rather than for treatment, medicinal or therapeutic effects.
RESEARCH OBJECTIVES
American consumers encounter a variety of plant-derived psychoactive products in the marketplace and elsewhere. These products vary along several dimensions and range from conventional foods (nutmeg, coffee) to garden seeds (morning glory, devil’s trumpet) to dietary supplements (ephedra, kava) to drugs (morphine). Some of these products have been associated with religious rituals (e.g., peyote, Salvia divinorum) in specific cultural contexts. Seeds of certain weedy plants (e.g. Datura stramonium) are found in the wild and collected by individuals seeking psychoactive experiences.
The fact that a web of regulations surrounds these categories of goods does not mean that they are unavailable. In addition, there are products illegally in the marketplace that may claim to fall within one category, but that may not meet regulatory standards for that category. For example, products that claim to be dietary supplements that are to be smoked fail to meet the requirements of DSHEA, the 1994 law that regulates dietary supplements in the United States, as are the unapproved sale of products that purport to be replacements for prescription drugs. These are considered to be midbranded drugs, illegal, yet readily available.
Since these products are natural, much of the public may assume that these products are safe. However, the recent experience with ephedra illustrates the potential for serious health consequences from unregulated use of psychoactive natural products. Although it was legally marketed for years, ephedra has only recently been deemed unsafe by the U.S. Food and Drug Administration (FDA). Moreover, the short- and long-term effects of these psychoactive natural products on the brain and other body organ systems are unclear. Given that many consumers are buying and using these psychoactive products and may be unaware of the abuse potential and/or other health risks of some ingredients, we seek to encourage the development of research programs that investigate the psychopharmacology of psychoactive natural products, including the chemical characterization and evaluation, pharmacokinetics and their interaction with active or inactive ingredients, or drugs of abuse.
Listed below are examples of areas of research that are of programmatic interest. These examples are not meant to be all-inclusive.
Classification/Mechanisms of Action:
o Both animal and human research can be used to elucidate drug classification (e.g., stimulant, depressant, hallucinogen) and mechanisms of action of psychoactive natural products. To this end, operant conditioning and drug discrimination procedures in animals or humans could be used to further investigate these areas. Other measures of subjective effects, including effects on psychological, motivational, cognitive and emotional processes are also of interest.
o Since current knowledge about natural product psychopharmacology may be limited, it will be especially useful to extract, isolate, and characterize the directly active and indirectly active metabolites of these natural products, and then compare them to well-characterized psychoactive drugs, such as caffeine, nicotine, cocaine, opiates, etc., in terms of their neurobiological, behavioral and cognitive effects. Furthermore, understanding mechanisms of action of active components through binding assays, microdialysis, and other approaches may lead to the discovery of novel ligands and the development of potential pharmacotherapies for treating drug addiction and other diseases.
o Investigations into the pharmacokinetic and pharmacodynamic properties of psychoactive natural products are also of interest. These may include, but are not limited to, studies that investigate ligand affinity and efficacy, receptor localization, and investigations into the neural circuitry that underlies the psychoactive effects of these drugs.
Chemistry, Distribution, and Metabolism:
o Research studies in understanding the chemistry, toxicology, pharmacodynamics, pharmacokinetics and the mechanisms of action of psychoactive natural products is encouraged to better understand their efficacy, usefulness, adverse effects and/or abuse potential, if any. Areas of interest include, but are not limited to:
1) Development of methods to analyze and characterize active and inactive ingredients of psychoactive natural products.
2) Studies on absorption, distribution, metabolism and excretion of active ingredients, and interaction of active ingredients with their metabolites and endogenous substances.
3) Research on changes in cellular metabolic profiling (metabolomics) after administration of psychoactive natural products and their active ingredients.
4) Characterization, standardization, and comparison of efficacy and toxicity of psychoactive natural products with their pharmaceutical formulations (e.g., tablets, capsules, elixir).
5) Screening and identification of target receptors for active ingredients leading to new ligand development and structure activity investigations.
6) Development of ligands by chemical synthesis for structure activity relationship (SAR) studies.
7) Development of bioavailability studies of active ingredients.
Behavioral, Physiological, and Toxicological Effects:
o Little is known about the subjective effects of psychoactive natural products that are marketed or used as psychedelics, stimulants, euphoriogenics, or anxiolytics. Many drugs of abuse produce a change in either magnitude or duration of their subjective effects with repeated exposure. As such, it is important to investigate both the acute and chronic subjective effects of these products.
o It is important to investigate possible physiological effects, such as cardiovascular effects, endocrine effects, etc., following both acute and chronic exposure to psychoactive natural products. Gender differences are also of interest, especially as they relate to endocrine effects.
o Psychoactive natural products may affect cognitive ability. Studies designed to understand the acute effects of psychoactive natural products on cognition, learning and memory, and motivation (e.g., conditioned reinforcement or incentive motivation) are needed.
o Although the acute toxicological effects associated with psychoactive natural products have been studied, there has been little or no research into the possible long-term neurotoxicity or psychological/functional consequences of these agents. Such studies are needed.
o Little is known about the short- and long-term effect of using psychoactive natural products in combination with other psychoactive natural products, or with drugs of abuse. For example, combining sedative and hallucinogenic natural products may result in a different set of health or abuse risks as compared to a single psychoactive natural product taken separately. Additionally, multiple psychoactive natural products may be marketed (and thus taken) as a single product. It is therefore important to investigate the short- and long-term effects of psychoactive natural products alone and in combination with other psychoactive drugs or products.
Prenatal or Developmental Effects:
o Since psychoactive natural products are widely available and may be used by pregnant women, animal models investigating the physiological, behavioral, and toxicological effects of these products on both pregnant mother and offspring are needed.
o Little is known of how stage of development interacts with the effects of psychoactive natural products. These products may produce different subjective, physiological, and cognitive effects occurring in children, adolescents and adults. Issues related to vulnerability of children and adolescents to both the reinforcing and adverse consequences of psychoactive natural product use are of interest. The effects of dose should also be investigated, as it is not known how dosages intended for adults will affect younger users. It is expected that these studies will employ epidemiological methods, survey data, animal models, or other approaches that do not involve administering these products to children or adolescents.
o Investigations focused on the maternal-fetal pharmacokinetics and pharmacodynamics, and how placental formation and function may be altered by use of psychoactive natural products, including placental transport of these agents, are encouraged. These types of studies would shed light on how the growth and development of the fetus and offspring are affected by these psychoactive natural products. Research in this area could focus on studies of transfer of drug to fetus through placenta, biochemical and pharmacokinetic effects on placenta and fetus such as receptor binding, interaction with transporters, and enzymes, drug absorption, distribution, metabolism and elimination. It is expected that these studies will employ epidemiological methods, survey data, animal models, or other approaches that do not involve administering these products to pregnant mothers.
o Development of methodologies for analyzing drug concentration in fetal fluids, meconium and fetal hairs, as well as placental transfer of drugs, concentration of drugs and their metabolites in fetal circulation, and their possible effects on fetuses and offspring are needed. Appropriate animal model studies on fetal exposure to psychoactive natural products are also encouraged.
See Section VIII, Other Information - Required Federal Citations,
for policies related to this announcement.
Section II. Award Information
1. Mechanism of Support
This funding opportunity will use the NIH Small Research Grant (R03) award
mechanism. The applicant will be solely responsible for planning, directing,
and executing the proposed project.
This FOA uses just-in-time concepts. It also uses the modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement). All applications submitted in response to this FOA must use the modular budget format. Specifically, since you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, Modular Budget Component, of the Application Guide).
Competing renewal (formerly competing continuation ) applications will not be accepted for the R03 grant mechanism. Small grant support may not be used for thesis or dissertation research. Up to two resubmissions (formerly revisions/amendments") of a previously reviewed small grant application may be submitted. See NOT-OD-05-046, April 25, 2005.
For specific information about the R03 programs, see: http://grants.nih.gov/grants/funding/r03.htm.
2. Funds Available
Although the financial plans of the NIH Institutes and Centers (ICs) provide
support for this program, awards pursuant to this funding opportunity are
contingent upon the availability of funds and the submission of a sufficient
number of meritorious applications.
A project period of up to two years and a budget for direct costs of up to two $25,000 modules, or $50,000 per year, may be requested (i.e., a maximum of $100,000 over two years in four modules of $25,000 each). Commensurate F&A costs are allowed.
F&A costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit an application(s) if your organization
has any of the following characteristics:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research as the Project Director/Principal Investigator (PD/PI)
is invited to work with his/her institution/organization 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
support.
2. Cost Sharing or Matching
This program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
Applicants may submit more than one application, provided each application
is scientifically distinct.
Section IV. Application and Submission Information
Registration and Instructions for Submission via Grants.gov
To download a SF424 (R&R) Application Package and SF424
(R&R) Application Guide for completing the SF424 (R&R) forms for this
FOA, link to http://www.grants.gov/Apply/
and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
Applicants must download the SF424 (R&R) application forms and SF424 (R&R)
Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package directly attached to a specific FOA can be used.
You will not be able to use any other SF424 (R&R) forms (e.g., sample
forms, forms from another FOA), although some of the "Attachment"
files may be useable for more than one FOA.
For further assistance contact GrantsInfo, Telephone 301-710-0267, Email:
[email protected].
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application
Submission
Prepare all applications using the SF424 (R&R) application forms and in
accordance with the SF424 (R&R) Application Guide (MS
Word or PDF).
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form
Note: While both budget components are included in the SF424 (R&R)
forms package, the NIH R03 uses ONLY the PHS398 Modular Budget. (Do not
use the detailed Research & Related Budget.)
Foreign Organizations
Several special provisions apply to applications submitted by foreign organizations:
Proposed research should provide a unique research opportunity not available in the United States.
3. Submission Dates and Times
See Section IV.3.A for
details.
3.A. Submission, Review and
Anticipated Start Dates
Opening Date: May 2, 2006 (Earliest date an application may be
submitted to Grants.gov
Letters of Intent Receipt Date(s): Not Applicable
Application Submission/Receipt Date(s): Standard dates apply, please
see http://grants1.nih.gov/grants/funding/submissionschedule.htm.
AIDS Application Submission/Receipt Date(s): Please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council Review Date(s): Please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest Anticipated Start Date(s): See http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
3.A.1. Letter of Intent
A letter of intent is not required for the funding
opportunity.
3.B. Sending an Application to the NIH
To submit an application in response to this FOA,
applicants should access this FOA via http://www.grants.gov/Apply and follow
steps 1-4. Note: Applications must only be submitted electronically.
PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C. Application Processing
Applications may be submitted on or after the opening date and
must be successfully received by Grants.gov no later than 5:00 p.m.
local time (of the applicant institution/organization) on
the application submission/receipt date(s). (See Section IV.3.A. for all dates.)
If an application is not submitted by the receipt date(s) and time, the application
may be delayed in the review process or not reviewed.
Upon receipt, applications will be transferred from Grants.gov
to the NIH Electronic Research Administration process for validation. Both
the PD/PI and the Signing Official for the organization must verify the submission
via Commons within two
(2) business days of notification of the NIH validation.
Upon receipt, applications will be evaluated for completeness by the Center
for Scientific Review, NIH. Incomplete applications will not be reviewed.
There will be an acknowledgement of receipt of applications from Grants.gov
and the Commons. Information related to the assignment
of an application to a Scientific Review Group is also in the Commons.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note that such an application is considered a "resubmission" for the SF424 (R&R).
4. Intergovernmental Review
This initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles,
and other considerations described in the NIH Grants Policy
Statement.
Pre-Award Costs are allowable. A grantee may, at its own risk and without
NIH prior approval, incur obligations and expenditures to cover costs up to
90 days before the beginning date of the initial budget period of a new award
if such costs: are necessary to conduct the project, and would be allowable
under the grant, if awarded, without NIH prior approval. If specific expenditures
would otherwise require prior approval, the grantee must obtain NIH approval
before incurring the cost. NIH prior approval is required for any costs to
be incurred more than 90 days before the beginning date of the initial budget
period of a new award.
The incurrence of pre-award costs in anticipation of a competing or non-competing
award imposes no obligation on NIH either to make the award or to increase
the amount of the approved budget if an award is made for less than the amount
anticipated and is inadequate to cover the pre-award costs incurred. NIH expects
the grantee to be fully aware that pre-award costs result in borrowing against
future support and that such borrowing must not impair the grantee's ability
to accomplish the project objectives in the approved time frame or in any
way adversely affect the conduct of the project. See the NIH Grants
Policy Statement.
6. Other Submission Requirements
The NIH requires the PD/PI to fill in his/her Commons User ID in the PROFILE
Project Director/Principal Investigator section, Credential log-in field
of the Research & Related Senior/Key Person Profile component. The applicant
organization must include its DUNS number in its Organization Profile in the
eRA Commons. This DUNS number must match the DUNS number provided at CCR registration
with Grants.gov. For additional information, see Tips and Tools for Navigating
Electronic Submission on the front page of Electronic Submission of Grant Applications.
Renewal (formerly competing continuation or Type 2 ) applications are not permitted.
All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, with the following requirements for R03 applications:
Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
Plan for Sharing Research Data
Not Applicable.
Sharing Research Resources
NIH policy requires that grant awardee recipients make unique research
resources readily available for research purposes to qualified individuals
within the scientific community after publication (See the NIH Grants Policy
Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the resources sharing plan and any related data sharing plans
will be considered by Program staff of the funding organization when making
recommendations about funding applications. The effectiveness of the resource
sharing will be evaluated as part of the administrative review of each Non-Competing
Grant Progress Report (PHS 2590). See Section
VI.3., Reporting.
Section V. Application Review
Information
1. Criteria
Only the review criteria described below will be considered in the review
process.
2. Review and Selection Process
Applications submitted for this funding opportunity
will be assigned to the ICs on the basis of established PHS referral guidelines.
Appropriate scientific review groups 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:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The NIH R03 small grant is a mechanism for supporting discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research plan is restricted to 10 pages, a small grant application will not have the same level of detail or extensive discussion found in an R01 application. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem, placing less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.
The goals of NIH-supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written comments, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application.
Note that an 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 scientific health
problem? If the aims of the application are achieved, how will scientific
knowledge or clinical practice be advanced? What will be the effect of these
studies on the concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?
Approach: Are the conceptual or clinical framework,
design, methods, and analyses adequately developed, well integrated, well
reasoned, and appropriate to the aims of the project? Does the applicant acknowledge
potential problem areas and consider alternative tactics?
Innovation: Is the project original and innovative? For example:
Does the project challenge existing paradigms or clinical practice; address
an innovative hypothesis or critical barrier to progress in the field? Does
the project develop or employ novel concepts, approaches, methodologies, tools,
or technologies for this area?
Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the PD/PI and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?
Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
2.A. Additional Review Criteria:
In addition to the above criteria, the following
items will continue to 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 item 6 of the Research Plan
component of the SF424 (R&R).
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 item 7 of the Research Plan component of the SF424
(R&R).
Care and Use of Vertebrate Animals in Research: If vertebrate animals
are to be used in the project, the five items described under item 11 of the
Research Plan component of the SF424 (R&R) will be assessed.
Biohazards: If materials or procedures are proposed that are potentially
hazardous to research personnel and/or the environment, determine if the proposed
protection is adequate.
2.B. Additional Review Considerations
Budget and Period of Support: The reasonableness of the proposed budget
and the appropriateness of the requested period of support in relation to
the proposed research may be assessed by the reviewers. Is the percent effort
listed for the PD/PI appropriate for the work proposed? Is each budget category
realistic and justified in terms of the aims and methods?
2.C. Sharing Research Data
Not Applicable.
2.D. Sharing Research Resources
NIH policy requires that grant awardee recipients make unique research resources
readily available for research purposes to qualified individuals within the
scientific community after publication (See the NIH Grants Policy Statement
http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will be responsible for the administrative review of the plan
for sharing research resources.
The adequacy of the resources sharing plan will be considered by Program staff
of the funding organization when making recommendations about funding applications.
Program staff may negotiate modifications of the data and resource sharing
plans with the awardee before recommending funding of an application. The
final version of the data and resource sharing plans negotiated by both will
become a condition of the award of the grant. The effectiveness of the resource
sharing will be evaluated as part of the administrative review of each Non-Competing Grant
Progress Report (PHS 2590). See Section
VI.3., Reporting.
Model Organism Sharing Plan: Reviewers are asked to assess
the sharing plan in an administrative note. The sharing plan itself should
be discussed after the application is scored. Whether a sharing plan is reasonable
can be determined by the reviewers on a case-by-case basis, taking into consideration
the organism, the timeline, the applicant's decision to distribute the resource
or deposit it in a repository, and other relevant considerations. For the
R03 mechanism, the presence or adequacy of a plan should not enter into the
scoring of the application.
3. Anticipated Announcement and Award Dates
Not Applicable.
Section VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed, the PD/PI will be able to access his/her Summary Statement (written critique) via the NIH eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant.
For details, applicants may refer to the NIH Grants
Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart
A: General.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization. The NoA signed by the grants management officer
is the authorizing document. Once all administrative and programmatic issues
have been resolved, the NoA will be generated via email notification from
the awarding component to the grantee business official.
Selection of an application for award is not an authorization to begin performance.
Any costs incurred before receipt of the NoA are at the recipient's risk.
These costs may be reimbursed only to the extent considered allowable pre-award
costs. See Section
IV.5., Funding Restrictions.
2. Administrative
and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy
Statement as part of the NoA. For these terms of award, see the
NIH Grants
Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart
A: General and Part II:
Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions
for Specific Types of Grants, Grantees, and Activities
3. Reporting
When multiple years are involved, awardees will be required to submit the
Non-Competing Grant
Progress Report (PHS 2590) annually and financial statements as required
in the NIH
Grants Policy Statement.
We encourage your inquiries concerning
this funding opportunity 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:
1. Scientific/Research Contacts:
Allison Chausmer, Ph.D.
Behavioral and Cognitive Research Branch
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Boulevard,
Room 4282, MSC 9555
Bethesda, MD 20892-9555
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 402-5088
FAX: (301) 594-6043
Email: [email protected]
Matthew Rudorfer, M.D.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard,
Room 7160, MSC 9635
Bethesda, MD 20892-9635
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-1185
FAX: (301) 594-6784
Email: [email protected]
2. Peer Review Contacts:
Not Applicable.
3. Financial or Grants Management
Contacts:
Gary Fleming, J.D.
National Institute on Drug Abuse
6101 Executive Boulevard,
Room 250, MSC 8403
Bethesda, MD 20892-8403
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: [email protected]
Joy Knipple
National Institute of Mental Health
6001 Executive Boulevard,
Room 6131, MSC 9605
Bethesda, MD 20892-9605
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-8811
FAX: (301) 443-6885
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and Use
of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects Protection:
Federal regulations (45CFR46) require that applications
and proposals involving human subjects must be evaluated with reference to
the risks to the subjects, the adequacy of protection against these risks,
the potential benefits of the research to the subjects and others, and the
importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The establishment
of data and safety monitoring boards (DSMBs) is required for multi-site clinical
trials involving interventions that entail potential risks to the participants
(NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts,
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
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 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 funding opportunity
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.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research
resources including the sharing of model organisms for biomedical research
(see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors
to elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement
http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the application/proposal
a description of a specific plan for sharing and distributing unique model
organism research resources generated using NIH funding or state why such
sharing is restricted or not possible. This will permit other researchers
to benefit from the resources developed with public funding. The inclusion
of a model organism sharing plan is not subject to a cost threshold in any
year and is expected to be included in all applications where the development
of model organisms is anticipated.
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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is 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 SF424 (R&R); 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 Clinical
Research:
The NIH maintains a policy that children (i.e., individuals
under the age of 21) must be included in all clinical 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 (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 applications
for research involving human subjects and individuals designated as key personnel.
The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to
the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole
or in part with direct costs from NIH. The author's final manuscript is defined
as the final version accepted for journal publication, and includes all modifications
from the publishing peer review process.
NIH is requesting that authors submit manuscripts
resulting from 1) currently funded NIH research projects or 2) previously
supported NIH research projects if they are accepted for publication on or
after May 2, 2005. The NIH Public Access Policy applies to all research grant
and career development award mechanisms, cooperative agreements, contracts,
Institutional and Individual Ruth L. Kirschstein National Research Service
Awards, as well as NIH intramural research studies. The Policy applies to
peer-reviewed, original research publications that have been supported in
whole or in part with direct costs from NIH, but it does not apply to book
chapters, editorials, reviews, or conference proceedings. Publications resulting
from non-NIH-supported research projects should not be submitted.
For more information about the Policy or the submission
process please visit the NIH Public Access Policy Web site at http://PublicAccess.nih.gov/ and
view the Policy or other Resources and Tools including the Authors' Manual
(http://publicaccess.nih.gov/publicaccess_manual.htm).
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).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
Website (http://www.hhs.gov/ocr/) provides
information on the Privacy Rule, including a complete Regulation Text and
a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and research
contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
HIV/AIDS Counseling and Testing Policy for the National Institute on Drug
Abuse: Researchers funded by NIDA who are conducting research in community
outreach settings, clinical, hospital settings, or clinical laboratories and
have ongoing contact with clients at risk for HIV infection, are strongly
encouraged to provide HIV risk reduction education and counseling. HIV counseling
should include offering HIV testing available on-site or by referral to other
HIV testing service for persons at risk for HIV infection including injecting
drug users, crack cocaine users, and sexually active drug users and their
sexual partners. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html.
National Advisory Council on Drug Abuse Recommended
Guidelines for the Administration of Drugs to Human Subjects: The National
Advisory Council on Drug Abuse recognizes the importance of research involving
the administration of drugs to human subjects and has developed guidelines
relevant to such research. Potential applicants are encouraged to obtain
and review these recommendations of Council before submitting an application
that will administer compounds to human subjects. The guidelines are available
on NIDA's Home Page at www.nida.nih.gov under the Funding, or may
be obtained by calling (301) 443-2755.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must
be self-contained within specified page limitations. Unless otherwise specified
in an NIH solicitation, Internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Furthermore, we caution reviewers that their anonymity
may be compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health Service (PHS) is committed to achieving
the health promotion and disease prevention objectives of "Healthy People
2010," a PHS-led national activity for setting priority areas. This 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 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.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment
from qualified health professionals who have made a commitment to pursue a
research career involving clinical, pediatric, contraception, infertility,
and health disparities related areas. The LRP is an important component of
NIH's efforts to recruit and retain the next generation of researchers by
providing the means for developing a research career unfettered by the burden
of student loan debt. Note that an NIH grant is not required for eligibility
and concurrent career award and LRP applications are encouraged. The periods
of career award and LRP award may overlap providing the LRP recipient with
the required commitment of time and effort, as LRP awardees must commit at
least 50% of their time (at least 20 hours per week based on a 40 hour week)
for two years to the research. For further information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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