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 Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov)
Title: Alcohol Pharmacotherapy and the Treatment and Prevention of HIV/AIDS (R03)
Announcement
Type
New
Request for Applications (RFA) Number: RFA-AA-09-008
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (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 (4) weeks prior to the grant submission date. See Section IV.
Catalog of Federal
Domestic Assistance Number(s)
93.273
Key Dates
Release/Posted Date: February 12, 2009
Opening Date: February 16, 2009 (Earliest date an application may be submitted to
Grants.gov)
Letters of Intent Receipt Date(s): Not applicable
NOTE: On-time submission requires that
applications be successfully submitted to Grants.gov no later than 5:00 p.m.
local time (of the applicant institution/organization).
Application Due Date(s): April
16, 2009
AIDS Application Due Date(s): Not Applicable
Peer Review Date(s): July/August 2009
Council Review Date(s): August 2009
Earliest Anticipated Start Date(s): September 1, 2009
Additional Information To Be
Available Date (Activation Date): Not Applicable
Expiration Date:
April 17, 2009
Due Dates for E.O. 12372
Not Applicable
Additional
Overview Content
Executive Summary
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. Receipt, Review, and Anticipated
Start Dates
1. Letter of Intent
B. Submitting an Application Electronically
to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
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 Contacts
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
Purpose
The Effects of Alcohol Pharmacotherapies on the Treatment and Prevention of HIV/AIDS
Under this Funding Opportunity Announcement (FOA), the National Institute on Alcohol Abuse and Alcoholism requests research grant applications to conduct initial studies of the safety and feasibility of pharmacotherapies for alcohol use disorders in HIV-infected populations. These studies will set the stage for future research to: 1) test innovative combined pharmacologic therapies for alcohol use disorders in HIV+ populations for the purpose of improving adherence to antiretroviral medications, reducing the rate of viral mutation and toxicity related to alcohol-ARV interactions, and reducing sexual risk-taking; and 2) assess the potential usefulness of pharmacological interventions for alcohol use disorders in preventing secondary HIV infections in targeted high risk populations of gay men and minority women. Currently available alcohol pharmacotherapies may be tested in multiple regimens (e.g., those that do not require daily dosing) to determine safety and efficacy and to improve HIV/AIDS-related clinical outcomes, including survival. It is expected that alcohol interventions will include a behavioral component meant to enhance the effects of the pharmacotherapy under examination. These behavioral interventions should improve adherence to the pharmacotherapy regimen being tested and improve the effects of the medication. Studies funded under this initiative will lay the foundation for a future Cooperative Agreement to test alcohol treatments in populations of special interest, including but not limited to minority women and gay men.
Background
In the US, approximately 20% of all HIV patients in treatment for HIV have been diagnosed with current co-occurring alcohol use disorders. The rates are even higher for a diagnosis of lifetime alcohol use disorders, with estimates of 26% to 60% in people living with HIV/AIDS as compared with 14% to 24% in the general population. This population, while highly clinically relevant, has been underrepresented in intervention studies, often labeled non-compliant, and screened out of efficacy trials of ARV medications. Disease models for addressing the complex course of the AIDS epidemic require that this population be identified and treated effectively to control the spread of HIV/AIDS. This includes at-risk populations such as young gay men, among whom the incidence of HIV infection has been directly linked to sexual risk-taking under the influence of alcohol and drugs (Attributable Fraction: Sex Under the Influence: 29%, Heavy Drinking: 8.1%) and minority women, who are experiencing the highest rates of new HIV infection in the U.S. The current proposed projects will directly impact the type and quality of care available to this substantial segment of HIV+ individuals and inform both primary and secondary preventive intervention activities.
Pharmacological interventions for alcohol use disorders have not been evaluated in individuals with HIV at any stage in the infection, including during progression to AIDS, in the early stages of treatment with highly active antiretroviral therapies (HAART), or at the point of treatment failure when so-called salvage therapies are needed. Effective treatment for alcohol use disorders early in the course of disease and, in particular, initiation of medications for alcohol dependence may improve adherence, slow progression, and reduce risks for transmission. Biological markers of treatment response, including CD4 lymphocyte count, HIV viral RNA levels, and liver function as measured by AST, ALT, and GGT are directly responsive to continued drinking among HIV+ individuals and easily measured.
Heavy Drinking in HIV-positive Individuals and HAART Medication Adherence
The impact of alcohol use on HIV treatment outcomes is substantial. Alcohol problems in HIV-positive patients are associated with poor adherence to HAART medications. While HAART adherence in the general HIV+ samples ranges from 60% to 70%, estimates for adherence in HIV-positive at-risk drinkers are significantly reduced at 35-40%. A recent study using a large national sample of HIV-positive and HIV-negative patients examined the relationship between alcohol consumption and medication adherence and found a strong temporal inverse dose response association between alcohol and medication adherence. The effect of alcohol was most pronounced in HIV-positive individuals, with an odds ratio for non-adherence of 1.8 in non-binge drinkers and 4.3 in binge drinkers. In this study, alcohol consumption was the most significant predictor of HAART medication adherence, with the greatest adherence associated with recent abstinence from alcohol. These findings support the argument that any reduction in heavy drinking may have a positive effect on HAART adherence.
Heavy Drinking and Sexual Risk Taking
Sexual risk behaviors (e.g. sexual intercourse without condom use; multiple sexual partners, etc.) that accompany alcohol use in HIV-positive individuals have major public health implications given the predominant role that sexual transmission plays in the current HIV epidemic. Alcohol use at any level is associated with increased sexual risk behaviors. The evidence for the impact of the treatment of alcohol use disorders on decreasing sexual risk behaviors is mixed. There are data indicating that individuals who receive treatment for alcohol problems experience reductions in risky sexual behaviors, including a decline in the number of sexual partners and high-risk partners, accompanied by increased condom use. Patients who completely abstain from alcohol use for the year following treatment achieve the greatest reductions in these behaviors. On the other hand, other studies have shown no change in the prevalence of sexual risk behaviors among individuals receiving treatment for alcohol use disorders.
Medications for Alcohol Use Disorders
Several medications have been approved by the Food and Drug Administration (FDA) to treat alcohol dependence. These include oral naltrexone, extended-release injectable naltrexone, acamprosate, and disulfiram. In addition, topiramate has recently demonstrated impressive treatment outcome in alcohol dependent patients. These compounds have not been tested in individuals with co-occurring HIV infection and alcohol use disorders.
Oral Naltrexone
Naltrexone, an opioid antagonist, was first approved for alcoholism treatment by the FDA in December 1994. Since then, it has been approved in over 35 countries around the world. Currently, the results of 29 clinical trials of naltrexone have been conducted in different populations and under a variety of conditions. Most of these studies have demonstrated the efficacy of naltrexone, particularly in reducing relapse to heavy drinking. The effect size of naltrexone is similar to many medications used to treat other chronic, complex diseases, such as diabetes, depression, cancer, and cardiovascular diseases. In the COMBINE study, the largest alcohol pharmacotherapy trial ever conducted, naltrexone was effective when used with a Medical Management therapy. These results indicate that naltrexone may be used successfully in primary care and general mental health care settings.
Several studies have investigated the mechanism of action of naltrexone and have found that it curbs craving, attenuates alcohol-induced stimulation, and increases subjective ratings of sedation. Recent studies have further suggested that it diminishes the positive association between heavy drinking and mood state and disrupts the association between alcohol-induced stimulation and alcohol consumption.
The safety profile of naltrexone is favorable. It is not addictive, has no interactions with alcohol or antidepressants, and has few serious side effects. The most common side effects are nausea and headache.
Efforts are being made to determine the effectiveness of naltrexone in various groups. In a recent study, naltrexone reduced heavy drinking in a population of less severe alcohol dependence/abuse patients, referred to as early problem drinkers. In two preliminary studies naltrexone appeared effective in older alcoholics, as well as in schizophrenic alcohol dependent or abusing patients. Despite the known adverse effects of alcohol problems on HIV-positive individuals and the demonstrated benefit of naltrexone in heavy drinkers, there has not been a systematic evaluation of the efficacy and tolerability of naltrexone in HIV-positive patients or of the impact of this treatment on HIV-related clinical outcomes.
Extended-Release Injectable Naltrexone
Adherence to medications is essential in producing optimal treatment outcomes. For example, several studies have indicated that taking naltrexone 70 to 90 percent of the time is required to achieve its full benefit. To enhance compliance, two pharmaceutical companies have developed long-acting depot formulations of naltrexone that are effective for 30 days after administration. They have reported that in multi-site clinical trials of the naltrexone depot formulations, alcohol dependent patients receiving them drank fewer days and had fewer days of heavy drinking than the placebo depot group. In 2006 the FDA approved one of these long-acting formulations, Vivitrol, for the treatment of alcoholism. This has provided a viable treatment option for patients who do not want to take or may have problems taking their medications daily.
Acamprosate
Acamprosate was studied extensively and approved in Europe years before approval in the US. Studies have consistently shown that individuals treated with acamprosate are more likely to complete treatment, have longer times to their first drink, have greater abstinence rates, and demonstrate longer cumulative abstinence periods than placebo-treated patients. Still, acamprosate does not work for everyone. For example, two large US trials failed to confirm the efficacy of acamprosate. The reason for the discrepancy between the European and US findings may be that patients in European trials had more severe dependence than patients in the US trials.
Acamprosate's mechanism of action has yet to be definitively identified, although several studies suggest that it modulates the activity of the glutamate system. The side-effect profile of acamprosate appears favorable. There is no liability for drug dependence or interactions with other medications often taken by alcoholics, including disulfiram and antidepressants. The most common side effect is diarrhea. Since acamprosate is not metabolized by the liver, it is not contraindicated in liver disease, an advantage for those treated with HAART.
Disulfiram
Disulfiram (Antabuse) is an aversive agent that has been used to treat alcoholism for over half a century. It inhibits aldehyde dehydrogenase, an enzyme involved in catabolizing acetaldehyde to acetic acid, resulting in accumulation of acetaldehyde. If alcohol is consumed by an individual on disulfiram, an intense uncomfortable reaction occurs, referred to as the disulfiram-ethanol reaction. Symptoms include facial flushing, tachycardia, nausea, vomiting, hypotension, chest pain, and headaches. At doses of 250 mg daily, disulfiram itself may produce certain adverse effects. These include mild effects such as sedation, drowsiness, headache, garlic-like or metallic taste, dermatitis, and skin rash as well as moderate to severe effects, including hepatotoxicity and peripheral neuropathy. Several studies have demonstrated that disulfiram is effective in reducing alcohol consumption. Medication compliance appears to be a critical component for a positive treatment outcome with disulfiram. Recently disulfiram treatment has been shown to be beneficial in patients with comorbid cocaine dependence and alcohol dependence or abuse. Due to the risk of hepatotoxicity, it is essential that a physician examine the patient for symptoms and signs of hepatotoxicity and obtain liver function tests at onset of treatment and throughout the trial period. This is particularly important if disulfiram is used in combination with HAART medications.
Topiramate
Topiramate, a sulphamate fructopyranose derivative, facilitates GABA activity, antagonizes glutamate activity at the α-amino-3-hydroxy-5-methylisoxazole-4-propionic acid (AMPA) and kainate receptors, inhibits L-type calcium channels, and reduces voltage-dependent sodium channel activity. It is currently approved for epilepsy in many countries around the world, including the US and Western Europe, and for migraine in the US. Two recent clinical trials demonstrated that topiramate is effective in treating alcohol dependent patients, with an effect size greater than that observed with naltrexone and acamprosate. Importantly, efficacy was established in subjects who were drinking at the time of starting the medication. In contrast, most of the trials for naltrexone and acamprosate involved subjects who were abstinent before beginning the trial. Finally, the side-effects of topiramate are generally more severe than those of naltrexone and acamprosate. They include dizziness, paresthesias, psychomotor slowing, memory or concentration impairment, and weight loss.
Populations with Comorbid Disorders
A primary objective of this initiative is to encourage research on the feasibility and efficacy of medications in HIV-infected patients with alcohol use disorders. Many of these patients may also suffer from other substance use disorders. For example, as many as 90 percent of cocaine addicts in both treatment and community settings have a problem with alcohol. Problem drinking is particularly prevalent among patients in methadone maintenance, with rates ranging from 16 to 33%, and has been associated with increased criminal activity, a higher incidence of depression and anxiety, greater likelihood of treatment failure, and higher rates of high risk sexual behavior and HIV infection. In addition, patients suffering from alcohol and other substance abuse comorbidity have a higher suicide rate, have less social support, and are more likely to drop out of treatment. Applications are encouraged to study this population in alcohol and substance abuse treatment settings.
Behavioral Interventions in Pharmacotherapy Trials
Choosing the appropriate behavioral intervention to combine with medications in these trials is vital for a successful outcome. For the alcohol component, it is essential that the therapy focuses on compliance enhancement. This consists of providing reminders, reviewing side-effects of the medication, and identifying obstacles to adherence. The therapy should also help the patient set a goal to either become abstinent or cut down to a safe level of drinking. Two brief therapies that have been successfully used in alcohol pharmacotherapy trials are the COMBINE Medical Management Therapy and the Brief Behavioral Compliance Enhancement Treatment (BBCET) Therapy. To address the issues associated with HIV infection, the investigators may need to integrate components of HAART Medication Adherence Management, counseling for sexual risk behaviors, and counseling to address the specific needs of HIV-positive patients.
Monitoring the Safety of Patients
Since there is little or no information on combining medications to treat alcohol use disorders with HAART medications, it is essential for the safety of the subjects that these trials be closely monitored. This includes monitoring the side-effects and toxicity of the combined medications. Liver function tests should be obtained regularly throughout the treatment period. It is also recommended that each study have an independent Data and Safety Monitoring Board.
Coordination of Research Effort
Within 3 months after awards have been made, NIAAA will convene a meeting of grantees to identify and agree upon a core set of alcohol and HIV-related outcomes that shall be standardized across all studies funded under this initiative.
Research Objectives
General goals for this FOA include but are not limited to the development of effective pharmacological interventions for alcohol use disorders among HIV+ individuals to:
See Section VIII, Other Information - Required Federal
Citations, for policies related to this
announcement.
Section
II. Award Information
1. Mechanism of Support
This
FOA will utilize the expanded R03 grant mechanism to support projects including
pilot and feasibility studies; small, self-contained research projects; and to
foster the establishment of new research collaborations between HIV/AIDS and
alcohol researchers. As the R03 is intended to support small research projects
that can be carried out in a short period of time with limited resources, it is
intended that, with the use of this mechanism, investigators and collaborative
research groups will be able to conduct initial pilot and feasibility studies
to better position them for a subsequent R01 application. The Project
Director/Principal Investigator (PD/PI) will be solely responsible for
planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts (see SF424 (R&R) Application Guide). It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, a U.S. organization submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) must use the PHS398 Modular Budget component.
All foreign applicants must complete and submit budget requests using the Research & Related Budget component.
2. Funds Available
NIAAA
intends to commit approximately $1M dollars in FY2009 to fund 4-6
applications. The maximum allowable award is $100,000 per year over a maximum
project period of 2 years, or a total of $200,000 in direct costs per award.
Because
the nature and scope of the proposed research will vary from application to
application, it is anticipated that the size and duration of each award will
also vary. Although the financial plans of the IC(s) provide support for this
program, awards pursuant to this funding opportunity are contingent upon the
availability of funds.
Facilities
and Administrative (F&A) costs requested by consortium participants are not
included in the direct cost limitation. See NOT-OD-05-004.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A.
Eligible Institutions
The following
organizations/institutions are eligible to apply:
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her 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.
More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
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
Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.
Resubmissions. Resubmission applications are not permitted in response to this FOA.
Renewals. Renewal applications are not permitted in response to this FOA.
Section IV. Application and Submission Information
To
download a SF424 (R&R) Application Package and SF424 (R&R) Application
Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for
Grant Electronically button in this FOA or 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 NIH eRA Commons.
Several additional separate actions are required before an applicant can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered
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.
Both the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
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 the SF424 (R&R)
Application Guide for this FOA through Grants.gov/Apply.
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 for this FOA through Grants.gov/Apply.
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, 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 Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in 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 or Research & Related
Budget, as
appropriate (See Section IV.6., Special Instructions, regarding appropriate required
budget component.)
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
Foreign
Organizations (Non-Domestic
[non-U.S.] Entities)
NIH policies concerning grants to Foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from Foreign organizations must:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States (U.S.) or that augment existing U.S. resources.
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in item 15 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan [Section 14 of the Research Plan Component in the SF424 (R&R)], must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.
When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.
3.
Submission Dates and Times
See Section IV.3.A. for details.
3.A.
Submission, Review, and Anticipated Start Dates
Opening
Date: February 16, 2009 (Earliest date an application may be submitted to
Grants.gov)
Application Due
Date(s): April 16, 2009
Peer Review
Date(s): July/August 2009
Council Review Date(s): August 2009
Earliest
Anticipated Start Date(s): September 1, 2009
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.
3.B.
Submitting an Application Electronically to the NIH
To submit an
application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp
and follow Steps 1-4. Note: Applications must only be submitted
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
In order to expedite the review, applicants are requested to notify the NIAAA Referral Office by email ([email protected].) when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
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 due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s)
and time, the application may be delayed in the review process or not reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.
Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the IC. Incomplete and non-responsive applications will not be reviewed.
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
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 or renewal
award if such costs: 1) are necessary to conduct the project, and 2) 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 or renewal 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 and Information
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD(s)/PI(s) 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.
Organizational DUNS
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 Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
PHS398 Research Plan Component Sections
Page limitations of the PHS398 Research Plan component must be followed as outlined in the SF424 (R&R) Application Guide. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component 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.
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:
Appendix Materials
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not comply with the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.)
(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources or state appropriate reasons why such sharing is restricted or not possible (see Sharing Model Organisms Policy, and NOT-OD-04-042.)
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.)
Foreign Applications (Non-Domestic [non-U.S.] Entities)
Indicate how the proposed project has specific relevance to the mission and objectives of the NIH/IC and has the potential for significantly advancing the health sciences in the United States.
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 that are
complete and
responsive to this FOA will be evaluated for scientific and
technical merit by an appropriate peer review group convened by NIAAA and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/),
using the review criteria stated below.
As part of the scientific peer review, all applications will:
Applications submitted in response to this FOA will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:
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
critiques, 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. Each of these criteria will
be addressed and considered in assigning the overall score, and weighted 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 meritorious 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 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? For applications
designating multiple PDs/PIs, is the leadership approach, including the
designated roles and responsibilities, governance, and organizational
structure, consistent with and justified by the aims of the project and the
expertise of each of the PDs/PIs?
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 PD(s)/PI(s) and other key personnel 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? Do(es) the PD(s)/PI(s) and investigative team bring complementary
and integrated expertise to the project (if applicable)?
Environment: Do(es) the
scientific environment(s) 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 rating:
Resubmission Applications (formerly revised/amended applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?
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 the Human Subjects Sections
of the PHS398 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 the Human Subjects Sections of the PHS398
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 adequacy of the plans for their care and use
will be assessed. See the Other Research Plan Sections of the PHS398 Research
Plan component of the SF424 (R&R).
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. The priority score should not be
affected by the evaluation of the budget.
Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.
2.C. Resource Sharing Plan(s)When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.
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 or 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
Awardees will be
required to submit the Non-Competing
Continuation Grant Progress Report (PHS 2590) annually and financial
statements as required in the NIH Grants
Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished, when a recipient changes institutions, or when an award is terminated.
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 (program), peer review, and financial or grants management issues:
1. Scientific/Research Contact(s):
Deidra Roach, M.D.
Division
of Treatment and Recovery Research
National
Institute on Alcohol Abuse and Alcoholism
5635
Fishers Lane, Rm. 2040
Bethesda, MD 20892, MSC 9304
Telephone:
(301) 443-5820
Fax:
(301)443-8774
Email:
[email protected]
2. Peer Review Contact(s):
Abraham P. Bautista, Ph.D.
Chief, Extramural Project Review Branch
Office
of Extramural Activities
National
Institute on Alcohol Abuse and Alcoholism
5635
Fishers Lane, Room 2085
Bethesda, MD 20892, MSC 9304
Telephone:
(301) (301) 443-9737
Fax: 443-6077
Email:[email protected]
3. Financial/Grants Management Contact(s):
Ms. Judy Fox
Chief,
Grants Management Branch
National
Institute on Alcohol Abuse and Alcoholism
5635
Fishers Lane, Room 3023
Bethesda,
MD 20892, MSC 9304
Telephone:
(301) ) 443-4704
Fax: (301) 443-3891
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 (45 CFR 46) 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).
Sharing Research Data:
Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their
institutions, on issues related to institutional policies and local
institutional review board (IRB) rules, as well as local, State and Federal
laws and regulations, including the Privacy Rule. Reviewers will consider the
data sharing plan but will not factor the plan into the determination of the
scientific merit or the priority score.
Policy for Genome-Wide
Association Studies (GWAS):
NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/
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. Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal 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.
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.
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) application; 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.
Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can
be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research.
NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators
funded by the NIH must submit or have submitted for them to the National
Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed
manuscripts upon acceptance for publication, to be made publicly available no
later than 12 months after the official date of publication. The
NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more
information, see the Public Access webpage at http://publicaccess.nih.gov/.
Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS)
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 HHS 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.
URLs
in NIH Grant Applications or Appendices:
All applications and proposals
for NIH funding must be self-contained within specified page limitations. For
publications listed in the appendix and/or Progress report, Internet addresses
(URLs) or PubMed Central (PMC) submission identification numbers must be used
for publicly accessible on-line journal articles. Publicly accessible
on-line journal articles or PMC articles/manuscripts accepted for publication
that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference
in either the Bibliography & References Cited section, the Progress Report
Publication List section, or the Biographical Sketch section of the NIH grant
application. A URL or PMC submission identification number citation may be repeated
in each of these sections as appropriate. There is no limit to the number of
URLs or PMC submission identification numbers that can be cited.
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 FOA 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. 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 Part 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 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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