Part I Overview Information


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/)

Title: Drug Abuse Dissertation Research: Epidemiology, Prevention, Treatment, Services, and/or Women and Sex/Gender Differences (R36)

Announcement Type
This is a reissue of PAR-06-446.

Update: The following update relating to this announcement has been issued:

Program Announcement (PA) Number: PAR-10-020

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)
93.279

Key Dates
Release/Posted Date: November 4, 2009
Opening Date: January 16, 2010 (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): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: (Extended to May 8, 2013 per NOT-DA-13-007), Originally January 8 ,2013

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. Submission, 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

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 of this FOA

The National Institute on Drug Abuse (NIDA) announces the availability of NIH Dissertation Award grants (R36) to support drug abuse doctoral dissertation research in epidemiology, prevention, treatment, services, and/or women and sex/gender differences, areas in which there is a significant need for new investigators. Grant support is designed to encourage doctoral candidates from a variety of academic disciplines and programs to conduct research in these areas of interest to NIDA. It is hoped that this program will ultimately facilitate the entry of promising new investigators into the field of drug abuse research.

Special Program Considerations for Recruiting Minority Researchers

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

Research Objectives

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

The descriptions below are examples of the research foci of this grant program and are provided to guide potential applicants to determine whether a given scientific topic may be appropriate for this initiative. These descriptions are not intended to be comprehensive. In addition, given the complexity of drug abuse research, it is permitted to conduct the proposed dissertation research in conjunction with an ongoing research study or to use extant data. Research studies focused on HIV/AIDS and Health Disparities are encouraged.

Epidemiology:

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

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

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

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

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

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

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

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

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

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

Prevention:

Studies that use findings on cognitive strategies and functioning to improve or develop targeted drug abuse or drug-related HIV prevention messages and approaches.

Studies on the efficacy of drug abuse prevention program and strategies that are largely untested but widely used such as: case management, mentoring, job training, and challenge activities.

Studies to develop and test the efficacy of interventions for specific contexts such as primary care settings, college and/or personnel orientation programs, workplaces, faith-based settings, and community recreational settings.

Tests for the effectiveness of proven drug abuse or HIV prevention interventions for sexual minorities, underserved youth, or for individuals at-risk for co-occurring drug abuse, psychiatric disorders, anti-social behavior, and/or high-risk sexual behaviors.

Studies to analyze longitudinal data to determine the long-term effectiveness of drug abuse prevention programs on drug use, abuse, and dependence and potential crossover effects on outcomes such as HIV & STI risk, criminal justice involvement, and academic achievement.

Studies of the initiation, development, and continuity of community coalitions to prevent drug abuse and their impact on selection and implementation of effective drug abuse prevention strategies.

Studies to develop and pilot test brief preventive intervention programs designed to reduce risk for drug abuse and sexual risk taking in hard-to-reach populations.

The development and assessment of physiological and biochemical measures that may elucidate cognitive and affective factors associated with individual responsiveness to particular prevention interventions.

The development of methodological approaches to solve common problems faced in the analysis of complex multi-wave datasets.

Pilot drug abuse or drug-related HIV prevention studies designed to identify novel approaches to risk reduction, such as through altering physical environments, promoting physical activity, and promoting mindfulness-based preventive interventions.

Treatment:

Behavioral and integrative treatment research at NIDA is guided by a stage model of therapy development. For a detailed description of this model, as well as NIDA's therapy development and testing priorities, please see the Behavioral Therapies Development Program Announcement at: (http://grants.nih.gov/grants/guide/pa-files/PA-10-011.html) Examples of behavioral treatment research appropriate for this announcement include, but are not limited to the following:

Utilizing genetic, neuropsychological, behavioral, or other diagnostic data to tailor treatment to specific subgroups.

Utilizing relevant research from the animal model literature (e.g., avoidance and impulsivity paradigms) to develop or improve treatments/interventions.

Utilizing relevant research from the developmental (e.g., basic research on familial and peer influences during adolescence) or social psychology (e.g., basic research on stereotyping) literatures to improve treatments.

Stage I studies developing or adapting behavioral interventions that promote adherence to drug and alcohol abuse pharmacotherapy

Adapting/modifying evidence-based treatments for use in non-traditional and community settings, into community-friendly formats (e.g., individual to group, briefer formats, less intensive delivery, computer-assisted delivery, etc.), and evaluating their resulting potency

Developing sleep hygiene modules for incorporation into drug abuse treatment protocols for drug abusers with insomnia.

Developing and assessing treatment provider training procedures for evidence-based treatments (e.g., computerizing training procedures; this can include initial training as well as supervision requirements).

Developing interventions to promote adherence to medical treatment regimens in HIV+ drug users.

Computerizing, or partially computerizing evidence-based HIV prevention interventions for individuals in drug abuse treatment

Developing interventions to reduce pain in individuals addicted to prescription drugs, non-drug abusing populations, or individuals with chronic pain.

Research involving secondary analyses of existing behavioral treatment research data sets to identify predictors, moderators, or mediators of treatment outcome, mechanisms of action of treatment, or secondary effects of treatment on participants in various contexts (e.g., peer group, school, work, family) or on participants? family members (e.g., children).

Conducting secondary analysis of combined behavioral and pharmacological treatment clinical trials.

Research on instrument development and/or psychometric analysis of tools for the clinical assessment of drug abuse, treatment efficacy, treatment fidelity, and HIV risk, or for constructs believed to be related to mechanisms of action of behavioral treatment efficacy.

Research to develop and test a therapy module to be added to an existing therapy to address targeted issues (e.g., adding an HIV risk reduction module to a family therapy for drug-abusing adolescents).

Research to integrate innovative health technologies into new or existing behavioral and integrative treatments.

Research testing a principle of behavior change among drug-abusers in treatment (e.g., by adding more frequent or multi-method assessments to an existing study in order to track behavior change over time).

Services:

Studies to assess the impact of financing and organizational and managerial factors on access to and use, quality, efficiency, costs, and outcomes of prevention and treatment services.

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

Drug abuse service delivery systems and models, such as continuity of care, development of therapeutic rapport, service linkages and integration models.

Studies that advance the adoption and implementation of evidence-based drug abuse prevention and treatment interventions into service delivery systems (e.g., specialty care, primary care, criminal justice, child welfare).

Drug abuse treatment and prevention services for HIV seropositive patients and for those at risk of HIV infection and other diseases that are a consequence of drug abuse.

Studies focusing on management strategies (e.g., work team models, quality management) and business practices aimed at improving the quality, effectiveness, and efficiency of drug abuse treatment and prevention services.

Research focusing on the development or improvement of research methods---including but not limited to study design, measurement, data collection, and analytic procedures---for studying the societal impact of drug abuse and/or the delivery, quality, outcomes, and economics of drug abuse prevention or treatment services.

Women and Sex/Gender Differences:

Through this dissertation award program, NIDA seeks to foster research on females and sex/gender differences in all areas of drug abuse research. From basic cellular and genetics research to epidemiology, prevention, treatment, and services research, investigators are encouraged to explore the possible importance of sex/gender differences in their chosen area of study and to explore drug abuse issues specific to females. Examples of research areas include, but are not limited to the following:

Sex/Gender differences in the basic behavioral, biological, and genetic mechanisms underlying drug abuse and addiction; and laboratory (both human and animal), clinical, and epidemiological studies of sex/gender differences in the determinants of initiation, progression, maintenance of drug use and addiction, and responsiveness to treatment.

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

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

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

The development and evaluation of sex/gender-specific interventions directed at preventing HIV infection and treating HIV/AIDS among drug using populations.

For additional background and research areas of interest dealing with women and sex/gender differences, see http://grants.nih.gov/grants/guide/pa-files/PA-07-329.html.

Questions on the relevance of a particular research topic to NIDA's scientific mission and other questions about this FOA should be addressed to the program contact listed under INQUIRIES. Potential applicants are strongly encouraged to discuss their application with the appropriate program contact.

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 use the National Institutes of Health (NIH) Dissertation Award (R36) mechanism. The predoctoral student is the Project Director/Principal Investigator (PD/PI) of the application. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project under the supervision, and with the approval, of a university-approved and appointed doctoral committee. The student-PD/PI must have an appointment at the applicant institution (e.g., research assistant).

These awards support research activities related to preparation of a dissertation and do not support study leading to the M.D., D.O., or D.D.S., or similar professional degrees unless they are part of a combined degree program (see: Individual Pre-doctoral National Research Award for M.D./Ph.D. Fellowships - PA-99-089, which may be obtained from: http://grants.nih.gov/grants/guide/pa-files/PA-09-207.html. For additional information on training opportunities, please visit NIDA?s Research Training Opportunities Website (http://www.nida.nih.gov/ResearchTraining/Traininghome.html).

This FOA uses ?Just-in-Time? information concepts (see SF424 (R&R) Application Guide). It also uses the non-modular budget format.

Dissertation awards are not renewable nor may they be transferred to another PD/PI. Applicants may submit one resubmission in response to this FOA.

2. Funds Available

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. However, the total project period for an application submitted in response to this FOA may not exceed two years and may be extended without additional funds for up to 12 months. Grants to support dissertation research will provide no more than $50,000 in direct costs per year.

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

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

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.

The PD/PI for a dissertation research grant must be enrolled in an accredited doctoral degree program in the behavioral, biomedical, or social sciences and must propose to conduct research in one of the areas specified in this funding opportunity announcement. The PD/PI must be a registered doctoral student in good standing.

The PD/PI doctoral student must be a citizen or a non-citizen national of the United States or an individual who has been lawfully admitted for permanent residence (i.e., in possession of currently valid Permanent Resident Card (USCIS Form I-551) at the time of application.

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

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. A doctoral candidate may submit only one application in response to this announcement.

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) are permitted only a single amendment (A1). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).

Renewals. Recipients of the R36 award are not eligible to submit a renewal application.

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.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. 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 with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered ?on-time? (see 3.C.1 for more information about on-time submission).

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 http://www.grants.gov/applicants/get_registered.jsp

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 PD(s)/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

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.

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 301-435-0714, Email: GrantsInfo@nih.gov.

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 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 Research & Related Budget

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

SPECIAL INSTRUCTIONS

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: January 16, 2010 (Earliest date an application may be submitted to Grants.gov) Letter of Intent Receipt Date(s): Not applicable.
Application Due Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please 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. 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.

3.C. Application Processing

3.C.1 Submitting On-Time

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. All applications must meet the following criteria to be considered ?on-time?:

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step ? applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified 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 assembled application before it automatically moves forward to NIH for further processing.

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. 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 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. However, the NIH will accept a resubmission application, but such application must include an Introduction (1 page maximum) addressing the critique from the previous review.

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: 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 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 NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Letter of Certification: A letter from the faculty committee or university official directly responsible for supervising the development and progress of the dissertation research must be submitted with the application. The letter must: (a) fully identify the members of the dissertation committee and certify their approval of the dissertation proposal; (b) certify that all requirements for the doctoral degree, except the dissertation and, if necessary, the clinical internship, are completed or will be completed by the time the grant award starts; (c) note that the university official or faculty committee expects the doctoral candidate to proceed with the approved project proposal with or without NIDA support; and (d) briefly describe the facilities and resources for the project and certify that they are adequate to conduct the proposed research. As only 1 .pdf file is allowed for the Letter of Support item in the PHS Research Strategy, combine this letter with Letters of Support (below) into one file.

Letters of Support: Information on the student's academic standing as well as a commitment from the school to implement the study as proposed must be included in the application. The student's advisor must submit with the grant application a letter of recommendation in support of the candidate and the proposed research dissertation. This should be placed in the Letters of Support attachment.

Official Transcript: A copy of an official transcript of the applicant's graduate school record should be included with the application. The transcript should be placed in the Appendix.

Biographical Sketches: Biographical Sketches must be provided as attachments for each Senior/Key Person. The mentor is considered a key person on the proposed project and his/her profile must be included under the Senior/Key Person Profile(s) Component. For the ?doctoral candidate,? the attached Biographical Sketch must also contain a scientific autobiography that states his/her career goals, including reference to their interest in the specific areas of research designated in this FOA and a description of their intended career trajectory. This information will be used by NIDA program staff to determine how the proposed study addresses program priorities.

Project Description: The applicant must provide a narrative project description (not to exceed 6 pages) that contains a detailed scientific and technical discussion of the following specific points:

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

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

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

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

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

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.?

Research Strategy Page Limitations

The R36 application Research Strategy section of the PHS398 may not exceed 6 pages, including tables, graphs, figures, diagrams, and charts. See Table of Page Limits.

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts.

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.. 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: Not Applicable

(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 NIH Guide 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/.)

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

Review Process

Applications submitted for this funding opportunity will be assigned on the basis of established PHS referral guidelines to the ICs for funding consideration.

Applications that are complete will be evaluated for scientific and technical merit by (an) appropriate scientific review group(s) 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:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).

Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)/Mentor(s). Is the work proposed appropriate to the experience level of the applicant? Does the applicant show promise as a research investigator in areas relevant to the proposal? Is the proposed research project consistent with the long-term research interests of the applicant? Are the faculty advisor/dissertation chair and other doctoral committee members appropriately qualified to provide guidance as needed? Have the faculty advisor/dissertation chair and any other participating members of the committee indicated that they will provide sufficient time to allow completion of the dissertation? Will the faculty advisor/dissertation chair provide the necessary supervision and mentoring to the applicant?

Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the applicants adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Selection Process

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:

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

When multiple years are involved, 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.

Section VII. Agency Contacts


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):

Jessica Chambers, Ph.D.
National Institute on Drug Abuse
Division of Clinical Neuroscience and Behavioral Research
Behavioral and Integrative Treatment Branch
6001 Executive Boulevard, Suite 3154, MSC 9593
Bethesda, MD 20892-9593
Phone: 301-443-2237
Fax: 301-443-6814
Email: jessica_chambers@nih.gov

2. Peer Review Contact(s):

Not applicable

3. Financial/Grants Management Contact(s):

Debra Dudley

Grants Management Branch/OPRM

National Institute on Drug Abuse/NIH/DHHS

6101 Executive Boulevard, Room 270

Bethesda, MD 20892

Telephone: (301) 443-6710

FAX: (301) 594-6849

Email: ddudley@nida.nih.gov

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).

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-09-116.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/.


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