Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

National Institutes of Health (NIH)
U.S. Food and Drug Administration  (FDA)

Components of Participating Organizations

National Institute on Drug Abuse (NIDA)

Funding Opportunity Title

Population Assessment of Tobacco and Health (PATH) Biospecimen Access (X01)

Activity Code

X01 Resource Access Award

Announcement Type

New

Related Notices
  • NOT-OD-18-009 - Reminder: FORMS-E Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2018.
  • October 23, 2017 - Notice of Change in the Due Date for PAR-17-458. See Notice NOT-DA-17-055.
Funding Opportunity Announcement (FOA) Number

PAR-17-458

Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.279

Funding Opportunity Purpose

 The Population Assessment of Tobacco and Health (PATH) Study provides the scientific community with biospecimens (urine, plasma, and serum) and related research data on behaviors, attitudes, biomarkers and health outcomes associated with tobacco use in the U.S.  This opportunity allows investigators to apply for access to the biospecimens from the PATH Study.  Information about the PATH Study and this resource may be found on the PATH Study series page at the University of Michigan’s National Addiction & HIV Data Archive Program (NAHDAP) website, part of the Inter-University Consortium for Political and Social Research’s (ICPSR) website (https://doi.org/10.3886/Series606).

Key Dates

 

Posted Date

August 15, 2017

Open Date (Earliest Submission Date)

New Date February 1, 2018

Letter of Intent Due Date(s)

Not Applicable.

Application Due Date(s)

New Dates March 28, 2018, September 26, 2018, March 28, 2019, September 26, 2019, March 26, 2020, September 28, 2020, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

New Dates July 2018, January 2019, July 2019, January 2020, July 2020, January 2021

Advisory Council Review

Not Applicable

Earliest Start Date

New Date July 15, 2018

Expiration Date

New Date November 1, 2020 per issuance of NOT-DA-17-055. (Original Expiration Date: August 1, 2020)

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4.  

    Table of Contents

    Part 1. Overview Information
    Part 2. Full Text of the Announcement

    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information


    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description

    Purpose

    This Funding Opportunity Announcement (FOA) allows investigators to apply for access to the Population Assessment of Tobacco and Health (PATH) Study biospecimens for use in conducting tobacco-related research studies. The PATH Study is a collaboration between the National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), and the Center for Tobacco Products (CTP), U.S. Food and Drug Administration (FDA). It was launched in 2011 to inform FDA's regulatory activities under the Family Smoking Prevention and Tobacco Control Act. The PATH Study is an ongoing longitudinal cohort study on tobacco use behavior, attitudes and beliefs, and tobacco-related health outcomes. The PATH Study is planned through 2024.

    The PATH Study collects data from adults and youth. Parents are also interviewed and their responses are appended to their youth's record in the Youth dataset. For the baseline wave (Wave 1) the study sampled over 150,000 mailing addresses across the United States to create the national sample of tobacco users and non-users: over 32,000 adults and 13,000 youth. The number of cases will vary from wave to wave.

    Detailed information on the policy for obtaining PATH Study biospecimens, and the application and review processes may be found on the PATH Study webpage at the University of Michigan’s National Addiction & HIV Data Archive Program (NAHDAP) website, part of the Inter-University Consortium for Political and Social Research’s (ICPSR) website (https://doi.org/10.3886/Series606).  Applicants should visit this website before applying for access PATH Study biospecimens.

    Background

    The Family Smoking Prevention and Tobacco Control Act (FSPTCA), signed by the President in June 2009, created the FDA Center for Tobacco Products (CTP) and granted it authority to regulate the manufacture, marketing, and distribution of cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco in order to protect public health. The law also gave FDA the ability to regulate additional tobacco products, commonly referred to as “deeming” them through rulemaking.  In 2016 FDA finalized a rule that extends FDA's regulatory authority to all tobacco products including electronic cigarettes or electronic nicotine delivery systems (ENDS), cigars, pipe tobacco, hookah tobacco, and other tobacco products such as nicotine gels. A full description of the FSPTCA can be found at: http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm298595.htm

    The PATH Study is a national cohort study designed to generate longitudinal epidemiologic data on tobacco use behaviors including patterns of use, attitudes, beliefs, exposures, and related health.  The cohort is a household-based, nationally representative sample of approximately 46,000 participants.  These include both youth (12 to 17 years) and adult (18 years and older) current users of a wide array of tobacco products, former tobacco product users, and nonusers. The participants were recruited from 156 geographical primary sampling units (PSUs) across the U.S. in which a PSU is a county or group of counties.  The data generated by the PATH Study will contribute to the evidence base used to inform FDA’s regulatory mission under the TCA.

    The PATH Study was launched in 2011 and consists of a Field Test study followed by four annual (Waves 1 through 4) and three biennial (Waves 5 through 7) waves of data and biospecimen collection. The 1st annual wave began in September 2013 and was completed in December 2014.  Waves 2 through 4 began in October of 2014, 2015, and 2016, respectively, and were completed approximately 1 year after being started. Wave 5, the first biennial wave, will begin in 2018. The multi-wave design allows for the longitudinal assessment of the participants’ patterns of use of tobacco products, tobacco exposures, health, and risks for disease.

    PATH Study Biospecimen and Data Resource

    Biospecimens and questionnaire data are collected from participants during each of four annual waves (Waves 1 to 4) and three subsequent biennial waves (Waves 5 through 7).  Biospecimens from subsamples of participants in each wave are analyzed for biomarkers of tobacco exposure and harm.

    Stored biospecimens available to researchers include urine, serum, and plasma. Questionnaire data includes information on use of tobacco products and behaviors (addiction, cessation, relapse, etc.), exposures, attitudes, beliefs, knowledge, and health status.  Biospecimens from subsamples of PATH Study participants, including tobacco product nonusers and as well as a diverse mix of tobacco product users, were analyzed for biomarkers of harm and tobacco exposure.  Information about the numbers and types of biospecimens, questionnaire and biomarker data that are available to applicants may be found at the (NAHDAP) website, (https://doi.org/10.3886/Series606).

    Research Scope

    Investigators proposing meritorious and feasible studies consistent with PATH Study objectives and/or research priorities for tobacco regulatory science will be given highest priority for access to PATH biospecimens.  Studies that address other objectives which expand the knowledge of tobacco use and/or tobacco related health outcomes will also be considered, but will be a lower priority.  The PATH Study objectives may be found at (https://doi.org/10.3886/ICPSR36231.

    Application Procedures - Biospecimen Availability

    Interested applicants are required to contact the NIH PATH Study team at least 5 months in advance of the application submission deadlines to determine whether there is sufficient quantity of the biospecimens required for the proposed study.  A letter from the PATH Study team documenting that there is sufficient quantity of the biospecimens required for the proposed study must be included with the application.  The PATH Study team should be contacted at: PATHStudyBiospecimens@westat.com.

    For more information on the procedures to determine biospecimen availability, go to the PATH Study series page at the NAHDAP website (https://doi.org/10.3886/Series606. 

    See Section VIII. Other Information for award authorities and regulations.

    Section II. Award Information
    Funding Instrument

    Other: A mechanism that is not a grant or cooperative agreement.  Examples include access to research resources or pre-applications.

    Application Types Allowed

    New

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

    Clinical Trial?

    Clinical Trials Not Allowed for due dates on or after January 25, 2018: Only accepting applications that do not propose clinical trials

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    The total number of projects granted access to biospecimens is dependent on the number of meritorious applications and the availability of biospecimens. 

    Award Budget

    Not Applicable; funds are not awarded via the X01 mechanism.

    Award Project Period

    The scope of the proposed project should determine the project period.  The maximum project period is 5 years.  

    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
    Eligible Organizations

    Higher Education Institutions

    • Public/State Controlled Institutions of Higher Education
    • Private Institutions of Higher Education

    The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

    o   Hispanic-serving Institutions

    o   Historically Black Colleges and Universities (HBCUs)

    o   Tribally Controlled Colleges and Universities (TCCUs)

    o   Alaska Native and Native Hawaiian Serving Institutions

    o   Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

    Nonprofits Other Than Institutions of Higher Education

    • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
    • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

    For-Profit Organizations

    • Small Businesses
    • For-Profit Organizations (Other than Small Businesses)

    Governments

    • State Governments
    • County Governments
    • City or Township Governments
    • Special District Governments
    • Indian/Native American Tribal Governments (Federally Recognized)
    • Indian/Native American Tribal Governments (Other than Federally Recognized)
    • Eligible Agencies of the Federal Government
    • U.S. Territory or Possession

    Other

    • Independent School Districts
    • Public Housing Authorities/Indian Housing Authorities
    • Native American Tribal Organizations (other than Federally recognized tribal governments)
    • Faith-based or Community-based Organizations
    • Regional Organizations
    Foreign Institutions

    Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
    Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
    Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

    Required Registrations

    Applicant Organizations

    Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

    • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
    • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
    • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
    • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

    Program Directors/Principal Investigators (PD(s)/PI(s))

    All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

    Eligible Individuals (Program Director/Principal Investigator)

    Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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.

    For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

    2. Cost Sharing

    This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

    3. Additional Information on Eligibility
    Number of Applications

    Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

    The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

    • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
    • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
    Section IV. Application and Submission Information
    1. Requesting an Application Package

    Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

    2. Content and Form of Application Submission

    It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

    For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

    Page Limitations

    All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed with the following exceptions or additional requirements:

    For this specific FOA, the Research Strategy section is limited to 12 pages.

    Instructions for Application Submission

    The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

    SF424(R&R) Cover

    All instructions in the SF424 (R&R) Application Guide must be followed.  With the following additional instructions as this is not an application for funding:

    Total Federal Funds Requested: Enter $0

    Total Federal and Non Federal Funds: Enter $0

    Estimated Program Income: Enter $0.

    SF424(R&R) Project/Performance Site Locations

    All instructions in the SF424 (R&R) Application Guide must be followed.  

    SF424(R&R) Other Project Information

    All instructions in the SF424 (R&R) Application Guide must be followed. With the following additional instructions:

    Describe facilities where laboratory analyses will be done in Facilities and Other Resources.  

    Describe instrumentation that will be used to conduct laboratory analyses in Equipment.   

    SF424(R&R) Senior/Key Person Profile

    All instructions in the SF424 (R&R) Application Guide must be followed. 

    PHS 398 Cover Page Supplement

    All instructions in the SF424 (R&R) Application Guide must be followed.

    PHS 398 Research Plan

    All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

    Research Strategy

    Significance

    Explain how the proposed use of biospecimens relates to PATH Study objectives, and how results will inform the scientific community, public health policy and/or tobacco regulation.

    Explain how the proposed project will improve scientific knowledge and technical capability for tobacco control and regulatory science.

    Describe how your study aims make use of the unique nature of the PATH Study design and biospecimens.  Provide justification for requesting these specific biospecimens and explain why other sources of similar biospecimens are not appropriate. 

    Approach

    Describe how your overall research strategy and use of specific methods and analyses will accomplish the specific aims of the study.  Describe how the choice of participant variables, biospecimens, assays, and statistical analyses will answer the research questions.  List challenges, and potential confounders and biases that might be encountered in conducting the proposed study and what measures will be taken to minimize these issues.

    Biospecimen Information:  List participant characteristics (variables) to define participant groups for source of biospecimens.   Describe numbers, types and volumes of requested biospecimens. Include a clear justification for number of biospecimens and volume(s) of biospecimens being requested.  

    PATH Study biospecimens may be used to validate previous studies or used in combination with biospecimens from other studies to increase sample size and study power.  However, if biospecimens are used for the latter purpose, investigators must show in their application that the biospecimens from the PATH Study and other studies are comparable.

    Methodology/Assays: List each laboratory assay planned for the biospecimens.  Provide the following information for each assay:

    • Volume required (include both dead and assay volumes); multiplex assay approaches that minimize volume requirements are preferred;
    • Methodologies and instrumentation (include assay kit name if commercial kit);
    • Analyte stability and assay validation for type of biospecimen requested;
    • Assay performance (precision, specificity, accuracy, linearity of range, limits of detection);
    • Quality control (QC) plan (proportion of QC samples, estimated batch size, use of a pooled sample or individual replicates, plan for evaluating assay performance, and the source of QC samples);
    • Competency of laboratories conducting the analyses;
    • Relevant preliminary data demonstrating experience with the assay.

    Power and Effect Size: When appropriate, provide power calculations and anticipated size of a detectable effect for each aim.

    Statistical Analyses: Provide a detailed statistical analysis plan including the following:  enumeration of all exposure and outcome variables (primary and secondary) and covariates; statistical models and assumptions; plans for evaluating assumptions required by the models; and other statistical issues germane to the proposed research such as measurement error, multiple comparison testing, bias, interactions, and data adjustments.   Individuals conducting data analyses should include their biosketches with the application, even if they are not senior/key personnel on the project.  

    Protection of Human Subjects: Applicants must consult with their local IRB to determine whether the proposed research constitutes human subjects research or is exempt, and must provide documentation of the IRB's determination and approval of the proposed project. 

    Letters of Support: Applicants must include a letter from the PATH Study team documenting that there is sufficient quantity of the biospecimens required for the proposed study.  

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

    • All applications must include a Data Sharing Plan.

    Appendix:

    Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

    PHS Human Subjects and Clinical Trials Information

    Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

    When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

    If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

    Study Record: PHS Human Subjects and Clinical Trials Information
    All instructions in the SF424 (R&R) Application Guide must be followed.

    Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

    PHS Assignment Request Form

    All instructions in the SF424 (R&R) Application Guide must be followed. 

    3. Unique Entity Identifier and System for Award Management (SAM)

    See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

    4. Submission Dates and Times

    Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

    Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

    Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

    Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

    All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

    Not Applicable

    7. Other Submission Requirements and Information

    Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

    Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

    For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

    Important reminders:

    All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

    The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

    See more tips for avoiding common errors.

    Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

    Post Submission Materials

    Applicants are required to follow the instructions for post-submission materials, as described in the policy.

    Section V. Application Review Information
    1. Criteria

    Only the review criteria described below will be considered in the review process.  All applications submitted to this mechanism will be evaluated for scientific and technical merit by the PATH Biospecimen Access Committee and PATH Study management.

    Overall Impact

    Reviewers will provide an overall impact 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 review criteria and additional review criteria (as applicable for the project proposed).

    Scored Review Criteria

    Reviewers will consider each of the review criteria below in the determination of scientific 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? Is there a strong scientific premise for the project? 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?  

    Additional Criteria Specific to this FOA:

    • Does the application describe how successful completion of aims will contribute to scientific knowledge and improvements in technical capability for tobacco control and regulatory science?  
    • Can the study aims be accomplished using PATH Study biospecimens and data?
    • Do the specific aims address PATH Study objectives?
    • Have the investigators provided adequate justification for use of PATH Study biospecimens and successfully explained why other sources of similar biospecimens are not appropriate?
    • Does the proposed research make use of the questionnaire and biomarker data associated with the biospecimens to help answer the research questions?
    Investigator(s)

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   

    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? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? 

    Additional Criteria Specific to this FOA:

    • Are the variables selected to define participant groups appropriate for fulfilling the specific aims of the study?
    • Are the types, numbers and volumes of biospecimens justified?
    • Have the proposed assays been validated for use with the specific types of biospecimens requested? Have sufficient preliminary data been presented to demonstrate accuracy and robustness of the proposed assays?  Have the investigators provided assay validation data?  If multiple assays are available for a proposed analyte, have the investigators justified their choice for using a particular assay? Have the  investigators described the laboratory quality control plan and if so, is it adequate?
    • Have the investigators provided effect sizes and used power calculations to determine the sample sizes needed to detect significant effects for each aim? Did they state the power levels they wished to achieve with the proposed sample sizes?
    • Does the statistical analysis plan adequately describe the data that will be analyzed and the statistical methods that will be used? Does the plan address statistical issues germane to the research such as measurement error, multiple comparison testing, bias, interactions, and data adjustments?   Are individuals with sufficient expertise and experience proposed to conduct the data analyses?

    If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion 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 investigators 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 evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, 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. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

    Inclusion of Women, Minorities, and Children 

    When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

    Vertebrate Animals

    The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

    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.

    Resubmissions

    Not Applicable

    Renewals

    Not Applicable

    Revisions

    Not Applicable

    Additional Review Considerations

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

    Applications from Foreign Organizations

    Not Applicable.

    Select Agent Research

    Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

    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; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

    Authentication of Key Biological and/or Chemical Resources:

    For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

    2. Review and Selection Process

    X01 applications will be evaluated for scientific and technical merit by the PATH Study Biospecimen Access Committee and PATH Study management using the above review criteria.

    3. Anticipated Announcement and Award Dates

    After the review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for review, advisory council review, and earliest start date.

    Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

    Section VI. Award Administration Information
    1. Award Notices

    Any application selected for access to the resource in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on the website.

    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. More information is provided at Award Conditions and Information for NIH Grants.

    Cooperative Agreement Terms and Conditions of Award

    Not Applicable

    3. Reporting

    Investigators are required to submit annual progress reports.  Additional information about the requirements for annual progress reports may be found at (https://doi.org/10.3886/Series606).

    Section VII. Agency Contacts

    We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

    Application Submission Contacts

    eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

    Scientific/Research Contact(s)

    Heather L. Kimmel, Ph.D.
    National Institute on Drug Abuse (NIDA)
    Telephone: 301-443-6504
    Email: heather.kimmel@nih.gov

    Peer Review Contact(s)

    Heather L. Kimmel, Ph.D.
    National Institute on Drug Abuse (NIDA)
    Telephone: 301-443-6504
    Email: heather.kimmel@nih.gov

    Financial/Grants Management Contact(s)

    Not Applicable

    Section VIII. Other Information

    Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

    Authority and Regulations

    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 Part 75.

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