National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
X01 Resource Access Award
- August 31, 2022- Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
- August 5, 2022- Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.
See Section III. 3. Additional Information on Eligibility.
The Population Assessment of Tobacco and Health (PATH) Study provides the scientific community with biospecimens (urine, plasma, serum, and genomic DNA) and related research data on behaviors, attitudes, biomarkers and health outcomes associated with tobacco use in the U.S. This notice of funding opportunity (NOFO) 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 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://nida.nih.gov/research/nida-research-programs-activities/population-assessment-tobacco-health-path-study/data-access).
Not Applicable
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| April 30, 2024 | Not Applicable | Not Applicable | July 2024 | August 2024 | December 2024 |
| October 31, 2024 | Not Applicable | Not Applicable | November 2024 | January 2025 | April 2025 |
| April 30, 2025 | Not Applicable | Not Applicable | July 2025 | August 2025 | December 2025 |
| October 31, 2025 | Not Applicable | Not Applicable | November 2025 | January 2026 | April 2026 |
| April 30, 2026 | Not Applicable | Not Applicable | July 2026 | August 2026 | December 2026 |
| October 30, 2026 | Not Applicable | Not Applicable | November 2026 | January 2027 | April 2027 |
All applications are due by 5:00 PM local time of applicant organization.
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.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the NOFO) 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.
- Use the NIH ASSIST system to prepare, submit and track your application online.
- 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.
- Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
Purpose
This notice of funding opportunity (NOFO) 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 (https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/family-smoking-prevention-and-tobacco-control-act-overview). The PATH Study is an ongoing longitudinal cohort study on tobacco use behavior, attitudes and beliefs, and tobacco-related health outcomes, and is planned through 2024.
The PATH Study collects data from adults and youth. Parents are 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 a national sample of tobacco users and non-users: over 32,000 adults and 13,000 youth. The number of cases varies from wave to wave.
Detailed information on the policies for obtaining PATH Study biospecimens, types of biospecimens available, and the application and review processes may be found on the PATH Study Biospecimen Access Program web page on 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://nida.nih.gov/research/nida-research-programs-activities/population-assessment-tobacco-health-path-study/biospecimen-access). Applicants should review this information before applying for access to the 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, and 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 rule making. In 2016, the 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 on FDA’s website (https://www.govinfo.gov/content/pkg/PLAW-111publ31/pdf/PLAW-111publ31.pdf).
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 outcomes. 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) users of a wide array of tobacco products, former tobacco product users, and non-users. 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 the FDA’s regulatory mission under the FSPTCA.
The PATH Study consists of four annual (waves 1 through 4) and three biennial (waves 5 through 6) primary waves of data and biospecimen collection. The first annual wave began in September 2013 and concluded in December 2014. Waves 2 through 4 began in October 2014, October 2015, and December 2016, respectively, and concluded approximately one year later. Wave 5, the first biennial wave, began in December 2018 and concluded approximately one year later. Wave 6 began in March 2021 and concluded in November 2021. Due to the pandemic, Wave 7 began in January 2022 and concluded in April 2023. No biospecimens were collected at Waves 6 or 7 due to the COVID-19 pandemic. Wave 8 data and biospecimen collection is planned for 2024. The multi-wave design allows for the longitudinal assessment of the participant's 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 though 7). Stored biospecimens available to researchers include urine, serum, plasma, and genomic DNA. Genomic data is only available for wave 1. Detailed information on specimen availability is located on the PATH study Biospecimen Access Program web page. 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 as well as a diverse mix of tobacco product users, were analyzed for biomarkers of potential harm and tobacco exposure. Information about the numbers and types of biospecimens, questionnaire and biomarker data that are available to applicants is located on the NAHDAP website (https://nida.nih.gov/research/nida-research-programs-activities/population-assessment-tobacco-health-path-study/data-access)
Research Scope
Investigators proposing meritorious and feasible studies including exploratory or pilot studies, consistent with PATH Study objectives and/or research priorities for tobacco regulatory science will be given the highest priority for access to PATH Study biospecimens. Studies that address other objectives that expand the knowledge of tobacco use and/or tobacco related health outcomes will also be considered but will be a lower priority.
Application Procedures - Biospecimen Availability
Interested applicants are required to contact the PATH Study team at least five months in advance of the application submission deadlines to determine whether there is sufficient quantity of the biospecimens required for the proposed study. Applications must include written confirmation from the PATH Study team indicating sufficient numbers of biospecimens. The PATH Study team should be contacted at PATHStudyBiospecimens@westat.com.
For more information on the procedures to determine biospecimen availability, review the application procedures on the NAHDAP website (https://nida.nih.gov/research/nida-research-programs-activities/population-assessment-tobacco-health-path-study/biospecimen-access).
See Section VIII. Other Information for award authorities and regulations.
Other: A mechanism that is not a grant or cooperative agreement. Examples include access to research resources or pre-applications.
Resubmission
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.
Not Allowed: Only accepting applications that do not propose clinical trials.
The total number of projects granted access to biospecimens is dependent on the number of meritorious applications and the availability of biospecimens.
Not Applicable; funds are not awarded via the X01 mechanism.
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 from this NOFO.
1. Eligible Applicants
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:
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- 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)
Local 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)
Federal Government
- 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
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.
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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
- System for Award Management (SAM) – 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.
- Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
- eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. 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 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.
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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.
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 NOFO 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, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. 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.
- An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).
1. Requesting an Application Package
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. 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 instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity 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.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.
All instructions in the SF424 (R&R) Application Guide must be followed.
Please follow these 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.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Please follow these 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.
Include the letter about the proposed study and written confirmation from the PATH Study team indicating sufficient numbers of biospecimens in Research & Related Other Project Information.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
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/or 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 biosecimens 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: Briefly describe participant characteristics (variables) to define participant groups for source of biospecimens.
- 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. If the biospecimens are used to validate previous studies or are used in combination with biospecimens from other studies, how comparable are those biospecimens from these other studies to the PATH Study biospecimens?
Methodology/Assays:
List each laboratory assay planned for the biospecimens. Provide the following information for each assay: Describe numbers, types and volumes of requested biospecimens. Include a clear justification for number of biospecimens and volume(s) of biospecimens being requested.
- Volume required (include justification for volume requested, and both dead and assay volumes); a clear justification for number of biospecimens and volume(s) of biospecimens being requested; 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:
- Provide power calculations and anticipated size of a detectable effect for each aim. Include details on the statistical approach used to calculate power calculations and/or study size. If submitting a proposal for exploratory or pilot analyses, power analyses and directional hypotheses are not required, but can be included if effect sizes from related research are available.
Statistical Analyses:
- Provide a detailed statistical analysis plan including the following: enumeration of all exposure and outcome variables (primary and secondary) and covariate; statistical models and assumption; 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.
Timeline:
- Provide a proposed timeline for each step of the process from the receipt of biospecimens until the completion of statistical analysis of the data. Please include details that will allow us to evaluate the feasibility of the timeline.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. Applicants must provide documentation of the IRB's determination if their application is approved. Note: the use of de-identified biospecimens from the PATH Study does not meet the NIH definition of human subjects research. If these data are combined with data from other human subjects, consult with your local IRB to determine the IRB exemption status.
Biospecimen Availability:
- 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.
Other Plan(s):
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
- Not Applicable
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) 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 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
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.
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
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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.
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.
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 only as described in the NIH Grants Policy Statement.
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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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 form. 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 NOFO for information on registration requirements.
The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier 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 and responsiveness by NIDA, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in the policy
1. Criteria
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
The X01 Resource Access Program invites eligible institutions to seek access to NIH research resources, which are specified in each X01 NOFO. This includes programs where institutions will request access to submit to the resource (e.g., high throughput screening assays) as well as programs where access to a specific NIH research resource is needed to conduct certain research. Important factors in the peer review of X01 applications are the need for, and potential benefit of, gaining access to the resource, specifications for any assays proposed, timelines for completion and plans for follow-on studies.
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 the prior research that serves as the key support for the proposed project rigorous? 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?
Specific to this NOFO:
How will successful completion of aims 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? How adequately do the specific aims address PATH Study objectives? How adequate is the justification for use of PATH Study biospecimens and the explanation of why other sources of similar biospecimens are not appropriate?
How adequately 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?
Specific to this NOFO:
How strong are the expertise and experience of the individuals who will conduct the data analyses?
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?
Specific to this NOFO:
Does the application challenge and seek to shift current research in the field of tobacco science as it relates to the manufacture, distribution, and marketing of tobacco products? How will the outcomes of the project provide new information to further develop the knowledge base that informs the manufacture, distribution, and marketing of tobacco products in order to protect public health?
Approach
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed 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?
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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Specific to this NOFO:
How adequately are the variables selected to define participant groups appropriate for fulfilling the specific aims of the study? How adequately are the types, numbers and volumes of biospecimens justified?
To what extent 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, to what extent 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?
For studies that are not pilot or exploratory, 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?
To what extent does the statistical analysis plan adequately describe the data that will be analyzed and the statistical methods that will be used? How adequately does the plan address statistical issues germane to the research such as measurement error, multiple comparison testing, bias, interactions, and data adjustments? Are these effect sizes and power levels appropriate to address the proposed scientific aims?
Timeline: Is there a timeline? To what extent is the timeline realistic, organized, and complete, indicating that the investigators have a clear understanding of the steps required for the completion of the project?
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 individuals of all ages (including children and older adults), 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 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 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 Individuals Across the Lifespan
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 individuals of all ages (including children and older adults) 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 Animals 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
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 Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.
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.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
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.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
As these X01 applications are reviewed by the PATH Study, they will not undergo Advisory Council review.
3. Anticipated Announcement and Award Dates
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 eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.
1. Award Notices
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
An X01 does not result in a Notice of Award (NoA). Rather, selected applicants will receive access to resources provided by the Population Assessment of Tobacco and Health (PATH) Study Biospecimen. Successful applicants will receive instructions for next steps. .
An X01 does not result in a Notice of Award (NoA). Rather, selected applicants will receive access to resources provided by the Population Assessment of Tobacco and Health (PATH) Study Biospecimen. Successful applicants will receive instructions for next steps.
Not Applicable
Recipients that access the PATH Study Biospecimens will be required to adhere to the separate agreements that are associated with the PATH Study' s plan for data sharing and any limitations to the extent of or timelines for data sharing to ensure that the proper balance is maintained between maximizing the timely sharing of scientific data and the protection of IP.
4. Reporting
Investigators are required to following the reporting requirements as found? ?i?n? the Policies and Procedures for Investigators document at the PATH Study Biospecimen Access website (https://nida.nih.gov/research/nida-research-programs-activities/population-assessment-tobacco-health-path-study/biospecimen-access). In brief, investigators are required to inform the PATH Study team of their progress, first in completing project initiation activities and subsequently, in analyzing biospecimens and disseminating results to the PATH Study team as outlined in the Policies and Procedures document.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Heather L. Kimmel, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-6504
Email: heather.kimmel@nih.gov
Heather L. Kimmel, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-6504
Email: heather.kimmel@nih.gov
Not Applicable
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.
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 and 2 CFR Part 200.
and Human Services (HHS)
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