Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

National Institutes of Health (NIH)

Centers for Disease Control and Prevention (CDC)

Components of Participating Organizations

National Institute on Drug Abuse (NIDA)

National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention (NCHHSTP/CDC)

Funding Opportunity Title

Hepatitis C Virus (HCV) Advanced Molecular Detection in Support of Systems for Prevention, Treatment and Control of HIV, HCV and Related Comorbidities in Rural Communities Affected by Opioid Injection Drug Epidemics in the United States (U24)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreement

Announcement Type

New

Related Notices
  • November 08, 2016 - Notice of Pre-Application Informational Conference Call for Prospective Applicants to RFA-DA-17-014 & RFA-DA-17-023 . See Notice NOT-DA-17-003.
  • October 14, 2016 - Notice of Correction of Responsiveness Criteria for Applications Submitted to RFA-DA-17-023. See Notice NOT-DA-16-043.
Funding Opportunity Announcement (FOA) Number

RFA-DA-17-023  

Companion Funding Opportunity

RFA-DA-17-014 UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement

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

93.279, , 93.941,

Funding Opportunity Purpose

This FOA will support a Center for HCV next-generation sequencing (advanced molecular detection) using Global Hepatitis Outbreak and Surveillance Technology (“GHOST”) to be developed in collaboration with CDC’s Division of Viral Hepatitis. The GHOST Center will support HCV next-generation sequencing activities of research projects funded by the companion RFA (RFA-DA-17-014).

Key Dates

 

Posted Date

October 6, 2016

Open Date (Earliest Submission Date)

December 10, 2016

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

January 10, 2017, by 5:00 PM local time of applicant organization. All types of applications allowed for this funding opportunity announcement are due on these dates.

No late applications will be accepted for this Funding Opportunity Announcement.

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)

January 10, 2017, by 5:00 PM local time of applicant organization. All types of applications allowed for this funding opportunity announcement are due on these dates.

No late applications will be accepted for this Funding Opportunity Announcement.

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.

Scientific Merit Review

March 2017

Advisory Council Review

May 2017

Earliest Start Date

June 2017

Expiration Date

January 11, 2017

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research Instructions for 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.


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
Background

Many rural communities have experienced dramatic increases in prescription drug use that have led to increased injection drug use, increased opioid overdose, increased incidence of acute HCV, and potential for localized HIV and HCV outbreaks similar to the 2015 outbreaks in Scott County, Indiana. Rising overdose deaths and substance abuse treatment rates indicate sharp increases in opioid use, including injection use in rural areas, particularly in Appalachia, the Southwest US, and other areas across the country. The demographic profile of rural people who inject drugs (PWID) differs from PWID involved in previous urban HIV and HCV epidemics; i.e., rural PWID include higher percentages of non-Hispanic whites under 30 years of age.

Rural communities face challenges in implementing services to prevent and control substance abuse, HIV and hepatitis C virus (HCV) infections and co-morbid conditions including hepatitis B virus (HBV) infection and sexually transmitted diseases (STDs). Those challenges include the more recent emergence of opioid injection use in rural areas compared to urban areas. Moreover, few states have public health surveillance systems that can effectively detect infectious disease outbreaks and field staff who can investigate those outbreaks within rural networks of PWID. State and local health departments often lack the research and clinical infrastructure to address the consequences of opioid and other drug injection epidemics, particularly in rural areas. Access to public health services including HIV, HCV, HBV or STD testing and treatment are limited. These areas have low population densities and are often located far away from concentrations of health care services for drug treatment, infectious disease management, and syringe services programs (SSPs) (where permitted by law). Rural areas often lack public transport links to metropolitan areas with well-developed services, and motor vehicle ownership often is relatively low, despite the need for private transportation. Stigma and confidentiality in small communities pose additional challenges to establishing and maintaining those services. High rates of medical use of prescription opioids often lead to high rates of non-medical use of prescription opioids; and high rates of non-medical use of prescription opioids often lead to high rates of opioid addiction, injection drug use, and unmet needs for substance abuse services in these communities.  State and local laws and law enforcement policies often limit the local availability of some services, with some exceptions that enable the delivery of more services in response to local conditions. The US Department of Health and Human Services recently released guidance to enable state and local authorities to re-direct federal assistance for syringe service programs: https://www.aids.gov/pdf/hhs-ssp-guidance.pdf.

Purpose

This FOA also will support a Center for HCV next-generation sequencing (advanced molecular detection) using Global Hepatitis Outbreak and Surveillance Technology (“GHOST”) to be developed in collaboration with CDC’s Division of Viral Hepatitis. The GHOST center will support HCV next-generation sequencing activities of research projects funded by RFA-DA-17-014," HIV, HCV and Related Comorbidities in Rural Communities Affected by Opioid Injection Drug Epidemics in the United States: Building Systems for Prevention, Treatment and Control (UG3/UH3)" which will conduct community assessments of HIV, HCV and comorbid conditions as well as intervention projects which increase public health services available for the prevention and detection of HIV, HCV, HBV, STIs and linkage to care, as well as linkage to drug treatment.

Organizations that apply for the community research projects to be funded under RFA-DA-17-014 also are eligible to apply to this FOA, although study teams must submit separate applications for each FOA and each application should reflect the distinct aims, objectives, expertise, etc. needed for each project. U24 recipients will need to participate in project planning and implementation activities with PDs/PIs from the RFA-DA-17-014 awards.

Applicants are encouraged to visit the Frequently Asked Questions site for more information at https://www.drugabuse.gov/supplemental-information-nida-rfas-da-17-014-da-17-023.   

Specific Topics of Research Interest

One site is expected to be funded to build capacity for Global Hepatitis Outbreak and Surveillance Technology (GHOST), a comprehensive system that includes next-generation sequencing (NGS) technologies, bioinformatics and computational approaches. GHOST will aid in establishing HCV transmission links, outbreak investigations and molecular surveillance.

The GHOST site will provide laboratory support to all state public health programs involved in the research projects funded under RFA-DA-17-014 to effectively investigate HCV outbreaks and to identify HCV transmission networks among PWID, including those with concurrent HIV infection. By delineating transmission networks, the selected site will provide sequence data to guide public health interventions for disrupting transmission of HCV disease in PWID communities. CDC will provide technical assistance to the site to establish the GHOST laboratory.

The GHOST laboratory will be responsible for providing viral sequences to identify HCV transmission links among PWID and for uploading viral sequences to a cloud website shared by CDC; managing the collection and storage of serum specimens from HIV- and HCV-infected participants from all Community Response sites funded under RFA-DA-17-014; and for shipping specimens to CDC for syphilis testing and phylogenetic mapping for HIV and HCV, as well as for GHOST validation testing, as needed.

The GHOST site activities will include development of essential infrastructure, namely: physical laboratory facility; laboratory equipment to support all stages of the laboratory process; trained staff; laboratory procedures; quality control measures; specimen shipment from participating programs and storage; and modes of communication with participating sites. The GHOST site will participate in testing specimens, depositing sequences and analyzing transmission links among PWID using GHOST. The GHOST laboratory is expected to be closely integrated with the programs funded under RFA-DA-17-014—namely to collect, store, and test specimens from them.

NOTE: Should no GHOST site be funded under RFA-DA-17-023, each of the funded Community Response sites funded under RFA-DA-17-014 will collect, store and ship specimens for syphilis testing and phylogenetic mapping for HIV and HCV, as well as for GHOST testing to CDC. 

Only domestic projects taking place in the United States will be considered.

Applicants will need to demonstrate that the GHOST center will target and serve rural areas of the United States. Applicants will need to demonstrate that their projects target rural areas of the United States; hence they should be able to work with dispersed locations with limited resources. Experience with outreach and collaboration with rural locations, particularly in the context of viral hepatitis or other infectious disease outbreaks is desirable. Applicants should provide a rationale for their “rural” focus that makes use of the multiple US government criteria for “rural” geography and/or other allowances based on population size that are mentioned below. There are a number of different geographic classifications for “rural” including those developed by the US Census Bureau, the National Center for Health Statistics, the US Department of Agriculture and the Health Resources and Services Administration (HRSA). These definitions vary in their level of restrictiveness and their relationship with rural health and public health service programs. The following is a HRSA-supported website that provides links for these criteria and an interactive decision tool that may be helpful to applicants in developing their rationale: https://www.ruralhealthinfo.org/am-i-rural/help. In addition, projects that are based in Micropolitan Statistical Areas, as defined by the US Office of Management and Budget https://www.whitehouse.gov/sites/default/files/omb/assets/bulletins/b10-02.pdf will be considered responsive as will projects that are based in Metropolitan Statistical Areas of 250,000 persons or less.

Applications including the following types of studies will be considered non- responsive and will not be reviewed:

  • Phase III clinical trials
  • Cohort studies
  • Studies of communities outside the United States or its territories
  • Studies whose aims are not focused on the areas identified by the FOA
  • Studies that do not include collaboration with a state or local health department, as evidenced by a letter of support and description of collaborative activities in the application
  • Studies not focused on rural communities
  • Studies that do not include collaboration with a state or local substance abuse agency
Special Considerations

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects:  The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects.   Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects.  The guidelines are available on NIDA's Web site at

http://www.nida.nih.gov/about/organization/nacda/CouncilStatement.html.

Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants: The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community.  Please see (http://ww2.drugabuse.gov/about/organization/nacda/points-to-consider.html) for details.

Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit:  NIDA strongly encourages investigators involved in human-subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection of the PhenX Toolkit (www.phenxtoolkit.org).  Please see NOT-DA-12-008 (http://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html) for further details. 

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

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed

New

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

Funds Available and Anticipated Number of Awards

One award will be funded for up to 5 years, corresponding to a total of $370,000, for fiscal year 2017. Future year amounts will depend on annual appropriations; however, plans are to provide $370,000 per year in subsequent years

Award Budget

Application budgets are limited to $370,000 direct costs in each year of the project.  

Award 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)
  • 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.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
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 instructions in the Research Instructions for 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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to: NIDALetterofIntent@mail.nih.gov

Applicants are encouraged to send the letter of intent by email to the email address above but as an alternative, the letter may also be sent to:

Office of Extramural Policy and Review
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Suite 4243, MSC 9550
Bethesda, MD 20892-9550

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

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.  

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.  

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed. Project budget should include an estimate of how much it will cost to assay each participant (including labor, sequencing kits, library preparation, barcoding, storage, sample preparation, salaries, overhead, etc.)

R&R Subaward Budget

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: 

Specific Aims: Provide the overall goals or hypotheses for the entire project.

Research Strategy:  In preparing the application, investigators should consider that the application will be assigned a single overall impact score. Applications should accomplish the following:

  • Describe the available laboratory facility, available and required equipment for conducting all stages of the laboratory processes, personnel, experience in performing basic molecular testing and next-generation sequencing, or plans to acquire training in application of next-generation sequencing.
  • Describe how the study aims will contribute to the improvement of public health, particularly for surveillance and control of HCV.
  • Describe the group expertise of the investigator team as a whole, without duplicating information on the biosketches, including their relevant laboratory experience, their interaction with public health systems (with particular attention to public health systems serving rural areas) and their familiarity with next generation sequencing.
  • Provide a detailed description of the sequencing resources to be leveraged to generate the proposed sequence information.
  • Describe plans for affordable shipment of specimens in conditions suitable for molecular testing and appropriate storage of specimens.
  • Describe the expected turnaround time for reporting the data back to sites starting from receipt of specimens at the GHOST facility. 
  • Present a timeline for establishing the entire infrastructure for testing specimens and describe the expected volume of specimens to be tested per month/year.
  • Include plans for sustaining NGS activities and application of GHOST beyond the life of this project.
  • Describe evaluation measures for successful NGS activities and its application to molecular analyses conducted by participating sites.
  • Provide plans for protecting the NGS data integrity and security. No participant’s personally identifiable information should be accepted or stored.
  • Discuss any impediments that could require an addendum to the implementation plan, milestones, or timeline with a discussion of alternative approaches.
  • Provide a strategy to collaborate with state and/or local health departments as well as with CDC in establishing the GHOST center and conducting its activities. Description of prior collaborations with state and/or local health departments and/or CDC should be noted.
  • Provide a plan to coordinate the GHOST activities with CDC and with the community and clinical research sites to be funded under the companion RFA (RFA-DA-17-014) .
  • Describe the entire laboratory process including plans for specimen storage, processing and shipment to local or CDC reference laboratories.
  • Describe how specimens will be de-identified before shipment to the CDC for testing and include a description of the language to be used in informed consent forms to allow testing of de-identified samples by the CDC.
  • Provide plans to conduct quality control for the entire laboratory process, especially GHOST activities.
  • Provide plans for preventing cross-contamination among specimens and contamination with PCR products in order to avoid erroneous detection of transmission.
  • Project Timelines

Letters of Support: Provide all appropriate letters of support, including any letters necessary to demonstrate the support of laboratories, health department(s), and other collaborators.  If co-funding or in-kind support is planned from non-NIH sources, letter(s) outlining details of the commitment (e.g. type, amount and source of support), signed by a business official on organization letterhead,  must be included in the Letters of Support. 

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,.

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

The project funded under this FOA is expected to work collaboratively toward core data collection measures and methods that will enable the construction of data sets that are harmonized and facilitate progressive data sharing models.  Consistent with achieving the goals of the program, finished, de-identified datasets are expected to be made available for the research community at the close of the study through deposit at the National Addiction and HIV Data Archive Program: https://www.icpsr.umich.edu/icpsrweb/content/NAHDAP/about.html or another site to be determined by the Executive Steering Committee of the cooperative agreement. More information about the Executive Steering Committee is in Section VI below (Cooperative Agreement Terms and Conditions of Award). Steps also are expected that enable sharing of research findings with the broader research and, public health, and health services communities.  Applications are, therefore, expected to provide a well thought-out plan for widely sharing data and resources generated by the research project.  After all awards have been made, the Executive Steering Committee, composed of members of the funding agencies and the individual project teams will develop a unified policy for data and resource release, such as harmonized interview instrument(s) and other data collection.  During the study the Executive Steering Committee will consider as a group (and usually by consensus) various proposals to analyze aggregate data and will support such efforts.  The application is expected to include a statement that the investigators will abide by the Executive Steering Committee’s data and resource policy, consistent with the relevant NIH policies, laws and regulations.

Use of Common Data Elements (CDEs) such as those defined on the National Library of Medicine website (https://www.nlm.nih.gov/cde/) is encouraged.

A Genome Data Sharing Plan that is congruent with the NIH Genome Data Sharing policy (https://gds.nih.gov/) should be included in each application. Any sequences from individuals need to be de-identified and made available through the NIH database dbGap (http://www.ncbi.nlm.nih.gov/gap). Informed consent forms must include language that enables sharing of de-identified genomic information derived from samples via this database or other databases.

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 Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information
1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of 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 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 proposed Center address the needs of the research project network that it will serve? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research project network?  Does the project identify a critical barrier to the establishment of local molecular HCV surveillance activities? How will successful completion of the aims change the concept and practice of molecular surveillance and contribute to improvement of public health interventions to control infectious disease consequences of opioid injection abuse? 

How will successful completion of the aims improve public health interventions to control HCV related to opioid injection abuse? 

Will the project advance knowledge about dissemination of HCV and the structure of contact networks as related to disease transmission among PWID, and facilitate development of novel and efficient strategies for utilization of care and prevention services to reduce the rate of opioid injection and its comorbidities?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the GHOST Laboratory? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing infectious disease laboratory research? Do the investigators demonstrate significant experience with coordinating collaborative clinical research? Do the PD(s)/PI)(s) have experience in managing large projects? Do the PD(s)/PI(s) and/or investigator team have experience conducting large laboratory projects? Do the PD(s)/PI(s) or investigator team have experience working with rural environments where resources may be dispersed or limited in terms of resources or technology?  Do the PD(s)/PI(s) or investigator team have experience working in the context of clinical or community-based research projects and developing collaborative protocols with investigators working in field or clinic settings?

How familiar are the PD(s)/PI(s) and investigator team with next-generation sequencing? What experience do the PD(s)/PI(s) have in conducting sustained next-generation sequencing projects?  Are there dedicated personnel to perform HCV NGS or will technicians be involved in other activities as well? Are there an adequate number of technicians serving on the project?  Do technicians have sufficient experience with basic molecular techniques and next-generation sequencing? Do technicians have adequate experience in processing and storing specimens for molecular testing?  Does the application describe hiring technical personnel for the project? If so, what laboratory skills are required?  Is there a plan for training local personnel in HCV NGS and GHOST at CDC or on-site by CDC experts?

 Does the PD/PI have experience in outbreak investigations? Do the PD(s)/PI(s) have experience in providing laboratory services in support of public health surveillance mandated by law or regulation?  How familiar is the PD/PI with NGS? What experience do the PD(s)/PI(s) have in conducting sustained NGS-based projects? Is HCV sequenced in the PD(s)/PI(s)’s laboratory? What pertinent molecular NGS methods are being used, how long the methodology has been performed, how often it is performed and the annual test volume?  Do the PD(s)/PI(s) and technicians have experience in maintaining chain of custody while conducting molecular testing? 

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?    

Does the application propose novel instrumentation in coordinating the research project network the Laboratory will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of instrumentation proposed? 

Does the project propose novel approaches to integration of NGS into infectious disease surveillance? Does the project include a plan to sustain NGS activities over the entire funded period? Is there a plan for long-term maintenance of the established NGS-based activities with the participating programs in support of outbreak investigations and surveillance?  Does the project address the issue of cost-effectiveness of the NGS-based testing? Does the application describe a plan to sustain affordable NGS activities throughout the project?  Does the project propose novel approaches to quality control and quality assessment?  Are novel approaches taken to develop cost-effective and sustainable services to sites collecting specimens?    

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research project network the Laboratory will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the project network, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project network is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the project network? Are an appropriate plan for work-flow and a well-established timeline proposed?  Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?  Does the application have a plan to conduct vigorous quality control? What is a strategy to prevent cross-contamination?  Does the application describe how standard operating procedures will be developed and implemented?  What steps are planned to maintain standard and high-quality testing?  Are the aims of the project achievable?  Does the project include a plan to support other sites collecting specimens for HCV NGS?  How will specimens from collaborating sites be transported to the GHOST center and where will specimens be stored?  How sufficient is the plan for transporting specimens from collaborating sites to the GHOST center and for how specimens are stored? 

How will collaborators and CDC receive NGS data?  How will efforts be coordinated with CDC?  Does the project address the issue of cost-effectiveness of the NGS-based testing?  Is there a plan for long-term maintenance of the established NGS-based activities with the participating programs in support of outbreak investigations and surveillance? Does the application describe a plan to sustain affordable NGS activities throughout the entire funded project?

How will the GHOST laboratory serve to efficiently support the research and molecular surveillance activities targeting communities at greatest risk of adverse events related to opioid abuse? How feasible are the steps toward establishing local molecular HCV surveillance activities? How adequate are the laboratory and technical support for the project? Are the aims of the project achievable?

How well does the application justify how the proposed location of the Next-Generation Sequencing (NGS) center will assure effective receipt of specimens and return of results to collaborating centers? How will the laboratory provide technical assistance for the molecular surveillance activities for grantee investigation in targeted communities at risk of HCV related to opioid abuse?

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 institutional environment in which the Laboratory will operate contribute to the probability of success in facilitating the research project network it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the laboratory proposed? Will the Laboratory benefit from unique features of the institutional environment, infrastructure, or personnel?  Are resources available within the scientific environment to support electronic information handling?  Do applications strongly justify the specific location of the GHOST center?  Is there strong laboratory and technical support for the project?  What laboratory facility is available for the project? Is there sufficient space for all necessary equipment? Is there a specialized clean area for PCR work?

What precautions will be implemented to prevent cross-contamination of specimens? Is there a dedicated area and equipment for handling and aliquoting specimens?  What next-generation sequencing equipment is available? What equipment is available for extraction of nucleic acid, cDNA synthesis, PCR, quantification and purification of amplicons?

Does the project team have access to nucleic acid sequencing infrastructure to enable completion of the aims of the project?  Will the equipment be shared with other projects or dedicated to the HCV NGS-based surveillance?  What is the technical capacity of the laboratory? How many NGS runs can be performed per month? How many specimens can be processed for sequencing per month?  Does the laboratory have adequate storage capacity for collected specimens?  How adequate is existing equipment for the project? If purchase of equipment is proposed, how adequate will the environment be for performing this project?

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). A Genome Data Sharing Plan should be included in each application. Any sequences from individuals need to be de-identified and made available through the NIH database dbGap (http://www.ncbi.nlm.nih.gov/gap). Informed consent forms must include language that enables sharing of de-identified genomic information derived from samples via this database or other databases.    

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIDA, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all 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.
  • Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the NIDA Advisory Council or Board. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.     
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 VI. Award Administration Information
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.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.

Any application awarded 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 this 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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

 The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities.  Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities.  Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

  • All aspects of their study, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, dissemination of data, tools, and technologies, and collaboration with other investigators.
  • The awardee agrees to accept close coordination, cooperation, and participation of NIH, CDC and other federal staff in those aspects of scientific and technical management of the study including those outlined under "NIH, CDC, and Other Federal Staff Responsibilities" and to work cooperatively with other awardees where it is scientifically advantageous to pursue common methods and protocols.
  • Awardees will participate in annual meetings of the awardees and will provide representation to the Executive Steering Committee (ESC, see below) and will support any other committees, task forces, and advisory panels related to the project, as needed and will participate in regularly scheduled conference calls with the awarding agencies. Project budgets should include travel for participation in these activities.
  • Upon implementation of the project, the awardee will follow the procedures required by the protocol regarding study conduct and monitoring, data collection, and implementation of clinical guidelines or disease reporting, as needed.
  • The awardee will maintain facilities that can accept, properly store, and ship volumes of specimens generated through RFA DA 17-014 awardees to perform testing through Global Hepatitis Outbreak and Surveillance Technology (GHOST), and other tests as needed.
  • Support or other involvement of industry or any other third party in the study--e.g., participation by the third party; involvement of project resources or citing the name of the project or the NIH support; or special access to project results, data, findings, or resources--may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party will occur with the concurrence by the NIH Program Officer to ensure objectivity of research.
  • Obtaining prior written approval of the NIH Grants Management Specialist in consultation with the NIH Program Officer for a change in any of the key personnel identified in the Notice of Award.
  • Award recipients will own the rights in any tangible work products created under the terms of the cooperative agreement. Work products may include such things as research reports, papers, research, findings, training curricula, data sets, books, patient tools, and other materials. All such products shall be made accessible to the public under NIH’s Public Access Policy https://publicaccess.nih.gov/ and are subject to Government rights of access, as appropriate, in accordance with NIH’s legal directives and authorities.

NIH, CDC, and Other Federal Staff Responsibilities. NIH and CDC staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

  • The NIH and CDC Project Scientists will have access to the data and work with the PD(s)/PI(s) to ensure the objectives of the program are being met.  The primary responsibility for the program resides with the awardee, although specific tasks and activities will be shared among the awardee and the NIH and CDC Project Scientists.
  • NIH and CDC staff will act as a resource and facilitator for activities of the awardee, and will coordinate activities with federal and non-federal agencies outside of the project awardees. A project Executive Steering Committee (ESC) with representation from CDC, NIH and the project sites will be organized to facilitate regular communication among awardees, NIH, CDC and other federal agencies such as the Appalachian Regional Commission, SAMHSA, or HRSA which may have programmatic interests in the projects or may co-fund the overall RFA or individual projects. The ESC also may engage members who provide substantive scientific, programmatic, or clinical knowledge from academia, government, private industry or other relevant sectors.
  • The NIH, as primary funder and administrator reserves the right to phase out or curtail the award (or an individual component of the award) in the event of inadequate progress or data reporting, and will do so with the consultation of other federal partners. NIH support of this study is contingent upon adequate participant recruitment based on the Grantee’s Milestone Accrual Plan submitted at the time of funding.
  • The Grantee is expected to demonstrate best effort compliance. Failure to achieve minimally acceptable milestone recruitment levels may result in the withholding future support and/or negotiating an orderly close-out of this study.
  • NIH and CDC will serve as resources to provide: scientific/programmatic support in the development and modification of study protocols and the design of project activities; advice in the selection of sources or resources; advice in management and technical performance; and assistance in the preparation of publications, as warranted.
  • Participate in the monitoring of issues relating monitoring of data integrity and quality control through consideration of the annual reports, site visits, laboratory logs, etc.  This review may include, but is not limited to, compliance with the study protocol, adherence to uniform data collection procedures, and the timeliness and quality of data reporting as needed to the administration and evaluation core.
  • NIH and CDC Scientific Program Officers will interact with the PD(s)/PI(s) on a regular basis to monitor progress. Monitoring may include: regular communication with the PD(s)/PI(s) and his/her staff, periodic site visits for discussion with the awardees’ research team, observation of field data collection and management techniques, fiscal reviews, and other relevant stewardship matters.
  • CDC will take primary responsibility for matters such as reporting of communicable diseases, review of laboratory protocols, and provision of specialized laboratory testing including Global Hepatitis Outbreak and Surveillance Technology (GHOST).
  • Additionally, NIH and CDC will appoint Program Officials who will be responsible for the normal scientific and programmatic stewardship of the award; will be named in the award notice; and serve as Agency representatives to the Executive Steering Committee.

Areas of Joint Responsibility include:

  • The PD(s)/PI(s) provide, in concert with the NIH staff, support necessary to ensure that sites and investigators, and NIH and other research partners fully comply with federal regulatory requirements, including but not limited to those relating to human subjects protections, informed consent, and reporting of adverse events.
  • Awardees and NIH will jointly develop appropriate confidentiality procedures for data collection, processing, storage and analysis to ensure the confidentiality of data on individual health care provider organization patients, health care providers and other institutions.
  • All awardees and NIH will cooperate to ensure the timely and broad dissemination of lessons learned, to inform researchers and health care systems engaged in research in health care settings.
  • The Project ESC will facilitate these joint activities and, in particular, provide facilitation of research protocols, human subjects and other regulatory protocols (including adverse event reporting), data harmonization, manuscript and other information dissemination planning, and initial clearance of manuscripts or other dissemination products.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution.  A Dispute Resolution Panel composed of three members will be convened.  It will have three members: a designee of the Grantee chosen without NIH staff voting, one NIH designee, and a third designee from CDC with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee.  This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

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

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
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)

Richard A. Jenkins PhD
National institute on Drug Abuse (NIDA)
Telephone: 301-443-1923
Email: jenkinsri@mail.nih.gov

Walter (Paul) Smutz, PhD
National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention (NCHHSTP)
Telephone: 404-718-8830
Email: pos1@cdc.gov

Peer Review Contact(s)

Mark Swieter, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-5844
Email: mswieter@mail.nih.gov

Financial/Grants Management Contact(s)

Edith Davis
National Institute on Drug Abuse (NIDA)
Telephone: (301) 827-6697
Email: edavis1@mail.nih.gov

Carla Harper
National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention (NCHHSTP)
Telephone: 770-488-2439
Email: auy1@cdc.gov

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, 247 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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