Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

Agency for Healthcare Research and Quality (AHRQ)

NOTE:  The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.  Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA. Also note that AHRQ may have different page limits than NIH for the application Research Strategy; if this is the case, page limits are indicated within the individual FOA. AHRQ Grants Policy and Information to applicants regarding Funding Opportunity Announcement procedures can be found at http://www.ahrq.gov/funding/policies/foaguidance/index.html

Components of Participating Organizations

Agency for Healthcare Research and Quality (AHRQ)

Funding Opportunity Title

Increasing Access to Medication-Assisted Treatment (MAT) in Rural Primary Care Practices (R18)

Activity Code

R18 Research Demonstration and Disseminations Projects

Announcement Type

New

Related Notices

  • January 6, 2016 - Notice to Define the Term 'Rural' for AHRQ Funding Opportunity Announcement RFA-HS-16-001. See Notice NOT-HS-16-003.
  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)

Funding Opportunity Announcement (FOA) Number

RFA-HS-16-001

Companion Funding Opportunity

None

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

93.226 

Funding Opportunity Purpose

This initiative will fund demonstration research projects that implement Medication-Assisted Treatment (MAT) for opioid use disorder in primary care practices in rural areas of the United States.  In addition to expanding access to this evidence-based therapy in underserved communities, this initiative will discover and test solutions to overcoming known barriers to implementation of MAT in primary care and create training and implementation resources to support future efforts to expand access to MAT.

Key Dates
Posted Date

December 2, 2015

Open Date (Earliest Submission Date)

February 4, 2016

Letter of Intent Due Date(s)

February 1, 2016

Application Due Date(s)

March 4, 2016, 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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Generally, four months after receipt date.

Advisory Council Review

Not Applicable

Earliest Start Date

Generally, four months after peer review date.

Expiration Date

March 5, 2016

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

Table of Contents

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

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

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

This initiative will fund demonstration research (R18) projects that implement Medication-Assisted Treatment (MAT) for opioid use disorder in primary care practices in rural areas of the United States.  While expanding access to this evidence-based therapy in underserved communities, this initiative will discover and test solutions to overcoming known barriers to implementation of MAT in primary care and create training and implementation resources to support future efforts to expand access to MAT. 

Definitions of Key Terms

For the purposes of this FOA, the following definitions apply:

Primary Care:  AHRQ defines primary care as the provision of integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, including prevention and health promotion, developing a sustained partnership with patients, and practicing in the context of family and community. 

Primary Care Practices:  Primary care practices are health care organizations that are dedicated to the provision of primary care utilizing lead clinicians such as family medicine physicians, general internal medicine physicians, general practice physicians, general pediatric physicians, geriatrician physicians, nurse practitioners, and physician assistants.

Opioid Use Disorder (OUD): Opioid Use disorder (OUD) is a substance use disorder defined as a problematic pattern of opioid use leading to clinically significant impairment or distress occurring within a 12 month period.  It can involve misuse of prescribed opioid medications, use of diverted opioid medications, or use of illicitly obtained heroin.

Medication-Assisted Treatment (MAT):  Medication-assisted treatment (MAT) is the use of FDA-approved opioid agonist and antagonists medications, in combination with counseling and behavioral therapies, to provide a whole-patient approach to the treatment of substance use disorders.  MAT includes screening, assessment (which includes determination of severity of opioid use disorder, including presence of physical dependence and appropriateness for MAT), initiation, maintenance, and on-going support for recovery.  Research shows that when treating substance-use disorders, a combination of medication and behavioral therapies, as provided in MAT, is most successful.

Buprenorphine: This medication is a partial opioid agonist approved by the FDA in 2002.  It has a lower risk of abuse, dependence, and side effects compared with other drugs.  It can be prescribed by a certified physician, thus eliminating the need to visit specialized treatment clinics.  Buprenorphine often is offered as a combination medication with naloxone, which reduces its potential for abuse.

Naltrexone: This medication is used for the treatment of opioid dependence and alcohol use disorders. As an opioid antagonist, naltrexone blocks the effects of opioids and has demonstrated effectiveness in reducing alcohol consumption, the effects of alcohol, and cravings for alcohol.  Because patient compliance can be an issue with naltrexone, the FDA has approved Vivitrol, an injectable form of naltrexone that is administered monthly.

Background

According to the Diagnostic and Statistical Manual of Mental Disorders (DSM-V), opioid use disorder is defined as “a problematic pattern of opioid use leading to clinically significant impairment or distress occurring within a 12-month period”. This pattern may include compulsive and self-administered opioids for no legitimate medical purpose, or if required, used in doses in excess of what would be needed. Opioids that are misused include illegal drugs, such as heroin; and legally available prescription pain relievers, such as oxycodone and hydrocodone.  Individuals are at risk for serious adverse effects including overdose and death.

It is estimated that in 2013, 1.8 million American adults had an opioid use disorder related to prescription pain relievers, and 517,000 had an opioid use disorder related to heroin. In 2013, over 16,000 individuals died as a result of prescription opioid overdose; and over 14,000 from illicit drug overdose. Opioid use disorders can accompany other clinical co-morbidities such as HIV/HCV infections, chronic pain, and psychiatric disorders. In addition to health-related issues, opioid use disorder may affect an individual’s interpersonal relationships, employment, and involvement in criminal activities.

In 2000, the US Congress passed the Drug Addiction Treatment Act (DATA), to expand treatment options beyond opioid treatment programs. This allowed office-based physicians to obtain a waiver so they could prescribe buprenorphine, which is one of the FDA-approved pharmacotherapies for the treatment of opioid use disorders in conjunction with counseling and behavioral therapies. A 2006 study found a 74% retention rate at 6 months for those that received opioid use disorder treatment in an office based setting, with 62% still in treatment and 12% having completed treatment. In addition the number of physicians who obtained a waiver grew from nearly 1000 in 2002 to over 4000 in 2005. Over half of these physicians did not report a specialty in addiction medicine or addiction psychiatry, indicating that efforts were successful in engaging other physician specialists, including general internists and family physicians, in prescribing these medications.  The 2006 evaluation, however, raised a concern about whether individuals in treatment could access appropriate counseling resources.

Medication-Assisted Treatment (MAT) is an evidence-based approach to treating opioid use disorder that uses FDA-approved medications (e.g., buprenorphine, buprenorphine/naloxone or injectable extended release naltrexone), in combination with psychosocial treatments.  MAT is a safe and effective strategy for decreasing the frequency and quantity of opioid use and reducing the risk of overdose and death.  In addition to medication, MAT involves psychosocial treatment and engagement with the community.  This type of treatment can include social skills training; individual group and couples counseling; cognitive behavioral therapy; motivational interviewing; and family therapy. The 2015 American Society of Addiction Medicine practice guideline stipulates that at minimum the psychosocial treatment should include: an assessment of psychosocial needs; supportive individual and/or group counseling; linkages to existing family support systems; and referrals to community-based services. Addiction is a chronic, relapsing condition, and thus MAT should include assessment, diagnosis, treatment planning, psychosocial treatment, medication monitoring to promote adherence, and social services to support patients as they build new drug-free lives and enter long-term recovery. 

Although MAT has evidence to support it as an effective treatment for opioid use disorders, it remains underutilized, being used by fewer Americans than who might benefit from receiving it. Researchers have identified a significant gap between treatment need and capacity.

As part of an integrated Department of Health and Human Services multi-pronged initiative, DHHS is working to increase access to MAT: 

The Substance Abuse and Mental Health Services Administration (SAMHSA), Medication Assisted Treatment: Prescription Drug and Opioid Addiction grant program awarded grants to 11 states to expand and enhance state treatment service systems to increase capacity and accessibility to comprehensive, coordinated, and evidence-based MAT and “wrap-around”/recovery support services for people with opioid use disorders. 

The Health Resources and Services Administration (HRSA) is providing funding to approximately 300 Community Health Centers to expand services for those with substance use disorders, including medication-assisted treatment for opioid use disorder.

The National Institute on Drug Abuse (NIDA) is currently supporting research on the effects of the Affordable Care Act on MAT implementation, and the efficacy of implementation strategies for MAT in medical and criminal justice settings.

This FOA recognizes that primary health care settings offer another tremendous opportunity for expanding access to MAT, especially in areas that may lack access to community-based, specialty treatment centers.

The majority of physicians who are certified to prescribe buprenorphine-naloxone practice in urban counties.  Half of US counties, mainly rural, lack a physician certified to prescribe the medications used in MAT. For these reasons, this FOA specifically targets rural primary care practices. 

Given efforts by HRSA to expand delivery of MAT in community health centers, applicants under this initiative must not focus on supporting community health centers already receiving support for MAT from HRSA. Applicants may, however, engage community health centers that are not receiving support from HRSA.

There are many recognized barriers to implementing MAT in rural primary care practices.  Barriers exist at the patient/community level, at the practice level, at the larger health system level, and the policy/financing level.  At the practice level, barriers to implementing MAT in rural primary care practices include:

  • Negative attitudes towards individuals with substance use disorders and low levels of motivation to treat substance use disorders or reduce health care provider stigma
  • Limitations in prescriber knowledge, skills, and experience including the need for certification and on-going training and support
  • Lack of access to psychosocial supports, including individual patient counseling and community-based support resources
  • Limited resources for initiation of MAT programs and on-going financing to support maintenance of services
  • Lack of coordination of MAT with broader health care community, including decisions of whether to treat only patients that receive primary care at the practice or becoming a referral center to other primary care practices.

These and other barriers were discussed at the 2014 Buprenorphine Summit, convened to bring together national leaders working with opioid use disorders to establish the state of the field and develop strategies for moving forward. (SAMHSA-NIDA, 2014).

The goals of this FOA are to:

1.  Study the planning, initiation, and delivery of MAT by primary care clinicians, teams, and practices in rural communities. 

2.  Develop and test resources and training materials to assist primary care practices and physicians in overcoming barriers to initiating and sustaining the delivery of MAT in rural primary care practices.

As part of this Research Dissemination and Implementation grant, applicants must:

1.  Define a rural region or set of rural communities that will be served and describe the current availability of opioid use disorder treatment services and the degree of unmet need.

2.  Describe in detail a comprehensive model or models for the delivery of MAT that utilizes primary care providers and practices that will be implemented in the region or communities.  The model must include the provision of both medications and supportive psychosocial services.

Consistent with recommendations from Federal Agencies such as the NIDA and SAMHSA, the primary medications of interest under this initiative are buprenorphine, buprenorphine/naloxone, and extended-release injectable naltrexone.  While methadone is an important option for treating opioid addiction, models proposing to include methadone will be deemed non-responsive to the RFA and will not undergo peer view.

3.  Describe in detail a plan for recruiting and engaging primary care providers and practices, providing necessary prescriber and staff training, and supporting physicians and practices in initiating and implementing the proposed MAT model.

AHRQ is particularly interested in approaches that leverage health IT, tele-health, and tele-training to address the needs of rural primary care practices.  This includes both the potential use of Project ECHO-like models (http://echo.unm.edu/) for providing training and support for primary care professionals and office staff and the potential use of tele-health and mobile technologies to provide patients with psychosocial support services.

4.  Identify at least five major barriers to the provision of MAT by rural primary care physicians, teams, and practices and explain how the proposed MAT model and implementation intervention is expected to address and overcome these barriers.

5.  Propose a robust, multi-level intervention evaluation that will examine the ability of recruited primary care practices to deliver MAT, the effect of the initiative of expanding access to MAT within the region or communities, the experience of primary care physicians and staff members in implementing the MAT model, and the effectiveness of the initiative to address recognized barriers to the implementation of MAT in rural primary care practices.

6.  Detail a comprehensive dissemination plan that will ensure that stakeholders, including health care decision makers, health care systems, primary care professionals, and the public, are informed of the initiative’s progress and findings in an on-going and timely manner.

References

SAMHSA–NIDA. Buprenorphine Summit - Report of Findings.   September 22-23, 2014.

See Section VIII. Other Information for award authorities and regulations.
Section II. Award Information
Funding Instrument

Grant

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

AHRQ anticipates investing up to $4 million in the first year of this initiative and up to $12 million over three years to support up to 4 awards.

Awards issued under this FOA are contingent upon the submission of a sufficient number of meritorious applications.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary. The total amount awarded and the number of awards will depend upon the number, quality, duration, and costs of the applications received.

Award Budget

Applications may be up to 3 years in duration with a budget supported by AHRQ not to exceed $1 million in total costs in any given year.  An application with a budget exceeding $1 million in total costs in any given year or a project period exceeding 3 years will not undergo peer review.  Funding beyond the first year will be contingent upon review and acceptance by Agency staff of an annual progress report.

Award Project Period

The project period may not exceed 3 years.  

These projects are authorized by 42 U.S.C. 299a, which provides that AHRQ shall conduct and support research, support demonstration projects, and disseminate information on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness, and value of health care services.

All applications submitted and AHRQ grants made in response to this FOA are subject to 45 CFR Part 75 (Uniform Administrative Requirements, Cost Principles and Audit Requirements for HHS Awards; http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75) , the HHS Grants Policy Statement (see http://www.ahrq.gov/funding/policies/hhspolicy/index.html and  http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf), and the terms and conditions set forth in the Notice of Award.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

You may submit an application(s) if your institution/organization is a (an):

Public or non-profit private institution, such as a university, college, or a faith-based or community-based organization;

  • Unit of local or State government;
  • Eligible agency of the Federal government.
  • Indian/Native American Tribal Government (Federally recognized)
  • Indian/Native American Tribal Government (Other than Federally recognized);
  • Indian/Native American Tribally Designated Organization.

The following types of Higher Education Institutions are always encouraged to apply for AHRQ support as Public or Non-Profit 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)

AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism.  For-profit organizations may participate in projects as members of consortia or as subcontractors only.  Because the purpose of this program is to improve healthcare in the United States, foreign institutions may participate in projects as members of consortia or as subcontractors only.  Applications submitted by for-profit organizations or foreign institutions will not be reviewed.  Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

HHS grants policy requires that the grant recipient perform a substantive role in the conduct of the planned project or program activity and not merely serve as a conduit of funds to another party or parties. If consortium/contractual activities represent a significant portion of the overall project, the applicant must justify why the applicant organization, rather than the party(s) performing this portion of the overall project, should be the grantee and what substantive role the applicant organization will play. Justification can be provided in the Specific Aims or Research Strategy section of the PHS398 Research Plan Component sections of the SF424 (R&R) application.  There is no budget allocation guideline for determining substantial involvement; determination of substantial involvement is based on a review of the primary project activities for which grant support is provided and the organization(s) that will be performing those activities.

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.

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.
  • 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 Director/Principal Investigator (PD/PI)

The PD/PI must have an eRA Commons account.  The PD/PI should work with his/her 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, he/she 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/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support.

Only one PD/PI may be designated on the application.

2. Cost Sharing

This FOA does not require cost sharing.

While there is no cost sharing requirement included in this FOA, AHRQ welcomes applicant institutions, including any collaborating institutions, to devote resources to this effort.  An indication of institutional support from the applicant and its collaborators indicates a greater potential of success and sustainability of the project.  Examples of institutional support would include: donated equipment and space, institutional funded staff time and effort, or other resource investments.  Applicant institutions should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project. This information can be included at the end of the budget justification section of the application, but institutional support dollars are not to be shown/included in the detailed budget request. 

3. Additional Information on Eligibility
Number of Applications

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

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

Applicants must obtain the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

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

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

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 AHRQ 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/PI
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent electronically to:

Phillip E. Jordan, M.A.
Email: phillip.jordan@ahrq.hhs.gov

Technical Assistance Conference Call

AHRQ encourages applicants to take advantage of a technical assistance conference call sponsored by AHRQ program staff. The purpose of the conference call is to respond to questions about the preparation of an application in response to this FOA. The conference call will take place on January 13, 2016 at 1:00 pm EST. To register to participate in the conference call, please send an e-mail request to Phillip.Jordan@ahrq.hhs.gov by January 11, 2016.  All registrants will be sent an e-mail reply which will contain information on the call and call-in information by COB January 11, 2016. Potential applicants are encouraged to contact AHRQ staff with any questions (see Section VII, Agency Contacts, below).

The conference call is open to any individual or organization intending to apply. Participation is not a prerequisite to applying. Participants are encouraged to submit questions via email prior to the conference call. Please submit up to five questions with your name and the name of your institution to Phillip Jordan (phillip.jordan@ahrq.hhs.gov). Please include the phrase “Increasing MAT: Questions” in the subject line.  Questions of a similar topic and nature may be grouped at the sole discretion of AHRQ staff.  Notes from the conference call will be posted on the AHRQ web site.

Page Limitations

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

  • For this specific FOA, the Research Strategy section is limited to 25 pages.
Instructions for Application Submission

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

SF424(R&R) Cover

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

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 or Modular Budget

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

Budget Component:  Special Instructions for AHRQ applications

AHRQ is not using the Modular Grant Application and Award Process.  Applicants for funding from AHRQ are to ignore application instructions concerning the Modular Grant Application and Award Process, and prepare applications using instructions for the Research and Related Budget Components of the SF 424 (R&R).  Applications submitted in the Modular format will not be reviewed.

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 that are not otherwise specified within this Funding Opportunity Announcement must be followed, with the following additional instructions: 

Research Strategy

The research plan section of the application is limited to 25 total pages.  Applications where the research plan section exceeds 25 pages will not undergo peer review.  Below are suggested page limits for each component of the research plan, which are intended to allow flexibility in developing the research plan.

The research plan section must include the following seven sections:

1.  The Region (recommended no longer than 2 pages)

2.  Model for the Delivery of MAT in Rural Primary Care Practices (recommended no longer than 4 pages)

3.  Plan for Supporting Rural Primary Care Practices in Implementing MAT (recommended no longer than 8 pages)

4.  Barriers to Implementing MAT in Rural Communities and How the Proposed Model and Implementation Plan Will Address These Barriers (recommended no longer than 4 pages)

5.  Evaluation Plan (recommended no longer than 4 pages)

6.  Project Timeline (recommended no longer than 1 page)

7.  Dissemination (recommended no longer than 2 pages)

Section 1:  The Region

AHRQ suggests this section be no longer than 2 pages and should accomplish the following:

Define the geographic region or series of rural communities to be served, including:

-The population and its health status, with attention to opioid use disorders

-Regions and/or communities must be above the national average for opioid abuse and/or overdose death rates

-The health care environment, including the availability of treatment for opioid use disorders

-Applicants must demonstrate that the region or communities are underserved in terms of access to SUD services.

-The total number of primary care practices and primary care professionals in the region

-Other substance abuse treatment services and initiatives occurring in the region and how the proposed project is aligned with them. If not aligned, discuss how competition and confusion will be avoided or minimized.

- Applicants may not propose to work in communities funded under the SAMHSA Targeted Capacity Expansion: Medication Assisted Treatment - Prescription Drug and Opioid Addiction (MAT-PDOA) grant program, but may work within these States.

Section 2:  Model for the Delivery of MAT in Rural Primary Care Practices

AHRQ suggests this section be no longer than 4 pages and should accomplish the following:

Describe in detail an evidence-based, comprehensive approach to the delivery of MAT by primary care physicians and primary care practices.

The model may contain variations that will be customized to individual practices or different models that may be used in different practices or communities.

The model must be comprehensive and address both the provision of FDA-approved medications and the provision of psychosocial support.

Applicants should describe a comprehensive approach for delivering ongoing MAT services including how the primary care practices will:

-Screen patients for opioid use disorders

-Assess readiness to change/motivation for all patients who screen positive

-Use motivational interviewing or other evidence-based strategies to help patients prepare to quit using opioids

-Determine appropriate drug and dose to prescribe

-Arrange for and deliver or assure delivery of social/behavioral services

-Monitor progress and update treatment plans

In addition, the applicant should describe:

-How the primary care practice will be reimbursed for all services provided

-     Note that this grant is not to provide reimbursement for any services provided. The funds from this grant must not be used to pay for MAT services. The project should assist practices with developing a plan for sustainable financing for the provision of MAT services

-How services will be provided (e.g. offer MAT during all clinic hours or only during selected days/sessions)

-MAT service workflow and team composition

It is likely that the model will involve the linking of primary care practices to community-based resources. 

The model may include support for specialists that provide either consultation for practice physicians and/or staff members or who deliver services directly to patients.  If the model relies on services provided outside of the primary care practice, the initiative must detail how it will ensure that these services are available to all primary care practices participating in the project.

Provide a logic model for the overall comprehensive MAT model approach and explanation of how individual components of the model are expected to contribute to its success.

Section 3:  Plan for Supporting Rural Primary Care Practices in Implementing MAT

AHRQ suggests this section be no more than 8 pages and should accomplish the following:

Describe plans for practice and physician recruitment, including:

-How primary care practices and physicians within the region will be identified

-How primary care practices will be recruited and engaged

-How many primary care physicians and practices will be engaged

-An estimate of the percent of primary practices that will agree to participate and the percent participating that will drop out

Describe in detail the support that will be given to primary care practices and physicians to assist them in initiating the delivery of MAT, including:

            -Motivating physicians and practice staff to deliver MAT

            -Training physicians to prescribe MAT and receive necessary certification

            -Training practice staff members to deliver all components of MAT protocol

            -Providing on-going support for delivery of MAT

            -Creating linkages with community resources

In the event regulations change and additional providers are able to prescribe medications for MAT, proposals should reflect engagement, training, and support for these providers.

The application should include a general timeline of the approach for working with an individual primary care practice.

Discuss potential challenges and barriers to supporting primary care practices and potential mitigation strategies.

Section 4:  Barriers to Implementing MAT in Rural Communities and How the Proposed Model and Implementation Plan Will Address These Barriers

AHRQ suggests this section be no more than 4 pages and should accomplish the following:

Applicants should list at least five recognized barriers to the delivery of MAT by rural primary care practices and for each barrier describe how the proposed MAT model and implementation plan described in Sections 2 and 3 will address and overcome these barriers.

Section 5:  Evaluation

AHRQ suggests this section be no more than 4 pages and should accomplish the following:

Describe a multi-level evaluation plan that determines the effectiveness of the project in increasing access to MAT in the region, the experience of primary care physicians and primary care practice staff in initiating and delivering MAT, and the effectiveness of the strategies proposed in Section 3 in addressing the barriers described in section 4.

Applicants are encouraged to incorporate both quantitative and qualitative measurement and analysis methods as appropriate. 

Applicants are strongly encouraged to utilize the methods of implementation science to document and evaluate the implementation of the proposed intervention.  The use of the RE-AIM framework or a similar implementation evaluation methodology is encouraged. 

Applicants are encouraged, but are not required, to consider examining the impact of their intervention on racial, ethnic, and other health and health care disparities.

The evaluation plan should include a plan for measuring process and outcomes measures such as:

-# primary care practices in the region or communities eligible for participation

-# primary care practices approached for recruitment

-# primary care practices engaged

-# physicians who achieved certification for MAT prescribing as a result of project

-# primary care practices successfully initiating the delivery of MAT services as a result of project

-Patient/physician/staff experience with the delivery of MAT (acceptance and satisfaction)

This funding opportunity is directed at understanding and overcoming health system barriers to the implementation of MAT in rural areas with a focus on primary care practices.  It is not focused on demonstrating the effectiveness of MAT.  The unit of analysis is expected to be the primary care practice and rural community.  Applicants are not required to propose measuring patient-level outcomes.

The proposed evaluation should include assessment of the delivery of MAT by engaged practices, such as:

-Percentage of eligible patients screened for OUD

-Percentage of screened patients diagnosed with OUD

-Percentage of patients with OUD who receive counseling regarding psychosocial and pharmacologic treatment options for opioid addiction

-Percentage of patients with OUD receiving FDA-approved medications for OUD

-Percentage of patients with OUD receiving psychosocial supports

-Percentage of patient with OUD retained in treatment over time.

The evaluation plan should include:

Articulation of clear evaluation questions; data collection, quality assurance, and management plans; and analytic methods and the relationship between them.

Section 6:  Project Timeline

AHRQ suggests this section be no longer than 1 page and accomplish the following:

Provide a project timeline showing the major scheduled milestones (events, activities, data gathering, analysis, and reporting) for the project.

A description of the applicant's plan for obtaining Institutional Review Board (IRB) approval of the project.  AHRQ encourages applicants to consider approaches that increase the chance that data collection will not be delayed.

A more detailed Gantt chart should be included as an appendix.

The timeline should document how all aspects of the proposed work described in the preceding and following sections will be accomplished within 36 months.

Section 7:  Dissemination

AHRQ suggests this section be no more than 2 pages in length.

In order to accomplish the major goals of this initiative it is important the results and team insights be clearly communicated with multiple stakeholders, including health care decision makers, health care systems, primary care professionals, and the public.  It is equally important that these results and insights be shared in a timely manner.

While it is not the main focus of this initiative at this phase to ensure sustainability of the implementation infrastructure, providing information about the structure and resources required for implementation of successful approaches is very important.

This section should accomplish the following:

Describe plans for making information publically available about the project, its planned approach to working with primary care practices and rural communities, and the external context in which the approach is being implemented.  It is expected that this will be done within the first six months of the project and be updated regularly.

Describe plans for sharing results of the intervention with the range of stakeholders noted above.  It is expected that results will be shared in a timely manner and not only through peer-reviewed publications and presentations. 

Describe plans for sharing insights into the implementation of the intervention with the range of stakeholders noted above.  It is expected that findings will be shared in an on-going manner throughout the project period and not only through peer-reviewed publications and presentations.  For example, in year 1 it is expected that grantees may share materials developed for recruiting practices, educational materials targeted to staff to reduce the stigma associated with providing MAT, and lessons learned about supporting primary care physicians certified and trained to prescribe FDA-approved medications.  In year 2, grantees might share materials such as screening tools and protocols, resources for linking primary care practices with community-based resources including referral forms and partnership agreements, and early evaluation results. 

Document a commitment to cooperating with AHRQ and its contractors in promoting the applicant’s work and findings.  Activities may include: 

-Reviewing project descriptions that AHRQ or contractor develops for dissemination on AHRQ websites and providing timely feedback;

-Providing brief, high-level quarterly updates on the progress of the grant to AHRQ and AHRQ contractors; and

-Sharing information on any grant outputs (e.g., results, publications, tools) for inclusion in AHRQ initiative descriptions.

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.

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

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

For efficient grant administration, AHRQ grant administration procedures will be used and conducted in accordance with the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The Grants Policy Statement can be found at http://www.ahrq.gov/funding/grants/policies/hhspolicy.html.

Pre-award costs are allowable. A grantee may, at its own risk and without AHRQ prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs are necessary to conduct the project and would be allowable under the grant, if awarded, without AHRQ prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain AHRQ approval before incurring the cost. AHRQ prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on AHRQ either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. AHRQ expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project.

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:

The PD/PI must include his/her 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 AHRQ. 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.

The applicant should pay particular attention to the SF424 (R&R) application guide instructions concerning letters of support. Letters of support, recommendation, or affirmation from any entity or individual not directly participating in the project should not be included.

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

In order to expedite the review, applicants are requested to notify the AHRQ Referral Office by email Gerald.Calderone@ahrq.hhs.gov when the application has been submitted.  Please include the FOA number and title, PD/PI name, and title of the application.

Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html). However, initiation of IRB review, if necessary or applicable, is strongly encouraged to assure timely commencement of research.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks

Priority Populations

AHRQ supports research, evaluations, and demonstration projects concerning the delivery of health care in inner-city and rural areas (including frontier areas), and health care for priority populations.  Priority populations include low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care.  42 USC 299(c).  Women and members of minority groups are included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate, e.g. because of the lack of connection between the study and the health of women or particular minorities.  Investigators should review the document entitled, “AHRQ Policy on the Inclusion of Priority Populations,” which is available http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html.  Applicants under this FOA should consider and discuss including priority populations in the research design as specified in this Notice.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing; the format of the final dataset; the documentation to be provided; whether or not any analytic tools also will be provided; whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use); and the mode of data sharing (e.g., under its own auspices by mailing a disk or posting data on its institutional or personal website or through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Data Confidentiality

The AHRQ confidentiality statute, 42 USC 299c-3(c), requires that information that is obtained in the course of AHRQ supported activities and that identifies individuals or establishments be used only for the purpose for which it was supplied.  Information that is obtained in the course of AHRQ-supported activities and that identifies an individual may be published or released only with the consent of the individual who supplied the information or is described in it.  There are civil monetary penalties for violation of the confidentiality provision of the AHRQ statute. 42 USC 299c-3(d).  In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected.  The description of the procedures should include a discussion of who will be permitted access to this information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded.  Identifiable patient health information collected by grantees under this FOA will also be obtained and managed in accordance with the HIPAA Privacy Rule, 45 CFR Parts 160 and 164. 

The grantee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds that established by the HIPAA Security Rules, if applicable, and that established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.

Sharing Research Resources:  Rights in Data

Unless otherwise provided in grant awards, AHRQ grantees may copyright, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ support, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses.  Such copyrights and patents are subject to a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce, publish, use or disseminate for any purpose consistent with AHRQ’s statutory responsibilities and to authorize others to do so for any purpose consistent with AHRQ’s statutory responsibilities. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers.  In addition, subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits.  Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products. 

AHRQ requests that grantees notify the Office of Communications and Knowledge Transfer (OCKT) when an AHRQ-funded research article has been accepted for publication in a peer-reviewed journal. Researchers should submit manuscripts that have been accepted for publication in a peer-reviewed journal to JournalPublishing@ahrq.hhs.gov at least four to six weeks in advance of the journal’s expected publication date. 

Regulations applicable to AHRQ grantees concerning intangible rights and copyright can be found at 45 CFR 75.322.

Other Special Requirements

Applications must include a plan and budget for three team members, including the PI,  to travel to the Washington, DC area once a year for each year of the grant to participate in a two-day meeting with other grantees.  The first meeting is expected to be held in late fall 2016.

Applicants must demonstrate a commitment to cooperate with AHRQ and its contractors on dissemination activities.   

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

The mission of AHRQ is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work with the U.S. Department of Health and Human Services (HHS) and other partners to make sure that the evidence is understood and used.  

AHRQ's priority areas of focus are:

  • Improve health care quality by accelerating implementation of patient-centered outcomes research (PCOR).
  • Make health care safer.
  • Increase accessibility by evaluating Affordable Care Act (ACA) coverage expansions.
  • Improve health care affordability, efficiency, and cost transparency.

As part of this mission, applications submitted to AHRQ to support health services research are evaluated for scientific and technical merit through the AHRQ peer review system. 

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures that are described in 42 CFR Part 67, Subpart A.  Incomplete and/or non-responsive applications or applications not following instructions given in this FOA will not be reviewed.  Only the review criteria described below will be considered in the review process.

Administrative Criteria:  Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and for responsiveness by AHRQ.

Merit Review Criteria:  Merit Review Criteria, as described below, will be considered in the review process.

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

How likely is it that the proposed plan for supporting rural primary care practices will be successful? 

How likely is it that the proposed project will produce information useful to primary care practices who plan to deliver MAT in the future?

How likely is that the proposed project will produce information useful to other stakeholders about how to support primary care practices in rural or other communities in expanding access to MAT?

Does the proposed project target rural communities with high rates of opioid use disorder and/or opioid overdose deaths that currently have limited access to MAT treatment services?

Does the project’s implementation plan propose meaningful responses to recognized barriers to the implementation of MAT in primary care practice?

Investigator(s)

Are the PD/PI, collaborators, and other researchers well suited to the project?

Is the work proposed appropriate to the experience level of the PD/PI and other researchers?

Do the PD/PI and investigative team bring complementary and integrated expertise to the project (if applicable)?

Do investigators and other team members have appropriate skills and experience for their roles in the project?

Is the leadership approach, governance and organizational structure appropriate for the project?

Does the team have substantial experience with the proposed approach and relations with primary care practices that ensure that the project can recruit and engage primary care practices and deliver the proposed approach within the proposed timeline?

Is it likely that the proposed project and team will be able to develop the necessary partnerships for an effective MAT program, including community-based service organizations and specialty providers?

Innovation

The goal of this FOA, to increase access to MAT, is not in and of itself innovative.  Successful projects may in fact propose the use of multiple best practices in supporting rural primary care practices in initiating and sustaining the delivery of MAT.  The FOA also requires a multi-level evaluation, but does not specifically require innovation.

Does the application propose an implementation strategy that is likely to be successful in engaging primary care practices in delivering MAT?

Is the proposed implementation strategy likely to overcome barriers to the delivery of MAT in rural primary are practices?

Does the application bring together resources from across various organizations and stakeholders to improve the chances of project success?

Approach

The Approach to Implementation

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented?

Does the application propose an implementation strategy that is likely to be successful in engaging primary care practices in delivering MAT?

Does the application describe a comprehensive model of MAT that includes both the prescription of medications and the delivery of support services?

Is the proposed implementation strategy likely to overcome barriers to the delivery of MAT in rural primary are practices?

Is the proposed model for implementation feasible and conceptually well-thought out?

Is the practice recruitment plan realistic, and how likely is the applicant to succeed in recruiting the proposed number of practices?

Will the project successfully reach a substantial number of rural primary care practices?

How likely is it that the proposed approach will succeed in developing the necessary partnerships with community-based organizations to implement MAT?

Does the proposed approach address the potential barriers to implementation and include an adequate plan for addressing them?

The Approach to Evaluation

Does the application clearly articulate evaluation questions, and are the measurement, data collection and management, and analytic plans adequate to answer those questions?

Does the application include a robust, multi-level evaluation that is likely to produce results that are meaningful and valid?

How likely is it that the evaluation will be able to produce findings on implementation of MAT in primary care?

Does the evaluation plan include a well-defined, feasible, and sound data collection plan that is likely to produce needed data, including the measures and frequency of data collection required in this FOA?

Is a feasible plan in place for obtaining necessary OHRP-recognized IRB approvals within the proposed project timeline?

The Approach to Dissemination

Has the applicant identified key topics for dissemination products, including descriptive information about the region and planned approach, quantitative results, and lessons learned about the process of implementation and the internal and external context in which it was delivered?

Does the application bring together resources from across various organizations and stakeholders to improve the chances of project success?

Has the applicant identified dissemination alternatives to peer-reviewed publications and presentations?

How likely is it that the dissemination proposed will provide results and findings in a timely manner to a variety of stakeholders throughout the course of the project?

Has the applicant demonstrated a commitment to cooperate with AHRQ and its contractors on dissemination activities?

Environment

How extensive are the capacities, experience, expertise and other resources of the applicant institution and participating organizations, institutions, and other entities? How well-aligned are they with the needs and aims of the project? How likely are they to contribute to the project’s success?

Does the application effectively leverage regional and local expertise?

Is there sufficient evidence of suitable arrangements and agreements for collaboration among all members of the project and other partners?

Do partnering organizations have a history of successfully working together and a commitment to supporting MAT in primary care?

Is there a strong management plan?

Is there evidence of institutional commitment and support from all proposed organizations?

Is the region and/or rural communities clearly defined and logical? 

Does the proposed project benefit from features of the region such as recent or on-going health and health care initiatives, health information exchanges, clinical environments, community settings, and patient populations?

Have potential environmental obstacles (e.g., political/interest group opposition; regulations) and the means for avoiding or mitigating their effects been identified?

Has the applicant provided clear evidence of no overlap or intersection with other federal MAT and OUD treatment initiatives?  

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.

Degree of Responsiveness

Reviewers will assess how well the application addresses the purpose and objectives of this FOA.  How responsive is the application to the special eligibility criteria, including the project requirements, noted in the FOA? []

Inclusion of Priority Populations 

Reviewers will assess the adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups).  Reviewers will assess the adequacy of attention to AHRQ priority populations (see above discussion on Priority Populations in section IV.6 “Other Submission Requirements”).

Budget and Period of Support

The committee will evaluate whether the proposed budget is reasonable and whether the requested period of support is appropriate in relation to the proposed research. [].

Privacy and Security Protections for Patients

Reviewers will assess the resources and processes to be used to address privacy and security issues in the development and implementation of the intervention.

Resubmissions

Not Applicable

Renewals

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.

Not Applicable 

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group  in accordance with AHRQ 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.

Applications will be assigned on the basis of AHRQ referral guidelines to the appropriate AHRQ Office or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA.  The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by peer review.
  • Availability of funds.
  • Responsiveness to goals and objectives of the FOA.
  • Relevance and fit within AHRQ research priorities, as well as overall programmatic and geographic balance.
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.

Generally, applicants should anticipate eight months between the application submission date and the earliest possible start date.

Section VI. Award Administration Information
1. Award Notices

If the application is under consideration for funding, AHRQ will request "Just-In-Time" information from the applicant.  Just-In-Time information generally consists of information on other support, any additional information necessary to address administrative and budgetary issues, and certification of IRB approval of the project's proposed use of human subjects.  For details regarding IRB approval, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). 

If all administrative and programmatic issues are resolved, 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 AHRQ 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.  See also Section IV.5., “Funding Restrictions.”

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the AHRQ web site at http://www.ahrq.gov/fund/postawrd.htm#terms.

2. Administrative and National Policy Requirements

All AHRQ grant and cooperative agreement awards are subject to OMB's Uniform Grant Guidance, HHS’s “Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards,” (http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75), and the HHS Grants Policy Statement (see http://www.ahrq.gov/funding/policies/hhspolicy/index.html), and the terms and conditions set forth in the Notice of  Award.

A standard term and condition of award will be included in the Notice of Award (NOA) that states:  “in any grant-related activity in which family, marital, or household consideration are, by statute or regulation, relevant for purposes of determining beneficiary eligibility or participation, grantees must treat same-sex spouses, marriages, and households on the same terms as opposite-sex spouses, marriages, and households, respectively. By “same-sex spouses,” HHS means individuals of the same sex who have entered into marriages that are valid in the jurisdiction where performed, including any of the 50 states, the District of Columbia, or a U.S. territory or in a foreign country, regardless of whether or not the couple resides in a jurisdiction that recognizes same-sex marriage.  By “same-sex marriages,” HHS means marriages between two individuals validly entered into in the jurisdiction where performed, including any of the 50 states, the District of Columbia, or a U.S. territory or in a foreign country, regardless of whether or not the couple resides in a jurisdiction that recognizes same-sex marriage.  By “marriage,” HHS does not mean registered domestic partnerships, civil unions or similar formal relationships recognized under the law of the jurisdiction of celebration as something other than a marriage.”

All applicants will be subject to a term and condition that applies the terms of 48 CFR section 3.908 to the award, and requires that grantees inform their employees in writing of employee whistleblower rights and protections under 41U.S.C. 4712 in the predominant native language of the workforce.

As necessary, additional Terms and Conditions will be incorporated into the NoA.

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually unless specified otherwise in the terms of the award.   Grantees are required to submit expenditure data on the Federal Financial Report (FFR; SF 425) annually.

For details regarding progress report submission, refer to http://www.ahrq.gov/fund/noncomp.htm.  If instructions on the AHRQ website are different from the RPPR Instructions, follow the instructions on the AHRQ website. Progress reports are due 3 months before the anniversary of the award. In addition to the annual progress report, recipients will be required to submit quarterly progress reports to AHRQ. Detailed instructions on additional reporting requirements will be provided with the grant award.

Expenditure data is to be reported on the Federal Financial Report (FFR; SF 425). AHRQ requires annual financial expenditure reports for ALL grant programs as described in the HHS Grants Policy Statement (http://www.ahrq.gov/fund/hhspolicy.htm).  AHRQ implementation of the FFR retains a financial reporting period that coincides with the budget period of a particular project.  However, the due date for annual FFRs is 90 days after the end of the calendar quarter in which the budget period ends.  For example, if the budget period ends 4/30/2015, the annual FFR is due 9/30/2015 (90 days after the end of the calendar quarter of 6/30/2015).

A final Progress Report, final Federal Financial Report, and Final Invention Statement are required when an award ends.  All final reports are due within 90 days of the project period end date.  For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.

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 AHRQ 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 HHS Grants Policy Statement (http://www.ahrq.gov/fund/hhspolicy.htm) for additional information on this reporting requirement.

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 CenterTelephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Direct your questions about general FOA issues, including information on the inclusion of priority populations to:

Phillip E. Jordan, M.A.
Agency for Healthcare Research and Quality (AHRQ)
Center for Evidence and Practice Improvement
Telephone: 301-427-1035
Email: Phillip.Jordan@ahrq.hhs.gov

Peer Review Contact(s)

Direct your questions about peer review issues of grant application made in response to this FOA to:

Nghia Vo, M.D.
Agency for Healthcare Research and Quality (AHRQ)
Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
Telephone: 301-427-1191
Email: Nghia.Vo@ahrq.hhs.gov

Financial/Grants Management Contact(s)

Direct your questions regarding fiscal matters to:

Kathryn Carr
Agency for Healthcare Research and Quality (AHRQ)
Office of Management Services
Grants Management
Telephone: 301-427-1025
Email: Kathryn.Carr@ahrq.hhs.gov

Section VIII. Other Information

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

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

Authority and Regulations

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authority of 42 USC 299 et seq., and in accordance with 45 CFR Part 75 and other referenced applicable statutes and regulations.  All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm.

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