Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

Agency for Healthcare Research and Quality (AHRQ), Patient-Centered Outcomes Research Institute (PCORI, http://www.pcori.org/)

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, which can be found within each individual FOA (see Section IV below). AHRQ Grants Policy and Information to applicants regarding Funding Opportunity Announcement procedures can be found at Funding Opportunity Announcement Guidance

Components of Participating Organizations

Agency for Healthcare Research and Quality (AHRQ)

Center for Outcomes and Evidence (COE)

Funding Opportunity Title

Patient-Centered Outcomes Research (PCOR) for Treatment Options in Uterine Fibroids: Developing a Prospective Multi-Center Practice-based Clinical Registry (P50)

Activity Code

P50 Specialized Center

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HS-14-006

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.226   

Funding Opportunity Purpose

The Agency for Healthcare Research and Quality (AHRQ), in partnership with the Patient-Centered Outcomes Research Institute (PCORI), invites applications for funding to examine the relative effectiveness of treatment options for women of childbearing age with uterine fibroids. For women with symptomatic uterine fibroids, it is unclear which treatment strategies are more effective in managing symptoms and addressing patient preferences for reproductive options. As a result, patients and their clinicians often must decide on a plan of action without guidance from strong scientific evidence. Due to the complexity of treatment options, high quality evidence can help women select specific treatment options tailored to their individual preferences. AHRQ and PCORI intend to fund one application that will include a registry Research and Data Coordinating Center (RDCC) to build a registry infrastructure that involves six to ten separate and geographically diverse clinical centers (CC).

Key Dates
Posted Date

September 30, 2013

Letter of Intent Due Date(s)

November 15, 2013

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.

Application Due Date(s)

December 16, 2013

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

December 17, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 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. While some links are provided, 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.

Looking ahead: NIH/AHRQ are committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. See NOT-OD-13-075 and  NIH’s Applying Electronically website for more information.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of 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

AHRQ in partnership with PCORI request research grant applications to examine the relative effectiveness of treatment options for women of childbearing age with uterine fibroids. For women with symptomatic uterine fibroids, it is unclear which treatment strategies are more effective in managing symptoms and addressing patient preferences for reproductive options. As a result, patients and their clinicians often must decide on a plan of action without guidance from strong scientific evidence. Due to the complexity of treatment options, high quality evidence can help women select specific treatment options tailored to their individual preferences.

Background

Uterine fibroids are common.  A recent Internet-based survey of over 20,000 women in 8 countries including the United States reported a self-reported prevalence of uterine fibroids ranging from 4.5% to 9.4% in women of child-bearing age. Fibroids are also common in pregnancy; ranging from 8% in white women to 18% in black women by ultrasound examination. One screening study using medical records, self-report, and ultrasound in a group of 1364 women 35 to 49 years old randomly selected from an urban health plan estimated a cumulative incidence of >80% for black women and almost 70% for white women by age 50. The difference between black and white women was highly significant (OR 2.9, 95%CI 2.5 to 3.4, P<0.001).

Fibroids are benign and often asymptomatic.  Often, no treatment is required, but for those who are symptomatic, fibroids can cause significant morbidity including heavy bleeding, pelvic pain and pressure. Women with submucous and intramural fibroids are also at increased risk for decreased fertility. Further, treatments for fibroids pose a significant burden. An analysis of the National Inpatient Sample (NIS) data found that more than 260,000 hysterectomies (abdominal, laparoscopic, and vaginal) were performed in 2007 in women with a primary or secondary ICD9-CM diagnosis of uterine fibroids.

A number of treatment options exist for women with symptomatic fibroids. Medical treatments include nonsteroidal anti-inflammatory drugs to alleviate pain, and hormonal therapies including oral contraceptives to control bleeding. Gonadotropin-Releasing Hormone (GnRH) agonists also reduce fibroid volume and control bleeding. GnRH agonists can cause menopausal symptoms and typically are not used for longer than 6 months. These agents are FDA-approved for use before surgery to reduce bleeding. Other agents like mifepristone, ulipristal acetate, and epigallocatechin gallate are in clinical trials.

Procedural treatments include hysterectomy, myomectomy, hysteroscopy, endometrial ablation, uterine artery embolization (UAE), and focused ultrasound ablation using magnetic resonance guidance. Hysterectomy is a definitive treatment for women who no longer desire reproduction. Myomectomy is an option for women who wish to preserve their uterus and fertility. However, more than one-third of women who have had myomectomy will need additional surgical interventions. Hysteroscopy permits removal of intracavitary fibroids by means of a resectoscope or uterine morcellator. This method is not well suited for removal of large fibroids or those embedded deep within the uterine wall. Uterine artery embolization (UAE, also known as uterine fibroid embolization, UFE) can be used to treat women with fibroids who are not interested in future pregnancy. Most UAEs can be performed in an outpatient setting. Compared to hysterectomy, UAE has higher minor complication rates. Endometrial ablation may be an option for women with excessive bleeding who have completed childbearing and have an endometrial cavity with minimal distortion. Patient satisfaction after endometrial ablation is high, but the ability of the procedure to achieve amenorrhea is variable (15% to 60%). Focused ultrasound ablation with magnetic resonance guidance is one of the least invasive treatment options; it was approved by FDA in 2004 for the treatment of fibroids. One cohort study reported short-term (6 to 12 mo) symptom reduction using this technique. Whether this approach offers long-term symptom relief is unknown.

A 2007 AHRQ systematic review of treatments for women with uterine fibroids concluded that there is a lack of high quality evidence supporting the effectiveness of most interventions for symptomatic fibroids. Specifically, “there is a lack of well-conducted trials in U.S. populations that directly compared treatment options, including the option of expectant management, and that followed women to determine whether their objectives for treatment were met by the intervention received.” Cochrane reviews and other reports have also concluded that there are gaps in information available to address patient and clinician decision making and treatment selection.

In March 2013, the PCORI convened an ad hoc uterine fibroids workgroup composed of patients, researchers, and a broad spectrum of stakeholders including payers and clinical experts to identify research gaps and questions that, if answered, would provide new information to help patients and providers make more informed decisions and improve health outcomes. This workgroup concluded that questions on the relative effectiveness of the available treatments and differential effectiveness in subgroups (see below) and other modifying factors are of high priority. Stakeholder groups in previous research prioritization efforts, such as those undertaken by AHRQ, have reported that different subpopulations may have different childbearing aims and therapeutic goals, and these subpopulations should be clearly prespecified in research studies. For example, women who have had multiple (versus none) prior uterine procedures for fibroids and are interested in childbearing should be clearly prespecified as a subgroup of interest. These stakeholders also suggested that the most important outcomes to consider were durability of symptom relief, and reproductive outcomes. The workgroup stressed that the outcomes to consider in a particular study will have to take into account the severity of the disease in the population of interest. Similarly, the treatment options to consider will also have to factor in patients’ reproductive preferences and therapeutic goals. 

Research Areas of Interest

Based on prior stakeholder input, this FOA identifies the following topic areas of particular interest:

Comparisons of interventions to evaluate the relative effectiveness of available procedural or nonprocedural treatments including medical and complementary therapies for uterine fibroids.

The relative effectiveness of procedural treatments (e.g., hysterectomy, myomectomy, uterine artery embolization, magnetic resonance image-guided focused ultrasound, endometrial ablation) on durability of symptom relief and patient reported outcomes, as well as reproductive outcomes, harms, and other outcomes.

Promising strategies to identify and choose treatment options for fibroid management, including those tailored for different subpopulations.

Evaluation of groups of reproductive-age women who differ by symptom severity, reproductive preferences, or other risk factors.

Factors that modify the clinical response to all treatments, including fibroid size and location, pre-procedural therapies to shrink fibroids, disease severity, prior treatments for symptomatic fibroids, prior reproductive history, family history, and demographics including race and age.

Questions on innovative methods to investigate causal inference in non-randomized comparative studies and heterogeneity of treatment effects using data derived from large registries.

Research Objectives

Based on stakeholder input and the review of ongoing trials as reported in ClinicalTrials.gov, it has been determined that the optimal approach to gather information on relative effectiveness among all the available treatment options is to develop a multi-center nationally representative uterine fibroids treatment registry, from which rigorous comparative treatment effectiveness and safety research can be conducted. The research based on this registry will help to develop scientific evidence regarding the patient-centered outcomes (symptoms, patient reported outcomes, reproductive outcomes, harms and others) comparing the different therapies of interest. The therapies include expectant management, medical, procedural, combined medical and procedural, and complementary therapies.

As stated previously, the comparative effectiveness of these options is unknown. It is impractical to study the comparative effectiveness of these options in randomized clinical trials given the difficulty in enrolling the sample sizes needed in a timely fashion to reach valid conclusions. Moreover, randomized clinical trials have a number of limitations that are hard to overcome for examining the comparative effectiveness of interventions where patient value and preference and the long term outcomes are central to therapeutic considerations. Prospective multi-center clinical studies using a uterine fibroids registry will help to elucidate the patient-centered outcomes of the various treatment options. A registry that captures real world experience with these treatment options would be a valuable resource to inform decision makers (patients, physicians, hospitals, and policy makers) about comparative effectiveness and will ultimately serve to improve patient-centered outcomes, quality of life, and safety.

AHRQ is requesting applications to develop a multi-center registry of women who have received medical or surgical treatments for uterine fibroids.  The project is also required to conduct multiple collaborative and prospective studies using data from this registry. The development of a large scale practice-based uterine fibroids registry is intended to advance new knowledge and to conduct innovative comparative effectiveness research. Further, the registry-based studies will help facilitate the inclusion of traditionally understudied subpopulations with inherent vulnerabilities, disparities, or risks of serious adverse outcomes. Improved evidence on clinical effectiveness will inform decisions made by patients and clinicians.

Research studies proposed as part of developing the registry must be designed as multi-center initiatives and serve to guide infrastructure development. The studies conducted through the multi-center registry infrastructure, as the registry itself, should be implemented as part of the clinical practice and integral to the clinical work flow. They should be expected to have potential high impacts in advancing the evidence base and have a substantial capacity to inform decision-making that improves patient-centered outcomes. The studies must be set up to address questions that are of concern to patients. Studies must be powered to address clinically important and patient-centered endpoints and must also be able to study comparative effectiveness and safety across demographic and clinical subpopulations. Three research studies are to be included in this registry application.

Examples of research studies that are responsive to the research plan requirements of this FOA are indicated below. These include, but are not limited to:

The proposed research projects must start with a critique and synthesis of available data and the medical literature and critically evaluate the evidence and the outstanding research, and identify the important questions that should be answered. Based on the critique, the application must describe an approach to address these questions. The proposed approach must specify the analytic design, statistical power, and feasibility of addressing the unanswered questions.

Both AHRQ and PCORI place a strong emphasis on engagement of stakeholders in research that they support, and in particular, patients.  Applications must include a patient and stakeholder engagement plan, and a governance structure and protocol that will serve to guide and oversee the registry data collection and management functions, potential quality of care improvement and research use of the registry data, confidentiality and security of the registry data, as well as the analytical and publication plans and all aspects of the conduct of the research.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New

The OER Glossary and the PHS 398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

AHRQ intends to fund 1 award of up to $4,000,000 total costs (including both direct and indirect costs), for fiscal year 2014.

Future year amounts will depend on the availability of PCORI funding.

Award Budget

The total costs (direct and indirect) for a project awarded under this FOA will not exceed $4,000,000 per year or $20,000,000 for the entire project period.

Award Project Period

The project period may not exceed 5 years.

AHRQ and PCORI are authorized to make this award by 42 U.S.C. 299a(a) and 42 U.S.C. 1320e(d)(2)(B), respectively.  The award is funded under an agreement with PCORI pursuant to 42 U.S.C. 299b—37(g).

All applications submitted and AHRQ grants made in response to this FOA are subject to AHRQ's grant regulations at 42 CFR Part 67, Subpart A, the HHS Grants Policy Statement (see http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html and  http://dhhs.gov/asfr/ogapa/grantinformation/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): 

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.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the PHS 398 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.

Program Director/Principal Investigator (PD/PI)

The PD/PI must have an eRA Commons account and should work with his/her organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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. 

The PD/PI must commit a minimum of 25% effort per year for the duration of the project.

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 any application that is essentially the same as one already reviewed within the past thirty-seven months, except for submission:

Section IV. Application and Submission Information


1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS 398 Application Guide, 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.

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:


The letter of intent can be sent electronically, and should be sent to:

Uterine Fibroid Registry FOA
Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Email: UFRegistryFOA@ahrq.hhs.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

Uterine Fibroid Registry FOA
Attention: Amy Lindinha
Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Email: UFRegistryFOA@ahrq.hhs.gov

Page Limitations

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, in addition to the following page limitations to the application:

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the PHS 398 Application Guide, and should be used for preparing the research strategy section of the multi-component application.

The Research Strategy section of the application should consist of the following components:

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

In order to achieve the study's goals, the proposed application for a multi-center registry and research studies must  include as part of its investigative team expertise and experience in:

1. large scale patient registries that are practice-based and/or can be readily interfaced with electronic health records;

2. clinical and epidemiological research that involved longitudinal data from multiple sources;

3. patient reported outcomes and measurements; and

4. stakeholder and patient engagement activities throughout all stages of the research execution and dissemination activities.

In addition to the applicant institution and its key personnel, all consortium clinical centers as the additional project/performance sites and their respective key personnel should be identified and their role delineated.

Table of Contents

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Do not use Form Page 3 of the PHS 398; a more comprehensive table of contents is needed for a multi-project application.

Note that applications will be scientifically reviewed with respect to the overall approach of the core functions of registry including design, governance, infrastructure, as well as the 3 proposed research projects.  Applicants should prepare a detailed Table of Contents that will enable reviewers to readily locate specific information pertinent to the overall application, as well as to each component in the research strategy section.

The detailed Table of Contents must also include a page reference for the budget for each component (e.g., Core Registry Functions and Research Project 1, Research Project 2, Research Project 3, etc.).  Further, each research project must be identified by number (e.g. Research Project 1), title, and responsible Project Leader.  The page location of an OVERALL BUDGET should be indicated in the "Table of Contents."   Separate proposed budgets for proposed components are required as described under Budget Component below.

Detailed Budget for Initial Budget Period

All instructions in the PHS 398 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 should 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.

Budget for Entire Proposed Period of Support

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Composite and Component Budgets

Do not use Form Page 4 of PHS Form 398 to create the composite budget.  Instead, using the suggested format presented below, prepare an overall Composite Budget for All Proposed Years of Support. Detailed budget is required not only for the initial budget period but the entire requested priod of support as well. (Justification for budget elements should not be presented here, but in the individual budgets of the projects and cores.)  FOR EXAMPLE (figures are for illustrative purpose only):

Component

Year 1

Year 2

Year 3

Year 4

Year 5 

All Years

Project 1.

75,000

150,000

150,000

150,000

150,000

  675,000

Project 2.

75,000

150,000

150,000

150,000

150,000

  675,000

Project 3.

75,000

150,000

150,000

150,000

150,000

  675,000

Core Infrastructure/ Registry Functions.

775,000

550,000

550,000

550,000

550,000

2,975,000

Totals

1,000,000

1,000,000

1,000,000

1,000,000

1,000,000

5,000,000

 

 

 

 

 

 

 

AHRQ and PCORI intend to commit up to $4,000,000 total costs in FY 2014 to fund one application that will include a registry Research and Data Coordinating Center (RDCC) to build a registry infrastructure that involves six to ten separate and geographically diverse clinical centers (CC).  Additional details regarding the description and requirements for the RDCC and CC are indicated below in the Research Strategy section. 

AHRQ plans to award a total amount of up to $20,000,000 (total costs) over five years. The applicant must submit an overall composite budget for the overall registry and individual budgets and budget justifications for the RDCC and each of the three research projects. The individual budgets, totaled together, must equal the composite budget.  As detailed budget is required, applicants should identify and with narrative justification as appropraite in the corresponding components of the registry infrastructure core and research projects. As a general guidance, allowable research budget costs allocated to RDCC may include but are not limited to: personnel time/effort (e.g., PD/PI, co-investigators, statisticians/methodologists, database/information engineers, research/project coordinators, etc.), site visits relate to training and data assurance/auditing and steering committee meeting expenses, data collection and data repository as well as web development and hosting, etc., that are related to registry data infrastructure maintainence and data quality assurance.

Applications must identify the potential source(s) for any drugs, substances, or devices that are being considered for the proposed clinical studies that are currently unavailable commercially.

The funds allocated to CC must include only allowable research costs and must not include research participation costs. As detailed budget is required, applicants should identify and with narrative justification as appropraite in the corresponding components of the registry infrastructure core and research projects. As a general guidance, allowable research budget costs allocated to CC may include but are not limited to: personnel time effort (e.g., lead co-investigators, research coordinators, etc.), supplies and equipment, patient enrollment materials, clinical services such as imaging studies and laboratory tests that are not part of the routine clinical care, and the admistration of the follow up patient-report health outcomes questionnaires (e.g., health and functional status and quality of life, etc.).    

Biographical Sketch

All instructions in the PHS 398 Application Guide must be followed.

Resources

All instructions in the PHS 398 Application Guide must be followed.

Research Plan

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims: The specific aims should address the specific Purpose/Research Objectives of this funding opportunity.

Research Strategy: The Research Strategy should address the following, along with the specifics of the three research projects that address topic areas of particular interest and other clinical dilemma questions of importance to treatment decision-making:

1. PD/PI Responsibility --  The PD/PI must have a demonstrated track record of successful leadership of a multi-disciplinary team, including multi-center clinical collaboration. A minimum time commitment of 25% per year is required from the PD/PI, and a minimum time commitment of 15% per year from the lead Co-Investigator at each Clinical Center (CC) is also required (see details on the CC below). The PD/PI is responsible for coordination of all phases of multi-center clinical studies, maintaining a manual of operations development, data collection and management, data safety and monitoring, confidentiality, adverse events, quality assurance, data analysis, distributed data entry, electronic communications, and administrative management and coordination.

The application must delineate the PD/PI role in leading the Research and Data Coordinating Center (RDCC) which is the applicant organization and leads the development of a registry including six to ten geographgically diverse Clinical Centers/Systems (CC) as well as establishing governance through a Registry Steering Committee (RSC) (see details on the RSC below).

To inform the registry development activities, the application must address the preliminary discussions the PD/PI has engaged in with relevant obstetric-gynecologic specialty societies and other important stakeholders regarding any on-going data standardization and transmission efforts and coordinate with all participating clinical centers on the harmonization of such protocols.

Given the nature of registry data and infrastructure across multiple clinical centers/systems (CC), the application must describe the plan of collaborative work between the RDCC and the participating CCs, as well as include a description of how the projects align with the goals of the AHRQ Effective Health Care Program (e.g, see http://www.ahrq.gov/funding/policies/foaguidance/index.html#r01; and http://www.effectivehealthcare.ahrq.gov/index.cfm/submit-a-suggestion-for-research/how-are-research-topics-chosen/) and those of the PCORI (e.g., see http://pcori.org/research-we-support/priorities-agenda/). The PD/PI must report to the Registry Steering Committee (RSC)  quarterly on patient recruitment and study progress. The PD/PI will ensure disclosure of conflicts of interest across all investigative teams at the participating clincial cenetrs (CCs). Further, the application must describe RDCC plans for administrative management of the data collection and quality control, and support of the RSC. A plan must also be included for the development and maintenance of a web site with both public and secure components that would include information for investigators.

Within three months after the start date of the award, the PD/PI as lead for RDCC, will be required to organize the first meeting of the RSC where a Chair and members of the steering committee will be elected/ approved. RDCC will also explore and establish a central institutional review board (IRB) review, if feasible, to facilitate and expedite the conduct of research studies.

The application must propose three studies using data from the registry to address topics related to comparative effectiveness in the multicenter environment within a 5 year time frame. The initiation of the proposed research studies may begin within the first year of the grant performance period, if feasible. If research projects do not begin in the first year, then at least two studies must start within the first 6 months of the second year of the grant performance period.  The application must describe how the proposed research projects will provide new and important information that is distinct from existing studies and how the study extends what is already known. The research studies must be agreed to by all clinical centers that will be participating in the registry. The proposed studies must demonstrate detailed knowledge of the conduct of multi-center clinical studies, involve large number and a broad spectrum of patient populations (including racial and ethnic minority populations) and require multicenter participation. The application must explain how the proposed research projects will provide actionable information that meets the Effective Health Care program goals in comparative effectiveness. Specifically, what are the potential impacts of the findings from the proposed research and how will these findings relate to specific knowledge gaps relevant to improving health care? The PD/PI, in collaboration with CCs, will ensure proposal adherence, accurate and timely transmission of collected data, and dissemination of research findings.  Plans for the studies should also include methodological and analytical specifics, from the power requirements for the particular research hypotheses and outcomes of interest to the statistics techniques for assessing long term outcomes and pertinent population subgroups as pre-specified in the protocols, etc.

Since these research studies will be observational in nature, good practices related to observational designs are expected. Specifically, the study should pre-specify a protocol for primary data analysis; adjustments for observed covariates should be transparent, straight forward, and convincing; and the analyses should address possible biases from unmeasured covariates.

2. The Registry -- The application must discuss various aspects of study design that would be important in developing clinical proposals including eligibility, sample size and power calculations; methods and frequency of data collection, monitoring the accuracy of data collection, quality control and training, and certification for multiple proposals.  As this registry is expected to collect data from a nationally diverse sample of women who will have been exposed to one or more of the available therapies of interest including specific medical therapies (e.g., GnRH agonists), myomectomy, hysteroscopy, endometrial ablation, uterine artery embolization, focused ultrasound ablation using magnetic resonance guidance, hysterectomy, and others, it would be desirable that a consortium of 6 to 10 Clinical Centers from geographically diverse regions contribute data to this registry.  Concurrently, the data should represent the racial/ethnic distribution of women with fibroids. Therefore, a specific recruitment and retention sampling plan should be created and evaluated on an on-going basis.  The application should provide brief rationales on the different clinical centers selected as part of the consortium.

The registry must collect sufficient data including information on pre-specified covariates (e.g., fibroid size and location, pre-procedural therapies to shrink fibroids, disease severity, prior treatments including repeat procedures for symptomatic fibroids, reproductive history, childbearing aims, family history, and demographics including race and age) to permit a rigorous assessment of comparative effectiveness among the available therapies.  Patient-centered data should be included as informed by the stakeholders. Such data could include symptom ratings, information considered before consenting to a treatment, patient satisfaction with clinician communication.  Because the total number of hysterectomies performed annually for women with symptomatic fibroids vastly outnumber all the other available therapies combined, no more than 25% of the data collected for this registry should be from women with hysterectomy to ensure (statistically) sufficient number of patients with other therapeutic experiences is included in the registry.  A non-biased approach to selecting women with hysterectomy for inclusion in the registry must be implemented.

3. The Registry Steering Committee (RSC) -- The registry will have a RSC as the governing body of the registry development. Upon award, the study investigative team will convene a RSC as the primary high-level decision-making body for the development of the registry and the finalization of design protocols as well as the analytical priorities of the study. Members of the Steering Committee should include the RSC chair, the PI of the study, the lead co-investigator from each of the clinical centers (CCs), a representative of PCORI and a representative of AHRQ both serving in ex officio capacity, a patient representative, and up to two external scientific methodological and/or content experts who are not affiliated with the RDCC or CCs. The Steering Committee will have overall responsibility for the development and finalization of the protocols common to all clinical sites. The Steering Committee will approve the study goals and methods, monitor the study's progress, and approve revisions to the study protocols. The Steering Committee will meet every three (3) months or more often, as needed.  One of these Steering Committee meetings should be in-person.  The RSC chair shall be a well-regarded researcher not directly affiliated with the applicant institution or the RDCC and shall not have a financial conflict of interest (as defined in 42 C.F.R. Part 50, Subpart F). The RDCC will support and implement per RSC guidance processes that ensure the CCs adhere to registry policies and data collection requirements and will have a data safety and monitoring plan.

It is anticipated that the registry will be a resource for conducting numerous non-AHRQ supported secondary research studies in addition to three large scope study proposals outlined in the application. The RSC will be responsible for developing a plan and process for approving other secondary non-AHRQ funded research projects submitted by participating researchers that require the use of the registry data.

Specifically, RDCC will support the RSC in identifying and prioritizing topics for investigation and evaluate secondary non-AHRQ funded research ideas developed by participating physician-researchers.  All study proposals performed by the registry investigators must be approved by the RSC before initiation.  It is anticipated that more than one protocol will be active at any given time.

The RSC with support from RDCC will ensure that study results are reported in the scientific literature in a timely manner and promptly disseminated to those directly involved in the care of patients.

Funds must be budgeted to convene RSC meetings as often as four times annually -- one of which must be an in-person meeting.  In addition, RSC should plan to hold teleconference on a monthly basis throughout the project period.

4. Data Safety Monitoring Plan -- Data safety monitoring plans are required in all research grant applications when support is sought to study the effect of a health-related intervention on outcomes in human subjects, including biomedical, behavioral, public health, health care system, and/or diagnostic interventions that potentially affect the outcome of the study participants.  AHRQ is committed to the protection of human subjects and their data in its research programs.  See “Protection of Human Subjects” in Section V.1., below.  In accordance to the federal human subject protection regulations (45 CFR 46.102) and AHRQ’s Data and Safety Monitoring Policy (NOT-HS-11-015, http://grants.nih.gov/grants/guide/notice-files/NOT-HS-11-015.html), all applications must include a data safety monitoring plan. There must be a system for the appropriate oversight and monitoring of the conduct of research to ensure the safety of study participants and the validity and integrity of the data for all AHRQ-conducted or supported research. The method and degree of monitoring must commensurate with the degree of risk involved for study participants and the size and complexity of the research. Applications that do not include a data safety monitoring plan will not undergo peer review or consideration for funding.

Data and safety monitoring involving some level of independent monitoring, generally in the form of a Data and Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC), is required for research studies involving: interventions that entail potential risk to research participants, multiple sites, blinded (masked) designs, or vulnerable populations (e.g., children, pregnant women, frail elderly).

The application must highlight specifics of the unique data that can be included in the registry through primary data collection and describe how the collection of certain patient reported outcomes not otherwise available will be done. Special attention must be given to the rigor and efficiency of the data collection and management systems, protocols for data confidentiality and the governance for data use and sharing.

5. Clinical Centers (CC) Participating in the Registry -- The application must describe the critical responsibilities of CCs in recruitment of patients and data   collection. It is expected that individual CCs will vary in nature and experience, and thus may represent both different patient populations and unique expertise. For example, the CCs could be geographically diverse major medical centers with existing relationships with private or community hospitals and physician practices. The lead co-investigator at each CC must demonstrate clinical research excellence and a proven ability to recruit patients from various racial/ethnic groups. Each CC will enroll eligible patients, assess clinical interventions on a broad range of therapeutics, and contribute data to the registry.

The applicant institution that serves as the RDCC can also itself serve as a CC, with the following provisos: 1) The CC must be functionally separate and independent from the RDCC; 2) The CC should have its own co-investigator (distinct from the PD/PI) and team members.

The application must include detailed sections on the applicant’s clinical and data resources and capabilities. The application must include six to ten CCs each with sufficient patient volume in the practice to support recruitment to support a variety of studies in the registry. For each CC the application must provide a detailed description of the clinical and data collection/management capabilities.

Below are some of the specific and desired critical data that can help to address important comparative effectiveness questions:

1. Patient characteristics (demographic variables such as age, race, ethnicity, pregnancy history, reproductive aims, and co-morbid conditions)

2. Procedural characteristics (i.e., type of devices used)

3. In-hospital and procedural complications (such as mortality, bleeding, other)

4. 2 to 4 years follow-up data including pregnancy outcomes

5. Substantial number of people in important subgroups (e.g., African American women, women who have had multiple different or same procedures for symptomatic fibroids)

6. Long term activity, functioning, and quality of life measures to address specific study questions

The application must discuss the agreements and operational arrangements between CCs to define all data elements, definitions, collection, transmission protocols, etc., across all registry participants.  It must also describe the timeliness, ownership, signed usage agreements, and governance on use of data contained in the registry. Specifically, across all CCs where local data collection and databases will be used to develop the registry, concrete plans for the following issues must be included in the application:

1. Willingness of data owners to collect the essential set of data elements

2. How data can be shared (centralized collection and study by study basis)

3. Data access and ownership

4. Data Use Agreements or Memoranda of Understanding

5. Restrictions on using the data

6. Medical device and procedure coding and diagnostic information

7. Short and long term health outcome collection plans

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.

Appendix for the Entire Application

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS 398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. Other Submission Requirements and Information

Applications must be postmarked on or before the due dates in Part I. Overview Information.

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and for responsiveness by AHRQ.  Applications that are incomplete and/or non-responsive 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 at 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. However, all applicants are required to develop a plan for sharing data in further advancing the research in treatments for uterine fibroids.  The plan should include 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; a brief description of a model data-sharing 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). References to data sharing may also be appropriate in other sections of the application.

The study section review will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.  The proposed data sharing plan, however, will be assessed and subjected to approval by AHRQ program officials.  Any changes to the data sharing plan must be discussed in advance with the relevant program official.   

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's Office of Communications and Knowledge Transfer (OCKT) wishes to be consulted in advance of publication in order to coordinate announcements of new AHRQ-supported research results with other AHRQ dissemination activities.  Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in AHRQ's grants regulation at 42 CFR Part 67, Subpart A (available in libraries and from the GPO's website at http://www.gpoaccess.gov/cfr/index.html) which incorporates additional applicable provisions on Rights in Data, including 45 CFR Part 74 and 37 CFR Part 401.  

In accordance with PCORI’s legislative mandate on public dissemination, the award recipient shall, not later than 90 days after the completion of the study, collaborate with AHRQ and PCORI in order to make the study’s findings available to clinicians, patients, and the general public.  As stated in Section VI below, all final reports are due to AHRQ within 90 days of the project period end date.  PCORI encourages openness in research and freedom of access to underlying data by persons with a serious interest in the research, and AHRQ intends to make available to the public data developed for research supported by the agency.  Accordingly, the awardee(s) will be encouraged to explore opportunities to use existing and emerging internet distribution models and, when appropriate, publicly-accessible repositories, journals, or similar mechanisms that result in broad access for the interested field and public.  Both AHRQ and PCORI may also determine to release the final progress report on AHRQ and PCORI websites upon review and acceptance of the report from the awardee. 

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 improve the quality, safety, efficiency, and effectiveness of health care for all Americans. 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 overall 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 overall 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 overall project address an important problem or a critical barrier to progress in the field? If the aims of the overall project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

Investigator(s)

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

Innovation

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

Approach

Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the overall project?  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

Does the proposed multi-center registry consists of participating entities/practices with the clinical  and patient recruitment capacity that will be necessary to ensure excellence in conducting all of the project’s essential processes, including the provision of protocol-driven high standard of care, research data collection and coordination, long term follow up and the active engagement of relevant stakeholders, etc.?   

Environment

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

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Patient-Centeredness

How important to patients (and their caregivers) are the questions to be answered by the studies? How important to patients (and their caregivers) are the primary and secondary outcomes and how they are being measured?

Stakeholder and Patient Engagement

Does the application describe how paients and stakeholders were or will be identified and engaged in the research?  Does the application demonstrate meaningful stakeholder and patient engagement by their inclusion in the research plan and their roles and functions in the registry governance structure and protocols in guiding the execution of the registry and research activities?

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? [NOTE: Information may be added here]

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. [NOTE: Information may be added here].

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. (Note: use this as appropriate)

Additional Review Considerations

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 initial merit review, all applications will:

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established 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:

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

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). 

Once all administrative and programmatic issues have been 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 AHRQ’s grants regulations at 42 CFR Part 67, Subpart A, the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm), and the terms and conditions set forth in the Notice of  Award.  

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

3. Reporting

When multiple years are involved, grantees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually.

The annual progress reports must include Sections 2.2.6 A through F as described in the general PHS form 2590 instructions.  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 PHS form 2590 instructions, follow the instructions on the AHRQ website.

The Progress Report is to include descriptive and evaluative comments on both completed activities and plans for the remainder of that year, including any changes foreseen in the future.  At a minimum, the reports will include descriptive comments on:  progress to date measured against project aims; methodological changes implemented; key preliminary findings; significant problems and resolutions; inclusion of priority populations; and project related publications, presentations, and dissemination activities.  AHRQ does not currently limit the length of the progress report to 2 pages. AHRQ will provide the due date for submitting annual progress reports.  In addition to the annual progress report, recipients may be required to submit quarterly progress reports to AHRQ. Detailed instructions on 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 (see 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 will be 90 days after the end of the calendar quarter in which the budget period ends.  Note that this is a change in due dates of annual FFRs and may provide up to 60 additional days to report, depending upon when the budget period end date falls within a calendar quarter.  For example, if the budget period ends 4/30/2013, the annual FFR is due 9/30/2013 (90 days after the end of the calendar quarter of 6/30/2013).

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.

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 Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Direct your questions about general FOA issues, including information on the inclusion of priority populations to UFRegistryFOA@ahrq.hhs.gov.  

Uterine Fibroid Registry FOA
Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Email: UFRegistryFOA@ahrq.hhs.gov

For reasons of equity and consistency, all scientific/research (program related) inquiries pertaining to general FOA issues must be submitted, and will only be answered, via email. A compilation of frequently asked questions and answers will be posted at: http://www.ahrq.gov/fund/grantix.htm.

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
Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
Telephone: (301) 427-1191
Fax: (301) 427-1562
E-mail address:  Nghia.Vo@ahrq.hhs.gov

Financial/Grants Management Contact(s)

Direct your questions regarding fiscal matters to:

Carol Harris
Office of Management Services
Grants Management
Agency for Healthcare Research and Quality
Telephone: (301) 427-1448
Fax: (301) 427-1462
E-mail address:  Carol.Harris@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.

Authority and Regulations

AHRQ and PCORI are authorized to make this award by 42 U.S.C. 299a(a) and 42 U.S.C. 1320e(d)(2)(B), respectively.  The award is funded under an agreement with PCORI pursuant to 42 U.S.C. 299b—37(g).

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, 42 CFR Part 67 and in accordance with 45 CFR Parts 74 or 92 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.

Also, see http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html and  http://dhhs.gov/asfr/ogapa/grantinformation/hhsgps107.pdf), and the terms and conditions set forth in the Notice of Award.


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