Source: http://grants2.nih.gov/grants/guide/rfa-files/RFA-HS-10-009.html
Timestamp: 2015-03-03 17:46:41
Document Index: 374723320

Matched Legal Cases: ['arts 160', 'arts 160', 'art 67', 'art 67', 'art 46', 'art 67', 'arts 74']

RFA-HS-10-009: Recovery Act 2009 Limited Competition OS ARRA: Comparative Effectiveness Research to Optimize Prevention and Healthcare Management for the Complex Patient (R21) Part I
Overview Information Participating
Organizations Agency for Healthcare Research and Quality
(AHRQ), (http://www.ahrq.gov)
Components of Participating Organizations Center for Primary
Care, Prevention and Clinical Partnerships (CP3), ( http://www.ahrq.gov/)
Center for Outcomes and Evidence, (COE), (http://www.ahrq.gov/)
Title: Recovery Act 2009
Limited Competition OS ARRA: Comparative Effectiveness
Research to Optimize Prevention and Healthcare Management for the Complex
Patient (R21) Note: The policies, guidelines terms and conditions stated in this announcement may
differ from those used by the NIH.
Type Reissue: This Funding Opportunity Announcement
(FOA) is a reissue of RFA-HS-08-003 and is funded under the American Recovery & Reinvestment Act of 2009
(Recovery Act).
Applications (RFA) Number: RFA-HS-10-009 NOTICE: Applications submitted in response to this FOA
for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research
Catalog of Federal Domestic Assistance Number(s) 93.715
Key Dates Release/Posted Date: December 17, 2009
Opening Date: December 20, 2009
Letters of Intent Receipt
Date(s): January 8, 2010
Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). Application Due Date(s): January 20, 2010
Peer Review Date(s): Generally four months after
receipt date Earliest Anticipated Start Date(s): Generally four months after peer review date Additional Information To Be
Available Date (Activation Date): Not Applicable Expiration Date: January 21, 2010 Due Dates for E.O. 12372 Not
Overview Content Executive Summary Purpose. This AHRQ FOA, supported by funds provided to AHRQ under the
American Recovery & Reinvestment Act of 2009 (“Recovery Act” or “ARRA”),
Public Law 111-5, invites Exploratory/Developmental grant (R21) applications
from organizations that aim to understand the comparative value
of different strategies in the prevention and management of chronic illness in
persons with specific constellations of co-morbid conditions. Exploratory
research studies will contribute evidence to help guide the appropriate
integration (i.e., prioritization, timing, provision and coordination) of
therapeutic and preventive services in individuals with multiple chronic
conditions. This work should improve our understanding of the comparative
value of interventions to patients with multiple conditions, how the safety and
effectiveness of specific interventions may be affected by co-morbid
conditions, and how interventions may need to be modified for specific patient
populations with multiple conditions. This information should help
clinicians better integrate care provided to such individuals, help patients make
informed decisions about health care choices, and help policymakers identify
better ways to measure and promote quality care for complex patients.
FOA will use the AHRQ Exploratory/ Developmental (R21) grant mechanism. Funds Available and Anticipated Number
of Awards. The total amount expected to be awarded is $6,000,000
and the anticipated number of awards is 12-18. Awards issued under this
FOA are contingent upon the availability of funds and the submission of a
sufficient number of meritorious applications. Because the
the numbers, quality, duration, and costs of the applications received. Budget and Project Period: There are three types of projects that will be funded under
this FOA. They are described in detail in Section I of the full text of
this FOA. These types of projects have varying project period duration
limits and total cost budget limits (indirect costs are included in the total
cost limitation). Applications must clearly indicate which type of
project or combination of types is proposed. An application with a budget that exceeds the budget limit or the project
period duration stated in the FOA for the type of project proposed
will not be reviewed. Research Strategy Length: The Research Plan component of the application may not
exceed 15 pages, including tables, graphs, figures, diagrams, and
Institutions/Organizations: Institutions/organizations
listed in Section III, 1.A. are eligible to apply. Eligible Project Directors/Principal Investigators
(PDs/PIs): Any individual with the skills, knowledge, and resources
institution/organization to develop an application for support. This
individual should devote a considerable portion of his/her time to the project
(at least 20% annually through the project duration). If
the Project Director/Principal Investigator devotes less than 20% of his/her
time to the project, an explicit justification must be provided. Individuals from underrepresented racial and ethnic groups
as well as individuals with disabilities are always encouraged to apply for
AHRQ support.
of PDs/PIs: Only one PD/PI may be designated on the application
Applications: Applicants
scientifically distinct. Resubmissions: Because this is a
one-time-only solicitation, resubmissions are not permitted. Renewals: Renewal applications are not permitted
Materials. See Section IV.1 for application materials. General
impaired are available at: TTY: (301) 451-5936 While
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
Description 1. Research
& Human Services (HHS) Definition of Comparative Effectiveness Research
will use the definition of comparative effectiveness research used in the
Federal Coordinating Council’s (FCC’s) Report to Congress to guide the HHS
operational plan with regard to Office of the Secretary (OS) ARRA funds. The
definition is as follows:
effectiveness research is the conduct and synthesis of research comparing the
benefits and harms of different interventions and strategies to prevent,
diagnose, treat and monitor health conditions in “real world” settings. The purpose of this research is to improve health outcomes by developing and
disseminating evidence-based information to patients, clinicians, and other
decision-makers, responding to their expressed needs about which interventions
are most effective for which patients under specific circumstances.
provide this information, comparative effectiveness research must assess a
comprehensive array of health-related outcomes for diverse patient populations
and sub-groups. Defined
interventions compared may include medications, procedures, medical and
assistive devices and technologies, diagnostic testing, behavioral change, and
delivery system strategies.
research necessitates the development, expansion, and use of a variety of data
sources and methods to assess comparative effectiveness and actively
disseminate the results.
Priority-Setting Process and Inputs for use
of ARRA OS Funds
were four main inputs for priorities for ARRA OS comparative effectiveness
research funds: public input, an internal Departmental workgroup, the FCC
report, and the Institute of Medicine (IOM) report. The FCC identified
the following as minimum threshold criteria which must be met to be considered
for funding: 1) Included
within statutory limits of ARRA and the Council’s definition of comparative
effectiveness research;
2) Potential
to inform decision-making by patients, clinicians or other stakeholders;
to expressed needs of patients, clinicians or other stakeholders;
4) Feasibility of research topic (including time necessary for research). The
Comparative Effectiveness Research-Coordination and Implementation Team will
require the use of the FCC’s prioritization criteria for scientifically
meritorious research and investments for all projects funded with OS ARRA
funds. These criteria are: 1) Potential
impact (based on prevalence of condition, burden of disease, variability in
outcomes, costs, potential for increased patient benefit or decreased harm),
to evaluate comparative effectiveness in diverse populations and patients
sub-groups and engage communities in research,
3) Addresses
existing uncertainty within the clinical and public health communities
regarding management decisions and variability in practice,
4) Addresses
a need or is unlikely to be addressed through other organizations, 5) Potential
for multiplicative effect. Finally,
investments funded from this appropriation must address at least one of the
following topic areas: 1) One of
the 100 IOM topic recommendations;
issue within one the MMA 14 priority conditions identified by AHRQ (pursuant to
Section 1013 of the Medicare Prescription Drug Improvement and Modernization
Act of 2003) which are not currently addressed; and/or 3) Fall
into one of the AHRQ identified evidence gaps.
The current list of
conditions includes:
and non-traumatic joint disorders Cancer Cardiovascular
disease, including stroke and hypertension Dementia,
including Alzheimer's disease Depression
and other mental health disorders Developmental
delays, attention-deficit hyperactivity disorder, and autism Diabetes
mellitus Functional
limitations and disability Infectious
diseases including HIV/AIDS Obesity Peptic
ulcer disease and dyspepsia (digestive system conditions) Pregnancy
including preterm birth Pulmonary
disease/asthma Substance
abuse disorders AHRQ seeks research grant applications for projects in the
area of comparative effectiveness research to respond to the Recovery
Act. In this FOA, AHRQ has operationalized the definition of comparative
effectiveness research with the additional specification that evaluation of
treatments includes any potential medical intervention under consideration,
whether prognostic, preventive, diagnostic, therapeutic, or palliative. In FY 2010, AHRQ intends to support research grants focusing
on comparative effectiveness of different clinical treatments and services, as
authorized by Section 1013 of the Medicare Prescription Drug Improvement and
Modernization Act of 2003, Pub. L. No. 108-173. The intent of these research
project grants is to support research focusing on the generation and
translation of new scientific evidence and analytic tools in an accelerated
format and the integration of evidence into practice and decision-making in the
health care system. AHRQ is especially interested in studies that include
under represented and AHRQ priority populations such that potential clinical
heterogeneities and population subgroups are considered in study design and
proposed methodologies, and that subgroup analyses can be performed and
research results and findings are relevant for all populations. The applicant’s
specific plans for inclusion of priority populations will be evaluated by the
scientific review committee and will be a component of the assigned priority
Americans are growing older today in a way unlike any
preceding generation. The demographic swell of the post-war baby boom
combined with medical advancements in the 20th century that led to declines in deaths from infectious diseases, and to a
transition to chronic diseases as a primary cause of death in
the United States will result in an unprecedented number of older Americans
with chronic illnesses. The health care system in this country is
unprepared for the challenges posed by a growing population of patients with
complex combinations of chronic diseases. The complicated medical
regimens, interactions of different diseases, and cumulative effect of
different conditions on morbidity, mortality, and quality of life make it
difficult to identify optimal approaches for such patients. The past twenty years have brought significant efforts
in the field of evidence-based medicine to optimize medical care provided to
patients through the promulgation of guidelines by professional groups (e.g.,
American College of Cardiology), special expert bodies (e.g., United States
Preventive Services Task Force, the Joint National Committee on Prevention,
Detection, Evaluation, and Treatment of High Blood Pressure) and by the
implementation of various quality metrics (for example the Healthplan Employer
Data and Information Set (HEDIS) established by the National Committee on
Quality Assurance). Most guidelines and metrics focus on the simplest
applicable case (e.g., anticoagulation in the patient with uncomplicated atrial
fibrillation) and few, if any, of these efforts have considered explicitly how
the guideline should be modified in order to be implemented in a complex
patient.(1) Further, most recommendations for preventive services
target the healthy patient and fail to provide guidance on the preferred timing
and relative appropriateness of these services for patients whose care is
complicated as a result of multiple chronic conditions. The lack of even
primitive morbidity or mortality risk adjustment in guidelines and quality
measures threatens to provide incentive for excess intervention in potentially
inappropriate candidates.(2,3) Both
patients and providers are burdened by this situation. Patients with
multiple chronic illnesses may end up on excessively complex medical regimens
as clinicians continue to add or intensify therapies without good evidence that
doing so will improve the quality or quantity of life. Some patients with
comorbid conditions may be at increased risk of the harms of preventive or
therapeutic interventions, and at the same time less likely to attain the
potential benefits associated with those interventions when applied to
otherwise healthy individuals. At present, few guidelines or quality
measurement schemes, provide guidance in the care of complex patients or
recognize the appropriateness of modification of standards developed for
uncomplicated conditions. Objectives of this
FOA The objectives of this FOA are to:
Support comparative effectiveness research to allow
prioritization of evidence-based services (testing and treatment) for
patients with multiple co-morbidities (including physical and mental
conditions), and suggest appropriate adaptations (in timing and frequency)
of recommended preventive and care management guidelines for these
patients. Provide evidence to clarify how co-existing chronic
conditions modify the safety or comparative value of proven treatments for
chronic diseases and recommended preventive interventions. Provide evidence to refine chronic disease quality
measures for complex and frail patients. It is expected that the work from this FOA will provide the
foundation for further studies that test the impact of such adaptations, assess
the barriers and facilitators to implementing adaptations, examine tools to
implement tailored interventions, and investigate the implications for
patient-centered health care of such personalized approaches to prevention and
care management. To achieve these objectives, expected research approaches
include mathematical modeling, statistical modeling, or epidemiologic studies
that may be based on data from population surveys, medical databases from
electronic health records, and possibly insurance claims data. Of
interest are modeling projects that use newly developed or existing
population-based datasets to estimate how the application and timing of
specific, recommended therapeutic and preventive services will affect overall
outcomes for the complex patient, especially as the patient ages. Modeling studies must consider how to optimize the management of patients with
at least two chronic co-morbid conditions and the provision of at least one
preventive service or chronic disease intervention. Studies focusing on
AHRQ priority populations, including racial and ethnic groups, are encouraged
(see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html). All types of studies are welcome to include
a mental health co-morbidity. For the purposes of this FOA, the following definitions
Comparative effectiveness research is the
HHS definition described above under “HHS Definition of Comparative Effectiveness
Research.” Specifically, AHRQ is interested in supporting efforts that:
1. Conduct, support, or synthesize research that compares the
clinical outcomes, effectiveness, and appropriateness of items, services, and
procedures that are used to prevent, diagnose, or treat diseases, disorders,
and other health conditions; and, 2. Encourage the development and use of clinical registries,
clinical data networks, and other forms of electronic health data that can be
used to generate or obtain outcomes data.
A complex patient is one with two or more chronic
conditions where each condition may influence the care of the other
condition(s) through limitations of life expectancy, interactions between drug
therapies, difficulties in establishing adequate care coordination, and/or
direct contraindications to therapy for one condition by other conditions
themselves. While challenges posed by demographic characteristics such as lack
of insurance or poverty clearly affect complexity in clinical practice, for the
purposes of this FOA, we focus on physical and mental/behavioral illnesses.
Chronic conditions refer to physical and
mental/behavioral illnesses or impairments that have persistent or recurring
health consequences lasting for years and in most cases may contribute to
increased risk of early mortality. When selecting the two or more chronic conditions to be
studied, applicants must include at least one of the targeted priority
conditions established by the HHS Secretary under Section 1013 of the MMA
of 2003. These fourteen conditions were identified through a process involving
discussion with and extensive input from the public, as well as Federal
agencies, and are relevant to the Medicare, Medicaid, and State Children's
Health Insurance Program (CHIP) programs as listed above. Preventive services are of three types,
primary, secondary and tertiary. Primary preventive services are those
provided to asymptomatic individuals to prevent the onset of a targeted
condition, while secondary prevention serves to identify and treat persons who
have already developed risk factors or preclinical disease but in whom the
condition has not become clinically apparent. Broad areas of primary and
secondary prevention include screenings, behavioral counseling and preventive
medication. Specific services include, but are not limited to,
colonoscopy, mammograms, Pap smears, counseling regarding obesity or smoking
cessation, and aspirin use to prevent myocardial infarction (MI) in men or
stroke in women. Chronic disease interventions, which might generically be referred to as tertiary prevention, refer to clinical
testing or therapeutics aimed at slowing progression and managing symptoms of
specific chronic disease processes and thereby preventing complications of the
disease. Examples include: monitoring and treatments to improve glycemic
control in patients with diabetes, use of aspirin in individuals who have
already suffered an MI, or prescription of anti-inflammatory, “controller”
inhaled medications to someone with moderate to severe asthma. While many types of
projects and approaches may be responsive to this announcement, AHRQ will fund
three types of projects: Epidemiologic descriptions based on secondary analysis of
large data sets of specific chronic illnesses for which there are no recently
assembled data which describe the natural history, impact on quality of life
over time, and life expectancy. In addition to describing the natural
course of the disease, applications must describe the cumulative burden of
therapies for the conditions over time, such as the number and types of
medications, other recommended treatments, and services for tertiary
prevention. Applications should describe at least two (2) chronic
illnesses, and applications will be greatly strengthened if they include
descriptions of the epidemiology of the conditions for individuals, both with
and without co-morbid chronic conditions. At least one of the chronic
conditions must be one of the priority conditions identified above. Applications
must clearly document either the lack of published information describing the
epidemiology of the condition, or the need to update information due to
developments in treatment that have altered the condition’s epidemiology.
AHRQ expects a focus on priority population groups, including racial and
ethnic minority populations. Studies that focus on this type of secondary
data analysis are expected to be proposed with project period total cost
budgets in the range of $250,000 to $375,000 and take 12-18 months to complete. Applications in this category that exceed $375,000, or 18 months, will not
undergo peer review.
Analytic epidemiologic studies,
e.g., using a retrospective cohort design, that assess the benefits and harms
of preventive or therapeutic interventions in “real world” settings for
patients who have multiple chronic co-morbid conditions. These studies
would need to use cohorts with sufficient clinical data, and to use innovative
statistical techniques in order to determine the relative positive and negative
impacts of prevention/therapy in a population with comorbid illness compared to
an otherwise healthy population. Studies of this type are expected to
have project period total costs in the range of $400,000 to $500,000, and take
up to two years to complete. Modeling studies that use accepted
techniques to project the impact of recommended chronic disease interventions
and preventive services on patients with two or more co-morbid chronic
conditions.4 Both decision models and cost-effectiveness analysis
models are acceptable. Expected findings would be expressed in terms of
life years gained, quality adjusted life years, or costs per quality adjusted
life years. Studies of this type must describe the chronic conditions of
interest, treatment guidelines that will be utilized for selecting therapeutic
interventions to be modeled, and preventive service(s) to be modeled. At
least one of the chronic conditions to be modeled must be one of the priority
conditions identified above. The use of nationally-recognized and
evidence-based guidelines and preventive service recommendations such as those
of the U.S. Preventive Services Task Force are encouraged wherever possible
within projects. Models
used in these studies should be sufficiently comprehensive to model the impact
of the co-morbid condition on issues of competing morbidity and/or mortality,
and on benefits and harms of the intervention if appropriate. Modeling
projects may use existing data sets or propose conducting an epidemiologic study
as foundational to the model. Modeling projects are expected to be
proposed with budgets for the project period in the $300,000 to $500,000 total
costs range and may take between 18 months and two years.
Project requirements: Projects must identify which project type(s) are proposed.
For each project type, at least one of the chronic conditions under study
must be selected from the list of priority conditions described above. Additionally, at least one of the chronic conditions must be a physical, rather
than mental or behavioral, illness or impairment.
Outcomes of interest include, but are not limited to,
morbidity, mortality, quality of life, functional outcomes, benefits of
interventions and harms of interventions. Projects must describe which outcomes
are being used and how each will be measured. Projects that propose epidemiologic descriptions using
existing large datasets for the purpose of providing descriptions of the
complex patient population must describe at least two, and preferably three,
different conditions singly and in combination. AHRQ
expects inclusion of priority populations, including racial and ethnic groups
when related data are available.
Analytic epidemiology studies should target at least one
chronic disease or preventive intervention, and must describe the study
population’s health status with regard to at least two additional co-morbid
Projects that propose modeling studies must use one of the
following frameworks to structure this part of the research:
Start from a specific co-morbidity cluster and build
out an approach to chronic disease interventions in those diseases and
prevention in others
Start from a particular preventive service or a chronic
disease intervention and show how the appropriateness frame is
altered by various constellations of co-morbid conditions With either framework, modeling studies must model
simultaneously: Two (2) or more chronic conditions and One (1) or more preventive or chronic disease
intervention(s) Projects are further encouraged to incorporate patient age
into the model. Investigators are encouraged to select a mental health issue
as one of the chronic conditions in both epidemiologic description projects and
modeling projects. Recognizing that these are exploratory grants, applicants
must describe next steps in translating their research into information that
can improve healthcare decisions made by clinicians and their patients with
multiple chronic conditions. Applicants are encouraged to describe if and
how current treatment guidelines and quality of care measures may need to be
adjusted as a result of their findings. The applicant must address the following project
requirements in the Research Plan portion of the application: In the Specific Aims Section:
The applicant must identify the chronic conditions and
preventive services to be studied, explicitly noting the inclusion of one or
more priority conditions. Epidemiologic descriptive studies must identify
at least two chronic conditions. Analytic epidemiology studies must
assess a therapeutic intervention in an index condition and describe two other
chronic co-morbid conditions. Modeling studies must identify at least two
chronic conditions and at least one preventive or chronic disease intervention. All studies must describe the selected outcomes of interest. Whenever possible, all studies should provide a comparison
of complex patients to healthy ones. Analytic epidemiology studies and
modeling studies should provide the relative effect of providing preventive
services in patients with and without chronic conditions. Quantification of
the relative effective should be provided if possible. In the Background and Significance Section:
The applicant must demonstrate an understanding of the
current challenges in treating complex patients in primary care and provide the
rationale for focusing on the specific chronic conditions and preventive
services. The applicant must describe the racial, ethnic, and gender
characteristics of the population included in the study and provide the
scientific reasoning and/or clinical considerations for the inclusion or
exclusion of particular populations. In the Research Design and Methods Section:
The applicant must describe the proposed project type
(descriptive epidemiologic, analytic epidemiologic, and/or modeling) and
describe the methodology that will best enable the research objectives to be
realized. The design must include a conceptual or clinical framework and
a timeline with specific milestones, covering all phases of the
project. The narrative should include a description of the dataset, data
collection plans (if any) and a well-developed analysis plan. Projects
for modeling studies must include details of 1) the model structure, 2) the
underlying assumptions, 3) discussion of how the natural history of the index
condition and the comorbid conditions will be included in the model, and 4)
possible data sources. To the extent possible, applicants should discuss
any anticipated limitations or cautions needing to be exercised in generalizing
Applicants must adequately discuss potential next steps;
that is, how the expected results of this preliminary work will inform future
comparative effectiveness and other research, and how results could be adapted
and integrated into treatment guidelines for complex patients focusing on AHRQ
priority populations, and quality improvement measures, both locally and
1. Mechanism of Support This FOA will use the
AHRQ Exploratory/Developmental Research Grant (R21) award mechanism. The
individual researcher sponsored by each organizational applicant will be solely
responsible for planning, directing, and executing his or her proposed
projects. AHRQ is not using the Modular Grant Application and Award
Process. Applications submitted in modular format will not be
reviewed. 2. Funds Available This initiative is supported by funds provided to AHRQ under
the American Recovery & Reinvestment Act of 2009 (“Recovery Act” or
“ARRA”), Public Law 111-5. AHRQ has designated $6,000,000 to fund 12-18 grants,
contingent upon the submission of a sufficient number of scientifically
meritorious applications. There are three types of projects that will be
funded under this FOA. They are described in detail in Section I of the
full text of this FOA. These types of projects have varying project
period duration limits and total cost budget limits (indirect costs are
included in the total cost limitation). Applications must clearly
indicate which type of project or combination
of types is proposed. An application with a budget
that exceeds the budget limit or the project period duration
stated in the FOA for the type of project proposed will not be
reviewed. 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. Although the financial plans of AHRQ provide
number of meritorious applications. The total costs for a grant awarded
under this FOA will not exceed $500,000 for the entire project period.
Funding for this program is provided
under the American Recovery and Reinvestment Act of 2009 (Recovery Act). The purposes of the Recovery Act are to preserve and create jobs and promote
economic recovery in the United States, and to provide investments needed to
increase economic efficiency by spurring technological advances in science and
health. Consistent with these goals, eligible domestic (United States)
institutions/organizations who are planning to submit applications that include
foreign components should be aware that requested funding for any foreign
component should not exceed 10% of the total
requested total costs or $25,000 (aggregate total for a subcontract or multiple
subcontracts), whichever is less. AHRQ awards under
the Recovery Act will be for up to two years. Section III. Eligibility Information 1.
Eligible Institutions The
following organizations/institutions are eligible to apply. Consistent
with the purposes of the Recovery Act (in particular, to preserve and create
jobs and promote economic recovery in the United States, and to provide
investments needed to increase economic efficiency by spurring technological
advances in science and health), applicants must be a domestic (United
States) institution/organization of one of the types listed below. The United States institution/organization
must be located in the 50 states, territories and possessions of the U.S., Commonwealth of Puerto Rico, Trust Territory of the Pacific Islands, or District of Columbia. Foreign organizations/institutions are not permitted as the applicant organization.
Public or non-profit private
institution, such as a university, college, or a faith-based or community-based
organization; Units of local or State government; Eligible agencies of the Federal
government. Indian/Native American Tribal
Designated Organizations. AHRQ’s authorizing
legislation does not allow for-profit organizations to be eligible to lead
applications under this research mechanism, thus for the purpose of this FOA,
AHRQ will make grants only to non-profit organizations. 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.
to develop an application for support. This individual should devote a
considerable portion of his/her time to the project (at least 20% annually
through the project duration). If the Project Director/Principal Investigator
devotes less than 20% of his/her time to the project, an explicit justification
must be provided. Individuals
disabilities are always encouraged to apply for AHRQ support. Cost Sharing or Matching This program does not
require cost sharing for applications in response to this FOA.
While there is no cost sharing requirement included in this FOA, AHRQ welcomes
applicant institutions, including any collaborating institutions, to devote
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 included in the detailed budget request.
Eligibility Criteria Number of Applications. Applicants may submit more
than one application, provided each application is scientifically distinct. Resubmissions. Resubmission
applications are not permitted in response to this FOA. Section IV. Application and Submission Information
whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must
be complete by the submission deadline for the application to be considered
“on-time” (see 3.C.1 for more information about on-time submission).
is required for institutions/organizations at both: Grants.gov (http://www.grants.gov/applicants/get_registered.jsp) and eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm) A PD/PI should work with his/her institution/organization to make
sure he/she is registered in the NIH eRA Commons. Several
Registered Your
Registration (CCR) as part of the Grants.gov registration process. If your organization does not have a
Taxpayer Identification Number (TIN) or Employer Identification Number
registration. The CCR also validates the EIN against
Internal Revenue Service records, a step that will take an additional one
to two business days.
Registration in the eRA Commons To find out if
an organization is already Commons-registered, see the "List of Grantee
Organizations Registered in NIH eRA Commons.” Direct questions
Refer to the NIH eRA Commons
System (COM) Users Guide.
The individual designated as the
PD/PI on the application must be registered also in the NIH eRA Commons prior
to the submission of the application. The
PD/PI must hold a PI account in the Commons. Applicants should not share a
Commons account for both a Signing Official (SO) role and a PI role;
however, if they have both a PI role and an Internet Assisted Review (IAR)
role, both roles should exist under one Commons account. A PD/PI must be affiliated with
the applicant organization. PDs/PIs located at another institution need
not be affiliated with the applicant organization, but must be affiliated with
their own organization to be able to access the Commons. This registration/affiliation must
be done by the AOR/SO or his/her designee who is already registered in the
Commons. Both the PD/PI and
to view the application image. Several of the steps of
their organization/institution is already registered in both Grants.gov and the Commons. The NIH and AHRQ will
Telecommunications for the hearing impaired: TTY:
(301) 451-5936 2.
to AHRQ. Some fields within the SF424 (R&R) application components,
although not marked as mandatory, are required by AHRQ (e.g., the “Credential”
component must contain the PD/PI’s assigned eRA Commons User ID).
application has several components. The forms package associated with this FOA
in Grants.gov/APPLY includes all applicable components, required and optional. A completed
PHS398 Research & Related
Budget Optional Components: PHS398 Cover Letter File Research & Related Subaward Budget Attachment(s)
INSTRUCTIONS Applications Involving a
Application Guide for further instruction regarding the use of the
subaward budget form. 3.
Date: December 20, 2009 (Earliest date an application may be submitted to
Letters of Intent Receipt Date(s): January 8, 2010
Application Due Date(s): January 20, 2010 Peer Review Date(s): Generally four months after receipt date Earliest
Anticipated Start Date(s): Generally four months after peer review date 3.A.1.
Letter of Intent To allow AHRQ staff to
estimate the potential peer review workload and plan the review (e.g.,
anticipate the nature of reviewer expertise to be required), prospective
applicants may submit a letter of intent that includes an acknowledgement of
interest in this funding opportunity (please refer to the number and title of
this funding opportunity), a few comments on the subject of the proposed
research, background expertise of key personnel, and the nature and role of
participating institutions. Please include the name and email address of
the Principal Investigator.
This letter of intent is
not required, is not binding, and is not considered in the review of a
subsequent application. However, these letters are administratively very
helpful, as indicated above. To be most useful, the letter of intent is to
be sent by the date listed above and at the beginning of this document.
The letter of intent can be
sent electronically, and should be sent to: Gloria Washington
Center for Primary Care, Prevention
& Clinical Partnerships
Telephone: (301) 427-1590
FAX: (301) 427-1595
E-mail address: healthcaremanagement@ahrq.hhs.gov
The letter of
intent is to be sent by the date listed in Section IV.3.A
Assistance Applicants
may submit questions to AHRQ via email at healthcaremanagement@ahrq.hhs.gov. AHRQ will respond to
questions via email only. In addition, based on inquiries received, AHRQ
will post a list of Frequently Asked Questions (FAQs) and responses to these
questions, as appropriate, after the release of this FOA at http://www.AHRQ.gov/fund/grantix.htm.
of a similar topic and nature may be grouped at the sole discretion of AHRQ
3.B. Submitting an Application Electronically to AHRQ To submit an application in response to
this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED. 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
IV.3.A. for all dates.) If an application
been addressed, and the assembled application has been created in the eRA
Commons, the PD/PI and the Authorized Organization Representative/Signing
Official (AOR/SO) have two weekdays (Monday – Friday, excluding Federal
holidays) to view the application image to determine if any further action is
move forward after two weekdays if no action is taken. Some warnings may
the option to “Reject” the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application
package (e.g., some part of the application was lost or didn’t transfer
correctly during the submission process). The AOR/SO should first contact the eRA Commons
Helpdesk to confirm the system error, document the
issue, and determine the best course of action. NIH will not penalize the
applicant for an eRA Commons or Grants.gov system issue.
completeness by the Center for Scientific Review, NIH, and AHRQ. Incomplete or
will not accept any application in response to this funding opportunity that is
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. Use of CMS Data Purchase of Centers for
Medicare & Medicaid Services (CMS) public-use data, if required, should be
discussed in the application narrative and included in the budget. Projects
will ordinarily not use CMS (Medicare or Medicaid) data involving individual
identifiers. However, for applications that propose to use Medicare or Medicaid
data that are individually identifiable, applicants should state explicitly in
the “Research Design and Methods” section of the Research Plan (form 398) the
specific files, time periods, and cohorts proposed for the research. In
consultation with CMS, AHRQ will use this information to develop a cost
estimate for obtaining the data. This estimate will be included in the
estimated total cost of the grant at the time funding decisions are made. Applicants should be aware
that for individually identifiable Medicare and Medicaid data, Principal
Investigators and their grantee institutions will be required to enter into a
Data Use Agreement (DUA) with CMS to protect the confidentiality of data in
accordance with the confidentiality provision in the AHRQ statute, 42 USC
299c-3(c); the Health Insurance Portability and Accountability Act of 1996
(HIPAA) Privacy Rule at 45 CFR Parts 160 and 164, if applicable; and standards
set out in OMB Circular A-130, Appendix III–Security of Federal Automated
Information Systems. The use of the data will be restricted to the purposes and
time period specified in the DUA. At the end of this time period, the grantee
will be required to return the data to CMS or certify that the data have been
destroyed. Unless AHRQ is able to
negotiate exceptional arrangements, the DUA will include the requirement that
the data user agrees to submit to CMS, a copy of all findings within 30 days of
making such findings, for the sole purpose of assuring CMS that data
confidentiality is maintained. The user further agrees not to submit these
findings to any third party (including but not limited to any manuscript to be
submitted for publication) until receiving CMS's approval to do so. In developing research
plans, applicants should allow time for refining, obtaining approval, and
processing of their CMS data requests. Requests may take six months from the
time they are submitted to complete. Applications proposing to contact
beneficiaries or their providers require the approval of the CMS Director and
may require meeting(s) with CMS staff. CMS data are provided on
IBM mainframe tapes using the record and data formats commonly employed on
these computers. Applicants should either have the capability to process these
tapes and formats or plan to make arrangements to securely convert them to
other media and formats. Questions regarding CMS
data should be directed to the AHRQ program official listed under Agency Contacts
(see Section VII). To avoid double counting,
applicants should not include the cost of identifiable CMS data in the
budget. In the event the total costs of the project plus the cost of CMS
data is greater than the total cost cap of this FOA, the budget for the project
will be adjusted so that the total costs awarded to the recipient plus the CMS
data costs do not exceed the cost cap. 4.
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/fund/hhspolicy.htm
Pre-award costs are allowable. A grantee may, at its own
risk and without AHRQ prior approval, incur obligations and expenditures to
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
obtain AHRQ approval before incurring the cost. AHRQ prior approval is required
initial budget period of a new award. The incurrence of
no obligation on AHRQ either to make the award or to increase the amount of the
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
the conduct of the project.
Requirements PD/PI Credential (e.g., Agency
requirements such as page limits. All attachments must be provided to AHRQ in
be sure that you observe the direct cost, project period, and page number
requirements. Special
Instructions for Modular Grant 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. Appendix Materials
Also see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html. Do not use the Appendix to circumvent the page limitations
of the Research Plan component. An application that does not comply with the
required page limitations may be delayed in the review process. No supplemental/updated information will be accepted.
The Healthcare Research and
Quality Act of 1999, in amending the Public Health Service Act, directed AHRQ,
in carrying out its mission, to conduct and support research and evaluations,
and to support demonstration projects, with respect to 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. This authority is found at
42 USC 299(c). To implement this statutory mandate, AHRQ published a
Notice in the NIH Guide on February 28, 2003, establishing a new Agency policy
on the Inclusion of Priority Populations in health services research (see 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. Publication Transmittal:
General AHRQ Requirements In keeping with the
Agency's efforts to translate the results of AHRQ-funded research into practice
and policy, grantees are to inform the AHRQ Office of Communications and
Knowledge Transfer (OCKT) when articles from their AHRQ-supported activities
are accepted for publication in the professional literature. Grantees
should also discuss any ideas about other dissemination and marketing efforts
with OCKT staff. The goal is to ensure that efforts to disseminate
research findings are coordinated with other Agency activities to maximize
awareness and application of the research by potential users, including
clinicians, patients, health care systems and purchasers and policymakers.
This is critical when outreach to the general and trade press is
involved. Accordingly, contact with the media will take place with close
coordination between OCKT and the press offices of the grantee's
institutions. In cases when products are created (such as annual or final
reports, Web-based tools, CD-ROMs), grantees will be asked to submit to OCKT a
brief plan describing how the product will be publicized. An OCKT staff
person will be assigned to each product and will coordinate the implementation
of the plan, especially issues related to printing and electronic
dissemination, and outreach to the media. Assessment of AHRQ Grant
Programs In carrying out its
stewardship of research programs, AHRQ may request information essential to an
assessment of the effectiveness of Agency research programs. Accordingly,
grant recipients are hereby notified that they may be contacted after the
completion of awards for periodic updates on publications resulting from AHRQ
grant awards, and other information helpful in evaluating the impact of
AHRQ-sponsored research. AHRQ expects grant
recipients to keep the Agency informed of publications, as well as the known
uses and impact of their Agency-sponsored research. Applicants must agree to
notify AHRQ immediately when a manuscript based on research supported by the
grant is accepted for publication, and to provide the expected date of
publication as soon as it is known, regardless of whether or not the grant
award is still active. HCUP & MEPS
Applicants are encouraged to make use
of AHRQ’S Healthcare Cost and Utilization Project (HCUP) or the Medical
Expenditure Panel Survey (MEPS). HCUP is a family of health care
databases and related software tools and products developed through a
Federal-State-Industry partnership. HCUP databases bring together the
data collection efforts of State data organizations, hospital associations,
private data organizations, and the Federal government to create a national
information resource of patient-level health care data. HCUP databases
provide data beginning in 1988 and contain encounter-level information for all
payers compiled in a uniform format with privacy protections in place. HCUP includes three nationwide databases, the Nationwide Inpatient Sample (NIS),
the Kids’ Inpatient Database (KID), and the Nationwide Emergency Department
Sample (NEDS), and three types of State databases, the State Inpatient
Databases (SID), the State Ambulatory Surgery Databases (SASD), and the State
Emergency Department Databases (SEDD). More information on HCUP can be
found at http://www.hcup-us.ahrq.gov/home.jsp.
The MEPS is conducted to
provide nationally representative estimates of health care use, expenditures,
sources of payment, and insurance coverage for the U.S. civilian,
non-institutionalized population. MEPS is composed of three component
sample. The MEPS IC collects data on health insurance plans obtained
through employers and unions, including the number and types of private
insurance plans offered, employer characteristics, premiums, and contributions
by employers and employees. More information on the MEPS is available at http://www.meps.ahrq.gov.
Applicants’ use of HCUP
and/or MEPS data does not preclude the use of secondary data sources or primary
AHRQ encourages applicants
to write Informed Consent (IC) and HIPAA Authorization documents for research
to be understandable to all potential research participants, including those
with low levels of literacy and limited English proficiency. AHRQ recommends
that IC and Authorization documents be written in accordance with health
literacy principles, and that IC and Authorization documents be available in
multiple languages if potential research participants include individuals with
limited English proficiency. AHRQ also recommends adopting a process to verify
potential research participants’ understanding. IC documents must provide
information in language understandable to potential participants (45 CFR 46.116).
For covered entities under the Privacy Rule, authorization documents must
include core elements and required statements in (45 CFR 164.508(c) and
must be written in plain language. The AHRQ Informed Consent and Authorization
Toolkit for Minimal Risk Research (http://www.ahrq.gov/fund/informedconsent/)
provides sample forms and guidance on adapting them, and also describes an
appropriate process for obtaining informed consent and authorization.
produced under an AHRQ-funded grant should be appropriate for the target
audience. This includes individuals from diverse cultural, language, and
literacy backgrounds. Audience testing should be part of the development
process. AHRQ’s Talking Quality website (http://www.talkingquality.gov/) and
AHRQ’s guide and checklist for developers and purchasers of health information
(IT) that is designed to be accessed and used by consumers (http://healthit.ahrq.gov and select Health
IT Tools) are resources applicants can use to ensure appropriateness of
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
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
application. The reasonableness of the data sharing plan or the rationale
of scientific merit or the priority score.
Section V. Application Review Information 1.
Criteria Administrative Criteria: Upon receipt, applications will be reviewed by AHRQ for completeness and
responsiveness. Merit Review
Criteria are described below. The review criteria described below will be
not following instructions given in this FOA will not be reviewed. As part of the initial merit review, all applications will: Undergo a selection process in which only those
applications. The following will be considered in making funding decisions: Scientific merit of the proposed project as determined by
peer review Availability of funds
Responsiveness to goals and objectives of the FOA Relevance to program priorities Programmatic balance, including geographic
and institutional diversity
Portfolio balance within AHRQ and DHHS The reviewers will apply the FOA-specific review
criteria. Each application will be evaluated on its own merit. There is no intrinsic difference in the scientific merit or potential impact of
the three different types of studies anticipated. AHRQ R21 exploratory/developmental grant is a mechanism for
supporting novel scientific ideas or new model systems, tools, or technologies
that have the potential to significantly advance our knowledge or the status of
health-related research. It is important to remember that the content
expectations and review criteria for this R21 mechanism are distinct from the
more common R01 mechanism. The R21 mechanism is an
exploratory/developmental grant application and there is a 15-page limitation
for Research Plan component. This R21 mechanism does not require the
presentation of pilot data, demonstrated generalizability of the results, nor
the expectation of more extensive preliminary information that would be
expected in a 25-page R01 application. Preliminary data may be included if
available. Reviewers will carefully determine the scientific merit
of the application based on the material presented in the application and will
carefully consider the conceptual framework, the level of innovation, and the
potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through
literature citations, data from other sources, or, when available, from
investigator-generated data. In their written critiques, reviewers will be asked to
assess the strengths and weakness of the application in terms of the following
a substantial impact on the pursuit of the FOA’s goals. Each of these criteria
will be addressed and considered in assigning the overall score, weighting them
as appropriate for each application. Significance Approach Innovation Investigators Environment Budget Note that an application
scientific impact and thus warrant a high priority score. For example, an
innovative but is essential to move a field forward. Significance: How significant are the
chronic diseases and preventive services selected? The criteria on which
significance will be assessed are: The condition is relatively common; It is frequently accompanied by other important
co-morbidities; There are effective treatments (especially if there are
quality metrics built around these treatments); The appropriate use of those treatments is likely to be
influenced by the co-morbidities. At least one condition must be a priority condition
established by HHS under Section 1013 of the MMA (see Section I, “Funding
Opportunity Description”).
If the aims of the application are achieved, how will
scientific knowledge or clinical practice be advanced? What will be the
effect of these studies on the concepts and methods of analysis used to
understand and improve the care of complex patients? How will this study
improve the treatments, services, or preventive interventions provided to
complex patients? Approach: To what extent has the
applicant adequately addressed at least two chronic conditions (for descriptive
epidemiology studies) or one index intervention and two other co-morbid
conditions (for analytic epidemiology studies), or if a model is proposed, one
or more preventive or therapeutic chronic disease interventions, and at least
two other chronic conditions? To what degree are the conceptual or
clinical framework, design, methods, and analyses adequately developed,
To what extent has the applicant used up-to-date, evidence-based
guidelines/recommendations where appropriate? Has the applicant provided
comparisons of patients with and without chronic conditions? To the extent
possible, has the applicant proposed quantifying the relative effect of
providing a preventive service in individuals without chronic conditions to
individuals with one or more chronic conditions? Does the applicant
acknowledge and show an understanding of potential problem areas and consider
alternative tactics? Innovation: Because this is an
exploratory grant, how does the applicant discuss the next steps? How
well has the applicant addressed how findings will inform current
institutional/national quality improvement measures and treatment
guidelines? Investigators: Are the PD/PI and other
key personnel appropriately trained and well suited to carry out this
work? To what extent is the investigative team cross-disciplinary
including members with clinical expertise as well as rigorous methodologic
expertise and experience? Is the work proposed appropriate to the
experience level(s) of the principal investigator(s) and other researchers? Is
the PD/PI time commitment to the project at least 20% annually over the course
of the award?
Environment: How is the project situated
with regard to data availability, computing environment, and appropriate
availability of statistical expertise? Will the PI’s work with other
investigators on the project team be facilitated or potentially hindered by the
structures of his or her department or institution? Is there
evidence of appropriate support? Budget: Is the proposed budget reasonable and
necessary and is the requested period of support appropriate in relation to the
proposed research as described earlier in this announcement? 2.A.
Additional Review Criteria In addition to the above
criteria, the following items will be considered in the determination of
scientific merit and the priority score: Degree of
responsiveness: How well does the
application address the purpose and objectives of this FOA; how will results
inform the prioritization, timing, provision and/or coordination of treatments
and preventive services? How responsive is the application to the special
eligibility criteria, including the project requirements, noted in the FOA? Does the application
include one or more comparative effectiveness priority conditions?
Inclusion: Adequacy of plans to address the needs of both
genders, racial and ethnic minorities (and subgroups). Adequacy of
attention to AHRQ priority populations (see above discussion on Priority
Populations in section IV.6 “Other Submission Requirements,” and inclusion
criteria included in section VIII of Required Federal Citations, below.)
Protection of Human Subjects from Research Risk: The
involvement of human subjects and protections from research risk relating to
their participation in the proposed research will be assessed. See the “Human
Subjects Sections” of the PHS398 Research Plan component of the SF424
Protections for Patients: The resources and processes to be used to address privacy and security issues
in the development and implementation of the intervention will be assessed. Applications submitted in
proposed project as determined by peer review Availability of funds Responsiveness to goals and
objectives of the FOA Relevance to program
priorities Programmatic balance
Portfolio balance within
AHRQ and HHS The AHRQ R21 provides support for projects
designed to develop, test, and evaluate health services activities, and to
foster the application of existing knowledge, in order to improve the quality,
safety, efficiency, and effectiveness of health care for all Americans. Appeals
will not be permitted. See Recovery Act of 2009: AHRQ Announces Suspension of
Grants Funding Appeals Process (see NOT-HS-09-011,
http://grants.nih.gov/grants/guide/notice-files/NOT-HS-09-011.html).
Pursuant to 42 USC
299c-3(c), information obtained in the course of any AHRQ supported-study that
identifies an individual or entity must be treated as confidential in
accordance with any explicit or implicit promises made regarding the possible
uses and disclosures of such data. 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. These regulations serve to limit the
disclosure of personally identifiable patient information by covered entities
investigators. The HHS Office of Civil Rights is the enforcement body for
this regulation. Additional information about the regulations, their
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 (see HIPAA website in prior paragraph) 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 National Institute of
Standards and Technology (NIST) has published several implementation guides for
this circular. They are: An Introduction to Computer Security: The NIST
Handbook; Generally Accepted Principals and Practices for Securing Information
Technology Systems; and Guide for Developing Security Plans for Information
Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/. 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, unless otherwise provided in
grant awards, or seek patents for, as appropriate, final and interim products
and materials developed in whole or in part with AHRQ funds, including, but not
limited to, methodological tools, measures, software with documentation,
literature searches, and analyses. Such copyrights and patents are subject to
a worldwide irrevocable AHRQ license to use and permit others to use these
products and materials for government purposes. In accordance with its
legislative dissemination mandate, AHRQ purposes may include, subject to
statutory confidentiality protections, making project materials, databases,
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). 3.
Anticipated Announcement and Award Dates Not
applicable. Section
Award Notices After the peer review of the application is completed, the
via the NIH eRA Commons. 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 issues, and certification of IRB approval of the
project's proposed use of human subjects. For details, 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
the applicant organization. The NoA will be generated via email notification
from the awarding component to the grantee business official. The NOA
signed by the grants management officer is the authorizing document.
The terms of the NoA
will reference the requirements of the Recovery Act.
AHRQ terms of award, all funding provided under the Recovery Act will be
subject to the HHS Standard Terms and Conditions for American Recovery and
Reinvestment Act of 2009 (ARRA). The full text of these terms approved for
AHRQ awards can be found in the following document: Department of Health and
Human Services Standard
Terms and Conditions for American Recovery and Reinvestment Act of
2009 (see http://www.ahrq.gov/fund/arraterms.htm).
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
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, and are
As necessary, additional Terms and Conditions will be
incorporated into the award statement.
3. Reporting Grantees
will be required to submit the Non-Competing
Grant Progress Report (PHS 2590) annually for awards with project periods that exceed 12 months.
The annual progress reports
must include Section 2.2.6 items 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 will
provide the timetable for these progress reports.
Financial Status Reports (FSRs; SF 269) are required
annually by AHRQ for ALL grant programs as described in the HHS Grants Policy
Statement (see http://www.ahrq.gov/fund/hhspolicy.htm). This report must be
submitted for each budget period no later than 90 days after the close of the
budget period. A hard copy of the report should be submitted to the
assigned grants management specialist.
Until such time as HHS has migrated to the SF 425 FFR, award
recipients will utilize the SF 269 FSR.
Section 1512 of the Recovery Act requires prime
recipients of the ARRA funds to submit quarterly reports, due no later than 10
calendar days after each calendar quarter in which the recipient receives the
award (January 10, April 10, July 10, and October 10). Accordingly, in
addition to the standard AHRQ terms of award, all funding provided under the
Recovery Act must comply with the statutory reporting requirements and will be
Reinvestment Act of 2009 (ARRA) as described above and found on the AHRQ
Website at http://www.ahrq.gov/fund/arraterms.htm.
addition, AHRQ is currently developing AHRQ-specific reporting requirements. Detailed information and requirements on the specific AHRQ reporting venues and
reporting timeline will be included in the Notice of Grant Award and
incorporated into AHRQ Terms and Conditions of Award. A final Progress Report,
Final Invention Statement, and Financial Status Report are required when an
award ends. For further details regarding grant closeout requirements, refer
to http://www.ahrq.gov/fund/closeout.htm. Section
VII. Agency Contacts This FOA is subject to
restrictions on oral conversations during the period of time commencing with
the submission of a formal application (also including submission of a letter
of intent) by an individual or entity and ending with the award of the
competitive funds. Federal officials may not participate in oral
communications initiated by any person or entity concerning a pending
application for a Recovery Act competitive grant or other competitive form of
Federal financial assistance, whether or not the initiating party is a
federally registered lobbyist. This restriction applies unless:
the communication is purely logistical;
the communication is made at a widely attended gathering;
the communication is to or from a Federal agency official and another Federal
Government employee;
the communication is to or from a Federal agency official and an elected chief
executive of a state, local or tribal government, or to or from a Federal
agency official and the Presiding Officer or Majority Leader in each chamber of
a state legislature; or
the communication is initiated by the Federal agency official.
see: http://www.whitehouse.gov/omb/assets/memoranda_fy2009/m09-24.pdf
Please note, the
President’s memorandum applies to communications prior to the award of a grant
or other Recovery Act funding; it does not apply to communications with
officials regarding the administration of a grant that has already been
and questions from potential applicants concerning this funding opportunity are
encouraged and welcome. Inquiries may be made in writing or by telephone, and
fall into three areas: scientific/research (program), peer review, and
Scientific/Research Contact(s): Direct your questions about general FOA
issues, including information on the inclusion of priority populations to:
Mary Barton, MD, MPP
Agency for Healthcare Research and
Telephone: (301) 427-1638
Fax: (301) 427-1597.
E-mail address: Mary.Barton@ahrq.hhs.gov
Telephone: (301) 427-1585
Fax: (301) 427-1597
E-mail address: Therese.Miller@ahrq.hhs.gov
Peer Review Contact(s): Direct your questions about peer review
issues of grant applications made in response to this FOA to:
Kishena Wadhwani, PhD., MPH.
Office of Extramural Research,
Education and Priority Populations
E-mail address: Kishena.Wadhwani@ahrq.hhs.gov
Financial/Grants Management Contact(s): Direct inquiries regarding fiscal matters to
either George Gardner or Michelle Burr as described below: George Gardner Office of Performance Accountability,
E-mail address: George.Gardner@ahrq.hhs.gov
Michelle Burr Office of Performance Accountability,
Telephone: (301) 427-1451
E-mail address: Michelle.Burr@ahrq.hhs.gov
Federal Citations The American Recovery And Reinvestment Act of 2009 (Pub. L. No. 111-5): http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1enr.pdf
Standard Terms and Conditions for Recovery Act Awards: The full
text of these terms approved for AHRQ awards
can be found in the following document: http://www.ahrq.gov/fund/arraterms.htm
Inclusion of Women and
Minorities in Research Study Populations:
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 are
provided that inclusion is inappropriate, e.g., because of the lack of
connection between the study and the health of women or particular minorities.
All investigators proposing
research involving human subjects should read the UPDATED "NIH Guidelines
on the Inclusion of Women and Minorities as Subjects in Clinical
Research," published in the NIH Guide for Grants and Contracts on August
2, 2000 (http://grants.nih.gov/grants/guide/notice-files/not-od-00-048.html). A complete copy of the updated
Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. To the extent possible, AHRQ
requires adherence to these NIH Guidelines.
Investigators may obtain
copies from the above sources or from the NIH Guide Web site at http://grants.nih.gov/grants/guide/index.html. AHRQ Program staff may also
provide additional information concerning these policies (see Section VII,
Agency Contacts).
Human Subjects Protection: Federal
regulations at 45 CFR Part 46 require that applications and proposals involving
human subjects research must be evaluated in accordance with those regulations,
with reference to the risks to the subjects, the adequacy of protection against
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). Standards for Privacy of
Individually Identifiable Health Information:
The HHS "Standards for
Privacy of Individually Identifiable Health Information" regulation was
mandated by the Health Insurance Portability and Accountability Act of 1996
(HIPAA) which governs the protection of individually identifiable health
information. It is administered and enforced by the DHHS Office for Civil
Rights (OCR). The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a
complete Regulation Text and a set of decision tools that may be used to
determine whether a researcher is a staff member of a covered entity.
Compliance with the Privacy Rule for those classified under the Rule as
"covered entities" is mandatory. Decisions about applicability
and implementation of the Privacy Rule reside with covered entities.
Project Officers will assist grantees in resolving questions about the
applicability of HIPAA requirements.
through the Freedom of Information Act:
OMB Circular A-110 provides
access to certain research data developed with Federal support through the
Freedom of Information Act (FOIA), 5 U.S.C. 552, in certain
circumstances. Data that are (1) first produced in a project that is
effect of law (i.e., a regulation or administrative order) may be accessed
through FOIA. If no Federal action is taken having the force and effect of law
in reliance upon an AHRQ-supported research project, the underlying data are
not subject to this disclosure requirement. Furthermore, even if a
Federal regulatory action is taken in reliance on AHRQ-supported research data
under FOIA, disclosure of confidential identifiable data from such study is
data might also be exempted from FOIA disclosure requirements under "the (b)(4)
exemption," 5 USC 552(b)(4), for example,
if it constitutes trade secrets or commercial information. NIH has
provided general related guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm which does not include discussion of
the exception applicable to
confidential identifiable data collected under AHRQ's authorities.
Should applicants wish to
place data collected under this FOA in a public archive, which can provide
protections for the data (e.g., as required by confidentiality provisions of
the statute applicable to AHRQ-supported projects, 42 USC 299c-3(c) and manage
the distribution of non-identifiable data for an indefinite period of time,
they may. The application should include a description of any archiving plan in
the study design and include information about this in the budget justification
section of the application. In addition, applicants should consider how to
structure informed consent statements or other human subject protection
procedures to permit or restrict disclosures of identifiable data, as
The Public Health Service
setting health improvement priorities for the United States. AHRQ encourages
applicants to submit grant applications with relevance to the specific
objectives of this initiative. Potential applicants may obtain a copy of
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
described in the HHS Grants Policy Statement. The HHS Grants Policy Statement
can be found at http://www.ahrq.gov/fund/hhspolicy.htm.
The PHS strongly encourages all grant
recipients to provide a smoke-free workplace and discourage the use of all
tobacco products. In addition, Public Law 103-227, the Pro-Children Act of
consistent with the Public Health Service mission to protect and advance the
physical and mental health of the American people.
1. Boyd CM, Darer J, Boult C, Fried LP, Boult L, Wu AW. Clinical
practice guidelines and quality of care for older patients with multiple
comorbid diseases: implications for pay for performance. JAMA. 2005;294(6):716-24.
2. Walter LC, Davidowitz NP, Heineken PA, Covinsky KE. Pitfalls
of converting practice guidelines into quality measures: lessons learned from a
VA performance measure. JAMA. 2004;291(20):2466-70. 3. Werner RM, Greenfield S, Fung C, Turner BJ. Measuring
quality of care in patients with multiple clinical conditions: summary of a
conference conducted by the Society of General Internal Medicine. J Gen
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