Expired RFA-HS-10-015: ARRA OS: Recovery Act 2009 Limited Competition: Scalable Distributed Research Networks for Comparative Effectiveness Research (R01)

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

Part I Overview Information

Participating Organizations
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov)

Components of Participating Organizations
Center for Outcomes and Evidence (COE), AHRQ (http://www.ahrq.gov)

Title: ARRA OS: Recovery Act 2009 Limited Competition: Scalable Distributed Research Networks for Comparative Effectiveness Research (R01)

Note: The policies, guidelines terms and conditions stated in this announcement may differ from those used by the NIH.

Announcement Type
This Funding Opportunity Announcement (FOA) is a new Request for Applications (RFA)

Update: The following update relating to this announcement has been issued:

August 16, 2010 - IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Request for Applications (RFA) Number: RFA-HS-10-015

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.715

Key Dates
Release/Posted Date: January 21, 2010
Opening Date: February 10, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not applicable
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): March 10, 2010
Peer Review Date(s): Generally four months after receipt date
Earliest Anticipated Start Date(s): September, 2010
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: March 11, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content
Executive Summary

This AHRQ Funding Opportunity Announcement (FOA), supported by funds provided to AHRQ by the Office of the Secretary (OS) under the American Recovery & Reinvestment Act of 2009 ( Recovery Act or ARRA ), Public Law 111-5, invites Research Project Grant (R01) applications from organizations that propose to develop the infrastructure and improve the methodology for collecting prospective data from electronic clinical databases to generate new evidence on the comparative effectiveness of healthcare interventions.

Purpose. The goal of this FOA is to enhance the capability and capacity of electronic health networks designed for distributed research to conduct prospective, comparative effectiveness research on outcomes of clinical interventions. The clinical interventions include, but are not limited to, diagnostics, therapeutics (drugs and biologics), medical devices, behavioral interventions, and surgical procedures used in clinical care.

These distributed research network projects will build on and expand existing electronic health infrastructure with the ultimate goal of implementing broad, scalable and sustainable systems that enable the collection of longitudinal and comprehensive data across diverse healthcare delivery settings (such as ambulatory, in-patient, and long-term care facilities) to evaluate effectiveness of clinical interventions for a diverse set of clinical conditions.

Mechanism of Support: This FOA will use the AHRQ Research Project Grant (R01) mechanism.
Funds Available and Anticipated Number of Awards: A total of $25 million is available over three years and AHRQ anticipates awarding up to a maximum of three grants. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary. The total amount awarded and the number of awards will depend upon the quality, duration, and costs of the applications received.
Budget and Project Period: The total costs for the three year project/budget period for individual grants awarded under this FOA will not exceed $8.31 million. The total costs for a grant awarded under this FOA are expected to range from $2 million to $2.77 million total costs per year. Total costs may not exceed $2.77 million annually. The duration of the project may not exceed three years. The grantee is required to accelerate the work where and when feasible.
Application Research Strategy Length: The Research Strategy section of the R01 application may not exceed 30 pages, including tables, graphs, figures, diagrams, and charts. Technical details on the infrastructure and electronic linkages can be submitted in an appendix.
Eligible Institutions/Organizations: Institutions/organizations listed in Section III, 1.A. are eligible to apply.
Eligible Project Directors/Principal Investigators (PDs/PIs): Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/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. The PI/PD must devote a minimum level of effort of 20% annually (2.4 calendar months) to the project.
Number of PDs/PIs: Only one PD/PI may be designated on the application.
Number of Applications: Applicants may submit more than one application, provided each application is scientifically distinct
Resubmission(s): Because this is a one-time-only solicitation, resubmissions are not permitted.
Renewals: Renewal applications are not permitted in response to this FOA.
Special Date(s): This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates.
Application Materials: See Section IV.1 for application materials.
General Information: For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:
- SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
- General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
Hearing Impaired: Telecommunications for the hearing impaired are available at: TTY: (301) 451-5936

While grant awards are made to institutions rather than individuals, this announcement and its instructions are written to inform individual researchers of this funding opportunity and facilitate the submission of grant applications by their organizations.

Table of Contents

Part I Overview Information

Part II 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 - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Comparative effectiveness research (CER) 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.

To 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.
This 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

There were four main inputs for priorities for ARRA OS CER funds: public input, an internal Departmental workgroup, the Federal Coordinating Council (FCC) for CER 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 CER;

2) Potential to inform decision-making by patients, clinicians or other stakeholders;

3) Responsiveness to expressed needs of patients, clinicians or other stakeholders;

4) Feasibility of research topic (including time necessary for research).

The CER-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),

2) Potential to evaluate comparative effectiveness in diverse populations and patient 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

2) An issue within one the 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;

3) Fall into one of the AHRQ identified evidence gaps.

The current list of priority conditions includes:

Arthritis 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 pre-term birth
Pulmonary disease/asthma
Substance abuse

The goal of this FOA is to enhance the capability and capacity of electronic health networks designed for distributed research to conduct prospective, comparative effectiveness research on outcomes of clinical interventions.

The clinical interventions for comparative effectiveness research include, but are not limited to, diagnostics, therapeutics (drugs and biologics), medical devices, behavioral interventions, and surgical procedures used in clinical care.

One approach to building a distributed research network is to link information from multiple clinical organizations with different electronic medical records (EMRs) and information technology (IT) architectures using middleware to build a database containing standardized information behind the firewall of each organization. This database can connect to other databases such as practice management databases, hospital databases, and pharmacy fill/refill databases. The standardized database can present data from selected fields (thus de-identifying individual patient information) for internet-based queries using the open source Globus toolkit (http://www.globus.org/toolkit/) or similar toolkits used for building computing Grids. Grid computing enables complex queries to be passed to local nodes without crossing an organization s firewall. An example of such an approach is provided by one (of two) recently-completed AHRQ-supported pilot projects to establish a distributed research network called Distributed Ambulatory Research in Therapeutics Network (DARTNet). DARTNet has successfully linked information across five different EMRs used in different ambulatory care settings to conduct a comparative effectiveness study on oral hypoglycemics. DARTNet can also provide clinical decision support and collect relevant clinical information at the point of care; this capability can be used for conducting observational studies and practical clinical trials. The summary report of this project is available at: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=317

A second approach for distributed research is to link information across large, standardized databases that reside within large health care delivery organizations such as health maintenance organizations (HMOs). The second AHRQ-supported pilot study has specified the design characteristics of a large-scale distributed research network to conduct population-based studies. These include: distributed analytic capabilities; minimal data transfer; scalability; fine-grained authorizations and permissions; strong security and authentication; automated, extensive auditing; ability to address multiple topics; standardized, reusable data model; menu-driven query; creation of project-specific datasets; and pre-approved institutional review Board (IRB) and Data Use Agreements (DUA) for standard queries, single IRB or delegation, DUA templates. A report that describes these design characteristics is available at: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=316;

Applicants are strongly encouraged to read these two pilot projects prior to writing the proposal. Note: Applicants are not limited to either one of the two models described in the AHRQ pilot projects and can propose either a hybrid model or a completely different model that meets the requirements of this FOA.

The primary goal of the distributed research projects funded by this FOA is to advance the capability and capacity of electronic data collection infrastructure to conduct prospective, comparative effectiveness research with an emphasis on developing the capability of near-real time data extraction and analysis as well as of new data collection at the point-of-care with minimal impact on clinical workflow. These capabilities are particularly useful in comparing a wide range of clinical outcomes (including patient-reported outcomes) of different interventions, especially comparison of newly-approved drugs and devices to traditional interventions used to diagnose and treat a diverse set of clinical conditions and diseases, including rare diseases or events. These capabilities will also allow the rapid evaluation of new therapeutic outcomes of concern such as the association of osteonecrosis of the jaw with use of certain bisphosphonates. The infrastructure developed in the projects is expected to become a long-term national resource, therefore the scalability and sustainability of the infrastructure is an important secondary goal.

The distributed research network projects shall demonstrate the capability of the proposed data systems and infrastructure to collect and accurately link relevant and valid patient-level information, such that data from these systems can readily be used to produce methodologically rigorous and clinically meaningful prospective (observational and experimental) studies while maintaining the privacy and confidentiality of a patient’s information. Comparative effectiveness studies that make use of the proposed infrastructure will need to incorporate data from different care delivery sites and cover diverse patient populations to yield valid and generalizable conclusions. Although the primary purpose of the distributed research network projects is to enhance the capability and capacity of conducting comparative effectiveness research, it is anticipated that data obtained in these projects may also be used for healthcare quality improvement and other appropriate purposes. An example of this dual-function capability is demonstrated by the DARTNet project.

Requirements for Projects

1) All proposals must develop an electronic health network that collects and accurately links electronic data from multiple and different healthcare delivery settings, such as clinics, hospitals, and long-term care facilities. The primary focus of the proposals must be on developing the electronic network and demonstrating its capabilities for conducting methodologically rigorous comparative effectiveness studies on outcomes of diagnostics and therapeutics using clinically enriched and validated data, as detailed later.

2) The electronic networks must have the capability of collecting health-related quality of life and other relevant patient reported outcomes at the point-of-care to compare effectiveness of interventions.

3) The networks must have the capability of near-real time data extraction of de-identified patient-level data from relevant databases, near-real time data analysis, and the capability of near-real time new data collection for a variety of clinical interventions and clinical conditions at the point-of-care with minimal impact on clinical workflow.

4) All projects must collect data and study the comparative effectiveness of interventions in an AHRQ priority population: http://www.ahrq.gov/qual/nhdr07/Chap4.htm. Data collected from priority populations must be adequate to perform rigorous analysis and support conclusions generalizable to the priority population group. The study population is not limited to a priority population but it must include one. In particular, projects that design the electronic data infrastructure such that it can be used to ascertain evidence of comparative effectiveness pertinent or unique to the under-served in healthcare or underrepresented patient populations in clinical trials are strongly encouraged.

5) All funded projects must collect data and study the comparative effectiveness of interventions targeting at least two conditions from the list of the AHRQ priority conditions or the IOM priority topics for comparative effectiveness research. The lists are available at http://effectivehealthcare.ahrq.gov/index.cfm/submit-a-suggestion-for-research/how-are-research-topics-chosen/; and http://www.iom.edu/~/media/Files/Report%20Files/2009/ComparativeEffectivenessResearchPriorities/Stand%20Alone%20List%20of%20100%20CER%20Priorities%20-%20for%20web.ashx;

6) The capability of collecting information on the use of diagnostics to compare the effectiveness of new diagnostics with existing diagnostics, and the impact of these diagnostics on clinical decision-making and on patient outcomes is of special interest to AHRQ. A proposal limited to evaluating diagnostic accuracy or the impact of test information on treatment decisions without also considering impact on health outcomes will not be considered responsive. Diagnostics (as a category) includes laboratory tests (including gene-based tests) and imaging tests.

7) The applicant will demonstrate the capabilities of the network by assembling sets of comparative cohorts commensurate with the stage of development of the network i.e., the cohorts assembled in the earlier stages of development of the network are anticipated to be smaller or less complex, or both, compared to those assembled in later stages. The cohorts may be assembled on the basis of clinical condition or disease, treatments, age and/or other demographic factors, care delivery site, geographic region, or any combination of these or other factors. For each set of comparable cohorts, the network must demonstrate the ability to collect adequate clinical, demographic, and other relevant patient-specific data to minimize bias and confounding in the analysis and interpretation of outcomes of these cohorts. As the network expands to include other organizations and/or databases, the complexity and size of these cohorts will also increase.

For example, the initial cohort may consist of breast cancer patients designed to compare effectiveness of different therapeutic regimens in late-stage breast cancer. The cohort can subsequently be expanded to include early-stage breast cancer patients and they can belong to several different subgroups distinguished on the basis of test results (ER-positive; ER-negative; HER2-positive; HER2-negative; high, low or intermediate risk for cancer recurrence based on the scores of gene expression profiling tests like Oncotype DX etc.), in order to compare effectiveness of different therapeutic regimens within a sub-group of breast cancer patients. This would test the network’s ability to collect information on test utilization, test results, treatment decisions based on test results, and outcomes of different therapeutic regimens in similar sub-groups of patients.

Alternatively, the initial cohort may be assembled of coronary heart disease patients receiving care in an ambulatory care setting in a rural area, and the subsequent cohorts include ambulatory care clinics in urban areas, hospital in-patient facilities, and long-term care facilities, so that outcomes of similar patients receiving different clinical interventions in different healthcare delivery settings can be compared.

8) The networks must assemble at least four pairs of cohorts of increasing size and complexity during the course of three years of the project. These cohorts should address a minimum of two clinically unrelated diseases or conditions. The final set of cohorts must have the ability to compare outcomes of patients with multiple co-morbidities that have received care in different healthcare delivery sites.

9) The intent of this FOA is to test the capability of an electronic network in assembling prospective cohorts and collecting all relevant information needed to conduct rigorous comparative effectiveness studies that will yield valid and generalizable conclusions. The networks must have the capability to conduct prospective observational studies and clinical trials. The timeline and resources for these projects will not allow the conduct of prospective studies of adequate size, duration and/or complexity to make definitive conclusions on the comparative effectiveness of different clinical interventions.

10) Clinical informatics: The design of the clinical informatics infrastructure must ensure the infrastructure is readily scalable and interoperable across a variety of software platforms and IT architectures. The use of open-source software-based data platforms and linkages is strongly encouraged. The applications need to provide details on their approach to linking data and ensure this is consistent with ongoing national efforts to harmonize health IT standards. The timeline and resources for these projects do not allow for developing and testing new network system architectures or building a de-novo informatics infrastructure. Applicants that have already developed and tested a clinical informatics infrastructure (even on a small scale) will have the highest priority.

11) Governance: The applications must provide adequate details of a governance plan for project oversight, especially on issues related to data linkage, access, and privacy and confidentiality of patient information. In addition, the governance plan should describe provisions for oversight and responsibility concerning operational issues and scientific and technical concerns related to study design, implementation and data analysis. The plan must address potential solutions to barriers raised by organizational, business or other considerations that will impede collaboration and sharing of data between the partner organizations of the network. Provisions to review and manage the conflict of interest of investigators and center personnel on an ongoing and regular basis must be included. The governance plan must also describe provisions for obtaining input and feedback concerning important aspects of the design of data collection infrastructure as well as on the comparative research undertaken. End-user feedback will be important in designing the infrastructure so that the data are efficiently collected and clinical workflow is minimally impacted. The patient’s perspective must also be represented in the governance plan.

12) Scientific collaboration: Applications must budget to travel at least two, and preferably three, persons to AHRQ for an annual program meeting and at least one person for three in-person meetings annually that are convened by the Electronic Data Methods (EDM) forum. [See related FOA: ARRA-AHRQ Recovery Act 2009 Limited Competition: Electronic Data Methods (EDM) Forum for Comparative Effectiveness Research (U13) (RFA-HS-10-006)]. Most meetings are expected to last for two days.

13) Minimum effort of personnel: The PD/PI must budget for at least 20% effort annually (2.4 calendar months). There must also be a program manager/coordinator who must budget for 100% of effort annually (12 calendar months) to manage the project. There must be an appropriate mix of time allocated for senior and junior scientists to ensure the successful conduct of the study as well as training of new investigators. Budgeted effort of other personnel must be appropriate to the needs of the project.

14) Scalability and sustainability: The applicant must specify the approach taken to make the infrastructure scalable and sustainable.

15) Reporting: ARRA-specific reporting requirements are described in Section VI of this FOA.

In 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.

It is anticipated that the details of the approach used to build the clinical informatics infrastructure as well as the results of comparative effectiveness studies will be published in peer-reviewed literature as well as reported to AHRQ. Quarterly conference calls with the AHRQ program officer, and other individuals deemed necessary by the program officer, are required. These calls will review the progress on all aspects of the project and collaboratively discuss any challenges affecting the project and potential solutions to the challenges. Annual progress reports will detail the progress on all scientific, technical and programmatic aspects of the project.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism of Support

This Funding Opportunity Announcement (FOA) will use the Research Project Grant (RO1) 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 $25 million total costs to fund up to three research project grant applications under this FOA, contingent upon the submission of a sufficient number of scientifically meritorious applications.

The total costs across the three years of support for individual grants awarded under this FOA will not exceed $8.31 million. Applications are limited to $2.77 million total costs per year. Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation. Applications with project periods that exceed 3 years or budgets that exceed $2.77 million total costs in any given year or $8.31 million total costs over three years, 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 support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

Grantees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually.

Funding for this program is provided under the 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 total costs (aggregate total for a subcontract or multiple subcontracts), whichever is less. AHRQ awards under the Recovery Act will be for up to three years.

Section III. Eligibility Information

1. Eligible Applicants

1.A. 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 or in the 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.

You may submit an application(s) if your institution/organization has any of the following characteristics:

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 Government (Federally Recognized);
Indian/Native American Tribal Government (Other than Federally Recognized);
Indian/Native American Tribally 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. 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 be returned without review. Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the 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. The PI/PD must devote a minimum level of effort of 20% annually (2.4 calendar months) to the project.

2. 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 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 that plan to provide support 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 included in the detailed budget request.

3. Other-Special 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.

Renewals. Renewal applications are not permitted in response to this FOA.

Research on Humans:

All Federal regulations on research on human subjects will apply. Successful applicants will be required to have IRB approval prior to commencing research.

Applications must specify a data safety and monitoring plan that provides for the appropriate level of oversight and monitoring of the conduct of research to ensure the safety of participants, and the validity and integrity of the data. The method and degree of monitoring must be commensurate with the degree of risk involved for participating subjects and the size and complexity of the research. Applications that do not include a data and 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 health risk to research participants due to the nature of the intervention. A DSMB or DMC will also be needed to coordinate collection of valid data across multiple sites.

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine 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).

A one-time registration 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)

PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered

Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor 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 (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
Direct questions regarding Grants.gov registration to:
Grants.gov Customer Support
Contact Center Phone: 800-518-4726
Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
Email [email protected]

2) Organizational/Institutional 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 regarding the Commons registration to:
eRA Commons Help Desk
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
Email [email protected]

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

The individual(s) designated as PDs/PIs on the application must be registered also in the NIH eRA Commons. In the case of multiple PDs/PIs, all PDs/PIs must be registered and be assigned the PI role in the eRA Commons prior to the submission of the application.
Each PD/PI must hold a PD/PI account in the Commons. Applicants should not share a Commons account for both an Authorized Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role and an NIH Internet Assisted Review (IAR) role, both roles should exist under one Commons account.
When multiple PDs/PIs are proposed, all PDs/PIs at the applicant organization must be affiliated with that 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 PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo -- Telephone 301-710-0267; Email: [email protected].

Telecommunications for the hearing impaired: TTY: (301) 451-5936

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to AHRQ. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by AHRQ (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The SF424 (R&R) application has several components. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Research & Related Budget

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form, as appropriate to the required budget component

SPECIAL INSTRUCTIONS

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: February 10, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): N/A
Application Due Date(s): March 10, 2010
Peer Review Date(s): Generally four months after receipt date
Earliest Anticipated Start Date(s): September 2010

3.A.1. Letter of Intent

Not applicable

3.A.2. Technical Assistance

Applicants may submit questions to AHRQ via email at [email protected]. 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 approximately 4 weeks after the release of this FOA at http://www.AHRQ.gov/fund/grantix.htm.

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. All attachments must be provided to AHRQ in PDF format, filenames must be included with no spaces or special characters, and a pdf extension must be used.

In order to expedite the review, applicants are requested to notify the AHRQ Referral Office by email [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

3.C. Application Processing

3.C.1 Submitting On-Time

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time :

All registrations must be complete prior to the submission deadline
The application must receive a Grants.gov tracking number and timestamp (or eRA help desk ticket confirming a system issue preventing submission) by 5:00 p.m. local time on the submission deadline date.
Any system identified errors/warnings must be corrected and the submission process completed within the error correction window.

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

Initial application submission must be on-time.
The AOR/institutions is expected to enforce that application changes made within the error correction window are restricted to those necessary to address system-identified errors/warnings. NIH may reject any application that includes additional changes.
Proof of on-time submission (e.g., Grants.gov timestamp and tracking number) and description of all changes made within the window must be documented in the PHS 398 Cover Letter component of the application.

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified errors have 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 assembled application before it automatically moves forward to NIH for further processing.

If everything is acceptable, no further action is necessary. The application will automatically move forward to the Division of Receipt and Referral in the Center for Scientific Review for processing after two weekdays, excluding Federal holidays.
Prior to the submission deadline, the AOR/SO can Reject the assembled application and submit a changed/corrected application within the two-day viewing window. This option should be used if it is determined that some part of the application was lost or did not transfer correctly during the submission process, the AOR/SO will have the option to Reject the application and submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to ensure that the issues are addressed and corrected. Once rejected, applicants should follow the instructions for correcting errors in Section 2.12 of the SF 424 (R&R) application guide, including the requirement for cover letters on late applications. The Reject feature should also be used if you determine that warnings are applicable to your application and need to be addressed now. Remember, warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two weekdays if no action is taken. Some warnings may need to be addressed later in the process.
If the two-day window falls after the submission deadline, the AOR/SO will have 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.
If the AOR/SO chooses to Reject the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted, but it will be subject to the NIH late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment.
Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two weekdays.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and AHRQ. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons . The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.

AHRQ will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. AHRQ will not accept any application that is essentially the same as one already reviewed. However, AHRQ will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

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. Intergovernmental Review

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/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 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

The PI/PD must devote a minimum level of effort of 20% annually (2.4 calendar months) to the project. A program manager/coordinator must devote a level of effort of 100% annually (12 calendar months) to manage the project.

Applications must budget to travel two, and preferably three, persons (at a minimum the project PI and program manager must travel) to AHRQ for an annual Scalable DRN program meeting. In addition, at least one project personnel will be required to attend three in-person meetings convened by the Electronic Data Methods (EDM) Forum annually. Most meetings are expected to last two days. [See related FOA: ARRA-AHRQ Recovery Act 2009 Limited Competition: Electronic Data Methods (EDM) Forum for Comparative Effectiveness Research (U13), RFA-HS-10-006].

The PI and other key personnel of the Scalable DRN study are expected to contribute to the activities of the EDM Forum. [See related FOA: ARRA-AHRQ Recovery Act 2009 Limited Competition: Electronic Data Methods (EDM) Forum for Comparative Effectiveness Research (U13), RFA-HS-10-006], on a regular basis. Participation may involve activities such as meetings, teleconferences, participation in working groups, or other similar activities.

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

PHS398 Research Plan Component Sections

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

Specific Aims is limited to 1 page.
Research strategy, including tables, graphs, figures, diagrams, and charts, is limited to 30 pages. See Table of Page Limits.

Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these 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

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (see http://grants.nih.gov/grants/funding/424/index.htm). 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. An application that does not comply with the required page limitations may be delayed in the review process.

No supplemental/update information will be accepted.

Priority Populations

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, 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 surveys: the Household Component (HC), the Medical Provider Component (MPC), and the Insurance Component (IC). The Household Component is the core survey, and it forms the basis for the MPC sample and part of the IC 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 data collection.

Health Literacy

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 164.508c) 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.

Consumer Products

All consumer products 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 consumer products.

Plan for Sharing Research Data

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

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

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 considered in the review process.

2. Review and Selection Process

Review Process

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.

As part of the initial merit review, all applications will:

Undergo a selection process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score
Receive a written critique

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.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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 application address all requirements for distributed research network projects? Does this study address an important problem? 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, methods, technologies, treatments, services, or preventative interventions that drive this field? How will the infrastructure developed through this project advance our ability to collect meaningful data for studies on the comparative effectiveness of healthcare interventions? How will the specific comparative effectiveness studies proposed in this project inform important healthcare decisions?

Investigators: Are the PD/PI and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level(s) of the principal investigator(s) and other researchers? Do the PD/PI and investigative team bring complementary and integrated expertise to the project?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area?

Approach: Are the conceptual, informatics and clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Environment: Does the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment(s), or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

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 (R&R).

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.)

Budget: Is the proposed budget reasonable and is the requested period of support appropriate in relation to the proposed research?

Privacy and Security 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. In addition, the review criteria listed in the Priority-Setting Process and Inputs for Use of ARRA OS Funds section (Part II-Section I) will also be used.

Degree of responsiveness: How well does the application address 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?

1. Additional criteria for proposed infrastructure:

a. Applicant must arrange for partnership with multiple clinical organizations having different IT environments and must document commitments from those sites.

b. Proposed project must involve data collection from more than one type of care delivery site (e.g. hospital, long-term care facility, ambulatory clinic etc.).

c. Applicant must provide explanation and detail on how proposed infrastructure will support the collection of improved data, i.e., clinically-enriched patient-specific data that will allow for better, timely and more valid (both internally and externally valid) comparative effectiveness research than would be feasible with existing data related to studies proposed in the application.

d. Applicant must describe the near-real time data extraction and data analysis capability of the network.

e. Applicant must describe the collection of new point-of-care clinical data relevant to the proposed study and steps taken to minimize burden and clinical workflow for the data collection.

f. Applicant must describe how the proposed infrastructure will be leveraged or modified to address the evidentiary needs for underserved or underrepresented patient population groups.

g. Applicant must include technical detail on the clinical informatics approach adequate to assess its feasibility, including consideration of issues related to interoperability and scalability as well as the sustainability of the infrastructure.

h. Applicant must demonstrate a track record of successfully collecting and managing electronic health care data, preferably from disparate sources. To address this criterion, applicant should submit letters from previous partner organizations, attesting to the usability and positive contribution of data collected and to the applicant’s ability to work cooperatively with partner facilities.

2. Additional review criteria for comparative effectiveness research to be undertaken using data collected through proposed infrastructure:

a. Application must include scientific team with expertise in comparative effectiveness research.

b. Application must demonstrate that the applicant’s comparative effectiveness research team is involved with the infrastructure. development aspects of the project as well as the specification and design of comparative effectiveness studies included in the application.

c. Application must focus on at least two priority conditions, particularly those that would benefit most from this infrastructure.

d. Application must address a priority patient population that is under-represented in randomized controlled clinical trials or with limited access to healthcare, or both, such as elderly, pediatric, patients of different race/ethnicity and socioeconomic status, multiple co-morbidities, etc.

e. Application must reflect real-world populations.

f. Application must compare effectiveness of clinical interventions (diagnostics, devices, drugs, biologics, procedures, counseling and behavioral intervention or a combination of these).

g. Application must focus on health outcomes.

h. Application must describe how the proposed research will yield internally valid as well as generalizable conclusions.

i. Application must describe the assembly of at least four pairs of comparative effectiveness cohorts that increase in size and/or complexity during the conduct of the project.

j. Application must describe a governance plan meeting all the requirements laid out in the FOA.

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the impact/priority score:

2.B. Additional Review Considerations

Not Applicable

2.C. Resource Sharing Plan(s)

Data Confidentiality

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 and define when and how such information can be disclosed e.g., to researchers. Thus, health care plans ordinarily will require either patient authorization for disclosures of identifiable information to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations), which will involve review to ensure that identifiable health information will be appropriately safeguarded by the investigators. The DHHS Office of Civil Rights is the enforcement body for this regulation. Additional information about the regulations, their implementation, and alternative methods of permissible disclosures to researchers (limited data sets with data use agreements, de-identified data sets, data about deceased persons, and data use to develop protocols) can be obtained from: http://www.hhs.gov/ocr/hipaa/

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 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, 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).

Selection Process

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended 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
Portfolio balance within AHRQ and DHHS

Appeals will not be permitted. See Recovery Act of 2009: AHRQ Announces Suspension of Grants Funding Appeals Process (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-09-011.html).

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information

1. Award Notices

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 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 notification in the form of a Notice of Award (NoA) will be provided to 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.

In addition to the standard 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: 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 Restrictions.

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 subject to the requirements of the HHS Grants Policy Statement that are applicable based on the recipient type and the purpose of this award (see http://www.ahrq.gov/fund/hhspolicy.htm).

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

3. Reporting

The awardees are required to have a quarterly teleconference call with the AHRQ program officer to update progress on the project and to collaboratively discuss any challenges or problems affecting the project and the potential solutions to these challenges or problems.

Grantees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually.

The annual progress report summary 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 submit quarterly report, 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 subject to the HHS Standard Terms and Conditions for American Recovery and Reinvestment Act of 2009 (ARRA) as described above and found on the ARHQ Website at http://www.ahrq.gov/fund/arraterms.htm.

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.

For additional information 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 awarded.

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research (program), peer review, and financial or grants management issues.

1. Scientific/Research Contact(s):

Direct your questions about general FOA issues, including information on the inclusion of priority populations to: Scalable [email protected]
Due to staffing resource constraints, all scientific/research (program-related) inquiries pertaining to general FOA issues must be submitted by e-mail and will only be acknowledged by e-mail.

Amy Lindinha
Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1600
E-mail address: Scalable [email protected]

2. Peer Review Contact(s):

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

Kishena Wadhwani, Ph.D., M.P.H.
Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1556
Fax: (301) 427-1562
E-mail address: [email protected].

3. Financial/Grants Management Contact(s):

Direct inquiries regarding fiscal matters to either George Gardner or Michelle Burr:

George Gardner
Office of Performance Accountability, Resources and Technology
Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1450
Fax: (301) 427-1462
E-mail address: [email protected]

Michelle Burr
Office of Performance Accountability, Resources and Technology
Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1451
Fax: (301) 427-1462
E-mail address: [email protected].

Section VIII. Other Information

Required 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 these risks, the potential benefits of the research to the subjects and others, 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 Department of Health and Human Services (DHHS) "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.

Access to Research Data 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 supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and 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 statutorily protected under 42 USC 299c-3(c), and thus is exempted from disclosure under "the (b)(3) exemption in FOIA(3). It is important for applicants to understand the scope of this requirement and its limited potential impact on data collected with AHRQ support. Proprietary 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 warranted.

Healthy People 2010:

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for 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 "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authority of 42 USC 299 et seq. and, 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.

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 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the Public Health Service mission to protect and advance the physical and mental health of the American people.