Part I Overview Information


Department of Health and Human Services

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

Components of Participating Organizations
Office of Extramural Research, Education and Priority Populations (OEREP), (http://www.ahrq.gov)

Title:  CHIPRA Pediatric Healthcare Quality Measures Program Centers of Excellence (U18)

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 RFA.

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

Request for Applications (RFA) Number: RFA-HS-11-001  

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)
93.226

Key Dates
Release/Posted Date: April 22, 2010
Opening Date: May 30, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date: June 1, 2010
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:  June 30, 2010
Peer Review Date: approximately 4 months after due date
Earliest Anticipated Start Date: approximately 4 months after peer review
Expiration Date: July 1, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

This funding opportunity announcement (FOA) solicits Cooperative Research Demonstration and Dissemination Projects (U18) grant applications from applicant organizations that propose to advance and improve measures of children’s healthcare quality in specified priority areas. 

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
1. Research Objectives


Section II. Award Information

1. Mechanism of Support

2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants

    A. Eligible Institutions
    B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information

2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review, and Anticipated Start Dates
          1. Letter of Intent
          2. Technical Assistance
    B. Submitting an Application Electronically to AHRQ
    C. Application Processing   
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices

2. Administrative and National Policy Requirements
     A. Cooperative Agreement Terms and Conditions of Award
         1. Principal Investigator Rights and Responsibilities
         2. AHRQ Responsibilities
         3. Collaborative Responsibilities
3. Reporting

Section VII. Agency Contacts
1. Scientific/Research Contact(s)

2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description (start here)


1. Research Objectives

This FOA solicits Cooperative Research Demonstration and Dissemination Projects (U18) grant applications that propose to advance and improve measures of children’s healthcare quality.   This FOA implements Section 401(a) of the Children’s Health Insurance Program Reauthorization Act of 2009 (Public Law 111-3), which amends title XI (42 U.S.C. 1301 et seq.) by inserting after section 1139 the new section 1139A(b):   “Advancing and Improving Pediatric Quality Measures.”  This section calls for the establishment of a Pediatric Quality Measures Program to:  improve and strengthen the initial core child health care quality measures established by the Secretary under  (42 U.S.C. 1301 Sec. 1139A(a)); expand on existing pediatric quality measures used by public and private health care purchasers and advance the development of such new and emerging quality measures; and increase the portfolio of evidence-based, consensus pediatric quality measures available to public and private purchasers of children’s healthcare services, providers, and consumers.  Measures developed by the Pediatric Quality Measures Program are to be considered for the improved core measure set to be made available for public and private purchasers, programs and providers by January 1, 2013, as required by CHIPRA.  

Background:  

Attention to children’s health care quality measurement and improvement is a longstanding focus of the children’s health services research community. The CHIPRA legislation, passed by Congress and signed by the President in early 2009, recognizes the need to focus on healthcare quality measurement and improvement for the nation’s children, and provides an implicit roadmap for linking quality measurement to quality improvement, including reporting to Congress and the public on progress.

Title IV of CHIPRA required the Secretary of the U.S. Department of Health and Human Services to establish a Pediatric Quality Measures Program (PQMP).   The Secretary delegated the Centers for Medicare and Medicaid Services (CMS) with responsibility for PQMP and many other CHIPRA provisions.   CMS and AHRQ signed a Memorandum of Understanding (MOU 09-119) in April 2009 giving AHRQ the lead responsibility for implementing PQMP in close collaboration with CMS.   

Data collected over time show that health care quality for children overall is often far from optimal.   Reports continue to document persistent disparities in children’s healthcare quality by race and ethnicity and income.  For example, black children are 1.5 times as likely as white children to have emergency department visit rates of 6 hours or more in which the patient was admitted to the hospital or transferred to another facility.  Uninsured children are 3.2 times as likely as privately insured children to not have their height and weight measured by a healthcare professional, and 1.5 times likely to receive no vision screening and get no advice about car safety.  Poor children are 1.7 times as likely as high-income children to not be up to date in their early immunizations, and 3.7 times to experience poor provider-parent communication.   Among children with special healthcare needs, poor children are twice as likely to be without family-centered care.   Black children are between two and three times as likely as white children to experience ambulatory-care sensitive hospitalizations for asthma. 

In addition to the variations by demographic characteristics of children, healthcare quality varies across geographic regions and States, and between Medicaid and commercial populations.  These variations in care not only affect children after birth, but many children are born premature or otherwise get off to a poor start in life, potentially due to variations in the quality of care provided during the perinatal period.   

Despite these compelling national and regional statistics, which persist over time, there are relatively few measures that are valid, important in terms of children’s health outcomes, and actionable at appropriate levels of the healthcare financing and delivery systems.  In recent interviews, State Medicaid and CHIP officials have expressed a need for measures on critical child health topics and measures that can be compared across providers and plans and across programs within States, across States, and to national data.  Healthcare providers have called for a smaller set of meaningful measures that do not vary by payer.  CHIPRA recognizes these needs for children’s healthcare measures to be available at more actionable levels, and to be comparable across States, purchasers, providers, and consumers.  As noted above, there is also a particular interest expressed in CHIPRA to collect healthcare quality data so that comparisons can be made by race, ethnicity, socioeconomic status, and special healthcare needs status.

The United States as a whole is in need of an aggressive research program to develop, enhance, implement and evaluate performance measures for assessing healthcare quality.  CHIPRA provides an unprecedented opportunity to implement such a research program in children’s healthcare quality measurement.   The program will result in new and enhanced healthcare quality measures that are evidence-based and usable across public and private purchasers and programs, providers, and consumers, and able to identify disparities in race, ethnicity, socioeconomic status, and special health care needs status, to be extractable and shareable using health IT, publicly reportable, and to be used in periodic reports to Congress.   The measures will be developed over time, and used in periodic updates of the initial core measure set.  In addition, the Centers of Excellence approach, combined with the opportunity for multi-institution consortia is designed to provide a basis for continuing and collaborative scientific and practical infrastructures for healthcare quality measurement development and enhancement across the nation in the future..    Because of likely advances in health IT, clinical science, healthcare delivery structures, and population demographics, there will continue to be a need for enhancement and development of measures. 

Legislative requirements:

CHIPRA requires that the measures developed under the Pediatric Quality Measures Program shall, at a minimum, be:

Needs documented during the identification of an initial, recommended core set of children’s healthcare quality measures: 

Activities undertaken to identify the initial, recommended core measure set resulted in the identification of several high-priority suggestions for future development and enhancement of measures (http://www.gpo.gov/fdsys/pkg/FR-2009-12-29/html/E9-30802.htm;http://www.ahrq.gov/chip/corebackgrnd.htm).   High priority topics include:  a) specific sites and types of care (inpatient care, specialty care, substance use care, mental health prevention and treatment quality), b) health outcome measures, c) measures of the “most integrated health care settings,” d) availability of service measures, and e) duration of enrollment and coverage measures.   In addition to the creation of measures of quality for specific topics, the expert group recognized the need for methodological work.   For example, no measures could be identified for which data were consistently collected and reported across States and Medicaid and CHIP programs.   Measures that are currently tailored to particular programs or populations (e.g., Medicaid managed care; EPSDT recipients) will need to be respecified.  There are some recommended measures (and others that were found to be valid and feasible) that would not require data collection by State Medicaid and CHIP programs per se.  For example, rates of low birth weight babies among public program beneficiaries can be derived by linking birth certificate data to enrollment data, or by improving the collection of mothers’ and infants’ insurance source data on birth certificates.  More work is needed to standardize methods for linking birth certificate to enrollment data.  Similarly, few programs collect data on race and ethnicity, and special health care need status measurement seems to be restricted to the use of CAHPS® surveys of family experiences of care.      

Attention to health information technology opportunities to collect and report measures is important.  While CHIPRA provides for development of a model format for a pediatric electronic health record, the measures themselves must be enhanced to align with the use of such records.  

Specific research objectives:   This program aims to achieve:

a) The development of new pediatric healthcare quality measures to meet explicit high priority objectives to be identified through a public process;

b) The enhancement of existing measures within an explicit  set of priorities to be identified through a public process; and

c) Development or enhancement of cross-cutting methodologies that will allow:

1)  Pediatric healthcare quality measures that enable data capture and sharing via health IT,

2) Valid identification and comparison of racial and ethnic, socioeconomic, and special healthcare need disparities;

3) Risk adjustment methodologies; and

4) Other methodological needs to be specified.    

Specifically, the set of awards made under this FOA is expected to result in the following over the 4-year award period:

As required by CHIPRA, the measures are expected to be evidence-based (i.e., have strong underlying scientific soundness), valid, reliable, feasible for immediate use, and directly linkable to high-leverage opportunities for reaching the nation’s goal of improving healthcare quality and outcomes for children

In addition, each measure should be usable within a health IT infrastructure that meets criteria for “meaningful use” (e.g., electronic health record, computerized prescription order entry system, health information exchange, interoperable cross-setting care transition arrangements, and usable by patients with personal health records).   

Measures must be specified so that data can be collected vertically and horizontally across public and private providers, programs, plans, patient types and other stakeholder entities.  Measures must be able to assess disparities in children’s healthcare quality by race/ethnicity, socioeconomic status, and special health care needs status.

Measures must be practical.  To that end, applicants are required to specify a user group that includes frontline healthcare providers from a variety of care settings, in addition to engaging State programs, private insurers, patients and families.  

Specific measure development and enhancement priorities for work to be done by awardees will be set by a public priority setting process and communicated to awardees after awards are made.   In addition, beginning measurement criteria to be used by awardees will be set by a transparent process and measure criteria will be further enhanced throughout the award period with the help of the awardees.   A transcript of the public expert meeting on CHIPRA measure criteria held by AHRQ, with the involvement of CMS, is available at http://www.ahrq.gov/chip/chipra/mc022410/mcemtranscr.htm.  Reviewing the transcript may help potential applicants understand the kinds of criteria that awardees will be required to use, and areas for future development.

For purposes of submitting an application, applicants may wish to focus on one or more of the priority topic areas or methodological issues identified during the process for identifying the initial core set of children’s healthcare quality measures, as noted above, as examples of how their work would be done.    

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 AHRQ Cooperative Research Demonstration and Dissemination Projects Grant (U18) award mechanism.  The individual researcher(s) sponsored by each organizational grantee 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.

In the cooperative agreement mechanism, the PD/PI retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with AHRQ staff being substantially involved as a partner with the PI, as described in Section VI.2, Administrative Requirements, Cooperative Agreement Terms and Conditions of Award.

2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration 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.  Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation.

AHRQ intent to commits up to $13,820,000 in FY 2010 to fund 7 to 9 projects submitted in response to this FOA.  Applications may be up to 4.years in duration with a budget supported by AHRQ not to exceed $2,000,000 per year in total costs to the government.  Applications with project periods that exceed 4 years or budgets that exceed $2,000,000 total costs per year will not be reviewed.

The total costs awarded under this FOA will not exceed $2 million annually for the entire project period. Funding beyond the first year will be contingent upon a review by Agency staff of the non-competing continuation report.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

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

Consortia of up to 3 institutions/organizations are strongly encouraged to apply.  This FOA permits only one PI/PD per application.   If you are submitting as a consortium of institutions/organizations, each organization in the consortium must demonstrate that it meets the criteria above.  

Because the purpose of this program is to improve healthcare in the United States, foreign institutions may participate in projects as subcontractors only.  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(s) 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.

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 can be included at the end of the budget justification section of the application, but institutional support dollars are not to be shown/included in the detailed budget request.

3. Other-Special Eligibility Criteria

Number of Applications.  Applicants may submit more than one application, provided each application is scientifically distinct.  However, AHRQ will not accept similar grant applications with essentially the same research focus from the same applicant organization.

Resubmissions.  Applicants are not permitted to submit a resubmission application in response to this FOA. 

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

In order to meet the criteria for required expertise, consortia of organizations are encouraged to apply.  However, one organization and one PI/PD must agree to be the responsible party for purposes of grant administration. 

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.

A one-time registration is required for institutions/organizations at both:

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

2) Organizational/Institutional Registration in the eRA Commons

If a consortium of organizations is submitting, each organization must meet the registration requirements in these sections.  

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

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.

If the submission involves co-PDs/PI(s), each PD/PI must meet the requirements in this section.

Note that if a PD/PI is also an AHRQ peer reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

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 in both Grants.gov and the Commons. AHRQ will accept electronic applications only from organizations that have completed all necessary registrations.

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 301-435-0714; Email: GrantsInfo@nih.gov.

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. Some components are required, others are optional. 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
Research & Related Budget (See Section IV.6., regarding appropriate required budget component.) 

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

SPECIAL INSTRUCTIONS  

Applications Involving a Single Institution

When a single institution is involved, 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: May 30, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date: June 1, 2010
Application Due Date:  June 30, 2010
Peer Review Date: approximately 4 months after due date
Earliest Anticipated Start Date(s): approximately 4 months after peer review

3.A.1. Letter of Intent

To allow AHRQ staff to estimate the potential peer review workload and plan the review (e.g., anticipate the nature of reviewer expertise to be required), prospective applicants may submit a letter of intent that includes an acknowledgement of interest in this funding opportunity (please refer to the number and title of this funding opportunity), a few comments on the subject of the proposed research, background expertise of key personnel, and the nature and role of participating institutions.  Please include the name and email address of the PI/PD.

This letter of intent is not required, is not binding, and is not considered in the review of a subsequent application.  However, these letters are administratively very helpful, as indicated above. To be most useful, the letter of intent is to be sent by the date listed above and at the beginning of this document.

The letter of intent can be sent electronically, and should be sent to CHIPRAqualitymeasures@ahrq.hhs.gov or to:

AIPC Letters of Intent
Office of Extramural Research Education and Priority Populations
Division of Priority Populations
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850

The letter of intent is to be sent by the date listed in Section IV.3.A

3.A.2. Technical Assistance

AHRQ encourages applicants to take advantage of a technical assistance conference call sponsored by AHRQ program staff.  The purpose of the conference call is to provide potential applicants with background information and respond to questions about the preparation of an application in response to this FOA.  The conference call will take place on May 25, 2010 at 11:00 a.m.   To register to participate in the conference call, please send an e-mail request to CHIPRAqualitymeasures@ahrq.hhs.gov by May 20, 2010.  All registrants will be sent an e-mail reply which will contain information on the call, including call-in information, by May 24, 2010.  Potential applicants are encouraged to contact AHRQ staff with any questions (see Section VII, Agency Contacts, below).

The conference call is open to any individual or organization intending to apply.  Participation is not a prerequisite to applying.  Participants are encouraged to submit questions via email prior to the conference call.  Please submit up to five questions with your name and the name of your institution to CHIPRAqualitymeasures@ahrq.hhs.gov  by May 20, 2010.  Questions of a similar topic and nature may be grouped at the sole discretion of AHRQ staff.  Notes from the conference call will be posted on the AHRQ web site. 


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 NIH 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 Gerald.Calderone@ahrq.hhs.gov when the application has been submitted.  Please include the FOA number and title, PD/PI name, and title of the application.

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”:

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:

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.

Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by AHRQ. Incomplete and/or non-responsive 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

Use of CMS data may be a feature of work by awardees.   In order to estimate the costs of obtaining such data, consult RESDAC at http://www.resdac.umn.edu/Medicare/requesting_data.asp

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 Privacy rules 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

This FOA has several specific submission requirements.  Given the final common pathway for use of the measures to be developed and enhanced under this FOA and other related activities (see Scientific Knowledge above), awardees must coordinate their work with each other, with AHRQ and CMS, and with a CHIPRA Pediatric Quality Measures Program  Coordinating Center (the “Coordinating Center”) to be established under a separate funding mechanism.  Specifically, PI/PDs will be expected to demonstrate their willingness and ability to participate in the following activities, including budget estimates of the costs of participation:

  1. Annual public meetings during which awardees will share their progress on measure development and enhancement.   Participation will be in person for the PI/PD, and others may participate by webinar and phone. 
  2. During the first year of the award, monthly 2 to 3 hour Steering Committee meetings to be convened by webinar and phone. 
  3. During years 2, 3, and 4 of the award, bi-monthly 2 to 3 hour Steering Committee meetings to be convened by webinar and phone.

In addition, submissions must also indicate the awardees’ willingness to adhere to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information.” 

Applicants must explicitly address their capacity and willingness to:  

  1. Conduct measure development and/or enhancement work on priorities identified through a public process.  (The stated capabilities and experience of awardees for addressing relevant aspects of the work will be considered in selection of awardees and in subsequent designation of awardee-specific priorities.).
  2. Conduct measure development and/or enhancement work using measurement criteria developed using a public process.
  3. Establish, or participate in, a stewardship arrangement that will work to sustain and enhance measurement work conducted under this FOA. 

Applications submitted in response to this FOA must also address their capacity to:

While there is not a specific dollar limit on budgeted equipment or supplies, any funds requested for equipment, hardware, software, and supplies should be well justified. 

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

AHRQ requires the PD/PI(s) to fill in their 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 Sections

Page limitations of the PHS398 Research Plan component must be followed as outlined in the SF424 (R&R) Application Guide, incorporating “Just-in-Time” information concepts, and with the following additional requirements:

Warning:  Please be sure that you observe the total 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).

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.

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.   

This FOA focuses on development and enhancement of healthcare quality measures for children, one of AHRQ’s priority populations, and is also relevant to other priority populations, including racial and ethnic minorities, low-income, rural, inner-city, special healthcare needs.  In addition, given the CHIPRA emphasis on prevention and health promotion services that would prevent prematurity and promote healthy birth, women are also a priority population addressed by this FOA, who should be addressed by applicants.  Quality measures for prenatal and perinatal services may also be included as priorities and must be addressed by applicants. 

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.

Data Sources

Once priorities for measure development and enhancement are identified, awardees under this FOA are expected to consider using available federal data sources in their work.  Applicants’ use of federal data does not preclude the use of other data sources or primary data collection.  

AHRQ Data Sources

AHRQ’s data sources include the Healthcare Cost and Utilization Project (HCUP), the Medical Expenditure Panel Survey (MEPS), and the Consumer Assessment of Healthcare Providers and Systems (CAHPS).  

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) and the Kids’ Inpatient Database (KID), and the Nationwide Emergency Department Sample (NEDS), and three types of State databases, the State Inpatient Databases (SID), the State Ambulatory Surgery Databases (SASD), and the State Emergency Department Databases (SEDD). In addition, the AHRQ Quality Indicators, including the Pediatric Quality Indicators (PDIs) have been developed for use with hospital discharge data, including the NIS and SID.     More information on HCUP and the AHRQ Quality Indicators 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, insurance coverage, and, to some extent, healthcare quality, 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 HC includes a number of measures of healthcare quality at multiple systems levels, including, but not limited to, survey items in the MEPS HC Child Health Supplement.    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.

CAHPS®.  The CAHPS program is a public-private initiative to develop standardized surveys of patients' experiences with ambulatory and facility-level care.   Health care organizations, public and private purchasers, consumers, and researchers use CAHPS results to:

The National CAHPS Benchmarking Database (the CAHPS Database) is the National repository for data from the CAHPS family of surveys. This database is an important resource for participating organizations, researchers, and others interested in using comparative CAHPS survey results and detailed benchmark data. Benchmark data are available for the CAHPS Health Plan Survey and CAHPS Hospital Survey. A new component is being developed for the Clinician & Group Survey.   For more information about CAHPS, visit https://www.cahps.ahrq.gov/default.asp.

CMS Data Sources

Applicants should consider use of CMS data obtained from State Medicaid and CHIP programs, including, but not limited to, MSIS data and EPSDT report data.  MSIS data may be particularly useful for the assessment across States of healthcare quality by race and ethnicity.  

The Medicaid Statistical Information System (MSIS) is CMS’s largest statistical data collection and reporting system.  MSIS is a set of raw Medicaid eligibility and claims data that State Medicaid agencies submit to CMS as mandated by the Balanced Budget Act (BBA) of 1997. Medicaid Valid Tapes Files consist of five types of data submitted by the states on a quarterly basis for transactions that occurred or were submitted in the fiscal quarter:

  1. Eligibility actions in the quarter, by month - for the current quarter and retroactive determinations
  2. Claims adjudicated for payment in the quarter.
  3. Inpatient hospital claims
  4. Long-term care (Home Health Agency, Hospice and Skilled Nursing Facility) claims
  5. All other Medicaid covered services (formerly included Prescription Claims)
  6. Prescription drug - Pharmacy Claims

Since MSIS collects eligibility information, including information on race and ethnicity, it can potentially address Medicaid and CHIP access and coverage questions.  As it covers all Medicaid categories of services, it can provide a data source for measures that seek to address whether benefits appropriate to health care needs are provided for enrollees.  Through the claims data, access to individual providers and health care quality disparity issues can potentially be addressed22 More information about requesting CMS MSIS data may be obtained at www.resdac.umn.edu .

Other Data Sources

Other Federal agencies have developed healthcare quality measures and/or their data are sometimes used to measure healthcare quality (e.g., see the National Healthcare Quality Report and the National Healthcare Quality Report at the AHRQ website http://www.ahrq.gov/qual/qrdr08.htm; visit the National Quality Measures Clearinghouse at the AHRQ website http://www.qualitymeasures.ahrq.gov/; see the HRSA Title V block grant measures; CMS MSIS http://www.cms.hhs.gov/MSIS/, CMS EPSDT data http://www.cms.hhs.gov/MedicaidEarlyPeriodicScrn/; and SAMHSA http://www.nationaloutcomemeasures.samhsa.gov/).   Applicants are expected to consider these data sources as they develop measurement development and enhancement strategies in response to specified priorities. 

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:

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: Can the proposed CHIPRA PQMP Center of Excellence address important problems? If the aims of the application are achieved, how will scientific knowledge, clinical practice, and children’s health outcomes be advanced? What will be the effect of the measure development and enhancement work on the concepts, methods, technologies, treatments, services, preventative interventions, and healthcare financing and delivery structures that drive this field?   How will the field of healthcare quality measurement for children’s healthcare be advanced by the work?   How will the CHIPRA-outlined priority topics for measurement be addressed?   How will identification and reduction of racial, ethnic, socioeconomic, and health status-drive disparities be addressed in the development and enhancement work?  What methodological advances, including use of health IT for enhancing measurement capacity and use, will be stimulated by the work?  How will the measures be used to drive quality improvement to improve children’s health?

Investigators: Is 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?  Does the PD/PI and investigative team bring complementary and integrated expertise to the project?  In particular, is the level of expertise in health IT relevant to quality measure development and enhancement?  What is the experience of the proposed investigators in previous measure development or enhancement, development and application of appropriate measure criteria, disparities within quality, and work on Medicaid, CHIP and other public or private purchasers, programs, and providers.   Does the team include key personnel with detailed knowledge of the healthcare delivery infrastructure for perinatal and children’s services; and a systems approach to consideration of healthcare.  The healthcare delivery infrastructure for perinatal services and children includes not only traditional medical care settings such as community hospitals, children’s hospitals, primary care practices, and medical subspecialty practices.  Children, especially children with special health care needs, use services and products provided by multiple service providers (e.g., nutritionists/dieticians; medical foods; occupational/speech therapists; mental health providers other than psychiatrists; childfind services, school-based services, early intervention services, newborn screening, reproductive health services).  The availability of healthcare quality measures for these services lags behind measures for the mainstream healthcare delivery system.  Coordination across services and the services themselves are in need of quality measure development.  

Minimum levels of effort: The PI/PD is expected to spend at least 10% of their time on work for this FOA.  A minimum level of effort (5% of time) is also expected of: high level experts in applying health IT to development and enhancement of healthcare quality measures.   A minimum level of effort of 5% each is expected of high level experts in measurement relevant to racial, ethnic, income, geographic or special health care needs disparities.   A minimum level of effort of 10% of time each is expected of high level experts in at least two of the following measure domains and types:  structure, process, outcomes, administrative data, survey data, medical record data, linkages of public health data to healthcare financing and delivery system data (e.g., enrollment).    A minimum level of effort of 5% is expected of project personnel with high level expertise in healthcare delivery and financing beyond the mainstream medical care delivery system and linkages between the traditional  medical delivery system and other key healthcare components for children (e.g., nursing, occupational therapy, physical therapy, speech therapy, mental health services, substance abuse services, dental services, perinatal services). 

What is the past experience and capacity of investigators to work collaboratively with child and family advocates, providers, and public programs during the process of measure development and enhancement.   

Innovation: Is the Centers of Excellence approach 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?   Although the measure criteria and priorities will not be known until after the application submission date, the applicant should address what novel approaches to measure and measurement methods the applicant can bring to bear in general. 

Approach: Are the approaches to using specified measurement criteria within an overall conceptual framework, and strategy for 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?   What measure development and enhancement frameworks are being applied, and how will they be implemented throughout the project period?   Are modifications to available frameworks required due to the CHIPRA requirements or other advances in healthcare quality improvement and measurement?  If so, how will they be developed?      Applicants should demonstrate how they would be able to produce a set number of measures and measure enhancements to contribute to the overall goals of this initiative (5 new measures every 18 months and 14 enhanced measures every year, across all awardees).  

Applicants must also state explicitly that they are willing to a) use the measurement criteria being developed through a public process and expert meeting; and b) develop and enhance measures prioritized through a separate public process.  Note that the measure criteria and the priorities will not be known until after the application submission deadline. 

Environment: Do(es) the scientific and practical (user) environment(s) in which the work will be done contribute to the probability of success?  Do the proposed healthcare quality measurement enhancement and development activities benefit from unique features of the scientific environment(s), or subject populations, or employ useful collaborative arrangements?  Is there evidence of institutional support?   What is the health IT environment with respect to healthcare quality measure development and enhancement?   Do(es) the scientific environment(s) have existing partnerships with stakeholder groups specified in the legislation and frontline provider users of measurement?   Do(es) the scientific environment(s) provide the capacity for investigators and others on the project team(s) to collaborate with other awardees, the Coordinating Center, AHRQ, CMS, and others (e.g., using webinar capabilities, transmission of large documents).   If additional resources will be needed to create the needed environment, indicate which resources are needed, and how they would be paid for with an award under this FOA or another source of funds and expertise.

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 and related activities (e.g., travel to annual meetings, rapid turnaround interaction with stakeholders and the Coordinating Center)?

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 measures or measurement approaches will be assessed.

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?

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 45 CFR Parts 160 and 164, the Federal Privacy Rule developed by the Department of Health and Human Services (DHHS) pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  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

AHRQ grantees may copyright, unless otherwise provided in grant awards, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ funds, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses.  Such copyrights and patents are subject to a worldwide irrevocable AHRQ license to use and permit others to use these products and materials for government purposes.  In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, 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:

3. Anticipated Announcement and Award Dates

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

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI(s) 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 the Notice of Award (NOA) will be generated via email notification from the awarding component to the grantee business official at the applicant organization.  The NOA signed by the AHRQ grants management officer is the authorizing document.

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.

Activities conducted under this award that involve the collection of information e.g., conducting surveys or requesting responses to uniform questions from nine or more persons, establishments or other entities, are currently required by HHS to be cleared by OMB under the Paperwork Reduction Act (PRA) (44 USC 3501-3521).  Submissions for clearance under PRA are through AHRQ and HHS. Therefore, affected grantees should include the time in their proposed timelines to develop materials and receive necessary clearances.  It typically takes at least six months from date of initial submission to AHRQ to receive clearances ,and sometimes much longer if submissions are incomplete or the justification for the proposed data collection plans are questioned during the clearance process.  Information collection that requires PRA clearance may not begin until grantees receive written notification via e-mail from AHRQ that clearance has been obtained.  Detailed information on the PRA can be found at http://www.hhs.gov/ocio/policy/collection/.

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator(s) as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to otherwise applicable OMB administrative guidelines:  DHHS grant administration regulations at 45 CFR Parts 74 or 92 (Part 92 is applicable for State and local Governments), and other DHHS, PHS, and AHRQ grant administration policy statements.  AHRQ will use these procedures in evaluating and administering the cooperative agreements under this FOA.

The administrative and funding instrument used for this program will be the cooperative agreement U18, an "assistance" mechanism (rather than an "acquisition” mechanism), in which substantial AHRQ programmatic involvement with the grantees is anticipated during the performance of the activities.  Under the cooperative agreement, the AHRQ purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities.  Consistent with this concept, the dominant role and prime responsibility resides with the PD/PI for the project as a whole, although specific tasks and activities may be shared between a grantee and AHRQ as described in this subsection of the FOA. Cooperative activities are intended to strengthen the individual grantee activities through the facilitation of data sharing, data access and communications.

All cooperative activities that include significant government involvement will require prior approval by the AHRQ Program Officer.

2. A.1. Principal Investigator Rights and Responsibilities

The PD/PI will have the primary responsibility for developing and/or enhancing measures and measurement methodologies consistent with the measurement criteria and measurement priorities identified by AHRQ using the public processes described above.  

Grantees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and AHRQ policies.

2. A.2. AHRQ Responsibilities

AHRQ program staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

AHRQ staff will provide awardees with a set of measurement criteria to be used in development and enhancement of measures.  The measurement criteria will be developed prior to awards being made through a public process.   The measurement criteria are intended to be an evidence-based melding of existing measurement criteria, with special attention to additional specificity regarding special characteristics of children and the healthcare delivery system available to them; the needs of Medicaid, CHIP, and other public programs; and identification of disparities in children’s healthcare.  AHRQ program staff will also work with awardees to make the best matches between awardee capabilities and expertise and the measurement priorities identified using the public process called for in the CHIPRA legislation.   Priorities will be identified and publicized prior to making awards under this FOA, but not before applications are due.   AHRQ program staff may require more frequent updates on development and enhancement of particular measure and methodology categories than typically required, in response to policy needs.

Additionally, AHRQ program staff will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

2.A.3. Collaborative Responsibilities

Awardees will be required to work collaboratively with each other, with AHRQ and CMS, and with the coordinating center in order to advise AHRQ and CMS on challenges faced by the awardees in meeting the award requirements; participate in periodic meetings of principal investigators; participate in annual public meetings with stakeholders; and promote the exchange of timely information across the awardees, and make recommendations as to the readiness of measures and methodologies for implementation.  

3. Reporting

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

The annual progress reports must include 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.

A final Progress Report, 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


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may be written or by telephone, and 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:

Denise Dougherty, Ph.D.
Office of Extramural Research, Education, and Priority Populations
Divisions of Priority Populations
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1868
Fax: (301) 427-1562
E-mail address:  denise.dougherty@ahrq.hhs.gov

2. Peer Review Contact(s):

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

Kishena C.  Wadhwani, Ph.D.
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
email:   Kishena.Wadhwani@ahrq.hhs.gov

3. Financial/Grants Management Contact(s):

Direct inquiries regarding fiscal matters to: 

Al Deal
Office of Performance Accountability, Resources and Technology
Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1806
Fax: (301) 427-1792
E-mail address:  al.deal@ahrq.hhs.gov

Section VIII. Other Information


Required Federal Citations

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 (HIPAA) of 1996 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:

The OMB Circular A-110 has been revised to provide access to research data developed with Federal support through the Freedom of Information Act (FOIA) 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) 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, 5 USC 552(b), 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, 5 USC 552(b)(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.


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