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Part I Overview Information

Department of Health and Human Services

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

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

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

Title: AHRQ Conference Grant Program (R13)

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 Program Announcement. This FOA supercedes previous AHRQ Conference Grant FOA s, including PA-09-231(the AHRQ Small Grant Program for Conference Support) and PAR-09-257(the AHRQ Grant Program for Large or Recurring Conferences).

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

Program Announcement (PA) Number: PA-13-017

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: November 8, 2012
Opening Date: January 1, 2013 (Earliest date an application may be submitted to Grants.gov)
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): February 1, May 1, August 1, and November 1 annually, beginning February 1, 2013
Peer Review Date(s): Generally two to four months after receipt date
Earliest Anticipated Start Date(s): Generally three months after peer review date
Expiration Date: November 2, 2016

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Purpose. The Agency for Healthcare Research and Quality (AHRQ), announces its interest in supporting conferences through the AHRQ Conference Grant Program. AHRQ seeks to support conferences that help to further its mission to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. The types of conferences eligible for support include:

1) Research development - conferences where issues or challenges in the practice and delivery of health care are defined and a research agenda or strategy for studying them is developed;

2) Research design and methodology - conferences where methodological and technical issues of major importance in the field of health services research are addressed or new designs and methodologies are developed;

3) Dissemination and implementation conferences conferences where research findings and evidence-based information and tools are summarized, communicated and used by organizations and individuals that have the capability to use the information to improve the outcomes, quality, access to, and cost and utilization of health care services; and/or,

4) Research training, infrastructure and career development - conferences where faculty, trainees and students are brought together with stakeholders to develop, share or disseminate research products, experiences, curricula, syllabi, training competencies. These types of conferences are not for the training of individuals in health services research.

AHRQ is especially interested in supporting conferences that demonstrate strategies that include plans for disseminating complementary conference materials and products beyond the participants attending the event. Such strategies might include, but are not limited to, submitting articles for publication, posting information on a web site, and seeking formal opportunities to discuss conference information with others.

Although it is anticipated that most applications will request a project period which does not exceed one year, AHRQ will accept applications that request a project period of up to three years and that support the same conference on an annual basis if proposed by a permanently sponsoring organization.

Applicants may request full or partial support for conferences. In the case of partially-supported conferences, AHRQ’s objective review will consider the overall structure and design of the conference as well as the sub-component for which support is being requested.

AHRQ encourages applicants to seek co-sponsorship of conferences. The applicant is solely responsible for planning, directing, and executing the proposed project.

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.

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions and links in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 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
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. Reporting
3. Administrative and National Policy Requirements

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

1. Research Objectives
The Agency for Healthcare Research and Quality (AHRQ), announces its continued interest in supporting conferences through its Conference Grant Program. A conference is a symposium, seminar, workshop, or any other organized and formal meeting, whether conducted face-to-face or via the Internet, where individuals assemble (or meet virtually, e.g., through webinars) to exchange information and views or explore or clarify a defined subject, problem, or area of knowledge, whether or not a published report results from such meeting. A meeting that is conducted as part of the normal course of doing business is not considered a conference. AHRQ support for a conference grant will not exceed $35,000 direct costs annually over any project period duration. Facilities and Administrative (F&A) costs (indirect costs) are not allowed for conference grants.

This Program is intended to complement and promote AHRQ's core research, dissemination, and implementation activities by providing a mechanism for Agency stakeholders and others to:

1) develop health services research agendas and identify strategies and mechanisms for studying them;

2) discuss and develop consensus around health services research methodological and technical issues;

3) disseminate and implement health services research information and tools for formulating or evaluating health policy, and for managing health care programs;

4) improve quality and effectiveness of health care or purchasing health services; and

5) develop partnerships with stakeholder organizations and build their capacity to participate in research activities and using the results of health services research.

Conference Objectives

AHRQ seeks to support conferences that help to further its mission to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. The types of conferences eligible for support include:

1) Research development - conferences where issues or problems in the practice and delivery of health care are defined and a research agenda or strategy for studying them is developed;

2) Research design and methodology - conferences where methodological and technical issues of major importance in the field of health services research are addressed or new study designs and methodologies are developed;

3) Dissemination and implementation conferences conferences where research findings and evidence-based information and tools are summarized, communicated and used by organizations and individuals that have the capability to use the information to improve the outcomes, quality, access to, and cost and utilization of health care services; and,

4) Research training, infrastructure and career development - conferences where faculty, trainees and students are brought together with stakeholders to develop, share or disseminate research products, experiences, curricula, syllabi, or competencies. These types of conferences are not for the training of individuals in health services research.

Conference sessions should include health services research. AHRQ has particular interest in supporting conference grants in the following portfolio areas: comparative effectiveness, health information technology (health IT), patient safety, prevention and care management, value, and healthcare innovations and emerging areas. To learn more about AHRQ’s focus within these portfolios of work, please visit http://www.ahrq.gov/fund/portfolio.htm.

The conference should address issues related to priority populations--low income groups; racial and ethnic minority groups; women; children; the elderly; individuals with special health care needs, including individuals with disabilities and those who need chronic care and end-of-life health care; and individuals living in inner-city, rural, and frontier areas--to the extent appropriate to the conference topic.

The topic selected must be important to Agency stakeholders such as consumers and patients; clinicians and other providers; institutions; health plans; purchasers; and policymakers in all sectors (e.g., Federal, State and local governments; voluntary associations; international organizations; and foundations).

AHRQ is especially interested in supporting conferences that which include plans for disseminating conference materials and products beyond the participants attending the event. Such strategies might include, but are not limited to, submitting articles for publication, posting information on a web site and other current forms of social media methods, implementation of conference findings and seeking formal opportunities to discuss conference information with others.

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 Conference Grant (R13) award mechanism. The applicant is solely responsible for planning, directing, and executing the proposed conference.

2. Funds Available

Because the nature and scope of the proposed conferences 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 receipt of a sufficient number of meritorious applications. Facilities and administrative (F&A) costs (indirect costs) are not allowed on grants in support of conferences.

The total costs awarded under this FOA will not exceed $35,000 annually. Although it is anticipated that most applications will request a project period that does not exceed one year, AHRQ will accept applications with a project period of up to three years that support the same conference on an annual basis, if proposed by a permanently sponsoring organization.

AHRQ’s Grants-on-Line Database (GOLD) database search engine provides abstracts of recent and past funded projects (see http://gold.ahrq.gov/projectsearch/).

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:

AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism, thus 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 not be reviewed. Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible. In the case of an international conference, the U.S. representative organization of an established international scientific or professional society is the eligible grantee. Grant funds may not be used to provide general support for international conferences held outside the United States or Canada. However, grant funds may be awarded to support specific aspects of an international conference held outside the United States or Canada provided the applicant is the U.S. representative organization of an established international scientific or professional society.

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

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.

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 should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project. This information can be included at the end of the budget justification section of the application, but institutional support dollars are not to be shown/included in the detailed budget request.

3. 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 may submit one resubmission application, but such application must include an introduction addressing specifically each issue raised in the previous peer review critique (Summary Statement).

Renewals: Applicants may not submit a renewal application.

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 to six weeks. 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 .

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

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 PD/PI 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. An active entity registration (formerly CCR registration) must be maintained, to be renewed at least annually. Use the Sam.gov Manage Entity function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.

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 301-945-7573; 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 (https://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/APPLYincludes 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

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: January 1, 2013 (Earliest date an application may be submitted to Grants.gov)
Application Due Date(s): February 1, May 1, August 1, and November 1 annually, beginning February 1, 2013
Peer Review Date(s): Generally two to four months after receipt date
Earliest Anticipated Start Date(s): Generally three months after peer review date

3.A.1. Letter of Intent

A letter of intent is not required for this funding opportunity.

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/web/grants/applicants/apply-for-grants.html and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

In order to expedite the review, applicants are requested to notify the AHRQ Referral Office by email [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

Applications must be received on or before the application receipt date described above (see Section IV.3.A. for all dates). If an application is received after that date, the application may be delayed in the review process or not reviewed.

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.

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 PD/PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

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

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

AHRQ will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see https://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.

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

An award will not be made if the conference date for which support is requested has passed. The conference must be held within 12 months of the budget period start date of the award.

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 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 conference objectives in the approved time frame or in any way adversely affect the conduct of the conference.

6. Other Submission Requirements

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders: A PD/PI must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Special Budget Requirements

Applications may request full or partial support for conferences.

AHRQ will support up to $35,000 direct costs annually. Facilities and Administration Costs (F&A) (indirect costs) are not allowed on grants in support of conferences.

Where partial support of a conference is requested from AHRQ, peer reviewers will consider the overall structure and design of the conference as well as the sub-component for which support is being requested.

Sources and amounts of other funding for the conference must be clearly identified. In addition to including a detailed budget reflecting the amount of funding requested from AHRQ, applications must include a composite categorical budget (in the Budget Justification section of the Research & Related Budget Component of the SF424) for the total cost of the conference including all anticipated sources of funding. Applications that do not include a composite budget will not undergo peer review or funding consideration. Any anticipated program income (e.g., registration fees) should be specified as one source of funding. Note: Program income may not be used for otherwise unallowable costs; AHRQ does not recommend that grantees use program income to purchase food as such charges may be disallowed in an audit because AHRQ does not allow its awarded funds to be used for the purchase of food.

Allowable and Unallowable Costs

Expenses allowed under the Conference Grant Program follow the guidelines described in the HHS Grants Policy Statement (http://www.ahrq.gov/fund/hhspolicy.htm), unless otherwise stated in this funding opportunity announcement. Areas of particular relevance to conference grants and exceptions to the general policies are described below.

Direct Cost Expenditures

a. Equipment.Grant funds may be used for rental of necessary equipment for the conference. Funds may not be used for the purchase of equipment. Rental expenses should be listed under the other expenses category.

b. Travel. Proposed per diem or subsistence allowances must be reasonable and will be limited to the days of attendance at the conference plus actual travel time required to reach the conference location by the most direct route available. Travel costs are limited to the extent provided for by formal institutional travel policy. If the grantee institution has no formal travel policy, the Department of Health and Human Services travel regulations shall be applied in determining the amount of travel chargeable to grant funds. Where meals and/or lodging are furnished without charge or at a nominal cost, the proposed per diem or subsistence allowance must take this into consideration. Transportation costs for those attending and participating in the conference and paid with grant funds may not exceed economy class fares. U.S. carriers must be used where possible. For local participants in the conference, grant funds may not be used to pay per diem or expenses other than local mileage.

c. Supplies. Grant funds may be used for the purchase of conference supplies, provided the supplies are received and used during the project period.

d. Conference Services. Grant funds may be used for necessary recording of proceedings, simultaneous translation, and subsequent transcriptions.

e. Publication Costs. Grant funds may be used to pay for the publication and dissemination of conference proceedings.

f. Registration Fees. Charges for registration fees may NOT be paid from grant funds.

g. Entertainment and Personal Expenses. Costs of amusement, diversion, social activities, ceremonials, and related incidental costs such as meals, lodging, rentals, transportation, gratuities, bar charges and personal telephone calls of participants or guests, are not allowable.

h. Federal Employees. Grant funds may not be used to cover the cost of travel or any payment to a full-time Federal employee, except when that employee is on leave without pay status from his or her employing office.

i. Honoraria. Honoraria or other payments given for the purpose of conferring distinction on or to symbolize respect, esteem, or admiration for the recipient may not be paid from grant funds. Speaker fees for services rendered, however, are allowable.

j. Alteration and Renovations. Grant funds may not be used to support facility alteration or renovations of any kind.

k. Food. Grant funds may NOT be used for the purchase of food of any kind (refreshments, meals, etc.). AHRQ will not award funds to support the cost of food for any conference grant.

l. Promotional Items. Grant funds may NOT be used for the purchase of promotional items which include, but are not limited to, clothing and commemorative items such as pens, mugs/cups, folders/folios, lanyards, and conference bags.

m. Salaries. In accordance with the established policies of the recipient, salaries of professional personnel, clerical assistants, editorial assistants, and other nonprofessional staff are allowable, but only in proportion to the time or effort spent directly related to the conference/meeting.

n. Consultant Services. Consultant fees, including travel and supporting costs (e.g. per diem) are allowable.

o. The following are NON-allowable costs:

Note: The list above is not all inclusive. The applicant should contact AHRQ staff regarding any other items being considered for which there are questions regarding whether or not the items are allowed to be included. Please also refer to the HHS Grants Policy Statement for additional information regarding costs.

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.

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

AHRQ requires the PD/PI 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 SAM 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 that are not otherwise specified within this Funding Opportunity Announcement are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

The Conference Plan section of the application (uploaded as the Research Strategy attachment), must describe the objectives, specific program, and logistical arrangements for the meeting. Describe the format and list the agenda and speakers, including the principal topics to be covered, problems to be addressed, and developments or contributions the conference/meeting might stimulate. Provide a detailed justification for the conference/meeting, including the scientific need, specific AHRQ area of interest addressed, timeliness, and how the conference/meeting will serve a public purpose.

Applications must provide the following additional information in as much detail as possible:

It is recommended but not mandated that Federal space be used for conferences. A Federal Facilities Tool to help locate meeting space is available at http://fedmeetingspace.cfoc.gov/. If conference will be held in a physical facility, provide the name and address of the facility and indicate whether it is Federal or non-Federal space.

Describe plans for publicizing the conference/meeting to all interested participants and for publishing the proceedings (with the latter possibility not being required). Identify related conferences/meetings held on the subject during the past 3 years [and how the proposed conference/meeting is similar to, and/or different from these, and why it is still necessary and useful]. If this is one of a series of periodic conferences/meetings held by a permanent sponsoring organization, briefly describe and evaluate the last conference/meeting in the series.

Budget Component

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 https://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not comply with the required page limitations may be delayed in the review process.

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). Women and members of minority groups are included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate, e.g. because of the lack of connection between the study and the health of women or particular minorities. Investigators should review the February 2003 policy entitled, AHRQ Policy on the Inclusion of Priority Populations, which is available at https://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) 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). 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 164.508(c) and must be written in plain language. The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research (http://www.ahrq.gov/fund/informedconsent/) provides sample forms and guidance on adapting them, and also describes an appropriate process for obtaining informed consent and authorization.

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
Not Applicable.

Section V. Application Review Information

1. Criteria

Administrative Criteria: Upon receipt, applications will be reviewed by AHRQ for completeness and responsiveness.

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

2. Review and Selection Process
The mission of AHRQ is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. As part of this mission, applications submitted to AHRQ to support health services research are evaluated for scientific and technical merit through the AHRQ peer review system.

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

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

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 this conference 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 this conference on the concepts, methods, technologies, treatments, services or preventative interventions that drive this field?

A. The topic selected must clearly address the Agency mission to improve the quality, safety, efficiency, and effectiveness of health care for all Americans.

B. The conference topic and objective(s) must be succinctly and clearly stated, and reflected in all aspects of the conference proposal.

C. Conference sessions should include health services research. AHRQ has particular interest in supporting conference grants in the following portfolio areas: comparative effectiveness, health information technology (health IT), patient safety, prevention and care management, value, and healthcare innovations and emerging areas. To learn more about AHRQ’s focus within these portfolios of work, please visit http://www.ahrq.gov/fund/portfolio.htm.

D. The conference should address issues related to priority populations--low income groups; racial and ethnic minority groups; women; children; the elderly; individuals with special health care needs, including individuals with disabilities and those who need chronic care and end-of-life health care; and individuals living in inner-city, rural, and frontier areas--to the extent appropriate to the conference topic.

E. The topic selected must be important to Agency stakeholders such as consumers and patients; clinicians and other providers; health care institutions; health plans; purchasers; and policymakers in all sectors (e.g., Federal, State and local governments; voluntary associations; international organizations; and foundations).

F. The products of the conference should have the potential to inform future research, policy, practice, training of health services researchers, or enhance AHRQ's collaborative relationships.

G. Expected conference outcomes should have a national or regional impact or make a significant contribution to a particular field. If the conference is state or regionally based, plans for a broad dissemination of conference materials and some indication of national relevance must be included.

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 program director(s)/principal investigator(s) and other researchers? Does the PD/PI and investigative team bring complementary and integrated expertise to the project (if applicable)? Does the conference planning staff and/or advisors include persons with the requisite education, training and experience?

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

Approach: Are the conceptual or 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?

A. Does the applicant clearly identify the conference type/category? The conference must be for the purpose of one of the following categories: 1. disseminate research results; 2. formulate a research agenda; 3. develop a research methodology; or 4. research training, infrastructure and career development.

B. If the meeting format includes a call for abstracts, the application should include a summary of the process for soliciting, reviewing and selecting research to be presented at the conference.

C. The conference format must support the conference purpose and facilitate expected outcomes.

D. If a planning committee is included, it should include representation from the research, implementation and user communities, and include a process for outreach to a subset of the conference target audience. To the extent consistent with the conference design, topic and goal(s), the planning process should include outreach to people of differing views, and outreach to representatives of one or more of the Agency priority populations.

E. Speakers selected or proposed, or criteria for speaker selection, must be appropriate for the session topic. A plan should be in place to identify other presenters if those originally sought are unavailable.

F. Evaluation of the conference results must be included in the design.

G. A draft agenda with supporting details and speakers should be included.

H. Conference date and venue are stated in project description or conference plan section.

Environment: Does the environment(s) in which the conference is being planned contribute to the probability of success? Does the proposed conference benefit from unique features of the environment(s), or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Does the applicant organization have the institutional resources, infrastructure, and demonstrated capacity to support the proposed conference?

2.A. Additional Review Criteria

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

Inclusion: Adequacy of plans to address the needs of 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 .

Budget: Is the proposed budget reasonable and is the requested period of support appropriate in relation to the proposed conference? Is a composite budged included?

Degree of responsiveness: How well does the application address the purpose and objectives of this FOA? Is the application responsive to the special eligibility criteria noted in the FOA?

Resubmission Applications (formerly revised/amended applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

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:

2.B. Additional Review Considerations

Not Applicable

2.C. Resource Sharing Plan(s)

Data Confidentiality

The AHRQ confidentiality statute,42 USC 299c-3(c), requires that information obtained in the course of any AHRQ supported-study that identifies individuals or establishments be used only for the purpose for which it was supplied. Information that is obtained in the course of AHRQ-supported activities and that indentifies an individual may be published or released only with consent of the individual who supplied the information or is described in it. There are civil monetary penalties for violation of the confidentiality provision of the AHRQ confidentiality 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 support, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses. Such copyrights and patents are subject to a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce, publish, use or disseminate for any purpose consistent with AHRQ’s statutory responsibilities and to authorize others to do so for any purpose consistent with AHRQ’s statutory responsibilities. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers. In addition, subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products. AHRQ's Office of Communications and Knowledge Transfer (OCKT) wishes to be consulted in advance of publication in order to coordinate announcements of new AHRQ-supported research results with other AHRQ dissemination activities. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in AHRQ's grants regulation at 42 CFR Part 67, Subpart A (available in libraries and from the GPO's website at http://www.gpoaccess.gov/cfr/index.html) which incorporates additional applicable provisions on Rights in Data, including 45 CFR Part 74 and 37 CFR Part 401.

3. Anticipated Announcement and Award Dates

Generally, applicants should anticipate five 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 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 and any additional information necessary to address administrative issues prior to award.

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.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization once any/all administrative and programmatic issues have been resolved. 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.

In addition to standard grant requirements, the grantee is required to comply with the following terms and conditions:

1. Agreement for up to 5 AHRQ staff to attend the conference without paying a registration fee.

2. Agreement to hold the conference within 12 months of the budget period start date of the award.

3. The understanding that under no circumstance will support be provided for conferences held prior to the budget period start date of the grant award.

4. Agreement to submit to AHRQ, no later than 90 days after the dates of the conference, an original and two copies of an executive summary and one-page abstract of the conference and summary of participant's evaluation ratings/comments. This summary should include a discussion of what was learned from the conference, as well as what might be done differently in the future based on lessons learned. At the time of the award, the program official will determine how many copies of the conference products will be required for distribution to AHRQ staff and other DHHS colleagues.

5. To the extent relevant to the particular conference design, topic and goal, agreement to disseminate germane AHRQ product(s).

6. Agreement to list AHRQ as a meeting supporter on conference materials, subsequent proceedings and references.

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

2. Administrative and National Policy Requirements

All AHRQ grant and cooperative agreement awards are subject to AHRQ s grants regulations at 42 CFR Part 67, Subpart A, the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm), and the terms and conditions set forth in the notice of grant award.

As necessary, additional Terms and Conditions will be incorporated into the Notice of Award.

3. Reporting

A final Progress Report, final Federal Financial Report, and Final Invention Statement are required when an award ends. For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.

Multiple Year Conference Award Requirements:

In addition to the closeout requirements described above, when multiple years are involved, grantees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually.

The annual progress reports must include Sections 2.2.6 A through F as described in the general PHS form 2590 instructions. For details regarding progress report submission, refer to http://www.ahrq.gov/fund/noncomp.htm. If instructions on the AHRQ website are different from the PHS form 2590 instructions, follow the instructions on the AHRQ website.

The annual 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. For AHRQ awards, the annual progress report is generally due 4 months before the start date of the next budget period.

Expenditure data is to be reported on the Federal Financial Report (FFR; SF 425). AHRQ requires annual financial expenditure reports for ALL grant programs as described in the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm). AHRQ implementation of the FFR retains a financial reporting period that coincides with the budget period of a particular project. However, the due date for annual FFRs will be 90 days after the end of the calendar quarter in which the budget period ends. Note that this is a change in due dates of annual FFRs and may provide up to 60 additional days to report, depending upon when the budget period end date falls within a calendar quarter. For example, if the budget period ends 4/30/2013, the annual FFR is due 9/30/2013 (90 days after the end of the calendar quarter of 6/30/2013).

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:

Linda Franklin
Office of Extramural Research, Education, and Priority Populations
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1904
Fax: (301) 427-1562
E-mail address: [email protected]

Please note: Applicants are also encouraged to contact AHRQ Program Officials prior to submitting an application to ensure that the conference application submission aligns with AHRQ’s current research priorities and portfolios. AHRQ staff contacts can be found at http://www.ahrq.gov/fund/staffcon.htm.

2. Peer Review Contact(s):

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

Linda Franklin
Office of Extramural Research, Education, and Priority Populations
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1904
Fax: (301) 427-1562
E-mail address: [email protected]

3. Financial/Grants Management Contact(s):

Direct inquiries regarding fiscal matters to:

Brian Campbell
Office of Performance Accountability, Resources and Technology
Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1266
Fax: (301) 427- 1462
E-mail address: [email protected]

Section VIII. Other Information

Required Federal Citations

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 HIPAA Privacy Rule, 45 CFR Parts 160 and 164,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.

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, disclosure of such data is limited in accordance with the AHRQ confidentiality statute, 42 USC 299c-3(c). NIH has provided general related guidance at https://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 2020:

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2020," 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 2020" 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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