RFA-DP-17-005PUBLICATIONAMENDMENT.pdf

Centers for Disease Control

National Center for Chronic Disease Prevention and Health Promotion Extramural Research Program Office

Health Promotion and Disease Prevention Research Centers: Special Interest Project Competitive

Supplements (SIPS)

RFA-DP-17-005

Application Due Date: 02/22/2017

Health Promotion and Disease Prevention Research Centers: Special Interest Project Competitive Supplements

(SIPS)

RFA-DP-17-005

TABLE OF CONTENTS

Part 1. Overview Information Key Dates Required Application Instructions Executive Summary

Part 2. Full Text Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 1. Overview Information Participating Organization(s) Centers for Disease Control Components of Participating Organizations National Center for Chronic Disease Prevention and Health Promotion Extramural Research Program Office

(NCCDPHP ERPO)

National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) Funding Opportunity Announcement (FOA) Title Health Promotion and Disease Prevention Research Centers: Special Interest Project Competitive Supplements (SIPS) Activity Code Amendment 1. February 10, 2017

Appendix A: "Questions from Potential Applicants and CDC Responses" added to Section VIII. "Other Information"

Applications in reponse to this FOA will be funded using the U48 activity code.

Funding Opportunity Announcement Type New Funding Opportunity Announcement Number

RFA-DP-17-005

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.135 Category of Funding Activity:

Health FOA Purpose This RFA will provide supplemental funding to Prevention Research Centers (PRCs) to design, test, and disseminate effective applied public health prevention research strategies to include behavioral interventions, environmental or system-wide solutions, and strategies that address major causes of disease and disability.

Research strategies align with public health priorities such as the Healthy People 2020 topic areas: Arthritis;

Cancer; HIV/STD and Sexual Health; and School-based Health.

Key Dates Publication Date: To receive notification of any changes to RFA-DP-17-005, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

Letter of Intent Due Date: 01/23/2017 December 9, 2016 To receive notification of any changes to RFA-DP-17-005, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

Application Due Date: 02/22/2017 http://www.grants.gov http://www.grants.gov/

On-time submission requires that electronic applications be error-free and made available to CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM U.S. Eastern Time. Note:

HHS/CDC grant submission procedures do not provide a period of time beyond the application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review: 04/01/2017

Secondary Review: 05/01/2017

Estimated Start Date: 09/30/2017

Expiration Date: 02/23/2017 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

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. 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 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.

Note: The Research Strategy component of the Research Plan is limited to 12 pages.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Executive Summary Purpose. This RFA will provide supplemental funding to Prevention Research Centers (PRCs) to design, test, and disseminate effective applied public health prevention research strategies to include behavioral interventions, environmental or system-wide solutions, and strategies that address major causes of disease and disability.

Mechanism of Support. Cooperative Agreement Funds Available and Anticipated Number of Awards. The CDC intends to commit a total of approximately $3,914,800 (direct and indirect) for the entire project period. It is anticipated that up to 6 awards will be made. Awards issued under this FOA are contigent upon aibility of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded and the number of awards will depend upon the number, quality, duration and cost of the applications received.

Budget and Project Period. The estimated total funding (direct and indirect) for the first budget period, 09/30/2017 – 09/29/2018, is $2,064,800. The estimated total funding (direct and indirect) for the entire project period, 09/30/2017 – 09/29/2019, is $3,914,800.

Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. Application and Submission Information of this announcement.

Eligible Institutions/Organizations. Institutions listed in Section III, 1.A. are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE: CDC does not make awards to individuals directly, but to institutions/organizations. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

Number of PDs/PIs. Applications may include more than one PI; however, the first PI listed on the http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#SectionIV http://era.nih.gov/commons/index.cfm#SectionIII1A

Number of PDs/PIs. Applications may include more than one PI; however, the first PI listed on the application will be the “contact PI” for all correspondence. Any additional PIs are permitted, but would be referred to as Co-PIs.

Number of Applications. A PRC may apply for multiple SIPs; however, a separate application must be submitted for each SIP. A PRC may submit only one application per SIP.

Application Type. New Special Date(s). A summary of the questions and answers received from applicants will be published as an FOA amendment prior to the application receipt date. Questions and answers will be shared via e-mail with the PRC PI and any additional e-mail contacts.

Application Materials. See Section IV.1 for application materials. Please note that Form D is to be used when downloading the application package.http://grants.nih.gov/grants/funding/424/index.htm #inst Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: (770) 488-2783.

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority Awards for this FOA are made under the authorization of Section 301(a) of the Public Health Service Act as amended, 42 U.S.C.

241(a), and Section 1706 of the Public Health Service Act, 42 U.S.C. 300u-5 .

1. Background and Purpose The PRC Program was established by Congress in 1984 (Public Law 98-551) to conduct research in health promotion, disease prevention, and methods of appraising health hazards and risk factors. Congress mandated that the centers be located at academic health centers capable of providing multidisciplinary faculty with expertise in public health, relationships with professionals in other relevant fields, graduate training and demonstrated curricula in disease prevention, and a capability for residency training in public health or preventive medicine. 7 The PRCs also serve as demonstration sites for the use of new and innovative applied public research and activities for disease prevention and health promotion. CDC administers the PRC Program and provides leadership, technical assistance, and oversight. 8 Funded PRCs are able to compete for SIPs, research projects sponsored by CDC, HHS, and other federal agencies, to conduct research and other activities in priority areas. Funded PRCs are encouraged to apply for SIPs that expand and strengthen their PRC’s mission and increase their applied public health research activities.

The SIP mechanism, created in 1993, allows the PRCs to compete for research projects sponsored by CDC organizational units and other HHS agencies. A SIP is a health promotion and disease prevention research project that focuses on a topic of interest or a gap in knowledge or research. It can also support the development of effective state and local public health strategies.

Prevention research includes applied public health research that develops and evaluates health promotion and disease prevention and control strategies that are community- and population-based. It can involve testing interventions for efficacy, effectiveness, or translational power; may focus on primary, secondary, or tertiary prevention; or may improve health and prevent disease through approaches that involve changes to individual behavior, policy or environmental structure, health systems, or socio-economic factors. Prevention research may provide initial evidence of the efficacy or effectiveness of a health promotion or prevention strategy, raise current evidence to a higher level, or provide evidence of the effectiveness of a practice-based http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm#SectionIV1 http://grants.nih.gov/grants/funding/424/index.htm#inst http://grants.nih.gov/grants/funding/424/index.htm#inst strategy, raise current evidence to a higher level, or provide evidence of the effectiveness of a practice-based strategy.

Healthy People 2020 and other National Strategic Priorities The US Department of Health and Human Services (HHS), Centers for Disease Control and Prevention (CDC), National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) seeks competitive supplement cooperative agreement applications for the Health Promotion and Disease Prevention Research Centers Program. This FOA aligns with the following public health priorities:

Healthy People 2020 Objectives1.

The National Prevention Strategy2.

CDC’s Winnable Battles3.

NCCDPHP’s Domains of Chronic Disease Prevention4.

This FOA is expected to fund research that will focus on developing and evaluating the evidence for strategies that improve population health outcomes. Information on specific Healthy People 2020 and other National Strategic Priorities are described for each Special Interest Projects in Section IX. Special Interests Project Descriptions. This FOA includes the Healthy People 2020 topic areas of Arthritis; Cancer;

HIV/STD and Sexual Health; and School-based Health. The following are the current SIPs and associated topic areas:

Arthritis: SIP 17-001;

School-based Health: SIP 17-002;

Cancer: SIP 17-003, and SIP 17-004;

HIV and Sexual Health: SIP 17-005 and SIP 17-006.

Public Health Impact Public Health Impact of this Opportunity

Accomplishing the objectives of these projects willresult in improvements in the delivery and outcomes of public health programs and practice:

SIP 17-001 Community-based Short and Longer Term Evaluation of the Chronic Pain Self-Management Program (CPSMP)

US adults living with chronic pain have a limited choice of affordable, evidence-based, pain self-management programs in their community. Study results will be used to assess whether CPSMP is a promising practice for chronic pain self-management and whether there is sufficient evidence for development of public health infrastructure to support wide-scale dissemination of CPSMP.

SIP 17--002 Evaluation of the Effectiveness of School-based Health Services Interventions on Student Outcomes

This proposed evaluation will help identify the barriers, facilitators to implementation of school health services policies, protocols, and practices; identify staffing and training needs of school health services’ staff within a large school district; and identify strategies that can be used to create and foster external partnerships as well as referral networks for students. The intended long term impact of this evaluation can contribute to understanding best practices in improving health status, providing clinical linkages to care and improving academic performance for students with chronic health conditions through school-based health services.

SIP 17-003 Formative Study of Patient Navigators with the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) and the Colorectal Cancer Control Program (CRCCP)

Patient navigation has been shown to increase cancer screening completion, including for breast, cervical, and colorectal (CRC) cancers. Patient navigation can help to increase cancer screening among disparate populations so that breast, cervical, and CRC will be either avoided completely or detected early, leading to better health outcomes. This project will provide critical information about the current delivery of this evidence-based intervention in CDC’s NBCCEDP and CRCCP programs.

SIP 17-004 Assessing the Lifetime Economic Burden in Younger, Midlife, and Older Women with Metastatic Breast Cancer

Economic costs identified from this project will address the knowledge base for breast cancer in women in different life stages; inform public health decisions on strategies to reduce the impact of mBC on patient’s well-being; inform health care system and society about how economic factors influence the welfare of mBC patients; and provide data to inform development of effective interventions. In addition, the outcomes from this project could be used to generate new economic knowledge that will promote the optimal design of cancer control strategies to improve the quality of a woman’s life if her breast cancer progresses to a metastatic stage.

SIP 17-005 Understanding Provision of Confidential Sexual Health Services to Adolescents

Understanding provider, parent, and adolescent perspectives on provision of confidential SHS will yield a comprehensive assessment that can inform intervention to enhance confidentiality and adolescents’ receipt of SHS. Increasing receipt of preventive services, including behavioral counseling, can reduce risk behavior and improve sexual and reproductive health outcomes.

SIP 17-006 Communicating With Youth to Prevent HIV, Other STIs, and Pregnancy: Identifying Key Messages, Messengers, and Communication Channels

Understanding the communication messages, messengers, and channels that can be used to encourage key protective behaviors for reducing pregnancy and the transmission of HIV and other STIs among youth will allow public health professionals to better provide critical information to youth in order to improve sexual and reproductive health outcomes.

References:

References for individual SIPS can be found in Section IX. Special Interest Project Descriptions

Relevant Work As appropriate, this information will be provided for each SIP in the individual descriptions contained in Section IX. Special Interests Project Descriptions of this announcement.

2. Approach As appropriate, the information that follows (up to Section II. Award Information) will be provided for each SIP in the individual descriptions contained in Section IX. Special Interests Project Descriptions of this announcement.

Objectives/Outcomes

Target Population

Collaboration/Partnerships

Evaluation/Performance Measurement

Translation Plan

Section II. Award Information

Funding Instrument Type: Cooperative Agreement A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed:

New - An application that is submitted for funding for the first time. Includes multiple submission attempts within the same round.

Estimated Total Funding: $3,914,800 The estimated total funding (direct and indirect) for the first budget period, 09/30/2017 – 09/29/2018, is $2,064,800. The estimated total funding (direct and indirect) for the entire project period, 09/30/2017 – 09/29/2019, is $3,914,800.

Anticipated Number of Awards:

Awards issued under this FOA are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Award Ceiling: $600,000 Per Project Period Award Floor: $0 Per Project Period Total Project Period Length:

2 year(s)

Throughout the project period, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: Others (see text field entitled "Additional Information on Eligibility" for clarification)

Additional Eligibility Category:

2. Foreign Organizations Foreign Organizations are not eligible to apply.

http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

Foreign components of U.S. Organizations are eligible to apply.

For this announcement, applicants may include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Special Eligibility Requirements Others (see text field entitle "Special Eligibility Requiements" for clarification.

Competition is limited to Prevention Research Centers (PRCs) institutions funded under DP-14-001.

Special eligibility requirement(s) may apply to each SIP (see Section IX Special Interests Project Description).

4. Justification for Less than Maximum Competition Competition is limited to Prevention Research Centers under CDC Program Announcement DP14-001 because they are uniquely positioned to perform, oversee, and coordinate applied public health research that promotes the field of health promotion and chronic disease prevention research due to their established relationships with multidisciplinary faculty and community partners.

5. Responsiveness An application will be responsive if it meets the following requirements:

• Complies with items 1, 2, 3, and 10 of this section (see Section III. Eligibility Information).

• The budget for the application’s Year 1 costs does not exceed the Year 1 ceiling amount for the specific SIP (see Section II. Award Information).

Unresponsive applications will not be entered into the review process. Applicants will be notified that their application did not meet the submission requirements.

6. Required Registrations Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https://eportal.nspa.nato. int/AC135Public/Docs/US%20Instructions%2 0for%20NSPA%20NCAGE.pdf System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, https://www.sam.gov/portal/SAM/#1.

Grants.gov eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes.

The “one-time” registration process will take three to five days to complete. However, it is best to start the registration process at least two weeks prior to application submission.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://www.sam.gov/portal/SAM/%231 http://www.Grants.gov https://public.era.nih.gov/commons/public/login.do?TYPE=33554433&REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-http%3a%2f%2fpublic%2eera%2enih%2egov%2fcommons http://www.Grants.gov register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization. All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

7. Universal Identifier Requirements and System for Award Management (SAM) All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements.

The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An AOR should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Web Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

Additionally, all applicant organizations must register in the System for Award Management (SAM).

Organizations must maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later. SAM is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient. Additional information about registration procedures may be found at the SAM internet site at https://www.sam.gov/index.html.

If an award is granted, the grantee organization must notify potential sub-recipients that no organization may receive a subaward under the grant unless the organization has provided its DUNS number to the grantee organization.

8. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for HHS/CDC support.

9. Cost Sharing This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement,(http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf), applications received in response to the same funding opportunity announcement generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Only applicants affiliated with institutions funded as PRCs under CDC Program Announcement Funding Opportunity Announcement (FOA) DP14-001 are eligible to compete for Special Interest Project (SIP) supplemental funding. A Prevention Research Center may apply for multiple SIPs; however, a separate application must be submitted for each SIP. A PRC may submit only one application per SIP.

Although the financial plans of the CDC 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. Continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that http://fedgov.dnb.com/webform https://www.sam.gov/index.html of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal Government.

All page limitions described in this indivicual FOA must be followed. For this specific FOA, the Research Strategy component of the Research Plan narriative is limited to 12 pages. Supporting materials for the Research Plan narrative included as appendices may not eendices.xceed 10 PDF files with a maxium of 30 pages for all appendices. Any pages in excess of these limits will be discarded and will not be considered in the review process. Other criteria may also be provided for each SIP in Section IX Special Interest Project Descriptions.

If your application is incomplete or non-responsice to the special requirements listed in this section, it will not enter into the review process. An applicant will be notified of this determination.

Section IV. Application and Submission Information

1. Address to Request Application Package Applicants must download the SF424 (R&R) application package associated with this funding opportunity from www.Grants.gov.

If access to the Internet is not available or if the applicant encounters difficulty accessing the forms on-line, contact the HHS/CDC Office of Grants Services (OGS) Technical Information Management Section (TIMS) staff at (770) 488-2700 or ogstims@cdc.gov for further instructions. Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern Time. CDC Telecommunications for the hearing impaired or disabled is available at: TTY 1-888-232-6348.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide.htm and here:

http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf, except where instructed in this Funding Opportunity Announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

The forms package associated with this FOA includes all applicable components, mandatory and optional.

Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF 424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

In conjunction with the SF424 (R&R) components, CDC grants applicants should also complete and submit additional components titled “PHS398.” Note the PHS398 should include assurances and certifications, additional data required by the agency for a complete application. While these are not identical to the PHS398 application form pages, the PHS398 reference is used to distinguish these additional data requirements from the data collected in the SF424 (R&R) components. A complete application to CDC will include SF424 (R&R) and PHS398 components. These forms can be downloaded from http://grants.nih.gov/grants/forms.htm Do not include “hyperlinks” in any part of your submission, as they do not show when the application is uploaded into Grants.gov.

Separate Application Submissions Required

Applicants must submit a separate application package for each selected Special Interest Project (SIP) through www.Grants.Gov, including pertinent, required PDF attachments.

SF424 Research and Related (R&R) Face Page Form

Instructions for completing the SF424 Research and Related (R&R) Face Page form are provided in the SF424 (R&R) Application Guide. In addition, applicants must complete four fields on the Face Page as http://www.Grants.gov mailto:pgotim@cdc.gov http://grants.nih.gov/grants/how-to-apply-application-guide.htm http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf http://grants.nih.gov/grants/forms.htm http://www.Grants.Gov follows:

• Field # 4.a. (Federal Identifier): Enter the 8-character, alpha-numeric portion only of your organization’s grant number (located on the Notice of Grant Award). Example: DP001234 (Do not enter spaces or other characters in this field).

• Field # 4.b. (Agency Routing Identifier): Enter the SIP Project Number (for example, SIP 11-040) and a descriptive title for the SIP. Field 4.b. will accommodate a maximum of 75 characters.

• Field # 8 (Type of Application): Select “New” only for each submission.

• Field # 11 (Descriptive Title of Applicant’s Project): Applicants must enter the exact project title as used in their original PRC application (including spacing and punctuation). The original PRC title can be found on the Notice of Award.

These responses are necessary for SIP applications to be submitted and processed electronically. If your application is incomplete or non-responsive to these four requirements, it will not be processed.

3. Letter of Intent Due Date for Letter of Intent: 01/23/2017 Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CIO staff to estimate the potential review workload and plan the review.

By the date listed above and in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Name of the Applicant

Descriptive title of proposed research

Name, address, and telephone number of the PD(s)/PI(s)

Names of other key personnel

Participating institutions

SIP number and title of SIP proposal

The letter of intent should be sent to:

Scientific/Research Contact(s)

Michael A. Brown, M.P.H.

Scientific Program Official

Extramural Research Program Operations and Services

Centers for Disease Control and Prevention

4770 Buford Hwy, NE

Mailstop F-80

Atlanta, GA 30342

Telephone: (770) 488-5118

E-mail: mab5@cdc.gov

4. Required and Optional Components A complete application has many components, both required and optional. The forms package associated with this FOA in Grants.gov includes all applicable components for this FOA, required and optional.

5. PHS 398 Research Plan Component The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of 16 components. Not all 16 components of the Research Plan apply to all Funding Opportunity Announcements (FOAs). Specifically, some of the following 16 components are for Resubmissions or Revisions only. See the SF 424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide.htm and here:

http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Funding Opportunity Announcement Description).

Follow the page limits stated in the SF 424 (R&R) unless otherwise specified in the FOA. As applicable to and specified in the FOA, the application should include the bolded headers in this section and should address activities to be conducted over the course of the entire project, including but not limited to:

1. Introduction to Application (for Resubmission and Revision ONLY) - provide a clear description about the purpose of the proposed research and how it addresses the specific requirements of the FOA.

2. Specific Aims – state the problem the proposed research addresses and how it will result in public health impact and improvements in population health.

3. Research Strategy – the research strategy should be organized under 3 headings: Significance, Innovation and Approach. Describe the proposed research plan, including staffing and timeline.

4. Inclusion Enrollment Report (Renewal and Revision applications ONLY)

5. Progress Report Publication List (for Continuation ONLY)

Human Subjects Section

6. Protection of Human Subjects

7. Inclusion of Women and Minorities

8. Targeted/Planned Enrollment Table (for New Application ONLY)

9. Inclusion of Children

Other Research Plan Sections

10. Vertebrate Animals

11. Select Agent Research

12. Multiple PD/PI Leadership Plan.

13. Consortium/Contractual Arrangements

14. Letters of Support

15. Resource Sharing Plan(s)

16. Appendix

Component 4 (Inclusion Enrollment Report) applies only to Renewal and Revision applications for clinical research. Clinical research is that which is conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies). Follow the page limits in the SF 424 (R&R) Application Guide unless otherwise specified in the FOA. All instructions in the SF424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf must be followed along with any additional instructions provided in the FOA.

Applicants that plan to collect public health data must submit a Data Management Plan (DMP) in the Resource Sharing Plan section of the PHS 398 Research Plan Component of the application. A DMP is http://grants.nih.gov/grants/how-to-apply-application-guide.htm http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf%20 http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf

Resource Sharing Plan section of the PHS 398 Research Plan Component of the application. A DMP is required for each collection of public health data proposed. Applicants who contend that the public health data they collect or create are not appropriate for release must justify that contention in the DMP submitted with their application for CDC funds.

The DMP may be outlined in a narrative format or as a checklist but, at a minimum, should include:

• Descriptions of the data to be produced in the proposed project

• How access will be provided to the data (including provisions for protection of privacy, confidentiality, security, intellectual property, or other rights)

• Use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use

• Plans for archival and long-term preservation of the data, or explaining why long-term preservation and access cannot be justified Examples of DMPs may be found here: University of California https://dmp.cdlib.org/, or USGS, http://www.usgs.gov/datamanagement/plan/dmplans.php

6. Appendix Do not use the appendix to circumvent page limits. A maximum of 10 PDF documents are allowed in the appendix. Additionally, up to 3 publications may be included that are not publically available. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

7. Page Limitations All page limitations described in this individual FOA must be followed. For this specific FOA, the Research Strategy component of the Research Plan narrative is limited to 12 pages. Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 30 pages for all appendices.

8. Format for Attachments Designed to maximize system-conducted validations, multiple separate attachments are required for a complete application. When the application is received by the agency, all submitted forms and all separate attachments are combined into a single document that is used by peer reviewers and agency staff. Applicants should ensure that all attachments are uploaded to the system.

CDC requires all text attachments to the Adobe application forms be submitted as PDFs and that all text attachments conform to the agency-specific formatting requirements noted in the SF424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf.

9. Submission Dates & Times Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov (http://www.grants.gov), the online portal to find and apply for grants across all Federal agencies. The eRA Commons systems retrieve the application from Grants.gov and check the application against CDC business rules. If no errors are found, the application will be assembled in the eRA Commons for viewing by the applicant before moving on for further CDC processing.

If errors are found, the applicant will be notified in the eRA Commons. They must make required changes to the local copy of their application and submit again through Grants.gov.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

https://dmp.cdlib.org/ http://www.usgs.gov/datamanagement/plan/dmplans.php http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf http://grants.nih.gov/grants/guide/url_redirect.htm?id=11128 http://www.grants.gov/

Once you can see your application in the Commons, be sure to review it carefully as this is what the reviewer will see. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons (http:// grants.nih. gov/grants /guide/url_redirect .htm? id=11123).

Information on the submission process is provided in the SF424 (R&R) Application Guide.

Note: HHS/CDC grant submission procedures do not provide a period of time beyond the grant application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e. error correction window).

The application package is not complete until it has passed the Grants.gov/eRA Commons validation process. This process and email notifications of receipt, validation or rejection may take two (2) business days.

Applicants are strongly encouraged to allocate additional time prior to the submission deadline to submit their applications and to correct errors identified in the validation process. Applicants are encouraged also to check the status of their application submission to determine if the application packages are complete and error-free. Applicants who encounter system errors when submitting their applications must attempt to resolve them by contacting the Grants.gov Contact Center ( 1-800-518-4726; support@grants.gov). If the system errors cannot be resolved, applicants must contact TIMS at 770-488-2700; ogstims@cdc.gov for guidance at least 3 calendar days before the deadline date.

After submission of your application package, applicants will receive a “submission receipt” email generated by Grants.gov. Grants.gov will then generate a second e-mail message to applicants which will either validate or reject their submitted application package. This validation process may take as long as two (2) business days. A third and final e-mail message is generated once the applicant’s application package has passed validation and the grantor has confirmed receipt of the application.

Unsuccessful Submissions: If an application submission was unsuccessful, the applicant must:

1. Track his/her submission and verify the submission status (tracking should be done initially regardless of rejection or success).

a. If the status states “rejected,” do #2a or #2b.

2. Check his/her emails from both Grants.gov and eRA Commons for rejection notices.

a. If the deadline has passed, he/she should email the Grant Management Specialist listed in the FOA (pgotim@cdc.gov) explaining why the submission failed. b. If there is time before the deadline, he/she should correct the problem(s) and resubmit as soon as possible.

Due Date for Applications: 02/22/2017

Electronically submitted applications must be submitted no later than 5:00 p.m., ET, on the listed application due date.

10. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review (http:// www. whitehouse.gov/ omb/ grants_spoc).

11. Funding Restrictions

All HHS/CDC awards are subject to the federal regulations, 45 CFR 75, terms and conditions,and other requirements described in the HHS Grants Policy Statement. Pre-award costs may be allowable as an expanded authority, but only if authorized by CDC.

For more information on expanded authority and pre-award costs, go to:

http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf .

CDC requires that mechanisms for, and cost of, public health data sharing be included in grants,cooperative agreements, and contracts. The cost of sharing or archiving public health data may also be included as part of the total budget requested for first-time or continuation awards.

Fulfilling the data-sharing requirement must be documented in a Data Management Plan (DMP) that is http://grants.nih.gov/grants/guide/url_redirect.htm?id=11123 mailto:support@grants.gov mailto:www.pgotim@cdc.gov http://www.whitehouse.gov/omb/grants_spoc developed during the project planning phase prior to the initiation of generating or collecting public health data and must be included in the Resource Sharing Plan(s) section of the PHS398 Research Plan Component of the application.

Applicants who contend that the public health data they collect or create are not appropriate for release must justify that contention in the DMP submitted with their application for CDC funds (for example, privacy and confidentiality considerations, embargo issues).

Awardees who fail to release public health data in a timely fashion will be subject to procedures normally used to address lack of compliance (for example, reduction in funding, restriction of funds, or award termination) consistent with 45 CFR 74.62 or other authorities as appropriate. For further information, please see: http://www.cdc.gov/grants/additionalrequirements/index.html for revised AR-25.

General FY 15 Appropriations Act Provisions

HHS recipients must comply with all terms and conditions outlined in their grant award, including grant policy terms and conditions contained in applicable Department of Health and Human Services (HHS) Grant Policy Statements, requirements imposed by program statutes and regulations, and HHS grant administration regulations, as applicable; as well as any requirements or limitations in any applicable appropriations acts.

12. Other Submission Requirements and Information

Application Submission Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

Applicants must complete all required registrations before the application due date. Section III.6 "Required Registrations" contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically (http://grants.nih.gov/grants/guide /url_ redirect.htm? id=11144).

Important reminders: All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(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 CDC.

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.

If the applicant has an FWA number, enter the 8-digit number. Do not enter the letters “FWA” before the number. If a Project/Performance Site is engaged in research involving human subjects, the applicant organization is responsible for ensuring that the Project/Performance Site operates under and appropriate Federal Wide Assurance for the protection of human subjects and complies with 45 CFR Part 46 and other CDC human subject related policies described in Part II of the SF 424 (R&R) Application Guide and in the HHS Grants Policy Statement.

See more resources to avoid common errors and submitting, tracking, and viewing applications: http:// grants.nih. gov/grants/ Electronic Receipt /avoiding _errors.htm or http:// grants. nih.gov/grants/ Electronic Receipt/submit _app.htm Upon receipt, applications will be evaluated for completeness by the CDC Office of Grants Services (OGS) and responsiveness by OGS and the Center, Institute or Office of the CDC. Applications that are incomplete and/or nonresponsive will not be reviewed.

Section V. Application Review Information http://www.cdc.gov/grants/additionalrequirements/index.html http://grants.nih.gov/grants/guide/url_redirect.htm?id=11144 http://grants.nih.gov/grants/ElectronicReceipt/avoiding_errors.htm http://grants.nih.gov/grants/ElectronicReceipt/avoiding_errors.htm http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm

1. Criteria Only the review criteria described below will be considered in the review process. As part of the CDC mission (http:// www.cdc.gov/ about/ organization/ mission.htm), all applications submitted to the CDC in support of public health research are evaluated for scientific and technical merit through the CDC 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 review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Does the work address a scientific problem of great importance to public health research and/or practice?

What is the potential or actual impact of the research on public health in the US and/or globally?

Will the work be influential in that it will lead others to investigate the problem, open new areas of research, or change the scientific approach or public health practice, and how will this improve and be of value to public health?

If successful, do the research results have the potential to be scalable and reach a large portion of the population at risk?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? Have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Do the investigators have a successful track record in public health research?

Is there evidence of past collaborations with the proposed research team?

Have previous research results…