PKG00245954-instructions.pdf

Centers for Disease Control

National Center for Immunization and Respiratory Diseases Extramural Research Program

Office

Understanding and Improving Immunization Services among Adult Hospital Inpatient and

Observation/Clinical Decision Unit Settings

RFA-IP-19-003

Application Due Date: 02/01/2019

Understanding and Improving Immunization Services among Adult Hospital Inpatient and

Observation/Clinical Decision Unit Settings

RFA-IP-19-003

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 Immunization and Respiratory Diseases Extramural Research Program Office (NCIRD ERPO) Notice of Funding Opportunity (NOFO) Title Understanding and Improving Immunization Services among Adult Hospital Inpatient and Observation/Clinical Decision Unit Settings Activity Code U01 - Research Project - Cooperative Agreement

Notice of Funding Opportunity Type New Agency Notice of Funding Opportunity Number

RFA-IP-19-003

Assistance Listings (CFDA) Number(s) 93.185 Category of Funding Activity:

Health NOFO Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to support research to: 1) obtain a better understanding of existing vaccination practices, and adult vaccination coverage levels, for adult hospital inpatients and patients admitted to 24-hour observation or clinical decision units and 2) implement and evaluate intervention(s) to improve the approach to delivering vaccination services, and adult vaccination coverage levels, among the populations above, using CDC’s Standards for Adult Immunization Practices for all Advisory Committee on Immunization Practices (ACIP)-recommended adult immunizations.

Key Dates Publication Date: To receive notification of any changes to RFA-IP-19-003, 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: 12/15/2018

Application Due Date: 02/01/2019

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

Eastern Time. Applications must be submitted using the Application Submission System & Interface for Submission Tracking (ASSIST) module which is a web-based service used for the preparation and submission of grant applications to CDC through Grants.gov. ASSIST provides the ability for applicants to prepare their applications online, and offers the applicant additional capabilities including the ability to preview the application image, validate the application against required business rules, and prepopulate data from an applicant organization's records, therefore identifying issues earlier in the application submission process.

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the application due date time 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: 03/14/2019

Secondary Review: 04/16/2019

Estimated Start Date: 08/01/2019

Expiration Date: 02/02/2019 Due Dates for E.O. 12372: Due no later than 60 days after the application receipt date.

Required Application Instructions

**ELECTRONIC APPLICATION SUBMISSION VIA ASSIST IS PREFERRED**

It is recommended that applicants use ASSIST for the electronic preparation and submission of applications through Grants.gov to CDC. ASSIST is an alternative method to prepare and submit applications, and provides many features to facilitate the application submission process which improves data quality (e.g., pre-population of organization data, pre-submission validation of business rules, and preview of the application image used for review). Use of the Grants.gov downloadable Adobe application packages and submission process will still be supported.

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) 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 15 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 http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

Executive Summary

Purpose: The purpose of this research is to: 1) obtain a better understanding of existing vaccination practices, and adult vaccination coverage levels, for adult hospital inpatients and patients admitted to 24-hour observation or clinical decision units and 2) implement and evaluate intervention(s) to improve the approach to delivering vaccination services, and adult vaccination coverage levels, among the populations described above, using CDC’s Standards for Adult Immunization Practices for all Advisory Committee on Immunization Practices (ACIP)-recommended adult immunizations.

Mechanism of Support: U01 – Research Project - Cooperative Agreement Funds Available and Anticipated Number of Awards: The estimated total funding available, including direct and indirect costs, for the entire three (3)-year project period is $3,000,000. The number of anticipated awards is up to two (2). Awards issued under this NOFO are contingent upon availability 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 year (12-month budget period) is $1,000,000 with individual awards ranging from $300,000 to $500,000 for the first year. The estimated total funding (direct and indirect) for the entire project period is $3,000,000. The project period is anticipated to run from 08/01/2019 to 07/31/2022.

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/organizations listed in Section III.1 of this announcement 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. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

Number of PDs/PIs. There will only be one PD/PI for each application.

Number of Applications. Only one application per institution (normally identified by having a unique DUNS number) is allowed Application Type. New.

Application Materials. See Section IV.1 for application materials. Please note that

Form E is to be used when completing the application package.

Hearing Impaired. Telecommunications for the hearing impaired are available at:

TTY: 1-888-232-6348

Part 2. Full Text

Section I. Funding Opportunity Description

Statutory Authority Section 317(k)(1) of the Public Health Service Act, as amended [42 U.S.C. 247b(k)(1)].

1. Background and Purpose Immunizations are needed throughout the lifespan, but adult vaccination rates are low in the U.S., especially among high-risk adults. The Standards for Adult Immunization Practice are a set of standards developed and adopted by the National Vaccine Advisory Committee in recognition that all healthcare professionals in every healthcare setting should take steps to ensure that their adult populations are fully immunized. Routine immunization delivery is often considered a primary role of outpatient clinic care, whereas hospital admission, or admission to hospital observation or clinical decision unit, is primarily intended to address acute clinical needs that may not be possible to address in the outpatient setting. Inpatient hospital and 24 hour-observation unit settings might also be used to provide assessment of, and intervention for, preventive health needs like routine immunizations among adult populations.

The purpose of the research supported by this Notice of Funding Opportunity (NOFO) is to: 1) obtain a better understanding of existing vaccination practices, and adult vaccination coverage levels, for adult hospital inpatients and patients admitted to 24-hour observation or clinical decision units and 2) implement and evaluate intervention(s) to improve the approach to delivering vaccination services, and adult vaccination coverage levels, among the populations described above, using CDC’s Standards for Adult Immunization Practices for all Advisory Committee on Immunization Practices (ACIP)-recommended adult immunizations. Key components of the standards include systematizing approaches to assessing adult immunization needs, strongly recommending needed vaccines, administering these needed vaccines, and documenting vaccines administered in the jurisdiction’s immunization information system (IIS, a.k.a. vaccine registry).

Successful completion of the study will allow for improved understanding of existing vaccination needs of adult inpatients and those admitted to observation units.

Healthy People 2020 and other National Strategic Priorities Adult immunizations are part of the core components of multiple Healthy People 2020 objectives (please see: https://www.healthypeople.gov/2020/topics-objectives/topic/immunizati on-and-infectious-diseases/objectives).

Public Health Impact Findings from this study should lead to improved immunization coverage among adult populations and should subsequently result in reduced morbidity and mortality in adults throughout the U.S. from vaccine-preventable diseases.

Relevant Work

Advisory Committee on Immunization Practices (ACIP) website, adult immunization schedule: https://www.cdc.gov/vaccines/schedules/hcp/adult.html https://www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases/objectives https://www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases/objectives https://www.cdc.gov/vaccines/schedules/hcp/adult.html

Guide to Community Preventive Services (The Community Guide) is a collection of evidence-based findings from US Community Preventive Services Task Forces which includes evidence strategies for increasing adult immunization rates and delivery (https ://www.thecommunityguide.org/search/adult%20immunization).

Standards for Adult Immunization Practices is available at: (https://www.cdc.gov/vacci nes/hcp/adults/for-practice/standards/index.html).

2. Approach The application’s research plan should include proposed activities and study design to: 1) understand existing vaccination practices and adult vaccination coverage levels; and 2) implement and evaluate intervention(s) to improve the approach to delivering vaccination services to adult hospital inpatients and patients in 24-hour observation units or clinical decision units, as part of CDC’s Standards for Adult Immunization Practices for all Advisory Committee on Immunization Practices (ACIP)-recommended adult immunizations.

The proposed study should include three (3) phases:

Phase 1: Evaluation of vaccination services and vaccination coverage of adult patients The application should describe the approach to conduct an initial comprehensive evaluation of existing vaccination practices and vaccination coverage levels of ACIP-recommended vaccines among a chosen adult study population of inpatients and patients admitted to 24-hour observation or clinical decision units. The application should describe:

Identification and recruitment of facilities.

Methods for conducting the evaluation (e.g., surveys and/or qualitative interviews or focus groups).

Methods for assessing baseline vaccination coverage among adult patients including methods for: determining sample size, sampling the patient population, and source of vaccination information (e.g., vaccination records review from the electronic health record (EHR) and/or the state/local Immunization Information System).

Phase 2: Intervention Based on the expected results from the Phase 1 evaluation, the application should describe the development and implementation of an approach to improving adult immunization rates among the study population as part of routine care through use of evidence-based interventions and the Standards for Adult Immunization Practices. The application should ideally describe the development of an intervention(s) that is protocol-based, including use of standing orders and other order sets that can be integrated into existing routine Electronic Health Records systems, in addition to other methods described in the Guide to Community Preventive Services (The Community Guide). Given that the intervention may not have been selected as of the writing of the application, it is understood that some specifics cannot be provided at this time, but relevant considerations should be addressed.

Phase 3: Evaluation The application should describe the development of an evaluation plan to monitor and evaluate the implementation of the intervention(s) to achieve project goals/objectives. The plan should https://www.thecommunityguide.org/search/adult%20immunization https://www.thecommunityguide.org/search/adult%20immunization https://www.cdc.gov/vaccines/hcp/adults/for-practice/standards/index.html https://www.cdc.gov/vaccines/hcp/adults/for-practice/standards/index.html describe the methods for data collection and the planned analyses and statistical tests to evaluate the impact of the intervention on improving vaccination delivery and coverage among the study population. In addition to an evaluation of the change in routine adult vaccination coverage level among the study population, it is expected that the application will describe an evaluation of changes in healthcare practitioner (not limited to physician) knowledge, attitudes, and beliefs toward adult vaccination, as well as their attitudes toward the intervention, to determine which components of the intervention were found most helpful and most likely to sustain the activities.

Evaluation of the cost to implement the intervention will also be an important component of this phase. At the end of the study, the recipient is expected to develop a final report, or manuscript, based on the findings from this study, suitable for submission to a peer-reviewed journal.

Objectives/Outcomes Whenever possible, applications should include objectives written in the SMART format (e.g., Specific, Measurable, Achievable, Realistic and Time-bound).

The research application should address the following objectives and outcomes:

Objectives

1. Assess the following among study healthcare facilities, including:

o Existing facility level policies and protocols to assess patients’ immunization needs, strongly recommend these needed immunizations, offer/administer these needed immunizations, and process(es) for documenting/reporting immunizations administered to the jurisdiction’s immunization information system.

o Knowledge, attitudes, and beliefs (KABs) toward vaccination and delivery of vaccination services among healthcare personnel and administrators in the participating facilities as part of routine care in these settings.

o Immunization coverage for Advisory Committee on Immunization Practices (ACIP)-recommended vaccines among adult patients, including by facility/setting, and by race/ethnicity, age, and medical conditions pertinent to ACIP adult immunization needs.

2. Develop and implement evidenced-based approach(es) to delivering vaccination services and improving vaccination coverage among adult hospital inpatients and patients in 24-hour observation units or clinical decision units, as part of CDC’s Standards for Adult Immunization Practices for all ACIP-recommended adult immunizations.

Outcomes:

1. Improved understanding of existing vaccination practices of healthcare facilities in the study and immunization coverage for adult hospital inpatients and patients admitted to 24-hour observation or clinical decision units.

2. Improved evidenced-based approach to delivering vaccination services and coverage among adult hospital inpatients and patients in 24-hour observation units or clinical decision units, as part of CDC’s Standards for Adult Immunization Practices for all Advisory Committee on Immunization Practices (ACIP)-recommended adult immunizations.

Target Population Adult hospital inpatients and adult patients admitted to 24-hour observation or clinical decision units. Target population should be from more than one hospital or hospital setting within one or multiple jurisdictions, including underserved areas in the U.S.

Collaboration/Partnerships The overall healthcare system of individual facilities in the study should be involved in the process of accomplishing the objectives of the study. The applicant is encouraged to include letters of support for cooperating healthcare systems as part of the application package. Findings from the study are expected to inform best practices to improve adult immunization coverage among other healthcare facilities with similar characteristics.

Evaluation/Performance Measurement The application should include measurable goals and aims based on a three (3)-year research project period. The application should include specific, measurable, achievable, realistic and time-phased (SMART) project objectives for each activity described in the application’s project plan, and describe the development and implementation of project performance measures based on specific programmatic objectives.

The Evaluation and Performance Measurement Plan should align with the proposed objectives and address the following, at a minimum:

Vaccination coverage level for each ACIP-recommended vaccine for adult patients among the study facilities: by facility, pertinent ACIP risk medical condition, age, gender, insurance status, and any other demographic factors that may be proposed in the application.

Percent of patients routinely assessed for vaccination needs, by provider type and setting and other patient factors listed above.

Percent of patients who received a strong recommendation for needed vaccinations by provider type and setting and other patient factors listed above.

Percent of patients who were administered needed vaccinations during the course of inpatient or observation unit stay, by provider type and setting and other patient factors listed above.

Percent of patients and number of administered vaccinations documented/reported to the jurisdiction’s immunization information system.

Cost to provide adult immunizations, including provider/staff time and cost of vaccine product.

Translation Plan The application should include a translation plan that describes how the significant findings resulting from this work may be used to promote, enhance, or advance translation of the research to practice or to inform policy. This section should be understandable to a variety of audiences, including policy makers, practitioners, public health programs, healthcare institutions, professional organizations, community groups, researchers, and other potential users. The application should identify which research findings may be translated, how these findings can guide future research or related activities, and recommendations for translation. If relevant, the application should describe how the results of this project could be generalized to populations and communities outside of the study. The application should describe how findings from the initial study will be disseminated via manuscripts prepared for publication in relevant scientific, peer-reviewed journals and presentations made at relevant scientific meetings. Options may include epidemiologic, public health, economics, health services, and medical decision-making venues.

In addition to the development of a final report in a format and of quality suitable for submission to a peer-reviewed journal, it is expected that the recipient will develop and implement a plan to disseminate findings at profession society or similar conferences in oral or written/poster format.

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: $3,000,000 Estimated Annual Fiscal Year Funding:

Year 1: $1,000,000 Year 2: $1,000,000 Year 3: $1,000,000

Estimated total funding available for the first 12-month budget period, including direct and indirect costs: $1,000,000 Estimated total funding available for the entire three (3)-year project period, including direct and indirect costs: $3,000,000

Anticipated Number of Awards: 2

The ceiling and floor amounts listed below are for the first 12-month budget period only.

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

Award Ceiling: $500,000 Per Budget Period Award Floor: $300,000 Per Budget Period Total Period of Performance Length: 3 year(s)

Throughout the Period of Performance, 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 NOFO.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

County governments City or township governments Special district governments Independent school districts Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education

Additional Eligibility Category:

Nonprofits Other Than Institutions of Higher Education:

Nonprofits (Other than Institutions of Higher Education) http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

Governments:

Eligible Agencies of the Federal Government U.S. Territory or Possession

Other:

Faith-based or Community-based Organizations Regional Organizations Bona Fide Agents: A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required.

Attach with "Other Attachment Forms."

Federally Funded Research and Development Centers (FFRDCs):

FFRDCs are operated, managed, and/or administered by a university or consortium of universities, other not-for-profit or nonprofit organization, or an industrial firm, as an autonomous organization or as an identifiable separate operating unit of a parent organization. A FFRDC meets some special long-term research or development need which cannot be met as effectively by an agency's existing in-house or contractor resources. FFRDC's enable agencies to use private sector resources to accomplish tasks that are integral to the mission and operation of the sponsoring agency. For more information on FFRDCs, go to https://dap.dau.mil/acquipedia/Pages/ArticleDetails.aspx?aid=5e3079b8 -44f2-43df-a0e7-9f379e8c48ed

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

Foreign components of U.S. Organizations are not eligible to apply.

For this announcement, applicants may not include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Special Eligibility Requirements

Additional Information on Eligibility:

Nonprofit private institutions of higher education The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Nonprofit Private Institutions of Higher Education:

https://dap.dau.mil/acquipedia/Pages/ArticleDetails.aspx?aid=5e3079b8-44f2-43df-a0e7-9f379e8c48ed https://dap.dau.mil/acquipedia/Pages/ArticleDetails.aspx?aid=5e3079b8-44f2-43df-a0e7-9f379e8c48ed

Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions

4. Justification for Less than Maximum Competition N/A

5. Responsiveness N/A

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/.

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 register with the eRA Commons or ensure their existing Principle Investigator (PD/PI) 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 eRA Commons registration process at least four (4) weeks prior to the application due date. ASSIST requires that applicant users have active eRA Commons account in order to prepare an application. It also requires that the applicant organization's Signing Official have an active eRA Commons Signing Official account in order to initiate the submission process. During the submission 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 https://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 https://www.grants.gov process, ASSIST will prompt the Signing Official to enter their Grants.gov Authorized Organizational Representative (AOR) credentials in order to complete the submission, therefore the applicant organization must ensure that their Grants.gov AOR credentials are active.

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 recipient 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 recipient 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, (https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf), applications received in response to the same Notice of Funding Opportunity 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 NOFO that is essentially the same as one currently pending initial peer http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform https://www.sam.gov/index.html http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf review unless the applicant withdraws the pending application.

Only one application per institution (normally identified by having a unique DUNS number) is allowed.

Section IV. Application and Submission Information

1. Address to Request Application Package In order to use ASSIST, applicants must visit https://public.era.nih.gov/assist where you can login using your eRA Commons credentials, and enter the Notice of Funding Opportunity Number to initiate the application, and begin the application preparation process.

If you experience problems accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via:

· E-mail: http://grants.nih.gov/support/index.html

· Phone: 301-402-7469 or (toll-free) 1-866-504-9552. The NIH eRA Service desk is available Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding federal holidays.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF-424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide.htm and here: https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf, except where instructed in this Notice of Funding Opportunity 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 package associated with this NOFO includes all applicable mandatory and optional forms.

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

When using ASSIST, all mandatory forms will appear as separate tabs at the top of the Application Information screen; applicants may add optional forms available for the NOFO by selecting the Add Optional Form button in the left navigation panel.

Please include all of the eight (8) mandatory forms listed below in the application package:

Mandatory

1. SF424(R&R)[V2.0];

2. PHS 398 Cover Page Supplement [V4.0];

3. Research and Related Other Project Information [V1.4];

4. Project/Performance Site Location(s) [V2.0];

5. Research and Related Senior/Key Person Profile (Expanded) [V2.0];

6. Research and Related Budget [V1.4];

7. PHS 398 Research Plan [V4.0];

8. PHS Human Subjects and Clinical Trials Information [V1.0].

https://public.era.nih.gov/assist http://grants.nih.gov/grants/how-to-apply-application-guide.htm https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf

Please include the one (1) optional form listed below, if applicable, in the application package:

Optional

1. R&R Subaward Budget Attachment(s) Form 5 YR 30 ATT.

3. Letter of Intent Due Date for Letter of Intent: 12/15/2018

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 CDC staff to estimate the potential review workload and plan the review.

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

Name of the applicant institution Descriptive title of proposed research Name, address, and telephone number of the PD(s)/PI(s) Names of other key personnel Participating institutions Number and title of this notice of funding opportunity (NOFO)

The letter of intent should be sent to:

Gregory Anderson, MPH, MS Extramural Research Program Office Office of the Associate Director of Science National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention Centers for Disease Control and Prevention U.S. Department of Health and Human Services 1600 Clifton Road, MS E-60 Atlanta, GA 30333 Telephone: 404-718-8833 Fax: 404-718-8822 Email: GAnderson@cdc.gov

4. Required and Optional Components A complete application has many components, both required and optional. The forms package associated with this NOFO in Grants.gov includes all applicable components for this NOFO, required and optional. In ASSIST, all required and optional forms will appear as separate tabs at the top of the Application Information screen.

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 components. Not all components of the Research Plan apply to all Notices of Funding Opportunities (NOFOs). Specifically, some of the following components are for Resubmissions or Revisions only. See the SF 424 (R&R) Application Guide https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/generalforms-e.pdf and https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Notice of Funding Opportunity Description).

Follow the page limits stated in the SF 424 unless otherwise specified in the NOFO. As applicable to and specified in the NOFO, 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 NOFO.

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 time line.

4. Progress Report Publication List (for Continuation ONLY)

Other Research Plan Sections

5. Vertebrate Animals

6. Select Agent Research

7. Multiple PD/PI Leadership Plan.

8. Consortium/Contractual Arrangements

9. Letters of Support

10. Resource Sharing Plan(s)

11. Authentication of Key Biological and/or Chemical Resources

12. Appendix

All instructions in the SF424 (R&R) Application Guide https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf and here:

https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf must be followed along with any additional instructions provided in the NOFO.

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 https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf 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

Please note the new requirement for a Data Management Plan (DMP). A Data Management Plan (DMP) is required for each collection of public health data proposed. The DMP may be outlined in a narrative format or as a checklist but, at a minimum, should include:

A description of the data to be collected or generated in the proposed project;

Standards to be used for the collected or generated data;

Mechanisms for, or limitations to, providing access to and sharing of the data (include a description of provisions for the protection of privacy, confidentiality, security, intellectual property, or other rights - this section should address access to identifiable and de-identified data);

Statement of the 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; and

Plans for archiving and long-term preservation of the data, or explaining why long-term preservation and access are not justified (this section should address archiving and preservation of identifiable and de-identified data).

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 NOFO must be followed. For this specific NOFO, the Research Strategy component of the Research Plan narrative is limited to 15 pages.

Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 50 pages for all appendices.

https://dmp.cdlib.org/ http://www.usgs.gov/datamanagement/plan/dmplans.php

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 https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf and here: https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf.

9. Submission Dates & Times Part I. Overview Information contains information about Key Dates. Applicants are strongly encouraged to allocate additional time and submit in advance of the deadline to ensure they have time to make any corrections that might be necessary for successful submission. This includes the time necessary to complete the application resubmission process that may be necessary, if errors are identified during validation by Grants.gov and the NIH eRA systems.

The application package is not complete until it has passed the Grants.gov and NIH eRA Commons submission and validation processes.

Organizations must submit applications using the ASSIST web-based application preparation and submission process.

ASSIST will validate applications before submission. If the system detects errors, then the applicant must correct errors before their application can be submitted.

Applicants are responsible for viewing their application in ASSIST after submission to ensure accurate and successful submission through Grants.gov. If the submission is not successful and post-submission errors are found, then those errors must be corrected and the application resubmitted in ASSIST.

Applicants are able to access, view, and track the status of their applications in the eRA Commons.

Information on the submission process is provided in the SF-424 (R&R) Application Guidance and ASSIST User Guide at https://era.nih.gov/files/ASSIST_user_guide.pdf.

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the grant application due date time 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).

Applicants who encounter problems when submitting their applications must attempt to resolve them by contacting the NIH eRA Service desk at:

Toll-free: 1-866-504-9552; Phone: 301-402-7469 http://grants.nih.gov/support/index.html Hours: Mon-Fri, 7 a.m. to 8 p.m. Eastern Time (closed on federal holidays)

Problems with Grants.gov can be resolved by contacting the Grants.gov Contact Center at:

Toll-free: 1-800-518-4726 https://www.grants.gov/web/grants/support.html support@grants.gov https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf https://era.nih.gov/files/ASSIST_user_guide.pdf http://grants.nih.gov/support/index.html https://www.grants.gov/web/grants/support.html mailto:support@grants.gov

Hours: 24 hours a day, 7 days a week (closed on federal holidays) If the applicant encounters problems that prevent the ability to submit an application which cannot be resolved by Grants.gov or NIH eRA Service Desks, then applicants must contact CDC Technical Information Management Section (TIMS) at 770-488-2700; ogstims@cdc.gov for guidance at least 3 calendar days before the deadline date. Therefore, it is important that applicants complete the application submission process well in advance of the due date time.

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. A third and final e-mail message is generated once the applicant's application package has passed validation and the grantor agency has confirmed receipt of the application.

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

1. Track 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 emails from both Grants.gov and NIH eRA Commons for rejection notices.

a. If the deadline has passed, he/she should email the Grants Management contact listed in the Agency Contacts section of this announcement and ogstims@cdc.gov explaining why the submission failed.

b. If there is time before the deadline, correct the problem(s) and resubmit as soon as possible.

Due Date for Applications: 02/01/2019

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) Your application is subject to Intergovernmental Review of Federal Programs, as governed by Executive Order 12372 (http://www.archives.gov/federal-register/codification/executive-order/12372.html). This order sets up a system for state and local review of proposed federal assistance applications. You should contact your state single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications, and to receive instructions on your state’s process. Click on the following link to get the current SPOC list:

https://www.whitehouse.gov/wp-content/uploads/2017/11/Intergovernmental_-Review- _SPOC_01_2018_OFFM.pdf.

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 http://www.archives.gov/federal-register/codification/executive-order/12372.html http://www.archives.gov/federal-register/codification/executive-order/12372.html https://www.whitehouse.gov/wp-content/uploads/2017/11/Intergovernmental_-Review-_SPOC_01_2018_OFFM.pdf https://www.whitehouse.gov/wp-content/uploads/2017/11/Intergovernmental_-Review-_SPOC_01_2018_OFFM.pdf allowable as an expanded authority, but only if authorized by CDC.

In accordance with the United States Protecting Life in Global Health Assistance policy, all non-governmental organization (NGO) applicants acknowledge that foreign NGOs that receive funds provided through this award, either as a prime recipient or subrecipient, are strictly prohibited, regardless of the source of funds, from performing abortions as a method of family planning or engaging in any activity that promotes abortion as a method of family planning, or to provide financial support to any other foreign non-governmental organization that conducts such activities. See Additional Requirement (AR) 35 for applicability (https://www.cdc.gov/grants/additionalrequirements/ar-35.html).

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