RFA-IP15-001 Amendment 1.pdf

Centers for Disease Control and Prevention

National Center for Immunization and Respiratory Diseases Extramural Research Program Office

Economic Studies of Immunization Policies and Practices

RFA-IP-15-001

Application Due Date: 03/03/2015

Economic Studies of Immunization Policies and Practices

RFA-IP-15-001

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 and Prevention Components of Participating Organizations National Center for Immunization and Respiratory Diseases Extramural Research Program Office (NCIRD

ERPO)

National Center for Immunization and Respiratory Diseases (NCIRD) Funding Opportunity Announcement (FOA) Title Economic Studies of Immunization Policies and Practices Activity Code U01 Research Project Cooperative Agreements

Funding Opportunity Announcement Type New Funding Opportunity Announcement Number

RFA-IP-15-001

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.083 Category of Funding Activity:

Health FOA Purpose Amendment I. A Summary of the Conference Call held on Tuesday, January 20, 2015 with Potential Applicants for Funding Opportunity Announcement (FOA): IP15-001 “Economic Studies of Immunization Policies and Practices” and Answers to Potential Applicant Questions has been added in red text as an amendment to this FOA in Section VIII. on pages 30-31.

The purpose of this funding announcement is to obtain economic information about vaccines and immunization policies, programs, and practices using economic and decision analyses and other appropriate methods. The results of these economic studies will be used to help inform policy and the development of effective interventions.

Key Dates Publication Date: To receive notification of any changes to RFA-IP-15-001, 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: 02/03/2015

Application Due Date: 03/03/2015

On-time submission requires that electronic applications be error-free and made available to CDC for 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: 04/15/2015

Secondary Review: 04/22/2015

Estimated Start Date: 09/01/2015

Expiration Date: 03/04/2015 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 25 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

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. The U.S. Advisory Committee on Immunization Practices (ACIP) provides advice and guidance to the Secretary of the Department of Health and Human Services, the Assistant Secretary for Health, and the CDC on the control of vaccine-preventable diseases, leading to a reduction in incidence and to the safe use of vaccines and related biological products, reducing the disease burden through timely and appropriate vaccinations and the overall economic impact to public health. The Committee develops written recommendations for the routine administration of vaccines to children, adolescents, and adults in the civilian population, including age for administration, number of doses and dosing interval, and precautions and contraindications.

Current routine vaccination recommendations made by the ACIP include 13 vaccines against 16 diseases for children aged 0 through 18 years, and more than 10 vaccines for adults aged 19 and older who have not been vaccinated or who are at high risk. More than half of the doses for childhood vaccination are purchased in the public sector, largely by way of the Federal Vaccines for Children and Section 317 Immunization Grant programs. Together, they account for over $4 billion worth of vaccine purchases.

The purpose of this funding announcement is to obtain economic information about vaccines and immunization policies, programs, and practices using economic and decision analyses and other appropriate methods. The results of these economic studies will be used to help inform policy and the development of effective interventions.

http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

Mechanism of Support. Cooperative Agreement Funds Available and Anticipated Number of Awards. Estimated total funding available, to include direct and indirect costs for the entire project period, is $900,000. The project period will be three years. There will be one award. The award issued under this FOA is contingent upon availability of funds and the total number of meritorious applications received.

Budget and Project Period. The estimated total funding (direct and indirect) for the first year (12 month budget period) will be $300,000. The estimated total funding (direct and indirect) for the second year (12 month budget period) will be $300,000 and for the third year (12 month budget period) will be $300,000. The estimated total funding (direct and indirect) for the entire project period will be $900,000. The project period will run from 09/01/2015 to 08/31/2018.

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 this project.

Number of Applications. Each eligible applicant institution may submit only one application.

Application Type. New Special Date(s). A potential applicant conference call will be held on Tuesday, January 20, 2015 from 10:00 am to 11:00 am Eastern Time. The bridgeline number is 1-866-662-8986;

passcode 8378091.

Application Materials. See Section IV.1 for application materials. Please note that Form C is to be used when downloading the application package:

http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

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

Section 301 of the Public Health Service Act (42 U.S.C. 241).

1. Background and Purpose

The U.S. Advisory Committee on Immunization Practices (ACIP) provides advice and guidance to the Secretary of the Department of Health and Human Services, the Assistant Secretary for Health, and the CDC on the control of vaccine-preventable diseases, leading to a reduction in incidence and to the safe use of vaccines and related biological products, reducing the disease burden through timely and appropriate vaccinations and the overall economic impact to public health. The Committee develops written recommendations for the routine administration of vaccines to children, adolescents, and adults in the civilian population, including age for administration, number of doses and dosing interval, and precautions and contraindications.

Current routine vaccination recommendations made by the ACIP include 13 vaccines against 16 diseases for children aged 0 through 18 years, and more than 10 vaccines for adults aged 19 and older who have not been vaccinated or are at high risk. More than half the doses for childhood vaccination are purchased in the public sector, largely by way of the Federal Vaccines for Children and Section 317 Immunization Grant programs. Together, they account for over $4 billion worth of vaccine purchases.

The purpose of this funding announcement is to obtain economic information about vaccines and immunization policies, programs, and practices using economic and decision analyses and other appropriate methods. The results of these economic studies will be used to help inform policy and the development of effective interventions.

Three studies will be conducted, including an analysis of the financial, economic, and epidemiologic relationships between vaccine-preventable infectious diseases and chronic diseases in adult populations, and the opportunity costs for immunization of failure to prevent chronic diseases. The specific vaccine-preventable disease(s) (VPD) and chronic disease(s) in the first study may include, but need not be limited to, the following: influenza and pneumococcal diseases and diabetes.

The application should include details for an approach to address the Research Objectives listed for Study 1 in Section I.2 below.

Two additional studies should be conducted on the following topics:

Study 2: Estimation of the cost of norovirus disease using traditional economic approaches along with dynamic infectious disease models;

Study 3: An analysis of issues related to provider reimbursement for adult vaccination services and their effects on vaccination of adults. The applicant should describe details for an approach to address the Research Objectives listed for Study 2 and Study 3 in Section I.2.

below.

Healthy People 2020 and other National Strategic Priorities

The NCIRD of CDC within HHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2020" and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA). This FOA addresses the “Healthy People 2020” focus area of Immunization and Infectious Diseases; specifically, the “Healthy People 2020” objectives that call for increasing the proportion of adults who are vaccinated with influenza, pneumococcal, Tdap and zoster vaccines and reducing the number of hepatitis A and hepatitis B illnesses, including through the use of vaccination. It also addresses the “Healthy People 2020” objectives that call for achieving and maintaining effective vaccination coverage levels for universally recommended vaccines among young children and adolescents. This FOA is in alignment with HHS/CDC/NCIRD’s performance goal(s) to reduce the number of indigenous vaccine-preventable diseases ( http://www.cdc.gov/fmo/PDFs/FY09_CDC_Online_Performan ce_Appendix.pdf). For more information, please see http://www.healthypeople.gov/2020/topics-objectives /topic/immunization-and-infectious-diseases

Public Health Impact http://www.cdc.gov/fmo/PDFs/FY09_CDC_Online_Performance_Appendix.pdf http://www.cdc.gov/fmo/PDFs/FY09_CDC_Online_Performance_Appendix.pdf http://www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases http://www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases

Many vaccines for adults are recommended based on risk status, notably the presence of chronic disease. The net cost of transition from a non-chronic-disease state to a chronic-disease state includes the cost of vaccination based on risk status and the medical costs of treating chronic diseases. Any savings that can be realized by not having to vaccinate adults who can be prevented from entering a chronic disease state (thereby averting morbidity and mortality) can be used in other public health priority areas, as can medical care savings from prevention of chronic disease.

Awareness of the cost and disease patterns associated with norovirus is necessary to set priorities for evaluation of potential norovirus prevention interventions. Effective and cost-effective interventions can prevent large numbers of cases of norovirus infection and avert substantial medical costs.

Study 3 will be an assessment of provider knowledge, practices, and experience related to insurance reimbursement policies and procedures. The information obtained will be used to educate providers and payers to facilitate improvement of adult vaccination. Successful assessment and education will lead to reduced morbidity and mortality associated with vaccine preventable diseases in adults.

Relevant Work

Pneumococcal ACIP Vaccine Recommendations, http://www.cdc.gov/vaccines/hcp/acip-recs/vacc-speci fic/pneumo.html

Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine for Adults with Immunocompromising Conditions: Recommendations of the Advisory Committee on Immunization Practices (ACIP), http://www.cdc.gov/mmwr/preview/mmwrhtml/mm614 0a4.htm

Cho BH, Stoecker C, Link-Gelles R, Moore, MR. “Cost-effectiveness of administering 13-valent pneumococcal conjugate vaccine in addition to 23-valent pneumococcal polysaccharide vaccine to adults with immunocompromising conditions.” Vaccine. 2013 Dec 5;31(50):6011-21.

Influenza ACIP Vaccine Recommendations, http://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/flu .html

Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP) — United States, 2014–15 Influenza Season, http ://www.cdc.gov/mmwr/preview/mmwrhtml/mm6332a3.htm

Diabetes & Flu: What You Need to Know and Do, http://www.cdc.gov/diabetes/news/flu.htm Colquhoun AJ, Nicholson KG, Botha JL, Raymond NT. “Effectiveness of influenza vaccine in reducing hospital admissions in people with diabetes.” Epidemiol. Infect. (1997), 119, 335-341

2. Approach

Objectives/Outcomes

The goal of Study 1 is to better understand the financial, economic, and epidemiologic relationships between vaccine preventable infectious diseases and chronic disease(s) in adult populations, and the opportunity costs for immunization of failure to prevent chronic diseases. The specific vaccine-preventable disease(s) (VPD) and chronic disease(s) in the first study may include, but need not be limited to, the following: influenza and pneumococcal diseases and diabetes.

The Objectives for Study 1 are to:

1. Estimate the differences in cost-of-illness (COI) between adults in a specific VPD state who are versus are not in a specific chronic disease state.

http://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/pneumo.html http://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/pneumo.html http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6140a4.htm http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6140a4.htm http://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/flu.html http://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/flu.html http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6332a3.htm http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6332a3.htm http://www.cdc.gov/diabetes/news/flu.htm

2. Estimate the likelihood of longer-term sequelae associated with the two groups described in Objective 1.

3. Estimate the COI of longer-term sequelae associated with the two groups described in Objective 1.

4. Estimate the differences in COI between adults in a chronic disease state who have versus have not been vaccinated against a specific VPD.

5. Estimate the net cost of preventing transition from the non-chronic-disease state to the chronic-disease state, including the costs averted by eliminating the need to vaccinate based on risk status.

The goal of Study 2 is to proportionally attribute the health and economic burden of norovirus disease by viral strain, route of transmission, specific food commodities, and contamination pathways. Norovirus vaccines are under development. A cost analysis as proposed in this study will allow rapid conduct of necessary cost-effectiveness, cost-utility, and cost-benefit analyses as soon as vaccines are available.

The Objectives for Study 2 are to:

1. Generate cost estimates corresponding to the characteristics noted in the study goal above.

2. Estimate medical, indirect and out-of-pocket costs accrued to payers, patients sick with norovirus, and caregivers.

3. Integrate traditional economic approaches with dynamic infectious disease models to examine the population-level effects of interventions, including norovirus vaccination.

The goal of Study 3 is to develop a better understanding of health and economic issues related to provider reimbursement for adult vaccination services and their effects on vaccination of adults.

The Objectives for Study 3 are to:

1. Characterize provider understanding of policies and procedures for reimbursement for adult immunization services.

2. Assess provider vaccine stocking and recommendation practices and how they are affected by reimbursement policies and procedures.

3. Quantify and categorize the reasons for rejection of claims for adult immunization services at the provider level.

In general, methods will be those used in economic analysis and evaluation. Analytic methods may include econometrics, decision analysis, conjoint analysis, contingent valuation, and/or others. Evaluation methods may include benefit-cost analysis, cost-utility analysis, and cost-effectiveness analysis. Specific methods may vary by study.

Target Population

Major adult age groups and target groups for vaccination based on occupation, health conditions, and/or lifestyle. (See http://www.cdc.gov/vaccines/schedules/hcp/adult.html)

Collaboration/Partnerships http://www.cdc.gov/vaccines/schedules/hcp/adult.html

The awardee should be able to assemble a research team with demonstrated experience in conducting vaccine policy analysis and health economic studies of vaccine preventable diseases from multiple perspectives. The awardee’s team should also be capable of employing multiple methods including benefit-cost analysis, contingent valuation, and conjoint analysis/discrete choice experiments. Economic and decision analyses conducted from a societal perspective and sub-perspectives should be the main research approaches used. Other analytic methods may be included. The awardee should collaborate with economists and disease/vaccine subject matter experts in NCIRD and CDC’s National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP). Applicants should detail a plan and process for collaborating with CDC staff to identify, prioritize, and devise timelines for multiple inquiries per year, including the ability to modify priorities/timelines as needed but within the scope of the proposed work. Applicants should be prepared to collaborate with CDC project staff and other CDC technical experts to develop and refine study objectives, methods, and data collection instruments. Applicants should be prepared to collaborate with CDC staff on data analysis plans and revision of manuscripts and other products resulting from this FOA.

Evaluation/Performance Measurement

The application should include an evaluation/performance measurement plan. Progress should be identified by achievement of relevant milestones which may include, but not be limited to, accumulation of relevant literature on costs of the subject vaccines and chronic disease states, identification of available and non-existing data for cost and epidemiologic inputs, and other relevant measures associated with the other studies to be conducted under the award. At a minimum, the plan should:

Describe how key CDC economics and disease expert collaborators will participate in the evaluation and performance measurement planning processes.

Describe the type of evaluations (i.e., process, outcome, or both) to be conducted.

Describe key evaluation questions.

Describe other information (e.g., performance measures to be developed by the applicant).

Describe potentially available data sources and feasibility of collecting appropriate evaluation and performance data.

Include objectives written in the SMART format and provide attributes that are Specific, Measurable, Achievable, Realistic and Time-bound.

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.

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: $900,000

Year 1: $300,000 Year 2: $300,000 Year 3: $300,000 Number of awards = 1 Estimated total funding available for the first year (12-month budget period) is $300,000 Estimated total funding available for entire project period is $900,000 for 3 years, including direct and indirect costs.

The award ceiling and floor descriptions below are for the first 12-month budget period.

Anticipated Number of Awards: 1

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

Award Ceiling: $300,000 Per Budget Period Award Floor: $0 Per Budget Period Total Project Period Length: 3 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/ asfr/ogapa/aboutog/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: 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) http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf

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 Private institutions of higher education For profit organizations other than small businesses Small businesses

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

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

Nonprofits Other Than Institutions of Higher Education:

Nonprofits (Other than Institutions of Higher Education)

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" when submitting via www.grants.gov.

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 include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Special Eligibility Requirements

N/A

4. Justification for Less than Maximum Competition

N/A

5. Responsiveness

To be responsive to this FOA, applicants must:

Address all study objectives listed under Studies 1, 2 and 3 (see Part 2. Section I.2. Research Objectives/Outcomes in this FOA).

Include in the application evidence of past performance in the form of an investigative team having conducted health services/economic research or immunization-related research and published related findings in a peer-reviewed journal.

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 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.

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 http://fedgov.dnb.com/webform 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/ asfr/ ogapa/ aboutog/ hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement, (http://www.hhs.gov/asfr/ogapa/aboutog/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 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 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 Procurement and Grants Office Technical Information Management Section (PGO TIMS) staff at (770) 488-2700 or pgotim@cdc.gov for further instructions. Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern Standard 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/funding/ 424/SF424_RR_Guide_General_VerC.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 https://www.sam.gov/index.html http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.Grants.gov mailto:pgotim@cdc.gov requirements from the data collected in the SF424 (R&R) components. A complete application to CDC will include SF424 (R&R) and PHS398 components.

3. Letter of Intent Due Date for Letter of Intent: 02/03/2015

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 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 Number and title of this funding opportunity

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 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 Part I, Section 5.5 of the SF 424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.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).

mailto:GAnderson@cdc.gov

Follow the page limits stated in the SF 424 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 unless otherwise specified in the FOA.

All instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf) must be followed along with any additional instructions provided in the FOA.

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 25 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.

8. Format for Attachments

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 (Part I, Section 2) (http://grants.nih.gov/ grants/funding/424/ SF424_RR_Guide_General_VerC.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.

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 CDC PGO TIMS at http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://grants.nih.gov/grants/guide/url_redirect.htm?id=11128 http://www.grants.gov/ http://grants.nih.gov/grants/guide/url_redirect.htm?id=11123 mailto:support@grants.gov system errors cannot be resolved, applicants must contact CDC PGO TIMS at 770-488-2700; www.pgotim@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: 03/03/2015

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 terms and conditions, cost principles, 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/asfr/ogapa/aboutog/hhsgps107.pdf.

Funds relating to the conduct of research involving human subjects will be restricted until appropriate assurances and Institutional Review Board approvals are in place.

12. Other Submission Requirements and Information

Projects that involve the collection of information, identical record keeping or reporting from 10 or more individuals and are funded by a grant/cooperative agreement and constitute a burden of time, effort, and/or resources expended to collect and/or disclose the information may be subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act.

mailto:support@grants.gov mailto:www.pgotim@cdc.gov http://www.whitehouse.gov/omb/grants_spoc

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 Procurement and Grants Office (PGO) and responsiveness by PGO 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

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.

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 http://www.cdc.gov/about/organization/mission.htm

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?

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)?