PKG00264150-instructions.pdf

Centers for Disease Control and Prevention

National Center for Immunization and Respiratory Diseases Extramural Research Program

Office

Promoting the Importance of Infant and Childhood Vaccination Among Pregnant Women by

Prenatal Care Providers

RFA-IP-21-001

Application Due Date: 02/02/2021

Promoting the Importance of Infant and Childhood Vaccination Among Pregnant Women by

Prenatal Care Providers

RFA-IP-21-001

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 Notice of Funding Opportunity (NOFO) Title Promoting the Importance of Infant and Childhood Vaccination Among Pregnant Women by Prenatal Care Providers Activity Code U01 – Research Project - Cooperative Agreement Please see Section VI.4. "Cooperative Agreement Terms and Conditions" for more information regarding substantial Federal scientific or programmatic involvement.

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

RFA-IP-21-001

Assistance Listings (CFDA) Number(s) 93.185 93.083 Category of Funding Activity:

Health NOFO Purpose The purpose of this notice of funding opportunity is to investigate the acceptability, feasibility, and effectiveness of promoting infant immunization during prenatal care visits, leading parents to vaccinate their children confidently. Prenatal care providers, including obstetricians and midwives, are trusted sources of information for pregnant women, yet many feel uncomfortable providing information or discussing concerns about infant vaccination, likely because they consider this to be outside their area of expertise. This represents a significant missed opportunity to provide important information to pregnant women from a trusted source, at a critical time, when research suggests maternal opinions about childhood vaccination are forming.

Key Dates Publication Date: To receive notification of any changes to RFA-IP-21-001, 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: 01/05/2021 https://www.grants.gov

Application Due Date: 02/02/2021

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 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: 04/13/2021

Secondary Review: 05/13/2021

Estimated Start Date: 09/01/2021

Expiration Date: 02/03/2021 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.

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

Note: The Research Strategy component of the Research Plan is limited to 20 pages.

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

Pages that exceed page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

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

Executive Summary

Purpose: The purpose of this notice of funding opportunity is to investigate the acceptability, feasibility, and effectiveness of promoting infant immunization during prenatal care visits, leading parents to vaccinate their children confidently. Prenatal care providers, including obstetricians and midwives, are trusted sources of information for pregnant women, yet many feel uncomfortable providing information or discussing concerns about infant vaccination, likely because they consider this to be outside their area of expertise. This represents a significant missed opportunity to provide important information to pregnant women from a trusted source, at a critical time, when research suggests maternal opinions about childhood vaccination are forming.

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 $1,500,000. The anticipated number of awards is one (1). 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 $500,000, 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 $1,500,000. The project period is anticipated to run from 9/01/2021 to 8/31/2024.

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. 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 F is to be used when completing the application package.

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority Public Health Service Act, Section 317(k)(1) [42 USC 247b(k)(1)], as amended.

1. Background and Purpose Although overall childhood vaccination coverage is high in the United States, vaccine hesitancy leading to the delay or refusal of vaccination is a growing concern. Health care providers are consistently rated as the parent’s most trusted source of vaccine information, and discussions and recommendations from a health care provider are the leading reasons that parents who initially planned to delay, or refuse, vaccines change their mind to acceptance. Thus, development of effective, evidence-based strategies to improve parent-provider vaccine conversations is critical for strengthening vaccine confidence among parents.

Evidence suggests that the prenatal period is a critical time for vaccine discussions, as most mothers make vaccine decisions for their child before or during pregnancy. Despite the desire for more information on pediatric vaccines from a healthcare provider, expectant mothers may have limited opportunities to have these discussions and, frequently, turn to the internet, media, or word of mouth for more information. In the process, they may encounter information on infant/child vaccination which may be unreliable and not evidence-based. This may lead women and expectant parents to question the safety or necessity of following Advisory Committee on Immunization Practices (ACIP) recommendations for their child. In the worst-case scenario, exposure to such information may lead to children missing recommended vaccines, leaving them susceptible to serious, and sometimes deadly, vaccine-preventable diseases.

Prenatal care providers, including obstetricians and midwives, are trusted sources of information for pregnant women. Prenatal providers may receive requests for information about newborn vaccination from expectant parents but may not feel comfortable providing information, or discussing concerns about infant vaccination, likely because they consider this to be outside their area of expertise. This represents a significant missed opportunity to provide important information to pregnant women from a trusted source, at a critical time, when maternal opinions about childhood vaccination are likely forming.

This funding opportunity seeks to investigate the acceptability, feasibility, and effectiveness of promoting infant immunization during prenatal care visits, leading parents to vaccinate their children confidently.

Healthy People 2030 and other National Strategic Priorities This NOFO relates to the following Healthy People 2030 objectives:

IID-01: Maintain the elimination of measles, rubella, congenital rubella syndrome (CRS), and acute paralytic poliomyelitis

IID-02: Reduce the proportion of children who receive 0 doses of recommended vaccines by age 2 years

IID-03: Maintain the vaccination coverage level of 1 dose of the measles-mumps-rubella (MMR) vaccine among children by age 2 years

IID-04: Maintain the vaccination coverage level of 2 doses of the measles-mumps-rubella (MMR) vaccine for children in kindergarten

IID-05: Reduce cases of pertussis among infants IID-06: Increase the vaccination coverage level of 4 doses of the diphtheria-tetanus-acellular pertussis (DTaP) vaccine among children by age 2 years IID-07: Reduce infections due to human papillomavirus (HPV) types prevented by the

9-valent vaccine in young adults IID-08: Increase the proportion of adolescents who receive recommended doses of the human papillomavirus (HPV) vaccine IID-09: Increase the proportion of people who get the flu vaccine every year IID-10: Reduce the rate of hepatitis A IID-11: Reduce the rate of acute hepatitis B

This NOFO also relates to CDC’s Vaccinate with Confidence strategic framework to strengthen vaccine confidence and prevent outbreaks of vaccine-preventable diseases in the United States.

Specifically, this work will help achieve the priority of empowering parents to make vaccine decisions by starting vaccine conversations early and strengthening provider-parent vaccine discussions.

Public Health Impact Under-vaccination can lead to a resurgence of vaccine-preventable diseases. For example, in 2019, under-vaccination contributed to a 30-year high in reported measles cases in the United States. The primary driver of these outbreaks was hesitancy by parents to vaccinate their children on time and according to the schedule recommended by the Advisory Committee on Immunization Practices. In turn, vaccine hesitancy is informed by misinformation.

This NOFO seeks to provide factual immunization information and correct any immunization-related misinformation consumed by expectant parents, before a child is born, in the hope that parents will be empowered with evidence-based information, as opposed to myths and misinformation, and will be confident about their decision to vaccinate their child according to the recommended schedule.

Relevant Work CDC recommends that pregnant women receive influenza vaccine and tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) during pregnancy, as this can reduce influenza and pertussis risk for themselves and their infants. Therefore, prenatal care providers are likely familiar with the importance of vaccination and have engaged in discussions with patients. However, discussions around vaccinating infants may be less familiar to this group.

Recent CDC-related work relevant to this NOFO includes the following:

1. RFA-IP-19-002 is a CDC-sponsored funding opportunity that is currently conducting research focused on increasing influenza and Tdap vaccination of pregnant women in OB/GYN practices in large health systems through Quality Improvement interventions.

Participating practices will be implementing evidence-based quality improvement strategies that have previously been shown to increase vaccination rates, thus improving vaccination coverage among pregnant women. Comparisons will be made of baseline and follow-up data in the same practice, as well as comparisons between intervention and control groups, to determine the most effective strategy, or combination of strategies, to increase vaccination coverage among pregnant women. Baseline and follow-up data will also be obtained to determine: 1) whether quality improvement interventions impacted providers’ knowledge, attitudes, and behaviors related to the National Vaccine Advisory Committee’s Standards for Adult Immunization Practice; 2) whether the providers think they are making strong vaccine recommendations to their patients; 3) the value they place on adult immunizations; and 4) any perceived or real barriers they have to implementing the Standards for Adult Immunization Practice and/or to vaccinating their patients.

2. CDC has conducted formative communications research with pregnant women and certified nurse midwives (CNMs) in recent years. A study of first-time expectant mothers found that the majority of participants made decisions about their babies’ vaccines while still pregnant, and these decisions remained stable over time. Most appeared to be receptive to immunization information, but relatively few were receiving it from obstetricians, midwives, or physicians. Topline findings from recent research with CNMs showed that CNMs discuss childhood vaccines with their pregnant patients less often than maternal vaccines and that CNMs were less confident in their ability to answer questions about childhood vaccines as compared to questions about maternal vaccines.

Other relevant work:

1. Mbaeyi S, Cohn A, Messonnier N. Pediatrics June 2020, 145 (6) e20200390. DOI: https ://doi.org/10.1542/peds.2020-0390

2. Paterson P, Meurice F, Stanberry L, et al. Vaccine hesitancy and healthcare providers.

Vaccine (2016) DOI: http://dx.doi.org/10.1016/j.Vaccine.2016.10.042

3. Wroe AL, Turner N, Salkovskis PM. Understanding and predicting parental decisions about early childhood immunizations. Health Psychol. 2004; Jab 23(1):33-41.

4. Danchin M, Costa-Pinto J, Attwell K, et al. Vaccine decision-making begins in pregnancy: Correlation between vaccine concerns, intentions and maternal vaccination with subsequent childhood vaccine uptake. Vaccine (2018). 36 (44), 6473-6479. DOI:

http://dx.doi.org/10.1016/j.Vaccine.2016.10.042

5. Vaccinating with Confidence. Protect communities. Empower families. Stop myths.

Available at: https://www.cdc.gov/vaccines/partners/vaccinate-with-confidence.html

6. Advisory Committee on Immunization Practices Child schedule. Recommended Child and Adolescent Immunization Schedule for ages 18 years or younger, United States, 2020. Available at: https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent .html https://doi.org/10.1542/peds.2020-0390 https://doi.org/10.1542/peds.2020-0390 http://dx.doi.org/10.1016/j.Vaccine.2016.10.042 http://dx.doi.org/10.1016/j.Vaccine.2016.10.042 https://www.cdc.gov/vaccines/partners/vaccinate-with-confidence.html https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html

7. Patel M, Lee AD, Clemmons NS, et al. National Update on Measles Cases and Outbreaks — United States, January 1–October 1, 2019. MMWR Morb Mortal Wkly Rep 2019;68:893–896. DOI: http://dx.doi.org/10.15585/mmwr.mm6840e2

8. Guidelines for vaccinating pregnant women. Available at: https://www.cdc.gov/vaccines /pregnancy/hcp-toolkit/guidelines.html

2. Approach The application should propose recruiting multiple prenatal care practices (obstetrical and, optionally, midwifery), in one or more geographic areas, that do not currently include in their prenatal care protocols a planned discussion about infant or childhood vaccination. Populations under study should include both rural and urban populations, and racially/ethnically diverse populations. Participating practices should agree to be randomized to one of the following study groups:

1. Control group: All providers in practices follow existing standards of care.

2. Intervention group: All providers in the practice implement the intervention for pregnant patients expecting their first child.

Intervention: The application should propose a protocol that includes a formal discussion with pregnant patients expecting their first child about infant and child vaccination to be delivered at specific prenatal encounters, and with the provision of specific educational materials that promote the importance of infant/childhood vaccination, outline what to expect (e.g., the ACIP schedule), and dispel myths/misinformation about infant/child vaccination. The application should describe how the award recipient will collaborate with prenatal care providers, or organizations, to ensure the protocol is practical and acceptable to implement.

The application should describe how the award recipient will ensure appropriate training and education of staff at participating practices randomized to the intervention group. This training and education should include an overview of childhood vaccination in general (e.g., ACIP-recommended schedule) as well as how to implement the study protocol in a consistent manner.

The application should describe what materials will be provided to patients and can either be newly developed by the award recipient, adapted from existing materials, or pre-existing.

Message testing for comprehensibility and acceptability of all newly developed, adapted, and existing materials should be conducted and/or documented. This step may be waived if there is written documentation and evidence that the materials have already been appropriately tested in a patient population similar to that of the study population. If materials will be newly developed, conducting formative research should be included. All formative research and testing of new materials should be done among a population of pregnant women who are similar to, but not the same as, those receiving care from practices participating in the study. Results of the formative research and testing must be complete prior to implementing the intervention phase of the study.

Assessment of study outcomes: Intervention success should be assessed by comparing study groups on the following outcomes:

1. Short term: As assessed via surveys and possibly other means, changes in patient attitudes and intentions related to infant and childhood vaccination prior to and after the http://dx.doi.org/10.15585/mmwr.mm6840e2 https://www.cdc.gov/vaccines/pregnancy/hcp-toolkit/guidelines.html https://www.cdc.gov/vaccines/pregnancy/hcp-toolkit/guidelines.html point in pregnancy when the intervention versus standard of practice has been delivered.

2. Intermediate term: As assessed via surveys and possibly other means, attitudes and intentions about the child related to infant and child vaccination assessed after delivery of their first child, at one or more specific points, based on the age of the child.

3. Long term: Among infants at 6 to 18 months of age, age-appropriate infant vaccination status according to the ACIP-recommended schedule. Vaccination records can be assessed using immunization information system searches and/or pediatric practice medical record review (parent self-report is not considered acceptable).

In addition, an assessment of the acceptability, feasibility, and cost of the intervention should be conducted from the practice, provider, and patient perspective. This assessment could include surveys, interviews, and/or focus groups of providers and patients in practices randomized to the intervention group.

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

At the end of the project period, the award recipient should be able to:

Describe changes in vaccine attitudes and intentions among pregnant women between the baseline and subsequent assessments within the intervention arm.

Describe whether the intervention, in comparison to standard of care, led to positive attitudes and intentions by pregnant women expecting their first child in terms of vaccinating their child according to the ACIP-recommended schedule.

Describe whether the intervention was successful in leading to greater infant vaccination that is in accordance with ACIP recommendations.

Describe whether the intervention was feasible and acceptable for prenatal providers and patients, and cost-effective to implement.

Make a statement about whether such an intervention is recommended, in a modified or unmodified form, to be used widely by similar prenatal care practices.

As appropriate, develop an implementation plan that can be used by appropriate stakeholders (e.g., health systems, immunization programs, professional associations) for scaling up the activity to be used by additional practices.

Target Population The target population for this research activity should be women who are pregnant with their first child who are receiving prenatal care at an obstetrical or midwifery practice. Populations under study should include both rural and urban populations, and racially/ethnically diverse populations. Practices that are geographically, socio-economically, and racially and ethnically diverse are encouraged.

Collaboration/Partnerships Collaborating with the state or local immunization program as well as relevant local professional organizations (e.g., American College of Obstetrics and Gynecology, American

Association of Pediatrics) is recommended. If the applicant is unable to demonstrate strong subject matter expertise in both obstetrical care and immunization services, establishing such collaborations and partnerships is critical.

The application should also describe how expertise from partners will be incorporated into the study team, to ensure appropriate guidance as the study is developed and implemented.

Applicants are encouraged to include letters of support from proposed collaborators (e.g., healthcare professional organizations, state/local immunization programs) indicating support and intent to participate in the project.

Evaluation/Performance Measurement The application should include measurable goals and aims based on a three (3)-year research project period. The application should describe 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 application should describe milestones and a timeline to achieve those milestones. In addition, the application should describe detailed plans to track progress toward the outcomes of the project.

PI’s of funded applications must submit an annual progress report showing project activities and outcomes based on the overall research goals and timeline. For more information on required Reporting, please see Section VI. of this NOFO.

Translation Plan The application should describe plans for how research findings will be reported and disseminated (e.g., peer-reviewed journals, scientific presentations) and specify how these activities are integrated into the three (3)-year project plan. Dissemination plans could include drafting of manuscripts for peer-reviewed publication, submission of abstracts to scientific conferences, and/or presentation of findings before national advisory committees or organizations to which research results are relevant.

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: $1,500,000

Estimated Total Funding for the entire three(3)-year project period, including direct and indirect costs: $1,500,000.

Estimated Total Funding for the first year (12-month budget period), including direct and indirect costs: $500,000.

Anticipated Number of Awards: 1

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

Award ceiling and floor are for the first 12-month budget period only.

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 http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf higher education Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled "Additional Information on Eligibility" for clarification)

Additional Eligibility Category:

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."

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. Additional Information on Eligibility

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

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

4. Justification for Less than Maximum Competition N/A

5. Responsiveness If an applicant requests a funding amount greater than the ceiling of $500,000, including direct and indirect costs, for the first 12-month budget period as indicated in Section II. of this NOFO, HHS/CDC will consider the application non-responsive and it will not enter into the review process. HHS/CDC will notify the applicant that the application did not meet the submission requirements.

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

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https://cage.dla.mil/

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/index.html .

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 https://cage.dla.mil/ https://www.sam.gov/index.html https://www.Grants.gov https://era.nih.gov/ https://www.grants.gov 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 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 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

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 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-f/general-forms-f.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.

Letters of Support from partners or other organizations should be placed in the PHS 398 Research Plan "Other Research Plan Section" of the application under "9. Letters of Support".

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

Mandatory https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf 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-f/general-forms-f.pdf

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].

If multiple collaborating institutions will be involved, please include in this section of the application your single IRB (sIRB) Plan:

Describe how you will comply with the single IRB review requirement under the Revised Common Rule at 45 CFR 46.114 (b) (cooperative research). If available, provide the name of the IRB that you anticipate will serve as the sIRB of record.

Indicate that all identified engaged institutions or participating sites will agree to rely on the proposed sIRB and that any institutions or sites added after award will rely on the sIRB.

Briefly describe how communication between institutions and the sIRB will be handled.

Indicate that all engaged institutions or participating sites will, prior to initiating the study, sign an authorization/reliance agreement that will clarify the roles and responsibilities of the sIRB and participating sites.

Indicate which institution or entity will maintain records of the authorization/reliance agreements and of the communication plan.

Note: Do not include the authorization/reliance agreement(s) or the communication plan(s) documents in your application.

Note: If you anticipate research involving human subjects but cannot describe the study at the time of application, include information regarding how the study will comply with the single Institutional Review Board (sIRB) requirement prior to initiating any multi-site study in the delayed onset study justification.

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: 01/05/2021

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 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

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 US8-1 Atlanta, GA 30333 Telephone: 404-718-8833 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-f/general-forms-f.pdf and http://grants.nih.gov/grants/how-to-apply-application-guide.htm 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, https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf 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-f/general-forms-f.pdf and here: http://grants.nih.gov/grants/how-to-apply-application-guide.htm 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 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:

• 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;

https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf 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 deidentified data).

Examples of DMPs may be found here: USGS, http://www.usgs.gov/products/data-and-tools/data-management/data-management-plans or University of California https://dmp.cdlib.org/ Letters of Support from partners or other organizations should be placed in the PHS 398 Research Plan "Other Research Plan Section" of the application under "9. Letters of Support".

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.

PLEASE NOTE all page limitations in this NOFO. Pages over the limit may be removed and not peer reviewed, possibly negatively affecting the overall impact score and funding.

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 20 pages.

Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 25 pages for all appendices. Pages that exceed page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

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-f/general-forms-f.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 http://www.usgs.gov/products/data-and-tools/data-management/data-management-plans http://www.usgs.gov/products/data-and-tools/data-management/data-management-plans 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…