RFA-IP-25-111_20241204.pdf

Centers for Disease Control and Prevention

NATIONAL CENTER FOR IMMUNIZATION AND RESPIRATORY DISEASES

Rapid-Cycle Survey Collaborative for Provider and Public Input on Immunization Issues

RFA-IP-25-111

02/06/2025

Table of Contents 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

Overview

Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations Components of Participating Organizations:

National Center for Immunization and Respiratory Diseases Notice of Funding Opportunity (NOFO) Title Rapid-Cycle Survey Collaborative for Provider and Public Input on Immunization Issues Activity Code U01 – Research Project - Cooperative Agreements

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

RFA-IP-25-111

Assistance Listings Number(s) 93.185 Category of Funding Activity HL - Health NOFO Purpose The purpose of this notice of funding opportunity (NOFO) is to support a research project to obtain timely input from representative samples of healthcare providers and of the public on critical immunization issues of importance to public health. The recipient is expected to: 1) conduct multiple surveys of providers and the public each year during the period of performance to collect immunization-related data using scientifically sound methods with adequate response rates that produce generalizable results; and 2) to disseminate these results broadly to assist in informing recommendations for new vaccines, developing strategies to improve immunization coverage, and instituting contingency plans to address urgent problems (e.g., vaccine supply shortages). Surveyed healthcare providers may include pediatricians, family physicians, obstetrician/gynecologists, general internists, pharmacists, and nurse practitioners. Surveyed members of the public may include subpopulations of special interest for consideration of immunization-related issues such as pregnant people, parents of children aged 0–5 years, people living in rural areas of the United States, and persons with chronic medical conditions.

Key Dates Publication Date:

To receive notification of any changes to RFA-IP-25-111, 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:

01/06/2025

Application Due Date:

02/06/2025

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 11:59 PM U.S. Eastern Time.

Applicants will use a system or platform to submit their applications through Grants.gov and eRA Commons to CDC. ASSIST, an institutional system to system (S2S) solution, or Grants.gov Workspace are options. ASSIST is a commonly used platform because it provides a validation of all requirements prior to submission and prevents errors.

For more information on 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 http://grants.nih.gov/support/index.html.

• E-mail: commons@od.nih.gov

• Phone: 301-402-7469 or (toll-free) 1-866-504-9552

• Hours: Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding Federal holidays

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:

04/03/2025 Secondary Review:

https://www.grants.gov/ http://grants.nih.gov/support/index.html mailto:commons@od.nih.gov

05/07/2025 Estimated Start Date:

09/01/2025 Expiration Date:

03/07/2025 Required Application Instructions It is critical that applicants follow the instructions in the How to Apply - Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

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

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

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

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

Executive Summary

• Purpose: The purpose of this notice of funding opportunity (NOFO) is to support a research project to obtain timely input from representative samples of healthcare providers and of the public on critical immunization issues of importance to public health. The recipient is expected to: 1) conduct multiple surveys of providers and the public each year during the period of performance to collect immunization-related data using scientifically sound methods with adequate response rates that produce generalizable results; and 2) to disseminate these results broadly to assist in informing recommendations for new vaccines, developing strategies to improve immunization coverage, and instituting contingency plans to address urgent problems (e.g., vaccine supply shortages). Surveyed healthcare providers may include pediatricians, family physicians, obstetrician/gynecologists, general internists, pharmacists, and nurse practitioners. Surveyed members of the public may include subpopulations of special interest for consideration of immunization-related issues such as pregnant people, parents of children aged 0–5 years, people living in rural areas of the United States, and persons with chronic medical conditions.

• Mechanism of Support: U01 - Research - Cooperative Agreement

• Funds Available and Anticipated Number of Awards: The estimated total funding available, including direct and indirect costs, for the entire 5-year period of performance is $3,750,000. The number of awards will be 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 https://grants.nih.gov/grants/how-to-apply-application-guide.html 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 Period of Performance: The estimated total funding (including direct and indirect costs) for the first year (12-month budget period) will be $750,000. The estimated total funding (including direct and indirect costs) for the entire period of performance will be $3,750,000. The period of performance is anticipated to run from 09/01/2025 to 08/31/2030.

• 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. CDC does not make awards to individuals directly. Individuals from organizations that are uniquely prepared to examine research relevant to undeserved 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 entity identifier or UEI number) is allowed.

• Application Type. New

• Application Materials. See Section IV.1 for application materials.

Section I. Funding Opportunity Description Statutory Authority Section 317(k)(1) of the Public Health Service Act, as amended (42 U.S.C. section 247b(k)(1)

1. Background and Purpose Vaccination is considered one of the top ten public health achievements of the 20th century.

Routinely recommended vaccines are safe and highly efficacious against a number of infectious diseases that can cause severe illness, permanent disability, and death. Despite the power of this prevention tool, coverage levels for most recommended vaccines remain below national goals such as those identified by the Healthy People 2030 objectives for vaccination of children, adolescents, and adults.

The U.S. immunization program continues to experience tremendous growth and encounter corresponding challenges. Since 2019, new or significantly revised vaccination recommendations for children, adolescents, and adults have been instituted for herpes zoster, influenza, meningococcal, pneumococcal, respiratory syncytial virus, and COVID-19 vaccines.

In the past five years, the United States has experienced numerous geographically disseminated outbreaks of vaccine-preventable diseases such as meningococcal disease, hepatitis A, polio, and measles, which was declared eliminated from the United States in 2000. Other programmatic challenges have included: 1) supply shortages for various newly-recommended vaccines and immunization products; 2) stagnating vaccination coverage levels for many adults including lack of progress in improving influenza and Tdap vaccination uptake among pregnant people; 3) increasing levels of vaccine hesitancy and dissemination of misinformation about vaccines; and

4) changes in how clinicians provide and are paid for vaccination services with the growth of accountable care organizations and other new payment models for health care.

All these issues were exacerbated by the COVID-19 pandemic, which engendered substantial increases in circulation of vaccine mis- and disinformation as well as disruptions to routine preventive care. Data collected both during and after the peak of the pandemic in the United States demonstrate decreases in receipt of several routinely recommended vaccines among children, adolescents, and adults of all ages, including receipt of influenza vaccine among pregnant people. In addition, longstanding disparities in vaccination of adults based on race/ethnicity, insurance status, geographic location, and other socio demographic factors persist.

When issues like these arise, it is critical to have a mechanism in place to quickly assess the effects of these issues on the immunization community, in particular the outpatient clinical practices that provide most vaccines administered to children, adolescents, and adults in the United States.

The purpose of this notice of funding opportunity (NOFO) is to support a research project to obtain timely input from representative samples of healthcare providers and of the public on critical immunization issues of importance to public health.

Healthy People 2030 and other National Strategic Priorities This NOFO supports the Healthy People 2030 (HP2030) focus area of “immunization and infectious diseases”: https://odphp.health.gov/healthypeople/objectives-and-data/browse-objectives/vaccination. The results of research conducted under this NOFO will be used to inform policies and develop evidence-based vaccination strategies that increase coverage with recommended vaccines for children, adolescents, and adults, in line with multiple HP2030 objectives to increase immunization coverage and decrease the incidence of vaccine-preventable diseases.

Public Health Impact Maintaining and improving coverage with recommended vaccines is critical to reducing morbidity and mortality from vaccine-preventable diseases among all Americans. Improved vaccination coverage provides additional protection for Americans against potentially deadly vaccine-preventable diseases. In addition, pockets of decreased vaccination coverage in specific geographic areas may result in sporadic outbreaks of vaccine-preventable diseases or permit the re-introduction of diseases that were previously eliminated in the United States; the current outbreaks of measles in multiple U.S. states are an example of this phenomenon.

Furthermore, research supported by this NOFO can be used to understand public preference for where to receive emergency use vaccines as well as clinician attitudes towards emergency use vaccines, or use of routine vaccines in an emergency setting or with a new population. Thus, this NOFO can strengthen programmatic efforts that will increase domestic preparedness for potential future infectious disease pandemics. Research conducted under this NOFO will be used by programs and policymakers at all levels to implement programs that support providers and public health officials in increasing vaccination coverage. This NOFO is aligned with the CDC’s priorities of respiratory virus season preparedness and response and support for young families.

Relevant Work https://odphp.health.gov/healthypeople/objectives-and-data/browse-objectives/vaccination https://odphp.health.gov/healthypeople/objectives-and-data/browse-objectives/vaccination

The following recent publications are examples of studies conducted under a previous funding mechanism with a similar purpose to the current NOFO:

1. Scherer AM, Gidengil CA, Gedlinske AM, et al. COVID-19 Vaccination Intentions, Concerns, and Facilitators Among US Parents of Children Ages 6 Months Through 4 Years. JAMA Netw Open. 2022;5(8): e2227437.

2. Scherer AM, Gedlinske AM, Parker AM, et al. Acceptability of Adolescent COVID-19 Vaccination Among Adolescents and Parents of Adolescents - United States, April 15-23, 2021. MMWR Morb Mortal Wkly Rep. 2021;70(28):997-1003.

3. Ryan GW, Askelson NM, Woodworth KR, et al. Unvaccinated Adolescents' COVID-19 Vaccine Intentions: Implications for Public Health Messaging. J Adolesc Health.

2023;73(4):679-685.

4. Kahn R, Zielinski L, Gedlinske A, et al. Health Care Provider Knowledge and Attitudes Regarding Adult Pneumococcal Conjugate Vaccine Recommendations - United States, September 28-October 10, 2022. MMWR Morb Mortal Wkly Rep. 2023;72(36):979-984.

5. Scherer AM, Parker AM, Gidengil CA, et al. COVID-19 Vaccine Uptake and Intentions Following US Food and Drug Administration Approval of the Pfizer-BioNTech COVID- 19 Vaccine. JAMA Intern Med. 2022;182(6):678-680.

6. Gidengil C, Scherer AM, Parker AM, et al. Lyme disease vaccine attitudes and intentions among parents of children aged 5-18 years in the United States. Vaccine.

2024;42(8):1899-1905.

2. Approach The purpose of this NOFO is to support a research project to obtain timely input from representative samples of healthcare providers and of the public on critical immunization issues of importance to public health. The recipient will receive guidance from CDC on the specific topics to be assessed. It is expected that the recipient will conduct a minimum of four (4) surveys each year during the period of performance. The target audience for each survey may vary but will involve either pediatricians, family physicians, obstetrician/gynecologists, general internists, or some combination of the specialties, or members of the public. For some topics, concurrently running surveys of physicians and of the public may be required. Whereas most surveys are expected to have sufficient lead time for development and implementation, it is possible that urgent issues requiring immediate action will arise. It is critical for the recipient to be flexible and able to quickly develop and implement a survey with very little lead time. Furthermore, the recipient should have the ability to obtain high survey response rates in a limited time frame as broadly generalizable data may be urgently necessary to inform development of national immunization recommendations, guidance, or action plans to address emergent public health concerns.

Objectives/Outcomes The objectives of this NOFO are: 1) to conduct multiple surveys of providers and the public each year during the period of performance to collect immunization-related data using scientifically sound methods with adequate response rates that produce generalizable results; and 2) to disseminate these results broadly to assist in informing recommendations for new vaccines, developing strategies to improve immunization coverage, and instituting contingency plans to address urgent problems (e.g., vaccine supply shortages).

Surveyed healthcare providers may include pediatricians, family physicians, obstetrician/gynecologists, general internists, pharmacists, and nurse practitioners. Surveyed members of the public may include subpopulations of special interest for consideration of immunization-related issues such as pregnant people, parents of children aged 0–5 years, people living in rural areas of the United States, and persons with chronic medical conditions.

The short-term expected outcome of this NOFO is increased knowledge of healthcare provider and public knowledge, attitudes, beliefs, and behaviors related to current and potential future national recommendations for use of vaccines in the United States. The medium-term expected outcome of this NOFO is an increased proportion of vaccine recommendations of the Advisory Committee on Immunization Practices are informed by evidence collected from the surveys conducted under this NOFO.

Each of the following activities to achieve the research objectives should be addressed by applicants in the research plan of an application to be considered for funding:

1) Describe the proposed mechanism for conducting surveys of a representative sample of healthcare providers and of the public to collect immunization-related data. The description must specify:

• Methods for construction of the sampling frames

• Sampling procedures

• Process for survey instrument development and testing/validation

• Methods for disseminating survey instruments

• Methods for achieving high response rates (i.e., 60-70% or higher)

• Methods for weighting the data collected to achieve representativeness, if applicable

• Sample timeline for survey development and dissemination, data analysis, provision of results to CDC, and dissemination of results through public forums (e.g., peer-reviewed journals and regional or national conferences)

2) Describe how to conduct a minimum of four (4) surveys per year utilizing the methodology described in objective 1) above. After an application is selected to be awarded, CDC staff will serve as consultants and collaborate with the award recipient to select and prioritize survey topics based on need and urgency.

3) Develop a plan to disseminate survey results broadly via publication in the peer-reviewed literature, presentation at scientific conferences, and provision of results in requested format to national advisory committees and professional groups developing immunization recommendations or policies.

Population of Focus The primary target populations for this project are: 1) healthcare providers including pediatricians, family physicians, general internists, and obstetrician/gynecologists that spend most of their time (i.e., >50%) providing primary care services, including immunizations, to patients; and 2) members of the public, who will be surveyed as patients to whom vaccination services are offered. Sampled physicians must be broadly representative of the universe of board-certified U.S. physicians in their respective specialties. Sampled members of the public must be representative of the U.S. population of interest with respect to age, sex/gender identity, race, ethnicity, geographic region of residence, and urban/rural location of residence. Mechanisms for surveying the public should be flexible as the targeted subpopulation will change for each survey depending on the vaccine or vaccination topic examined. Representativeness of the survey samples may be attained through sampling methods, weighting procedures, or both as needed.

In certain instances, healthcare providers who provide immunizations to patients less frequently may be targeted. These may include medical specialists (e.g. cardiologists, endocrinologists, oncologists, rheumatologists, etc.), pharmacists, and nurses in advanced practice. Specific plans to reach this secondary population are not required, but applicants should propose a flexible survey methodology that can be extended to multiple types of healthcare providers, as needed.

Collaboration/Partnerships Applications should detail a plan and process to identify, prioritize, and devise timelines for a minimum of four (4) surveys per year, including the ability to modify priorities/timelines as needed. The award recipient will receive technical assistance from CDC project staff and other CDC subject matter experts to develop and refine study objectives, methods, data collection instruments, data analysis plans, and revision of manuscripts and other products resulting from this NOFO.

Evaluation/Performance Measurement The application should include measurable goals and aims based on a 5-year research period of performance. 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.

Translation Plan Applicants 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 five-year project plan. For each survey, applicants should anticipate 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.

3. Funding Strategy N/A

Section II. Award Information Funding Instrument Type:

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

Application Types Allowed:

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

Estimated Total Funding:

$3,750,000 Year 1: $750,000

Year 2: $750,000

Year 3: $750,000

Year 4: $750,000

Year 5: $750,000

Anticipated Number of Awards:

Estimated total funding available for the first year (first 12 months), including direct and indirect costs: $750,000

Estimated total funding available for the entire period of performance, including direct and indirect costs: $3,750,000

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

Award Ceiling:

$750,000 Per Budget Period

Award Floor:

$400,000 Per Budget Period

Total Period of Performance Length:

5 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 (https://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.

If you are successful and receive a Notice of Award, in accepting the award, you agree that the award and any activities thereunder are subject to all provisions of 45 CFR Part 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

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

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category:

00 (State governments)

01 (County governments)

02 (City or township governments)

04 (Special district governments)

05 (Independent school districts)

06 (Public and State controlled institutions of higher education)

07 (Native American tribal governments (Federally recognized))

08 (Public housing authorities/Indian housing authorities)

11 (Native American tribal organizations (other than Federally recognized tribal governments))

12 (Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education)

13 (Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education)

20 (Private institutions of higher education)

25 (Others (see text field entitled "Additional Information on Eligibility" for clarification))

Additional Eligibility Category:

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."

Federally Funded Research and Development Centers (FFRDCs): FFRDCs are operated, managed, and/or administered by a university or consortium of universities, other not-for-profit or nonprofit organization, or an industrial firm, as an autonomous organization or as an identifiable separate operating unit of a parent organization. A FFRDC meets some special long-term research or development need which cannot be met as effectively by an agency's existing in-house or contractor resources. FFRDC's enable agencies to use private sector resources to accomplish tasks that are integral to the mission and operation of the sponsoring agency. For more information on FFRDCs, go to https://gov.ecfr.io/cgi-bin/searchECFR.

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 N/A

4. Justification for Less than Maximum Competition N/A

5. Responsiveness If an application requests a funding amount greater than the ceiling of $750,000 for the first budget period and the total of $3,750,000 for the 5-year period of performance 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 Unique Entity Identifier (UEI) number in order to begin each of the following registrations.

PLEASE NOTE: Effective April 4, 2022, applicants must have a Unique Entity Identifier (UEI) at the time of application submission. The UEI replaced the Data Universal Numbering System (DUNS) and is generated as part of SAM.gov registration. Current SAM.gov registrants have already been assigned their UEI and can view it in SAM.gov and Grants.gov. Additional information is available on the GSA website, SAM.gov, and Grants.gov-Finding the UEI.

https://gov.ecfr.io/cgi-bin/searchECFR?ob=r&idno=&q1=FFRDC&r=&SID=1510a9feb7999d185d40b026ad998cc0&mc=true https://www.gsa.gov/about-us/organization/federal-acquisition-service/technology-transformation-services/integrated-award-environment-iae/iae-systems-information-kit/unique-entity-id-is-here https://sam.gov/content/home https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/ https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: NCAGE Tool / Products / NCS Help Center (nato.int).

System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, SAM.gov.

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 Senior/Key Personnel (including Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing Principal Investigator (PD/PI) eRA Commons account is affiliated with the eRA commons account of the applicant organization. All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the eRA Commons registration process at least four (4) weeks prior to the application due date. ASSIST requires that applicant users have an 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 Unique Entity Identifier (UEI) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The UEI number is a twelve-digit number assigned by SAM.gov. An AOR should be consulted to determine the appropriate number. If the organization does not have a UEI number, an AOR should register through SAM.gov. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a UEI number.

Additionally, 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.gov 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 SAM.gov and the SAM.gov Knowledge Base.

https://eportal.nspa.nato.int/Codification/Support/en/Products/NCAGE/ https://sam.gov/content.gov https://grants.gov https://public.era.nih.gov/commons https://www.Grants.gov https://sam.gov/content/home https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fsd.gov%2Fgsafsd_sp%3Fid%3Dgsa_kb_view2%26kb_id%3Df66d8e6cdb76d4100d73f81d0f9619c6&data=04%7C01%7Ccshifflett%40dminc.com%7C8eee7a2adab549a3b3c008d925e9a364%7Cdb7ac9ef779d46e59bca00509580ad6b%7C0%7C0%7C637582507851821018%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=UrR%2B%2FM2wWF2fZG05Z8O6JS2C3FXXSl%2F7B3%2FB45XHRrg%3D&reserved=0

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 UEI number to the recipient organization.

8. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions 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. CDC does not make awards to individuals directly. Individuals from organizations that are uniquely prepared to examine research relevant to undeserved groups, as well as individuals with disabilities are encouraged to apply.

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

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

Only one application per institution [normally identified by having a unique entity identifier (UEI) number].

Section IV. Application and Submission Information

1. Address to Request Application Package Applicants will use a system or platform to submit their applications through Grants.gov and eRA Commons to CDC. ASSIST, an institutional system to system (S2S) solution, or Grants.gov Workspace are options. ASSIST is a commonly used platform because, unlike other platforms, it provides a validation of all requirements prior to submission and prevents errors.

To use ASSIST, applicants must visit https://public.era.nih.gov 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: http://grants.nih.gov/support/index.html

• Email: commons@od.nih.gov https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://public.era.nih.gov http://grants.nih.gov/support/index.html

• Phone: 301-402-7469 or (toll-free) 1-866-504-9552.

Hours: Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding Federal holidays.

2. Content and Form of Application Submission Application guides for FORMS-H application packages are posted to the How to Apply - Application Guide page.

It is critical that applicants follow the instructions in the SF-424 (R&R) Application Guide How to Apply - Application Guide 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 Application Guide to ensure you complete all appropriate “optional” components.

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

Please note: If requesting indirect costs in the budget based on a federally negotiated rate, a copy of the indirect cost rate agreement is required. Include a copy of the current negotiated federal indirect cost rate agreement or cost allocation plan approval letter.

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".

3. Letter of Intent Due Date for Letter Of Intent 01/06/2025

A Letter of Intent is requested as the information that it contains allows CDC staff to better plan and line up proper review panels for applications.

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 organization 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 emailed 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 https://grants.nih.gov/grants/how-to-apply-application-guide.html https://grants.nih.gov/grants/how-to-apply-application-guide.html https://grants.nih.gov/grants/how-to-apply-application-guide.html

Centers for Disease Control and Prevention U.S. Department of Health and Human Services 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 at How to Apply

- Application Guide for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Notice of Funding Opportunity Description).

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

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

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

3. Research Strategy – the research strategy should be organized under 3 headings:

Significance, Innovation, and Approach. Describe the proposed research plan, including staffing and timeline.

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. Other Plan(s)

12. Authentication of Key Biological and/or Chemical Resources

13. Appendix mailto:GAnderson@cdc.gov

All instructions in the SF424 (R&R) Application Guide at How to Apply - Application Guide 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 Other Plan(s) 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 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);

• A statement (required) of any limitations you may encounter with sharing data collected or generated under this award with CDC (such as legal, regulatory, policy, or technical concerns);

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

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

The AR-25 outlines the components of a DMP and provides additional information for investigators regarding the requirements for data accessibility, storage, and preservation.

https://www.cdc.gov/grants/additional-requirements/ar-25.html

CDC OMB approved templates may be used (e.g. NCCDPHP template https://www.cdc.gov/nccdphp/dch/media/files/Data-Management-Plan-template.docx

Other examples of DMPs may be found here: USGS, http://www.usgs.gov//products/data-and-tools/data-management/data-management-plans

Application guides for FORMS-H application packages are posted to the How to Apply - Application Guide page.

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 publicly available. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PLEASE NOTE: If applications go beyond the page limit designated for a given section, excess pages will be removed from the application prior to peer review and may negatively affect the application’s scoring.

https://grants.nih.gov/grants/how-to-apply-application-guide.html https://www.cdc.gov/grants/additional-requirements/ar-25.html https://www.cdc.gov/nccdphp/dch/media/files/Data-Management-Plan-template.docx 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

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 12 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 at .How to Apply - Application Guide.

Application guides for FORMS-H application packages are posted to the How to Apply - Application Guide page.

9. Submission Dates & Times Part I. Overview Information contains information about Key Dates. Applicants are strongly encouraged to allocate additional time and submit in advance of the deadline to ensure they have time to make any corrections that might be necessary for successful submission. This includes the time necessary to complete the application resubmission process that may be necessary, if errors are identified during validation by Grants.gov and the NIH eRA systems. The application package is not complete until it has passed the Grants.gov and NIH eRA Commons submission and validation processes. Applicants will use a platform or system to submit applications.

ASSIST is a commonly used platform because it provides a validation of all requirements prior to submission. If ASSIST detects errors, then the applicant must correct errors before their application can be submitted. Applicants should view their applications 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 must be resubmitted in ASSIST.

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

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

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

https://grants.nih.gov/grants/how-to-apply-application-guide.html https://grants.nih.gov/grants/how-to-apply-application-guide.html https://era.nih.gov/files/ASSIST_user_guide.pdf

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

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

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

Toll-free: 1-800-518-4726 https://www.grants.gov/support support@grants.gov Hours: 24 hours a day, 7 days a week; closed on Federal holidays

It is important that applicants complete the application submission process well in advance of the due date time.

After submission of your application package, applicants will receive a "submission receipt" email generated by Grants.gov. Grants.gov will then generate a second e-mail message to applicants which will either validate or reject their submitted application package. A third and final e-mail message is generated once the applicant's application package has passed validation and the grantor agency has confirmed receipt of the application.

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

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

a. If the status states "rejected," be sure to save time stamped, documented rejection notices, and do #2a or #2b

2. Check emails from both Grants.gov and NIH eRA Commons for rejection notices.

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

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

Due Date for Applications 02/06/2025

Electronically submitted applications must be submitted no later than 11:59 p.m., ET, on the listed application due date.

10. Funding Restrictions Expanded Authority:

http://grants.nih.gov/support/index.html https://www.grants.gov/support mailto:support@grants.gov

For more information on expanded authority and pre-award costs, go to https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf and speak to your GMS.

All HHS/CDC awards are subject to the federal regulations, in 45 CFR Part 75, terms and conditions, and other requirements described in the HHS Grants Policy Statement.