CDC-RFA-OE20-20010301SUPP23.pdf

Centers for Disease Control and Prevention

Center for Surveillance, Epidemiology, and Laboratory Services

CDC-RFA-OE20-2001: Enhancing Public Health Laboratory Capabilities and Increasing Capacity

CDC-RFA-OE20-20010301SUPP23

10/10/2022

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

Part 1. Overview Information Federal Agency Name:

Federal Centers for Disease Control and Prevention (CDC) Notice of Funding Opportunity (NOFO) Title:

CDC-RFA-OE20-2001: Enhancing Public Health Laboratory Capabilities and Increasing Capacity Announcement Type:

Revision - Type 3 - (Competitive supplement) Additional funds requested to expand the scope of work.

Agency Notice of Funding Opportunity Number:

CDC-RFA-OE20-20010301SUPP23

Assistance Listings Number:

93.322 Key Dates:

Due Date for Applications 10/03/2022

10/10/2022 Application must be successfully submitted to Grants.gov by 11:59 pm Eastern Standard Time on the deadline date.

Additional Overview Content:

This supplemental notice of funding opportunity is designed to increase the capacity of public health laboratories (PHLs) and address public health priorities such as COVID-19. CDC expects to award projects in November 2022. CDC is requesting the applicant submit workplan and budgets for a 7-month period of activity.

This supplemental funding is only available to the recipient, the Association of Public Health Laboratories (APHL), that received funding under the single source umbrella cooperative agreement (CoAg), CDC-RFA-OE20-2001: Enhancing Public Health Laboratory Capabilities and Increasing Capacity.

Executive Summary The purpose of this notice of funding opportunity (NOFO) is to announce the availability of supplemental funding for CDC’s collaboration with APHL. A complete description of the proposed projects and their respective anticipated amount of available supplemental funding are available in the attachments.

This supplemental funding opportunity enables APHL to engage in activities that enhance capabilities and increase capacity of PHLs nationwide, including COVID-19 preparedness and response activities such as testing, quality, and safety, reporting data management, surveillance and epidemiology.

The program strategies include strengthening the capabilities and increasing the capacity of PHLs science, management, and operations; policy, partnerships, and communication; training and capacity building; and laboratory quality, safety, and informatics for public health testing services, surveillance and response.

Measurable outcomes of the program will be in alignment with one (or more) of the following performance goal(s) for the Center for Surveillance, Epidemiology, and Laboratory Services.

Measurable outcomes of the program will be in alignment with one (or more) of the following performance goal(s) for the Center for Surveillance, Epidemiology, and Laboratory Services

GPRA goal(s)

This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For this purpose, research is defined at https://www.govregs.com/regulations/title42_chapterI_part2_subpartD_section2.52. Guidance on how CDC interprets the definition of research in the context of public health can be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html (See section 45 CFR 46.102(d)).

This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For this purpose, research is defined at https://www.govregs.com/regulations/title42_chapterI_part2_subpartD_section2.52. Guidance on how CDC interprets the definition of research in the context of public health can be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html (See section 45 CFR 46.102(d)).

Section I. Funding Opportunity Description Statutory Authority The program is authorized under sections 317(k)(2) and 307 of the Public Health Service Act, as amended (42 U.S.C. Sections 247b(k) and 242l). In addition, this program is authorized under 4002 of the Patient Protection and Affordable Care Act; Prevention and Public Health Funds (42 U.S.C. 300u-11); the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L. 116-123); the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), 2020 (P.L. 116 -136), the American Rescue Plan Act (ARP), 2021 Sections 2301 - 2605; and the https://www.govregs.com/regulations/title42_chapterI_part2_subpartD_section2.52 https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html

Paycheck Protection Program and Healthcare Enhancement Act, 2020 (P.L. 116-139). Projects may be funded using any of the applicable authorities listed in this section.

Background State, local, and territorial public health laboratories (PHLs) play an indispensable role in protecting the health of Americans from new, emerging, and existing health threats by conducting laboratory testing and providing other science-based services. The work of PHL systems is interdigitate with other aspects of public health work, including epidemiology. Public health professionals and policy makers use actionable information from PHLs daily to identify and prioritize these population health threats, and to develop and implement effective interventions. In order to fulfill their critical public health mission, PHLs must be capable of and effective at detecting and responding to a myriad of threats across a broad and expanding spectrum of health domains, including infectious and chronic diseases, chemical and radiological exposure, newborn disease, foodborne and waterborne diseases, public health emergencies, such as COVID-19, and others in the United States and globally.

Despite their critical functions, PHLs face serious challenges in developing the capacities and capabilities to perform their role. Among these challenges are the rapid emergence of new disease threats, the accelerating evolution in technology and testing methods, and the growing complexities in developing broad interoperability and improving data exchange between laboratory data systems, health information systems, and other data systems. In addition, ensuring safe laboratory practices with existing and new technologies, and enhancing the infrastructure and capacity of the public health laboratory workforce continue to be pressing priorities for PHLs. Furthermore, PHLs often face persistent fiscal problems, workforce reductions, and other problems that threaten their development of needed capabilities to address public health issues, and, in some cases, their ability to perform important testing services.

PHLs need to address these ongoing challenges to serve as effective partners, to integrate into the larger, national public health system. The overarching purpose of this cooperative agreement is to improve the effectiveness of PHLs, individually and as components of a national system, to improve public health in the United States and globally. CDC is taking a multi-pronged approach to provide needed COVID-19 funding to PHLs. In an effort to enhance PHL services, CDC will incorporate the expansion of PHL fellowship programs for laboratory science graduates and implement a new public health internship program for undergraduate students to gain experiences in PHL settings. Funding made available through the American Rescue Plan will improve the capacity of the nation's public-private clinical laboratory infrastructure to support rapid, large-scale responses to public health emergencies. CDC's approach aims to get public health resources out quickly during the COVID-19 declared emergency and enable broad access and opportunity to COVID-19 resources.

This NOFO aims to support efforts that will enhance the capabilities and increase the capacities of PHLs by strengthening (1) Science, Management, and Operations; (2) Policy, Partnership, and Communication; (3) Training and Capacity Building; and (4) Laboratory Quality, Safety, and Informatics for Public Health Testing Services, Surveillance and Response.

Purpose The purpose of this supplemental funding opportunity is to announce the availability of supplemental funding to enable APHL to provide resources and technical assistance to enhance the infrastructure and strengthen the capacity and capabilities of the nation’s PHLs, including responding to the demands of COVID-19 activities. The proposed projects support the overarching purpose of this 5-year cooperative agreement.

Program Implementation Recipient Activities For recipient activities, please refer to the attached project plans.

CDC Activities

1. Meet with the recipient’s public health staff at least monthly via conference calls to discuss emerging issues, project progress and future actions.

2. Foster communication, coordination and collaboration between CDC, PHLs, partners and other stakeholders of public health system.

3. Work with the recipient to identify and address challenges that may impeded the success of the project.

4. Provide guidance and input on branding of products, services, communications materials, websites or other digital platforms, or any other resource in which CDC is engaged in with the recipient as part of this CoAg. Note: license agreements must be entered into for use of the CDC logo by an third party, including this recipient

5. Provide technical assistance to ensure products that are a direct result of this NOFO are made available in the public domain.

6. Provide technical guidance to recipient to improve the quality and effectiveness of work plans, budget narrative, evaluation strategies, products and services for each focus area.

7. Provide access to technical guidance and training that will strengthen staff capacity relevant to implementation of all required activities of the program.

8. Ensure that established quality standards are met for training, guidance and technical tools.

9. Collaborate in analyzing data and information collected, and in preparing written summaries and manuscripts for peer-reviewed and non-peer reviewed publications and presentations, with CDC co-authorship, where appropriate.

10. Develop compatible platforms that align with established PHLs systems and protocols.

Funding Strategy Coronavirus Disease 2019 (COVID-19) Funds: A recipient of a grant or cooperative agreement awarded by the Department of Health and Human Services (HHS) with funds made available under the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L. 116-123); the Coronavirus Aid, Relief, and Economic Security Act, 2020 (the “CARES Act”) (P.L. 116-136); the Paycheck Protection Program and Health Care Enhancement Act (P.L. 116-139); the Consolidated Appropriations Act and the Coronavirus Response and Relief Supplement Appropriations Act, 2021 (P.L. 116-260) and/or the American Rescue Plan of 2021 [P.L. 117-2] agrees, as applicable to the award, to: 1) comply with existing and/or future directives and guidance from the Secretary regarding control of the spread of COVID-19; 2) in consultation and coordination with HHS, provide, commensurate with the condition of the individual, COVID-19 patient care regardless of the individual’s home jurisdiction and/or appropriate public health measures (e.g., social distancing, home isolation); and 3) assist the United States Government in the implementation and enforcement of federal orders related to quarantine and isolation.

In addition, to the extent applicable, Recipient will comply with Section 18115 of the CARES Act, with respect to the reporting to the HHS Secretary of results of tests intended to detect SARS–CoV–2 or to diagnose a possible case of COVID–19. Such reporting shall be in accordance with guidance and direction from HHS and/or CDC. HHS laboratory reporting guidance is posted at: https://www.hhs.gov/sites/default/files/covid-19-laboratory-data-reporting-guidance.pdf.

Further, consistent with the full scope of applicable grant regulations (45 C.F.R. 75.322), the purpose of this award, and the underlying funding, the recipient is expected to provide to CDC copies of and/or access to COVID-19 data collected with these funds, including but not limited to data related to COVID-19 testing. CDC will specify in further guidance and directives what is encompassed by this requirement.

This award is contingent upon agreement by the recipient to comply with existing and future guidance from the HHS Secretary regarding control of the spread of COVID-19. In addition, recipient is expected to flow down these terms to any subaward, to the extent applicable to activities set out in such subaward.

Section II. Award Information Type of Award:

CA (Cooperative Agreement) CDC substantial involvement in this program appears in the Activities Section above.

Award Mechanism:

U60 Cooperative Agreements in Occupational Safety and Health Research, Demonstrations, U60 Evaluation, and Education

Fiscal Year Funds:

Approximate Total Supplemental Funding:

$2,500,000 This amount is subject to availability of funds. Includes direct costs.

The recipient is encouraged to propose additional activities, performance measures, outputs and outcomes, as needed, to address. Applications should be scalable and must include a work plan and budget narrative. Proposed amounts are not guaranteed but they will be important factors in determining award levels. CDC and the recipient will work together to revise and further prioritize activities based on funding availability.

The table below lists the New Focus Area Project Plans to be funded in Year 2 of OE20-2001.

https://www.hhs.gov/sites/default/files/covid-19-laboratory-data-reporting-guidance.pdf https://www.hhs.gov/sites/default/files/covid-19-laboratory-data-reporting-guidance.pdf

Table 1. New Focus Area Project Plans

Project Title Focus Area Proposed Funding Amont

PulseNet Foodborne, Waterborne, Environmentally Transmitted Diseases

$50,000

Environmental Microbiology Foodborne, Waterborne, Environmentally Transmitte Diseases

$500,000

ID EZID-VBD Lyme MTTT Coding and ELR Reporting Infectious Disease $100,000

ID EZID-VBD Virtual Repository for Arboviral Clinical Reference Materials Infectious Disease $20,000

Vaccine Preventable Disease (VPD) Infectious Disease $250,000 Expanding eCR MPX Informatics $1,550,000 Laboratory Resource Exchange Preparedness $35,000

Approximate Number of Awards:

Approximate Average Award:

$2,000,000 This amount is for the budget period only and includes direct costs and indirect costs as applicable.

Floor of Individual Award Range:

$100,000 Ceiling of Individual Award Range:

$3,000,000 This ceiling is for a 12-month budget period.

This ceiling is for a 7-month budget period. This is inclusive of total project costs.

Anticipated Award Date:

November 22, 2022

Budget Period Length:

7 month(s)

Period of Performance Length:

3 year(s)

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.

Section III. Eligibility Information Eligible Applicants The following recipients may submit an application:

Eligibility Category:

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

Additional Information on Eligibility This supplemental funding opportunity announcement is a single-source eligibility. The only applicant eligible to apply is the Association for Public Health Laboratories (APHL) because this NOFO is a single-source award and due to specialized skills and abilities to enhance the capacity of public health laboratories (PHLs).

Required Registrations An organization must be registered at the three following locations before it can submit an application for funding at www.grants.gov.

PLEASE NOTE: Effective April 4, 2022, applicants must have a Unique Entity Identifier (UEI) at the time of application submission (SF-424, field 8c). The UEI 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.

a. Unique Entity Identifier (UEI):

All applicant organizations must obtain a Unique Entity Identifier (UEI) number by registering in SAM.gov prior to submitting an application. A UEI number is a unique twelve-digit identification number assigned to the registering organization.

If funds are awarded to an applicant organization that includes sub-recipients, those sub-recipients must provide their UEI numbers before accepting any funds.

b. System for Award Management (SAM):

The SAM is the primary registrant database for the federal government and the repository into which an entity must submit information required to conduct business as a recipient. All applicant organizations must register with SAM, and will be assigned a SAM number and a Unique Entity Identifier (UEI). All information relevant to the SAM number must be current at all times during which the applicant has an application under consideration for funding by CDC.

If an award is made, the SAM information must be maintained until a final financial report is submitted or the final payment is received, whichever is later. The SAM registration process can require 10 or more business days, and registration must be renewed annually. Additional information about registration procedures may be found at SAM.gov and the SAM.gov https://www.grants.gov/ https://www.gsa.gov/about-us/organization/federal-acquisition-service/office-of-systems-management/integrated-award-environment-iae/iae-systems-information-kit/unique-entity-identifier-update 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/ 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

Knowledge Base.

c. Grants.gov:

The first step in submitting an application online is registering your organization at www.grants.gov, the official HHS E-grant Web site. Registration information is located at the "Applicant Registration" option at www.grants.gov.

All applicant organizations must register at www.grants.gov. The one-time registration process usually takes not more than five days to complete. Applicants should start the registration process as early as possible.

Cost Sharing or Matching Cost Sharing / Matching Requirement:

No Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this NOFO exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

Other Special Requirements Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting a grant, loan, or an award.

Maintenance of Effort Maintenance of Effort is not required for this program.

Section IV. Application and Submission Information Address to Request Application Package Applicants must download the application package associated with this funding opportunity from Grants.gov.

If the applicant encounters technical difficulties with Grants.gov, the applicant should contact Grants.gov Customer Service. The Grants.gov Contact Center is available 24 hours a day, 7 days a week, with the exception of all Federal Holidays. The Contact Center provides customer service to the applicant community. The extended hours will provide applicants support around the clock, ensuring the best possible customer service is received any time it is needed. You can reach the Grants.gov Support Center at 1-800-518-4726 or by email at support@grants.gov. Submissions sent by email, fax, CD’s or thumb drives of applications will not be accepted.

Content and Form of Application Submission Unless specifically indicated, this announcement requires submission of the following information:

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 https://www.grants.gov/ http://www.grants.gov/ https://www.grants.gov/ https://www.grants.gov/ mailto:support@grants.gov

This is a supplemental to the original NOFO CDC-RFA-OE20-2001: Enhancing Public Health Laboratory Capabilities and Increasing Capacity.

Project Abstract A Project Abstract must be completed in the Grants.gov application forms. The Project Abstract must contain a summary of the proposed activity suitable for dissemination to the public. It should be a self-contained description of the project and should contain a statement of objectives and methods to be employed. It should be informative to other persons working in the same or related fields and insofar as possible understandable to a technically literate lay reader. This abstract must not include any proprietary/confidential information.

Project Narrative A Project Narrative must be submitted with the application forms. The project narrative must be uploaded in a PDF file format when submitting via Grants.gov. The narrative must be submitted in the following format:

30: Maximum number of pages Font size: 12 point unreduced, Times New Roman Double spaced Page margin size: One inch Number of all narrative pages; not to exceed the maximum number of pages.

The narrative should address activities to be conducted over the entire Period of Performance and must include the following items in the order listed.

Additional information may be included in the application appendices. The appendices must be uploaded to the "Other Attachments Form" of application package in Grants.gov. Note:

appendices will not be counted toward the narrative page limit. This additional information includes:

Additional information submitted via Grants.gov must be uploaded in a PDF file format, and should be named:

_________: Maximum number of allowable electronic attachments

Submission Dates and Times This announcement is the definitive guide on application content, submission, and deadline. It supersedes information provided in the application instructions. If the application submission does not meet the deadline published herein, it will not be eligible for review and the recipient will be notified the application did not meet the submission requirements.

This section provides applicants with submission dates and times. Applications that are submitted after the deadlines will not be processed.

If Grants.gov is inoperable and cannot receive applications, and circumstances preclude advance notification of an extension, then applications must be submitted by the first business day on which Grants.gov operations resume.

Application Deadline Date

Due Date for Applications 10/10/2022

10/10/2022 Explanation of Deadlines: Application must be successfully submitted to Grants.gov by 11:59 pm Eastern Time on the deadline date.

Not applicable

Pilot Program for Enhancement of Employee Whistleblower Protections All applicants will be subject to a term and condition that applies the terms of 48 CFR section

3.908 to the award and requires that recipients inform their employees in writing (in the predominant native language of the workforce) of employee whistleblower rights and protections under 41 U.S.C 4712.

Copyright Interest Provisions This provision is intended to ensure that the public has access to the results and accomplishments of public health activities funded by CDC. Pursuant to applicable grant regulations and CDC’s Public Access Policy, Recipient agrees to submit into the National Institutes of Health (NIH) Manuscript Submission (NIHMS) system an electronic version of the final, peer-reviewed manuscript of any such work developed under this award upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. Also at the time of submission, Recipient and/or the Recipient’s submitting author must specify the date the final manuscript will be publicly accessible through PubMed Central (PMC). Recipient and/or Recipient’s submitting author must also post the manuscript through PMC within twelve (12) months of the publisher's official date of final publication; however the author is strongly encouraged to make the subject manuscript available as soon as possible. The recipient must obtain prior approval from the CDC for any exception to this provision.

The author's final, peer-reviewed manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process, and all graphics and supplemental material associated with the article. Recipient and its submitting authors working under this award are responsible for ensuring that any publishing or copyright agreements concerning submitted articles reserve adequate right to fully comply with this provision and the license reserved by CDC. The manuscript will be hosted in both PMC and the CDC Stacks institutional repository system. In progress reports for this award, recipient must identify publications subject to the CDC Public Access Policy by using the applicable NIHMS identification number for up to three (3) months after the publication date and the PubMed Central identification number (PMCID) thereafter.

Federal Funding Accountability and Transparency Act of 2006 (FFATA), P.L. 109–282, as amended by section 6202 of P.L. 110–252 requires full disclosure of all entities and organizations receiving Federal funds including awards, contracts, loans, other assistance, and payments through a single publicly accessible Web site, www.USASpending.gov.

Compliance with this law is primarily the responsibility of the Federal agency. However, two elements of the law require information to be collected and reported by applicants: 1) information on executive compensation when not already reported through the SAM, and 2) similar information on all sub-awards/subcontracts/consortiums over $25,000.

For the full text of the requirements under the FFATA and HHS guidelines, go to:

https://www.gpo.gov/fdsys/pkg/PLAW-109publ282/pdf/PLAW-109publ282.pdf, http://www.usaspending.gov/ https://www.gpo.gov/fdsys/pkg/PLAW-109publ282/pdf/PLAW-109publ282.pdf, https://www.fsrs.gov/documents/ffata_legislation_110_252.pdf http://www.hhs.gov/grants/grants/grants-policies-regulations/index.html#FFATA.

Funding Restrictions Funding Restrictions:

Restrictions, which must be taken into account while writing the budget, are as follows:

Recipients may not use funds for research.

Recipients may not use funds for clinical care.

Recipients may only expend funds for reasonable program purposes, including personnel, travel, supplies, and services, such as contractual.

Recipients may not generally use HHS/CDC/ATSDR funding for the purchase of furniture or equipment. Any such proposed spending must be identified in the budget.

The direct and primary recipient in a cooperative agreement program must perform a substantial role in carrying out project objectives and not merely serve as a conduit for an award to another party or provider who is ineligible.

Other than for normal and recognized executive-legislative relationships, no funds may be used for: publicity or propaganda purposes, for the preparation, distribution, or use of any material designed to support or defeat the enactment of legislation before any legislative body the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or Executive order proposed or pending before any legislative body.

See Additional Requirement (AR) 12 for detailed guidance on this prohibition and additional guidance on lobbying for CDC recipients.

The recipient can obtain guidance for completing a detailed justified budget on the CDC website, at the following Internet address: http://www.cdc.gov/grants/interestedinapplying/applicationprocess.html

Other Submission Requirements Application Submission Submit the application electronically by using the forms and instructions posted for this funding opportunity on www.Grants.gov.

Note: Application submission is not concluded until successful completion of the validation process. After submission of your application package, recipients will receive a "submission receipt" email generated by Grants.gov. Grants.gov will then generate a second e-mail message to recipients which will either validate or reject their submitted application package.

This validation process may take as long as two (2) business days. Recipients are strongly encouraged check the status of their application to ensure submission of their application package is complete and no submission errors exists. To guarantee that you comply with the application deadline published in the Notice of Funding Opportunity, recipients are also strongly encouraged to allocate additional days prior to the published deadline to file their https://www.fsrs.gov/documents/ffata_legislation_110_252.pdf http://www.hhs.gov/grants/grants/grants-policies-regulations/index.html#FFATA.

https://www.cdc.gov/grants/additional-requirements/ar-12.html http://www.cdc.gov/grants/additionalrequirements/index.html http://www.cdc.gov/grants/additionalrequirements/index.html http://www.cdc.gov/grants/interestedinapplying/applicationprocess.html application. Non-validated applications will not be accepted after the published application deadline date.

In the event that you do not receive a ''validation'' email within two (2) business days of application submission, please contact Grants.gov. Refer to the email message generated at the time of application submission for instructions on how to track your application or the Application User Guide, Version 3.0 page 57.

Electronic Submission of Application:

Applications must be submitted electronically by using the forms and instructions posted for this notice of funding opportunity at www.grants.gov. Applicants can complete the application package using Workspace, which allows forms to be filled out online or offline. All application attachments must be submitted using a PDF file format. Instructions and training for using Workspace can be found at www.grants.gov under the "Workspace Overview" option.

Applications submitted through www.Grants.gov, are electronically time/date stamped and assigned a tracking number. The Authorized Organizational Representative (AOR) will receive an e-mail notice of receipt when HHS/CDC receives the application. The tracking number serves to document submission and initiate the electronic validation process before the application is made available to CDC for processing.

If the recipient encounters technical difficulties with Grants.gov, the recipient should contact Grants.gov Customer Service. The Grants.gov Contact Center is available 24 hours a day, 7 days a week. The Contact Center provides customer service to the recipient community. The extended hours will provide recipients support around the clock, ensuring the best possible customer service is received any time it’s needed. You can reach the Grants.gov Support Center at 1-800- 518-4726 or by email at support@grants.gov. Submissions sent by e-mail, fax, CD’s or thumb drives of applications will not be accepted.

After consulting with the Grants.gov Support Center, if the technical difficulties remain unresolved and electronic submission is not possible to meet the established deadline, organizations may submit a request prior to the application deadline by email to the Grants Management Specialist/Officer for permission to submit a paper application. An organization's request for permission must: (a) include the Grants.gov case number assigned to the inquiry, (b) describe the difficulties that prevent electronic submission and the efforts taken with the Grants.gov Support Center (c) be submitted to the Grants Management Specialist/Officer at least 3 calendar days prior to the application deadline. Paper applications submitted without prior approval will not be considered.

Section V. Application Review Information Eligible recipients are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the CDC-RFA-OE20-20010301SUPP23 Measures of effectiveness must relate to the performance goals stated in the "Purpose" section of this announcement. Measures of effectiveness must be objective, quantitative and measure the intended outcome of the proposed program. The measures of effectiveness must be included in the application and will be an element of the evaluation of the submitted application.

mailto:support@grants.gov

Criteria Eligible recipients will be evaluated against the following criteria:

Not Applicable Maximum Points: 0 This section is not applicable for this supplemental NOFO.

Budget (SF 424A) and Budget Narrative are reviewed, but not scored. Although the budget is not scored recipients should consider the following in development of their budget. Is the itemized budget for conducting the project, and justification reasonable and consistent with stated objectives and planned program activities?

If the recipients requests indirect costs in the budget, a copy of the indirect cost rate agreement is required. If the indirect cost rate is a provisional rate, the agreement should be less than 12 months of age. The indirect cost rate agreement should be uploaded as a PDF file with “Other Attachment Forms” when submitting via Grants.gov.

Review and Selection Process Review Eligible applications will be jointly reviewed for responsiveness by Center for Surveillance, Epidemiology, and Laboratory Services and Office of Grants Services (OGS). Incomplete applications and applications that are non-responsive will not advance through the review process. Recipients will be notified in writing of the results.

An objective review panel will evaluate complete and responsive applications according to the criteria listed in Section V. Application Review Information, subsection entitled "Criteria".

Selection In addition, the following factors may affect the funding decision:

This supplemental funding is only available to the recipient, the Association of Public Health Laboratories (APHL), that received funding under the single source umbrella cooperative agreement (CoAg), CDC-RFA-OE20-2001: Enhancing Public Health Laboratory Capabilities and Increasing Capacity.

CDC will provide justification for any decision to fund out of rank order.

Anticipated Announcement and Award Dates Successful recipients will receive a Notice of Award (NoA) from the CDC Office of Grants Services. The NoA shall be the only binding, authorizing document between the recipient and CDC. The NoA will be signed by an authorized Grants Management Officer and e-mailed to the program director. A hard copy of the NoA will be mailed to the recipient fiscal officer identified in the application.

Unsuccessful recipients will receive notification of the results of the application review by mail.

Section VI. Award Administration Information

Award Notices Successful recipients will receive a Notice of Award (NoA) from the CDC Office of Grants Services. The NoA shall be the only binding, authorizing document between the recipient and CDC. The NoA will be signed by an authorized Grants Management Officer and e-mailed to the program director. A copy of the NoA will be emailed to the recipient fiscal officer identified in the application.

Unsuccessful recipients will receive notification of the results of the application review via email.

Administrative and National Policy Requirements Administrative and National Policy Requirements, Additional Requirements (ARs) outline the administrative requirements found in 45 CFR Part 75 and the HHS Grants Policy Statement and other requirements as mandated by statute or CDC policy. CDC programs must indicate which ARs are relevant to the NOFO. Recipients must then comply with the ARs listed in the NOFO.

Do not include any ARs that do not apply to this NOFO. NOFO Recipients must comply with administrative and national policy requirements as appropriate. For more information on the Code of Federal Regulations, visit the National Archives and Records Administration: https://www.archives.gov/federal-register/cfr. For competing supplements, ARs remain in effect as published in the original announcement.

Continuing Continuations - AR-1: Human Subjects Requirements AR-2: Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research AR-3: Animal Subjects Requirements AR-8: Public Health System Reporting Requirements AR-9: Paperwork Reduction Act Requirements AR-10: Smoke-Free Workplace Requirements AR-15: Proof of Non-profit Status AR-25: Data Management and Access AR-26: National Historic Preservation Act of 1966 AR-28: Inclusion of Persons Under the Age of 21 in Research AR-29: Compliance with EO13513, "Federal Leadership on Reducing Text Messaging while Driving", October 1, 2009 AR-30: Information Letter 10-006, -Compliance with Section 508 of the Rehabilitation Act of AR-31: Research Definition AR-32: Appropriations Act, General Provisions AR-33: United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern AR-37: Prohibition on certain telecommunications and video surveillance services or equipment for all awards issued on or after August 13, 2020

The full text of the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards, 45 CFR 75, can be found at: https://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75

Should you successfully compete for an award, recipients of federal financial assistance (FFA) https://www.archives.gov/federal-register/cfr https://www.cdc.gov/grants/additional-requirements/ar-1.html https://www.cdc.gov/grants/additional-requirements/ar-2.html https://www.cdc.gov/grants/additional-requirements/ar-3.html https://www.cdc.gov/grants/additional-requirements/ar-8.html https://www.cdc.gov/grants/additional-requirements/ar-9.html https://www.cdc.gov/grants/additional-requirements/ar-10.html https://www.cdc.gov/grants/additional-requirements/ar-15.html https://www.cdc.gov/grants/additional-requirements/ar-25.html https://www.cdc.gov/grants/additional-requirements/ar-26.html https://www.cdc.gov/grants/additional-requirements/ar-28.html https://www.cdc.gov/grants/additional-requirements/ar-29.html https://www.cdc.gov/grants/additional-requirements/ar-29.html https://www.cdc.gov/grants/additional-requirements/ar-30.html https://www.cdc.gov/grants/additional-requirements/ar-30.html https://www.cdc.gov/grants/additional-requirements/ar-31.html https://www.cdc.gov/grants/additional-requirements/ar-32.html https://www.cdc.gov/grants/additional-requirements/ar-33.html https://www.cdc.gov/grants/additional-requirements/ar-33.html https://www.cdc.gov/grants/additional-requirements/ar-37.html https://www.cdc.gov/grants/additional-requirements/ar-37.html https://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75 https://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75 from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy).This includes taking reasonable steps to provide meaningful access to persons with limited English proficiency and providing programs that are accessible to and usable by persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting your legal obligation to take reasonable steps to ensure meaningful access to your programs or activities by limited English proficient individuals, see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on your specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and taking appropriate steps to provide effective communication, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html.

• For guidance on administering your project in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws, see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Reporting Federal Funding Accountability and Transparency Act of 2006 (FFATA), P.L. 109–282, as amended by section 6202 of P.L. 110–252 requires full disclosure of all entities and organizations receiving Federal funds including awards, contracts, loans, other assistance, and payments through a single publicly accessible Web site, http://www.USASpending.gov

Compliance with this law is primarily the responsibility of the Federal agency. However, two elements of the law require information to be collected and reported by applicants: 1) information on executive compensation when not already reported through the SAM, and 2) similar information on all sub-awards/subcontracts/consortiums over $25,000.

For the full text of the requirements under the FFATA and HHS guidelines, go to:

https://www.gpo.gov/fdsys/pkg/PLAW-109publ282/pdf/PLAW-109publ282.pdf, https://www.fsrs.gov /documents /ffata_legislation_ 110_252.pdf http://www.hhs.gov/grants/grants/grants-policies-regulations/index.html#FFATA.

Each funded recipient must provide CDC with an Annual Performance Report (APR) submitted via https://www.grantsolutions.gov/:

https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html https://www.lep.gov http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html https://www.hhs.gov/conscience/conscience-protections/index.html https://www.hhs.gov/conscience/conscience-protections/index.html https://www.hhs.gov/conscience/religious-freedom/index.html http://www.usaspending.gov/ https://www.gpo.gov/fdsys/pkg/PLAW-109publ282/pdf/PLAW-109publ282.pdf, https://www.fsrs.gov/documents/ffata_legislation_110_252.pdf http://www.hhs.gov/grants/grants/grants-policies-regulations/index.html#FFATA.

https://www.grantsolutions.gov/

1. The interim progress report is due no less than 120 days before the end of the budget period.

The Interim Progress report will serve as the non-competing continuation applications, and must contain the following elements:

a. Standard Form (“SF”) 424S Form.

b. SF-424A Budget Information-Non-Construction Programs.

c. Budget Narrative.

d. Indirect Cost Rate Agreement.

e. Project Narrative.

Additionally, funded recipients must provide CDC with an original, plus two hard copies of the following reports:

2. Federal Financial Report (FFR)(SF425): (Required) The annual FFR form (SF-425) is required and must be submitted through the Payment Management System (PMS) 90 days after the end of the budget period.

3. The Final Performance Report is due 90 days after the end of the period of performance. The Final FFR is due 90 days after the end of the period of performance and must be submitted through the Payment Management System (PMS).

Termination CDC may impose other enforcement actions in accordance with 45 CFR 75.371- Remedies for Noncompliance, as appropriate.

The Federal award may be terminated in whole or in part as follows:

(1) By the HHS awarding agency or pass-through entity, if the non-Federal entity fails to comply with the terms and conditions of the award;

(2) By the HHS awarding agency or pass-through entity for cause;

(3) By the HHS awarding agency or pass-through entity with the consent of the non-Federal entity, in which case the two parties must agree upon the termination conditions, including the effective date and, in the case of partial termination, the portion to be terminated; or

(4) By the non-Federal entity upon sending to the HHS awarding agency or pass-through entity written notification setting forth the reasons for such termination, the effective date, and, in the case of partial termination, the portion to be terminated. However, if the HHS awarding agency or pass-through entity determines in the case of partial termination that the reduced or modified portion of the Federal award or subaward will not accomplish the purposes for which the Federal award was made, the HHS awarding agency or pass-through entity may terminate the Federal award in its entirety.

Reporting of Foreign Taxes (International/foreign projects only) A. Valued Added Tax (VAT) and Customs Duties – Customs and import duties, consular fees, customs surtax, valued added taxes, and other related charges are hereby authorized as an allowable cost for costs incurred for non-host governmental entities operating where no applicable tax exemption exists. This waiver does not apply to countries where a bilateral agreement (or similar legal document) is already in place providing applicable tax exemptions and it is not applicable to Ministries of Health. Successful applicants will receive information on VAT requirements via their Notice of Award.

B. The U.S. Department of State requires that agencies collect and report information on the amount of taxes assessed, reimbursed and not reimbursed by a foreign government against commodities financed with funds appropriated by the U.S. Department of State, Foreign Operations and Related Programs Appropriations Act (SFOAA) (“United States foreign assistance funds”). Outlined below are the specifics of this requirement:

1) Annual Report: The recipient must submit a report on or before November 16 for each foreign country on the amount of foreign taxes charged, as of September 30 of the same year, by a foreign government on commodity purchase transactions valued at 500 USD or more financed with United States foreign assistance funds under this grant during the prior United States fiscal year (October 1 – September 30), and the amount reimbursed and unreimbursed by the foreign government. [Reports are required even if the recipient did not pay any taxes during the reporting period.]

2) Quarterly Report: The recipient must quarterly submit a report on the amount of foreign taxes charged by a foreign government on commodity purchase transactions valued at 500 USD or more financed with United States foreign assistance funds under this grant. This report shall be submitted no later than two weeks following the end of each quarter: April 15, July 15, October 15 and January 15.

3) Terms: For purposes of this clause:

“Commodity” means any material, article, supplies, goods, or equipment;

“Foreign government” includes any foreign government entity;

“Foreign taxes” means value-added taxes and custom duties assessed by a foreign government on a commodity. It does not include foreign sales taxes.

4) Where: Submit the reports to the Director and Deputy Director of the CDC office in the country(ies) in which you are carrying out the activities associated with this cooperative agreement. In countries where there is no CDC office, send reports to VATreporting@cdc.gov.

5) Contents of Reports: The reports must contain:

a. recipient name;

b. contact name with phone, fax, and e-mail;

c. agreement number(s) if reporting by agreement(s);

d. reporting period;

e. amount of foreign taxes assessed by each foreign…