CDC-RFA-TS19-19020301SUPP21.pdf

Centers for Disease Control and Prevention

AGENCY FOR TOXIC SUBSTANCES AND DISEASE REGISTRY

Early Detection of Certain Medical Conditions Related to Environmental Health Hazards Supplement

CDC-RFA-TS19-19020301SUPP21

06/26/2021

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:

Agency for Toxic Substances and Disease Registry (ATSDR) Notice of Funding Opportunity (NOFO) Title:

Early Detection of Certain Medical Conditions Related to Environmental Health Hazards Supplement Announcement Type:

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

Agency Notice of Funding Opportunity Number:

CDC-RFA-TS19-19020301SUPP21

Assistance Listings Number:

93.534 Key Dates:

Due Date for Applications 06/30/2021

06/26/2021 Application must be successfully submitted to Grants.gov by 11:59 pm Eastern Standard Time on the deadline date.

Additional Overview Content:

Executive Summary Under Grant No. TS19-1902, ‘Early Detection of Certain Medical Conditions Related to Environmental Health Hazards’, a non-research community service program to provide health screening for asbestos related disease, health education, and outreach are available to eligible residents of Libby and Troy, Montana. Libby was the site of a vermiculite mining and processing operation for much of the twentieth century. Because Libby vermiculite contains asbestos fibers, vermiculite workers and other residents were exposed to asbestos.

Under this NOFO, non-research supplemental funding will expand the community service scope of grant TS19-1902. Categories of supplemental activities will include: protect program patients and care providers from contracting COVID-19; expand long-distance health screening for eligible persons residing outside the greater Libby, Montana area; and, implement a pilot program for collecting and analyzing patient tissue obtained for clinical the purpose of categorizing and diagnosing participants.

Measurable outcomes of the program will be in alignment with one (or more) of the following performance goal(s) for the AGENCY FOR TOXIC SUBSTANCES AND DISEASE

REGISTRY

GPRA goal(s)

Implement environmental health programs and interventions to protect and promote health.

Prepare for and respond to public health emergencies, including chemical, biological, radiological, and nuclear incidents; natural disasters; and extreme weather events. Identify, characterize, and monitor health outcomes and environmental exposures to guide actions that protect and promote health.

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 42 U.S.C. Section 1397h; Program for Early Detection of Certain Medical Conditions Related to Environmental Health Hazards.

Background Libby, Montana was the site of a vermiculite mining and processing operation from the early 1920’s through 1990. While it was in operation, Libby was the world’s largest source of vermiculite. The commercial uses of vermiculite include insulation, fire proofing, and as a soil conditioner. Unfortunately, Libby vermiculite is contaminated with amphibole asbestos. This has resulted in asbestos-related morbidity and mortality in vermiculite workers, their family members, and residents with neither occupational nor para-occupational exposure.

Reports of pervasive asbestos-related health outcomes in Libby prompted a concerted response by the federal government in 1999. A large component of this response was community-based screening conducted by the Agency for Toxic Substances and Disease Registry (ATSDR) in 2000 and 2001 in which 7,307 persons were screened. Additional screening was funded by ATSDR via a grant to the Montana Department of Health and Human Services 2003-2008 and to the Lincoln County Health Department 2009-2011. Libby was subsequently declared an environmental public health emergency and language was included in the Affordable Care Act (ACA, Public Law 111-148; https://www.hhs.gov/sites/default/files/ppacacon.pdf) to continue to make screening available to persons with potential past exposure to vermiculite while they 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 https://www.hhs.gov/sites/default/files/ppacacon.pdf resided in the Libby area. Persons with positive screening results may be eligible for Medicare benefits.

The present notice of funding opportunity (NOFO) is to provide supplemental funding for screening activities currently being funded under the ACA. That screening program is expected to result in improved survival of participants with asbestos-related cancers, reduced rates of smoking-related diseases, and improved quality of life for participants.

Purpose The purpose of the program is to: (1) protect patients and program staff from contracting COVID-19 while participating in or implementing the screening program funded under CDC- RFA-TS19-1902, ‘Early Detection of Certain Medical Conditions Related to Environmental Health Hazards’; (2) Expand the program’s long distance screening efforts for participants unable to travel to Libby; and (3) Implement a pilot program for collecting and analyzing patient tissue for the purpose of improved patient classification and diagnosis.

Program Implementation Recipient Activities Recipient Activities:

1. Implement a vigorous COVID-19 testing and vaccination program for CARD patients.

2. Implement clinic facility modifications, including HVAC systems, resulting in improved protection of patients and staff from contracting COVID-19. Facility modifications must be reasonable and directly connected to preventing program participants from contracting

COVID-19.

3. Expand long-distance health screening for persons eligible for the program residing outside the greater Libby, Montana area.

4. Implement a pilot program for collecting and analyzing patient tissue for the purpose of improved patient classification and diagnosis regarding the presence of asbestos fibers and tissue changes resulting from asbestos exposure.

Many patients seen by the grant recipient already have a compromised pulmonary system and would likely have dire clinical outcomes after contracting COVID-19. Thus, risks to patients would be mitigated through vaccination of patients and staff and implementation of engineering controls, such as HVAC system improvements and physical barriers to separate patients and staff. Delaying implementation of activities designed to protect program participant from COVID-19 potentially increases their present risk of contracting the disease and prevents their full participation in the screening program, possibly resulting in delay of access to benefits available under the ACA. Further, protecting clinic staff, caregivers of program participants and other clinic patients is necessary to protect program participants given high transmission rates for COVID-19. In addition, supplemental funds will be used for activities designed to improve participation among persons eligible for the program who have moved away from Libby. Those activities will include targeted marketing and coordinating clinical activities from areas where many Libby emigres now reside. Finally, published studies have demonstrated elevated antinuclear antibody (ANA) titers and associated elevations of systemic autoimmune disease in Libby patients and Libby amphibole asbestos has been identified in lung and other tissue.

Supplemental funds would be used to collect, store and test serum and other tissue obtained for a clinical purpose, such as lung biopsy specimens and sputum, for elevated ANA titers and fiber counts, respectively. Test results would allow classifying patient risk for autoimmune disease and correlating clinical findings with asbestos fiber burden.

The project approach for TS19-1902 with the addition of supplemental activities and outcomes follow (bold font indicates period of performance outcome). The strategies and activities will both supplement those of TS19-1902 and introduce new ones (e.g., COVID-19 vaccinations) that will also be in support of those original activities and strategies.

Strategies and Activities Short-term Outcomes Intermediate Outcomes Long-Term Outcomes

Supplement community outreach -Media campaign -Community events

Supplenent health screening -Standardized health surveys -Spirometry -Chest radiography -High-resolution computed tomography -Fecal occult blood test -Quality control processes

Health Education/Materials for Community and Physicians -Asbestos-related disease education -Exposure risk education -Smoking cessation programs

COVID-19 vaccination

Collection, storage and analysis of patient tissue

Target audience aware of screening services

Target audience aware of Medicare eligibility

Individuals with correct diagnosis enrolled in Medicare

Increased knowledge of the following among target community and physicians:

-Exposure prevention -Risks of smoking -Asbestos-related disease -Disease management

Increased participation in screening among eligible persons living outside of Lincoln County

Target audience aware of vaccine availability

COVID-19 cases prevented

Target population enrolled in disease management programs

Target population enrolled in treatment (for lung cancer or other asbestos-related cancers)

Target population reduce their exposure to asbestos

Target population reduce their rate of smoking

Providers improve smoking reduction/cessation programs

Improved treatment/management of individuals with asbestos-related disease

Community members with negative results seek continued screening

Patients are correctly classified based tissue analysis

Increased survival from lung cancer

Increased survival from mesothelioma

Increased survival from other asbestos-related cancers

Reduced rate of smoking-related diseases

Improved quality of life

CDC Activities ATSDR will routinely monitor recipient performance and required grant administration, and as such, will not be substantially involved in the program.

Funding Strategy N/A

Section II. Award Information Type of Award:

G (Grant) CDC substantial involvement in this program appears in the Activities Section above.

Award Mechanism:

U61 Preventive Health Activities Regarding Hazardous Substances

Fiscal Year Funds:

Approximate Total Supplemental Funding:

$ 999,999 This amount is subject to availability of funds. Includes direct and indirect costs.

Approximate Number of Awards:

Approximate Average Award:

$ 999,999 This amount is for the budget period only and includes direct costs and indirect costs as applicable.

Floor of Individual Award Range:

$ 999,999 Ceiling of Individual Award Range:

$ 999,999 This ceiling is for a 12-month budget period.

Anticipated Award Date:

September 01, 2021

Budget Period Length:

12 month(s)

Period of Performance Length:

1 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:

00 (State governments)

01 (County governments)

02 (City or township 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)

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

Additional Information on Eligibility Eligibility is limited - only current applicants funded under TS19-1902 will be considered eligible.

Required Registrations System for Award Management and Universal Identifier Requirements An organization must be registered at the three following locations before it can submit an application for funding at www.grants.gov.

a. Data Universal Numbering System: All applicant organizations must obtain a Data Universal Numbering System (DUNS) number. A DUNS number is a unique nine-digit identification number provided by Dun & Bradstreet (D&B). It will be used as the Universal Identifier when applying for federal awards or cooperative agreements. The applicant organization may request a DUNS number by telephone at 1-866-705-5711 (toll free) or Internet at http://fedgov.dnb.com/webform/displayHomePage.do. The DUNS number will be provided at no charge. If funds are awarded to an applicant organization that includes sub-recipients, those sub-recipients must provide their DUNS 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. 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 usually requires not more than five business days, and registration must be renewed annually.

https://www.grants.gov/ http://fedgov.dnb.com/webform/displayHomePage.do

Additional information about registration procedures may be found at https://www.sam.gov/SAM/.

c. Grants.gov: The first step in submitting an application online is registering your organization through www.grants.gov, the official HHS E-grant website. Registration information is located at the "Applicant Registration" option at www.grants.gov. All applicant organizations must register with www.grants.gov. The one-time registration process usually takes not more than five days to complete. Applicants must start the registration process as early as possible.

Cost Sharing or Matching Cost Sharing / Matching Requirement:

No 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:

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

20: Maximum number of pages Font size: 12 point unreduced, Times New Roman Single 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.

Background Approach (Purpose, Outcomes, Strategies and Activities) Applicant Evaluation and Performance Measurement Plan Organizational Capacity of Applicants to Implement the Approach Work Plan

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

Number Of Days from Publication 60

06/26/2021

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

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, https://www.fsrs.gov/documents/ffata_legislation_110_252.pdf http://www.hhs.gov/grants/grants/grants-policies-regulations/index.html#FFATA.

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 application. Non-validated applications will not be accepted after the published application deadline date.

http://www.cdc.gov/grants/additionalrequirements/index.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

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-TS19-19020301SUPP21 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.

Criteria Eligible recipients will be evaluated against the following criteria:

mailto:support@grants.gov

Plan Maximum Points: 50 Are the facility modifications necessary to protect patients and staff from COVID-19 identified?

Is the plan for facility modifications feasible?

Is a COVID-19 vaccination plan presented?

Is a plan for communicating with community about the vaccination program presented?

Is a plan presented for expanding long-distance screening? Is a plan presented for collecting, storing, and analyzing patient tissue?

Personnel Maximum Points: 25 Is a detailed staffing plan provided?

Do the proposed staff members have the appropriate experience?

Are staff roles clearly defined?

Is a management structure proposed that will provide adequate oversight of the requirements of this NOFO?

Methods Maximum Points: 25 Are the methods for modifying the clinical facility feasible?

Are the methods for implementing a COVID-19 vaccination program feasible, reasonable and direclty connected to protecting program participants from COVID-19?

Are the methods for expanding long-distance screening feasible?

Are the methods for collecting, storing and analyzing patient tissue feasible?

Review and Selection Process Review Eligible applications will be jointly reviewed for responsiveness by AGENCY FOR TOXIC SUBSTANCES AND DISEASE REGISTRY 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".

A technical review of the application will be conducted by ATSDR program staff.

Selection Applications will be funded in order by score and rank determined by the review panel.

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

Anticipated Announcement and Award Dates 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 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.

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-7 Executive Order 12372 Review AR-8 Public Health System Reporting Requirements AR-9 Paperwork Reduction Act Requirements AR-10 Smoke-Free Workplace Requirements AR-11 Healthy People 2030 AR-12 Lobbying Restrictions AR-14 Accounting System Requirements AR-15 Proof of Non-Profit Status AR-16 Security Clearance Requirement AR-19 Third Party Agreements-ATSDR (AR-19) AR-24 Health Insurance Portability and Accountability Act Requirements AR-25 Data Management and Access AR-29 Compliance with EO13513, "Federal Leadership on Reducing Text Messaging While Driving", October 1, 2009.

AR-37 Prohibition on certain telecommunications and video surveillance services or equipment for all awards 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

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) https://www.archives.gov/federal-register/cfr https://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75 http://www.usaspending.gov/ 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.

Reporting Requirements for Competing and Non-Competing Continuations with Two or More Years Only:

Each funded recipient must provide CDC with an Annual Performance Report (APR) submitted via 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 120 days after the end of the period of performance. The Final FFR is due 120 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;

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://foa.grantsolutions.gov/www.grants.gov

(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 government;

f. amount of any foreign taxes reimbursed by each foreign government;

g. amount of foreign taxes unreimbursed by each foreign government.

6) Subagreements. The recipient must include this reporting requirement in all applicable subgrants and other subagreements.

Section VII. Agency Contacts CDC encourages inquiries concerning this announcement.

For programmatic technical assistance and general inquiries, contact:

First Name:

Theodore Last Name:

Larson Project Officer Department of Health and Human Services Centers for Disease Control and Prevention

Street 1:

4770 Buford Highway NE, MS F57 Street 2:

City:

Atlanta State:

GA Georgia Zip:

30041 Telephone:

(770) 488-3695 Email:

thl3@cdc.gov For financial, grants management, budget assistance and general inquiries, contact:

mailto:VATreporting@cdc.gov.

Address:

First Name:

Kristal Last Name:

Thompson-Black Grants Management Specialist Department of Health and Human Services Office of Grants Services

Street 1:

2939 Flowers Rd Mailstop TV-1 Street 2:

City:

Atlanta State:

GA Georgia Zip:

30341 Telephone:

770-488-2734 Email:

fmn4@cdc.gov Section VIII. Other Information Other CDC Notice of Funding Opportunities can be found at www.grants.gov.