PUBLISHED Foa_Content_of_CDC-RFA-CK22-2202.pdf

Centers for Disease Control and Prevention

National Center for Emerging and Zoonotic Infectious Diseases

Continuing Enhanced National Surveillance for Prion Diseases in the United States

CDC-RFA-CK22-2202

03/29/2022

Table of Contents A. Funding Opportunity Description

B. Award Information

C. Eligibility Information

D. Application and Submission Information

E. Review and Selection Process

F. Award Administration Information

G. Agency Contacts

H. Other Information

I. Glossary

Part I. Overview Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Subscribe" button link to ensure they receive notifications of any changes to CDC-RFA- CK22-2202. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Centers for Disease Control and Prevention (CDC) / Agency for Toxic Substances and Disease Registry (ATSDR) B. Notice of Funding Opportunity (NOFO) Title:

Continuing Enhanced National Surveillance for Prion Diseases in the United States C. Announcement Type: New - Type 1:

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.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52- 2.pdf. 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)).

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-CK22-2202

E. Assistance Listings Number:

93.084 F. Dates:

1. Due Date for Letter of Intent (LOI):

01/28/2022

2. Due Date for Applications:

https://www.grants.gov/ https://www.grants.gov/ https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html

03/29/2022 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Due Date for Informational Conference Call:

N/A

G. Executive Summary:

1. Summary Paragraph The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2022 funds for a cooperative agreement program to continue enhanced national surveillance for human prion diseases in the United States. The purpose of the funding is to continue an active surveillance program since 1997 to monitor the occurrence of potentially emerging human transmissible spongiform encephalopathies (TSEs) in the United States. In 1997, in collaboration with the American Association of Neuropathologists (AANP), the National Prion Disease Pathology Surveillance Center was established to enhance national Creutzfeldt-Jakob Disease (CJD) surveillance and to make possible laboratory investigation of newly emerging prion diseases. This pathology center provided the services of a cutting edge prion disease laboratory, filling a critical public health gap for monitoring prion diseases in humans. Brain tissues and clinical laboratory information on clinically suspected and diagnosed cases of human prion disease have been evaluated at the NPDPSC for approximately 20 years to confirm diagnoses and determine the type of prion disease, including whether the patients had variant CJD or some other possible emerging prion disease in the United States.

a. Eligible Applicants:

Open Competition

b. Funding Instrument Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards

d. Total Period of Performance Funding:

$20,000,000

e. Average One Year Award Amount:

$4,000,000

f. Total Period of Performance Length:

g. Estimated Award Date:

August 31, 2022

h. Cost Sharing and / or Matching Requirements:

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.

https://www.grants.gov/

Part II. Full Text A. Funding Opportunity Description

1. Background

a. Overview Prion diseases, also known as transmissible spongiform encephalopathies (TSEs), are a group of animal and human brain diseases that are invariably fatal and often characterized by a long incubation period and a multifocal neuropathologic picture of neuronal loss, spongiform changes, and astrogliosis. Prion diseases that occur in humans include variant Creutzfeldt-Jakob disease (CJD) and classic forms of CJD, including those classified as sporadic or genetic. Classic CJD generally occurs with an incidence between 0.5 and 2 cases per million annually. In recent years in the United States, the annual age-adjusted incidence has been between 1 and 1.4 cases per million. Since US surveillance for CJD began in 1979, the annual number of reported cases has increased substantially although the age-adjusted incidence has remained relatively stable.

The increase in numbers of reported cases largely reflects the known increased risk of CJD in people in their 60s and 70s, the aging of the US population and, more recently, the greater use of improved laboratory diagnostic tests (e.g., CSF RT-QuIC and MRIs). Variant CJD (vCJD) was first identified in 1996 in the United Kingdom where, as of June 2021, 178 probable and definite cases have been reported. An additional 54 cases have been identified in residents of 11 countries outside the United Kingdom, including four cases in the United States. In 1976, the occurrence of vCJD surprised most health authorities because it represented infections of humans by a cattle prion, the agent of classic bovine spongiform encephalopathy (BSE). This first recognized zoonotic prion disease led US and Canada to implement measures, such as stopping the feeding of cattle rendered animal protein, to reduce the spread of BSE in cattle in 1997, six years before the first endemic cases of classic BSE in North America occurred. The strict animal feeding restrictions established and maintained in North America has prevented significant spread of BSE, and, as indicated by human disease surveillance, has prevented vCJD. Another prion disease of potential public health concern is chronic wasting disease (CWD) of deer and elk. In 1999, CWD in free-ranging cervids was detected only in Colorado and Wyoming. By 2021 it had been detected in 25 states, two Canadian provinces, South Korea, Norway, Finland and Sweden. Of particular concern are the facts that unlike BSE, CWD is naturally communicable from animal-to-animal, the CWD prions can contaminate the environment from stool, urine, drool and carcasses of infected animals, and humans hunt and consume deer and elk. In addition, multiple strains of CWD have been reported, no highly effective, practical measures for stopping the CWD outbreak in the wild are presently available, and the number of people potentially exposed to CWD is increasing. Although to date, human prion disease surveillance provides evidence against the occurrence of human CWD, the pathogenicity of CWD may not be stable.

Consistent with past guidance from a World Health Organization consultation indicating that humans should avoid consumption of any part of an animal with a prion disease, CDC recommends that to be as safe as possible, hunters should minimize their exposures to CWD and avoid consuming meat from any CWD infected animal.

b. Statutory Authorities Sections 301(a) and 317(k)(2) of the Public Health Service Act (42 USC sections 242(a) and 247b(k)(2)), as amended.

c. Healthy People 2030 This program addresses the “Healthy People 2030” focus area(s) of Infectious Diseases.

www.healthypeople.gov.

d. Other National Public Health Priorities and Strategies Not Applicable

e. Relevant Work The announcement will continue to support and build upon existing CDC activities outlined in CDC-RFA-CK17-1705 (ends August 31, 2022). Measurable outcomes of the program will be in alignment with one (or more) of the following performance goal(s) for the National Center for Emerging and Zoonotic Infectious Diseases. https://www.cdc.gov/ncezid/pdf/ncezid-strategic-plan-2018-2023-508.pdf

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

CK22-2202 – National CJD Pathology Surveillance Project

STRATEGIES AND

ACTIVITIES

SHORT-TERM

OUTCOMES

INTERMEDIATE

OUTCOMES

LONG-TERM

OUTCOMES

Perform tests necessary to confirm human prion diseases or diagnose them with high specificity and characterize the infecting prions.

Evaluate the usefulness of new diagnostic methods.

Periodically contact neurologists and neuropathologists reminding them of the importance of (a) reporting suspected prion disease cases and (b) their helping to arrange for submission to the surveillance center brain tissue from patients with clinically suspected and diagnosed prion disease.

Improved human prion disease diagnoses and continued monitoring for emerging of new prion diseases in the United States.

Increased awareness of US clinicians, public health personnel and pathologists of available support for them to confirm, by state-of-the-art techniques, the diagnoses of human prion disease and the mechanism for reporting suspected cases of CJD, variant CJD and possibly new human prion diseases.

Maintain improved

Improved efficiency of national prion disease surveillance.

Increased submissions of appropriate tissue specimens to confirm the presence or absence of a prion disease in patients clinically diagnosed or suspected to have a prion disease.

Increased availability of surveillance specimens for

Provide credible prion disease surveillance to improve the confidence/trust from the US public that if variant CJD or some other new human prion disease, such as human CWD, were to emerge in this country, it would be detected early.

Serve as the ultimate measure of efficacy of the ongoing CDC, http://www.healthypeople.gov/ https://www.cdc.gov/ncezid/pdf/ncezid-strategic-plan-2018-2023-508.pdf https://www.cdc.gov/ncezid/pdf/ncezid-strategic-plan-2018-2023-508.pdf

Collaborate with CDC, state and local HDs, the CJD Foundation and other facilities.

Enhance the collection, completeness, and reporting of epidemiologic information to CDC.

Provide consultations to general practice clinicians, neurologists and pathologists.

Collect autopsy brain tissue specimens on descendants with prion disease.

Disseminate program findings to the public.

confirmations (e.g.

through brain autopsies) of prion disease cases among physician-diagnosed or suspected prion disease cases and collect autopsy lymphoreticular tissues on any of these decedents known to have had a relatively high risk of exposure to CWD.

Improved pubic access to surveillance information about human prion diseases.

prion disease experts to facilitate basic and applied prion disease-related research.

USDA, and FDA efforts to reduce to a minimum the risks of iatrogenic and other acquired food and blood-related human prion disease.

Reduce the overall negative impact of prion diseases on US patients, families, and communities.

i. Purpose

The CDC announces the availability of FY 2022 funds for a cooperative agreement to continue enhanced national surveillance for human prion diseases in the United States. The purpose is to continue an active surveillance program to help confirm suspected and clinically diagnosed cases of human prion disease and to monitor the occurrence of potentially emerging human TSEs in the United States.

ii. Outcomes The recipient is expected to achieve the following short term outcomes:

Improved prion disease diagnoses and continue monitoring for emerging of new prion diseases in the United States.

Improved awareness of clinicians, public health personnel and pathologists' awareness of available support for them to confirm, by state-of-the-art techniques, the diagnoses of human prion disease and the mechanism for reporting suspected cases of CJD, variant CJD and possibly new human prion diseases.

Increased number of confirmed prion disease cases (e.g. through increased autopsies) among physician-diagnosed or suspected prion disease cases.

Improved public access to surveillance information about human prion diseases.

The recipient is expected to achieve the following intermediate outcomes:

Improved efficiency of national prion disease surveillance.

Increased submission of specimens to confirm the presence or absence of a prion disease in patients clinically diagnosed or suspected to have a prion disease.

Make available surveillance specimens to prion disease experts to facilitate basic and applied prion disease- related research.

The recipient is expected to achieve the following long-term outcomes:

Provide reassurance to the US public that if variant CJD or some other new human prion disease, such as human CWD, were to emerge in this country, it would be detected early.

Serve as the ultimate measure of efficacy of the ongoing CDC, USDA and FDA efforts to reduce to a minimum iatrogenic CJD, including the risks of food and blood related human prion disease.

Reduce the overall negative impact of prion diseases on US patients, families, and communities.

iii. Strategies and Activities

Strategy 1: Perform the tests necessary to confirm human prion diseases or diagnose them with high specificity and characterize the infecting prions.

Strategy 2: Evaluate the usefulness of new diagnostic methods.

Strategy 3: Periodically contact neurologists and neuropathologists reminding them of the importance of (a) reporting suspected prion disease cases and (b) their helping to arrange for submission to the surveillance center brain tissue from patients with clinically suspected and diagnosed prion disease.

Strategy 4: Collaborate with CDC, state and local health departments, the CJD Foundation and other facilities

Strategy 5: Enhance the collection, completeness, and reporting of epidemiologic information to the CDC.

Strategy 6: Provide consultations to general practice clinicians, neurologists and pathologists.

Strategy 7: Collect autopsy brain tissue specimens on decedents with prion disease.

Strategy 8: Disseminate program findings to the public.

In addition, the large number of brain tissues and other laboratory samples collected as part of this project are in the public domain and should be made accessible for analysis by other investigators. The applicant should describe a detailed plan on how the samples will be made accessible to other investigators

1. Collaborations

a. With other CDC projects and CDC-funded organizations:

The recipient is expected to collaborate with CDC funded state and local Health Departments and the CJD Foundation to encourage increased utilization of the prion disease diagnostic services funded by this program.

b. With organizations not funded by CDC:

The recipient is expected to collaborate with state and local Health Departments that may not be funded by CDC and other centers as identified and/or recommended by CDC. Some examples include American Academy of Neurology and American Association of Neuropathologists.

2. Target Populations This project does not target specific populations. It collects autopsy brain tissue specimens on decedents with prion disease, provides consultations to general practice clinicians, neurologists and pathologists and disseminates program findings to the public.

a. Health Disparities N/A

iv. Funding Strategy N/A

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

Strategy/Activity 1: Perform the tests necessary to confirm human prion diseases or to diagnose them with high specificity and characterize the infecting prions to monitor for the emergence in the United States of new human prion diseases such as endemic variant CJD or possibly human

CWD.

Measure: # of referrals received from Physicians on patients who die from a clinically suspected prion disease.

Strategy/Activity 2: Evaluate the usefulness of new diagnostic methods to improve the sensitivity of national prion disease surveillance Measure: assess effects of new methods on the number of identified prion disease cases

Strategy/Activity 3: Periodically contact neurologists and neuropathologists reminding them of the importance of (a) reporting suspected prion disease cases, particularly suspected variant CJD cases and other prion disease cases of increased public health importance (e.g., possible human CWD, iatrongenic disease) and (b) their helping to arrange for submission to the surveillance center brain tissue from patients with clinically suspected and diagnosed prion disease.

Measure: # of neurologists and neuropathologists contacted

Strategy/Activity 4: Collaborate with CDC, state and local health departments and other health facilities to establish effective ways to increase accurate diagnoses of prion diseases, including increasing the number of autopsies among physician-diagnosed or suspected prion disease cases.

Measure: # of Prion diseases cases diagnosed from autopsies Measure: # of these autopsies specifically coordinated by the recipient

Strategy/Activity 5: Enhance the collection, completeness, and reporting to CDC of epidemiologic information, including copies of the death certificates, on deceased patients with highly probable prion disease based on very specific new diagnostic tests (e.g. RT-QuIC positive cerebrospinal fluid) and/or with brain tissue-confirmed prion diseases.

Measure: # of times RT-QuIC utilized to confirm suspected cases of prion diseases Measure: proportion of such patients for whom death copies of death certificates were obtained and for whom sufficient information was collected to determine the likely epidemiologic classification of the disease (e.g, iantrogenic or sporadic CJD).

Strategy/Activity 6: Provide consultations as needed, particularly on the clinical and neuropathological manifestations of variant CJD, to neurologists and pathologists in the United States by participating in association conferences, using the internet, publications, phone consultations etc.

Measure: # of conferences, presentations and consultations provided

Strategy 7: Monitor for the potential occurrence of human CWD by collecting and examining relevant tissue specimens on decedents with suspected prion disease who were at increased risk of exposure to the CWD agent as a result of their hunting or venison consumption.

Evaluation: Number of such tissue specimens collected and examined.

Strategy/Activity 8: Disseminate program findings to the public.

Measure: # of presentations and/or publications, providing quarterly updates of the number of referrals and confirmed cases of prion disease to project website.

The recipient is expected to achieve the following short term outcomes:

Short term outcome 1: Improved prion disease diagnoses and continue monitoring for emerging of new prion diseases in the United States.

Measure: Provide state of the art diagnostic services on at least 1000 specimens submitted to the recipient of this contract to help US physicians diagnoseis prion disease and obtain lymphoreticular tissues at autopsy on at least 5 cases with suspected potentially emerging prion disease (e.g., neurodegenerative illness in a patient with history of exposure to an animal harvested from an area where chronic wasting disease (CWD) has been found).

Short term outcome 2: Improved awareness of clinicians, public health personnel and pathologists' awareness of available support for them to confirm, by state-of-the-art techniques, the diagnoses of human prion disease and the mechanism for reporting suspected cases of CJD, variant CJD and possibly new human prion diseases.

Measure: The recipient of this award should create a website to advertise its prion disease diagnostic services using state-of-the-art techniques and the required protocols for submission of specimens; the website should also provide guidance on the mechanism for reporting suspected cases of CJD, variant CJD and possibly new human prion diseases.

Short term outcome 3: Increased number of confirmed prion disease cases (e.g. through increased autopsies) among physician-diagnosed or suspected prion disease cases.

Measure: Obtain at least 250 diagnostic tissue referrals of physician-diagnosed or suspected prion disease decedents for confirmation of the prion disease diagnosis.

Short term outcome 4: Improved public access to surveillance information about human prion diseases.

Measure: Make results of its surveillance information generally available on its website.

The recipient is expected to achieve the following intermediate outcomes:

Intermediate outcome 1: Improved efficiency of national prion disease surveillance.

Measure: Provide US physicians with a single, centralized place for obtaining prion disease diagnostic information and tests and share results of tests in a timely manner.

Intermediate outcome 2: Increased submission of specimens to confirm the presence or absence of a prion disease in patients clinically diagnosed or suspected to have a prion disease.

Measure: In collaboration with CDC, encourage physicians at professional meetings and through patient support groups to submit specimens on patients for whom prion disease is in the differential diagnosis to help confirm the presence orf absence of a prion disease; obtain tissues on at least 250 referrals.

Intermediate outcome 3: Make available surveillance specimens to prion disease experts to facilitate basic and applied prion disease- related research.

Measure: Provide surveillance specimens to support at least 5 reviewed research projects of established prion disease experts, including basic and applied prion disease-related research.

The recipient is expected to achieve the following long-term outcomes:

Long term outcome 1: Provide reassurance to the US public that if variant CJD or some other new human prion disease, such as human CWD, were to emerge in this country, it would be detected early.

Measure: The recipient of this award in collaboration with CDC should interpret the results of the ongoing prion disease surveillance and both the recipient of this award and CDC should provide to the US public (website/literature/conferences) the interpretation of the evidence obtained for or against the emergence in the US of variant CJD or some other new human prion disease.

Long term outcome 2: Serve as the ultimate measure of efficacy of the ongoing CDC, USDA and FDA efforts to reduce to a minimum iatrogenic CJD, including the risks of food and blood related human prion disease.

Measure: Make available the interpretation of results of human prion disease surveillance to show that the advice of CJD and efforts of USDA and FDA are or are not adequately preventing human chronic wasting disease, iatrogenic CJD cases, and prion disease related to food (variant CJD) or blood. Ideally the number of such CJD cases identified through human surveillance will be zero or close to zero, or if not, this surveillance will reveal the problem that should be addressed.

Long term outcome 3: Reduce the overall negative impact of prion diseases on US patients, families, and communities.

Measure: The recipient of this award in cooperation with CDC a) should enable patients and family members to learn from their physicians based on test results from the recipient of this award about whether they or their loved one has or had a prion disease and b) should enable the community to know with data produced and disseminated by the recipient of this award and CDC, rather than through less reliable sources, whether variant CJD or a more recent new prion disease in the community has emerged.

ii. Applicant Evaluation and Performance Measurement Plan Applicants must provide an evaluation and performance measurement plan that demonstrates how the recipient will fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this NOFO. At a minimum, the plan must describe:

How the applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement.

How key program partners will participate in the evaluation and performance measurement planning processes.

Available data sources, feasibility of collecting appropriate evaluation and performance data, and other relevant data information (e.g., performance measures proposed by the applicant)

Plans for updating the Data Management Plan (DMP) as new pertinent information becomes available. If applicable, throughout the lifecycle of the project. Updates to DMP should be provided in annual progress reports. The DMP should provide a description of the data that will be produced using these NOFO funds; access to data;

data standards ensuring released data have documentation describing methods of collection, what the data represent, and data limitations; and archival and long-term data preservation plans. For more information about CDC’s policy on the DMP, see https://www.cdc.gov/grants/additional-requirements/ar-25.html.

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

Where the applicant chooses to, or is expected to, take on specific evaluation studies, the applicant should be directed to:

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

Describe key evaluation questions to be addressed by these evaluations.

Describe other information (e.g., measures, data sources).

Recipients will be required to submit a more detailed Evaluation and Performance Measurement plan, including a DMP, if applicable, within the first 6 months of award, as described in the Reporting Section of this NOFO.

c. Organizational Capacity of Recipients to Implement the Approach The recipient should describe existing laboratory capacity to perform diagnostic tests for human prion diseases and characterize infecting prions; describe past experience and achievement in successfully completing the types of recipient activities necessary for achieving the purpose of this project; describe the ability to successfully collaborate with state and local health departments and professional associations whose members are involved in the care and diagnosis of CJD patients such as the American Academy of Neurology, the American Association of Neuropathologists, and the United States and Canadian Academy of Pathologists.

d. Work Plan Recipient should submit a proposed workplan for the strategies and/or activities outlined in the logic model section.

e. CDC Monitoring and Accountability Approach Monitoring activities include routine and ongoing communication between CDC and recipients, site visits, and recipient reporting (including work plans, performance, and financial reporting).

Consistent with applicable grants regulations and policies, CDC expects the following to be included in post-award monitoring for grants and cooperative agreements:

Tracking recipient progress in achieving the desired outcomes.

Ensuring the adequacy of recipient systems that underlie and generate data reports.

Creating an environment that fosters integrity in program performance and results.

Monitoring may also include the following activities deemed necessary to monitor the award:

Ensuring that work plans are feasible based on the budget and consistent with the intent of the award.

Ensuring that recipients are performing at a sufficient level to achieve outcomes within stated timeframes.

Working with recipients on adjusting the work plan based on achievement of outcomes, evaluation results and changing budgets.

Monitoring performance measures (both programmatic and financial) to assure satisfactory performance levels.

Monitoring and reporting activities that assist grants management staff (e.g., grants management officers and specialists, and project officers) in the identification, notification, and management of high-risk recipients.

f. CDC Program Support to Recipients

In a cooperative agreement, CDC staff is substantially involved in the program activities, above and beyond routine grant monitoring. The project is divided into eight strategies and/or activities. The recipient will be responsible for all strategies and/or activities outlined below:

CDC staff will provide support by:

Providing assistance in the dissemination and public health interpretation of results Facilitating collaborations with public health officials, neurologists and families of suspected cases to increase the number of referrals Providing feedback to the applicant in the formation and execution of their plan to make collected tissue samples available to other investigators

B. Award Information

1. Funding Instrument Type:

CA (Cooperative Agreement) CDC's substantial involvement in this program appears in the CDC Program Support to Recipients Section.

2. Award Mechanism:

U38

3. Fiscal Year:

4. Approximate Total Fiscal Year Funding:

$4,000,000

5. Total Period of Performance Funding:

$20,000,000 This amount is subject to the availability of funds.

Estimated Total Funding:

$20,000,000

6. Total Period of Performance Length:

year(s)

7. Expected Number of Awards:

8. Approximate Average Award:

$4,000,000 Per Budget Period

9. Award Ceiling:

$0 Per Budget Period

This amount is subject to the availability of funds.

10. Award Floor:

$0 Per Budget Period

11. Estimated Award Date:

August 31, 2022

12. Budget Period Length:

12 month(s)

Throughout the project period, CDC will continue the award based on the availability of funds, the evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the federal government. The total number of years for which federal support has been approved (project period) will be shown in the “Notice of Award.” This information does not constitute a commitment by the federal government to fund the entire period. The total period of performance comprises the initial competitive segment and any subsequent non-competitive continuation award(s).

13. Direct Assistance Direct Assistance (DA) is not available through 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.

C. Eligibility Information

1. Eligible Applicants Eligibility Category:

99 (Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility")

00 (State governments)

01 (County governments)

02 (City or township governments)

04 (Special district governments)

06 (Public and State controlled institutions of higher education)

05 (Independent school districts)

07 (Native American tribal governments (Federally recognized))

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

23 (Small businesses)

22 (For profit organizations other than small businesses)

20 (Private institutions of higher education)

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

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

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

08 (Public housing authorities/Indian housing authorities)

Additional Eligibility Category:

Government Organizations:

State controlled institutions of higher education

State governments or their bona fide agents (includes the District of Columbia)

Local governments or their bona fide agents

American Indian or Alaska Native tribal governments (federally recognized or state-recognized)

Territorial governments or their bona fide agents in the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau

Non-government Organizations

American Indian or Alaska native tribally designated organizations

Other

Ministries of Health

2. Additional Information on Eligibility Hospitals, Laboratories and other public and/or private entities may apply.

3. Justification for Less than Maximum Competition N/A

4. 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.

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

D. Application and Submission Information

1. 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: For applications due on or after April 4, 2022, applicants must have a unique entity identifier (UEI) at the time of application submission (SF-424, field 8c). In preparation for the federal government’s April 4, 2022 transition to the Unique Entity Identifier (UEI) from the Data Universal Numbering System (DUNS), applicants must obtain a UEI. 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. Entities registering in SAM.gov prior to April 4, 2022 must still obtain a DUNS number before registering in SAM.gov registration. Additional information is available on the GSA website, SAM.gov, and Grants.gov- Finding the UEI.

a. Data Universal Numbering System:

All applicant organizations must obtain a Data Universal Numbering System (DUNS) number to register in SAM.gov prior to April 4, 2022. A DUNS number is a unique nine-digit identification number provided by Dun & Bradstreet (D&B).

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 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/ http://fedgov.dnb.com/webform/displayHomePage.do 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.

Step System Requirements Duration Follow Up

Data Universal Number System

(DUNS)

(Required until April 4, 2022)

1. Click on http:// fedgov.dnb.com/ webform

2. Select Begin DUNS search/request process

3. Select your country or territory and follow the instructions to obtain your DUNS 9-digit #

4. Request appropriate staff member(s) to obtain DUNS number, verify & update information under DUNS number

1-2 Business Days

To confirm that you have been issued a new DUNS number check online at (http:// fedgov.dnb.com/ webform) or call 1-866-705-

System for Award Management

(SAM)

1. Retrieve organizations DUNS number (required until April 4, 2022)

2. Go to SAM.gov and designate an E-Biz POC (You will need to have an active SAM account before you can register on grants.gov). The UEI is generated as part of your registration.

3-5 Business Days but up to 2 weeks and must be renewed once a year

For SAM Customer Service Contact https://fs d.gov/ fsd-gov/ home.do Calls: 86 6-606-8220

3 Grants.gov

1. Set up an individual account in Grants.gov using organization new DUNS number to become an authorized organization representative

(AOR)

2. Once the account is set up the E-BIZ POC will be notified via email

3. Log into grants.gov using the

Same day but can take 8 weeks to be fully registered and approved in the system (note, applicants MUST obtain a DUNS number and SAM account before applying on grants.gov)

Register early!

Log into grants.gov and check AOR status until it shows you have been approved 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://grants.gov/ https://www.grants.gov/ http://www.grants.gov/ https://www.grants.gov/ http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform https://sam.gov/content/home https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do password the E-BIZ POC received and create new password

4. This authorizes the AOR to submit applications on behalf of the organization

2. Request Application Package Applicants may access the application package at www.grants.gov.

3. Application Package Applicants must download the SF-424, Application for Federal Assistance, package associated with this notice of funding opportunity at www.grants.gov.

4. Submission Dates and Times If the application is not submitted by the deadline published in the NOFO, it will not be processed. Office of Grants Services (OGS) personnel will notify the applicant that their application did not meet the deadline. The applicant must receive pre-approval to submit a paper application (see Other Submission Requirements section for additional details). If the applicant is authorized to submit a paper application, it must be received by the deadline provided by OGS.

a. Letter of Intent Deadline (must be emailed)

Number Of Days from Publication 0

01/28/2022

b. Application Deadline

Number Of Days from Publication 60

03/29/2022 11:59 pm U.S. Eastern Standard Time, at www.grants.gov. 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.

Due Date for Information Conference Call N/A

5. Pre-Award Assessments Risk Assessment Questionnaire Requirement

CDC is required to conduct pre-award risk assessments to determine the risk an applicant poses to meeting federal programmatic and administrative requirements by taking into account issues such as financial instability, insufficient management systems, non-compliance with award conditions, the charging of unallowable costs, and inexperience. The risk assessment will include an evaluation of the applicant’s CDC Risk Questionnaire, located at https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf, as well as a review of the applicant’s history in all available systems; including OMB-designated repositories of government-wide eligibility and financial integrity systems (see 45 CFR 75.205(a)), and other sources of historical information. These systems include, but are not limited to: FAPIIS (https://www.fapiis.gov/), including past performance on federal contracts as per Duncan Hunter https://www.grants.gov/ https://www.grants.gov/ https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf

National Defense Authorization Act of 2009; Do Not Pay list; and System for Award Management (SAM) exclusions.

CDC requires all applicants to complete the Risk Questionnaire, OMB Control Number 0920- 1132 annually. This questionnaire, which is located at https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf, along with supporting documentation must be submitted with your application by the closing date of the Notice of Funding Opportunity Announcement. If your organization has completed CDC’s Risk Questionnaire within the past 12 months of the closing date of this NOFO, then you must submit a copy of that questionnaire, or submit a letter signed by the authorized organization representative to include the original submission date, organization’s EIN and DUNS.

When uploading supporting documentation for the Risk Questionnaire into this application package, clearly label the documents for easy identification of the type of documentation. For example, a copy of Procurement policy submitted in response to the questionnaire may be labeled using the following format: Risk Questionnaire Supporting Documents _ Procurement Policy.

Duplication of Efforts

Applicants are responsible for reporting if this application will result in programmatic, budgetary, or commitment overlap with another application or award (i.e. grant, cooperative agreement, or contract) submitted to another funding source in the same fiscal year. Programmatic overlap occurs when (1) substantially the same project is proposed in more than one application or is submitted to two or more funding sources for review and funding consideration or (2) a specific objective and the project design for accomplishing the objective are the same or closely related in two or more applications or awards, regardless of the funding source. Budgetary overlap occurs when duplicate or equivalent budgetary items (e.g., equipment, salaries) are requested in an application but already are provided by another source. Commitment overlap occurs when an individual’s time commitment exceeds 100 percent, whether or not salary support is requested in the application. Overlap, whether programmatic, budgetary, or commitment of an individual’s effort greater than 100 percent, is not permitted. Any overlap will be resolved by the CDC with the applicant and the PD/PI prior to award.

Report Submission: The applicant must upload the report in Grants.gov under “Other Attachment Forms.” The document should be labeled: "Report on Programmatic, Budgetary, and Commitment Overlap.”

6. Content and Form of Application Submission Applicants are required to include all of the following documents with their application package at www.grants.gov.

7. Letter of Intent N/A https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf

8. Table of Contents (There is no page limit. The table of contents is not included in the project narrative page limit.): The applicant must provide, as a separate attachment, the “Table of Contents” for the entire submission package.

Provide a detailed table of contents for the entire submission package that includes all of the documents in the application and headings in the "Project Narrative" section. Name the file "Table of Contents" and upload it as a PDF file under "Other Attachment Forms" at www.grants.gov.

9. Project Abstract Summary A project abstract is included on the mandatory documents list and must be submitted at www.grants.gov. The project abstract must be a self-contained, brief summary of the proposed project including the purpose and outcomes. This summary must not include any proprietary or confidential information. Applicants must enter the summary in the "Project Abstract Summary" text box at www.grants.gov.

10. Project Narrative (Unless specified in the "H. Other Information" section, maximum of 20 pages, single spaced, 12 point font, 1-inch margins, number all pages. This includes the work plan. Content beyond the specified page number will not be reviewed.)

Applicants must submit a Project Narrative with the application forms. Applicants must name this file “Project Narrative” and upload it at www.grants.gov. The Project Narrative must include all of the following headings (including subheadings): Background, Approach, Applicant Evaluation and Performance Measurement Plan, Organizational Capacity of Applicants to Implement the Approach, and Work Plan. The Project Narrative must be succinct, self-explanatory, and in the order outlined in this section. It must address outcomes and activities to be conducted over the entire period of performance as identified in the CDC Project Description section. Applicants should use the federal plain language guidelines and Clear Communication Index to respond to this Notice of Funding Opportunity. Note that recipients should also use these tools when creating public communication materials supported by this NOFO. Failure to follow the guidance and format may negatively impact scoring of the application.

a. Background Applicants must provide a description of relevant background information that includes the context of the problem (See CDC Background).

b. Approach

i. Purpose

Applicants must describe in 2-3 sentences specifically how their application will address the public health problem as described in the CDC Background section.

ii. Outcomes https://www.grants.gov/

Applicants must clearly identify the outcomes they expect to achieve by the end of the project period, as identified in the logic model in the Approach section of the CDC Project Description.

Outcomes are the results that the program intends to achieve and usually indicate the intended direction of change (e.g., increase, decrease).

iii. Strategies and Activities

Applicants must provide a clear and concise description of the strategies and activities they will use to achieve the period of performance outcomes. Applicants must select existing evidence-based strategies that meet their needs, or describe in the Applicant Evaluation and Performance Measurement Plan how these strategies will be evaluated over the course of the project period.

See the Strategies and Activities section of the CDC Project Description.

1. Collaborations

Applicants must describe how they will collaborate with programs and organizations either internal or external to CDC. Applicants must address the Collaboration requirements as described in the CDC Project Description.

2. Target Populations and Health Disparities Applicants must describe the specific target population(s) in their jurisdiction and explain how such a target will achieve the goals of the award and/or alleviate health disparities. The applicants must also address how they will include specific populations that can benefit from the program that is described in the Approach section. Applicants must address the Target Populations and Health Disparities requirements as described in the CDC Project Description.

c. Applicant Evaluation and Performance Measurement Plan Applicants must provide an evaluation and performance measurement plan that demonstrates how the recipient will fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this NOFO. At a minimum, the plan must describe:

How applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement. The Paperwork Reduction Act of 1995 (PRA): Applicants are advised that any activities involving information collections (e.g., surveys, questionnaires, applications, audits, data requests, reporting, recordkeeping and disclosure requirements) from 10 or more individuals or non-Federal entities, including State and local governmental agencies, and funded or sponsored by the Federal Government are subject to review and approval by the Office of Management and Budget. For further information about CDC’s requirements under PRA see http://www.hhs.gov/ ocio/policy/collection/.

How key program partners will participate in the evaluation and performance measurement planning processes.

Available data sources, feasibility of collecting appropriate evaluation and performance data, data management plan (DMP), and other relevant data information (e.g., performance measures proposed by the applicant).

http://www.hhs.gov/ocio/policy/collection/

Where the applicant chooses to, or is expected to, take on specific evaluation studies, they should be…