TS-24-0032.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

CDC-RFA-TS-24-0032

04/15/2024

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-TS- 24-0032. 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:

Early Detection of Certain Medical Conditions Related to Environmental Health Hazards

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 purposes of this NOFO, research is defined as set forth in 45 CFR 75.2 and, for further clarity, as set forth in 42 CFR 52.2 (see eCFR :: 45 CFR 75.2 -- Definitions and https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR- 2007-title42-vol1-sec52-2.pdf. In addition, for purposes of research involving human subjects and available exceptions for public health activities, please see 45 CFR 46.102(l) (https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section- 46.102#p-46.102(l)).

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-TS-24-0032

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.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.102#p-46.102(l) https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.102#p-46.102(l)

E. Assistance Listings Number:

93.534

F. Dates:

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

The LOI date will generate once the Synopsis is published if Days or a Date are entered.

2. Due Date for Applications:

04/15/2024 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 Under this five-year funding opportunity, the recipient will make health screening for asbestos related disease, health education, and outreach available to residents of Libby and Troy, Montana meeting eligibility criteria. Libby, Montana was the site of a vermiculite mining and processing operation for much of the twentieth century. Because Libby vermiculite contains asbestos, vermiculite workers and other residents were consequently exposed. Community-based health screening for asbestos-related abnormalities has been conducted in Libby under several programs beginning in 2000.

Under this NOFO, the recipient will provide screening, health education, and outreach services for residents and former residents of Libby and Troy, Montana, a geographic area declared a public health emergency under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA).

a. Eligible Applicants:

Open Competition

b. Funding Instrument Type:

G (Grant)

c. Approximate Number of Awards

d. Total Period of Performance Funding:

$15,000,000

e. Average One Year Award Amount:

$3,000,000

f. Total Period of Performance Length:

5 year(s)

g. Estimated Award Date:

August 01, 2024

h. Cost Sharing and / or Matching Requirements:

No https://www.grants.gov/

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.

Part II. Full Text

A. Funding Opportunity Description

1. Background

a. Overview Libby, Montana was the site of a vermiculite mining and processing operation from the early 1920’s through1990. While it was in operation, Libby was the world’s largest source of vermiculite. In spite of commercial uses that include insulation, fire proofing, and as a soil conditioner, Libby vermiculite is contaminated with amphibole asbestos. This has resulted in asbestos-related morbidity and mortality in vermiculite workers, their family members, and area residents with neither occupational nor para-occupational exposure. In June 2009, the U.S Environmental Protection Administration declared a public health emergency for the Libby Asbestos Site, which includes the cities of Libby and Troy (June 19, 2009 memo from Lisa Jackson, EPA Administrator).

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. 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 resided in the Libby area. Persons with certain positive diagnoses may be eligible for Medicare benefits.

In 2011, a grant was awarded to the Center for Asbestos Related Disease (CARD) to conduct screening activities under the ACA. This screening included the use of a standardized health survey, spirometry, and chest radiography as well as high-resolution computed tomography (HRCT) and the fecal occult blood test (FOBT). Screening activities were expanded under the ACA to include community outreach and health education. Further, the scope of ACA screening was expanded from being Libby-based to also include persons who emigrated from Libby.

The present NOFO is for the continuation of the activities begun under previous awards to CARD. This 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.

b. Statutory Authorities https://www.hhs.gov/sites/default/files/ppacacon.pdf

Affordable Care Act (ACA) Section 10323(b) amends Title XX of the Social Security Act (42 U.S.C 1397 et seq.) to establish a "Program for Early Detection of Certain Medical Conditions Related to Environmental Health Hazards." (Section 2009 of the Social Security Act, as amended) (42 U.S.C. 1397h).

c. Healthy People 2030 This program addresses the “Healthy People 2030” focus area of Environmental Health available at https://health.gov/healthypeople/objectives-and-data/browse-objectives/environmental-health.

d. Other National Public Health Priorities and Strategies Measurable outcomes of the program will be in alignment with the following performance measure for ATSDR: Determine human health effects associated with exposures to priority hazardous substances.

e. Relevant Work The present NOFO was immediately preceded by a similar one in which the recipient offered community-based health screening, community outreach, and health education to current and past residents of Libby and Troy, Montana (TS19-1902, Early Detection of Certain Medical Conditions Related to Environmental Health Hazards). In addition, ATSDR conducted health screening in Libby in 2000 and 2001, and the Montana Department of Public Health and Human Services also offered health screening 2003–2008 under an ATSDR grant.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

Strategies and Activities

Short-term Outcomes

Intermediate Outcomes Long-Term Outcomes

Community outreach

-Media campaign

-Community events

Screening

-Standardized health surveys

-Spirometry

-Chest radiography

-High-resolution computed tomography

-Fecal occult blood test

Increased awareness of screening services for medical conditions

Increased awareness of Medicare eligibility

Increased enrollment in Medicare for individuals with covered diagnoses

Increased knowledge of the

Increased enrollment in disease management programs

Increased referrals for treatment (for lung cancer or other asbestos-related cancers)

Reduction in asbestos exposure

Decreased rate of smoking

Increased awareness of smoking reduction/cessation

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

Development of long-term

-Quality control processes

Health Education/Materials for Community and Physicians

-Asbestos-related disease education

-Exposure risk education

-Smoking cessation programs following among target community and physicians:

-Exposure prevention -Risks of smoking -Asbestos-related disease -Disease management programs in target population

Improved treatment/management of individuals with asbestos-related disease

Increased continuity of screening among community members with negative screening results surveillance for health outcomes associated with post-Superfund clean-up exposures

Increased understanding of health outcomes and treatments for this population

i. Purpose The purpose of the program is to (1) provide medical screening to persons with possible exposure to amphiboles that occurred in Libby and Troy, Montana; (2) conduct nationwide outreach to raise awareness of the screening program among persons eligible to participate and of the availability of certain Medicare benefits; and (3) provide health education to detect, prevent, and treat environmental health conditions. The three components of this project (screening, outreach and education) should be conducted in an integrated manner.

ii. Outcomes As shown in the Logic Model, a series of short and intermediate-term outcomes are expected to be achieved as a result of awardee efforts.

Short-term Outcomes:

• Increased awareness of screening services for medical conditions: Awareness of the screening program among current and former residents of Libby and Troy will be increased.

• Increased awareness of Medicare eligibility: Awareness of the Medicare benefit eligibility among current and former residents of Libby and Troy will be increased.

• Increased enrollment in Medicare for individuals with a qualifying diagnosis. Screening participants diagnosed with an asbestos-related disease are eligible to be enrolled in Medicare.

• Increased knowledge of the following among community and physicians:

o Exposure prevention: Recognition of potential asbestos exposure pathways.

o Risks of smoking: Recognition of the health risks associated with smoking.

o Asbestos-related disease: Recognition of disease associated with asbestos exposure.

o Disease management: How to diagnose and treat asbestos-related diseases.Disease management: How to diagnose and treat asbestos-related disease

Intermediate Outcomes:

• Increased enrollment in disease management programs: Participants with a positive screening result are referred for treatment and diagnosis.

• Increased referrals for treatment (for cancer or other asbestos-related, nonmalignant disease).

• Reduction in asbestos exposure.

• Decreased rate of smoking.

• Increased awareness of smoking reduction and cessation programs in target population.

• Improved treatment/management of individuals with asbestos-related diseases.

• Increased continuity of screening among community members with negative results.

iii. Strategies and Activities a

In general, the recipient should conduct community outreach using various media (e.g., the internet, press releases and advertisements) to increase awareness of the federal screening and health benefit programs among residents of Libby and Troy, MT, as well as among former residents who no longer live in those communities. After screening candidates complete pre-screening questions to demonstrate eligibility to the recipient, the recipient should conduct screening via chest radiography, high-resolution computed tomography, and the fecal immunochemical test. If additional tests become available during the project (e.g., testing for mesothelin), the recipient should consider adding them to the screening routine, if supported by the scientific literature and approved by ATSDR. The recipient should communicate the screening result with individual candidates and their physicians as well as organize and manage all screening data in a database. The recipient should also conduct health education via community meetings and an annual newsletter.

Some specifications for carrying out activities under this grant, which are described in the ACA legislation (http://www.gpo.gov/fdsys/pkg/PLAW-111publ148/pdf/PLAW-111publ148.pdf) are summarized below, and should be followed to ensure consistency of the program:

1. Community Outreach.

a. Relevant outcome: Increased awareness of screening services for medical conditions and Medicare eligibility.

b. Outreach activities:

i. Internet: The recipient should establish a web site containing program information.

ii. Traditional mail: The recipient should communicate with screening candidates via letters and other mailed materials.

iii. In Libby: The recipient should use the local media (newspaper and radio advertisements) and community meetings.

iv. Outside of Libby: The recipient should use press releases and advertisements in national newspapers and magazines and other resources such as social media.

v. Phone center: The recipient should establish a toll-free phone number staffed with persons who can answer questions about federal screening and health services and receive calls from screening candidates.

2. Screening.

a. Relevant outcome: Increased enrollment in Medicare for individuals with a covered diagnosis.

b. Eligibility for screening: An at-risk individual is defined as having been present for an aggregate total of 6 months in the geographic area subject to an emergency declaration (the towns of Libby and Troy, in Lincoln County, Montana), as specified by ACA, during a period ending:

i. not less than 10 years prior to the date of an individual’s application for screening under this program; and

ii. prior to the implementation of all the remedial and removal actions specified in the Record of Decision for Operating Unit 4 and the Record of Decision for Operating Unit 7.

The recipient should ensure each participant furnishes documentation (e.g., mail delivered to a Libby address during the time period specified above, or a letter from ATSDR containing results from a previous screening) to demonstrate eligibility for screening.

c. Screening components: Each candidate will be evaluated with radiologic testing (a posterior-anterior (PA) chest radiograph and possibly chest high-resolution computed tomography (HRCT)). All candidates should be evaluated initially via a PA radiograph; if the radiograph results obtained through a B-reading are judged to be equivocal by the screening participant’s physician, then the candidate may also be evaluated via HRCT. Screening for colorectal cancer should be conducted in accordance with applicable guidelines1 and should include screening with a high sensitivity fecal immunochemical test (FIT) in adults aged 50 to 75 years.

d. Locations:

i. Libby and surrounding areas: If expertise does not reside within the applicant’s organization, it may subcontract with local provider entities in the immediate area or reimburse individual provider entities according to a predetermined fee schedule to conduct screening. ATSDR anticipates fewer than 4,000 persons in Libby and surrounding areas would be eligible for screening based on previous screening programs. To maintain continuity with the current screening program, the recipient should implement the screening program for the Libby area prior to initiating the screening program outside of Libby.

ii. Outside of Libby: After implementing the Libby area screening program, the recipient should expand screening to areas outside of Libby. The recipient may reimburse individual provider entities according to a predetermined fee schedule or subcontract with local provider entities if feasible to screen candidates no longer living in Libby. ATSDR anticipates the universe of screening candidates no longer residing in Libby is fewer than 8,000 based on U.S. Census data.

iii. All radiographs and HRCT scans should be read within one business day by an onsite radiologist (i.e., a radiologist reporting to the local provider entity). If an urgent abnormality (e.g., breast or lung cancer) is detected, those results should be immediately communicated to the screening participant and his/her primary care physician.

e. The screening candidate will be deemed positive if one of the following conditions is present:

i. Asbestosis, pleural thickening, or pleural plaques as established by:

1. Interpretation by a single ‘B Reader’ qualified physician of a plain chest x-ray, or

2. Interpretation of a computed tomography of the chest by a qualified physician (a physician with board certification in radiology or pulmonary medicine or an interpretation provided by the awardee, for patients in the Libby area).

3. Note: This clause shall not apply to pleural thickening or pleural plaques unless there are symptoms or conditions requiring medical treatment as a result of these diagnoses

ii. Mesothelioma, or malignancies of the lung, colon, rectum, larynx, stomach, esophagus, pharynx, or ovary, as established by:

1. Pathologic examination of biopsy tissue, or

2. Cytology from bronchioalveolar lavage.

f. Follow-up: If a patient has an initial negative B-reading, he or she may be entitled to a second and last reading by another B-reader in the panel described below.

Since asbestos-related diseases require a sufficient latency between exposure and the actual development of disease and considering that the sensitivity and specificity of screening procedures are not perfect, candidates that are not initially eligible for screening, may be entitled to additional screening, as described in the table below. The schedule for additional screening should take into consideration age and the risk of developing asbestos-related disease, according to categories of exposure (see table below for suggested follow-up schedules).

g. Quality control: To improve the consistency of screening activities, the recipient should implement the following strategies:

i. Form a panel of B-readers to serve as “acceptable B-readers” for the purposes of screening ARD under this program, to be approved by ATSDR. ATSDR anticipates that the panel will consist of at least 5 B-readers, three of which will also be board-certified radiologists. The recipient should select panel members based on the following criteria:

1. NIOSH B reader certification.

2. Active in reading at least 20 films for asbestos B reading per month as indicated on the Interpreting Physician Certification Document (CDC/NIOSH(M)2.12).

3. Board certification in radiology or pulmonary medicine.

4. Experience with asbestos-related disease.

5. Preference should be given to readers holding an academic appointment at a medical school in the U.S.

ii. Create a repository of program radiograph and HRCT images.

iii. Randomly sample radiographs held in the repository periodically for review by the entire panel of B-readers. This review will have no influence on already established status of patient benefits under the program but will serve solely to bring consistency to the screening program.

iv. Randomly sample HRCTs held in the repository for review by the radiologists sitting on the panel. Again, this review will have no influence on already established status of patient benefits under the program but will serve solely to bring consistency to the screening program.

h. Screening flow: The recipient should coordinate the flow of screening participants through the system. Steps in screening flow may include:

i. Pre-screening to confirm eligibility for screening according to ACA language, as described above in Section b., Eligibility for screening.

ii. Initial enrollment and obtaining participant’s consent (Prior to screening, the recipient will obtain consent from each participant).

iii. Prior to screening, mailing information to each screening participant about the screening program (including an overall program description, list of affiliated providers in the area, letter to personal physician or affiliated provider explaining screening requirements, and instructions for how to send radiographic exams to the recipient).

iv. Appointment scheduling.

v. Administration of screening components (radiography (radiograph and

HRCT) and FIT, as appropriate).

vi. Onsite radiology reading.

vii. Dissemination of urgent results from onsite radiology reading, if necessary.

viii. Routing radiographs to B-readers and HRCT scans to radiologists.

ix. Collecting B-reader/radiologist interpretations and disseminating to the screening physician along with a blank final diagnosis letter (to be completed by the screening physician). One copy of the final diagnosis letter will be returned to the grant recipient, and one will be sent to the screening participant.

x. Creating a disposition for each screening participant (i.e., ARD positive or negative).

xi. Storing all screening data in a database.

xii. Reporting results to ATSDR.

xiii. According to screening results, mailing a letter to participants with instructions for how to contact SSA, if necessary, and pertinent education materials.

i. Data storage: The recipient should create and maintain a database containing survey and clinical data as well as the disposition of participants. Data elements for this database should include: number of calls received via the program’s toll-free number, number of individuals eligible for screening, screening results

(including B readings, HRCT readings, and final diagnosis), and number of individuals with follow-up screenings.

j. National network of providers: The recipient should establish a national network of health care providers to administer the screenings, including providers that administer the required radiologic tests (radiographs and HRCT).

k. Participant disposition, reporting, and radiologic image access:

i. The recipient should create a database to track the screening disposition for all participants.

ii. Using this database, the recipient should provide a written quarterly report to ATSDR summarizing the results of screening including number of people screened, as well as costs for administrative and outreach activities.

iii. While all screening data will reside with and be owned by the recipient, the recipient should provide ATSDR with access to all radiograph and HRCT images and other screening data collected for this program for quality control, reporting, and research purposes.

3. Health education.

a. Relevant outcome: Increased knowledge of the following among target community and physicians: exposure prevention; risks of smoking; asbestos-related disease; and disease management.

b. Activities:

i. Newsletter to participants: An annual newsletter should contain topics related to asbestos exposure and resulting health outcomes and ways participants can improve their health (e.g., smoking cessation).

ii. Physician education: Pamphlets describing ATSDR educational resources available to physicians, such as Case Studies in Environmental Medicine and Grand Rounds in Environmental Medicine, may be disseminated to physicians who are likely to provide care for ARD patients.

Table showing suggested follow-up schedules.

Category Retesting Frequency Workers <= 35 years old Workers 36-45 years old Workers >= 46 years old Non-workers <= 35 years old Non-workers 36-45 years old Non-workers <= 46 years old

Every 3 years Every other year Every year Every 5 years Every 3 years Every other year

References

U.S. Preventive Services Task Force. Screening for colorectal cancer: U.S. Preventive Services Task Force Recommendation Statement. JAMA 2021; 325(19): 1965-1977.

Levin B, Lieberman DA, McFarland B, et al. Screening and surveillance for the early detection of colorectal cancer and adenomatous polyps, 2008: A joint guideline from the American Cancer

Society, the U.S. Multi-Society Task force on Colorectal Cancer, and the American College of Radiology. Gastroenterology 2008;134:1570–95.

Rex DK, Johnson DA, Lieberman DA, Burt RW, Sonnenberg A. Colorectal cancer prevention 2000: screening recommendations of the American College of Gastroenterology. Am J Gastroenterol 2000; 95:868–77.

Davila RE, Rajan E, Baron TH, et al. ASGE guideline: Colorectal cancer screening and surveillance. Gastrointent Endosc 2006;63:546–57.

U.S. Preventive Services Task Force. Guide to Clinical Preventive Services. Available at https://www.ahrq.gov/professionals/clinicians-providers/guidelines-recommendations/guide/index.html

1. Collaborations

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

The recipient will be expected to collaborate with ATSDR to optimize program reports.

b. With organizations not funded by CDC:

N/A

2. Population(s) of Focus The populations of focus, as specified in the ACA legislation, are at-risk individuals for environmental health conditions, as defined below. An at-risk individual is defined as having been present for an aggregate total of 6 months in the geographic area subject to an emergency declaration (the towns of Libby and Troy, in Lincoln County, Montana), as specified by ACA, during a period ending:

1. not less than 10 years prior to the date of an individual’s application for screening under this program; and

2. prior to the implementation of all the remedial and removal actions specified in the Record of Decision for Operating Unit 4 and the Record of Decision for Operating Unit 7.

This NOFO, including funding and eligibility, is not limited based on, and does not discriminate on the basis of race, color, national origin, disability, age, sex (including gender identity, sexual orientation, and pregnancy) or other constitutionally protected statuses.

a. Health Disparities The goal of health equity is for everyone to have a fair and just opportunity to attain their highest level of health. Achieving this requires focused and ongoing societal efforts to address historical and contemporary injustices; overcome economic, social, and other obstacles to health and healthcare; and eliminate preventable health disparities.

Broadly defined, social determinants of health are non-medical factors that influence health outcomes. They are the conditions in which people are born, grow, work, live, and age, and the wider set of forces and systems shaping the conditions of daily life. These forces (e.g., racism, climate) and systems include economic policies and systems, development agendas, social norms, social policies, and political systems. See content below and in other sections (e.g., https://www.ahrq.gov/professionals/clinicians-providers/guidelines-recommendations/guide/index.html https://www.ahrq.gov/professionals/clinicians-providers/guidelines-recommendations/guide/index.html

Approach, Collaborations, Populations of Focus) for information on how this specific NOFO affects social determinants of health.

A health disparity is a preventable difference in the burden of disease, injury, violence, or opportunities to achieve optimal health that are experienced by populations that have been socially, economically, geographically, and environmentally disadvantaged. Health disparities are inextricably linked to a complex blend of social determinants that influence which populations are most disproportionately affected by these diseases and conditions.

N/A

iv. Funding Strategy N/A

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

The recipient will track and report on appropriate process measures for the strategies/activities they have undertaken. These measures are to help track the implementation of strategies and their component activities. ATSDR will work with the recipient in the 6 months following award to finalize these measures.

Strategy/Activities Process Measures/Indicators Community Outreach

Media campaign

Community events

Screening

Standardized health surveys

Spirometry

Chest radiography

High-resolution computed tomography

Fecal immunochemical blood test

Quality control processes

Health Education for Community/Physicians

Asbestos-related disease education

Exposure risk education

Types of outreach events

Number of outreach events (by types)

Number of tests run (by test type)

Number of peer review readings conducted, by type

Number radiologic test results in which CARD physicians and external readers agree

Number and type of education materials produced

Methods for disseminating education materials

Demographics of health education participants

Smoking cessation programs

Short-Term Outcomes Outcome Measures

Increased awareness of screening services for medical conditions

Increased awareness of Medicare eligibility

Increased enrollment in Medicare for individuals with a covered diagnosis.

Increased knowledge of the following among target community and physicians:

Exposure prevention

Risks of smoking

Asbestos-related diseases

Disease management

Number of target population residing outside of Libby that are aware of screening services

Number of target population aware of Medicare benefits prior to outreach

Percent of target audience who heard about screening through different outreach methods

Percent of target population that can correctly identify:

Exposure prevention Risks of smoking Asbestos-related diseases Disease management

Intermediate Outcomes Outcome Measures

Increased enrollment in disease management programs

Increased referrals for treatment (for lung cancer or other asbestos-related cancers)

Reduction in asbestos exposure

Decreased rate of smoking in target population

Increased efforts by healthcare providers to expand awareness of smoking reduction/cessation programs

Number of people with positive screening results who enroll in relevant follow-up care

Number of people with a positive diagnosis that choose to seek care from providers other than recipient

Smoking frequency among target population

Percent of persons newly diagnosed at earlier stage

Improved treatment/management of individuals with asbestos-related diseases

Increased continuity of screening among community members with negative results

Number of persons who receive treatment for symptoms that may not have otherwise been treated

Number of people with initial negative screening that return for additional screening

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 applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement, including, as applicable to the award, how findings will contribute to reducing or eliminating health disparities and inequities.

• 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).

• How evaluation findings will be disseminated to communities and populations of interest in a manner that is suitable to their needs.

• 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.

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).

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

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 applicant must address the organizational capacity requirements as described in the CDC Project Description.

d. Work Plan A work plan is a program management tool intended to provide direction and structure for the entire program as well as each required activity. It should be used for program planning and implementation as well as evaluation and monitoring the progress toward reaching program goals. At the time of application, each applicant will submit a detailed work plan for the first year of the project, and a high-level work plan for the subsequent years of funding. Post award, CDC/ATSDR will work with recipients to finalize the format and content of the work plan. Each year recipients will submit an updated work plan as part of their Annual Performance Report (APR) and continuation application.

Additionally, the work plan should describe any anticipated challenges that will be addressed to successfully complete the activities in the NOFO, particularly related to development of the state action plan and state level evaluation plan as well as implementation of selected prevention approaches.

The following work plan format (see table below) is offered as an example to show the essential elements that should be included in the work plan submitted with the application. The work plan goals and objectives align with the strategies and activities shown in the logic model. Applicants may submit the work plan in a format that is most conducive for them; however, the essential elements must be included, and it must be clear how the components in the work plan crosswalk to the strategies and activities, outcomes, and evaluation and performance measures presented in the logic model and the narrative sections of the NOFO. Post award, CDC will provide further details and standard tools or templates for an enhanced work plan to monitor recipients activities as part of Evaluation and Performance Measurement.

Goal 1: Conduct community outreach

Objective 1A: Continue media campaign

Objective 1B: Continue participation in community events

Goal 2: Administer health screening

Objective 2A: Continue collection of patient information using standardized health surveys

Objective 2B: Continue spirometry testing

Objective 2C: Continue administering chest radiography

Objective 2D: Continue administering high-resolution computed tomography

Objective 2E: Continue implementing quality control processes

Goal 3: Provide health/education materials for community and physicians

Objective 3A: Continue to provide asbestos-related disease education

Objective 3B: Continue exposure risk education

Objective 3C: Continue smoking cessation programs.

Period of Performance Outcome (from Outcomes section and/or logic model)

Outcome Measure (from Evaluation and Performance Measurement section)

Strategies and Activities

Process Measure (from Evaluation and Performance Measurement section)

Responsible Position/Party Completion Date

1.

2.

3.

4.

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.

B. Award Information

1. Funding Instrument Type:

G (Grant)

2. Award Mechanism:

U61

3. Fiscal Year:

4. Approximate Total Fiscal Year Funding:

$3,000,000

5. Total Period of Performance Funding:

$15,000,000 This amount is subject to the availability of funds.

Estimated Total Funding:

$3,000,000

6. Total Period of Performance Length:

5 year(s) year(s)

7. Expected Number of Awards:

8. Approximate Average Award:

$3,000,000 Per Budget Period

9. Award Ceiling:

$3,000,000 Per Budget Period

This amount is subject to the availability of funds.

10. Award Floor:

$0 Per Budget Period

11. Estimated Award Date:

August 01, 2024

12. Budget Period Length:

12 month(s)

Throughout the period of performance, 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 (period of performance) 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:

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))

2. Additional Information on Eligibility Eligible applicants that can apply for this funding opportunity are listed below according to the authorizing legislation:

• A hospital or community health center.

• A Federally qualified health center.

• A facility of the Indian Health Service.

• A National Cancer Institute-designated cancer center.

• An agency of any State or local government.

• A nonprofit organization

A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application.

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: Effective April 4, 2022, applicants must have a Unique Entity Identifier (UEI) at the time of application submission (SF-424, field 8c). The UEI is generated as part of SAM.gov registration. Current SAM.gov registrants have already been assigned their UEI and can view it in SAM.gov and Grants.gov. Additional information is available on the GSA website, SAM.gov, and Grants.gov- Finding the UEI.

a. Unique Entity Identifier (UEI):

All applicant organizations must obtain a Unique Entity Identifier (UEI) number associated with your organization’s physical location prior to submitting an application. A UEI number is a unique twelve-digit identification number assigned through SAM.gov registration. Some organizations may have multiple UEI numbers. Use the UEI number associated with the location of the organization receiving the federal 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 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/ 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 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

System for Award Management

(SAM)

1. Go to SAM.gov and create an Electronic Business Point of Contact (EBiz 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.

7-10 Business Days but may take longer and must be renewed once a year

For SAM Customer Service Contact https://fsd.gov/ fsd-gov/ home.do Calls:

866-606-8220

2 Grants.gov

1. Set up an account in Grants.gov, then add a profile by adding the organization's new UEI number.

2. The EBiz POC can designate user roles, including Authorized Organization Representative

(AOR).

3. AOR is authorized to submit applications on behalf of the organization in their workspace.

Allow at least one business day (after you enter the EBiz POC name and EBiz POC email in SAM) to receive a UEI (SAM) which will allow you to register with Grants.gov and apply for federal funding.

Register early!

Applicants can register within minutes.

2. Request Application Package Applicants may access the application package at www.grants.gov. Additional information about applying for CDC grants and cooperative agreements can be found here:

https://www.cdc.gov/grants/applying/pre-award.html 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 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/ 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 http://www.grants.gov https://www.cdc.gov/grants/applying/pre-award.html

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)

b. Application Deadline

Due Date for Applications 04/15/2024

04/15/2024 11:59 pm U.S. Eastern 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 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 LOI is not requested or required as part ofthe application for this NOFO.

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, Word, or Excel file format 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.