CDC-RFA-TS19-1902.pdf

Centers for Disease Control

Agency for Toxic Substances and Disease Registry

Early Detection of Certain Medical Conditions Related to Environmental Health Hazards

CDC-RFA-TS19-1902

Application Due Date: 04/30/2019

Early Detection of Certain Medical Conditions Related to Environmental Health Hazards

CDC-RFA-TS19-1902

TABLE OF CONTENTS

Part I. Overview Information A. Federal Agency Name B. Funding Opportunity Title C. Announcement Type D. Agency Funding Opportunity Number E. Assistance Listings (CFDA) Number F. Dates G. Executive Summary

Part II. Full Text 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 Information Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notifications Emails" link to ensure they receive notifications of any changes to CDC-RFA-TS19-1902. 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 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-TS19-1902

E. Assistance Listings (CFDA) Number:

93.534 F. Dates:

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

2. Due Date for Applications: 04/30/2019, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

3. Date for Informational Conference Call:

N/A

G. Executive Summary:

1. Summary Paragraph:

Under this five-year funding opportunity, the recipient will make available to residents of Libby and Troy, Montana meeting eligibility criteria, health screening for asbestos related disease, health education, and outreach. 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 exposed to asbestos. 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, 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.grants.gov and Liability Act (CERCLA).

a. Eligible Applicants: Open Competition

b. NOFO Type: Grant

c. Approximate Number of Awards: 1

d. Total Period of Performance Funding: $12,500,000

e. Average One Year Award Amount: $2,500,000

f. Total Period of Performance Length: 5

g. Estimated Award Date: 09/01/2019

h. Cost Sharing and / or Matching Requirements: N 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

Part II. Full Text

1. Background

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

The present notice of funding opportunity (NOFO) is for the continuation of the screening activities previously funded by ATSDR. 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 42 U.S.C. Section 1397h; Program for Early Detection of Certain Medical Conditions Related to Environmental Health Hazards.

c. Healthy People 2020 This program addresses the “Healthy People 2020” focus area of Environmental Health available at https://www.healthypeople.gov/2020/topics-objectives/topic/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 (TS15-1501, Affordable Care Act Program for Early Detection of Certain Medical Conditions). 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

Target audience aware of screening services

Target audience aware of Medicare eligibility

Individuals with correct diagnosis

Target population enrolled in disease management programs

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

Target population reduce

Increased survival from lung cancer

Increased survival from mesothelioma

Increased survival from other asbestos-related cancers https://www.healthypeople.gov/2020/topics-objectives/topic/environmental-health

-Chest radiography -High-resolution computed tomography -Fecal occult blood test -Quality control processes

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

Increased knowledge of the following among target community and physicians:

-Exposure prevention -Risks of smoking -Asbestos-related disease -Disease management their exposure to asbestos

Target population reduce their rate of smoking

Providers improve smoking reduction/cessation programs

Improved treatment/management of individuals with asbestos-related disease

Community members with negative results seek continued screening

Reduced rate of smoking-related diseases

Improved quality of life

i. Purpose The purpose of the program is to (1) provide medical screening to persons with possible exposure to amphibole asbestos 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) will 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 recipient efforts.

Short-term Outcomes:

Target audience aware of screening services: Awareness of the screening program among current and former residents of Libby and Troy will be increased.

Target audience aware of Medicare eligibility: Awareness of the Medicare benefit eligibility among current and former residents of Libby and Troy will be increased.

Individuals with qualifying diagnosis enrolled in Medicare: Screening participants with an asbestos-related disease are enrolled in Medicare.

Increased knowledge of the following among target 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.

Intermediate Outcomes:

Target population enrolled in disease management programs: Participants with a positive screening result are referred for treatment and diagnosis.

Target population enrolled in treatment (for cancer or other asbestos-related, nonmalignant disease).

Target population reduces their exposure to asbestos.

Target population reduces their rate of smoking.

Provider improves smoking reduction cessation programs.

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

Community members with negative results seek continued screening.

iii. Strategies and Activities In general, the recipient will conduct community outreach, health screening and health education. Community outreach should be conducted using various media (e.g., the internet, press releases and promotions/announcements) 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 health screening via chest radiography, high-resolution computed tomography, and the fecal occult blood 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: Target audience made aware of screening services 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 promotions/announcements) and community meetings.

iv. Outside of Libby: The recipient should use press releases and promotions/announcements 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: Individuals with the correct diagnosis enrolled in Medicare.

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.

iii. 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 (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 guidelines and should include screening with a high sensitivity fecal occult blood test (FOBT) 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. In order 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. Positive screening result definition: 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:

Interpretation by a single ‘B Reader’ qualified physician of a plain chest x-ray, or 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 Center for Asbestos-Related Diseases (CARD) Clinic, for patients in the Libby area).

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:

Pathologic examination of biopsy tissue, or 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, as follows:

Category Retesting

Frequency Workers <= 35 years old

Every 3 years

Workers 36-45 years

Every other year old Workers >= 46 years old

Every year

Non-workers <= 35 years old

Every 5 years

Non-workers 36-45 years old

Every 3 years

Non-workers >= 46 years old

Every other year

g. Quality control: To assure the consistency of screening activities, the recipient will 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:

NIOSH B reader certification.

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).

Board certification in radiology or pulmonary medicine.

Experience with asbestos-related disease.

Preference will 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 FOBT, 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 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 participant 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.

References U.S. Preventive Services Task Force. Screening for colorectal cancer: U.S. Preventive Services Task Force Recommendation Statement. JAMA 2016; 315(23): 2564-2575.

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 programs and CDC-funded organizations:

N/A

b. With organizations not funded by CDC:

N/A

2. Target Populations The target populations, 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.

Environmental health conditions are defined as:

1. Asbestosis, pleural thickening, or pleural plaques as established by

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

b. 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 Center for Asbestos-Related Diseases (CARD) Clinic, for patients in the Libby area). 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.

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

a. Pathologic examination of biopsy tissue or

b. Cytology from bronchioalveolar lavage.

a. Health Disparities 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

Types of outreach events Number of outreach events (by type)

Screening Number of tests run (by test type)

Standardized health surveys Spirometry Chest radiography High Resolution Computed Tomography Fecal occult blood test Quality control processes

Number of peer review reading conducted, by type

Health Education for Community and Physicians

Asbestos-related disease education Exposure risk education Smoking cessation programs

Number and type of education materials produced Methods for disseminating education materials Demographics of health education participants

Outcome Measures As noted in the logic model and narrative, recipients are being held accountable for the short-term and intermediate outcomes in the project period. The tables below show some potential outcome measures for all relevant outcomes. These measures are to help track progress on achievement of the accountable outcomes. ATSDR will work with recipients in the 6 months following award to finalize these measures for all relevant outcomes.

Short-Term Outcomes Potential Outcome Measures Target audience aware of screening services Target audience aware of Medicare eligibility Individuals with correct diagnosis enrolled in Medicare Increased knowledge of the following among target community and physicians:

Exposure prevention Risks of smoking Asbestos-related 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 Potential Outcome Measures Target population enrolled in disease management programs Target population enrolled in treatment (for

Number of people with positive diagnosis who enroll in follow-up care Number of people with a positive diagnosis choose cancer or other asbestos-related cancers) Target population reduce their exposure to asbestos Target population reduce their rate of smoking Providers improve smoking cessation programs Improved treatment/management of individuals with asbestos-related diseases Community members with negative result seek continued screening to seek care for providers other than recipient Number of people with a positive diagnosis choose not to seek care for their condition Percent decrease in incidence of pleural plaque among those with sufficient latency Smoking frequency among target population Percent of persons newly diagnosed at earlier stage Number of persons who receive treatment for symptoms that may not have otherwise been treated Number of people with initial negative screening that report back 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.

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), if applicable, for accuracy throughout the lifecycle of the project. 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/additionalrequirements/ar-25.html.

Where the applicant chooses to, or is expected to, take on specific evaluation studies, they 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 https://www.cdc.gov/grants/additionalrequirements/ar-25.html plan, including a DMP, if applicable, within the first 6 months of award, as described in the Reporting Section of this NOFO.

The recipient will be required to submit a DMP within the first 6 months of the award.

c. Organizational Capacity of Recipients to Implement the Approach The recipient shall have staff with skills in these topic areas:

Non-research program administration: program planning, program evaluation, performance monitoring, financial reporting, budget management and administration, personnel management and project management. Note: Regarding financial reporting, the recipient will have a financial management system that will allow proper funds management and segregation of funds by program and meet the requirements as stated in The Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards found at "https://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75#se45.1.75_1302"45 CFR 75.302. The financial system should permit the preparation of reports required by general and program-specific terms and conditions; and the tracing of funds to a level of expenditure adequate to establish that such fund have been used according to the Federal statutes, regulations, and the terms and conditions of the Federal award.

Community outreach: Selection of appropriate outreach method, creation of audience-appropriate messaging, evaluation of outreach method efficacy.

Health screening: Spirometry, ordering appropriate radiologic test for a given patient, management of digital radiologic images, managing radiologist interpretations of program images, quality control of program radiology and radiologic image interpretations, administering standardized health surveys, ordering other screening tests (e.g., fecal occult blood test) when appropriate.

Health education: Production of health education materials (e.g., brochures, newsletters, videos), selection of appropriate materials dissemination methods, administration of smoking cessation programs, evaluation of health education activities.

To demonstrate proficiency in these topic areas, the applicant should submit an organizational chart, letters of support, and CVs. These files should be named "CVs/Resumes", "Letters of Support", and "Organizational Charts", respectively and uploaded to www.grants .gov. In addition, files containing examples of health education materials should be named "Health Education Materials" and uploaded to www.grants.gov.

d. Work Plan A sample work plan format is presented below to show how a traditional work plan aligns with the logic model and narrative.

In this format, the table would be completed for each period of performance outcome. If a particular activity leads to multiple outcomes, it should be described under each outcome measure.

Period of Performance

Outcome Measure: [from https://www.grants.gov/

Outcome:

[from Outcomes section and/or logic model]

Evaluation and Performance Measurement section]

Strategy and Activities

Process Measure [from Evaluation and Performance Measurement section]

Position/Party Date

1.

2.

3.

4.

5.

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: Grant

2. Award Mechanism: U61

3. Fiscal Year: 2019

4. Approximate Total Fiscal Year Funding: $2,500,000

5. Approximate Period of Performance Funding: $12,500,000

This amount is subject to the availability of funds.

Estimated Total Funding: $12,500,000

6. Approximate Period of Performance Length: 5 year(s)

7. Expected Number of Awards: 1

8. Approximate Average Award: $2,500,000 Per Budget Period

9. Award Ceiling: $2,500,000 Per Budget Period

This amount is subject to the availability of funds.

10. Award Floor: $0 Per Project Period

11. Estimated Award Date: 09/01/2019

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.

C. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

County governments

City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled "Additional Information on Eligibility" for clarification)

Additional Eligibility Category:

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.

The award ceiling for this NOFO is $2,500,000 per budget period. CDC will consider any application requesting an award higher than this amount as non-responsive and it will receive no further review.

3. Justification for Less than Maximum Competition

NA

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.

a. Data Universal Numbering System:

All applicant organizations must obtain a Data Universal Numbering System (DUNS) number.

A DUNS number is a unique nine-digit identification number provided by Dun & Bradstreet (D&B). It will be used as the Universal Identifier when applying for federal awards or cooperative agreements.

The applicant organization may request a DUNS number by telephone at 1-866-705-5711 (toll free) or internet at http:// fedgov.dnb. com/ webform/ displayHomePage.do. The DUNS number will be provided at no charge.

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

b. System for Award Management (SAM):

The SAM is the primary registrant database for the federal government and the repository into which an entity must submit information required to conduct business as a recipient. All applicant organizations must register with SAM, and will be assigned a SAM number. All information relevant to the SAM number must be current at all times during which the applicant has an application under consideration for funding by CDC. If an award is made, the SAM information must be maintained until a final financial report is submitted or the final payment is received, whichever is later. The SAM registration process can require 10 or more business days, and registration must be renewed annually. Additional information about registration procedures may be found at www.SAM.gov.

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 1 Data

Universal Number System

(DUNS)

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 #

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 https://www.grants.gov/ http://fedgov.dnb.com/webform/displayHomePage.do https://www.sam.gov/portal/public/SAM/ 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

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

1-866-705-5711

2 System for Award Management

(SAM)

formerly Central Contractor Registration

(CCR)

1. Retrieve organizations DUNS number

2. Go to www.sam.gov and designate an E-Biz POC (note CCR username will not work in SAM and you will need to have an active SAM account before you can register on grants.gov)

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

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

866-606-8220

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 password the E- BIZ POC received and create new password

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

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

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. If Internet access is not available, or if the online forms cannot be accessed, applicants may call the CDC OGS staff at 770-488- 2700 or e-mail OGS ogstims@cdc.gov for assistance. Persons with hearing loss may access CDC telecommunications at TTY 1-888-232-6348.

4. Submission Dates and Times http://www.sam.gov https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do https://www.grants.gov mailto:ogstims@cdc.gov

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 or postmarked by) Due Date for Letter of Intent: N/A

b. Application Deadline Due Date for Applications: 04/30/2019 , 11:59 p.m. 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.

Date for Information Conference Call N/A

5. CDC Assurances and Certifications All applicants are required to sign and submit “Assurances and Certifications” documents indicated at http://wwwn.cdc.gov/ grantassurances/ (S(mj444mxct51lnrv1hljjjmaa)) /Homepage.aspx.

Applicants may follow either of the following processes:

Complete the applicable assurances and certifications with each application submission, name the file “Assurances and Certifications” and upload it as a PDF file with at www.grants.gov

Complete the applicable assurances and certifications and submit them directly to CDC on an annual basis at http://wwwn.cdc.gov/ grantassurances/ (S(mj444mxct51lnrv1hljjjmaa))/ Homepage.aspx

Assurances and certifications submitted directly to CDC will be kept on file for one year and will apply to all applications submitted to CDC by the applicant within one year of the submission date.

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 https://www.grants.gov http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx https://www.grants.gov http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf 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 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 LOI is not requested or required as part of the application for this NOFO.

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.