cdc-rfa-ts15-1501.pdf

Centers for Disease Control and Prevention

Agency for Toxic Substances and Disease Registry

Affordable Care Act Program for Early Detection of Certain Medical Conditions Related to

Environmental Health Hazards

CDC-RFA-TS15-1501

Application Due Date: 05/11/2015

Affordable Care Act Program for Early Detection of Certain Medical Conditions Related to Environmental Health Hazards

CDC-RFA-TS15-1501

TABLE OF CONTENTS

Part I. Overview Information

Federal Agency NameA.

Funding Opportunity TitleB.

Announcement TypeC.

Agency Funding Opportunity NumberD.

Catalog of Federal Domestic Assistance (CFDA) NumberE.

Dates F.

Executive Summary G.

Part II. Full Text

Funding Opportunity Description A.

Award Information B.

Eligibility Information C.

Required Registrations D.

Review and Selection Process E.

Award Administration Information F.

Agency Contacts G.

Other Information H.

Glossary I.

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-TS15-1501. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Agency for Toxic Substances and Disease Registry (ATSDR) B. Funding Opportunity Title:

Affordable Care Act Program for Early Detection of Certain Medical Conditions Related to Environmental Health Hazards C. Announcement Type: New - Type 1 This announcement is only for non-research domestic activities supported by ATSDR. If research is proposed, the application will not be considered Research for this purpose is defined at http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public -health-research-nonresearch.pdf.

D. Agency Funding Opportunity Number:

CDC-RFA-TS15-1501

E. Catalog of Federal Domestic Assistance (CFDA) Number:

93.534 F. Dates:

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

2. Due Date for Applications: 05/11/2015, 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:

This four-year funding opportunity offers, 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. The program described in this FOA builds upon previous programs and extends a program begun in 2011 under the Affordable Care Act.

This program will provide screening, health education, and outreach services for residents and former residents of a geographic area subject to declared public health emergencies under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), such https://foa.grantsolutions.gov/announcementmodule/www.grants.gov https://foa.grantsolutions.gov/announcementmodule/www.grants.gov http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.grants.gov as residents of Libby and Troy, Montana. This is regarding the non-research grant for the next funding cycle or continuation for ACA screening.

a. Eligible Applicants: Open Competition

b. FOA Type: Grant

c. Approximate Number of Awards: 1

d. Total Project Period Funding: $10,000,000

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

f. Number of Years of Award: 4

g. Estimated Award Date: 05/01/2015

h. Cost Sharing and / or Matching Requirements: N

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 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; http://www.gpo.gov/fdsys/ pkg/PLAW-111publ148/pdf/ PLAW-111publ148.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.

In 2011, a grant was awarded to the Center for Asbestos Related Disease (CARD) to conduct screening activities under 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 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 screening was expanded from being Libby-based to also include persons who emigrated from Libby.

The present funding opportunity announcement (FOA) is for the continuation of the activities begun under the previous FOA by 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

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 2020

This program addresses the “Healthy People 2020” focus area of Environmental Health available at http://www.healthypeople.gov.

d. Other National Public Health Priorities and Strategies

Measurable outcomes of the program will be in alignment with the following performance for ATSDR: Determine human health effects associated with exposures to priority hazardous substances.

e. Relevant Work

The present FOA was immediately preceded by a similar one in which community-based health screening, community outreach, and health education was offered to current and past resident of Libby and Troy, Montana. 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

Activities Short-Term Outcomes Intermediate Outcomes Long-Term Outcomes

Community outreach

- Media campaign

- Community events

Screening

- Standardized health surveys

Target audience aware of screening services*

Target audience aware of Medicare eligibility*

Individuals with qualifying diagnosis enrolled in Medicare*

Target population enrolled in disease management programs*

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

Increased survival from lung cancer

Increased survival from mesothe- lioma

Increased

- Spirometry

- Chest radiography

- High-resolution computed tomography

- Fecal occult blood test

- Quality control processes

Health Education/ Materials for Community and Physicians

- Asbestos- related disease education

- Exposure risk education

- Smoking cessation programs

Increased knowledge of the following among target community and physicians*:

- Exposure prevention

- Risks of smoking

- Asbestos-related disease

- Disease management cancers)*

Target population reduce their exposure to asbestos*

Target population reduce their rate of smoking*

Providers improve smoking reduction/ cessation programs*

Improved treatment/ management of individuals with asbestos- related disease*

Community members with negative results seek continued screening* survival from other asbestos-related cancers

Reduced rate of smoking- related diseases

Improved quality of life

* indicates project period outcome

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) 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 awardee 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:

Exposure prevention: Recognition of potential asbestos exposure pathways.

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

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

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

Intermediate Outcomes:

Target population enrolled in disease management programs: Participants with a positive screening 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 grantee 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 grantee, the grantee should conduct 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 grantee should consider adding them to the screening routine, if supported by the scientific literature and approved by ATSDR. The grantee should communicate the screening result with individual candidates and their physicians as well as organize and manage all screening data in a database. The grantee 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. Goal: To increase awareness of new federal screening and health services programs, including Medicare benefits, among current and former Libby residents.

b. Outreach activities:

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

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

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

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

v. Phone center: The grantee 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. Goal: To provide asbestos-related disease (ARD) screening to at-risk individuals for environmental health conditions (as defined below).

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 grantee should insure 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 guidelines1 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 grantee 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 grantee should expand screening to areas outside of Libby: The grantee 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

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 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:

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, as follows:

Category Retesting Frequency Workers <= 35 years old Every 3 years Workers 36-45 years old Every other year 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 grantee 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 grantee 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 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 grantee 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 grantee will obtain consent from each participant. The grantee will also invite each participant to participate in ATSDR’s Tremolite Asbestos Registry).

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 grantee).

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 grantee 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 grantee 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 grantee 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 grantee should create a database to track the screening disposition for all participants.

ii. Using this database, the grantee 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 grantee, the grantee 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. Goal: To educate persons with possible asbestos exposure and their physicians in actions that can detect, prevent, and treat environmental health conditions. Because most of the health outcomes associated with exposure to Libby amphibole is pulmonary, smoking cessation should be one of the main areas of focus.

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. AHRQ Publication 08-05124-EF-3. Rockville: Agency for Healthcare Research and Quality, 2008. Available: www.ahrq.gov

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.

http://www.ahrq.gov/CLINIC/cps3dix.htm#cancer.

1.Collaborations

N/A

a. With CDC-funded programs:

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

b. With organizations external to 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:

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

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.

Environmental health conditions are defined as:

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 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:

1. Pathologic examination of biopsy tissue or

2. Cytology from bronchioalveolar lavage.

a. Inclusion

N/A

iv. Funding Strategy (for multi-component FOAs only)

N/A

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

The grantee 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 awardee 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

Standardized health surveys

Spirometry

Chest radiography

High Resolution Computed Tomography

Fecal occult blood test

Quality control processes

Number of tests run (by test type)

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, awardees 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 awardees 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

Reasons people come in for screening

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 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

Number of people with positive diagnosis who enroll in follow-up care

Reasons that people with a positive diagnosis choose to seek care for providers other than grantee

Reasons that people with 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

c. Organizational Capacity of Awardees to Execute the Approach

d. Work Plan

Workplans must include, at a minimum:

A descriptive detailed year-one workplan, including objectives, activities and timelines to support the achievement of FOA outcomes. These activities must be in alignment with the FOA Logic Model and should have appropriate performance measures or milestones for accomplishing tasks. A high-level workplan for years two through four should address how progress will continue.

1.

Staff and administrative roles and functions to support the implementation of the award.

Awardee should identify and assign staff, contractors, and/or consultants, sufficient in number and expertise, to carry out the activities of the FOA.

2.

A description of administration and assessment processes to ensure successful implementation and quality assurance.

3.

e. CDC Monitoring and Accountability Approach Monitoring activities include routine and ongoing communication between CDC and awardees, site visits, and awardee 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 awardee progress in achieving the desired outcomes.

Ensuring the adequacy of awardee 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:

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

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

Working with awardees 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.

Other activities deemed necessary to monitor the award, if applicable.

These activities may include 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 grantees.

B. Award Information

1. Funding Instrument Type: Grant

2. Award Mechanism:

3. Fiscal Year: 2015 Estimated Total Funding: $2,500,000

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

5. Approximate Project Period Funding: $10,000,000

6. Total Project Period Length: 4 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

10. Award Floor: None

11. Estimated Award Date: 05/01/2015 Throughout the project period, CDC will continue the award based on the availability

Throughout the project period, CDC will continue the award based on the availability of funds, the evidence of satisfactory progress by the awardee (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 project period comprises the initial competitive segment and any subsequent non-competitive continuation award(s).

12. Budget Period Length: 12 month(s)

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

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)

2. Additional Information on Eligibility

From the preceding FOA elibility section:

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 FOA is $2,500,000. CDC will consider any application requesting an award higher than this amount as non- responsive and it will receive no further review. If a pre-application is required, then specify here and include it in the special eligibility requirements section. (http:// www.hhs.gov/ asfr/ ogapa/ aboutog/ hhsgps107.pdf)

3. Justification for Less than Maximum Competition

NA

4. Cost Sharing or Matching Cost Sharing / Matching Requirement:

No

5. Maintenance of Effort

Maintenance of effort is not required for this program.

D. Required Registrations

Additional materials that may be helpful to applicants: http://www.cdc.gov/od/pgo/funding/docs/Financial ReferenceGuide.pdf.

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-awardees, those sub-awardees 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 an awardee. All applicant organizations must register with SAM, and will be assigned a SAM number. All information relevant to the SAM number must be current at all times during which the applicant has an application under consideration for funding by CDC. If an award is made, the SAM information must be maintained until a final financial report is submitted or the final payment is received, whichever is later. The SAM registration process usually requires not more than five business days, and registration must be renewed annually. 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 http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.cdc.gov/od/pgo/funding/docs/FinancialReferenceGuide.pdf http://www.grants.gov http://fedgov.dnb.com/webform/displayHomePage.do http://fedgov.dnb.com/webform/displayHomePage.do https://www.SAM.gov http://www.Grants.gov organization through www.grants.gov, the official HHS E-grant website. Registration information is located at the "Get Registered" option at www.grants.gov.

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

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 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 PGO staff at 770-488-2700 or e-mail PGO PGOTIM@cdc.gov for assistance. Persons with hearing loss may access CDC telecommunications at TTY 1-888-232-6348.

4. Submission Dates and Times If the application is not submitted by the deadline published in the FOA, it will not be processed. PGO 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 PGO.

a. Letter of Intent Deadline (must be emailed or postmarked by) N/A

b. Application Deadline Due Date for Applications: 05/11/2015, 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.

5. CDC Assurances and Certifications All applicants are required to sign and submit “Assurances and Certifications” documents indicated at http://www.cdc.gov/grants/interestedinapplying/applicationprocess.html.

Complete the applicable assurances and certifications on an annual basis, name the file “Assurances and Certifications” and upload it as a PDF file 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.

6. Content and Form of Application Submission http://www.Grants.gov http://www.grants.gov http://www.grants.gov http://www.grants.gov http://www.grants.gov http://www.grants.gov https://foa.grantsolutions.gov/announcementmodule/PGOTIM@cdc.gov%20 http://www.grants.gov http://www.cdc.gov/grants/interestedinapplying/applicationprocess.html http://www.grants.gov/ http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx

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 FOA.

8. Table of Contents (No page limit and not included in Project Narrative limit): The applicant must provide, as a separate attachment, the “Table of Contents” for the entire submission package.

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

9. Project Abstract Summary (Maximum 1 page)

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 (Maximum of 20 pages, single spaced, Calibri 12 point, 1-inch margins, number all pages.

Content beyond 20 pages will not be considered. The 20 page limit includes the work plan.

For a multi-component FOA, maximum page limit is 25.)

The Project Narrative must include all of the bolded headings shown in this section. The Project Narrative must be succinct, self-explanatory, and in the order outlined in this section. It must address outcomes and activities to be conducted over the entire project period as identified in the CDC Project Description section. Applicants must submit a Project Narrative with the application forms. Applicants must name this file “Project Narrative” and upload it at www.grants.gov.

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

b. Approach

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

http://www.grants.gov http://www.grants.gov http://www.grants.gov

ii. Outcomes Applicants must clearly identify the outcomes they expect to achieve by the end of the project period. Outcomes are the results that the program intends to achieve. All outcomes must indicate the intended direction of change (e.g., increase, decrease, maintain). (See the logic model in the Approach section of the CDC Project Description.)

iii. Strategies and Activities Applicants must provide a clear and concise description of the strategies and activities they will use to achieve the project period outcomes. Applicants must select existing evidence-based strategies that meet their needs, or describe in the Applicant Evaluation and Performance Measurement Plan, how these strategies will be evaluated over the course of the project period. (See CDC Project Description: Strategies and Activities section.)

1. Collaborations Applicants must describe how they will collaborate with programs and organizations either internal or external to CDC.

2. Target Populations Applicants must describe the specific target population(s) in their jurisdiction and explain how such a target will achieve the goals of the award and/or alleviate health disparities. Refer back to the CDC Project Description section – Approach: Target Population.

c. Applicant Evaluation and Performance Measurement Plan Applicants must provide an overall evaluation and performance measurement plan that is consistent with the CDC Evaluation and Performance Measurement Strategy section of the CDC Project Description of this FOA. Data collected must be used for ongoing monitoring of the award to evaluate its effectiveness, and for continuous program improvement.

The plan must:

Affirm the ability to collect the performance measures and respond to the evaluation questions specified in the CDC strategy. (For guidance regarding the Paperwork Reduction Act, please visit http://www.hhs.gov/ocio/policy/collection/infocollectfaq.html) Describe how key program partners will participate in the evaluation and performance measurement planning processes.

Describe how evaluation findings will be used for continuous program quality improvement.

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

Describe the type of evaluation(s) (i.e., process, outcome, or both) to be conducted.

Describe key evaluation questions to be addressed by these evaluations.

Describe other information relevant to the evaluation (e.g., measures, data sources)

Awardees will be required to submit a more detailed evaluation and performance http://www.hhs.gov/ocio/policy/collection/infocollectfaq.html

Awardees will be required to submit a more detailed evaluation and performance measurement plan within the first 6 months of the project, as outlined in the reporting section of the FOA.

d. Organizational Capacity of Applicants to Implement the Approach Applicant must address the organizational capacity requirements as described in the CDC Project Description.

11. Work Plan (Included in the Project Narrative’s 20 page limit)

Applicants must prepare a work plan consistent with the CDC Project Description Work Plan section. The work plan integrates and delineates more specifically how the awardee plans to carry out achieving the project period outcomes, strategies and activities, evaluation and performance measurement.

Applicants must name this file "Work Plan" and upload it as a PDF file at www.grants.gov.

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

12. Budget Narrative Applicants must submit an itemized budget narrative, which may be scored as part of the Organizational Capacity of Awardees to Execute the Approach. When developing the budget narrative, applicants must consider whether the proposed budget is reasonable and consistent with the purpose, outcomes, and program strategy outlined in the project narrative. The budget must include:

Salaries and wages Fringe benefits Consultant costs Equipment Supplies Travel Other categories Contractual costs Total Direct costs Total Indirect costs

Indirect costs will not be reimbursed under grants to foreign organizations, international organizations, and foreign components of grants to domestic organizations (does not affect indirect cost reimbursement to the domestic entity for domestic activities). The CDC will not reimburse indirect costs unless the recipient has an indirect cost rate covering the applicable activities and period.

For guidance on completing a detailed budget, see Budget Preparation Guidelines at:http://www.cdc.gov/grants/interestedinapplying/applicationresources.html .

If applicable and consistent with the cited statutory authority for this announcement, applicant http://www.cdc.gov/grants/interestedinapplying/applicationresources.html

If applicable and consistent with the cited statutory authority for this announcement, applicant entities may use funds for activities as they relate to the intent of this FOA to meet national standards or seek health department accreditation through the Public Health Accreditation Board (see: http://www.phaboard.org). Applicant entities to whom this provision applies include state, local, territorial governments (including the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau), or their bona fide agents, political subdivisions of states (in consultation with states), federally recognized or state-recognized American Indian or Alaska Native tribal governments, and American Indian or Alaska Native tribally designated organizations. Activities include those that enable a public health organization to deliver public health services such as activities that ensure a capable and qualified workforce, up-to-date information systems, and the capability to assess and respond to public health needs. Use of these funds must focus on achieving a minimum of one national standard that supports the intent of the FOA. Proposed activities must be included in the budget narrative and must indicate which standards will be addressed.

Applicants must name this file “Budget Narrative” and upload it as a PDF file at www.grants.gov. If requesting indirect costs in the budget, a copy of the indirect cost-rate agreement is required. If the indirect costs are requested, include a copy of the current negotiated federal indirect cost rate agreement or a cost allocation plan approval letter for those Grantees under such a plan. Applicants must name this file “Indirect Cost Rate” and upload it at www.grants.gov.

N/A

13. Tobacco and Nutrition Policies Awardees are encouraged to implement tobacco and nutrition policies.

Unless otherwise explicitly permitted under the terms of a specific CDC award, no funds associated with this FOA may be used to implement the optional policies, and no applicants will be evaluated or scored on whether they choose to implement these optional policies.

CDC supports implementing evidence-based programs and policies to reduce tobacco use and secondhand…