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CDC-RFA-DP18-1816: Well-Integrated Screening and Evaluation for Women Across the Nation (WISEWOMAN)

Frequently Asked Questions and Answers

Updated 6/26/18

Application Requirements – General Page 37 states that there is a maximum of 20 pages for the Project Narrative and page 62 states a 30 page limit. Please clarify which is correct. Page 37 of the NOFO states that “Unless specified in the “H. Other Information” section, there is a maximum of 20 pages for the Project Narrative. In the “H. Other Information” section on page 62, it states that for this NOFO there is a 30 page limit for the Project Narrative, inclusive of the Work Plan. This 30 page limit is inclusive of both Core and Innovation Components, if applicable. Do appendices or supportive attachments referenced in the Project Narrative count towards the 30 page limit as well? The 30 page limit only applies to the information required for the Project Narrative (Background, Approach, Evaluation and Performance Measurement Plan, Organizational Capacity to Implement the Approach) and Work Plan. It does not include the additional attachments referenced in the NOFO. The 30 page limit applies to all applicants, regardless of whether applicants are applying for the Core Component only or both Core and Innovation Components. Do you need to have a discrete Project Narrative section for each component or include one Project Narrative? Applicants applying for both Core and Innovation Components should submit a single application with a separate Project Narrative for each component that is clearly identified as Core and Innovation. Will a work plan template be provided, or do applicants create one based off the NOFO document? A sample work plan template is provided starting on page 22 of the NOFO. Applicants are not required to use the work plan template but are required to include all of the elements listed within the template. What information is required for inclusion in the Letter of Intent besides stating intent to submit an application in response to this NOFO? Do applicants need to identify if the applicant plans to apply for the Innovation Component and identify which strategies in the Letter of Intent?

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The letter of intent should state the applicant’s intent to apply for the NOFO and should indicate plans to apply for the Innovation Component, if applicable. Letters do not have to identify the innovation strategy/strategies that will be proposed in the application. Is the data management plan separate or is it included in the page limit? The data management plan is part of the Evaluation and Performance Measurement Plan that must be submitted as part of the Project Narrative. Therefore, the data management plan is included in the 30 page limit for the Project Narrative. Please clarify attachment requirements and limitations. Page 62 lists required application documents and “Optional attachments, as determined by CDC programs.” Which of these optional attachments are required for this NOFO response? As stated on page 13 of the NOFO, letters of support with a firm commitment from providers and partners should be included in the application. The following are optional attachments:

Resumes / CVs

Position descriptions

Organization Charts

Indirect Cost Rate, if applicable

Memorandum of Agreement (MOA)

Memorandum of Understanding (MOU)

Bona Fide Agent status documentation, if applicable Are the optional attachments recommended? Will this be considered when reviewing the application? Applicants should determine the best information to include to support their application. Please refer to the Review and Selection Process section of the NOFO to determine how various sections of the application will be evaluated. Should data/statistics be formally cited in the narrative? It is up to the applicant to determine the best information that should be included to meet the requirements noted in the Project Narrative section. Is there a citation preference, i.e. APA, etc.? Is a citation page required or recommended? Applicants can determine the best way to note citations. There are no specific requirements for citations.

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Please clarify the requirements for reporting Duplication of Efforts (page 35). How are applicants advised to report potential overlaps in competitive NOFO application for personnel costs that will be resolved after awards? Refer to page 35 of the NOFO regarding requirements for reporting Duplication of Efforts. The applicant must upload the report in Grants.gov under “Other Attachment Forms.” Is it correct that the project logic model isn’t required in the application? A logic model for the Core Component is not required to be submitted in the application. Those applying for the Innovation Component should submit a logic model for the proposed program. Should applicants submit a logic model for each innovation strategy selected or one model including all strategies selected? Applicants applying for the Innovation Component should submit one logic model for all strategies selected under Innovation. What are expectations for inclusion of Memorandums of Agreement? Do contractual agreements fall under this umbrella? Can these be provided upon award because our institution cannot enter into formal agreements until a Notice of Award is received? Memorandums of Agreement (MOAs) and Memorandums of Understanding (MOUs) are optional attachments that can be submitted with the application but not required to be submitted with the application. Please refer to the definition of MOU/MOA on page 65 of the NOFO. As stated on page 13 of the NOFO, letters of support with a firm commitment from providers and partners should be included in application. If awarded, MOUs or MOAs with these partner organizations or contracts must be submitted within 90 days of award. Page 13 of the NOFO states, “If awarded, MOUs or MOAs with these partner organizations or contracts must be submitted within 90 days of award.” Page 46 of the NOFO, states under “Core Component Collaborations – 5 points”: “The inclusion and quality of Memorandums of Agreement for all proposed partners.” Please clarify whether MOAs/MOUs are required to be submitted by the application deadline in order to contribute to the applicant’s overall score. MOUs and MOAs are not required to be submitted as part of the application but may be submitted as optional attachments. MOUs and MOAs that are submitted as part of the application will be reviewed and factored into the scoring under Collaborations.

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Question regarding Core and Innovation Components- Do they need to be completely separate or just distinguishable? The work plans are separated out but can the narrative and budget have labels for both or separate documents? Applicants applying for both Core and Innovation Components should submit separate Project Narratives and budgets for each component. What is the exact deadline for letters of support? Page 13 of the NOFO states, “Letters must be dated within 45 days of the application.” Please confirm reader’s assumption that this means Letters of Support are due by August 13, 2018, based upon the current application due date of June 29, 2018. Letters of support should be included in the application and must be dated within 45 days of the application; therefore if the application is submitted on the June 29th deadline, the letters of support must be dated anywhere between May 16, 2018 and June 29, 2018. How should attachments be uploaded? For example, should all letters of support be combined into one PDF attachment document labeled Letters of Support or should each be uploaded separately? Is there a limitation on the number of attachments or number of pages included in each attachment? It is preferred for letters of support to be combined into one PDF. There is no limitation on the number of attachments; however Grants.gov suggests limiting the file size of the entire grant application package including all the attachments to 200MB. Is there an electronic template of the recommended work plan as put in the funding opportunity? If so, would it be possible for you and/or your team to send that to me? No, there is not an electronic template of the work plan. Is there a required font size for the work plan and/or other tables included in the Project Narrative?

All of the content in the Project Narrative should be 12 point font, including the work plan.

My current WISEWOMAN Program and NBCCEDP has established relationships with the clinics, programs and hospital owned and managed by our organization. In order to meet the Collaboration section of the NOFO, are we required to obtain letters of support from our own clinics, programs and hospital? Applicants should submit letters of support with a firm commitment from organizations and clinics that will have a role in helping to achieve specific NOFO activities and outcomes. As stated on page 15 of the NOFO, these letters must state the role of organizations and clinics and specify how they will help the applicant achieve the goals and outcomes of the NOFO and by component, as appropriate.

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Could you please clarify if all of this information should be a narrative within the work plan or in the other applicable narrative sections supporting the work plan e.g., Strategies & Activities; Collaborations; Target Populations and Health Disparities, Evaluation and Performance Measurement, and Organizational Capacity? The required components of the Project Narrative are on pages 36-39 of the NOFO. The Project Narrative should include the following components:

• Background • Approach (The section includes Purpose, Outcomes, Strategies and Activities, Collaborations,

Target Populations and Health Disparities) • Evaluation and Performance Measurement Plan • Organizational Capacity to Implement the Approach • Work Plan

Guidance on the work plan is provided in the NOFO on pages 21-26. Information on what should be included in narrative form of the work plan for the Core Component are provided on pages 21-22 of the NOFO. Information on what should be included in narrative form of the work plan for the Innovation Component are provided on pages 25-26 of the NOFO. All applicants must apply for the Core Component in order to be considered for the Innovation Component via a single application that clearly identifies the Core and Innovation Components. Only those successful applicants under the Core Component will be eligible for Innovation Component funding. Regarding the work plan template, please define Responsible Position/Party. Responsible position/party is referring to the position or party that has primary responsibility for overseeing the activity and ensuring it is completed. Could you please clarify the preferred order of the Application? Are you requesting:

Core Component a. Project Abstract Summary b. Project Narrative c. Etc. Innovations Component d. Project Abstract Summary e. Project Narrative f. Etc.

Or this: Project Abstract Summary g. Core Component h. Innovations Component

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Project Narrative i. Core Component j. Innovations Component

All applicants applying for both the Core and Innovation components must submit a single application that clearly identifies the Core and Innovation components. Core and Innovation components will be reviewed, scored, and ranked separately. Applicants should determine the best way to organize their application.

With the letters of support, can it be addressed To Whom It May Concern or would it have to be directed to a specific person of the program? The letter does speak in regards to the program support/partnership for the particular state. Letters of supports are not required to be directed to a specific person. As stated on page 13 of the NOFO, applicants should submit letters of support from organizations and clinics that will have a role in helping to achieve specific NOFO activities and outcomes. These letters must state the role of organizations and clinics and specify how they will help the applicant achieve the goals and outcomes of the NOFO and by component, as appropriate.

Application Requirements – Budget Does the budget narrative have a page limit? There is no page limit for the budget narrative. Is there an excel template for the budget narrative? There is no excel template for the budget narrative. However, applicants must include all of the elements listed on page 39 of the NOFO in the Budget Narrative section. Applicants are strongly encouraged to review CDC’s Budget Preparation Guidelines at: http://www.cdc.gov/grants/interestedinapplying/applicationresources.html for guidance in preparing their budget. Can you provide specific examples of what can be included as match? Match funds must be tied to services or activities that directly benefit the WISEWOMAN Program. Examples of matching funds include:

donated staff time paid for by non-federal funds;

donated staff time, or professional development provided by partners such as American Heart Association, American Lung Association, Department of State Parks and Recreation, and State universities;

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donated memberships to health/wellness facilities;

donated materials or literature on heart health;

contributions to the cost of mailings;

donated media time for public education and awareness, and to promote WISEWOMAN;

donated services provided by local service providers;

uncompensated time providers/staff/volunteers spend in WISEWOMAN trainings and advisory meetings.

Can state funds designated to support environmental approaches to increase physical activity and healthy food be used as a match? Match funds must be tied to services or activities that directly benefit the WISEWOMAN Program. Environmental approaches to increase access to physical activity and healthy food in communities that serve WISEWOMAN participants may be appropriate sources of match funding. Does the budget and budget justification need to be broken down between Core and Innovation sections? Yes. Applicants should submit separate budgets and budget justifications for Core and Innovation Components. Is there a 60/40 requirement (At least 60% spent on direct services and no more than 40% spent on indirect services)? There is not a 60/40 requirement. How does CDC suggest applicants calculate the number of women to be served given the allotted budget – is there a way to know the allowable reimbursement rates for the reimbursable clinical services (i.e., how would an applicant know how much of their Core and Innovation budget proposal to target towards clinical services)? Applicants should determine reimbursement rates for clinical services at a rate that does not exceed the Medicare reimbursement rate for the same services. Applicants should review the required services noted in the NOFO, including screening, risk reduction counseling, medical follow-up, and healthy behavior support services and work with proposed providers to estimate costs. Applicants should propose the number of women served based on the estimated costs with the goal of achieving maximum reach and impact. The amount allocated for clinical services (if any) for the Innovation Component will vary depending on the strategy and activities proposed. CDC will provide technical assistance and feedback to recipients post award regarding how much to allocate in their budget for clinical services for the Core and Innovation Components. Should applicants budget for a meeting in Atlanta?

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As indicated on page 29 of the NOFO, CDC will host a meeting/training during the first 18 months of the period of performance and later in the period of performance (for a total of 2 meetings/trainings for recipients). Applicants should budget for at least 2 key staff persons (e.g., program director/manager, data and evaluation staff) to attend a 3 day meeting in Atlanta. CDC will provide more information to recipients post award. Can funding from this award be used to pay for mental health counseling?

WISEWOMAN funding may not be used to pay for mental health counseling. However, as noted on page 12 of the NOFO, recipients are expected to collaborate with organizations to provide resources appropriate for underserved sub-populations that address participant barriers to accessing care and changing behavior. Can funding from this award be used to pay for SBIRT (Screening, Brief Intervention, and Referral for Treatment) substance abuse counseling? WISEWOMAN funding may not be used to pay for SBIRT substance abuse counseling. However, as noted on page 12 of the NOFO, recipients are expected to collaborate with organizations to provide resources appropriate for underserved sub-populations that address participant barriers to accessing care and changing behavior. Regarding the two budgets, can we put the majority of the budget (staff, operating, travel, etc.) in the Core and only put specific staff needed and program costs/travel/training, etc. in the Innovation component? Or should we prorate both? All applicants must apply for the Core Component in order to be considered for the Innovation Component via a single application that clearly identifies the Core and Innovation Components. Only those successful applicants under the Core Component will be eligible for Innovation Component funding. Therefore, the proposed budget for the Core Component must be reasonable and feasible to allow for all Core-related activities to be accomplished. The proposed budget for the Innovation Component should reflect all costs associated with completing Innovation activities above and beyond Core activities.

Are we allowed to include indirect costs in the WISEWOMAN budget using our federally negotiated indirect cost rate agreement? Applicants may include indirect costs or administrative costs in the budget, but not both. Successful programs will receive recipient-specific guidance post award to address required and recommended adjustments to budget allocations originally proposed during the application process. Can WISEWOMAN funds be used to support the purchase of nicotine replacement therapy (NRT)?

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WISEWOMAN funds cannot be used for NRT. Recipients should collaborate with CDC-funded tobacco programs to offer resources to support tobacco cessation.

Can WISEWOMAN funds be used to pay for tobacco quitline services? No.

Can WISEWOMAN funds be used to support incentives? CDC will provide technical assistance and feedback to recipients post award regarding proposed

budgets.

Is there a price limit for incentives? CDC will provide technical assistance and feedback to recipients post award regarding proposed budgets.

In the SF-424, are applicants required to separate out the core and innovation component funding? Applicants applying for both Core and Innovation Components should submit separate budgets and budget justifications for each component.

For clarity, we would only have to submit the 1st year budget, is this correct? Applicants should only submit a budget for the first year of the program.

Is the federally negotiated indirect rate allowed or not allowed? If not, do we still include the Indirect Rate Agreement in the application? If requesting indirect costs in the budget, a copy of the indirect cost-rate agreement is required. Please see response above regarding the indirect cost rate. Can Title V funds of the Indian Health Care Improvement Act be used as match? Please refer to pages 2-3 and 32 of the NOFO for match requirements. CDC will provide technical

assistance and feedback to recipients post award regarding proposed budgets.

Applicant Eligibility

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We have selected a Bona Fide agent for the CDC cancer funding in our state. Does this mean that the health department cannot be the lead applicant? Below you will find a list of the eligible applicants. We will accept an application from the entities listed below or their bona fide agent (as listed). We cannot make the decision on who should submit the application for your organization. You should check with your state to determine if your organization or bona fide agent should submit the application. Please see the eligible applicants below: Eligibility is limited by Congressional statute and applicants must be recipients of National Breast and Cervical Cancer Early Detection Program (NBCCEDP) funding. WISEWOMAN is authorized under NBCCEDP to expand screening services inclusive of cardiovascular risk. WISEWOMAN program participants must be eligible for NBCCEDP to receive WISEWOMAN services; therefore, only organizations who are currently receiving NBCCEDP awards may apply. These include:

State governments or their Bona Fide Agents (this includes the District of Columbia)

Territorial governments or their Bona Fide Agents (this includes 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)

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

American Indian/Alaska Native tribally designated organizations I see that 21 grants will be awarded and there seem to currently be 21 grants. Is this intended for the current 21 grantees? Or is this an opportunity for 21 additional grantees? This is a competitive NOFO; therefore it is open to both current awardees as well as those not currently funded by WISEWOMAN. The approximate number of awards that will be funded is 21. Programmatic – General If award date is 9/29/18 and the program gets awarded, would the work commence on 10/1/18, or would funding and screening goals be backtracked to 7/1/18? The start date is September 30, 2018; therefore work should commence on this date. Is it a requirement of the grant to work in the same practices/FQHCs that the state NBCCEDP recruited? WISEWOMAN services do not have to be offered in the same provider sites that NBCCEDP provides services. When selecting provider sites for WISEWOMAN, recipients should ensure that providers have capacity to meet WISEWOMAN service delivery requirements including employing clinical systems of care with demonstrated success in blood pressure control. Providers must have a process to ensure that WISEWOMAN program participants are eligible for NBCCEDP in order to receive WISEWOMAN services.

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Is it a requirement to work in the same regions as the state NBCCEDP? WISEWOMAN services do not have to be offered in the same regions as the state NBCCEDP. Applicants must target locations where the population experiences disparities in CVD risk factors, morbidity, and/or mortality. Is it a requirement to work with the same contractors that the state NBCCEDP is contracting with? Recipients are not required to work with the same contractors as the state NBCCEDP. However, recipients are encouraged to leverage resources by cost sharing contracts such as data management and evaluation contracts and any other contracts used to support activities that cut across chronic disease programs and relate to recipient program activities. Shall we expect a period of non-service delivery while CDC approves our readiness to provide services? In the past, there was a 6 month period in which we could not provide services due to the data system. CDC expects recipients to plan and implement required strategies, including providing clinical services at the beginning of year 1. Recipients should have partnerships or contracts with community groups that have the capacity to provide healthy behavior support services within 30 days post contract/award. The data management system must be implemented in a timely manner, no later than January 2019 as noted on page 16 of the NOFO. How will the change in program year interface with BCCP? Or does it matter, since visits no longer need to be integrated? Recipients should partner with their CDC-funded National Breast and Cervical Cancer Early Detection Program to identify and leverage opportunities to enhance their work. Given current breast and cervical cancer screening guidelines, a NBCCEDP eligible women may not receive services annually, does the initial WISEWOMAN screening office visit have to occur at the same time as the NBCCEDP office visit? The NBCCEDP and WISEWOMAN office visits do not have to occur at the same time. However, programs should strive to have integrated office visits when practical in order to conserve funds. Can WISEWOMAN funds be used to pay for the integrated office visit?

No. WISEWOMAN funds should not be used to pay for office visits that occur at the same time as the NBCCEDP office visit. When the NBCCEDP and WISEWOMAN office visit is integrated, NBCCEDP funds should be used to pay for this part of the visit costs

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What is the CDC’s perspective on non-integrated visits in the coming funding opportunity? Is this something that will be allowed, and if so what are the restrictions to non-integrated visits? Programs should strive to have NBCCEDP and cardiovascular screenings occur simultaneously (integrated) when practical. Can funds be used to pay for medications? No. WISEWOMAN funds cannot be used for medication. However, WISEWOMAN providers are expected to provide support for participants to access low or no cost medication options as part of their work. National guidelines on HTN/BP and A1C have been updated in the past year – will CDC address and/or provide their updated guidelines (“national clinical care guidelines”) on a new Technical Assistance Guide? CDC will provide technical assistance regarding national guidelines to recipients post award. Recently the American Heart Association updated their guidelines for pre-hypertension and hypertensive, when completing the application should the grantee consider and adhere to the new guidelines? What is the perspective of the CDC on this matter? Recipients should adhere to evidence-based guidelines. For hypertension, one such guideline example is the 2017 American College of Cardiology (ACC)/American Heart Association (AHA) Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults. CDC will be examining the updated recommendations closely to determine their effect on national cardiovascular disease prevention activities. What clinical services can WISEWOMAN funds support? Are there key differences between allowable clinical services from the current 2013-2018 cooperative agreement? Applicants should include clinical services in their budget that are described in the delivery of services flow diagram on pages 10 of the NOFO and will help lead to the outcomes of the NOFO. CDC will provide feedback and technical assistance to recipients post-award on allowable clinical services that WISEWOMAN funds can support.

Is there a definitive timeline on how long someone can be kept on case management? Did not see that anywhere. CDC will provide technical assistance and feedback to recipients post award regarding implementation of WISEWOMAN services.

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Is medication adherence coaching a large part of case management? CDC will provide technical assistance and feedback to recipients post award regarding implementation of WISEWOMAN services. Any issues with socioeconomic case management in addition to treatment plan case management (food, housing, clothing, etc.)? CDC will provide technical assistance and feedback to recipients post award regarding implementation of WISEWOMAN services.

Do proposed Innovation sites have to be a subset of Core sites in Fiscal Year 1? Applicants should propose provider sites with the capacity to implement the expectations for Core and Innovation.

We are looking at telehealth sites for Innovation development in FY 1 that might not be available as a Core site until fiscal year 2. Would that be acceptable to propose? Applicants should propose provider sites with the capacity to implement the expectations for Core and Innovation.

Programmatic – Program Participant Eligibility

Can applicants request to serve eligible women 30-64 years of age, rather than 40-64? Applicants should only include plans to serve women in the target age range of 40-64 years old. Do women need to be screened by NBCCEDP to be eligible for WISEWOMAN services or only eligible for NBCCEDP services? WISEWOMAN participants must be low income women ages 40-64 who are uninsured or under-insured and who participate in the National Breast and Cervical Cancer Early Detection Program. Technical assistance regarding the flow of services between NBCCEDP and WISEWOMAN will be provided to recipients post award. Can you please clarify if women eligible for WISEWOMAN MUST be enrolled or eligible for enrollment in the NBCCEDP? WISEWOMAN program participants must be eligible for NBCCEDP to receive WISEWOMAN services.

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Can programs provide patient navigation and HBSS to Medicaid-insured eligible women? WISEWOMAN must be the payer of last resort. (Exception: Indian Health Services is the payer of last resort if these funds are available.) Programs can provide WISEWOMAN services to eligible under-insured women if services are not covered by their insurance. Are women enrolled in NBCCEDP for Navigation-only considered “enrolled in NBCCEDP” and therefore eligible for WISEWOMAN? Low-income women ages 40-64 who are uninsured or under-insured and who participate in the National Breast and Cervical Cancer Early Detection Program are eligible to participate in WISEWOMAN. Technical assistance regarding the flow of services between NBCCEDP navigated women and WISEWOMAN participants will be provided to recipients post award. Can a patient currently enrolled in and screened for WISEWOMAN program services continue participation in the new funding period without being rescreened and re-enrolled (i.e. collecting new data, lab values, HBSS referrals, consent forms, etc.)? CDC will provide technical assistance to recipients post award regarding requirements for women who received WISEWOMAN services in the past. Programmatic – Strategy Do the baseline screening and rescreening on page 10 of the NOFO have to include labs? Yes, baseline screening and rescreening must include lab tests. What are the required components of the cardiovascular health risk assessment discussed on page 10

of the NOFO?

The required components of the cardiovascular health risk assessment will be based on the MDEs that are currently in the process of being approved by the Office of Management and Budget (OMB). Recipients will be provided guidance post award regarding the cardiovascular health risk assessment. In reading the NOFO, it’s unclear whether our WISEWOMAN program can pay for the actual HBSS services patients receive. We understand that we would be supporting the linkages and referrals for HBSS – but we’re looking for clarification about us paying the actual HBSS services received. WISEWOMAN funds can be used for the cost for program participants to participate in healthy behavior support services.

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What are accepted evidence-based lifestyle programs for HBSS? Applicants should propose lifestyle programs with evidence of effectiveness in improving an individual’s health status by increasing physical activity, improved healthy eating, prevention and control of hypertension, weight loss when appropriate, and/or smoking cessation if content also includes physical activity and nutrition. Applicants should engage organizations serving the population as well as representatives of the target population in selecting lifestyle programs. In addition to the list below of approved lifestyle programs, applicants should identify evidence-informed programs in their community that may be appropriate for their population. Examples of programs that are appropriate lifestyle programs include:

YMCA’s Blood Pressure Self-Monitoring program. If you’re interested in learning if a local Y near you has the YMCA’s Blood Pressure Self-Monitoring program, please visit www.ymca.net/blood-pressure-self-monitoring and click on the link to the list of participating Ys. If you do not see your local Y listed, check-in with your local Y to see if they intend to deliver the program anytime soon. Y-USA is currently working to roll the program out to more Ys. If you have questions about a specific Y or who to talk to at the Y, please email ebhi@ymca.net with your question.

Weight Watchers

Supplemental Nutrition and Assistance Program and Education (SNAP-ED)

Expanded Food and Nutrition Education Program (EFNEP)

Taking Off Pounds Sensibly (TOPS)

Curves Complete

National DPP is allowable for individuals with high blood pressure and prediabetes or at high risk for type 2 diabetes if the applicant can describe how hypertension will be documented and reportable.

In regard to connections on Lifestyle Programs or HBSS, is health coaching going to be considered an

approved method of HBSS?

As noted in the flow diagram on page 10 of NOFO, health coaching is one of the healthy behavior support services. Will chronic disease self-management education programs (e.g., Better Choices, Better Health) now be allowed as an LSP, or does it still have to be prevention-based programs? Applicants should propose lifestyle programs with evidence of effectiveness in improving an individual’s health status by increasing physical activity, improved healthy eating, prevention and control of hypertension, weight loss when appropriate, and/or smoking cessation if content also includes physical activity and nutrition. Is Diabetes Self-Management Education and Support (DSMES) allowed as a reimbursable HBSS if a women is diagnosed with diabetes?

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Currently, WISEWOMAN will provide reimbursement for women who participate in the National Diabetes Prevention Program. What are considered evidence-based and evidence-informed strategies for ensuring participant engagement in HBSS? Recipients should use evidence from published studies and their own evaluation results from previous experience to identify evidence-based and evidence-informed strategies for ensuring participant engagement in HBSS. Can you please define/explain what you mean by telehealth technology? Applicants that are proposing to implement the telehealth technology strategy for the Innovation Component should explain how they are currently using telehealth technology and how they propose to expand its use to promote management of hypertension and high blood cholesterol. The intent of the strategy on telehealth technology is for applicants to use their existing telehealth technology to expand its use. Is the intent of the Innovation Component to focus activities where NBCCEDP eligible clients would be the target audience or can the Innovation Component strategies and activities be focused for the general population? Innovation strategies and activities should benefit the target population and communities served by WISEWOMAN. How is CHW defined for the Innovation Component (is it inclusive of health navigators?) CHWs are known by a variety of names, including community health advisor, outreach worker, community health representative (CHR), promotora/promotores de salud (health promoter/promoters), patient navigator, navigator promotores (navegadores para pacientes), peer counselor, lay health advisor, peer health advisor, and peer leader. As expressed by the CHWs section of the American Public Health Association, CHWs are frontline public health workers who are trusted members of and/or have an unusually close understanding of the community served. Applicants may determine the public health workers they consider as community health workers but should be consistent with this definition. Is the 1st strategy in the ‘Strategies, Outcomes and Performance Measures’ Table on pages 16-17 of the NOFO specific to clinical care delivery/reimbursement to NBCCEDP participants, and the 2nd and 3rd strategies are work focused on the overall target health system(s) to improve clinical care to all women regardless of insurance status?

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Although outcomes of the NOFO may impact the overall health care system that recipients are working with, the outcomes tied to each strategy under the Core Component are focused on improving outcomes for WISEWOMAN participants. Can there be more than 5 activities in each strategy? There are no limitations on the number of activities that may be proposed per strategy. However, activities should be key actions that will be completed to achieve progress toward performance measure targets and should not include each and every step you will take to accomplish a major milestone (e.g., plan a training, implement the training, compile feedback on the training, write a report on the training, etc.). Does the application need to address the four domains (epidemiology and surveillance, environmental approaches, health care systems and community linkages) in each strategy? Applicants are not required to organize their activities around the areas of epidemiology and surveillance, health systems, community-clinical linkages and environmental changes. The strategies in this NOFO cross all four areas with a focus on health systems and community clinical linkages. For the Core Component, applicants must demonstrate organizational capacity to successfully implement all required strategies in the areas of epidemiology and surveillance, health systems, community-clinical linkages and environmental changes as noted on page 20 of the NOFO. Please clarify the expectations for bidirectional referrals for the Core Component compared to the expectations for bidirectional referrals established under the Innovation Component strategy. How are these different? The intent of the bi-directional referral strategy under the Innovation Component is for recipients to implement novel approaches in processes or systems to enhance bi-directional referrals between community programs/resources and health care systems. The expectation under the Innovation Component is that recipients will use the additional funds to expand efforts or increase facilitation of communication to achieve greater reach than what they will achieve through Core funding (e.g., expanded efforts in additional sectors/settings to implement bi-directional referrals, increase and track number of women referred, etc.). CDC will provide technical assistance and feedback to recipients post award to finalize Core and Innovation activities. Page 47 of the NOFO states, under “Program Strategy – 15 points”: “The extent to which the applicant demonstrates the ability to develop a jurisdiction-wide infrastructure to promote long-term sustainability/coverage for CHWs. (if applicable)” Please clarify under what circumstances this specific strategy would be applicable and what is meant by a “jurisdiction-wide infrastructure” as this terminology is not used elsewhere in the NOFO. The other references to “community health workers” (pages 3 and 9) do not include any references to jurisdiction-wide coverage. Applicants should propose approaches that promote improved infrastructure to secure long term sustainability and coverage for CHWs. Applicants should identify the jurisdiction (e.g., large health

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systems, county, regional, statewide) that the activities will reach and anticipated outcome of the proposed activities to secure sustainability and coverage. All proposals must work towards developing statewide infrastructure. If proposed activities are not statewide, applicants should describe how activities will contribute, intersect with or enhance statewide efforts. Can you use WISEWOMAN funds to pay for any of the following healthy behavior related services?

k. One on one health coaching l. The Diabetes Prevention Program m. Diabetes Self-Management Education programs n. The “Stanford” Chronic Disease Self-Management Education program o. Medical Nutrition Therapy p. Cooking Classes and Programs

WISEWOMAN funds may be used for health coaching and evidence-based lifestyle programs. Please see previous response for list of approved evidence-based lifestyle programs. Applicants may propose additional evidence-informed healthy behavior support services that may be appropriate for their population. CDC will provide feedback and technical assistance to recipients post award regarding allowable services. Can subgrantees self-refer women to services that cannot be paid for with WISEWOMAN funds if they are funded through another funding mechanism? CDC will provide technical assistance and feedback to recipients post award regarding referrals to services funded through another funding mechanism. Data, Evaluation, and Performance Management What will the Minimum Data Elements (MDE) collection and reporting requirements be? The MDEs required to be collected and reported for this cooperative agreement are being prepared for review by the Office of Management and Budget (OMB). Recipients will be provided this information after approved by OMB. When will the MDEs be defined or will they remain the same as the current program? The MDEs required to be collected and reported for this cooperative agreement will align with the strategies and outcomes of the NOFO and are being prepared for review by OMB. What client level variables (demographics, tests performed, results) are required for data collection and reporting? The MDEs required to be collected and reported for this cooperative agreement are being prepared for review by OMB. Recipients will be provided this information post award.

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Are WISEWOMAN and NBCCEDP MDEs/program data linked? Some of the MDE fields will contain shared data between NBCCEDP and WISEWOMAN. The MDEs required to be collected and reported for this cooperative agreement are being prepared for review by OMB. Will the lifestyle questionnaire need to be completed by the patient? (these are currently part of the MDE's) The MDEs required to be collected and reported for this cooperative agreement are being prepared for review by OMB. Recipients will be provided guidance post award regarding data that should be collected from the patient. Will the MDEs still be submitted twice each year of the program? CDC will provide this information to recipients post award. Please clarify how much detail should be included about the Data Management Plan in the application itself versus the more detailed Evaluation and Performance Measurement plan that will be submitted within the first 6 months of the award. Page 38 states “Recipients will be required to submit a more detailed plan (including the DMP elements) within the first 6 months of award…” but the same page also states “At a minimum, the (Applicant Evaluation and Performance Measurement Plan) must describe…available data sources, feasibility of collecting appropriate evaluation and performance data, data management plan (DMP), and other relevant… A Data Management Plan for each collection and/or generation of public health data funded by this award should include the 5 main points in the application:

A description of the data collected or generated in the proposed project

Standards to be used for the collected or generated data

Mechanisms for or limitations to providing access to and sharing of the data

Statements of the use of the data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represents, and the potential limitation for use

Plans for archiving and long-term preservation of the data, or explaining why long-term preservation and access are not justified.

Please clarify the types of data that are subject to a Data Management Plan. Does the data management plan need to address de-identified evaluation data collected via qualitative methods such as surveys, interviews, and focus groups? Or, is the data management plan required only for tracking identifiable clinical data and referral at the individual level? A Data Management Plan (DMP) is required for data the recipient collects or generates with funds from the cooperative agreement, not just identifiable clinical data. CDC will provide additional support and

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guidance on data required in the DMP as part of the Evaluation and Performance Measurement Plan once recipients are funded. For additional information, see the web link: https://www.cdc.gov/grants/additionalrequirements/ar-25.html.

Could you clarify what is expected in the work plan for the Period of Performance Outcome?

As stated in the work plan templates provided in the NOFO, the period of performance outcome should be taken from the outcomes section and/or logic model. The period of performance outcomes for the Core Component are provided in the logic model on pages 6-7 and in the outcomes section on pages 7-8 of the NOFO. Applicants applying for the Innovation Component should develop a logic model and program outcomes for the Innovation Component. One of the boxes in the work plan template is labeled Outcome Description. Could you provide some information about what you are looking for there? The Outcome Description box should contain the relevant short-term and intermediate outcomes that the selected strategy is working towards. These can be taken from the outcomes section and/or logic model. How does the CDC suggest we establish a baseline value for performance measure #4 if we do not know how many providers or practices the program will be able to contract with? Are estimations acceptable or are we bound to the targets provided in the application? Applicants should propose to work with providers with the capacity to meet the criteria outlined in the NOFO and propose the number of providers keeping in mind the goal of achieving maximum reach and impact. CDC will provide technical assistance and feedback to recipients post award regarding any adjustments needed. Recipients will have the opportunity to revise their baseline values early in the first year of the program.

Are baseline value, year 1 target, year 5 target, and data source required components in the work plan for short-term, intermediate, and long-term performance measures? These are required components for each short-term, intermediate, and long-term performance measure. There will be the opportunity to revise the baselines, year 1 targets, year 5 targets, and data sources during the first year of the program. The table of strategies, outcomes, and performance measures on pages 16-17 of the NOFO identifies performance measures for all outcomes except "Increased engagement in self-management among women at-risk for and with cardiovascular disease." How does CDC want grantees to measure patient engagement in self-management for this outcome? What performance measure should we use? While this is an important outcome for the WISEWOMAN program, there is no required performance measure for recipients to report. CDC will be responsible for reporting data related to this outcome.

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Applicants may choose to develop performance measures related to this outcome as part of their recipient-led evaluations and include those measures in their Evaluation and Performance Measurement Plan.

Should the Innovation application performance measures mirror those under Core or do applicants need to propose our own Innovation performance measures? Applicants applying for the Innovation Component should identify performance measures that align with selected innovative strategies. These performance measures should include both new performance measures and a subset of the measures listed in the Core Component as noted on page 21 of the NOFO.

Other Will the background section be scored? While there is not a specific score assigned to the background section for the Core Component, the background section is a required part of the Project Narrative. Any application that does not include a background section will be considered non-responsive. Will this cooperative agreement always be on a September funding cycle? The budget period for this cycle of WISEWOMAN funding will commence on September 30th each year for the next 5 years.