CDC-RFA-OE17-1702 Amend 1.pdf

Image Description: Centers for Disease Control

Centers for Disease Control

Center for Surveillance, Epidemiology and Laboratory Services

Increasing Public Awareness and Provider Education About Primary Immunodeficiency Disease

CDC-RFA-OE17-1702

Application Due Date: 04/26/2017

Increasing Public Awareness and Provider Education About Primary Immunodeficiency Disease

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.

Application and Submission Information 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-OE17-1702. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Centers for Disease Control and Prevention (CDC) / Agency for Toxic Substances and Disease Registry

(ATSDR)

B. Funding Opportunity Title:

Increasing Public Awareness and Provider Education About Primary Immunodeficiency Disease C. Announcement Type: New - Type 1 This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For this purpose, research is defined at https://www.gpo.gov/fdsys/pkg /CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf. Guidance on how CDC interprets the definition of research in the context of public health can be found at http://www.cdc.gov/od/science/integrity /docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf.

Note: This is not a solicitation for applications.

Amendment I: FOA amended to update the following sections as indicated by red text.

The following sections were amended: Eligibility Information, Application and Submission Information and Review and Selection Process.

D. Agency Funding Opportunity Number:

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

93.980 F. Dates:

1. Due Date for Letter of Intent (LOI): 02/24/2017

2. Due Date for Applications: 04/26/2017, 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

Awardees may not use funds for international activities.

3. Date for Informational Conference Call:

N/A

G. Executive Summary:

1. Summary Paragraph:

https://foa.grantsolutions.gov/www.grants.gov https://foa.grantsolutions.gov/www.grants.gov https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf 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

The purpose of the program is to strengthen the nation’s capacity to carry out public health activities in the area of primary immunodeficiency diseases (PID) by increasing and improving physician education and public health awareness for/of primary immunodeficiency diseases. The objective is to disseminate educational information on a national level to health care providers, educators, third-party payers, impacted families, and others who may help expedite clinical recognition and improve health outcomes for Americans with primary immunodeficiency diseases.

a. Eligible Applicants: Open Competition

b. FOA Type: Grant

c. Approximate Number of Awards: 1

d. Total Project Period Funding: $4,607,500

e. Average One Year Award Amount: $921,500

f. Total Project Period Length: 5

g. Estimated Award Date: 07/01/2017

h. Cost Sharing and / or Matching Requirements:

N

Part II. Full Text A. Funding Opportunity Description

Part II. Full Text

1. Background

a. Overview Primary Immunodeficiency Diseases (PID) are a group of primarily single-gene disorders of the immune system. Primary denotes the genetic nature of the defects, differentiating them from secondary or acquired immunodeficiencies caused by malnutrition, infection, chemotherapy, or other external agents. The defining characteristics of primary immunodeficiency diseases make them candidates for a public health intervention approach. Although the clinical manifestations and underlying genetic defects are diverse, primary immunodeficiency diseases share the common feature of increased susceptibility to infection and collectively result in substantial morbidity and shortened life spans. However prompt diagnosis and treatment can be lifesaving and may result in marked improvements in the quality and length of life. The heterogeneity of primary immunodeficiency diseases and the limited understanding of the relation between genotype and phenotype also hinder intervention efforts. Additional obstacles include the difficulty of diagnosis in the absence of a high index of suspicion and the lack of awareness of health care providers and the public which impedes the timely recognition of affected person by using a combination of clinical suspicion and diagnostic testing.

b. Statutory Authorities This program is authorized under section 317(k)(2) of the Public Health Service Act, (42 U.S.C 247b(k)(2):

Project grants for preventive health services).

c. Healthy People 2020 This program addresses the “Healthy People 2020” topic(s) {https://www.healthypeople.gov/ 2020/topics https://www.healthypeople.gov/2020/topics-objectives/topic/educational-and-community-based-programs

This program addresses the “Healthy People 2020” topic(s) {https://www.healthypeople.gov/ 2020/topics -objectives/topic/educational-and-community-based-programs} of education and community-based programs, and health communications. The Office of Public Health Genomics (OPHG), Center for Surveillance, Epidemiology and Laboratory Services (CSELS), CDC, which facilitates this grant activity serves the CDC priorities of Advance Evidence-based Health Policies, Prevent Illness, Injury and Premature Death, and Support of State, Tribal and Local Health Departments.

Healthy People 2020 goals are also served by focusing resources into areas where genomics can enhance prevention of disease

d. Other National Public Health Priorities and Strategies CDC Key National Priority: Better at preventing illness, injury, disability and death (http://www.cdc.gov /about/organization/strategic-framework/index.html )

e. Relevant Work CDC has funded public awareness and physician education campaigns for primary immunodeficiency diseases for many years.

CDC MMWR article about a public health strategy approach to primary immunodeficiency diseases: http ://www.cdc.gov/mmwr/preview/mmwrhtml/rr5301a1.htm

2. CDC Project Description

a. Approach

Bold indicates project period outcome.

Increasing Public Awareness and Provider Education About Primary Immunodeficiency Disease (PID) https://www.healthypeople.gov/2020/topics-objectives/topic/educational-and-community-based-programs https://www.healthypeople.gov/2020/topics-objectives/topic/educational-and-community-based-programs http://www.cdc.gov/about/organization/strategic-framework/index.html http://www.cdc.gov/about/organization/strategic-framework/index.html http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5301a1.htm http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5301a1.htm

Increasing Public Awareness and Provider Education About Primary Immunodeficiency Disease (PID) Strategies/Activities ST Outcomes MT Outcomes LT Outcomes

Provide financial assistance for planning, design, and implementation of materials and displays

Disseminate educational information on a national level to health care providers, educators, third-party payers, impacted families, and others

Form partnerships with the health care community

Conduct evaluation and quality improvement processes

Develop materials and implement displays about primary immunodeficiency diseases

Providers engage in education opportunities

Skills and knowledge of the healthcare workforce increase of primary immunodeficiency diseases

Findings of evaluation and quality improvement processes are used to guide action

Improved integration of primary immunodeficiency prevention into clinical care

Expedited clinical recognition of primary immunodeficiency

Increased community and health care provider knowledge of primary immunodeficiency

Increase the number of people appropriately diagnosed with primary immunodeficiency

Increased access to care for people with primary

Improved health outcomes -for full & independent lives for people with primary

i. Purpose The purpose of the program is to strengthen the nation’s capacity to carry out public health activities in the area of primary immunodeficiency diseases (PID) by increasing and improving physician education and public health awareness for/of PID. The intent is to disseminate educational information on a national level to health care providers, educators, third-party payers, impacted families, and others who may help expedite clinical recognition and improve health outcomes for Americans with primary immunodeficiency diseases.

ii. Outcomes The intended outcomes of the grant include:

- Development of materials and implementation of displays

- Providers engage in education opportunities

- Skills and knowledge of healthcare providers about primary immunodeficiency diseases increases

- Improve integration of primary immunodeficiency diseases prevention into clinical care

- Expedited clinical recognition of primary immunodeficiency diseases

- Increase community and provider knowledge of primary immunodeficiency diseases

- Increase the number of people appropriately diagnosed with primary immunodeficiency diseases

- Increase access to care for people with primary immunodeficiency diseases.

- Improve health outcomes for people with primary immunodeficiency diseases to live full & independent lives

- Increase access to care for people with primary immunodeficiency diseases.

iii. Strategies and Activities Strategies

1. Provide financial assistance for planning, design, and implementation of materials and displays.

2. Disseminate educational information on a national level to public and private health care providers, educators, third-party payers, impacted families, and others.

3. Form partnerships with health care community.

4. The awardee will conduct evaluation and quality improvement efforts.

1. Collaborations

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

Awardee is required to collaborate with CDC programs and CDC funded programs including state public health departments. Specifically CDC funded programs focused on newborn screening, healthy childhood development, and efforts dedicated to ensuring that children thrive should be included where appropriate.

b. With organizations not funded by CDC:

The awardee should consider collaboration with organizations not funded by CDC when such mutual partnership opportunities can advance the stated goals of the grant. For example, this might include donated media when appropriate.

2. Target Populations Target populations will include young children and their families who are at risk for developing primary immunodeficiency diseases.

Awardee efforts will include a focus on populations at risk who may face even greater impact from primary immunodeficiency diseases because of issues involving health disparities and reduced access to quality health care.

Target populations for physician education efforts would include a wide array of health care providers including physicians, physicians' assistants, and nurses.

Applicant should consider a plan to include underserved populations such as tribal, ESOL, and disabled populations.

a. Health Disparities Awardee efforts will include a focus on populations at risk who may face even greater impact from primary immunodeficiency diseases because of issues involving health disparities and reduced access to quality health care. Early diagnosis and quality and appropriate follow-up health care are critical determinants of better health outcomes for children with primary immunodeficiency diseases.

iv. Funding Strategy CDC provides funding for this grant to reduce the burden of primary immunodeficiency diseases. Funding for activities should be allocated per the strategy to best meet the short, medium, and long term outcome goals.

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy Strategy 1: Provide financial assistance for planning, design, and implementation of materials and displays. Process measure: materials and displays funded and implemented.

Strategy 2: Disseminate educational information on a national level to public and private health care providers, educators, third-party payers, impacted families, and others. Process measure: educational information disseminated on a national level to intended audience.

Strategy 3: Form partnerships with health care community. Process measure: working collaborations formed to facilitate communication messages and materials which support the goals of the campaigns.

Strategy 4: The awardee will conduct evaluation and quality improvement efforts. Process measure:

evaluation conducted of completed work and documented efforts to improve the operations and effectiveness of the grant activities in an ongoing fashion.

Short Term Outcome 1: Development of materials and implementation of displays. Outcome measure: Primary immunodeficiency materials developed and displayed on a national scale.

Short Term Outcome 2: Providers engage in education opportunities. Outcome measure: On a national scale, health care providers reached with appropriate messages about identifying patients with primary immunodeficiency diseases.

Short Term Outcome 3: Skills and knowledge of healthcare providers about primary immunodeficiency diseases increases. Outcome measure: As a result of the awardee's work, the knowledge of healthcare providers about primary immunodeficiency diseases increases.

Short Term Outcome 4: Findings of evaluation and quality improvement processes are used to guide action.Outcome measure: Awardee conducts annual evaluation efforts - and as data and information becomes available - engages in a continual effort to improve the quality of the grant activities.

Medium Term Outcome 5: Improve integration of primary immunodeficiency diseases prevention into clinical care. Outcome measure: As a result of the awardee's work, diagnostic procedures and follow-up for primary immunodeficiency diseases are more integrated into clinical care on a national scale.

Medium Term Outcome 6: Expedited clinical recognition of primary immunodeficiency diseases.

Outcome measure: As a result of the awardee's work, clinical recognition of primary immunodeficiency diseases occurs more rapidly and more often than it did previously - on a national scale.

Medium Term Outcome 7: Increase community and provider knowledge of primary immunodeficiency diseases. Outcome measure: As a result of the awardee's work, general community/public and healthcare provider knowledge of primary immunodeficiency diseases increases on a national scale.

Long Term Outcome 8: Increase the number of people appropriately diagnosed with primary immunodeficiency diseases. Outcome measure: As a result of the awardee's work, the annual rate of children identified/diagnosed with primary immunodeficiency diseases increases.

Long Term Outcome 9: Increase access to care for people with primary immunodeficiency diseases. Outcome measure: As a result of the awardee's work, more health care systems and providers across the nation are knowledgeable of the signs of primary immunodeficiency diseases and thus more people have access to health care where primary immunodeficiency disease is understood and considered for diagnosis.

considered for diagnosis.

Long Term Outcome 10: Improve health outcomes for people with primary immunodeficiency diseases to live full & independent lives. Outcome measure: As a result of the awardee's work, more people -especially children - have improved health outcomes from earlier detection and follow-up care than before.

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

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

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

Available data sources, feasibility of collecting appropriate evaluation and performance data, and other relevant data information (e.g., performance measures proposed by the applicant) Plans for updating the Data Management Plan (DMP), if applicable, for accuracy throughout the lifecycle of the project. The DMP should provide a description of the data that will be produced using these FOA funds; access to data; data standards ensuring released data have documentation describing methods of collection, what the data represent, and data limitations; and archival and long-term data preservation plans. For more information about CDC’s policy on the DMP, see https://www.cdc.gov/grants/additionalrequirements/ar-25.html.

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

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

Describe key evaluation questions to be addressed by these evaluations.

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

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

c. Organizational Capacity of Awardees to Implement the Approach The ideal applicant will have ten years of experience in: conducting effective physician education and public awareness campaigns for primary immunodeficiency diseases, collaborating effectively with health care and public health partners, and maximizing resources dedicated to campaign materials development and distribution to meet outcome goals.

d. Work Plan Applicants must include a work plan that allows the CDC Project Officer to monitor implementation of activities and progress on project period outcomes. The work plan should be detailed and should focus on the first year of the project period with only a high-level plan for subsequent years. Work plans should demonstrate alignment among the outcomes, strategies, activities, timelines, and staffing/collaborations.

Additional information on performance measures and data sources can also be included.

Applicants must provide a work plan for the proposed activities. Applicants must construct logical, stepwise work plans that include:

detailed plans covering the first year of the project period and high-level plans for subsequent years. Work plans must demonstrate alignment between https://www.cdc.gov/grants/additionalrequirements/ar-25.html activities (with appropriate performance measures or milestones for accomplishing tasks) and achievement of the FOA project period outcomes shown in the logic model. Additional information on data sources and target population can also be included.

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 deemed necessary to monitor the award:

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

Ensuring that 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.

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.

This RFA's logic model will be used as a standard to evaluate progress from implementing the grant's activities.

B. Award Information

1. Funding Instrument Type: Grant

2. Award Mechanism: Grant 191 P76: Projects to Design and Implement Health Exhibits/Materials for Public Education: Provides financial assistance to eligible organizations to plan, design, and implement displays and/or instructional materials related to diseases, disorders, and conditions that affect various populations, and how such populations can reduce the impact on their lives. (PHS Act, Section 317(k)(2).

3. Fiscal Year: 2017

4. Approximate Total Fiscal Year Funding:

$921,500

5. Approximate Project Period Funding:

$4,607,500

This amount is subject to the availability of funds.

Estimated Total Funding: $4,607,500

6. Total Project Period Length:

5 year(s)

7. Expected Number of 1

7. Expected Number of Awards:

8. Approximate Average Award:

$921,500 Per Budget Period

9. Award Ceiling: $921,500 Per Budget Period

This amount is subject to the availability of funds.

10. Award Floor: $921,500 Per Budget Period

11. Estimated Award Date: 07/01/2017

12. Budget Period Length: 12 month(s)

Throughout the project period, CDC will continue the award based on the availability of funds, the evidence of satisfactory progress by the 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).

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

C. Eligibility Information

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

Additional Eligibility Category:

2. Additional Information on Eligibility

C. Eligibility Information

Additional Information for Eligibility:

Entities that submit a response to this application must be a domestic entity. International organizations are not eligible to respond to this application..

3. Justification for Less than Maximum Competition

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

No

5. Maintenance of Effort

Maintenance of effort is not required for this program.

D. Application and Submission Information

1. Required Registrations An organization must be registered at the three following locations before it can submit an application for funding at www.grants.gov.

a. Data Universal Numbering System:

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

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

If funds are awarded to an applicant organization that includes sub-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 can require 10 or more business days, and registration must be renewed annually. Additional information about registration procedures may be found at www.SAM.gov.

c. Grants.gov:

The first step in submitting an application online is registering your organization at www.grants.gov, the official HHS E-grant Web site. Registration information is located at the “Get Registered” option at www.grants.gov.

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

Step System Requirements Duration Follow Up

1 Data Universal Number System

(DUNS)

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

2. Select Begin

DUNS

search/request process

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

1-2 Business Days

To confirm that you have been issued a new DUNS number check online at (http:// fedgov.dnb.com/ webform) or call 1-866-705-5711Image Description:

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

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

2 System for Award Management

(SAM)

formerly Central Contractor Registration

(CCR)

1. Retrieve organizations DUNS number

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

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

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

866-606-8220Image Description:

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

(AOR)

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

3. Log into grants.gov using the password the E-BIZ POC received and create new password

Same day but can take 8 weeks to be fully registered and approved in the system (note, applicants

MUST

obtain a

DUNS

number and SAM account before applying on grants.gov)

Register early! Log into grants.gov and check AOR status until it shows you have been approved http://www.sam.gov https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do

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

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

3. Application Package Applicants must download the SF-424, Application for Federal Assistance, package associated with this funding opportunity at www.grants.gov. If Internet access is not available, or if the online forms cannot be accessed, applicants may call the CDC OGS staff at 770-488-2700Image Description: or e-mail OGS ogstims@cdc.gov for assistance. Persons with hearing loss may access CDC telecommunications at TTY 1-888-232-6348Image Description: .

4. Submission Dates and Times If the application is not submitted by the deadline published in the FOA, it will not be processed. Office of Grants Services (OGS) personnel will notify the applicant that their application did not meet the deadline.

The applicant must receive pre-approval to submit a paper application (see Other Submission Requirements section for additional details). If the applicant is authorized to submit a paper application, it must be received by the deadline provided by OGS.

a. Letter of Intent Deadline (must be emailed or postmarked by) Due Date for Letter of Intent: 02/24/2017

b. Application Deadline Due Date for Applications: 04/26/2017 , 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.

Awardees may not use funds for international activities.

Date for Information Conference Call

N/A

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

Applicants may follow either of the following processes:

Complete the applicable assurances and certifications with each application submission, name the file “Assurances and Certifications” and upload it as a PDF file with at www.grants.gov Complete the applicable assurances and certifications and submit them directly to CDC on an annual basis at http://wwwn.cdc.gov/ grantassurances/ (S(mj444mxct51lnrv1hljjjmaa))/ Homepage.aspx

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

Duplication of Efforts http://www.grants.gov http://www.grants.gov mailto:ogstims@cdc.gov http://www.grants.gov http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx

Applicants are responsible for reporting if this application will result in programmatic, budgetary, or commitment overlap with another application or award (i.e. grant, cooperative agreement, or contract) submitted to another funding source in the same fiscal year. Programmatic overlap occurs when (1) substantially the same project is proposed in more than one application or is submitted to two or more funding sources for review and funding consideration or (2) a specific objective and the project design for accomplishing the objective are the same or closely related in two or more applications or awards, regardless of the funding source. Budgetary overlap occurs when duplicate or equivalent budgetary items (e.g., equipment, salaries) are requested in an application but already are provided by another source.

Commitment overlap occurs when an individual’s time commitment exceeds 100 percent, whether or not salary support is requested in the application. Overlap, whether programmatic, budgetary, or commitment of an individual’s effort greater than 100 percent, is not permitted. Any overlap will be resolved by the CDC with the applicant and the PD/PI prior to award.

Report Submission: The applicant must upload the report in Grants.gov under “Other Attachment Forms.”

The document should be labeled: "Report on Programmatic, Budgetary, and Commitment Overlap.”

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

7. Letter of Intent All potential applicants are requested to provide a letter of intent, indicating their intention to apply for this

FOA.

Descriptive title of proposed project.

Name, address, and telephone number of the Principal Investigator/Project Director.

Names of other key personnel.

Participating institutions.

Number and title of this funding opportunity.

LOI Submission Address: Submit the LOI by express mail, delivery service, fax, or E-mail to:

Attn: Scott Bowen

OPHG, CSELS, CDC

1600 Clifton Road NE

MS: E33

Atlanta, GA 30333

Fax: (404) 498 0140

Email: msb4@cdc.gov

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CDC Program staff to estimate and plan the review of submitted applications.

Requested LOI's should be provided no later than the date indicated in Section IV entitled "Application and Submission Information".

mailto:msb4@cdc.gov

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

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

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

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

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

b. Approach

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

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

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

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 the Strategies and Activities section of the CDC Project Description.

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

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

Applicant must address how they will include specific populations that can benefit from this funding opportunity announcement.

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

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

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

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

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

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

Describe key evaluation questions to be addressed by these evaluations.

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

Awardees will be required to submit a more detailed Evaluation and Performance Measurement plan (including the DMP elements) within the first 6 months of award, as described in the Reporting Section of this FOA.

Developing and/or expanding, implementing, and evaluating the health impact of a national educational and http://www.hhs.gov/ocio/policy/collection/

Developing and/or expanding, implementing, and evaluating the health impact of a national educational and outreach campaign targeted to providers and the public to enhance early identification and awareness of Primary Immunodeficiency diseases. The applicant is encouraged to review the scope and nature of public health strategies identified by a CDC expert panel of PI disease and reported in Applying Genetics and Public Health Strategies to Primary Immunodeficiency Disease. This publication is available on CDC’s web page at http://www.cdc.gov/genomics/events/conference/PI/pisynop.htm and further relevant information is available at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5301a1.htm .

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

Applicants must demonstrate organizational capacity to effectively conduct the activities listed in the FOA. Applicants must demonstrate skills sets and staffing plans to address increase public health awareness about primary immunodeficiency diseases.

Applicants must have experience working with external partners and stakeholders and must demonstrate a history of successful partnerships. Applicants must be fully capable of managing the required activities.

11. Work Plan (Included in the Project Narrative’s 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.

12. Budget Narrative Applicants must submit an itemized budget narrative. 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 could include the cost of collecting, managing, sharing and preserving data.

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 https://cdcmail.cdc.gov/owa/redir.aspx?C=f7db239f51fc498587d6f224bdaa92ba&URL=http%3a%2f%2fwww.cdc.gov%2fgenomics%2fevents%2fconference%2fPI%2fpisynop.htm https://cdcmail.cdc.gov/owa/redir.aspx?C=f7db239f51fc498587d6f224bdaa92ba&URL=http%3a%2f%2fwww.cdc.gov%2fmmwr%2fpreview%2fmmwrhtml%2frr5301a1.htm domestic entity for domestic activities).

For guidance on completing a detailed budget, see Budget Preparation Guidelines at: http:// www.cdc.gov /grants /interested in applying /application resources.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.

13. Funds Tracking Proper fiscal oversight is critical to maintaining public trust in the stewardship of federal funds. Effective October 1, 2013, a new HHS policy on subaccounts requires the CDC to set up payment subaccounts within the Payment Management System (PMS) for all new grant awards. Funds awarded in support of approved activities and drawdown instructions will be identified on the Notice of Award in a newly established PMS subaccount (P subaccount). Grantees will be required to draw down funds from award-specific accounts in the PMS. Ultimately, the subaccounts will provide grantees and CDC a more detailed and precise understanding of financial transactions. The successful applicant will be required to track funds by P-accounts/sub accounts for each project/cooperative agreement awarded.

Applicants are encouraged to demonstrate a record of fiscal responsibility and the ability to provide sufficient and effective oversight. Financial management systems must meet the requirements as described 2 CFR 200 which include, but are not limited to, the following:

Records that identify adequately the source and application of funds for federally-funded activities.

Effective control over, and accountability for, all funds, property, and other assets.

Comparison of expenditures with budget amounts for each Federal award.

Written procedures to implement payment requirements.

Written procedures for determining cost allowability.

Written procedures for financial reporting and monitoring.

14. Intergovernmental Review

Executive Order 12372 does not apply to this program.

http://www.cdc.gov/grants/interestedinapplying/applicationresources.html http://www.cdc.gov/grants/interestedinapplying/applicationresources.html http://www.phaboard.org

15. Pilot Program for Enhancement of Employee Whistleblower Protections Pilot Program for Enhancement of Employee Whistleblower Protections: All applicants will be subject to a term and condition that applies the terms of 48 Code of Federal Regulations (CFR) section 3.908 to the award and requires that grantees inform their employees in writing (in the predominant native language of the workforce) of employee whistleblower rights and protections under 41 U.S.C. 4712.

16. Copyright Interests Provisions This provision is intended to ensure that the public has access to the results and accomplishments of public health activities funded by CDC. Pursuant to applicable grant regulations and CDC’s Public Access Policy, Recipient agrees to submit into the National Institutes of Health (NIH) Manuscript Submission (NIHMS) system an electronic version of the final, peer-reviewed manuscript of any such work developed under this award upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. Also at the time of submission, Recipient and/or the Recipient’s submitting author must specify the date the final manuscript will be publicly accessible through PubMed Central (PMC). Recipient and/or Recipient’s submitting author must also post the manuscript through PMC within twelve (12) months of the publisher's official date of final publication; however the author is strongly encouraged to make the subject manuscript available as soon as possible. The recipient must obtain prior approval from the CDC for any exception to this provision.

The author's final, peer-reviewed manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process, and all graphics and supplemental material associated with the article. Recipient and its submitting authors working under this award are responsible for ensuring that any publishing or copyright agreements concerning submitted articles reserve adequate right to fully comply with this provision and the license reserved by CDC. The manuscript will be hosted in both PMC and the CDC Stacks institutional repository system. In progress reports for this award, recipient must identify publications subject to the CDC Public Access Policy by using the applicable NIHMS identification number for up to three (3) months after the publication date and the PubMed Central identification number (PMCID) thereafter.

17. Funding Restrictions Restrictions that must be considered while planning the programs and writing the budget are:

Awardees may not use funds for research.

Awardees may not use funds for clinical care except as allowed by law.

Awardees may use funds only for reasonable program purposes, including personnel, travel, supplies, and services.

Generally, awardees may not use funds to purchase furniture or equipment. Any such proposed spending must be clearly identified in the budget.

Reimbursement of pre-award costs generally is not allowed, unless the CDC provides written approval to the awardee.

Other than for normal and recognized executive-legislative relationships, no funds may be used for:

publicity or propaganda purposes, for the preparation, distribution, or use of any material designed to support or defeat the enactment of legislation before any legislative body the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or Executive order proposed or pending before any legislative body

See Additional Requirement (AR) 12 for detailed guidance on this prohibition and additional guidance on lobbying for CDC awardees.

The direct and primary recipient in a cooperative agreement program must perform a substantial role http://www.cdc.gov/grants/additionalrequirements/index.html#ar12…