cdc-rfa-oe15-1501 amend 2.pdf

Centers for Disease Control and Prevention

Center for Surveillance, Epidemiology and Laboratory Services

PPHF 2015: Immunization Grants-CDC Partnership: Strengthening Public Health Laboratories-financed in part by 2015 Prevention and Public Health Funds

CDC-RFA-OE15-1501

Application Due Date: 05/26/2015

PPHF 2015: Immunization Grants-CDC Partnership: Strengthening Public Health Laboratories-financed in part by 2015 Prevention and Public Health Funds

CDC-RFA-OE15-1501

TABLE OF CONTENTS

Part I. Overview Information

Federal Agency NameA.

Funding Opportunity TitleB.

Announcement TypeC.

Agency Funding Opportunity NumberD.

Catalog of Federal Domestic Assistance (CFDA) NumberE.

Dates F.

Executive Summary G.

Part II. Full Text

Funding Opportunity Description A.

Award Information B.

Eligibility Information C.

Required Registrations D.

Review and Selection Process E.

Award Administration Information F.

Agency Contacts G.

Other Information H.

Glossary I.

Part I. Overview Information Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notifications Emails" link to ensure they receive notifications of any changes to CDC-RFA-OE15-1501. 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) B. Funding Opportunity Title:

PPHF 2015: Immunization Grants-CDC Partnership: Strengthening Public Health Laboratories-financed in part by 2015 Prevention and Public Health Funds C. Announcement Type: New - Type 1 This announcement is only for non-research domestic activities supported by CDC. If research is proposed, the application will not be considered Research for this purpose is defined at http://www.cdc. gov/od/ scien ce/ integrity/ docs/cdc- policy- distinguishing- public- health- research- nonresearch. pdf.

D. Agency Funding Opportunity Number:

CDC-RFA-OE15-1501

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

93.765

93.322 F. Dates:

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

2. Due Date for Applications: 05/26/2015, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

3. Date for Informational Conference Call: 04/15/2015 April 15, 2015; 2:00 pm-4:00 pm Eastern Daylight Time, Call-in number: 1-877-579-0622 (toll free) Participant Passcode: 5721734

G. Executive Summary:

1. Summary Paragraph:

Amendment 1 (May 08, 2015)

The purpose of this amendment is to incorporate prevention and public health fund language and authority.

The Prevention and Public Health Fund (Title IV, Section 4002) was established under the Patient Protection and Affordable Care Act to provide for expanded and sustained national investment in prevention and public health programs to improve health and help restrain the rate of growth in private and public sector health care costs.

This 5-year cooperative agreement will award funds to improve the effectiveness, capabilities, and sustainability of public health laboratories (PHLs) — individually and as components of a national PHL

Additional CFDA Number:

https://foa.grantsolutions.gov/announcementmodule/www.grants.gov https://foa.grantsolutions.gov/announcementmodule/www.grants.gov http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.grants.gov system — in the United States and in other countries that CDC supports. The FOA aims to improve PHL infrastructure, develop a well-trained and maintained PHL workforce, and strengthen the PHL system in order to promote quality and safe laboratory practice in the entire health system as it pertains to public health in the United States and globally. Activities conducted through this cooperative agreement will use science-based knowledge to identify best practices that will improve PHL effectiveness, capabilities, and sustainability.

The awardee will conduct activities in six cross-cutting areas and four program-specific areas.

Cross-Cutting Areas will support: • Public Health Laboratory Strengthening and Leadership • Public Health Preparedness and Response • Global Health • Laboratory Systems and Standards • Workforce Development

• Informatics Capacity

Program-Specific Areas will support: • Newborn Screening • Food Safety • Infectious Diseases • Environmental Health

Each cross-cutting and program-specific area must be written as a stand-alone section of the application: (1) Public health laboratory strengthening and leadership, (2) Public health preparedness and response, (3) Global health, (4) Laboratory systems and standards, (5) Workforce development, (6) Informatics Capacity,

(7) Newborn screening, (8) Food safety, (9) Infectious diseases and (10) Environmental health.

a. Eligible Applicants: Single

b. FOA Type: Cooperative Agreement

c. Approximate Number of Awards: 1

d. Total Project Period Funding: $125,000,000

e. Average One Year Award Amount: $25,000,000 $25 Million ($7,283,000 base priority projects, and $17,717,000 cross-cutting and program-specific projects)

f. Number of Years of Award: 5

g. Estimated Award Date: 07/01/2015

h. Cost Sharing and / or Matching Requirements: N Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this FOA exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

Consistent with the cited authority for this announcement and applicable grants regulations, sources for cost sharing or matching may include complementary foundation funding, other U.S. government funding sources including programs supported by HHS or other agencies (e.g., Department of Agriculture, Department of Education, Department of Housing and Urban Development, Department of Transportation, Environmental Protection Agency, U.S. Park Service) and other funding sources. Applicants should coordinate with multiple sectors such as public health, transportation, education, health care delivery, and agriculture.

Part II. Full Text A. Funding Opportunity Description

1. Background

a. Overview

Public health laboratories (PHLs) play an indispensable role in protecting Americans and people in other countries from new, emerging, and existing health threats by conducting laboratory testing and providing other science-based services. Public health professionals and policy makers use actionable information from PHLs daily to identify and prioritize these population health threats and to develop and implement effective interventions. In order to continue their critical public health mission, PHLs must be sustainable and capable of detecting myriad threats across a broad and expanding spectrum of health domains, including infectious and chronic disease, chemical and radiological exposure, birth defects, and others. However, PHLs face serious challenges in developing the capabilities to perform their role. These challenges include the rapid emergence of new disease threats, such as viral hemorrhagic fevers, extensive restructuring of the nation’s healthcare system, the accelerating evolution in testing and information, and ensuring safe laboratory practices with existing and new technologies. PHLs often face persistent fiscal problems, mandated workforce reductions, and other problems that threaten their development of needed capabilities to address public health issues and, in some cases, their ability to perform important testing services. PHLs need to address these ongoing challenges to effectively serve as partners integrated into the larger, national public health system and to contribute to achievement of Healthy People 2020 goals and those of additional U.S. health strategies.

The overarching purpose of this 5-year cooperative agreement is to improve the effectiveness, capabilities, and sustainability of PHLs — individually and as components of a national PHL system — in the United States and in other countries where CDC supports PHLs to promote quality and safe laboratory practices in the entire health system as it pertains to public health. Activities will be conducted in six cross-cutting areas and four program-specific areas. Activities will generate specific short-, medium-, and long-term outcomes.

b. Statutory Authorities

This cooperative agreement is authorized under sections 317(k)(2) and 307 of the Public Health Service Act [42 U.S.C Sections 247b and 247b-2and 247b-3 ] as amended.

Title IV Section 4002 of the Affordable Care Act, Prevention and Public Health Fund.

c. Healthy People 2020

The achievement of many Healthy People 2020 goals and objectives hinges critically on the effectiveness, capabilities, and sustainability of state and local public health laboratories (PHLs) in the United States. The Healthy People 2020 goals and objectives that support this FOA are:

• Environmental Health

• Food Safety

• Global Health

• Health Communication and Health Information Technology

• Healthcare-Associated Infections

• HIV

• Immunization and Infectious Diseases

• Maternal, Infant, and Child Health

• Occupational Safety and Health

• Preparedness

• Public Health Infrastructure

• Respiratory Diseases

• Sexually Transmitted Diseases

Additional Healthy People 2020 goals and objectives may be addressed as implementation of this cooperative agreement proceeds. The healthy people website is accessible at www.healthypeople.gov.

http://www.healthypeople.gov

d. Other National Public Health Priorities and Strategies

This cooperative agreement aligns with, and supports, other relevant national strategies including, among others, the:

Global Health Security Agenda U.S. National Prevention Strategy HHS Strategic Plan, 2014-2018 The Guide to Community Preventive Services (Community Guide) CDC Winnable Battles CDC Surveillance Strategy

Additional priorities and strategies are identified in individual cross-cutting and program-specific areas (see attachments).

e. Relevant Work

This cooperative agreement builds on the body of knowledge developed through previously funded FOA’s that enhanced the work and capabilities of PHLs in the United States and abroad. The previously funded FOA was CDC-RFA-HM10-1001.

2. CDC Project Description

a. Approach

i. Purpose

This 5-year cooperative agreement aims to promote quality and safe PHL practice, improve PHL infrastructure, strengthen the PHL system, and to develop a well-trained PHL workforce in the U.S. and globally. Activities conducted through this cooperative agreement will use science-based knowledge to identify best practices that will improve PHL effectiveness, capabilities, and sustainability. Through this 5-year cooperative agreement, public health laboratories will become a much stronger component of the public health and healthcare systems.

Toward fulfillment of that purpose, the partnership envisioned in this FOA will conduct activities in the following six cross-cutting areas and four program-specific areas

ii. Outcomes

See Figure 1 (Master Logic Model). The awardee is expected to show SMART (Specific, Measurable, Achievable, Relevant, and Time-bound) progress made toward the short-term and mid-term outcomes for the 5-year project period. Each of the cross-cutting and program-specific activity areas focuses on one or more of these outcomes.

In general, the cross-cutting and program-specific projects will achieve the following:

Short-term outcomes

(1) PHLs use multiple communication streams and channels; (2) Prepared network of public and private laboratories; (3) Laboratory safety protocols and continuity of operations plan that are exercised, evaluated and continually improved; (4) Effective, efficient, and secure standards-based information exchange and transfer (interoperability) among PHLs and bi-directionally between PHLs and CDC that contributes to a strengthened public health surveillance system (including implementation of the following components of the CDC Surveillance Strategy: the National Notifiable Diseases Surveillance System (NNDSS) Modernization Initiative, the BioSense Enhancement Initiative, and the Informatics Workforce Development initiative); (5) PHLs seek and achieve voluntary accreditation; (6) PHLs have leadership succession plans in place tied to organizational improvement objectives; (7) Improved management and technical practices that increase individual PHL sustainability; (8) Expanded and improved laboratory response to public health occurrences;

(9) Adoption of practices that improve the safety and quality of PHLs; and (10) Training opportunities and other workforce development programs increase professional competencies among the PHL workforce.

Mid-term outcomes

(1) More competent, collaborative, and practice-ready PHL workforce; (2) Improved laboratory methods, systems, and informatics capacity; (3) Better training and guidance; (4) Laboratories are more effectively prepared to respond to public health needs, including emergencies; (5) Better public health laboratory detection and response programs; (6) Model policies and tools for quality and safe PHL practice; and (7) Assurance that CLIA standards and good laboratory practices are followed by PHLs and are promoted to clinical laboratories performing tests of public health importance.

Long-term outcomes

(1) Reduced incidence and prevalence of preventable diseases and public health threats; (2) Reduced morbidity and mortality equitably delivered throughout the United States and the world; (3) Protection of the public from public health threats; (4) Sustainable and resilient PHLs that effectively and efficiently adapt to evolving public health needs; (5) Changes in regulations resulting in a more efficient, quality, and safe PHL system ; and (6) Revised standards for the PHL system resulting in a more efficient, higher quality, and safe PHL system.

The awardee is expected to show SMART (Specific, Measurable, Achievable, Relevant, and Time-bound) progress made toward the short-term and mid-term outcomes for the 5-year project period. Each of the cross-cutting and program-specific areas focuses on one or more of these outcomes.

iii. Strategies and Activities

The planning and preparation of your response to this FOA should be in alignment with the activities listed in the Master Logic Model as outlined for each project.

Each project has a separate attachment that details specific strategies and activities (see attachments).

Applicants must address each cross-cutting and program-specific project. The strategies and related activities described in these attachments are overarching CDC recommendations. The included activities are not exhaustive.

Section 1: Cross-cutting projects (See Attachment A-F)

Section 2: Program-specific projects (See Attachments G-J) A. Public Health Laboratory Strengthening and Leadership B. Public Health Preparedness and Response C. Global Health D. Laboratory Systems and Standards E. Workforce Development F. Informatics Capacity G. Newborn Screening H. Food Safety I. Infectious Diseases J. Environmental Health

1.Collaborations

Each cross-cutting and program-specific project that appears in this FOA has its own program guidance that provides collaboration information (if applicable) specific to that CDC program. See Attachments A-J

a. With CDC-funded programs:

Regardless of the category under which they are funded, the awardee is expected to collaborate with CDC to improve technical and program guidance, and evaluation. The awardee is also expected to participate in stakeholder meetings and provide expert consultation to CDC/CSELS and programs (as requested).

b. With organizations external to CDC:

The awardee is encouraged to build and/or continue strategic public health laboratory partnerships and collaborations with organizations that have a role in achieving the FOA outcomes and proposed activities.

Applicants must include letters of support, as appropriate, and name the file “letters of support” and upload it as a PDF file at www.grants.gov.

2. Target Populations

Each cross-cutting and program-specific project that appears in this FOA has its own program guidance that provides target population information (if applicable) specific to that CDC program. See Attachments A-J

a. Inclusion

N/A

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

The applicant is required to undertake an evidence-based approach in their proposed programs in response to CDC’s funding strategy that will be essential for rationalizing, prioritizing, and directing base funding to support those activities that are also in alignment with the mission of CDC. In doing so, the applicant will address evidenced-based gaps and needs in PHLs and workforce, CDC strategic priorities, including the CDC Surveillance Strategy, among other national public health priorities and strategies. Additionally, the awardee is required to collaborate with CDC/CSELS in making final allocations of base funding for priority projects.

In responding to this FOA, the applicant should consider the average one year award amount of $25 million, of which, approximately $7,283,000 has been allocated for base priority projects areas, and $17,717,000 for cross-cutting and program-specific projects areas. Note that CIOs across the agency may provide additional funding to support both cross-cutting and program-specific area activities. CDC/CSELS will provide overall guidance on resource allocation for each cross-cutting and program-specific area during the pre-application informational call. A more detailed discussion with the awardee will occur during Budget Negotiations. See levels of funding support for each specific project area in Attachments A-J.

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

Evaluation and performance measurement allows the awardee and CDC to track progress and measure outcomes of awardee’s effort.

The purpose of evaluation and performance measurement is to help CDC and the awardee: (1) Monitor the extent to which activities planned were successfully completed (e.g., were activities implemented correctly in the expected timeframe?); (2) Demonstrate how capacity building activities contribute towards program outcomes (e.g., were outcomes of interest achieved?); and (3) Inform decisions about future programming that drive continuous program improvement for more efficient and effective program performance (e.g., what and how could things be improved?).

While each cross-cutting and program-specific area will have a detailed Evaluation and Performance Measurement Strategy described in their individual attachment (i.e., a listing of performance measures), the overall CDC Evaluation and Performance Measurement Strategy will focus on both process and outcome evaluation. Process evaluation is conducted to monitor activities during the implementation and operation of a program while an outcome evaluation examines the longer-term successes and accomplishments of a program. Potential data sources will include the awardee application and progress reports (e.g., work plans, performance measures), surveys, and interviews with select public health agencies.

While each cross-cutting and program-specific area’s Evaluation and Performance Measurement Strategy may differ, below are some examples of the main evaluation questions to be addressed by the FOA during this project period. The evaluation questions reflect priorities of stakeholders, and assess contributions that span across the CDC cross-cutting and program-specific areas, from strategies and activities employed by the awardee to outcomes accomplished by the overall program.

ii. Applicant Evaluation and Performance Measurement Plan

Applicants must provide an initial evaluation and performance measurement plan to show how they will identify progress in implementing activities in their program strategies and achieving their selected outcomes CDC will work with the awardee during the first six months of the project period to finalize an evaluation and performance measurement plan to better monitor the progress of the activities implemented and outcomes achieved. As a first step, applicants must provide an overall evaluation and performance measurement plan that is consistent with the CDC strategy, as stated above. This plan, at a minimum, must address six points.

1. Identify principal program partners and describe how they will participate in the implementation of the evaluation plan as described within this FOA.

2. Consider the eleven evaluation questions outlined above in the CDC Evaluation and Performance Measurement Strategy. These questions will establish the scope and focus of the evaluation.

3. Describe how performance measures (and associated data) could help answer evaluation questions.

4. Describe how evaluation findings will be used to strengthen public health laboratories.

5. Discuss how data (i.e., performance measurement data) will be used and shared by the principal program partners.

6. Discuss any barriers or challenges expected for implementing the plan, responding to performance measures, and reporting on evaluation results. Describe how these potential barriers would be overcome.

In addition, applicants may also describe other measures to be developed or additional data sources and methods that applicants will use to answer the evaluation questions outlined above in the CDC Evaluation and Performance Measurement Strategy.

c. Organizational Capacity of Awardees to Execute the Approach

Applicants must demonstrate organizational capacity to effectively conduct the activities listed in the FOA. Applicants must demonstrate skills sets and staffing plans to address the strengthening of public health laboratories domestically and abroad. Additionally, the applicant must demonstrate a minimum of 15 years of experience working with the Centers for Disease Control and Prevention in the strengthening of PHL practice both domestically and abroad. Applicants must have experience working with external partners and stakeholders of PHLs and must demonstrate a history of successful partnerships, credibility, and influence among PHLs, as well as demonstrate relationships, productivity, and influence in health care writ large. Applicants must be fully capable of managing the required deliverables in accordance with 45 and 74 C.F.R.

Successful applicants will identify and hire staff (if needed) with appropriate qualifications to implement and manage every cross-cutting and program-specific project within this FOA.

d. Work Plan

Applicants must provide a work plan for each cross-cutting and program-specific project. 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 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. (Note: applicants will incorporate this Work Plan into their Approach for each cross-cutting and program-specific project.

The applicant must name this file “Work Plan” and upload it as a PDF file at www.grants.gov. The work plan is a guide to the awardee in implementing their work. It assists the Project Officer in monitoring awardee activities, and reflects activities supported by the annual budget. The applicant should consider inclusion of language on how to sustain activities after funding ends.

The work plan should include the following:

• Project Narrative

• Approach

• Activities and timelines to support achievement of FOA outcomes

• Specific public health needs the program will address

• Personnel and systems to support implementation of the award

• Collaborations with other stakeholders

• Evaluation and assessment processes to ensure continuous quality improvement and public health impact The awardee must provide a detailed evaluation and performance measurement plan within the first six months of the project. This more detailed plan must be developed by the awardee as part of first-year project activities, with support from CDC. This more detailed plan must build on the elements stated in the initial plan, and must be no more than 25 pages. At a minimum, and in addition to the elements of the initial plan, this plan must:

• Indicate the frequency that evaluation and performance data are to be collected

• Describe how data will be reported

• Describe how evaluation findings will be used to ensure continuous quality and program improvement

• Describe how evaluation and performance measurement will yield findings that will demonstrate the value of the FOA (e.g., effect on improving public health outcomes, effectiveness of FOA as it pertains to performance measurement, cost-effectiveness, or cost-benefit)

• Describe dissemination channels and audiences (including public dissemination)

• Describe other information requested and as determined by the CDC program When developing evaluation and performance measurement plans, applicants are encouraged to use the Introduction to Program Evaluation for Public Health Programs: A Self-Study Guide, available at: http://www .cdc.gov/eval/guide/index.htm.

Note: Post award, the awardee is expected to work collaboratively with CDC subject matter experts on development of the work plan. The final version will be submitted within 30 days of the notice of award.

e. CDC Monitoring and Accountability Approach Monitoring activities include routine and ongoing communication between CDC and awardees, site visits, and awardee reporting (including work plans, performance, and financial reporting). Consistent with applicable grants regulations and policies, CDC expects the following to be included in post-award monitoring for grants and cooperative agreements:

Tracking awardee progress in achieving the desired outcomes.

Ensuring the adequacy of awardee systems that underlie and generate data reports.

Creating an environment that fosters integrity in program performance and results.

Monitoring may also include the following activities:

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

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

Working with awardees on adjusting the work plan based on achievement of outcomes, evaluation results and changing budgets.

Monitoring performance measures (both programmatic and financial) to assure satisfactory performance levels.

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

These activities may include monitoring and reporting activities that assist grants management staff (e.g., grants management officers and specialists, and project officers) in the identification, notification, and management of high-risk grantees.

See each cross-cutting and program-specific project (See Attachments A-J).

The awardee must provide quarterly financial reporting in an effort to ensure sound fiscal management.

Financials will include the awardee’s forecasting/spend-down plan. (See Appendix B for a sample template.)

This will ensure both CDC and the awardee are monitoring the cooperative agreement funds and individual programmatic activities. The spend-down plan will ensure funds are expended in support of approved activities; tracking and reporting of expenditures are performed in a timely manner; unobligated balances are prevented; and persons responsible for fiscal management, including oversight of sub-recipients, are identified.

http://www.cdc.gov/eval/guide/index.htm http://www.cdc.gov/eval/guide/index.htm

The awardee must submit performance measures annually as a minimum, and may require reporting more frequently. Performance measure reporting must be limited to collection of data from measurable indicators.

When funding is awarded initially, CDC programs must specify required reporting frequency, data fields, and format, including, but not limited to, periodic project area status updates for continuous project improvement.

Such updates should include both programmatic and financial information to ensure that the awardee and CDC may work together in making programmatic adjustments, if necessary, to ensure that outcomes are met successfully within stated timeframes.

f. CDC Program Support to Awardees (THIS SECTION APPLIES ONLY TO COOPERATIVE

AGREEMENTS)

CDC staff will have substantial involvement beyond site visits and regular performance and financial monitoring during the project period. CDC staff will collaborate or participate in project or program activities.

This includes the following:

1. Technical assistance in the following: evaluation, performance measurement, work plan development, program planning, and specific subject matter expertise for projects.

2. Financial monitoring and negotiations to ensure proposed activities and resource allocations are in alignment with CDC priorities.

3. National coordination of activities where appropriate.

4. Ensuring that established agency quality standards are met for training, guidance, and technical tools, that redundant effort is eliminated, and that platforms are compatible with established agency systems and protocol.

5. Developing mechanisms for documenting and sharing lessons learned.

6. Technical assistance to ensure products that are a direct result of this FOA is made available in the public domain.

B. Award Information

1. Funding Instrument Type: Cooperative Agreement CDC's substantial involvement in this program appears in the

CDC Program Support to Awardees Section.

2. Award Mechanism: U60

3. Fiscal Year: 2015 Estimated Total Funding: $125,000,000

4. Approximate Total Fiscal Year Funding: $25,000,000

5. Approximate Project Period Funding: $125,000,000

6. Total Project Period Length: 5 year(s)

7. Expected Number of Awards: 1

8. Approximate Average Award: $25,000,000 Per Budget Period

$25 Million ($7,283,000 base priority projects, and $17,717,000 cross-cutting and program-specific projects)

9. Award Ceiling: None

None

10. Award Floor: None

11. Estimated Award Date: 07/01/2015 Throughout the project period, CDC will continue the award based on the availability of funds, the evidence

Throughout the project period, CDC will continue the award based on the availability of funds, the evidence of satisfactory progress by the awardee (as documented in required reports), and the determination that continued funding is in the best interest of the federal government. The total number of years for which federal support has been approved (project period) will be shown in the “Notice of Award.” This information does not constitute a commitment by the federal government to fund the entire period. The total project period comprises the initial competitive segment and any subsequent non-competitive continuation award(s).

12. Budget Period Length: 12 month(s)

13. Direct Assistance Direct Assistance (DA) is available through this FOA.

Limited opportunities for Direct Assistance (DA) may be available through this FOA. Funding made through the Prevention and Public Health Fund (Affordable Care Act) does not have the statutory authority for DA.

An official state, tribal nation, local or territorial government applicant may request that CDC provide Direct Assistance (DA) in the form of federal personnel (such as Career Informatics Field Officer) as a part of the grant awarded through this FOA. If your request for DA is approved as a part of your award, CDC will reduce the funding amount provided directly to you as a part of your award. The amount by which your award is reduced will be used to provide DA; the funding shall be deemed part of the award and as having been paid to you, the awardee.

C. Eligibility Information

1. Eligible Applicants Eligibility Category: Others (see text field entitled "Additional Information on Eligibility" for clarification)

2. Additional Information on Eligibility

This FOA has been approved for single source competition. The eligible applicant organization for this FOA is the Association for Public Health Laboratories (APHL).

The award ceiling for this FOA is $0. CDC will consider any application requesting an award higher than this amount as non- responsive and it will receive no further review. If a pre-application is required, then specify here and include it in the special eligibility requirements section. (http:// www.hhs.gov/ asfr/ ogapa/ aboutog/ hhsgps107.pdf)

3. Justification for Less than Maximum Competition

CDC has determined that the Association of Public Health Laboratories (APHL) is the sole organization qualified to apply for this FOA. This determination was based on several factors, including its credibility and influence with the target audience for this cooperative agreement. For example, APHL’s membership includes all State and Territorial PHL directors, and is the single national organization representing PHLs.

APHL was originally founded by PHL directors as the Association of State and Territorial Public Health Laboratory Directors (ASTPHLD) in 1951 in order to represent their profession, support their work in public health, and help address their needs for program advocacy, policy, educational and workforce development. The name of the group was changed to APHL in 1998 when the membership broadened to include county and other local PHLs. Thus, APHL is uniquely capable of having the credibility and http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf influence among PHL directors to successfully achieve the outcomes of this cooperative agreement. In addition, APHL has been a critical partner to CDC in forming the National Laboratory System (NLS), the National Laboratory Training Network (NLTN), and the Laboratory Response Network (LRN). APHL is the only organization that has the capacity to reach out quickly and effectively to the entire US and Territorial PHL system, and this has proven to be of critical importance during a public health emergency.

This is largely due to their being the coordinating body for members which include all governmentally-funded U.S. State, territorial, and local PHL members. Further, APHL is the only organization that has both the depth and breadth of knowledge and experience to provide training and technical assistance across the variety of disciplines with a similar level of sophistication. Other organizations focus on a profession or a discipline and are too narrow for the purpose of this FOA.

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

No

Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this FOA exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

Consistent with the cited authority for this announcement and applicable grants regulations, sources for cost sharing or matching may include complementary foundation funding, other U.S. government funding sources including programs supported by HHS or other agencies (e.g., Department of Agriculture, Department of Education, Department of Housing and Urban Development, Department of Transportation, Environmental Protection Agency, U.S. Park Service) and other funding sources. Applicants should coordinate with multiple sectors such as public health, transportation, education, health care delivery, and agriculture.

5. Maintenance of Effort

Maintenance of effort is not required for this program.

D. Required Registrations

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

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

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

The applicant organization may request a DUNS number by telephone at 1-866-705-5711 (toll free) or Internet at http:// fedgov.dnb.com/webform/displayHomePage.do. The DUNS number will be provided at no charge.If funds are awarded to an applicant organization that includes sub-awardees, those sub-awardees must provide their DUNS numbers before accepting any funds.

b. System for Award Management (SAM): The SAM is the primary registrant database for the federal government and the repository into which an entity must submit information required to conduct business as an awardee. All applicant organizations must register with SAM, and will be assigned a SAM number. All information relevant to the SAM number must be current at all times during which the applicant has an application under consideration for funding by CDC. If an award is made, the SAM information must be maintained until a final financial report is submitted or the final payment is http://www.cdc.gov/od/pgo/funding/docs/FinancialReferenceGuide.pdf http://www.cdc.gov/od/pgo/funding/docs/FinancialReferenceGuide.pdf http://fedgov.dnb.com/webform/displayHomePage.do information must be maintained until a final financial report is submitted or the final payment is received, whichever is later. The SAM registration process usually requires not more than five business days, and registration must be renewed annually. Additional information about registration procedures may be found at www.SAM.gov.

c. Grants.gov: The first step in submitting an application online is registering your organization through www.grants.gov, the official HHS E-grant website. Registration information is located at the "Get Registered" option at www.grants.gov.

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

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

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

4. Submission Dates and Times If the application is not submitted by the deadline published in the FOA, it will not be processed. PGO personnel will notify the applicant that their application did not meet the deadline. The applicant must receive pre-approval to submit a paper application (see Other Submission Requirements section for additional details). If the applicant is authorized to submit a paper application, it must be received by the deadline provided by PGO.

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

b. Application Deadline Due Date for Applications: 05/26/2015, 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov. If Grants.gov is inoperable and cannot receive applications, and circumstances preclude advance notification of an extension, then applications must be submitted by the first business day on which grants.gov operations resume.

Date for Informational Conference Call: 04/15/2015

April 15, 2015; 2:00 pm-4:00 pm Eastern Daylight Time, Call-in number: 1-877-579-0622 (toll free) Participant Passcode: 5721734

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

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

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

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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

Letter of intent is not required as part of the application for this FOA.

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

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

9. Project Abstract Summary (Maximum 1 page)

A project abstract is included on the mandatory documents list and must be submitted at www.grants.gov.

The project abstract must be a self-contained, brief summary of the proposed project including the purpose and outcomes. This summary must not include any proprietary or confidential information. Applicants must enter the summary in the "Project Abstract Summary" text box at www.grants.gov.

10. Project Narrative (Maximum of 20 pages, single spaced, Calibri 12 point, 1-inch margins, number all pages. Content beyond 20 pages will not be considered. The 20 page limit includes the work plan. For a multi-component FOA, maximum page limit is 25.)

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

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

b. Approach

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

ii. Outcomes Applicants must clearly identify the outcomes they expect to achieve by the end of the project period.

Outcomes are the results that the program intends to achieve. All outcomes must indicate the intended direction of change (e.g., increase, decrease, maintain). (See the logic model in the Approach section of the CDC Project Description.)

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

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

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

Target Populations: Applicants must describe how they will achieve the goals of the proposed activities.

Refer back to the CDC Project Description section – Approach: Target Population.

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

The plan must:

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

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

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

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

Describe key evaluation questions to be addressed by these evaluations.

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

Applicants must provide an initial evaluation and performance measurement plan to show how they will identify progress in implementing activities in their program strategies and achieving their selected outcomes.

CDC programs will work with the awardee during the first six months of the project period to finalize an evaluation and performance measurement plan to better monitor the progress of the activities implemented and outcomes achieved. Data collected must be used for ongoing monitoring of the award to evaluate its effectiveness, and for continuous program improvement.

The plan must

• Describe how principal program partners will be engaged in the evaluation and performance measurement planning processes.

• Describe the type of evaluations to be conducted (i.e., process and/or outcome).

• Describe evaluation questions to be answered.

• Describe other information, as determined by the CDC program (e.g., performance measures to be developed by the applicant) that must be included.

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• Describe potentially available data sources and feasibility of collecting appropriate evaluation and performance data.

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

• Describe how evaluation and performance measurement will contribute to development of that evidence base, where program strategies are being employed that lack a strong evidence base of effectiveness.

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

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

Applicant must address the organizational capacity requirements as described in the CDC Project Description. Applicants should indicate whether the applicant receives other federal or non-federal funding to support their PHL-related activities. [CDC requires CVs/Resumes and Organizational Charts. Applicants must name this file “CVs/Resumes” or “Organizational Charts” and upload it at www.grants.gov.]

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

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

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

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

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

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

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

If applicable and consistent with the cited statutory authority for this announcement, applicant entities may use funds for activities as they relate to the intent of this FOA to meet national standards or seek health http://www.grants.gov http://www.grants.gov http://www.cdc.gov/grants/interestedinapplying/applicationresources.html http://www.phaboard.org department accreditation through the Public Health Accreditation Board (see:…