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Centers for Disease Control

National Center for Immunization and Respiratory Diseases

Improving Standard Immunization Practices Among Pharmacists and Other Healthcare

Providers

CDC-RFA-IP18-1803

Application Due Date: 06/11/2018

Improving Standard Immunization Practices Among Pharmacists and Other Healthcare

Providers

CDC-RFA-IP18-1803

TABLE OF CONTENTS

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

Part II. Full Text A. Funding Opportunity Description B. Award Information C. Eligibility Information D. Application and Submission Information E. Review and Selection Process F. Award Administration Information G. Agency Contacts H. Other Information I. Glossary

Part I. Overview Information Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notifications Emails" link to ensure they receive notifications of any changes to CDC-RFA-IP18-1803. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Centers for Disease Control and Prevention (CDC) / Agency for Toxic Substances and Disease Registry (ATSDR) B. Notice of Funding Opportunity (NOFO) Title:

Improving Standard Immunization Practices Among Pharmacists and Other Healthcare Providers C. Announcement Type: New - Type 1 This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For this purpose, research is defined at https ://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf.

Guidance on how CDC interprets the definition of research in the context of public health can be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html (See section 45 CFR 46.102(d)).

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-IP18-1803

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

93.268 F. Dates:

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

2. Due Date for Applications: 06/11/2018, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

Letter of intent (LOI) is not requested or required as part of the application for this NOFO.

3. Date for Informational Conference Call:

NA

G. Executive Summary:

1. Summary Paragraph:

The purpose of this NOFO is to support the implementation of immunization practice standards by national-level pharmacy organizations and improve communication among pharmacists, state and local immunization programs, and other health care providers. In addition to maintaining knowledge in current recommendations of the Advisory Committee on Immunization Practices (ACIP) and proper vaccine administration and storage and handling of vaccines, immunization practice standards include documentation of vaccines administered in state or local immunization information systems (IIS) and promoting pandemic influenza vaccination preparedness coordination activities with public health partners. During the 5-year cooperative agreement period, applicants should develop and implement sustainable communication plans to promote national standard operational procedures for immunization https://www.grants.gov https://www.grants.gov https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html https://www.grants.gov practice standards among their membership that include routine submission of immunization data to state or local IIS and sharing vaccination records with other health care providers.

Applicants should also develop and implement plans to formalize agreements between pharmacies, pharmacy associations, and public health programs for pandemic influenza vaccination program preparedness and response activities.

a. Eligible Applicants: Open Competition

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 2

d. Total Period of Performance Funding: $2,000,000

e. Average One Year Award Amount: $200,000

f. Total Period of Performance Length: 5

g. Estimated Award Date: 09/30/2018

h. Cost Sharing and / or Matching Requirements: N

Part II. Full Text A. Funding Opportunity Description

Part II. Full Text

1. Background

a. Overview Over the past 25 years, pharmacists increased the volume and diversity of immunization services.

While the range of vaccines that pharmacists offer and the ages of patients allowed to be vaccinated by pharmacists vary depending on state regulations, pharmacies have greatly expanded patients’ access to vaccines, offering vaccinations on a walk-in basis during hours of greater convenience for patients at multiple locations. Pharmacy-based influenza vaccinations have been successful in vaccinating 28% of patients who would otherwise not have received the vaccine.

Immunization Information Systems (IIS) are central repositories of immunization records in public health jurisdictions. First implemented in the 1990s, 80% of major pharmacies in the United States reported vaccines administered to IIS. Pharmacists are central in “immunization neighborhood” by assessing vaccination needs of patients, administering vaccines, and documenting and following up with other health care professionals to ensure continuity of care.

The purpose of this NOFO is to strengthen and support sustainable implementation of immunization practice standards by national-level pharmacy organizations and improve communication among pharmacists, state and local immunization programs, and other health care providers with the following activities:

Education and training on current Advisory Committee on Immunization Practices (ACIP) guidelines and recommendations

Training on proper vaccine administration and storage and handling of vaccines to ensure safe and effective vaccination practices

Implementation of immunization practice standards including documentation of vaccines administered in the state or local IIS and transfer of vaccination records to other health care providers

Promote the development and implementation of formalized relationships between pharmacies, pharmacy associations, and public health programs for pandemic influenza vaccination preparedness

b. Statutory Authorities This program is authorized under the Patient Protection and Affordable Care Act (PL 111-148), Title IV,Section 4002 (Prevention and Public Health Fund) and Section 317 of the Public Health Service Act [42U.S.C. 247b(k)(1)]. For-profit entities are not eligible applicants under the Statutory Authority.

c. Healthy People 2020 Measurable outcomes of the program will be in alignment with Healthy People 2020 goals for immunization and infectious diseases (https://www.healthypeople.gov/2020/topicsobjectives /topic/immunization-and-infectious-diseases) .

Healthy People 2020 goals for immunization and infectious diseases including, but not limited to specific objectives, e.g., IID-1. Reduce, eliminate, or maintain elimination of cases of vaccine-preventable diseases and IID-13. Increase the percentage of adults who are vaccinated against pneumococcal disease at https://www.healthypeople.gov/2020/topics-objectives/topic/immunizati on-and-infectious-diseases/objectives

d. Other National Public Health Priorities and Strategies General:

Advisory Committee on Immunization Practices recommendations and guidelines at http ://www.cdc.gov/vaccines/hcp/acip-recs/index.html

Community Preventive Services Task Force findings and systematic reviews on evidence-based interventions to improve vaccinations at http://www.thecommunityguide.org/vacci nes/vpd-jphpm-recs-IIS.pdf

Immunization disparity-focus

HHS Action Plan to Reduce Racial and Ethnic Health Disparities to promote integrated approaches, evidence-based programs, and best practices to reduce health disparities, https://www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases https://www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases https://www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases/objectives https://www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases/objectives http://www.cdc.gov/vaccines/hcp/acip-recs/index.html http://www.cdc.gov/vaccines/hcp/acip-recs/index.html http://www.thecommunityguide.org/vaccines/vpd-jphpm-recs-IIS.pdf http://www.thecommunityguide.org/vaccines/vpd-jphpm-recs-IIS.pdf including disparities in immunization rates among minorities at https://www.minorityhe alth.hhs.gov/omh/browse.aspx?lvl=2&;lvlID=26

HPV-focus

President’s Cancer Panel Recommendations on HPV vaccination at http://deainfo.nci.nih .gov/advisory/pcp/annualReports/HPV/index.htm#sthash.j0M1EEMZ.dpbs

Adult immunization-focus

Standards for Adult Immunization Practice at http://www.cdc.gov/vaccines/hcp/patient-ed /adults/for-practice/standards/index.html.

National Adult and Influenza Immunization Summit to address and resolve adult and influenza immunization issues at https://www.izsummitpartners.org/

Pandemic preparedness-focus Pandemic preparedness activities at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6306a1.htm ?s_cid=rr6306a1_e, http://www.astho.org/Programs/Infectious-Disease/Pandemic-Influenza /MOU-Toolkit-for-Public-Health-and-Pharmacies/, and http://www.astho.org/Infectious-Disease /Pandemic-Influenza/MOU-State-Pharmacy-Pandemic-Influenza-Vaccination-Campaign/

e. Relevant Work CDC-RFA-IP15-1504PPHF15: Improving Immunization Collaboration Among Pharmacists and Other Healthcare Providers--Financed Solely by PPHF 2015 Prevention and Public Health Funds

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

• Provide education and training on current

ACIP

recommendations

• Provide training on proper vaccine administration and storage and handling of vaccines to ensure safe and effective vaccination practices

• Implement sustainable immunization practice standards including

• Increased pharmacist competencies in the use of adult and child/adolescent immunization schedules and immunization practice standards

• Increased pharmacist competencies in proper vaccine administration, storage, and handling

• Improved implementation of immunization practice standards on current

ACIP

recommendations

• Safe and effective administration of recommended vaccines

• Established data exchange with IIS at IIS Functional Standards 2013-2017 and clinical decision support for

• Routine implementation of immunization practice standards

• Improved communication among pharmacists and state and local immunization programs and other health care providers

• Integrated and comprehensive pandemic vaccination preparedness https://www.minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlID=26 https://www.minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlID=26 http://deainfo.nci.nih.gov/advisory/pcp/annualReports/HPV/index.htm#sthash.j0M1EEMZ.dpbs http://deainfo.nci.nih.gov/advisory/pcp/annualReports/HPV/index.htm#sthash.j0M1EEMZ.dpbs http://www.cdc.gov/vaccines/hcp/patient-ed/adults/for-practice/standards/index.html http://www.cdc.gov/vaccines/hcp/patient-ed/adults/for-practice/standards/index.html https://www.izsummitpartners.org/ http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6306a1.htm?s_cid=rr6306a1_e http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6306a1.htm?s_cid=rr6306a1_e http://www.astho.org/Programs/Infectious-Disease/Pandemic-Influenza/MOU-Toolkit-for-Public-Health-and-Pharmacies/ http://www.astho.org/Programs/Infectious-Disease/Pandemic-Influenza/MOU-Toolkit-for-Public-Health-and-Pharmacies/ http://www.astho.org/Infectious-Disease/Pandemic-Influenza/MOU-State-Pharmacy-Pandemic-Influenza-Vaccination-Campaign/ http://www.astho.org/Infectious-Disease/Pandemic-Influenza/MOU-State-Pharmacy-Pandemic-Influenza-Vaccination-Campaign/ documentation of vaccines administered in the state or local IIS and transfer of vaccination records to other health care providers

• Develop and implement pandemic vaccination preparedness activities through formalized relationships between pharmacies, pharmacy associations, and public health programs

• Established data exchanges with IIS and protocols to standardize sharing vaccination records and forecast information with other health care providers

• Developed protocols for vaccination referral and data exchange with other vaccination service providers

• Developed strategies to collaborate with public health programs and coordinate formalized agreements on pandemic influenza vaccination program planning and response immunization in the pharmacy health information system

• Routinized processes to maintain a current list of other vaccination service providers and evaluation for effectiveness of referrals and accuracy and completeness of data exchange

• Implemented activities to promote improved coordination between pharmacies and public health programs for formalized agreements on pandemic influenza vaccination program planning and response activities between public health programs and pharmacies

i. Purpose The purpose of this NOFO is to improve support for implementation of immunization practice standards by national-level pharmacy organizations and improve communication among pharmacists and immunization programs and other health care providers. Applicants should develop and implement sustainable national operational procedures consistent with immunization practice standards, including proper administration, use of IIS, sharing vaccination records with other health care providers (e.g., primary care providers) and formalize agreements to support public health pandemic activities.

ii. Outcomes The logic model describes the relationship between the program’s activities and intended outcomes. The purpose of this NOFO is to: 1) provide education and training for pharmacists on current ACIP recommendations; 2) provide training on proper vaccine administration, storage, and handling of vaccines; 3) sustainable routine implementation of immunization practice standards, including improved communication among pharmacists and state and local immunization programs and health care providers, and 4) integrated and comprehensive pandemic vaccination preparedness activities.

The logic model describes the relationship between the program’s activities and intended outcomes. The purpose of this NOFO is to: 1) provide education and training for pharmacists on current ACIP recommendations; 2) provide training on proper vaccine administration, storage, and handling of vaccines; 3) sustainable routine implementation of immunization practice standards, including improved communication among pharmacists and state and local immunization programs and health care providers, and 4) integrated and comprehensive pandemic vaccination preparedness activities.

Applicants are expected to achieve the short-term outcomes and show progress toward achieving intermediate outcomes listed on the logic model.

Short-term outcomes are: 1) increased pharmacist competencies in the use of adult and child/adolescent immunization schedules and immunization practice standards, 2) increased pharmacist competencies in proper vaccine administration, storage, and handling, 3) established data exchanges with IIS and protocols to standardize sharing vaccination records and forecast information with other health care providers, 4) developed protocols for vaccination referrals (for vaccines not stocked by the pharmacy) and data exchange with other vaccination service providers, and 5) developed strategies to collaborate with public health programs and pharmacy associations and coordinate formalized agreements for pandemic vaccination preparedness to improve pharmacies’ ability to process ordering and receiving pandemic influenza vaccines from public health programs during an influenza pandemic.

Intermediate outcomes are: 1) improved implementation of immunization practice standards on current ACIP recommendations, 2) safe and effective administration of recommended vaccines,

3) established data exchange with IIS at IIS Functional Standards 2013-2017 and clinical decision support for immunization in the pharmacy health information system, 4) routinized processes to maintain a current list of vaccination service providers for vaccines not stocked by the pharmacy and evaluations for effectiveness of referrals and accuracy and completeness of data exchange, and 5) developed in-house emergency operations plans for pandemic response that include policies and procedures to coordinate communications and other activities, defined roles and responsibilities, and © decision-making hierarchy (in the context of formalized agreements on pandemic influenza vaccination program planning and response collaboration with public health programs).

iii. Strategies and Activities Applicants should propose a combination of activities. Applicants are expected to implement the following activities listed under each strategy.

Provide education and training on current ACIP recommendations

Document training modalities, training topics and objectives, trainer qualifications, lists of attendees, and demonstrated trainee competencies

Provide training on proper vaccine administration and storage and handling of vaccines to ensure safe and effective vaccination practices

Document training modalities, training topics and objectives, trainer qualifications, lists of attendees, and demonstrated trainee competencies

Implement immunization practice standards, including documentation of vaccines administered in the state or local IIS and transfer of vaccination records to other health care providers

Establish data exchange with IIS

Transmit patient vaccination records and forecasting information to other health care providers through electronic or other means, in addition to providing vaccination documentation directly to patients

Provide periodic summary vaccination records and forecasting information of patients to their clinical service providers and collaboratively identify strategies to update their vaccinations

Compile, verify, and periodically review a listing of vaccination service providers where patients may receive vaccines that are not stocked by the pharmacy

Follow up and document in pharmacy health information system vaccinations received by patients who were referred out

Maintain a current list of vaccination service providers to which patients are referred, and routinize referral and data sharing practices that ensure documentation of administered vaccines in IIS

Develop and implement plans to promote pandemic vaccination preparedness activities by formalizing relationships between pharmacies, pharmacy associations, and public health programs

Coordinate with public health emergency preparedness and immunization programs in the state and state pharmacy associations to promote use of formal memorandum of understanding (MOU) for pandemic vaccination response plans to improve pharmacies’ ability to process ordering and receiving pandemic influenza vaccines from public health programs during an influenza pandemic.

Applicants are strongly encouraged to propose additional activities to help meet the purpose of this NOFO. A rationale should accompany each proposed additional activity. Additional proposals might include activities in community outreach, quality improvement, enhanced data sharing and communication, and dissemination and promotion of best practices (e.g., publications and presentations).

1. Collaborations

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

Successful applicants that are funded will be required to collaborate and coordinate with CDC-funded state and local health department immunization programs to address barriers to vaccinating adults and adolescents in pharmacy practices; implement immunization practice standards, including submitting vaccination data to IIS; notify health care providers of patients who received vaccines; and engage in pandemic vaccination preparedness activities. Applicants should include details on their proposed collaborations with health department immunization programs. Applicants are not required to collaborate directly with other CDC-funded projects.

b. With organizations not funded by CDC:

Successful applicants that are funded will be required to collaborate with external partners and organizations that have a role in achieving the outcomes and proposed activities in this NOFO.

Collaboration with state or local pharmacy and other associations, affiliates, or chapters will be required. Applicants should include details on their proposed collaborations with external partners and organizations. Concrete evidence of relationship between collaborating partners such as memorandum of understanding, memorandum of agreement, or letter of support should be submitted with the application. Applicants must file the MOU or MOA, as appropriate, name the file “MOUs/MOAs,” and upload it as a PDF file at www.grants.gov.

2. Target Populations Adults, adolescents, and other populations that are at risk for vaccine-preventable diseases are the target populations for this NOFO. Applicants should identify and define which of these target populations they will focus on.

a. Health Disparities Racial and ethnic minorities and uninsured and underinsured populations generally have the lowest vaccination coverage rates. Applicants should define and identify sub-populations, within their constituency, that are at increased risk for vaccine-preventable diseases and develop strategies to increase their vaccine uptake to help reduce health disparities.

iv. Funding Strategy

NA

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy CDC will monitor applicants’ implementation of proposed activities (process evaluation) and determine applicants’ progress on achieving proposed outcomes (outcome evaluation).

Evaluation of the project should align with the project’s short- and intermediate-term outcomes.

Activities and process evaluation

Activity: Provide education and training on current ACIP recommendations http://www.grants.gov/ o Process evaluation – May include reviewing training modalities, training objectives and activities, trainer qualifications, and characteristics of trainees on training activities related to current ACIP recommendations

Activity: Provide training on proper vaccine administration, storage, and handling of vaccines to ensure safe and effective vaccination practices o Process evaluation – May include reviewing training modalities, training objectives and activities, trainer qualifications, and characteristics of trainees on training activities related to proper vaccine administration, storage, and handling

Activity: Implement immunization practice standards, including documentation of vaccines administered in the state or local IIS and transfer of vaccination records to other health care providers o Process evaluation – May include reviewing implementation plans to perform vaccination assessments, recommend vaccines needed by patients, administer vaccines needed or make referrals, and submit data to IIS; establish data exchange with IIS; maintain a list of vaccination service providers where patients may receive vaccines that are not stocked by the pharmacy; review patient vaccination records and forecasting information with other health care providers and collaboratively identify strategies to update their vaccinations; and develop and routinize vaccination referral and data sharing practices that ensure documentation of administered vaccines in IIS

Activity: Develop and implement plans to promote pandemic vaccination preparedness activities by formalizing relationships between pharmacies, pharmacy associations, and public health programs o Process evaluation – May include evaluating plans to develop formal memorandum of understanding (MOU) to improve pharmacies’ ability to process ordering and receiving pandemic influenza vaccines from public health programs during an influenza pandemic

Outcomes and outcome Measures Short-term:

Increased pharmacist competencies in the use of adult and child/adolescent immunization schedules and immunization practice standards o Outcome measure – The number of pharmacists trained in the use of adult and child/adolescent immunization schedules and immunization practice standards o Outcome measure – The percent of pharmacists attending educational trainings who show an increase in knowledge of adult and child/adolescent immunization schedules and immunization practice standards as indicated by pre- and post-testing.

Increased pharmacist competencies in proper vaccine administration, storage, and handling o Outcome measure – The number of pharmacists trained in proper vaccine administration, storage, and handling o Outcome measure – The percent of pharmacists attending educational trainings who show an increase in knowledge of proper vaccine administration, storage, and handling as indicated by pre- and post-testing

Established data exchanges with IIS and protocols to standardize sharing vaccination records and forecast information with other health care providers o Outcome measure – Increase from baseline in the number of pharmacies enrolled in the state/local IIS o Outcome measure – Increase from baseline in the number of pharmacies reporting data to the state/local IIS

Developed protocols for vaccination referral and data exchange with other vaccination service providers o Outcome measure – Increase in the number of pharmacy's with written protocols for vaccination referral and data exchange with other vaccination service providers

Developed strategies to collaborate with public health programs and coordinate formalized agreements on pandemic influenza vaccination program planning and response o Outcome measure – Increase in the number of formalized MOUs between pharmacy's , pharmacy associations, and public health programs on integrated and comprehensive pandemic vaccination preparedness activities

Intermediate:

Improved implementation of immunization practice standards on current ACIP recommendations o Outcome measure – Increase in the completeness of vaccination data submitted by the pharmacies in IIS

Established data exchange with IIS at IIS Functional Standards 2013-2017 and clinical decision support for immunization in the pharmacy health information system o Outcome measure – Increase from baseline in the number of pharmacies who have established data exchange with IIS at IIS Functional Standards 2013-2017 and clinical decision support for immunization in the pharmacy health information system

Routinized processes to maintain a current list of other vaccination service providers and evaluation for effectiveness of referrals and accuracy and completeness of data exchange o Outcome measure – Increase from baseline in the number of pharmacy's who maintain a list of vaccination service providers where patients may receive vaccines that are not stocked by the pharmacy o Outcome measure – Increase from baseline in the number of pharmacy's with written protocols for reviewing patient vaccination records and forecasting information with other health care providers and collaboratively identifying strategies to update their vaccinations o Outcome measure – Increase from baseline in the number of pharmacies reporting complete and accurate data to the state/local IIS

Implemented activities to promote improved coordination between pharmacies and public health programs for formalized agreements on pandemic influenza vaccination program planning and response o Outcome measure – Increase in the number of pharmacy's with written in-house emergency operations plans for pandemic response that include policies and procedures to coordinate communication and other activities, defined roles and responsibilities, and decision-making hierarchy o Outcome measure – Participation, as appropriate, in national or tabletop exercises

At the start of the project, CDC and applicants will review the Awardee Evaluation and Performance Management Plan (AEPMP), and ensure that the proposed process and outcome measures are consistent with the work plan, concrete, and achievable. Six months following the award date, if necessary, awardee-applicants will submit additional details or revisions to their

AEPMP.

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

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

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

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

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

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

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

Describe key evaluation questions to be addressed by these evaluations.

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

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

Applicants should provide an evaluation and performance measurement plan that demonstrates their ability to fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this NOFO. At a minimum, the plan should:

https://www.cdc.gov/grants/additionalrequirements/ar-25.html

Describe plans to collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement.

Identify key program partners to plan and conduct evaluation and performance measurements.

Identify available data sources, feasibility of collecting appropriate evaluation and performance data, and other relevant information (e.g., performance measures proposed by the applicant)

Plans for updating the Data Management Plan (DMP), if applicable, should be included for accuracy throughout the lifecycle of the project. The DMP should provide a description of the data that will be produced using these NOFO funds; access to data; data standards ensuring released data have documentation describing methods of collection, what the data represent, and data limitations; and archival and long-term data preservation plans. For more information about CDC’s policy on the DMP, see https://www.cdc.gov/grants/additionalrequirements/ar-25.html. If applicants choose to conduct an evaluation study, the following descriptions should be included in the study:

Type of evaluation (i.e., process, outcome, or both)

Key evaluation questions to be addressed

Other relevant information (e.g., measures, data sources)

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

c. Organizational Capacity of Recipients to Implement the Approach

Applicants should demonstrate sufficient organizational capacity and conduct a high level of program planning and evaluation, performance monitoring, budget management and financial reporting, data management, and personnel management. Applicants should also demonstrate the organizational capacity to manage partnerships with other national, state, tribal and territorial stakeholders to ensure a coordinated execution of planned activities.

Applicants should have the ability to: 1) communicate with a national constituency of pharmacists, 2) lead a national group of immunizing pharmacists, and 3) demonstrate an ability to impact measurable changes in vaccination services.

Evidence of an ability to communicate with a national constituency of pharmacists includes evidence of a pharmacist or pharmacy membership on a national level (e.g., active or dues paying membership in two-thirds of the states). Evidence of leading a national group of immunizing pharmacists includes documented substantial national leadership role in immunization on behalf of pharmacists and pharmacies, the organization’s impact on practice- and national-level immunization rates, and organizational relationships with state chapters and peer professional organizations. Evidence of a demonstrated ability to impact measurable changes in immunization includes documented records of outreach, education, and implementation of pharmacy systems change or behavior change among pharmacists; achievements and measurable improvements in immunization or other relevant health services; a history of collaborating with multiple partners and experience in assembling internal and external resources to execute projects of national scope; and have the ability to disseminate, publicize, and promote messages on immunization nationally.

d. Work Plan Applicants should identify and describe the proposed work plan under this NOFO in no more than 15 pages. Applicants should provide a detailed work plan for the first year of the project and a high-level work plan for subsequent years. Objectives in the work plan should be in SMART (specific, measurable, achievable, relevant, and time-bound) format. CDC will provide feedback and technical assistance to applicants to finalize the work plan after the award.

This NOFO contains four core activities: 1) provide education and training on current ACIP recommendations; 2) provide training on proper vaccine administration, storage, and handling of vaccines to ensure safe and effective vaccination practices; 3) implement immunization practice standards, including documentation of vaccines administered in the state or local IIS and transfer of vaccination records to other health care providers; and 4) develop and implement plans to promote pandemic vaccination preparedness activities by formalizing relationships between pharmacies, pharmacy associations, and public health programs.

The work plan should align with the activities and outcomes in the logic model and evaluation and performance measures strategies. The work plan should include strategies, processes, and timeline with milestones and performance measures for each of the four core activities; identify and assign staff, contractors, or consultants in sufficient in number and expertise to perform proposed activities; and administrative and assessment processes to ensure successful implementation, reporting, and quality assurance.

At the start of the project, CDC will review the Awardee Evaluation and Performance Management Plan (AEPMP) and ensure that the proposed process and outcome measures are consistent with thework plan, concrete, and achievable. Six months following the award date, if necessary, applicants will submit additional details or revisions to the AEPMP.

e. CDC Monitoring and Accountability Approach Monitoring activities include routine and ongoing communication between CDC and recipients, site visits, and recipient reporting (including work plans, performance, and financial reporting).

Consistent with applicable grants regulations and policies, CDC expects the following to be included in post-award monitoring for grants and cooperative agreements:

Tracking recipient progress in achieving the desired outcomes.

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

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

Monitoring may also include the following activities deemed necessary to monitor the award:

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

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

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

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

Monitoring and reporting activities that assist grants management staff (e.g., grants management officers and specialists, and project officers) in the identification, notification, and management of high-risk recipients.

Monitoring activities include routine and ongoing communication between CDC and successful applicants (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 recipients progress in achieving the desired outcomes Ensuring the adequacy of recipients systems that 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 budget

Other activities deemed necessary to monitor the award as applicable. These activities may include additional 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 recipients with difficulties meeting performance requirements.

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

COOPERATIVE AGREEMENTS)

CDC will provide the following support to applicants:

provide technical assistance in identifying major immunization issues, setting program priorities, and implementing and evaluating project activities assist in the review of immunization messages and materials for technical accuracy and for compliance with proven health education and communication strategies facilitate the transfer of successful prevention interventions and program models to other areas through meetings of grantees, workshops, conferences, newsletters, and communications with project officers

In addition, CDC and applicants will share information through email and telephone calls.

B. Award Information

1. Funding Instrument Type: Cooperative Agreement CDC's substantial involvement in this program appears in the CDC Program Support to Recipients Section.

2. Award Mechanism: H23

3. Fiscal Year: 2018

4. Approximate Total Fiscal Year Funding: $400,000

5. Approximate Period of Performance Funding: $2,000,000

This amount is subject to the availability of funds.

Estimated Total Funding: $2,000,000

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

7. Expected Number of Awards: 2

8. Approximate Average Award: $200,000 Per Budget Period

9. Award Ceiling: $200,000 Per Budget Period

This amount is subject to the availability of funds.

10. Award Floor: $100,000 Per Budget Period

11. Estimated Award Date: 09/30/2018

12. Budget Period Length: 12 month(s)

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

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

C. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

County governments City or township governments Special district governments Independent school districts Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Small businesses Others (see text field entitled "Additional Information on Eligibility" for clarification)

Additional Eligibility Category:

2. Additional Information on Eligibility For-profit entities are not eligible, per program’s statutory authority.

Organizations that meet the eligibility criteria will be evaluated responsiveness criteria in order to advance to objective review. Eligible applications will be reviewed for responsiveness in accordance with the factor below Work Plan development must not exceed the established Award Ceiling of $200,000 per budget period, as identified in Section B, 9. Applications submitted above this ceiling will be considered non-responsive and will not be forwarded for Phase II objective review.

3. Justification for Less than Maximum Competition

NA

4. Cost Sharing or Matching Cost Sharing / Matching Requirement: No

5. Maintenance of Effort Maintenance of effort is not required for this program.

D. Application and Submission Information

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

a. Data Universal Numbering System:

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

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

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

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

b. System for Award Management (SAM):

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

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

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 1-866-705-5711

2 System for Award Management

(SAM)

formerly Central Contractor Registration

(CCR)

1. Retrieve organizations DUNS number

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

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

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

866-606-8220

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

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

3. Log into grants.gov using the password the E-

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

MUST

obtain a

Register early!

Log into grants.gov and check AOR status until it shows you have been approved https://www.sam.gov/portal/public/SAM/ https://grants.gov/ https://www.grants.gov/ https://www.grants.gov/ https://www.grants.gov/ http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://www.sam.gov https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do

BIZ POC received and create new password

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

DUNS

number and

SAM

account before applying on grants.gov)

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

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

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

OGS.

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

b. Application Deadline Due Date for Applications: 06/11/2018 , 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.

Letter of intent (LOI) is not requested or required as part of the application for this NOFO.

Date for Information Conference Call

NA

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:

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

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 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…

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