ATTACHMENT_3-Domain_3_Sample_RFTOP.doc

ATTACHMENT 3 SAMPLE TASK ORDER 3

Domain 3: RFTOP 2016-3-Task Order 001 Improving antibiotic use through implementation and evaluation of Core Elements of Antibiotic Stewardship in Nursing Homes or Long Term Acute Care Hospitals

Estimated Price Range:

FORMCHECKBOX

Over $300,000 but less than $500,000 Base Award

FORMCHECKBOX

Over $1,000,000 but less than $1,500,000 Option Period 1

FORMCHECKBOX

Over $700,000 but less than $1,000,000 Option Period 2

Proposed Period of Performance: This award will be a base period of 12 months, which includes two (2) 12 month option periods. Work for the base period shall begin from date of award of the order and shall continue for a period of 12 months. Funding for Option Periods 1 and 2 will be subject to availability of funds.

Page Suggestion: The Contractor shall limit the proposal for this task order to 15 pages single-spaced pages.

SECTION B – DESCRIPTION OF WORK

1. Background and Need

Antibiotic resistance leads to 2 million illnesses and 23,000 deaths each year in the United States. Antibiotic use is a major driver of antibiotic resistance, and thus appropriate antibiotic use, or antibiotic stewardship, is critical to slowing and stopping the development of resistance.

Antibiotics are among the most frequently prescribed medications in nursing homes and long term acute care hospitals (LTACHs). For example up to 70% of residents in a nursing home receiving one or more courses of systemic antibiotics when followed over a year. Similar to findings in hospitals, studies have shown that 40–75% of antibiotics prescribed in nursing homes may be unnecessary or inappropriate. Harms from antibiotic overuse are significant for the frail and older adults receiving care in nursing homes. These harms include risk of serious diarrheal infections from Clostridium difficile, increased adverse drug events and drug interactions, and colonization and/or infection with antibiotic-resistant organisms.

The Centers for Disease Control and Prevention (CDC) has released the Core Elements of Antibiotic Stewardship for Nursing Homes and Core Elements of Antibiotic Stewardship for Acute Care Hospitals (which can be applied to LTACHs) but it is unknown to what degree these critical healthcare facilities across the United States have implemented the Core Elements principals. This Request for Task Order Proposal aims to evaluate implementation of the Core Element recommendations in nursing homes and/or LTACHs. http://www.cdc.gov/longtermcare/prevention/antibiotic-stewardship.html.

2. Scope of Work CDC will contract with selected vendors to improve antibiotic use in nursing homes and/or LTACHs through implementation and evaluation of Core Elements of Antibiotic Stewardship for Nursing Homes. The goals of the project will be to:

1. Assess, at the level of the provider where possible, baseline volume and rate per total resident days of overall antibiotic use. In addition, explore opportunities for measuring appropriateness of antibiotic use and selection for targeted conditions

2. Implement scalable and sustainable antibiotic stewardship programs based on the Core Elements of Antibiotic Stewardship for Nursing Homes or (for LTACHs) Core Elements of Antibiotic Stewardship Acute Care Hospitals

3. Evaluate programs based on overall volume and rate per total resident days of overall antibiotic use; may also include appropriateness of antibiotic use and selection for targeted conditions (if possible)

4. Track resident outcomes of hospital readmissions, Clostridium difficile infections, and mortality

5. Assess feasibility and acceptability of antibiotic stewardship programs (ASP’s) in nursing homes and/or LTACHs

6. Assess cost of interventions and potential cost-savings of ASP’s in nursing homes and/or LTACHs The contractor will be responsible for developing any necessary IRB protocols and obtaining and maintaining all necessary local IRB approvals to fulfill the project objectives. The contractor will be responsible for data analyses of primary and secondary outcomes and for preparation of a draft of peer-reviewed manuscript.

3. Contractor Furnished Property The contractor shall provide all labor, expertise, materials, and supplies and perform all services required to carry out the work under this contract.

Base Period Task 1: Communications with COR/CDC Science Officer and Contracting Officers Representative (COR)

Task 1a: Arrange and Attend Start-Up Meeting

· Within 2 weeks of the effective date of the task order, the contractor shall schedule a teleconference with the COR/CDC Science Officer, COR Contracting Officer’s Representative (COR)/Science Officer identified at time of award.

· The contractor shall provide an agenda for the teleconference at least three days prior to the scheduled meeting.

· The purpose of this meeting will be to discuss critical contract performance milestones, to delineate roles and responsibilities, and to establish communication protocols. Each task and deliverable will be reviewed during this meeting.

· The contractor shall provide meeting minutes no later than 1 week after the teleconference.

Task 1b: Maintain Communication with CDC Staff

· The contractor shall arrange monthly conference calls between the contractor and CDC project staff during the duration of the project.

· The contractor shall provide an agenda 2 business days prior to call and meeting minutes within 2 business days for all monthly conference calls.

· The contractor communicate with the COR/CDC Science Officer and COR whenever a problem/ change arises in the project.

· The contractor shall respond to all e-mail and telephone communications from the COR/CDC Science Officer or designee within 3 business days.

Task 1c: Submit Quarterly Progress Reports

· The contractor shall produce written quarterly progress reports that shall be submitted to COR/CDC Science Officer on the 10th day following the three months being reported.

· The reports shall include, at minimum, the current status of all tasks, problems encountered during the previous quarter, proposed or implemented solutions, planned activity for the upcoming quarter, and interim data analyses.

· The contractor shall prepare and submit a quarterly progress report containing a summary of project activities and status updates on invoices.

Task 2: Recruitment of Included Facilities Task 2a: Select a mixture of at least 10 contractor-owned nursing home facilities, LTACHs or networks of varying bed sizes in different geographic areas (rural, urban, etc.).

· Sites should be selected in coordination with the COR/CDC Science Officer.

· Each included nursing home or LTACH should include a physician champion to assist with education and implementation of interventions.

· The contractor shall provide to the COR/CDC Science Officer the characteristics of included facilities, including

· Type of facility (short term rehab, long term care)

· Free-standing or connected to hospital or acute care facility

· Number of providers

· Urban, suburban or rural location

· Age group served

· Specialty status: single or multi-specialty

· Overall mix of payers of residents/patients served

Task 3: Protocol Development Task 3a: Define 1-year baseline period

· The contractor shall define at least one full calendar year baseline period for which data on all outcomes are available to be used as the comparison period to the intervention period.

· The baseline period shall be retrospective in order to complete the project within 3 years.

Task 3b: Develop protocol for baseline data collection (if needed)

· The contractor shall develop a protocol, coordinating with the COR/CDC Science Officer and staff.

· The protocol shall include data collection forms and consent forms for the project.

· The IRB protocol should include an analytic plan for monitoring during the baseline period and for evaluating providers’ knowledge, attitudes and practices surrounding appropriate antibiotic use.

· The protocol shall be approved by the COR/CDC Science Officer prior to submission to IRB.

Task 3c: Obtain and maintain IRB approval for baseline data collection (if needed)

· The contractor shall obtain all needed local IRB approvals and/or exemptions.

· Any modifications to the protocol required by IRB should be approved by COR/CDC Science Officer and the contractor.

· The contractor shall provide the COR/CDC Science Officer with all documentation of IRB approvals and/or exemptions.

· The contractor shall renew IRB approval as required by IRB for the duration of the project.

· The contract shall prepare and submit any needed protocol modifications or amendments for IRB approval.

· The COR/CDC Science Officer will submit for CDC IRB approval as required.

Task 4: Collection and Analysis of Baseline Data

Task 4a: Assess demographic characteristics of providers at included facilities

· The contractor shall work with included facilities to assess demographic characteristics of providers at included nursing homes or LTACHs that may be associated with differing antibiotic prescribing behaviors. The contractor shall provide the COR/CDC Science Officer with a summary of included unidentifiable provider characteristics within two months of IRB approval. Total numbers of providers at included facilities and changes in providers at included facilities shall be tracked by the contractor for the duration of the project. Demographic characteristics shall include:

· Type of education (e.g., physician, nurse practitioner, physician assistant)

· Location of education (e.g. in the United States or outside of United States)

· Specialty, e.g. family practice, geriatrics, internal medicine, pulmonary/critical care

· Age and sex

· Years in practice

Task 4b: Assess knowledge, attitudes and practices of a sample of providers and perceived provider-level barriers to appropriate antibiotic prescribing. The contractor may perform this assessment by surveying up to 9 providers that can speak to the knowledge, attitudes and behaviors of their peers.

· The contractor shall assess provider knowledge, attitudes and practices surrounding overall antibiotic use and antibiotic use in their facility and practice.

· The contactor shall assess perceived provider-level barriers to appropriate antibiotic prescribing in included facilities in order to design interventions that improve antibiotic prescribing.

· The contractor shall assess which conditions providers feel are the most important conditions at which to target appropriate antibiotic use interventions.

· The contractor shall include a summary of these knowledge, attitudes, and practices and perceived barriers and proposed solutions to barriers.

· Summary shall be provided to the COR/CDC Science Officer within two months of IRB approval of protocol.

Task 4c: Assess overall volume and rate of systemic antibiotic use per resident days of therapy (DOT) at the facility level during baseline period

· Assessment of antibiotic use and rate shall be include total antibiotic use, by class and agent.

· Rates shall be calculated as days of therapy (DOT).

· The contractor shall provide the COR/CDC Science Officer with a summary of overall volume and rates per facility of systemic antibiotic use during baseline period.

· Summary shall be provided to the COR/CDC Science Officer within 3 months of completion of the baseline period and IRB approval.

Task 4d: Assess feasibility of measuring appropriateness of use and selection of systemic antibiotics for targeted conditions appropriate to the setting and feasibility of data collection at the facility level during baseline period

· To determine appropriateness, the contractor should be able to obtain the following information on resident/patient encounters from the medical record

· Resident/patient demographic characteristics: age and sex

· Diagnoses and indications for antibiotic use for each encounter

· Laboratory testing results, e.g. rapid streptococcal testing and urinalysis results, cultures

· Resident/patient comorbidities

· Medication allergies

· Recent systemic antibiotic use prior to illness episode

· Ideally, the contractor will involve providers at program facilities in defining targeted conditions.

· The contractor should develop a sustainable, automated system to produce feedback reports at the facility level on appropriateness of antibiotic prescribing for targeted conditions if determined to be a measureable outcomes for this project.

· The contractor shall update analytic plan as necessary.

Task 4e: Measure resident/patient-level outcomes associated with antibiotic use and/or under-prescribing during baseline period

· The contractor should have access to longitudinal data to measure resident-level outcomes, including the following:

· Clostridium difficile infections within 12 weeks of index encounter

· Severe adverse reactions to antibiotics, e.g., Stevens-Johnsons syndrome, anaphylaxis

· ED visits within 1 month of index encounter

· Subsequent hospitalizations/transfers within 1 month of index encounter

· Mortality

· The contractor shall update analytic plan as necessary.

Task 5: Base Period Final Report

The contractor shall provide, within 14 days of the end of the base period, an interim final report that summarizes the work to date and next steps including a summary of selected facilities, and a summary of the collection and analysis of the baseline data, including:

· A summary of provider characteristics at included facilities

· An assessment of the knowledge, attitudes and practices of providers and perceived provider-level barriers to appropriate antibiotic prescribing in each facility

· A retrospective assessment of the overall volume and rate of systemic antibiotic use per facility during baseline period

· A retrospective assessment of systemic antibiotic use and selection at the ward/unit level during the baseline period

· Resident/patient level outcomes associated with antibiotic use and/or under-prescribing during the baseline period

Option Period 1

Option Period 1 Task 1: Communications with CDC Project Staff

Option Period 1 Task 1a: Arrange and Attend Start-Up Meeting

· Within 2 weeks of the effective date of the Option Period 1, the contractor shall schedule a teleconference with the COR/CDC Science Officer identified at time of award.

· The contractor shall provide an agenda for the teleconference at least three days prior to the scheduled meeting.

· The purpose of this meeting will be to discuss critical contract performance milestones, to delineate roles and responsibilities, and to establish communication protocols. Each task and deliverable will be reviewed during this meeting.

· The contractor shall provide meeting minutes no later than 1 week after the teleconference.

Option Period 1 Task 1b: Maintain Communication with CDC Staff

· The contractor shall arrange monthly conference calls between the contractor and COR/CDC Science Officer and COR during the duration of the project.

· The contractor shall provide an agenda 2 business days prior to call and meeting minutes within 2 business days for all monthly conference calls.

· The contractor communicate with the COR/CDC Science Officer whenever a problem/ change arises in the project.

· The contractor shall respond to all e-mail and telephone communications from the COR/CDC Science Officer or designee within 3 business days.

Option Period 1 Task 1c: Submit Quarterly Progress Reports

· The contractor shall produce written quarterly progress reports that shall be submitted to COR/CDC Science Officer and COR on the 10th day following the three months being reported.

· The reports shall include, at minimum, the current status of all tasks, problems encountered during the previous quarter, proposed or implemented solutions, planned activity for the upcoming quarter, and interim data analyses.

· The contractor shall prepare and submit a quarterly progress report containing a summary of project activities and status updates on invoices.

Option Period 1 Task 1d: Attend a joint meeting at CDC for all Office of Antibiotic Stewardship SHEPheRD vendors

· The contractor shall attend a meeting at CDC for all Office of Antibiotic Stewardship SHEPherD contracts in which contractors will share lessons learned and interim results.

· The purpose of this meeting will be to encourage cross-cutting collaboration between antibiotic stewardship activities across the spectrum of healthcare and to update funders on progress made to date.

· Meeting is being planned for fall 2017.

Option Period 1 Task 2: Design Interventions Based on Core Elements

Design scalable and sustainable antibiotic stewardship programs that incorporate all Core Elements of Antibiotic Stewardship for Nursing Homes and/or LTACHs that can be implemented across a network of nursing homes

· The contactor shall develop programs that incorporate all Core Elements of Antibiotic Stewardship for Nursing Homes and/or LTACHs (using Core Elements for Acute Care Hospitals):

· Program activities may target overall antibiotic use and/or appropriateness of antibiotic use or selection for targeted conditions. Overall antibiotic use and appropriateness of antibiotic use or selection for targeted conditions should be tracked as outcome measures.

· Programs should be designed to be scalable to multiple nursing homes and/or LTACHs without negatively impacting nursing home and/or LTACHs operations.

· Programs should be designed to sustainable, such that if found to be effective, these interventions can be continued after the end of the evaluation period.

· Ideally, the contractor will include providers at intervention facilities in developing programs.

· The contractor should design programs that help providers overcome barriers to appropriate prescribing.

Option Period 1 Task 3: Protocol Development for Pilot and Implementation of Interventions

Option Period 1 Task 3a: Develop IRB protocol for pilot and implementation

· The contractor, coordinating with the COR/CDC Science Officer and staff, shall develop a protocol to be submitted for IRB approval or exemption.

· The protocol shall include data collection forms and consent forms for the project.

· The IRB protocol should include an analytic plan for monitoring and evaluating outcomes of interventions.

· The protocol shall be approved by the COR/CDC Science Officer prior to submission to IRB.

Option Period 1 Task 3b: Obtain and maintain IRB approval or exemption

· The contract shall obtain all needed local IRB approvals or exemptions. Any modifications to the protocol required by IRB should be approved by COR/CDC Science Officer and the contractor.

· The contractor shall provide the COR/CDC Science Officer with all documentation of IRB approvals.

· The contractor shall renew IRB approval as required by IRB.

· The contract shall prepare and submit any needed protocol modifications or amendments for IRB approval.

· The COR/CDC Science Officer shall submit for CDC IRB approval as required.

Option Period 1 Task 4: Pilot Implementation of Interventions based on Core Elements

Option Period 1 Task 4a: Pilot antibiotic stewardship programs at 1–2 nursing homes and/or LTACHs representing the sizes and locations planned for inclusion in the study and modify activities based on results of pilot testing.

· Pilot testing of program activities should occur at a limited number of nursing homes and/or LTACHs in order allow for modification of activities based on acceptability, feasibility, and use of activities.

· Up to 9 provider representatives at nursing homes and/or LTACHs in pilot testing should be surveyed to determine acceptability of program activities.

· Modifications to activities should be pilot-tested prior to implementation across the network of nursing homes and/or LTACHs.

· The contractor shall provide a summary of designed, piloted and modified program activities that is approved by CDC project staff.

· The pilot testing period should not be included in the baseline or program activity analysis timeframes for nursing homes and/or LTACHs with pilot testing.

Option Period 1 Task 4b: Arrange and attend site visit by CDC staff during pilot testing, which may also need to occur during implementation periods as needs arise.

· The contractor shall arrange and attend site visit with contractor and CDC project staff at included pilot facilities within first two weeks of pilot.

· Additional site visits during implementation may be arranged as necessary.

Option Period 1Task 5a: Implement Scalable and Sustainable Antibiotic Stewardship Programs Based on the Core Elements of Antibiotic Stewardship for Nursing Homes

· After completion of pilot and approval of final interventions by COR/CDC Science Officer, the contractor shall begin implement previously designed interventions at least 5 nursing home facilities and/or LTACHs for at least one calendar year.

Option Period 1 Task 5b: Begin the Assessment of Primary and Secondary Outcomes of Interventions

Primary outcomes:

1. Overall volume and rate of systemic antibiotic use per days of therapy (DOT) at the unit/ward and facility level

2. Appropriateness of use and selection of antibiotics for targeted conditions at the unit/ward and facility level

Secondary outcomes

1. Resident-level outcomes potentially associated with

a. Clostridium difficile infections within 12 weeks of index encounter

b. Severe adverse reactions to antibiotics, e.g., Stevens-Johnsons syndrome, anaphylaxis

c. Subsequent hospitalizations/transfers within 1 month of index encounter

d. Mortality

2. Intervention-level outcomes

a. Acceptability in nursing home and/or LTACH settings among providers

b. Feasibility and sustainability of interventions

c. Cost of interventions

d. Potential cost-savings of interventions

e. Resident, patient and customer satisfaction scores at the facility level

Option Period 1 Task 6: Option Period 1 Final Report The contractor shall provide, within 14 days of the end of the Option Period 1, an interim final report that summarizes the implementation process and preliminary evaluation of primary and secondary outcomes. The report will also include preliminary lessons learned, recommendations for necessary modifications to the interventions based on lessons learned and plans for next steps.

Option Period 2

Option Period 2 Task 1: Communications with CDC Project Staff

Option Period 2 Task 1a: Arrange and Attend Start-Up Meeting

· Within 2 weeks of the effective date of Option Period 2, the contractor shall schedule a teleconference with the COR/CDC Science Officer identified at time of award.

· The contractor shall provide an agenda for the teleconference at least 3 days prior to the scheduled meeting.

· The purpose of this meeting will be to discuss critical contract performance milestones, to delineate roles and responsibilities, and to establish communication protocols. Each task and deliverable will be reviewed during this meeting.

· The contractor shall provide meeting minutes no later than 1 week after the teleconference.

Option Period 2 Task 1b: Maintain Communication with CDC Staff

· The contractor shall arrange monthly conference calls between the contractor and CDC project staff during the duration of the project.

· The contractor shall provide an agenda 2 business days prior to call and meeting minutes within 2 business days for all monthly conference calls.

· The contractor communicate with the COR/CDC Science Officer whenever a problem/ change arises in the project.

· The contractor shall respond to all e-mail and telephone communications from the COR/CDC Science Officer or designee within 3 business days.

Option Period 2 Task 1c: Submit Quarterly Progress Reports

· The contractor shall produce written quarterly progress reports that shall be submitted to COR/CDC Science Officer on the 10th day following the three months being reported.

· The reports shall include, at minimum, the current status of all tasks, problems encountered during the previous quarter, proposed or implemented solutions, planned activity for the upcoming quarter, and interim data analyses.

· The contractor shall prepare and submit a quarterly progress report containing a summary of project activities and status updates on invoices.

Option Period 2 Task 2a: Continued Implementation of Scalable and Sustainable Antibiotic Stewardship Programs Based on the Core Elements of Antibiotic Stewardship for Nursing Homes and/or Acute Care Hospitals (for LTACHs) Across a Network of Facilities.

· Continue implementation of interventions in at least 5 nursing home facilities and/or LTACHs.

· Interventions should span one full calendar year (same as the baseline data collection period) in order to adequately compare data pre and post intervention.

· The intervention period may span Option Period 1 and Option Period 2.

Option Period 2 Task 2b: Continued Evaluation of Interventions based on Core Elements by assessing primary and secondary outcomes for at least one year after implementation

· The contractor shall evaluate the interventions through monitoring of primary and secondary outcomes for one year after full-scale implementation begins.

· The contractor shall conduct quarterly interim analyses of primary outcomes and resident-level secondary outcomes and include results of these interim analyses in quarterly progress reports.

· The contractor shall report results of all outcomes in the final report.

Primary outcomes:

1. Overall volume and rate of systemic antibiotic use per days of therapy (DOT) at the unit/ward and facility level

2. Appropriateness of use and selection of antibiotics for targeted conditions at the unit/ward and facility level

Secondary outcomes

3. Resident-level outcomes potentially associated with

a. Clostridium difficile infections within 12 weeks of index encounter

b. Severe adverse reactions to antibiotics, e.g., Stevens-Johnsons syndrome, anaphylaxis

c. Subsequent hospitalizations/transfers within 1 month of index encounter

d. Mortality

4. Intervention-level outcomes

a. Acceptability in nursing home and/or LTACH settings among providers

b. Feasibility and sustainability of interventions

c. Cost of interventions

d. Potential cost-savings of interventions

e. Resident/patient and customer satisfaction scores at the facility level

· The contractor shall conduct quarterly interim analyses of primary outcomes and resident-level secondary outcomes and include results of these interim analyses in quarterly progress reports.

· The contractor shall monitor primary and secondary outcomes for one year after implementation of interventions.

· The contractor should report results of all outcomes in the final report.

Option Period 2 Task 3: Analysis and Final Reports

Option Period 2 Task 3a: Analyze final data and present findings

· The contractor shall finalize the analytic plan to be reviewed with CDC staff.

· The contractor shall analyze data to determine effectiveness of interventions by comparing baseline and intervention periods for primary and secondary outcomes.

· The contractor shall conduct a cost-effectiveness analysis of interventions.

· The contractor shall examine correlation of overall rate of systemic antibiotic use per facility with appropriateness of use for targeted conditions, if feasible. The purpose of this analysis will be to determine if overall antibiotic use rates can be used as proxy measurements for appropriateness of antibiotic use at the provider and facility level.

· The contractor shall present analyses to CDC project staff.

Option Period 2 Task 3b: Final reports

· The contractor shall produce final written reports of implementation and evaluation of Core Elements of Antibiotic Stewardship for Nursing Homes and/or Acute Care Hospitals. These reports shall include draft and final reports. The draft report will be submitted to the COR/CDC Science Officer. The final report should be ready within 4 weeks after receiving comments and recommendations on the draft report by CDC staff.

· Reports should include full results of final data analysis including effectiveness of interventions and cost-effectiveness analysis.

· Reports should include lessons learned and recommendations for future efforts to implement the Core Elements of Antibiotic Stewardship for Nursing Homes and/or Acute Care Hospitals.

· Additionally, the contractor shall lead a peer-reviewed manuscript to be written in collaboration with CDC staff.

Deliverables Summary Table

The following deliverables shall be provided to the Science Officer and relevant CDC staff no later than the dates specified below:

Base Period

Frequency Due Date

Minutes – 2 days after each scheduled call

Within 12 months of award

Within 12 months of award

Option Period 1

Minutes – 2 days after each scheduled call

Option Period 2

Minutes – 2 days after each scheduled call

4. General Information

A. Place of Performance: The work to be performed under this contract will be performed at the Contractor’s facility and associated academic, healthcare or research facilities as required.

B. Type of Contract: The government will award a firm-fixed price.

C. Contractor Travel: Contractor will be required to travel during the performance of this contract. The contractor shall attend a meeting at CDC for all Office of Antibiotic Stewardship SHEPheRD vendors in which vendors will share lessons learned and interim results. The purpose of this meeting will be to encourage cross-cutting collaboration between antibiotic stewardship activities across the spectrum of healthcare. Travel shall be in accordance with the Federal Travel Regulation (FTR).

D. Data Rights 52.227-14 Rights in Data-General, Alternate IV (Dec 2007). As prescribed in 27.409(b)(5), substitute the following paragraph (c)(1) for paragraph (c)(1) of the basic clause: (c) Copyright—(1) Data first produced in the performance of the contract. Except as otherwise specifically provided in this contract, the Contractor may assert copyright in any data first produced in the performance of this contract. When asserting copyright, the Contractor shall affix the applicable copyright notice of 17 U.S.C. 401 or 402, and an acknowledgment of Government sponsorship (including contract number), to the data when such data are delivered to the Government, as well as when the data are published or deposited for registration as a published work in the U.S. Copyright Office. For data other than computer software, the Contractor grants to the Government, and others acting on its behalf, a paid-up, nonexclusive, irrevocable, worldwide license for all such data to reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly, by or on behalf of the Government. For computer software, the Contractor grants to the Government and others acting on its behalf, a paid-up, nonexclusive, irrevocable, worldwide license for all such computer software to reproduce, prepare derivative works, and perform publicly and display publicly (but not to distribute copies to the public), by or on behalf of the Government.

E. Confidentiality of Information: Work on this project may require that personnel have access to Privacy Information. Personnel shall adhere to the Privacy act, Title 5 of the U.S. Code, Section 552a and applicable agency rules and regulations. The user agency will identify and provide direction and guidance for safeguarding all information subject to the Privacy Act. Reports and case files containing individual personal information are confidential. The CDC is not authorized to release individual case reports, and access to individual case data is strictly controlled. The contractor personnel are required to work with case records as well as databases. It is a requirement that the data remain in a controlled access environment.

F. Section 508: Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services. Regardless of format, all Web content or communications materials produced for publication on or delivery via CDC Web sites - including text, audio or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors1) or consultants responsible for preparing or posting content intended for use on an CDC-funded or CDC-managed Web site must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents below. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW or PWS, shall be the responsibility of the contractor or consultant retained to produce the Web-suitable content or communications material. Checklists for various file formats are available at http://www.hhs.gov/web/508/index.html.

The following Section 508 provisions apply to the content or communications material identified in this SOW or PWS: 36 CFR 1194.21 (for software and programmatic elements in websites), 36 CFR 1194.22 (for documents and websites), and 36 CFR 1194.24 (for video and multimedia content) References: HHS Policy for Section 508 Electronic and Information Technology (E&IT) (January 2005): http://www.hhs.gov/od/Final_Section_508_Policy.html HHS Section 508 Web site: http://508.hhs.gov/ HHS ASPA Web Communications Division Web site: http://www.hhs.gov/web/policies/index.html US General Services Administration (GSA) Section 508 Web site: http://www.section508.gov/index.cfm 1 Prime contractors may enter into subcontracts in the performance of a Federal contract, but the prime remains obligated to deliver what is called for under the contract.

G. The below information complies with HHSA Security compliance requirements for E-Government Act of 2002 (FISMA 2002) and Federal Information Security Modernization Act of 2014 (FISMA 2014)

Security Compliance

The contractor must have the ability to host and maintain a system for data collection, management, use, and reporting to support activities funded by the federal government. We provide the following information to assist in the preparation of documents necessary for the Security Assessment and Authorization (SA&A) of an Information System. The FISMA 2014, (Federal Information Security Modernization Act of 2014) and the below federal policies dictate the framework for assuring information security for data systems operated by or on behalf of the Federal government. These are summarized below.

OMB Circular A-130 (https://www.whitehouse.gov/omb/Circulars_a130_a130trans4/) establishes policy for the management of Federal information resources, pursuant to a number of laws and regulations, including the Paperwork Reduction Act of 1980 (amended in 1995), the Computer Security Act of 1987, and other laws. Circular A-130 requires all federal information systems to have security plans, emergency response capabilities, designated individuals who are responsible for security, security awareness training, and regular review of the system. Appendix III of Circular A-130, entitled “Security of Federal Automated Information Resources,” establishes a minimum set of controls to be included in Federal automated information security programs; assigns Federal agency responsibilities for the security of automated information; and links agency automated information security programs (such as the DHHS AISSP) with OMB Circular No. A-123

The Federal Information Security Management Act of 2002 (P.L. 107-347) (FISMA) ( http://csrc.nist.gov/drivers/documents/FISMA-final.pdf ) and the Federal Information Security Modernization Act of 2014 (P.L. 113-283) (FISMA 2014) (https://www.congress.gov/113/plaws/publ283/PLAW-113publ283.pdf) requires each agency to develop, document, and implement an agency-wide information security program to safeguard information and information systems that support the operations and assets of the agency, including those provided or managed by another agency, contractor (including sub-contractor), or other source. The National Institute of Standards and Technology (NIST) has issued a number of publications that provide guidance in the establishment of minimum security controls for management, operational, and technical safeguards needed to protect the confidentiality, integrity, and availability of a Federal information system and its information.

Pursuant to Federal and HHS Information Security Program Policies the following standards and guidelines apply:

· FIPS Publication 200, Minimum Security Requirements for Federal Information and Information Systems (http://csrc.nist.gov/publications/fips/fips200/FIPS-200-final-march.pdf),

· FIPS Publication 199, Standards for Security Categorization of Federal Information and Information Systems (http://csrc.nist.gov/publications/fips/fips199/FIPS-PUB-199-final.pdf),

· NIST Special Publication 800-18, Guide for Developing Security Plans for Federal Information Systems (http://csrc.nist.gov/publications/nistpubs/800-18-Rev1/sp800-18-Rev1-final.pdf),

· NIST Special Publication 800-60, Guide for Mapping Types of Information and Information Systems to Security Categories Vol. 1 (http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol1-Rev1.pdf) and Vol. 2 (http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf),

· NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems: A Security Life Cycle Approach (http://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-37r1.pdf),

· NIST Special Publication 800-53, Security and Privacy Controls for Federal Information Systems and Organizations (http://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf),

· NIST Special Publication 800-63, Electronic Authentication Guideline (http://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-63-2.pdf).

The System Security Plan (SSP) is part of the Security Assessment and Authorization (SA&A) process required by the FISMA 2014 and NIST Special Publication 800-18, 800-37 and will include selected mandatory controls required by NIST Special Publication 800-53, Volume I & II. The successful contractor in conjunction with the NCEZID Information System Security Officer (ISSO) will submit SA&A documentation to the CDC Chief Information Security Officer (CISO). The successful completion of the SA&A documents will result in an award of an Authority To Operate. Based on guidance in FIPS 199 and NIST SP 800-60 the system will be assigned an overall security category (SC) of LOW or MODERATE based on (confidentiality, LOW/MODERATE), (integrity, LOW/MODERATE), and (availability, LOW/MODERATE) impact levels. These impact levels will be initially determined by the NCEZID ISSO and confirmed by the CDC Certifying Authority as part of the SA&A process.

The successful contractor is responsible for providing pertinent security information to the NCEZID ISSO and Security Staff and assisting in completing the below CDC SA&A documents to include Annual Assessments, Annual Business Continuity Plan, Re-Certifications and applicable significant/non-significant change requests. Appropriate security templates will be provided to the successful Contractor by the NCEZID Security Staff. Completed documents will be sent by the NCEZID Security Staff to the CDC Chief Information Security Office (CISO) for review, approval and subsequent issuance of an Authority To Operate (ATO)

· Baseline System Information (BSI)

· Privacy Impact Assessment (PIA)

· System Security Plan (SSP)

· Business Continuity Plan (BCP)

· Risk Assessment Report (RAR)

The Contractor shall respond to the following seven security–associated requirements in the application:

(1) Position Sensitivity Designations CDC requires a Public Trust Level 5 for the following

The following position sensitivity designations and associated clearance and investigation requirements apply under this licensing contract:

Level 5: Public Trust - Moderate Risk (Requires Suitability Determination with NACIC, MBI or LBI). Licensor employees assigned to a Level 5 position with no previous investigation and approval shall undergo a National Agency Check…