ATTACHMENT_1-Domain_1_Sample_RFTOP.docx

ATTACHMENT 1 SAMPLE TASK ORDER 1

DOMAIN 1: RFTOP 2016-1-Task Order 001 Protocol Development: Multicenter study evaluating the Use of Probiotics for Primary Prevention of CDI among Hospitalized Adults

Estimated Price Range:

|X| Over $200,000 but less than $285,000

Proposed Period of Performance: Work shall begin from date of award of the order and shall continue for a period of 6 months. This is a non-severable project that will be fully funded at the time of award.

Page Suggestion: The Contractor shall limit the proposal for this task order to 10 pages single-spaced.

SECTION B – DESCRIPTION OF WORK

1. Background and Need Clostridium difficile was estimated to cause almost half a million infections in the United States in 2011, and 29,000 died within 30 days of the initial diagnosis. Use of probiotics for prevention of Clostridium difficile infection (CDI) is receiving increasing attention. However, the evidence supporting their efficacy and safety when used for this purpose is inconclusive. Additional studies are needed that assess the effectiveness of using probiotics to prevent.

2. Scope of Work This project is focused on engaging an experienced team of healthcare epidemiologists to write a protocol for a multicenter study evaluating the use of probiotics for primary prevention of CDI among hospitalized adults.

The goals of the project are to:

1. Explore existing literature regarding previous scientific studies on this topic and use this information to help discern which probiotics shall be studied, which study populations shall be included, and how to overcome methodologic weaknesses identified in previous studies.

2. Write a full protocol for a multicenter intervention study using probiotics for primary prevention of CDI among hospitalized adults in a network of acute care hospitals. (Note: contractors need not necessarily have access to the healthcare settings and patient populations sufficient for implementing the protocol, the task is specifically to produce a high quality protocol, not to implement the protocol. If the contractor does not have access to information from an existing network of acute care hospitals upon which to base the protocol, the protocol can be written for a hypothetical network of acute care hospitals with characteristics similar to an appropriate group of US hospitals)

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

Task 1: Start Up Meeting

· The Contractor shall arrange and conduct an initial meeting (by teleconference) with the Contracting Officer’s Representative (COR)/Science Officer within 2 weeks of the effective date of the task order. The purpose of the meeting will be to discuss critical contract performance milestones, to delineate roles and responsibilities, and to establish communication protocols.

· The Contractor shall submit an agenda for the above meeting within 1 week of the effective date of the task order.

Task 2: Maintain Communication with the Contracting Officer’s Representative (COR)/Science Officer

· The Contractor shall coordinate with the Contracting Officer’s Representative (COR)/Science Officer. The Contractor shall maintain regular communications both the COR/SO involved with the project. The chief means of communication will be via conference calls that will be scheduled every month throughout the project period required to complete the project. Additional calls will be scheduled as needed. The Contractor shall provide an agenda and meeting minutes for each call. All conference calls shall be scheduled and administered by the Contractor. The Contractor shall respond to all emails and telephone communications from the Science Officer within 2-3 working days.

Task 3: Mid Project Progress Report

· On the 5th day following the 3 months following the award date, the contractor shall prepare and submit a quarterly progress report containing a summary of the activities. The report shall contain, at a minimum, the current progress on each of the requirements set forth below, problems encountered during the month, solutions implemented, planned activity for the upcoming month and any other information mutually agreed upon between the contractor and the Contracting Officer’s Representative (COR)/Science Officer Task 4: Study Protocol Development

· Based on information from the specific network of acute care facilities in which the study will be implemented and monthly teleconference discussions with the Contracting Officer’s Representative (COR)/Science Officer, the Contractor will develop a full intervention study protocol for a multicenter study evaluating the use of probiotics for primary prevention of CDI among hospitalized adults by the end of month 6. The intervention strategy detailed in this protocol must be approved by the Contracting Officer’s Representative (COR)/Science Officer.

· This protocol will reflect a thorough background knowledge of the subject matter, will be tailored as appropriate to the experience of the network of healthcare facilities in which the study protocol will be implemented, and will reflect a study design that overcomes methodologic weaknesses identified in previous studies of use of probiotics for primary prevention of CDI. The protocol will include detailed sample size calculations based on expected effect sizes from previous work.

· The protocol will contain a detailed analytic plan, including appropriate rationale and detailed statistical methods to be employed.

· The final protocol will be reviewed in detail and then discussed during a protocol delivery conference call.

Task 5: Intervention Study Protocol Development Meeting

· The Contractor shall incorporate input from Contracting Officer’s Representative (COR)/Science Officer to fully develop Task 4 study protocol. Task 4 study protocol will be reviewed and approved by Contracting Officer’s Representative (COR)/Science Officer before finalization.

· The Contractor shall arrange and conduct a 1-2 day protocol development meeting (in person) with the Contracting Officer’s Representative (COR)/Science Officer no later than month 3 after the effective date of the task order. The purpose of the meeting will be to review progress made towards each deliverable and discuss issues critical to the design of a successful study protocol.

· The Contractor shall deliver a presentation on the current project status to the Contracting Officer’s Representative (COR)/Science Officer

· The Contractor shall submit an agenda for the above meeting no fewer than 2 weeks before the Intervention Study Protocol Development meeting.

· The CDC Science officer will approve the date and agenda of the protocol development meeting.

· Contractor shall refine the protocol based on CDC recommendations.

Task 6: Final Project Meeting

· The Contractor shall deliver a final presentation on the final project results to the Contracting Officer’s Representative (COR)/Science Officer within 6 months of award start.

· The Contractor shall submit an agenda for the above meeting no fewer than 2 weeks before the final project meeting.

· The CDC Science officer will approve the date and agenda of the final meeting.

Deliverables Summary Table The following deliverables shall be provided to the Contracting Officer’s Representative (COR)/Science Officer no later than the dates specified below:

Base Tasks- Deliverables Schedule Period of Performance: 6 months

Frequency Due Date

Agenda at least one day before the conference call. Response to emails and telecommunications within 2-3 days of event.

Meeting within 6 months of contract award.

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 contract.

C. Contractor Travel: Contractor will be required to travel during the performance of this contract to meet with CDC regarding the Intervention Study Protocol Development process. The purpose of this meeting will be to deliver a presentation on the current project status to the Contracting Officer’s Representative (COR)/Science Officer. 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.

5. Government Furnished Property, Equipment, and Services Not applicable.

6. Payment Terms

Payment will be subject to receipt of deliverables in accordance with the payment schedule established herein and in accordance with FAR 52.232-25. Prompt Payment, which states that the due date for making invoice payments shall be the 30th day after the designated billing office (see block 21 of the order) has received a proper invoice from the contractor or the 30th day after Government acceptance of the services provided by the contractor, whichever is later.

Schedule of Milestones for Performance-Based Payments

In accordance with FAR 52.232-32, PERFORMANCE BASED PAYMENTS (April 2012), upon successful completion of an event, the contractor may request performance based payments. The determination of eligibility for receipt of payment will be made by the Contracting Officer upon written certification from the Contracting Officer’s Representative (COR) that the performance milestone has been met. It is anticipated that each milestone payment will approximate the estimated timeline listed below but variation is anticipated and eligibility for payment could occur sooner or later depending upon the time of completion of the designated milestone. Milestone payments are subject to the terms of FAR 52.232-32 incorporated in this contract.

The COR receiving and acceptance of monthly performance based payments is based on verification that work on the contract was satisfactorily performed during the month and that, at a minimum, the following activities were satisfactorily performed.

Performance Based Payment Schedule

Status summary reports of project tasks, accomplishments, plans for next reporting period including status for each active protocol

Study Protocol Development Design

Within 6 months of contract award 25% of award, to be divided into 6 equal monthly installments

Performance of Work Requirements Summary

1. The purpose of this section is to:

A. List the contract requirements considered most critical to acceptable contract performance.

B. Show, where applicable, the maximum allowable degree of deviation from perfect performance for each requirement that shall be allowed by the Government before contract performance is considered unsatisfactory.

C. Define the procedure the Government shall use in reducing the Contractor's payment if satisfactory performance is not rendered.

2. The Government's quality assurance procedures are based on actual performance of the contract and all areas will be reviewed periodically, (e.g. weekly, quarterly).

3. The criteria for acceptable and unacceptable performance are as follows:

A. Contract requirements. The criteria for requirements are the level of performance deemed acceptable to the Government.

B. If the quality of work does not comply with the contract requirements the Contracting Officer Representative (COR) will initiate and the Contractor shall be required to complete a Contract Discrepancy Report (CDR).

C. The CDR will require the Contractor to explain in writing why performance was unacceptable, how performance will be returned to an acceptable level, and how recurrence of the problem will be prevented in the future. The Contractor will not be paid for services not rendered in accordance with the standards set forth in this contract.

D. If the level of performance is deemed unacceptable to the Government concurrent with two unsatisfactory ratings, monthly payment will be reduced for unsatisfactory performance by the percentage as shown in the chart below:

and Acceptability Quality Level

Disincentive

Method of performance assessment

Review progress reports.

Review written protocol.

7. Security Compliance 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:

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

1. 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),

1. 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),

1. 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),

1. 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),

1. 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),

1. 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)

1. Baseline System Information (BSI)

1. Privacy Impact Assessment (PIA)

1. System Security Plan (SSP)

1. Business Continuity Plan (BCP)

1. 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 and Inquiry Investigation plus a Credit Check (NACIC), a Minimum Background Investigation (MBI), or a Limited Background Investigation (LBI).

Upon award, the Licensor will be required to submit a roster of all staff (including sub-contractor staff) working under the contract that will have the ability to access NCEZID sensitive information from the system. .

Non-Disclosure Agreements The Contractor and any sub-Contractors or employees are forbidden from sharing any technical or logistical information they may gain in conjunction with matters related to this task order that could jeopardize the physical or information security of CDC or its employees, projects, or information systems.

The following apply to Licensor employees and their subcontractors associated with the project:

1. Personnel may not begin work under the contract until the contractor has submitted the employee roster and non-disclosure agreements as described above.

1. Personnel without necessary background investigations will not have access to sensitive project data.

1. Violation of these conditions may lead to termination of the contract.

It is the Contractor's responsibility to ensure that all employees have met CDC and federal requirements, such as, for example, completion of background checks, before gaining or utilizing access to CDC information technology resources.

(2) Privacy Compliance Licensor in conjunction with CDC Center ISSO shall conduct and maintain an initial Privacy Impact Assessment (PIA) as defined by Section 208 of the FISMA 2014. Periodic reviews shall be conducted by the system owner, with assistance from the CDC Center ISSO and contractor, to determine if a major change to the system has occurred, and if a PIA update is needed.

(3) Contractor’s Official Responsible for Information Security The contractor shall include in the “Information Security” part of the Technical Proposal the name and title of its official who will be responsible for all information security requirements shall the contractor be selected for an award.

(4) Rules of Behavior The contractor’s employees and subcontractors shall comply with the HHS Information Technology General Rules of Behavior.

(5) Information Security Training HHS policy requires that contractors and subcontractors shall receive security training commensurate with their responsibilities for performing work under the terms and conditions of their contractual agreements. The successful contractor shall be responsible for assuring that each employee, including subcontractors, has completed the HHS Computer Security Awareness Training course (or another course designated by CDC) prior to performing any contract work, and thereafter completing the HHS-specified annual refresher course during the period of performance of the contract. This would be provided at the Contractor's expense and would be the Contractor's responsibility to plan and arrange.

The successful contractor shall maintain a listing of all individuals who have completed this training and shall submit this listing to the project officer.

(6) HSPD-12 Compliance Federal Information Processing Standard 201 (FIPS-201) (vii) compliant, Homeland Security Presidential Directive 12 (HSPD-12) card readers shall: (a) be included with the purchase of servers, desktops, and laptops; and (b) comply with FAR Subpart 4.13, Personal Identity Verification.

As part of the Federal HSPD-12 directive, all information systems deployed within/outside of any federal infrastructure must be able to support HSPD-12 compliant Personal Identity Verification (PIV) of federal employees and contractors. The government has complied with HSPD-12 by issuing PIV cards with embedded digital certificates to all users of federal information systems. In accordance with this directive, all Contractors providing hardware and software to the federal government are now required to ensure that these PIV cards will integrate with their software and hardware at the application level. Contractor must be able to implement and support PIV card integration.

(7) Encryption All sensitive CDC-funded data stored on desktop computers used on behalf of HHS shall be secured either through a FIPS 140-2 compliant encryption solution or through adequate physical security and operational controls at the desktop’s residing location.

All mobile devices, portable media and transfer data files that contain CDC- data shall have full-disk encryption using FIPS 140-2 compliant algorithms.

Special Clearances:

|_| OMB

|_|Human Subjects

SPECIAL CLAUSES:

HHSAR 352.224-70, Privacy Act (Dec 2015) This contract requires the Contractor to perform one or more of the following:

(This contract requires the Contractor to perform one or more of the following: (a) design; (b) develop; or (c) operate a Federal agency system of records to accomplish an agency function in accordance with the Privacy Act of 1974 (Act) (5 U.S.C. 552a(m)(1)) and applicable agency regulations. The term system of records means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. Violations of the Act by the Contractor and/or its employees may result in the imposition of criminal penalties (5 U.S.C. 552a (i)).The Contractor shall ensure that each of its employees knows the prescribed rules of conduct in 45 CFR part 5b and that each employee is aware that he/she is subject to criminal penalties for violation of the Act to the same extent as Department of Health and Human Services employees. These provisions also apply to all subcontracts the Contractor awards under this contract which require the design, development or operation of the designated system(s) of records (5 U.S.C. 552a(m)(1)). The contract work statement: (a) Identifies the system(s) of records and the design, development, or operation work the Contractor is to perform; and (b) specifies the disposition to be made of such records upon completion of contract performance.

HSSAR 352.270-4a Notice to Offerors, Protection of Human Subjects (December 18, 2015)

(a) The Department of Health and Human Services (HHS) regulations for the protection of human subjects, 45 CFR part 46, are available on the Office for Human Research Protections (OHRP) website at: http://www.hhs.gov/ohrp/index.html.

These regulations provide a systematic means, based on established ethical principles, to safeguard the rights and welfare of human subjects participating in research activities supported or conducted by HHS.

(b) The regulations define a human subject as a living individual about whom an investigator (whether professional or student) conducting research obtains data or identifiable public information through intervention or interaction with the individual, or identifiable private information. In most cases, the regulations extend to the use of human organs, tissue, and body fluids from individually identifiable human subjects as well as to graphic, written, or recorded information derived from individually identifiable human subjects. 45 CFR part 46 does not directly regulate the use of autopsy materials; instead, applicable state and local laws govern their use.

(c) Activities which involve human subjects in one or more of the categories set forth in 45 CFR 46.101(b)(1)-(6) are exempt from complying with 45 CFR part 46. See http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.

(d) Inappropriate designations of the noninvolvement of human subjects or of exempt categories of research in a project may result in delays in the review of a proposal.

(e) In accordance with 45 CFR part 46, offerors considered for award shall file an acceptable Federal-wide Assurance (FWA) of compliance with OHRP specifying review procedures and assigning responsibilities for the protection of human subjects. The FWA is the only type of assurance that OHRP accepts or approves. The initial and continuing review of a research project by an institutional review board shall ensure that: the risks to subjects are minimized; risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result; selection of subjects is equitable; and informed consent will be obtained and documented by methods that are adequate and appropriate. Depending on the nature of the research, additional requirements may apply; see http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.111 for additional requirements regarding initial and continuing review. HHS regulations for the protection of human subjects (45 CFR part 46), information regarding OHRP registration and assurance requirements/processes, and OHRP contact information is available at the OHRP website (at http://www.hhs.gov/ohrp/assurances/index.html).

(f) Offerors may consult with OHRP only for general advice or guidance concerning either regulatory requirements or ethical issues pertaining to research involving human subjects. ONLY the contracting officer may offer information concerning a solicitation.

(g) The offeror shall document in its proposal the approved FWA from OHRP, related to the designated Institutional Review Board (IRB) reviewing and overseeing the research. If the offeror does not have an approved FWA from OHRP, the offeror must obtain an FWA before the deadline for proposal submission. When possible, the offeror shall also certify the IRB’s review and approval of the research. If the offeror cannot obtain this certification by the time of proposal submission they must include an explanation in their proposal. Never conduct research covered by 45 CFR part 46 prior to receiving certification of the research’s review and approval by the IRB.

(End of provision)

HHSAR 352.270-4b Protection of Human Subjects (December 18, 2015)

(a) The Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 45 CFR part 46 and with the Contractor’s current Federal-wide Assurance (FWA) on file with the Office for Human Research Protections (OHRP), Department of Health and Human Services. The Contractor further agrees to provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR part 46 and the Assurance of Compliance.

(b) The Contractor shall bear full responsibility for the performance of all work and services involving the use of human subjects under this contract and shall ensure that work is conducted in a proper manner and as safely as is feasible. The parties hereto agree that the Contractor retains the right to control and direct the performance of all work under this contract. Nothing in this contract shall create an agency or employee relationship between the Government and the Contractor, or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever. The Contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent Contractor without creating liability on the part of the Government for the acts of the Contractor or its employees.

(c) Contractors involving other agencies or institutions in activities considered to be engaged in research involving human subjects must ensure that such other agencies or institutions obtain their own FWA if they are routinely engaged in research involving human subjects or ensure that such agencies or institutions are covered by the Contractors’ FWA via designation as agents of the institution or via individual investigator agreements (see OHRP website at: http://www.hhs.gov/ohrp/policy/guidanceonalternativetofwa.pdf).

(d) If at any time during the performance of this contract the Contractor is not in compliance with any of the requirements and or standards stated in paragraphs (a) and (b) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. The Contracting Officer may communicate the notice of suspension by telephone with confirmation in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer’s written notice of suspension, the Contracting Officer may, after consultation with OHRP, terminate this contract in whole or in part.

(End of clause)

HHSAR 352.270-12 Needle Exchange (December 18, 2015) The Contractor shall not use any funds obligated under this contract to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.

(End of Clause)

CONTRACTING OFFICER REPRESENTATIVE:

TBD

SCIENCE OFFICER:

TBD

8. Technical Evaluation Criteria

Award: This task order will be awarded to the contractor whose proposal is considered to be the most advantageous to the Government, price and other factors identified below considered. Technical factors will be more important in the evaluation than price. The Government will not make an award at a significantly higher overall cost to the Government to achieve only slightly superior performance.

Technical Evaluation for this RFTOP is as follows:

A. Technical Approach (5):

1. The contractor’s proposal shall be evaluated according to the extent that it reflects a clear understanding of issues related to performing intervention and other epidemiologic studies having to do with healthcare associated infections and antimicrobial resistance. This includes a clear demonstration of understanding the issues specific to this research question (i.e. prevention of CDI), including practical recruitment of participants, human subjects protection, statistical analysis and sample size, study design, and other relevant issues. Specifically with regard to sample size and power calculations, the contractor shall base calculations on either: 1) data from an actual network of hospitals, or 2) the assumption that CDI rates in a hypothetical network of hospitals where the protocol will be implemented are reflective of rates reported from US hospitals as reflected in publically available reports. Evaluation will also take into account of the extent to which the contractor explicitly acknowledges and identifies weaknesses in methodologic design that have been present in previous studies of use of probiotics for prevention of CDI, and explicitly addresses how the protocol will specifically be designed to avoid such weaknesses.

2. Evaluation will also take into account of the extent to which the contractor explicitly anticipates and acknowledges potential barriers to success of the project, and explicitly addresses how the protocol will specifically be designed to overcome such barriers. The contractor’s proposal will be evaluated according to the soundness, practicality, and feasibility of the contractor’s technical approach for developing intervention and other epidemiologic study protocols having to do with healthcare associated infections and antimicrobial resistance. This discussion shall be in the contractor’s own words; not a restatement of the listed requirements. The contractor is to provide a specified plan for the protocol development.

B. Staffing and Management Plan (15):

1. The contractor shall provide a detailed statement of staffing and management approach for managing the development of the study protocol in this task order by demonstrating their understanding of the labor requirements for this task. Contractors are required to demonstrate that they are capable of providing a preponderance of the work and that subcontracting will be utilized to supplement task order efforts. Strong preference will be given to contractors demonstrating this capability.

2. The contractor shall include (a) resumes from key personnel outlining the credentials and background of key management, professional, and technical personnel to be used for this task order, including the percent time on this and other projects; (b) a detailed plan that describes current staff available for this task order and how the team will interface with CDC, as well as the Offeror’s approach to rapidly obtain and/or replace qualified staffing resources to support the contract; (c) a clear delineation of staff authorities and line of responsibility with special emphasis on relationships with CDC partners; (d) a detailed description of how conflicts are managed; and (e) a measurement of fiscal responsibility and accountability paying particular attention to the deliverable timeline in this task order. Ideal staffing to successfully accomplish the tasks of this acquisition include:

a) The preponderance of the work is performed by the prime is preferred.

b) Project Manager with sufficient time devoted to overseeing the implementation of the project. This person shall have experience executing research projects in healthcare settings related to Public Health, Infectious Disease or Healthcare-associated Infections.

c) One or more Research Associates/Clinicians with experience in hospital epidemiology and infectious disease assessment evidenced by publications in peer-reviewed scientific journals.

d) One or more Research Associates with experience in mathematical and/or statistical analysis, including complex power calculations, as evidenced by publications in peer-reviewed scientific journals.

C. Similar Experience (10):

1. The contractor’s proposal shall describe in detail the current contractors experience for developing and implementing Research Protocols related to prevention of healthcare associated infections, antibiotic resistance, and other adverse events associated with healthcare. Contractors are required to demonstrate that they are capable of providing a preponderance of the work and that subcontracting will only be utilized to supplement task order efforts. Strong preference will be given to contractors demonstrating this capability in the field of human healthcare epidemiology, with an emphasis on the epidemiology of HAIs, antibiotic resistance, and healthcare safety. Evidence of such experience shall be reflected by a substantial bibliography of peer reviewed scientific articles with lead authorship by staff directly employed by the prime vendor, and also by previous success in attracting federal funding in the form of grants and contracts related to infectious diseases, and healthcare associated infections in particular.

2. Contractors must demonstrate prior success in initiating and leading multiple steps across the spectrum of scientific inquiry related to healthcare associated infections, antibiotic resistance, and other adverse events associated with healthcare, including formulating a research question, developing a detailed research plan and protocol, successfully implementing the protocol, analyzing and interpreting results, and serving as lead authors in publication of the findings in peer reviewed literature. Expertise in clinical trial design, including statistical expertise in complex power calculations involving clustered designs and analyses, is an advantage. Contractors in this domain need not have access to the healthcare settings and patient populations sufficient for implementing the protocol they develop as part of this task order.

SHEPheRD RFTOP 2016-1-001