CISA 2012-N-14296 5_24_ 2012.doc

SOLICITATION, OFFER AND AWARD

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

2. CONTRACT NO.

200-2012-50430

3. SOLICITATION NO.

2012-N-14296

4. TYPE OF SOLICITATION

X

NEGOTIATED (RFP)

5. DATE ISSUED

05/24/2012

6. REQUISITION/PURCHASE NO.

OHCVLD12-2012-43958

Centers for Disease Control and Prevention (CDC)

Procurement and Grants Office (PGO)

Acquisition & Assistance, Branch II, Team I

2920 Brandywine Road

Atlanta, GA 30341-5539

Approved as to Form and Legality: _____________________________

NOTE: In sealed bid solicitations “offer” and “offeror” mean “bid” and “bidder.”

SOLICITATION

9. Sealed offers in original and 3 copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in address in block 7., mailroom 1110 until

3:30PM

local time 06/25/2012 CAUTION -- LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME

Jeff Miller

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(770) 488-2651

C. E-MAIL ADDRESS

afx2@cdc.gov

11. TABLE OF CONTENTS

(x)

DESCRIPTION

(x)

DESCRIPTION

X

OFFER (Must be fully completed by offeror)

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52-232-8)

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

CODE

FACILITY

16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED

20. AMOUNT

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

ITEM

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

IMPORTANT -- Award will be made on this form, or on Standard Form 26, or by other authorized official written notice.

AUTHORIZED FOR LOCAL REPRODUCTION

STANDARD FORM 33 (REV. 9-97)

PREVIOUS EDITION IS UNUSABLE

Prescribed by GSA

FAR (48 CFR) 53.214©

Section B - Supplies Or Services And Prices/Costs

Base Period: 9/1/2012 – 8/31/2013

ITEM

Contractor shall provide all labor, supervision, equipment, materials, supplies, travel, transportation, and perform all work necessary to provide public health, scientific, and technical services in support of advancing vaccine safety activities, as specifically required under individual Task Orders under the resulting contract.

Option Period I: 9/1/2013 – 8/31/2014

ITEM

Contractor shall provide all labor, supervision, equipment, materials, supplies, travel, transportation, and perform all work necessary to provide public health, scientific, and technical services in support of advancing vaccine safety activities, as specifically required under individual Task Orders under the resulting contract.

Option Period II: 9/1/2014 – 8/31/2015

ITEM

Contractor shall provide all labor, supervision, equipment, materials, supplies, travel, transportation, and perform all work necessary to provide public health, scientific, and technical services in support of advancing vaccine safety activities, as specifically required under individual Task Orders under the resulting contract.

Option Period III: 9/1/2015 – 8/31/2016

ITEM

Contractor shall provide all labor, supervision, equipment, materials, supplies, travel, transportation, and perform all work necessary to provide public health, scientific, and technical services in support of advancing vaccine safety activities, as specifically required under individual Task Orders under the resulting contract.

Option Period IV: 9/1/2016 – 8/31/2017

ITEM

Contractor shall provide all labor, supervision, equipment, materials, supplies, travel, transportation, and perform all work necessary to provide public health, scientific, and technical services in support of advancing vaccine safety activities, as specifically required under individual Task Orders under the resulting contract.

Option Period V: 9/1/2017 – 8/31/2018

ITEM

Contractor shall provide all labor, supervision, equipment, materials, supplies, travel, transportation, and perform all work necessary to provide public health, scientific, and technical services in support of advancing vaccine safety activities, as specifically required under individual Task Orders under the resulting contract.

Option Period VI: 9/1/2018 – 8/31/2019

ITEM

Contractor shall provide all labor, supervision, equipment, materials, supplies, travel, transportation, and perform all work necessary to provide public health, scientific, and technical services in support of advancing vaccine safety activities, as specifically required under individual Task Orders under the resulting contract.

Option Period VII: 9/1/2019 – 8/31/2020

ITEM

Contractor shall provide all labor, supervision, equipment, materials, supplies, travel, transportation, and perform all work necessary to provide public health, scientific, and technical services in support of advancing vaccine safety activities, as specifically required under individual Task Orders under the resulting contract.

Option Period VIII: 9/1/2020 – 8/31/2021

ITEM

Contractor shall provide all labor, supervision, equipment, materials, supplies, travel, transportation, and perform all work necessary to provide public health, scientific, and technical services in support of advancing vaccine safety activities, as specifically required under individual Task Orders under the resulting contract.

Option Period IX: 9/1/2021 – 8/31/2022

ITEM

Contractor shall provide all labor, supervision, equipment, materials, supplies, travel, transportation, and perform all work necessary to provide public health, scientific, and technical services in support of advancing vaccine safety activities, as specifically required under individual Task Orders under the resulting contract.

B.1 GENERAL

The purpose of this indefinite delivery, indefinite quantity (IDIQ) contract is to provide the Centers for Disease Control and Prevention (CDC), National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Division of Healthcare Quality Promotion (DHQP), Immunization Safety Office (ISO), an “as needed” mechanism to obtain required services through the issuance of individual task orders in support of vaccine safety monitoring and evaluation that meet public health priorities for CDC. Work performed under this contract will be based on the following technical requirements: Clinical Immunization Safety Assessment (CISA) project will be a resource to address clinical vaccine safety issues and provide a public health service to the nation. The project will also contribute to or conduct studies to answer questions about why certain individuals experience adverse events following immunization (AEFI), that are believed to be causally linked to vaccines, and how to prevent them. Results from such studies shall provide evidence to better inform vaccination practices. The awardees of the resultant contracts, independently and not as an agent of the United States Government, shall furnish personnel, facilities, supplies and equipment (except that specifically addressed within the individual task order) necessary to perform the individual Task Orders under the contract.

B.2 TASK ORDER CONTRACT

Orders for services will be placed by individual Request for Task Order Proposals (RFTOPs) under this contract in accordance with Section C.5, Technical Requirements and other applicable contract clauses.

The types and number of awards will be based on the government’s best value determinations (considering technical quality and proposed cost) of the proposals submitted. Ordering under this contract will be conducted through task orders. RFTOPs will be competed among eligible contractors in unless an exception to competition is authorized by the Contracting Officer in accordance with Federal Acquisition Regulations (FAR) 16.505.

B.3 TYPE OF CONTRACT

This is a multiple award, IDIQ type contract. At the discretion of the Contracting Officer, the government may use a variety of task order types under this contract, including Firm Fixed Price (FFP), Labor Hours (LH), Time and Materials (T&M), and Cost Plus Fixed Fee (CPFF) contracts.

Each RFTOP issued under this contract will identify the Government’s determination of task order type.

B.4 MINIMUM GUARANTEE

The contract guarantees that task orders amount to a minimum of $10,000. In the event that during its contract term the contractor receives obligations of less than this minimum, the Government will fund the difference between the actual obligation and the guaranteed minimum.

B.5 MAXIMUM CONTRACT AMOUNT

The contract ceiling amount is $50,000,000 up to a 10-year period B.6

BASE AND OPTION PERIODS

The term of this IDIQ contract is a one (1) year base period and nine (9) one-year option periods, comprising a ten (10) year ordering period if all options are exercised by the Government.

B.7

SERVICE CONTRACT ACT

The contract labor categories are considered bona fide executive, administrative, professional labor and generally exempt from the Service Contract Act. Each RFTOP will be reviewed for applicability.

B.8 CONTRACT ADMINISTRATION

Please submit any and all questions in writing to Jeff Miller at afx2@cdc.gov. All questions must be submitted in writing by e-mail no late than Wednesday, June 6, 2012.

B.9 ADDITIONAL INFORMATION

See section L for important information as to what is required to be submitted in response to this request for proposal (RFP).

Section C – Performance Work Statement C.1 Background and Need Vaccines are one of the most effective means of reducing or eliminating morbidity and mortality from selected infectious diseases.1 However, no vaccine is completely effective or safe. The licensed vaccines currently in routine use in the United States have been judged by the Food and Drug Administration (FDA), with input from its advisory committee, to be safe and effective.2 Serious adverse events following immunization (AEFI), which may or may not be causally related to vaccines, are rare. However, clinical trials may not be large enough to detect these rare events and AEFI may not be observed until the vaccine is widely used in populations after clinical trials are complete.3 Similarly, special populations, such as persons with autoimmune diseases or immunodeficiency, may be excluded from or not be adequately represented in clinical trials; AEFI in these populations may not be detected until after licensure.

A comprehensive vaccine safety system exists in the United States.4 The Centers for Disease Control and Prevention’s (CDC) Immunization Safety Office (ISO) and FDA co-manage the Vaccine Adverse Event Reporting System (VAERS).4,5 The main goal of VAERS is to identify potential vaccine safety problems (“signals”) that can be further assessed in other systems, such as CDC’s Vaccine Safety Datalink.6 The VAERS form collects information on demographics, health history, vaccine(s) received, and signs and symptoms of the adverse events experienced.5 Information from the reports is entered into a database that is maintained by the VAERS contractor. Medical records are requested for non-manufacturer reports coded as serious (i.e., death, life-threatening, hospitalization, prolongation of hospitalization or permanent disability) and for other reports of interest.

Consistent with good pharmacovigilance practices, CDC and FDA staff review and analyze VAERS reports at the individual and aggregate levels.7 While aggregate analysis is especially useful to look for disproportionate reporting patterns, the International Society of Pharmacoepidemiology (ISPE) has stated that “careful descriptions of relevant clinical features in published case reports can contribute to the growth in understanding about the safety of medical products.”8 Information from individual case reviews contributes to the understanding of biologic mechanisms for AEFI and may also help generate and refine hypotheses about risk factors for AEFI that could be further studied. In a recent report from the Institute of Medicine (IOM), information from published case reviews of AEFI helped provide mechanistic evidence for causality assessments.9

To advance knowledge of vaccine safety and inform clinical and public health practice, high quality epidemiological and clinical research is also essential. CDC’s Immunization Safety Office Scientific Agenda highlights several vaccine safety research needs10 and new research needs continue to emerge. Studies are needed to identify risk factors for AEFI, including host and genomic risk factors, especially in vulnerable populations. In addition, studies are needed to identify and evaluate preventive strategies for AEFI. It is essential for vaccine safety infrastructure to keep pace with new research and development technologies in vaccinology, as well as advances in the fields of genomics and biomarkers. Having a project that facilitates CDC’s collaboration with vaccine safety researchers at prominent academic medical centers or health care institutions strengthens national capacity for innovative vaccine safety research.

Educating and assisting healthcare providers who assess patients who may have AEFI is also important. Healthcare providers must frequently communicate with parents and patients about the benefits and risks of vaccination and address difficult questions about vaccine safety.11 In recent years, this task has become more challenging for several reasons, including a more complex immunization schedule, heightened public attention to vaccine safety issues, and the widespread use of the internet and social networking to receive health information. CDC responds to questions about vaccine safety from healthcare providers and other constituents, including state health departments, other federal agencies, and professional societies (e.g., the American Academy of Pediatrics).12 Two primary sources of immunization inquiries to CDC have been the CDC telephone information line (1-800-CDC-INFO/1-800-232-4636) and the CDC vaccine e-mail account (nipinfo@cdc.gov [NIPINFO is the commonly used term for the National Immunization Program]).1,3,5 ISO is referred complex vaccine safety inquires that cannot be addressed by the experienced NIPINFO staff who respond to these vaccine queries. Inquiries may also come directly to ISO staff, particularly from state health departments. Since 2002, ISO has maintained an inquiry tracking system for vaccine safety inquiries.12 While the most common reason for inquires during 2002-2009 was to address questions about VAERS data, 21% of the inquires ISO received during this time period were for clinical advice about a vaccine safety concern.12 During this time, some of the clinical cases of AEFI received by ISO, particularly those in need of clinical advice, were referred to the Clinical Immunization Safety Assessment (CISA) Project for assessment.

Mission

The overall mission of the Clinical Immunization Safety Assessment (CISA) Project is to improve understanding of adverse events following immunization (AEFI) at the individual-patient level.

Goals

1) To serve as a vaccine safety resource for consultation on clinical vaccine safety issues, including individual case reviews, and assist with immunization decision-making

2) To assist CDC in developing strategies to assess individuals who may be at increased risk for AEFI

3) To conduct and contribute to studies to identify risk factors and preventive strategies for AEFI, particularly in special populations

C.2 Project Objective

CDC seeks to re-establish the CISA Project to improve vaccine safety at the individual-patient level. The proposed CISA Project builds on the experience of the previous CISA network. which has been in place since 2002.13 The scope of the new CISA project is responsive to recommendations from a 2010 external program review of the previous CISA network14 and aligns with objectives in the US 2010 National Vaccine Plan.15 The purpose of this CISA Project indefinite delivery, indefinite quantity (IDIQ) contract is to provide the CDC’s Division of Health Care Quality Promotion (DHQP), Immunization Safety Office (ISO) with an “as needed” mechanism to obtain required services, including an ongoing service for expert consultation, through the issuance of individual Task Orders. These Task Orders would support vaccine safety monitoring and evaluation that meet public health needs for CDC. CDC may make multiple awards to contract with certain organizations (e.g., academic centers or health plans) in the United States. The CISA Project will be a resource to address clinical vaccine safety issues and provide a public health service to the nation. The project will also contribute to or conduct studies to answer questions about why certain individuals experience AEFI that may be causally linked to vaccines, and how to prevent them. Results from such studies shall provide evidence to better inform vaccination practices.

C.3 Scope of Work

The Contractor shall provide all labor, supervision, equipment, materials, supplies, travel, transportation, and perform all work necessary to provide public health, scientific, and technical services in support of advancing vaccine safety activities, as specifically required under individual Task Orders under this contract.

The two main requirements for this CISA IDIQ contract include:

1. Clinical case reviews and evaluation of vaccine safety issues, and coordination activities to support this function.

2. Research studies to advance knowledge of vaccine safety and inform clinical and public health practices.

C.4 Technical Requirements

C.4.1 - Requirement 1: Clinical case reviews and evaluation of vaccine safety issues, and coordination activities to support this function.

As specified in individual Task Orders, the Contractor may conduct work under this technical requirement. Work will include all activities, as identified by the Government, regarding vaccine safety. Under this requirement, Contractors may participate in clinical review and evaluation activities conducted within the CISA Project.

The Contractor may conduct clinical reviews of vaccine safety cases to assist the Government in responding to practicing clinicians and/or health department personnel. The Contractor may also conduct case reviews to assist the Government with surveillance for AEFI, for example by reviewing a striking case report of a novel AEFI reported to VAERS. The Contractor may also develop a systematic approach for a clinical inquiry response service, which can assist healthcare workers or public health professionals who have vaccine safety questions. The Contractor should be capable of evaluating vaccine safety cases and issues that affect children and adults.

The Contractor may provide a synthesis of the clinical case reviews, and other emerging vaccine safety issues. This work may lead to a broader understanding of vaccine safety issues and inform clinical or public health practices. For example, the Contractor may be asked to assist CDC to synthesize vaccine safety evidence for the Advisory Committee on Immunization Practices (ACIP).16 The Contractors may also help to generate and refine hypotheses on risk factors for AEFI that are in need of further study.

The Contractor may provide clinical expertise in various disciplines. In this capacity, the Contractor may need input from experts who can participate in the clinical review, synthesis and evaluation activities. In addition to knowledge of vaccine safety, examples of the areas of expertise include pediatrics, internal medicine, allergy, neurology, and obstetrics and gynecology. The Contractor may also provide selected subject matter expertise to CDC for other ongoing activities regarding vaccine safety.

Examples of other activities that Contractors may be asked to undertake as part of this clinical evaluation requirement include: 1) Developing vaccine safety algorithms to assist practicing clinicians in the assessment and management of patients with vaccine safety concerns; 2) Facilitating biological specimen collection and transfer from individuals who experienced serious AEFI, to a specified biological repository; 3) Identifying and contacting individuals with AEFIs who were identified through VAERS or other sources, to obtain consent and enroll them for participation in vaccine safety studies supported by the Government (the contractor may or may not be a co-investigator in these studies).

The Contractors may also develop an Emergency Response plan. This plan will outline activities to rapidly support enhanced vaccine safety clinical case reviews and evaluation activities, in the case of an urgent public health incident or emergency situation necessitating implementation of an emergency vaccination program. For example, in 2009-10 CISA conducted clinical case reviews of AEFI to support the US emergency response to H1N1 pandemic influenza.13,17 In the event of an emergency, Task Orders may be issued to Contractors for the execution of the Emergency Response plan.

The Contractor may conduct activities that support the management and development of the clinical requirement within CISA as specified in the applicable Task Orders. Examples of such services include logistical activities needed to prepare cases for presentation to clinical working groups (e.g., coordinating schedules for subject matter expert participation); clinical case tracking; organizing phone conferences and preparing minutes; providing cost reports; maintaining a secure internal website. The Contractor may also provide the appropriate facilities, data management, and other equipment necessary for conducting this requirement. This includes the appropriate office facilities, record keeping, disaster recovery plans, computer hardware and software, communication, and conferencing equipment.

Deliverables: to be specified within specific Task Orders

C.4.2 Requirement 2: Research studies to advance knowledge of vaccine safety and inform clinical and public health practice

As specified in individual Task Orders, the Contractor may conduct work under this technical requirement. The Contractor shall perform all work necessary to develop, conduct and/or participate in research studies, as specifically required under individual Task Orders under this contract. The Contractor may lead or participate as co-investigators in research conducted for single or multi-site studies, which meet CDC’s public health vaccine safety needs. The project period for these studies may be up to ten years. CDC may elect to issue two types of Task Orders for some studies: 1) Contractor to lead the study and, 2) Contractor(s) to contribute data and / or participate as co-investigators in the study. Studies may seek to identify risk factors for AEFI, including host and genetic risk factors, particularly in special populations that may be at increased risk for vaccine preventable disease or AEFI. Studies may also assess the safety of newly licensed or recommended vaccines or evaluate strategies to prevent AEFI.

Under this contract requirement, Contractors may conduct all activities that would support the management and development of this research requirement within CISA as required in the applicable Task Orders. Activities include those directly related to conduct of the study such as enrolling patients, collecting patient data (including biological specimens), and analyzing data. In addition, the Contractor may obtain Institutional Review Board (IRB) documentation, organize phone conferences and meetings, prepare minutes, and provide cost reports to CDC. The Contractor may also provide the appropriate facilities, data management, and other equipment necessary for conducting this requirement. This includes the appropriate office facilities, record keeping, disaster recovery plans, computer hardware and software, communication, and conferencing equipment.

Deliverables: to be specified within specific Task Orders

C.5 Place of Performance

Services will be performed at vendor specified site in the United States (50 states or the District of Columbia). All aspects of work related to this contract must be performed in the U.S.; this includes work performed by the Contractor and any sub-Contractors. Under the technical input from CDC, internationally based subject matter experts may participate in specified discussions.

C.6 Reporting Schedule

The Contractor’s reporting requirements will be defined in each individual Task Order. Reports may include weekly, monthly, or quarterly reports, along with a final report.

C.7 Travel

Any required travel will be identified on individual Task Orders as necessary. The Contractor shall coordinate all travel requirements with the CDC Contracting Officer’s Representative (COR) and obtain written approval from the Contracting Officer prior to beginning such travel.

The Government will reimburse the Contractor for travel related costs. The Contractor shall submit receipts for airfare, lodging, car rentals, and other incidental travel-related expenses. Travel costs shall not exceed the maximum per diem rates set forth in the Federal Travel Regulation (FTR). The Federal Travel Regulation per diem rates and regulations can be found at the following website: http://www.gsa.gov/portal/category/21287 C.8 Training

The Contractor, at its own expense, shall perform training for their professional staff associated with required competencies for each Task Order. The Government shall be responsible to provide orientation and training on specific department, unit, site, programs or education requirements, policies, and procedures peculiar to the work to be performed by the Contractor and unique to CDC operations if required for specific Task Orders and approved in advance by the Contracting Officer and the COR. The Government will not authorize training for Contractor employees to attend seminars, symposiums, or user group conferences unless determined that attendance is mandatory or deemed likely to enhance the performance of Task Order requirements and such training is approved in advance by the Contracting Officer. The Contractor shall assume full responsibility for keeping Contractor professional employees abreast of advances in relevant state-of-the-art technologies.

C.9 Special Considerations These shall be specified as applicable on an individual Task Order basis:

C.9.1 Vaccine Adverse Event Reporting System (VAERS) Access for Clinical Evaluation and Research

a. Some Task Orders may require the Contractor to have access to data and information from VAERS. The VAERS public site is located at: http://vaers.hhs.gov/index. When applicable, the Contractor shall identify essential staff that need routine access to VAERS reports and records with personal identifiers. The Contractors will coordinate with CDC to obtain the VAERS Virtual Private Network (VPN) access. The VAERS VPN is an internal government service. The Contractor will provide essential staff of the CISA project access to select reports of VAERS reports.

b. The VAERS VPN allows authorized users to establish a secure connection to the VAERS application. The VAERS VPN provides a secure computer network that uses the Internet to allow remote offices or individual users with secure access to the VAERS application and database. Access would be limited to a subset of the VAERS reports stored in the VAERS data repository, including text and images. CDC would provide the VAERS’s Contractor with a listing of VAERS reports / VAERS ID’s to be flagged for CISA access. Access would be modeled after the current read-only access by the Government, and should provide the CISA Project participants with the ability to:

1. Search for reports by VAERS ID, Patient First and Last Name, Date Range, and Vaccine Type; and

2. View the all of the available VAERS report information, including images of the associated documents.

c. The Contractors will coordinate with CDC to obtain the VAERS Virtual Private Network (VPN) access and provide essential staff of the CISA Project access to select reports of VAERS reports.

d. The Contractor may have access to the CDC’s VAERS external search tool. This tool will allow the Contractor to search the database, and is particularly useful for conducting aggregate case analyses for more than one AEFI. For example this tool may be used to search for all reported cases of anaphylaxis after influenza vaccine. Note: This database is similar to the database used by the CDC staff and is not publically available. The limitations of VAERS will apply, see http://vaers.hhs.gov/data/index

e. The Contractor shall meet Government security requirements for access to the VAERS system, and have signed appropriate data use and privacy agreements for the Government and for VAERS. The Contractor’s staff shall complete the VAERS rules of behavior form. They may be provided with authorization for access to the VAERS VPN, once this is completed.

f. The Contractor shall comply with the safeguarding procedures for report forms, records, and electronic data as required by the National Childhood Vaccine Injury Act (NCVIA) - 42 U.S.C. 300aa-25, and the provisions of the Privacy Act’s Epidemiologic Studies and Surveillance of Disease Problems System Notice 09-20-0136. The Contractor shall maintain a system to ensure that information which could identify an individual (such as name, street address, telephone number of the person who received the vaccine and that person’s legal representative) shall not be made available to any person, except the duly authorized staff of CDC, FDA and other participating federal entities. The restriction on access to identifying information applies to all information received from the VAERS activity, regardless of physical form (paper, electronic, other).

C.9.2 Human Research Protection

a. All Contractors and sub-Contractors involved in research studies must adhere to federal and institutional polices for human subjects protection. Information on the federal policy can be found at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

C.9.3 CDC Scientific Review and Clearance

a. All Contractors and sub-Contractors must adhere to CDC policies for scientific review and clearance of protocols, abstracts, and manuscripts. Information on this policy can be found at: http://www.cdc.gov/maso/Policy/PublicUse.pdf C.9.4 Assurance of Confidentiality Section 308(d)

a. In the event an Assurance of Confidentiality is needed, which is covered by Section 308(d) of the Public Health Service Act (42 U.S.C. 242m), the Contractor shall complete such an agreement. Information can be found at: http://www.law.cornell.edu/uscode/text/42/242m.

C.9.5 Rehabilitation ACT

a. Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, and the Architectural and Transportation Barriers Compliance Board’s Electronic and Information (EIT) Accessibility provisions (36 CFR part 1194), require that, unless an exception applies, all Electronic and Information products and services developed, acquired, maintained, or used by any Federal department or agency permit:(1) Federal employees with disabilities to have access to and use information and data that is comparable to the access and use of information and data by Federal employees who are not individuals with disabilities; and (2) Members of the public with disabilities seeking information or services from a Federal agency to have access to and use of information and data that is comparable to the access and use of information and data by members of the public who are not individuals with disabilities.

C.9.6 Information Security and Confidentiality

In addition to the specifications in HHS Acquisition Regulation (HHSAR) 352.239-70, 352.239-71, 352.239-72, in Section H, the Contractor should adhere to the following CDC’s National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) specifications regarding informational technology, security, and privacy.

Addition to HHSAR 352.239-72 (c) (1) (i) (B):

The Contractor shall identify and document appropriate types of information for Federal Information Systems/applications using NIST SP 800-60, Guide for Mapping Types of Information and Information Systems to Security Categories Vol.1 and Vol. 2.

Addition to HHSAR 352.239-72 (c) (4) (i):

Appropriate security templates will be provided to the Contractor by the NCEZID’s Security Staff. Completed documents will be sent to the CDC Chief Information Security Officer (CISO) for review, approval and subsequent issuance of an Authority To Operate (ATO)

· Baseline System Information (BSI)

· Privacy Impact Assessment (PIA)

· Host Characterization Worksheet (HCW)

· System Security Plan (SSP)

· Security Baseline Worksheet (SBW)

· Business Continuity Plan (BCP)

· Risk Assessment Report (RAR)

Addition to HHSAR 352.239-72:

The following security associated requirements applies to the Contractor:

(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 Contractor will be required to submit a roster of all staff (including sub-Contractor staff) working under the Contractor that will have the ability to access NCEZID sensitive information from the system. The roster shall be submitted to the Project Officer/ Technical Monitor, with a copy to the Contracting Officer, within 14 calendar days of the effective date of the contract. Any revisions to the roster as a result of staffing changes shall be submitted within 15 calendar days of the change. The Contracting Officer shall notify the Contractor of the appropriate level of suitability investigations to be performed, but the Contractor’s employees and subcontractors who have met investigative requirements within the last five years may only require an updated or upgraded investigation. An electronic template, “Roster of Employees Requiring Suitability Investigations,” is available for Contractor use at: http://ais.nci.nih.gov/forms/Suitability-roster.xls. Upon receipt of the Government’s notification of applicable suitability investigations required, the Contractor shall complete and submit the required forms within 30 days of the notification.

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 Contractor 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.

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

3) 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

The Contractor in conjunction with CDC Center ISSO shall conduct and maintain an initial Privacy Impact Assessment (PIA) as defined by Section 208 of the E-Government Act of 2002. Periodic reviews shall be conducted by the system owner, with assistance from the CDC Center Information System Security Officer (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 the provider’s name and title of its official who will be responsible for all information security requirements regarding this contract.

(4) Rules of Behavior

The Contractor’s employees and subcontractors shall comply with the HHS Information Technology General Rules of Behavior, available at: http://www.hhs.gov/ocio/policy/hhs-ocio-2010-0002.001s_hhs_rules_of_behavior.html

(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 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 Contractor shall maintain a listing of all individuals who have completed this training and shall submit this listing to the project officer.

C.10 Government Furnished Property / Information To be specified on individual Task Orders.

C.11 CISA BASIC PERFORMANCE WORK STATEMENT REFERENCES

1. Salmon D, Pavia A, Gellin B. Editor’s Introduction: Vaccine Safety throughout the Product’s Life Cycle. Pediatrics;2011; May;127 Suppl 1:S1-4. Epub 2011 Apr 18, available at http://pediatrics.aappublications.org/content/127/Supplement_1/S1.full, accessed on February 29, 2012

2. Marshall V and Baylor N. Food and Drug Administration Regulation and Evaluation of Vaccines, Pediatrics;2011; May;127 Suppl 1:S23-30. Epub 2011 Apr 18, available at http://pediatrics.aappublications.org/content/early/2011/04/18/peds.2010-1722E.full.pdf+html, accessed on February 29, 2012

3. Ball R, Horne D, Izuriet H et al. Statistical, Epidemiologic, and Risk Assessment Approaches to Evaluating Safety of Vaccines throughout the lifecycle at the Food and Drug Administration, Pediatrics;2011; May;127 Suppl 1:S31-8. Epub 2011 Apr 18, available at http://pediatrics.aappublications.org/content/127/Supplement_1/S31.full, accessed on February 29, 2012

4. Zhou, W, Pool V, Iskander J et al. Surveillance for Safety After Immunization: Vaccine Adverse Event Reporting System (VAERS) --- United States, 1991--2001. Morbidity and Mortality Weekly Report (MMWR). January 24, 2003 / 52(ss01);1-24, available at http://www.cdc.gov/mmwr/preview/mmwrhtmL/ss5201a1.htm, accessed on February 29, 2012

5. HHS, Vaccine Adverse Event Reporting System, available at http://vaers.hhs.gov/index, accessed on October 16, 2011

6. Baggs J, Gee J, Lewis E et al. The Vaccine Safety Datalink: A Model for Monitoring Immunization Safety, Pediatrics;2011; May;127 Suppl 1:S45-53. Epub 2011 Apr 18, available at http://pediatrics.aappublications.org/content/127/Supplement_1/S45.long, accessed on February 29, 2012

7. Food and Drug Administration. Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment, March 2005, available at http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdf, accessed on March 5th, 2012

8. Kelly WN, Arellena FM, Barnes J et al. Guidelines for submitting adverse event reports for publication, Pharmacoepidemiology and drug safety 2007; 16: 581–587, available at www.pharmacoepi.org/resources/pds1399.pdf, accessed on February 29, 2012

9. Institute of Medicine (IOM). Adverse Effects of Vaccines: Evidence and Causality, Released August 25, 2011, available at http://www.iom.edu/Reports/2011/Adverse-Effects-of-Vaccines-Evidence-and-Causality.aspx, accessed on October 16, 2011.

10. Centers for Disease Control and Prevention’s Immunization Safety Office Scientific Agenda, available at http://www.cdc.gov/vaccinesafety/Activities/agenda.html, accessed on January 15, 2012

11. American Academy of Pediatrics Immunization, available at http://www.aap.org/immunization/, accessed on October 16, 2011.

12. Miller, E, Batten B, Hampton L, Tracking Vaccine Safety Inquiries to Detect Signals and Monitor Public Concerns. Pediatrics;2011;127;S1, originally published April 18, 2011, available at http://pediatrics.aappublications.org/content/early/2011/04/18/peds.2010-1722M.abstract

13. LaRussa P et al. Understanding the Role of Human Variation in Vaccine Adverse Events: The Clinical Immunization Safety Assessment (CISA) Network. Pediatrics. 2011 May;127 Suppl 1:S65-73, available at http://pediatrics.aappublications.org/content/127/Supplement_1/S65.long, accessed on February 29, 2012

14. CDC Executive Summary: External Peer Review of the Clinical Immunization Safety Assessment (CISA) Network, Immunization Safety Office, Division of Healthcare Quality Promotion December 9-10, 2010, Atlanta, Georgia, available at http://www.cdc.gov/vaccinesafety/00_pdf/CISA-exec-summary-peer-review-june2011.pd, accessed on October 16, 2011.

15. US Department of Health and Human Services. 2010 National Vaccine Plan, available at http://www.hhs.gov/nvpo/vacc_plan/2010%20Plan/nationalvaccineplan.pdf, accessed on October 16, 2011.

16. CDC, Advisory Committee on Immunization Practices (ACIP), available at http://www.cdc.gov/vaccines/recs/acip/, accessed on January 27, 2012.

17. Salmon D, Akhtar A, Mergler M et al. Immunization-Safety Monitoring Systems for the 2009 H1N1 Monovalent Influenza Vaccination Program. Pediatrics 2011; 127:S78-S86, available at http://pediatrics.aappublications.org/content/127/Supplement_1/S78.full, accessed on February 29, 2012 Section D - Packaging And Marking

There are no clauses/provisions included in this section.

Section E - Inspection And Acceptance E.1 Inspection and Acceptance (Jul 1999)

Inspection and acceptance of the articles, services, and documentation called for herein shall be accomplished by the Contracting Officer, or his duly authorized representative (who for the purposes of this contract shall be the Project Officer) at the destination of the articles, services or documentation.

(End of Clause)

Section F - Deliveries Or Performance

F.1 Deliverable(s) Schedule (Jul 1999)

Deliverables requirements will be as set forth in individual task orders.

(End of Clause)

F.2 Period of Performance (Task/Delivery Order Contracts) (Jul 1999)

(a) Contract: The term of this IDIQ contract is a one (1) year base period and nine (9) one-year option periods, comprising a ten (10) year ordering period if all options are exercised by the Government.

(b) Task Orders: The time for completion for each task or delivery order shall be determined under each individual task or delivery order through the mutual agreement of the parties involved. Task/delivery orders under this contract may be awarded by the Contracting Officer at any time within the contract period. The actual performance of the work shall not extend more than 6 months beyond the basic contract period of performance.

F.3 Place(s) of Performance (Jul 1999)

The Contractor shall perform all work under this contract at the contractor’s facilities.

(End of Clause)

Section G - Contract Administration Data

G.1 Evaluation of Contractor Performance (Service) (Jan 2000)

(a) Purpose

In accordance with FAR 42.1502, the Contractor's performance will be periodically evaluated by the Government, in order to provide current information for source selection purposes. These evaluations will therefore be marked “Source Selection Information.”

(b) Performance Evaluation Period

The Contractor's performance will be evaluated at least annually.

(c) Evaluators

The performance evaluation will be completed jointly by the Project officer and the Contracting officer.

(d) Performance Evaluation Factors

The contractor's performance will be evaluated in accordance with the attachment listed in Section J titled Performance Evaluation Report.

(e) Contractor Review

A copy of the evaluation will be provided to the contractor as soon as practicable after completion of the evaluation. The contractor shall submit comments, rebutting statements, or additional information to the Contracting Officer within 30 calendar days after receipt of the evaluation.

(f) Resolving Disagreements Between the Government and the Contractor

Disagreements between the parties regarding the evaluation will be reviewed at a level above the Contracting Officer. The ultimate conclusion on the performance evaluation is a decision of the contracting agency. Copies of the evaluation, contractor's response, and review comments, if any, will be retained as part of the evaluation.

(g) Release of Contractor Performance Evaluation Information

The completed evaluation will not be released to other than Government personnel and the contractor whose performance is being evaluated. Disclosure of such information could cause harm both to the commercial interest of the Government and to the competitive position of the contractor being evaluated as well as impede the efficiency of Government operations.

(h) Source Selection Information

Departments and agencies may share past performance information with other Government departments and agencies when requested to support future award decisions. The information may be provided through interview and/or by sending the evaluation and comment document to the requesting source selection official.

(i) Retention Period

The agency will retain past performance information for a maximum period of three years after completion of contract performance for the purpose of providing source selection information for future contract awards.

(End of Clause)

G.2 Payment by Electronic Funds Transfer (Dec 2005)

(a) The Government shall use electronic funds transfer to the maximum extent possible when making payments under this contract. FAR 52.232-33, Payment by Electronic Funds Transfer – Central Contractor Registration, in Section I, requires the contractor to designate in writing a financial institution for receipt of electronic funds transfer payments.

(b) In addition to Central Contractor Registration, the contractor shall make the designation by submitting the form titled “ACH Vendor/Miscellaneous Payment Enrollment Form” to the address indicated below. Note: The form is either attached to this contract (see Section J, List of Attachments) or may be obtained by contacting the Contracting Officer or the CDC Financial Management Office at (404) 498-4050.

(c) In cases where the contractor has previously provided such designation, i.e., pursuant to a prior contract/order, and been enrolled in the program, the form is not required unless the designated financial institution has changed.

(d) The completed form shall be mailed after award, but no later than 14 calendar days before an invoice is submitted, to the following address:

The Centers for Disease Control and Prevention

Financial Management Office (FMO)

P.O. Box 15580

Atlanta, GA 30333

Or – Fax copy to: 404-638-5342

G.3 Electronic Subcontracting…