A19. Request for Proposal 75D301 22R 72305_VSD IDIQ F.docx

SOLICITATION, OFFER AND AWARDPAGES

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

2. CONTRACT NO.

75D301D

3. SOLICITATION NO.

75D301-22-R-72305

07/11/2022

6. REQUISITION/PURCHASE NO.

00HCVLDE-2022-62957

Centers for Disease Control and Prevention (CDC) Office of Acquisition Services (OAS) 2900 Woodcock Blvd, MS TCU-4 Atlanta, GA 30341-4004

Approved as to Form and Legality: _____________________________

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

SOLICITATION

(Hour)

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

Gordon D. Barritt

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(770) 488-2724

C. E-MAIL ADDRESS

ins4@cdc.gov

11. TABLE OF CONTENTS

(x)PAGE(S)

SEC.

SEC.

PAGE(S)

DESCRIPTION

(x)

DESCRIPTION

XK

REPRESENTATIONS, CERTIFICATIONS, AND

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 calendar days (60 calendar days unless a differentCALENDAR DAYS

(Type or Print)

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

18. OFFER DATE

AWARD (To be completed by Government)

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

21. ACCOUNTING AND APPROPRIATION

Centers for Disease Control and Prevention (CDC) Office of Acquisition Services (OAS) 2900 Woodcock Blvd, MS TCU-4 Atlanta, GA 30341-4004

Centers for Disease Control and Prevention (FMO) PO Box 15580 404-718-8100

Atlanta, GA 30333-0080

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.

FAR (48 CFR) 53.214©

Section B - Supplies Or Services And Prices/Costs

Vaccine safety monitoring and evaluation meeting public health priorities for CDC. Work performed will be based on VSD project infrastructure activities, active surveillance and monitoring, and Epidemiologic studies and evaluations. Ordering Period for Task Orders is 9/1/2022 - 8/31/2027. Contract Type will be determined at the Task Order Level. This CLIN is not funded. If required, this CLIN will be used to fund the Guaranteed Minimum on a fixed price basis. IDIQ amount of $5,000.00.The maximum amount for all task orders under all VSD IDIQ contracts shall not exceed $149,000,000.00 1 Job

$149,000,000.00

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. The Contractor 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 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. Unless otherwise stated, the terms, conditions, technical requirements, administrative data, and special contract requirements of the IDIQ contract are applicable to any and all task orders issued under this IDIQ.

B.3 MINIMUM GUARANTEE

The contract guarantees that task orders amount to a minimum of $5,000. 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 $149,000,000.00

B.6 Ordering Period

The IDIQ contract provides a single 5-year ordering period, during which the Government may issues task orders as needed to meet program needs. The Ordering period is September 1, 2022 – August 31, 2027. No task order may be issued with a period of performance end date later than September 29, 2029.

B.7 SERVICE CONTRACT ACT

The contract labor categories are executive, administrative, professional labor and specifically noted in the task order, are exempt from the Service Contract Act.

Section C - Description/Specification/Work Statement Title: Vaccine Safety Datalink Project

Period of Performance: 9/1/2022 – 8/31/2027

C.1 Background and Need

High vaccination coverage has significantly reduced vaccine-preventable disease morbidity and mortality worldwide, especially among children. Vaccines are generally regarded as safe and effective; however serious adverse events following immunization (AEFI) can occur. While vaccine safety is rigorously assessed during pre-licensing clinical trials, sample sizes are not adequate to detect rare adverse events, long term adverse events are not examined, and populations are not heterogeneous. In recent years, public concerns about the safety of vaccines have grown. Immunization safety programs are an important component to inform public policy and maintain the public trust in our national immunization program. Close monitoring of vaccine safety protects the public’s health and contributes to safer vaccines and vaccination practices.

The Vaccine Safety Datalink (VSD) project, created in 1990 by Centers for Disease Control and Prevention (CDC), is a post-licensure vaccine safety system that has made important contributions to addressing urgent questions about vaccine safety and other immunization-related issues and has helped inform US vaccination policy. Through its partnership with participating US managed care organizations, the VSD has adapted to a changing environment over time. Such adaptations include the development of a distributed data model and the development of dynamic data files as well as the implementation of near-real time adverse event monitoring for new vaccines. In addition, the evolution of the VSD has allowed for increase of the population under study, creation of innovative study designs and statistical methodologies, and the ability to expand to other data sources.

With the current vaccine safety contract mechanism coming to an end, the Immunization Safety Office seeks to continue to conduct rigorous vaccine safety evaluation and monitoring through a large, diverse, population-based system.

C.2 Project Objectives

The VSD Project provides the Centers for Disease Control and Prevention (CDC), Division of Healthcare Quality Promotion (DHQP), Immunization Safety Office (ISO) an “as needed” mechanism to obtain services through the issuance of task orders that support vaccine safety monitoring and evaluation, and that align with public health priorities for CDC.

1) Overview of contract requirements for the VSD Project

i. Execute awarded task orders under three technical areas:

· VSD project infrastructure activities

· Active surveillance and monitoring

· Epidemiologic studies and evaluations

2) VSD Project Objectives: The purpose of this project is to conduct vaccine safety research and surveillance. Contractors will provide a data infrastructure and expertise in which adverse events following immunization can be evaluated and can support the enhancement and development of vaccine safety methodologies. The objectives of the VSD project are divided into two categories: Scientific and Programmatic.

Scientific Project Objectives

1) Monitor and evaluate the safety of newly licensed vaccines

2) Evaluate the safety of new vaccine recommendations for existing vaccines

3) Evaluate clinical disorders following immunizations

4) Assess vaccine safety in special high-risk populations

5) Develop and evaluate methodologies for vaccine safety assessment

6) Respond to vaccine safety concerns and/or vaccine safety signals through ad-hoc analyses and studies

7) Ad hoc vaccine effectiveness studies may also be conducted

Programmatic Project Objectives

1) Create quality core data infrastructure through administrative/computerized data files and data linkages to efficiently conduct vaccine safety monitoring and evaluation

2) Ensure quality data by regularly conducting data quality and data assurance checks

3) Ensure access to additional data sources such as medical chart review, member surveys, and ad-hoc data sources

4) Establish a secure distributed data model allowing each participating contractor to maintain ownership of their data while allowing access to researchers to transfer analytic datasets and/or summarized output and to conduct vaccine safety monitoring and evaluation.

5) Ensure high quality research though a rigorous research proposal process

6) Evaluate and monitor the safety of vaccines and respond to emerging vaccine safety concerns

7) Ad hoc vaccine effectiveness studies may also be conducted

8) Participate in a data sharing program, as outlined in the National Center for Health Statistics Research Data Center’s Guidelines for Proposal Submission (https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/accessing-data.html)

C.3 Contract Structure

The basic contract will establish the general scope and ordering period for task orders to be issued against this contract. It is anticipated that multiple task orders will be issued to the contractors to work on VSD in areas identified in this Scope of Work. Each task order shall have a discrete period of performance independent of the IDIQ contract.

Individual task orders exceeding $3,000 not awarded to all contractors will be competed in accordance with the fair opportunity process described in FAR 16.505(b)(1) unless an exception to fair opportunity in documented in accordance with FAR 16.505(b)(2). All task orders will be solicited by email. Contractors will have a minimum of 10 calendar days to respond.

C.4 Scope of work

The purpose of this contract is to create and maintain a data infrastructure that will allow the Government and contractors to monitor and evaluate adverse events following vaccination.

The main requirements for this VSD IDIQ are:

1. Conduct high-quality VSD infrastructure activities that will allow for scientifically rigorous and efficient monitoring of vaccine safety

2. Conduct active surveillance and monitoring of adverse events following immunization

3. Conduct analysis of vaccine safety data through single- and multi-site studies. Ad hoc vaccine effectiveness studies may also be conducted

C.5 Technical Requirements

5.1 - Requirement 1: Conduct VSD infrastructure activities that will allow for scientifically rigorous and efficient monitoring of vaccine safety.

The contractor, as an independent organization and not as an agency of the Government, shall furnish the personnel, facilities, equipment, and supplies necessary to establish a working infrastructure to support both project support services as well as data management of VSD data files.

Under this contract requirement, contractors will conduct activities to support the management and development of work within the VSD as required in the applicable task orders. This includes all programmatic tasks that support the VSD. Examples of such work include participation on VSD conference calls, working groups, site visits, and annual meetings. It also includes management of overall project activities such as study tracking, Institutional Review Board (IRB) and Data Use Agreement (DUA) documentation as well as support for external presentation of ongoing VSD work.

In addition to program support services, creation and maintenance of a high-quality data infrastructure is considered an ongoing need of the government so that rigorous and efficient vaccine safety monitoring and evaluation can be conducted. The contractor shall establish a study population for all ages whose total medical history of health care encounters is readily accessible electronically. Data created from the study population will be organized following a standardized data dictionary in which data will be accessed through a distributed data model. Data will be available through annual data files and well as through data files that are updated on a more frequent basis (i.e., weekly or monthly). The contractor shall be responsible for maintaining the integrity of each data file on a continual basis by repeated error checking and editing procedures. The contractor shall conduct chart reviews as required by the VSD infrastructure and/or other task orders.

Deliverables: to be specified within individual task orders.

5.2 - Requirement 2: Active Surveillance and Monitoring of Adverse Events following Immunization.

Work under this requirement will include all activities, as identified by the Government, regarding the active surveillance and monitoring of adverse events following immunization. Vaccine safety active surveillance and monitoring will occur for vaccines that are recently licensed or with new immunization recommendations, as well as for specific adverse health outcomes following vaccinations of interest. Specific vaccine safety surveillance projects will be identified through surveillance task orders, but may be also implemented ad hoc, particularly to monitor adverse health outcomes that may be designated as a potential vaccine safety concern (i.e., “signal”) or in emergency situations. Surveillance protocols may be written by CDC or a task order may be issued for a protocol to be written. Additional task orders may be issued for contractors to contribute data for surveillance studies as well as for conducting chart reviews according to the written protocol.

VSD conducts near real-time monitoring for vaccines that have been recently licensed or with new recommendations called Rapid Cycle Analysis (RCA). RCA is a near real-time surveillance method that uses sequential statistical methodologies. Examples of active vaccine safety surveillance activities using RCA that may be conducted through this contract requirement include:

1. Influenza vaccine safety

2. PCV 20 vaccine safety

3. Meningococcal vaccine safety among males and females

4. COVID-19 vaccine safety

Other types of surveillance and monitoring may include screening analyses of vaccines using non-sequential statistical methodologies, outcomes-based surveillance which is surveillance of health outcomes following many vaccines, and other data mining methods. Through this requirement, it is expected that surveillance activities will be conducted in an efficient manner, including expeditious processes for IRB and DUA approvals and modifications. During the period of surveillance, response to a potential vaccine safety signal may be required. Contractors will be required to conduct signal assessment/refinement/investigation. Any contractor leading a specific surveillance analysis for which a signal arises will be required to conduct signal verification and follow-up. Contractors contributing data (participating on the surveillance analysis) in which a potential signal arises will conduct chart review as needed to provide support for signal verification and follow-up. Results shall be documented and submitted as required by applicable task orders.

Deliverables: to be specified within individual task orders.

5.3 - Requirement 3: Conduct analysis of vaccine safety data through single- and multi-site studies. Ad hoc vaccine effectiveness studies may also be conducted.

Specific studies will be initiated as individual task orders on an as-needed basis under this requirement. The contractor shall perform studies or contribute data for studies as required by applicable task orders. Vaccine safety studies may be led by the Government or a task order may be competed and awarded to one contractor to lead a study. Additional “participating site” task orders may be issued for contractors to contribute data for specific studies as well as conduct chart review.

Vaccine safety studies or studies that may support future vaccine safety studies may include automated data only (i.e., standardized data files that follow the VSD data dictionary) or may use automated data supplemented with other types of data such as additional electronic data (pharmacy, laboratory data), medical record review, interviews with patients, surveys, or clinical or laboratory information. The contractor shall evaluate new methodologies for vaccine safety as part of this requirement. Results shall be documented and submitted as required by applicable task orders. The contractor shall attend technical reviews, meetings, conference calls, and conferences as required.

Ad hoc vaccine efficacy studies may be conducted and led by the Government or a task order may be competed and awarded to one contractor to lead a study. Additional “participating site” task orders may be issued for participation for contractors to contribute data for specific studies as well as conduct chart review.

Deliverables: to be specified within individual task orders.

Section D - Packaging And Marking

There are no clauses/provisions included in this section.

Section E - Inspection And Acceptance

E.3 FAR 52.246-1 Contractor Inspection Requirements (Apr 1984)

The Contractor is responsible for performing or having performed all inspections and tests necessary to substantiate that the supplies or services furnished under this contract conform to contract requirements, including any applicable technical requirements for specified manufacturers’ parts. This clause takes precedence over any Government inspection and testing required in the contract’s specifications, except for specialized inspections or tests specified to be performed solely by the Government.

(End of Clause)

Section F - Deliveries Or Performance

Section G - Contract Administration Data

G.1 CDCP G010 Contract Communications/Correspondence (Jul 1999)

The Contractor shall identify all correspondence, reports, and other data pertinent to this contract by imprinting thereon the contract number from Page 1 of the contract.

(End of Clause)

G.2 CDCP 009 Contracting Officer (Jul 1999)

(a) The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions, or other stipulations of this contract.

(b) No information, other than that which may be contained in an authorized modification to this contract, duly issued by the Contracting Officer, which may be received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract.

(End of Clause)

G.3 CDC0_G008 Contracting Officer’s Representative (COR) (Jul 2017) Performance of the work hereunder shall be subject to the technical directions of the designated COR for this contract.

As used herein, technical directions are directions to the Contractor which fill in details, suggests possible lines of inquiry, or otherwise completes the general scope of work set forth herein. These technical directions must be within the general scope of work and may not alter the scope of work or cause changes of such a nature as to justify an adjustment in the stated contract price/cost, or any stated limitation thereof.

In the event that the Contractor believes full implementation of any of these directions may exceed the scope of the contract, he or she shall notify the originator of the technical direction and the Contracting Officer, immediately or as soon as possible, in a letter or e-mail separate of any required report(s). No technical direction, nor its fulfillment, shall alter or abrogate the rights and obligations fixed in this contract.

The Government COR is not authorized to change any of the terms and conditions of this contract. Contract changes shall be made only by the Contracting Officer by properly written modification(s) to the contract.

The Government will provide the Contractor with a copy of the COR delegation memorandum upon request.

G.4 CDC0 G018 Payment by Electronic Funds Transfer (Feb 2018)

(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 –System for Award Management, in Section I, requires the contractor to designate in writing a financial institution for receipt of electronic funds transfer payments.

(b) In the case that EFT information is not within the System of Award Management, FAR 52.232-34 requires mandatory submission of Contractor’s EFT information directly to the office designated in this contract to receive that information (hereafter: “designated office”); see below. The contractor shall submit the EFT information within 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 Office of Financial Resources at 678-475-4510.

(c) In cases where the contractor has previously provided such information, 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 Office of Financial Resources (OFR) P.O. Box 15580 Atlanta, GA 30333 Or – Fax copy to: 404-638-5342 (End of Clause)

C.5. CDCA_G01101 Contractor Billing Instructions for Cost-Type Contracts (Mar 2022) The Contractor shall submit a detailed breakout of costs and supporting backup information and shall place the following signed Contractor Certification on each invoice/voucher submitted under this contract:

I certify that this voucher reflects (fill in Contractor’s name) request for reimbursement of allowable and allocable costs incurred in specific performance of work authorized under Contract (fill in contract number)/Task (fill-in task order number, if applicable), and that these costs are true and accurate to the best of my knowledge and belief.

(Original Signature of Authorized Official) Typed Name and Title of Signatory Introduction Reimbursement procedures related to negotiated cost-type contracts require that Contractors submit to the Government adequately prepared claims. The instructions that follow are provided for Contractors’ use in the preparation and submission of invoices or vouchers requesting reimbursement for work performed. The preparation of invoices or vouchers as outlined below will aid in the review and approval of claims and enable prompt payment to the Contractor.

1. Forms to Be Used In requesting reimbursement, Contractors may use the regular Government voucher form, Standard Form 1034, “Public Voucher for Purchases and Services Other Than Personal,” and Standard Form 1035, “Continuation Sheet,” or the Contractor’s own invoice form. If the Contractor desires to use the Government’s standard forms, a request for the forms should be submitted to the Contracting Officer. If the Contractor uses his own invoice, the billing must conform to the instructions set forth herein.

2. Submission of Invoices or Vouchers Will be conducted in accordance with HHSAR 352.232-71 Electronic Submission of Payment Requests

3. Preparation of Invoices or Vouchers- All invoices or vouchers must include the following information:

a. Summary of All Costs – typically inserted on the Standard Form 1034 A summary of all current costs must be shown. This summary consists of a list identifying the general categories and the amounts incurred during the period covered by the billing, together with the portion of fixed fee (if any) payable for that period. The reimbursable costs incurred and the dates of the period for which the charges are claimed must fall within the period specified in the contract.

b. Details of Costs Claimed – typically inserted on the Standard Form 1035 (continuation sheet) A detailed breakdown must be provided to substantiate the categories shown on the summary of costs. The following describes some of the categories that might appear on your billings:

(1) Direct Labor Direct Labor costs consist of salaries and wages paid for scientific, technical, and other work performed directly for the contract and pursuant to the contract terms. Labor costs, excluding fringe benefits and overtime premium pay, will be billed as follows:

List the titles and amounts for employees whose salaries or wages, or portions thereof, were charged to the contract; show the rate (or hours) worked, and amount for each individual. The cost of direct labor, which is charged directly to the contract, must be supported by time records maintained in the contractor’s office.

(2) Fringe Benefits If it is the Contractor’s established practice to treat fringe benefits as a direct cost, such costs should be billed separately as a single item.

NOTE: Fringe benefits, bonuses, etc., are usually treated as indirect costs for inclusion in the overhead pool; however, they may be treated as direct labor costs or as an “Other Direct Charge” if such treatment is in accordance with the Contractor’s established accounting procedures.

(3) Premium Pay Premium pay is the difference between the rates and amounts paid for overtime or shift work and amount normally paid on a straight time basis. Generally such pay is not included in the direct labor base and should not be included in the billing for “direct labor” unless the Contractor has consistently followed this practice in the past as a matter of policy. Premium pay of any kind unless provided for in the contract must be authorized by the Contracting Officer in advance. Billings for unauthorized premium pays have caused frequent delays in payment due to suspensions and exchange of correspondence. Citations of authorization for premium pay will avoid delays in payment. Authorized premium pay may be shown as a single item on the summary of costs. However, it must be separately itemized for each position, or job category, showing the amount, and a citation of the Contracting Officer’s letter of authorization on the continuation sheet of the invoice or voucher.

(4) Materials and Supplies Only those items, which the Contractor normally treats as “direct costs”, should be claimed under this heading. Major classifications of material only should be billed separately under appropriate classification. Items costing less than $25.00 may be listed by category of materials or supplies. Show the description and dollar amount of individual classifications. All such charges must be supported by the Contractor’s office records.

(5) Travel When authorized in the contract as a direct cost, travel costs that are directly related to specific contract performance may be billed as a direct cost. Travel cost detail should show:

(a) Name of traveler and official title,

(b) Purpose of trip,

(c) Dates of departure and return to starting point (station or airport),

(d) Transportation costs, identified as to rail, air, private automobile (including mileage and rate) and taxi.

(e) If claim for subsistence is on per diem basis, show number of days, rate and amount, as authorized in contract.1 If claim is based on actual cost of subsistence, show, on a daily basis, the amounts claimed for lodging and meals separately.

(f) Reference to Contracting Officer’s letter of authorization if required by contract.

(6) Consultant Fees Identify the consultant by name, number of days utilized, and amount of fee.

(7) Equipment Nonexpendable personal property must be specifically approved in writing by the Contracting Officer or authorized by the terms of the contract. Billing data should include a description of item, make model, quantity, unit cost, total cost, and date approved by the Contracting Officer, if applicable. A copy of the vendor’s bill may be submitted in lieu of the identifying information.

(8) Burden Pending establishment of final contract indirect cost rates for each of the Contractor’s fiscal years, the Contractor will be reimbursed based on his submittal of provisional rates as set forth in the contract. The contract may provide for more than one type of indirect cost rate, such as overhead rate, and general and administrative expense rate, in which case the direct cost bases (e.g., direct labor, total direct cost, etc.)

(9) Fixed Fee Ordinarily the fixed fee is stated in the contract as a lump sum and may be billed in the ratio of incurred costs to total estimated cost as set forth in the contract, with the final 15 percent to be billed on the final invoice or voucher. Contract terms govern the method of payments.

c. Cumulative Amount Claimed – typically inserted on Standard Form 1035 (continuation sheet) separate section/page The Contractor must show the cumulative amounts claimed by categories from the contract award date through the date of the current invoice or voucher, as well as the estimated cost to complete per category.

QUICK CHECKLIST FOR INVOICE SUBMISSION:

· Standard Forms 1034 and 1035 recommended. If submitting own forms, statement must conform to billing instructions

· Quarterly billing as a minimum

· Vouchers must be collated

· Detail of Cost Claimed

C.6. CDC0_G018 Payment by Electronic Funds Transfer (Feb 2018)-.

(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 –System for Award Management, in Section I, requires the contractor to designate in writing a financial institution for receipt of electronic funds transfer payments.

(b) In the case that EFT information is not within the System of Award Management, FAR 52.232-34 requires mandatory submission of Contractor’s EFT information directly to the office designated in this contract to receive that information (hereafter: “designated office”); see below. The contractor shall submit the EFT information within 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 Office of Financial Resources at 678-475-4510.

(c) In cases where the contractor has previously provided such information, 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 Office of Financial Resources (OFR) P.O. Box 15580 Atlanta, GA 30333 Or – Fax copy to: 404-638-5342

C.7. CDC42.0003 Billing Rates (May 2015)

(f) As defined in FAR Subpart 42.7, Billing Rate means an indirect cost rate established temporarily for interim reimbursement of incurred indirect costs. Billing rates may be adjusted as necessary pending establishment of final indirect rates

(g) Notwithstanding the provisions of the clause entitled Allowable Cost and Payment (FAR 52.216-7), allowable indirect costs under this contract shall be determined by applying the following provisional billing rates to the bases specified below:

TYPE EFFECTIVE PERIOD (FROM - TO) RATE LOCATION APPLICABLE TO BASE

Bases: (1)

(h) The above rates are provisional billing rates only and shall apply from the date of award until such time as the rates are revised by modification. Any modification to change the above rates will also state the effective period covered by the revised rates.

(i) Billing rates may be prospectively or retroactively revised by mutual agreement of the Contracting Officer and the contractor at either party’s request. When agreement cannot be reached, the billing rates may be unilaterally determined by the Contracting Officer as set forth in FAR 42.704.

(j) Final indirect rates shall be established in accordance with FAR Clause 52.216-7, Allowable Cost and Payment. As required by that clause, the contractor shall submit an adequate final indirect cost rate proposal to the Contracting Officer and auditor within the 6 month period following the expiration of each of its fiscal years. Upon receipt of the final indirect cost rate proposal and pending the establishment of final indirect cost rates, the contractor and the Government may mutually agree to revise the provisional billing rates to reflect the proposed indirect cost rates until the proposal has been audited and settled.

C.8. HHSR 352.232-71 Electronic Submission of Payment Requests

(a) Definitions. As used in this clause— Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

(End of Clause)

Section H - Special Contract Requirements Electronic and Information Technology Accessibility Notice

(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 Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/standards.htm.

(c) The Section 508 accessibility standards applicable to this contract are: 1194.

205 WCAG 2.0 Level A & AA Success Criteria 302 Functional Performance Criteria 502 Inoperability with Assistive Technology 503 Applications 504 Authoring Tools 602 Support Documentation 603 Support Services

In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and documentation detail - whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(e) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

Additional Requirement – 1: Human Subjects Requirements If the proposed project involves research on human subjects, the applicant must comply with the Department of Health and Human Services (DHHS) Regulations (Title 45 Code of Federal Regulations Part 46) regarding the protection of human research subjects, unless that research is exempt as specified in the regulation (45 CFR 46.104). All awardees of CDC grants and cooperative agreements and their performance sites engaged in research involving human subjects must obtain (1) Federal wide Assurance (FWA) of compliance with the Regulations, and (2) initial and continuing approval of the research by an appropriately constituted and registered institutional review board (IRB) unless exempt from continuing review (45 CFR 46.109(f)).

An FWA is required for all applicants conducting human subjects research, regardless of whether the research is subject to the U.S. Federal Policy for the Protection of Human Subjects (also known as the Common Rule). An institution must have a valid FWA to receive HHS support for research involving human subjects. Each FWA must designate at least one IRB registered with the Office for Human Research Protections (OHRP). Before obtaining an FWA, an institution must either register its own IRB (an “internal” IRB) or designate an already registered IRB operated by another organization.

In order to obtain a FWA for the Protection of Human Subjects, the applicant must complete an on-line application at the Office for Human Research Protections (OHRP) website or write to the OHRP for an application.

To obtain a FWA, or for more information, contact the OHRP at: https://www.hhs.gov/ohrp.

Institutions must submit all FWAs, including new FWAs, electronically using the electronic submission system available through the OHRP website, unless an institution lacks the ability to do so electronically. If an institution believes it lacks the ability to submit its FWA electronically, it must contact OHRP by telephone or email (see https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/contact/index.html) and explain why it was unable to submit its FWA electronically.

If an Institution lacks the ability to submit its FWA electronically, after consulting with OHRP, it must send the FWA application to OHRP in writing, by: FAX ((240)453-6909; email (IRB@hhs.gov or FWA@hhs.gov); or mail (Division of Policy and Assurances, Office for Human Research Protections, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852).

Note: In addition to other applicable committees, Indian Health Service (IHS) institutional review committees must also review the project if any component of IHS will be involved with or will support the research. If any American Indian community is involved, its tribal government must also approve the applicable portion of that project.

C.6 IT Security

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

Security Compliance

· If the contractor will host or create an information system on behalf of the CDC, provide IT services to the CDC, or provide IT products to the CDC, then the contractor shall comply with the applicable IT security references below (Standards 1 - 4).

· If the contract is the vendor to provide the products as hardware and/or software to CDC, the vendor shall comply with the applicable IT security references Standards 1, 2, and 5.

Standard-1: Procurements Requiring Information Security and/or Physical Access Security

1. Baseline Security Requirements

1) Applicability. The requirements herein apply whether the entire contract or order (hereafter “contract”), or portion thereof, includes either or both of the following:

a. Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) employee will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information.

b. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor) employee will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of “information technology” (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

2) Safeguarding Information and Information Systems. In accordance with the Federal Information Processing Standards Publication (FIPS)199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor (and/or any subcontractor) shall:

a. Protect government information and information systems in order to ensure:

· Confidentiality, which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;

· Integrity, which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and

· Availability, which means ensuring timely and reliable access to and use of information.

b. Provide security for any Contractor systems, and information contained therein, connected to an HHS network or operated by the Contractor on behalf of HHS regardless of location. In addition, if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less, bring the situation to the attention of the other party.

c. Adopt and implement the policies, procedures, controls, and standards required by the HHS Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain the HHS Information Security Program security requirements, outlined in the HHS Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing fisma@hhs.gov.

d. Comply with the Privacy Act requirements and tailor FAR clauses as needed.

3) Information Security Categorization. In accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories, Appendix C, and based on information provided by the ISSO, CISO, or other security representative, the risk level for each Security Objective and the Overall Risk Level, which is the highest watermark of the three factors (Confidentiality, Integrity, and Availability) of the information or information system are the following:

Based on information provided by the ISSO, Privacy Office, system/data owner, or other security or privacy representative, it has been determined that this solicitation/contract involves:

[ ] No PII [ x ] Yes PII

4) Personally Identifiable Information (PII). Per the Office of Management and Budget (OMB) Circular A-130, “PII is information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual.” Examples of PII include, but are not limited to the following: social security number, date and place of birth, mother‘s maiden name, biometric records, etc.

PII Confidentiality Impact Level has been determined to be: [ ] Low [ x ] Moderate [ ] High

5) Controlled Unclassified Information (CUI). CUI is defined as “information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information.” The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 32 CFR, part 2002) when handling CUI. 32 C.F.R. 2002.4(aa) As implemented the term “handling” refers to “…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re-using, and disposing of the information.” 81 Fed. Reg. 63323. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, shall be:

a. marked appropriately;

b. disclosed to authorized personnel on a Need-To-Know basis;

c. protected in accordance with NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations if handled by internal Contractor system; and

d. returned to HHS control, destroyed when no longer needed, or held until otherwise directed. Destruction of information and/or data shall be accomplished in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

6) Protection of Sensitive Information. For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability.