QA 4-25-22.pdf

SOLICITATION

# QUESTION ANSWER

1 Is there a deadline for submitting questions for this opportunity?

Yes, see “CDCA_L002 INQUIRIES (JUL 2017)” for detailed information

2 Will the Government accept cost plus fixed-fee (CPFF) proposal submissions and/or fixed-price and/or time and material proposal submissions?

See FAR Clause 52.216-1 for procedures for proposing other contract types. This clause references the Exception procedures listed in Section L of the solicitation. Per these procedures, should the offeror wish to propose an exception to the terms and conditions of the solicitation, please provide the required information to allow the Government to conduct a thorough review of the proposed exception.

Please additionally note, that 52.216-1 states that the Government contemplates award of a Cost- Reimbursable type contract (the contemplation is not exclusive to a singular contract type under the Cost Reimbursable umbrella). As such both FAR Clauses 52.216-8 and 52.216-11 are included in the solicitation.

3 Is there an Excel available for submission of pricing?

No, offeror format for submission of Cost Data Information will suffice

4 To ensure offerors have time to prepare proposals that meet your expectations, will the CDC consider answering questions on a rolling basis (as opposed to responding to all questions collected on Wednesday, May 4)?

As a goal, the Government intends to turn around answers to questions as quickly as possible on a rolling basis.

5 Please confirm whether 2-pg resumes (requested in RFP section 4. Subfactor Four – Staffing Plan) are excluded from the total Technical Proposal 35-page limit.

CDCA_L011 provides guidance for pages excluded from the page count. This guidance is revised to exclude the resumes stated under Subfactor Four from the page count.

See solicitation Amendment 0001

6 The RFP requires contractors to identify and recommend 15-30 healthcare facilities to enroll study participants (p.7, Task 3).

We know there are currently 17 domestic (U.S.)

institutions working with the incumbent, Vanderbilt. Does the CDC expect [to] continue with these institutions upon contract award? Or, would the contractor need to identify an additional 15-30 sites (i.e., ultimate management of a maximum of 47 sites)? If contractors should consider additional sites, should those be domestic only or would the CDC consider international locations?

The Government does not require specific healthcare facilities for the surveillance, but provides in Task 3 a standards-based, objective structure for the contractor to use in identifying, proposing and enrolling healthcare facilities. The RFP does not require specific healthcare facilities, but requires the successful contractor to provide its recommended list to CDC for final approval during the timing noted in the RFP.

Section C – Description and Specifications, Section 4, #3 Task 3 (b) is revised from:

“b. be geographically diverse and representative of the U.S. population and have a diverse population of patients with respect to sex, age, race, ethnicity, and underlying conditions” to:

“b. be geographically diverse and representative of the U.S. population, and have a diverse population of patients with respect to sex, age, race, ethnicity, and underlying conditions, and be a healthcare facility operating and enrolling patients for this surveillance within one of the fifty (50) states of the United States and the District of Columbia.”

(Revised text highlighted.)

See amendment 0001

7 The RFP refers to an existing CDC-approved case-control protocol (p. 7, Task 4) and current IVY Network’s Standard Operating Procedures on specimen collection and shipment (p.9, Task 7b).

Will the CDC please provide these documents so non-incumbent offerors [in preparation of their proposal]? At [a] minimum, please provide the protocol synopsis.

Should an offeror require a copy of the current case-control protocol and/or current Standard Operating Procedures in preparation of a proposal, please submit a request to the Contract Specialist, Mark Draluck (syq1@cdc.gov), specifying the specific document(s) requested along with a copy of the completed and executed NDA located in Exhibit 1, below:

8 Is the evaluation of therapeutics (p. 10, Optional Task 10) part of the CDC’s current protocol/program?

No.

9 Please advise whether offerors should include specimen collection kits and shipping supplies in our proposals or whether offerors should assume those will be provided by the healthcare facilities (sites)?

Section C – Description and Specifications, Section 6 – Government Furnished Materials does not include government-supplied specimen collection kits and shipping supplies.

The offeror is responsible for providing all labor, materials, equipment and any other item for the successful performance of its proposed technical approach to meeting this requirement. Each offeror should provide sufficient technical descriptions of the specimen collection approach and strategy in its proposal.

10 Is sample testing currently performed at the site level? Or should offerors propose central labs services for the SARS-CoV-2 influenza, and RSV analysis?

Each offeror should propose their strategy for lab services for testing of SARS-CoV-2, influenza, and RSV in a technical manner that aligns to the offeror’s technical approach that meets the requirements stated in the RFP.

11 Will the selected contractor receive PBMC isolates or receive whole blood samples that they must isolate into PBMCs?

The selected contractor is responsible for designing a technical approach that meets the technical requirements as stated in the RFP. This requires the successful contractor to have the capability to receive whole blood samples and generate PBMC isolates either at their facility or through subcontracts.

12 Will the CDC expect the contractor to provide Ct values as part of reporting SARS-CoV-2 RT-PCR results?

Yes, see Amendment 0001

13 Task 7(a) on page 9 of the RFP: The task states that the contractor will collect, store, and ship biospecimens. Should the contractor also budget for analyzing the biospecimens? The solicitation states, “The specimens will be used to evaluate susceptibility to severe infection and mechanisms of disease attenuation as well as vaccine failure and intrahost virus evolution.” We are reaching out for clarity on whether the contractor should plan to perform these laboratory analyses or simply send the specimens to CDC, where the laboratory

The contractor is responsible for analyzing the biospecimens

See amendment 0002 analyses will be performed outside of the contractor’s scope of work.

14 On page 6 of the RFP, under goal 5, the document says, “Submit all eligible SARS-CoV-2 respiratory specimens for sequencing to allow for sentinel genomic surveillance of hospitalized patients.”

Should the offeror propose to complete the sequencing laboratory work or simply ship specimens to CDC for the sequencing laboratory work to be completed outside the contractor’s scope of work and funding? That is, is the contractor responsible for providing the specimens only or provide both the specimens and the genomic sequencing results?

The contractor is responsible for providing specimens and genomic sequencing results

See amendment 0002

EXHIBIT 1

CEN T ER S FO R D IS EA S E CO N T RO L A N D PR EV EN TIO N (CDC)

NO N-D IS C LO SU RE AG R E EM E NT

RFP # 75D30122R72124 (“RFP”)

RFP Descriptive Title: Surveillance of Acutely Ill Adults with Respiratory Viruses, including SARS- CoV-2

CDC Information Management Services (CIMS) Contract Domain: Information Management

Name of Offeror: ___________________________________________ (“Offeror”)

The Centers for Disease Control and Prevention has issued the RFP referenced above for services related to the surveillance of acutely ill adults with respiratory viruses, including SARS-CoV-2. The RFP references documents titled “Case Control Protocol” and “IVY Network’s Standard Operating Procedures on Specimen Collection and Shipment,” which the Government has not included in the RFP because it contains non-public, sensitive, confidential or proprietary information. The Government will release these documents to prospective offerors of this RFP if the offeror (1) represents that it intends to submit a proposal for the RFP, and (2) executes this Non-Disclosure Agreement (“Agreement”).

Offeror1 represents that it intends to submit a proposal for the RFP. Therefore, in consideration of the promises and covenants contained in this Agreement, the parties hereto agree as follows:

1. Confidential Information and Materials

a) "Confidential Information" shall mean any non-public, proprietary or procurement sensitive information that the CDC specifically marks and designates, either orally or in writing, as confidential or which, under the circumstances surrounding the disclosure, ought to be treated as confidential.

"Confidential Information" includes, but is not limited to, independent government estimates, independent costs and prices, product schematics or drawings, descriptive material, system specifications, software (source code or object code), and customer information, CDC's business policies or practices, information received from others that CDC is obligated to treat as confidential, and other materials and information of a confidential nature.

b) "Confidential Information" shall not include any materials or information which Offeror shows:

i. is, at the time of disclosure, generally known by or available to the public or became so known or available thereafter through no fault of Offeror; or

ii. is legally known to Offeror at the time of disclosure by CDC through independent means other than through work on a CDC-funded contract or task order, provided that Offeror shall have the burden of establishing such independent prior knowledge by competent written proof and/or evidence; or

iii. is furnished by CDC to third parties without restriction; or

1 As used herein, the term “Offeror” includes Offeror’s employees, consultants, parent, subsidiaries, affiliates or related parties owners, employees, staff and consultants.

iv. is furnished to Offeror by a third party who legally obtained said information and the right to disclose it; or

v. is developed independently by Offeror, through its employees, either before or after the term of Offeror’s engagement for Offeror’s own use and not for the use of the Government, where Offeror can document such independent development and use.

c) "Confidential Materials" shall mean all tangible materials containing confidential information, including without limitation drawings, schematics, written or printed documents, computer disks, tapes, and compact disks (CD), whether machine or user readable.

d) For purposes of this Agreement, “procurement-sensitive information” includes, but is not limited to, all information related to or arising from the documents referenced about including the RFP or any amendments; questions from potential offerors; non-public information regarding this procurement;

all documents, conversations, discussions, data, correspondence, electronic mail (e-mail), presentations, or any other written or verbal communications relating to, concerning, or affecting proposed or pending solicitation or award for this procurement; procurement data; contract information plans; strategies; source selection information and documentation; offerors’ identities;

technical and cost data; the identity of government personal involved in the acquisition; the schedule of key technical and procurement events in the award determination process; and any other information that may provide an unfair competitive advantage to a contractor or potential contractor if improperly disclosed to them, or any of their employees.

2. Restrictions

a) Offeror understands that it shall not disclose any Confidential Information to any other party without the prior written authorization of a CDC Contracting Officer. However, Offeror may disclose Confidential Information in accordance with judicial or other governmental orders, provided Offeror shall give CDC reasonable written notice at least seven (7) business days prior to such disclosure and shall comply with any applicable protective order or equivalent.

b) Offeror shall not use any Confidential Information or Confidential Materials of CDC specifically related to the above referenced documents for any purposes other than preparation of its proposal or a contract awarded to it in response to the RFP unless CDC provides prior express authorization or approval in writing.

c) Offeror shall take reasonable security precautions, which shall in any event be as great as the precautions it takes to protect its own confidential information, to keep confidential the CDC’s Confidential Information and the documents referenced above. Offeror may disclose Confidential Information or Confidential Materials only to Offeror's employees, staff or consultants on a need-to-know basis for the purposes of preparing Offeror’s proposal. Offeror shall instruct all employees, staff or consultants to which it gives access to the above referenced documents to maintain confidentiality and to refrain from making unauthorized electronic or hard copies. Offeror shall maintain appropriate written agreements with its employees, consultants, parent, subsidiaries, affiliates or related parties, who receive, or have access to, CDC’s Confidential Information in order for Offeror to comply with the terms of this Agreement.

d) Confidential Information and Confidential Materials may be disclosed, reproduced, summarized or distributed only in pursuance of Offeror's contractual relationship with CDC, and only as otherwise provided herein. Offeror agrees to segregate all such Confidential Materials from the confidential materials of others to prevent commingling.

3. Rights and Remedies

a) No provision of this Agreement is to be construed as making the above referenced documents or any information related to it public without restriction.

b) Offeror understands that by receiving the above referenced documents, it will have access to non-public information, including confidential and privileged information contained in government-owned information technology systems. Offeror acknowledges that it acquires no ownership interest in the above referenced documents released pursuant to this Agreement.

c) Offeror agrees to use the above referenced documents solely for purposes required in the preparation of its proposal in response to this RFP. Offeror agrees that it will not disclose, publish, divulge, release, or make known in any manner or to any extent, to any individual, company, entity or third party the above referenced documents or any information contained therein unless covered by an exception noted herein.

d) Offeror shall inform all employees, consultants or contractors of Offeror given access to the above referenced documents of the restrictions specified herein, and Offeror shall require that those parties be bound by this Agreement. Furthermore, Offeror represents that it will not release the above referenced documents information in any form to any of its employees, consultants or contractors unless it has confirmed and has the right to bind such parties to the restrictions specified herein.

e) This Agreement shall be construed, and the legal relations between the parties hereto shall be determined, in accordance with United States federal law for all purposes.

f) This Agreement is non-transferrable. Offeror shall not assign or otherwise transfer this Agreement.

Upon notice of award, Offeror shall certify to CDC that the above referenced document information has been destroyed and/or deleted from any electronic, physical or other file system in which the information can be stored or accessed.

g) CDC retains the right to terminate this Agreement, in the event that CDC determines that Offeror fails to meet the requirements of this Agreement. In the event of termination, Offeror shall immediately take such actions as are described in the preceding paragraph and certify that the above referenced documents information has been destroyed and/or deleted.

h) Offeror shall notify the CDC immediately upon discovery of any unauthorized use or disclosure of

Confidential Information or Confidential Materials, or any other breach of this Agreement by Offeror, and will cooperate with CDC in every reasonable way to help CDC regain possession of the Confidential Information and/or Confidential Materials and prevent further unauthorized use or disclosure.

4. Miscellaneous

a) All Confidential Information, Confidential Materials and procurement-sensitive information are and shall remain the sole and exclusive property of CDC.

b) All Confidential Information, Confidential Materials and procurement-sensitive information are provided "as is," and CDC makes no warranty regarding the accuracy or reliability of such information or materials. CDC does not warrant that it will release any product concerning which information has been disclosed as a part of the Confidential Information, Confidential Materials or procurement-sensitive information. CDC will not be liable for any expenses or losses incurred or any action undertaken by Offeror as a result of the receipt of the above referenced documents or any information related to it. The entire risk arising out of the use of this information remains with Offeror.

c) Offeror understands that federal laws including, 18 U.S.C. 641 and 18 U.S.C. 2071, provide criminal penalties for, among other things, unlawfully removing, destroying or converting to personal use, or use of another, any public records.

d) This Agreement constitutes the entire Agreement between the parties with respect to the subject matter hereof. It shall not be modified except by a written agreement dated subsequent to the date of this Agreement and signed by both parties.

e) Unless a CDC Contracting Officer provides, none of the provisions of this Agreement shall be deemed to have been waived by any act or acquiescence on the part of CDC, its agents, or employees.

No waiver of any provision of this Agreement shall constitute a waiver of any other provision(s) or of the same provision on another occasion. Failure of either party to enforce any provision of this Agreement shall not constitute waiver of such provision or any other provisions of this Agreement.

f) This Agreement shall be construed and governed by the laws of the United States.

g) If any provision of this Agreement shall be held by a court of competent jurisdiction to be illegal, invalid or unenforceable, the remaining provisions shall remain in full force and effect. Should any of the obligations of this Agreement be found illegal or unenforceable as being too broad with respect to the duration, scope or subject matter thereof, such obligations shall be deemed and construed to be reduced to the maximum duration, scope or subject matter allowable by law.

IN WITNESS WHEREOF, the parties hereto have executed this Agreement by their duly authorized representatives as of the date accepted by the Contracting Officer indicated below.

Executed on Behalf of Offeror: ___________________________________________________

By: _____________________________________________ Name: ___________________________________________ Position/Title:* ____________________________________ Email: ___________________________________________ Date: _________________ *Indicate your formal title if you are signing as an authorized representative on behalf of a company or entity. If you are signing as an individual, fill in the Title line as “individual”

Executed on Behalf of the Centers for Disease Control and Prevention

By: ________________________________________ Pellumbeshe Hoxhaj Contracting Officer & Team Lead Branch I, Team 1

CDC/OCOO/OFR/OAS

Date: _________________