75D301-20-Q-72597 RFQ Amendment 1.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

PAGE OF PAGES

1 3

2. AMENDMENT/MODIFICATION NO.

00001

3. EFFECTIVE DATE

9/8/2020

4. REQUISITION/PURCHASE REQ. NO.

5. PROJECT NO. (If applicable)

6. ISSUED BY CODE 7. ADMINISTERED BY (If other than Item 6) CODE

Centers for Disease Control and Prevention

(CDC)

Office of Acquisition Services (OAS)

2900 Woodcock Blvd, MS TCU-4

Atlanta, GA 30341-4004

Sarah Turner, Contract Specialist, kwp9@cdc.gov

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

X

9A. AMENDMENT OF SOLICITATION NO.

75D301-20-Q-72597

9B. DATED (See Item 11)

9/2/2020

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (See Item 13)

CODE FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers X is extended, is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEGMENT

TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT

IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

N/A

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

The purpose of this amendment is to convey answers to questions received from potential offerors.

The proposal deadline is extended to Friday, September 11, 2020 at 4:00 pm Eastern.

Solicitation 75D301-20-Q-72597 is hereby amended as described on page 2 of this amendment.

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

16A. NAME OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

15C. DATE SIGNED

16B. UNITED STATES OF AMERICA

BY ___________________________________________

(Signature of Contracting Officer)

16C. DATE SIGNED

NSN 7540-01-152-8070 STANDARD FORM 30 (REV. 10-83)

PREVIOUS EDITION UNUSABLE 30-105 Prescribed by GSA

FAR (48 CFR) 53.243

ITEM 10A.

mailto:kwp9@cdc.gov

Amendment to 75D301-20-Q-72597

(A) The Questions and Answers received for this RFQ are below:

1. With questions due late Friday before a holiday weekend, we are concerned there will not be sufficient time to complete the proposal once answers are returned.

Will the government allow for a 1-week extension to Thursday, September 17?

i. The proposal deadline is extended to Friday, September 11, 2020 at

4:00 pm Eastern.

2. Is there an existing draft or IRB-approved protocol for this project? If yes, can

CDC provide a copy of the protocol?

i. Government Response: Yes, we have a Blanket IRB, 7227 that covers our de-identified specimens. We will share this externally after award.

3. Is the contractor required to use CDC’s IRB or can we use our own IRB for human subjects’ approval?

i. Government Response: The contractor is not required to use the

CDC’s IRB and will need to get human subjects’ approval through their organization.

4. For REDCap data entry, will the contractor be required to program the REDCap survey or will CDC complete this activity?

i. Government Response: CDC has programed REDCap survey and will share with awarded vendor.

5. If required data elements are not found in medical records, would CDC prefer a mixed methods approach, such as patient survey, or would missing data be acceptable?

i. Government Response: This would depend on what data is missing and how that impact the characterization of the specimens.

6. If subjects are enrolled in the NIH Valley Fever study, are they precluded from providing specimens for the CDC biobank project?

i. Government Response: If there are no prohibition associated with the

NIH Valley Fever study partner, our perspective is there is nothing precluding these specimens from the CDC biobank project.

7. Is CDC expecting regular shipments of serum from the contractor or would CDC prefer to receive all serum samples in one shipment at end of contract period?

i. Government Response: Shipments should occur at least once a quarter, although we would be agreeable to monthly shipments if the quantity is reasonable.

8. For storing serum prior to shipment to CDC, what is the preferred freezer temperature for the samples?

i. Government Response: Specimens should be frozen at -20 or lower.

9. We understand there are two species of Coccidioides that cause human disease with one typically found in California and the other found outside of California.

What is CDC’s preference for the geographical distribution of samples to account for the different Coccidioides species and to account for other factors?

i. Government Response: Coccidioides specimens of all species meet the requirement of this procurement.

10. The RFP states that FAR Subpart 13.1 Simplified Acquisition Procedures apply to this procurement. Please confirm whether or not the offer must be at or below the simplified acquisition threshold. FAR 13.003 states that anticipated dollar values between the micro-purchase threshold and simplified acquisition threshold must be reserved for small businesses, but this procurement is listed as full and open competition, which leads us to believe we are not limited by the simplified acquisition threshold.

i. Government Response: Yes, this award will be made under the

Simplified Acquisition threshold, currently set at $250,000. The small business set-aside applies when there is an expectation that two or more small businesses can complete the requirement; this is not anticipated for this requirement.

(B) This amendment constitutes the entirety of the changes to RFQ # 75D301-20-Q-72597.