AMENDMENT 01 OF SOLICITATION 75D301 23R 72644.docx

75D301 23R 72644-01

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

04/07/2023

4. REQUISITION/PURCHASE REQ. NO.

00HCVLDE-2023-73357

5. PROJECT NO. (If applicable)

Centers for Disease Control and Prevention (CDC)()

Office of Acquisition Services (OAS) 2900 Woodcock Blvd, MS TCU-4 Atlanta, GA 30341-4004

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

X

9A. AMENDMENT OF SOLICITATION NO.

75D301 23R 72644 9B. DATED (See Item 11) 04/07/2023

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (See Item 13)

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 is extended, X 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 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)

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

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

ITEM 10A.

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 purposes of this amendment are to:

a. Change the Inquiry Due Date.

b. Amend a Clause to the IDIQ

c. Change the Contracting officer of record.

d. Amend a portion of the Sample Task Order RFP

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

Kristopher Lemaster

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

1. IDIQ Section L.4 Inquiries. Inquiries should be received no later than date is changed from “May 5, 2023” to “April 12, 2023.”

2. IDIQ Section I1 Clauses Incorporated by Reference. Add 52.227-14 Alternate IV Rights in Data – General (December 2007).

3. IDIQ (and all Task Orders issued thereunder)The CDC designated Contracting Officer is Kristopher Lemaster.

4. Attachment 1. Solicitation for CISA Sample Task Order #1

a. Section 6.1 is changed to read,

b. Task 1: Clinical Consultations and Issue Evaluations (BASE):

The purpose of this Task is for the Contributing Contractor to provide one primary Principal Investigator (PI) and one secondary Principal Investigator to participate in the CISA Clinical Vaccine Safety Evaluation activities and assist CDC and the Lead Contractor in meeting clinical vaccine safety and public health needs. Having secondary PIs for this Base Task is optional; if secondary PIs are desired, 1 or 2 secondary PIs may be provided. These activities will extend to safety monitoring of the use of licensed and authorized vaccines in the U.S. CDC seeks to maintain the CISA Clinical Vaccine Safety Evaluation activity at its current functional level. This activity covers two CISA goals: 1) To serve as a vaccine safety resource for U.S. healthcare providers with complex vaccine safety questions about a specific patient to assist with immunization decision-making; 2) To assist the CDC and its partners in evaluating emerging vaccine safety issues.

c. Section 6.2 is changed to read

d. Task 2: Clinical On-Call Services (SUPPLEMENTAL):

The purpose of this Task is for Contributing Contractor to provide one primary Principal Investigator (PI) and one secondary Principal Investigators to participate in CISA Clinical On-Call Service for Vaccine Safety Evaluation. Including an additional secondary PI (for a total of 2 secondary PIs) is an option.The PI and secondary PI(s) can be the same as in Task 1. Core CISA Clinical On-Call activities include participating in Day Call and Night Call duties, serving as a vaccine safety resource for the clinical evaluation of vaccine safety issues including individual case reviews. In addition, Contributing Contractor shall provide medical subject matter experts in some or all of the medical specialties for children and adults.

e. Section 7.0 Scope of Work the following paragraph is deleted The primary PI shall have a current U.S. medical license from at least 1 of the 50 states or Washington DC, board certification in a medical specialty, and substantive expertise in infectious diseases or vaccine safety. The secondary Principal Investigator shall have a current U.S. medical license from least 1 of the 50 states or Washington DC and board certification in a medical specialty. Medical subject matter experts (SMEs) shall have clinical expertise in their field

f. Section 7.1 is Changed to read

g. Task 1: Clinical Consultations and Issue Evaluations (BASE) Under Task 1, the primary PI is anticipated to provide approximately 116 hours per contract year and the secondary PI is anticipated to provide approximately 36 hours per contract year (Table 1). In addition the secondary PI may cover for the primary PI when he/she is not available.

· The primary and secondary PI(s) shall have a current U.S. medical license from at least 1 of the 50 states or Washington DC, board certification in a medical specialty, and substantive expertise in vaccine safety OR infectious diseases.

· Medical subject matter experts (SMEs) shall have clinical expertise in their field.

· Having secondary PIs for this Base Task is optional; if secondary PIs are desired, 1 or 2 secondary PIs may be provided. PIs may provide back-up to each other Working Groups and general responsibilities of the Contractor are described below:

e Section 7.1.3 is Changed to read, Medical Subject Matter Experts (SMEs) Support The Contributing Contractor shall identify and have available medical Subject Matter Experts (SMEs) to support specific assignments in the Clinical Case Evaluation activity and meet the objective above. The PI may provide SME support if their expertise matches the public health need (approximately 20 additional hours per contract

e. . Task 7.2 is changed to read

f. Task 2: Clinical On-Call Services: (SUPPLEMENTAL) The purpose of this Task is for Contributing Contractor to provide one primary Principal Investigator and one or two secondary Principal Investigators to participate in CISA Clinical On-Call Service for vaccine safety evaluation. Core CISA Clinical On-Call activities includes participating in Day On-Call and Night On-Call duties and serving as a vaccine safety resource for the clinical evaluation of vaccine safety issues including individual case reviews. The Contributing Contractor shall designate a primary PI and 1 or 2 secondary PIs to be available to contribute expertise and provide consultation to the CISA Clinical On-Call Service to meet the objective described in Section 6.2 above.

The primary and secondary PIs shall have a current U.S. medical license from at least 1 of the 50 states or Washington DC, and either 1) board certification in pediatric or adult infectious diseases, OR 2) board certification in another medical specialty and substantial clinical infectious diseases experience.

The CISA Project’s core CISA Clinical On-Call activities for the Contributing Contractor are listed below. All functions specified in Task 1 may apply to Task 2

g. Section 8.1.4.7 Delete the following. This plan outlines activities, at the direction of the Government, to rapidly support in-depth vaccine safety clinical case reviews and synthesis in the case of an urgent public health incident or emergency situation. CDC will review and approve plan updates/enhancements. In the event of an emergency, Task Orders may be issued by the Government for the execution of this plan. This plan will include maintaining and periodically updating a spreadsheet with names and basic contact information of clinical and vaccine safety subject matter experts located/affiliated with the Lead and Contributing CISA Contractors who could be called upon in a public health emergency to help assess vaccine safety clinical cases and/or issues

h. Section 16 Evaluation Criteria Task 1, Page 27, detailed Evaluation Criteria 3. Experience and Expertise change to read, For Task 1 the Offeror choose to apply, the narrative should include the following:

Experience and Expertise Criteria:

I. The Offeror shall provide a narrative of the primary PI, secondary PI, and other Key Personnel’s relevant experience and a publications list.

In the narrative, the Offeror shall include if the primary and secondary PI (secondary PI may service as a back-up)

a. Is currently a U.S.-licensed physician in one of the 50 states (please provide documentation)

b. Has clinical expertise in an area of medicine, such as pediatrics or internal medicine. Board certification would be considered in evaluating this expertise (provide documentation if applicable)

c. Has substantive expertise in vaccine safety or infectious diseases.

II. A description of at least three previous studies or projects in vaccine safety or a related area that was completed within the past five years. The previous studies or projects should clearly demonstrate the Offeror’s experience in performing projects of similar scope and complexity to the requirements described in this Task Order.

III. Previous work with a Governmental or large organization include number, type of funding mechanism (e.g., contract), customer/agency name and contract title;

IV. Name, address, and phone number of at least one customer contacts (Contracting Officer or Project Officer) for a previous project funded by a source outside the Contractor’s organization.

Section 16 Evaluation Criteria. Task 2 On-Call Services. Detailed Evaluation Criteria, Experience and Expertise. Page 28 is changed to read The Offeror shall provide a description of at least three previous studies or projects in the area of vaccine safety or related to this Task Order, completed within the past five years, that clearly demonstrates the Offeror’s experience in performing projects of similar scope and complexity to the requirements described in this Task Order. The project should also describe:

For the Task 1 and each Supplemental Task the Offeror choose to apply, the narrative should include the following:

Experience and Expertise Criteria:

I. The Offeror shall clearly document experience with Clinical On-Call Service for Vaccine Safety Evaluation in the United States.

II. The Offeror shall provide a narrative of each PI’s relevant experience and a publications list. In the narrative, the Offeror shall include for each of primary and secondary PIs

a. Is currently a U.S.-licensed physician in one of the 50 states (please provide documentation)

b. Has either 1) board certification in pediatric or adult Infectious diseases, or 2) board certified in another medical specialty AND substantial clinical infectious diseases experience.

III. Previous work with a Governmental or large organization includes number, type of funding mechanism (e.g. contract), customer/agency name and contract title IV. Name, address, and phone number of at least one customer contact (Contracting Officer or Project Officer) for a previous project funded by a source outside the Contractor’s organization.

V. The Offeror shall also provide a narrative of the PI’s and other personnel’s relevant experience and a publications list.

VI. Resume detailing relevant experience and training of the Principal Investigators (PIs), who will conduct work