Pediatric COVID-19 Vaccines.pdf

11. DELIVERY FOR FOB

DESTINATION UNLESS

BLOCK IS MARKED

19.70SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

1. REQUISITION NUMBER PAGE 1 OF

2. CONTRACT NO. 3. AWARD/EFFECTIVE

DATE

4. ORDER NUMBER 5. SOLICITATION NUMBER

75D301-22-R-72484

6. SOLICITATION

ISSUE DATE

11/16/2022

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

Joshua Houston

b. TELEPHONE NUMBER (No collect calls)

(404) 498-2384

8. OFFER DUE DATE/

LOCAL TIME

11/28/2022

9. ISSUED BY CODE 8219 10. THIS ACQUISITION IS 12. DISCOUNT TERMS

Centers for Disease Control and Prevention (CDC)

Office of Acquisition Services (OAS)

2900 Woodcock Blvd, MS TCU-4

Atlanta, GA 30341-4004

X UNRESTRICTED

SET ASIDE: % FOR

SMALL BUSINESS

SMALL DISADV. BUSINESS

8(A)

SIC: 325412

SIZE STANDARD:

X SEE SCHEDULE

13a. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB X RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE 8219

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

Atlanta, GA 30341-4004

CODE 18a. PAYMENT WILL BE MADE BY CODE 434

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

Atlanta, GA 30333-0080

TELEPHONE NO.

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

SEE ADDENDUM

19.

ITEM NO.

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

Pediatric COVID-19 Vaccines

See Continuation Page

(Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN COPIES

TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER ALL ITEMS SET

FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL SHEETS SUBJECT

TO THE TERMS AND CONDITIONS SPECIFIED HEREIN.

29. AWARD OF CONTRACT: REFERENCE OFFER

DATED . YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

HEREIN, IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (Signature of Contracting Officer)

30b. NAME AND TITLE OF SIGNER (Type or print) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

Pellumbeshe Hoxhaj

31c. DATE SIGNED

32a. QUANTITY IN COLUMN 21 HAS BEEN 33. SHIP NUMBER 34. VOUCHER NUMBER

RECEIVED INSPECTED

PARTIAL FINAL

36. PAYMENT 37. CHECK NUMBER

32b. SIGNATURE OF AUTHORIZED GOV’T REPRESENTATIVE 32c. DATE COMPLETE PARTIAL FINAL

41a. I CERTIFY THIS AMOUNT IS CORRECT AND PROPER FOR PAYMENT

41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

38. S/R ACCOUNT NUMBER 39. S/R VOUCHER NUMBER

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

42c. DATE REC’D 42d. TOTAL CONTAINERS

40. PAID BY

AUTHORIZED FOR LOCAL REPRODUCTION SEE REVERSE FOR OMB CONTROL NUMBER AND PAPERWORK BURDEN STATEMENT STANDARD FORM 1449 (10-95)

ACCEPTED, AND CONFORMS TO THE

CONTRACT, EXCEPT AS NOTED

35. AMOUNT VERIFIED

CORRECT FOR

17a. CONTRACTOR/

OFFEROR

FACILITY

CODE

IS CHECKED

Solicitation No. 75D301-22-R-72484

Page i

TABLE OF CONTENTS

Section Document/Clause/Provision Page No.

A Standard Form 1449

B Continuation of SF1449 (Block 19 – 24) 1

C Contract Clauses 3

D Contract Documents, Exhibits or Attachments 22

E Solicitation Provisions 26

SECTION B - CONTINUATION OF SF1449

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE

(PRICE PER

DOSE, INCL.

FET*)

MAXIMUM

EXTENDED

PRICE

(INCL. FET*)

0001 COVID-19 Vaccine - Pediatric

(age 0 through 18 years)

Min. Order Size: 100 Doses

Fed. Excise Tax: $0.75 per dose

Ordering period: One year from date of award

Maximum:

30 Million

Doses

Minimum:

100 Doses

*Federal excise tax (FET)

Note:

1. The delivery date is to be determined and the delivery location will be shown on delivery orders.

2. Proposed Quantity and Presentation: Offerors may propose any number of vaccines or presentations of Emergency Use Authorizations (EUA) and/or Biologics License

Application (BLA) COVID-19 vaccines indicated for children 0 through 18 years of age.

B.1 Background

The Centers for Disease Control and Prevention (CDC) awards contracts to the manufacturers of pediatric vaccines for the purchase of standard commercial pediatric vaccines.

Vaccines are one of the most cost-effective ways to prevent disease and reduce healthcare costs.

The Vaccine for Children (VFC) program, established pursuant to Section 13631 of the Omnibus

Budget Reconciliation Act of 1993 (OBRA ’93), guarantees federal support for the purchase and supply of sufficient quantities of vaccine to the States to cover a defined group of children. The program helps assure the implementation of effective immunization practices and proper use of vaccines to achieve higher immunization coverage. Children (18 years-of-age or younger) who qualify for immunization through the VFC purchase program include those who are (1)

Medicaid-eligible, (2) without health insurance, (3) American Indian/Alaska native (as defined in

Subsection (h)(3) of the OBRA ’93), or (4) children with health insurance, which does not cover the cost of vaccines, if they receive their immunizations at a Federally-qualified health center or rural health clinic (as defined by the Social Security Act). Health care providers who agree to certain requirements are eligible through the States to receive free vaccine through this VFC purchase program.

The establishment of these contracts provides an opportunity to utilize VFC funds and Section

317 vaccine purchase funds to obtain vaccines at prices below those available in the commercial marketplace. In addition, awardees may opt to purchase additional quantities of vaccine under any resulting contract to provide immunizations for children who are not federally vaccine-eligible children using state and local funds.

Offerors for this requirement must be manufacturers of pediatric vaccines in accordance with 42

U.S.C. § 1396s. The term "manufacturer" means any corporation, organization, or institution, whether public or private (including Federal, State, and local departments, agencies, and instrumentalities), which manufactures, imports, processes, or distributes under its label any pediatric vaccine. The term "manufacture" means to manufacture, import, process, or distribute a vaccine.

B.2. Definitions

OBRA Orders – Vaccine orders under Section 1928(a) (2)(A) of the Social Security Act.

317 Orders – Vaccine orders under Section 317(j) of the Public Health Service Act.

State and Local Orders – Vaccine orders placed by authorized immunization programs using state or local funds in accordance with Section 1928(d)(4)(B) of the Social Security Act.

Manufacturer – As defined in Subsection (h) (4) of the Social Security Act, means any corporation, organization, or institution, whether public or private, which manufactures, imports, processes, or distributes under its label any pediatric vaccine.

Awardees – Includes State health departments and certain local health agencies authorized to order hereunder.

B.3 Type of Contract

Indefinite delivery/indefinite quantity (IDIQ) contract with firm-fixed-price delivery orders.

SECTION C - CONTRACT CLAUSES

C.1 FAR 52.252-2 Clauses Incorporated by Reference (Feb 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov.

(End of Clause)

FAR SOURCE TITLE AND DATE

52.204-13 System for Award Management Maintenance (Oct 2018)

52.204-18 Commercial and Government Entity Code Maintenance (Aug

2020)

52.212-4 Contract Terms and Conditions—Commercial Products and

Commercial Services (Nov 2021)

52.232-40 Providing Accelerated Payments to Small Business Subcontractors

(Nov 2021)

HHSAR SOURCE TITLE AND DATE

352.203-70 Anti-Lobbying (Dec 2015)

C.2 52.212-5 Contract Terms and Conditions Required To Implement Statutes or

Executive Orders—Commercial Products and Commercial Services (OCT 2022)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or

Executive orders applicable to acquisitions of commercial products and commercial services:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or

Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further

Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services

Developed or Provided by Kaspersky Lab and Other Covered Entities (NOV 2021) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video

Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV

2015).

(5) 52.233-3, Protest After Award (AUG 1996) ( 31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws

108-77 and 108-78 ( 19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

[Contracting Officer check as appropriate.]

_X_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (JUN

2020), with Alternate I (NOV 2021) ( 41 U.S.C. 4704 and 10 U.S.C. 2402).

_X_ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (NOV

2021) ( 41 U.S.C. 3509)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and

Reinvestment Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

_X_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract

Awards (JUN 2020) (Pub. L. 109-282) ( 31 U.S.C. 6101 note).

__ (5) [Reserved].

__ (6) 52.204-14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111-

117, section 743 of Div. C).

__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery

Contracts (OCT 2016) (Pub. L. 111-117, section 743 of Div. C).

_X_ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with

Contractors Debarred, Suspended, or Proposed for Debarment. (NOV

2021) ( 31 U.S.C. 6101 note).

_X_ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility

Matters (OCT 2018) ( 41 U.S.C. 2313).

__ (10) [Reserved].

__ (11) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (OCT

2022) ( 15 U.S.C. 657a).

_X_ (12) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business

Concerns (OCT 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer)

( 15 U.S.C. 657a).

__ (13) [Reserved]

__ (14) (i) 52.219-6, Notice of Total Small Business Set-Aside (NOV

2020) ( 15 U.S.C. 644).

__ (ii) Alternate I (MAR 2020) of 52.219-6.

__ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (NOV

2020) ( 15 U.S.C. 644).

__ (ii) Alternate I (MAR 2020) of 52.219-7.

_X_ (16) 52.219-8, Utilization of Small Business Concerns (OCT

2022) ( 15 U.S.C. 637(d)(2) and (3)).

__ (17) (i) 52.219-9, Small Business Subcontracting Plan (OCT

2022) ( 15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (NOV 2016) of 52.219-9.

_X_ (iii) Alternate II (NOV 2016) of 52.219-9.

__ (iv) Alternate III (JUN 2020) of 52.219-9.

__ (v) Alternate IV (SEP 2021) of 52.219-9.

__ (18) (i) 52.219-13, Notice of Set-Aside of Orders (MAR 2020) ( 15 U.S.C. 644(r)).

__ (ii) Alternate I (MAR 2020) of 52.219-13.

__ (19) 52.219-14, Limitations on Subcontracting (OCT 2022) ( 15 U.S.C. 637s).

_X_ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (SEP

2021) ( 15 U.S.C. 637(d)(4)(F)(i)).

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-

Aside (OCT 2022) ( 15 U.S.C. 657f).

_X_ (22) (i) 52.219-28, Post Award Small Business Program Rerepresentation (OCT

2022) ( 15 U.S.C. 632(a)(2)).

__ (ii) Alternate I (MAR 2020) of 52.219-28.

__ (23) 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically

Disadvantaged Women-Owned Small Business Concerns (OCT 2022) ( 15 U.S.C. 637(m)).

__ (24) 52.219-30, Notice of Set-Aside for, or Sole-Source Award to, Women-Owned

Small Business Concerns Eligible Under the Women-Owned Small Business Program (OCT

2022) ( 15 U.S.C. 637(m)).

__ (25) 52.219-32, Orders Issued Directly Under Small Business Reserves (MAR

2020) ( 15 U.S.C. 644(r)).

__ (26) 52.219-33, Nonmanufacturer Rule (SEP 2021) ( 15U.S.C. 637(a)(17)).

_X_ (27) 52.222-3, Convict Labor (JUN 2003) (E.O.11755).

_X_ (28) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (JAN

2022) (E.O.13126).

_X_ (29) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

_X_ (30) (i) 52.222-26, Equal Opportunity (SEP 2016) (E.O.11246).

__ (ii) Alternate I (FEB 1999) of 52.222-26.

_X_ (31) (i) 52.222-35, Equal Opportunity for Veterans (JUN 2020) ( 38 U.S.C. 4212).

__ (ii) Alternate I (JUL 2014) of 52.222-35.

_X_ (32) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN

2020) ( 29 U.S.C. 793).

__ (ii) Alternate I (JUL 2014) of 52.222-36.

_X_ (33) 52.222-37, Employment Reports on Veterans (JUN 2020) ( 38 U.S.C. 4212).

_X_ (34) 52.222-40, Notification of Employee Rights Under the National Labor

Relations Act (DEC 2010) (E.O. 13496).

_X_ (35) (i) 52.222-50, Combating Trafficking in Persons (NOV

2021) ( 22 U.S.C. chapter 78 and E.O. 13627).

__ (ii) Alternate I (MAR 2015) of 52.222-50 ( 22 U.S.C. chapter 78 and E.O. 13627).

__ (36) 52.222-54, Employment Eligibility Verification (MAY 2022) (Executive Order

12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial products or commercial services as prescribed in

FAR 22.1803.)

__ (37) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–

Designated Items (May 2008) ( 42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (ii) Alternate I (MAY 2008) of 52.223-9 ( 42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential

Hydrofluorocarbons (Jun 2016) (E.O. 13693).

__ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693).

__ (40) (i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN

2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (OCT 2015) of 52.223-13.

__ (41) (i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s

13423 and 13514).

__ (ii) Alternate I (Jun2014) of 52.223-14.

__ (42) 52.223-15, Energy Efficiency in Energy-

Consuming Products (MAY 2020) ( 42 U.S.C. 8259b).

__ (43) (i) 52.223-16, Acquisition of EPEAT®-Registered Personal

Computer Products (OCT 2015) (E.O.s 13423 and 13514).

__ (ii) Alternate I (JUN 2014) of 52.223-16.

_X_ (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While

Driving (JUN 2020) (E.O. 13513).

__ (45) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).

__ (46) 52.223-21, Foams (Jun2016) (E.O. 13693).

__ (47) (i) 52.224-3 Privacy Training (JAN 2017) (5 U.S.C. 552 a).

__ (ii) Alternate I (JAN 2017) of 52.224-3.

__ (48) (i) 52.225-1, Buy American-Supplies (OCT 2022) ( 41 U.S.C. chapter 83).

__ (ii) Alternate I (OCT 2022) of 52.225-1.

__ (49) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (OCT

2022) ( 41 U.S.C.chapter83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19

U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-

283, 110-138, 112-41, 112-42, and 112-43.

__ (ii) Alternate I (JAN 2021) of 52.225-3.

__ (iii) Alternate II (JAN 2021) of 52.225-3.

__ (iv) Alternate III (JAN 2021) of 52.225-3.

__ (v) Alternate IV (Oct 2022) of 52.225-3.

_X_ (50) 52.225-5, Trade Agreements (OCT 2019) ( 19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X_ (51) 52.225-13, Restrictions on Certain Foreign Purchases (FEB 2021) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the

Department of the Treasury).

__ (52) 52.225-26, Contractors Performing Private Security Functions Outside the United

States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for

Fiscal Year 2008; 10 U.S.C. 2302Note).

__ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007)

( 42 U.S.C. 5150).

__ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area

(Nov2007) ( 42 U.S.C. 5150).

__ (55) 52.229-12, Tax on Certain Foreign Procurements (FEB 2021).

__ (56) 52.232-29, Terms for Financing of Purchases of Commercial

Products and Commercial Services (NOV 2021) ( 41 U.S.C. 4505, 10 U.S.C. 2307(f)).

__ (57) 52.232-30, Installment Payments for Commercial Products and Commercial

Services (NOV 2021) ( 41 U.S.C. 4505, 10 U.S.C. 2307(f)).

_X_ (58) 52.232-33, Payment by Electronic Funds Transfer-System for Award

Management (OCT2018) ( 31 U.S.C. 3332).

__ (59) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award

Management (Jul 2013) ( 31 U.S.C. 3332).

__ (60) 52.232-36, Payment by Third Party (MAY 2014) ( 31 U.S.C. 3332).

__ (61) 52.239-1, Privacy or Security Safeguards (AUG 1996) ( 5 U.S.C. 552a).

_X_ (62) 52.242-5, Payments to Small Business Subcontractors (JAN

2017) ( 15 U.S.C. 637(d)(13)).

__ (63) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial

Vessels (NOV 2021) ( 46 U.S.C. 55305 and 10 U.S.C. 2631).

__ (ii) Alternate I (APR 2003) of 52.247-64.

__ (iii) Alternate II (NOV 2021) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

[Contracting Officer check as appropriate.]

__ (1) 52.222-41, Service Contract Labor Standards (AUG 2018) ( 41 U.S.C. chapter67).

__ (2) 52.222-42, Statement of Equivalent Rates for Federal

Hires (MAY 2014) ( 29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price

Adjustment (Multiple Year and Option Contracts) (AUG

2018) ( 29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price

Adjustment (May 2014) ( 29U.S.C.206 and 41 U.S.C. chapter 67).

__ (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements

(May 2014) ( 41 U.S.C. chapter 67).

__ (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (MAY 2014) ( 41 U.S.C. chapter 67).

__ (7) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order

14026 (JAN 2022).

__ (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2022) (E.O.

13706).

__ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020)

( 42 U.S.C. 1792).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, as defined in FAR 2.101, on the date of award of this contract, and does not contain the clause at 52.215-2, Audit and Records-Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the

Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR subpart 4.7, Contractor

Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the

Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e) (1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1), in a subcontract for commercial products or commercial services. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause-

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (NOV

2021) ( 41 U.S.C. 3509).

(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further

Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services

Developed or Provided by Kaspersky Lab and Other Covered Entities (NOV 2021) (Section 1634 of Pub. L. 115-91).

(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video

Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(v) 52.219-8, Utilization of Small Business Concerns (OCT

2022) ( 15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds the applicable threshold specified in FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(vi) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

(vii) 52.222-26, Equal Opportunity (SEP 2015) (E.O.11246).

(viii) 52.222-35, Equal Opportunity for Veterans (JUN 2020) ( 38 U.S.C. 4212).

(ix) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN

2020) ( 29 U.S.C. 793).

(x) 52.222-37, Employment Reports on Veterans (JUN 2020) ( 38 U.S.C. 4212).

(xi) 52.222-40, Notification of Employee Rights Under the National Labor Relations

Act (DEC 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(xii) 52.222-41, Service Contract Labor Standards (AUG 2018) ( 41 U.S.C. chapter 67).

(xiii) (A) 52.222-50, Combating Trafficking in Persons (NOV

2021) ( 22 U.S.C. chapter 78 and E.O 13627).

(B) Alternate I (MAR 2015) of 52.222-50 ( 22 U.S.C. chapter 78 and E.O. 13627).

(xiv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements

(May 2014) ( 41 U.S.C. chapter 67).

(xv) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (MAY 2014) ( 41 U.S.C. chapter 67).

(xvi) 52.222-54, Employment Eligibility Verification (MAY 2022) (E.O. 12989).

(xvii) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order

14026 (JAN 2022).

(xviii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2022) (E.O.

13706).

(xix) (A) 52.224-3, Privacy Training (Jan 2017) ( 5 U.S.C. 552a).

(B) Alternate I (JAN 2017) of 52.224-3.

(xx) 52.225-26, Contractors Performing Private Security Functions Outside the United

States (OCT 2016) (Section 862, as amended, of the National Defense Authorization Act for

Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xxi) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (JUN

2020) ( 42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xxii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (NOV

2021) ( 46 U.S.C. 55305 and 10 U.S.C. 2631). Flow down required in accordance with paragraph

(d) of FAR clause 52.247-64.

(2) While not required, the Contractor may include in its subcontracts for commercial products and commercial services a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of clause)

C.3 Special Terms and Conditions

C.3.1 Shelf Life

Vaccine provided under this contract shall have a minimum 12 month shelf life remaining upon delivery to the consignee, or as specified within each Contract Line Item Number (See Section

B, Continuation of SF 1449).

C.3.2 Packaging and Packing Requirements

1. Packaging:

All items shall be packaged in standard commercial manner.

2. Packing:

a. Product shall be packed to ensure maintenance of FDA recommended temperature during transit and safe arrival at destination. An electronic temperature monitoring device is required with each shipment unless Contractor has obtained prior approval from CDC to use an alternative monitoring method.

b. Contractor will provide the Contracting Officer Representative (COR) with documentation that explains the cause of each temperature excursion and stability data used by the contractor to determine if the cold chain was adversely affected by temperature variance. Upon review of data and recommendation provided, CDC will notify appropriate parties if the vaccine is accepted or rejected.

C.3.3 Contract Ordering Period

The contract ordering period shall begin on the date of award and shall end one year later.

C.3.4 Time of Delivery

Delivery of vaccine and required documentation is required to be made at destination within 15 working days after receipt of electronic, written, or telephonic order (telephone orders to be confirmed in writing). The required documentation includes the packing list, Electronic Data

Interchange (EDI), and Drug Supply Chain Security Act (DSCSA) documentation. Shipments delivered with incorrect or missing packing list, EDI, or DSCSA documentation will be quarantined and considered not ready to be received into inventory until the discrepancy is resolved. Days during which vaccine is in quarantine at CDC's depots count toward the 15 working day requirement.

C.3.5 Place of Delivery

For refrigerated and frozen vaccines, the Contractor shall be required to deliver vaccines F.O.B.

Destination, as directed by delivery orders to the CDC centralized distribution locations currently in Aurora, CO and Memphis, TN.

For ultra-cold vaccines, the contractor shall provide delivery options for both of the following:

(1) bulk delivery of vaccines F.O.B. destination, as directed by delivery orders to the

CDC centralized distribution locations currently in Aurora, CO and Memphis, TN; and

(2) drop ship delivery of vaccines F.O.B. destination as directed by delivery orders to provider locations.

In addition, vaccine stockpile order(s) shall be delivered to another single location to be determined by CDC.

C.3.6 Amendment to OBRA Statute

In the event of an amendment of 42 U.S.C. Section 1396(s), any terms of the contract affected by such an amendment will be modified in accordance with the revised statute. The Contracting

Officer and the Contractor shall meet to discuss such modifications to the contract before finalization of any changes to the contract.

C.3.7 Product Licensure or Authorization

a. The vaccines produced and delivered under this contract shall be manufactured under a current establishment and product license or authorization issued by the Food and Drug Administration as indicated below:

_____________ (Provide BLA or EUA #)

b. If applicable, the Current Good Manufacturing Practice Regulations (CGMPR’s) (21CFR

Parts 210, 211) will be the standard to be applied for manufacturing, processing and packing of drugs, chemicals, biologicals, and reagents.

c. The Contractor shall advise the Contracting Officer immediately of any relocation of his prime manufacturing facility or the relocation of any subcontractor’s facility, and if at any time during the life of the contract, the item listed under this contract fails to meet CGMPR’s and/or a negative Food and Drug Administration Quality Assurance Evaluation is received; the contract may be terminated, in whole or in part, without further liability to the Government.

C.3.8 Placement of Orders

a. Vaccine under this contract will be ordered by delivery orders in the Vaccine Tracking System

(VTrckS). Orders shall be placed by Health and Human Services (HHS), the Centers for Disease

Control and Prevention (CDC), CDC on behalf of eligible awardees, or by the awardees. The

CDC will provide the contractor with a list of awardees. Each awardee will be identified with a unique identification number in the vaccine ordering system. Orders shall be placed by electronic transfer. In the event of an emergency (i.e. temporary loss of the IT system) should an order be communicated outside of VTrckS via email or orally, an actual purchase order will be created in

VTrckS and transmitted via electronic data interface (EDI) as soon as possible, thereafter.

Contractors shall be able to interface with the CDC electronic vaccine ordering system. If unable to interface at the time of award, the vendor shall complete interface implementation no later than 3 months after contract award.

b. Orders shall be submitted to the Ordering Address specified in Contract Clauses Paragraph

C.3.12, Contractor’s Ordering/Payment Address, and shall contain the following minimum information:

1. Date of order;

2. Contract number and order number;

3. Item description, quantity, and unit price;

4. Delivery or performance date;

5. Place of delivery or performance (including consignee);

6. Packaging, packing, and shipping instruction, if any;

7. Accounting and appropriation data;

8. Statement to indicate if partial deliveries are not acceptable; (lack of a statement shall be construed to mean partial deliveries are acceptable and payment shall be made as required elsewhere herein); and

9. Any other pertinent data.

C.3.9 Delivery Order Limitations

a. Minimum Order Size: Individual delivery orders issued under this contract must meet the minimum order size as specified within each Contract Line Item Number (See Section B, Continuation of SF 1449). When the Government requires supplies covered by this contract in amounts less than stated above, the Government is not obligated to purchase, nor is the

Contractor obligated to furnish those supplies under this contract.

b. Maximum Order: The maximum quantity specified within each Contract Line Item Number

(See Section B, Continuation of SF1449) is the maximum number of doses that may be ordered during the contract period of performance. Contractors are advised that the maximum quantity represents their commitment to the Government under their contract.

c. Delivery Orders shipments:

1. Shipments shall be sent with all transaction information necessary to be compliant with applicable Drug Supply Chain Security Act requirements regarding Transaction Information

(TI), Transaction History (TH), and Transaction Statement (TS). Initially, paper documentation or portal access will be acceptable, but EDI messaging between contractors and CDC will transition to allow electronic transmission of information.

2. The Government reserves the right to reject vaccine doses that exceed delivery order requirements. The Government shall notify the Contractor when excess doses have been delivered to distribution sites. The Contractor is responsible for contacting the distribution site to make arrangement for the return of the excess doses and will be responsible for shipping cost associated with their return.

3. Bulk order shipments, when possible, shall consist of

a. One NDC per skid

b. Full skid quantities with same lot number

c. Full case quantities (when total order size allows)

C.3.10 FAR 52.216-18 Ordering (Aug 2020)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from the effective date of the contract through the expiration date of the contract.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) A delivery order or task order is considered "issued" when—

(1) If sent by mail (includes transmittal by U.S. mail or private delivery service), the

Government deposits the order in the mail.

(2) If sent by fax, the Government transmits the order to the Contractor's fax number; or

(3) If sent electronically, the Government either—

(i) Posts a copy of the delivery order or task order to a Government document access system, and notice is sent to the Contractor; or

(ii) Distributes the delivery order or task order via email to the Contractor's email address.

(d) Orders may be issued by methods other than those enumerated in this clause only if authorized in the contract.

C.3.11 FAR 52.216-22 Indefinite Quantity (Oct 1995)

(a) This is an indefinite quantity contract for the supplies specified and effective for the period stated in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies specified in the Schedule up to and including the quantity designated in the Schedule as the “maximum.” The Government shall order at least the quantity of supplies designated in the Schedule as the “minimum.”

(c) Except for any limitations on quantities in the Delivery Order Limitations clause or in the

Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor’s and Government’s rights and obligations with respect to that order to the same extent as if the order were completed during the contract’s effective period;

provided, that the Contractor shall not be required to make any deliveries under this contract after fifteen (15) working days beyond the expiration date of the contract.

C.3.12 Contractor's Ordering/Payment Address

Submission of all orders for Contractor’s vaccines and payment of invoices shall be addressed as referenced below:

Ordering Address Payment Address

C.3.13 Invoice Submission

1. Invoice submission under this contract will be made as follows:

a. Federal Government: The Contractor shall submit invoices via Electronic Data Interchange

(EDI).

b. Awardees: The Contractor shall submit one hard copy of its invoice(s) to the address specified on the delivery order.

c. In accordance with 5 CFR part 1315 (Prompt Payment), CDC's Office of Financial Resources is the designated billing office for the purpose of determining the payment due date under FAR

32.904.d. The Contractor agrees to include the following information on each invoice:

1. Contractor’s name, invoice number, and invoice date;

2. Contract number, or other authorization for delivery of property and/or services;

3. Description, cost or price, and quantity of property and/or services actually delivered or rendered;

4. Shipping and payment terms;

5. Other substantiating documentation or information as required by the contract;

6. Name where practicable, title, phone number, and complete mailing address of responsible official to whom payment is to be sent;

7. NDC and Lot number of vaccine vials/syringes shipped;

8. CDC accounting and appropriation data as described on the delivery order;

9. Electronic Funds Transfer (EFT) and Taxpayer Identification Number (TIN); and

10. Purchase Order (PO) Number and PO Line Item Number.

C.3.14 Method of Payment

a. Federal Government:

1. The Government will use electronic funds transfer when making payment under this contract IAW FAR Clause 52.232-33, payment by Electronic Funds Transfer - System for

Award Management (Oct 2018).

2. Payments for vaccine purchases will be tracked in the CDC vaccine ordering system.

3. The Government is not liable for payments related to orders submitted by states, cities, or territories.

b. Awardees: By check

C.3.15 Contracting Officer

(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.

C.3.16 Contracting Officer Representative (COR)

A COR will be designated in writing by the Contracting Officer to serve during the period of performance of the contract. The COR shall be responsible for guidance in regard to the technical aspect of the contract, provide a point for liaison between the Contractor and other

Government agencies and be the general focal point to address technical and logistical problems relating to the performance under the contract. The COR shall not have the authority to make any commitments or authorize any changes which affect the contract price, terms and/or conditions;

any such changes shall be referred to the Contracting Officer for action.

C.3.17 Return Privileges

Return privileges for credit, reimbursement, or exchange do not apply to this contract except vaccines not conforming to the specifications set forth herein.

C.3.18 Restrictions on Use of Vaccines

Vaccines obtained under this contract shall be used only in children 18 years of age and younger as authorized under Section 1928 of the Social Security Act. Sale of such vaccine to any person or entity or reimbursement of vaccine costs is strictly prohibited. Free distribution of such vaccine is also prohibited, except where such vaccine is administered in the context of Federal and Awardee immunization program activities.

C.3.19 Federal Excise Tax Credit

Negotiated prices for the vaccines included in this Contract may include a Federal Excise Tax

(See Continuation of SF 1449 for applicable Contract Line Item Numbers). If for any reason the vaccine is returned (other than for resale) or destroyed, the Contractor shall within 6 months following the date the vaccine is returned or destroyed, file a claim for credit or refund relative to any tax previously paid on such vaccine. The Contractor agrees to credit or refund the amount of such excise tax to the purchaser to the extent that the Contractor receives a credit or refund from the Federal Government. Any such credit or refund to the purchaser is expressly conditioned upon the authorized purchaser providing a written summary of events leading to the request for credit or refund. The purchaser shall return all undistributed vaccine to the Contractor for proper disposal, unless destruction of the vaccine renders return impossible. If destruction of the vaccine renders return impossible and is therefore destroyed by the purchaser, the authorized purchaser must provide a written summary of events to the Contractor within 30 days of said destruction. If a contract is in place with the Contractor at the time when a credit or refund is due; the purchaser may elect to receive vaccine which will be purchased at the current contract price in lieu of a cash payment. Otherwise, the Contractor shall refund the amount due to the purchaser’s account. If a credit or refund is issued by the Contractor for state or local funds, it shall be submitted to the state or local public health entity identified in the request for FET credit. For all Federal Excise Tax refund and other checks sent to the government, each shall reference the Purchase Order number(s) and line item(s) of origin. Whenever a check is sent to

CDC in response to a return PO, the following documentation shall be included with the check and sent to the COR. This documentation shall include a mapping between the check number and the return PO numbers and associated PO line item numbers that are covered by the check.

If a credit or refund is issued by the Contractor to the Federal Funds account, it shall contain the

Contractor’s DUNS and TIN/EIN and shall be submitted either via EDI (for credit) or to the following address (for check):

Centers for Disease Control and Prevention

Office of Financial Resources (OFR)

Attn: Debt Management Branch

P.O. Box 15580

Atlanta, GA 30329-4027

C.3.20 Delinquent Delivery Reports

The Contractor shall provide CDC with a weekly electronic listing of all CDC orders that have not been shipped within the agreed upon delivery schedule. The report shall include the following information: order number, date of order, and status of order in number of pending/undelivered doses. The report shall also provide an explanation as to the cause for the delinquent delivery as well as when the vaccine will be delivered. This notification shall not relieve the contractor from meeting its obligations under the contract and shall not limit the

Government’s right to seek relief for any breach of contract for failure to perform, including termination for cause.

C.3.21 Biological Surveillance Data Reports

A. The Contractor shall submit a monthly report of historical sales data for the United States by month and state specifying the name of the vaccine, NDC #, and the total number of doses sold

(segregated by CDC and non-CDC sales), in a standardized format acceptable to the Contractor and the CDC. The report shall be submitted electronically to the COR by the 15th of the month.

Information related to vaccine sales through CDC contracts is not considered proprietary. CDC acknowledges that those reports pertaining to private sales unrelated to this contract are confidential and proprietary information of the Contractor, and shall not use reports for any purpose other than CDC’s internal tracking and reporting purposes and shall not further disclose such reports without the Contractor’s prior written consent unless required by the law or other

Federal authority; provided that, no Contractor authorization shall be required for the CDC to include the data from the Contractor’s report in a report in which aggregated data from multiple

Contractors is summarized, so long as, with respect to multi-sourced products, the CDC’s aggregated report does not include any data which could be individually identified as the

Contractor’s. In the event that CDC is required by law or other Federal authority to disclose such reports required to be held confidential hereunder, CDC shall notify the Contractor prior to making such disclosure in accordance with law or other Federal authority.

B. Data Reports to Manufacturers

The Government will submit monthly reports of all vaccine data specifying doses by project, zip code, and NDC # in a standardized format. For all vaccines except direct ship vaccines, the

Government shall provide distribution data. Because the Government does not distribute direct ship vaccines, purchase data will be provided. The reports shall be submitted electronically to the Contractor by the 15th of the month for the previous month. The Government shall also provide the Contractor with an annual Vaccine Tracking System (VTrckS) spend plan for each

Awardee and an annual providers list during the first quarter of the fiscal year.

C.3.22 Prohibitions on Inducements

The Contractor is expressly prohibited from offering, providing, or arranging inducements of any kind to providers or authorized purchasers ordering vaccine under this contract for the purpose of obtaining orders for vaccine. Examples of such inducements include, but are not limited to:

entertainment, meals, and free or reduced prices for syringes, vaccines, or other medical products or supplies. If the Contractor has entered into similar agreements with the authorized purchasers which offer inducements relative to its commercial business, these agreements must be clear that they do not apply to purchases made under the CDC Federal contracts.

C.3.23 Contract Changes

Notwithstanding FAR Clause 52.212-4(c), Changes, the parties hereby agree that modifications for funding and other administrative changes (e.g., changes to CDC accounting data) that do not affect the terms and conditions of the contract may be made unilaterally by the CDC.

C.3.24 Vaccine specific information – Images, SDS, HDA, PI, and NDC Mapping Template

1. Upon contract award, for all new vaccines, the Contractor agrees to provide the following to the COR:

o Camera-ready vaccine product images in .pdf format and written authorization for CDC to use the images. (CDC will use the images to illustrate the Contractor’s products on the

CDC vaccine ordering system and for inclusion in CDC provider training materials.)

o Safety Data Sheet (SDS) o Healthcare Distribution Alliance (HDA) form, and o Package Insert (PI)

Additionally, Contractor agrees to provide updated product images, SDSs, HDA forms, and PIs

a. if these items change or new NDCs are added during the course of the contract, and

b. for existing vaccines if requested.

2. For each vaccine available on this contract (new and previously offered), Contractor shall complete the information in the template below. If there is more than one component/NDC within the unit of use, each component NDC should be listed separately along with component name.

Unit of Sale (Box/Carton) Unit of Use

(Vial/Syringe)

NDC (5-4-2

format)

Brand Name/Trade

Name Description/Presentation NDC (5-4-2 format)

C.3.25 Advance Notice of Supply Issues

The Contractor agrees to provide advance notification to COR and the CDC Contracting Officer of any supply issue which may result in the Contractor’s failure to deliver vaccine within the agreed upon delivery schedule specified in the contract. This notification shall be given as soon as the Contractor becomes aware of the scope of the problem that may impede the timely delivery of vaccine. This notification shall not relieve the Contractor from meeting its obligations under the contract and shall not limit the Government’s right to seek relief for any breach of contract for failure to perform, including termination for cause. Furthermore, any deviation from the delivery schedule due to a vaccine supply issue will demonstrate reasonably equal treatment with respect to the fulfillment of orders between CDC and the non-government customers.

C.3.26 Authorized Distributor of Record (ADR) Agreements

In accordance with the Prescription Drug Marketing Act (PDMA) of 1998, it is requested that all suppliers provide a written statement included as an attachment in Section D of this solicitation, which designates the CDC as the ADR for all vaccines subject to distribution under this contract.

C.3.27 Use of VFC Provider Lists and Distribution of Material

a. Contractors are prohibited from utilizing VFC providers lists obtained from any source for any mailing or other communication with VFC providers, except as approved in writing by the

CDC COR. In addition, contractors are prohibited from otherwise communicating with VFC providers regarding the VFC program, except as approved in writing by the CDC COR. To the extent that Contractors have established relationships with VFC providers or authorized purchasers under this contract that are independent from the VFC program, communications related to such independent relationships are not covered by this provision and do not require

CDC consent.

b. Contractors are prohibited from providing names and/or addresses of VFC providers to any third party, except as needed to comply with the terms of this contract, in which cases the CDC

COR shall be notified in writing.

c. Any Contractor that ships vaccine directly to VFC providers is prohibited from inserting any promotional or other material that is promotional in nature for any product that the Contractor produces, into shipping containers for vaccine purchased under this contract, except for material related to use of the vaccine as approved in writing by the CDC COR. Additionally, any shipping container inserts that are required, such as handling instructions or educational materials, should not contain any promotional material as part of its content.

C.3.28 New FDA Product License

Manufacturers who receive a new FDA product license for a vaccine already included within the scope of a VFC resolution may…