A19. RFP 75D301 23R 72644.pdf

PAGES

15A. NAME

AND

ADDRESS

OF

OFFEROR

SEC. PAGE(S) SEC. PAGE(S)

(Date) (Hour)

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amend-ments to the SOLICITATION for offerors and related documents numbered and dated:

(Type or Print)

SOLICITATION, OFFER AND AWARD 1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

1 58

2. CONTRACT NO.

3. SOLICITATION NO.

75D301-23-R-72644

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

04/03/2023

6. REQUISITION/PURCHASE

NO.

00HCVLDE-2023-73357

7. ISSUED BY CODE 8219 8. ADDRESS OFFER TO (If other than Item 7) 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

9. Sealed offers in original and copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in until 3PM EDT local time 05/05/2023

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) DESCRIPTION (x) DESCRIPTION

PART I – THE SCHEDULE PART II – CONTRACT CLAUSES

X A SOLICITATION/CONTRACT FORM 1 X I CONTRACT CLAUSES 35

X B SUPPLIES OR SERVICES AND PRICES/COSTS 2 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

X C DESCRIPTION/SPECS./WORK STATEMENT 3 X J LIST OF ATTACHMENTS 43

X D PACKAGING AND MARKING 3 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 10 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 11 X K OTHER STATEMENTS OF OFFERORS 44

X G CONTRACT ADMINISTRATION DATA 12 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 49

X H SPECIAL CONTRACT REQUIREMENTS 17 X M EVALUATION FACTORS FOR AWARD 57

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 different period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52-232-8)

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

AMENDMENT NO. DATE AMENDMENT NO. DATE

CODE FACILITY 16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT

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

21. ACCOUNTING AND APPROPRIATION

10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( ) 23. SUBMIT INVOICES TO ADDRESS SHOWN IN (4 copies unless otherwise specified)

ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 8219 25. PAYMENT WILL BE MADE BY CODE 434 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.

AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 33 (REV. 9-97)

PREVIOUS EDITION IS UNUSABLE Prescribed by GSA

FAR (48 CFR) 53.214©

K

Section B - Supplies Or Services And Prices/Costs

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE NOT TO EXCEED:

0001 CISA Base IDIQ

CISA IDIQ -

Clinical Immunization Safety Assessment activities meeting public health priorities for CDC. Work performed will be based on CISA project requirements. Ordering Period for Task Orders under this IDIQ is 9/15/2023 - 9/14/2028..

Contract CLIN 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 IDIQ amount of $5,000.00. The maximum amount for all task orders under all CISA IDIQ contracts shall not exceed $86,000,000.00

MAXIMUM

VALUE

$86,000.000.00

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 of September 29, 2029

B.7 SERVICE CONTRACT ACT

The contract labor categories are executive, administrative, professional labor and generally exempt from the Service Contract Act. Each RFTP will be reviewed for applicability.

Section C - Description/Specification/Work Statement C.1 Background and Need

Vaccines are one of the most effective means of reducing or eliminating morbidity and mortality from selected infectious diseases.i However, no vaccine is completely effective or safe and concerns about vaccine safety may lead to decreased uptake of vaccine.ii The licensed vaccines currently in routine use in the United States have been judged by the Food and Drug Administration (FDA), with input from its advisory committee, to be safe and effective.iii Serious adverse events following immunization (AEFI), which may or may not be causally related to vaccines, are rare. However, clinical trials may not be large enough to detect these rare events and AEFI may not be observed until the vaccine is widely used in populations after clinical trials are complete.iv Similarly, special populations, such as persons with autoimmune diseases or immunodeficiency, may be excluded from or not be adequately represented in clinical trials; AEFI in these populations may not be detected until after licensure.

A comprehensive vaccine safety system exists in the United States.5 The Centers for Disease Control and Prevention’s (CDC) Immunization Safety Office (ISO) and FDA co-manage the Vaccine Adverse Event Reporting System (VAERS).v,vi The main goal of VAERS is to identify potential vaccine safety problems (“signals”) that can be further assessed in other systems, such as CDC’s Vaccine Safety Datalink.vii The VAERS form collects information on demographics, health history, vaccine(s) received, and signs and symptoms of the adverse events experienced.6,8 Information from the reports is entered into a database that is maintained by the VAERS contractor.

Medical records are requested for all reports coded as serious,8 which includes adverse events resulting in death or hospitalization, and for other reports of special interest.

Consistent with good pharmacovigilance practices, CDC and FDA staff review and analyze VAERS reports at the individual and aggregate levels.6, 9 While aggregate analysis is especially useful to look for disproportionate reporting patterns, the International Society for Pharmacoepidemiology (ISPE) has stated that “careful descriptions of relevant clinical features in published case reports can contribute to the growth in understanding about the safety of medical products.”10 Information from individual case reviews contributes to the understanding of biologic mechanisms for AEFI and may also help generate and refine hypotheses about risk factors for AEFI that could be further studied. In a report from the Institute of Medicine (IOM), information from published case reviews of AEFI helped provide mechanistic evidence for causality assessments.11

To advance knowledge of vaccine safety and inform clinical and public health practice, high quality clinical assessments and clinical research are also essential. Emerging vaccine safety issues and new research needs continue to emerge. Studies are needed to identify risk factors for AEFI, especially in vulnerable populations. In addition, studies are needed to identify and evaluate preventive strategies for AEFI. It is essential for vaccine safety systems and infrastructure to keep pace with cutting edge research and technologic developments in vaccinology, as well as advances in related clinical fields. Having a project that facilitates CDC’s collaboration with vaccine safety researchers and clinical experts at prominent academic medical centers or health care institutions strengthens national capacity for clinical consultation, surveillance, and innovative vaccine safety research.

Educating and assisting healthcare providers who assess patients who may have AEFI is also important. Healthcare providers must frequently communicate with parents and patients about the benefits and risks of vaccination and address difficult questions about vaccine safety. In recent years, this task has become more challenging for several reasons, including a more complex immunization schedule, heightened public attention to vaccine safety issues, and the widespread use of the internet and social networking by consumers to receive health information. CDC responds to questions about vaccine safety from healthcare providers and other constituents, including state health departments, other federal agencies, and professional societies (e.g., the American Academy of Pediatrics).12 A main source of immunization inquiries to CDC has been through CDC-INFO (https://www.cdc.gov/cdc-info/index.html).5 ISO is referred complex vaccine safety inquires that cannot be addressed by other programs.

Inquiries may also come directly to ISO staff, particularly from state health departments. Since 2002, ISO has maintained an inquiry tracking system for vaccine safety inquiries.12 While the most common reason for inquires during 2002-2009 was to address questions about VAERS data, 21% of the inquiries ISO received during this time period were for clinical advice about a vaccine safety concern.12 During this time, some of the clinical cases of AEFI received by ISO, particularly those in need of specialist clinical advice, were referred to the Clinical Immunization Safety Assessment (CISA) Project13 for assessment.

In recent years, the CISA Project has contributed to vaccine safety monitoring efforts during several emergency responses, including the 2009 H1N1 pandemic14 and the 2019 COVID-19 pandemic. Since December 2020, CISA has operated a 24/7 on-call service for U.S. healthcare providers and state health departments with complex questions about COVID-19 vaccine safety.13

Mission

The overall mission of the Clinical Immunization Safety Assessment (CISA) Project is to improve understanding of adverse events following immunization (AEFI) at the individual patient level.

Goals

1) 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) Assist the Centers for Disease Control and Prevention (CDC) and its partners in evaluating emerging vaccine safety issues

3) Conduct clinical research studies to better understand vaccine safety and identify preventive strategies for

AEFI

C.2 Project Objective

CDC seeks to establish the CISA Project 2023-2028 to improve vaccine safety at the individual patient level. This proposed CISA Project builds on the experience of the current CISA Project (started in 2012)13 and the previous CISA network (started in 2001).15 The scope of the CISA Project 2023-2028 is guided by lessons learned from real world experience in the CISA Project during the past decade, particularly during the global COVID-19 pandemic. It also aligns with objectives in the U.S. Vaccines National Strategic Plan: 2021-2025.16

The purpose of this CISA Project indefinite delivery, indefinite quantity (IDIQ) contract is to provide the CDC’s Division of Health Care Quality Promotion (DHQP), Immunization Safety Office (ISO) with an “as needed” mechanism to obtain required services, including an ongoing service for expert clinical consultation, through the issuance of individual Task Orders. These Task Orders would support vaccine safety monitoring and evaluation that meet public health needs for CDC. CDC may make multiple awards to contract with certain organizations (e.g., academic centers or health plans) in the United States. The CISA Project will be a resource to address clinical vaccine safety issues and provide a public health service to the nation. The project will also contribute to or conduct studies to answer questions about the safety of vaccines recommended for use in the United States and how to prevent AEFI. Results from such studies shall provide evidence to better inform vaccination practices. CISA research studies are registered on ClinicalTrials.gov and described on the CISA website.

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 CISA 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.

https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/studies.html

C.4 Scope of Work

The Contractor shall provide all labor, supervision, equipment, materials, supplies, travel, transportation, and perform all work necessary to provide public health, scientific, and technical services in support of advancing vaccine safety activities, as specifically required under individual Task Orders under this contract.

The two main requirements for this CISA IDIQ contract include:

1. Clinical consultations and issue evaluations: provide clinical consultations for vaccine safety cases, perform clinical case reviews and evaluation of vaccine safety issues, and coordinate activities to support these functions.

2. Research studies to advance knowledge of vaccine safety and inform clinical and public health practices.

C.5 Technical Requirements

C.5.1 - Requirement 1: Clinical Consultations and Issue Evaluations: provide clinical consultations for vaccine safety cases, perform clinical case reviews and evaluation of vaccine safety issues, and coordinate activities to support these functions.

As specified in individual Task Orders, the Contractor may conduct work under this technical requirement. Work will include all activities, as identified by the Government, regarding vaccine safety. The Contractor may assist the Government in providing clinical consultation services to U.S. healthcare providers and health departments with a complex vaccine safety question about an individual patient, which is one of the main goals of CISA. . Advice from CISA is used to assist providers and health departments with clinical decision making; however, provision of direct patient care is the responsibility of the treating healthcare provider and out of scope for the CISA Project.

The Contractor may also conduct case reviews to assist the Government with surveillance for AEFI, for example by reviewing cases of a new vaccine safety concern identified in VAERS. The Contractor shall be capable of evaluating vaccine safety cases and issues that affect children and adults. The Contractor may provide on-call consultation services outside of business hours, particularly during public health emergencies about urgent vaccine safety cases or issues.

The Contractor may provide a synthesis of the clinical case reviews, and other emerging vaccine safety issues. This work may lead to a broader understanding of vaccine safety issues and inform clinical or public health practices. For example, the Contractor may be asked to assist CDC to synthesize vaccine safety evidence for the Advisory Committee on Immunization Practices (ACIP).17 The Contractors may also help to generate and refine hypotheses on risk factors for AEFI that need further study.

The Contractor shall provide clinical expertise in various medical disciplines/specialties. In this capacity, the Contractor may need input from experts who can participate in the clinical review, synthesis, and evaluation activities. In addition to knowledge of vaccine safety and pediatric and adult infectious diseases, examples of the areas of expertise that may be required include pediatric and adult subspecialties of allergy, neurology, hematology, and cardiology, and also obstetrics and gynecology. The Contractor shall also provide selected subject matter expertise to CDC for other ongoing activities regarding vaccine safety.

Examples of other activities that Contractors may be asked to undertake as part of the clinical evaluations technical requirement include: 1) developing vaccine safety algorithms or contributing to clinical guidance to assist practicing clinicians in the assessment and management of patents with vaccine safety concerns; 2) assisting CDC with enhanced surveillance for emerging vaccine safety concerns, particularly by reviewing VAERS reports; 3) facilitating biological specimen collection and transfer from individuals who experienced serious AEFI, to a specified biological repository; 3) identifying and contacting individuals with AEFIs who were identified through VAERS or other sources, to obtain consent and enroll them for participation in vaccine safety studies supported by the Government (the Contractor may or may not be a co-investigator in these studies).

The Contractors may also develop an Emergency Response plan. This plan will outline activities to rapidly support enhanced vaccine safety clinical case reviews and evaluation activities in the case of an urgent public health incident or emergency situation necessitating implementation of an emergency vaccination program. For example, in 2009- 2010 CISA conducted clinical case reviews of AEFI to support the US emergency response to H1N1 pandemic influenza.viii During 2020-2022 CISA has operated a 24/7 on-call service for COVID-19 vaccine safety consultation.13 CISA has provided technical input for COVID-19 vaccine clinical guidance and contributed to several enhanced surveillance activities for COVID-19 vaccine.18,19,20 In the event of an emergency, Task Orders may be issued to Contractors for the execution of the Emergency Response plan.

The Contractor may also conduct activities that support the management and development of the clinical evaluations technical requirement within CISA as specified in the applicable Task Orders. Examples of such services include logistical activities needed to prepare cases for presentation to clinical working groups (e.g., coordinating schedules for subject matter expert participation); clinical case tracking; organizing phone conferences and preparing minutes;

providing cost reports; and maintaining a secure internal website. The Contractor may also provide the appropriate facilities, data management, and other equipment necessary for conducting this requirement. This includes the appropriate office facilities, record keeping, disaster recovery plans, computer hardware and software, communication, and conferencing equipment. The Contractor may also host and coordinate the CISA Annual Meeting.

Deliverables: To be specified within specific Task Orders

C.5.2 Requirement 2: Research studies to advance knowledge of vaccine safety and inform clinical and public health practice

As specified in individual Task Orders, the Contractor may conduct work under this technical requirement. The Contractor shall perform all work necessary to develop, conduct and/or participate in research studies, as specifically required under individual Task Orders under this contract. The Contractor may lead or participate as co-investigators in research conducted for single or multi-site studies which meet CDC’s public health vaccine safety needs. The project period for these studies may be up to five years. CDC may elect to issue two types of Task Orders for some studies: 1) Contractor to lead the study and, 2) Contractor(s) to contribute data and/or participate as co-investigators in the study. Studies may seek to identify risk factors for AEFI, including host (genetic) risk factors, particularly in special populations that may be at increased risk for vaccine preventable diseases. Studies may also assess the safety of newly licensed or recommended vaccines or evaluate strategies to prevent AEFI. Studies may use a randomized clinical trial design. CISA has published results from several research studies in children, adults, and pregnant women.21,22,23

Under this contract technical requirement, Contractors may conduct all activities that would support the management and development of this research requirement within CISA as required in the applicable Task Orders.

Activities include those directly related to conduct of the study such as enrolling patients, collecting patient data (including biological specimens), and analyzing data. In addition, the Contractor may obtain Institutional Review Board (IRB) documentation, organize phone conferences and meetings, prepare minutes, and provide cost reports to CDC. The Contractor may also provide the appropriate facilities, data management, and other equipment necessary for conducting this requirement. This includes the appropriate office facilities, record keeping, disaster recovery plans, computer hardware and software, communication, and conferencing equipment.

Deliverables: To be specified within specific Task Orders

C.6 Place of Performance Services will be performed at vendor specified site in the United States. All aspects of work related to this contract must be performed in the U.S.; this includes work performed by the Contractor and any sub-Contractors. Under the technical input from CDC, internationally based subject matter experts may participate in specified discussions.

C.7 Reporting Schedule The Contractor’s reporting requirements will be defined in each individual Task Order. Reports may include weekly, monthly, or quarterly reports, along with a final report.

C.8 Travel Attendance and participation at CDC scientific meeting and conferences.

The contractor shall notify CDC in advance of any travel plans and will adhere to all federal travel policies. The number of staff permitted to attend the Annual Conference will be determined and approved by CDC.

All conference travel will be authorized and funded in advance by the Government via task order modification.

The Government will reimburse the Contractor for travel related costs. The Contractor shall submit receipts for airfare, lodging, car rentals, and other incidental travel-related expenses. Travel costs shall not exceed the maximum per diem rates set forth in the Federal Travel Regulation (FTR).

C.9 Training The Contractor, at its own expense, shall perform training for their professional staff associated with required competencies for each Task Order. The Government shall be responsible for providing orientation and training on specific department, unit, site, programs or education requirements, policies, and procedures peculiar to the work to be performed by the Contractor and unique to CDC operations if required for specific Task Orders and approved in advance by the Contracting Officer and the Contracting Officer Representative (COR). The Government will not authorize training for Contractor employees to attend seminars, symposiums, or user group conferences unless determined that attendance is mandatory or deemed likely to enhance the performance of Task Order requirements and such training is approved in advance by the Contracting Officer. The Contractor shall assume full responsibility for keeping Contractor professional employees abreast of advances in relevant state-of-the-art technologies.

C.10 REFERENCES

1. Salmon D, Pavia A, Gellin B. Editor’s Introduction: Vaccine Safety throughout the Product’s Life Cycle.

Pediatrics;2011; May;127 Suppl 1:S1-4. Epub 2011 Apr 18, available at http://pediatrics.aappublications.org/content/127/Supplement_1/S1.full, accessed on January 13, 2022.

2. DeStefano F, Bodenstab HM, Offit PA. Principal Controversies in Vaccine Safety in the United States. Clinical Infectious Diseases. 2019; Aug 1;69(4):726-731, available at https://academic.oup.com/cid/article/69/4/726/5316263, accessed on January 13, 2022.

3. Marshall V and Baylor N. Food and Drug Administration Regulation and Evaluation of Vaccines, Pediatrics;2011; May;127 Suppl 1:S23-30. Epub 2011 Apr 18, available at http://pediatrics.aappublications.org/content/early/2011/04/18/peds.2010-1722E.full.pdf+html, accessed on January 13, 2022.

4. Ball R, Horne D, Izuriet H et al. Statistical, Epidemiologic, and Risk Assessment Approaches to Evaluating Safety of Vaccines throughout the lifecycle at the Food and Drug Administration, Pediatrics. 2011; May;127 Suppl 1:S31-8. Epub 2011 Apr 18, available at http://pediatrics.aappublications.org/content/127/Supplement_1/S31.full, accessed on January 13, 2022.

5. CDC. About the Immunization Safety Office (ISO), available at https://www.cdc.gov/vaccinesafety/iso.html, accessed on January 13, 2022.

6. Shimabukuro TT, Nguyen M, Martin D, DeStefano F. Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS). Vaccine. 2015 Aug 26;33(36):4398-405. Epub 2015 Jul 22, available at, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4632204/, accessed on January 13, 2022.

7. McNeil MM, Gee J, Weintraub ES et al. The Vaccine Safety Datalink: successes and challenges monitoring vaccine safety. Vaccine. 2014 Sep 22;32(42):5390-8. Epub 2014 Aug 6, available at https://stacks.cdc.gov/view/cdc/81251, accessed on January 13, 2022.

8. HHS, Vaccine Adverse Event Reporting System, available at https://vaers.hhs.gov/index, accessed on January 13, 2022.

9. Food and Drug Administration. Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment, March 2005, available at https://www.fda.gov/media/71546/download, accessed on January 13, 2022.

10. Kelly WN, Arellena FM, Barnes J et al. Guidelines for submitting adverse event reports for publication, Pharmacoepidemiology and drug safety 2007; 16: 581–587, available at https://onlinelibrary.wiley.com/doi/epdf/10.1002/pds.1399, accessed on January 13, 2022.

http://pediatrics.aappublications.org/content/127/Supplement_1/S1.full https://academic.oup.com/cid/article/69/4/726/5316263 http://pediatrics.aappublications.org/content/early/2011/04/18/peds.2010-1722E.full.pdf+html http://pediatrics.aappublications.org/content/127/Supplement_1/S31.full https://www.cdc.gov/vaccinesafety/iso.html https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4632204/ https://stacks.cdc.gov/view/cdc/81251 https://onlinelibrary.wiley.com/doi/epdf/10.1002/pds.1399

11. Institute of Medicine (IOM). 2012l Adverse Effects of Vaccines: Evidence and Causality, available at https://www.nap.edu/catalog/13164/adverse-effects-of-vaccines-evidence-and-causality, accessed on January 13, 2022.

12. Miller, E, Batten B, Hampton L, et al. Tracking Vaccine Safety Inquiries to Detect Signals and Monitor Public Concerns. Pediatrics. 2011;127;S1, available at https://publications.aap.org/pediatrics/article/127/Supplement_1/S87/30146/Tracking-Vaccine-Safety-Inquiries-to-Detect, accessed on January 13, 2022.

13. CDC. Clinical Immunization Safety Assessment (CISA) Project, available at https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/index.html, accessed on January 13, 2022.

14. Salmon D, Akhtar A, Mergler M et al. Immunization-Safety Monitoring Systems for the 2009 H1N1 Monovalent Influenza Vaccination Program. Pediatrics 2011. 127:S78-S86, available at http://pediatrics.aappublications.org/content/127/Supplement_1/S78.full, accessed on January 13, 2022.

15. LaRussa P et al. Understanding the Role of Human Variation in Vaccine Adverse Events: The Clinical Immunization Safety Assessment (CISA) Network. Pediatrics. 2011;127 Suppl 1:S65-73, available at http://pediatrics.aappublications.org/content/127/Supplement_1/S65.long, accessed on January 13, 2022.

16. US Department of Health and Human Services. Vaccines. National Strategic Plan fo the United States: 2021- 2025, available at https://www.hhs.gov/sites/default/files/HHS-Vaccines-Report.pdf, accessed on January 13, 2022.

17. CDC, Advisory Committee on Immunization Practices (ACIP), available at https://www.cdc.gov/vaccines/acip/index.html, accessed on January 13, 2022.

18. CDC. Clinical Care Considerations for COVID-19 Vaccination, available at https://www.cdc.gov/vaccines/covid-19/clinical-considerations/index.html, accessed on January 13, 2022.

19. CDC COVID-19 Response Team. Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine — United States, December 14–23, 2020. 2021; 70(2);46–51.

20. See I, Su JR, Lale A et al. US Case Reports of Cerebral Venous Sinus Thrombosis With Thrombocytopenia After Ad26.COV2.S Vaccination, March 2 to April 21, 2021. JAMA. 2021;325(24):2448-2456.

21. Walter EB, Klein N, Wodi P et al. Fever After Influenza, Diphtheria-Tetanus-Acellular Pertussis, and Pneumococcal Vaccinations. Pediatrics. 2020 Mar;145(3):e20191909. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7055925/, accessed on January 13, 2022.

22. Schmader KE, Liu C, Harrington T et al. Safety, Reactogenicity, and Health-Related Quality of Life After Trivalent Adjuvanted vs Trivalent High-Dose Inactivated Influenza Vaccines in Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jan 4;4(1):e2031266.

23. Fortner KB, Swamy GK, Broder KR et al. Reactogenicity and immunogenicity of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant and nonpregnant women. Vaccine. 2018 Oct 8;36(42):6354-6360. Available at https://pubmed.ncbi.nlm.nih.gov/30219367/, accessed on January 13, 2022.

https://www.nap.edu/catalog/13164/adverse-effects-of-vaccines-evidence-and-causality https://publications.aap.org/pediatrics/article/127/Supplement_1/S87/30146/Tracking-Vaccine-Safety-Inquiries-to-Detect https://publications.aap.org/pediatrics/article/127/Supplement_1/S87/30146/Tracking-Vaccine-Safety-Inquiries-to-Detect https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/index.html http://pediatrics.aappublications.org/content/127/Supplement_1/S78.full http://pediatrics.aappublications.org/content/127/Supplement_1/S65.long https://www.hhs.gov/sites/default/files/HHS-Vaccines-Report.pdf https://www.cdc.gov/vaccines/covid-19/clinical-considerations/index.html https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7055925/ https://pubmed.ncbi.nlm.nih.gov/30219367/

Section D - Packaging And Marking

There are no clauses/provisions included in this section.

Section E - Inspection And Acceptance

FAR SOURCE TITLE AND DATE

52.246-6 Inspection - Time-and-Material and Labor-Hour (May 2001)

52.246-5 Inspection of Services - Cost-Reimbursement (Apr 1984)

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

FAR SOURCE TITLE AND DATE

52.242-15 Stop-Work Order (Aug 1989)

52.242-15 Alternate I Stop-Work Order - Alternate I (Apr 1984)

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)

G.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

G.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

G.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.

G.8. HHSR 352.232-71 Electronic Submission of Payment Requests (Feb 2022)

(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…