Statement of Work 2023-77317.docx

Statement of Work / Performance Work Statement Title: Adult-Onset Respiratory Recurrent Papillomatosis (AORRP) in the United States Period of performance of this contract is: September 30, 2023, to September 29, 2024 Base Period: September 30, 2023, to September 29, 2024

SECTION 1 – BACKGROUND

Recurrent respiratory papillomatosis (RRP) is characterized by wart-like lesions in the respiratory tract as a result of infection with human papillomavirus (HPV) types 6 or 11.1 These HPV types can cause both juvenile-onset RRP (JORRP) and adult-onset RRP (AORRP), which have distinct risk factors.2 While JORRP is associated with a clinical triad of firstborn child delivered vaginally to a young mother unvaccinated against HPV,3 AORRP has been linked with a higher number of lifetime sex partners and a higher frequency of oral sex than among adult controls.4-6 AORRP is not a reportable disease and little is known about its epidemiology.

AORRP can cause substantial morbidity; it is usually benign but has a malignant transformation rate of 1–7%.7 In AORRP, papillomas are typically restricted to the larynx, particularly the vocal folds, but can also involve the nasopharynx, tracheobronchial tree, and/or rarely the pulmonary parenchyma.8 Currently, surgery is the mainstay therapy, as there is no definitive medical cure. The goal of surgery is to remove visible disease while maintaining the integrity of the surrounding tissues, specifically preserving the normal anatomy of the vocal cords and avoiding development of stenosis. Another option for AORRP management is adjuvant therapy with the goal to increase the time interval between procedures.

AORRP is not a nationally notifiable condition, and there have been few efforts to characterize the burden of AORRP in the United States: a pre-vaccine era 1995 study projected incidence at the time to be 1.8 per 100,000 adults, with 3623 new cases per year (95% CI: 2359, 4887) and 9015 active cases (95% CI: 6435, 11591) in the United States.9 The lack of specific ICD-9 or ICD-10 codes makes investigation through electronic databases difficult as standardized methods have not been established. Further challenges to defining the burden of AORRP include respiratory symptoms that may lead to misdiagnoses as well as disease variability from spontaneous remission to aggressive disease progression.

HPV vaccines have been available in the United States since 2006; vaccination is routinely recommended for adolescents at age 11 or 12 years (or can start at age 9 years).10 Since 2019, catch-up vaccination has been recommended for all persons through age 26 years, and shared clinical decision-making has been recommended for some adults through age 45 years.11 Because RRP is caused primarily by HPV types preventable by HPV vaccination, impacts of the U.S. vaccination program are expected to include declines in RRP over time. Significant declines in JORRP following HPV vaccine introduction in the United States were recently reported.12 However, other HPV-associated conditions affecting the head and neck (e.g., oropharyngeal cancers) have been increasing among adults in the United States over the past few decades;13 factors associated with increases in oropharyngeal cancer could also be resulting in increases in AORRP. AORRP surveillance data are needed to establish baseline prevalence as well as trends over time as HPV vaccination coverage increases in the United States.

SECTION 2 – PURPOSE/OBJECTIVE

The overall objective of this project is to estimate prevalence of AORRP and establish an organized dataset of AORRP cases to provide important demographic and clinical information on this rare disease in the United States.9 This project will involve one coordinating clinical site (the contractor) collecting data from medical chart abstractions from AORRP patients treated in geographically diverse clinical sites (subcontractors).

Specific aims of this project are:

1) Estimate prevalence of AORRP in the United States.

2) Assess demographic and clinical characteristics collected through medical chart abstractions of persons with AORRP seen for care at the participating clinical sites, including demographic and clinical characteristics of interest such as sex, race/ethnicity, age at symptom onset, age at diagnosis, and HPV vaccination history.

Performance objectives for the contractor are to collect data from medical chart abstractions performed at each participating clinical site during the previous 5 calendar years (January 1, 2018–December 31, 2022).

Required results are a database of epidemiologic and clinical data on AORRP patients from a geographically diverse set of clinical sites in the United States.

SECTION 3 – SCOPE OF WORK

The contractor will provide all labor, materials, and equipment and perform all work necessary to collect AORRP data from electronic medical records through a medical cart abstraction. The contractor will recruit a variety of otolaryngology clinical sites, oversee collection of data, and format and submit data to CDC. Prior to collection of data, the contractor shall ensure they have any required IRB approvals and consent forms or waivers required to perform the work. All data submitted must be free of personal identifiers.

SECTION 4 – TASKS TO BE PERFORMED

Task 1: Using Government-furnished draft materials, the contractor shall work with CDC to finalize study materials suitable for IRB review at CDC, contractor’s site, and subcontractors’ sites as appropriate.

1. Necessary study materials include, but are not limited to, the protocol, standardized medical chart abstraction form, consent forms or waivers, database for the entry of the corresponding chart abstraction data, and data dictionary for coding all variables in the database.

Task 2: Contractor shall identify and recruit a geographically diverse group of clinical sites across the United States, each of which has cared for at least one patient with AORRP between January 1, 2018, and December 31, 2022 (e.g., adult otolaryngologists, ENT specialists, or others who perform laryngoscopy).

1. The Contractor shall identify participating institutions that have the capacity to perform the scope of work (including at least one institution in 5 or more of the 10 HHS Regions of the United States).

2. The contractor shall confirm the list of participating sites and confirm institutional review board (IRB) approvals for each applicable site.

a. The Contractor shall assist sites to secure IRB documents and send to CDC, confirming eligibility to participate for the duration of the project.

b. If a central IRB is required, CDC will serve as the central IRB.

Task 3: The contractor shall distribute the medical chart abstraction form to each participating site and report participant data to CDC quarterly.

1. The contractor shall provide training on data collection in accordance with the protocol developed.

2. For patients who sought care for AORRP at a participating site between January 1, 2018, and December 31, 2022, existing electronic health and medical records shall be abstracted using a standardized medical chart abstraction form to collect demographic and clinical elements.

a. Potential chart abstraction elements may include: geographic site, year, sex, race/ethnicity, age at initial AORRP symptom onset, age at initial AORRP diagnosis, HPV vaccination history (e.g., vaccine product, number of doses and date/s), month and year presented, total number of otolaryngology visits during the calendar year, state of residence, clinical presentation (e.g., stridor, difficulty breathing during exercise, snoring), measures of severity including number of surgeries per year and overall morbidity, therapeutic modalities administered (e.g., medications, surgeries), and other medical or behavioral risk factors for AORRP (e.g., STD diagnoses including HIV and anogenital warts, sexual behavior including lifetime number of sex partners of any sex, age at first oral/anal/vaginal sex, and oral sex practices).

3. The contractor shall ensure return of all chart abstraction forms from each participating site, enter data into the database for submission to CDC, and check the dataset for completeness.

a. The contractor shall submit an updated chart abstraction dataset (as an Excel document or SAS dataset) and all project documentation to CDC at least quarterly.

SECTION 5 – GOVERNMENT FURNISHED INFORMATION

The Government will provide a draft protocol and medical chart abstraction form that will be used to develop the final documents for this activity. The Government will also provide data storage for the final datasets at CDC and mechanism for secure transfer of data.

SECTION 6 – PLACE OF PERFORMANCE AND CONTRACT SUPPORT HOURS

SUBSECTION A – PLACE OF PERFORMANCE

The contract may be performed entirely off-site, primarily at the facilities of the contractor and subcontractors as appropriate. Travel to a government facility is not required. Meetings conducted between the contractor and CDC will be held virtually (e.g., via Zoom)

SECTION 7 – TRAVEL

Travel is not required to perform any tasks related to this contract.

SECTION 8 – DELIVERABLES/REPORTING SCHEDULE

• Task 1: Using Government-furnished draft materials, contractor shall work with CDC to finalize study materials suitable for IRB review at CDC, contractor’s site, and subcontractors’ sites as appropriate.

o Final protocol, medical chart abstraction form, database, and data dictionary – Protocol including medical chart abstraction form and consent form or waiver. CDC will review all documents prior to submission to an IRB.

Quantity: 1 protocol, 1 medical chart abstraction form, 1 database, and 1 data dictionary Due date: Within 3 months of contract award, by December 31, 2023 Deliver to: COR (Angela Conley) and Subject Matter Expert (Rayleen Lewis)

• Task 2: Contractor shall identify and recruit a geographically diverse group of clinical sites across the United States (including at least one institution in 5 or more of the 10 HHS Regions of the United States), each of which has provided care for at least one patient with AORRP between January 1, 2018, and December 31, 2022 (e.g., adult otolaryngologists, ENT specialists, or others who perform laryngoscopy).

o List of collaborating institutions – Provide a 1-page site report for each collaborating site selected to participate in the project, listing point of contact and basic information about the site including catchment area and geographic coverage.

Quantity: 1 report per site Due date: By December 31, 2023 Deliver to: COR (Angela Conley) and Subject Matter Expert (Rayleen Lewis) o IRB approval from each participating site – Obtain and maintain proof of local IRB approvals for each collaborating site and submit an electronic copy to CDC.

Quantity: 1 per site Due date: December 31, 2023 Deliver to: COR (Angela Conley) and Subject Matter Expert (Rayleen Lewis)

• Task 3: The contractor shall distribute the medical chart abstraction form to each participating site and report data to CDC quarterly. The contractor shall ensure collection of all data from medical charts of AORRP patients at each participating site, enter data into the database for submission to CDC, and check the dataset for completeness.

o Database with medical chart abstraction data – Enter all medical chart abstraction data into a database compatible with the data structure and dictionary and submit electronic files (Excel or SAS dataset) to CDC with no personal identifiers. The contractor shall review all data for completeness prior to reporting data to CDC.

Quantity: 1 database and corresponding data dictionary Quarterly, by March 31, June 30, and September 30 Deliver to: COR (Angela Conley) and Subject Matter Expert (Rayleen Lewis)

SECTION 9 – REFERENCE MATERIALS

1. Derkay CS, Bluher AE. Update on Recurrent Respiratory Papillomatosis. Otolaryngol Clin North Am. Aug 2019;52(4):669-679. doi:10.1016/j.otc.2019.03.011

2. Taliercio S, Cespedes M, Born H, et al. Adult-onset recurrent respiratory papillomatosis: a review of disease pathogenesis and implications for patient counseling. JAMA Otolaryngol Head Neck Surg. Jan 2015;141(1):78-83. doi:10.1001/jamaoto.2014.2826

3. Amiling R, Meites E, Querec TD, et al. Juvenile-onset Recurrent Respiratory Papillomatosis in the United States, Epidemiology and HPV Types — 2015–2020. Journal of the Pediatric Infectious Diseases Society. 2021:Aug 17;10(7):774-781. doi:10.1093/jpids/piab016.

4. Kashima HK, Shah F, Lyles A, et al. A comparison of risk factors in juvenile-onset and adult-onset recurrent respiratory papillomatosis. Laryngoscope. Jan 1992;102(1):9-13. doi:10.1288/00005537-199201000-00002

5. Ruiz R, Achlatis S, Verma A, et al. Risk factors for adult-onset recurrent respiratory papillomatosis. Laryngoscope. Oct 2014;124(10):2338-44. doi:10.1002/lary.24730

6. Omland T, Akre H, Lie KA, Jebsen P, Sandvik L, Brondbo K. Risk factors for aggressive recurrent respiratory papillomatosis in adults and juveniles. PloS one. 2014;9(11):e113584. doi:10.1371/journal.pone.0113584

7. Hasegawa Y, Sato N, Niikawa H, et al. Lung squamous cell carcinoma arising in a patient with adult-onset recurrent respiratory papillomatosis. Jpn J Clin Oncol. Jan 2013;43(1):78-82. doi:10.1093/jjco/hys179

8. Hu L, Benedict PA, Garber D, Wang B, Amin MR, Branski RC. Laryngeal distribution of adult-onset recurrent respiratory papillomatosis: A longitudinal study. Laryngoscope. Sep 2019;129(9):1993-1997. doi:10.1002/lary.27694

9. Derkay CS. Task force on recurrent respiratory papillomas. A preliminary report. Arch Otolaryngol Head Neck Surg. Dec 1995;121(12):1386-91. doi:10.1001/archotol.1995.01890120044008

10. Markowitz LE, Dunne EF, Saraiya M, et al. Human papillomavirus vaccination: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. Aug 29 2014;63(RR-05):1-30.

11. Meites E, Szilagyi PG, Chesson HW, Unger ER, Romero JR, Markowitz LE. Human Papillomavirus Vaccination for Adults: Updated Recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep. Aug 16 2019;68(32):698-702. doi:10.15585/mmwr.mm6832a3

12. Meites E, Stone L, Amiling R, et al. Significant Declines in Juvenile Onset Recurrent Respiratory Papillomatosis following HPV Vaccine Introduction in the United States. Clin Infect Dis. 2021 Sep 7;73(5):885-890. doi:10.1093/cid/ciab171.

13. Van Dyne EA, Henley SJ, Saraiya M, Thomas CC, Markowitz LE, Benard VB. Trends in Human Papillomavirus-Associated Cancers - United States, 1999-2015. MMWR Morb Mortal Wkly Rep. Aug 24 2018;67(33):918-924. doi:10.15585/mmwr.mm6733a2

SECTION 10 – MINIMUM VENDOR QUALIFICATIONS

The minimum qualifications of the vender are that they are an 1) expert in recurrent respiratory papillomatosis (RRP), 2) have experience conducting studies on RRP, and 3) have demonstrated experience conducting a multi-site study.

SECTION 11 – ADDITIONAL REQUIREMENTS

Information Security and Privacy Information security is not applicable. Procurement/Solicitation WILL NOT involve the handling, processing, storage, or transmission of PII. No privacy requirements apply to this solicitation. Privacy Act DOES NOT apply to this solicitation. Offerors WILL NOT require access to sensitive information to prepare an offer.

Human Subjects Protections in Research DOES NOT INCLUDE activities or tasks that meet the definition of research.

Paperwork Reduction Act (PRA) PRA does not apply.

Section 508 Compliance Electronic and Information Technology Accessibility

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508.

The complete text of the Section 508 Final Provisions can be accessed at http://www.access-aboard.gov/sec508/standards.htm.

(c) The Section 508 accessibility standards applicable to this contract are: 1194.

205 WCAG 2.0 Level A & AA Success Criteria 302 Functional Performance Criteria 502 Inoperability with Assistive Technology 504 Authoring Tools 602 Support Documentation 603 Support Services In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and documentation detail - whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508.

In order to facilitate the Government's determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(e) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

(End of verbiage) Printing No print clearance required.

SECTION 1 – PROPOSED CONTRACT TYPE

Firm Fixed Price

SECTION 2 – OPTIONAL SPECIAL CONSIDERATIONS

SUBSECTION A – PAYMENT CLAUSES

Payments in the amount shown in Section B of the contract will be made quarterly upon completion of the required deliverable.

The contractor will be paid quarterly based upon the submission of the required data. Quarterly payments will not exceed ¼ of the total price for the project.

SUBSECTION B – DATA RIGHTS CLAUSES

Rights in Data delivered under this contract shall be determined and allocated in accordance with the DFARS FAR 52.227-17 (Rights in Data-Special Works).

SECTION 3 – EVALUATION FACTORS

The Offeror will be evaluated based on their provided management plan, staffing plan, plan to recruit subcontractors, and price analysis.

SUBSECTION A – TECHNICAL

Technical Evaluation Criteria:

This solicitation will be awarded to the Offeror whose proposal is considered to be the most advantageous to the Government, price and other factors identified below considered.

The offeror will provide a written proposal describing the project management and staffing plans, to include:

• A management plan discussing the technical approach to this project. Provide information regarding protocol development, IRB approval process and timeline, coordinating sites, and data management plans.

• A staffing plan listing the members of the team who will conduct the project. Desired qualifications include current expertise in the clinical care of patients with RRP, previous experience conducting scientific research on RRP with systematic collection of data from medical records, experience conducting multi-site research, and history of relevant scientific publications regarding RRP. The offeror will provide staffing information including number of staff, role, and percent time, along with a resume or curriculum vitae (CV) for each staff member, specifying level of prior experience with RRP.

• Discuss how subcontractors (clinical sites) will be identified, recruited, and managed under the contract.

Proposals will be evaluated using a numerical score:

• Soundness of the scientific or technical approach for executing the requirements of the statement of work (up to 30 points)

• Managerial ability to achieve delivery or performance requirements as demonstrated by the proposed use of management and other personnel resources, and to successfully manage the project, as evidenced by the management plan and demonstrated by previous experience OTHER CONSIDERATIONS AND ADDITIONAL INFORMATION FOR OFFICE OF ACQUISITION SERVICES (up to 40 points) • Availability, qualifications, experience, education, and competence of professional, technical, and other personnel, to include proposed subcontractors and consultants, as evidenced by resumes and explanations of previous efforts (up to 20 points)

• Soundness of the proposed staff time, and validity of proposed subcontracting (up to 10 points) In addition, a price analysis of the quote will be conducted to determine reasonableness of the offeror’s price. A best-value continuum will be used to determine relative importance of cost or price. All evaluation factors other than cost or price, when combined, are approximately equal to cost or price.

52.232-39 52.232-40 352.222-70 Unenforceability of Unauthorized Obligations (Jun 2013) Providing Accelerated Payments to Small Business Contractors (Dec 2013) Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015)

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/browse/index/far (End of Clause)

FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Jan 2021)

(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 items:

(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 (Jul 2018) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2020) (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 items:

[Contracting Officer check as appropriate.] __ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (June 2020), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Jun 2020) (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.)

__ (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).

__ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Jun 2020) (31 U.S.C. 6101 note).

__ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C. 2313).

__ (10) [Reserved].

__ (11)

(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Mar 2020) (15 U.S.C. 657a).

__ (ii) Alternate I (Mar 2020) of 52.219-3.

__ (12)

(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Mar 2020) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (ii) Alternate I (Mar 2020) of 52.219-4.

__ (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.

__ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).

__ (17)

(i) 52.219-9, Small Business Subcontracting Plan (Jun 2020) (15 U.S.C. 637(d)(4)).

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

__ (iii) Alternate II (Nov 2016) of 52.219-9.

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

__ (v) Alternate IV (Jun 2020) 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 (Mar 2020) (15 U.S.C. 637(a)(14)).

__ (20) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Mar 2020) (15 U.S.C. 657f).

__ (22)

(i) 52.219-28, Post Award Small Business Program Rerepresentation (Nov 2020) (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 (Mar 2020) (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 (Mar2020) (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 (Mar 2020) (15U.S.C. 637(a)(17)).

__ (27) 52.222-3, Convict Labor (Jun 2003) (E.O.11755).

__ (28) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan2020) (E.O.13126).

__ (29) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

__ (30)

(i) 52.222-26, Equal Opportunity (Sep 2016) (E.O.11246).

_X_ (ii) Alternate I (Feb 1999) of 52.222-26.

__ (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.

__ (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.

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

__ (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

__ (35)

(i) 52.222-50, Combating Trafficking in Persons (Oct 2020) (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 (Oct 2015). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 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.

__ (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) 52.225-1, Buy American-Supplies (Jan2021) (41 U.S.C. chapter 83).

__ (49)

(i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (Jan 2021)(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.

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

__ (51) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (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 (Nov2007) (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 (Jun 2020).

__ (56) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

__ (57) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (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).

__ (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 (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).

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

__ (iii) Alternate II (Feb 2006) 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 items:

[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).

_X_ (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 Under Executive Order 13658 (Nov 2020).

__ (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (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 items. 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 (Jun 2020) (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 (Jul 2018) (Section 1634 of Pub. L. 115-91).

(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2020) (Section 889(a)(1)(A) of Pub. L. 115-232).

(v) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (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 (Oct 2020) (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 (May2014) (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 (Oct 2015) (E.O. 12989).

(xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (Nov 2020).

(xviii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (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 (Feb 2006) (46 U.S.C. Appx. 1241(b) 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 items a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of clause) Alternate I (Feb 2000). As prescribed in 12.301(b)(4)(i), delete paragraph (d) from the basic clause, redesignate paragraph (e) as paragraph (d), and revise the reference to "paragraphs (a), (b), (c), or (d) of this clause" in the redesignated paragraph (d) to read "paragraphs (a), (b), and (c) of this clause".

Alternate II. (Nov 2020) As prescribed in 12.301(b)(4)(ii), substitute the following paragraphs (d)(1) and (e)(1) for paragraphs (d)(1) and (e)(1) of the basic clause as follows:

(d)(1) The Comptroller General of the United States, an appropriate Inspector General appointed under section 3 or 8 G of the Inspector General Act of 1978 (5 U.S.C. App.), or an authorized representative of either of the foregoing officials shall have access to and right to—

(i) Examine any of the Contractor’s or any subcontractors’ records that pertain to, and involve transactions relating to, this contract; and

(ii) Interview any officer or employee regarding such transactions.

(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), and (c), of this clause, the Contractor is not required to flow down any FAR clause in a subcontract for commercial items, other than—

(i) Paragraph (d) of this clause. This paragraph flows down to all subcontracts, except the authority of the Inspector General under paragraph (d)(1)(ii) does not flow down; and

(ii) Those clauses listed in this paragraph (e)(1). Unless otherwise indicated below, the extent of the flow down shall be as required by the clause-

(A) 52.203-13, Contractor Code of Business Ethics and Conduct (Jun 2020) (41 U.S.C. 3509).

(B) 52.203-15, Whistleblower Protections Under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub. L. 111-5).

(C) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(D) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2020) (Section 889(a)(1)(A) of Pub. L. 115-232).

(E) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (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.

(F) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

(G) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246).

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

(I) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) (29 U.S.C. 793).

(J) 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.

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

(L) ___ (1) 52.222-50, Combating Trafficking in Persons (Oct 2020) (22 U.S.C. chapter 78 and E.O 13627).

___ (2) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

(M) 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).

(N) 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).

(O) 52.222-54, Employment Eligibility Verification (Oct 2015) (Executive Order 12989).

(P) 52.222-55, Minimum Wages Under Executive Order 13658 (Nov 2020).

(Q) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706).

(R) (1) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).

(2) Alternate I (Jan 2017) of 52.224-3.

(S) 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).

(T) 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.

(U) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64

CDCA_G001 – Invoice Submission (Jan 2022)

(a) The Contractor shall submit the original contract invoice/voucher to the address shown below:

The Centers for Disease Control and Prevention Office of Financial Resources (OFR) P.O. Box 15580 Atlanta, GA 30333

Or – The Contractor may submit the original invoice via facsimile or email:

Fax: 404-638-5324 Email: fmoapinv@cdc.gov

HHSAR 352.232-71 Electronic Submission of Payment Requests

(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.