REQUEST FOR QUOTATIONS74303revised2.doc

REQUEST FOR QUOTATIONS

(THIS IS NOT AN ORDER)

THIS RFQ

PAGE OF PAGES

1. REQUEST NO.

75D301-22-Q-74303

2. DATE ISSUED

03/01/2022

3. REQUISITION/PURCHASE REQUEST NO.

00HCVGED-2022-56517

4. CERT. FOR NAT. DEF.

UNDER BDSA REG. 2

AND/OR DMS REG. 1

RATING

5a. ISSUED BY

Centers for Disease Control and Prevention (CDC)

Office of Acquisition Services (OAS)

2900 Woodcock Blvd, MS TCU-4

Atlanta GA 303414004

6. DELIVERY BY (Date)

5b. FOR INFORMATION CALL (No collect calls)

c. CITY

10. PLEASE FURNISH QUOTATIONS TO

THE ISSUING OFFICE IN BLOCK 5a ON

OR BEFORE CLOSE OF BUSINESS (Date)

IMPORTANT: This is a request for information, and quotations furnished are not offers. If you are unable to quote, please so indicate on this form and return it. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this quotation or to contract for supplies or services. Supplies are of domestic origin unless otherwise indicated by quoter. Any representations and/or certifications attached to this Request for Quotations must be completed by the quoter.

11. SCHEDULE (Include applicable Federal, State and local taxes)

ITEM NO.

(a)

SUPPLIES/SERVICES

(b)

QUANTITY

(c)

UNIT

(d)

UNIT PRICE

(e)

AMOUNT

(f)

This RFQ is for labor, materials, equipment and perform all work necessary to collect Adult Onset Respiratory Recurrent Papillomatosis (AORRP) data from a variety of otolaryngology clinical sites, oversee collection of data and format and submit data to CDC.

b. 20 CALENDAR DAYS

c. 30 CALENDAR DAYS

d. CALENDAR DAYS

NOTE: Additional provisions and representations

SIGN QUOTATION

15. DATE OF

QUOTATION

a. NAME OF QUOTER

c. COUNTY

AREA CODE

AUTHORIZED FOR LOCAL REPRODUCTION

STANDARD FORM 18 (REV. 6-95)

Previous edition not usable

Prescribed by GSA

FAR (48 CFR) 53.215-1(a)

Section B - Supplies Or Services And Prices/Costs

Project Title: Burden of Adult Onset Respiratory Recurrent Papillomatosis (AORRP) in the United States

During the period July 1, 2022 through June 30, 2023 1 Job

Option 1 Year 2- AORRP Items:

Project Title: Burden of Adult Onset Respiratory Recurrent Papillomatosis (AORRP) in the United States

During the period July 1, 2023 through June 30, 2024 1 Job

B.2 Payment Terms.

In accordance with FAR 52.232.32, Performance-Based Payments (Apr 2012), upon successful completion of an event, the Contractor may request performance-based payments.

The determination of eligibility for receipt of payment will be made by the Contracting Officer upon written certification from the COR that that the performance milestone was met. It is anticipated that the completion date for each event will vary and eligibility for payment could occur sooner or later depending upon the time of completion of the designated event. Milestone payments are subject to the terms of FAR 52.232-32.

B.3 Payment Milestone Schedule

To be completed by vendor.

Statement of Work

Title: Burden of Adult Onset Respiratory Recurrent Papillomatosis (AORRP) in the United States

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.

ADDIN EN.CITE

These HPV types can cause both juvenile onset RRP (JORRP) and adult onset RRP (AORRP), which have distinct risk factors.

ADDIN EN.CITE

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.

ADDIN EN.CITE

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%.

ADDIN EN.CITE

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.

ADDIN EN.CITE

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).

ADDIN EN.CITE

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.

SUBSECTION A – DEFINITIONS

N/A

SECTION 2 – PURPOSE

The overall objective of this project is to establish an organized dataset of AORRP cases to provide important information on annual prevalence, clinical history, and HPV vaccine impact on this rare disease in the United States.9

This new project will involve one coordinating clinical center (the contractor) collecting data on AORRP patients from up to 40 other geographically diverse clinical centers (subcontractors) where AORRP patients are treated.

Specific aims of this study are:

1) Assess characteristics of all persons with AORRP presenting for care at the participating clinical center each calendar year, including sex, race/ethnicity, age at symptom onset, clinical presentation (e.g., stridor, difficulty breathing during exercise, snoring), age at diagnosis, measures of morbidity including number of surgeries, and medical or behavioral risk factors for AORRP (e.g., HPV vaccination history, number of sex partners).

2) Determine trends in incidence and prevalence of AORRP presenting for care each year, to assess HPV vaccine impact in the United States.

Performance objectives for the contractor are to collect epidemiologic data on all AORRP patients at each participating clinical center during the previous calendar year. Required results are an annual database of epidemiologic data on AORRP patients from a geographically diverse set of clinical centers in the United States.

SECTION 3 – SCOPE OF WORK

The contractor will provide all labor, materials, equipment, and perform all work necessary to collect AORRP data from a variety of otolaryngology clinical sites, oversee collection of data, format and submit data to CDC. Prior to collection of data, the contractor shall ensure they have all required IRB and consents required to perform the work. All data submitted must be free of personal identifiers.

SECTION 4 – TASKS TO BE PERFORMED

The contractor will perform the following tasks:

1) Using Government-furnished draft materials, finalize the protocol, standardized epidemiologic survey form, and consent form; these will be suitable for IRB review. Create a database for the entry of the corresponding survey data, and maintain a data dictionary for coding all survey variables in the database.

2) Identify and establish a geographically diverse group of health care providers across the United States each of which cares for at least one current patient with AORRP (e.g., adult otolaryngologists, ENT specialists, or others who perform laryngoscopy), to determine which institutions have the capacity to perform the scope of work. The Contractor will identify an overall total of 10-40 participating institutions (including 1-4 institutions from each of the 10 HHS Regions of the United States, with a minimum of 1 institution and a maximum of 20 institutions in any single region).

3) Confirm list of participating physicians and institutional review board (IRB) approvals for each applicable site. The Contractor will assist sites to secure IRB approvals and will keep copies of current IRB documents from each site confirming eligibility to participate for the duration of the study.

4) Distribute the epidemiologic burden survey to each participating institution and provide training on data collection in accordance with the protocol developed. Existing electronic health and medical records will be abstracted using standardized forms to collect at a minimum the following elements for each patient presenting with incident or prevalent AORRP during the previous full calendar year: site, month and year presented, total number of otolaryngology visits during the calendar year, sex, race/ethnicity, state of residence, age at initial AORRP symptom onset, clinical presentation (e.g., stridor, difficulty breathing during exercise, snoring), age at initial AORRP diagnosis, measures of morbidity including number of surgeries per year and overall, and medical or behavioral risk factors for AORRP (e.g., self-reported and documented HPV vaccination history including number of doses and date/s, 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).

5) Ensure return of all annual surveys from each site, enter survey data into the database for submission to CDC, and check the dataset for completeness.

6) Submit an updated epidemiologic burden dataset (as an Excel or SAS dataset) and all study documentation to CDC at least quarterly.

SECTION 5 – GOVERNMENT FURNISHED MATERIALS

The Government will provide a draft study protocol and draft epidemiologic burden survey that will be used to develop the final documents for the study. The Government will also provide data storage for the final datasets at CDC and mechanism for secure transfer of data.

SECTION 6 – PERIOD OF PERFORMANCE

The period of performance for this contract will be 1 base year (12 months) with an option for an additional 1 year (12 months). Work will begin on July 1, 2022. The following is the contract period of performance:

Base Year:

July 1, 2022 through June 30, 2023 Option year 1:

July 1, 2023 through June 30, 2024

SECTION 7 – PLACE OF PERFORMANCE

None of the tasks described in this contract will be performed at the Centers for Disease Control and Prevention site. The places of performance will be as determined by the clinical sites who have seen one or more patients during the previous year and submit an IRB determination from their Institutional Review Board approving their participation in the project.

SECTION 8 – DELIVERABLES/REPORTING SCHEDULE

and

Subject Matter Expert (Elissa Meites)

and

Subject Matter Expert (Elissa Meites)

and

Subject Matter Expert (Elissa Meites)

SECTION 9 – TRAVEL

No travel will be authorized under this contract.

SECTION 10 – 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 11 – CONTRACTING OFFICER’S REPRESENTATIVE INFORMATION

A. Contracting Officer’s Representative:

Cindy Brown, Administrative Officer

Division of Viral Diseases, Centers for Disease Control and Prevention

1600 Clifton Road, MS H24-5

Atlanta, GA 30329

Telephone: 404-639-6443

Email: ctt9@cdc.gov B. Subject Matter Expert:

Elissa Meites, Medical Officer

Division of Viral Diseases, Centers for Disease Control and Prevention

1600 Clifton Road, MS H24-5

Atlanta, Georgia 30329

Telephone: 404-639-6407

E-mail: dri9@cdc.gov Section D Clauses

52.204-19

52.246-9

52.243-1AltV

52.227-11

52.227-14 Alt IV

352.222-70

Incorporation by Reference of Representations and Certifications (Dec 2014)

Inspection of Research and Development (Short Form) Apr 1984

Changes -- Fixed Price (Aug 1987)

Patent Rights – Ownership by the Contractor May 2014

Data Rights May 2014

Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015)

52.213-4 Terms and Conditions—Simplified Acquisitions (Other Than Commercial Products and Commercial Services). (Jan 2022)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses that are incorporated by reference:

(1) The clauses listed below implement provisions of law or Executive order:

(i) 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)).

(ii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Nov 2021) (Section 1634 of Pub. L. 115-91).

(iii) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Nov 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

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

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

(vi) 52.222-26, Equal Opportunity (Sept 2016) (E.O.11246).

(vii) 52.225-13, Restrictions on Certain Foreign Purchases (Feb 2021) (E.O.s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

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

(ix) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Pub.L.108-77, 108-78 (19 U.S.C. 3805 note)).

(2) Listed below are additional clauses that apply:

(i) 52.232-1, Payments (Apr 1984).

(ii) 52.232-8, Discounts for Prompt Payment (Feb 2002).

(iii) 52.232-11, Extras (Apr 1984).

(iv) 52.232-25, Prompt Payment (Jan 2017).

(v) 52.232-39, Unenforceability of Unauthorized Obligations (Jun 2013).

(vi) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Nov 2021) .

(vii) 52.233-1, Disputes (May 2014).

(viii) 52.244-6, Subcontracts for Commercial Products and Commercial Services (Nov 2021).

(ix) 52.253-1, Computer Generated Forms (Jan 1991).

(b) The Contractor shall comply with the following FAR clauses, incorporated by reference, unless the circumstances do not apply:

(1) The clauses listed below implement provisions of law or Executive order:

(i) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020)(Pub. L. 109-282) (31 U.S.C. 6101 note) (Applies to contracts valued at or above the threshold specified in FAR 4.1403(a) on the date of award of this contract).

(ii) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2022) (E.O. 13126) (Applies to contracts for supplies exceeding the micro-purchase threshold, as defined in FAR 2.101 on the date of award of this contract).

(iii) 52.222-20, Contracts for Materials, Supplies, Articles, and Equipment., Contracts for Materials, Supplies, Articles, and Equipment (Jun 2020) (41 U.S.C.chapter 65) (Applies to supply contracts over the threshold specified in FAR 22.602 on the date of award of this contract, in the United States, Puerto Rico, or the U.S. Virgin Islands).

(iv) 52.222-35, Equal Opportunity for Veterans (Jun 2020) (38 U.S.C. 4212) (Applies to contracts valued at or above the threshold specified in FAR 22.1303(a) on the date of award of this contract).

(v) 52.222-36, Equal Employment for Workers with Disabilities (Jun 2020) (29 U.S.C. 793) (Applies to contracts over the threshold specified in FAR 22.1408(a) on the date of award of this contract, unless the work is to be performed outside the United States by employees recruited outside the United States). (For purposes of this clause, "United States" includes the 50 States, the District of Columbia, Puerto Rico, the Northern Mariana Islands, American Samoa, Guam, the U.S. Virgin Islands, and Wake Island.)

(vi) 52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212) (Applies to contracts valued at or above the threshold specified in FAR 22.1303(a) on the date of award of this contract).

(vii) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67) (Applies to service contracts over $2,500 that are subject to the Service Contract Labor Standards statute and will be performed in the United States, District of Columbia, Puerto Rico, the Northern Mariana Islands, American Samoa, Guam, the U.S. Virgin Islands, Johnston Island, Wake Island, or the outer Continental Shelf).

(viii)

(A) 52.222-50, Combating Trafficking in Persons (Nov 2021) (22 U.S.C. chapter 78 and E.O. 13627) (Applies to all solicitations and contracts).

(B) Alternate I (Mar 2015) (Applies if the Contracting Officer has filled in the following information with regard to applicable directives or notices: Document title(s), source for obtaining document(s), and contract performance location outside the United States to which the document applies).

(ix) 52.222-55, Minimum Wages Under Executive Order 13658 (Nov 2020) (Applies when 52.222-6 or 52.222-41 are in the contract and performance in whole or in part is in the United States (the 50 States and the District of Columbia)).

(x) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706) (Applies when 52.222-6 or 52.222-41 are in the contract and performance in whole or in part is in the United States (the 50 States and the District of Columbia.))

(xi) 52.223-5, Pollution Prevention and Right-to-Know Information (May 2011) (E.O. 13423) (Applies to services performed on Federal facilities).

(xii) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693)(applies to contracts for products as prescribed at FAR 23.804(a)(1)).

(xiii) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693) (Applies to maintenance, service, repair, or disposal of refrigeration equipment and air conditioners).

(xiv) 52.223-15, Energy Efficiency in Energy-Consuming Products (May 2020) (42 U.S.C. 8259b) (Unless exempt pursuant to 23.204, applies to contracts when energy-consuming products listed in the ENERGY STAR® Program or Federal Energy Management Program (FEMP)) will be-

(A) Delivered;

(B) Acquired by the Contractor for use in performing services at a Federally-controlled facility;

(C) Furnished by the Contractor for use by the Government; or

(D) Specified in the design of a building or work, or incorporated during its construction, renovation, or maintenance).

(xv) 52.223-20, Aerosols (Jun 2016) (E.O. 13693) (Applies to contracts for products that may contain high global warming potential hydrofluorocarbons as a propellant or as a solvent; or contracts for maintenance or repair of electronic or mechanical devices).

(xvi) 52.223-21, Foams (Jun 2016) (E.O. 13693) (Applies to contracts for products that may contain high global warming potential hydrofluorocarbons or refrigerant blends containing hydrofluorocarbons as a foam blowing agent; or contracts for construction of buildings or facilities.

(xvii) 52.225-1, Buy American-Supplies (Nov 2021) (41 U.S.C. chapter 67) (Applies to contracts for supplies, and to contracts for services involving the furnishing of supplies, for use in the United States or its outlying areas, if the value of the supply contract or supply portion of a service contract exceeds the micro-purchase threshold, as defined in FAR 2.101 on the date of award of this contract, and the acquisition-

(A) Is set aside for small business concerns; or

(B) Cannot be set aside for small business concerns (see 19.502-2), and does not exceed $25,000).

(xviii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations., Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020) (42 U.S.C. 1792) (Applies to contracts greater than the threshold specified in FAR 26.404 on the date of award of this contract, that provide for the provision, the service, or the sale of food in the United States).

(xix) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct 2013)(Applies when the payment will be made by electronic funds transfer (EFT) and the payment office uses the System for Award Management (SAM) as its source of EFT information).

(xx) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (Applies when the payment will be made by EFT and the payment office does not use the SAM database as its source of EFT information).

(xxi) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Nov 2021) (46 U.S.C. 55305)(Applies to supplies transported by ocean vessels (except for the types of subcontracts listed at 47.504(d)).

(2) Listed below are additional clauses that may apply:

(i) 52.204-21, Basic Safeguarding of Covered Contractor Information Systems (Nov 2021) (Applies to contracts when the contractor or a subcontractor at any tier may have Federal contract information residing in or transiting through its information system.)

(ii) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Nov 2021) (Applies to contracts over the threshold specified in FAR 9.405-2(b) on the date of award of this contract).

(iii) 52.211-17, Delivery of Excess Quantities (Sept 1989) (Applies to fixed-price supplies).

(iv) 52.247-29, F.o.b. Origin (Feb 2006) (Applies to supplies if delivery is f.o.b. origin).

(v) 52.247-34, F.o.b. Destination (Nov 1991) (Applies to supplies if delivery is f.o.b. destination).

(c) 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):

[Insert one or more Internet addresses]

(d) Inspection/Acceptance. The Contractor shall tender for acceptance only those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. The Government must exercise its postacceptance rights-

(1) Within a reasonable period of time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(e) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence, such as acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(f) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges that the Contractor can demonstrate to the satisfaction of the Government, using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor’s records. The Contractor shall not be paid for any work performed or costs incurred that reasonably could have been avoided.

(g) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(h) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(End of clause)

HHSAR 352.232-71 Electronic Submission of Payment Requests (February 2, 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 Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

(End of Clause) CDCA_H040 Government Property (Jul 2017)

(a) Government-Furnished Property (GFP). In accordance with the terms of FAR 52.245-1, Government Property, the Government reserves the right to supply the Contractor, as Government-furnished property, any additional supplies, equipment, and materials determined by the Contracting Officer to be necessary and in the best interest of the Government.

(b) Contractor-Acquired Property (CAP). The Contractor must receive written consent from the Contracting Officer prior to purchase of any CAP not expressly identified in the contract, and as defined in FAR 52.245-1.

(c) Accountable and Sensitive Government Property. The Government will provide property labels and other identification for contractor-acquired Government property that is considered Accountable as defined in the HHS Logistics Management Manual (LMM) https://intranet.hhs.gov/abouthhs/manuals/lmm/index.html or considered Sensitive as defined in CDC's Sensitive Items List (http://intranet.cdc.gov/ofr/documents/contracts/Authorized-Prohibited-List.pdf)

(d) The contractor shall be responsible for the control and accountable record keeping of any Government property used in the performance of this contract predominately outside the confines of a Government controlled workspace in accordance with the HHS Contracting Guide found on the OSSAM Government Property and Contractors Property intranet page. (http://intranet.cdc.gov/ossam/property-shipping- receiving/property-management/government-property-contractors/index.html)

(e) The Chief of the Office of Safety, Security and Asset Management (OSSAM), Asset Management Services Office, Centers for Disease Control and Prevention (CDC), is hereby designated as the Property Administrator for this contract. The Contractor shall identify each item of equipment furnished by the Government to the Contractor or acquired by the Contractor using contract funds, with a suitable decal, tag, or other marking, as prescribed by the Property Administrator, and shall follow the guidance set forth in the HHS Contracting Guide.

(End of Clause) 52.232-32 Performance-Based Payments. (Apr 2012)

(a) Amount of payments and limitations on payments. Subject to such other limitations and conditions as are specified in this contract and this clause, the amount of payments and limitations on payments shall be specified in the contract’s description of the basis for payment.

(b) Contractor request for performance-based payment. The Contractor may submit requests for payment of performance-based payments not more frequently than monthly, in a form and manner acceptable to the Contracting Officer. Unless otherwise authorized by the Contracting Officer, all performance-based payments in any period for which payment is being requested shall be included in a single request, appropriately itemized and totaled. The Contractor’s request shall contain the information and certification detailed in paragraphs (l) and (m) of this clause.

(c) Approval and payment of requests.

(1) The Contractor shall not be entitled to payment of a request for performance-based payment prior to successful accomplishment of the event or performance criterion for which payment is requested. The Contracting Officer shall determine whether the event or performance criterion for which payment is requested has been successfully accomplished in accordance with the terms of the contract. The Contracting Officer may, at any time, require the Contractor to substantiate the successful performance of any event or performance criterion which has been or is represented as being payable.

(2) A payment under this performance-based payment clause is a contract financing payment under the Prompt Payment clause of this contract and not subject to the interest penalty provisions of the Prompt Payment Act. The designated payment office will pay approved requests on the _________ [Contracting Officer insert day as prescribed by agency head; if not prescribed, insert "30th"] day after receipt of the request for performance-based payment by the designated payment office. However, the designated payment office is not required to provide payment if the Contracting Officer requires substantiation as provided in paragraph (c)(1) of this clause, or inquires into the status of an event or performance criterion, or into any of the conditions listed in paragraph (e) of this clause, or into the Contractor certification. The payment period will not begin until the Contracting Officer approves the request.

(3) The approval by the Contracting Officer of a request for performance-based payment does not constitute an acceptance by the Government and does not excuse the Contractor from performance of obligations under this contract.

(d) Liquidation of performance-based payments.

(1) Performance-based finance amounts paid prior to payment for delivery of an item shall be liquidated by deducting a percentage or a designated dollar amount from the delivery payment. If the performance-based finance payments are on a delivery item basis, the liquidation amount for each such line item shall be the percent of that delivery item price that was previously paid under performance-based finance payments or the designated dollar amount. If the performance-based finance payments are on a whole contract basis, liquidation shall be by either predesignated liquidation amounts or a liquidation percentage.

(2) If at any time the amount of payments under this contract exceeds any limitation in this contract, the Contractor shall repay to the Government the excess. Unless otherwise determined by the Contracting Officer, such excess shall be credited as a reduction in the unliquidated performance-based payment balance(s), after adjustment of invoice payments and balances for any retroactive price adjustments.

(e) Reduction or suspension of performance-based payments. The Contracting Officer may reduce or suspend performance-based payments, liquidate performance-based payments by deduction from any payment under the contract, or take a combination of these actions after finding upon substantial evidence any of the following conditions:

(1) The Contractor failed to comply with any material requirement of this contract (which includes paragraphs (h) and (i) of this clause).

(2) Performance of this contract is endangered by the Contractor’s-

(i) Failure to make progress; or

(ii) Unsatisfactory financial condition.

(3) The Contractor is delinquent in payment of any subcontractor or supplier under this contract in the ordinary course of business.

(f) Title.

(1) Titleto the property described in this paragraph (f) shall vest in the Government. Vestiture shall be immediately upon the date of the first performance-based payment under this contract, for property acquired or produced before that date. Otherwise, vestiture shall occur when the property is or should have been allocable or properly chargeable to this contract.

(2) "Property," as used in this clause, includes all of the following described items acquired or produced by the Contractor that are or should be allocable or properly chargeable to this contract under sound and generally accepted accounting principles and practices:

(i) Parts, materials, inventories, and work in process;

(ii) Special tooling and special test equipment to which the Government is to acquire title;

(iii) Nondurable (i.e., noncapital) tools, jigs, dies, fixtures, molds, patterns, taps, gauges, test equipment and other similar manufacturing aids, title to which would not be obtained as special tooling under paragraph (f)(2)(ii) of this clause; and

(iv) Drawings and technical data, to the extent the Contractor or subcontractors are required to deliver them to the Government by other clauses of this contract.

(3) Although title to property is in the Government under this clause, other applicable clauses of this contract (e.g., the termination clauses) shall determine the handling and disposition of the property.

(4) The Contractor may sell any scrap resulting from production under this contract, without requesting the Contracting Officer’s approval, provided that any significant reduction in the value of the property to which the Government has title under this clause is reported in writing to the Contracting Officer.

(5) In order to acquire for its own use or dispose of property to which title is vested in the Government under this clause, the Contractor shall obtain the Contracting Officer’s advance approval of the action and the terms. If approved, the basis for payment (the events or performance criteria) to which the property is related shall be deemed to be not in compliance with the terms of the contract and not payable (if the property is part of or needed for performance), and the Contractor shall refund the related performance-based payments in accordance with paragraph (d) of this clause.

(6) When the Contractor completes all of the obligations under this contract, including liquidation of all performance-based payments, title shall vest in the Contractor for all property (or the proceeds thereof) not-

(i) Delivered to, and accepted by, the Government under this contract; or

(ii) Incorporated in supplies delivered to, and accepted by, the Government under this contract and to which title is vested in the Government under this clause.

(7) The terms of this contract concerning liability for Government-furnished property shall not apply to property to which the Government acquired title solely under this clause.

(g) Risk of loss. Before delivery to and acceptance by the Government, the Contractor shall bear the risk of loss for property, the title to which vests in the Government under this clause, except to the extent the Government expressly assumes the risk. If any property is lost (see 45.101), the basis of payment (the events or performance criteria) to which the property is related shall be deemed to be not in compliance with the terms of the contract and not payable (if the property is part of or needed for performance), and the Contractor shall refund the related performance-based payments in accordance with paragraph (d) of this clause.

(h) Records and controls. The Contractor shall maintain records and controls adequate for administration of this clause. The Contractor shall have no entitlement to performance-based payments during any time the Contractor’s records or controls are determined by the Contracting Officer to be inadequate for administration of this clause.

(i) Reports and Government access. The Contractor shall promptly furnish reports, certificates, financial statements, and other pertinent information requested by the Contracting Officer for the administration of this clause and to determine that an event or other criterion prompting a financing payment has been successfully accomplished. The Contractor shall give the Government reasonable opportunity to examine and verify the Contractor’s records and to examine and verify the Contractor’s performance of this contract for administration of this clause.

(j) Special terms regarding default. If this contract is terminated under the Default clause, (1) the Contractor shall, on demand, repay to the Government the amount of unliquidated performance-based payments, and (2) title shall vest in the Contractor, on full liquidation of all performance-based payments, for all property for which the Government elects not to require delivery under the Default clause of this contract. The Government shall be liable for no payment except as provided by the Default clause.

(k) Reservation of rights.

(1) No payment or vesting of title under this clause shall-

(i) Excuse the Contractor from performance of obligations under this contract; or

(ii) Constitute a waiver of any of the rights or remedies of the parties under the contract.

(2) The Government’s rights and remedies under this clause-

(i) Shall not be exclusive, but rather shall be in addition to any other rights and remedies provided by law or this contract; and

(ii) Shall not be affected by delayed, partial, or omitted exercise of any right, remedy, power, or privilege, nor shall such exercise or any single exercise preclude or impair any further exercise under this clause or the exercise of any other right, power, or privilege of the Government.

(l) Content of Contractor’s request for performance-based payment. The Contractor’s request for performance-based payment shall contain the following:

(1) The name and address of the Contractor;

(2) The date of the request for performance-based payment;

(3) The contract number and/or other identifier of the contract or order under which the request is made;

(4) Such information and documentation as is required by the contract’s description of the basis for payment; and

(5) A certification by a Contractor official authorized to bind the Contractor, as specified in paragraph (m) of this clause.

(m) Content of Contractor's certification. As required in paragraph (l)(5) of this clause, the Contractor shall make the following certification in each request for performance-based payment:

I certify to the best of my knowledge and belief that-

(1) This request for performance-based payment is true and correct; this request (and attachments) has been prepared from the books and records of the Contractor, in accordance with the contract and the instructions of the Contracting Officer;

(2) (Except as reported in writing on __________), all payments to subcontractors and suppliers under this contract have been paid, or will be paid, currently, when due in the ordinary course of business;

(3) There are no encumbrances (except as reported in writing on _________) against the property acquired or produced for, and allocated or properly chargeable to, the contract which would affect or impair the Government's title;

(4) There has been no materially adverse change in the financial condition of the Contractor since the submission by the Contractor to the Government of the most recent written information dated _____________; and

(5) After the making of this requested performance-based payment, the amount of all payments for each deliverable item for which performance-based payments have been requested will not exceed any limitation in the contract, and the amount of all payments under the contract will not exceed any limitation in the contract.

(End of clause)

52.217-9 Option to Extend the Term of the Contract (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 15 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 2 years.

(End of clause) CDC 37.0001 Non-Personal Services (Jun 2020)

(a) Personal services shall not be performed under this contract. Although the Government may provide sporadic or occasional instructions within the scope of the contract, the Contractor is responsible for control and supervision of its employees. If the Contractor (including its employees) believes any Government action or communication has been given that would create a personal services relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

(b) The contractor shall comply with, and ensure their employees and subcontractors comply with, CDC Policy titled "Contractor Identification and Safeguarding of Non-Public Information". No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. In all communications with third parties in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work. The contractor is limited to performing the services identified in the contract statement of work and shall not interpret any communication with anyone as a permissible change in contract scope or as authorization to perform work not described in the contract. All contract changes will be incorporated by a modification signed by the Contracting Officer.

(c) The Contractor shall ensure that all of its employees and subcontractor employees working on this contract are informed of the terms and conditions herein. The Contractor agrees that this is a non-personal services contract; and that for all the purposes of the contract, the Contractor is not, nor shall it hold itself out to be an agent or partner of, or joint venture with, the Government. The Contractor shall notify its employees that they shall neither supervise nor accept supervision from Government employees. The substance of the terms herein shall be included in all subcontracts at any tier.

(d) The terms and conditions above do not limit the Government's rights under other terms of the contract, including those related to the Government's right to inspect and accept or reject the services performed under this contract.

HHSAR 352.239-74 Electronic and Information Technology Accessibility (Dec 2015).

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contract or order must comply with the “Architectural and…