75N91021Q00081.pdf

COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS

I. General Information

Document Type: Combined Solicitation/Synopsis

Solicitation Number: 75N91021Q00081

Posted Date: 06/28/2021

7/28/2021

7/28/2021

Original Response Date:

Current Response Date:

Classification Code: R702 – Support – Management: Data Collection

Set Aside: N/A

NAICS Code: 541990 – All Other Professional, Scientific, and Technical Services

II. Contracting Office Address

National Cancer Institute

9609 Medical Center Drive

Rockville, Maryland 20892

III. Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal

Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for

Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and any other written solicitation document will not be issued.

This solicitation is a Request for Quotations (RFQ). This solicitation, 75N91021Q00081, is issued as a request for quote (RFQ) and includes all applicable provisions and clauses in effect through FAR Federal Acquisition

Circular (FAC) 2021-03 (01/14/2021), simplified acquisition procedures for other than commercial items.

The associated North American Industry Classification System (NAICS) code for this procurement is 541990, with a small business size standard of $16.5 million.

The Government intends to issue multiple firm fixed-price type purchase orders awards as a result of this solicitation

The goal of this acquisition is to obtain data on a group of proton-treated pediatric cancer patients and a group of photon-treated pediatric cancer patients to serve as a comparison group. The contractor(s) shall retrieve existing data from medical records for pediatric cancer patients treated at their institution with proton or photon therapy. De-identified clinical and treatment data obtained from this procurement will be used to evaluate the risks and benefits of proton therapy versus photon therapy for children with cancer. All interested companies shall provide quotation(s) for the requirement defined in

Attachment 1 – Statement of Work.

IV. Place of Performance

Service shall be performed remotely from the Contractor’s facility.

V. Non-severable Services

The services acquired under this purchase order are non-severable services or work that results in a final product or end-item and for which benefit is received only when the entire project is complete.

VI. Period of Performance

The anticipated period of performance shall consist of one (1) 12-month base period as follows:

Base Period August 1, 2021 – July 30, 2022 (Estimated)

VII. Basis for Award and Evaluation

Award shall be made using a tradeoff process. All evaluation factors other than cost or price, when combined, are significantly more important than cost or price. A technically acceptable quote is one in which the quoter(s) complies with the Statement of Work (SOW) and does not take exception, nor object to any of the terms of the

RFQ. Quotes that are not technically acceptable will not be considered for award.

Evaluation and award will be conducted in accordance with the requirements of FAR 13.106. The technical evaluation will be a determination based on information furnished by the Contractor. The Government is not responsible for locating or securing any information which is not identified in the quotation. The Government intends to evaluate quotations and make multiple awards. Quotations should contain the quoter’s best terms from a price and technical standpoint. However, the Government reserves the right to request quote revisions that seek additional price discounts, provide revisions to the technical quote, or clarify aspects of the quote. In the event quote revisions are requested, the Government will not necessarily be seeking revisions from all quoters. The Government may reject any or all quotes if such action is in the public interest; accept other than the lowest quote; and waive informalities and minor irregularities in quotes received.

The following Criterion and Sub-Criteria will be used to determine acceptability (See Attachment 2 – Technical

Evaluation Criterion:

1. Criterion 1- Technical Evaluation Criteria (Attachment #2)

2. Criterion 2– Past Performance

a. Subfactor #1 - Recency and relevancy of present/past performance in relation to this effort

– In order to receive a rating of “acceptable” for this subfactor, quoter must, at a minimum provide past experience on similar type contract(s). The past experience should indicate successes of the contractor in completing /meeting delivery dates and customer satisfaction. The Government considers “recent” present/past performance to be within the past 3 years. The Government considers “relevant” present/past performance to be present/past performance effort involved in similar scope and magnitude of effort and complexities this solicitation requires.

The Government may also use past performance information obtained from other than the sources identified by the quoter. Information obtained from the Past Performance Information Retrieval System (PPIRS) database located at http//www.ppirs.gov is one of the sources that will be utilized. PPIRS functions as the central warehouse for performance assessment reports received from several Federal performance information collection systems and is sponsored by the DOD E-Business Office and administered by the Naval Sea Logistics Center Detachment

Portsmouth.

NOTE: In accordance with FAR 15.305 (a)(2)(iv)), in the case of an offeror without a record of relevant past performance or for whom information on past performance is not available or so sparse that no meaningful past performance rating can be reasonably assigned, the offeror shall be determined to have unknown past performance.

In the context of acceptability/unacceptability, “unknown” will be considered “acceptable.”

3. Criterion 3– Price

VIII. Privacy Act

It has been determined that this contract is subject to the Privacy Act of 1974, because this contract provides for the design, development, or operation of a system of records on individuals. The System of Records Notice

(SORN) that is applicable to this contract is 09-25-0200. The design, development, or operation work the

Contractor is to perform is the assembly of existing data from medical records for a group of pediatric cancer patients who received proton or photon therapy.

IX. PURCHASE ORDER CLAUSES

52.213-4 Terms and Conditions-Simplified Acquisitions (Other Than Commercial Items) (FEB 2021).

(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) (section743 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 Kaspersk

Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(iii) 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).

(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 (Jun 2008) (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 (DEC 2013).

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

(viii) 52.244-6, Subcontracts for Commercial Items (NOV 2020).

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

https://www.acquisition.gov/far/52.203-19#FAR_52_203_19 https://www.acquisition.gov/far/52.204-23#FAR_52_204_23 https://www.acquisition.gov/far/52.204-25#FAR_52_204_25 https://www.acquisition.gov/far/52.222-3#FAR_52_222_3 https://www.acquisition.gov/far/52.222-21#FAR_52_222_21 https://www.acquisition.gov/far/52.222-26#FAR_52_222_26 https://www.acquisition.gov/far/52.225-13#FAR_52_225_13 https://www.acquisition.gov/far/52.233-3#FAR_52_233_3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.233-4#FAR_52_233_4 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.232-1#FAR_52_232_1 https://www.acquisition.gov/far/52.232-8#FAR_52_232_8 https://www.acquisition.gov/far/52.232-11#FAR_52_232_11 https://www.acquisition.gov/far/52.232-25#FAR_52_232_25 https://www.acquisition.gov/far/52.232-39#FAR_52_232_39 https://www.acquisition.gov/far/52.232-40#FAR_52_232_40 https://www.acquisition.gov/far/52.233-1#FAR_52_233_1 https://www.acquisition.gov/far/52.244-6#FAR_52_244_6 https://www.acquisition.gov/far/52.253-1#FAR_52_253_1

(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 2020) (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 (OCT 2020)(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).

https://www.acquisition.gov/far/52.204-10#FAR_52_204_10 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/far/4.1403#FAR_4_1403 https://www.acquisition.gov/far/52.222-19#FAR_52_222_19 https://www.acquisition.gov/far/2.101#FAR_2_101 https://www.acquisition.gov/far/52.222-20#FAR_52_222_20 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.222-35#FAR_52_222_35 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/22.1303#FAR_22_1303 https://www.acquisition.gov/far/52.222-36#FAR_52_222_36 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/22.1408#FAR_22_1408 https://www.acquisition.gov/far/52.222-37#FAR_52_222_37 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/22.1303#FAR_22_1303 https://www.acquisition.gov/far/52.222-41#FAR_52_222_41 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-chapter67-front&num=0&edition=prelim https://www.acquisition.gov/far/52.222-50#FAR_52_222_50 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.222-55#FAR_52_222_55 https://www.acquisition.gov/far/52.222-6#FAR_52_222_6 https://www.acquisition.gov/far/52.222-41#FAR_52_222_41 https://www.acquisition.gov/far/52.222-62#FAR_52_222_62 https://www.acquisition.gov/far/52.222-6#FAR_52_222_6 https://www.acquisition.gov/far/52.222-6#FAR_52_222_6 https://www.acquisition.gov/far/52.222-41#FAR_52_222_41 https://www.acquisition.gov/far/52.223-5#FAR_52_223_5 https://www.acquisition.gov/far/52.223-11#FAR_52_223_11 https://www.acquisition.gov/far/23.804#FAR_23_804 https://www.acquisition.gov/far/52.223-12#FAR_52_223_12 https://www.acquisition.gov/far/52.223-15#FAR_52_223_15 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/23.204#FAR_23_204

(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 (JAN 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 (FEB 2006) (46 U.S.C. App. 1241)

(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 (JUN 2016) (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 (JUN 2020) (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).

(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 post acceptance 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 https://www.acquisition.gov/far/52.223-20#FAR_52_223_20 https://www.acquisition.gov/far/52.223-21#FAR_52_223_21 https://www.acquisition.gov/far/52.225-1#FAR_52_225_1 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/2.101#FAR_2_101 https://www.acquisition.gov/far/19.502-2#FAR_19_502_2 https://www.acquisition.gov/far/52.226-6#FAR_52_226_6 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/26.404#FAR_26_404 https://www.acquisition.gov/far/52.232-33#FAR_52_232_33 https://www.acquisition.gov/far/52.232-34#FAR_52_232_34 https://www.acquisition.gov/far/52.247-64#FAR_52_247_64 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/47.504#FAR_47_504 https://www.acquisition.gov/far/52.204-21-0#FAR_52_204_21 https://www.acquisition.gov/far/52.209-6#FAR_52_209_6 https://www.acquisition.gov/far/9.405-2#FAR_9_405_2 https://www.acquisition.gov/far/52.211-17#FAR_52_211_17 https://www.acquisition.gov/far/52.247-29#FAR_52_247_29 https://www.acquisition.gov/far/52.247-34#FAR_52_247_34 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.

FAR 52.252-1 PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

This solicitation incorporates one or more solicitation provisions 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. The quoter is cautioned that the listed provisions may include blocks that must be completed by the quoter and submitted with its quotation. In lieu of submitting the full text of those provisions, the quoter may identify the provision by paragraph identifier and provide the appropriate information with its quotation. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

https://www.acquisition.gov/Far/ and/or http://www.hhs.gov/policies/hhsar/.

• 52.203-18 Prohibition on Contracting with Entities that Require Internal Confidentiality Agreements or

Statements-Representation

• 52.204-7 System for Award Management

• 52.204-16 Commercial and Government Entity Code Reporting

• 52.204-17 Ownership or Control of Offeror

• 52.204-20 Predecessor of Offeror

• 52.204-22 Alternative Line Item Proposal

• 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services

• 52.204-26 Covered Telecommunications Equipment or Services-Representation

• 52.209-11 Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law

• 52.225-20 Prohibition on Conducting Restricted Business Operations in Sudan – Certification

• 52.225-25 Prohibition on Contracting with Entities Engaging in Certain Activities or Transaction

Relating to Iran-Representation and Certifications

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): http://www.acquisition.gov/far/ and/or http://www.hhs.gov/policies/hhsar/.

• 52.204-19 Incorporation by Reference of Representations and Certifications

• 52.216-24 Limitation of Government Liability https://www.acquisition.gov/Far/ http://www.hhs.gov/policies/hhsar/ http://www.acquisition.gov/far/ http://www.hhs.gov/policies/hhsar/

• 52.216-25 Contract Definitization

• 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving

• 52.224-1 Privacy Act Notification

• 52.224-2 Privacy Act

• HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice

• HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations

• HHSAR 352.224-70 Privacy Act

X. QUOTATION SUBMISSION / GENERAL INSTRUCTIONS

This Request for Quotation (RFQ) does not commit the Government to pay any cost for preparation and submission of a quote. In addition, the Contracting Officer is the only individual who can legally commit the

Government to the expenditure of public funds in connection with this proposed acquisition. By submitting a quote in response to this solicitation, it is understood that your firm’s quote shall become a part of the official contract file.

Per FAR Clause 52.213-4 Terms and Conditions-Simplified Acquisitions (Other Than Commercial Items), which are applicable to this acquisition, and FAR Part 13 – Simplified Acquisition Procedures, quotations received in response to this solicitation may not exceed the simplified acquisition threshold.

Quotes must stipulate that it is predicated upon all the terms and conditions of this RFQ and be signed by an official authorized to bind the organization. In addition, the quote must contain a statement to the effect that it is firm for a period of at least 60 days from the date of receipt thereof by the Government.

Quotes must provide clear responses, specifically addressing the requirements listed above. Quotes which merely offer to conduct a project in accordance with the requirements of the Government's scope of work will not be eligible for award.

Quotes must be submitted with a completed copy of Attachment 4 - FAR 52.204-24 Representation Regarding

Certain Telecommunications and Video Surveillance Services or Equipment OR provide a copy of valid representation in the System for Award Management (SAM) at www.sam.gov.

Quoters shall prepare a price quotation that contains all information necessary to allow for a comprehensive evaluation of the prices quoted. Specifically, quotations must include the following:

• Federal Tax Identification Number (TIN);

• Data Universal Numbering System (DUNS) Number; and

• Business Size (e.g., small or large)

Questions must be submitted electronically (via email) to Contracting Officer, Mark Brady, at mark.brady@nih.gov and Contract Specialist, Justin Balster, at justin.balster@nih.gov in MS Word or

Adobe Portable Document Format (PDF), no later than 3:00 PM EST on Wednesday, July 14th

2021.

Quotations must be submitted electronically (via email) to Contracting Officer, Mark Brady, at mark.brady@nih.gov and Contract Specialist, Justin Balster, at justin.balster@nih.gov in MS Word or

Adobe Portable Document Format (PDF), no later than 3:00 PM EST on Wednesday, July 28 th

2021.

QUOTES RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED.

Please refer to solicitation no: 75N91021Q0008 on all correspondence.

Attachments:

Attachment 1 – Statement of Work

Attachment 2 – Technical Evaluation Criteria

Attachment 3 – Electronic Invoicing Instructions

Attachment 4 – FAR 52.204-24 Representation

Attachment 5 – 508 Compliance http://www.sam.gov/ mailto:mark.brady@nih.gov mailto:justin.balster@nih.gov mailto:mark.brady@nih.gov

Statement of Work

1.0 TITLE

US Pediatric Proton/Photon Therapy Cohort Study

2.0 BACKGROUND

The Radiation Epidemiology Branch (REB), Division of Cancer Epidemiology and Genetics (DCEG), National Cancer Institute (NCI) carries out studies to quantify second cancer risks associated with ionizing radiation exposures in pediatric cancer patients. REB has a specific interest in the risk of second tumors following proton therapy in children, because concerns have been raised about whole-body scatter doses from neutrons, brain necrosis and other late effects including second tumors.

Pediatric radiation oncology is undergoing rapid changes due to the widespread introduction of proton therapy. By reducing high-dose exposure to nearby normal tissue, protons should reduce a wide-range of serious adverse-effects, such as second cancers. To date, few studies have directly evaluated the potential benefits or risks of protons for children, and some case series have raised concerns about serious unanticipated side-effects, such as brain necrosis.

There is widespread agreement amongst the clinical and scientific community that large-scale collaborative efforts are urgently required to address these questions. We propose to establish the US Pediatric Proton Therapy study, a prospective cohort study including pediatric cancer patients treated with proton therapy and a comparison group of similar patients treated with photon therapy. This new cohort will build upon a foundation created by the US Pediatric Proton Consortium Registry (PPCR), which currently includes 20 US proton therapy centers and has recruited >3000 pediatric proton patients who have actively enrolled in the registry since 2012. To examine whether proton therapy results in improved outcomes compared to photon therapy, there is a critical need to obtain data from large, representative sample of pediatric proton patients and a control group of similar patients treated with photon therapy. NCI’s primary aim is to obtain data on additional proton patients and to add a comparison group of photon patients in order to quantify the subsequent cancer risks after proton compared to photon therapy. Subsequent cancers are one of the most common and serious adverse-effects of pediatric radiotherapy. The 2018 REB site visit strongly supported the proposed cohort study and the suitability of the intramural research environment for this complex and long-term effort. They also agreed with the motivation and justification for urgent development due to the impending transition from photons to protons despite the absence of direct evidence regarding long term outcomes. Due to this transition it may be impossible to identify a suitable comparison group of photon patients in the future.

Pediatric cancer is rare and therefore in order to assemble both proton therapy and comparison photon therapy cohorts of adequate size, multiple pediatric treatment centers need to be included. No single center will have enough patients to obtain data for the target size of 10,000 proton and 10,000 photon patients meeting eligibility criteria.

2.1 OBJECTIVE

The goal of this acquisition is to obtain data on a group of proton-treated pediatric cancer patients and a group of photon-treated pediatric cancer patients to serve as a comparison group. The contractor(s) shall retrieve existing data from medical records for pediatric cancer patients treated at their institution with proton or photon therapy. De-identified clinical and treatment data obtained from this procurement will be used to evaluate the risks and benefits of proton therapy versus photon therapy for children with cancer.

3.0 SCOPE

The contractors shall identify all proton treated pediatric patients and all photon treated pediatric cancer patients at their institution. For all patients meeting inclusion criteria, they will retrieve required data elements from existing medical records and enter data elements (not to include personal identifiers) into a secure data collection tool developed by the Pediatric Proton Consortium Registry (PPCR) team at Massachusetts General Hospital (MGH). The contractors shall locate radiotherapy and imaging data from eligible proton- or photon-treated pediatric patients, de-identify as necessary, and upload the de-identified data to an online imaging file repository maintained by the PPCR team at MGH.

4.0 CONTRACT REQUIREMENTS/ AND PERSONNEL QUALIFICATIONS

The Contractor shall perform the following tasks from the Contractor’s existing medical records:

4.1 Study Patient Identification

4.1.1 Based on existing medical records, identify a) all proton-treated treated pediatric cancer patients who were less than 22 years of age at diagnosis and treated with protons since January 1, 2007, and b) all photon-treated pediatric cancer patients who were less than 22 years of age at diagnosis, diagnosed with Hodgkin lymphoma, a central nervous system tumor, neuroblastoma or sarcoma, and treated with photon therapy since January 1, 2007.

4.1.2 Compile a list of eligible patient records, overall and by cancer diagnosis, treated with proton or photon therapy at the study center. Patient records shall be eligible to have data abstracted and included in the study after the patient has completed proton or photon therapy. Patients treated with proton therapy shall not be included if they are already part of the PPCR.

4.1.3 Obtain any regulatory approvals required by the treating institution for retrieval and release of de-identified clinical and treatment details from existing medical records for proton- or photon-treated pediatric cancer patients.

4.2 Data Collection

4.2.1 Participate in training on the study protocol and data collection procedures.

4.2.2 Abstract specified diagnosis and treatment data elements from medical records (not to include identifiers) for all eligible patients as identified in 4.1.1 above.

Data elements to be abstracted will differ depending upon the cancer diagnosis of each patient. Basic demographic and diagnosis data will be abstracted for all eligible patient records (sex, race, ethnicity, cancer diagnosis, type of radiation therapy). Only for patient records in specific diagnosis groups (CNS tumors, sarcomas, Hodgkin lymphoma, neuroblastoma, bone tumors), a more extensive list of data elements including treatment variables will be required. Required data elements will include sex, race, ethnicity, insurance status, state of residence, state of diagnosis and treatment, all cancer diagnoses and associated cancer details, all courses of radiotherapy received, chemotherapy agents received, surgeries performed for treatment of the primary cancer, and details of any subsequent cancer diagnoses or treatments if applicable.

4.2.3 Enter de-identified abstracted data for eligible patient records into the study-specific data collection tool maintained by the PPCR. The data collection tool will include automated workflows to specify the extent of data and specific data elements required for each patient based on the cancer diagnosis entered.

4.2.4 To ensure quality of data abstraction, have two abstractors independently abstract data from a subset of 10 of the first 100 records to identify areas of discordance where additional training is required. Provide documentation of the outcome of the re-abstraction to NCI.

4.2.5 Maintain a list of study ID and patient identifiers to include name, date of birth and date of cancer diagnosis for each patient on a secure institutional server, separate from the study data collection platform and not accessible by study staff outside the institution (i.e. coordinating center or NCI).

4.2.6 Retrieve and obtain copies of de-identified electronic radiation treatment records including Digital Imaging and Communications in Medicine (DICOM)-RT Image, organ-at-risk contours (RT Structure Set), final treatment plans (RT Plan), dose distribution (RT Dose), and treatment plans (RT Plan). Include review by a radiation physicist/dosimetrist to ensure collection of the correct file types and inclusion of final treatment plans as necessary. In the event diagnostic imaging and/or radiation treatment-related files are archived, center staff will be required to unarchive original treatment plans as needed. De-identified imaging and treatment-related files, including DICOM files, will be uploaded to a secure file repository. The MIMcloud system (MIM Software, Inc.) will be available as the primary file repository because it is already in use for the Pediatric Proton Consortium Registry, but alternative secure solutions can be used if necessary at the discretion of the Contractor. The file repository will not include patient identifiers or linkages that would allow re-identification.

4.2.7 Provide NCI and the study coordinating center with bi-annualprogress report summarizing the number of eligible patient records identified, number of eligible records with data abstracted and number of patient records with imaging and treatment files uploaded to the study file repository.

4.2.8 Take required steps to ameliorate issues with data quality or completeness, as identified by NCI.

Contractor Qualifications: The Contractor shall have at least 500 pediatric cancer patients treated with protons or photons since January 1, 2007 and meeting the eligibility criteria outlined in 4.1.1. The contractor shall have the capacity to identify all eligible patients treated at the institution,to perform required data abstraction on all eligible patients, and to upload de-identified electronic radiation treatment records within the specified period of performance.

5.0 TYPE OF ORDER

This is a firm fixed price purchase order.

6.0 PERIOD OF PERFORMANCE

The period of performance shall be for 12 months from date of award (with a estimated award date in August 2021).

7.0 PLACE OF PERFORMANCE

Work shall be performed at the Contractor’s facility.

8.0 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE

The NCI Principal Investigator (PI), technical point of contact and Contract Officer’s Representative (COR) shall review the deliverables submitted by the Contractor for acceptance within 14 days of receipt, to ensure consistency with the contract terms and approve the submitted reports. At the completion of the review, the NCI technical point of contact or COR shall notify the Contractor as to the acceptability of the deliverable. If any changes or revisions are required of the Contractor, the revised deliverables shall be submitted to the PI, technical point of contact and COR within 14 days of the date of notification. If no comments or request for revisions are provided within 14 business days, the deliverables shall be considered acceptable. In general, the NCI PI and technical point of contact shall provide technical scientific review and approval of all deliverables submitted by the Contractor.

All deliverables shall be sent electronically per the following schedule:

Table of deliverables (see Attachment for Progress Report template)

Deliverable Description Due Date

#1 Progress Report

Number of eligible proton and photon patients identified, number of eligible patient records with data abstracted and entered into REDCap system, and number of eligible patient records with imaging and treatment plan files uploaded to the study file repository. Numbers to be reported overall and by type of cancer, age in years at cancer diagnosis, and calendar year of cancer diagnosis.

6 months after award

#2 Initial Quality Control Report

Provide documentation of re-abstraction of 10 of first 100 eligible patient records and evaluation of concordance between initial abstraction and re-abstraction.

6 months after award

#5 Final Progress Report

Total number of eligible proton and photon patients identified, number of eligible patient records with data abstracted and entered into REDCap system, and number of eligible patient records with imaging and treatment plan files uploaded to the study file repository. Numbers to be reported overall and by type of cancer, age in years at cancer diagnosis, and calendar year of cancer diagnosis.

12 months after award

9.0 PAYMENT

Payment shall be made bi-annually. Payment authorization requires submission and approval of invoices to the COR and NIH OFM, in accordance with Attachment 3 – Electronic Invoicing

Instructions.

Technical Evaluation Criteria US Pediatric Proton/Photon Therapy Cohort

Criterion 1: Eligible population 60 points

1. Demonstrate ability and experience to identify a minimum of 500 pediatric cancer patients treated with protons (any diagnosis) or photons (diagnosed with Hodgkin lymphoma, central nervous system tumors, neuroblastoma, or sarcoma) at your institution.

Criterion 2: Technical capability 30 points

1. Demonstrate ability and experience to collect data on pediatric cancer diagnosis and treatment from electronic medical records

2. Demonstrate ability and experience locating, obtaining and deidentifying patient radiation treatment plans, including DICOM files for all eligible patients. Radiation treatment plans may not be part of a patient’s standard medical record and may be physically/electronically housed separately in radiation oncology departments. This could include manual work to retrieve from archived materials.

3. Demonstrate ability and experience to maintain quality control over the data collection

Criterion 3: Organizational Capability 10 points

1. Demonstrate organizational capability to support data abstraction from medical records and availability of RT-DICOM files for pediatric cancer patients.

TOTAL 100 points

Revised: February 10, 2021

Invoice and Payment Provisions

The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase

Agreement (BPA) Orders/Calls: Prompt Payment (Jan 2017) FAR 52.232-25. Highlights of this clause and NIH implementation requirements follow:

I. Invoice Requirements A. An invoice is the Contractor's bill or written request for payment under the contract for supplies delivered or services performed. A proper invoice is an "Original" which must include the items listed in subdivisions 1 through 12, below, in addition to the requirements of FAR 32.9. If the invoice does not comply with these requirements, the Contractor will be notified of the defect within 7 days after the date the designated billing office received the invoice (3 days for meat, meat food products, or fish, and 5 days for perishable agricultural commodities, dairy products, edible fats or oils) with a statement of the reasons why it is not a proper invoice. (See exceptions under II., below.) Untimely notification will be taken into account in the computation of any interest penalty owed the Contractor.

1. Contractor: Name, Address, Point of Contact for the invoice (Name, title, telephone number, e-mail and mailing address of point of contact).

2. Remit-to address (Name and complete mailing address to send payment).

3. Remittance name must match exactly with name on original order/contract. If the Remittance name differs from the Legal Business Name, then both names must appear on the invoice.

4. Invoice date.

5. Unique invoice #s for all invoices per contractor regardless of site.

6. NBS document number formats must be included for awards created in the NBS: Contract Number;

Purchase Order Number; Task or Delivery Order Number and Source Award Number (e.g., Indefinite Delivery Contract number; General Services Administration number); or, BPA Call Number and BPA Parent Award Number.

7. Data Universal Numbering System (DUNS) or DUNS + 4 as registered in the Central Contractor Registration (CCR).

8. Federal Taxpayer Identification Number (TIN). In those exceptional cases where a contractor does not have a DUNS number or TIN, a Vendor Identification Number (VIN) must be referenced on the invoice. The VIN is the number that appears after the contractor’s name on the face page of the award document.

9. Identify that payment is to be made using a three-way match.

10. Description of supplies/services that match the description on the award, by line billed.*

11. Freight or delivery charge must be billed as shown on the award. If it is included in the item price do not bill it separately. If identified in the award as a separate line item, it must be billed separately.

12. Quantity, Unit of Measure, Unit Price, Extended Price of supplies delivered or services performed, as applicable, and that match the line items specified in the award.*

* NOTE: If your invoice must differ from the line items on the award, please contact the Contracting Officer before submitting the invoice. A modification to the order or contract may be needed before the invoice can be submitted and paid.

B. Shipping costs will be reimbursed only if authorized by the Contract/Purchase Order. If authorized, shipping costs must be itemized. Where shipping costs exceed $100, the invoice must be supported by a bill of lading or a paid carrier's receipt.

C. The Contractor shall submit invoice to the National Institutes of Health/Office of Financial Management (NIH/OFM) via email at invoicing@nih.gov with a copy to Contracting Officer, Contracting Officer’s Representative, and Program point of contact, as directed. The invoices must be emailed in accordance with instructions below. Do not submit supporting documentation (e.g., receipts, time sheets, invoices, etc.) with your payment request unless specified elsewhere in the contract or requested by the Contracting Officer. The invoice shall be transmitted as an attachment via email to the address listed above in one of the following formats: Word, or Adobe Portable Document Format (PDF). The Contractor must submit only one invoice per email.

Please Note: NIH/OFM will not accept invoices postmarked and/or delivered in-person on/after December 1, 2020.

For inquiries regarding the status of invoices such as receipt of invoices, due date, request for payment of invoices, etc., contact NIH/OFM Customer Service via email at ofm_customer_service@incontactemail.com or via phone at 301-496-6088. To send your inquiries via other available communication methods see the NIH/OFM Customer Service website at https://ofm.od.nih.gov/Pages/Customer-Service.aspx.

The NIH/OFM Customer Service is open Eastern Standard Time Monday – Friday from 8:30 a.m. to 5:00 p.m. and is closed between 12:00 p.m. to 1:00 p.m.

In order to facilitate the prompt payment of invoices, it is recommended that the contractor submit a photocopy of the invoice to the “Consignee” designated for the acquisition in blocks 6A – 6E of the OF-347 of the Order/Award document.

II. Invoice Payment A. Except as indicated in paragraph B., below, the due date for making invoice payments by the designated payment office shall be the later of the following two events:

1. The 30th day after the designated billing office has received a proper invoice.

2. The 30th day after Government acceptance of supplies delivered or services performed.

B. The due date for making invoice payments for meat and meat food products, perishable agricultural commodities, dairy products, and edible fats or oils, shall be in accordance with the Prompt Payment Act, as amended.

III. Interest Penalties

A. An interest penalty shall be paid automatically, if payment is not made by the due date and the conditions listed below are met, if applicable.

1. A proper invoice was received by the designated billing office.

2. A receiving report or other Government documentation authorizing payment was processed and https://ofm.od.nih.gov/Pages/Home.aspx mailto:invoicing@nih.gov https://ofm.od.nih.gov/Pages/Home.aspx https://ofm.od.nih.gov/Pages/Customer-Service.aspx mailto:ofm_customer_service@incontactemail.com https://ofm.od.nih.gov/Pages/Customer-Service.aspx there was no disagreement over quantity, quality, or contractor compliance with a term or condition.

3. In the case of a final invoice for any balance of funds due the contractor for supplies delivered or services performed, the amount was not subject to further settlement actions between the Government and the Contractor.

B. Determination of interest and penalties due will be made in accordance with the provisions of the Prompt Payment Act, as amended, the Contract Disputes Act, and regulations issued by the Office of Management and Budget.

IV. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR 52.232-40 (December 2013)

a. Upon receipt of…