36C25024Q0013_1.docx

VHAPG Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT

GENERAL INFORMATION

CONTRACTING OFFICE ADDRESS

Department of Veterans Affairs Network Contracting Office 3140 Governor’s Place Blvd. Suite 210 Kettering OH 45409-1337

POINT OF CONTACT*

Contracting Officer LouAnn Gilliland louann.gilliland@va.gov 937-268-6511

ADDITIONAL INFORMATION

DESCRIPTION

Description

The Department of Veterans Affairs, VHA Regional Procurement Office Central, Network Contracting Office 10, located at 3140 Governor s Place Blvd., Suite 210, Kettering, OH 45409 intends to award a single-award, firm-fixed-priced FSS contract from 10/01/2023 until 09/30/2024 to Progenics Pharmaceuticals, Inc., a Lantheus company. A determination by the Government not to compete the proposed acquisition will be based upon responses of this notice, it is solely within the discretion of the Government. Inquiries shall be emailed to LouAnn.Gilliland@va.gov. Any response to this notice must show clear and convincing evidence that competition would be advantageous to the Government in future procurements. The Progenics Pharmaceuticals, Inc.’s address is at 331 Treble Cove Road, North Billerica, MA, 01862, United States. This award will be for the Nuclear Medicine Clinic at the Ann Arbor VAMC, Ann Arbor, MI 48105. The acquisition is conducted under authority of the Multiple Award Schedule Program; FAR Subpart 8.405-6(b) Items Peculiar to one Manufacturer. The primary statutory authorities for the MAS program are 41 U.S.C. 152(3), Competitive Procedures, and 40 U.S.C. 501, Service for Executive Agencies. It is the Government’s belief the proposed candidate is the sole manufacturer capable of meeting the requirement. The associated North America Classification Systems (NAICS) Code is 325412 and the Small Business Size Standard is 1,300 employees. It is the Government’s belief the proposed candidate is the only source with the required capabilities to successfully meet the requirement for PYLARIFY® (piflufolastat F 18) Injection, which is a radioactive diagnostic agent for men with prostate cancer. This is an FDA approved, proprietary item available only through the sole manufacturer and authorized supplier of PYLARIFY. This notice satisfies the requirement at FAR 5.201(b)(1), to publicize the proposed contract action. This notice of intent is not a request for competitive proposals. No solicitation documents are available at this time. Interested parties may give written notice to LouAnn.Gilliland@va.gov by 12:00pm e.s.t. on September 11, 2023. No telephone requests will be accepted.

Special Notice Special Notice

Special Notice

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C250-23-AP-3475

(1) Contracting Activity: Department of Veterans Affairs, VISN 10, Dayton Medical Center, Dayton, Ohio is seeking to purchase (for bridge contract: 10/1/2023 – 09/30/2024) Pylarify, a radioactive drug for the Ann Arbor VAMC – Nuclear Medicine, Ann Arbor, MI, 48105.

2237# 506-24-1-020-0001

(2) Description of Action: PYLARIFY Radiopharmaceutical

Order against: |X| FSS Contract Number: _____36F79719D0710____

(3) Description of Supplies or Services: Nuclear Radioactive Drug F-18 Piflufolastat (Pylarify) – A prostate cancer treatment drug.

The estimated value of the proposed action is ____________ Nuclear Medicine is requesting procurement of radioactive drug F-18 Piflufolastat (Pylarify) used for therapy treatment of metastatic castrate resistant prostate cancer from FDA approved sole source vendor Progenic Pharmaceutical, Inc. This radioactive therapy drug is to be ordered and received by trained Nuclear Medicine staff only.

Estimated period of performance: 10/01/2023 – 09/30/2024.

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

|_| FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

|X| FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

This is currently the only product that is FDA approved. The effectiveness for prostate cancer detection has changed patient care standard practices for Oncology. Oncology recommended guidance is that patients with diagnosed prostate cancer are to receive a Nuclear F-18 Piflufolstat (Pylarify) PET/CT scan. This is part of cancer treatment workup. The delay of this scan can delay therapy treatment planning for current and future patients, which could potentially lead to a life/death outcome. The radioactive drug F-18 Piflufolastat (Pylarify) is manufactured and distributed in the USA by a sole vendor. All Nuclear Medicine imaging agents are unique and highly specialized, specific to each individual patient.

|_| FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

|_| FAR 8.405-6(b): Items peculiar to one manufacturer:

|_| A patent, copyright or proprietary data limits competition. The proprietary data is:

|_| These are “direct replacements” parts/components for existing equipment.

|_| The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing.

(5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination:

This is the only vendor FDA approved for manufacturing F-18 Piflufolastat Pylarify prostate imaging radioactive drug.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted.

VetCert was queried using NAICS Code 325412, which provided 130 potential SD/VOSB vendors. DSBS was also queried using the same NAICS Code, along with key word “Pylarify”; this search provided no potential vendors. In addition to the above searches, eCMS, FPDS, SAM.gov, SCMC, PBM Formulary Specialty Medications, and the NAC (Pharmaceutical Catalog) were all reviewed for any updated information on this FDA approved radioactive drug. This product was found on the NAC (Pharmaceutical Catalog), showing as a single source vendor that could provide this product. This radioactive drug is manufactured in the USA. Therefore, the Contracting Officer believes that placing an order against this contract would be in line with BAA requirements and does not require any further action. Recommend FSS Sole Source to Progenic Pharmaceutical, Inc.

(7) Any Other Facts Supporting the Justification:

Nuclear Medicine is currently using F18-Pylarify Piflufolastat in FY22 (36C25022F0389), which will end on 9/30/2023. New contract needed for continue use in FY23.

(8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made:

Should a requisition of this nature occur, the market will be surveyed.

(9) Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

Completed 4/27/2023

RUSSELL CUTINO JR.

NUCLEAR MEDICINE, CHIEF

ANN ARBOR VAMC

(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

CONTRACTING OFFICER

NETWORK CONTRACTING OFFICE 10

STATEMENT OF WORK

Nuclear Medicine Radioactive Drug F-18 Piflufolastat (Pylarify)

1.0 Summary:

The VA Ann Arbor Healthcare System (VAAAHS) has a requirement for radiopharmaceutical F-18 Piflufolastat (Pylarify). It is necessary to obtain this product and service that are both vital and critical to patient care from an outside nuclear pharmacy and sole vendor. Contractor shall furnish radioactive isotope F-18 Piflufolastat Pylarify for diagnostic imaging.

2.0 Requirements:

• Contractor must be licensed by the U.S. Nuclear Regulatory Commission (USNRC), or a State with a formal Agreement with the USNRC that allows the State to regulate radioactive materials (Licensee) and be regularly established in the business of providing radiopharmaceuticals at the scale and frequency necessary to meet this requirement. The radiopharmaceuticals must be shipped from the Licensee directly to locations of use requested by the VAAAHS. Non-manufacturing waiver is not applicable to this solicitation/contract.

• Contractor/licensee shall meet all applicable USNRC, Department of Veterans Affairs National Health Physics Program (NHPP), Department of Transportation (DOT), Food and Drug administration (FDA), State, and Federal requirements, rules, and/or regulations related to the supply of radiopharmaceuticals.

• The contractor will meet all radiopharmaceutical requirements for VAAAHS (Ann Arbor VAMC) in unit dose form. (See Price/Cost Schedule)

• All packages containing radioactive material must be labeled and shipped in accordance with Title 49, Code of Federal Regulations (CFR) Part 172 and 173, and Title 10, CFR Part 71.

• Contractor/licensee shall perform all quality control procedures as required by Federal, and when applicable, State regulatory agencies. Quality Control results will be furnished to VAAHS upon request.

• Contractor/supplier shall abide by Title 10, CFR, which states: A Licensee may use for medical purposes only:

(a) By-product material or cyclotron produced materials manufactured, labeled, packaged, and distributed in accordance with a license issued pursuant to the regulations in Title 10, CFR, Part 35 and/or the equivalent regulations of an Agreement State.

(b) Reagent kit that has been manufactured, labeled, packed and distributed in accordance with approval by the NRC pursuant to Title 10 CFR 32.72 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use.

• The contractor shall provide radiopharmaceuticals during standard hours of care Monday through Friday from 6:30 a.m. (EST) until 4 p.m. (EST), not including Federal holidays. Federal holidays include the following:

New Year’s Day, Martin Luther King Day, Presidents Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Thanksgiving Day, Christmas Day, Juneteenth. Federal holidays also include any day specifically declared by the President of the United States as a holiday.

NOTE: If the holiday falls on a Saturday, it will be officially observed on the Friday before the holiday. If the holiday falls on a Sunday, it will be officially observed on the Monday following the holiday.

• For the placement of orders, the contactor will be contacted by staff nuclear medicine technologists assigned to the nuclear medicine department at the Ann Arbor VA Medical Center.

• All routine orders for radiopharmaceutical doses will be placed via phone, fax, or internet with the contractor one day before they are needed and prior to the VA Nuclear Medicine Clinic close of business. The order shall include specified activities of doses, calibration times, and patient name, and Authorized User. The contractor shall deliver the ordered radiopharmaceutical doses to Ann Arbor VA Medical Center, 2215 Fuller Road, Ann Arbor, MI 48105, Nuclear Medicine Clinic, Room D764 between 6:30 a.m. (EST) and 4 p.m. (EST).

• Orderable dose calibration times will be Monday, Tuesday, Wednesday, Thursday, and Friday from 10:30 a.m. to 4 p.m.

• The contractor shall calibrate all radiopharmaceutical doses to ensure proper activity ranges of +/- 10 percent of the specified ordered dose based on specific requirements provided by Nuclear Medicine Clinic based on guidelines outlined in 10 CFR Part 35.

• Radiopharmaceutical Returns for Credit: Ann Arbor VAMC and TOPC facilities require the contractor to accept returns for full credit toward future orders under the following conditions:

(a) Product(s) ordered or shipped in error.

(b) Product(s) damaged in shipment

(c) Concealed shipping damages

(d) Recalled product(s)

(e) Outdated products in unopened, original container.

(f) Product ordered but notified from vendor of failure to deliver/procure product

(g) Product delivered past calibrated time and out of 8.0-10.0mCi range.

• The contractor shall provide a daily packing slip accompanying all radiopharmaceutical shipments to the Nuclear Medicine Clinic for all orders placed. The packing slip shall include a bar code that works with the Nuclear Medicine Information System (NMIS) for tracking purposes.

• All invoices for payment shall be submitted via government electronic payment portal (Tungsten System).

• The contractor shall be able to work within NMIS, the current Nuclear Medicine management program at Ann Arbor VAMC. This shall allow for the receipt, inventory, and proper documentation of radiopharmaceutical doses dispensed.

• The contractor shall ensure that all radiopharmaceutical doses provided are compounded and calibrated by or under the supervision of a certified Nuclear Medicine Pharmacist.

• The contractor shall provide courier service that is in accordance with DOT, USNRC and other applicable regulating authorities enabling the delivery of all radiopharmaceuticals. All couriers shall be licensed. Couriers shall submit all paperwork required for access to Ann Arbor VA Medical Center. The contractor shall be responsible for the removal of carrier containers and “empty” non-radioactive shielded carriers (lead pigs, lead vial containers, etc…) from the clinic within 72 hours of delivery.

• All couriers will deliver product through the facility via approve route by facility VA Police. Approved route information will be provided by VA Ann Arbor Nuclear Medicine Department or Radiation Safety Officer.

• The contractor shall notify Ann Arbor VAMC Nuclear Medicine Clinic Nuclear Medicine Clinic immediately should the inability arise to provide radiopharmaceutical doses. The inability to provide radiopharmaceuticals will be credited in full.

• The contractor shall provide any training or education required to meet commercial standards related to use of radiopharmaceuticals to all staff Nuclear Medicine Technologists stationed at Ann Arbor VAMC and TOPC.

Effective Date: 02/01/2022 Page 9 of 9 image1.png