Amendment_1_NIH-P16-0018F_5-24-2016.pdf

NATIONAL INSTITUTES OF HEALTH CLINICAL CENTER

Combined Synopsis/Solicitation NIH-P16-0018F

AMENDMENT NUMBER ONE (1)

DATE OF ISSUANCE: May 24, 2016

The above numbered solicitation is amended as set forth below. Offerors must acknowledge receipt of the amendment prior to the hour and the date specified in the solicitation or as amended, by one of the following methods:

I. By acknowledging receipt of this amendment as part of the offeror’s proposal (Please note that this is the preferred method); or

II. By separate letter or e-mail which includes a reference to the solicitation and amendment numbers.

FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR

THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

REJECTION OF YOUR OFFER.

The purpose of this amendment is to 1) provide responses to questions submitted by potential Offerors concerning Combined Synopsis/Solicitation NIH-P16-0018F titled, “FDG Unit Doses in Shielded Delivery and Administration Containers” and 2) make corrections/changes to Combined Synopsis/Solicitation NIH-P16-0018F titled, “FDG Unit Doses in Shielded Delivery and Administration Containers” for the

National Institutes of Health

NOTE: OFFERORS ARE ADVISED THAT RESPONSES TO QUESTIONS REFERRED TO IN

THIS SECTION ARE PROVIDED FOR INFORMATIONAL PURPOSES ONLY. NEITHER

THE TECHNICAL REQUIREMENTS/SPECIFICATIONS NOR TERMS AND CONDITIONS

OF THE RFP ARE CHANGED UNLESS CHANGED BY A FORMAL CORRECTION/CHANGE

AS SPECIFIED IN SECTION “B”, BELOW.

A. QUESTIONS AND RESPONSES

I. Vendor Question 1: For Section K, if we answer Paragraph (d) does not apply for

1(b)(2)(ii), do we still need to complete the other parts of Section K (parts 2-8), or does that suffice for all of Section K?

Government Response to Vendor Questions 1:

Paragraph (d) may apply if the offeror’s electronic representations and certifications are up-to-date on SAM. Otherwise, the offeror must fully complete the solicitation-provided representations and certifications and include the completed representations and certifications as an attachment to the offeror’s proposal. As provided below, the

Contracting Office is amending the solicitation by providing an updated representations and certifications form. If the offeror is not updating on SAM, please be sure to complete and provide to the Contracting Office the correct completed form. Section K is removed in its entirety and replaced by FAR 52.212-3, provided as “Attachment 4,” in the amended list of attachments.

II. Vendor Question 2: I was curious to know if SDVOSB status will be a weighted factor in this award?

Government Response to Vendor Question 2:

Although a weighted evaluation factor for SDVOSB involvement is often used by the

U.S. Department of Veterans Affairs, the National Institutes of Health do not have the same agency-specific procurement rules. Rather, the evaluation factors are clearly provided in Section M of the RFP, those factors comply with FAR Part 15, and there is no weighted evaluation factor for SDVOSB involvement.

III. Vendor Question 3: “Attachments_for_Combined_Syn-Sol_NIH-P16-0018F” file. The

Summary of Related Activities form asks for a listing of different individuals, and their

“committed levels of effort” on other projects.

Our industry does not really work on a project basis so I am not sure this form applies, and I do not know how we would answer this. Our pharmacy staff would be working daily to provide NIH, as well as the other customers that are serviced out of the pharmacy, with their ordered products. I am not sure how to translate that to certain

“committed levels of effort.”

Can you advise if the completion of this form is mandatory for our submission, and if so, how to translate what we do to fit the requirements of this form?

Government Response to Vendor Question 3:

Attachment 7 (Summary of Related Activities) is often used for NIH procurements which involve research being conducted by key personnel. However, it does not apply here. Hence, an offeror is not required to include it with the offeror’s proposal.

Attachment 7 is deleted from the RFP in its entirety.

IV. Vendor Question 4: For some of our commercial customers we offer a price and then discount it on the invoice to arrive at a lower net price. Would an on-invoice discount like this be acceptable for NIH?

Government Response to Vendor Question 4:

Because this solicitation seeks to create a single award IDIQ with fixed-price task orders based on a menu of prices established in the master contract, the Attachment 5 unit prices which the offeror commits to in its proposal shall be the unit prices upon which task order pricing will be based. Hence, after contract formation, an offeror will not be allowed to change its unit prices. Indeed, the RFP states the following at

Section L.

[T]he proposal must provide a fixed price, as in the pricing provided must not be conditioned upon taxes, surcharges, or some other reservation which would prospectively change the price. Of note, the offeror only being valid for

180 days is an acceptable exception to the preceding statement. However, during contract performance, the NIH making changes to the quantities ordered under the IDIQ portion of the contract will not justify an adjustment to an offeror’s unit prices. In sum, the failure of an offeror to propose a fixed price will result in the proposal being discarded as unacceptable.

V. Vendor Question 5: For Attachment 5 Pricing Table, the line item that is for the STAT

FDG dose, can we split out the cost of the F18 FDG Unit Dose and the STAT order price?

Government Response to Vendor Question 5:

The RFP at Section L states the following.

Because the contemplated contract is a single-award IDIQ with fixed-price orders, an offeror’s unit prices must be fully loaded, as in each per dose price must include applicable overhead costs, fringe costs, G&A costs, profit, taxes, surcharges, etc.

If the offeror changes any of the pre-set quantities in the pricing table, fails to provide any per unit pricing, or otherwise fails to provide a total price, the offeror’s proposal shall be discarded as unacceptable and given no further consideration.

In accordance with the RFP and the Attachment 5 Pricing Table, for each year of contract performance, an offeror must provide two fully loaded unit prices—a fully loaded unit price for a standard order (includes all allocated costs and profit, including for the unit dose, containment, transportation, taxes, etc.); and a fully loaded unit price for a STAT order (includes all allocated costs and profit, including for the unit dose, containment, transportation, taxes, etc.). The sought unit prices are intended to be fully loaded unit prices. If an offeror deviates from this pricing structure, such as by creating a different pricing table, the offeror’s proposal shall be discarded as unacceptable.

VI. Vendor Question 6:

I would like to request that the delivery containers section be modified to include any alternative containers that have shielding provided for distribution of each radioactive drug that meet DOT requirements in addition to safe handling and storage by end users to maintain occupational exposures ALARA.

Government Response to Vendor Question 5:

The requirement is stated as objective standards which reflect the Government’s minimum needs. As part of that, there is no requirement as to the composition of the dose administration container (“pig”), or the transportation container. Hence, the pig may be made of lead, tungsten, or another material. At the same time, as stated in the statement of work, the as low as reasonably achievable (“ALARA”) standard is no more than 37 milliRoentgen (mR) per hour (hr) for a 4-5 mL dose of 7.5 mCi 18 F-

FDG, as measured from the center of the dose administration container with the FH

40G multi-purpose digital survey meter. All solutions are welcome that meet the

SOW-stated standards. However, if a solution does not meet the SOW-stated standards, NIH is not going to imperil the physical safety of employees by lessening those standards.

B. Combined Synopsis/Solicitation CORRECTION/CHANGES

The above number Combined Synopsis/Solicitation is amended as set forth below.

1. Synopsis: Added: May 16, 2016 12:17 pm, paragraphs 2, sentence 1, “The solicitation is being issued using simplified acquisition procedures under the authority of FAR 13.5 Test Program for certain Commercial Items and is open to business of all sizes,” is deleted in its entirety. This solicitation is not using simplified acquisition procedures, and is not under the authority of FAR 13.5 Test

Program for Certain commercial Items. Rather, the RFP is a combination FAR Parts 12 and 15 solicitation which seeks to purchase commercial items.

Paragraph 2 now reads:

The solicitation is being issued under FAR Part 15, “Contracting by

Negotiation,” and is full and open to business of all sizes. Evaluations will be made using the Lowest Price Technically Acceptable source selection criteria.

Accordingly, offerors are apprised that it is possible that only the lowest-price, timely submitted proposal may be evaluated.

2. The Attachment 3 Statement of Work is modified as follows.

The following paragraph is removed.

Each shielded pig, when loaded with one dose of 7.5 mCi 18 F-FDG, must not emit radiation greater than 37 milliRoentgen (mR) per hour (hr), as measured on the exterior surface at the center of the pig. The measurement is made by the FH 40G Multi-Purpose Digital Survey Meter (Thermo Scientific

Eberline ESM model FH40G-L).

In its place, the following paragraph is added.

Each shielded pig, when loaded with one 4-5 mL dose of 7.5 mCi 18 F-FDG, must not emit radiation greater than 37 milliRoentgen (mR) per hour (hr), as measured on the exterior surface at the center of the pig. The measurement is made by the FH 40G Multi-Purpose Digital Survey Meter (Thermo Scientific

Eberline ESM model FH40G-L).

3. Attachments 1: Packaging and Delivery of Proposals, is deleted in its entirety.

Please provide proposals in electronic form only. Proposals must be sent to the Contract Specialist by the date and time specified in the Combined

Synopsis/Solicitation NIH-P16-0018F.

4. These attachments are deleted in their entirety. They are not pertinent to the above Combined Synopsis/Solicitation:

Attachment 7: Summary of Related Activities, Attachment 8: Proposal Summary and Data Record, NIH-2043

Attachment 9: Offeror’s Points of Contact (this information should be contained within the Offeror’s Proposal)