Attachments_for_Combined_Syn-Sol_NIH-P16-0018F.pdf

Attachments as listed in Section J of the Combined Synopsis/Solicitation NIH-P16-0018F

Attachment 1: Packaging and Delivery of Proposals (1 page)

Attachment 2: Proposal Intent Response Sheet (1 page)

Attachment 3: Statement of Work (5 pages)

Attachment 4: Section K - Representations, Certifications, and Other Statements of Offerors pages)

Attachment 5: Pricing Table (1 page)

Attachment 6: Past Performance Questionnaire (2 pages)

Attachment?: Summary of Related Activities (1 page)

Attachment 8: Proposal Summary and Data Record, (2 pages)

Attachment 9: Offeror's Points of Contact (1 page)

Attachment Disclosure of Lobbying Activities, OMB form (2 pages)

Attachment Invoice Instructions for Fixed Price Contracts NIH(RC)-2 (3 pages)

Combined Synopsis/Solicitation

Attachment Packaging and Delivery of Proposals

PACKAGING AND DELIVERY OF PROPOSALS

Your proposal shall be organized as specified in SECTION L.2. General Instructions. Shipment and marking shall be as indicated below.

EXTERNAL PACKAGE MARKING

In addition to the address cited below, mark each package as follows:

TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY"

PLEASE READ THE FOLLOWING INFORMATION CAREFULLY:

NUMBER OF COPIES

TECHNICAL PROPOSAL: ORIGINAL* AND J COPIES TO:

BUSINESS PROPOSAL: ORIGINAL* AND J COPIES TO:

If hand-delivered or delivery service If using U.S. Postal Service

Lisa Schaupp, Contract Specialist Lisa Schaupp, Contract Specialist

Office of Purchasing and Contracts Office of Purchasing and Contracts

6707 Democracy Suite 106 6707 Democracy Suite 106

Bethesda, MD 20892-5480 Bethesda, 20892-5480

*THE ORIGINALS MUST BE READILY ACCESSIBLE FOR DATE STAMPING PURPOSES.

NOTE: Please be aware that the U.S. Postal Service's "Express Mail" DOES NOT deliver to the Rockville, Maryland address AND delivery to the Bethesda, Maryland address will result in a delayed delivery to our office in Rockville, MD (up to 3 - 5 days). If a proposal is not received at the place, date, and time specified herein, it will be considered a "late proposal."

Attachment 2: Proposal Intent Response Sheet

PROPOSAL INTENT RESPONSE FORM

RFP No:

RFP Title: FDG Unit Doses in Shielded Delivery Administration Containers

Please review the Request for Proposal (RFP). Furnish the information requested below and return this page to the Contracting Officer/Contract Specialist identified on Section Form by the earliest practical date

Your expression of intent is not binding but will greatly assist us in planning for proposal evaluation.

Choose one of the following Options:

Do intend to submit a proposal O Do Not intend to submit a proposal

If you are not responding to this RFP, please provide your reason(s):

Please provide the following contact information:

Name (First, Middle Initial, Last):

Title:

Organization:

E-mail:

Attachment Statement of Work

STATEMENT OF WORK

Procurement of in Shielded Delivery and Administration System Nuclear Pharmacy, Nuclear Medicine

Department of Radiology and Imaging Sciences Clinical Center

National Institutes of Health Bethesda, MD 20892

A. BACKGROUND

The NIH Clinical Center Nuclear Pharmacy regularly purchases and compounds radiopharmaceuticals (radioactive drugs) for life-saving clinical nuclear medicine procedures which are essential for the NIH Clinical Center to achieve optimal patient care. These radiopharmaceuticals are United States Food and Drug Administration (FDA) approved drugs for use in patients. They are also radioactive materials that are regulated by the United States Nuclear Regulatory Commission (USNRC) through the NIH radioactive material license (RAM) administered by the NIH Radiation Safety Office (RSO). Accordingly, procurement and use of these radiopharmaceutical drugs must meet federal regulations to ensure safety and minimize health risks to both the staff and patients. Hence, only qualified vendors that meet the FDA and USNRC regulations can provide these radiopharmaceuticals for compounding and dispensing at the NIH Nuclear Pharmacy to NIH Clinical Center patients.

As part of NIH obtaining these materials, only RSO certified Nuclear Medicine personnel can order the radiopharmaceuticals directly for patient use. The NIH Nuclear Medicine clinic performs imaging and therapy procedures for patients admitted to the NIH Clinical Center. These procedures are essential and necessary for the NIH clinical staff to save patients' lives and minimize suffering. The contractor supplying the radiopharmaceuticals shall be supporting this function.

By way of further background information, Fludeoxyglucose, or fludeoxyglucose F (USAN and USP), also commonly called fluorodeoxyglucose and abbreviated or FDG, is a radiopharmaceutical (radioactive drug) approved by the FDA for use in the medical imaging modality positron emission tomography (PET). Chemically, it is a glucose analog, with the positron-emitting radioactive isotope substituted for the normal hydroxyl group at the 2' position in the glucose molecule. The uptake of by tissues is a marker for the tissue uptake of glucose, which in turn is closely correlated with certain types of tissue metabolism. After is injected into a patient, a PET scanner can form two-dimensional or three-dimensional images of the distribution of within the body. Since its development in had a profound influence on research in the neurosciences. The subsequent discovery in that

FDG accumulates in tumors underpins the evolution of PET as a major clinical tool in cancer diagnosis. is now the standard radiotracer used for PET and cancer patient management. The images can be assessed by a nuclear medicine physician or radiologist to provide diagnoses of various medical conditions.

Since emits high energy ionizing radiation (500 keV), the drug must be properly shielded to minimize unnecessary radiation exposure to both NIH staff and patients (FO Roberts, DH Gounawardana, et a. Radiation Dose to PET Technologists and Strategies to Lower Occupational Exposure. J Med 2005; 33:44-47).

Although public health data do not absolutely establish the occurrence of cancer following exposure to low doses and dose rates, the radiation protection community conservatively assumes that any amount of radiation may pose some risk for causing cancer and hereditary effect, and the risk is higher for higher radiation exposures (http://www.nrc.gov/about-nrc/radiation/health-effects/rad-exposure-cancer.html). A linear no-threshold (LNT) dose-response relationship is used to describe the relationship between radiation dose and the occurrence of cancer. The dose-response model suggests that any increase in dose, no matter how small, results in an incremental increase in risk. The USNRC accepts the LNT hypothesis as a conservative model for estimating radiation risk. In addition, the USNRC has mandated the "ALARA" concept in the Code of Federation Regulations (10 C.F.R. § 20.1003).

ALARA is an acronym for "as low as is reasonably achievable," which means making every reasonable effort to maintain exposures to ionizing radiation as far below the dose limits as is practical, consistent with the purpose for which the licensed activity is undertaken Hence, 10 C.F.R. § provides that "[t]he licensee shall use, to the extent practical, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and doses to members of the public that are as low as is reasonably achievable (ALARA)." 10 C.F.R. §

In complying with the ALARA regulations as well as USNRC recommendations for achieving and maintaining a safety conscious work environment (NRC Regulatory Issue Summary Guidance For Establishing And Maintaining A Safety Conscious Work Environment, ML052220239), the NIH Nuclear Pharmacy requires the qualified vendor to deliver each unit dose of in shielded dose administration container (referred to as a "pig"), which sits inside a further shielded shipping container.

This configuration provides the lowest reasonably achievable radiation exposure to the staff and patients in the NIH Nuclear Medicine Clinic (USNRC Regulatory Guide 8.18, Information Relevant to Ensuring that Radiation Exposures at Medical Institutes will be As Low As Is Reasonably Achievable, April Revision 2).

Finally, each radiopharmaceutical must be properly compounded, dispensed, calibrated and delivered for a specific patient at a specific time on a specific date. The useful dose activity (radioactivity) of FDG decays away very fast minutes).

Hence, the dose must be delivered at a specific, required time and contain a specific, required dose activity in order for the imaging/therapy study to be properly performed.

B. P U R P O S E

The purpose of the SOW is to procure unit doses of each contained in a shielded single-dose administration container (referred to as a "pig"), and at least two pigs further contained in a shielded shipping container. The complete system must meet DOT regulations, USNRC ALARA, and Government weight guidelines. The deliveries must come from a source appropriately licensed by the FDA and USNRC as described below. In turn, the deliveries shall allow the NIH Nuclear Medicine Department of Radiology and Imaging Sciences to perform clinical imaging studies as required by necessary patient care protocols at the NIH Clinical Center.

C. P L A C E OF PERFORMANCE/DELIVERY

The radioactive drugs must be delivered to the National Institutes of Health in Bethesda, MD. A radiopharmaceutical shall not be considered delivered unless: (1) it is delivered in a proper dose administration and shipping system; (2) the radiopharmaceutical arrives at the specified point of destination; (3) the contractor/contractor's agent has placed the radiopharmaceutical in the custody of an NIH RSO certified Nuclear Medicine person; and (4) the radiopharmaceutical is delivered on time.

D. REQUIREMENTS OF THE DELIVERY S Y S T E M

The Government has no specific requirement as to the composition of the shielded single-dose administration container/pig, or the shielded shipping container that two or more pigs will sit in. For example, the Government has seen systems comprised of lead or tungsten shielding. Rather, the Government requires a system that meets the following standards.

(1) The shielded shipping container, when loaded with two doses contained in individual pigs, cannot weigh more than 51.0 pounds. A shipping container which can only carry one dose will not be acceptable.

This requirement derives from the US Occupational Safety & Health Administration (OSHA) and the National Institute of Occupational Safety and Health (NIOSH). OSHA has found that lifting heavy items is one of the leading causes of injury in the workplace Accordingly, previous NIOSH guidelines state that maximum weight to be lifted with two hands, under ideal conditions, is 51 pounds." Guidelines for Manual Material Handling, DHHS (NIOSH) Publication at (Apr. 2007). However, OSHA currently recommends that "lifts be limited to 35 pounds or less." OSHA, Safe Patient Handling, OSHA Pamphlet 3708 (Feb. Hence, in order to minimize weight lifting injuries to the staff, the NIH Nuclear Pharmacy seeks the FDG doses to be shipped in acceptably shielded containers which weigh as little as is possible. Unfortunately, the NIH Nuclear Pharmacy is currently not confident that it will obtain an adequate system if it limits the weight of the loaded shipping container to 35 pounds. Thus, the NIH Nuclear Pharmacy seeks a dose administration and transportation system, when loaded with two doses, which does not weigh more than 51 pounds.

Doses are typically delivered to secure storage, which is not a large area, and must accommodate other materials, in addition to the doses. Consequently, in order to ensure that the deliveries meet space constraints, each shipping container must contain at least two doses.

(2) In order to facilitate handling of each single-dose pig, the pig must have a durable handle. A strap or similarly tractable handle shall not suffice this requirement.

This requirement helps ensure safe handling of each pig. Specifically, a nuclear medicine technologist typically must walk each pig down a relatively long hallway.

Hence, having a durable handle to grasp on to, and use to control the pig, allows a technologist to safely and securely control the pig. Additionally, if there is an issue with the FDG dose which requires staff to calibrate the dose, staff must be able to manipulate the pig and the dose contained therein within the confines of a biological safety cabinet. A durable handle also helps facilitate this activity.

(3) Each shielded pig, when loaded with one dose of 7.5 F-FDG, must not emit radiation greater than 37 per hour (hr), as measured on the exterior surface at the center of the pig. The measurement is made by the FH 40G Digital Survey Meter (Thermo Scientific Eberline ESM model FH40G-L).

In accordance with 10 C.F.R. § the NIH Nuclear Pharmacy is required to limit radiation dosage to employees and members of the public to the extent as low as is reasonably achievable. The Pharmacy knows that there are pigs currently available that limit exposure to as low as 37 milliRoentgen per hour (hr). Hence, 37 milliRoentgen (mR) per hour (hr) is the currently demonstrated standard for as low as is reasonably achievable.

(4) The shielded pig must allow a nuclear medicine technologist to administer a dose of to a patient without completely the dose from the containment of the pig.

In order to further the goal of limiting radiation exposure to employees to as low as is reasonably achievable, the pig shielding must allow a technologist to administer the directly to the patient without completely un-shielding the dose from the containment of the pig. For example, the pig could be constructed to allow a staff member to insert a 4-5 syringe containing the into an IV line, and allow a staff member to push the plunger on the syringe, all without the staff member having to remove the syringe from the shielding of the pig. The Government is open to various ways a proposed pig may facilitate safe dose administration, but any pig which requires a technologist to remove the syringe from the pig in order to administer the dose is not acceptable.

E. OTHER REQUIREMENTS

(1) The production facility of the must be approved by the FDA (or the approval request pending and on file with the FDA), with registration in good standing, to produce for human use.

(2) The offeror must be licensed, with the license in good standing, by either the USNRC, or the relevant State Radioactive Materials Licensing Agency (provided that the State has an agreement with the USNRC which makes its approval a sufficient alternative to USNRC approval), for the production and/or distribution of

This requirement may also be applied to any subcontractor, sub-subcontractor, manufacturer, carrier, or other entity which the offeror is relying upon to create or handle the depending on the offeror's performance approach.

(3) The calibrated dose activities shall be between and within of calibrated activity ordered by the NIH

(4) The required calibration times for the doses shall be between 6 a.m. to 6 p.m. Eastern Time (ET).

(5) The contractor shall provide Monday-to-Friday dose deliveries to the NIH campus in Bethesda, MD. Each dose shall be delivered no later than 30 minutes prior to the appointed calibration time for that dose. Delivery times and locations shall be specified by the NIH Radiopharmacy when an order is placed. The typical order will be placed on the business day prior to the requested delivery, or earlier, as circumstances allow. Typically, but not guaranteed, the contractor will be able to deliver multiple doses in one delivery.

Administrative note, when the contractor makes a delivery, it should also retrieve empty pigs and shipping containers.

(6) When requested, the contractor shall provide a STAT or (Immediate) delivery. A STAT order is a request for delivery of a dose as soon as is possible.

When NIH makes a STAT order, the contractor shall deliver the unit dose no later than 3 hours after the order is placed. Although not guaranteed, NIH typically places 1-2 STAT orders per week. Additionally, unlike normal orders, a STAT order may require a weekend delivery. Recognizing that a STAT order may increase a contractor's costs (e.g., employees, lost efficiencies, overtime, etc.), NIH requests a different unit price for STAT orders than it does for normal orders.

(7) The packaging and transport of all deliveries shall meet relevant U.S.

Department of Transportation transportation requirements for radioactive materials.

Attachment 4: Section K - Representations, Certifications, and Other Statements of Offerors

SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER

STATEMENTS OF OFFERORS

Updated through FAC 2005-86

Last updated: 02/2016

This SECTION is made up of six parts as follows:

1. Annual Representations and Certif ications, FAR 52.204-8

2. Commercial and Government Entity Code Reporting, FAR 52.204-16

3. Information Regarding Responsibility Matters, FAR 52.209-7

4. Cost Account ing Standards

5. Cer t i f icat ion Regarding Traff icking in Persons Compl iance Plan

6. Certification Regarding Environmental Tobacco Smoke

7. Certification of Institutional on Financial Conflicts of Interest

8. Disaster or Emergency Area Representat ion

To Be Completed bv the Offeror: This document must be completed and included as part of your Business

Proposal. By submission of its signed offer, the offeror makes the fol lowing Representations and Certifications:

1. ANNUAL REPRESENTATIONS AND CERTIFICATIONS (FEB 2016), FAR Provision 52.204-8

(a) (1) The North American Industry Classification System code for this acquisition is

[insert NAICS

(2) The Small Business Size Standard is [insert size standard].

(3) The small business size standard for a concern which submits an offer in its own name, other than on a construction or service contract, but which proposes to furnish a product which it did not itself manufacture, is employees.

(b) (1) If the provision at 52.204-7, System for Award Management, is included in this solicitation, paragraph (d) of this provision applies,

(2) If the provision at 52.204-7 is not included in this solicitation, and the offeror is currently registered in System for Award Management (SAM), and Representations and Certifications section of SAM has completed the Representations and Certifications section of SAM electronically, the offeror may choose to use paragraph (d) of this provision instead of completing the corresponding individual representations and certifications in the solicitation. The offeror shall indicate which option applies by checking one of the fol lowing boxes:

(i) Paragraph (d) applies.

(ii) Paragraph (d) does not apply and the offeror has completed the individual representations and certifications in the solicitation. [See Individual Representations and

Certifications/

(c) (1) The fol lowing representations or certifications in SAM are applicable to this solicitation as indicated:

(i) 52.203-2, Certificate of Independent Price Determination. This provision applies to solicitations when a firm-fixed-price contract or fixed-price contract wi th economic price adjustment is contemplated, unless—

(A) The acquisition is to be made under the simplified acquisition procedures in Part 13;

(B) The solicitation is a request for technical proposals under two-step sealed bidding procedures; or

(C) The solicitation is for util ity services for which rates are set by law or regulation.

(ii) Certification and Disclosure Regarding Payments to Influence Certain Federal

Transactions. This provision applies to solicitations expected to exceed $150,000.

(iii) 52.204-3, Taxpayer Identification. This provision applies to solicitations that do not include the provision at 52.204-7, System for Award Management.

(iv) 52.204-5, Women-Owned Business (Other Than Small Business). This provision applies to solicitations that —

(A) Are not set aside for small business concerns;

(B) Exceed the simplified acquisition threshold; and

(C) Are for contracts that will be performed in the United States or its outlying areas.

(v) 52.209-2, Prohibition on Contracting wi th Inverted Domestic Corporations— Representation.

(vi) 52.209-5, Certification Regarding Responsibility Matters. This provision applies to solicitations where the contract value is expected to exceed the simplified acquisition threshold.

(vii) 52.209-11, Representation by Corporations Regarding Delinquent Tax Liability or Felony

Conviction under any Federal Law.

(viii) Place of Performance-Sealed Bidding. This provision applies to invitations for bids except those in which the place of performance is specified by the Government.

(ix) 52.215-6, Place of Performance. This provision applies to solicitations unless the place of performance is specified by the Government.

(x) 52.219-1, Small Business Program Representations (Basic & Alternate This provision applies to solicitations when the contract will be performed in the United States or its outlying areas.

(A) The basic provision applies when the solicitations are issued by other than DoD, NASA, and the Coast Guard.

(B) The provision with its Alternate applies to solicitations issued by DoD, NASA, the Coast

Guard.

(xi) 52.219-2, Equal Low Bids. This provision applies to solicitations when contracting by sealed bidding and the contract will be performed in the United States or its outlying areas.

(xii) Previous Contracts and Compliance Reports. This provision applies to solicitations that include the clause at 52.222-26, Equal Opportunity.

(xii) Affirmative Action Compliance. This provision applies to solicitations, other than those for construction, when the solicitation includes the clause at 52.222-26, Equal Opportunity.

(xiii) 52.222-38, Compliance wi th Veterans' Employment Reporting Requirements. This provision applies to solicitations when it is anticipated the contract award will exceed the simplified acquisition threshold and the contract is not for acquisition of commercial items.

(xiv) Biobased Product Certification. This provision applies to solicitations that require the delivery or specify the use of USDA-designated items; or include the clause at 52.223-2, Affirmative Procurement of Biobased Products Under Service and Construction Contracts,

(xv) 52.223-4, Recovered Material Certification. This provision applies to solicitations that are for, or specify the use of, EPA-designated items.

(xvi) 52.225-2, Buy American Certificate. This provision applies to solicitations containing the clause at 52.225-1.

(xvii) 52.225-4, Buy American-Free Trade Trade Act Certificate. (Basic, Alternates II, and III.) This provision applies to solicitations containing the clause at 52.225¬

3.

(A) If the acquisition value is less than $25,000, the basic provision applies.

(B) If the acquisition value is $25,000 or more but is less than $50,000, the provision with its

Alternate applies.

(C) If the acquisition value is $50,000 or more but is less than$79,507, the provision with its

Alternate II applies.

(D) If the acquisition value is $79,507 or more but is less than $100,000, the provision with its

Alternate III applies.

(xviii) Trade Agreements Certificate. This provision applies to solicitations containing the clause at 52.225-5.

(xix) 52.225-20, Prohibition on Conducting Restricted Business Operations in Sudan-

Certification. This provision applies to all solicitations.

(xx) 52.225-25, Prohibition on Contracting wi th Entities Engaging in Certain Activities or Transactions

Relating to and Certification. This provision applies to all solicitations.

(xxi) 52.226-2, Historically Black College or University and Minority Institution

Representation. This provision applies to solicitations for research, studies, supplies, or services of the type normally acquired f rom higher educational institutions.

(2) The fol lowing certifications are applicable as indicated by the Contracting Officer: [Contracting

Officer check as appropriate.]

(i) 52.204.17, Ownership or Control of Offeror

(ii) 52.222-18, Certification Regarding Knowledge of Child Labor for Listed End Products.

Exemption f rom Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment Certification.

52.222- 52 Exemption f rom Application of the Service Contract Labor Standards to Contracts for Certain Services-Certification.

9, wi th its Alternate Estimate of Percentage of Recovered Material Content for

EPA-Designated Products (Alternate only).

52.227-6, Royalty Information.

(A) Basic.

(B) Alternate

(vii) 52.227-15, Representation of Limited Rights Data and Restricted Computer Software.

(d) The of feror has completed the annual representat ions and cert i f icat ions electronical ly via the

SAM websi te accessed through After reviewing the SAM database information, the offeror verifies by submission of the offer that the representations and certifications currently posted electronically that apply to this solicitation as indicated in paragraph (c) of this provision have been entered or updated within the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201); except for the changes identified below [offeror to insert identifying change by clause number, title, date]. These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer.

FAR Clause No. Title Date Change

Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted on SAM.

(End of Provision)

_ ( i v )

_ ( v )

_ ( v i )

2. COMMERCIAL AND GOVERNMENT ENTITY CODE REPORTING, (JUL 2015) FAR Provision 52.204-16

Note to Offeror: This provision is incorporated by reference and is applicable when the resultant contract will contain FAR Provision 52.204-6 and/or FAR Provision 52.204-7.

3. INFORMATION REGARDING RESPONSIBILITY MATTERS, (JUL 2013) FAR Provision 52.209-7

Note to Offeror: This provision is applicable when the resultant contract is expected to exceed

$500,000.

(a) Definitions. As used in this provision —

Administrative proceeding means a non-judicial process that is adjudicatory in nature in order to make a determination of fault or liability (e.g., Securities and Exchange Commission Administrative proceedings, Civilian Board of Contract Appeals Proceedings, and Armed Services Board of Contract

Appeals Proceedings). This includes administrative proceedings at the Federal and State level but only in connection with performance of a Federal contract or grant. It does not include agency actions such as contract audits, site visits, corrective plans, or inspection of deliverables.

Federal contracts and grants with total value greater than $10,000,000

(1) The total value of all current, active contracts and grants, including all priced options; and

(2) The total value of all current, active orders including all priced options under indefinite-delivery, indefinite-quantity, 8(a), or requirements contracts (including task and delivery and mult iple-award Schedules).

Principal means an officer, director, owner, partner, or a person having primary management or supervisory responsibilities wi th in a business entity (e.g., general manager; plant manager; head of a division or business segment; and similar positions).

(b) The offeror does not have current active Federal contracts and grants with total value greater than $10,000,000.

(c) If the offeror checked "has" in paragraph (b) of this provision, the offeror represents, by submission of this offer, the information it has entered in the Federal Awardee Performance and Integrity

Information System (FAPIIS) is current, accurate, and complete as of the date of submission of this offer w i th regard to the fol lowing information:

(1) Whether the offeror, and/or any of its principals, has or has not, within the last five years, in connection wi th the award to or performance by the offeror of a Federal contract or grant, been the subject of a proceeding, at the Federal or State level that resulted in any of the fol lowing dispositions:

(i) In a criminal proceeding, a conviction.

(ii) In a civil proceeding, a finding of fault and liability that results in the payment of a monetary fine, penalty, reimbursement, restitution, or damages of $5,000 or more.

(iii) In an administrative proceeding, a finding of fault and liability that results in —

(A) The payment of a monetary fine or penalty of $5,000 or more; or

(B) The payment of a reimbursement, restitution, or damages in excess of $100,000.

(iv) In a criminal, civil, or administrative proceeding, a disposition of the matter by consent or compromise with an acknowledgment of fault by the Contractor if the proceeding could have led to any of the outcomes specified in paragraphs (c)(l)(i), (c)(l)(i i), or (c)(l)(ii i) of this provision.

(2) If the offeror has been involved in the last five years in any of the occurrences listed in (c)(1) of this provision, whether the offeror has provided the requested information with regard to each occurrence.

(d) The offeror shall post the information in paragraphs (c)(l)(i) through (c)(l)(iv) of this provision in FAPIIS as required through maintaining an active registration in the System for Award Management database at (see

COST ACCOUNTING STANDARDS

(1) Cost Accounting Standards Notices and Certification (October 2015), FAR Provision 52.230-1

Note: This notice does not apply to small businesses or foreign governments. This notice is in three parts, identified by Roman numerals through III.

Offerors shall examine each part and provide the requested information in order to determine Cost Accounting Standards (CAS) requirements applicable to any resultant contract.

the offeror is an educational institution, Part II does not apply unless the contemplated contract will be subject full or modified CAS-coverage pursuant to 48 CFR respectively.

Disclosure Statement - Cost Accounting Practices and Certification

(a) Any contract in excess of $750,000 resulting f rom this solicitation wil l be subject to the requirements of the Cost Accounting Standards Board (48 CFR Chapter 99), except for those contracts which are exempt as specified in 9903.201-1.

(b) Any offeror submitting a proposal which, if accepted, will result in a contract subject to the requirements of 48 CFR Chapter 99 must, as a condition of contracting, submit a Disclosure

Statement as required by 9903.202. When required, the Disclosure Statement must be submitted as a part of the offeror's proposal under this solicitation unless the offeror has already submitted a Disclosure Statement disclosing the practices used in connection the pricing of this proposal. If an applicable Disclosure Statement has already been submitted, the offeror may satisfy the requirement for submission by providing the information requested in paragraph (c) of Part of this provision.

CAUTION: In the absence of specific regulations or agreement, a practice disclosed in a

Disclosure Statement shall not, by virtue of such disclosure, be deemed to be a proper, approved, or agreed-to practice for pricing proposals or accumulating and reporting contract performance costdata.

Checkthe appropriate box below:

| Certificate of Concurrent Submission of Disclosure Statement.

The offeror hereby certifies that, as part of the offer, copies of the Disclosure

Statement have been submitted as follows:

(i) original and one copy to the cognizant Contracting Officer (ACO), or cognizant Federal agency official authorized to act in that capacity (Federal official), as applicable, and;

(ii) one copy to the cognizant Federal auditor.

(Disclosure must be on Form No. CASB DS-1 or CASB DS-2, as applicable.. Forms may be obtained from the cognizant ACO or Federal official and/or from the looseleaf version of the Federal Acquisition Regulation).

Date of Disclosure Statement:

Name and Address of Cognizant ACO or Federal Official Where Filed:

The offeror further certifies that the practices used in estimating costs in pricing this proposal are consistent wi th the cost accounting practices disclosed in the

Disclosure Statement.

| | (2) Certificate of Previously Submitted Disclosure Statement.

The offeror hereby certifies that the required Disclosure Statement was filed as fol lows:

Date of Disclosure Statement:

Name and Address of Cognizant ACO or Federal Official Where Filed:

The offeror further certifies that the practices used in estimating costs in pricing this proposal are consistent with the cost accounting practices disclosed in the applicable

Disclosure Statement.

|(3) Certificate Exemption.

The offeror hereby certifies that the offeror together with all divisions, subsidiaries, and affiliates under common control, did not receive net awards of negotiated prime contracts and subcontracts subject to CAS totaling more than $50 million or more in the cost accounting period immediately preceding the period in which this proposal was submitted. The offeror fuVther certifies that if such status changes before an award resulting from this offeror will advise the

Contracting Officer immediately.

| |(4) Certificate of Interim Exemption.

The offeror hereby certifies that :

(i) the offeror first exceeded the monetary exemption for disclosure, as defined in

(3) of this subsection, in the cost accounting period immediately preceding the period in which this offer was submitted, and

(ii) in accordance with 48 CFR 9903.202-1, the offeror is not yet required to submit a Disclosure Statement. The offeror further certifies that if an award resulting from this proposal has not been made within 90 days after the end of that period, the offeror will immediately submit a revised certificate to the Contracting

Officer, in the form specified under subparagraph (c)(1) or (c)(2) of Part of this provision, as appropriate, to verify submission of a completed Disclosure

Statement.

CAUTION: Offerors currently required to disclose because they were awarded a prime contract or subcontract of $50 million more in the current cost accounting period may not claim this exemption (4). Further, the exemption applies only in connection with proposals submitted before expiration of the 90-day period following the cost accounting period in which the monetary exemption was exceeded.

| | (5) Certificate of Disclosure Statement Due Date by Educational Institution.

(ALTERNATE 1996)

If the offeror is an educational institution that, under the transition provisions of 48

CFR 9903- 202-l(f), is or will be required to submit a Disclosure Statement after receipt of this award, the offeror hereby certifies that {check one and complete):

• A Disclosure Statement Due Date of has been established with the cognizant Federal agency.

• 00 The Disclosure Statement will be submitted within the 6-month period ending months after receipt of this award.

Name and Address of Cognizant ACO or Federal Official Where Filed:

II. Cost Accounting for Modified Contract Coverage

If the offeror is eligible to use the modified provisions of 48 CFR 9903.201-2(b) and elects to do so, the offeror shall indicate by checking the box below. Checking the box below shall mean that the resultant contract is subject t o the Disclosure and Consistency of Cost Accounting Practices clause in lieu of the Cost Accounting Standards clause.

| | The offeror hereby claims an exemption f rom the Cost Accounting Standards clause under the provisions of 48 CFR 9903.201-2(b) and certifies that the of feror is eligible for use of the Disclosure and Consistencyof Cost Accounting Practices clause duringthe cost accounting period immediately preceding the period in which this proposal was submitted, the offeror received than $50 million in awards of CAS-covered prime contracts and subcontracts. The offerorfurther certifies that if such status changes before an award resulting f rom this proposal, the offeror will advise the Contracting Officer immediately.

CAUTION: An offeror may not claim the above eligibility for modified contract coverage if this proposal is expected to result in the award of a CAS-covered contract of $50 million or more or if, during its current cost accounting period, the offeror has been awarded a single CAS-covered prime contract or subcontract of $50 million or more.

III. Additional Cost Accounting Standards Applicable to Existing Contracts

The offeror shall indicate below whether award of the contemplated contract would, in accordance with subparagraph (a)(3) of the Cost Accounting Standards Clause, require a change in established cost accounting practices affecting existing contracts and subcontracts.

• Y E S NO

(2) Proposal Disclosure-Cost Accounting Practice Changes. (March 2005)(FAR Provision

The offeror shall check "yes" below if the contract award wil l result in a required or unilateral change in cost accounting practice, including unilateral changes requested to be desirable changes.

If the offeror checked "Yes" above, the shall—

(1) Prepare the price proposal in response to the solicitation using the changed practice for the period of performance for which the practice wil l be used; and

(2) Submit a description of the changed cost accounting practice to the Contracting Officer and the

Cognizant Federal Agency Official as pricing support for the proposal.

maintained wi th such federal funds. The law does not apply to children's services provided in private residences; portions of facilities used for inpatient drug or alcohol t reatment ; service providers whose sole source of applicable federal funds is Medicare or Medicaid; or facilities where coupons are redeemed.

Failure to comply wi th the provisions of the law may result in the imposit ion of a civil monetary penalty of up to $1,000 for each violation and/or the imposit ion of a n administrative compliance order on the responsible entity.

By submission of its signed offer, the offeror/contractor (for acquisitions) or applicant/grantee (for grants) certifies that the submitting organization will comply with the requirements of the Act and will not allow smoking within any portion of any indoor facility used for the provision of services for children as defined by the Act.

The submitting organization agrees that it will require that the language of this certification be included in any subawards which contain provisions for children's services and that all subrecipients shall certify accordingly.

7. CERTIFICATION OF INSTITUTIONAL POLICY ON FINANCIAL CONFLICTS OF INTEREST

Note: This certification is applicable to all Research and Development (R&D) Contracts except Phase and Contracts with Federal Agencies.

By Submission of its signed offer, the offeror certifies that:

(1) there is in effect at the Institution (the term Institution includes any contractor, public or private, excluding a

Federal agency) an up-to-date, wr i t ten and enforced administrative process to identify and manage, financial conflicts of interest wi th respect to all research projects for which funding is sought or received f rom the NIH;

(2) the Institution shall promote and enforce Investigator compliance wi th this part's requirements including those pertaining to disclosure of significant financial interests;

(3) the Institution shall manage financial conflicts of interest and provide initial and ongoing reports to NIH consistent wi th this part;

(4) the Institution agrees to make information available, promptly upon request, to the Contracting Officer relating to any Investigator disclosure of financial interests and the Institution's review of, and response to, such disclosure, whether or not the disclosure resulted in the Institution's determination of a financial conflict of interest; and

(5) the Inst i tut ion shall ful ly comply w i th the requirements of 45 CFR Part 94.

8. DISASTER OR EMERGENCY AREA REPRESENTATION, (Aug 2006), FAR Provision 52.226-3

Note: This provision is applicable for acquisitions that are set-aside for a Disaster or Emergency Area under FAR Subpart 26.2. See Section Solicitation, paragraph entitled "Notice of Disaster or

Emergency Area Set-Aside."

a. Set-aside area. is: _

[Contracting Officer fill in with definite geographic boundaries.]

b. Representations. The offeror represents as part of its offer that it is, is not a firm residing or primarily doing business in the designated area.

c. Factors to be considered in determining whether a f i rm resides or primarily does business in the designated area include—

(1) Location(s) of the firm's permanent office(s) and date any office in the designated area(s) was established;

(2) Existing state licenses;

(3) Record of past work in the designated area(s) how much and for how long);

(4) Number of permanent employees the f i rm employs in the designated area;

(5) Membership in local and state organizations in the designated area; and

(6) Other evidence that establishes the f i rm resides or primari ly does business in the designated area.

(e) If the offeror represents it is a f irm residing or primarily doing business in the designated area, the offeror shall furnish documentation to support its representation if requested by the Contracting Officer.

The solicitation may require the offeror to submit w i th its offer documentation to support the representation.

(End of Provision)

Attachment 5: Pricing Table

Attachment 5 Pricing Table Please be sure to follow the solicitation instructions, paying close attention to the section titled "COMPLETING THE ATTACHMENT 5

PRICING TABLE" on page 21 of the RFP. As provided in the RFP, the unit prices must be fully loaded. Also, as part of an offeror estimating its per unit costs and ascertaining its per unit pricing, please keep in mind the offeror will retrieve empty pigs and shipping containers, which may eliminate some costs.

Performance Item Description Unit Price (In

D o l l a r s )

Estimated Quantity (In

Sub-Total (In

Base Year

FDG unit dose in a Shielded Delivery and Administration System

("Standard Order") 3,000

Base Year

STAT order a FDG unit dose in a

Shielded Delivery and Administration System

("STAT Order") 100

Option Year 1 Standard Order 3,000

Option Year 1 STAT Order 100

Option Year 2 Standard Order 3.000

Option Year 2 STAT Order 100

Option Year 3 Standard Order 3,000

Option Year 3 STAT Order 100

Option Year 4 Standard Order 3.000

Option Year 4 STAT Order

Total Evaluated Price

Attachment 6: Past Performance Questionnaire

Attachment 6

NIH PAST PERFORMANCE INFORMATION QUESTIONNAIRE

Please complete the following questionnaire and return via e-mail to the following:

National Institutes of Health

Lisa. gov (Email)

This survey pertains to:

Agency/Company/Entity:

Contract Number: Date of Survey:

Name of Person Completing Survey:

Signature of Person Completing Survey:

Your Company/Agency/Entity:

Your Role in this Contract (circle one):

Contracting Officer Contract Specialist Project Officer Other

Contract Value (including options): $

Performance Period:

Ms. Lisa Schaupp. Contract Specialist by 9:00 a.m. ET on May 26. 2016 (Date) (Name)

(including option periods)

Type of Contract:, Attachment 6

NIH PAST PERFORMANCE INFORMATION QUESTIONNAIRE

RATINGS

Please respond to each of the following prompts with a rating that is based on objective measurable performance indicators to the maximum extent possible. Commentary to support rating may be provided on page 3.

Assign each area a rating ofO (Unsatisfactory), 1 (Poor), 2 (Fair), 3 (Good), 4 (Excellent), or 5 (Outstanding). Circle the appropriate rating. If you do not have enough personal knowledge or feedback from internal customers who directly received products and services from the contractor to make a determination on any the performance criteria below, please circle "N/A " (not applicable/no opinion).

1. Timeliness of performance 0 1 2 3 4 5 N/A

2. Quality of performance 0 1 2 3 4 5 N/A

3. Vendor's record of forecasting and controlling costs 0 1 2 3 4 5 N/A

4. Accuracy of the vendor's billing 0 1 2 3 4 5 N/A

5. Effectiveness of the vendor's management 0 1 2 3 4 5 N/A

6. Vendor's cooperativeness 1 2 3 4 5 N/A

7. Vendor's commitment to customer satisfaction 0 1 2 3 4 5 N/A

O V E R A L L

Overall, would you characterize the vendor as committed to customer satisfaction.

Yes No (circle one)

2. Would you recommend selection of this again?

Yes No (circle one)

ADDITIONAL COMMENTS

Attachment 7: Summary of Related Activities

SUMMARY OF R E L A T E D ACTIVITIES

The following specific information must be provided by the offeror pertaining to the Project Director, Principal Investigator, and each of any other proposed key professional individuals designated for performance under any resulting contract.

a. Identify the total amount of all presently active federal contracts/cooperative agreements/grants and commercial agreements citing the committed levels of effort for those projects for each of the key individuals* in this proposal.

Professional's Name and Title/Position:

Identifying Number Agency Total Effort Committed

*lf an individual has no obligation(s), so state.

b. Provide the total number of outstanding proposals, exclusive of the instant proposal, having been submitted by your organization, not presently accepted but in an anticipatory stage, which will commit levels of effort by the proposed professional individuals*.

Professional's Name and Title/Position:

Identifying Number Agency Total Effort Committed

*lf no commitment of effort is intended, so state.

c. Provide a statement of the level of effort to be dedicated to any resultant contract awarded to your organization for those individuals designated and cited in this proposal.

Name Title/Position Total Proposed Effort

Summary of Related Activities (1/2011)

Combined Synopsis/Solicitation NIH-P

Attachment 8: Proposal Summary and Data Record, DEPARTMENT OF HEALTH AND HUMAN SERVICES

PUBLIC HEALTH SERVICE

NATIONAL INSTITUTES OF HEALTH

PROPOSAL SUMMARY AND DATA RECORD

RFP/CONTRACT NUMBER

PROJECT TITLE (Title or RFP or Contract Proposal)

LEGAL NAME AND ADDRESS OF OFFEROR PLACE OF PERFORMANCE (Full address including ZIP)

TYPE OF CONTRACT PROPOSED

COST-REIMBURSEMENT PRICE [

ESTIMATED TIME REQUIRED TO COMPLETE PROJECT

ESTIMATED DIRECT COSTS IN PROPOSED YEAR (From Budget

PROPOSED STARTING DATE

organization, description of services, basis for selection, responsible person employed by subcontractor and cost information.)

NAME AND TITLE OF PRINCIPAL INVESTIGATOR SOCIAL SECURITY

NO.

EST. HOURS

WEEKLY

AREA

NAME AND TITLE OF CO-INVESTIGATOR (Use attachment if necessary.)

NAME AND TITLE OF INDIVIDUAL(S) AUTHORIZED TO

NEGOTIATE CONTRACTS

NAME AND TITLE OF INDIVIDUAL(S) AUTHORIZED TO

EXECUTE CONTRACTS

AREA CODE/TELEPHONE NUMBER

AREA CODE/TELEPHONE NUMBER

DOES THIS PROPOSAL INVOLVE EXPERIMENTS WITH HUMAN

Institution's General Assurance re: Human Subjects DATE APPROVED Institution's Review Board's Approval of this Proposal APPROVED

NO

YES

YES

•PENDING

An example of the informed consent this study is enclosed A Clinical Protocol is enclosed

OFFEROR'S ACKNOWLEDGMENT OF AMENDMENTS TO THE RFP (Use attachment if necessary)

ERRATA NUMBER DATE ERRATA NUMBER DATE

NAME, ADDRESS, AND PHONE NUMBER OF

COGNIZANT GOVERNMENT AUDIT AGENCY

NUMBER OF EMPLOYEES CURRENTLY EMPLOYED

NAME, ADDRESS, AND PHONE NUMBER OF

COGNIZANT GOVERNMENT AUDIT AGENCY

DOLLAR VOLUME OF BUSINESS PER ANNUM

NAME, ADDRESS, AND PHONE NUMBER OF

COGNIZANT GOVERNMENT AUDIT AGENCY

THIS OFFER EXPIRES DAYS FROM THE

DATE OF THIS OFFER days if not specified)

THE INSTITUTION

SIGNATURE OF PRINCIPAL INVESTIGATOR SIGNATURE OF BUSINESS REPRESENTATIVE

TYPED NAME AND TITLE TYPED NAME AND TITLE

EMPLOYER IDENTIFICATION NUMBER DATE OF OFFER

NIH-2043

June

Provision of the Social Security Number is voluntary. Social Security

Numbers are requested for the purpose of accurate and efficient identification, review, and management of NIH Extramural Programs.

Authority for requesting this information is provided by Title III, Section

301, and Title IV of the Public Health Service Act, as amended.

Attachment 9: Offeror's Points of Contact

O F F E R O R ' S POINTS OF CONTACT

Complete the following and return with the BUSINESS PROPOSAL.

Business Representative

(Name, Title, Address* and Contact Information of individual with whom daily contact is required.)

Name: Telephone:

Title: Fax:

Office: E-Mail:

Organization:

*Street Address:

City, State, Zip Code:

Proposed Principal Investigator (Name, Institutional Title, Address, and Contact Information)

Name: Telephone:

Title: Fax:

Office: E-Mail:

Organization:

*Street Address:

City, State, Zip Code:

These exact addresses are necessary to ensure that contact can be made with the proper individual(s) in the most expeditious manner.

*Please use actual street address, not P.O. Box.

Offeror's Points of Contact

Combined Synopsis/Solicitation NIH-P

Attachment Disclosure of Lobbying Activities, OMB form SF-LLL

D I S C L O S U R E OF LOBBYING ACTIVITIES Approved by O M B

Complete this form to disclose lobbying activities pursuant to 31 U.S.C. 0348-0046

(See reverse for public burden disclosure.)

1. Type of Federal Action:

a. contract

b. grant

c. cooperative agreement

d. loan

e. loan guarantee

f. loan insurance

2. Status of Federal Action:

a. bid/offer/application initial award

c. post-award

3. Report Type:

a. initial filing

' b. material change For Material Change Only:

vear quarter date of last report

4. Name and Address of Reporting Entity:

| | Subawardee

Tier , if known :

Congressional District, if known :

5. If Reporting Entity in No. 4 is a Subawardee, Enter Name

Congressional District, known:

Federal 7

CFDA Number, if applicable :

8. Federal Action Number, if known: 9. Award Amount, if known:

a. Name and Address of Lobbying Registrant individual, last name, first name, Ml):

b. Individuals Performing Services address if different from No.

name, first name, Ml):

A Information requested through this form is authorized by title 31 U.S.C. section 1352. This disclosure of lobbying activities Is a material representation of fact upon which reliance was placed by the tier…