16-223-SOL-00027.pdf

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1. Notice of Combined Synopsis/Solicitation

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6.

This announcement constitutes the only solicitation and a written solicitation will not be issued.

2. Notice of Request for Proposal

This solicitation, identified as 16-223-SOL-00027, is issued as a request for proposal (RFP) in accordance with the requirements of FAR Parts 12 and 15.

3. Notice of FAC

This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2005-88, effective 16 May 2016.

FAR provisions and clauses referenced in this solicitation can be found on the following website:

https://www.acquisition.gov/far/index.html.

HHSAR provisions and clauses referenced in this solicitation can be found on the following website:

http://farsite.hill.af.mil/vfhhsara.htm

4. Notice of NAICS/Set-Aside This solicitation is full and open under the associated NAICS code 541910, Marketing Research and Public Opinion Polling, with a small business size standard of $15 Million.

5. Contract Line Items

The government intends to award a single-award IDIQ contract with an anticipated ceiling of $60 Million, and a guaranteed minimum of $3,000. This contract will have an ordering period of five years from the date of award.

The government reserves the right to award Firm-Fixed-Price, Time-and-Material or Labor-Hour type task orders under this contract.

6. Contract Requirements

Please see Attachment 1, for the Base Contract Statement of Work, and Attachments 2 and 3, for the anticipated Task Orders’ Statement of Work, for a full description of the services to be acquired.

7. Deliveries, Acceptance, and Performance Dates

Unless otherwise noted in the Task Order Statement of Work, all work will be performed at the contractor’s facility. Each task/delivery order issued under this contract will specify:

• Duration of performance;

• Specific tasks to be performed https://www.acquisition.gov/far/index.html http://farsite.hill.af.mil/vfhhsara.htm

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• Specific deliverables/deliverable due dates;

• The name of the Task Order Contracting Officer Representative responsible for inspection and acceptance;

and

• Acceptance terms if other than FOB Destination

8. Instructions to Offerors

The provision at 52.212-1, Instructions to Offerors—Commercial Items, applies to this acquisition. Addenda to this provision are as follows:

8.1 Format

Each proposal shall consist of three separate volumes – A technical volume, a pricing volume, and a past performance volume.

• Each volume shall include a cover sheet which clearly identifies each volume by volume number and volume name (i.e., Volume I, Technical Approach), solicitation number, and date of submission, and shall include page headers with the same information.

• The Offeror shall submit each volume in its native format (e.g. Word, Excel) as well as in PDF format. Each volume shall be sent as a separate document. The PDF format is the version of record.

• An individual authorized to contractually bind the Offeror shall sign the cover page of the each volume.

Specific formatting instructions for each volume are as follows:

Technical Volume

Note: The Offeror shall ensure that the technical volume is free of any pricing information.

a. General Formatting Instructions:

Offerors shall use the following page setup parameters:

• Margins – Top, Bottom, Left, Right – 1”

• Gutter – 0”

• From Edge – Header, Footer – 0.5”

• Page Size, Width – 8.5”

• Page Size, Height – 11”

Each paragraph shall be separated by at least one blank line. Offerors are encouraged to use Calibri 11 point font.

However, a font of equivalent size may be used. Tables and illustrations may use a reduced font size not less than 10-point and may be landscape.

b. Page Limitations

The technical volume is limited to 50 pages. A page in the technical volume that contains a table, chart, graph, etc., not otherwise excluded below, is subject to the page limitation.

The following items are not included in the 50 pages limit:

• Cover Page

• Table of Contents

• Dividers

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c. Organization

The technical volume shall contain the following sections:

1. Technical Approach to the IDIQ and Task Orders - The Offeror shall provide a narrative that details its technical approach to performing the tasks presented in the IDIQ SOW, Attachment 1. The narrative shall also specifically address how the Offeror will perform all tasks associated with the IDIQ and the tasks specifically cited under Attachments 2 and 3. The narrative shall specifically detail the risks and challenges the Offeror anticipates encountering in performance under this contract and its specific approach to managing or mitigating them. At a minimum, the Offeror’s narrative shall detail the Offeror’s specific methods for the following:

• Establish a mechanism for CTP to elicit assessments and evaluations of tobacco-related public education activities

• Qualitatively and quantitatively measure and report to the government the degree to which these activities lead to successful outcomes

• Identify the need for effectiveness-improving adjustments

• Assess and report to the government the long-term public health impact of these activities

2. IDIQ and Task Order Staffing – The Offeror shall provide a narrative description of its approach to staffing the

IDIQ contract and the specific staffing of the Task Order. In specific, the Offeror shall demonstrate that is has the ability to provide staff with the technical skill sets and labor mix to perform all tasks and the offeror has a feasible approach to hiring, training, and maintaining qualified staff through the duration of the contract. The offeror shall provide for each labor category its title, description, and critical skills/training.

3. Management Approach - The Offeror shall provide a narrative that describes how it will manage all aspects of contract performance to ensure timely, high quality services. The Offeror shall also provide a Quality Assurance Plan that details how they plan to accomplish the tasks presented in the SOW. The Government will evaluate the clarity, adequacy, and feasibility of the Offeror’s Management Approach to implementing and managing all aspects of contract.

4. Relevant Experience - The Offeror shall provide a narrative describing, at a minimum, three contracts, which have been worked under within the past three years, where it has supported projects of similar type, size, complexity, and scope. Projects in which a proposed sub-contractor/partner to this solicitation was the prime contractor may be counted as relevant experience.

5. Submission of Organizational Conflict of Interest Plan

The work described in this SOW involves the evaluation of CTP’s public education campaigns that are designed to shape tobacco-related knowledge, opinions, attitudes, and behaviors among individuals and within communities. Due to the nature of the work described, offerors should be certain to disclose organizational relationships with companies in the broadcasting industry, companies in the tobacco industry, companies that have performed marketing and related services for FDA, and all other relevant relationships. The disclosure must include past, present, or planned interests bearing on whether the contractor (including its chief executives and directors, or any proposed consultant or subcontractor) have a conflict of interest.

The offeror shall submit, along with its business/cost proposal, an Organizational Conflict of Interest Plan describing the mitigation strategy that will be employed to identify actual, apparent, and/or potential conflict of interest situations that may arise as a result of the work under this contract. The offeror will describe the steps that will be taken to avoid or mitigate an actual, apparent, and/or potential conflict.

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The prospective contractor shall certify, to the best of its knowledge and belief, that it is not aware of any information bearing on the existence of any potential organizational conflict of interest. If the prospective contractor cannot so certify, it shall provide a disclosure statement in its plan. The disclosure of potential or existing conflicts of interest must address actual, apparent and potential organizational conflicts of interest within the offeror’s entire corporate umbrella, including parent companies, sister companies, affiliates, subsidiaries, and other interests held by the offeror; generally limited up to third tier relations unless there are potential conflict of interest concerns related to more distant affiliates.

Offerors who have disclosed a conflict shall describe how any such conflicts will be avoided, mitigated, or neutralized. This information will provide the Agency with an opportunity to assess its vulnerabilities relative to organizational conflicts of interest of individual offerors prior to award. The fact that an offeror has a relationship with an organization will not necessarily disqualify the offeror for consideration for award on the basis of actual or potential conflicts of interest.

Past Performance Volume There is no page limit to the past performance volume. This volume will consist of:

• A listing of at least three past performance references, who the offer has worked with within the past three years, to whom the government may contact. It is preferred these submissions are also those which were submitted under the Technical Volume, Relevant Experience section.

• It is preferred the past performance submissions are available on PPIRS (Past Performance Information Retrieval System)

• The listing shall include the references Company Name, DUNS, Contract Number, Contract type, Contract Value, Period of Performance, Current Company POC who may be reached, Phone Number and email.

Price Volume There is no page limit to the pricing volume. The price volume shall consist of the following elements:

• Acknowledgement of the solicitation and any amendments.

• A complete version of the pricing worksheets Attachment 4 (BASE IDIQ Pricing Table), Attachement 4

Fresh Empire Pricing Table and Attachment 4 The Real Cost Pricing Table. The pricing worksheets provided by FDA includes all formulas necessary to arrive at the “Grand Total” total evaluated price of the contract. The Offeror shall not change any formulas within the Excel Workbook.

• All labor rates are to be fully loaded labor rates.

• Indicate on Attachment 4 (Pricing Table) all labor categories proposed under this IDIQ. Each labor category identified as an Service Contract Act (SCA) category as provided in Attachment 8, shall be annotated in this spreadsheet and the rate shall broken down in the Labor Breakdown Tab of this worksheet. The offeror may manipulate this worksheet as necessary to appropriately show the labor rate in accordance with the SCA and the formulation of the fully loaded rate.

• Attachment 8 is for the DC Statewide local (DC/VA/MD states) as indicated in attachment 8. The offeror shall adhere to the DOL rates associated with the location where the offeror will be performing the work proposed under the contract.

• Each Attachment 4 worksheet applicable to a Task Order SOW, shall be filled out with rates proposed on the BASE IDIQ Pricing Table, and any proposed fixed Materials/ODCs. The Task Order SOWs are reflective of the work to be performed under this IDIQ. It is anticipated approximately 6-10 Task Orders will be awarded during the life of this IDIQ.

• A narrative detailing any assumptions not addressed elsewhere in the proposal.

• Copies of any subcontracts among the Prime Contract and proposed subcontractors.

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• If offeror is a large business for the NAICS being solicited, provide a Small Business Subcontracting Plan in accordance with Attachment 7.

• A completed copy of the provision at 52.212-3, Offeror Representations and Certifications—Commercial Items, as specified in Article 10, below.

8.2 Submission – Due Date/Manner of Submission

Offerors shall submit proposals via email to Phillip Frame (phillip.frame@fda.hhs.gov) with a copy (cc) to Aimee Swann (aimee.swann@fda.hhs.gov) no later than June 6, 2016 at 1:00 p.m. Eastern Time. The subject line shall reference RFP 16-223-SOL-00027. All past performance questionnaires must be submitted by this date and time, too. The Government will not consider any past performance questionnaires receive after June 6, 2016 at 1:00 p.m. Eastern Time.

8.3 Questions and Answers

Offerors may submit questions regarding this RFP. Offerors shall submit all questions to Phillip Frame via email at (phillip.frame@fda.hhs.gov) with a copy (cc) to Aimee Swann (aimee.swann@fda.hhs.gov). The government must receive the questions no later than June 20, 2016. The subject line shall reference: Contractor Questions RFP 16- 223-SOL-00027. The Government will not answer questions received after this date, and will not answer questions submitted to individuals other than the named contact(s). All questions shall be in writing.

The Government will post answers to any questions asked and – if required – any solicitation amendments necessitated by the questions and answers to Fedbizopps.

9. Evaluation Criteria

The provision at 52.212-2, Evaluation—Commercial Items, applies to this solicitation.

(a) The Government intends to award a five year IDIQ contract resulting from this solicitation to the responsible Offeror(s) whose offer is the most advantageous to the Government, price and other factors considered. The Government will make award to the Offeror(s) whose proposal represents the best value to the Government as determined by using tradeoffs among the technical evaluation factors, past performance and cost or price. Offerors are placed on notice that any proposals which do not respond to all the technical factors cited herein will be deemed reflective of an inherent lack of technical competence and may be grounds for the rejection of the proposal(s). Offerors shall ensure that any relevant prior experience to be considered is documented within the proposal.

Past performance will be rated as positive, negative or neutral. NOTE: Firms lacking relevant performance history or for who no information is available may not be evaluated favorably or unfavorably on this factor and shall receive a neutral rating.

The relative importance of the following technical evaluation factors is decending order of importance, Technical Approach to the IDIQ and Task Orders, IDIQ and Task Orders’ staffing plan, management approach, relevant experience and Conflict of Interest. Technical evaluation factors, when combined, are significantly more important than cost or price. While price is not a weighted factor, the importance of price will increase with the degree of equality of the quotations. This is a Trade Off-best value evaluation in that award will not be automatically made to the Offeror proposing the lowest price or to the Offeror receiving the highest rating.

(b) A written notice of award or acceptance shall be made by the Contracting Officer. All unsuccessful Offerors shall also be notified by the Contracting Officer within three (3) days after award. Before the mailto:phillip.frame@fda.hhs.gov mailto:aimee.swann@fda.hhs.gov mailto:phillip.frame@fda.hhs.gov mailto:aimee.swann@fda.hhs.gov

16-223-SOL-00027 Page 6 of 23 offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(c) (The Government reserves the right to make an award based on initial proposals received, thus Offerors should ensure that their quotations represent their best offer. The Government reserves the right to make award without discussions.

(d) The Government will evaluate proposals using an adjectival rating scheme. Proposals will be evaluated adjectivally and categorized as Excellent, Highly Acceptable, Acceptable, Minimally Acceptable or Unacceptable for the technical evaluation factors. The Government will evaluate each factor on the basis of those adjectives. Please see categorization definitions below:

Category

Definition

Excellent

The Offeror demonstrates that the solicitation requirements have been analyzed, evaluated, and synthesized into proposed approaches, plans, and techniques that, when implemented, will result in superior and efficient performance.

The technical proposal has significant strengths, which indicate beneficial features or innovations that will substantially benefit the program.

The technical proposal has no significant weaknesses. Any minor weaknesses are insignificant when compared to the strengths.

Very Good evaluated, and synthesized into proposed approaches, plans, and techniques that, when implemented, should result in effective and efficient performance.

The technical proposal has significant strengths and/or several minor strengths, which indicate a proposed approach that will benefit the program.

The technical proposal has few weaknesses, and the strengths of the technical proposal more than offset any weaknesses.

Acceptable evaluated, and synthesized into proposed approaches, plans, and techniques that, when implemented, should result in adequate performance.

The technical proposal has modest strengths.

The weaknesses in the technical proposal are offset by the strengths.

Marginal

The Offeror demonstrates a limited understanding of the solicitation requirements, resulting in proposed approaches, plans, and techniques that are incomplete and should result in inadequate performance when implemented.

The technical proposal has few strengths.

The weaknesses in the technical proposal are not offset by the strengths.

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Unacceptable

The Offeror demonstrates a superficial, incomplete, or incorrect understanding of the RFQ requirements, resulting in proposed approaches, plans, and techniques that are deficient and should result in poor performance when implemented.

The technical proposal has few strengths.

The technical proposal has significant weaknesses and/or many minor weaknesses that are not offset by strengths

9.1 Technical Evaluation

The government will evaluate the offeror’s technical proposal to the criteria as follows:

1. Technical Approach to the IDIQ and Task Orders – The government will evaluate the Offeror’s level of understanding of the support to be provided and the extent to which the Offeror’s proposed technical approach demonstrates understanding, knowledge, and ability to perform all task areas detailed in the Statement of Work. The government will determine proposals to be technically acceptable with respect to the Offeror’s approach to the IDIQ if the proposal:

o Demonstrates a complete, workable approach to performing all task areas specified in the Base SOW

(Attachment 1) o Demonstrates a complete, workable approach to performing the work prescribed in the Task Orders’

SOW (Attachment 2 and Attachment 3) o Identifies risks and challenges typical to the IDIQ tasks that may have an impact on the SLAs and describes a workable approach to managing or mitigating them.

2. IDIQ and Task Orders’ Staffing Plan - The government will evaluate whether the Offeror’s Staffing Plan and Key Personnel demonstrate the ability to perform the tasks described in this solicitation so as to offer a quality and appropriate solution to meet the Government’s needs. The government will determine a proposal to be acceptable under this factor if it:

o Demonstrates that the Offeror will be able to provide personnel with the skill sets required using the labor categories set forth in solicitation.

o Demonstrates that the proposed personnel have the necessary skill sets required to perform all tasks under each Task Order.

o Demonstrates a feasible approach to hiring, training, and maintaining qualified staff through the duration of the contract.

3. Management Approach - The government will evaluate the clarity, adequacy, and feasibility of the Offeror’s Management Approach to implementing and managing all aspects of the contract. The government will determine a proposal to be acceptable under this factor if it describes a comprehensive approach to managing all aspects of contract performance to ensure the quality of the services provided under the contract.

4. Relevant Experience - The government will evaluate the extent to which the Offeror’s proposal demonstrates the performance of effort on current and previous contracts which are relevant to the Statement of Work (SOW) in terms of type, scope, complexity, and size. The government will determine a proposal to be acceptable under this factor if:

o At least one of the relevant experiences cited had a total value similar to the anticipated value of the potential contract to be awarded.

o At least one of the relevant experiences cited was for an IDIQ contract or BPA with concurrent task orders/BPA calls, similar in size/scope of each Task Order.

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5. Conflict of Interest - The government will evaluate the extent to which the Offeror’s proposal demonstrates the absence of or mitigation of any organizational conflict of interest.

9.2 Past Performance

The Government will assess the relative performance risks associated with each offer. Performance risks are those associated with an offeror’s likelihood of success in performing the acquisition requirements as indicated by that offerors record of past performance. The assessment of performance risk is not intended to be a product of a mechanical or mathematical analysis of an offerors performance on a list of contracts but rather the product of subjective judgment by the Government after it considers relevant information.

The Government will consider the currency and relevance of the information, source of the information, context of the data, and general trends in the offerors performance. The Government may rely upon data from sources other than the references submitted by the Offeror, such as PPIRS.

When assessing performance risks, the Government will focus on the past performance of the offeror as it relates to all acquisition requirements, such as the offerors record of performing according to specifications, including standards of good workmanship; the offerors adherence to contract schedules, including the administrative aspects of performance; the offerors reputation for reasonable and cooperative behavior and commitment to customer satisfaction; and generally, the offerors business-like concern for the interest of the customer.

Offerors with a documented history of good workmanship, adherence to schedules and customer satisfaction will be given a performance risk rating of “Low Risk.” Offerors with a documented history of poor workmanship, failure to adhere to schedules, and low levels of customer satisfaction will be given a performance risk rating of “High Risk”. Offerors without a record of relevant experience or past performance, or for whom information on past performance is not available, will not be evaluated favorably (“Low Risk”) or unfavorably (“High Risk”) but will be given a neutral evaluation.

If the performance information contains negative information on which the Offeror has not been previously been given an opportunity to comment, the government will provide the Offeror an opportunity to comment on it prior to its consideration in the evaluation, and any Offeror comment will be considered with the negative performance information.

The lack of a past performance record may result in an unknown performance risk assessment, which will neither be used to the advantage or disadvantage of the Offeror.

9.3 Pricing

Price will be evaluated separately from past performance and the technical factors, and will be evaluated for fairness and reasonability in terms of reasonable and realistic pricing - that the proposed prices are calculated based on reasonable and realistic assumptions.

Offerors are cautioned that an unrealistically high or low price, or unbalanced pricing, as proposed initially or subsequently, may be grounds for eliminating a proposal from further consideration, either on the basis that the Offeror does not understand the required services or has made an imprudent offer. The Government will evaluate the Offeror’s ability to deliver an efficient, low-risk price service at a fair and reasonable price. As part of this evaluation, the Government will evaluate:

o Total Evaluated Price – This value is the sum of both task order pricing worksheets, Attachment 4 The Real Cost Pricing Table and Attachment 4 Fresh Empire Pricing Table.

o The Task Order labor mix and materials/Travel/ODCs are realistic for the proposed technical response.

16-223-SOL-00027 Page 9 of 23 o Small Business Subcontracting Plan -Whether the Offeror has demonstrated its ability to comply with the Health and Human Services small business subcontracting goals Attachment 7.

o Applicable Rates Proposed are in accordance with the Service Contract Act.

9.4 Basis of Award

The Government will use tradeoff method of determining which proposal received represents the best value to the government.

10. Other Solicitation Provisions

10.1 FAR Provisions

o As specified in Article 8 of this solicitation (above), Offerors shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications—Commercial Items, in the pricing volume of its proposal.

10.2 HHSAR Provisions

o HHSAR 352.215-1 Instructions to Offerors – Competitive Acquisition

11. Contract Terms and Conditions – Commercial Items

The clause at 52.212-4, Contract Terms and Conditions—Commercial Items, applies to this acquisition. 52.212-4 Alternate I also applies to any time-and-material or labor-hour task orders issued under this IDIQ contract.

12. Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Items

The clause at 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders— Commercial Items, applies to this acquisition. The additional FAR clauses cited in the clause that have a “check” or an “x” next to them are applicable to the acquisition. Full text of that clause is in Attachment 5.

13. Other Contract Requirements

13.1 FAR Clauses

Incorporated by Reference

Incorporated in Full Text

• 52.209-7 – Information Regarding Responsibility Matters (Jul 2013)

(a) Definitions. As used in this provision—

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“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 proceeding 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” means—

(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 multiple-award Schedules).

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

(b) The offeror [_] has [_] 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, that 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 with regard to the following information:

(1) Whether the offeror, and/or any of its principals, has or has not, within the last five years, in connection with 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 following 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)(1)(i), (c)(1)(ii), or (c)(1)(iii) 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.

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(d) The offeror shall post the information in paragraphs (c)(1)(i) through (c)(1)(iv) of this provision in FAPIIS as required through maintaining an active registration in the System for Award Management database via https://www.acquisition.gov (see 52.204-7).

(End of provision)

• FAR 52.216-18 Ordering (OCT 1995)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of task orders by the Contracting Officer. Such orders may be issued from Contract Award (TBD) through five years from contract award

(TBD).

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) If mailed, a delivery order or task order is considered “issued” when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or by email.

(End of Clause)

• FAR 52.216-19 Order Limitations. (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than $3,000.00, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor—

(1) Any order for a single item in excess of $60,000,000.00;

(2) Any order for a combination of items in excess of $60,000,000.00; or

(3) A series of orders from the same ordering office within 30 days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 3 days after issuance, with written notice stating the Contractor’s intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of Clause)

• FAR 52.216-22 Indefinite Quantity (OCT 1995) https://www.acquisition.gov/

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(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the “maximum.” The Government shall order at least the quantity of supplies or services designated in the Schedule as the “minimum.”

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor’s and Government’s rights and obligations with respect to that order to the same extent as if the order were completed during the contract’s effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after one year.

(End of Clause)

• FAR 52.216-31 Time-and-Materials/Labor-Hour Proposal Requirements—Commercial Item Acquisition

(FEB 2007).

(a) The Government contemplates award of a Time-and-Materials or Labor-Hour type of contract resulting from this solicitation.

(b) The offeror must specify fixed hourly rates in its offer that include wages, overhead, general and administrative expenses, and profit. The offeror must specify whether the fixed hourly rate for each labor category applies to labor performed by—

(1) The offeror;

(2) Subcontractors; and/or

(3) Divisions, subsidiaries, or affiliates of the offeror under a common control.

(End of provision)

• FAR 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor any time prior to the expiration of the contract.

(End of Clause)

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• FAR 52.225-2 -- Buy American Certificate (May 2014)

(a) The offeror certifies that each end product, except those listed in paragraph (b) of this provision, is a domestic end product and that for other than COTS items, the offeror has considered components of unknown origin to have been mined, produced, or manufactured outside the United States. The offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products, i.e., an end product that is not a COTS item and does not meet the component test in paragraph (2) of the definition of “domestic end product.” The terms “commercially available off-the-shelf (COTS) item,” “component,” “domestic end product,” “end product,” “foreign end product,” and “United States” are defined in the clause of this solicitation entitled “Buy American—Supplies.”

(b) Foreign End Products:

Line Item No.: Country of Origin:

[List as necessary]

(c) The Government will evaluate offers in accordance with the policies and procedures of Part 25 of the Federal Acquisition Regulation.

(End of Provision)

• 52.233-2 Service of Protest (Sep 2006)

(a) Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the Government Accountability Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from

Contracting Officer: Phillip Frame 5230 Fishers Ln Room 2115 Rockville, MD 20857 Phillip.Frame@fda.hhs.gov

(b) The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO.

(End of Provision)

• 52.242-15 Stop-Work Order (AUG 1989)

(a) The Contracting Officer may, at any time, by written order to the Contractor, require the Contractor to stop all, or any part, of the work called for by this contract for a period of 90 days after the order is delivered to the Contractor, and for any further period to which the parties may agree. The order shall be specifically identified as a stop-work order issued under this clause. Upon receipt of the order, the Contractor shall immediately comply with its terms and take all reasonable steps to minimize the incurrence of costs allocable to the work covered by the order during the period of work stoppage. Within a period of 90 days after a stop-work is delivered to the mailto:Phillip.Frame@fda.hhs.gov

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Contractor, or within any extension of that period to which the parties shall have agreed, the Contracting Officer shall either—

(1) Cancel the stop-work order; or

(2) Terminate the work covered by the order as provided in the Default, or the Termination for Convenience of the Government, clause of this contract.

(b) If a stop-work order issued under this clause is canceled or the period of the order or any extension thereof expires, the Contractor shall resume work. The Contracting Officer shall make an equitable adjustment in the delivery schedule or contract price, or both, and the contract shall be modified, in writing, accordingly, if—

(1) The stop-work order results in an increase in the time required for, or in the Contractor’s cost properly allocable to, the performance of any part of this contract; and

(2) The Contractor asserts its right to the adjustment within 30 days after the end of the period of work stoppage;

provided, that, if the Contracting Officer decides the facts justify the action, the Contracting Officer may receive and act upon the claim submitted at any time before final payment under this contract.

(c) If a stop-work order is not canceled and the work covered by the order is terminated for the convenience of the Government, the Contracting Officer shall allow reasonable costs resulting from the stop-work order in arriving at the termination settlement.

(d) If a stop-work order is not canceled and the work covered by the order is terminated for default, the Contracting Officer shall allow, by equitable adjustment or otherwise, reasonable costs resulting from the stop-work order.

(End of clause)

13.2 HHSAR Clauses

• HHSAR 352.203-70 Anti-Lobbying (Dec 2015)

• HHSAR 352.208-70 Printing and Duplication (Dec 2015)

• HHSAR 352.211–3 Paperwork Reduction Act (Dec 2015)

• HHSAR 352.219–70 Mentor-Protégé Program (Dec 2015)

• HHSAR 352.222–70 Contractor Cooperation in Equal Employment Opportunity Investigations. (Dec 2015)

• HHSAR 352.224-70 Privacy Act (Dec 2015)

• HHSAR 352.224–71 Confidential Information (Dec 2015)

• HHSAR 352.227-70 Publications and Publicity (Dec 2015)

• HHSAR 352.231–70 Salary Rate Limitation (Dec 2015)

• HHSAR 352.237–75 Key Personnel (Dec 2015)

• HHSAR 352.239-73 Electronic and Information Technology Accessibility Notice (Dec 2015)

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

• HHSAR 352.270-4a Notice to Offerors, Protection of Human Subjects (Dec 2015)

• HHSAR 352.270-4b Protection of Human Subjects (Dec 2015)

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• HHSAR 352-270-10 Notice to Offerors – Protection of Human Subjects, Research Involving Human Subjects

Committee (RIHSC) Approval of Research Protocols Required (Dec 2015)

13.3 FDA Specific Terms and Conditions

• Organizational Conflict of Interest

(a) Purpose. The purpose of this clause is to ensure that the contractor and its subcontractors:

(1) Are not biased because of their financial, contractual, organizational, or other interests which relate to the work under this contract, and

(2) Do not obtain any unfair competitive advantage over other parties by virtue of their performance of this contract.

(b) Scope. This clause applies to performance or participation by the contractor, its parents, affiliates, divisions and subsidiaries, and successors in interest (hereinafter collectively referred to as “contractor”) in the performance of this contract as a prime contractor, subcontractor, co-sponsor, joint venturer, consultant, or in any similar capacity.

(c) Warrant and Disclosure. The warrant and disclosure requirements apply to both the contractor and all subcontractors. The contractor warrants that, to the best of the contractor's knowledge and belief, there are no relevant facts or circumstances which would give rise to an organizational conflict of interest, as defined in FAR Subpart 9.5, and that the contractor has disclosed all relevant information regarding any actual or potential conflict. The contractor agrees it shall make an immediate and full disclosure, in writing, to the Contracting Officer of any potential or actual organizational conflict of interest or the existence of any facts that may cause a reasonably prudent person to question the contractor's impartiality because of the appearance or existence of bias or an unfair competitive advantage. Such disclosure shall include a description of the actions the contractor has taken or proposes to take in order to avoid, neutralize, or mitigate any resulting conflict of interest.

(d) Remedies. The Contracting Officer may terminate this contract for convenience, in whole or in part, if the

Contracting Officer deems such termination necessary to avoid, neutralize or mitigate an actual or apparent organizational conflict of interest. If the contractor fails to disclose facts pertaining to the existence of a potential or actual organizational conflict of interest or misrepresents relevant information to the Contracting Officer, the Government may terminate the contract for default, suspend or debar the contractor from Government contracting, or pursue such other remedies as may be permitted by law or this contract.

(e) Subcontracts. The contractor shall include a clause substantially similar to this clause, including paragraphs (f) and (g), in any subcontract or consultant agreement.

(f) Prime Contractor Responsibilities. The Contractor shall determine in writing whether the interests disclosed present an actual, or significant potential for, an organizational conflict of interest. The contractor shall identify and avoid, neutralize, or mitigate any subcontractor organizational conflict prior to award of the contract to the satisfaction of the Contracting Officer. If the subcontractor's organizational conflict cannot be avoided, neutralized, or mitigated, the contractor must obtain the written approval of the Contracting Officer prior to entering into the subcontract. If the contractor becomes aware of a subcontractor's potential or actual organizational conflict of interest after contract award, the contractor agrees that the Contractor may be required to eliminate the subcontractor from its team, at the contractor's own risk. The contractor shall obtain from its subcontractors or consultants the disclosure required in FAR Part 9.507

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(g) Waiver. The contractor may seek a waiver from the Head of the Contracting Activity by submitting such waiver request to the Contracting Officer, including a full written description of the requested waiver and the reasons in support thereof.

(End of clause)

• Personnel Security

Personnel Security Clearance Requirements

1. BACKGROUND

The Office of the Assistant Secretary for Management and Budget, Department of Health and Human Services (DHHS), requires that DHHS employees and contractor employees (including subcontractors) who shall be working in a DHHS-owned or leased space and/or who shall have access to DHHS equipment, and non-public privileged, proprietary, or trade secret information, undergo a background investigation of some type.

Contractor employees who shall be in DHHS-owned or lease space for less than thirty (30) days are exempted from the background investigation requirement. These contractor employees must be escorted at all time while in DHHS-owned or leased space.

2. GENERAL

The contractor shall submit the following items to the Contracting Officer, ten (10) calendar days prior to commencement of work under this contract:

a. Certification that all required security form packets and a list of contractor employees names for whom the requisite security information has been provided to Division of Security Operations, Policy and Planning, Personnel Security Staff.

b. "Contractor's Commitment to Protect Non-public Information Agreement" forms signed by each employee named in paragraph a. above.

With the exception of costs associated with fingerprinting Contractor employees outside of the FDA Personnel Security Office, the Government shall conduct all required background investigations at no cost to the contractor.

The cost of fingerprinting Contractor employees at any location other than the FDA Personnel Security Office shall be borne by the Contractor.

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Contractor employees shall obtain security badges in order to access to DHHS-owned or leased property without an escort. (See Section 3 for details on the badging process) However, in the event that work must commence before security badges can be issued, contractor employees shall be allowed onto DHHS-owned or leased property, but must be escorted at all times.

All Contractor employees who undergo a background investigation are required to log onto the Office of Personnel Management’s (OPM’s) Electronic Questionnaire for Investigation Processing (e-QIP) system to complete the forms necessary to initiate their background investigations. The forms required vary with the position risk levels for the contract.

The position risk levels for this contract are Level 5 .

There are two (2) potential position risk levels, which are:

a. Non-Sensitive Positions (Level 1) (SEE CHART A) - Positions which involve the lowest degree of adverse impact on the efficiency of the Agency. The forms set forth by CHART A are required for Non-Sensitive Positions (Level 1). Contractor employees assigned to Level 1 who receive a security badge shall be required to provide additional security information for a background investigation as specified in Paragraph 4 below.

b. Public Trust Positions (Levels 5 or 6) (SEE CHART B) - Positions in which the incumbent's actions or inaction could diminish public confidence in the integrity, efficiency, or effectiveness of assigned Government activities, whether or not actual damage occurs. The forms set forth by CHART B are required for Public Trust Positions (Levels 5 or 6). Contractor employees assigned Levels 5 or 6 must receive security badge as well as a background investigation.

In order to access the e-QIP system, Contractor employees must provide the appropriate Personnel Security Specialist with the following information: (a) full name; (b) position title; (c) social security number; (d) date of birth; (e) place of birth; (f) email address; and (g) phone number. The Personnel Security Specialist shall use this information to initiate each Contractor employee into the e-QIP system. Once this is done, each Contractor employee shall receive an email that contains a web link to access the e-QIP system, as well as instructions and additional forms needed to initiate the suitability background investigation. The COR for the contract shall provide the name of the appropriate Personnel Security Specialist to the Contractor.

A Contractor’s failure to comply with the e-QIP processing guidelines shall result in that Contractor’s employees being denied access to FDA property until all security processing has been completed.

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3. BADGING PROCESS

The government COR shall sponsor Contractor employees on the FDA Form 3391 for the purpose of obtaining an FDA Security Access Card. In order to obtain one, a contractor employee must receive a “favorable” fingerprint return. Fingerprints must be submitted to the Personnel Security Office at least ten (10) days prior to the commencement of work. Fingerprints shall be submitted in one of two ways, depending on where the contract shall be performed:

a. Contractor employees who shall work in the Washington D.C. metro area shall, at the direction of the government COR or his/her designee, contact the Personnel Security Branch to schedule a fingerprinting appointment, or

b. Contractor employees who shall work in a field office shall submit fingerprints to:

Food and Drug Administration

Badging & Credentialing Office

10903 New Hampshire Avenue

Building 32, Room 1205

Silver Spring MD 20993

Phone: 301-796-4582

Upon the receipt of a “favorable” fingerprint return, each Contractor employee must present two forms of identification in order to receive his or her badge. One form of identification must be a government-issued photo identification document. Acceptable forms of photo identification are referenced on the FDA Form 3391.

Acceptable forms of secondary identification are listed on the back of the I-9 Form. This form can be obtained at http://uscis.gov/graphics/formsfee/forms/files/i-9.pdf

An individual who receives an unfavorable report may appeal that finding by submitting a written request to the Personnel Security Staff.

4. BACKGROUND INVESTIGATIONS

The Government shall conduct an additional background investigation for those individuals named to risk Levels 1, 5 and 6 serving under this contract.

http://uscis.gov/graphics/formsfee/forms/files/i-9.pdf

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