16-223-SOL-00101.pdf

SOLICITATION: 16-223-SOL-00101

COMPREHENSIVE DATA MANAGEMENT SERVICES

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. Another written solicitation will not be issued.

2. NOTICE OF REQUEST FOR PROPOSALS

This solicitation, identified as 16-223-SOL-00101, is issued as a request for proposals (RFP) in accordance with the requirements of FAR Part 12 and 15.

3. NOTICE OF FAC

This solicitation document incorporates provisions and clauses in effect through Federal Acquisition Circular FAC 2005-89-1, effective August 15, 2016.

FAR provisions and clauses referenced in this RFP can be found on the following website: http://farsite.hill.af.mil/vffara.htm

HHSAR provisions and clauses referenced in this RFP can be found on the following website: http://farsite.hill.af.mil/vfhhsara.htm

4. NOTICE OF NAICS/SET-ASIDE

This solicitation is a total small business set aside for firms certified with the socio-economic designation of 8(a) by the Small Business administration (SBA). The associated NAICS code 518210; Data Processing, Hosting, and Related Services, with a small business size standard of$25 Million.

5. CONTRACT LINE ITEMS

5.1 Labor Schedule

The Government anticipates awarding a single award Indefinite Delivery Indefinite Quantity (IDIQ) contract with an anticipated ceiling of $103,000,000.00, and a guaranteed minimum of $3,000.00. FDA reserves the right to award Firm-Fixed-Price, Time-and-Material or Labor-Hour type task and/or delivery orders under this contract.

5.2 Pricing Terms

Labor Rates proposed for each task order issued against the resulting IDIQ contract must be in accordance with the proposed labor categories and fixed labor rates. If a task order’s stated period of performance must be extended as a result of Government delay, the Contractor may request that the most current labor rates be used to price the work effort during the extended period. However, in no event shall the Contractor perform, or be paid for any work which exceeds the stated price or not-to-exceed dollar amount of a task order.

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

For Firm Fixed Price (FFP) task orders issued under this contract, the applicable FFP for a task order shall be based on a combination of the proposed level of effort, fixed labor rate for labor mix proposed and other direct costs (ODCs). The total FFP is the amount agreed upon by the Government and the Contractor at the time the task order is issued.

Each Labor-Hour or Time-and-Materials task order will contain a ceiling price.

6. CONTRACT REQUIREMENTS

See Attachment A for the Statement of Work for a full description of the supplies/services to be acquired.

7. DELIVERIES, ACCEPTANCE, AND PERFORMANCE DATES

The resultant contract will have an ordering period of five years from the date of award. Each task/delivery order issued under this contract will specify:

• Duration of performance;

• Delivery/performance locations;

• Specific tasks to be performed (if applicable);

• 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

• Invoicing Instructions

8. INSTRUCTIONS TO OFFERORS

The provision at 52.212-1 (OCT 2015), Instructions to Offerors—Commercial Items, applies to this acquisition. Addenda to this provision are as follows:

8.1 FORMAT

Each proposal shall consist of four (4) separate volumes. Volumes 1 and 2 shall be individually bound.

Each of these volumes shall not be located or bound with any other volume of an Offeror’s proposal.

Volume one (1) shall contain Offerors response to Factor 1. Volume two (2) shall contain offerors response to Factors 2-5. Offerors shall provide pricing in Volume four (4) and past performance information in volume three (3). Each volume shall include a cover sheet which clearly identifies each volume by number, solicitation number, and date of submission. The pages of Offeror’s proposal 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 titled as follows:

Volume 1 – Response to Factor I Volume 2 – Response to Factors 2 – 5 Volume 3 – Past Performance Volume 4 – Price

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.

The specific formatting instructions for each volume are as follows:

Volumes 1 & 2

Note: The Offeror shall ensure that the non-price volumes are 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, the font of each Offeror’s written proposal shall be of no smaller that 10-point and no larger than 12 point.. Tables and illustrations may use a reduced font size not less than 10-point and may be landscape.

b. Page Limitations

Volume 1 is limited to ten (10) pages. Volume 2 is limited to sixty (60) pages. A page in either technical volume that contains a table, chart, graph, etc., not otherwise excluded below, is subject to the page limitations.

The following items are not included in the stated page limitations:

• Cover Page

• Table of Contents

• Glossary

• Dividers

• Resumes

• Letter of Commitments

• Contractor Teaming Arrangements (if applicable)

c. Organization

VOLUME 1

o Evaluation Factor 1: Multiple Concurrent Task Order Scenario - Go/No Go

The Offeror shall demonstrate whether it passes the Go/No Go Factor of successfully resourcing and managing multiple, concurrent orders (task or call) issued from a single procurement instrument by providing the data elements defined below and through the narrative response required by the second part of this factor. Each Offeror shall provide:

1. An affirmative response to the question that they have relevant experience performing as

Prime Contractor on an IDIQ contract with a minimum of 3 multiple and concurrently performing orders in the past 3 years. The response will include one citation with the following data elements:

i. The basic contract or agreement number and name (if applicable)

ii. The number and name (if applicable) for each order

iii. The value for each order

iv. A brief description of the performance/technical requirement of the basic contract or agreement and disclosure of any risk and mitigation strategies executed.

v. The period of performance (PoP) of the contract and each order cited

vi. The number of contractor full time equivalents (FTEs) that were invoiced during the PoP of the basic procurement instrument considering all orders.

Information shall be provided in a manner that is definitively traceable to each order issued from the contract or agreement.

VOLUME 2

o Evaluation Factor 2: Technical Understanding and Approach to the IDIQ and the Task Order

The Offeror shall provide a narrative describing their understanding of the type of services required within the Base IDIQ Statement of Work, Attachment A, and the Offeror’s approach (from both a business and technical standpoint) to providing these services and discuss, at a high level, the types of risks associated with this type of work and general mitigation strategies the Offeror may employ. The Offeror’s shall also discuss their capability to comply with and accommodate changes in Federal legislative mandates and agency policies.

The Offeror shall provide a narrative description of its approach to performing the work described in Attachment C. The narrative shall describe the Offeror’s understanding of the whole project, how the Offeror intends to satisfy the technical requirements, any risks it foresees in carrying out its approach, and mitigation strategies for those risks.

o Evaluation Factor 3: Management Understanding and Approach to the IDIQ and the Task Order

The Offeror shall provide a narrative description of its approach to managing the requirements in the IDIQ statement of work (SOW), Attachment A. The description shall include a discussion of the Program Manager’s role and the organization’s structure to support and perform under this contract. Additionally, the narrative shall describe how the Offeror will manage performance risks. The Offeror shall provide a signed letter of commitment and resume for the proposed IDIQ Program Manager and recruitment plan describing how it intends to ensure that it will be able to adequately resource Task Orders, including the initial sample task order within two weeks of contract award including the necessity of having to or obtaining necessary security clearances.

The Offeror shall provide rationale and narrative description of its proposed management approach to performing the work required in Attachment C. This should describe its organizational structure and how it proposes to manage this task and include a Task Order Management Plan. The Offeror shall describe its methodology for managing the tasks, performance measures it will use to monitor performance, any management tools it will use, how it will ensure quality products are delivered, and how it will communicate to stakeholders o Evaluation Factor 4: Off-Site Facilities to the IDIQ

The Offeror shall provide a narrative description of its ability to possess a fully functional facility for the sample task order and its ability to acquire additional facilities for multiple, concurrent off-site task orders.

The Offeror shall also provide the following documentation in support of the sample task order:

• The facility is owned or leased by the Offeror;

• The Offeror must propose ONLY one (1) facility to perform all services during the ID/IQ

Period of Performance, inclusive of Task Order 1 and future awarded task orders;

• The facility is within a 20 miles radius of the FDA White Oak Campus

• The proposed facility square footage is contiguous and capable of supporting the functions outlined in Task Order SOW Task areas. Current footage for the initial task order is 2,600 contiguous usable square feet

• The facility is able to have a FDA Verizon data cable line installed for direct connection from the FDA White Oak Campus to the Contractor’s facility. The facility also has to have a robust IT infrastructure to support the initial Virtual Private Network (VPN) connections that data entry personnel will be using for the a number of months until and FDA network can be deployed.

• The offsite facility is compliant with all FISMA building and physical regulations

• The Facility has the ability to be expanded beyond the needs of the first task order to other future task orders as needed.

The Contractor shall provide documentation demonstrating they possess the fully improved facility and meet ALL criteria above. The Contractor must provide a detailed architectural blue print of the proposed facility showing individual data entry workstations.

o Evaluation Factor 5: Relevant Experience

The Offeror shall provide information about 3 projects that are most similar to this effort in terms of type, scope, complexity and size. The Offeror shall describe their current and past experience, identifying other organizations in which they have performed similar tasks including the degree of their involvement (prime or subcontractor), the size of the customer’s organization, and other information to describe their expertise and performance in the subject areas, highlighting the organization’s demonstrated successes. Projects listed may include those entered into by the Federal Government, State and Local Governments, and commercial contracts.

For each project identified above, the Offeror shall submit the following information:

• Name of contracting activity ( Federal Government Agency, Local Government, Commercial Customer)

• Contract number

• Contract Type

• Total Contract Value, and Subcontract value (if applicable)

• Contracting Officer contact information (phone, fax, email)

• Project Officer/Contracting Officer’s Technical Representative contact information

(phone, fax, email)

• Administrative Contracting Officer’s contact information – if different from item 5

(phone, fax, email)

• Description of work

• Narrative highlighting the relevance of the work performed in terms of type, scope, complexity and size

VOLUME 3

Past Performance

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

• A listing of at least three past performance references to whom the FDA may contact. The listing shall include the references Company Name, DUNS, Contract type, Contract Value, Period of Performance, Current Company POC who may be reached, Phone Number and email.

• To the maximum extent practicable, the three past performance references are to be attainable through the Past Performance Information Retrieval System (PPIRS).

• If there are no references for the offeror on PPIRS, the offeror will provide the Past Performance Questionnaire (Attachment D), at a minimum, to the references provided for the reference to return to the government point of contact for this solicitation.

VOLUME 4

Price

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 E. The Offeror will provide both the hours and labor categories for task order. Labor categories will include on site and offsite rates as applicable within the worksheet.

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

• Indicate on Attachment E (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 J 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 E 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.

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

• Copies of documents which clearly define Offeror’s teaming arrangement among the Prime

Contract and proposed subcontractors.

• A narrative description clearly describing how the Offeror will comply with the limitations on subcontracting clause (FAR 52.219-14 (NOV 2011)) incorporated into this RFP and the resultant contract.

• A completed copy of the provision at 52.212-3 (APR 2016), 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) no later than October 21, 2016 at 1:00 p.m. Eastern Time. The subject line shall reference RFP 16-223-SOL-00101. All past performance questionnaires must be submitted by this date and time, too. FDA will not consider any past performance questionnaires receive after October 21, 2016 at 1:00 p.m. Eastern Time.

8.3 Questions and Answers

Offerors may submit questions regarding this RFP. All questions shall be in writing. Offerors shall submit all questions to Phillip Frame via email at (phillip.frame@fda.hhs.gov), with a copy (cc:) to Sharon Masciana (Sharon.Masciana@fda.hhs.gov). The FDA must receive questions no later than October 7, 2016. The subject line shall reference: “Contractor Questions - 16-223-SOL-00101: Data Management Program (DMP)”. The FDA reserves the right to not respond to questions received after this date and time. Questions submitted to individuals or through mechanisms other than those defined in this solicitation will not receive a response.

mailto:phillip.frame@fda.hhs.gov mailto:phillip.frame@fda.hhs.gov mailto:Sharon.Masciana@fda.hhs.gov

FDA will post responses to questions via issuance of a solicitation amendment(s) to FedBizOpps.

9. BASIS OF AWARD & EVALUATION CRITERIA

The provision at 52.212-2 (OCT 2014), Evaluation—Commercial Items, applies to this RFP. Paragraph

(a) of this provision is tailored as follows:

The Government intends to award one (1) Indefinite Delivery Indefinite Quantity (IDIQ) contract to the responsible offeror whose proposal conforming to the requirements of the solicitation represents the best value. Best value is defined as the offer that results in the most advantageous acquisition decision for the Government, as determined by an integrated trade-off assessment among price and non-price factors and Sub-factors. The Government reserves the right to make award with or without discussions.

The Contracting officer will conduct a separate determination of responsibility in accordance with FAR 9.1.

9.1 Factor 1 – Multiple Concurrent Task Order Management (Go/No Go)

Factor 1 is a binary Go/No Go factor. If an Offeror’s proposal is not able to demonstrate that they satisfy the requirements of Factor 1 its proposal will not be evaluated further. The Government will determine that the Offeror passes Factor 1 Multiple Concurrent Task Order Management if:

o The Offeror provides the required data elements for relevant experience to validate their affirmative response. The Government will evaluate Offerors demonstrable ability, capacity and experience resourcing multiple orders issued concurrently or within short suspense periods.

o Offeror’s response to Attachment B:

• The Offeror’s response to ramping up and staffing the three sample task orders, is logical, reasonable, and likely to be effective.

• The Offeror’s proposed recruiting and retention strategy is reasonable and likely to be effective.

• The Offeror’s quality management approach takes into consideration a reasonable training and communication strategy that is likely to result in uniform quality and continuous improvement across the task orders.

9.2 Weighted Technical Factors

Factors 2, 3, 4 and 5 are listed below and will be evaluated in descending order of importance.

9.2.1 Factor 2 - Technical Understanding of and Approach to the IDIQ and the sample task order

The Government will evaluate the extent to which the Offeror’s proposal demonstrates a full understanding of the requirements. This includes the extent to which the Offeror’s proposal demonstrates:

1) Understanding of the Comprehensive Data Management requirements, at a high level of knowledge, proficiency, and understanding of the task areas detailed in the IDIQ Statement of Work.

2 ) Overall technical capability to provide the wide range of requirements detailed in the

Statement of Work of the IDIQ.

3) Technical feasibility and viable methodologies and processes that will result in Government success at an acceptable risk to the Government.

The Government will evaluate the extent to which the Offeror's proposal demonstrates understanding of the Task Order requirements, the risks associated with the requirement, and that the proposed technical approach is sound, logical, likely to be effective, and proactive in mitigating risks.

9.2.2 Factor 3 - Management Understanding and Approach to the IDIQ and the sample task order

The Government will evaluate the clarity and effectiveness of the Offeror’s comprehensive approach to managing all aspects of contract performance and administration.

The Offeror’s proposal should demonstrate a comprehensive and effective management approach to ensure the accomplishment of the FDA objectives, to include:

1) An appropriate and efficient management approach and organizational structure to effectively provide the services required by the resultant IDIQ contract in a timely manner;

2) Identification of risks and proposed mitigations in regard to staffing, recruitment, and retention of qualified personnel;

3) An understanding of the Program Manager role which demonstrates the skills and experience necessary to successfully perform that role.

The Government will evaluate the extent to which the offeror's TO Management and Control Plan demonstrates the clarity and effectiveness of the Offeror's comprehensive approach to managing all aspects of task order performance and administration.

9.2.3 Factor 4 – Offsite Facilities

The Government will evaluate if the documentation provides evidence that the Offeror has the ability to possess a fully functional facility for the sample task order and its ability to acquire additional facilities for multiple, concurrent off-site task orders that adheres to FDA IT Facilities Requirements.

The Government will evaluate if the documentation provides evidence that the Offeror has a fully functional facility that adheres to the following requirements:

1) Sub-Factor A: The facility must be owned or leased by the Contractor;

2) Sub-Factor B: The Offeror must propose ONLY one (1) facility to perform all services during the

ID/IQ Period of Performance inclusive of Task Order 1 and future awarded task orders;

3) Sub-Factor C: All facilities must be within a 20 mile radius of the White Oak FDA Campus

4) Sub-Factor D: The proposed facility square footage must be contiguous and capable of supporting the functions outlined in ID/IQ SOW Task areas. Current footage for task order one footprint is 2600 contiguous usable square feet

5) Sub-Factor E: The facility be capable of directly connecting to the FDA network via a dedicated high speed network link. In addition the contractor must demonstrate the sites IT capability to host, via Virtual Private Network (VPN) the expected number of initial data entry personnel until an FDA network can be installed.

9.2.4 Factor 5 Relevant Experience

The Government will evaluate the extent to which the Offeror’s proposal demonstrates the success of efforts on current and previous contracts, which are relevant to the Statement of Work in terms of type, scope, complexity, and size.

9.3 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.

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, FDA 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.

9.4 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 low price, or unbalanced pricing of line items, as proposed initially or subsequently, may be grounds for eliminating a quote 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 Offerors proposed Labor Hour (LH) price in response to the sample task order (Attachment E) will be evaluated for reasonableness and realism for the work to be performed. The final proposed and evaluated price of the first task order will be the awarded value.

o Compliance with Limitations on Subcontracting: Whether the Offeror has demonstrated its ability to comply with the limitations on subcontracting clause.

9.5 Basis of Award

The non-price factors are listed below and will be evaluated in descending order of importance. The sub-factors within each factor are of equal importance.

Factor 2 -Technical Understanding and Approach to the IDIQ and first task order Factor 3 - Management Understanding and Approach to the IDIQ, and first task order Factor 4 - Offsite Facilities Factor 5 - Relevant Experience

The non-price Factors will be evaluated adjectivally and categorized as Excellent, Highly Acceptable, Acceptable, Marginal or Unacceptable. As technical merit of offerors’ proposals becomes equal, the evaluated price may become the determining factor.

The Government will evaluate past performance as a risk assessment, not as a weighted technical evaluation factor. Past Performance will be given a rating of Low Risk, Neutral, or High Risk. Offerors with no record of past performance information will be evaluated neither positively nor negatively for this factor, receiving a rating of “Neutral.”.

10. COMMERCIAL ITEM PROVISIONS AND CLAUSES

10.1 The provision at FAR 52.212-3 (JUL 2016), Offeror Representations and Certifications- Commercial Items, (May 2015) applies to this acquisition. Offerors are to provide required data as Attachment F with their proposals IAW with Article 8.1 of this solicitation.

10.2 The clause at FAR 52.212-4 (MAY 2015), Contract Terms and Conditions—Commercial Items, applies to this acquisition. See Article 12.1 of this solicitation.

10.3 The clause at FAR 52.212-5 (JUN 2016), 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 G.

11. OTHER SOLICITATION PROVISIONS

11.1 Federal Acquisition Regulations (FAR) Provisions

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

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address (es): http://farsite.hill.af.mil/vffara.htm

FAR PROVISION # TITLE DATE

FAR 52.204-7 SYSTEM FOR AWARD MANAGEMENT (JUL 2013)

FAR 52.216-31 TIME-AND-MATERIALS/LABOR HOUR PROPOSAL REQUIREMENTS

COMMERICIAL ITEM ACQUISITION (FEB 2007)

FAR 52.222-24 PRE-AWARD ON SITE EQUAL OPPORTUNITY COMPLIANCE (FEB 1999)

EVALUATION

FAR 52.222-25 AFFIRMATIVE ACTION COMPLIANCE (APR 1984)

11.2 Health & Human Services Acquisition Regulations (HHSAR) Provisions

HHSAR PROVISION # TITLE DATE

HHSAR 252.239-74 ELECTRONIC & INFORMATION TECHNOLOGY ACCESSIBILITY (DEC 2015)

** Please see ID/IQ SOW (Attachment A) for applicable standards. ** http://farsite.hill.af.mil/

12. CONTRACT TERMS AND CONDITIONS INCROPORATED BY REFERENCE

12.1 Federal Acquisition Regulation (FAR) Clauses

FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

Also, the full text of a clause may be accessed electronically at this/these address (es):

_http://farsite.hill.af.mil/ vffara.htm

FAR CLAUSE # TITLE DATE

FAR 52.212-4Alt I CONTRACT TERMS & CONDITIONS – COMMERCIAL ITEMS (MAY 2014)

FAR 52.227-14 RIGHTS IN DATA – GENERAL (MAY 2014)

FAR 52.232-40 PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

CONTRACTORS (DEC 2013)

FAR 52.242-15 STOP - WORK ORDER (AUG 1989)

FAR 52.245 -1 GOVERNMENT PROPERTY (APR 2012)

FAR 52.247-34 F.O.B DESTINATION (NOV 1991)

FAR 52.247-35 F.O.B DESTINATION, WITHIN CONSIGNEE’S PREMISES (APR 1984)

12.2 Health & Human Services Acquisition Regulation (HHSAR) Clauses

HHSAR CLAUSE # TITLE DATE

HHSAR 352.203-70 ANTI-LOBBYING (DEC 2015)

HHSAR 352.208-70 PRINTING AND DUPLICATION (DEC 2015)

HHSAR 352.222-70 CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT OPPORTUNITY

INVESTIGATIONS (DEC 2015)

HHSAR 352.223-70 SAFETY AND HEALTH (DEC 2015)

HHSAR 352.224-70 PRIVACY ACT (DEC 2015)

HHSAR 352.227-70 PUBLICATIONS AND PUBLICITY (DEC 2015)

HHSAR 352.231-70 SALARY RATE LIMITATION (DEC 2015)

HHSAR 352.233-71 LITIGATION AND CLAIMS (DEC 2015)

13. CONTRACT TERMS AND CONDITIONS INCORPORATED BY FULL TEXT

13.1 FAR Clauses

FAR 52.216-18 ORDERING (OCT 1995)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from ___Date of Base Contract Award__ through __Five years (TBD at time of award).

(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 electronic commerce methods only if authorized in the Schedule. (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 _$1,000.00______, 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 $10,000,000.00.

(2) Any order for a combination of items in excess of $50,000,000.00; or

(3) A series of orders from the same ordering office within _____15____ days that together call for quantities exceeding the limitation in subparagraph (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)

(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 the stated period of performance end date of the contract. (END OF CLAUSE)

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 prior to the stated period of period end date of the contract. (END OF CLAUSE)

FAR 52.219-18 NOTIFICATION OF COMPETITION LIMITED TO ELIGIBLE 8(a) CONCERNS (JUN 2003)

(a) Offers are solicited only from small business concerns expressly certified by the Small Business Administration (SBA) for participation in the SBA’s 8(a) Program and which meet the following criteria at the time of submission of offer --

(1) The Offeror is in conformance with the 8(a) support limitation set forth in its approved business plan; and

(2) The Offeror is in conformance with the Business Activity Targets set forth in its approved business plan or any remedial action directed by the SBA.

(b) By submission of its offer, the Offeror represents that it meets all of the criteria set forth in paragraph (a) of this clause.

(c) Any award resulting from this solicitation will be made to the Small Business Administration, which will subcontract performance to the successful 8(a) offeror selected through the evaluation criteria set forth in this solicitation.

(d)

(1) Agreement. A small business concern submitting an offer in its own name shall furnish, in performing the contract, only end items manufactured or produced by small business concerns in the United States or its outlying areas. If this procurement is processed under simplified acquisition procedures and the total amount of this contract does not exceed $25,000, a small business concern may furnish the product of any domestic firm. This paragraph does not apply in connection with construction or service contracts.

(2) The [insert name of SBA’s contractor] will notify the Food and Drug Administration’s Contracting Officer in writing immediately upon entering an agreement (either oral or written) to transfer all or part of its stock or other ownership interest to any other party.

13.2 HHSAR Clauses

352.237-75 KEY PERSONNEL (DEC 2015)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract.

The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the contractor or Government.

For the purposes of the resultant contract, the IDIQ Program Manager shall be considered key personnel. Key personnel may also be designated in task orders by labor category, role or function.

13.3 FOOD & DRUG ADMINISTRATION (FDA) REQUIREMENTS

13.3.1 CONTRACTOR ADVERTISING OF CONTRACT AWARD:

The Contractor shall not refer to the product or service awarded under this contract in commercial advertising, as defined in FAR 31.205–1, in any manner which states or implies the Food and Drug Administration's approval or endorsement of the product or service being provided; or, states or implies that the product or service being provided is considered to be superior to other industry products or services. The Contractor may request the Contracting Officer to make a determination as to the propriety of promotional material.

13.3.2 FDA PERSONNEL OBSERVICE THE FOLLOWING DAYS AS HOLIDAYS:

New Year's Day Columbus Day Washington's Birthday Veterans' Day Memorial Day Thanksgiving Day Independence Day Christmas Day Labor Day Martin Luther King's Birthday

Any other day designated by Federal statue Any other day designated by Executive Order

Observance of such days by Government personnel shall not be cause for an extension to the delivery schedule or period of performance or adjustment to the price, estimated cost, or fee(s), if any, except as set forth in the contract.

Except for designated around-the-clock or emergency operations, Contractor personnel will not be able to perform on-site under this contract with FDA on holidays set forth above. The Contractor will not charge any holiday as direct charge to the contract. In the event Contractor personnel work during a holiday observed by the Contractor other than those above, no form of holiday or other premium compensation will be reimbursed as either a direct or indirect cost. However, this does not preclude reimbursement for authorized overtime work.

In the event the FDA grants administrative leave to its Government employees at the site, on-site Contractor personnel shall also be dismissed if the site is being closed. However, the Contractor shall continue to provide sufficient personnel to perform around-the-clock requirements of critical efforts already in progress or scheduled and shall be guided by the instructions issued by the Contracting Officer or her/his duly appointed representative. In each instance when the site is closed to Contractor personnel as a result of inclement weather, potentially hazardous conditions, explosions, or other special circumstances, the Contractor will direct its staff as necessary to take actions such as reporting to its own site(s) or taking appropriate leave consistent with its policies. The cost of salaries and wages to the Contractor for the period of any such site closure shall be a reimbursable item of direct cost under the contract for employees whose regular time is normally a direct charge if they continue to perform on contract work; otherwise, the costs are reimbursable as indirect costs in accordance with the Contractor's established accounting policy.

13.3.3 REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE:

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in FDA funded programs is encouraged to report such matters to the HHS Inspector General’s Office in writing or on the Inspector General’s Hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477), 8:00 am – 5:30 pm Eastern Time, Monday –Friday. Fax 1-800-223-8164, TTY 1-800-377-4950. All telephone calls will be handled confidentially. The e-mail address is hhstips@oig.hhs.gov and the mailing address is:

HHS TIPS Hotline

TIPS HOTLINE

P.O. Box 23489 Washington, D.C. 20026

13.3.4 FDA PERSONNEL SECURITY CLEARANCE REQUIREMENTS (AUG 2006):

See Attachment H

13.3.5 IDENTIFICATION OF CONTRACTOR EMPLOYEES:

During the period of this contract, the rights of ingress and egress to and from any Government office for Contractor representatives shall be made available as required. All Contractor employees whose duties under this contract require their presence at any Government facility shall be clearly identifiable by a distinctive badge furnished by the Government. All prescribed information shall immediately be delivered to the FDA Personnel Security Branch for cancellation or disposition upon the termination of the employment of any Contractor personnel. All on-site Contractor personnel shall abide by security regulations applicable to that site.

13.3.5 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.–1, and 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

(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.

(h) As a regulatory agency charged with protection of the public health, the Food and Drug Administration (FDA) must maintain public confidence in the integrity of its decisions. The FDA has various policies and procedures that safeguard against both actual and apparent conflict of interest (COI) on the part of its employees. It is additionally critical that the FDA be assured that there is no actual or apparent COI on the part of either the Contractor's organization or its individual employees in performance of this contract action.

(i) Offerors submitting proposals to perform work under this contract must assure the protection of the information and data they receive in performance or under this contract from unauthorized use or disclosure, and must avoid actions that would cause a reasonable person to question the impartiality of the Contractor, its employees, or the Government in the performance of this immediate contract and potential participation in future actions. Contractor will be held to the restrictions of the Organizational Conflict of Interest clause, unless an acceptable mitigation of risk plan is proposed, found acceptable by the Government and enforced

(j) POTENTIAL CONFLICTS OF INTEREST SPECIFIC TO THIS CONTRACT - Offerors shall review the Statement of Work included in each RFTOP in detail to identify any particular aspects that may present organizational or individual COI, either actual or apparent.

(k) DEFINITION OF CONFLICT OF INTEREST - Conflict of interest means that because of other activities or relationships with other persons or organizations, a person or organization is unable or potentially unable to render impartial assistance or advice to the Government, that the person's or organization's objectivity in performing the contract is or might be otherwise impaired, or that the person or organization has or might acquire an unfair competitive advantage (See FAR 9.501).

(End of clause)

13.3.6 FDA 1350 ACCESS TO NON-PUBLIC INFORMAITON:

All Contractor and subcontractor employees are required to sign the Contractor's Commitment to Protect Non-Public Information (NPI) Agreement (Form FDA 3398) provided as Attachment I to this contract (See Section J). If a person who has signed this agreement resigns, is dismissed, or is otherwise no longer working on this contract, the Contractor shall notify the FDA Project Officer and the Contracting Officer. Any new Contractor or subcontractor employee assigned to this contract shall sign the form, and the Contractor shall hand-deliver it to the Contracting Officer ten (10) days prior to said new employee's commencement of work on this contract.

The prime Contractor, subcontractors, and consultants shall not be provided nor possess non-public information in any form unless written approval has been granted, nor shall they have unaccompanied access to an FDA facility unless a facility clearance has been granted.

Briefings An FDA representative (typically, the Contracting Officer’s Representative) will conduct an orientation briefing for the Contractor and subcontractor employees. The briefing will stress: (1) the importance of protecting non-public information; (2) specified computer/IT requirements as outlined in the DHHS Automated Information Systems Security Program Handbook; and (3) the consequences of unauthorized disclosure of non-public information. Briefing updates will be conducted annually.

The Contractor shall brief all Contractor employees, subcontractors and consultants regarding the sensitivity of the information to be handled under the contract and of their responsibility to protect it.

The briefing shall stress that the information is non-public…