Solicitation_06162015_FINAL.pdf

SOLICITATION: HHSF223-15-SOL-1142795

Contents

1. NOTICE OF COMBINED SYNOPSIS/SOLICITATION

2. NOTICE OF REQUEST FOR PROPOSAL

3. NOTICE OF FAC

4. NOTICE OF NAICS/SET-ASIDE

5. CONTRACT LINE ITEMS

5.1 Labor Schedule

5.2 Pricing Terms

6. CONTRACT REQUIREMENTS

7. DELIVERIES, ACCEPTANCE, AND PERFORMANCE DATES

8. INSTRUCTIONS TO OFFERORS

8.1 FORMAT

8.2 Submission – Due Date/Manner of Submission

8.3 Questions and Answers

9. BASIS OF AWARD & EVALUATION CRITERIA

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

9.2 Weighted Technical Factors

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

9.2.2 Factor 3 - Management Understanding and Approach to the IDIQ

9.2.3 Factor 4 - Relevant Experience

9.2.4 Factor 5 - Response to Sample Task Order

9.3 Pricing

9.4 Past Performance

9.5 Basis of Award

10. COMMERCIAL ITEM PROVISIONS AND CLAUSES

11. OTHER SOLICITATION PROVISIONS

11.1 Federal Acquisition Regulations (FAR) Provisions

11.2 Health & Human Services Acquisition Regulations (HHSAR) Provisions

12. CONTRACT TERMS AND CONDITIONS INCROPORATED BY REFERENCE

13. CONTRACT TERMS AND CONDITIONS INCORPORATED BY FULL TEXT

13.1 FAR Clauses

13.2 FOOD & DRUG ADMINISTRATION REQUIREMENTS

13.2.1 CONTRACTOR ADVERTISING OF CONTRACT AWARD:

13.2.2 FDA PERSONNEL OBSERVICE THE FOLLOWING DAYS AS HOLIDAYS:

13.2.3 REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE:

13.2.4 FDA PERSONNEL SECURITY CLEARANCE REQUIREMENTS (AUG 2006):

13.2.5 IDENTIFICATION OF CONTRACTOR EMPLOYEES:

13.2.5 ORGANIZATIONAL CONFLICT OF INTEREST:

13.2.6 FDA 1350 ACCESS TO NON-PUBLIC INFORMAITON:

13.2.7 GOVERNMENT-FURNISHED DATA AND MATERIALS:

13.2.8 NOTICE TO THE GOVERNMENT OF DELAYS

13.2.9 PERSONNEL

13.2.10 NON-PERSONAL SERVICES AND INHERENTLY GOVERNMENT FUNCTIONS

13.2.11 ADDITIONAL SECURITY AND CONFIDENTIALITY REQUIREMENTS

14. CONTRACT MANAGEMENT

14.1 CONTRACTING OFFICER

14.2 CONTRACTING OFFICER REPRESENTATIVE

14.2.1 IDIQ CONTRACTING OFFICER REPRESENTATIVE

14.2.2 TASK ORDER CONTRACTING OFFICER REPRESENTATIVE

14.3 PLACE OF PERFORMANCE

14.4 TRAVEL

14.5 INVOICING INSTRUCTIONS AND REQUIREMENTS

14.6 CONTRACT FINANCIAL REPORTING PER T&M TASK ORDER:

14.7 TRANSITION

14.8 ORDERING PROCEDURES

14.9 CONTRACTOR PERFORMANCE EVALUATION(S)

14.10 INSURANCE REQUIREMENTS

15. PROPOSAL DUE DATE AND TIME

16. NAME AND TELEPHONE NUMBER OF RESPONSIBLE OFFICIAL

17. LIST OF ATTACHMENTS

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 PROPOSAL

This solicitation, identified as HHSF223-15-SOL-1142795, 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 2005-82, effective 7 May 2015.

FAR and 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 541519; Other Computer Related Services, with a small business size standard of$27.5 Million.

5. CONTRACT LINE ITEMS

5.1 Labor Schedule

The Government anticipates awarding a single award Indefinite Delivery Indefinite Quantity (IDIQ) contract with an ordering ceiling of $103,000,000.00. The guaranteed minimum will be equal to the value of task order HHSF22301001T which will be issued at time of base contract award. FDA reserves the right to award Firm-Fixed-Price, Time-and-Material or Labor-Hour type task and/or delivery orders under this contract. See Attachment A for Labor Category descriptions.

5.2 Pricing Terms

The agreed upon negotiated Labor Rates shall be fixed for the duration of this contract (See Attachment B). Labor Rates proposed for each task order issued against the resulting IDIQ contract must be in accordance with the defined 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 not-to-exceed dollar amount of a task order.

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. The Contractor shall comply with FAR 52.232-7 Payments under Time-and-Materials and Labor-Hour Contracts (Aug 2012), in regards to the ceiling price for the individual task order(s).

6. CONTRACT REQUIREMENTS

See Attachment C 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

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 four (4) separate volumes – 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 volume number and volume name (i.e., Volume I, Technical Approach to Factor 1), 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.

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:

o Margins – Top, Bottom, Left, Right – 1” o Gutter – 0” o From Edge – Header, Footer – 0.5” o Page Size, Width – 8.5” o 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

Volume 1 is limited to ten (10) pages. Volume 2 is limited to forty (40) 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:

o Cover Page o Table of Contents o Dividers o Resumes o Letter of Commitments o Contractor Teaming Arrangements (if applicable)

There are no page limitations to volumes 3 & 4

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 managing multiple, concurrent task orders on a contract. The narrative provided should be no more than 5 pages, not including attachments. The total response should not exceed 10 pages. The Offeror shall provide:

1. An affirmative response to the question that they have relevant experience performing on an IDIQ or BPA contract with at least 3 multiple and concurrently performing task orders in the past 3 years. The response will include one citation with the following data elements:

i. The Base Contract Number

ii. The Name and Number for each Task Order

iii. The Value for each Task Order

iv. A brief description of the scope of work

v. The Period of Performance (PoP) of the Contract and the Task Orders

vi. The number of Contractor Full Time Equivalents (FTEs) that were invoiced during the PoP

vii. Statement whether the Offeror was Prime on the Contract

2. A response to the questions based on the scenario contained within Attachment D. At a minimum, Offerors responses should consider the following:

i. An approach, including risks and benefits, to responding to and staffing the three sample scenario task orders

ii. A recruiting and retention strategy, including risks and benefits

iii. A quality management approach

VOLUME 2

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

The Offeror shall provide a narrative describing their understanding of the type of services required and the Offeror’s approach to providing these services. It should also discuss, at a high level, the types of risks associated with this type of work and general mitigation strategies the Offeror may employ.

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

The Offeror shall provide a narrative description of its approach to managing the requirements in the IPS IDIQ statement of work (SOW). The description should include a discussion of the Program Manager’s role and the organization structure to support and perform under this contract. Additionally, the narrative should describe how the Offeror will manage performance risks. The Offeror shall also provide a recruitment plan describing how it intends to ensure that it will be able to adequately staff Task Orders in a timely manner.

o Evaluation Factor 4: 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:

1. Name of contracting activity ( Federal Government Agency, Local Government, Commercial

Customer)

2. Contract number

3. Contract Type

4. Total Contract Value, and Subcontract value (if applicable)

5. Contracting Officer contact information (phone, fax, email)

6. Project Officer/Contracting Officer’s Technical Representative contact information (phone, fax, email)

7. Administrative Contracting Officer’s contact information – if different from item 5 (phone, fax, email)

8. Description of work

9. Narrative highlighting the relevance of the work performed in terms of type, scope, complexity and size o Evaluation Factor 5: Response to Sample Task Order

5.1. Sub Factor - Technical Understanding and Approach

The Offeror shall provide a narrative description of its approach to performing the work described in Attachment E. The narrative should 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.

5.2. Sub-Factor – Management Approach

The Offeror shall provide rationale and narrative description of its proposed management approach to performing the work required in Attachment E. This should describe its organizational structure and how it proposes to manage this task and include a Program 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.

VOLUME 3

Past Performance

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

o A listing and brief description of the three past performance references to whom the Offeror sent the past performance questionnaires, Attachment F. Performance references shall be current within three years of the RFQ closing date.

o The past performance questionnaires that the Government receives. Note: Past performance references shall send completed past performance questionnaires directly to the Contract Specialist identified in Article 8.3, below. FDA will not consider any questionnaires submitted by the Offeror along with its quote.

VOLUME 4

o Evaluation Factor 6: Price

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

o Acknowledgement of the solicitation and any amendments.

o A complete version of the pricing worksheets Attachment B. 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. (Please note that the Offeror will not be required to use the number of annual hours in the spreadsheet for actual performance under this contract. Each task order will include labor categories and number of hours appropriate to the project. The quantities listed are for evaluation purposes only. ) o A narrative detailing any assumptions not addressed elsewhere in the proposal.

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

o A narrative description of how the Offeror will comply with the limitations on subcontracting clause (FAR 52.219-14) incorporated into this RFP and the resultant contract.

o 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

The Contractor shall submit:

o Five (5) paper copies of the Technical Proposal (Volumes 1, 2 & 3);

o Five (5) CDs or DVDS containing copies of the Technical Proposal o Two (2) paper copies of the Price Proposal (Volume 4) o Two (2) CDs or DVDs containing copies of the Price proposals

To the address below, no later than Tuesday June 30, 2015 NLT 3:00 p.m. Eastern Time.

Food and Drug Administration Attn: Narissa Charles Office of Acquisitions & Grants Services 5630 Fishers Lane, Room 2116 Rockville, MD 20857

All past performance questionnaires must be also be submitted by this date and time. FDA will not consider any past performance questionnaires receive after the defined proposal submission requirements.

The Contractor shall clearly mark the proposals as “Response to HHSF223-15-SOL-1142795: Information Technology and Program Management Support Services,” and may hand deliver or ship the proposals to the address above.

** Note: Offerors are advised that physical proposals will not be considered submitted or “under the Government’s Control” until after they have cleared physical security requirements at the defined location for proposal submission. Please allow sufficient time as proposals cannot be accepted until they have gone through security. The FDA will not be held responsible for any delays in proposal submission resulting from the installation’s physical security procedures and protocols. Any proposals submitted after the defined submission date and time will be considered late.

8.3 Questions and Answers

Offerors may submit questions regarding this RFP. All questions shall be in writing. Offerors shall submit all questions to Narissa Charles, Contract Specialist via email at (Narissa.Charles@fda.hhs.gov) with a copy (cc) to James Whitt, Contracting Officer (james.whitt@fda.hhs.gov). The FDA must receive questions no later than 3:00 pm, Monday June 22, 2015. The subject line shall reference: “Contractor Questions - HHSF223-15-SOL-1142795: Information Technology and Program Management Support Services”. 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.

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

9. BASIS OF AWARD & EVALUATION CRITERIA

The provision at 52.212-2, Evaluation—Commercial Items, applies to this RFP. Paragraph (a) of this provision is tailored as follows:

o The Government will 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.

o 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.

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

9.1 Factor 1 – Multiple Con Current 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 mailto:Narissa.Charles@fda.hhs.gov mailto:james.whitt@fda.hhs.gov 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 o Offeror’s response to Attachment D:

• 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 includes a reasonable training and communication approach, and 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. Sub-factors 5.1 and 5.2 are weighted equally.

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

The Government will evaluate the extent to which the Offeror’s proposal demonstrates a full understanding of the requirements to provide technical support to the Government in performing its IT mission. This includes the extent to which the Offeror’s proposal demonstrates:

1) Understanding of the Government’s IT development challenges and processes and 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.

9.2.2 Factor 3 - Management Understanding and Approach to the IDIQ

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 this IDIQ 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 perform that role.

9.2.3 Factor 4 - 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 IPS Statement of Work in terms of type, scope, complexity, and size.

9.2.4 Factor 5 - Response to Sample Task Order

1) Factor 5 Sub factor 1: TO Technical Understanding and Approach:

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.

2) Factor 5 Sub factor 2: TO Management and Control Plan:

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.

9.3 Pricing

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 figure is the grand total price from the Pricing Worksheets, Attachment B “Labor Category Pricing Sheet”. It is comprised of the sub-totals from both the “Cost Estimates @ the Gov and CTR Sites”. The grand total shall be provided by each offeror for “evaluation purposes” only.

o The Cost Estimates at both sites assume that 60% work will be performed at the Government’s site and 40% will be performed at the Contractor’s site.

o Offerors proposed Labor Hour (LH) price in response to the sample task order (Attachment E).

The final proposed and evaluated price will be the awarded value of of the first task order of the IDIQ contract.

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

9.4 Past Performance

Risk Evaluation: 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.

9.5 Basis of Award

The non-price factors (Factors 2, 3, 4 and 5) when combined are more important than Factor 6; Price.

The non-price Factors will be evaluated adjectivally and categorized as Excellent, Highly Acceptable, Acceptable, Marginal or Unacceptable. As technical merit of an offeror’s proposal 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.

10. COMMERCIAL ITEM PROVISIONS AND CLAUSES

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

10.2 The clause at FAR 52.212-4, 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, 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 H.

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/

FAR PROVISION # TITLE DATE

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

FAR 52.212-3 OFFEREOR REPRESENTATIONS AND CERTIFICATION

--COMMERCIAL ITEMS (MAR 2015)

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

COMMERICIAL ITEM ACQUISITION (FEB 2007)

11.2 Health & Human Services Acquisition Regulations (HHSAR) Provisions

HHSAR PROVISION # TITLE DATE

HHSAR 352.215-1 INSTRUCTIONS TO OFFERORS –COMPETITIVE ACQUISITIONS (N/A)

HHSAR 252.230-73 ELECTRONIC & INFORMATION TECHNOLOGY ACCESSIBILITY (JAN 2010)

** Please see ID/IQ SOW (Attachment C) 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/____

FAR CLAUSE # TITLE DATE

FAR 52.212-4Alt I CONTRACT TERMS & CONDITIONS – COMMERCIAL ITEMS (MAY 2015)

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 1999)

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 352.202-1 DEFINITIONS (JAN 2006)

HHSAR 352.203-70 ANTI-LOBBYING (JAN 2006)

HHSAR 352.222-70 CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT OPPORTUNITY

INVESTIGATIONS (JAN 2010)

HHSAR 352.223-70 SAFETY AND HEALTH (JAN 2006)

HHSAR 352.224-70 PRIVACY ACT (JAN 2006)

HHSAR 352.227-70 PUBLICATIONS AND PUBLICITY (JAN 2006)

HHSAR 352.231-71 PRICING ADJUSTMENTS (JAN 2001)

HHSAR 352.233-71 LITIGATION AND CLAIMS (JAN 2006)

HHSAR 352.239-70 STANDARD FOR SECURITY CONFIGURATIONS (JAN 2010)

HHSAR 352.239-71 STANDARD FOR ENCRYPTION LANGUAGE (JAN 2010)

HHSAR 352.239-72 SECURITY REQUIREMENT FOR FEDERAL INFORMATION TECHNOLOGY

RESOURCES (JAN 2010

See Standards listed in Attachment C

HHSAR 352.242-70 KEY PERSONEL (JAN 2006)

Key Personnel (as applicable) will be designated for each task order

HHSAR 352.242-71 TOBACCO FREE FACILITIES (JAN 2006)

HHSAR 352.242-73 WITHHOLDING OF CONTRACT PAYMENTS (JAN 2006)

HHSAR 352.270-1 ACCESSIBILITY OF MEETINGS, CONFERENCES, AND SEMINARS

TO PERSONS WITH DISABILITIES (JAN 2001)

13. CONTRACT TERMS AND CONDITIONS INCORPORATED BY FULL TEXT

13.1 FAR Clauses

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE

ORDERS – COMMERCIAL ITEMS (MAY 2015)

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 provided in Attachment H.

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 (dates will be inserted upon contract 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 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MARCH 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 1 day; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least days 10 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed _____66 months or 5.5 years______. (END OF CLAUSE)

FAR 52.219-17 SECTION 8(a) AWARD (DEC 1996)

(a) By execution of a contract, the Small Business Administration (SBA) agrees to the following:

(1) To furnish the supplies or services set forth in the contract according to the specifications and the terms and conditions by subcontracting with the Offeror who has been determined an eligible concern pursuant to the provisions of section 8(a) of the Small Business Act, as amended (15 U.S.C. 637(a)).

(2) Except for novation agreements and advance payments, delegates to the _FDA Office of Acquisition and Grant Services (OAGS) the responsibility for administering the contract with complete authority to take any action on behalf of the Government under the terms and conditions of the contract; provided, however that the contracting agency shall give advance notice to the SBA before it issues a final notice terminating the right of the subcontractor to proceed with further performance, either in whole or in part, under the contract.

(3) That payments to be made under the contract will be made directly to the subcontractor by the contracting activity.

(4) To notify the ___________ [insert name of contracting agency] Contracting Officer immediately upon notification by the subcontractor that the owner or owners upon whom 8(a) eligibility was based plan to relinquish ownership or control of the concern.

(5) That the subcontractor awarded a subcontract hereunder shall have the right of appeal from decisions of the cognizant Contracting Officer under the “Disputes” clause of the subcontract.

(b) The offeror/subcontractor agrees and acknowledges that it will, for and on behalf of the SBA, fulfill and perform all of the requirements of the contract.

(c) The offeror/subcontractor agrees that it will not subcontract the performance of any of the requirements of this subcontract to any lower tier subcontractor without the prior written approval of the SBA and the cognizant Contracting Officer of the ______________ [insert name of contracting agency].

13.2 FOOD & DRUG ADMINISTRATION REQUIREMENTS

13.2.1 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.

13.2.2 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 Any other day designated by the President's

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.

13.2.3 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

13.2.4 FDA PERSONNEL SECURITY CLEARANCE REQUIREMENTS (AUG 2006):

See Attachment I

13.2.5 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.

13.2.5 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.

(End of clause)

13.2.6 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 J 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 and shall not be disclosed to any unauthorized party. The Contractor shall conduct an updated briefing annually and shall submit a report to the FDA Project Officer within ten (10) days after the briefing which includes: an outline of the briefing; copies of any briefing materials; the date the briefing was conducted; and the names of the attendees.

If this is an information technology/telecommunications (IT/TC) contract, in addition to the above briefings, the FDA COR and the FDA Center/Office Information Systems Security Officer (ISSO) will brief the Contractor and subcontractor personnel on security measures required pertinent to any hardware/software being utilized. Furthermore, appropriate Contractor and subcontractor personnel shall attend training courses as directed by the FDA to fulfill requirements of the Computer Security Act of 1987. These courses are generally one (1) day in length, and attendance at one (1) course is sufficient. This training will be provided at no cost to the Contractor.

13.2.7 GOVERNMENT-FURNISHED DATA AND MATERIALS:

All Government furnished information, data, materials, and property will be identified on each task order. The Government shall retain all rights and privileges, including those of patent and copy, to all Government-furnished data and materials. The Contractor shall neither retain nor reproduce for private or commercial use any data or other materials furnished under this contract. The Contractor agrees not to assert any rights at common law or in equity or establish any claim to statutory copyright in such data. These rights are not exclusive and are beyond any other rights and remedies to which the Government is otherwise entitled elsewhere in this contract.

13.2.8 NOTICE TO THE GOVERNMENT OF DELAYS

In the event the Contractor encounters difficulty in meeting performance requirements, or when the Contractor anticipates difficulty in complying with the contract delivery schedule or completion date, or whenever the Contractor has knowledge that any actual or potential situation is delaying or threatens to delay the timely performance of this contract, the Contractor shall immediately notify the Contracting Officer and COR in writing, giving pertinent details. This data shall be informational only in character and this provision shall not be construed as a waiver by the Government of any delivery schedule or date, or any rights or remedies provided by law or under this contract.

13.2.9 PERSONNEL

The Contractor shall ensure that all Contractor support personnel are adequately trained, possess the credentials specified in the appropriate labor categories, and are otherwise fully qualified to provide the high level of support required by this contract prior to being assigned to task orders awarded. Please see Attachment A Description of Labor Categories.

13.2.10 NON-PERSONAL SERVICES AND INHERENTLY GOVERNMENT FUNCTIONS

Pursuant to FAR 37.1, no personal services shall be performed under this contract. All work requirements shall flow only from the Project Officer to the Contractor's Project Manager. No Contractor employee will be directly supervised by the Government.