2015050__Amendment_2.pdf

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AMENDMENT #2, RFP No. NIAID-DAIDS-NIHAI2015050

Amendment No. 2 RFP No. NIAID-DAIDS-NIHAI2015050

“NIAID HIV and Other Infectious Diseases Clinical Research Support Services (CRSS)”

Solicitation Number:

Amendment Number:

Amendment Issue Date:

NIAID-DAIDS-NIHAI2015050

Two (2)

June 30, 2016

Response Date: July 15, 2016 (Unchanged) Issued By: Michelle L. Scala

Contracting Officer

OA/DEA/NIAID/NIH/DHHS

5601 Fishers Lane, Room 3D10, MSC 9821 Bethesda, Maryland 20892-9821

Points of Contact: PRIMARY:

Rosemary Gomes, Contract Specialist Phone: 240-669-5374 Email Address: Rosemary.Gomes@nih.gov

SECONDARY:

Michelle L. Scala, Contracting Officer Phone: 240-669-5156 Email Address: mscala@niaid.nih.gov

The purpose of this amendment is to: 1) provide responses to questions from potential offerors regarding the solicitation; 2) modify Attachment 5, Additional Business Proposal Instructions and Uniform Cost Assumptions for clarification to Offerors questions.

Offerors must acknowledge receipt of this amendment by identifying this amendment number and date of the amendment on each copy of the proposal submitted. Failure to receive your acknowledgement may result in the rejection of your proposal. Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

Responses to Questions from Potential Offerors:

Question 1:

There are contract deliverables outlined for generating audit and assessment reports with a delivery schedule (in the RFP, Article C.2, Reporting Requirements – page 13; and applicable PWS; 3A), but there is no requirement for provision of visit confirmation or follow-up letters to document findings. Please confirm DAIDS expectations or should offer propose as per recommended processes.

Response to Question 1:

The offeror should perform all tasks associated and necessary for the successful performance of 3.A.2. “Clinical Research Site Assessments”, of Attachment 3, Performance Work Statement mailto:Rosemary.Gomes@nih.gov mailto:anhughes@niaid.nih.gov

(PWS), the conduct and reporting of site assessments. These tasks typically would include a variety of activities such as scheduling the visits, communicating with the sites as necessary on logistics and reporting audit or site assessment visit observations to the COR.

Question 2:

Attachment 5, Additional Business Proposal Instructions and Uniform Cost Assumptions (page 2);

A1, A2, and A3; please confirm the PWS references; we believe they should be PWS A2, A3, and A4 respectively and not what is presently noted.

Response to Question 2:

Correct. The PWS references should be PWS A2, A3, and A4. Please see revised Attachment 5, Additional Business Proposal Instruction and Uniform Cost Assumptions.

Question 3:

Regarding PWS Section 3.A.2 (page 3) of Attachment 4. “2. Clinical Research Site and Study Auditing”. Please clarify if the contractor is going to receive and manage the responses to the findings/deficiencies identified in the audit reports.

Response to Question 3:

No. The Contractor will not be expected to receive or manage the responses to the findings/deficiencies identified in the audit reports.

Question 4:

Please clarify the experience that is requested in response to Sections 3A.3 and 3A.4 of Attachment 4. There is inconsistency between the PWS and Attachment 4 instructions for these two sections, as shown below. Should the offeror describe experience with preparation of study-specific clinical and technical documents in response to Att 4. Section 3A.4? If so, what experience is requested in response to Att 4 Section 3A.3?

PWS Attachment 3

Attachment 4

(Att3 p4) 3A.5 Clinical Trial and Other Related Support At the request of the COR, provide additional support services to support the planning, development, implementation and coordination of DAIDS-supported clinical research trials/studies. This shall include the following:

a. Study-Specific Clinical and Technical Documents: Assist in the preparation of study-specific and related clinical and technical documents for clinical research trials/studies and other activities.

b. Translations and other document support services (protocol translations, communications with the press, other related documents)

(p.4) 3A. 3 Clinical Trial and Other Related Support Describe organizational experience in the provision of a broad range of other related support services to support the planning, implementation and coordination of DAIDS supported clinical research. Include the names and/or geographic location of the clinical research sites for which assistance has been provided, brief summaries of the type of assistance provided, length of time on site, and the types of personnel employed to provide services.

(Att 3 p. 6) 3A.8. Ad Hoc Clinical Trial/Study-Specific Support As requested by the COR, provide a variety of

3A.4 Clinical Trials and Other Related Support and Ad Hoc Clinical Trial Study- Specific Support support services to clinical research sites, including support during study initiation and/or to generate recommendations to assist in correcting deficiencies in site performance.

Describe organizational experience in the preparation of study-specific clinical and technical documents. Include the following:

1) A listing of ongoing and completed clinical trials/studies for which assistance has been provided

2) A brief description of difficulties/problems encountered in the development, review, revision and finalization of study-specific clinical and technical documents

Response to Question 4:

• PWS Section 3.A.4 “Additional Support for Study Specific Readiness” correlates with Attachment 4, Section 3.A.3 “Clinical Trial and other related Support”.

• PWS Section 3.A.5 “Clinical Trials and Other Related Support” correlates with Attachment 4, Section 3.A.4 “Clinical Trials and Other Related Support and Ad Hoc Clinical trial/Study Specific Support”.

• The offeror should use Attachment 4, Section 3.A.3 as a guide to describe organizational experience in the “provision of a broad range of other related support services to support the planning, implementation and coordination of DAIDS supported clinical research”.

Question 5:

Are there service level agreements in place and are they satisfactory?

Response to Question 5:

As noted in Attachment 3, Performance Work Statement, 3.C.7. DAIDS Learning Portal a the Contractor shall provide training support services to include providing proposed plans and procedures for maintenance and support of a DAIDS Learning Portal and the provision of help desk support.

Question 6:

Is there a knowledge base of remedies or responses to common requests and incidents?

Response to Question 6:

As noted in Attachment 3, Performance Work Statement, 3.C.7. DAIDS Learning Portal, the Contractor shall provide training support services to include providing proposed plans and procedures for maintenance and support of a DAIDS Learning Portal and the provision of help desk support.

Question 7:

What percentage of incidents require escalation and what are the common escalation types?

Response to Question 7:

As noted above, the Contractor shall propose plans and procedures for support of a DAIDS Learning Portal and the provision of help desk support. The government anticipates the incident handling may vary depending on a particular proposed plan and procedure(s).

Question 8:

If the current service provider provides service desk trend reporting please may we see one?

Response to Question 8:

As noted above, the Contractor shall propose plans and procedures for support of a DAIDS Learning Portal and the provision of help desk support. The government anticipates service desk trends may vary depending on the particular proposed plan and procedure(s).

Question 9:

How many new users are provisioned during a typical month?

Response to Question 9:

New user requests vary based on a variety of factors, consequently a typical monthly amount of new users can’t be estimated.

Question 10:

How are incidents logged; is there a ticketing system? If so, what platform is currently used?

Response to Question 10:

As noted above, the Contractor shall propose plans and procedures for support of a DAIDS Learning Portal and the provision of help desk support.

Question 11:

Will the offeror be provided with access to assess the Westat technology environment to include:

infrastructure, application and content, authentication (single sign on), security components and interfaces?

Response to Question 11:

As per the Attachment 3, PWS, Section 3.C.7. DAIDS Learning Portal, the incumbent Contractor shall transition an existing website to its server and operate, manage and maintain, utilizing commercially available software, a web-based system for the central management of all training categories and topics, within seventy-five (75) business days of contract award. All former contractor deliverables, all paper and electronic files and databases, the training and QA/QC plans, SOPs and all software and hardware used by the incumbent contractor will be transferred to the incumbent Contractor to enable the transition of the existing DLP website.

Question 12:

Can you provide us with the Westat Technical Documentation for the DLP?

Response to Question 12:

As per the Attachment 3, PWS, Section 3.C.7. DAIDS Learning Portal, the incumbent Contractor shall transition an existing website to its server and operate, manage and maintain, utilizing commercially available software, a web-based system for the central management of all training categories and topics, within seventy-five (75) business days of contract award. All former contractor deliverables, all paper and electronic files and databases, the training and QA/QC plans, SOPs and all software and hardware used by the incumbent contractor will be transferred to the incumbent Contractor to enable the transition of the existing DLP website.

Question 13:

Is it anticipated that the current DLP backup and recovery systems will be migrated or will the offeror be responsible for establishing new processes and procedures?

Response to Question 13:

As per the Attachment 3, PWS, Section 3.C.7. DAIDS Learning Portal, the incumbent Contractor shall transition an existing website to its server and operate, manage and maintain, utilizing commercially available software, a web-based system for the central management of all training categories and topics, within seventy-five (75) business days of contract award. All former contractor deliverables, all paper and electronic files and databases, the training and QA/QC plans, SOPs and all software and hardware used by the incumbent contractor will be transferred to the incumbent Contractor to enable the transition of the existing DLP website.

Question 14:

Can you provide guidance on the storage requirements for DLP (i.e. size of files, configurations, databases and applications to be transitioned)?

Response to Question 14:

All former contractor deliverables, all paper and electronic files and databases, the training and QA/QC plans, SOPs and all software and hardware used by the incumbent contractor will be transferred to the incumbent Contractor to enable the transition of the existing DLP website.

Offeror’s should reference the RFP-specific materials, DAIDS Learning Portal Overview 7. DLP Overview Flyer available via an electronic reading room at:

https://ecollab.niaid.nih.gov/readingroom/NIAIDCRSS/SitePages/Home.aspx

Question 15:

Who currently maintains the DLP Domain Names and will this be transitioned?

Response to Question 15:

All former contractor deliverables, all paper and electronic files and databases, the training and QA/QC plans, SOPs and all software and hardware used by the incumbent contractor will be transferred to the incumbent Contractor to enable the transition of the existing DLP website.

Question 16:

Does the response to Question 9 in the RFP Amendment mean that the offeror will be using the current CRSS SharePoint Program for document collaboration during the project or will the offeror be responsible for creating its own document collaboration environment?

Response to Question 16:

As part of the overall project management requirement for this work, the contractor shall be responsible for proposing its own collaboration environment to be used to achieve the successful project management of all contract related data, documents and other materials associated with the contract.

Question 17:

The Section 508 Compliance Template form given in the RFP is designed to be completed by an existing government contractor. Please provide guidance as to how this should be completed.

Response to Question 17:

Per the solicitation, section L - Instructions, Conditions, and Notices to Offerors, 2. Instructions to offerors, b. Technical Proposal Instruction, Paragraph 4., any vendor submitting a proposal/quotations/bid in response to this solicitation must demonstrate compliance with the established EIT accessibility standards. Additionally, per Article C.2. Reporting Requirements b.3 of the RFP the awarded contractor will submit annual 508 compliance report. Please follow https://ecollab.niaid.nih.gov/readingroom/NIAIDCRSS/SitePages/Home.aspx the instructions provided in Attachment 9 on how to fill out the form - “508 Evaluation Template”.

Question 18:

Can the government say more about how much Section 508 compliance work is envisioned in the solicitation?

Response to Question 18:

The offeror should carefully review the PWS to determine those deliverables that must be 508 compliant. As an example, please see the PWS, Section 3.C.7, page 9, where it is noted that the DLP “must be compliant with Section 508 of the Rehabilitation Act”.

Question 19:

Are there any prior year Section 508 Compliance reports that can be provided as examples?

Response to Question 19:

Please reference the website http://www.hhs.gov/web/section-508/ . After award, the Government will give Contractor additional information/materials/guidance regarding 508 Compliance reports.

Question 20:

Is it acceptable to propose lower than the suggested 48.10 FTE?

Response to Question 20:

The main requirement of the Contract is to provide 48.10 FTEs. Lower than 48.10 FTE will not be accepted.

Question 21:

The Clinical Research Site Audits listed in Section 1.A.2, Attachment 5 page 2, designates 3 international site audits for 4 days on site. The travel section cost assumptions on the following page, Attachment 5 page 3 section 2C4, GCP Audits, has the international audits listed for 3 days on site. Please clarify how many days on site are required per audit.

Response to Question 21:

The international GCP audits will be for 4 days on site.

This is a discrepancy. Attachment 5, ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS AND UNIFORM COST ASSUMPTIONS, Paragraph 1.A.2), Clinical Research Audits is correct, while Paragraph 2.c.4), is not. Therefore, Attachment 5, SECTION 3, UNIFORM COST ASSUMPTIONS, paragraph 2, Travel, paragraph c.4), has been revised in amendment 1.

Question 22:

Attachment 5 page 3, Section 2.C.4. is not clear what “Assume one domestic and two three-day site visits” means. Please clarify. Should Section 1.A.2. on Attachment 5 page 2 list one domestic site audit?

Response to Question 22:

Attachment 5, SECTION 3, UNIFORM COST ASSUMPTIONS, paragraph 2, Travel, paragraph c.4), is revised to read as follows:

http://www.hhs.gov/web/section-508/

4) GCP Audits: Assume three international GCP audits per year to DAIDS clinical trial sites.

Two (2) trips to Africa/South Africa (Kampala, Uganda, Johannesburg, SA) and one (1) trip to South America (Rio de Jenerio, Brazil), four (4) days on site for each visit.

Question 23:

Instructions for c.5) Clinical Research Laboratory Audits and Reports: The table lists Chonbur, Thailand as a destination. Should this be Chonburi and, if so, this would mean that Chonburi is listed twice. Also, please confirm that the site in South Africa is PWSeto, or should this be Soweto.

Response to Question 23:

Yes, Chonburi is the location and Chonburi should be LISTED TWICE and yes, the South Africa site location is Soweto, Attachment 5, SECTION 3, UNIFORM COST ASSUMPTIONS, paragraph 2, Travel, paragraph c.5), is revised to reflect the changes.

END OF AMENDMENT No. 2

RFP No. NIAID-DAIDS-NIHAI2015050

Attachment 5_Revised_06292016 Additional Business Proposal Instructions 1

ATTACHMENT 5: ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS

AND UNIFORM COST ASSUMPTIONS

NIAID HIV AND OTHER INFECTIOUS DISEASES

CLINICAL RESEARCH SUPPORT SERVICES (CRSS)

NIAID-DAIDS-NIHAI2015050

In addition to the format requirements for the Business Proposal that are contained in Section L of the solicitation, the information presented in this section of the RFP is intended to provide uniform cost assumptions and business clarifications.

Offerors are advised to give careful consideration to the Performance Work Statement, all reference material provided as attachments, the Technical Evaluation Criteria, and, the RFP as a whole, in the development of your proposal. The information requested in these instructions should be used as a guide for the development and formatting of your Business Proposal. Offerors should consider and include the information requested here, as well as any other information which will benefit the proposal.

BUSINESS PROPOSAL – TABLE OF CONTENTS

SECTION 1 – PROPOSAL COVER SHEET (use form NIH 2043 identified in Section J of the solicitation)

SECTION 2 – COST OR PRICE SUPPORT

Section L of the RFP specifies the minimum documentation requirements for cost data and all cost related support. All related documentation should be included in a clearly marked section of the proposal.

SECTION 3 – UNIFORM COST ASSUMPTIONS

It is anticipated that a level of effort type contract will be awarded. The period of performance will be for one year beginning approximately May 15, 2017 through May 14, 2018. The requirement will be the delivery of 48.10 full time equivalents (FTEs) for the base period (Year 1). If Options to extend the term of the contract are exercised, the Contractor shall provide 48.10 FTEs per year for the option periods 1 through 6 (contract years 2 through 7). Uniform cost assumptions for Options for Increased Level of Effort are described in SECTION 4 below.

The intended base year and option structure is as indicated in the table below and the Offerors must structure their Business Proposal to indicate proposed costs for each of the periods listed below. Please refer to Section 4 - Level of Effort, for a sample of the anticipated/expected LOE.

Additional Business Proposal Instructions 2

Option Period FTEs Base Period May 15, 2017 – May 14, 2018 48.10

Options to Extend the Term of the Contract Option 1 May 15, 2018 – May 14, 2019 48.10 Option 2 May 15, 2019 – May 14, 2020 48.10 Option 3 May 15, 2020 – May 14, 2021 48.10 Option 4 May 15, 2021 – May 14, 2022 48.10 Option 5 May 15, 2022 – May 14, 2023 48.10 Option 6 May 15, 2023 – May 14, 2024 48.10

1. Technical Cost Assumptions – Base Period of Performance

Offerors shall use the following uniform technical cost assumptions for selected CRSS functions, specified within the Performance Work Statement (PWS), for the preparation of Business Proposals for the Base Period of Performance. For cost estimating purposes, please note the following: (i) technical cost assumptions are based on those selected CRSS functions representing the most frequently used task areas under the existing contract and, therefore, those task areas most likely to be utilized under the new contract, (ii) technical cost assumptions are not meant to be all inclusive in terms of the full range of clinical research support services that may be provided, and (iii) Attachment 7 entitled “Additional RFP-Specific Materials” provides detailed information on DAIDS-supported clinical research sites.

A. CLINICAL RESEARCH SUPPORT (PWS section A)

1) Clinical Research Site Assessment Visits and Reports (PWS section A.21)

a. A total of five (5) clinical research site assessment visits per year:

i. One (1) domestic visit (Boston, MA)

ii. Four (4) international visits; two (2) in Africa/South Africa (Kampala, Uganda, Johannesburg, SA) and two (2) in South America (Lima Peru, Rio De Janeiro, Brazil)

iii. including both new and existing clinical research sites

b. Three (3) days on site for each visit

c. Delivery of a completed DAIDS Assessment Module upon completion of each visit

2) Clinical Research Site Audits (PWS section A.32)

a. A total of three (3) international clinical research site audit visits per year

b. Two (2) in Africa/South Africa (Kampala, Uganda, Johannesburg, SA) and one (1) in South America (Rio de Janerio, Brazil), including both new and existing clinical research sites

c. Four (4) days on site for each visit

d. Delivery of a completed Audit Report upon completion of each visit

3) Additional Support for Study-Specific Clinical Research Site Readiness (PWS A.34)

a. Review of Clinical Quality Management Plan – two (2) per year

b. Targeted Training – one (1) per year

i. Five (5) days on site

ii. Delivery of tailored training

Additional Business Proposal Instructions 3

iii. Evaluative Report

B. LABORATORY (PWS section B)

1) Clinical Research Laboratory Audits and Reports (PWS section B.1)

a. A total of one hundred forty (140) laboratory audits per year; twenty

(20) laboratory audits of domestic clinical research sites within the NIAID/DAIDS HIV/AIDS Clinical Trials Networks; one hundred twenty

(120) laboratory audits for clinical research sites within the NIAID/DAIDS HIV/AIDS Clinical Trials Networks located throughout South America, Africa, and Asia.

i. Five (5) days on site for each audit

ii. Delivery of a comprehensive report upon completion of each audit

2) cGMP Audits (PWS Section B.2)

a. Three (3) cGMP audits per year (2 domestic (Seattle, WA and New York, NY), 1 international (Lyon, France)

b. Five (5) days on site for each audit

c. Delivery of a comprehensive report upon completion of each audit

3) GLP Audits (PWS Section B.2)

a. Three (3) GLP audits per year (2 domestic (Seattle, WA and New York, NY), 1 international (Johannesburg, South Africa)

b. Five (5) days on site for each audit

c. Delivery of a comprehensive report upon completion of each audit

2. Travel

The following General Cost Assumptions apply:

a. Assume all airfare to be economy class.

b. Assume two days travel time for travel destinations outside of the traveler’s country of residence

c. Assume hotel and per diem at U.S. government rates for the applicable city/location.

1) Contract Initiation Meeting: Assume one meeting at DAIDS offices in Rockville, Maryland within five (5) business days after the effective date of the contract to discuss contract initiation. Assume that this meeting will require a one-night stay and shall be attended by all of the Contractor’s key personnel.

2) Contract overview meeting to DAIDS: Assume one meeting at DAIDS offices in Rockville, Maryland within forty (40) business days after the effective date of the contract to present contract staff and capabilities to DAIDS staff. Assume that this meeting will require a one-night stay and shall be attended by all of the Contractor’s key personnel and functional leads.

3) Clinical Site Assessment Visits: Assume one domestic and four three-day clinical site assessment visits per year to DAIDS clinical trial sites One (1) domestic visit (Boston, MA), two (2) in Africa/South Africa (Kampala, Uganda, Johannesburg, SA) and two (2) in South America (Lima Peru, Rio De Janeiro, Brazil)

4) GCP Audits: Assume one domestic and two three-day site visitsthree international GCP audits per year to DAIDS clinical trial sites. Two (2) trips to

Additional Business Proposal Instructions 4

Africa/South Africa (Kampala, Uganda, Johannesburg, SA) and one (1) trip to South America (Rio de Janerio, Brazil), four (4) days on site for each visit.

5) Clinical Research Laboratory Audits and Reports: Assume a total of one hundred forty (140) laboratory audits per year; twenty-five (25) laboratory audits of domestic clinical research sites within the NIAID/DAIDS HIV/AIDS Clinical Trials Networks; one hundred fifteen (115) laboratory audits for clinical research sites within the NIAID/DAIDS HIV/AIDS Clinical Trials Networks located throughout South America, Africa, and Asia. Five (5) days on site for each audit. Use the following destinations from the contractor’s location for air fare cost assumptions:

USA

Each Destination x 2 =

Africa/South Africa Each destination x 5 = 50

South America Each destination x 7 = 35

Asia Each Destination x 5 = 35

Seattle, Washington Harare, Zimbabwe Buenos Aires, Argentina Chennai, India

San Francisco, California Lusaka, Zambia Belo Horizonte, Brazil Pune, India Rockville, Maryland Mbarara, Uganda Iquitos, Peru Bangkok, Thailand

Rochester, New York Kampala, Uganda Sao Paulo, Brazil Chiang Mai, Thailand

Port St. Lucie, Florida Moshi, Tanzania Rio de Janeiro, Brazil Chiang Rai, Thailand

Philadelphia, Pennsylvania Mbeya, Tanzania Chonburi, Thailand

Orlando, Florida Dar es Salaam, Tanzania Chonburi, Thailand

New York, New York Johannesburg, South Africa

Nashville, Tennessee Umlazi, South Africa

Los Angeles, California PWSetoSoweto, South Africa

A. cGMP Audits: Assume three (3) cGMP audits per year (2 domestic (Seattle, WA and NY, NY), 1 international (Lyon, France). Five (5) days on site for each audit.

B. GLP Audits: Three (3) GLP audits per year (2 domestic (Seattle, WA and NY, NY), 1 international (Johannesburg, SA)) Five (5) days on site for each audit

C. Other Site or Lab Visit – Assume 10 ad hoc site visits per year, three days on site. Assume 5 visits to Johannesburg, South Africa, 5 visits to Southeast Asia (Mumbai, India).

D. HIV/AIDS Clinical Trials Network Meetings: Assume one Contractor/subcontractor staff attending six Network meetings per year: four to be held in the greater Washington, DC metropolitan area, one in Baltimore, MD and one in Seattle, Washington.

E. Consultant Travel – Assume ten (10) trips per year, 4 domestic (Boston, MA, Seattle WA, Los Angeles, CA, NY, NY) and six international (2 trips to Johannesburg, SA 2 trips to Kampala, Uganda, 2 trips to Capetown, SA) to attend Network or other scientific meetings.

Additional Business Proposal Instructions 5

5) Government Furnished Property

Government Furnished Property is offered for this acquisition.

No Government Furnished Property is offered for this acquisition.

The purchase of Government Furnished Property will not be authorized as a direct charge under the resultant contract.

SECTION 4 – LEVEL OF EFFORT

The Government's requirement for the work set forth in the Performance Work Statement is

48.10 full time equivalents (FTEs). The table below is one example of a labor mix. While the total number of FTEs is required to be delivered, the contractor may propose a different labor mix. The direct labor effort includes subcontractor and consultant effort.

Labor Type

Base Year

Option 1 Year

Option 2 Year

Option 3 Year

Option 4 Year

Option 5 Year

Option 6 Year

Project Director (PD), Asst PD, Sr VP, Financial Analyst, Financial Assistant, Sr.

Functional Managers, Sr. Clinical Auditor

7.35 7.35 7.35 7.35 7.35 7.35 7.35

Project Manager 8.00 8.00 8.00 8.00 8.00 8.00 8.00 GCLP Lab Manager/Auditor 9.00 9.00 9.00 9.00 9.00 9.00 9.00

GMP Auditor 0.50 0.50 0.50 0.50 0.50 0.50 0.50 Data Manager, Biostatistician 0.75 0.75 0.75 0.75 0.75 0.75 0.75

CDISC Specialist, TB Expert 0.50 0.50 0.50 0.50 0.50 0.50 0.50

Trainer/ Instructional Designer 1.50 1.50 1.50 1.50 1.50 1.50 1.50

IT Manager, Systems Analyst Drupal Programmer Training Learning Portal Help Desk

7.25 7.25 7.25 7.25 7.25 7.25 7.25

IT SharePoint, IT Help Desk IT Security 4.25 4.25 4.25 4.25 4.25 4.25 4.25

Graphics 1.00 1.00 1.00 1.00 1.00 1.00 1.00 Quality Control 2.00 2.00 2.00 2.00 2.00 2.00 2.00 Program Assistants 6.00 6.00 6.00 6.00 6.00 6.00 6.00

TOTAL 48.10 48.10 48.10 48.10 48.10 48.10 48.10

SECTION 5 – OPTIONS

The Government may exercise options for an increased level of effort that may result from unanticipated increases in demand for the activities supported by the base requirements of this contract. Options for increased services may include the following:

Additional Business Proposal Instructions 6

Offerors should include a cost estimate for the addition of one monitor/project manager (up to two times per year) and two monitors/project managers (up to two times per year) to support additional activities. The direct labor effort includes subcontractor and consultant effort. The cost estimate should include a budget for the additional FTEs indicated in the table below:

Option Period FTEs Options for Increased Level of Effort (1.0 FTE up to 2 x per year)

Option 7 May 15, 2017 – May 14, 2018 1.00 Option 8 May 15, 2017 – May 14, 2018 1.00 Option 9 May 15, 2018 – May 14, 2019 1.00 Option 10 May 15, 2018 – May 14, 2019 1.00 Option 11 May 15, 2019 – May 14, 2020 1.00 Option 12 May 15, 2019 – May 14, 2020 1.00 Option 13 May 15, 2020 – May 14, 2021 1.00 Option 14 May 15, 2020 – May 14, 2021 1.00 Option 15 May 15, 2021 – May 14, 2022 1.00 Option 16 May 15, 2021 – May 14, 2022 1.00 Option 17 May 15, 2022 – May 14, 2023 1.00 Option 18 May 15, 2022 – May 14, 2023 1.00

Option 19 May 15, 2023 – May 14, 2024 1.00

Option 20 May 15, 2023 – May 14, 2024 1.00 Options for Increased Level of Effort (2.0 FTEs up to 2 x per year) Option 21 May 15, 2017 – May 14, 2018 2.0

Option 22 May 15, 2017 – May 14, 2018 2.0

Option 23 May 15, 2018 – May 14, 2019 2.0

Option 24 May 15, 2018 – May 14, 2019 2.0

Option 25 May 15, 2019 – May 14, 2020 2.0

Option 26 May 15, 2019 – May 14, 2020 2.0

Option 27 May 15, 2020 – May 14, 2021 2.0

Option 28 May 15, 2020 – May 14, 2021 2.0

Option 29 May 15, 2021 – May 14, 2022 2.0

Option 30 May 15, 2021 – May 14, 2022 2.0

Option 31 May 15, 2022 – May 14, 2023 2.0

Option 32 May 15, 2022 – May 14, 2023 2.0

Option 33 May 15, 2023 – May 14, 2024 2.0

Option 34 May 15, 2023– May 14, 2024 2.0

Additional Business Proposal Instructions 7

SECTION 6 - TABLE OF CONTENTS FOR DOCUMENTATION REQUIRED UNDER

SECTION L OF THE SOLICITATION

Refer to Section L of the solicitation for documentation requirements. All relevant documentation should be included in a clearly marked section of the proposal.

2015050_ Amendment_2 Final
ATTACHMENT 5- ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS-Revised_06292016
A. CLINICAL RESEARCH SUPPORT (PWS section A)

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