2015050__Amendment_1.pdf

AMENDMENT #1, RFP No. NIAID-DAIDS-NIHAI2015050

Amendment No. 1 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

One (1)

June 03, 2016

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: 30TURosemary.Gomes@nih.govU30T

SECONDARY:

Michelle L. Scala, Contracting Officer Phone: 240-669-5156 Email Address: 30Tmscala@niaid.nih.gov30T

The purpose of this amendment is to: 1) provide responses to questions from potential offerors regarding the solicitation; 2) revise PART I – Schedule, Articles B.4. and I.2.; 3) modify Attachment 4, Additional Technical Proposal Instructions, and Attachment 5, Additional Business Proposal Instructions and Uniform Cost Assumptions; and 4) update Attachment 11, Small Business Subcontracting Plan.

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:

Can DAIDS provide a uniform cost assumption or confirm the annual cost of the license fee and hosting cost for the database and web services for the Biological Specimen Inventory System listed in Article B.4 (c)?

Response to Question 1:

In the solicitation, PART I – SCHEDULE, ARTICLE B.4., ADVANCE UNDERSTANDINGS, paragraph c., Biological Specimen Inventory System, was included in error and is removed and therefore does not need to be addressed by the offeror.

mailto:Rosemary.Gomes@nih.gov mailto:anhughes@niaid.nih.gov

Question 2:

Can DAIDS confirm if the current DAIDS Learning Management System (DLMS) will be transferred at the end of the current program, or if the offeror should propose a new DLMS?

Response to Question 2:

The DLMS is housed by an external Government Agency and will not be transferred at the end of the current contract. The offeror has not been requested to propose a new DLMS. However, the Contractor will be required to interface with the DLMS to ensure continued electronic linkage and communications between DAIDS, the DAIDS Learning Portal and the DLMS. Please refer to Attachment 3, Performance Work Statement, Paragraph 3, Technical Requirements, subparagraph C.6., DAIDS Learning Management System (DLMS) interface and support, for more information.

Question 3:

If the DLMS will be transferred, can the DAIDS provide the name of the current DLMS vendor?

And, will the offeror be responsible for the license fees and hosting costs for the DLMS? If so, can DAIDS provide a Uniform Cost Assumption for the annual license fees and hosting costs?

Response to Question 3:

As stated above in response to question 2, the DLMS is not being transferred.

Question 4:

RFP, Pg 8, Article B.4. Advanced Understandings c. Biological Specimen Inventory System states “The contractor shall assume the Government license fee for the Biological Specimen Inventory System (BSI-II) software and shall hosting responsibilities for the database and web services for at least one year or until a different electronic inventory and management system is implemented.” Where does this requirement fit into the Performance Work Statement, are there any applicable Evaluation Factors or Additional Business proposal Instructions and Uniform Cost Assumptions related to this requirement?

Response to Question 4:

In the solicitation, PART I – SCHEDULE, ARTICLE B.4., ADVANCE UNDERSTANDINGS, paragraph c., Biological Specimen Inventory System, was included in error and is removed and therefore does not need to be addressed.

Question 5:

Please describe the role and responsibilities of the Senior Clinical Specialist position.

Response to Question 5:

We could find only one reference in the solicitation to the Senior Clinical Specialist position. In Attachment 4, Additional Technical Proposal Instructions, under Section 4: Scientific and Technical Personnel, the Senior Clinical Specialist is defined as Key Personnel for the proposed contract. The Government removes the requirement to identify the following positions as key personnel: Project Director, Associate Project Director, Senior Vice President, Senior Functional Area Managers, IT Manager, and Senior Clinical Specialist. Attachment 4, Additional Proposal Instructions, is revised accordingly.

Question 6:

Attachment 8 allows for only 1 name/title to be entered per section of the form although the form states that the information must be provided by the offeror pertaining to the Project Director, Principal Investigator, and each of any other proposed key professional individuals designated for performance under any resulting contract. The form seems to not allow for entry of information for multiple named key individuals? Is there another form that can be used?

Response to Question 6:

Attachment 8, Summary of Related Activities does allow for entry of information for multiple named key individuals under each paragraph in the provided table. If you need to add additional names, please duplicate the form. Ensure all proposed key individuals are listed.

Question 7:

Attachment 4, Section 4, page 9, states: For this contract key personnel are defined as: Project Director, Associate Project Director, Senior Vice President, Senior Functional Area Managers, IT Manager, and Senior Clinical Specialist. Please clarify the requirement for a Senior Vice President role as Key Personnel. Also, clarify if all of these positions stated should be considered as Key Personnel.

Response to Question 7:

See Response to Question 5 above and revised Attachment 4, Additional Technical Proposal Instructions.

Question 8:

Please confirm the DAIDS Learning Portal is currently Section 508 compliant.

Response to Question 8:

DAIDS is currently working to ensure all document and systems are Section 508 compliant.

Question 9:

The DAIDS CRSS SharePoint Overview document posted in the reading room indicates the contractor will be responsible for the DAIDS CRSS SharePoint Program including transfer, hosting and maintenance. Where does this requirement fit into the Performance Work Statement, are there any applicable Evaluation Factors or Additional Business proposal Instructions and Uniform Cost Assumptions related to this requirement?

Response to Question 9:

The Performance Work Statement (PWS) does not include a requirement for the Contractor be responsible for the DAIDS CRSS SharePoint Program, including transfer, hosting and maintenance. However, the Contractor is required to participate in the transition of contract-related data, documents, and other materials from the previous contractor (please refer to Attachment 3, PWS, Paragraph 3, Technical Requirements, Paragraph G, Initial Transition). In addition, managing the data, documents and other materials related to this contract is considered a part of project management of all contract activities. Please refer to Section M of the solicitation for Evaluation Factors and Attachment 4, Additional Technical Proposal Instructions, for any information related to the technical proposal and the evaluation of proposals submitted in response to the RFP. There is no specific “Uniform Cost Assumption” associated with this requirement.

Question 10:

Attachment 5: Additional Business proposal Instructions, Section 3 – Uniform cost assumptions, 1.A.2) Clinical Research Site Audits indicates Four (4) day on site for each visit but 2. Travel 4) GCP audits - indicates audits are three (3) days on site. Please verify which set of assumptions is correct for these audits: four days on site or three days on site?

Response to Question 10:

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), is revised to read as follows:

4) GCP Audits: Assume one domestic and two three-day site visits 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 11:

Are the examples and sample materials that are requested in the PWS (e.g., Completed Site Assessment Visit Report; Proposed report templates for Pre-FDA Inspection Site Visit Report and "for cause" GCP type audit) included in the 250 page limit?”

Response to Question 11:

Yes, the examples and sample materials that are requested in the PWS are included in the 250 page limit. Please refer to Attachment 1: Packaging and Delivery of Proposals for Use with eCPS, of the RFP to verify the items that are not counted towards the page limit.

Question 12:

Attachment 5: Additional Business proposal Instructions, Section 3 – Uniform cost assumptions, 1.B.2) cGMP Audits indicates 3 audits – 2 domestic (Seattle and Boston) and one international (Paris) however 2.A Travel calls for 3 audits – 2 domestic (Seattle and New York City) and one international (Lyon) Please verify which sites are to be used for bidding purposes.

Response to Question 12:

This is a discrepancy. Attachment 5, ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS AND UNIFORM COST ASSUMPTIONS, Paragraph 1.B.2), cGMP Audits, subparagraph a, is hereby revised to read as follows:

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

Question 13:

Attachment 5: Additional Business proposal Instructions, Section 3 – Uniform cost assumptions, 1.B.3) GLP Audits indicates 3 audits – 2 domestic (Seattle and Boston) and one international (Paris) however 2.B Travel calls for 3 audits – 2 domestic (Seattle and New York City) and one international (Johannesburg) Please verify which sites are to be used for bidding purposes.

Response to Question 13:

This is a discrepancy. Attachment 5, ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS AND UNIFORM COST ASSUMPTIONS, Paragraph 1.B.3), GLP Audits, subparagraph a, is hereby revised to read as follows:

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

Question 14:

Attachment 5: Additional Business proposal Instructions, Section 3 – Uniform cost assumptions, 1.B.1) Clinical Research Laboratory Audits indicates 140 total audits – 25 domestic and 115 international however 2.c.5 Travel calls for 20 domestic and 120 international. Please confirm that the table in 2.c.5 is correct and should be used for estimation purposes.’

Response to Question 14:

We are confirming that the table in 2.c.5 is correct and should be used for estimation purposes.

This is a discrepancy. Attachment 5, ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS AND UNIFORM COST ASSUMPTIONS, Paragraph 1.B.1), Clinical Research Laboratory Audits, paragraph a, is revised to read as follows:

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.

Question 15:

Article I.2 Authorized Substitutions of Clauses - d. FAR Clauses 52.219-9, Small Business Subcontracting Plan (October 2015), and 52.219-16, Liquidated Damages--Subcontracting Plan (January 1999) are deleted in their entirety. Please confirm if the requirement of a subcontracting plan has been removed from this opportunity.

Response to Question 15:

This was an oversight. We did not intend to delete the requirement for the Small Business Subcontracting Plan. PART I – SCHEDULE, ARTICLE I.2., AUTHORIZED SUBSTITUTIONS OF CLAUSES, paragraph d, is hereby deleted in its entirety.

Other Updates:

Attachment 11, Small Business Subcontracting Plan. has been updated and is attached.

END OF AMENDMENT No. 1 RFP No. NIAID-DAIDS-NIHAI2015050

Attachment 4_Revised_06032016 Additional Technical Proposal Instructions 1

ATTACHMENT 4: ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS,

FORMAT FOR TECHNICAL PROPOSAL, and TABLE OF CONTENTS

NIAID HIV AND OTHER INFECTIOUS DISEASES

CLINICAL RESEARCH SUPPORT SERVICES (CRSS)

NIAID-DAIDS-NIHAI2015050

It is strongly recommended that offerors use the following template as the UTable of ContentsU for the Technical Proposal. All information presented in the Technical Proposal should be presented in the order specified below.

These additional Technical Proposal instructions reflect the requirements of the solicitation and provide specific instructions and formatting for the Technical Proposal. While Section L of the solicitation provides a generic set of Technical Proposal instructions applicable to all NIH R&D solicitations, these instructions are tailored to the specific requirements of the RFP. The information requested in these instructions should be used to format and prepare the Technical Proposal, and should be used as a Table of Contents for your Technical Proposal. Offerors should follow the instructions in Section L of the solicitation, and include the information requested here.

Offerors are advised to give careful consideration to the Performance Work Statement, all reference materials, and attachments, the Technical Evaluation Criteria in Section M, and the solicitation as a whole in the development of their Technical Proposals.

Offerors proposing subcontracts to perform portions of the Performance Work Statement should clearly identify the specific tasks for which they plan to utilize subcontractors, as well as the method and level of integration/coordination between the prime Contractor and all proposed subcontractors, and the expected advantages of such an approach.

Offerors must refer to the solicitation Attachment entitled “Packaging and Delivery of the Proposal,” which details strict guidelines, including page limitations, formatting and layout of proposals, and prohibits the offerors use of links to internet web site addresses (URLs) to direct readers to alternate sources of information.

UPLEASE NOTE:U Several documents are being made available to offerors to assist in proposal preparation. These documents are included in an electronic reading room that can be accessed at:

38TUhttps://ecollab.niaid.nih.gov/readingroom/NIAIDCRSS/SitePages/Home.aspxU38T.

A listing of the available documents is provided below and is also included in “Attachment 7:

Additional RFP-Specific Materials.”

• DAIDS Extramural Clinical Trial Portfolio https://ecollab.niaid.nih.gov/readingroom/NIAIDCRSS/SitePages/Home.aspx

Additional Technical Proposal Instructions 2

• Other NIAID/DAIDS Clinical Research Support Contractors and Grantees

• DAIDS CRSS SharePoint Overview

• DAIDS CRSS Training Program Overview

• DAIDS Training Program Inventory

• DAIDS Learning Portal Overview

• DLP Overview Flyer

• DAIDS Site Assessment Tool

• GCLP Audit Module

Failure to access these additional RFP-specific materials is at the offeror’s risk.

TECHNICAL PROPOSAL – TABLE OF CONTENTS

SECTION 1:

1) PROPOSAL TITLE PAGE. Include RFP title and number, name of organization, DUNS number, and identify if the proposal is an original or a copy. Offerors that include in their proposals data that they do not want disclosed to the public for any purpose, or used by the Government except for evaluation purposes, shall also include the legend regarding Restriction on Disclosure and Use of Data prescribed by FAR 38T52.215-138T(e)]

2) TABLE OF CONTENTS

SECTION 2: TECHNICAL PROPOSAL OVERVIEW (suggested 3-page maximum)

A. A brief description of the activities to be performed by the offeror and all proposed subcontractors, including identification of all proposed subcontractors and a list of key personnel of the offeror and the proposed subcontractors with degrees, titles and role in the project.

B. By area of expertise, provide the total number of trained and experienced staff, the number available to be assigned to the contract for the offeror and all proposed subcontractors, and total number of additional staff to be hired and trained. At a minimum, include staff for the provision of the following research support services: (i) clinical research site assessments; (ii) clinical site auditing; (iii) GCLP, GMP, GLP laboratory auditing; (iv) training support services including management of DAIDS Learning Portal; and (v) contract oversight/project management.

C. Brief descriptions of the facilities and equipment to be made available by the offeror and all proposed subcontractors, including the offeror’s facility for housing senior contract management staff and all proposed regional and local field offices.

SECTION 3: TECHNICAL PLAN/APPROACH

Describe organizational experience provide proposed plans and procedures for performing the Performance Work Statement functions specified below for the offeror and all proposed https://www.acquisition.gov/far/current/html/52_215.html#wp1144408

Additional Technical Proposal Instructions 3 subcontractors. For each function, include information relevant to working with large and complex clinical trials networks involving both domestic and foreign clinical research sites, particularly sites located in resource-limited countries, and to clinical research on HIV/AIDS and other infectious diseases that are of relevance to HIV infection and at-risk populations.

A. CLINICAL RESEARCH SUPPORT (PWS Section 3. A)

1. Clinical Research Site Assessments and Additional Support for Study-

Specific Clinical Research Site Readiness

a. Organizational Experience: Describe organizational experience in planning, conducting and reporting the findings of clinical research site assessments with an emphasis on clinical research sites in resource-limited settings. Include the following:

1) A listing of assessments conducted to evaluate overall clinical research site capabilities for the conduct of human subjects research, identifying: (i) type of setting (e.g., hospital, clinic, etc.), (ii) geographic location and date of assessment, (iii) a description of the major problems/deficiencies encountered, and (iv) a brief description of the role of the offeror and/or any proposed subcontractors in ensuring appropriate implementation of approved corrective actions.

2) A listing of study-specific assessments conducted to evaluate clinical research site capabilities for conducting specific categories of clinical trials/studies identifying: (i) type of setting and geographic location, (ii) date of assessment and specific category of clinical trial/study, (iii) a description of the major problems/deficiencies encountered, and (iv) a brief description of the role of the offeror and any proposed subcontractors in ensuring appropriate implementation of approved corrective actions.

3) A brief description of experience in providing additional support for study-specific clinical research site readiness, e.g., preparation of study-specific materials, review of Clinical Quality Management Plans, provision of targeted training, etc. Include the type of additional support provided, identify the geographic location of sites, and describe role of the offeror and/or any proposed subcontractors.

b. Proposed Plans and Procedures:

Provide the following: For assessments to evaluate overall clinical research site capabilities for the conduct of human subjects research: a sample of a completed Clinical Site Assessment Visit Report (with all identifiers removed).

2. Clinical Research Site and Study Auditing

a. Organizational Experience:

1) Describe organizational experience in planning, conducting and reporting the findings of the following types of clinical research site and study auditing visits. For each type of auditing function, include: (i) a brief discussion of the most common problems/deficiencies identified, (ii) a brief description of recommendations made to correct identified problems/deficiencies, and (iii) brief description of observations:

Additional Technical Proposal Instructions 4

a) “For Cause” auditing visits. Include a listing of clinical trials/studies for which auditing has been performed, identifying: (i) title, (ii) phase, (iii) investigational product(s), (iv) sponsor, (v) sample size, and (vi) number of participating sites.

b) Process audits (such as Pre-FDA inspection audit or “mock audit”) or other related audits to review and verify compliance of clinical research site processes with all applicable regulations, policies and SOPs. Include a listing of the names and/or geographic locations of sites for which process audits have been conducted and the scope of clinical research performed by such sites.

b. Proposed Plans and Procedures:

Provide proposed plans and procedures for planning, conducting and reporting the findings of site and study auditing visits. Include: (i) a discussion of scheduling procedures, (ii) plans for preparing site personnel, including information/materials to be provided in advance, (iii) a proposed “for cause” and Pre-FDA Inspection Audit Plan; (iv) proposed report templates for Pre-FDA Inspection Site Visit Report and “for cause” GCP type audit).

3. Clinical Trial and other related support:

a. Organizational Experience: 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.

b. Proposed Plans and Procedures: Provide proposed plans and procedures for the provision of on-site assistance to clinical research sites. Discuss common clinical research activities for which assistance may be required, and the types of experts necessary and that could be provided.

4. Clinical Trials and Other Related Support and Ad Hoc Clinical Trial/Study

Specific Support

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

1) A listing of ongoing and completed clinical trials/studies for which assistance has been provided, identifying for each (where applicable):(i) title, (ii) investigational product(s), (iii) study population and sample size, (iv) number and location of participating sites, (v) sponsor, and (vi) those clinical and technical documents for which assistance has been provided and the specific role of the offeror and any proposed subcontracts in the preparation of such documents (e.g., major author, contributing author, reviewer, etc.).

NOTE: If any of these clinical trials/studies involve proprietary information/data that may not be shared outside of the involved sponsor(s), a general description of each clinical trial/study and the level of involvement may be provided.

Additional Technical Proposal Instructions 5

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

b. Proposed Plans and Procedures: Briefly discuss proposed plans and procedures for working with DAIDS Clinical Trials Networks, protocol teams, individual investigators, and DAIDS staff to provide assistance in developing study-specific clinical and technical documents.

5. Data Management

a. Organizational Experience: Describe organizational experience in the provision of data management services, particularly for large, complex clinical trials/studies.

Include the following:

1) A description of data management technical support and advice provided on data system improvements and implementation, including a discussion of major problems/deficiencies noted in site-specific data management capacity and operating systems and improvements implemented. In addition, describe any projects involving the inventory of existing data management tools, forms and practices.

2) A listing of clinical trials/studies for which data have been provided and data analyses performed for use in product licensure, identifying: (i) title, (ii) phase, (iii) sponsor, (iv) investigational product(s), (v) sample size, (vi) number of participating sites. For each project, identify the specific services provided, e.g., CRF design, preparation of data management manuals, data validation, assessment of data systems, etc.

inventory, assessment or audit of data management services to clinical research sites.

6. Biostatistical Design and Analysis

a. Organizational Experience: Provide a listing of clinical trials/studies for which biostatistical design and analysis assistance has been provided, identifying: (i) title, phase, (ii) sponsor, (iii) investigational product(s), (iv) sample size, (v) number of participating sites. For each project, identify the specific biostatistical design and analysis services provided and, where applicable, how effective collaboration and coordination with clinical research networks, data management centers and investigators was achieved.

b. Proposed Plans and Procedures: Briefly describe proposed plans and procedures for the provision of biostatistical design and analysis services, including biostatistical input into protocol design, preparation of interim data analysis plans and data analyses for interim review, and preparation of biostatistical sections of Clinical Study Reports.

Additional Technical Proposal Instructions 6

B. LABORATORY SUPPORT (PWS Section 3.B)

1. Audits of Clinical Research laboratories, cGMP Audits, GLP Audits

a. Organizational Experience: Describe organizational experience in the provision of support services relating to the evaluation and performance of clinical research laboratory testing (GCLP, cGMP and GLP audits). Include the following support functions and provide for each function a discussion of problems/deficiencies encountered and corrective/remedial actions recommended and implemented:

1) A listing of GCLP, cGMP and GLP audits conducted to assess the performance of site-specific clinical research laboratories for both safety and specialized testing. Identify the location of the sites audited and the safety and specialized tests involved. For laboratory audits, identify: (i) the scope of clinical research for which audits of safety and specialized testing have been conducted, (ii) the number and geographic location of the participating clinical research sites, and (iii) the specific safety and specialized tests involved.

2) Brief descriptions of laboratory training programs developed and implemented for clinical research site laboratory personnel on specialized or advanced GCLP topics.

3) Brief descriptions of services provided to non-U.S. clinical research sites to develop appropriate clinical research laboratory facilities, equipment and other resources. Include the names and/or geographic locations of sites for which such services have been provided.

provision of clinical research laboratory performance services. Include: (i) a detailed table of contents for proposed SOPs for monitoring of adherence to such procedures and GCLP, cGMP and GLP compliance, and (ii) proposed procedures for achieving effective coordination and communication with site-specific laboratories, and effective integration of support services and findings.

C. TRAINING (PWS Section 3.C)

1. Design and Development of New Training Products and Revision of Existing Training Products

a. Organizational Experience: Describe organizational experience in the design and development of new training products (or the revision of existing training products) to assist personnel involved in the conduct of clinical research, including staff of clinical research sites. Include the following support services and address the use of centralized on-line “learning portal” to house all training materials:

1) Brief descriptions of training courses designed, including the methods for delivery of training products and intended audience(s). Include 1 example of a recent training plan and 1 example of course materials developed for clinical research site personnel.

2) A listing of training products developed (or revised), identifying for each: (i) delivery methods, (ii) topics (iii) types of experts involved, and (iv) intended

Additional Technical Proposal Instructions 7 audience(s). Include 1 example of a recent training product developed for clinical research site personnel.

following training support services.

1) The design and development (or revision of existing) of training products, including the types of expertise required, topics and proposed methods to be used, including approaches to identify and recommend suitable training products available as well as new training products when warranted.

2) The provision and delivery of training sessions

3) The maintenance of a “Training Archive”

4) Staffing of resource rooms at DAIDS Network meetings

5) Coordination and interface with the DAIDS Learning Management System at

OPM.

6) The planning and delivery of training events using multiple methods, including training for clinical research sites with limited access to web-based technologies.

D. DAIDS Learning Portal and Provision of DLP Help Desk Support (PWS Section

3.C.7)

1. Organizational Experience: Describe organizational experience in the provision of services for the ongoing operations and maintenance of a web based, centralized site that houses training resources to assist personnel involved in the conduct of clinical research, including staff of clinical research sites, Federal research programs and study-/program-specific sponsors and collaborators. Include organizational experience with help desk support of centralized learning/training web-based systems.

2. Proposed Plans and Procedures: Provide proposed plans and procedures for maintenance and support of a DAIDS Learning Portal and the provision of help desk support.

E. OTHER CLINICAL RESEARCH SUPPORT SERVICES (PWS Section 3.D)

Describe organizational experience and provide proposed plans and procedures for performing the following other clinical research support services:

Technical and logistical support for meetings, teleconferences and video conferences, including scheduling, logistical arrangements, on-site administrative management support, and preparation of minutes/summaries. Including a listing of recent meetings for which such support services have been provided and describe for each the specific types of support provided. In addition, provide 1 example of a recently prepared meeting/teleconference/videoconference summary (with identifiers removed as appropriate) and 1 example of a post-meeting action item listing.

F. PROJECT MANAGEMENT (PWS Section 3.F)

1. Project Plan: Provide a proposed Project Plan including the following components:

Additional Technical Proposal Instructions 8

a. Management Structure: A description of the proposed management structure for the entire project, including: (i) a description of the roles and responsibilities of proposed staff of the offeror and all subcontractors; (ii) an organizational chart delineating lines of authority; and (iii) plans for achieving appropriate and ongoing communications among project staff.

b. Project Implementation and Management: Proposed plans for implementing and managing all contract activities, including project management systems and procedures to be utilized, and proposed plans for assessing the efficiency of internal project management procedures, including:

i. Internal timelines and tracking tools for planning and implementing contract assignments and metrics to be used to assess efficiency and timeliness of assignment planning and implementation.

ii. Personnel and other resources required, methods/tools to monitor progress/cost/schedule across projects and to proactively identify, track and resolve any quality assurance issues.

iii. Identification of project risks and risk management/mitigation strategies to address staff turnover, workload and scheduling problems.

iv. Plans for initial and ongoing training of clinical, technical and project management staff on procedures.

v. Procedures to ensure that all Contractor and subcontractor staff safeguard intellectual property, the confidentiality of human subjects and other data, other information provided by third parties or by the Government, as well data generated through this contract.

c. Plans and Procedures: Identify overall project plans developed and implemented over the past ten (10) years for projects of similar scope, size and complexity;

describe problems encountered in implementing such plans and actions taken to overcome or minimize identified problems, including modifications to overall project plans.

G. COORDINATION AND COLLABORATION WITH OTHER NIAID CLINICAL

RESEARCH SUPPORT CONTRACTORS AND GRANTEES (PWS Section 3.E)

Describe organizational experience and provide proposed plans and procedures for collaborating and coordinating clinical research support services with: (i) HIV/AIDS Clinical Trials Networks and clinical research sites, (ii) Network support entitles, including Statistical and Data Coordinating Centers and Central Laboratories, (iii) other clinical research partners, (iv) individual investigators conducting clinical research projects, and

(v) other DAIDS clinical research support contractors. Address plans and procedures for ensuring effective communication among all appropriate entities and methods to assist in adhering to established procedures and timelines.

H. INITIAL TRANSITION (PWS Section 3.G)

Provide a proposed Initial Transition Plan for full assumption of all contract responsibilities and functions no later than three (3) months following the contract effective date. The proposed Initial Transition Plan should include the following components:

1. A description of all initial transition activities to be undertaken.

2. Timelines for the completion of each transition activity.

Additional Technical Proposal Instructions 9

3. The names and titles of all personnel to be assigned to plan and implement the Initial Transition with descriptions of roles and responsibilities.

4. A listing and brief descriptions of the materials to be developed for orientation briefings for Contractor clinical, technical and administrative personnel.

SECTION 4: SCIENTIFIC AND TECHNICAL PERSONNEL

The Technical Proposal should include all information relevant to document individual training, education, experience, qualifications and expertise necessary for the successful completion of all contract requirements. Proposals should include a Staffing Plan with level of percent effort commitment for the conduct of the Performance Work Statement with role descriptions and level of effort of scientific and technical personnel, including scientific and technical personnel of all proposal subcontractors. Clearly identify who is to be assigned as Key Personnel. For this contract key personnel are defined as: Project Director, Associate Project Director, Senior Vice President, Senior Functional Area Managers, IT Manager, and Senior Clinical Specialist. Limit CVs to 2-3 pages, provide selected references for publications relevant to the scope of the RFP, and include experience with projects of similar scope, size and complexity carried out by the offeror and any proposed subcontractors.

A. Project Director and other senior level management staff (e.g. Project Director, Associate Project Director, Senior Functional Area Project Managers, Senior Clinical Specialist, IT Manager) with responsibility for planning, managing, coordinating, directing and reporting on all contract activities, ensuring that Contractor personnel are appropriately trained to implement DAIDS policies and procedures and to comply with regulatory requirements, and implementing quality assurance/quality control procedures to ensure the accuracy, completeness and timeliness of all contract activities.

B. Other Clinical and Technical Personnel with responsibility for performing the full range of clinical research support functions specified in the Performance Work Statement, including the following major areas of support: (i) clinical research site capacity assessment, (ii) clinical research compliance, (iii) laboratory compliance (GCLP/cGMP/GLP); (iv) training, and (v) other related clinical research support services.

C. Information Technology (IT) Personnel with responsibility for establishing and/or managing multiple IT systems including on-line training portal and help desk support and for interfacing, when necessary, with systems employed by DAIDS, DAIDS clinical research support contractors and grantees, and DAIDS research programs/networks/sites.

SECTION 5: FACILITIES, EQUIPMENT, AND OTHER RESOURCES

The Technical Proposal should document the availability, accessibility and adequacy of facilities, equipment, space and other resources necessary to carry out the Performance Work Statement, including:

A. Location and features of office space and facilities, including a floor plan and a list of equipment and resources dedicated to the project for the offeror and any proposed subcontractors. Please note whether facilities and office space are leased or owned.

B. Proposed plans and procedures to accommodate the need for DAIDS to have easy and

Additional Technical Proposal Instructions 10 rapid access to staff and documents housed at the offeror’s main facility or satellite office. Plans to ensure that such access can be accomplished successfully in a cost-effective and timely manner are essential and must be addressed in the Technical Proposal.

C. State-of-the-art field equipment, including laptops and wireless handheld devices for use at various activities conducted at both domestic and international clinical research sites and during meetings, teleconferences and videoconferences.

D. Information technology systems and equipment for contract-specific databases for interfacing with multiple DAIDS databases as well as databases of DAIDS-supported contractors and grantees.

SECTION 6: OPTIONS (PWS Section 3.H)

Options should be presented as a separate part of the Technical Proposal and clearly identified as such.

1) OPTIONS 1 - 6: Extend the Term of the Contract Discuss plans and procedures for continuing and providing the same services indicated in the Performance Work Statement beyond the contract base period. To address this option, offerors should describe the methods and procedures to maintain the operations specified in the Performance Work Statement beyond the base period, including retaining or recruiting necessary staff, and maintaining and/or acquiring required equipment and facility space.

2) OPTIONS 7 - 34: Increased Level of Effort

Discuss approaches for increasing the level of effort by one FTE up to two times per contract year and two FTEs twice a year in order to respond to the need for unanticipated additional capacity related to the activities in accordance with the Performance Work Statement. Each increase should be a separate option.

SECTION 7: OTHER CONSIDERATIONS

This section of the Technical Proposal should document other resources not covered in Sections 1 through 6 above but are necessary to carry out the Performance Work Statement.

[END OF ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS]

Attachment 5_Revised_06032016 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.

UBUSINESS PROPOSAL – TABLE OF CONTENTS

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

USECTION 2U – 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.

USECTION 3U – 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.1)

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.2)

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 America13T (Rio de Janerio, Brazil)13T, 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.3)

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-fivetwenty (2520) laboratory audits of domestic clinical research sites within the NIAID/DAIDS HIV/AIDS Clinical Trials Networks; one hundred fifteen twenty (115120) 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 (Boston, MA, Seattle, WA and New York, NY), 1 international (ParisLyon, 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 (Boston, MA, Seattle, WA and

New York, NY), 1 international (Paris, FranceJohannesburg, 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) UContract Initiation MeetingU: 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) UContract overview meeting to DAIDSU: 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) UClinical Site Assessment VisitsU: 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) UGCP AuditsU: Assume one domestic and two three-day site visits per year to DAIDS clinical trial sites. Two (2) trips to Africa/South Africa (Kampala, Uganda, Additional Business Proposal Instructions 4

Johannesburg, SA) and one (1) trip to South America13T (Rio de Janerio, Brazil)13T, three four (34) days on site for each visit.

5) UClinical Research Laboratory Audits and ReportsU: 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 Chonbur, Thailand

Orlando, Florida Dar es Salaam, Tanzania Chonburi, Thailand

New York, New York Johannesburg, South Africa

Nashville, Tennessee Umlazi, South Africa

Los Angeles, California PWSeto, South Africa

A. UcGMP Audits:U 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. UGLP AuditsU: 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…