BAA-NIAID-DMID-NIHAI22010101 - Amendment 3.pdf

BAA-NIAID-DMID-NIHAI2010101 Page 1 of 1

Amendment #3 (11/05/2010)

BAA-NIAID-DMID-NIHAI2010101

Amendment #3

“Targeted Clinical Research to Address Select Viral Infections”

Amendment Issue Date: November 5, 2010

Proposal Due Date/Time:

January 21, 2011, at 3:00 P.M., local time

[Changed]

Issued By: Richard Hartmann

Contracting Officer

OA/DEA/NIAID/NIH/DHHS

6700-B Rockledge Drive, Room 3214, Bethesda, Maryland 20892-7612

Points of Contact: PRIMARY:

outenj@niaid.nih.gov

John Outen, Contract Specialist

Phone: 301-451-7461

SECONDARY:

kennedyg@niaid.nih.gov

George Kennedy, Contracting Officer’s Representative

Phone: 301-451-2607

Offerors must acknowledge receipt of this Amendment on each copy of the proposal submitted.

Failure to receive your acknowledgment of this Amendment may result in the rejection of your proposal. PLEASE NOTE 2 ATTACHMENTS HAVE BEEN ADDED TO THIS

SOLICITATION.

Solicitation BAA-NIAID-DMID-NIHAI2010101 page 36 shall add the following:

ATTACHMENT 23 “ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS”

ATTACHMENT 24 “UNIFORM COST ASSUMPTIONS”

The hour and date specified for receipt of proposals HAS been extended.

mailto:outenj@niaid.nih.gov mailto:kennedyg@niaid.nih.gov

ATTACHMENT 23: ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS

TARGETED CLINICAL RESEARCH TO ADDRESS SELECT VIRAL INFECTIONS

BAA NUMBER NIAID-DMID-NIHAI2010101

It is strongly recommended that offerors use the following template as the format 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 BAA 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 BAA solicitations, these Additional Technical Proposal Instructions are tailored to the specific requirements of this BAA. The information requested in these instructions should be used along with Section L of the BAA 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 BAA, and include the information requested here.

Offerors are advised to give careful consideration to the Broad Agency Announcement

Description, Background and Introduction, Research and Technical Objectives, all reference materials and attachments, the Technical Evaluation Criteria in Section M, and the BAA as a whole in the development of their Technical Proposals.

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

Offerors must refer to the BAA 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.

FORMAT FOR TECHNICAL PROPOSAL

1. PROPOSAL TITLE PAGE. Include BAA title and number, name of organization, DUNS number, proposal part, and identify if the proposal is an original or a copy.

2. GOVERNMENT NOTICE FOR HANDLING PROPOSALS (See Attachment 1 of NIAID-

DMID-NIHAI2010101)

3. TABLE OF CONTENTS (Each offeror’s Technical Proposal shall include a Table of

Contents.)

4. TECHNICAL DISCUSSIONS

IN ADDITION TO THE GUIDANCE IN SECTION L OF THE BAA, THIS SECTION OF YOUR

TECHNICAL PROPOSAL SHOULD INCLUDE DOCUMENTATION TO DEMONSTRATE HOW

YOU WILL ACCOMPLISH THE WORK DETAILED IN YOUR STATEMENT OF WORK. IT IS

RECOMMENDED THAT YOUR PROPOSAL BE ORGANIZED IN ACCORDANCE WITH THE

ORDER OF YOUR STATEMENT OF WORK AND THE TECHNICAL EVALUATION CRITERIA

PROVIDED IN SECTION M.

THE SCIENTIFIC AND TECHNICAL DISCUSSION AND THE PROPOSED

STATEMENT OF WORK MUST BE PRESENTED AS A STAGED APPROACH WITH

DEFINED GOALS FOR THE DEVELOPMENT, IMPLEMENTATION, EXECUTION, AND

COMPLETION OF THE PROPOSED CLINICAL TRIAL. PROVIDE MILESTONES

WITH CLEARLY IDENTIFIED CRITERIA, INCLUDING TIMELINES TO MARK THE

COMPLETION AND SEPARATION OF MAJOR TASKS. AT A MINIMUM,

MILESTONES SHOULD INCLUDE AT LEAST THREE (3) DIFFERENT STAGES

REQUIRED TO COMPLETE A CLINICAL TRIAL, E.G., 1) START-UP AND PROTOCOL

DEVELOPMENT, 2) STUDY IMPLEMENTATION, AND 3) CLOSE-OUT, FINAL

ANALYSIS AND POSTING OF RESULTS, AS REQUIRED BY LAW.

A. SCIENTIFIC AND TECHNICAL MERIT

1. Protocol Development

a. Protocol Synopsis: Provide a detailed synopsis for the proposed Phase I, II, or IV clinical trial or study. The protocol synopsis should be limited to a maximum of 10 pages (included in the total page limits) and should include the following:

1) Rationale and Background (explain innovative aspects of the approach);

2) Study Objectives;

3) Primary hypothesis;

4) Study population(s) (describe inclusion/exclusion criteria and rationale for study population choices, addressing age, gender and demographic preferences);

5) Study arms and duration;

6) Description of study products, if applicable;

7) Primary and secondary endpoints;

8) Duration of follow-up of study subjects and contingency plans for any safety-related issues as needed; and

9) Sample size calculation and statistical method employed, rationale for the sample size calculation, and relevance to the power of outcome measurement.

10) Justification for selection of site location for proposed clinical trial conduct.

b. Protocol Timelines: Provide proposed timelines for all stages required to develop and complete a clinical trial, as noted above, encompassing protocol development, enrollment, protocol implementation, clinical trial completion and analysis of final study data.

2. Protocol Implementation

a. Recruitment and Retention of Study Participants: Provide a plan for the screening, recruitment, enrollment and retention of the number and types of subjects required to serve as subjects for the proposed clinical trial. Identify anticipated problems and difficulties that may arise in recruiting and retaining these subjects and discuss proposed approaches to overcome or minimize such problems and difficulties.

b. Access to Study Populations: Provide evidence of the disease to be studied at each proposed clinical site with documentation regarding numbers of patients visiting or admitted at each clinical site.

c. Selection of Proposed Clinical Sites: Provide a rationale for the selection of clinical sites proposed and describe approaches to be used and remedial actions to be taken when clinical sites fail to meet projected target accrual within the protocol timelines proposed.

d. Communication Plan: Provide a plan for communication with proposed clinical sites during protocol implementation and other critical times.

3. Clinical Trial Support Services

a. Statistical Support and Data Management:

1) Discuss proposed plans and procedures to be developed and implemented to ensure appropriate objectivity and independence in carrying out statistical support and data management services.

2) Describe plans and procedures to establish, maintain and update the data collection system and to provide for the quality control of all clinical and laboratory data in compliance with all current Federal regulations (21 CFR

11 and/or similar standards).

3) Describe how the data shall be presented to DMID/NIAID and what provisions shall be made available for DMID to query the data.

4) Describe plans and procedures to provide security against anticipated risks, including loss of confidentiality of subject electronic records and data summaries.

b. Clinical Site Monitoring:

For non-interventional studies provide a general description of plans and procedures necessary to monitor clinical sites for data accuracy and protection of human subjects.

NOTE: For interventional studies, DMID will establish plans and procedures appropriate to the proposed clinical study to monitor all participating clinical sites to verify that the rights and well-being of the subjects are protected, trial data are accurate, complete and verifiable, and the conduct of the trial is in compliance with Good

Clinical Practice (GCP), International Conference on Harmonization

(ICH) guidelines, the approved protocol, and all applicable regulatory requirements. For these studies, Clinical site and study monitoring visits during the conduct of interventional clinical trials will be conducted by DMID staff and/or DMID-designated entities. The contractor shall be required to provide to the DMID and/or DMID designated entities all essential documents related to the protocol that are required for oversight and verification.

c. Safety Oversight:

For non-interventional studies, describe safety monitoring activities that will be undertaken relevant to the type of study proposed. Technical

Requirements for the final Data and Safety Monitoring Plan are indicated in

Section L.

NOTE: For all interventional clinical trials, DMID will establish an independent Safety Oversight Structure, e.g., Data and Safety

Monitoring Board (DSMB), to review study data and monitor the safety of study participants, as indicated in the Post-Award

Requirements section contained in the Attachment entitled “Research and Technical Objectives.”

d. Other

1) Clinical Specimens

i. Identify laboratories and assays for endpoint assessments as necessary.

ii. Describe plans for the receipt, shipping, storage, handling, and testing of clinical specimens obtained as part of the study.

2) Acquisition of Study Product

i. Provide a letter of collaboration from a manufacturer documenting intent to supply any necessary study products (active and placebo).

NOTE: Offerors are expected to secure investigational study products free of charge from a manufacturer and should provide a letter from the manufacturer at the time the proposal is submitted indicating the intent to provide study products for the proposed study.

B. SCIENTIFIC AND TECHNICAL PERSONNEL

The Technical Proposal should include all information relevant to document individual education, training, experience, qualifications and expertise, including that of the

Principal Investigator (PI) and scientific and technical personnel of the prime contractor and any proposed subcontractors and consultants, including clinical investigators, laboratory personnel, statisticians for study design/analysis, and data management personnel, necessary for the successful completion of all scientific and technical requirements of the contract in compliance with all current Federal regulations (21 CFR Part 11, 21 CFR Part 312 and/or similar regulations). Clearly identify who is to be assigned as Key Personnel. Limit CVs to 2-3 pages and provide selected references for publications relevant to the scope of the BAA, and include experience (in particular, relevant clinical experience) with projects of similar scope, size and complexity.

C. PROJECT MANAGEMENT

1. Overall Project Management

a. Describe how the project will be organized and managed. Provide a

Staffing Plan indicating role descriptions, level of effort of key scientific and technical personnel, and clear lines of authority and responsibility for the personnel, including all proposed subcontractors. Include a diagram of the proposed organizational/management structure for the project.

b. Describe project management systems that will be used to track activities and to keep multiple activities on time and within budget. The plan should include a description of quality control methods that will be used to ensure the effective initiation, implementation, management and oversight of contract activities.

c. Discuss and outline communication, monitoring, and management of the project both internally and externally (at subcontractor facilities).

d. Discuss plans to organize a post-award contract initiation meeting.

Discuss plans to organize Annual Review Meetings to provide for a thorough assessment of contract status, progress, problems and approaches to their resolution, and future plans.

2. Acquisition and Management of Subcontractors

Describe plans to secure, execute, and manage any subcontractor services in accordance with the requirements established by Federal contracting regulations

(FAR Clause 52.244.2). Discuss proposed subcontract teaming plans, percentage of subcontract effort to the overall contract effort. Discuss how subcontractor performance will be assessed and identification of determining problems or deficiencies.

D. FACILITIES, EQUIPMENT AND OTHER RESOURCES

As appropriate to the proposed Statement of Work, the Technical Proposal must document the following:

a. ownership/lease of facilities, including availability of proposed facilities for the duration of the contract;

b. plan for obtaining, adding or deleting facilities as necessary due to progress or performance issues that arise during the course of the project;

c. clinical facilities for patient screening, enrollment, administration of study product(s), monitoring and follow-up, including inpatient facilities, where necessary, for the conduct of the proposed clinical trial;

d. laboratory facilities and equipment for performing protocol-specific tests to determine patient eligibility and monitor safety;

e. pharmacy facilities for receipt, storage, dispensing, and inventory of study product(s) (Note: Study products will be shipped to the pharmacies from

DMID’s Microbiology and Infectious Diseases Biological Resource

Repository (BRR));

f. facilities for the storage, under appropriate conditions, of clinical specimens, as required for the proposed clinical trial;

g. areas for the secure storage of patient records, including procedures for secure access for designated personnel only;

h. provision of computers at all clinical sites for the secure entry and maintenance of clinical and laboratory data; and

i. data management facility for receipt, verification, storage and retrieval of clinical and laboratory data.

ATTACHMENT 24: UNIFORM COST ASSUMPTIONS

TARGETED CLINICAL RESEARCH TO ADDRESS SELECT VIRAL INFECTIONS

BAA NUMBER NIAID-DMID-NIHAI2010101

In addition to the instructions and format requirements for the proposal that are contained in Section L of the BAA, the information presented in this attachment is intended to provide uniform cost assumptions that apply to the subject BAA.

Offerors are advised to give careful consideration to the Broad Agency Announcement

Description, Background and Introduction, Research and Technical Objectives, all reference material provided as attachments, the technical evaluation criteria, and, the BAA as a whole, in the development of your proposal. The information requested here should be used as further guidance for the development of your proposal. Offerors should consider and include the information provided below in the development of their Technical and

Business Proposal.

UNIFORM COST ASSUMPTIONS

General Instruction:

Offerors may submit proposals for more than one clinical trial; however, a separate

Business Proposal is required for each proposed clinical trial.

Provide a task-linked budget consisting of a breakdown of total direct costs linked to each stage, and each task/subtask within each stage. To the extent possible, stages should be planned and structured such that the highest level stage will have a duration of no more than two years.

The following uniform cost assumptions shall be used by all offerors in preparation of their cost proposal.

NOTE: Contractors are expected to furnish all property and equipment necessary to perform the activities outlined in their SOW.

A. Study Drugs:

Any Study Drug must be provided for the study by the Contractor (see Advanced

Understanding).

B. Statistical support and data management

Appropriate support in this area for the proposed clinical trial must be included in the proposal.

C. Laboratory Studies

D. Clinical monitoring costs

E. Meetings and Teleconferences

The Contractor shall be required to make all logistical arrangements for all contract meetings and teleconferences (except E.3. below). For cost purposes, assume that the conference room required for each meeting will need to accommodate 40 people. Assume that the Contractor shall prepare a 30-page hand-out for all 40 attendees at each meeting.

1. Contract Initiation Meeting: Assume one meeting in Bethesda, Maryland within 90 calendar days after the effective date of the contract to discuss contract initiation.

Assume that this meeting will require 1 to 1.5 days and shall be attended by the contractor’s Principal Investigator and key personnel. (Assume that subcontractor personnel will not attend this meeting.)

1. Annual Review Meetings: Assume one two-day meeting per year at the contractor’s site to discuss clinical trial status, progress and issues. The meeting shall be attended by the contractor’s Principal Investigator and key personnel, as well as any proposed subcontractor key personnel.

2. Other Contract Meetings: Assume an annual one-day meeting to be held in

Bethesda, Maryland to discuss contract specific issues.

4. Data and Safety Monitoring Board (DSMB) Meetings for interventional clinical trials:

It is anticipated that most DSMB meetings will be conducted by teleconference.

However, in the event of the necessity for a face-to-face meeting, assume one meeting every two years in Bethesda, Maryland. Assume that this will require a two-night stay and shall be attended by the contractor’s Principal Investigator and two other key personnel.

NOTE: The Contractor will NOT be required to make logistical arrangements for the DSMB meetings.

5. General Scientific Meetings: Offerors shall propose a total of $3,500 annually for the

Principal Investigator (PI) and up to three key personnel for travel to general scientific meetings for presentations of work conducted under this contract.

6. Protocol Specific Teleconferences: Assume up to one protocol specific teleconferences per month with participation of the contractor’s Principal Investigator and key personnel, as well as any proposed subcontractor key personnel. Assume that these teleconferences will have 20 participants per teleconference.

7. FDA Teleconference: Assume three teleconferences during the period of performance of the contract with the U.S. Food and Drug Administration (FDA) with participation of the contractor’s Principal Investigator and two other key personnel.

Assume that these teleconferences will have 30 participants per teleconference.

F. Alterations and Renovations

Facility alterations and renovations under this contract will not be provided.