REV ATTACH4 NIH-NIMH-10-024ADDITL PROP INSTR(FINAL2)121610.pdf

REVISED Attachment 4 – Additional Proposal Instructions RFP#: NIH-NIMH-10-024 (Amendment 01) December 16, 2010

Title: “New, Rapidly-Acting Treatments for Treatment-Resistant Depression (RAPID)”

ADDITIONAL PROPOSAL INSTRUCTIONS

A. ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS

1. Carefully read and follow the Business Proposal instructions in Section L of the

RFP

2. It is important to provide a written narrative with your business proposal, explaining how each cost element/type was estimated (e.g. what is the estimated cost based upon, what assumptions were used, and why?)

3. Carefully read the Notes to Offerors that relate to costs, included with the

Statement of Work.

4. A number of separate cost estimates are required with your proposal - see Notes to Offerors in the Statement of Work. Provide each cost estimate using the Excel template/Electronic Business Proposal link within the document (see ATTACHMENT 14 in the RFP), and send electronically when the proposal is sent (or provide copies of CDs with the proposal)

5. THERE ARE 6-9 SEPARATE BUDGETS REQUIRED, DEPENDING UPON

WHETHER YOU ARE PROPOSING TO CONDUCT BOTH DRUG AND

NON-DRUG TRIALS, OR EITHER DRUG OR NON-DRUG TRIALS. SEE

DETAILED IMPORTANT INSTRUCTIONS AT END OF THE

STATEMENT OF WORK, ATTACHMENT 3.

6. Proposed subcontract budgets should also be submitted, in as much detail as possible

7. Send to your clients the Past Performance Questionnaire (Attachment 6 to the RFP); this will allow a thorough review of past performance on similar projects prior to evaluating the technical proposal

B. ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS

1. The NIMH is not interested in receiving unnecessarily wordy or elaborate proposals. While there is no page limitation for technical proposals, proposals that are unnecessarily lengthy are not solicited and are inherently more difficult for reviewers to read and evaluate during the peer review process. NIMH believes that a well- organized, concise, focused proposal, with proper documentation and labeled attachments, is best.

2. Carefully read and follow the Technical Proposal instructions in Section L of the RFP

3. Offerors are advised to give careful consideration to the Statement of Work (SOW) and attachments, the Technical Evaluation Criteria in Section M, and the RFP as a whole in the development of their Technical Proposals.

4. It is strongly suggested that offerors organize the technical discussion/approach of your proposal to follow the Section M, Technical Evaluation Criteria from the RFP (below) – this will allow for a more efficient peer review of all proposals.

5. PROPOSALS MAY INCLUDE EITHER PHARMACOLOGICAL OR NON-

PHARMACOLOGICAL INTERVENTIONS, OR BOTH. IF ANY INTERVENTION IS

SUCCESSFUL AND NIMH DETERMINES THAT A LARGER CLINICAL TRIAL IS

INDICATED, THE PRIME WITH ITS NETWORK MUST BE CAPABLE OF CONDUCTING

A LARGE-SCALE CLINICAL TRIAL. THE CAPABILITY OF THE PROPOSED NETWORK

TO CONDUCT A LARGE CLINICAL TRIAL SHOULD BE ADDRESSED IN THE

TECHNICAL PROPOSAL.

AN ABBREVIATED VERSION OF THE TECHNICAL EVALUATION CRITERIA IS REPEATED

BELOW (SEE SECTION M FOR MORE DETAIL).

IN THE TECHNICAL PROPOSAL, INCLUDE A DETAILED DISCUSSION FOR EACH PART BELOW

AND ATTACH ANY DOCUMENTATION OR MATERIALS TO SUPPORT YOUR

EXPERIENCE/QUALIFICATIONS.

1. TECHNICAL APPROACH (40 Points)

The evaluation will assess:

a. Scientific value of the proposed study protocol for the first recommended intervention to be tested.

b. Procedures and experience obtaining necessary FDA approvals and access to study interventions.

c. Scientific value of proposed additional interventions to be tested (i.e., the second and subsequent interventions).

d. Proposed milestone schedules and timelines for timely completion of study trials.

e. Plan for management and analysis of study data.

f. Potential difficulties. Based upon the Offeror's experience, discuss any potential difficulties which may arise in performance of this contract and how they will be mitigated.

2. PERSONNEL AND MANAGEMENT PLAN (35 Points)

a. Quality and experience of the Contract Principal Investigator (Contract-PI).

b. Quality and experience of the proposed Site Principal Investigator(s) (Site-PIs).

c. Quality and experience of the other key personnel.

d. Quality and experience of the Data Management Center Principal Investigator (DMC-PI) and other personnel, if applicable.

e. Management plan for conducting multiple, concurrent trials.

3. QUALITY OF SUB-SITES (25 Points)

a. Adequacy and availability of the facilities and resources.

b. (AS APPLICABLE) SITES WITH EXPERIENCE IN DIFFERENT TREATMENT MODALITIES

WHICH EXPAND YOUR OWN CAPABILITIES (I.E., THE OFFEROR’S CAPABILITIES)

c. Availability of computer hardware, software and other equipment.

Title: “New, Rapidly-Acting Treatments for Treatment-Resistant Depression (RAPID)”