Amendment(2) HHSNIHNIMH-2010-024_122210.pdf

OMB Approval 2700-0042

1. CONTRACT ID CODE PAGE OF PAGES

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT N/A 1 4

2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

02 12/22/2010 N/A N/A

6. ISSUED BY CODE 7. ADMINISTERED BY (If other than Item 6)

CODE N/A

National Institutes of Health Office of Acquisitions – NIDA Neuroscience COAC NIMH R&D Contract Management Section 6001 Executive Boulevard, room 8154, MSC 9661 Bethesda, MD 20892-9661

8. NAME AND ADDRESS OF CONTRACTOR (No. Street, County, State and ZIP: Code) () 9A. AMENDMENT OF SOLICITATION NO.

TO ALL OFFERORS

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

X HHS-NIH-NIMH-10-024

9B. DATED (SEE ITEM 11)

11/29/2010

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing Items 8 and 15, and returning one (1) copy of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATA SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and data specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

() A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET

FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return _ copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

THE PURPOSE OF THIS AMENDMENT IS:

1) To extend the due date of proposals to Tuesday, January 18, 2011 at 4:30p.m. Eastern (local) time

2) To respond to offeror’s questions (see pages 2 - 4)

NOTE: OFFERORS SHOULD ACKNOWLEDGE RECEIPT OF ALL AMENDMENTS WITH THEIR PROPOSAL.

Continued on p. 2 Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

Bruce E. Anderson, Contracting Officer

15B. CONTRACTOR/OFFEROR 15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 16C. DATE SIGNED

(Signature of person authorized to sign)

BY _____________________________________________

(Signature of Contracting Officer)

NSN 7540-01-152-8070 30-105 STANDARD FORM 30 (REV. 10-83)

PREVIOUS EDITION UNUSABLE Computer Generated Prescribed by GSA

FAR (48 CFR) 53.243

RFP No.: HHS-NIH-NIMH-10-024 Amendment No.: 02 12/22/10

SPECIAL PROVISIONS

NIH RESPONSE TO QUESTIONS

New, Rapidly-Acting Treatments for Treatment-Resistant Depression (RAPID)

1. Can we send thumb drives instead of CDs??

RESPONSE: Yes.

2. Article B2 states:

A guaranteed minimum contract quantity/value and a maximum contract quantity/value for this initiative will be established during negotiations. The minimum quantity is the cost to set up trial number 1 and the maximum quantity is eight (8) Proof of Concept trials.

Based on this statement above, we are assuming task areas 3 and 4 will be part of the technical proposal but will not be included in the specs for the budget. Can you confirm this is correct??

RESPONSE: This is not correct. Budgets for both tasks 3 and 4 are required. Please read pages 26 through 30 of the Revised Attachment 3, Statement of Work dated December 16, 2010 which was provided in Amendment 1 to the RFP.

3. We'd like to confirm that only one 2043 form is needed for the total contract cost estimate (cost estimate

#2). Can you confirm this is correct?

RESPONSE: This is correct. This form is a “cover” page for the business proposal and one (1) NIH-2043 form is required per proposal. For the cost blanks on this form, use the estimated cost to conduct the 8 proof of concept trials.

4. We'd like clarification surrounding the budget and contract timelines. In the Revised Attachment 3 (Statement of Work) dated December 16, 2010, page 28, Item 4, it mentions that the estimated contract period is June 2011-May 2016. In the table, however, it shows an end budget date of Sept 30, 2017, which is greater than 5 years. Can you clarify the contract period for this proposal?

RESPONSE: The estimated contract period for this proposal was stated as maximum of five years and estimated to be June 2011 – May 2016. However, a task order could be accepted by a Contractor which requires performance beyond the 5-year period. Use the previous schedule provided in the Revised Statement of Work dated December 16, 2010 (Attachment 3 of the RFP), as copied below.

TOTAL BUDGET SCHEDULE

Proof of Concept trials

Begin preparations Complete Months

Trial #1 6/1/11 9/30/14 40 Trial #2 10/1/11 9/30/14 36 Trial #3 4/1/12 3/31/15 36 Trial #4 10/1/12 9/30/15 36 Trial #5 4/1/13 3/31/16 36 Trial #6 10/1/13 9/30/16 36 Trial #7 4/1/14 3/31/17 36 Trial #8 10/1/14 9/30/17 36

5. Can you give us the probability of the deadline being extended? The reason for this question is due to a concern of gathering all site budgets with complete business proposals during the holiday timeline?

RESPONSE: The due date for proposals has been extended to Tuesday, January 18, 2011 at 4:30p.m. Eastern (local) time. Note: You are strongly encouraged to provide as much detail as possible, from each site participating in Intervention #1, from the site’s business office, for the initial cost proposal. It is very important to provide items a. – e. as listed below from each proposed subcontractor in the Network, to allow the Government to properly evaluate your initial proposal. Most important is that the qualifications of each potential site are discussed in the Technical proposal.

a. Willingness to perform as a subcontractor for specific duties (list duties).

b. What priority the work will be given and how it will relate to other work.

c. The amount of time and facilities available to this project.

d. Information on their cognizant field audit offices.

e. How rights to publications and patents are to be handled.

f. A complete cost proposal in the same format as the offeror's cost proposal”

Regarding Item f., a complete cost proposal from the proposed sites is only required for the sites involved in the trial for intervention #1. (See the Revised Attachment 3, Statement of Work “Notes to Offerors” and the Revised Additional Proposal Instructions (Attachment 4) both dated December 16, 2010.

6. There is a section in the RFP that states: "It is anticipated that one or more cost-reimbursement contract awards will be made for a period of five years beginning on or about June 30, 2011.”

However, the chart on page 29 of 30 of the Revised Statement of Work (Attachment 3) dated December 16, 2010 (copied below) is stated with regards to budgeting periods asking us to create budgets that start on 6/1/11. Should we use the 6/1/11 date or the 7/1 date as a starting point?

TOTAL BUDGET SCHEDULE

Proof of Concept trials

Begin preparations Complete Months

Trial #1 6/1/11 9/30/14 40 Trial #2 10/1/11 9/30/14 36 Trial #3 4/1/12 3/31/15 36 Trial #4 10/1/12 9/30/15 36 Trial #5 4/1/13 3/31/16 36 Trial #6 10/1/13 9/30/16 36 Trial #7 4/1/14 3/31/17 36 Trial #8 10/1/14 9/30/17 36

RESPONSE: Use the 6/01/2011 date as a start date for the budgets.

7. Could you please advise if our university would be allowed to submit two separate proposals for this procurement, or can our university only submit one proposal? For example....can one professor in our department submit for RAPID from our university....and another professor submit for RAPID from our university?

RESPONSE: There is nothing within the Request For Proposals that disallows more than one proposal per firm (organization), however this is unusual. We would assume the proposals would be sufficiently technically different and that there are sufficient resources to perform both contracts, should both be awarded.

8. Are the subcontracted sites required to submit a small business subcontracting plan as part of their submission to the prime contractor?

RESPONSE: Submission of small business subcontracting plans from the Prime’s proposed subcontractors are not required with the Prime’s original proposal. Any subcontracts over $550,000 will be required to have plans approved by the Prime as a condition of the award. The requirement for subcontracting plans flows down from the Prime’s terms and conditions, and it is the responsibility of the Prime Contractor to include the appropriate flow down clauses within subcontract agreements.

9. We have clinical sites that will conduct the POC trials and additional clinical sites that will be added for the larger scale trials. We are compiling detailed budget proposals from the clinical sites conducting the POC trials. Do we also need to submit detailed budgets from the additional sites for the sample larger scale trials proposal?

RESPONSE: Detailed budget proposals are required as part of the proposal for any clinical sites that will be participating only in the first intervention (trial #1). Those sites that will be participating in future tasks (trials) will be required to submit detailed cost proposals prior to award of any task under the contract.

10. I am concerned about meeting the small business subcontracting plan guidelines. How do we respond to the small business subcontracting plan with many of our subcontractors being other than small businesses? Our plan would be to try to use small businesses for non-salary expenses as much as possible but I don't believe it will be at the percentage levels proposed in the small business subcontracting plan guidelines. Can you provide any suggestions on how to address this issue?

RESPONSE: Submission of the Prime’s small business subcontracting plan is not required with the Prime’s original proposal. Note: The small business subcontracting plan goals are suggested goals only, and each proposal will stand on its own merits. Sufficient justification should be provided to support any goals proposed.