Amendment(3) HHSNIHNIMH-2010-024(122310).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)

03 12/23/2010 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 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.: 03 12/23/10

SPECIAL PROVISIONS

NIH RESPONSE TO QUESTIONS

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

1. Is attachment 7 meant to be sent to the Contracting Officers on our current NIH contracts or only completed contracts? Should the sites send as well?

RESPONSE: Attachment 7 – “NIMH Task Order Forms” is a sample of the form that will be issued to the Awardee(s) when the Government is issuing a task order under an awarded IDIQ contract. This form does not need to be completed submitted by an offeror or their subcontractors as part of the Offeror’s proposal.

2. May a site that is capable of running both drug and non-drug trials only propose a single trial at the time of submission and state the capability for the other type in the technical proposal?

Or are two trials with their budgets required to be submitted in order to obtain a contract for both types?

RESPONSE: For the successful awardee(s), only one IDIQ contract will be awarded. Task orders will be awarded under that contract for any trials (interventions) that the Government orders. A cost budget is only required for the first intervention proposed not for any subsequent interventions discussed within the technical proposal. Yes, a site capable of running both may propose a single trial and discuss the capability of the other type in the technical proposal. Refer to the Revised Section M, 4. Technical Evaluation Criteria document dated December 16, 2010 posted as part of Amendment 1. Item 1.c. which states:

Scientific value of proposed additional interventions to be tested (i.e., the second and subsequent interventions). The Offeror should discuss additional novel interventions to be tested (beyond the recommended first intervention trial) with a rationale for each and a ranking order based upon scientific merit. The Offeror should also provide a plan for identifying other promising interventions for testing in the network, and describe any relevant previous experience collaborating with pharmaceutical companies using 3rd party compounds. The Government considers an Offeror with access to, and the capability to conduct, both drug and non-drug interventions as scientifically desirable because a wider range of possible interventions might be tested. However, the quality of the identified interventions is paramount above the diversity of interventions.

Also refer to the Revised Attachment 3, Statement of Work, dated December 16, 2010 (page 25):

Note 6 to Offerors (Identifying Future Interventions): To ensure there is a sufficient volume of trials to be conducted, the contractor should propose a methodology to be utilized by the intervention selection committee to identify promising candidates for future interventions for testing through the Network. Offerors should also discuss all experience collaborating and working with drug companies using 3rd party compounds.

RESPONSE: RFP No.: HHS-NIH-NIMH- 10-024 Amendment No.: 02

3. Given the importance of cost realism to preparation of contract budgets I am unsure how to address the items listed on page 28 of Revised Attachment # 3, Statement of Work (dated December 16, 2010). Is it expected that this budget would be a guestimate? Is it expected to be on the detailed budget sheets or in some other format?

RESPONSE:

As indicated on page 26 of Revised Attachment 3 (SOW), use the standard Excel spreadsheet as a format for each separate budget at:

(http://oamp.od.nih.gov/contracts/BUSCOST.HTM).

The Intervention #1 Budget described on page 26 will be based upon actual estimated costs for preparation effort and conducting the Offeror’s proposed first trial (intervention). As each Offeror’s intervention proposed will differ,, for the purpose of comparing cost proposals only NIMH is using Ketamine and sleep deprivation treatments in the Sample Tasks as examples of drug treatment and non-drug treatment trials. The instructions for completion of the sample task budgets described on pages 27 and 28 detail how to prepare each of the sample budgets. The sample task budgets are to be based upon the Prime and subcontractor sites actual costs as if their network were to perform Ketamine and sleep deprivation treatments as per the details and guidelines given on pages 27 – 30.

4. I am still having trouble understanding the budget structure of the proposal. Is the overall budget meant to be inclusive of all 8 trials? Or is the overall budget meant to only include the sample task/s?

RESPONSE: For cost comparison purposes only, assume the total contract budget will be based upon the details provided on page 28 of the Revised Attachment 3, Statement of Work.

Prepare each budget separately. Each proposal should include a minimum of six (6) separate cost budgets and one total (overall) contract budget with each on a separate Excel spreadsheet (link provided above) as described on pages 26 to 30.

5. Item 5 on page 1 of Revised Attachment 4 Additional Proposal Instructions, states that there should be 6-9 budgets depending on whether one or two tasks is chosen. Shouldn’t it be 5-9?

(overall and four stages of one task vs. overall and four stages of two tasks?) Or should it be 6-10 (overall and four stages of one task plus 8 task estimates vs. overall and four stages of two tasks plus 8 task estimates?)

RESPONSE: A minimum of six (6) individual cost budgets should be submitted with the proposal. The following separate cost budgets should be provided on individual Excel Spreadsheets (link provided above):

(1) Intervention #1 Budget (page 26 of SOW) to include preparation and conducting the trial

(actual first proposed intervention).

(2) Sample task 1 for preparation of proof of concept (POC) drug trial using Ketamine (if proposing initial drug intervention or if capable/plan to propose drug intervention later during contract performance)

RESPONSE: RFP No.: HHS-NIH-NIMH- 10-024 Amendment No.: 02

(3) Sample task 2 for preparation of POC non-drug trial using sleep deprivation treatment (if proposing non-drug initial intervention or if capable/plan to propose non-drug intervention later during contract performance)

(4) Sample task 3 for conducting POC drug trial using Ketamine(if proposing initial drug intervention or if capable/plan to propose drug intervention later during contract performance)

(5) Sample task 4 for conducting POC non-drug trial using sleep deprivation treatment (if proposing non-drug intervention or if capable/plan to propose non-drug intervention later during contract performance)

(6) Sample task 5 for conducting a larger-scale drug trial using Ketamine (if proposing initial drug intervention or if capable/plan to propose drug intervention later during contract performance)

(7) Sample task 6 for conducting a larger-scale non-drug trial using sleep deprivation (if proposing non-drug initial intervention or if capable/plan to propose non-drug intervention later during contract performance)

(8) Total contract budget/cost estimate

(9) Collection of Biomaterials

6. On what portion or portions of the budget should the small business plan be based?

RESPONSE: As indicated in Amendment #2, submission of the Prime’s small business subcontracting plan is not required with the Prime’s original proposal. When completing the small business plan, it must be based on the total estimated contract cost.

7. We want to propose an alternative method to NIMH’s request for collection biospecimen samples for shipment to the Rutgers biospecimen repository. Is it permissible to propose an alternate method? If so how should we respond?

RESPONSE: NIMH will not be providing any feedback or guidance as to any perspective offerors technical plans. Offerors are solely responsible for determining the scientific and methodological details of any proposed intervention(s). NOTE: If an Offeror’s proposal includes an alternative technical proposal for the collection of biospecimines, then the proposal must also include a separate cost budget proposal. Additionally, the proposal must include a separate cost budget proposal for the collection of biospecimines as outlined within the Revised Attachment 3, Statement of Work (pages 28 – 29).