Amendment(1) HHSNIHNIMH-2010-024(FINAL2).pdf

OMB Approval 2700-0042

1. CONTRACT ID CODE PAGE OF PAGES

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT N/A 1 5

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

01 12/16/2010 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 modify Attachment 3 (Statement of Work) (Attached in www.fbo.gov)

2) To modify Attachment 4 (Additional Proposal Instructions) (Attached in www.fbo.gov)

3) To modify Section M., Evaluation Factors for Award, Item 4.Technical Evaluation Criteria (Attached in www.fbo.gov)

4) To respond to offeror’s questions (see pages 2 - 5)

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

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.: 01 12/16/10

SPECIAL PROVISIONS

1. The Statement of Work (Attachment 3 to the RFP) is hereby modified in part to discuss the perceived value of proposing both pharmacologic and non-pharmacologic interventions and to revise and to correct in part the instructions for the individual cost proposals required. IT IS

IMPORTANT TO READ THE REVISED COST PROPOSAL INSTRUCTIONS IN THE

STATEMENT OF WORK, IN ITS ENTIRETY. The verbiage changed/added is both capitalized and shaded and are located on the following pages: 2, 3, 5, 6, 7, 8, 12, 14, 15, 22, 26, 27, 28, 29 and 30.

2. Section M, Technical Evaluation Factors for Award, Item 4. Technical Evaluation Criteria is hereby modified in part to discuss the value of proposing both pharmacologic and non-pharmacologic interventions, and proposing investigators and sites with diverse intervention experience and capabilities. The items changed/added are both capitalized and shaded.

3. Additional Proposal Instructions (Attachment 4 to the RFP) is hereby modified in part. The items changed are both capitalized and shaded.

4. NIH Reponses to questions (see below)

NIH RESPONSE TO QUESTIONS

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

1. Is it necessary to offer both pharmacologic trials and non-pharmacologic trials to be competitive?

RESPONSE: Offerors may propose either pharmacological intervention or non-pharmacological interventions, or both. The primary consideration will be the perceived efficacy of the trials proposed, but the capability to do both pharmacological and non- pharmacological trials is considered desirable.

We have amended the Statement of Work (Attachment 3) and the Technical Evaluation Factors in Section M – Evaluation Factors for Award, to clarify this factor. The amended documents can be found on www.fbo.gov for RFP: HHS-NIH-NIMH-10-024.

2. Are there any guidelines as to the NIMH budget?

RESPONSE: NIH will not be providing information about the estimated budget for RAPID - this is not public information. For the general scope of this initiative your attention is directed to the minimum and maximum estimated number of trials in the RFP, Article B.2 Prices/Costs, and to Attachment 3, Statement of Work, various sections, including Section E.2. Estimated Workload Schedule. Please note that this is an indefinite quantity contract, and it is unknown what trials will be required, how many trials, or even the size of trials (e.g., it is possible that a larger scale trial will be conducted instead of doing several proof of concept trials, etc.).

3. Can more than one network be proposed and supported, with collaborations between/among

Networks?

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RESPONSE: Each proposal must include only one (1) proposed network of sites capable of recruiting an adequate subject population. The network size could be “adjusted” during the contract to increase or decrease the total number of sites to accommodate different types of trials, concurrent trials, or potentially a larger trial. While the Government may make multiple awards which could expand the range of possible interventions, this would not increase the overall maximum scope of the initiative (i.e. up to 8 proof of concept trials). Any collaboration between possible multiple awardees is not anticipated.

4. The RFP instructions state that there could be up to 5 performance sites – is this a firm guideline or might more than 5 sites be permissible?

RESPONSE: The offeror should propose an initial network size that is determined to be optimal, realistic and feasible to manage, considering the estimated maximum number of trials. An excessive number of sites would potentially increase the overall operating costs and eventually exceed the scope of this initiative. The emphasis in this initiative is to focus on a select number of quality interventions to study.

5. Is the request for 5 or 6 sites? For example, should we list the PRIME Clinical Coordinating Center as a site + 4 or 5 other sites?

RESPONSE: The offeror should propose the number of sites that that they determine is optimal, realistic and feasible given the scope of this initiative. There is no specific number of sites required. See responses to previous similar question above.

6. Does the site business plan require a study qualification visit as one would do for a FDA registration trial or is this requirement closer to a feasibility survey?

RESPONSE: Neither a study qualification visit (for a FDA registration trial) nor a feasibility survey is applicable to this requirement.

7. We need clarification with regard to what is required for subcontractors/sites with the Business proposal. The RFP requires all the items below for each proposed subcontractor. Is this correct?

“If subcontractors are proposed, please include a commitment letter from the subcontractor detailing:

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”

RESPONSE: It is very important to provide items a. – e. as listed above 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.

Regarding item f., A COMPLETE COST PROPOSAL FROM THE PROPOSED SITES IS ONLY

REQUIRED FOR SITES INVOLVED IN THE TRIAL FOR INTERVENTION #1 (SEE THE

STATEMENT OF WORK “NOTES TO OFFERORS” AND THE ADDITIONAL PROPOSAL

INSTRUCTIONS).

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.

8. Do we need detailed site budgets, since they will be subcontractors, or is the request for subcontractor budgets information intended for a CC that intends to subcontract to a data center?

RESPONSE: All Network subcontract sites involved in the trial for intervention #1 should provide cost proposals in as much detail as possible. The Prime offeror must provide detailed budgets as outlined in the Statement of Work and Additional Proposal Instructions. See response to above similar question.

9. With respect to the items listed for subcontractors above (items a – f), we are specifically concerned that item f be clarified with respect to whether the cost proposal needs to go through the site business office or whether we can simply provide a summary budget.

RESPONSE: For intervention #1, an initial complete cost proposal in the same format as the offeror's cost proposal, should be provided from each site’s business office with as much detail as possible.

10. In the power calculation, the RFP specified a difference between groups of .8 as a proportion. Is it correct to assume that this is an effect size, not a difference in proportions?

RESPONSE: That is correct, .8 is an effect size, not a difference in proportions.

11. Is there a current incumbent for this contract?

RESPONSE: This is a new requirement. There is no incumbent.

12. Will there be a conference call where offerors can receive information and ask questions?

RESPONSE: No conference call has been scheduled. Any questions should continue to be submitted in writing to Marla Jacobson at jacobsonmj@mail.nih.gov.

13. Is it correct to assume that the lead intervention can be at any of the following stages, depending on the nature of the lead intervention?

a. IIa (first in disease state)

b. IIb (POC before Phase III); or

c. In between IIa and IIb

RESPONSE: This is correct.

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14. The provided ES approach assumes a parallel group trial but if we believe that other trial designs are more appropriate, should we propose them?. We don't want to be penalized on budget, but also want to do the best and most innovative trial. Can you provide any guidance about the design-cost tradeoff issues?

RESPONSE: We cannot advise an offeror regarding a particular technical approach or study design - it is the responsibility of the Offeror to determine the optimal study design. The technical approach will be evaluated by Reviewers in accordance with Section M of the RFP and they will rank the technical proposals without regard to proposed costs. However, costs are a factor in negotiations and eventual source selections. However, per Section M, technical approach is paramount. Final award(s) will be based upon a best value determination considering technical merit, cost, and other factors.

15. Will there be a website that will provide potential offerors with information about the RAPID RFP?

RESPONSE: No website is planned at this time; please continue to ask any questions and all Amendments to this RFP will be posted at www.fbo.gov.

16. Are detailed budgets needed for additional sites/subcontractors for the sample task for larger scale trials?

RESPONSE: Yes, you are strongly encouraged to provide as much detail as possible, from each site that would be participating in a larger-scale clinical trial, from the site’s business office, for the initial cost proposal. See response to Question #7 above for further details.

17. Are the percentages for small business subcontracting in the RFP required for the proposed small business subcontracting plan?

RESPONSE: The percentages are provided as target goals. Within the subcontracting plan, if the target goals are not proposed, the Offeror must provide sufficient detail justifying why the target goals are not feasible for this contract. The Offeror should focus on purchases from small businesses for the non-labor “other than direct costs” expenditures proposed.

18. Do you have a Word or fillable Adobe form for Section J attachment 6, Past Performance Survey that we have to send out to our collaborators and references?

RESPONSE: Yes, a Word form is available for the Past Performance Survey. Email:

jacobsonmj@mail.nih.gov to request the Word version.

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