SF30_Amend_01.pdf

OMB Approval 2700-0042

11. CONTRACT 10 COOE rAG~ OF PAGES

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

2. AMENDMENT/MODIFICATION NO. 13. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO.

PROJECT NO. (If applicable)

01 3/19/2015 N/A N/A

6. ISSUED BY CODEI 7. ADMINISTERED BY (If other than Item 6) CODEI N/A

NIMH R&D Contracts Section NIMH/NIA R&D Contracts Management Branch Office of Acquisitions, NIDA Neuroscience COAC National Institutes of Health, DHHS 6001 Executive Blvd., Rm. 8154 (MSC 9661)

8. NAME AND ADDRESS OF CONTRACTOR (No. Street, County, State and ZIP: Code) (D) 9A. AMENDMENT OF SOLICITATION NO. ,...___ x HHS-NIH-NIDA(MH)-14-005

9B. DATED (SEE ITEM 11)

TO ALL OFFERORS

2/20/2015

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE I 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 D 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.

(D) 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 D is not, D is required to sign this document and return ___ copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including sotcitationlcontract subjed matter where feasible.)

THE PURPOSE OF THIS AMENDMENT IS:

(1)To respond to offeror's questions to solicitation; and (2) modify RFP, Page 57(b), Technical Proposal Instructions.

The RFP, Page 57(b), Technical Proposal Instructions paragraph is hereby modified to read as follows: "A detailed work plan (by phase) must be submitted indicating how each aspect of the Statement of Work is to be accomplished."

NOTE: The Offer Due Date remains unchanged at April 6, 2015 by 4:00 p.m. (EST).

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 1 OA, 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)

158. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

NSN 7540-01-152-6070

PREVIOUS EDITION UNUSABLE

Rosanne Ogoh Contracting Officer, QA, NIDA Neuroscience COAC

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 16C. DATE SIGNED

BY

(Signature of Contracting Officer)

30-105 Computer Generated

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA

FAR (46 CFR) 53.243

RFP No.: HHS-NIH-NIDA(MH)- 14-005

SPECIAL PROVISIONS

Amendment No.: 01 Page 2of4

NIH RESPONSE TO QUESTIONS

1) In some places the RFP refers to algorithms (plural) and in other places algorithm (singular). Is it the intent of the RF A to solicit multiple, disorder-specific algorithms for which antipsychotic medications are prescribed or a single algorithm that cuts across disorders and focuses on antipsychotics?

A single algorithm would be preferable, but we are open to different approaches.

2) The pilot trial asks for tests of mediators and moderators but also specifies that approximately 40 participants are expected. Such a sample will not provide adequate statistical power to test mediators and moderators (even simple ones such as age and sex).

Please clarify whether 40 was meant to be suggested ( 400?) or whether we should drop pilot analysis of mediators and moderators.

The aim of the pilot is to test feasibility of patient and provider recruitement, and collection of data relevant to primary outcomes and moderator/mediator analyses. it is understood that the pilot study will not be able, due to small sample size, to test moderator/mediator hypotheses.

3) We would like to know howNIH/NIMH defines nonacademic mental health centers in the context of the project. Specifically, there are numerous outpatient community mental health clinics (CMHCs) that are self-standing entities (viz., not part of a hospital or a university) in which psychiatric residents in programs external to the CMHC may obtain training experience, and the CMHC does not itself have its own postgraduate medical education program. Do such sites count as "nonacademic" for the purpose of this project?

Yes, such sites can be considered non-academic.

4) In general, the RFP defines the population as 5-17 year-olds with "behavioral problems and mood disturbances who are not psychotic but for whom an antipsychotic medication is frequently prescribed in current community practice" (p. 98). Subsequent text notes that " ... most of the anti psychotic use in the community is for the management of non psychotic conditions, such as impulsive aggression related to ADHD or mood instability"

(p. 98), and "This population will consist of children and adolescents age 5-17 suffering from non-psychotic mood and behavioral disturbances, such as aggressive behavior, self injurious behavior, severe mood dysregulation with temper outbursts, or impulsive behavior" (pp. 99-100). There is potential heterogeneity in the underlying psychiatric disorders among young people experiencing these difficulties, and distinct strategies and algorithmic approaches may therefore be indicated. We assume, per evidence cited in the RFP and elsewhere, that the most prevalent group will be patients with the symptoms noted on p. 100 that arise in the context of ADHD with a disruptive disorder (ODD/CD) or disruptive mood dysregulation disorder (DMDD), and we perceive the RFP as clearly

RFP No.: HHS-NIH-NIDA(MH)-14-005 SPECIAL PROVISIONS Amendment No.: 01 Page 3 of4 addressing their needs. However, we are seeking clarification on whether NIMH envisions or requires the project to address the treatment of youth with "behavioral problems and mood disturbances who are not psychotic" whose primary psychiatric illness is (a) a major non-psychotic mood disorder, such as bipolar or depression spectrum disorders, or (b) an autism spectrum disorder.

It is correct that the most prevalent group and primary target of the Solicitation is that of children with disruptive disorder and/or mood dysregulation. The scope of the initiative is however broad and encourages investigators to include as large and diverse a sample as methodologically feasible.

5) Is the primary focus on prevention of new initiations of anti psychotics or does NIMH envision a two-pronged approach of preventing new prescriptions of antipsychotics AND reduction of antipsychotic use in youth who are already receiving antipsychotics? It appears that each may require different algorithms and implementation tactics.

It can be both. But it is primarily prevention of new initiations.

6) What are the page limits for this submission?

While there is no page limitations, proposals that are unnecessarily lengthy are inherently more difficult for reviewers to read and evaluate during the evaluation process. NIMH believes that a well- organized, concise, focused proposal, with proper documentation and with labeled attachments, is best.

7) Are there page limits per section?

See response to question no. 6 above.

8) Is there a budget cap for total direct costs for this award? Or total costs?

There is an Independent Government Cost Estimate (IGCE) for all procurements, however, prospective offerors must base their direct cost estimates in accordance with RFP, Page 45(d), Estimate of Effort.

9) Are there page limits for each resume?

There are no page limits/or resumes.

10) Are NIH-sty le biosketches acceptable in lieu of resumes?

Yes, resumes, CVs, and/or biosketches are acceptable.

RFP No.: HHS-NIH-NIDA(MH)- 14-005

SPECIAL PROVISIONS

Amendment No.: 01 Page 4 of4

11) We understand the FTE limits to pertain to the prime site and the budget for subcontractors is not included in that limit. Correct? What if there is significant subcontractor effort required to implement the trials across the network?

Correct. There are no known ratios for prime versus subcontractor level of effort proposed on unrestricted requirements. However, there are limitations on subcontracting/or contracts that have been set aside or reserved/or small business concerns or 8(a) concerns (e.g. see FAR 52.219-14, Limitations on Subcontracting). Therefore, prospective offerors must submit a proposal in accordance with its organizational needs and the government will evaluate each proposal in accordance with the RFP and provide the offeror with questions (if required).

12) Should the tasks in each phase be listed separately as part of the schedule with delivery dates (months) for each task?

See RFP, Article B.2., Estimated Cost - Option. In response to your question and for clarification purposes, phases 1-3 are added to the following chart.

Dates(Estimated and Fixed Fee ($) Estimated Cost subject to chanaeJ + Fixed Fee ($)

Base Period (Phase 1) 81112015 - 1131116 Option Period(s)

1(Phase2) 21112016 - 113112017 2 (Phase 3) 21112017 - 713112020

Total [Base Period & Option(s)] (Three Phases)

See RFP, Page 72, Business Proposal Instructions. The business proposal must include the proposed cost and/or price for each phase (1' 2, and 3) and proposed cost and/or price for total award (all phases); profit or fee (as applicable).