NIH-NIAAA-DTRR-2015-04_amendment_2_.pdf

OMB No.: 0990-0115

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

N/A

PAGE

OF PAGES

2. AMENDMENT/MODIFICATION NO.

2 (two)

3. EFFECTIVE

DATE

See block 16C

4. REQUISITION/PURCHASE

REQ. NO.

5. PROJECT NO. (if applicable)

6. ISSUED BY CODE

7. ADMINISTERED BY (If other than Item 5) CODE

National Institutes of Health National Institute on Alcohol Abuse and Alcoholism/ Eunice Kennedy Shriver National Institute of Child Health and Human Development Contracts Management Branch Executive Building, Suite 7A07

6100 EXECUTIVE BLVD MSC 7510

BETHESDA MD 20892-7510

8. NAME AND ADDRESS OF CONTRACTOR (No., street, city, county, State and ZIP Code)

9A. AMENDMENT OF SOLICITATION NO.

NIH-NIAAA-DTRR-2015-04

9B. DATED (SEE ITEM 11)

March 20, 2015

10A. MODIFICATION OF

CONTRACT/ORDER NO.

CODE

FACILITY CODE

10B. DATED (SEE ITEM 13)

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, X 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 _1__ copies 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 DATE 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 date 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 FAR 52.243-2. 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) and Contract ARTICLE B.4.

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 ___________ copy to the issuing office.

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

PURPOSE: To answer questions submitted for RFP no. NIH-NIAAA-DTRR-2015-04.

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

Jacquelin Jones, Contracting Officer NIAAA/NICHD Contracts Management Branch

15B. CONTRACTOR/OFFEROR

BY ______________________________________________

(Signature of person authorized to sign)

15C. DATE SIGNED

16B. UNITED STATES OF AMERICA

BY

(Signature of Contracting Officer)

16C.DATE

SIGNED

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AMENDMENT TO NIAAA SOLICITATION

HUMAN LABORATORY PARADIGMS

Solicitation Number: RFP NIH-NIAAA-DTRR-2015-04 Amendment Number: 2 Amendment Issue Date: March 20, 2015 Proposal Due Date: April 9, 2015, 3:00 pm Eastern

DATE, TIME, Local Time UNCHANGED

Issued By: Jacquelin Jones Contracting Officer

NIAAA/NICHD

Office of Acquisitions Contracts Management Branch 6100 Executive Blvd Room 7A07, MSC 7510 Bethesda, Maryland 208927510

Points of Contact: Jacquelin Jones, Contracting Officer E-Mail: jacquelin.jones@nih.gov

Katharine Minker, Contracting Officer E-Mail: katharine.minker@nih.gov

This amendment is issued to all potential offerors.

The above numbered solicitation is amended as set forth below. The hour and date specified for receipt of proposals HAS NOT been extended. Offerors must acknowledge receipt of this amendment by identifying this amendment number and date on each copy of the offer submitted. Failure to receive your acknowledgement may result in the rejection of your offer.

If by virtue of this amendment you desire to change an offer already submitted, such change may be made by e-mail, provided each e-mail makes reference to the solicitation and this amendment, and is received prior to the closing hour and date specified.

Except as provided herein, all terms and conditions of the RFP remain unchanged and in full force and effect.

THE PURPOSE OF THIS AMENDMENT is to answer questions that were submitted by the due date given in Amendment 1 of this RFP.

mailto:jacquelin.jones@nih.gov mailto:katharine.minker@nih.gov

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HLAB Pre-Proposal Questions (NIH-NIAAA-DTRR-2015-04)

TECHNICAL

1. Question: Does the NIAAA IND assure drug safety and tolerability; is efficacy the principal goal of HLAB testing?

Response: Efficacy is the primary goal, although, safety and tolerability will also be tested.

2. Question: Will the doses of the drug to be tested be specified by NIAAA? How many doses are to be tested?

Response: Yes – the doses will be determined by NIAAA and the pool of sites. The amount of doses will be determined by the drug chosen.

3. Question: Will we be informed – before the RFP - of wash in/wash out periods specific to each drug for which we are to prepare a TO2 proposal, or should we build in a standardized period to use for all drugs?

Response: The task for TO#2 is to provide the details regarding the conduct of an alcohol induced cue reactivity human lab study. If a wash in/ wash out period is part of the study design, then please include.

4. Question: Will we be informed of any of the drug’s pharmacokinetic and pharmacodynamic properties?

For example, what neurotransmitter system does the drug work on (could narrow pharmocogenetic range of interest)? Side effects? Toxic effects? Half-life?

Response: Yes to all of the above at the time the drug is selected.

5. Question: What is the target population for the drug’s intended use? Is it intended for use via primary care physicians without frequent supervision; outpatient drug treatment programs; inpatient detox programs for non-treatment seekers?

Response: All to be determined.

6. Question: Will drug and placebo packaging be done at a centralized site for all contract sites, or will each site need to establish this capability separately (and expensively)?

Response: This task will be performed by each site.

7. Question: Will assays of blood drug levels be performed by a single provider for all contract sites, or will each site need to establish this capability separately (and expensively, and variably)?

Response: For the sake of the proposal, please assume the responsibility of performing all assays will be a site responsibility.

8. Question: Who would be responsible for the design of the experiment(s) or studies under this award – NIAAA or the contractor? The instructions for completing the Technical Discussion section of the Technical Proposal state that applicants should specify objectives, a rationale, and an approach to complete the tasks specified in the RFP (p. 62). However, it seems to us that the precise nature of the studies to be carried out will be determined at a later date depending on the needs of NIAAA, which would affect the objectives/rationale/approach. Please clarify the responsibilities of the contractor versus NIAAA in determining the objectives and methods of the proposed research studies.

Response: The drug selected will be determined by NIAAA and consultants but the pool of sites will assist in developing the study design, etc.

9. Question: Please confirm: the T02 example provided (alcohol-induced cue reactivity) is just that; an example. That is, the intention is for us to offer the paradigm our lab is most interested in providing;

correct?

Response: The Business and Technical proposal should include examples of your successful paradigms/protocols to reflect your ability to perform TO #1 and specifically, propose to sample TO2 as a

P a g e | 4 proposal to conduct an alcohol – induced cue reactivity human lab study for comparison purposes across all offerors.

10. Question: Our lab can offer 3 paradigms that we think are useful for the NIAAA’s HLAB mission. Should we be writing up all 3 as TO2 examples, or just provide an example of one of them in the T02 section of our application, and describe the others in the TO1 section.

Response: See answer above. The paradigms that you have found to be successful should be reflected in TO #1 response. In your TO#2 response, you must provide a technical and business proposal for conducting an alcohol –induced cue reactivity human lab study.

11. Question: Area: PI/program Director: Will you allow for 2 PIs both as co-PIs to accommodate separate labs at one institution with complementary expertise in different paradigms?

Response: This is a contract and you will need to justify your staffing arrangements in your business proposal. Without seeing your justification and other staffing arrangements, it is not possible to provide an answer.

12. Question: About Task Order 1 and 2: The RFP specifies timeframes for each task order. Should the proposed costs be limited to a single time period for that task order?

Response: Yes, please limit your proposed costs to the period of performance for the particular task order.

13. Question: Task 2, the alcohol cue-reactivity paradigm, asks for costs to run 40 subjects through the paradigm. Based on the mechanism of action of the drug being tested, there may be a need for different cue-reactivity paradigms. Since the procedures for these different paradigms may be different their individual per subject costs will also vary. Costs will also vary based on duration of drug administration and potential dropouts after randomization. Can you please provide us with guidance on how to estimate the budgets so as to capture all these differences in individual subject costs?

Response: Please prepare your response in accordance with TO #2 specified paradigm, “alcohol-induced cue reactivity” human lab study. One of the tasks for the review group will be to compare offerors against a standard, that being, the ability to provide a competitively appropriate technical proposal and budget to conduct an alcohol-induced cue reactivity human lab study.

14. Question: Do you really mean for the applicant to supply a process on how to assess medication effects only on “Alcohol Induced Cue Reactivity” or are you using that as a catch all phrase to describe any of the possible paradigms listed on page 2. Our initial intent would be to describe our alcohol administration paradigm which could include “alcohol cue reactivity” but it goes beyond that simple concept. Is that acceptable or not?

Response: Please prepare your response in accordance with TO #2 specified paradigm, “alcohol-induced cue reactivity” human lab study. One of the tasks for the review group will be to compare offerors against a standard, that being, the ability to provide a competitively appropriate technical proposal and budget to conduct an alcohol-induced cue reactivity human lab study.

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Business

1. Question: Alternatively, are 2 applications allowed from the same institution?

Response: Yes, two separate departments from the same institutions may send a proposal in for this

RFP.

2. Question: About Task order 1 and 2: Can the same institution have separate proposals for each task order?

Response: Each proposal must submit responses to both Task Order 1 and Sample task Order 2

3. Question: The NIAAA intramural program routinely uses all 3 of the paradigms we will offer, using the same apparatus we propose. We would like to include them as a resource for performing TO2 projects in the case where scaling up our resources for recruiting might be problematic. They have expressed interest in this possibility. We would be interested in a collaborative application from this point on, or in describing their capacities in our response with the intent to subcontract their services from funding sent to ‘us’ as part of a NIAAA contract with our lab. Writing depends on the possibilities, so please render a judgment.

Response: You are allowed to use subcontractors as part of your proposal.

END OF AMENDMENT #2 TO RFP NIH-NIAAA-DTRR-2015-04