Amendment_2_HHS-NIH-NIDA(AG)-RFP-14-005.pdf

OMB Approval 2700-0042

11. CONTRACT ID CODE IPAG~ OF PAGES

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT NIA I 4

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

PROJECT NO. (If applicable)

02 See Block 16C NIA NIA

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

NIMHINIA R&D Contracts Management Branch

Office of Acquisitions - NIDA Neuroscience COAC National Institutes of Health 6001 Executive Boulevard, Room 8154, MSC 9661 Bethesda, MD 20892-9661

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

HHS-NIH-NIDA(AG)-RFP-14-005

TO ALL POTENTIAL OFFERORS x 9B. DATED (SEE rrEM 11)

12/31/2014

TITLE: OUTCOME PERFORMANCE MEASURE DEVELOPMENT FOR 10A. MODIFICATION OF CONTRACT/ORDER NO.

PERSONS WITH MULTIPLE CHRONIC CONDITIONS (MCC)

10B. DATED (SEE rrEM 13)

CODE I FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

[8J The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers l:8J is extended until 3:00 PM Local

Time on February 23, 2015, D 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 solicflationlcontract subject matter where feasible.)

PURPOSE: The purpose of this Amendment is to provide responses to the questions received and amend Section L.2.c. 7, See the Amendment continuation pages for the responses.

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)

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

NSN 7540-01-152-8070

PREVIOUS EDITION UNUSABLE

Fred Ettehadieh, OA, NIDA Neuroscience COAC

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

BY (\,~lcttl~ ""{Siinature of Contracting Officer)

30-105 Computer Generated

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA

FAR (48 CFR) 53.243

Solicitation No. HHS-NIH-NIDA(AG)-RFP-14-005 CONTINUTATION Page 2 of 4 Amendment No. 02 PAGE

Question 1. In Section L.1.d.: Estimate of Effort, NIH considers the effort for this project to be approximately 5,725 labor hours. Would NIH confirm if this effort is only for Phase I and not the Phase II option? If this assumption is correct, would NIH provide guidance on the labor hours expected for the Phase 11 option?

Response 1: The Estimate of Effort is for Phase 1 and Phase 2.

Question 2. Is there a page limit for proposals?

Response 2: No.

Question 3. Given the data collection and analysis that will need to occur in Phase 11, does NIH intend for Phase. II to occur after the initial two year project period, or as part of the performance period identified in the RFP?

Response 3: Phase II is part of the Option Year.

Question 4. On page 58, Section L.2.c.7, of the subject solicitation, under Subcontractors, a link is provided to obtain certain important information when subcontractors are educational institutions:

http://ocm.od.nih.gov/contracts/rfps/FDP/FDPclausecover.htm. However, the link appears to be non-functional. Can an updated link be provided?

Response 4: The requirements from that non-working link are no longer needed.

Section L.2.c.7 shall be amended to read:

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 offerer's cost proposal.

Amendment No. 02 PAGE

Question 5. In the Statement of Work (attachment 3, page 5), under Phase 2, item VI, the contractor is asked to "Construct the PRO performance measure by using average change or percentage improved over time (functional stability or functional gain)." However, the Phase II "cross-sectional or short-term prospective design" specified in item II of this section (previous page) will not produce the data necessary to represent meaningful average change or percentage improved over time required for a PRO PM. Please clarify how the offerer is to calculate average change or percentage improved over time with the Phase II data.

Response 5: If the offerer believes the Phase II data are not sufficient to evaluate change or stability, they should propose an alternative data collection scheme or secondary data analysis that could successfully evaluate change or percentage improved over time.

Question 6. In the Statement of Work (attachment 3, page 4), under Phase II, item I indicates: "Prepare a survey instrument containing disease ascertainment questions, PROMIS-29 Profile, VR-12 and SF-36." Is it necessary to include both the SF-36 and VR-12 in the Phase 2 survey?

Response 6: Offerers can plan to include the VR-12 and those questions from the SF- 36 that are not included as part of the VR-12 in the Phase II survey.

Question 7. Proposal due date is February 16, 2015. Since that is a Federal Holiday, can you provide a revised Proposal due date?

Response 7: The due date has been extended until 3:00 PM Local Time on February 23, 2015.

Question 8. Is the purpose of this contract to apply NQF criteria to objectively and thoroughly evaluate a PRO measure (i.e., SF-12NR-12 in Phase 1 and PROMIS-29 in Phase II) and report that evaluation to NQF? Or is the purpose to make the best possible case for the endorsements of these PRO measures using NQF criteria and report that to NQF as part of a dossier in support of their endorsement?

Response 8: The Government believes that PRO measures have some known strengths and weaknesses with respect to the NQF criteria, and some characteristics which remain to be understood. This project intends to incrementally develop the measures and make their best case to the NQF in support of endorsement.

Amendment No. 02 PAGE

Page 4 of4

Question 9. Does the Government expect the contractor to obtain full human subjects approval for both years of the project by the end of the first three months of Year 1 (i.e., the Phase II survey will need to be fully designed in Months 1-3 of Year 1 ), or might human subjects for the Phase II survey be submitted towards the end of Year 1?

Response 9: This is health survey work which is likely minimal risk, and we expect that an offerer can phase their survey design and human subjects review so that its approval can be obtained before a decision to proceed with Phase 11 is made near the end of Year 1.

Question 10. Is there an expectation to study the data at multiple periods in time?

What would be the goal of a simulation?

Response 10: There is an expectation that longitudinal data over time is needed to measure change or stability or percentage improved over time.

Simulation might be used to conduct sensitivity analysis or deal with missing data.

All other terms and conditions of this Solicitation remain unchanged.