HHS-NIH-DA-12-242_Amendment_04.pdf

OMB Approval 2700-0042

1. CONTRACT ID CODE PAGE OF PAGES

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT N/A 1 6

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

04 03/19/2012 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) (4 ) 9A. AMENDMENT OF SOLICITATION NO.

TO ALL OFFERORS

RFP TITLE: “New Experimental Medicine Studies: Fast-Fail Trials in Psychotic Spectrum Disorders (FAST-PS)”

X HHS-NIH-DA-12-242

9B. DATED (SEE ITEM 11)

02/03/2012

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 t l l tt id d h t l l tt k f t th li it ti d thi d t d i i d i t th i h d d t

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.

(4 ) 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 revise Section J. List of Attachments to include two additional attachments, to delete one attachment, and to re-number relevant attachments

2. To respond to Offeror’s questions (see pages 4 - 6)

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-DA-12-242 Amendment No.: 04 03/19/12

SPECIAL PROVISIONS

1. Section J. List of Attachments has been revised as follows:

A. To include the following Solicitation Attachments that were attached at the end of Solicitation

Document (RFP) but not included in the list provided in Section J. List of Attachments:

Attachment No. Title Location Attachment 4 Background See Attached Attachment 5 Sample Tasks See Attached Attachment 6 Additional Technical and Business Proposal Instructions

See Attached

Attachment 7 Past Performance Survey

See Attached

Attachment 8 Sample NIMH Task Order

See Attached

Attachment 9 Technical Evaluation Criteria

See Attached

B. The following Technical Proposal Attachments listed in Section J. List of Attachments are re-numbered:

Attachment No.

Title Location

Attachment

Targeted/Planned Enrollment Table PHS- 398/2590 (Rev. 6/09) http://grants.nih.gov/grants/funding/phs398/enrollment.pdf

Attachment

Inclusion Table (Formerly Annual Technical Progress Report Format for Each Study) http://grants.nih.gov/grants/funding/women_min/InclusionOld_F orm.pdf

Technical Proposal Cost Summary http://oamp.od.nih.gov/DGS/FORMS/Tech-Prop-Cost- Summ.pdf

Summary of Related Activities http://oamp.od.nih.gov/DGS/FORMS/summary-related-activities.pdf

Protection of Human Subject Assurance Identification/IRB Certification/Declaration of Exemption, OMB Form No. 0990-0263 (Formerly Optional Form 310) http://www.hhs.gov/ohrp/assurances/forms/of310.rtf

Intentionally left blank. Continued on Page 3.

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C. The following Business Proposal Attachments are hereby incorporated into Section J. List of

Attachments of the Solicitation Document (RFP):

No.

Title Location

Attachment

Proposal Summary and Data Record, NIH-2043 http://oamp.od.nih.gov/DGS/FORMS/NIH2043.pdf

Section K – Representations, Certifications, and Other Statements of Offerors

See Attached

D. The following Business Proposal Attachments listed in Section J. List of Attachments are re-numbered:

Title Location

Attachment

Small Business Subcontracting Plan http://www.hhs.gov/about/smallbusiness/subcontractplan.html

Breakdown of Proposed Estimated Costs (plus fee) w/Excel Spreadsheet http://oamp.od.nih.gov/contracts/BUSCOST.HTM

Offeror's Points of Contact http://oamp.od.nih.gov/DGS/FORMS/point-of-contact.pdf

Certificate of Current Cost or Pricing Data http://rcb.cancer.gov/rcb-internet/forms/cert-current-cost.pdf

Disclosure of Lobbying Activities, OMB Form SF-LLL http://www.gsa.gov/portal/forms/download/E0F5394ACA9DDC 4085256A3E005C7420

E. The following Informational Attachment listed in Section J. List of Attachments is deleted:

No.

Title Location

Attachment

Instructions for Completing Form NIH 2706 http://oamp.od.nih.gov/DGS/FORMS/instructions2706.pdf

Intentionally left blank. Continued on Page 4.

http://oamp.od.nih.gov/DGS/FORMS/NIH2043.pdf� http://www.hhs.gov/about/smallbusiness/subcontractplan.html� http://oamp.od.nih.gov/contracts/BUSCOST.HTM� http://oamp.od.nih.gov/DGS/FORMS/point-of-contact.pdf� http://rcb.cancer.gov/rcb-internet/forms/cert-current-cost.pdf� http://www.gsa.gov/portal/forms/download/E0F5394ACA9DDC4085256A3E005C7420� http://www.gsa.gov/portal/forms/download/E0F5394ACA9DDC4085256A3E005C7420� http://oamp.od.nih.gov/DGS/FORMS/instructions2706.pdf�

F. The following Information Attachments listed in Section J. are re-numbered:

Title Location

Attachment

Invoice/Financing Request Instructions-CRNIH(

RC)-1

http://oamp.od.nih.gov/DGS/FORMS/rc1.pdf

Privacy Act System of Records http://oma.od.nih.gov/ms/privacy/pa-files/read02systems.htm

Safety and Health, HHSAR Clause 352.223-70 http://oamp.od.nih.gov/DGS/FORMS/Safety-Health-hhsar-1- 06.pdf

Research Patient Care Costs, NIH(RC)-11 http://oamp.od.nih.gov/DGS/FORMS/rc11.pdf

Inclusion Enrollment Report http://grants.nih.gov/grants/funding/phs398/enrollmentreport.pd f

Disclosure of Lobbying Activities, OMB Form SF-LLL http://www.gsa.gov/portal/forms/download/E0F5394ACA9DDC 4085256A3E005C7420

Commitment to Protect Non- Public Information Contractor Agreement http://ocio.nih.gov/docs/public/Nondisclosure.pdf

Roster of Employees Requiring Suitability Investigations http://ocio.nih.gov/docs/public/Suitability-roster.xls

Employee Separation Checklist http://ocio.nih.gov/nihsecurity/Emp-sep-checklist.pdf

2. To respond to Offeror’s questions (see below)

NIH RESPONSE TO QUESTIONS

New Experimental Medicine Studies: Fast-Fail Trials in Psychotic Spectrum Disorders (FAST-PS)

1. Question #1: Is the RFP requesting proposals for qualified individual sites that NIH will link to conduct fast-fail trials? Is it requesting proposal for consortium of sites?

Response: Proposals are sought from Offerors that have the ability to meet the requirements outlined within the Solicitation Document (RFP). Offerors will need to propose what they determine to be an appropriate number of sites adequate to perform the tasks outlined in Attachment 3, Statement of Work. Refer to Amendments #2 and #3 to the RFP which address previous questions regarding subcontractor performance sites. Refer to Attachment 3, Statement of Work, III. Contractor Requirements. Also refer to Section M. and Attachment 9, Technical Evaluation Criteria, which address the basis for evaluation of proposals.

2. Question #2: Furthermore is the RFP requesting proposals for the compounds to be tested in FF trials or just the qualified sites?

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Response to Question #2: As noted in Attachment 3, Statement of Work and Section M., and Attachment 9, Technical Evaluation Criteria, the Offeror should propose compound(s) and the rationale for the compound(s) proposed as part of their technical proposal. These will be evaluated in accordance with Section M. and Attachment 9, Technical Evaluation Criteria.

3. Question #3: Are we allowed to budget in years 2 and 3 for COLA for salary effort?

Response: Offerors are expected to include all relevant costs in the five Sample task budgets. As the resultant contract is anticipated to be a cost reimbursement type contract, if it is the Offeror’s policy to grant COLAs each year, then proposal of COLAs is permissible. The Government will ask for documentation regarding COLA policies from Offerors in the competitive range. Refer to Attachment 5 for the cost assumptions to be utilized for each sample task. Also refer to Attachment 6 for additional instructions. Amendments 2 and 3 to the RFP addressed other questions regarding sample budgets.

4. Question #4: With our technical and business proposals, due we need to provide our comments about the contract itself (for example, any exceptions to clauses contained therein) or is that done when the proposals are selected for award?

Response: Any comments on contract FAR or other contract clauses as included within the RFP will be received during negotiations with those Offerors that are in the competitive range.

Therefore submission of these is not required with the technical and business proposals.

5. Question #5: It is possible to appoint another institution to be the Prime Contractor for my proposal instead of myself? Is this allowed since I have already sent in a letter of intent with me as the Prime Contractor?

Response: Attachment 2, Proposal Intent Responses are not binding as changes are permissible until technical and business proposals are received by the due date and time. If a contract is awarded, it is awarded to the Successful Offeror(s) who under any resultant contract become the Prime Contractor.

Review Section L.1. General Information, a. Instructions to Offerors - Competitive Acquisition, (f) Contract award for information regarding the process. Sections L. and Section M. provide important information regarding qualification of Offerors as well as details on submission of both Technical and Business proposals. Also refer to Attachments 3, 5, 6 and 9 for details regarding requirements of this Solicitation as well as. Offerors are reminded that they are responsible for reviewing the entire RFP and for submission of all required documents with their technical and business proposals.

6. Question #6: We do not meet the qualifications to be a Prime Contractor under this RFP but are interested in being a single performance site/subcontractor. What do we need to do?

Response: Regarding subcontracting opportunities, the Government is unable to facilitate communication between potential Offerors and those interested in becoming one of the performance sites. Offerors propose the subcontractor sites that they intend to use within their technical and business proposals.

7. Question #7: Regarding the budget assumptions for Sample Task 3 listed in Attachment 5, Sample Tasks. From review of the budget assumptions for Sample Task 3, aren’t clear about how to budget being that item j. Single ascending dose protocol over a 6 day time period is indicated. Would you please advise as to whether we should budget 8 patients total, or the number of patients we would propose if a full ascending protocol were used?

Response: Sample Tasks 3 and 5 are only for cost comparison purposes. No actual study is being requested or will be done for either of these Sample Tasks. The Offeror should provide a budget for Sample Task 3, running a trial in which eight (8) subjects participate. Six (6) receive active drug; 2 receive placebo. The trial lasts 6 days. Two (2) PET scans are obtained for each subject, one before starting Risperidone or placebo and one upon completion of the 6 days of drug/placebo administration.

8. Question #8: Are we allowed to submit the electronic files of the Technical Proposal and Appendices on USB flash drives rather that CDs? Based on Attachment 1, Page 3 of 3 it appears that we are allowed to use flash drives for the Business Proposal but not for the Technical Proposal and Appendices. Is that correct or were USB flash drives supposed to be allowed for the Technical Proposal as well?

Responses: Yes, USB flash drives are permitted for the Technical proposal and Appendices as well. As a reminder, the business and technical proposals must be submitted separately both for the original and paper copies as well as for the electronic copies. Refer to Attachment 1 for important information on submission of proposals.