HHS-NIH-DA-12-242_Amendment_02.pdf

OMB Approval 2700-0042

1. CONTRACT ID CODE PAGE OF PAGES

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT N/A 1 12

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

02 03/07/2012 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 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.

(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 modify Attachment 3, Statement of Work

2. To include the 508 compliance product assessment template which is due with the business proposal

3. To respond to Offeror’s questions (see pages 2 - 12)

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-DA-12-242 Amendment No.: 02 03/07/12

SPECIAL PROVISIONS

1. Attachment 3, Statement of Work is hereby modified in part as follows:

a. Item (8), of Task Area 2, 2. Development of Final Protocol, d. Design of database, computer system, and data management, is hereby removed as it is not required for an Offeror and/or proposed subcontractor’s internal (closed) data management system to be 508 compliant.

b. Item 2. Of II. FAST Organizational Structure, A. Overview is modified in part to remove the full-time employee requirement as the Contract Principal Investigator is not required to be full-time.

2. The 508 compliance product assessment (due with the business proposal) is attached in www.fbo.gov and can be located on the following website: http://www.hhs.gov/od/vendors/.

3. 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. On page 85 of the RFP, there is a statement that the “HHS Section 508 Product Assessment Template” is included in Section J. I could not find it in Section J. Please advise.

Response: As per the RFP, submission of this completed document is required as part of the business proposal. The HHS Section 508 Product Assessment Template document can be found on the following website: http://www.hhs.gov/od/vendors/. It is also attached to the same notice as this Amendment #02 to the Solicitation (RFP) at www.fbo.gov, published on March 07, 2012.

Note: 508 compliance is one of the evaluation factors that is evaluated but not scored. Refer to Section M. of the RFP.

2. If the aim of our proposal were to be perceived as a strategy that was not feasible due to recruitment difficulties, we would then propose to change inclusion criteria. Would this be acceptable?

Response: It is the Offeror's responsibility to propose an appropriate and feasible research design, including selection of measures, recruitment of human subjects, etc., for any proposed intervention in order to achieve the goals of the this initiative. All proposals will be evaluated according to the evaluation criteria listed in the RFP. Refer to Section M. Evaluation Factors and Attachment 9, Evaluation Criteria. For detailed discussion of the requirements, refer to Attachment 3, Statement of Work. Refer to Attachment 5, Sample Tasks and Attachment 6, Additional Technical and Proposal instructions regarding information on submission of detailed protocols.

3. What form of genetic stratification is desirable for POCM trials?

Response: The research plan and statistical analysis plan proposed by the Offeror should be designed appropriately for the Offeror to achieve the goals of the Solicitation (RFP). Refer to Attachment 3, Statement of Work.

4. Will all FAST studies be monitored by one of the NIMH DSMB’s or should our proposal include a plan for us to convene a special NIMH DSMB?

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Response to Question 4: All clinical trials performed under FAST will be reviewed by the NIMH Data and Safety Monitoring Board (DSMB). The NIMH DSMB will be convened by the NIMH.

Therefore, costs that pertain to convening a DSMB should not be included in the proposal. Refer to Attachment 3, Statement of Work Task Areas 2 and 3.

5. Will the NIMH DSMB be meeting more frequently in order to meet the proposed timeline for getting the studies done? If not, will their final approval be required before enrollment could start.

Response: Study data will be reviewed by the NIMH DSMB according to the Board’s review schedule, currently three times per year, at approximately 4-month intervals. For each clinical trial performed under this initiative, all study protocols and consent and assent forms have to be approved by the NIMH DSMB prior to beginning enrollment.

6. Will the NIMH DSMB act as an adaptive design committee to make determinations on study design? If not, we will appoint our own committee.

Response: The NIMH DSMB is an independent panel of experts in clinical trials who are appointed by NIMH to monitor trials that are conducted with NIMH funding. All clinical trials performed under this contract will be reviewed by the NIMH Data and Safety Monitoring Board (DSMB) to help ensure the safety of participants and the integrity of the data. It is the Offeror's/Contractor's responsibility to propose an appropriate trial design and approach, including how to resolve potential problems, to best achieve the goals of the FAST initiative. For more detail on the requirements and goals, refer to Attachment 3, Statement of Work.

7. Is a “letter of intent” requested?

Response: Yes, a letter of intent is required from the institution submitting the proposal and from each subcontractor proposed.

8. Will submitters be confined to those who submitted applications in response to the earlier pre-solicitation notice?

Response: No, Offerors (the institution/firm/organization that submit the proposals) should propose those subcontractor performance sites which they plan to use with their technical and business proposals as per the instructions in Attachment 6, Additional Technical and Business Proposal instructions, Attachment 5 – Sample Tasks and Attachment 3, Statement of Work as well as Section L. of the Solicitation Document (RFP).

9. Do subcontractors have to be identified at the time of submission?

Response: Yes. Refer to Attachment 6, Additional Technical and Business Proposal instructions, Attachment 5, Sample Tasks and Attachment 3, Statement of Work as well as Section L. of the Solicitation Document (RFP).

10. As part of our fast-fail proposal in we are exploring teaming arrangement to augment our multi-site capabilities. The network would be comprised of various performance sites. If such a teaming arrangement is achieved we would provide details of the sites and their experience and capabilities. Will we still need support letters from the PIs at each of the individual sites, or just one from the overall director of the network?

Response to Question 10: A letter from the site-PI at each of the participating sites should be submitted with the proposal.

11. Will Rutgers provide kits for phlebotomy and sample processing as well as shipping materials for DNA tubes and for biopsy biospecimens?

12. Response: RUDCR might provide tubes, labels, and shipping material upon request. However, the Offeror should include within the Sample Task Budgets 2-5 (i.e., for Sample Tasks 2-5), the cost estimate for collection of biomaterials (i.e., blood). For Sample Budgets 2 and 4, include the number of biomaterial samples recommended by the Offeror based upon the recommended compound(s). For Sample Budgets 3 and 5, assume each trial will require 2 samples for each subject. For details on collection of biomaterials, refer to the Statement of Work, Section III, item E.1. Arrange for the collection of biomaterials. Cost estimates should include costs for labor to collect blood and prepare for shipping, tubes, labels, shipping material, and overnight shipping to RUDCR. The Government estimates the cost for shipping material and overnight shipping to RUDCR to be $75 per shipment (each box can hold up to 8 vials).

13. How much flexibility is allowable with regard to drawing additional tubes for testing? Should we prepare a budget for sample processing and storage?

Response: It is the Offeror's responsibility to propose an appropriate research design in order to achieve the goals of the FAST initiative. Except for the listed number of biomaterial samples for the Sample Budgets 3 and 5, it is the Offeror's responsibility to propose appropriate measures (e.g., number of biomaterial samples, type of biomaterial measures) to best achieve the goal of

FAST.

14. Intellectual Property –it sounds like the RFP suggests that what is required here is assurance that I.P. Issues will be sorted out in writing before any clinical trial begins; thus we'd only need general assurances from our IP office and industry partners – is this correct?

Response: Submission of a plan from the Offeror that addresses how Intellectual Property matters will be addressed with both subcontractors (e.g. performance sites) and any third party compound suppliers is required. Any proposed subcontractor performance sites and/or any proposed third party compound suppliers should also include a statement about how IP issues will be addressed.

15. Are international sites allowed as members of the network (providing regulatory and budget issues are worked out?

Response: Yes

16. Is it possible for a person to be a prospective site or consultant for multiple applications?

Response: Yes, performance sites (subcontractors) and consultants can be included on more than one Offeror’s proposal. This includes proposed Principal Investigators.

17. If we have a clearly specified Contract Principal Investigator, is it permissible to designate an additional person who has complementary expertise as a Co-Principal Investigator if we clearly indicate the roles of these two individuals?

Response: Yes this is permissible.

18. Regarding the RFP, there is a statement that suggests that the Prime contractor for this project must have direct experience managing clinical trials. In our instance, clinical trials are performed by our co-located subsidiary. Does this qualify as “direct experience”?

Response: There are no mandatory qualification factors. It is up to the Offeror to propose the infrastructure and technical approach that meets the requirements as outlined in the Solicitation (RFP). Refer to Section M. Evaluation Factors and Attachment 9, Evaluation Factors for information regarding proposal evaluation Also refer to Attachment 6, Additional Technical and Business Proposal instructions.

19. To what extent are the proposed budgets used in scoring the proposal?

Response: Refer to Section M., 2. Cost/Price Evaluation. Technical is significantly more important that cost. Also refer to the contract maximum provided within the RFP. Cost is a factor and is scored separately (not part of the technical proposal). As indicated in Section M., Evaluation Factors for Award, 1. General, “Selection of an Offeror for contract award will be based on an evaluation of proposals against four factors. The factors in order of importance are:

technical, cost, past performance and Small Disadvantaged Business (SDB) participation.

Although technical factors are of paramount consideration in the award of the contract, past performance, cost/price and SDB participation are also important to the overall contract award decision. All evaluation factors other than cost or price, when combined, are significantly more important than cost. The Government intends to make an award(s) to that Offeror whose proposal provides the best overall value to the Government.”

20. We need clarification regarding submission of budgets. We’ve noted the requirement of several sample task budgets; however, we are unable to determine which budgets should be included in the total contract amount. We also see a requirement for a $9 million draft Small Business Subcontracting Plan. Could you please provide us with guidance? Should the total contract amount and the draft Small Business Subcontracting Plan be based solely on the administrative and novel concept budgets or should the total contract amount be based on all 5 sample task budgets?

Response: The contract maximum is $9,000,000 for the three-year performance period estimated to be 9/15/12 through 9/14/15. A budget for total contract amount is not requested/required. Instead, five (5) individual budgets are required, one for each of the Sample Tasks as per the details and cost assumptions provided in Attachment 5, Sample Tasks. Each Sample Task budget should be all inclusive (e.g. include all costs relevant to the Offeror’s infrastructure and technical approach) to complete the respective Sample Task. The plan should be completed based upon the Sample Task 1/Administrative Task (three years) and on Sample Tasks 2 and 4. For purposes of completing the Draft Small Business Subcontracting plan only, use the maximum number of FIH and POCM trials (as outlined in Sample Tasks 2 and 4) that could be completed within the contract maximum of $9.0 Million and within the three-year period of performance. Include all requirements/activities proposed within your Technical Approach that could potentially be subcontracted to either small businesses or other than small businesses, including academic institutions or non-profit institutions. For further details, reference the following: Article B.2 Prices/Costs and Article B.3., items a. – d., Attachment 5, Sample Tasks, Attachment 6, Additional Technical and Business Proposal Instructions

21. With regard to cost/price information required in the Business Proposal, we do not believe we have Certified Cost or Pricing Data. It appears that we must submit a written request for exception (p. 92) but we do not have a law or regulation establishing the price offered or commercial item exceptions. May we just submit “Data Other than Certified Cost or Pricing Data”

(p. 87)? If not, how should we proceed?

Response: Section L. c. Business Proposal Instructions, 4. Certified Cost and Pricing data, 4.

General Information (Page 92) provides clarification about this requirement. A certificate signed by the Offeror’s authorized representative is required (Section J. Attachment 19 –link to the certificate). Refer to Section L. c. Business Proposal Instructions, 4. Certified Cost and Pricing data, items 1. – 4., for details on how to satisfy the Certified Cost and Pricing Data requirement.

Since the RFP is not for commercial item services, a price index is not required.

22. Clarify the requirements for the “Subcontracted Items” section (p. 88). We anticipate the only subcontracts, to be with organization/compounding pharmacy and performance sites. Some could exceed $650,000. Performance sites will offer services for approved trials such as fMRIs or EEGs. We are unsure how to address the request for information related to “degree of competition, and basis for establishing source and reasonableness of price”?

Response: Discuss all services and or/supplies that are expected to be obtained through subcontractors. Subcontractors may include performance sites, third party vendors (e.g.

compound suppliers) or others depending upon the Offeror’s technical approach. Include all subcontractor costs regardless of type of service or product being provided, size or dollar value.

For those subcontractors estimated to exceed $650,000 a detailed budget with cost elements must be included to the same level of detail as the Offeror’s proposal. If consultants are proposed, include a separate cost element in the proposed budgets.

23. Please clarify p. 88 statement, “Key personnel will be separately estimated as above and identified.” We expect to explain each person’s contribution and level of effort in the business proposal under each task and we can identify which of these individuals are key personnel. We want to be sure nothing beyond that is required.

Response: For purposes of the Business Proposal, Data Other than Certified Cost or Pricing Data, key personnel refers to any personnel for which direct labor will be billed. In the proposed budget summary of direct labor, list each personnel/position with estimated cost. Refer to Section J., Attachment 17 for link to Excel spreadsheet/additional information.

24. Will the conference calls between the Offeror and subcontractors (when indicated) and the NIMH be scheduled and paid for by the sponsor? If the NIMH is not covering the cost of calls, how many NIMH representatives will be attending calls with the Steering Committee and also participating in site calls?

Response: The Contractor will be responsible for coordinating and paying for the cost of the conference calls. At this time, NIMH cannot determine how many NIMH representatives will attend the calls or how many telephone lines will be needed. The number of lines will depend on the organizational structure of the Contractor and the nature of the studies.

25. In the business proposal instructions, Section 6 (Salary Rate Limitation for FY2012) indicates that the salary limitation is at the Executive Schedule, Level I for FY2012. However, according to NOT-OD-12-035 issued in January 2012, “Effective with grant awards with an initial Issue Date on/after December 23, 2011, the salary limitation is limited to Executive Level II of the

Federal Pay Scale, $179,700”. Which salary limitation we should use in developing the business proposal for the FAST?

Response: As Public Law 112-74, signed into law on December 23, 2011, restricts the amount of direct salary to Executive Level II of the Federal Executive Pay scale, and since the Executive Level II salary is $179,700, the direct salary cap of $179,700 should be used.

26. What are allowable indirect rates?

Response: Indirect rates are structured differently for each firm/institution/organization. One of the documents to be submitted with the business proposal submission is a copy of the Offeror’s most recently negotiated indirect cost rate agreement (and all proposed subcontractor’s most recent indirect cost rate agreements) which includes information regarding what is included within the indirect rates. Refer to http://rates.psc.gov/ and http://rates.psc.gov/fms/dca/midatlantic.html for additional information regarding the process.

27. Can we charge indirect and fringe on base salaries?

Response: Indirect cost rates must be claimed based upon the Offeror’s and upon each proposed subcontractor’s negotiated indirect cost rate agreements. The agreements include information on the basis of which indirect costs are allocated. The agreements also provide information on the allowable fringe rate and how that is applied to labor costs.

28. Page 2 of Attachment 6 requires us to send our clients the “Past Performance Questionnaire.”

With regard to experience on Federal contracts, to whom do we send the questionnaire?

Response: Refer to Section L., c. Business Proposal Instructions, 12. Qualification of the Offeror, Section M., 7. Past Performance Factor for additional information. The Past Performance Questionnaires should be sent to clients where work of similar type, size, and scope was performed. When sending to Federal Agencies, send the Questionnaire to the Contracting Officer’s Technical Representative (Government Project Officer) and the Contracting Officer that administered the contract. If work of similar type, size, and scope was conducted under a grant mechanism, send the form to the Program Official. Forms may also be sent to non-governmental clients for whom work of similar type, scope, and size was performed.

29. When must the ORCA and Section K be completed if one competes for this mechanism?

Response: Before the proposal due date. Proof of the ORCA (Reps and Certs.) needs to be submitted with the business proposal. This is the case with the other requirements, such as registration with the Central Contractor Registration (for which a DUNS number is required).

Refer to your institution/organization/firm’s office that handles submission of proposals for federal contracts for further assistance.

30. Will the RFP permit the cost to implement and maintain an isolated data center to meet the FISMA requirements for the project?

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Response to Question 30: It is the Offeror’s determination as to whether or not to propose a separate data management center. The contract maximum (ceiling) is $9.0 million for the three-year period of performance. The quantity and type of trials to be conducted are unknown.

References to structure include Attachment 3, Statement of Work, Attachment 5, Sample Tasks and Attachment 6, Additional Technical and Business Proposal instructions, Attachment 9.

Evaluation Factors. It is also the Offeror’s determination as to how the costs for FISMA requirements should be proposed, e.g. direct or indirect costs. Generally costs pertaining to information security requirements including FISMA are considered indirect costs. NIST certification and accreditation (C&A) allows for adequate “compensating” controls that are equivalent to the FISMA required, NIST 800-53 recommended security controls for Federal information systems. Offerors should discuss how their current information systems are equivalent to the FISMA standards.

Note: As per Section M. Evaluation Factors, 1. General: “Selection of an Offeror for contract award will be based on an evaluation of proposals against four factors. The factors in order of importance are: technical, cost, past performance and Small Disadvantaged Business SDB) participation. Although technical factors are of paramount consideration in the award of the contract, past performance, cost/price and SDB participation are also important to the overall contract award decision. All evaluation factors other than cost or price, when combined, are significantly more important than cost. The Government intends to make an award(s) to that Offeror whose proposal provides the best overall value to the Government.”

31. Would the dates for submitting the FISMA reports (Deliverables #11-15 as stated in F.2.

Deliveries of the RFP) be negotiable if awarded?

Response: Yes, this is negotiable up to six months from date of contract award. It is suggested that each Offeror propose the timelines that are realistic for submission of FISMA contract deliverables in accordance with Article C.2 reporting Requirements, b. Other Reports/Deliverables, Article F.2 Deliveries, and as outlined in H.19 Information and Physical Access Security.

32. What level of documentation is expected to be in the proposal for industry and foundation partners (who will be providing compounds, and may facilitate access to subjects)? Will letters of support suffice?

Response: The level of documentation required from the 3rd party compound supplier should demonstrate the 3rd party's commitment to provide the compound(s). In regard to foundation partners, the Offeror should justify the need of the foundation partner and provide evidence of the partner's ability to access sufficient number of subjects for the Offeror to achieve the goal of the

FAST.

33. There are several sections of the RFP that refer to the need for a Contractor to comply with

Section H.19, Information and Physical Access Security. H.19.a. states that to perform the work specified in the RFP, Contractor personnel are expect to have routine (1) physical access to an HHS-controlled facility; (2) physical access to an HHS-controlled information system; (3) access to sensitive HHS data or information, whether in an HHS-controlled information system or in hard copy; or (4) any combination of circumstances (1) through (3). Our understanding of the work leads us to question which of the 4 items will be true for the Contractor. The data we gather will be data from the participating sites; we will not have access to HHS data as far as we can tell. Provide clarification as to how the work of the RFP fits with one of the 4 criteria stated in H.19.a.

Response to Question 33: As per Federal contracting regulations, data systems that house the data collected, running on Contractors (or subcontractor) servers in support of any resultant NIMH FAST contract are considered to be Federally-controlled information systems. Additionally, the data collected under any resultant contract are considered to be HHS data or information.

Information Security requirements do apply to any databases used to enter, house or analyze the FAST studies results. For purposes of any resultant FAST contract, Contractor employees will not have to have access to a HHS-controlled facility nor to a HHS-controlled information system.

The Contractor will not have to provide federally-compliant badges and smart card readers for access provided that some other form of two-factor authentication for remote access is used or that there is no remote access to the system. Depending upon the technical approach of the Offeror, relevant contractor and subcontractor employees will have to access to hardcopy and/or electronic forms of data and the data system(s) established to enter, maintain, and analyze any resultant data.

Refer to: Article H.19. Information and Physical Access Security, Article C.2 Reporting Requirements, b. Other Reports/Deliverables, 1. Information and Physical Access Reporting Requirements, 1. A – h. and Article F.2 Deliveries for specific requirements and deliverables.

34. Is the electronic data system, running on our servers, considered a Federally-controlled information system for the purposes of having to provide federally-compliant badges and smart card readers for access?

Response: The electronic data system, running on Contractors (or subcontractor) servers in support of any resultant NIMH FAST contract would be considered a Federally-controlled information system. However, the Contractor would not have to provide federally-compliant badges and smart card readers for access provided that some other form of two-factor authentication for remote access is used or that there is no remote access to the system.

Note: Information Security requirements do apply to the electronic data system. Refer to: Article H.19. Information and Physical Access Security, Article C.2 Reporting Requirements, b. Other Reports/Deliverables, 1. Information and Physical Access Reporting Requirements, 1. A – h. and Article F.2 Deliveries.

35. Does the electronic data system we use to capture data, a closed (internal) system, need to be Section 508-compliant?

Response: No, 508 compliance does not apply to a closed internal electronic data system as:

(1) It is not available to the public and (2) This procurement is for knowledge (Research and Development), the electronic data system is considered to be a Contractor incidental. This Amendment #02 to RFP modifies Attachment 3, Statement of Work Task Area 2, 2. Development of Final Protocol, d. Design of database, computer system, and data management item (8), to remove the requirement that the Offeror and/or proposed subcontractor’s internal (closed) data management system be 508 compliant.

Note: 508 compliance does apply to any websites made available to the public, and to any electronic contract deliverables including reports and datasets. The following is copied from Section M – Evaluation Factors for Award, 6. Evaluation of Electronic and information technology accessibility – Section 508 for important information regarding evaluation of 508 compliance.

Page10 of 12

Response to Question 35 continued:

"The Offeror's proposal must demonstrate compliance with the "Electronic and Information Technology Accessibility Provisions" set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the "Access Board") in 36 CFR part 1194 for all electronic and information technology (EIT) products and services developed, acquired, maintained, or used under this contract/order, including EIT deliverables such as electronic documents and reports.

If the Offeror’s proposal does not include a completed HHS "Section 508 Product Assessment Template" (hereafter referred to as the "Template") which demonstrates that EIT products and services proposed support applicable Section 508 accessibility standards, or, if the completed "Template" included in your proposal is considered "noncompliant," and the Government includes your proposal in the competitive range (for competitive proposals), or if the Government holds discussions with the selected source (for sole source acquisitions), you will be afforded the opportunity to further discuss, clarify or modify the "Template" during discussions and in your Final Proposal Revision (FPR). If your "Template" is still considered "noncompliant" by the Government after discussions, your proposal may not be considered further for award.”

36. If other network sites are over $650K total for the three years, is it true that a small business plan contracting plan is required? How will this apply to academic research sites?

Response: A small business plan is required for any Subcontractor performance sites (including academic research sites) over $650,000. However, the Subcontractor’s (over $650,000) Small Business Plans do not need to be submitted with the Offeror’s proposal. The following refers to what is required as part of the Offeror’s Business proposal (part of the Offeror’s Small Business Subcontracting Plan): Section L., c. Business Proposal Instructions, 7. Small Business Subcontracting Plan, d. Each plan must contain the following, subparagraph 9. “Assurances that the Offeror will include in all subcontracts the contract clause "Utilization of Small Business Concerns." Assure that all subcontractors, other than small businesses, in excess of $650,000 adopt a plan similar to the plan agreed upon by the Offeror.” Also refer to Section L., c. Business Proposal Instructions, 3. Data Other than Certified Cost or Pricing Data, c. Subcontractor Items for what is required with submission by each proposed subcontractor (including performance sites, e.g. academic research sites). Also refer to response to question #7 above, Section M., 1.

General regarding how SDB participation will be evaluated.

37. With regard to all proposal components related to HUB Zones and SBDs, we anticipate that the only subcontract we may have under this project, with the exception of our core performance sites, will be with an organization/compounding pharmacy to blind the drug. With that in mind, how do we approach these requirements?

Response: Since your institution is “Other than Small Business”, Section L., c. Business Proposal Instructions, 9. HUBZone Small Business Concerns is not applicable. However, Section L., c. Business Proposal Instructions, 10. Extent of Small Disadvantaged Business Participation does apply and will be evaluated as described within and in Section M. of the RFP. Refer to additional responses below for additional information.

38. Is the Small Business Subcontracting Plan due with the proposal or is it negotiated later?

Attachment 6 indicates that it is due with the proposal; however, Section L., c. Business Proposal Instructions, 7. Small Business Subcontracting Plan can be interpreted as saying it is negotiated later. Please clarify.

Response: A Draft (completed but not signed) Small Business Subcontracting Plan is due with the business proposal. The plan needs to be completed based upon the total contract maximum dollar value of $9,000,000. The initial plan will be reviewed and then will be negotiated with those Offerors in the competitive range. A final (signed by authorizing official) Small Business Subcontracting Plan will be due to with Final Proposal Revision.

39. It appears that the “HUBZone Small Business Concerns” section (Section L., c. Business Proposal Instructions, 9. HUBZone Small Business Concerns) does not apply to us since we are not a “small business Offeror.” Is that correct?

Response: Yes, this is correct.

40. With regard to the “Extent of Small Disadvantaged Business Participation” (Section L., c.

Business Proposal Instructions, 10.) please clarify what is required with the proposal beyond the SDB target table. This section states that the SDB portion of the proposal “shall describe the extent of participation of SDB concerns in the performance of this contact” but provides no guidance as to exactly what information is being sought. Section M. 8. Extend of Small Disadvantaged Business Participation includes six items (a. – f.) on which the proposal is evaluated. Should that be used as a guide for what the proposal should contain in this section or are there other components also required?

Response: Yes, those six items should be used as a guide. In addition the Small Business Subcontracting Plan (Section J. Attachment 16 - link to the document template provided) will be evaluated but not scored. The plan should be completed in its entirety and a draft (unsigned) submitted with the business proposal. Refer to Attachment 6 to the RFP, Additional Technical and Business Proposal Instructions for additional information and instructions on completion of the Small Business Subcontracting Plan.

41. Is it at all possible to get an extension?

Response: The proposal due dates were extended by one week. Refer to Amendment #01 to the RFP published on www.fbo.gov on March 05, 2012.

42. I would like to confirm eligibility criteria prior to submitting to this RFP. In reading this document and researching related documents I could not find specific details related to this area that would include or exclude our type of firm.

Response: There are no restrictions on the type of firms that can submit proposals to the RFP.

Part IV of the Solicitation Document (RFP) provides instructions to Offerors.

43. Are you expecting R-01 type submissions, with detailed protocols and specific drugs to be nominated in response to this announcement?

Response to Question 43: Detailed protocols are required for both a FIH trial using the compound proposed and for the POCM trial using the compound proposed. Refer to Attachment 6, Additional Technical and Business Proposal instructions, Attachment 5, Sample Tasks, and Attachment 3, Statement of Work. These attachments also address what is required for submission of compounds.

44. Although we are not able to take on Contractor responsibilities as set up in this RFP, I am hoping that we can suggest our compounds as potentials to test for this patient population. Both are IND ready.

Response: After a resultant contract is awarded, information will likely be elicited information from industry on proposed compounds for testing.

45. My colleague and I are considering responding to this RFP. We believe, that our consortium infrastructure and experience could be successfully applied to the needs of this solicitation, but neither of us has competed for an NIMH contract (as opposed to a grant), and much of the required documentation is new to us. Also, we want to be sure we understand some of the specifics of the RFP before we move ahead.

Response: It is recommended that institutions/firms/organizations consult with their Grants and Contracts, Business, and/or Legal Department as they may be of assistance with the proposals.

46. I am currently a half-time employee at one institution, and a half-time employee of another. The Statement of Work Attachment 3 states that the contract PI must be a full time employee of the prime Contractor. Would I be able to serve as Contract PI?

Response: Yes, this is permissible. The institution will need to demonstrate in their proposal that you, appointed as the Contract PI (with a halftime appointment at their institution), will have the required time to dedicate to any resultant FAST contract within the time dedicated to their institution. The RFP was amended to omit the full-time requirement as stated in Attachment 3, Statement of Work in Amendment #02 to RFP on March 07, 2012.

47. Has the COTR been identified?

Response: Information about the Contracting Officer’s Technical Representative (COTR) will not be provided until the draft contract document is forwarded to the successful Offeror. Any inquiries regarding FAST need to be submitted in writing to the Contract office point of contact:

jacobsonmj@mail.nih.gov.

48. Can you give us an idea of how many applications you are expecting in response to this RFP?

Response: No, we are unable to provide this information.

49. Can you provide us with copies of previously successful applications?

Response: No, we are unable to provide this information.

mailto:jacobsonmj@mail.nih.gov�