HHS-NIH-DA-12-242_Amendment_03.pdf

OMB Approval 2700-0042

1. CONTRACT ID CODE PAGE OF PAGES

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT N/A 1 13

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

03 03/14/2012 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 Article F.2 Deliveries

2. To revise clauses required by FAC 2005-55, effective February 2, 2012

3. To revise responses to Question #7 and #17 of Amendment #02 to the Solicitation (RFP)

4. To respond to Offeror’s questions (see pages 9 - 13)

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.:

03/14/12

SPECIAL PROVISIONS

1. ARTICLE F.2 DELIVERIES has been revised:

Item Description Method of Delivery/Quantity

Delivery Schedule

(1) In-Depth Study/Trial Task Progress Report

Electronic Monthly, 15 Calendar days after the completion of each full month in accordance with Article C.2 and as specified in the approved Task Order

(2) Draft Annual Study/Trial Progress Report

Electronic Annually, Provide a draft to the Contracting Officer and COR twenty

(20) calendar days prior to the annual study/trial report delivery date.

Provide detail in accordance with Article C.2

(3) Annual Study/Trial Progress Report

Electronic & one (1) Hardcopy

Annually, Due within 30 calendar days after the anniversary date of the contract each year.

Provide detail in accordance with Article C.2

(4) Draft Annual Progress Report

Electronic Annually, Twenty (20) calendar days prior to the delivery date.

Provide detail in accordance with Article C.2

(5) Annual Progress Report Electronic & one (1) Hardcopy

Annually, Due within 30 calendar days after the anniversary date of the contract each year.

Provide detail in accordance with Article C.2

(6) Draft Final Study/Trial Progress Report

Electronic Twenty (20) calendar days prior to the final study/trial progress report delivery date.

Provide detail in accordance with Article C.2

(7) Final Study/Trial Progress Report

Electronic & one (1) Hardcopy

Six (6) months from date that data is locked on each funded clinical trial (task order).

Provide detail in accordance with Article C.2

Amendment No.: 03

(8)

Draft Final Contract Progress Report

Electronic Twenty (20) calendar days prior to the final progress report delivery date. Provide detail in accordance with Article C.2.

(9) Final Contract Progress Report

Electronic & one (1) Hardcopy

Due on or before the completion date of the contract. Provide detail in accordance with Article C.2

(10) Summary of Salient Results

Electronic & one (1) Hardcopy

With each final study progress report and with the final contract progress report, in accordance with Article C.2

(11) Roster of Employees Requiring Suitability Investigations (including status updates on background investigations)

Electronic Within 14 calendar days of the effective date of the Contract and within 14 days of new contractor or subcontractor employees added to contract. In accordance with Article C.2 and Article H.19

(12) IT Security Plan (IT-SP) Electronic & one (1) Hardcopy

Within 30 days after award of the contract, in accordance with Article C.2 and Article H.19

(13) IT Risk Assessment (IT-

RA)

Electronic & one (1) Hardcopy

Within 30 days after contract award and annually thereafter, as per Article H.18.D.c.2.

In accordance with Article C.2 and Article H.19

(14) FIPS 199 Assessment Electronic & one (1) Hardcopy

Within 30 days, in accordance with H.19

(15) IT Security Certification and Accreditation (IT-

SC&A)

Electronic & one (1) Hardcopy

Within 3 months after contract award, in accordance with Article H.19 and Article C.2

(16) Employee Separation Checklist/Reporting of New and Departing Employees

Electronic In accordance with Article H.19

(17) Contractor – Employee Non-Disclosure Agreements

Electronic As applicable, within 60 days of contract award and within 60 days from new Contractor and/or subcontractor employees’ dates of hire. In accordance with Article C.2 and Article H.19

(18) Vulnerability Scanning Reports

Electronic Monthly, in accordance with Article C.2 and Article H.19

(19) Information Security Training and Report

Electronic Report to be submitted within 30 calendar days of contract award; and within 30 days of new contractor/subcontractor employee hire dates, and annually in with the Annual Progress Report. In accordance with Article H.19

(20) Section 508 Annual Report

Electronic Annually, with the corresponding Annual Progress Report and with the Final Report, in accordance with Article C.2 and Article H.20

(21) Final Data Set(s) and Other Material(s)

Electronic & one (1) Hardcopy

Within six (6) months from date data is locked on each clinical trial.

Provide in accordance with Article C.2

(22) Registration and reporting results to ClinicalTrials.gov

Submission at www.ClinicalTrials.gov

In accordance with Article H.5

(23) Minutes of Project Meetings

Electronic Weekly, and/or as meetings are held, in accordance with Article C.2

(24) Administrative Task Reports

Electronic Monthly, 15 Calendar days after the completion of each full month. In accordance with Article C.2

(25) Recruitment Reports Electronic Twice monthly, in accordance with Article C.2

(26) DSMB Reports Electronic Thrice yearly (April, August, and December) or as determined by the COR. In accordance with Article C.2 and Article H.4

(27) Annual Reports for Gender/Minority Tracking

Electronic & one (1) Hardcopy

Annually with the Annual Technical Progress Report.

Provide a total contract summary of these reports with the final study and contract reports. In accordance with Article C.2 http://www.clinicaltrials.gov/�

(28) Required Education – Protection of Human Research Participants

Electronic Prior to substitution of the Principal Investigator of other individuals, in accordance with Article H.3

(29) Small Business Subcontracting Reports

Submission at:

http://www.esrs.gov

Semi-annually, on April 30th (individual report) and October 30th (individual report and summary report) and at contract expiration (final report), in accordance with Article H.18

(30) Invention Reporting Requirement

Electronic & one (1) Hardcopy

Annually with the Annual Progress Report and with the Final Contract Progress Report. In accordance with Article C.3

(31) Government Property Report

Electronic If Government Property is authorized by Task Order, report will be due annually, with the Annual Study/Trial Progress Report. In accordance with Article G.7

2. In accordance with FAC 2005-55, effective February 2, 2012, the Solicitation Document (RFP) has been revised as follows:

A. Articles and Items throughout the Solicitation (RFP) Document have been updated to change the term Contracting Officer’s Technical Representative (COTR) to Contracting Officer’s Representative (COR).

B. ARTICLE B.4. PROVISIONS APPLICABLE TO DIRECT COSTS has been revised to add 1) Conferences & Meetings; 2) Food for Meals, Light Refreshments, and Beverages, and 3) Promotional Items.

C. ARTICLE H.7 SALARY RATE LIMITATION, HHSAR 352.231-70 (January 2010) has been revised in part as follows:

1. The title is changed to: ARTICLE H.7 SALARY RATE LIMITATION

2. The Schedule Level is changed from “Federal Executive Schedule Level 1” to

“Federal Executive Schedule Level II” which is applicable in FY12

D. ARTICLE H.28 USE OF FUNDS FOR CONFERENCES, MEETINGS AND FOOD has been added:

http://www.esrs.gov/�

ARTICLE H.28 USE OF FUNDS FOR CONFERENCES, MEETINGS AND FOOD

The Contractor shall not use contract funds to conduct meetings or conferences without prior written Contracting Officer approval.

In addition, the use of contract funds to purchase food for meals, light refreshments, or beverages is expressly prohibited.

The following conferences and/or meetings have been approved by the Contracting Officer and are hereby authorized under this contract:

Conference or Meeting Title

Conference or Meeting Location

Federal/NonFederal Space

Date of Conference

Not to Exceed

Estimate Cost

[ ] Federal [ ] NonFederal

E. ARTICLE H.29. USE OF FUNDS FOR PROMOTIONAL ITEMS has been added:

ARTICLE H.29. USE OF FUNDS FOR PROMOTIONAL ITEMS

The Contractor shall not use contract funds to purchase promotional items. Promotional items include, but are not limited to: clothing and commemorative items such as pens, mugs/cups, folders/folios, lanyards, and conference bags that are sometimes provided to visitors, employees, grantees, or conference attendees. This includes items or tokens given to individuals as these are considered personal gifts for which contract funds may not be expended

F. ARTICLE I.4.a FAR Clause 52.209-9, Updates of Publicly Available Information Regarding

Responsibility Matters (January 2011) has been deleted and replaced in its entirety as follows:

a. FAR Clause 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (February 2012)

(a) The Contractor shall update the information in the Federal Awardee Performance and Integrity Information System (FAPIIS) on a semi-annual basis, throughout the life of the contract, by posting the required information in the Central Contractor Registration database at https://www.acquisition.gov .

https://www.acquisition.gov/�

(b) As required by section 3010 of the Supplemental Appropriations Act, 2010 (Pub. L. 111- 212), all information posted in FAPIIS on or after April 15, 2011, except past performance reviews, will be publicly available. FAPIIS consists of two segments--

(1) The non-public segment, into which Government officials and the Contractor post information, which can only be viewed by--

(i) Government personnel and authorized users performing business on behalf of the Government; or

(ii) The Contractor, when viewing data on itself; and

(2) The publicly-available segment, to which all data in the non-public segment of FAPIIS is automatically transferred after a waiting period of 14 calendar days, except for--

(i) Past performance reviews required by subpart 42.15;

(ii) Information that was entered prior to April 15, 2011; or

(iii) Information that is withdrawn during the 14-calendar-day waiting period by the Government official who posted it in accordance with paragraph (c)(1) of this clause.

(c) The Contractor will receive notification when the Government posts new information to the Contractor's record.

(1) If the Contractor asserts in writing within 7 calendar days, to the Government official who posted the information, that some of the information posted to the non-public segment of FAPIIS is covered by a disclosure exemption under the Freedom of Information Act, the Government official who posted the information must within 7 calendar days remove the posting from FAPIIS and resolve the issue in accordance with agency Freedom of Information procedures, prior to reposting the releasable information. The contractor must cite 52.209-9 and request removal within 7 calendar days of the posting to FAPIIS.

(2) The Contractor will also have an opportunity to post comments regarding information that has been posted by the Government. The comments will be retained as long as the associated information is retained, i.e., for a total period of 6 years. Contractor comments will remain a part of the record unless the Contractor revises them.

(3) As required by section 3010 of Pub. L. 111-212, all information posted in FAPIIS on or after April 15, 2011, except past performance reviews, will be publicly available.

(d) Public requests for system information posted prior to April 15, 2011, will be handled under Freedom of Information Act procedures, including, where appropriate, procedures promulgated under E.O. 12600.

G. SECTION L.1 General Information, Subparagraph o. Promoting Efficient Spending has been added:

k. Promoting Efficient Spending

On September 21, 2011, the Office of Management and Budget issued Memorandum M-11-35 , entitled, "Eliminating Conference Spending and Promoting Efficiency in Government," emphasizing the President's priority to ensure that the Government operates with the utmost efficiency and eliminates unnecessary or wasteful spending. This was followed by the Executive Order on Delivering an Efficient, Effective, and Accountable Government ( EO 13576 ) and the Executive Order on Promoting Efficient Spending ( EO 13589 ). On January 3, 2012, the Department of Health and Human Services (DHHS) issued the memorandum "HHS Policy on Promoting Efficient Spending: Use of Appropriated Funds for Conferences and Meetings, Food, Promotional Items, and Printing, and Publications" (See http://www.hhs.gov/asfr/ogapa/acquisition/effspendpol_memo.html ).

In support of these directives, the NIH issued a January 30, 2012, Memorandum, entitled, "NIH Guidance Related to the HHS Policies on Promoting Efficient Spending: Use of Appropriated Funds for Conferences, Conference Grants and Meetings, Food, Promotional Items, and Printing and Publications." (See http://oamp.od.nih.gov/ )

Any contract awarded as a result of this solicitation will:

a. Specifically prohibit the use of contract funds for the provision of food for meals, light refreshments and beverages for any NIH funded meeting or conference; and

b. Limit the procurement of meeting space, promotional items, printing and publications.

H. SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF

OFFERORS, Part 1, Pages 1- 3, Annual Representations and Certifications, FAR Clause 52.204- 8, has been updated in accordance with Item II of FAC 2005-55.

I. SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF

OFFERORS, Part 2, Page 4, Information Regarding Responsibility Matters, FAR Provision 52.209-7 has been updated in accordance with Item II of FAC 2005-55.

3. Responses to Questions #7 and #17 of Amendment #02 to the Solicitation Document (RFP) have been revised:

Question #7: Is a “letter of intent” requested?

Revised Response to Question #7 of Amendment #02: Yes, a letter of intent is required from the institution submitting the proposal (the Offeror).

Question #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?

http://www.whitehouse.gov/sites/default/files/omb/memoranda/2011/m11-35.pdf� http://www.whitehouse.gov/the-press-office/2011/06/13/executive-order-delivering-efficient-effective-and-accountable-governmen� http://www.whitehouse.gov/the-press-office/2011/11/09/executive-order-promoting-efficient-spending� http://www.hhs.gov/asfr/ogapa/acquisition/effspendpol_memo.html� http://oamp.od.nih.gov/�

Revised Response to Question #17 of Amendment #02: No, co-Principal Investigators are not permitted. The responsibilities of the Contract-PI cannot be shared. Additionally, the Contract-PI must be an employee of the Offeror. Co-investigators may be proposed but only one Contract- Principal Investigator may be proposed.

4. 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)

a) Question 1: In Article B.1, Brief Description of Supplies or Services, it states “An Indefinite Delivery Indefinite Quantity Contract [singular] is anticipated.” However in Section L – Instructions, Conditions, and Notices to Offerors, a. Instructions to Offerors—Competitive Acquisition, (f) Contract Award, Item (6), the Solicitation states that “It is anticipated that one/multiple award will be made from this solicitation and that the award(s) will be made on/about 09/15/2012.on one/multiple awards. Does NIH intend to make only one or multiple awards?

If multiple awards are anticipated, how many awards does NIH desire to make?

Response to Question 1: NIMH intends to make one IDIQ award as stated in Article B.1, Brief Description of Supplies or Services. However, in the event that the Government determines that it would be in its best interest to make multiple awards, the following sections within the RFP allows flexibility to do so: Section L – Instructions, Conditions, and Notices to Offerors, a.

Instructions to Offerors—Competitive Acquisition, (f) Contract Award, Item (6), and Section L., 1.

General Information, c. Type of Contract and Number of Awards, 1.

b) Question 2: The Past Performance Survey in Attachment 7 of the RFP provides sample requests to be sent to “Offeror’s clients.” Does NIH prefer past performance questionnaires from the Prime’s contracts only, or both Prime and subcontractor’s past performance?

Response to Question 2: It is preferred that the past performance questionnaires (Attachment 7 to the RFP) be received from both the Offeror’s clients and those Subcontractors that are expected to exceed $650,000 for the total duration three-year period of contract performance.

c) Question 3: Section L., 2. Instructions to Offerors, a. General Instructions, Introduction, Item 11.

entitled “Selection of Offerors,” states “The acceptability of the scientific and technical portion of each research contract proposal will be evaluated by a technical review committee.” Will NIH be conducting both internal and external reviews? Please elaborate on the review process.

Response to Question 3: NIMH will convene an ad hoc scientific peer review group (i.e., Technical Evaluation Panel, also referred to as Technical Evaluation Committee) to conduct an initial review evaluating and scoring the technical proposals using the evaluation factors listed in Section M., and Attachment 9, Technical Evaluation Criteria of the RFP. Refer to those sections for information on the order of relative importance and weights assigned for evaluation purposes. Proposals will be judged solely on the written material provided by the Offeror.

Response to Question 3 (Continued): Additionally, a second level internal review will be conducted of the technical proposal as well as the business proposal in accordance with Section M., Evaluation Factors for Award. This includes evaluation of four factors as stated in Section M.

Note: Section M – Evaluation Factors for Award, Item 1. General states: “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.”

d) Question 4: Pages 15-16 of Attachment 3, Statement of Work specifies that the trial estimates for POCM, FIH, and POC trials will be 30, 8 and 30 respectively. Are those numbers the expected number of subjects to be expected in the Task Order RFPs?

Response to Question 4: The Trial Metrics stated in the Section III, O. Trial Timelines, Statement of Work, are only estimates. The actual number of subjects required for each clinical trial performed under this initiative will depend on various factors, including what compound to be tested, what type of trial (i.e., Phase Ia, Phase Ib, Phase IIa), type of trial design, etc.

e) Question 5: Attachment 9, Technical Evaluation Criteria (Section M) states that Sample Tasks 2 and 4 are to be included in the Technical Approach section of the Technical Proposal. The budgets for Sample Tasks 2 and 4 are also to be included in the Business Proposal. The Solicitation does not specify whether Task 1, 3, & 5 are also to be included in both the Technical and the Business Proposal or just within the Business Proposal only. Will NIH please provide direction on preferred proposal location of Administrative Task 1, and Sample Tasks 3 and 5?

Specifically, do Tasks 1, 3 and 5 go in the Business Proposal only?

Response to Question 5: Two different RFP Attachments need to be used for submission of the Sample Task Budgets.

(1) Sample Task Budgets 1 – 5 are to be included as part of the Business Proposal using Attachment 14, Breakdown of Proposed Estimated Costs (plus fee) w/Excel Spreadsheet (link provided in Section J, Business Proposal Attachments). This document requires entry of all cost categories and all costs including both direct and indirect costs. A total estimated contract or total sample task budget is not required. Instead, submit each Sample Task Budget (1 – 5) separately including all relevant costs based upon your Technical Approach and Infrastructure. Refer to Attachment 5, Sample Tasks, for cost assumptions and important details when completing these five (5) individual Sample Task budgets. Also refer to Attachment 6, Additional Technical and Business Proposal Instructions.

(2) Only the direct costs for Sample Tasks 2 and 4 are to be submitted with the Technical Proposal using Attachment 10: Technical Proposal Cost Summary (link to the document is provided in Section J. Technical Proposal Attachments). This document is for direct costs only and will be reviewed by the Peer Reviewers but will not be scored by the Peer Reviewers.

(3) Detailed protocols are required for Sample Tasks 2 and 4 and these are to be included in the Technical Proposal as they will be evaluated and scored in accordance with Attachment 9, Technical Evaluation Criteria.

Response to Question 5 Continued:

Response to Item (3) continued: Also refer to Attachment 6, Additional Technical and Business Proposal Instructions.

(4) Sample Tasks 1, 3 and 5 are to be submitted with the Business Proposal only.

As indicated in RFP Attachment 5, Sample Tasks:

“Sample Tasks 3 and 5 represent examples of how NIMH expects the Contractor will perform FIH and POCM clinical trials in the central nervous system. The examples, however, do not necessarily represent the appropriate measures for specifically testing Risperidone response. Cost estimates for Sample Tasks 3 and 5 will be used for cost estimate comparison purposes. Protocols and cost estimates for Sample Tasks 2 and 4 will be used to evaluate technical competence.”

f) Question 6: It is our understanding that no in-patient services are anticipated under this contract.

Is our understanding correct?

Response to Question 6: The type of services that will be required for each clinical trial performed under this imitative will depend on the nature of the compounds tested. Hence, it is preferred that each FAST-performance site have the Clinical Facility with both inpatient and outpatient capability where the clinical research is to be performed. To allow optimal opportunities to perform clinical trials under this contract, each FAST- site should have adequate facilities, equipment, support staff, and services to conduct early phase clinical trials. Refer to Attachment 3, Statement of Work, Section II, FAST Organizational Structure, B. Fast-PS Infrastructure, b.

Facilities.

g) Question 7: Section L., 2. Instructions to Offerors, c. Business Proposal Instructions, Item 10.

Extent of Small Disadvantaged Business Participation states that the authorized NAICS Industry Subsectors are identified elsewhere in the RFP. During a search, the only reference I found was to NACIS found in Section L., 1. General Information, Instructions to Offerors, b. NAICS Code and Size Standard. I do not believe this is the same as Industry Subsectors. Please advise where the Industry Subsectors are identified.

Response to Question 7: The Industry Subsectors were not stated elsewhere in the RFP. Item

10. Extend of Small Disadvantaged Business Participation has standard language included within. For this Research and Development requirement NAICS Industry Subsectors that are in support of a Research and Development requirement are authorized. Examples of subsectors that are permissible are: Subsector 541 – Professional, Scientific and Technical Services, Subsector 561 – Administrative and Supportive Services. There may be others depending upon the technical approach proposed by the Offeror. It is up to the Offeror to determine the appropriateness of other industry subsectors that may be appropriate for subcontracting under this Research and Development requirement. The NACIS code for this requirement is 541711;

Research and Development in Biotechnology. This is different from the Industry Subsectors. The list of subsectors can be located at http://www.sba.gov/size, “Small business size standards”;

“Table of Small Business Size Standards”; select either pdf file/excel file) to view the complete listing of industry subsectors.

http://www.sba.gov/size�

h) Question 8: We are confused about what is required in the Business Proposal for the Industry Subsector targets which are evaluated prior to determination of the competitive range versus the Draft Small Business Subcontracting Plan which will be negotiated with those Offerors within the competitive range.

Response to Question 8:

As indicated in Section M., Item 8. Extent of Small Disadvantaged Business Participation of the RFP, the Offeror's SDB Participation targets will be used in determining the relative merits of the Offeror's proposal and in selecting the Offeror whose proposal is considered to offer the best value to the Government. Refer to the information provided within Item 8. as the targets will be evaluated before determination of the competitive range based upon the six items listed (a. – f.).

Subsector 541 – Professional, Scientific and Technical Services and Subsector 561 – Administrative and Supportive Services are potential targets for the Small Disadvantaged Participation Plan. Additional potential targets may be appropriate depending upon the Offeror’s technical approach. The list of industry subsectors can be located at http://www.sba.gov/size, “Small business size standards”; “Table of Small Business Size Standards”; select either pdf file/excel file) to view the complete listing of industry subsectors. It is up to the Offeror to determine the appropriateness of other industry subsectors that may be appropriate for subcontracting under this Research and Development requirement.

Section L., 1. Instructions to Offerors, c. Business Proposal Instructions, Item 10. Extend to Small Disadvantaged Business Participation, provides an example of what should be provided within the Business Proposal for evaluation of the Extent of Small Disadvantaged Business Participation (evaluated prior to determination of the competitive range as indicated in Section M., Item 8.

Attachment 6, Additional Technical and Business Proposal Instructions provides additional details regarding completion of the Small Business Subcontracting Plan, which can be found in Section J., Business Proposal Attachments, Attachment 16. From the link provided, a Word version of the plan can be obtained. The Small Business Subcontracting plan will be negotiated with those Offerors in the Competitive Range.

The template for the Small Disadvantaged Business Subcontracting Plan document can be obtained from the link provided for Attachment 16, Business Proposal Attachments in Section J. of the RFP. As per page 5 of the Small Business Subcontracting Plan, the Offeror should list the “Products and/or Services” that will be subcontracted out and select which business type will be utilized. Additionally, the Offeror should provide a description of the products and/or services when completing item j. on page 5 of the plan. When evaluating the plan, the Government will review the technical approach proposed and determine what activities could potentially be subcontracted out to small businesses.

i) Question 9: It stated on the RFP that "no NIH Fiscal Year 2012 (October 1, 2011 - September 30, 2012) funds may be used to pay the direct annual salary of an individual through any contract awarded as a result of this solicitation at a rate in excess of the Executive Schedule, Level I* (direct salary is exclusive of Overhead, Fringe Benefits and General and Administrative expenses, also referred to as "indirect cost" or "facilities and administrative (F&A) costs")."

However, NIH website published "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." Could you please let us know which salary cap (level I or II) should be used for the proposal?

http://www.sba.gov/size�

Response to Question 9: The correct amount is $179,700. This Amendment #03, published on March 14, 2012 revised the Salary Limitation Clause. Also refer to Question #25 of Amendment 2 published on March 07, 2012 on www.fbo.gov for more details.

j) Question 10: If we have a compound that we would like to propose for testing under any resultant contract, what should we do?

Response to Question 10: Contract award is anticipated in September, 2012. It is likely that after award both NIMH and the Successful Offeror will consult industry regarding potential compounds for testing through this contract mechanism. Contact the Contract Specialist:

jacobsonmj@mail.nih.gov if you would like to be contacted regarding ideas and or information on potential compounds to be tested.

k) Question 11: Is it too late to send in the Proposal Intent form, Attachment 2 to the RFP?

Response to Question 11: No. If you intend to submit a proposal, please email the document to Jacobsonmj@mail.nih.gov. This assists NIMH with planning.

l) Question 12: We read Question #7 of Amendment #2 published on March 07, 2012 to www.fbo.gov which indicated that a proposal intent form is required from the institution submitting the proposal and from each subcontractor proposed. The RFP does not reference that subcontractors need to submit a proposal intent. If we include a list of the subcontractors as the form requires, but not a separate proposal intent form for each, is this sufficient?

Response to Question #12: Yes. Only the Offeror needs to submit the proposal intent document (Attachment #2). The names of the proposed Subcontractors, e.g. Collaborating Institutions and Co-investigators (include Subcontractors and Consultants) should be listed on the document. The response to Question #7 of Amendment #2 published on March 07, 2012 was revised in this Amendment #03 published on March 14, 2012 to www.fbo.gov.

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