RFP_Amendment_01_(Signed).pdf

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

OMB No. 0990-0115

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES

1 5

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

01 See Block 16C

6. ISSUED BY CODE MRN 7. ADMINISTERED BY (If other than Item 6) CODE

NIDA Section, Contracts Management Branch Blue Office of Acquisition, NIDA 6001 Executive Boulevard, Room 4211 – MSC 9559 Bethesda, Maryland 20892-9559

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

To All Potential Offerors

9A. AMENDMENT OF SOLICITATION NO.

NIHDA201800364

9B. DATED (SEE ITEM 11)

October 2, 2018

10A. MODIFICATION OF CONTRACT/ORDER NO.

CODE FACILITY CODE 10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer 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 Item 8 and 15, and returning 1 copies of the amendment; (b) 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 ACKNOWLEDG- MENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hours and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (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 data, etc.) SET FORTH IN ITEM 14, 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.)

PURPOSE: To respond to formal questions submitted in response to the solicitation. All other terms and conditions of the Request for Proposal (RFP) remain unchanged.

Proposal Due Date: 3:00 p.m. (Eastern) on November 16, 2018 (UNCHANGED)

Note: The offeror should acknowledge on the cover page or first page of its business and technical proposals receipt of the RFP and this Amendment.

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)

Andrew R. Hotaling, Contracting Officer, NIDA Section, CMB Blue

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)

29 OCT 2018

Request for Proposal Amendment No. 01 NIHDA201800364 Page 2 of 5

RESPONSES TO QUESTIONS

QUESTION 1: Page 1 states that the proposal is due Friday November 16 but three paragraphs below that (in the bold section), it states “It is anticipated that the initial performance period will start on or around February 2018.” Would this possibly be February 2019?

ANSWER 1: Yes. It is anticipated that the initial performance period will start on or around February 2019. For more information, see ARTICLE F.1. Period of Performance.

QUESTION 2: Would point-of-care rapid tests fit the requirement of this RFP?

ANSWER 2: Point-of-care rapid tests are not sufficiently precise or discriminating for this requirement. As noted in the Statement of Work, “The concentrations of such drugs and metabolites usually appear in biological materials at ng/g or ng/ml levels and therefore require the use of state of the art chromatography methods for separation and highly sensitive instrumentations for identification and quantification, such as gas chromatography-mass spectrometry (GC-MS), liquid chromatography-mass spectrometry (LC-MS), and LC-MS-MS.” See ARTICLE C.1. STATEMENT OF WORK and Attachment 03 for more information.

QUESTION 3: What kind of organization qualifies for offeror? We are a small business, can we submit a proposal?

ANSWER 3: Although this requirement has not been set-aside for small businesses, small businesses are encouraged to submit proposals. See also SECTION L.1.b.

QUESTION 4: What is the budget cap? (any guideline?)

ANSWER 4: There is no specified budget cap. However, as noted in SECTION M.1. of the RFP states, “All evaluation factors other than cost or price, when combined, are significantly more important than cost. The Government intends to make an award to that offeror whose proposal provides the best overall value to the Government.” For information concerning estimated level of effort, see SECTION F.3. LEVEL OF EFFORT and SECTION L.1.d LEVEL OF EFFORT.

QUESTION 5: I am inquiring about the submission process as this appears to be a formalized contract more so than the traditional written NIH format of a R-type grant. Is there a specified format for proposal of capabilities, method development scope, etc. or are the technical and business proposal documents the only components?

ANSWER 5: As noted in the RFP, “It is contemplated that a cost-reimbursement (level of effort) type contract will be awarded.” This RFP will not result in a grant. Offerors should refer to SECTION L – INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS and Attachment 1 – Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website for more information.

NIHDA201800364 Page 3 of 5

QUESTION 6: On pages 57-59, in the Business Cost Proposal instructions, FAR 52.215-20 is included. Historically, this is something that has been required of us at the time of award as opposed to the part of the proposal submission. Can you clarify if that would be the case for this RFP, or if we will be required to provide cost certification at the proposal submission stage?

ANSWER 6: Certified cost or pricing data is not required; however, data other than certified cost or pricing data is necessary to help establish price reasonableness or cost realism. Offerors should submit such information with the proposal pursuant to SECTION L.2.c.3 Data Other than Certified Cost or Pricing Data and SECTION L.2.c.4 Requirements for Certified Cost or Pricing Data and Data Other than Certified Cost or Pricing Data, FAR Clause 52.215-20 (October 2010) of the RFP.

QUESTION 7: On pg. 50 it is mentioned that a list of three contracts information are required to be submitted with the business proposal. Is this requirement mandatory? What is not clear is the alternatives the offeror (in this case the PI) could submit if he has not done any contract research (exceeding the 100 K amount) in the past with any government or non-government agency? However, it should be noted that the PI had two previous NIH R01 award. Will the information on these two R01 awards will be considered as a supporting document alternative to the contract research to evaluate the past performance?

ANSWER 7: Offerors are required to submit past performance information as described in SECTION L.2.a.14 of the RFP which states, “Offerors shall submit the following information as part of their Business proposal. A list of the last 3 contracts completed during the past three years and all contracts currently being performed that are similar in nature to the solicitation workscope. Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial concerns. Offerors may also submit past performance information regarding predecessor companies, key personnel who have relevant experience or subcontractors that will perform major or critical aspects of the requirement when such information is relevant to the instant acquisition. For the purposes of this solicitation, a "major subcontract" is defined as a subcontract with a dollar value exceeding $100,000.”

Offerors shall submit relevant past performance information, which includes past performance information of proposed key personnel (such as PIs). The NIH Research Project Grant Program (NIH R01) grant awards are not contracts required to be submitted with the business proposal.

Additionally, as noted in SECTION M, paragraph 8., of the RFP, “The lack of a relevant performance record may result in an unknown performance risk assessment, which will neither be used to the advantage nor disadvantage of the offeror.”

QUESTION 8: If the requirement mentioned on the past performance mentioned on Question 7 above is not acceptable, then please clarify if the organization could submit the past performance of its contracts (with other than the current PI of this proposal).

ANSWER 8: Yes. See Answer to Question 7.

NIHDA201800364 Page 4 of 5

QUESTION 9: Is there any page limitation or requirement for format and pagination for the technical section of the proposal?

ANSWER 9: There are no page limitations or specific pagination requirements for this requirement. However, Offerors should refer to SECTION L – INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS and ATTACHMENT 1, "Packaging and Delivery of the Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website" for more information.

QUESTION 10: Objectives: pg. 54. Do the objectives of the proposal have to be exactly the same as the requirement for the analysis of listed drug of abuse? For example, how many drugs of abuse from the list mentioned in the RFP does NIDA expect for quantitative analysis in the first year?

ANSWER 10: Offerors should include in the technical proposal objectives as described in SECTION L.2.b.1.a.1 of the RFP: “State the overall objectives and the specific accomplishments you hope to achieve. Indicate the rationale for your plan, and relation to comparable work in progress elsewhere. Review pertinent work already published which is relevant to this project and your proposed approach. This should support the scope of the project as you perceive it.” Additionally, the list of drugs of abuse to be analyzed will vary for a particular year depending on NIDA’s requirements. For proposal purposes, please provide a list of drugs of abuse that are presently validated in your laboratory with an LLOQ of at least 1 ng/mL. See SECTION L.2.b. and pages 3-4 of Attachment 03 for more information.

QUESTION 11: Should the objectives of the contract be defined for one year or for all five years of the proposed contract? Is there a requirement to outline specific aims of the proposal separately?

ANSWER 11: As stated in SECTION L.2.b., “A detailed work plan must be submitted indicating how each aspect of the statement of work is to be accomplished.” See SECTION L.2.b. for more information.

QUESTION 12: Methods: pg 54. The definition of method is not clear. The discussion on the proposal should be a general analytical methodology or there should be a specific protocol and methodology that should be discussed for the analysis of each drug of abuse listed in the RFP? Does the contractor need to specify details on the sample preparation protocol for all biological specimen in the method section?

ANSWER 12: As stated in SECTION L.2.b., “Your technical approach should be in as much detail as you consider necessary to fully explain your proposed technical approach or method.” The general bioanalytical methodology, such as LC-MS/MS, GC-MS/MS, or LC with electrochemical detection is appropriate. The required lower limits of quantitation for THC and cocaine plus their metabolites are listed. LLOQ for the other drugs listed (eg., morphine, naltrexone, LAAM) should be in the same range. Examples

NIHDA201800364 Page 5 of 5 of Offeror’s bioanalytical results in the literature would also be helpful in determining the Offeror’s qualifications. See SECTION L.2.b. for more information.

QUESTION 13: While the PI has the required registration from both Federal and State to conduct research on Class II to V controlled substances, it is not clear what documentation/evidence has to be provided in this proposal to demonstrate that the PI could obtained a registration for Class I substances?

ANSWER 13: The Offeror is required to provide information which documents and/or supports that it can meet the following mandatory qualification criteria: “In order to handle substances under the Controlled Substances Act of 1970, it is mandatory that offerors possess a Drug Enforcement Administration (DEA) Registration for Chemical Analysis or Research Registration for Schedules II to V and demonstrate the capability to obtain a DEA registration for Schedule I controlled substances.” See SECTION M.3 for more information.

QUESTION 14: Is it OK to identify graduate students (pursuing MS. or Ph.D) with 100% effort as key personnel in the project who could assist the PI in this proposal?

ANSWER 14: It is in the Offeror’s discretion to propose direct labor, including key personnel and non-key personnel, as the Offeror deems necessary to perform the Statement of Work. However, as described in ARTICLE G.2. KEY PERSONNEL, key personnel “are considered to be essential to work performance” and require additional notification and contract modification prior to the addition or deletion of key personnel.