Amendment_1_FINAL.pdf

Amendment No. 1

NIAID-DAIDS-NIHAI2014002

“Clinical Pharmacology Quality Assurance (CPQA)”

Solicitation Number: NIAID-DAIDS-NIHAI2014002

Amendment Number: One (1)

Amendment Issue Date: April 17, 2014

Proposal Due Date/Time: Wednesday, June 4, 2014 at 3:00 PM, Local Time (Unchanged)

Issued By: John R. Manouelian

Contracting Officer

OA/DEA/NIAID/NIH/DHHS

6700-B Rockledge Drive, Room 3214, MSC 7612 Bethesda, Maryland 20892-7612

Points of Contact: PRIMARY dena.nannetti@nih.gov Dena Nannetti, Contract Specialist Phone: 301.496.6424

SECONDARY

manouelj@mail.nih.gov John R. Manouelian, Contracting Officer Phone: 301.451.3694

Please note that we do NOT intend to extend the due date for submission of proposals as a result of this amendment. The date specified for receipt of proposals remains unchanged.

Offerors must acknowledge receipt of this Amendment by identifying this amendment number and date of the amendment on each copy of the proposal submitted. Failure to receive your acknowledgement may result in the rejection of your proposal. Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

AMENDMENT #1, RFP No. NIAID-DAIDS-NIHAI2014002 1 mailto:dena.nannetti@nih.gov mailto:manouelj@mail.nih.gov

The purpose of Amendment 1 is to: (1) revise the level of effort requirement to provide clarification regarding consultants and to correct an error in the table reflecting the level of effort required under the Options for Increased Level of Effort; (2) revise ATTACHMENT

5: ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS, SECTION 4 – OPTIONS,

so that it is more consistent with the information provided under SECTION L:

INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS, paragraph 1, General Information, subparagraph d., Level of Effort; (3) provide responses to questions received from potential offerors regarding the solicitation. As a result of the above revisions, the following areas of the solicitation are revised to read as follows:

SECTION L: INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS,

paragraph 1, General Information, subparagraph d., Level of Effort (found on pages 51-52 of the solicitation), is hereby amended to: (1) provide clarification regarding “consultant” effort; and (2) revise the table reflecting the number of full time equivalents required under the Options for Increased Level of Effort (all effort cited under Year 1 has been deleted, since the Options for Increased Level of Effort are only available to be exercised under Contract Years 2 through 7). As a result of the above, this item shall read as follows:

d. LEVEL OF EFFORT

The Government’s requirement for the work set forth in the Statement of Work of this solicitation is 8.85 Full Time Equivalents (FTEs) per year. The effort includes subcontractor effort and excludes consultant effort. It is estimated that the effort is constituted as specified below and will be expended approximately as follows:

Full Time Equivalents

Labor Category Base (Year 1)

Option 1 (Year 2)

Option 2 (Year 3)

Option 3 (Year 4)

Option 4 (Year 5)

Option 5 (Year 6)

Option 6 (Year 7)

Principal Investigator

0.25 0.25 0.25 0.25 0.25 0.25 0.25

Project Director and Other Professional Staff

2.90 2.90 2.90 2.90 2.90 2.90 2.90

Data Management

0.40 0.40 0.40 0.40 0.40 0.40 0.40

Research Techs. 5.20 5.20 5.20 5.20 5.20 5.20 5.20 Clerical 0.10 0.10 0.10 0.10 0.10 0.10 0.10 Totals 8.85 8.85 8.85 8.85 8.85 8.85 8.85 NOTE: While delivery of the total number of FTEs is a requirement for satisfactory performance of the contract, the labor mix provided above is the Government's estimate and should not be considered restrictive. Offerors should propose the labor mix they consider most appropriate for satisfactory performance of the work.

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OPTIONS FOR INCREASED LEVEL OF EFFORT – Increased Level of Effort for Additional Pharmacology Laboratories (Options 7-18):

During the course of the contract, it may be necessary to incorporate additional Labs to support new NIAID-supported clinical trials. Such an increase would require an increase in the Contractor's activities to be activated, at the discretion of the Government, as an Option.

Each Option of this type will implement work commensurate with the addition of one domestic or international Lab. Up to two Options per year may be exercised during years 2 through 7 of contract performance. If the Government elects to exercise these Options, the Contractor shall provide an additional 0.90 FTE per Option. The period of performance of an Option for Increased Services will not exceed the term of the Option year in which the Option is exercised. The effort includes subcontractor effort and excludes consultant effort. It is estimated that the level of effort is constituted as specified below and will be expended approximately as follows:

Full Time Equivalents

Labor Category Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Principal Investigator

0.02 0.02 0.02 0.02 0.02 0.02

Project Director and Other Professional Staff

0.12 0.12 0.12 0.12 0.12 0.12

Data Management

0.05 0.05 0.05 0.05 0.05 0.05

Research Techs. 0.70 0.70 0.70 0.70 0.70 0.70 Clerical 0.01 0.01 0.01 0.01 0.01 0.01 Totals 0.90 0.90 0.90 0.90 0.90 0.90 NOTE: While delivery of the total number of FTEs is a requirement for satisfactory performance of the contract, the labor mix provided above is the Government's estimate and should not be considered restrictive. Offerors should propose the labor mix they consider most appropriate for satisfactory performance of the work.

ATTACHMENT 5: ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS,

SECTION 4 – OPTIONS, is revised so that the table reflecting the full time equivalents required for the Options (Options 7-18) is more consistent with the corresponding table (for Options 7-18) provided under SECTION L: INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS, paragraph 1, General Information, subparagraph d., Level of Effort. As a result of the above, ATTACHMENT 5: ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS, SECTION 4 – OPTIONS, is revised. Please see revised Attachment, which is included with this Amendment.

AMENDMENT #1, RFP No. NIAID-DAIDS-NIHAI2014002 3

The following questions were received from potential offerors regarding the solicitation, including the Government’s response to each question:

Question 1:

Regarding Attachment 5 - Additional Business Proposal Instructions, Section 3 - Uniform Cost Assumptions, item 1.c.4 (found on page 3 of the referenced attachment of the solicitation) asks for the shipment of 1 mg AGRS/reference drug powder to one U.S. Lab and one non-U.S. Lab. AGRS/reference drug powders are normally obtained through NIH or through material transfer agreements, which prohibit the redistribution of such powders.

Please advise on how this re-shipment should be accomplished.

Response to Question 1:

The Contractor must abide by the policies contained within any agreement granted by the Provider of the AGRS/reference drug powders. For the purposes of estimating costs, the Offeror should assume only shipment costs. Any administrative (i.e., labor) costs associated with obtaining any material transfer agreements, if required, shall be accounted for within the Government’s stated level of effort requirement for this solicitation (see Section L:

INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS, paragraph 1, General Information, subparagraph d., Level of Effort). Attachment 5 – Additional Business Proposal Instructions, has also been revised to reflect this information and is included with this Amendment.

Question 2:

Regarding Attachment 3 – Statement of Work, Section 3 – Technical Requirements, item C.1.c) (found on page 5 of the referenced attachment of the solicitation), it states that the Contractor shall “acquire unidentifiable human tissue samples…”. Should the term “unidentifiable” be assumed to be equivalent to “de-identified”?

Response to Question 2:

No, offerors should not assume the term “unidentifiable” to be equivalent to “de-identified”.

“De-identifiable” is a particular example of how to make something unidentifiable, but does not hold the same meaning as “unidentifiable”. Therefore, the terms are not equivalent and cannot be interchanged.

Question 3:

Regarding Attachment 3 – Statement of Work, Section 3 – Technical Requirements, item E.

(found on page 7 of the referenced attachment of the solicitation), it states that “…the Contractor shall visit Labs and determine the degree of compliance with CLIA, cGCP, and other applicable federal, state and local regulations”. Should the level of cGCP be limited only to the specimen specific operations? Or should all cGCP detail be investigated (i.e., IRB consents, source documentation, etc.)?

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Response to Question 3:

The level of cGCP shall be limited to specimen specific operations. Attachment 3- Statement of Work has been revised to reflect this clarification and is included with the Amendment.

Question 4:

Regarding Attachment 3 – Statement of Work, Section 3 – Technical Requirements, the term “QC Standards” is not mentioned under item A. (found on page 2 of the referenced attachment of the solicitation). Whereas, item B.1.a) (found on page 4 of the referenced attachment of the solicitation) states that the Contractor shall “provide Labs with quality control (QC) materials similar to those described in Section A.2 above for drug stability studies. Further, Attachment 5 – Additional Business Proposal Instructions, Section 3 – Uniform Cost Assumptions, item 1)a.2. (found on page 2 of the referenced attachment of the solicitation) references the following activities: “Preparation of six sets of quality control standards…in…other appropriate non-plasma biomatrices…”. We question whether QC Standards belongs under item B. Support Assay Development, Validation, and Implementation rather than item A. Provide Pharmacology Proficient Testing (PT), of Section 3 – Technical Requirements of Attachment 3 – Statement of Work? Note: Within the Statement of Work, the QC Standards are listed as needed for stability studies, but not indicated as materials required for preparation by the Contractor. Please clarify.

Response to Question 4:

No, the reference to QC Standards does in fact belong under item A. Provide Pharmacology Proficient Testing (PT), of Section 3 – Technical Requirements of Attachment 3 – Statement of Work.

Question 5:

Regarding Attachment 3 – Statement of Work, Section 3 – Technical Requirements, item A.2.b) (found on page 3 of the referenced attachment of the solicitation) requires the Contractor to “confirm the quality (e.g., impurities) of all PT samples prior to distribution”.

Whereas, Attachment 5 – Additional Business Proposal Instructions, Section 3 – Uniform Cost Assumptions, item 1)a.3. (found on page 2 of the referenced attachment of the solicitation) references the following activities: “Prior to each PT round, pre-testing to determine accuracy of 25 representative PT samples…”. We question whether the term “quality” [under item A.2.b)] should be changed to “accuracy” (e.g., impurities)? Note: The terms “quality” and “impurities” are implied more in Attachment 3 – Statement of Work, Section 3 – Technical Requirements, item C.2. and Attachment 5 – Additional Business Proposal Instructions, Section 3 – Uniform Cost Assumptions, item 1)c.2.

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Response to Question 5:

No, the Government does not intend to change the term “quality” to “accuracy”, under Attachment 3 – Statement of Work, Section 3 – Technical Requirements, item A.2.b). We consider the terms “accuracy” and “impurity” to be components of the term “quality”.

Question 6:

Regarding Attachment 3 – Statement of Work, Section 3 – Technical Requirements, item B.1.b) (found on page 4 of the referenced attachment of the solicitation) requires the Contractor to “develop procedures that refine and improve sampling process, sample processing and storage of non-plasma biological samples”. Whereas, Attachment 5 – Additional Business Proposal Instructions, Section 3 – Uniform Cost Assumptions, item 1)b.2. (found on page 2 of the referenced attachment of the solicitation) references the following activities: “Development of one bioanalytical procedure/method each year at the Contractor’s facilities, which refines sample processing of cellular extract of peripheral blood mononuclear cells for drug analysis using HPLC-MS.” Though the wording is similar, the Statement of Work indicates preanalytical sampling handling and the uniform cost assumptions imply post-sampling and storage of the specimen and its analysis of the stored sample (cell lysate). Was the word “bioanalytical” an omission from the Statement of Work, or inadvertently included in the uniform cost assumptions? Please clarify.

Response to Question 6:

No, the word “bioanalytical” was not omitted from the Statement of Work [please note that the title of item B.1. of the Statement of Work, in which the referenced item 1. (i.e., item B.1.b) is located, is entitled, “Bioanalytical Assay Development”].

Question 7:

Regarding Attachment 5 – Additional Business Proposal Instructions, Section 3 – Uniform Cost Assumptions, item 1)c.2. (found on page 3 of the referenced attachment of the solicitation), it states the following: “Two analytical assessments on each lot of AGRS/reference drug powder for the purity in which up to 100 representative samples will be analyzed.” Are the words, “in which 100 representative samples will be analyzed” simply descriptive, such as 100 PT samples that will be analyzed by Labs? Or are the analyses of 100 samples part of the uniform cost assumptions in this statement? If the latter, what kind of samples will be analyzed (e.g., PT in which matrix)?

Response to Question 7:

The analyses of 100 samples are part of the uniform cost assumptions. These will be the samples of initial and periodic purity checks on each lot of AGRS or reference drug powders in appropriate solutions for analytical assessment. Attachment 5: ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS has been revised to reflect this clarification and is included with this Amendment.

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Question 8:

Regarding SECTION L: INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS, paragraph 1, General Information, subparagraph d., Level of Effort (found on pages 51-52 of the solicitation), is the effort for consultants included or excluded in these totals? If included, under which labor categories?

Response to Question 8:

No, the level of effort excludes consultant effort. The solicitation has also been amended, via this amendment, to provide this clarification.

Question 9:

How should effort be budgeted and broken down? Attachment 14 – Breakdown of Proposed Estimated Costs (plus fee) w/ Excel Spreadsheet states that you should “use the Labor – Percent of Effort worksheet if you track labor on a percent of effort basis…”. However, Attachment 9 – Technical Proposal Cost Summary asks for a breakdown of hours. Our organization tracks level of effort as a percentage of effort. Should our level of effort breakdown be provided in a percentage of effort format (as opposed to a labor hour format), even if the attachment directs the offeror to provide a breakdown of labor hours?

Response to Question 9:

Yes, offerors should provide their level of effort breakdown in a percentage of effort format.

Question 10:

How are Key Personnel defined? Should Key Personnel include only the Principal Investigator/Co-Principal Investigator or could consultants and/or other personnel (e.g., Additional Personnel, as listed under item 2.b.1.b.3. of Section L – Instructions, Conditions, and Notices to Offerors, found on page 69 of the solicitation) be considered as Key Personnel?

Response to Question 10:

Pursuant to HHSAR Clause 352.242-70, Key Personnel are considered essential to work performance and shall not be diverted without the written consent of the Contracting Officer (see ARTICLE G.2., KEY PERSONNEL, of the sample contract under PART I, THE SCHEDULE, SECTION G, of the solicitation). Key Personnel will be determined during negotiations.

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Question 11:

Regarding Section L – Instructions, Conditions, and Notices to Offerors, item 2.c.11.a.

Property (found on pages 80-81 of the solicitation), how is Government Property defined?

Specifically, does this include any property that has been purchased with Government funds?

Or is it equipment furnished by the Government and title to the equipment vests in the Government?

Response to Question 11:

Government Property can be considered both property that is Government-furnished or Contractor-acquired (i.e., purchased with Government funds and title is vesting with the Government). Please also see Attachment 7 – Contractor Acquired Property Under Predecessor Contract, which contains a listing of current property under the incumbent contract that will be transferred to any contract that is awarded as a result of this solicitation.

Question 12:

Regarding the Informational Attachments (Attachments 17-21) listed on page 45 the solicitation, are any of these attachments required to be included in the proposal submission?

If so, which ones are required?

Response to Question 12:

These attachments are for informational purposes only and are not required to be completed or included in the proposal submission. However, any contract that is awarded as a result of this solicitation will include these attachments and the contractor will be instructed on completion and submission of the attachments once the contract is awarded.

Question 13:

Regarding Article G.3. Invoice Submission/Contract Financing Request and Contract Financial Report, item a.2.d. (found on page 19 of the solicitation), it states that following:

“Invoice Matching Option. This contract requires a two-way match.” What is meant by “two-way match”?

Response to Question 13:

If a contract is awarded as a result of this solicitation, the Contractor is required to cite that the contract requires a “two-way match”, under the Invoice Matching Option field on the face page of all payment requests made as a result of any costs incurred in direct performance of this contract. The “two-way match” designation is an internal code that alerts the Office of Financial Management (OFM) of the National Institutes of Health (NIH) on how to process payment under this contract.

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Question 14:

Regarding Attachment 5 – Additional Business Proposal Instructions, Section 4 – Options (found on page 4 of the referenced attachment of the solicitation), how should offerors budget for the lab additions that result from the exercise of Options 7-18? Should offerors assume the addition of one new Lab (domestic or foreign) for each option? Or could one Lab continue for multiple years, and if so, would its renewal each year constitute as an option (meaning that in order to renew the lab each year, an option would need to be exercised)?

Response to Question 14:

As stated in Attachment 3 – Statement of Work, Section 3) item I., Options (found on pages 12-13 of the referenced attachment), Options 7-18 are related to increased level of effort needs associated with “unanticipated increases in demand for the activities supported by the base requirements of the contract”, which specifically includes the incorporation of additional pharmacology laboratories to support new NIAID-supported clinical trials.

During Contract Year 2, if Option 7 or 13 are exercised, it would constitute the addition of one new lab (either Domestic, if Option 7 is exercised, or International, if Option 13 is exercised). However, during Contract Years 3 through 7, any option of this type [i.e., Options 8-12 (one Domestic Lab each) and 14-18 (one International Lab each), respectively], could be for either the renewal of a Lab that was incorporated in a previous year, or for a new Lab (if a Lab exercised under a prior year is not renewed). However, it should be understood that the total effort associated with each option of this type (0.90 FTEs) is for one Lab, and no more than one Lab of each type (domestic or international) will exist during each Year for Options 7-18.

Question 15:

While reading the solicitation, we noticed certain instances (e.g., in Attachment 3 – Statement of Work, Attachment 5 – Additional Business Proposal Instructions, etc.) where the acronym “AGRS” (Analytical Grade Reference Standards) appears transposed to read as “ARGS”. Is this a typographical error or does the acronym “ARGS” represent something entirely different?

Response to Question 15:

This is a typographical error. All references to “ARGS” in the solicitation (including all attachments) are revised to read correctly as “AGRS”, which represents, “Analytical Grade Reference Standards”.

Question 16:

Is there a due date for any questions to be submitted regarding this solicitation?

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Response to Question 16:

As indicated on the face page of the solicitation, offerors are strongly encouraged to submit all questions regarding the solicitation by 3:00 pm (local time) on 05/05/2013, so that we can provide timely responses before proposals are due. The Government does not intend to extend the due date for proposal submission.

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