N01DA-16-5582_RFP_Amendment_1.pdf

“Population Assessment of Tobacco and Health (PATH) Study”

AMENDMENT OF SOLICITATION NO.: RFP-N01DA-16-5582

AMENDMENT NO.: 1

EFFECTIVE DATE: May 18, 2015

ISSUED BY:

National Institute on Drug Abuse, NIH Office of Acquisitions NIDA R&D Contracts Management Branch 6001 Executive Boulevard Suite 4211 MSC 9559 Bethesda, Maryland 20892-9559

Point of Contact: Brian H. O’Laughlin, Contracting Officer (E-mail: olaughlinb@mail.nih.gov)

Philip J. DeCastro, Contract Specialist (E-mail: decastropj@mail.nih.gov)

NAME AND ADDRESS OF CONTRACTOR: To All Offerors

The above numbered solicitation is amended as set forth below. The hour and date specified for receipt of Offers is NOT extended. Offerors must acknowledge receipt of this amendment on each offer submitted. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter, provided each letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

DESCRIPTION OF AMENDMENT (Organized by Uniform Contract Format (UCF) section headings, including solicitation contract subject matter where feasible)

PURPOSE: to revise and clarify some Request for Proposals (RFP) provisions and requirements by responding to questions submitted under the RFP. Unless specifically noted, all specifications remain unchanged.

The following responds to questions received under this solicitation.

QUESTION 1: The RFP does not include a requirement to plan for the storage of extant biospecimen samples collected in Waves 1 through 3. Should continued storage of biospecimen samples collected in Waves 1 through 3 be planned for in the budget?

ANSWER 1: Yes, continued storage of biospecimen samples collected in Waves 1 through 3 should be planned for in the budget.

Request for Proposal Amendment 1 N01DA-16-5582 Page 2 of 6 QUESTION 2: Task 5.6 of the Statement of Work (SOW) (Attachment 3) instructs the Contractor to plan for “the shipment of selected biospecimens from the repository to one or more analytic laboratories.” The cost of shipping to the analytic labs depends on the number of different assays (e.g. nicotine metabolites; creatinine; etc.) that will be conducted in the various laboratories, but that number is not provided in Section 5.6. How many assays should be planned for?

ANSWER 2: An Offeror should plan for 8 assays.

QUESTION 3: Task 5.6 Biospecimen Processing, Shipment, Storage, and Analysis of the SOW (Attachment 3): The RFP requires these activities for “(1) the urine and blood samples collected from aged-up 18 year olds in Wave 4 and from aged up 18 year olds and 19 year olds in Waves 5, 6, and 7; (2) the urine samples collected from a subsample of 11,000 continuing adult participants in each of Waves 4 through 7; and (3) the urine samples collected from a subsample of 5,500 continuing youth and/or aged-up youth in each of Waves 4 through 7.” This list does not seem to include any provision for specimens from replenishment sample in Waves 4 and 6.

Should the Contractor also plan for these as well?

ANSWER 3: The SOW states that the arrangements under Task 5.6 may vary from wave to wave. However, as specified, an Offeror should plan to make these arrangements for the three activities listed above and in the RFP in Task 5.6.

QUESTION 4: Task 5.5 Response Rates for Biospecimens, Wave 5 of the SOW (Attachment 3):

The RFP states: “The Contractor shall achieve a response rate of 77.4 percent for buccal cells,

77.4 percent for blood samples, and 77.4 percent for urine samples collected among continuing adults who also provided buccal cells, blood samples, and urine samples at baseline (i.e., Wave 1).” Does this refer only to individuals who provided all three specimens at baseline or does it refer to each specimen individually, whether or not the adult provided the other specimens?

ANSWER 4: This refers to each specimen individually, whether or not the adult provided the other specimens.

QUESTION 5: The RFP stipulates that each of the options 9-15 may be exercised, in varying numbers, in the base period and “any one of the eight Option Periods.” Can you confirm that this means each option may be exercised repeatedly in each of the eight option periods and not in only one of the eight periods?

ANSWER 5: Correct, for options 9-15, each option may be exercised repeatedly in each of the eight option periods. For example, option 9 may be exercised up to a total of 25 times in the base period and may be exercised up to another 25 times in each of the eight option periods as well.

N01DA-16-5582 Page 3 of 6 QUESTION 6: For each of the options 9-15, the solicitation provides estimated levels of effort for planning purposes. However, it is unclear to us how these should be treated in the budget/business proposal. Should we assume one exercise of each option, or multiple exercises of the option(s) (for example the RFP states that Option 9 may be exercised “up to 25 times in the base period”)?

ANSWER 6: In accordance with RFP Section M.5. Evaluation of Options, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement, except when it is determined not to be in the Government’s best interests. Evaluation of options will not obligate the Government to exercise the options.

QUESTION 7: Options 9, 10, and 12 have periods of performance of 2 years; Options 13, 14, and 15 have periods of performance of 3 years. If Options 9, 10, or 12 are exercised in Option Period 8, and Options 13, 14, or 15 are exercised in Option Periods 7 or 8, that would require their periods of performance to extend beyond the November 30, 2024, end date of Option Period 8. For planning and scheduling purposes, should we assume there would be no-cost extensions if these options are exercised in the final option periods of the contract, e.g., potentially to November 30, 2026 at the latest?

ANSWER 7: The Government cannot guarantee extensions, so an Offeror should not assume no-cost extensions. Please provide cost data based on the option periods of performance listed in the RFP.

QUESTION 8: Task 3.1 Current, Former, and Never Tobacco Users and Other Subgroups of the SOW (attachment 3): The RFP states that the Contractor shall oversample current, former, and never tobacco users for the cohort replenishment. Since these three tobacco user groups by definition include the entire population, they cannot all be oversampled; if some are oversampled, others must be undersampled. Can you clarify the intent of this requirement?

ANSWER 8: The corrected statement begins “The Contractor shall oversample current tobacco users for the cohort replenishment . . . .”

QUESTION 9: Task 3.4 Sample Design Plan, item (d) of the SOW (Attachment 3) calls for “establishing and maintaining a youth cohort at Wave 4 (emphasis added).” Does this refer to the replenishment of the already-established youth cohort with younger youths at Wave 4, rather than establishing a new, full youth cohort in parallel with the current cohort?

ANSWER 9: This refers to replenishment of the already-established youth cohort with younger youths at baseline.

N01DA-16-5582 Page 4 of 6 QUESTION 10: On the second page of the RFP cover letter, NIDA asks for an electronic copy of the Excel cost spreadsheet to be submitted on CD as part of the Business Proposal.

Attachment 1, Packaging and Delivery of the Business Proposal does not mention the CD. How many copies of the CD of the Excel spreadsheet should be delivered?

ANSWER 10: An Offeror shall deliver six CDs of the Business Proposal Excel spreadsheet.

QUESTION 11: Attachment 1, Packaging and Delivery of the Technical Proposal, after stating the number of hardcopies to be delivered, has a NOTE that says “If submitting CD-ROMs, include with the original and each copy.” Please clarify what files should be included on CD.

ANSWER 11: No Offeror shall deliver CDs of its Technical Proposal.

QUESTION 12: In Section B (page 6 of the RFP), a “Unit CPFF” is requested. Is the Government requesting a price for one unit of each of the Options denoted? The next column asks for “Total CPFF of Option.” Is the Government requesting a price for the total possible units? As an example, Option 9 may be exercised “Up to 25 times.” Should the formula for the “Total CPFF of Option” column be the price for one unit of Option 9 times 25 units? Please provide additional clarification.

ANSWER 12: With respect to “Unit CPFF,” the Government requests a cost plus fixed fee (CPFF) for one unit of each of the options denoted. The “Total CPFF of Option” would then include the CPFF for the total possible units, for example, “up to 25 times.”

QUESTION 13: A Technical Proposal Cost Summary (Attachment 7) is requested. Is the Government asking for this data for Core Tasks only, Core Tasks plus one unit of each Option Task, or Core Tasks plus all potential units of each Optional Task? Please provide additional clarification.

ANSWER 13: For evaluation purposes, it would be helpful if an Offeror provides data on core tasks plus one unit of each option task and breaks down the number of hours for each core task and one unit of each option task. However, as mentioned above, in accordance with RFP Section M.5. Evaluation of Options, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement, except when it is determined not to be in the Government’s best interests.

Evaluation of options will not obligate the Government to exercise the options.

N01DA-16-5582 Page 5 of 6 Additionally, the purpose of the amendment is to provide revisions to Articles B.4.; H.15.; I.3.;

L.1.a.; Attachment No. 1 (Packaging and Delivery of Proposal); and Attachment No. 3 (SOW) of the subject RFP. Unless specified below, all other terms and conditions of the RFP remain unchanged.

RFP-N01DA-16-5582 is revised as follows:

ARTICLE B.4. ADVANCE UNDERSTANDINGS, is revised to read:

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.

The Government may require the delivery of the service identified in the Schedule as an option item in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor within 60 days of the date the additional services are required.

ARTICLE H.15. OPTION PROVISION, is revised to read:

Unless the Government exercises its option pursuant to the Option Clause set forth in SECTION I, the contract will consist only of the Base Period of the Statement of Work as defined in SECTIONS C and F of the contract. Pursuant to ARTICLE B.4.; FAR Clause 52.217-9, Option to Extend the Term of the Contract; FAR Clause 52.217-7, Option for Increased Quantity-Separately Priced Line Item; and FAR Clause 52.217-8, Option to Extend Services, set forth in SECTION I of this contract, the Government may, by unilateral contract modification, require the Contractor to perform additional options set forth in the Statement of Work and also defined in SECTIONS C and F of the contract. If the Government exercises this option, notice must be given at least 60 days prior to the expiration date of this contract, and the estimated cost plus fixed fee of the contract will be increased as set forth in the ESTIMATED COST PLUS FIXED FEE Option Article in SECTION B of this contract.

ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES, is revised to insert between FAR Clause 52.217-7 and FAR Clause 52.219-4 the following:

FAR Clause 52.217-8, Option to Extend Services (November 1999).

“. . . The Contracting Officer may exercise the option by written notice to the Contractor within 60 days of the date the additional services are required.”

N01DA-16-5582 Page 6 of 6 SECTION L, 1.a.(f)(4) (p. 72-73), is revised to read:

The Government intends to evaluate proposals and award a contract without discussions with offerors (except clarifications as described in FAR 15.306(a)). Therefore, the offeror’s initial proposal should contain the offeror’s best terms from a cost or price and technical standpoint. The Government reserves the right to conduct discussions if the Contracting Officer later determines them to be necessary. In accordance with FAR 15.306(c), if the Contracting Officer determines that the number of proposals that would otherwise be in the competitive range exceeds the number at which an efficient competition can be conducted, the Contracting Officer may limit the number of proposals in the competitive range to the greatest number that will permit an efficient competition among the most highly rated proposals.

Attachment No. 1, PACKAGING AND DELIVERY OF THE PROPOSAL, NUMBER OF COPIES, is revised to read:

A. TECHNICAL PROPOSAL – ORIGINAL* AND 13 COPIES TO:

Attachment No. 3, STATEMENT OF WORK, TASK 3: Sample Design, Subtask 3.1, is revised to read:

3.1 Current, Former, Never Tobacco Users and Other Subgroups – The Contractor shall oversample current tobacco users for the cohort replenishment of Waves 4 and 6 and for planning purposes, a future Wave 8 to obtain stable estimates for each wave and for follow-up waves for cessation, relapse, tobacco-use patterns, attitudes, beliefs, and tobacco-related exposures. As specified by the NIDA COR, the Contractor shall oversample other population subgroups for the cohort replenishment of Waves 4 and 6 and for planning purposes, a future Wave 8 (e.g., racial-ethnic minorities, young adults, youth, and youth who are monozygotic and dizygotic twins).

All other terms and conditions of the RFP remain unchanged.