Questions_from_Contractor_with_Answers_from_COR_and_CS.docx

Req 1130639 - Questions

Questions from Contractor’s

Question #1 Since there are font size requirements for graphics and tables, is there a font size requirement for the text used in the body of the document?

Answer #1 General text font should be no smaller than 9-point Arial Narrow.

Question #2 The RFP states, “All critical information from appendices should be summarized in the technical proposal.”

Can the contracting office provide the referenced appendices?

Answer #2 Appendices are available on the FBO.gov site listing this RFP.

Question #3 Is the cover letter a part of page count restriction for any of the technical sections?

Answer #3 As stated in Section 11.3 of the RFP: The following items are not included in the page limit:

· Cover Page

· Table of Contents

· Dividers

· Past Performance Questionnaire

Question #4 Will the contracting office allow the offeror’s customers (who are filling out past performance questionnaires) submit electronically vs. sending hard copies via standard mail?

Answer #4 The contracting office shall allow the offeror’ s customers (who are filling out past performance questionnaires) to submit electronically or by sending hard copies via standard mail, as referenced on page 53 of the RFP. The vendor should complete and return the questionnaire to the government directly to:

Lacetta Bowman 5630 Fishers Lane Rockville MD 20850

Or by email to Lacetta.Bowman@fda.hhs.gov. If the offeror will be sending via email please reference CDER Performance Analysis Review.

Question #5 To confirm, does the contracting office require 3 past performance questionnaires completed, as well as 3 letters of recommendation from the same customer who is completing the questionnaire form?

Answer #5 The contracting office requires a minimum of 3 past performance questionnaires total.

Question #6 If letters of recommendation are required, are they considered part of page count restrictions in the technical volume? If they are not, where in the submittal should they be provided?

Answer #6 As stated in Section 11.3 of the RFP: The following items are not included in the page limit:

· Cover Page

· Table of Contents

· Dividers

· Past Performance Questionnaire Letters of recommendation will be considered part of the Past Performance Questionnaire and excluded from the page limit.

Question #7 Given that this is a FAR Part 12 solicitation for commercial items, can Contractors that do not provide services on an hourly basis provide proposals in accordance with their commercial practices, e.g. based on weekly rates or some other unit? Since the Government has provided "Estimated Annual Hours" for evaluation purposes, this will still allow the Government to evaluate yearly prices for the purposes of establishing one or more IDIQ contracts. Contractors can simply provide a build-up using their commercial practices to provide this yearly price.

Answer #7 Per section 1.4 of the RFP the services are to be provided at a fixed hourly rate. Offerors whose commercial rates practices differ may convert their rates to hourly rates.

Question #8 Are academic institutions eligible to apply to this RFP? I could not find anything in the text of the RFP that precluded the application from an academic institution, and we have had contracts with federal agencies previously, but I wanted to make sure we were an eligible applicant.

Answer #8 Academic institutions are eligible.

Question #9 The Scope of Work described in the RFP is quite broad. It is the expectation that the technical application is responsive to each of the items in the scope of work list or is it anticipated that applicants will provide details on a few of the items in that list?

Answer #9 Vendors should be as responsive as possible to the items listed.

Question #10 Will the task orders be issued from this list in the scope of work? What is the anticipated timeline for completion for task orders that are issued?

Answer #10 As stated in Section 2.3 of the RFP, key tasks performed for this contract “may include” the tasks listed. The timeline for completion of each task will depend on the task and be defined in the task order.

Question #11 The RFP States: “All critical information from appendices should be summarized in the technical proposal.” No appendices were identified as required. Are there appendices that are required to be summarized in the offeror’s technical proposal?

Answer #11 Appendices are available on the FBO.gov site listing this RFP. Appendices include the Past Performance Questionnaire responsive to the offeror’s Relevant Past Performance.

Question #12 Factor 1 – Personnel - “The Offeror shall describe the minimum qualifications, education and experience for each labor category proposed.” FDA has already provided this information on pages 6 and 7, by providing the labor category descriptions and qualifications. Can the contracting office provide more guidance on what offeror’s should include in this section? (e.g., resumes, biographical sketches, CVs)

Answer #12 The offeror should include a description of the personnel proposed for this contract. As stated in section 1.4, the pricing chart includes “labor categories that are anticipated to be required throughout the period of performance.” Vendors may add labor categories they anticipate to be required to complete tasks associated with this contract. Vendors should provide complete descriptions of labor categories they add.

Question #13 Factor 2 – Technical Understanding and Approach – the second paragraph references “management plans”, along with “methods for implementing, reviewing and effecting interim adjustments and corrections, and quality control and cost control procedures.”

Based on the current instructions, the management plan must be included within the 10 page limit of the core technical approach section (Factor 2). Given the page restriction of this section, will the contracting allow offerors to provide the management information outside of Factor 2 as an appendix, with a 3 page limit?

Answer #13 – would like to amend RFP Though the Contracting Office will not disqualify proposals that exceed the listed limits, offerors should present their proposal as clearly and concisely as possible and make every effort to adhere to listed page limit. The Contracting Office values contractors’ ability to synthesize information and present results in a concise manner.

Question #14 Factor 2 – Technical Understanding and Approach - the second paragraph references that computer services must be compatible with IBM PC Systems in a Microsoft Windows 7 environment using Microsoft desktop tools. Does this requirement refer to deliverables?

Answer #14 Yes, all services and deliverables must be compatible with a Microsoft Windows 7 environment using Microsoft desktop tools.

Question #15 Can Offerors propose additional labor categories, and provide the description, education and experience requirements of any additional labor categories that they feel are necessary?

Answer #15 As stated in section 1.4, the pricing chart includes “labor categories that are anticipated to be required throughout the period of performance.” Vendors may add labor categories they anticipate to be required to complete tasks associated with this contract. Vendors should provide complete descriptions of labor categories they add.

Question #16 No e-mail option is provided for proposal delivery. Will FDA amend the solicitation to allow for an e-mail delivery?

Answer #16 No

Question #17 Please clarify “good manufacturing practice industry” in the example of task number 8 listed in Section 2.3:

Develop and evaluate new ways to measure the benefit and other impacts of maintaining acceptable good manufacturing practice industry by proactively identifying problematic FDA inspection findings in ongoing surveillance programs to identify and prevent emerging problems that would otherwise lead to substandard product quality.

Is the intended wording is “good manufacturing industry practice”?

Answer #17 – would like to amend RFP Yes, the intended wording is “good manufacturing industry practice.”(See amendment Task 8 page 6)

Question #18 In reference to the Labor Rate Pricing Chart (Table #1) and Labor Categories Descriptions (RFP Section 2.4), which labor category should include support staff, such as administrative assistants, that bill at an hourly rate?

Answer #18 As stated in section 1.4, the pricing chart includes “labor categories that are anticipated to be required throughout the period of performance.” Vendors may add labor categories they anticipate to be required to complete tasks associated with this contract. Vendors should provide complete descriptions of labor categories they add.

Question #19 RFP page 9, Publications and Presentations: What criteria will the COR apply to: (1) determine what, if any, information may be releasable for publication, presentation, or through other means; (2) determine the content of the released information; and (3) determine authorship decisions?

Answer #19 It is anticipated that most work product resulting from this contract will remain internal to FDA. The decision to publish work product, research or any information resulting from this contract will be made solely at the Agency’s discretion. Released content must meet Agency standards and comply with Agency confidentiality requirements. Authorship decisions will be made in accordance with Agency policy.

Question #20 Will the Gov’t consider revising the clause to allow Contractor to publish and disseminate findings after the COR’s prior review for accuracy, content, manner of presentation of the information , as well as Privacy Act and/or Privacy rule and proprietary information?

Answer #20 No Question #21 Section 1.4 – Pricing:

Please confirm that for the “Total” column and row on the pricing chart, offerors shall enter the total costs calculated using the hourly rates and estimated annual hours entered (4,000 hours annually per labor category).

Answer #21 Yes, offerors should estimate the total costs per labor category for the period of performance of the contract and the total costs for all labor categories in each contract year, and enter these figures in the appropriate portions of the pricing chart.

Question #22 Section 5.7 – Option Periods:

The table states that Option Period 1 is from 2015 to 2016, Option Period 2 is from 2016 to 2017, etc. Should offers assume that Option Period 1 will be from 2016 to 2017 instead, as there is a Base Year?

Answer #22 Yes. The RFP will be revised accordingly

Question #23 Section 11.4 – Instructions & Evaluation for Technical Proposal:

For Factor 3, as an alternative to the Past Performance Questionnaire for this section, would it be acceptable to submit CPARS documents that correspond to applicable experiences as a prime contractor?

Answer #23 To the extent that information in CPARS documents is responsive to the items on the Past Performance Questionnaire, they will be accepted as an alternative to the Past Performance Questionnaire.

Question #24 Section 12 – Business Proposal Instructions:

Do the business proposal requirements apply to subcontractors? Do subcontractors need to submit labor rates?

Answer #24 If a prime contractor is submitting a proposal that includes subcontractors, the subcontractor is a part of the proposal and will need to meet business proposal requirements.

Question #25 Separate Management / Admin Plans? (RFP 11.4, Factor 2) Reference: In RFP 11.4, Factor 2: Technical, Page 52: the Government requires that the “Offeror shall provide information on the administration of the project tasks. This should include management plans, methods for implementing, reviewing and effecting interim adjustments and corrections, and quality control and cost control procedures.” On Page 53, the Government says that it “will also evaluate whether the Offeror’s administrative and management plans meet the requirements set forth in the IDIQ.”

Question: Can the Government please clarify:

1) Is it the Government’s intent for the Offeror to include separate administrative and management plans; or

2) Does the term “administrative plans” refer to “methods for implementing, reviewing and effecting interim adjustments and corrections, and quality control and cost control procedures”, etc. and do not require the Offeror to submit an administrative plan separate from the management plan?

Answer #25 Under “Factor 2: Technical Understanding and Approach”, the RFP states the offeror shall “provide information on the administration of the project tasks” and that “this should include management plans, methods for implementing, reviewing and effecting interim adjustments and corrections, and quality control and cost control procedures.” You do not need separate administrative and management plans; they can be a single plan.

Question #26 Will resumes be allowed / waived from the page count? (11.4, Factor 1) Reference: In RFP 11.4, Factor 1: Personnel, Page 51, the government states that “The Offeror shall describe the minimum qualifications, education and experience for each labor category proposed. Offeror shall demonstrate that it employs the personnel requisite to perform high caliber qualitative and quantitative analyses over the range of studies and evaluations presented in the Scope of Work.

“Offeror shall demonstrate that available personnel possess direct and recent experience with the application of advanced approaches to health outcomes research, other multi-attribute methods, pharmacoeconomics, cognitive science, decision science, modeling and decision analysis, health economics, other mathematical and statistical methods as applied to various topics including: estimation of benefits and risks associated with drug therapy, analyzing the drug development, manufacturing, quality, distribution, and prescribing.”

Question: Based on the need for a complete response to the above factor and requirements, would the government consider:

1. Allowing resumes to be included in the submission?

2. Excluding those resumes from the page count?

Answer#26 While resumes will be allowed, the page count for this section will not be waived. Though the Contracting Office will not disqualify proposals that exceed the listed limits, offerors should present their proposal as clearly and concisely as possible and make every effort to adhere to listed page limit. The Contracting Office values contractors’ ability to synthesize information and present results in a concise manner.

Question #27 Is the cover letter excluded from page count and not considered part of the cover page? (11.3) Reference: In RFP 11.3, Page 50, the government requires that the offeror submit a cover letter that includes “a POC (name and telephone number); a statement from the Offeror verifying that they are SAM.GOV Registered under NAICS code 541690. DUNS and TIN number shall be included in the cover letter.”

Question: Would the government please clarify if the required cover letter is excluded from page count and is considered to be separate from the cover page?

Answer #27 As stated in Section 11.3 of the RFP: The following items are not included in the page limit:

· Cover Page

· Table of Contents

· Dividers

· Past Performance Questionnaire The “cover page” should be considered synonymous with the “cover letter” mentioned in RFP 11.3, pg. 50.

Question #28 Do the letters of recommendation count as part of the page count for PP? (11.4) Reference: In RFP 11.4, Factor 3: Past Performance, Page 53, the government states that the "[o]fferor shall also provide FDA with letters of recommendation from project officers or other relevant personnel with detailed knowledge of the contractor’s performance on each the three reference projects."

Question: These letters would likely take up the space of any entire past performance section, and would leave the offeror with little or no room for a complete response to the Evaluation Criteria in 11.4. Would the government consider excluding the Letters of Recommendation from the page count in the RFP?

Answer #28 As stated in Section 11.3 of the RFP: The following items are not included in the page limit:

· Cover Page

· Table of Contents

· Dividers

· Past Performance Questionnaire Letters of recommendation will be considered part of the Past Performance Questionnaire and excluded from the page limit.

Question #29 Can the Government specify the font size for general text? (11.3) Reference: In RFP 11.3, Organization of Proposal, Page 49, the government states ““Text in graphics and charts shall be no smaller than 9-point Arial Narrow; text in tables shall be no smaller than 9-point Arial. Offerors shall use only 8.5 inch by 11 inch (210 mm by 297mm) paper, single-spaced pages with margins no less than one inch on each border and shall number each page consecutively. The size and font of headers and footnotes are not dictated. No fonts may be condensed.”

Question: The Government has specified the text size for graphics, charts and tables. Can the Government specify the font size for general text?

Answer #29 General text should be no smaller than 9-point Arial Narrow.

Question #30 Reference: RFP Page 24, Section 8.2 FAR CLAUSES BY FULL TEXT, Paragraph (c)(1) states:

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or executive orders applicable to acquisitions of commercial items:

_X_ (1) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67).

Question: The solicitation indicates that this is a contract covered by the Service Contract Act (SCA) thereby requiring all bidders to bid applicable SCA rates for service employees. Please specify the wage determination(s) to be used.

Answer #30 Please reference FAR 52.222-41

Question #31 Reference: On RFP Page 10, Section 5.6 PERIOD OF PERFORMANCE states: “The period of performance for the base period of the contract shall be one (1) year from the effective date of the contract.”

Question: For the most accurate pricing of the base period and subsequent option periods, would the FDA please provide an estimated contract start date?

Answer #31 We estimate a contract start date of June 1, 2015

Question #32 Reference: RFP Page 50, Section 11.3 ORGANIZATION OF PROPOSAL states: “The cover letter shall include; a POC (name and telephone number); a statement from the Offeror verifying that they are SAM.GOV Registered under NAICS code 541690. DUNS and TIN number shall be included in the cover letter”. However, RFP Page 1, Section 1.1 SOLICITATION DESCRIPTION, second paragraph states, “The associated North American Industrial Classification System (NAICS) code for this procurement is 541611”.

Question: Please clarify the NAICS code(s) that are associated with this procurement and which offerors must verify as being listed under their registration assertions in SAM.gov.

Answer #32 NAICS for this procurement will be 541611. The RFP will be revised accordingly.

Question #33 Reference: RFP Page 2, Section 1.4 PRICING, and Page 6, Section 2.4 LABOR CATEGORIES DESCRIPTIONS, enumerate and describe five labor categories: Analyst, Consultant, Senior Consultant, Principal 2, and Principal 1.

Question: We are concerned that there are too few labor categories to best perform this work. Would the Government accept contractors proposing additional labor categories?

Answer #33 As stated in section 1.4, the pricing chart includes “labor categories that are anticipated to be required throughout the period of performance.” Vendors may add labor categories they anticipate to be required to complete tasks associated with this contract.

Question #34 Page 1, Section 1.1, “Solicitation Description” says, “The associated North American Industrial Classification System (NAICS) code for this procurement is 541611. The size standard is $15.0.” Also, Page 50, Section 11.3, “Organization of Proposal” says, “The cover letter shall include; a POC (name and telephone number); a statement from the Offeror verifying that they are SAM.GOV Registered under NAICS code 541690. DUNS and TIN number shall be included in the cover letter.”

a) Is the NAICS code for this procurement 541611 or 541690?

Answer #34 NAICS for this procurement will be 541611. The RFP will be revised accordingly.

Question #35 Page 2, Section 1.4, “Pricing.” The RFP states, “The Contractor shall provide services in accordance with the Statement of Work at fixed hourly rates.”

a) Does the FDA anticipate both Contractor and Government site support during performance under the BPA?

b) If yes, may Contractors propose a modified Table 1 to present both government and contractor site rates?

c) With respect to “fixed” hourly rates, does the Government require the same rate for the base year and all options, or may the offeror incorporate rate escalations over the course of the contract for evaluation?

Answer #35

a) Section 5.2 states: “The Government may provide Government Furnished Property for use in direct performance of each task order. Each task order will specify if Government Furnished Property will be provided.” Task orders will also specify site of performance.

b) Yes. See amended RFP

c) Yes, labor rate escalations may be incorporated.

Questions #36 Page 2, Section 1.4, “Pricing.” Under Table 1, the FDA inserted, “____ % Fee for Material Handling Fee.”

a) May contractors propose separate material/handling rates for each contract period?

b) Is the material/handling fee considered a ceiling that must be adhered to during performance?

Answer #36

a) Yes

b) Yes

Question #37 Page 2, Section 1.4, “Pricing.” The last column on the right of Table 1 says, “Total”.

a) Please confirm this column must be calculated using the sum of all periods for each labor category calculated as follows:

· For each labor category, the base plus option periods must be calculated by taking annual hours (4000) x hourly rate/per period.

· The sum of all periods will be added together to form the total dollar amount that must be inserted in the Total column.

Answer #37 Yes, offerors should estimate the total costs per labor category for the period of performance of the contract and the total costs for all labor categories for each contract year, and enter these figures in the appropriate portions of the pricing chart.

Question #38 Page 6, Section 2.4, “Labor Category Descriptions.” The RFP notes experience and education requirements for each labor category.

a) Will the FDA accept years of experience/educational substitutions in place of educational/experience requirements (e.g., 2 years of experience equivalent to a Master’s degree)?

b) Will the Government please clarify degrees that are equivalent to a BS (e.g., all bachelor’s degrees)?

Answer #38

a) Yes, FDA will allow experience/educational substitutions in place of educational/experience requirements.

b) All Bachelor’s degrees will be considered equivalent to a Bachelor of Sciences degree.

Question #39 Page 24, FAR 52.212-5, CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS - COMMERCIAL ITEMS (MARCH 2015). The FDA has made a determination that the SCLS is applicable under this IDIQ by checking FAR 52.222-41, FAR 52.222-42, and FAR 52.222-43. In addition, paragraph (e) included (iii) 52.222-17 and (viii) 52.222-41.

a) Will the FDA please identify the applicable DOL Wage Determination (WD) that will apply during performance? If not, will the FDA please define the primary place of performance so contractors can identify the Wage Determination (WD) that will apply?

b) Will the FDA please specify which RFP labor categories (if any) have been identified to be SCLS applicable?

Answer #39 Please see FAR 52.222-41, FAR 52.222-42, and FAR 52.222-43

Question #40 Page 50, Section 11.3, “Organization of the Proposal.” The RFP states, “The following items are not included in the page limit: Cover Page, Table of Contents, Dividers, Past Performance Questionnaire.”

a) Will the Government please confirm what details concerning Past Performance Questionnaires should be included in the technical proposal?

b) Will the Government permit the use of a compliance matrix outside of the page limit?

Answer #40

a) Requirements regarding relevant past performance are included in Factor 3: Relevant Past Performance on page 53 of the RFP. The Past Performance Questionnaire is an attachment to the RFP and available on the FBO.gov page listing this RFP.

b) No. Though the Past Performance Questionnaire submitted by previous project officers will not count in the page limit, a compliance matrix developed by the offeror will be counted in the page limit.

Question #41 Page 52, Section 11.4, “Instructions & Evaluation for Technical Proposal (Volume I).” The RFP states, “The Offeror shall describe the minimum qualifications, education and experience for each labor category proposed.”

a) Given that minimum qualifications, education and experience are described for each labor category in Section 2.4 of the RFP (“Labor Category Descriptions”), will the Government please clarify what additional information the Offeror should provide in Volume I?

b) May the Offeror proposal additional labor categories other than the ones described in Section 2.4 of the RFP (“Labor Category Descriptions”)?

Answer #41- Would like to amend RFP

a) “Labor category” should be “proposed personnel”

b) As stated in section 1.4, the pricing chart includes “labor categories that are anticipated to be required throughout the period of performance.” Vendors may add labor categories they anticipate to be required to complete tasks associated with this contract. Vendors should provide complete descriptions of labor categories they add.

Question #42 Page 55, Section 12.1, “Small Business Subcontracting Plan.” The RFP states, “The following are the FDA’s small business goals: Small Businesses 33%, Small Disadvantaged Business 5.00%, Women-Owned Small Business 5.00%, HUBZone 3.00%, Service-Disabled Veteran-Owned Small Business 3.00%.

a) Are the percentage goals for SDB, WOSB, HUBZone and SDVOSB a subset of the SB goal or are they in addition to the SB goal (33% + 5% + 5%+3% + 3%=49%)?

Answer #42 They are in addition to the Small Business goal.

Question #43 Are academic institutions eligible to apply to this RFP? I could not find anything in the text of the RFP that precluded the application from an academic institution, and we have had contracts with federal agencies previously, but i wanted to make sure we were an eligible applicant.

Answer #43 See answer to question 8

Question #44 The Scope of Work described in the RFP is quite broad. It is the expectation that the technical application is responsive to each of the items in the scope of work list or is it anticipated that applicants will provide details on a few of the items in that list?

Answer#44 See answer to question 9

Question# 45 Will the task orders be issued from this list in the scope of work? What is the anticipated timeline for completion for task orders that are issued?

Answer #45 See answer to question 10