FDA RFP_Questions2.docx

FDA Document Control Rooms RFP No. FDA-SOL-08-00653

Questions:

1. Reference Past Performance Questionnaires page 142. The questionnaire states that the completed questionnaire needs to be returned to the Contracting Officer by June 9th? To allow sufficient time for our Program Officers to complete the questionnaires and since the proposal is not due until June 27th; can FDA extend the due date for completed questionnaires?

The closing date was amended to June 27th, 2008, 1400 ET.

2. Reference Pricing Schedules and Attachment 9 – can the contractor propose Additional and/or different labor categories with its submission to this RFP?

Potential bidders are required to use attachment 9 to submit pricing proposal for the base contract. However, additional or alternative labor categories may be proposed provided they meet the minimum qualification requirement in the Labor category.

3. Reference Attachment 9, since this is a Fixed Price contract and FDA is looking for the “most efficient manner to accomplish this requirement”, can the contractor propose a different labor category and hours mix than that presented on Attachment 9?

FDA is seeking to obtain contractual services for its Document Control Room SOW in accordance with the RFP therein.

4. Reference pg. 110 – Personnel and Resumes. The list of required resumes excludes the Records Management Specialist II labor category. Should resumes be provided for this labor category as well?

No, See Amendment 000005 for amended Personnel & Resumes requirements section.

5. Reference page 110 – Personnel and Resumes, states that resumes are required for all positions required under the first year of the contract. Page 135, Resumes, states that resumes are required for key personnel. Please confirm that resumes are required for all personnel.

See response to question 4.

6. Under what factor are resumes being evaluated?

Resumes shall be evaluated on the candidates’ functional responsibility experience, education, and related job experience.

7. Reference E.2 – please clarify the number of technical proposals required; is it 8 copies or 6 copies?

See Amendment 000005.

8. Reference Section E, Pre-Proposal Conference – the calendar days and dates do not match (for example June 6th is a Friday not Monday as identified in the RFP). In some cases, there are also conflicting times. Please clarify the due date, day, and time for the pre-submission of questions, final submission of questions, and pre-registration for the conference.

Amendment 000002 clarified due dates.

Pre-proposal conference registration due date is Friday June 6, 2008 at 10:00 am ET.

Deadline for Pre-submission of questions is 2:00 p.m. ET, Monday June 9, 2008 and final submission of questions due date June 13, 2008 at 2:00 p.m. ET.

9. Reference E.2, Separation of Technical and Business Proposals and F.7.1.2, Subfactor 2: Overall Rating for Pricing Schedule – Please confirm that pricing information is to be presented in the technical proposal and what level of pricing information is to be included in the Technical Proposal.

See Amendment 000005, pricing information shall be presented in the business proposal.

10. Reference E.3, Past Performance, page 134. It appears that some data may be missing at the end of this section. The last sentence reads, “References other than those identified by the offeror may be contacted by the Government to obtain additional information that will be.”

See Amendment 000005, revise and incorporate additional language as follows: References other than those identified by the offeror may be contacted by the Government to obtain past performance reference check.

11. Section E.2, Delivery Instructions, refers to Technical Proposal Volumes 1 and 2. Section E.2, General Instructions, only refers to one Technical Proposal Volume. Is Volume 2 required and if so, what information should be in Volume 2?

See Amendment 000005.

12. Reference the Evaluation Factors for Award. Section F.1, General Information, states that this is a best value award. It also states that technical factors are considered significantly more important than price/cost factors. However, Section F.7.1.2, Subfactor 2: Overall Rating for Pricing Schedule, appears to include pricing as part of the Technical Evaluation score. Please clarify if pricing will be considered as part of the Technical Evaluation score and again in the best value analysis.

See Amendment 5.

13. Reference F.9.1, since this is an 8(a) contract set aside will the prime 8(a) contractor be evaluated on its meaningful proposed use of other 8(a) contractors or small businesses under this contract?

Removed in it entirety, see amendment 000005

14. Can years of experience by substituted for education, i.e. 4 years of directly relevant experience in lieu of a Bachelors degree?

Yes, years of related job experience can be substituted for education.

15. Section F.2, Technical Evaluation states that the evaluation criteria (a through d) will evaluated in descending order of importance, yet the evaluation points are not in descending order. Please clarify the evaluation points.

Amendment 000002 amended the relevance of importance as follows:

16. Reference: Page 134, Paragraph E.3 TECHNICAL PROPOSAL INSTRUCTIONS, Past Performance Information. There is no reference in E.3 directing the Offeror to use the unnumbered or unreferenced “PAST PERFORMANCE QUESTIONNAIRE” that is included in the rear of the RFP.

See Amendment 000005

17. Is the “PAST PERFORMANCE QUESTIONNAIRE” on page 142 to be used for this purpose.

Yes

18. The RFP states on the top of the Past Performance Questionnaire (No Attachment Identification, only on page 142) a due date to “Contracting Officer, Patricia Pemberton by: June 9, 2008”. Can the FDA provide a two week extension to this date to June 23, 2008 if this is in fact the required date to allow sufficient time for our past and current customers to properly respond to the questionnaires?

See response to question one (1)

19. Can the FDA clarify the minimum number required and the maximum number of past performances allowed for the prime and any sub-contractors?

See Amendment 000005.

20. General – (no reference) Q1. Has the FDA conducted any pre-submission evaluations of conflicts of interest between existing agency project staff and incumbent personnel? Can offerors assume that certain project staff will be recluse from the evaluation process in light of existing personal relationships?

The Project Advisory Group panel committee members and the Contracting Officer(s) are the only staff members that will be part of the evaluation process.

21. Reference: Page 85, The paragraph numbering goes from D.6.4.1 to D.5.2 to D.5.3 and follows on page 86 with the next paragraph as D.6.6 then D.6.6.1. Is there missing information between these paragraph headings?

This was a typographical error, D.5.2 is D.6.4.2 & D.5.3 is D.6.5 -- There is no missing information between these paragraph headings.

22. Are there existing employees performing the work that relates to this solicitation?

Yes

23. Will these employees remain or will they leave based on contracts or employee agreements?

FDA has no influence or control over this matter. This is between the incumbent and employee.

24. Can these employees be considered to be hired by the winner of this solicitation?

FDA has no influence or control over this matter. Again this is an issue between the employee and the new contractor. However, this issue could be address in the offeror’s proposal.

25. Are the bidding firms permitted to talk to these employees to one gain an understanding of the work they perform and two discuss potential hiring scenarios?

No

26. Will there be a site visit to each of the locations where the work will be performed?

Yes, a site visit will be conducted at the pre-proposal conference on June 11, 2008.

27. Can we receive a copy of all data entry (DARRTS, COMIS, ) software database screen images?

Software database screen images will not be provided. The bidder is advised to reference Attachment Seven (7), with regards to data entry issues.

28. May we receive screen images of DARRTS (VGDS) process?

Screen images shall not be provided, again the bidder is advised to reference Attachment Seven (7).

29. May we receive screen images of the INVAS barcode tracking system?

Screen images shall not be provided, again the bidder is advised to reference Attachment Seven (7).

30. If the government furnished equipment becomes in-operable or fails to work correctly and that piece of equipment is essential to the daily operation, what commitment does FDA have to replacing or repairing the equipment so that the contractor can meet their daily performance requirements and goals?

Government furnished equipment are protected under maintenance agreements and FDA has systems in place to ensure that damaged or inoperable equipment shall be repaired or replace in a timely manner, so as to ensure that the down time is at a minimum.

31. During normal daily operations, how many courier service runs take place to/from the following locations:

A. White Oak Document Room

B. DDMAC (DR2)

C. Office of Business Process Support (OBPS) D. Electronic Document Room (EDR) E. White Oak Mail Room (W022) Mail Room F. White Oak Document Rooms in Building 51 G. Misc. locations with in the White Oak Facilities

8. Likewise, other courier stops requiring CDR courier services to:

A. MPN II (Rockville) B. Wilkins Ave. ((Rockville) C. US Mail/Scanning Facilities (Gaithersburg) D. Parklawn Building (Rockville)

A minimum of two courier runs are normal practice, however, based on the volume of material both priority and non-priority may require additional runs. This would be the case for all locations identified below.

33. Can we obtain a copy of the Online Query Module operating procedures to become proficient with its use?

A copy of the Online Query Module operating procedures shall not be provided

34. May we receive copies of all forms or be directed to where to obtain forms, such as, Form 356h?

Yes, http:/www.fda.gov./opacom/morechoices/fdaforms/cder.html

35. May we receive an operations document or training manual for the EDR Document Tracking System, Gateway data entry Submission system/link?

Operational documents or training manuals shall not be provided; the bidder is advised to reference Attachment Seven (7).

36. Is there an IT or Technical Plan associated with the support of this environment that we can have access to or a copy of?

No IT or Technical plan available.

37. Is this a new requirement?

8(a) Recompete

38. Who are the current incumbents?

39. Is the new Contractor expected to hire the current incumbent(s) staff?

See response to question 23.

40. What is allowed under teaming arrangements?

Part F.7.1 is removed in its entirety, see Attachment 000005 for revision.

41. Will there be a walkthrough of each facility involved in the requirement?

See response to question 26

42. Will there be an inspection of all of the government-furnished equipment to be used?

No inspection of GFE is necessary

43. Is there a schedule for replacement of GFE?

No

44. There is an implication that the activities will be shifting from paper-based to electronic-based documents over the life of the contract? Will the Contractor be expected to be proactively involved in this transformation?

Yes, the contractor shall be expected to shift their labor force to where their skills are more computer literate and capable to adjust to a more electronic environment.

45. Will the Government please provide copies of the Standard Operating Procedures for various functions listed in the Statement of Work?

Copies of SOPs will not be provided.

46. Ref RFP Section D.2.4, “The contractor shall provide the appropriate personnel and resources necessary to develop, implement, and manage an Inventory Control Management system.”

1. Will the Government please clarify this requirement?

2. Is it the Government’s intent that the winning contractor develops a system to replace INVAS?

3. If so, would that be done as part of the base task order or a future task order issued after the contract has been awarded?

4. Can you please provide a target timeline, objectives and expectation of the Government?

5. Does the Government expect the Contractor to propose a replacement system as part of this proposal?

FDA is requesting that the offerors develop a document tracking system that enables the offeror to control document movement amongst CDER’s Reviewer community and enables the offeror to manage the shelving storage availability and requirement needs.

47. Will FDA consider allowing a Site Visit for potential bidders?

See response to question 26.

48. The solicitation states, “Resumes shall be provided for each proposed individual to cover the labor resources required under the first year of the contract.” This information is only available to the incumbent and without it only the incumbent is qualified to compete on this solicitation. Can you provide us with the names and contact information of all incumbent personnel so we can contact these to obtain the required information?

See Amendment 000005

49. Do the applicable rates referenced here refer to loaded or unloaded labor rates?

See Amendment 000005 for clarification.

50. Section A.3, Page 3, 1st paragraph states “…this contract vehicle will be a hybrid Indefinite Delivery Indefinite Quantity, Firm Fixed Price (FFP).”

a. Does the term ‘hybrid’ imply both FFP and T&M/Labor Hour?

Yes

b. Is the work identified in Section D considered to be the 1st Task Order issued under this contract?

Yes, subsequent tasks will be issue however, similar in nature.

c. Are there other Task Orders expected to be placed under this contract vehicle?

Yes

51. Section A.3, Page 3, bolded last sentence, states “The requirement of this contract are broken down into a Fixed Price portion (Base) and an Indefinite Delivery Indefinite Quantity portion as follows:

a. Is the Indefinite Delivery Indefinite Quantity portion referred to in this sentence, the Option Periods?

Yes

b. And if so, are Option Periods to be priced as Fixed Price also?

Yes

52. Section A.3 refers to a Master Contract repeatedly and Section A.4 refers to a Base contract.

a. Is the term Master Contract interchangeable with Base Contract?

The term Master Contract is referred to as the umbrella contract.

The Base contract is referred too as the first task to be issued at the time of award utilizing attachment 9 as its pricing schedule.

53. Section A.4.d states “As consideration for the services using Attachment 9 – Base Projected hours for the FDA Document Control Room (Including Technical Exhibits 4 through 7).”

a. This sentence is incomplete; please clarify how it is to read.

b. Are Technical Exhibits the same as Attachments? If not, please provide.

Amendment 000002 amends page 3, A-4.d, revise and insert “as consideration for the services using attachment 9, Base Projected hours for the FDA Document Control Room, including attachments 5 through 8.

54. Section A.5.1 states “Alternatively, the Government may require an oral proposal/work plan covering any or the entire written work plan requirements listed below.”

a. Does the Government intend to have Orals as part of this review?

b. If so, how will the Contractor be notified, how much time will they have to present, and what will be required to be presented?

The Governments will not require oral presentation as part of this review, only for the issuance of ITO’s.

55. Section A.7 states “If travel is approved, the funding for travel shall be invoiced as a separate line item and shall be reimbursed in accordance with FAR 31.205-46.”

Is the price proposal to contain a line item for travel and if so, will the government provide a place holder to ensure that all bidders use the same number to develop their fixed price?

The Government does not anticipate travel however, as part of the pricing schedule Part A.7 will be utilized as the line item to accommodate travel.

56. Section B.23 states “The key personnel specified in this contract are considered to be essential to work performance, are the key personnel associated with a specific Task Order or are they to be identified as part of the Master Contract?

The key personnel are to be identified as part of the Master contract.

57. Section B.29 has a subheading entitled “Conflict of Interest Screening.”

a. Where this information should should be placed: the Technical Proposal or the Cost Proposal?

b. And does the FDA want this information placed in a certain location within the respective proposal?

Potential offorers may address this issue in their technical proposal.

58. Section B.31.2.b states “The position risk levels for this contract are _______.”

Please advise what the position risk level is for this contract.

Position Risk Level = Level-5c

59. Section D.10, page 110, states “Resumes shall be provided for each proposed individual to cover the labor resources required under the first year of the contract.” Section E.3 (Resumes) states “Resumes of all key personnel are required.”

a. Section D.10 and Section E.3 seem to be contradictory, one requiring resumes for all proposed personnel, while the other requires only resumes of key personnel. Please clarify.

b. If Section D.10 is correct, does FDA want resumes for ALL individuals required for the Base Year, all 243 people?

c.

See Amendment 000005, for revision.

60. Section D.10, page 110 states “Resumes should be arranged in alphabetical order.”

Should the resumes be listed by labor category and within the labor category, alphabetically by last name?

Yes

61. Section D.10, page 110 states “At a minimum, the contract manager and alternate will be designated as key staff.”

a. The contract manager, nor the alternate, is listed in Section A.8 or Attachment 9 as labor categories. Please clarify.

b. Or, are the Program Manager and Contract Manager being used interchangeably?

See Amendment 000005, for revision.

62. Attachment (9) indicates that a man-year is being calculated as 1888 hours. However, some of these hours do not divide into a reasonable number; hence, requiring a partial person. Please verify that these hours are accurate?

a. IND/NDA Volume Accountability System (INVAS), Records Mgmt Spec – II, 182630?

b. Miscellaneous Processing, Senior Task Leader, 94?

For part-a, the reference number is incorrect – value should be 15,104

For part-b, the reference number is incorrect – value should be 1,888

63. Section E.2.a.(i) states “via regular mail – sending two (2) originals, eight (6) copies,…” Does FDA want eight or six copies?

See Amendment 000005, for revision.

64. Section E.2, Separation of Technical and Business Proposals: “The technical Proposal must include direct cost and resources information, such as labor hours and categories and applicable rates, materials, subcontractors, travel, etc. and associated costs: so that the offeror’s understanding of the project may be evaluated. However, the technical Proposal should not included (sic) pricing data related to indirect cost rates or amounts, fee amounts (if any), and total cost.”

a. Please confirm that FDA wants Cost Information in the Technical proposal.

b. If cost information is to be included, do they want just the Direct Labor costs without indirect rates (fringe, Overhead, G&A, fee)?

c. Section F does not indicate that the direct cost information will be evaluated as part of the Technical Proposal. Where this information should be placed within the Technical Proposal?

See Amendment 000005 for revision.

65. Section E.2, page 133, states “Provision of social security number is voluntary.”

Does FDA want Social Security Number information and if so, why?

The information is voluntary.

66. Section E. 3 requires that the offeror provide, in their Technical Proposal response, a detailed work plan and technical discussion which includes: objective, approach, methods, schedule, past performance information, personnel, key personnel, additional personnel, resumes, and additional technical proposal information. Section F.2 states that the Technical Evaluation will be evaluated as follows:

· Technical Approach 25%

· Project Management and Operation 35%

· Relevant Experience 30%

· Past Performance 10%

None of the factors being evaluated in Section F are resumes. Where should the resumes be placed in the Technical Proposal?

See Amendment 000005 for revision.

67. Section F.9.1 states “…and 3) the meaningful proposed use of other 8(a) or Small Businesses under this contract.”

a. Because this is an 8(a) competitive procurement, is this clause pertinent?

b. If so, will the government deduct points if the offeror does not subcontract to other 8(a) or small businesses?

See Amendment 000005 for revision.

68. Section F.12 states “…the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement…” Is Attachment 9 to be used as a guide for pricing purposes or may the offeror propose a different level of effort for this project for the Base Year and subsequent option years?

Attachment is to be used for pricing and evaluation purposes.

69. Section E.3 (Personnel) requires that offerors describe the experience and qualifications of personnel assigned to this project as well as the total time each will be available for the program. Can this information be included in their resumes rather than separately called out?

Potential offerors are advised to submit sufficient documentation in order for the proposal to be evaluated fairly and in accordance with the evaluation criterion set forth.

70. Section E.3 (Key Personnel) requires that we provide each key person’s education, background, recent experience, and specific pertinent accomplishments and letters of commitment. Can the education, background, recent experience, and specific accomplishments be provided in their respective resumes rather than called our separately to respond to the proposal instructions?

See response to question 69.

71. Section E.3 (Additional Personnel) requires that we provide names, titles, and proposed duties of additional personnel who are required for full time employment, or on a subcontractor or consultant basis.

a. If the offeror has a subcontractor, do you want their information called out under this heading or shall we consolidate with all the resumes?

See response to question 69.

b. Are additional personnel considered to be those labor categories which may be proposed other than those called out in Section D.10 or Attachment 9?

Yes

c. Because subcontractors and consultants are defined in this section, should all subcontractor personnel have commitment letters included in the proposal, even if they are currently employed by the subcontractor?

See Amendment 000005 for revision.

72. Reference SF1449: Block 20 says: “Delivery: 07/31/2009.”

a. Should this date be 7/31/2008 or some other date?

Date is irrelevant at this time.

b. Will the government advise the anticipated contract start date?

Amendment 000005 inserts an anticipated date of September 1, 2008 award date.

73. The solicitation’s Past Performance Questionnaire (RFP page 142) lists June 9, 2008 as the closing date for the return of completed past performance questionnaires. This seems unusual with a proposal due date of June 27, 2008, and the Pre-proposal Conference not being held until June 11. Is the June 9 date correct? If so, will the government extend the return date for the questionnaires to coincide with the due date of the proposals?

See response to question 1.

74. There seems to be a conflict between the first sentence, which requires resumes for every individual, and the second sentence, which appears to require a smaller number of resumes. Is it your intent that offerors provide a resume for each of the listed labor categories for a total of seven resumes? Please clarify whether this is the case or whether you do require resumes for every individual to be utilized as a resource in the first year.

See Amendment 000005 for revision.

75. In the section Conflict of Interest Screening, Please clarify whether this applies to a corporation or just to an individual.

Corporation

76. D.1.5 USPS Mail Receipt (Page 35), please provide the frequency and approximate times of USPS delivery to the CDR.

USPS mail receipt at CDR is once in the morning and once in the afternoon.

77. E.2 Delivery Instructions (Page 131), please clarify the number of volumes and number of copies required for the Technical Proposal. If the Technical Proposal is to be submitted in two volumes, please define what information should be included in each volume.

See Amendment 000005 for revision.

78. The solicitation contains Wage Determination Number 05-2103 REV (04), dated 07/05/2007. Should bidders not use WD 05-2103 REV (06), dated 05/29/2008?

Amendment 000005 incorporated WD-05-2103 Rev (06) dated 05/29/2008.

79. On page 138, paragraph F.8 is missing. Is there a missing paragraph F.8 with content or is this a format error?

See Amendment 000005 for revision.

80. Due the complexity of tasks required by the FDA and its objectives stated in A-1 Background of the solicitation, more effort is required in preparing a proposal that meets FDA goals. Will the FDA extend the proposal submission date two weeks and establish the new due date of the proposal as July 11, 2008 at 2:00 PM?

Amendment 000004 extends the closing date to July 2nd, 2008 at 3:30 pm ET.

81. What is the contract value of the five years for the current contract?

Refer to Part A. 6, page 5

82. What is the current staffing of the current base contract by position?

Current staffing levels are not applicable for this exercise.

83. How many Individual Task Orders were contracted during the current contract year to date? What was the contract value of those task orders?

Refer to Part a.6, page 5 and B.4, page 9

84. Reference D.1.6, Will you please define what software and version of software DARRTS is utilizing (i.e. Documentum, FileNET etc.)?

The requested information will not be provided.

85. What are the underlying databases for COMIS, DARRTS, BMIS, ECH, OND, INVAS*, RMS-BLA, ADMIS, MACMIS ? Can the government provide current network infrastructure maps pursuant to the aforementioned systems and the overall mail room operations?

The government will not provide current network infrastructure maps to the systems and overall mailroom operations.

86. Reference D.2.4.4. Will you please specify if the INVAS tracking system is GOTS or COTS?

a. If GOTS please define the database and data structure fields.

b. If COTS please identify the manufacturer and current version of software.

INVAS was developed by CDER to track the physical location of IND, NDA, BLA, and ANDA volumes. The system makes use of bar-code technology and it specifies if the volume is located in the document control rooms or with a specific reviewer.

87. Reference D.2.5.2, does FDA currently supports the use of the DoD 5015.2 records management standards with the retirement of records?

No, NARA 44 U.S.C. 2907 & 44 U.S.C. 3103

88. Reference PERSONNEL AND RESUMES page 110 states "Resumes shall be provided for each proposed individual to cover the labor resources required under the first year of the contract." Does this mean for only the key personnel or does it include resumes for the total personnel projected for the base year (240+ estimated) found on page 128 of the solicitation?

See Amendment 000005 for revision.

89. It appears as if 1888 hours is the figure used to define a positions work for the year. Will you please describe the computations used by FDA to arrive at that number? (For example: 52 weeks x 40 hours/week = 2080 hours; minus two weeks leave @ 40 hours/week (80 hours) =2000 hours; minus ten government holidays @ 8 hours/day (80 hours) = 1920 hours; etc., etc. = 1888 hours.).

The computation scheme used to define these hours will not be provided.

90. A-4 Compensation for Base Fixed Price, item c. (Page 3), the solicitation states: “As consideration for performance of the work stated in D-1, ‘Statement of Work’ … “And in F.7.1 Technical Evaluation Criteria / Technical Approach (page 138), the solicitation states: “The government will evaluate … Part D.1. Clarify in both instances that Part D, Attachment 1 (Statement of Work), rather than D.1 (Central Document Room) is intended.

See Amendment 000005 for revision.

91. E.3 Technical Proposal Instructions / Additional Personnel (page 134). The solicitation states: “List names, titles, and proposed duties of additional personnel, if any, who will be required for full-time employment, or on a subcontractor or consultant basis. …. For all proposed personnel who are not currently members of the offeror’s staff, a letter of commitment or other evidence of availability is required. To what additional personnel does this clause refer?

All full-time personnel

92. A-4 COMPENSATION FOR BASE FIXED PRICE / item d (page 3);

FDA Document Control Room (Including Technical Exhibits 4 through 7). Clarify intent of reference to Technical Exhibits 4 though 7.

See response to question 53.

93. Past Performance Questionnaire (page 142), indicates that past performance evaluations are due “by June 9, 2008. It is unusual for reference evaluations to be required prior to the pre-proposal conference. We will not be able to make a bid-no-bid decision prior to clarifications received at the pre-proposal conference. Would you consider an extension of this deadline?

See response to question 1

94. Is the incumbent eligible to bid? However, Several of Alutiiq subsidiaries are eligible to bid.

95. The announcement indicates that FDA wants the contractor to propose staffing levels and create efficiencies but then includes a chart with base level projected hours that estimate the staffing levels needed. Is FDA anticipating proposals based on staff levels or based on a per task basis?

The chart should be used as an aid not as a model to determine staffing levels. The Bidder is responsible for providing what staffing levels are required to be success in managing this program.

96. FDA indicates that the project manager be available for on site meetings with government personnel within 30 minutes during morning business hours and within 60 minutes after normal business hours. How often does FDA anticipate an after business hours need? Does FDA expect a manager available 24 hrs a day 365 days a year?

The project manager shall be responsible for being available during the normal business hours, however, there may be times (Facility outages or Facility emergences) where his presence may be required during off-hours. These are usually very rare cases.

97. In the evaluation section of the RFP, FDA states that “prime offerers who are not small business concerns will be evaluated on their performance in using small business concerns as subcontractors, joint ventures and in other teaming arrangements.” Are non small business concerns eligible to compete for the contract?

See Amendment 000005 for revision.

98. Reference E.2 GENERAL INSTRUCTIONS, Separation of Technical and Business Proposals. “The technical Proposal must include direct cost and resources information, such as labor-hours and categories and applicable rates, materials, subcontracts, travel, etc., and associated costs; so that the offeror’s understanding of the project may be evaluated. Will you provide a template of the level of information you require in the technical proposal with examples? The instructions are confusing in that direct cost information suggests pricing information normally excluded from a technical proposal.

See Amendment 000005 for revision.

99. Reference F.6 Contracting with 8(a) Concerns. “If, after evaluating all offers, FDA concludes that two or more offers are in effect equally eligible to be selected for the award, then the offer that provides the greater, most varied and most realistic use of all the categories. QUESTION: Will you explain what this sentence means? What specific “categories” are being referred to?

See Amendment 000005 for revision.

Reference: E.2 Delivery Instructions. ii Hand delivery (including commercial courier) of two (2) originals, six (6) copiers, and two (2) duplicate CDs of a Technical Proposal (Volumes 1& 2). Will you please provide the content you require in Technical Volume 1 and Technical Volume 2? The Technical Proposal Instructions suggest only one (1) Technical Volume Proposal.

See Amendment 000005 for revision.

100. Reference: E.2 Delivery Instructions (b) “Questions in response to this solicitation…Final questions shall be received by not later than 10:00 am (local time), Thursday, 06/13/2008. No questions will be accepted after this date. No phone calls please. When will bidders receive the answers to the initial set of questions? Why does FDA adopt this very tight schedule for responses and not provide the answers to valid questions so that bidders can respond effectively? When will bidders receive answers in response to these questions?

June 17, 2008

101. E.2 (c) “Closing Date and Time. All proposals in response to this RFP shall be due at the address specified in (a), not later than 2:00 pm (local time) on 06/27/2008. Is the FDA willing to consider proposals from the vendor community that would allow for accelerated consolidation of document processing from one centralized location? During the pre-bidders conference, it was mentioned that such a plan was being considered, yet this effort had been put "on hold." Please describe future plans that FDA has for consolidation and the impact of new buildings being erected on the Maryland headquarters campus.

The information is not available at this time.

102. Will FDA entertain the possibility of replacing the existing system and repository with an alternate solution from the commercial marketplace? There are many Electronic Content Management (ECM) solutions available, including software/integration, ASP, and software-as-a-service models. Are any of these in scope for this program or future task orders during the term of this contract award?

No

103. As it was mentioned during the pre-bidders conference, the vendor awarded this program will be measured against certain SLA criteria, typically included in the RFP as "99%," yet the databases from which those statistics and reports will come are still being prepared and consequently no system for such measurements is in place for the incumbent today. Will the winning vendor be allowed to engage with FDA to assist in ensuring process optimization and best practice implementation, as well as the development of related metrics and reporting mechanisms, to ensure that the vendor's business relationship with FDA has a common, measurable set of mutually realistic expectations based on document management industry standards?

Amendment 000005 incorporated the Critical Processing Time Constraints.

104. What are the volumes of each class of incoming, outgoing, accountable, and inter office mail?

The Inter-office mail operation is not handled by the document room staff; therefore this information is not available. The Incoming, outgoing, and accountable volume information is not readily available.

105. How many driver positions are there on the current contract?

The current number of driver’s is not relevant to this exercise.

106. How many vehicles are in use on the current contract and are there any special licenses required for vehicle operations?

The driver shall be required to have a commercial driver’s license. The current number of vehicles is not relevant to this exercise.

107. What type of media is supplied to obtain correct addresses for misdirected mail?

Organizational Charts & Employee Directories

108. In section D.3.2.1 Incoming Mail Receipt, is the required logs currently hard or soft copy?

The Bidder shall be responsible for determining what process shall be used to document incoming mail receipt.

109. How often are the courier runs? Please provide a daily courier schedule.

See response to Question 31 on page 4.

110. QUESTION REGARDING PROPOSAL SUBMISSION DATE EXTENSION: Will the FDA extend the submission date to allow for a fair and open competition on this solicitation? Amendment 000004 extends the closing date to July 2nd, 2008 at 3:30 pm ET.

The major reasons justifying this request are below:

a. During the Pre-Proposal Conference, a handout was provided as a basis to discuss processes that must be followed by contractors and explained in their proposals. The discussion by FDA was confused, not included in the current solicitation and incomplete.

b. The questions that had to be submitted by contractors Friday, June 6, 2008 NLT 2:00 PM were not addressed or answered during the Pre-Proposal Conference, except to announce "the answers would be forthcoming in a future amendment" with no date as a target. Nonetheless, the date of Friday, June 13, 2008 at 10:00 AM remains the fixed date for final questions to be submitted!

c. The current solicitation requires a resume for all of the 240+ personnel proposed for the base year. When attendees questioned the rationale for placing this unusual requirement on any 8(a) company, the answer was the requirement would be reconsidered. I point out that the only company that might meet that requirement is the incumbent Native American firm, Alutiiq Security and Technology, LLC and the contracting officer verified Alutiiq will be competing for the follow-on contract as the prime contractor, once again.

d. When questioned what metrics would be used to evaluate the contractor's claim that it could meet the 99% accuracy standards for a variety of tasks in the SOW, the FDA briefer stated FDA was not currently checking the contractor's meeting those standards and had not developed the metrics that would be used. Clearly, these accuracy requirements must be re-examined and validated/substantiated or deleted before simply being left in the current RFP.

See response to question 103.

e. When asked if the FDA would consider an extension to the submission date, the Contracting Officer stated FDA is not currently considering an extension.

f. We want to compete for this contract. However, whether intended or not by the FDA, the current solicitation requirements all but ensure that the incumbent contractor currently has a significant and unfair advantage in this competition that is not in the best interests of the FDA. For the above reasons, I request that FDA keep this a fair competition by extending the proposal submission to the later date as follows:

1. Four weeks following FDA's answering the questions following the cutoff date of Friday, June 13, 2008 at 2:00 PM or,

2. Four weeks following FDA's publication of the final amendment to the solicitation affecting the proposal responses of bidders.

As stated earlier, it is clearly in the FDA's best interest to allow sufficient time for fully qualified competitors to submit their best proposals for accomplishing the SOW and goals in the FDA solicitation.

Amendment 000004 extends the closing date to July 2nd, 2008 at 3:30 pm ET.

111. Reference: Pre-Proposal Conference June 11, 2008 Oral Question and Answer Period, A question was asked from the floor if the courier vehicle(s) was GFE. The government’s response was yes. According to the FAR 51.201 (c ), GSA vehicles are not authorized in FFP contracts. The RFP indicates that the initial IDIQ contract will be issued as FFP. Q1. Is (Are) the courier vehicle(s) something other than a GSA vehicle? Q2. Should an Offeror include any other costs for the courier service?

Amendment 000005 incorporated a Cost Reimbursable Line Items for equipment.

112. Reference: Pre-Proposal Conference June 11, 2008 Oral Question and Answer Period, A question was asked from the floor if the slides from the overhead presentation reflecting SOW reference deliverables with acceptable times and qualities would be provide to the attendees? The government stated that these would be available by amendment via Fed Biz Ops. Q1. When will this deliverable quality data and schedule be made available?

June 17, 2008

113. What is the schedule for mail delivered to the Gaithersburg’s Scanning Facility?

Mail is delivered to the Gaithersburg’s Scanning Facility twice a day, once in the morning and once in the afternoon.

114. Does the contractor or government provide the vehicles and gas for mail delivery?

The Bidder shall be responsible for providing the Vehicles and all other ODC costs, such as vehicle insurance, maintenance, and gasoline.

115. How many government furnished vehicles are provided by FDA?

FDA does not furnish the vehicles and it shall be the Bidder to determine the number of vehicles required to support this program.

116. Does the contractor provide the personnel operating scanning equipment? If so, what are the labor categories or job titles?

All scanning equipment is government furnished. There is no specific labor category for the operation of the scanning equipment.

117. What entity currently provides certification for the personnel operating the scanning equipment?

The X-ray scanning machine is the only equipment that requires an operation certification. This is obtained after the operator completes the manufacturer’s training course.

Note: The Bidder shall be responsible for scheduling and providing this training to his staff responsible for operating the X-ray scanning machine.

118. How often must be the courier service for D.1.9.1 & D.1.9.2 be provided?

See Question 31 on page 4.

119. Are the labor categories restricted to those listed in the PWS?

No

120. Does the government provide the shredding equipment for task D.1.10.1 (Shredding)?

The shred is handled by a separate contractor.

121. Is there any historical data for the amount of shredding completed?

No

122. How often must office to office inventory and Document Room Inventory be conducted?

OGD office-to-office inventory is performed weekly.

Review Division office-to-office is performed monthly.

123. Does the government provide the barcode scanners system?

Yes

124. The PWS states requirement for Shelf Shifting (D.5.15.3) must be performed during off-hours. How often is the requirement completed annually? Is overtime involved?

The Shelf Shifting shall be performed once a year for all document rooms. Overtime will be required.

125. Is Ability1 or JWOD staffing involved for the mailroom portion of the contract?

No

126. Are mail clerk’s part of the current staffing plan?

No

127. Who is the incumbent contractor? What are the current annual contract value and the total for the last five years?

See Response to question 38

128. What is the volume of USPS mail handled and delivered to all locations by the contractor?

The document room staff only handles regulatory mail (documents related to applications) sent by Drug Sponsors.

129. Has the scope of work increased/decreased or remain the same under the new contract?

Increased

130. Will the Service Contract Act (SCA) apply to this solicitation and would the new contractor have the opportunity to transition the incumbent employees?

See response to question 78.

131. Does FDA have a vendor it uses for training on the Hermann X-Ray Scanning Machine?

No, the Bidder shall be responsible for scheduling training with the Hermann manufacturing Rep.

132. Will FDA consider having the Program Manager as the Key Personnel and wave the requirement for multiple resumes? The requirement for multiple resumes will only favor the incumbent contractor.

See Amendment 000005 for revision.

133. Will FDA please extend the due date for Past Performance Questionnaire to the due date of the proposal on June 27, 2008?

See Response to question 1.

134. The solicitation states, “Resumes shall be provided for each proposed individual to cover the labor resources required under the first year of the contract.” This information is only available to the incumbent and without it only the incumbent is qualified to compete on this solicitation. Can you provide us with the names and contact information of all incumbent personnel so we can contact these to obtain the required information?

No

135. Reference: Page 47, Section D.2.3 Section D.2.3 states “the contractor shall ensure that adequate filing space is maintained for all CDER regulatory document rooms”. We understand that we shall apply methods to optimize storage areas (i.e. shelf shifting) but given the fact documents and document rooms have a finite space, will the contractor be required to identify additional storage facilities? If so, shall the contractor reflect those cost estimates in the cost proposal?

No

136. Reference: Page 131, Section E.2 (a)(i) and E.2 (a)(ii), Regarding the number of originals and copies of the proposals required, Section E.2 states “…two (2) originals, eight (6) copies...” of the technical proposal. Is the correct number of copies eight or six?

See Amendment 000005 for revision.

137. Reference: Page 131, Section E.2 (a)(i) and E.2 (a)(ii); Section E.2, Page 12; Page 133, Section E.3 In section E.2 (p 132), it is stated that the Technical Proposal consists of volumes 1 & 2, and the Business Proposal is Volume 3. In section E.3 there is no instruction of how the technical proposal shall be divided into Volume 1 and Volume 2. In section E.2 (page 132) it states the Technical and Business proposals “must be prepared in two parts”. Please clarify the contents of the three (3) volumes as well as the distinction between the terms “volume” (used in section E.2, page 131) and “parts” (used in section E.2, Page 132).

See Amendment 000005 for revision.

138. Reference: Page 133 Section E.3 Schedule This RFP is for services not delivery of a product or construction project. Is the government asking the contractor to restate the Volumes of reports stated in Attachment 7 based on the timing requirements in the SOW? If so, what is the desired format?

139. Reference: Page 131, Section E.2 and Page 132, Section E.2 Section numbering was duplicated (E.2). Please verify no relevant information is missing.

140. Reference: Page 120-125; Attachment Three (3) and Pages 120-125; Attachment Three (3)/Attachment Four (4) Pages 120 to 125 are duplicated. Please verify no relevant information is missing.

See Amendment 000005 for revision.

141. Reference: Page 37, section D.1.7.1, paragraph 1 and section D.1.7.2, paragraph 1 Section D.1.7.1 indicates that desk copies, documents from the district office, and receipts of returned requests shall be date stamped, and section D.1.7.2 states that these items shall not be date stamped. Shall these items be date stamped or not?

Section D.1.7.2 title was amended so as to provide a more accurate description of the section content. See page 37 of the RFP.

142. Reference: Page 110, Section: Personnel and Resumes Q1: This section states, the following additional number of resumes shall be submitted:” and is followed by a table with headers stating “Labor Category” and “Resume(s) Required”. There are no stated number of resume(s) required”. Please state the number of resumes required for each labor category.

143. This section states: “Resumes shall be provided for each proposed individual to cover the labor resources required under the first year of the contract. The following additional number of resumes shall be submitted…”. If all base year resumes are required, are the “additional number of resumes” for personnel in the option years? Please clarify whether the “additional resumes” are in addition to all the resumes required for the base year.

The “additional resumes” are in addition to all the resumes required for the base year.

144. Page 110 states “Individuals whose resumes do not clearly show the required qualifications and availability will be considered unqualified and the proposed hours for that person will not be counted toward meeting the RFQ maximum resource requirements.” What are the maximum resource requirements? Are the hours listed in attachment 9 considered the maximum resource requirements?

The hours listed in attachment-9 are meant to be an estimate for what resources are required.

145. Reference: Page 110, Section: Personnel and Resumes and Page 135; Section: E.3. Resumes; Page 110 indicates there will be a number of resumes required for each labor category (see Question #8) and Page 135 under “Resumes” indicate that only resumes of Key personnel are required. Are we required to submit resumes for every labor category indicated on page 110, or only submit resumes for the positions identified as “key”? If we are required to submit resumes for every labor category described on page 110, please identify the location in the technical proposal where the “non-key” personnel resumes shall be placed.

See Amendment 000005 for revision.

146. Page 134; Section E.3; Regarding the sections titled “Personnel” and “Key personnel”, it is stated to “Describe the experience and qualifications of personnel who will be assigned work on this program” and “Identify key personnel including consultants that will be involved in the proposed program.” Please verify that the government wants descriptions of personnel who will be assigned work for the entire program duration (Base plus option years).

The government is interested in the base year only.

147. Reference: Page 25, Section B.30, Bottom paragraph – Federal Holidays & Executive Orders. Regarding section B.30, will the government include FAR clause 52.249-14 (Excusable Delays) into RFP Pages 32-22, Section D.1?

NO

148. Reference: Page 117, Section D, Attachment Three (3) – DOL Wage Determination The RFP includes WD 05-2103 (Rev. -4) dated 7/5/07, however, this version has been superseded since July 2007.