Amendment_1-_RFP_NHLBI-CSB-DE-2014-09-CM.pdf

SOLICITATION: NHLBI-CSB-DE-2014-09-CM

AMENDMENT: One (1)

TITLE: Clinical Research and Operations Management Support (CROMS)

EFFECTIVE DATE: January 30, 2014

ISSUED BY:

National Heart, Lung, and Blood Institute, NIH Office of Acquisitions, CSB, DERA 6701 Rockledge Drive, Suite 6042, MSC 7902 Bethesda, Maryland 20892-7902

Point of Contact: Cornelius Moore, Contracting Officer [E-mail – Cornelius.Moore@nih.gov]

The above numbered solicitation is amended as set forth below. The hour and the date specified for receipt of proposals has been changed to 4:00pm local time on February 18, 2014. Questions regarding this solicitation shall be submitted electronically by 4:00 PM local time on February 5, 2014. Offerors must acknowledge receipt of the amendment prior to the hour and the date specified for receipt of proposals, by one of the following methods:

A. By acknowledging receipt of this amendment on each copy of the proposal submitted. Please note that this is the preferred method.

B. By separate letter or email which includes a reference to the solicitation and amendment number.

All other terms and conditions of the solicitation remain unchanged.

DESCRIPTION OF AMENDMENT

PURPOSE: To revise Section A., Section L., of the solicitation and answer questions submitted in response to the Request for Proposals (RFP).

I. REFERENCE: Section A., item 8 is revised to read follows:

Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 4:00 pm local time on February 18, 2014. Questions regarding this solicitation shall be submitted electronically by 4:00 PM local time on February 5, 2014. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

II. REFERENCE: Section L., paragraph 2., sub-paragraph A., item 6. Page and Formatting Limitations (Page

47) is revised as follows:

6. Page and Formatting Limitations

The Technical Plan (objectives, approach, methods and procedures, and sub study proposal) of the technical proposal shall not exceed 30 single-sided pages or 15 double-sided pages. This page limitation does not include the cover sheet, abstract, table of contents, personnel, facilities, equipment and resources, other considerations, schedule, other support, cost information, and literature cited.

The substudy proposal section of the Technical Plan (included within the 30 page limit) shall not exceed 8 single-sided or 4 double-sided pages. Appendices shall not exceed a total of 100 single sided pages or 50 double-sided pages. Pages in excess of the limitation will be deleted and will be neither read nor evaluated. Each page of the technical proposal must be numbered sequentially.

Offerors are encouraged to limit the overall size of the technical proposal, inclusive of appendices, attachments, etc. Although no page limit has been placed on the business proposal, offerors are encouraged to limit its content to only those documents necessary to provide adequate support for the proposed costs.

Type density and size must be 10 to 12 points. If constant spacing is used, 15 cpi (characters per inch) or fewer shall be used, whereas proportional spacing should provide an average of no more

RFP-NHLBI-CSB-DE-2014-09-CM Amendment-1 than 15 cpi. There must be no more than six lines of text within a vertical inch. Margins must be no less than ½ inch around, exclusive of headers and footers.

III. REFERENCE: Section L., paragraph 2, sub-paragraph C., item 3., Alternate 1 (October 2010) of FAR Clause 52.215-20, Requirements for Certified Cost or Pricing Data and Data Other than Cost or Pricing Data (October 2010) (Page 74) is revised as follows:

Alternate I (October 2010) of FAR Clause 52.215-20, Requirements for Certified Cost or Pricing Data and Data Other than Cost or Pricing Data (October 2010). As prescribed in 15.408(l) (and see 15.403-5(b) (1)), substitute the following paragraph (b)(1) for paragraph (b)(1) of the basic provision:

(b)(1) The offeror shall submit certified cost or pricing data, data other than certified cost or pricing data, and supporting attachments in the following format:

The format specified in paragraph L.2.c.2. Certified Cost or Pricing Data, subparagraph 3. formats for Submission of Line Item Summaries shall be used for the submission of cost data. Submission of all other certified cost or pricing data shall be in accordance with Table 15-2 in FAR 15.408..

IV. REFERENCE: Responses to Questions (Attachment 1 of Amendment 1)

END OF AMENDMENT

Attachment 1

1. For purposes of the RFP, please confirm the Government intends offers to submit pricing only in relation to the 14 numbered Uniform Cost Instructions beginning on page 79?

No, Please refer to Section L Paragraph 2, Sub-paragraph C (page 69) i (Business Proposal Instructions) for information regarding pricing and the budget that is to be provided. The Uniform Cost Assumptions are to be incorporated into your overall budget.

2. Please confirm these are sample assumptions for proposal purposes only and that the value of the contract that will be awarded in the base year will not be based on these values?

Uniform Cost Assumptions are approximations of planned work and costs proposed will be the basis for the total award amount following negotiations. Once awarded, work will vary based on Government identified need and costs incurred will be reimbursed on a cost-reimbursement basis.

a. Assuming the statement in #2 is correct, how will the ceiling value of the base year (and individual option years) be determined given that the number and type of studies is not currently known?

See above, this will be determined during negotiations.

3. With regard to the Uniform Cost Instructions:

a. Does the Government want to see a separate price (with appropriate pricing detail) for each of the numbered assumptions (i.e., one set of spreadsheets using the specified format for each of the numbered assumptions so that there are effectively 14 different prices offered)?

No, see the answer to question 1 above.

b. With regard to Assumption 1, would the Government clarify if it wants to see individual pricing for each study listed in Assumptions 1a through 1e?

See above.

c. With regard to Assumption 1, does the Government want to see pricing for each study in 1a through 1e repeated in the base year and all four options? (e.g., in 1a should we provide pricing for 2 new single site studies per year for a total of 10 studies in 1a?)

Yes. Uniform Cost Assumption 1 describes an annual need.

d. Assuming the answer to 3c above is yes, does the Government also want the pricing for the other assumptions repeated annually (e.g., so that for assumption 2 we would price Study Design and Protocol Development Assistance for 3 studies per year across 5 years, totally 15 studies) Yes.

e. With regarding to providing pricing for studies can we assume that the NIDCR clinical sites will be reimbursed for their costs/activities through a different mechanism and that we do not need to include site payments in our proposed prices?

Yes.

f. Assumption 5 (Data Collection/Management) indicates that the Offeror will assume the transfer of data management activities for 10 ongoing clinical studies. Can the Government confirm that the data management system originally used for these studies will be utilized by the Offeror for the studies transferred? If so, will the Government provide the necessary licenses for the studies transferred or should the Offeror include them in our price?

No. The Offeror will need to provide systems for data management. The Government will transfer existing data and a description of the data structure, which will be housed on the Contractor’s system.

g. With regard to Assumption 7 (Regulatory Support) – Please confirm whether we should assume only a single new IND or IDE in year 1 with maintenance in the option years, or if there will be a new IND or IDE each year plus maintenance in the option years (e.g., 1 new IND in Year 1, 1 new IND in Year 2 plus maintenance of the Year 1 IND, 1 New IND in Year 2 plus maintenance of the INDs from years 1 and 2)?

Refer to Uniform Cost Assumption 1b and the one-year duration. Assume that a new IND/IDE study will occur in each year of the contract and that the study performance period (and IND/IDE maintenance) will be limited to one year in duration.

i. These instructions also indicate we should assume maintenance of 2 existing studies: Should we assume the same 5 SAEs and 1 Protocol Amendment during the 5 year period for each?

Yes. Uniform Cost Assumption 7 should be amended:

Current Assumption # 7. (SOW Task 5) - Regulatory Support - Assume 1 new IND or IDE applications will be submitted in Year 1 and maintained each year.

Each will have 5 SAEs and 1 protocol amendment in the 5 year period. Assume maintenance of 2 existing IND studies.

Revised Assumption # 7. (SOW Task 5) - Regulatory Support - Assume 1 new IND or IDE application will be processed each year and 2 existing IND studies will be maintained each year through the base year only. Also assume that 5 SAEs and 1 protocol amendment will be needed each year.

h. With regard to Assumption 9 (Clinical Site Monitoring) – Where should we assume the trials to occur so that we can accurately project travel costs? We understand that 20% of the visits will involve local travel to the NIH Clinical Center, but can you provide assumptions on the location of the other 80%?

Refer to Uniform Cost Assumption 1 for potential domestic site locations (ie, Minnesota, Boston, Birmingham and Seattle).

i. Regarding Assumption 8 (Specialized Operational Support) – Where should we assume shipments will be delivered? The Government states that 5 domestic shipments are to be made each. Can the Government further specify the meaning of “each?” Is it full distribution of 5 different products? Is it distribution of one product to 5 different sites?

This is a typo and should read “…shipments are to be made each year.” Assume shipping costs for 1 product to the following locations: Birmingham, Boston, Houston, Minnesota and Seattle.

j. For assumptions that don’t contain an annual quantity, does the Government just want us to provide a price for the activity listed without regard to the base period and option years? (e.g., Assumption 10-Safety Monitoring indicates to assume the processing of 20 SAE reports. Should we just price 20 SAE reports or 20 per year?)

Yes, for assumptions that do not contain a quantity, provide a cost for the activity for the base period and each option year.

k. For Assumption 11 (Safety Monitoring) – Should we assume support of 1 new committee in the base year plus maintenance of 15 existing committees, and then in Option Year 1 there would be 1 new committee, plus the committee started in the Base Year, plus the 15 existing committees (or just 1 new committee plus 15 maintenance committees per year in the base and all options)?

Offerors should assume support for 16 oversight committees per year – 1 new; 15 existing.

l. Also with regard to Assumption 11, please confirm the Government intended to use the terms “or” and “and” as listed in the assumption: “assume support of 1 new oversight committee (DSMB or CSOC) each year and maintenance of 15 ongoing oversight committees (DSMB and CSOC)?”

Oversight committees will be a combination of DSMB and CSOCs. Offerors should assume support for 16 total oversight committees per year – 1 new; 15 ongoing.

m. For Assumption 12, does the analysis support include the effort in support of the Clinical Study Report?

Yes.

n. For Assumption 13 (Information Management Systems) – The assumption indicates “5 clinical studies are added each year of the contract.” Can we assume these studies are no more than 1 year in duration each (i.e., should we assume 60 ongoing studies in the base year plus 5 new studies and the same for each option year, or continue to add 5 studies per year so that we effectively have 65, 70, 75, 80, and 85 studies over the base and options?)

For Information Management systems, study information may need to be provided for a longer duration than the study’s activities. Therefore, managing study information will be additive over 5 years, effectively 60 ongoing, 65, 70, 75, etc.

o. For Assumption 14c, how many call-in lines should we assume for each of the 150 teleconferences (e.g., how many separate lines calling in to the teleconference).

For proposal purposes, assume 5 call lines per teleconference.

4. Under the current contract, how many contractor (or subcontractor) personnel have been designated as “Level 5: Public Trust-Moderate Risk” and required the appropriate background investigation (per section H.9 of the RFP)?

This depends on the personnel proposed by the offeror. Personnel requiring access to sensitive material will require background investigations.

5. Article H.11 requires the contractor to create and/or Manage an NIH website. Does the creation/management of the website constitute access to an HHS information system or data, thereby triggering the various Personnel Security Responsibilities, Information Security Training, etc.?

Yes that is correct.

6. On page 74 in the Alternate I language of FAR Clause 52.215-20 there is a provision that says, “The format specified in paragraph L.2.c.4 Certified Cost or Pricing Data, Subparagraph 3.

Formats for Submission of Line Item Summaries shall be used for the submission of cost data.

Submission of all other certified cost or pricing data shall be in accordance with Table 15-2 in

FAR 15.408.”

a. Paragraph L.2.c.4 appears on page 74 and appears to concern the Salary Rate Limitation in Fiscal Year 2013 and does not have a Subparagraph 3. Please clarify this reference?

This was a typo. It should read L.2C.2.

b. Assuming we use the spreadsheet provided as Attachment 9 in section J, please confirm this will meet the requirements of Table 15-2 as it has in other NIH solicitations?

Only providing a spreadsheet does not fulfill the requirements. Additional information is required in order for the Government to determine the reasonableness of the costs provided. The information in Table 15-2 provides additional guidance and information.

7. Item 30 in the Deliverables Table on page 12 of the RFP indicates that the Offeror will “Establish

Websites and Databases from ongoing systems.” Can the Government define the current systems being utilized for websites and databases?

The current systems are outlined on page 81 of the RFP:

(SOW Task 10) - Information management systems - Assume transfer and maintenance of tracking information and documents of 60 ongoing clinical studies; establish a password protected website to share clinical study information and documents with NIDCR and clinical study investigators. Assume that 5 clinical studies are added each year of the contract.

8. Item 30 in the Deliverables Table on page 12 of the RFP indicates that the Offeror is to establish websites (plural). Item 31 indicates that the Offeror is to establish a Clinical Study Website. Can the Government provide further detail, clarification or explanation about the scope of the website deliverables?

Please refer to the response to question 7.

9. Page 68 of the RFP indicates that Proposals must include a copy of the “Offeror’s Clinical Site Monitoring and Quality Assurance implementation plan for with relevant monitoring SOPs.” The sentence in the RFP appears to be incomplete. Can the Government indicate the intended language to be included? Specifically, “Implementation plan for what?”

Please remove “for” from the sentence. Implementation of Clinical Site Monitoring and Quality Assurance.

10. Page 68, Are the sample Standard Operating Procedures to be included counted in the appendices page count? If yes, to the extent the requirement to include samples like this will cause our appendices to exceed 50 pages may we just include a copy of the first page of each SOP or a listing of all appropriate SOPs the company has in place?

The page limitation for the appendices has been increased to “not to eexceed 100 pages.” If the required information cannot be accommodated within this limitation, it is acceptable, to provide the first few pages or the amount that might be needed to give a clear indication of the information while staying within the limitation.

11. The RFP, on page 68, indicates that the proposal must include a copy of the Offeror’s Clinical Site Monitoring and Quality Assurance Plan. Are these plans to be included as part of the RFP page count? Is it the intent of the Government to receive templates for Monitor Plans and Quality Assurance Plans from the Offeror since there are multiple programs with differing requirements detailed in the RFP?

The Offeror’s Clinical Site Monitoring and Quality Assurance Plan shall address all the work proposed based on the Statement of Work. Include as part of the appendices page count.

12. Will the Offeror be indemnified by the Government (or any 3rd party) for negligence related to work that is transferred from another contractor?

The Government does not provide indemnification. The matter will be reviewed and decisions made on a case-by-case basis, if necessary.

13. In the Uniform Cost Assumptions, page 80, item 4 states that monitoring visits will last 2 days per visit while item 9 (SOW Task 7) indicates that the visit duration will be for a period of 3 days.

Can the Government provide clarification?

Uniform Cost Assumption # 4 and # 9 describe different types of visits. (#4: site operations assessment visits and follow-up interim monitoring visit; #9: clinical site monitoring) Please propose costs accordingly.

14. In the Uniform Cost Assumptions, page 81, item 11, the assumptions related to Safety Monitoring (DSMB or CSOC) are defined. Is the Offeror to select the 1 new oversight committee per year. On page 67 of the RFP, “Additional Technical Proposal Instructions, under “Personnel,” the Offeror must provide the qualifications, knowledge, experience, education, competence, availability, and decision making authority of the PI, Project Director, technical staff, and administrative support staff. Are the DSMB members for the one new committee each year to also be described as defined in Section 6, Personnel?

No. DSMB/CSOC members will be identified by the Government and will not be contractor staff.

The contractor will be responsible for DSMB/CSOC member honoraria.

15. Will the Offeror be responsible for the Trial Master File (TMF) for each of the clinical studies? If so, will the Offeror use a Government established system for eTMF or do we need to provide our own?

For IND studies, the IND sponsor will be responsible for their Trial Master File. The government will not supply a system for the eTMF.

16. Can the Government clarify whether or not the Offeror will be responsible for any site selection?

No. The Government will make the final determination on site selection.

17. In the Statement of Work, Attachment 3, page 6, Task 3. Section C . , Items 9 and 10, the Government clearly defines the elements of the reports. Is the number of reports and how the data will be reported to be determined at the discretion of the Offeror? Can the Government define the expected frequency of the delivery of the Data Management related reports?

Some reports will be required daily while others less frequently. In addition, refer to Section F.2 for a listing of specific deliverables.

18. Is the Offeror responsible for the development of DSMB or CSOC Charters for the respective clinical studies for which they are applied?

Yes. Charters will be developed using an NIDCR standardized template and in collaboration with NIDCR staff.

19. Is the Offeror expected to be responsible for planning and identifying the site for Investigator Meetings?

No.

20. In respect to the Statement of Work, page 6, Task 4, Training and Training Related Activities, item H, are the training materials currently available on the DMID website the property of DMID whereby the Offeror can utilize those materials and provide additions to the existing trainings?

Some DMID training materials posted on the DMID website have restricted access. This RFP is a NIDCR requirement. NIDCR Educational Materials are posted publicly on the NIDCR website (www.nidcr.nih.gov/Research/toolkit/). Other materials will need to be developed by the contractor.

21. Can the Government confirm whether the technical response is to be formulated to define the approach to the Statement of Work in consideration of the assumptions defined in the Uniform Cost Assumptions on pages 79-81 of the RFP, or are those assumptions merely to be used in developing the prices?

The offeror’s technical proposal should address all aspects of the statement of work and should be in line with Section L.2. of the RFP.

http://www.nidcr.nih.gov/Research/toolkit/

22. HHSAR Clause 352.231-70 is included in the RFP (p 34). It indicates that “an individual’s direct salary is the annual compensation that the Contractor pays for an individual’s direct effort (costs) under the contract)” (emphasis added). If a prime contractor or subcontractor employee has a normal gross annual salary of $200,000 (which would exceed Executive Level II if the employee worked full-time for a year under the contract) and only works 100 hours on the contract during a given year, their compensation for the direct effort under the contract will equal approximately $9,615 ($200,000/2080 = $96.15 * 100 = $9,615). Please confirm that in this situation there would be no violation of 352.231-70, because the compensation paid for the direct effort under the contract is far below the Executive Level II threshold?

This approach would be a violation. On page 74 of the RFP in order to calculate the salary:

" An individual's direct salary (or institutional base salary) is the annual compensation that the Contractor pays for an individual's appointment whether that individual's time is spent on research, teaching, patient care or other activities.”

23. With regard to SOW Task 8 ( Pharmacovigilance/Safety Monitoring): Is the vendor to assume that there is no safety database currently in place and that the request is to build one from scratch, or is the vendor to assume that a database is currently in place and the task would be for the successful transfer and ongoing maintenance of the database?

The Offeror will need to provide a system for safety monitoring. The Government will transfer existing safety data, which will be housed on the Contractor’s system.