Amendment1-Attachment1-Q and A - Post.pdf

Amendment 1 – Attachment 1

Questions and Answers

Request for Proposals (RFP) Number: 75N95022R00014

Project Title: NINDS Center for Clinical Trial Resources

Question Number Question and Answer

NINDS Responses

1.

Question: The instructions for the "Human Subjects" section of the RFP provide that this section is to be a separate "file" of the Technical Proposal. Can NINDS clarify if this should be a standalone file outside of the Technical Proposal? Or is a separate section within the Technical Proposal sufficient?

A separate section within the Technical Proposal IS sufficient.

2.

Question: The RFP lists the due date for the annual progress reports as last day of each contract year (9/29); however, the SOW gives a due date of a month later (10/30). Can you clarify which is correct?

Annual progress report is due on 9/29 of each contract year.

3.

Section L.2.c.4 Business Proposal Instructions, page 97, “Requirement for Certified Cost or Pricing Data”

Question: Please confirm that the Government expects sufficient competition such that offerors are not required to submit certified cost or pricing data per FAR 15.403- 1(b)?

Correct, offerors are not required to submit certified cost or pricing data.

4.

Section L.2.c.6, page 102, 352.231-70 Salary Rate Limitation (December 2015), HHSAR Clause 352.231‐70 is included in the RFP. 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.”

Question: If a prime contractor or subcontractor employee has a normal gross annual salary of $205,000 (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

The salary rate limitation is applied as an annual rate. Refer to the following website for additional information:

Salary Rate Limitation Questions and Answers | HHS.gov https://www.hhs.gov/grants/contracts/contract-policies-regulations/salary-rate-limitation/index.html https://www.hhs.gov/grants/contracts/contract-policies-regulations/salary-rate-limitation/index.html

NINDS Responses during a given year, their compensation for the direct effort under the contract will equal approximately $9,856 ($205,000/2080 = $98.56 * 100 = $9,856). Please confirm that this situation would not violate 352.231-70, because the compensation paid for the direct effort under the contract is far below the Executive Level II threshold?

• Consultants are not paid a “salary” and typically are just reimbursed by a company based on actual work performed. If a prime contractor uses a consultant with an hourly rate of $200 (which would appear to be in excess of the current Executive Level II salary divided by 2,080 hours) and the consultant only works 100 hours on the contract during a given year, their compensation for the direct effort under the contract will equal only $20,000. If the only direct effort this consultant performs under the contract in an annual period results in annual compensation of only $20,000, 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?

• Question (iii): If the Government determines that this rule would apply in either of the situations above, please confirm whether the salary rate limitation rule does not apply when the services are provided on a fixed price

NINDS Responses basis (per project or per deliverable) rather than on an hourly basis?

5.

Attachment 1, Statement of Work, Contract Start-up and Overall Project Management, page 4, Archived Clinical Research Datasets website.

Question. Is the Contractor responsible for hosting and managing the Archived Clinical Research Datasets website?

No. NINDS will manage the website, will receive, review and approve the data user agreements and will notify the contractor to release the data/metadata.

The contractor will only receive datasets from submitters (these will be submitted to NINDS) and will release datasets/metadata after NINDS notifies of approval.

6.

Attachment 1, Statement of Work, Performance Area 3, #2, page 6; De-identified data

Question: Are the datasets provided by NINDS de-identified, or is the de-identifying to be performed by the Contractor?

Datasets will be submitted deidentified.

The contractor would verify that datasets are properly deidentified.

7.

Performance Area 4, #16, page 9; The NINDS estimates 1 New Disease-Specific CDE Development will be required each year:

Question: Are there particular disease area NINDS is focusing on for the 5 new CDEs (one per performance year)?

To date we only have identified 2 projects, 1 is a new disease area and 1 is a revision.

CDE areas would be neuroscience-related, in support of the NINDS mission.

8.

Performance Area 4, #3, page 7; Oversight Committees will meet at least once every year in-person or in virtual meetings. It is anticipated this would require 1 - 2 Contractor staff for up to 2 days of travel as well as up to 18 in-person meetings per year).

We are currently conducting all meetings remotely. However, this may change depending on the pandemic progress.

NINDS Responses

Questions: Will NINDS clarify if the 18 meetings per year are in-person or if any are assumed to be virtual?

9.

Performance Area 2, #2, page 5; Statistical Support: meta-analysis or sub analysis of NINDS funded studies

Question: Will the meta-analysis be based on data read from published manuscripts?

The analysis is usually from unpublished data. However, we may need support for published data.

10.

Performance Area 2, page 5; Statistical and Methodological Support

Question: Is it acceptable for the Offeror to assume one type of each methodological and statistical support task will be completed per year?

No. The work would depend on the project that need the statistical support.

11.

Performance Area 4, #6, page 8; Copyright Protection Documentation Support

Question: How many copyrighted and trademarked instruments are in the CDEs?

To clarify, the contractor is expected to keep the Notices of Copyright updated.

This includes a current link to the copyrighted/trademarked instrument and the information in the form.

12.

Performance Area 4, #5, page 8; Maintenance and updating of the CDEs

Question: Can NINDS provide a description of the activities involved and the level of effort expected to maintain and update CDEs?

Please refer to page 6 thru 9 of the SOW.

Attachment 1, Statement of Work, This is variable. It depends on the type of

NINDS Responses

13.

Performance Area 4, #1, page 7; CDE Website

Question: What is the frequency of expected changes to the NINDS CDE website?

Within the frequency of time defined in the previous question, how much content typically changes on the website?

changes and new information. E.g. a new project or major revision will be probably about twice a year. Minor revisions and updates are done at least once a month.

14. Attachment 1, Statement of Work, Performance Area 4, #13, page 7; CDE Web-based Training Module Development

Question: The Tutorials page of the NINDS CDE website does not include any content. Is NINDS able to share a link to the existing trainings?

We do not have a current training module