Responses_to_Questions_received_2017N66628.pdf

RESPONSES TO THE QUESTIONS RECEIVED IN RESPONSE TO

REQUEST FOR PROPOSAL NUMBER 2017N66628

Question 1

Is there an incumbent contractor currently performing these services or if this is a new requirement. If there is an incumbent, could you please provide the contract number?

Response to Question 1:

No

Question 2

Is this a follow-on contract? If so, would it be possible for you to provide the incumbent information (we need the contract number and contractor).

Response to Question 2: No, this is not a follow-on contract.

Question 3

RFQ Section C, Page 5, The RFP references “the government central data coordinating site.” Could CDC clarify if a data coordinating center will be established under a separate contract mechanism?

Response to Question 3: No

Question 4

RFQ Section F.4, page 11, Section F.4, table of deliverables refers to Task 1, “Clinical Protocols” to be submitted from each clinical site. Can CDC clarify how this clinical protocol will differ from the “study protocol from the government” listed in the deliverables table Task 2?

Response to Question 4:

The clinical protocol will differs in that it refers to the policies, procedures, or clinical decision-making algorithms that clinics use routinely in the diagnosis and management of patients with ME/CFS in the target age group. The study protocol from the government refers to the protocol that will be followed for the RFP. There might be similarities and differences between clinics’ routine management and the study protocol.

Question 5

Section H5, Security Compliance (p.21) references “Based on guidance in FIPS 199 and NIST SP800-60 the system will be assigned an overall security category (SC) of LOW or MODERATE.” Can CDC specify the FIPS 199 security categorization level for this system? What is the expected level of involvement from the contractor to complete the required

SA&A documentation? Are there any ongoing SA&A activities that should be included in the proposed budget? Can CDC provide an estimated timeline for receiving the Authorization to Operate?

Response to Question 5

Organizations will have to categorize their information systems as low or moderate.

Question 6

Section L.4 (p. 43) indicates the “Government contemplates award of a Firm-Fixed Price contract.” Would CDC consider changing the contract type due to the uncertainty in level of effort required to enroll study subjects?

Response to Question 6

Yes

Question 7

Section L.10 (c ) (p.46) asks for “hourly rate for each proposed labor category.” Section M.3 (p.48) references “the

Government anticipates awarding a task order.” Could CDC clarify if this contract is issued under an established contract vehicle?

Response to Question 7

An established contract vehicle

Question 8

Can CDC provide the estimated level of effort per enrolled study subject, based on its past experience enrolling ME/CFS study participants?

Response to Question 8

The estimated level of effort per enrolled study subjects varies by clinic(s). Factors related to this variation might include the following:

- Recruitment conditions: For example, will clinic(s) recruit existing patients, new patients, or some combination of both?

- Staffing status: For example, will clinic(s) already have available all required and qualified research staff (e.g., physicians, study coordinators, IT or data management staff)?

Question 9

What Wage Determination is included with this requirement?

Response to Question 9

The Wage Determination will be for the state of the organizations that are awarded a contract.

Question 10

Will the contractor be required to submit a Privacy Impact Assessment?

Response to Question 10

Yes, the contractor will be required to submit the Privacy Impact Assessment after award.

Question 11

Are cover letter, table of contents, resumes, and appendices included in the 50 page count limit?

Response to Question 11

No, the cover letter, table of contents, resumes, and appendices are not included in the 50 page count limit.