NIMH-23-002448 Questions and Answers.FINAL.pdf

NIMH23002448

Financial and Clinical Monitoring Activities Support for NIMH Studies

Q and A

1. What is the anticipated volume of for-cause clinical site study reviews, research practices and audit report review, and financial audit report review?

The anticipated volume of for-cause clinical site study reviews is up to 150 studies. The anticipated volume of financial audit report review of supporting documentation is approximately 300 individual expenses submitted quarterly.

2. Does the government have existing monitoring protocols, review tracking and reporting systems, finding and corrective action tracking and reporting mechanisms, and status dashboards that the contractor is expected to use, maintain, and update?

The government does not have existing monitoring protocols, review tracking and reporting systems, finding and corrective action tracking and reporting mechanisms, and status dashboards that the contractor is expected to use, maintain, and update

3. Does NIMH have a grants risk management framework that reviews will align with? If not, will the contractor be responsible for risk assessment for reviews and creating the associated framework?

NIMH does not have a grants risk management framework that reviews will align with. The contractor will be responsible for risk assessment for reviews and creating the associated framework.

4. The government has requested a ‘cadre’ of clinical and financial auditors, but has provided a LOE estimate of less than 2 FTEs for clinical review and less than 1 FTE for financial audit;

would the government please confirm that their expectation is to have a number of part-time reviewers in each team?

Per the SOW, the level of effort is: Supervisory Program Manager 500 hours per period of performance, Clinical study audit report reviewers 2600 hours per period of performance, Psychiatrist reviewer 300 hours per period of performance, and Financial audit report reviewers 1200 hours per period of performance.

5. Does the LOE include NIMH expectations of enterprise activities outside of the audit review (e.g., coordination with other contractors or government teams to share findings, trends, and support alignment with enterprise risk strategy?

The LOE does not include NIMH expectations of enterprise activities outside of the audit review.

6. Solicitation lists the timeframe of funded programs requiring audit review. What is an estimate of number of grant-funded studies requiring an audit?

The estimate of grant-funded studies requiring an audit is up to 200 grants.

7. Will the use of commercially-available audit tools of technology be allowable expenses to conduct this work efficiently and consistently?

No, the contractor is expected to have the necessary expertise and tools to complete the work.

8. Does NIMH have access to an authorized electronic system in place for auditor use?

NIMH has access to an authorized electronic system, e.g., BOX.

9. What is the format that NIMH grant-related documents will be provided? Electronic or based on hardcopy conveyance of audit docs?

NIMH grant-related documents will be given in an electronic format.

10. Does NIMH expect all deliverables in electronic from or paper copies?

Deliverables will be in an electronic format.

11. What security access clearance level is required for prime and/or subs?

Level 1: Non-Sensitive (Requires Suitability Determination with an NACI). Contractor employees assigned to a Level 1 position are subject to a National Agency Check and Inquiry Investigation

(NACI).

12. Does past experience providing Audit program implementation for other HHS agencies considered favorable e.g. CDC, FDA?

See Technical Evaluation Criteria for how submissions will be evaluated.

13. Does successful past performance in rigorous grant reviews for other USG agencies count favorably towards NIMH selection criteria?

See Technical Evaluation Criteria for how submissions will be evaluated.

14. Would NIMH consider extending the due date for response to this solicitation from Apr 5, 2023 to Apr 19, 2023?

The submission deadline is revised to 9:00 a.m. EST, April 14, 2023. See Amendment 1 to the Combined Synopsis/Solicitation.

15. NIHM states the estimated LoE is based on similar contract award. Is there an incumbent for this work; if so, please name?

There is no incumbent for this work.

16. Would the government consider extending the deadline for response to this proposal to Monday, April 10th to support a more comprehensive technical response based on the answers to the submitted questions?

The submission deadline is revised to 9:00 a.m. EST, April 14, 2023. See Amendment 1 to the Combined Synopsis/Solicitation.

17. Confirm if this is a new requirement for the agency. If not, can you provide the previous contact information?

There is no incumbent for this work.

18. Regarding travel amount listed, please confirm the expected or anticipated days onsite and whether the cost listed is per person that is expected to travel.

The government is not mandating a set amount of travel. The government estimated 12 flights, 120 days of meals and incidentals and 120 days of per diem; however, offerors are expected to provide the best solution including required travel to accomplish the tasks.

19. Please confirm if each financial auditor is required to be a CPA or will the agency accept a lead financial auditor as CPA with certified government auditors?

NIMH will accept a lead financial auditor as CPA with certified government auditors.