Sickle Cell Disease Treatment Demonstration Program

The purpose of this amendment is to: 1) provide answers to questions received, 2) revise Attachment A - Statement of Work, and 3) correct the NAICS code in the Description field of the Notice.

1) The answers to all timely received questions are as follows: 

1. Regarding the request to include a plan that compares methodologies for conducting the data collection strategies - which dimension(s) of data collection methodology are required to be included in the comparison?  E.g. data source, techniques for linking data system, data entry mechanisms etc.   

The requested plan would include techniques for linking the data from multiple sites into a single data system and to a smaller degree data entry mechanism.  

2. Will MCHB share with applicants the approaches to data collection and "data repository" that the awarded regional sites will use at this time? 

The awarded regional sites are not currently using approaches to data collection and "data repository" at this time.  Each awarded regional site will work with HRSA and the awarded contractor to develop the approaches to data collection after the contract has been awarded.

3. Can an institution applying for the regional site participate in the National Coordinating Center? 

Yes.

4. Can an individual at an institution applying for the regional site be a subcontractor in the National Coordinating Center? 

Yes, an individual at an institution applying for the regional site can be part of a subcontract to the National Coordinating Center or a consultant to the NCC as long as the individual's job description on each of the application is distinct (different) and mechanisms are put in place to clearly distinguish the roles and financial compensation to the individual on each funding stream. (For clarification, subcontracts are usually made to companies and individuals are consultants.)

5. Is there a requirement for OMB approval of the data collection?

Yes, there is a requirement for OMB approval for the data collection.  

6. Task 3.3 Base Year states that the database the contractor creates "shall also be able to collect general information about the patient population, including demography information, geographical information, and information about services delivery." Please clarify whether this information must be at the level of data protected under HIPAA, or whether it can be deidentified or less granular?

All information collected by the contractor from the regional sites will be de-identified or less granular data.  The general information obtained about the patient population should be collected in a manner to allow HRSA to understand the need of the patient population, but should be de-identified so as to limit the ability of identify individuals.

7. Does HRSA anticipate that they will convene an external review committee or will the review occur internally within HRSA? 

Review will be conducted based on the evaluation criteria contained in the solicitation.  

8. Can a representative from a federal agency serve on the oversight steering committee?

Neither the authorizing legislation nor MCHB has language that would prevent a representative from another federal agency from serving on the oversight steering committee.  

9. When does MCHB anticipate announcing the funding of the awards? 

This award will be funded at the end of this fiscal year.

10. Is there any requirement that the National Coordinating Center for the Treatment Demonstration Program should also collaborate or exchange data/resources with the National Coordinating Center for the New Born Screening Program? 

No, there is no requirement that the National Coordinating Center for the Treatment Demonstration Program should collaborate or exchange data/resources with the National Coordinating Center for the Newborn Screening Program.  

11. Do the regional coordinating centers have any requirements pertaining to the development of the congressional report?

No, the regional coordinating centers do not have any requirements pertaining to the development of the congressional report.  The regional coordinating centers have requirements pertaining to developing data strategies and collecting and sending data to the National Coordinating Center.  

12. Would it be possible to offer subcontracts to academic institutions and other individuals with unique expertise without a small business contracting plan?

Yes, if the prime contractor is a small business, a subcontracting plan is not required. However, a subcontracting plan would be required if the prime is a large business, and the proposed total contract value exceeds $650,000.

13. Under Task 6.3 Report to Congress and Task 6.4 Presentation to MCHB Staff, the "Hemoglobinopathies Learning Collaborative" was mentioned.  This Learning Collaborative was not mentioned previously; does it still apply?  

No, the mention of the Hemoglobinopathies Learning Collaborative  was an error.  Please disregard all mention of the Hemoglobinopathies Learning Collaborative.

14. In the Schedule of Deliverables table, Clause F.6 of the RFP, Option Years 1 and 2, the Delivery Date of 5.1, Web-based Compendium of Tools and Materials, is 1 month prior to the end of Option Year 1 (and 2).  However, in Attachment A - Statement of Work, Task 5 (in both option years) states that the Web-based Compendium of Tools and Materials shall be delivered two months prior to the end of each Option Year.  Please clarify the schedule for submission of the Compendium of Tools and Materials.

The correct schedule for the submission of the Web-based Compendium of Tools and Materials should be one month prior to the end of each Option Year. Please see the revised Attachment A - Statement of Work attached.

2) Attachment A - Statement of Work is hereby revised in response to Question 14 above. Task 5.1 in Option Year 1 and Option Year 2 is corrected to reflect the correct submission date for the web-based Compendium of Tools and Materials. The attached, revised version should replace, in its entirety, Attachment A in the document RFP.SCDTDP.docx included in the Base Notice.

3) The NAICS code in the Description field of the Base Notice is hereby changed from 611710 to 541990. The NAICS code listed in the General Information side bar is correct, and remains unchanged.