QandA_1_through_10.docx

Q1: In Task 5, HCP are recruited to wear EHMRs in various styles and configurations during routine clinical practice for a 3 month study period. Several of these EHMRs or filter adapters are not currently NIOSH approved. HCP using respirators must do so in compliance with the OSHA Respiratory Protection standard. Among other requirements, this standard states that respirators must be NIOSH-approved and must be used in accordance with manufacturer instructions. By asking HCP engaging in this study to wear non-approved respirators or exhalation valve filters as a part of routine patient care duties that require respirator use, this effectively may place the hospital in violation of the OSHA Respiratory Protection standard. To avoid this, what does NIOSH suggest in being able to complete the contract?Can NIOSH provide documentation that use of these EHMRs and filter adapters being used as part of the contract is approved by NIOSH and does not violate manufacturer instructions? If not, hospital Respiratory Protection Program administrators may not allow such a study to proceed.

A1: Contracts resulting from this solicitation are all Research projects. All prototype respirators and prototype adaptors coupled with commercial respirators will undergo the applicable testing clauses according to Title 42 CFR Part 84 – Subpart K as that NIOSH approved respirators go through for certification. However, these prototype respirators and the commercial respirators fitted with prototype adaptors are not NIOSH approved. NIOSH-NPPTL-RB can provide results of this testing to the successful contractor(s) for use in their IRB applications and/or gaining waivers for ensuring protection equivalent of other respirators for OSHA RPP purposes.

Q2: Can NIOSH provide an expected target budget within which the contract applicant should structure the proposal? For example, if an applicant’s contract addressed all of the tasks and at least 4 of the respirator group assessments, what would be the maximum budget NIOSH would consider funding?

A2: An expected target budget cannot be provided. Contracts will be awarded based on best value to the government. Note that NIOSH will supply the respirators and accessories (prototype and commercial) needed for fulfilling the contract.

Q3: On Task 4, what method does NIOSH request or prefer to assess moisture content and inspired temperature of air within the respirator facemask?

A3: NIOSH does not have a specific or preferred method to measure these parameters. NIOSH is open to collaborating with the contractor to determine methods for these measurements. NIOSH is also open to a reduced list of parameters to be measured in Task 4, in consultation with the contractor to determine what is feasible and within the capability of the contractor.

Q4: Section 5 mentions that NIOSH will review and comment on any documents and webinars. Can you please provide some additional details on what NIOSH expects from webinars? For example, does this section refer to presentations that NIOSH would expect the contractors to perform to share their study results following completion of the research?

A4: Webinars are not required outputs for this contract, but if a contractor was interested in conducting a webinar, NIOSH would help to coordinate and also review the documents to be presented. Any webinars should be structured to disseminate study results to the general public.

Q5: The RFP states that all publications, including conference abstracts, will only be allowed to be submitted after a final report for the task has been received and approved by NIOSH. This suggests that no conference abstracts or interim results could be submitted until 3.5 years after signing of the contract, which may delay sharing of important information to interested stakeholders. Would NIOSH consider allowing sharing of interim results or conference presentations prior to completion of the final report, provided the NIOSH team has reviewed and agreed to what is being submitted or presented?

A5: All publications including conference abstracts pertaining to information from a given task will only be permitted after the report from that specific task has been received and approved by NIOSH. For example, if a contractor wanted to publish on the comfort of the EHMRs related to information acquired in Task 4, that would only be allowed following receipt of the deliverable, a summary report of those specific Task 4 findings and accepted by NIOSH. This is to ensure that all data for a task has been properly analyzed/reviewed before publications are compiled. The language in the SoW will be edited for more clarity on that point.

Q6: There are several separate protocols that will likely require Institutional Review Board review at the University-level. These include:

1) Deliverable 4, Task 1 – Surveys for HCP preferences

2) Deliverable 4, Task 3 – Individual evaluation of RHER features – this will likely involve Key Informant Interviews or Focus Groups, which will require use of Informed Consent forms.

3) Deliverable 4, Task 6 – Submission of facial width and length information to NIOSH from HCP who have undergone fit-testing.

4) Deliverable 4, Task 7 – Surveys for Patient perceptions

5) Deliverable 4, Task 8 – Log of days and hours the filters were used throughout the study.

While several of these Tasks may be considered “Exempt” research or quality improvement, and thus not “human subjects research”, they will still require submission of a protocol for review by the IRB. This will require considerable effort and time. The OMB approval will also.

· Does the OMB submission/review need to occur once ALL of the deliverables have been reviewed by the university IRB and received approval? Alternately, can items requiring OMB approval occur separately, once approved by the university IRB?

A6: NIOSH will be submitting a single OMB submission. To submit to OMB, NIOSH needs all of the IRB approved data collection tools. Development of all the data collection tools will occur collaboratively with NIOSH at the start of the project upon contract award, followed by IRB submission. The contractor will need to gain all IRB approvals/exemptions before the OMB approval process can begin. Data collection can only start after the OMB approval or a waiver is in place.

Q7: Proposal Submission: Should the Technical Approach proposal match the structure and format of the template for the Project Plan, listed in the RFP as Attachment #4?

A7: The Technical Approach proposal does not have to match the structure and format of the Project Plan template. Submitting the proposal using the project plan template is acceptable option and left to the discretion of the offeror.

Q8: Will the government only accept FFP proposals?

A8: The government will only accept Firm Fixed Priced proposals.

Q9: The specification requires that 15% of the participating HCPs treat pediatric populations. We have many hospitals with well over 2,000 beds but do not have a pediatric hospital. We do have pediatric office practices. Would it be responsive if our HCPs who engage in pediatrics work primarily in a clinic or office setting rather than a hospital?

A9: It is acceptable if the 15% study population is done with HCPs who engage directly with pediatric patients and caregiver/child dyads who work primarily in a clinic.

Q10: We broadly deployed masks from one vendor to our employees. If I follow the solicitation correctly, we cannot propose to trial that vendor’s masks in this SoW. We can only elect a new vendor or one of the other mask vendors or options in our proposal. Is this correct?

A10: The trial with the respirator/s in use by the study site will not be accepted. Note that all respirators and accessories, commercially available and prototypes will be provided by the government for the study.