CPR_BAA_FY2019_-_RFP_75D301-19-R-67904_Q&A.pdf

RFP# 75D301-19-R-67904

CPR BAA FY2019 Q&A

Question Number

RFQ

Reference

(if applicable) Question CDC Response 1 Topic 1: General question for Topic 1, Pages 6 - 10 Assumption that requires verification:

CDC or other HHS agency staff will be willing to make available or to discuss:

(a) testing standards that they consider acceptable to qualify sample results information for use in informing emergency response actions,

(b) emergency scenarios that can help inform clinical laboratory responses to investigational processes (such as surveys, questionnaires, interviews) that may be undertaken by offeror to Topic 1, and;

(c) the results of prior listing of clinical laboratories and their capabilities.

(a) Testing standards would not be determined until actual event and determination is made of which test to use. In general, laboratories should meet established standards under CLIA and adhere to any requirements for using an emergency test under EUA. (b)There are some publicly available planning scenarios that can be utilized. (c) This information is not available and the purpose of this BAA is to be able to gather this information.

2 Topic 1: Page 6, Background Section

It is noted in the background section that the supporting contractor will be looking at laboratories that can analyze clinical samples to help inform medical care follow-up in a large-scale outbreak.

QUESTION: In the context of this announcement, is large-scale response or emergency response limited to the analysis of human clinical samples, or should the scope be considered to include the analysis of other sample streams that may significantly impact human health during a CBR or emerging/anomalous disease event, to include sample types such as animal clinical, environmental, food/water used for human consumption, or food used for animal consumption?

Yes, other sample streams should be considered -- to the extent that they could impact a human health emergency.

3 Topic 1: Page 6, Background Section and general question for Topic 1.

QUESTION: Would the supporting contractor be looking/surveying laboratories that are Clinical Laboratory Improvement Amendments (CLIA) certified?

Yes.

4 Topic 1: Page 7, Element 1, Need

It was cited under the “Need” section that there had been a survey done by which defined there were 260,000 certified clinical laboratories in the United States and that 70,000 of these can conduct moderate and high complexity testing (based on the FDA definition of “high complexity” testing).

QUESTION: Would the supporting contractor for this project be allowed access to the information from the database of 260,000 laboratories from which this information was extracted?

This information is publicly available through DLS website https://wwwn.cdc.gov/clia/Resources/LabSearch.aspx.

5 Topic 1: Page 7, Element 1, General information

QUESTION: What is the current status of the relationship with CDC and these 70,000 clinical laboratories? Does CDC interact with them at all (perhaps through the CDC Laboratory Response Network [LRN] system or the CDC Influenza Division (ID))? If there was a major incident tomorrow, would CDC reach out to these clinical laboratories?

CDC does not have a direct relationship with 70,000 clinical laboratories. CDC has established relationships with the public health laboratories across the country, and relationships with the largest commercial reference laboratories. CDC is interested in identifying laboratories other than the large commercial reference laboratories.

6 Topic 1: Page 7, Element 1, A-G

For data that is to be collected via survey, currently it appears that CDC would like the project to survey laboratories about their testing capability, testing capacity, the equipment they have available, their workforce, laboratory informatics, laboratory safety, and specialize licensure.

QUESTIONS:

1. For workforce, are you seeking the number of employees and the certifications they have?

2. For informatics, are you asking if there is a common electronic portal through which results and information about samples can be exchanged? Or mainly if the Laboratory Management Information Systems (LIMS) have a way to share results and/or plug into each other?

3. Are there any additional variables you would like to request from the laboratories (such as whether they support more than one of the federal public health laboratory networks like CDC LRN, the Food Emergency Response Network, or the National Animal Health Laboratory Network)?

4. How should the supporting contractor measure the items under Element 1 (testing capabilities, testing capacity, etc.)? Would it be self-reported by the laboratories? Or is CDC envisioning that site visits would be needed to verify the reported information?

1. Yes 2. Yes to both questions 3. CDC has access to membership information for LRN, FERN and NAHLN 4. Self reported data is acceptable. Random sampling of site visits may be useful to verify data.

7 Topic 1: Page 8, Element 3, Surveying at least 30 clinical laboratories in each of the 10 HHS regions in each of the three categories

(1. Large academic medical centers; 2.

Regional hospital/healthcare systems, and 3. Regional commercial laboratory companies)

QUESTION: Are there any specific scenarios that CDC wants to propose as part of the survey to help formulate the answers from each of the entities being interviewed? For example, would the supporting contractor want to provide a survey question asking if the laboratories have the capability to analyze for specific fentanyl analogs? Or Ebola Virus Disease? Please advise.

Awardee should plan to provide multiple scenarios when surveying the laboratories. The response capabilities needed for various scenarios may be different depending on the risks associated with the disease/agents.

8 Topic 2 The suggested approach mentions surveys but there is also information about a PRA/OMB package for “focus groups or interviews.” Is it at the offeree’s discretion as to what type of primary data collection method(s) should be used? Or is the survey and expert panel required, and others (interviews, focus groups) optional if felt to be needed?

Data collection from public health and mental health agencies are required to understand what current resources and surveillance systems at the local, state, and national level exist to monitor mental health symptoms in an emergency, identify measures, identify best practices, understand how data can be used to address mental health issues, and to characterize the relationship between mental health agencies and public health. This data can be collected via surveys or through other methods, such as focus groups or interviews.

Offerors have discretion to propose the types and mix of information collection methodologies, which can include surveys, interviews, and/or focus groups. However, regardless of the mix of methods proposed, Offerors must be aware that OMB/PRA clearance is required for most federally-sponsored collection of information from the public involving 10 or more persons. Therefore, the timeline of proposed work must account for the fact that development of an OMB PRA package and receipt of approval to begin information collection can require 12 months. The expert panel is required to review findings from the literature review and data collection, and would reconvene to review and comment on a final guidance document, based on the individual opinions of the panel participants.

9 Topic 2 Given the title of this topic which includes both mental and behavioral health, we would like to confirm that surveillance for both mental health and substance use disorders is of interest and in-scope for this project. In the description of the project, at times only “mental health” is referenced.

This topic includes both mental and behavioral health. For purposes of this announcement, the terms are used in a generally synonymous manner. Surveillance for substance use disorders is in scope for this project.

10 Topic 3 Since the median infectious and lethal doses (ID50 and LD50) for the wild type biothreat organisms are known (DHS, at least, has these compiled though the compilation may be classified; the values could be taken from the open source literature), would it not be better to develop principles/guidelines based on this information for when an attenuated strain becomes sufficiently infectious and lethal to qualify for regulation under existing laws?

The Government has decided to remove Topic #3 from the 2019 CPR BAA, and will not accept concept papers or final proposals based on Topic# 3. Please see the revised RFP that is posted concurrently with this Q&A document.

11 Topic 3 How many select agents are performers expected to include? The Government has decided to remove Topic #3 from the 2019 CPR BAA, and will not accept concept papers or final proposals based on Topic# 3. Please see the revised RFP that is posted concurrently with this Q&A document.

12 Topic 3 Does the CDC have recommendations for the desired length of the period of performance for projects associated with Topic 3 beyond the three year limit noted in the solicitation? Is three years the expectation or would shorter periods of performance be preferred?

The Government has decided to remove Topic #3 from the 2019 CPR BAA, and will not accept concept papers or final proposals based on Topic# 3. Please see the revised RFP that is posted concurrently with this Q&A document.

13 Topic 3 Topic #3 requests a review article discussing the biosecurity risks posed by excluded select agent strains and toxins, which should include a discussion of how and how readily their virulence/toxicity could be restored (What we are looking for -point #2). We are concerned that such findings could point a malicious actor to the few pathogens/repair pathways that truly could be misused. Such information probably should not be published in a public forum. We note that "what we are looking for

- point #9" indicates that the research generated under this topic is expected to be published in peer-reviewed scientific journals.

Could CDC clarify which research and analysis findings are expected to be published? Given the dual use nature of the findings, might certain findings be withheld from peer-reviewed publication if deemed sensitive?

The Government has decided to remove Topic #3 from the 2019 CPR BAA, and will not accept concept papers or final proposals based on Topic# 3. Please see the revised RFP that is posted concurrently with this Q&A document.

14 Topic 3 Topic 3 of this BAA could energize the ongoing public debate on whether publishing scientific articles that describe the engineering of pathogens is a positive or negative for national and global security. One side argues that it is necessary to share the methods in order to regulate and defend against them, while the other side will prefer that these methods remain unpublished. Given that background, what is the Sponsor’s intent for the amount of detail to be included in scientific articles resulting from work performed in support of Topic 3 for this BAA? What type of review is anticipated prior to article submission?

The Government has decided to remove Topic #3 from the 2019 CPR BAA, and will not accept concept papers or final proposals based on Topic# 3. Please see the revised RFP that is posted concurrently with this Q&A document.

Base RFQ