Questions and Responses from NOFO Informational Webinars_May 2021.docx

Questions/Answers from NOFO Informational Webinars

1. Hospitals should be a mix of public and private sectors?

Answer: Hospitals may be a mix of public and private sectors.

2. Are there prioritized countries for Component One?

Answer: No, there are no prioritized countries for Component One.

3. When we are talking about AMR in enteric pathogens, are we also looking at parasites? There has been an increase in resistance in many parasites and limited new worming medicines available.

Answer: No, the focus of Component Two is resistant bacterial and fungal human pathogens. A few priority pathogens for some strategies within Component Two are described in the text of the NOFO. Please also refer to the 2019 CDC AR Threats Report (https://www.cdc.gov/drugresistance/biggest-threats.html) for the CDC list of top priority bacterial and fungal resistant pathogens of concern to human health (Urgent, Serious, Concerning, and Watch).

4. Can an applicant apply for all three components?

Answer: Yes, applicants may apply for all three components.

5. If we are applying for funding for multiple regions/countries under each component, do we need to submit one application per country per component?

Answer: Applicants should develop a proposal for each component they are applying to and submit as one application package in grants.gov.

6. Is the Project Director position required as key personnel?

Answer: Project Director or an equivalent is required as key personnel.

7. Which costs are covered, and which costs are not covered?

Answer: Please refer to the “Budget Narrative” section of the NOFO for guidance around allowable costs. Please refer to the “Funding Restrictions” section of the NOFO for guidance around costs that are not allowed.

8. For monitoring and evaluation, is there any CDC reference document outlining performance indicators or applicants can define indicators based on logic model provided?

Answer: Outcomes of interest are described in the “Outcomes” section of the NOFO. Additional information is available in the “Evaluation and Performance Management” and “Applicant Evaluation and Performance Measurement Plan” sections of the NOFO.

9. We intend to apply as a collaborative of three (3) institutions. Should all three institutions be registered on DUNS, SAM & grants.gov?

Answer: Yes, all three institutions should be registered with DUNS and SAM. Only one entity should enter the application in grants.gov.

10. It is said that no research can be done, what does that exactly mean?

Answer: This opportunity does not support research; it is a non-research opportunity.

11. Are the 20 pages inclusive of reference?

Answer: Please refer to the “Other Information” section of the NOFO for guidance around the acceptable attachments applicants can upload as PDF files as part of their application.

12. For Component One, will applicants be expected to demonstrate all strategies under that is addressed?

Answer: Applicants may select the component and strategy (or strategies) they wish to apply to for this opportunity.

13. The NOFO is very clear that applicants may choose to apply to one or more strategies under Component II. However, it is less explicit for Component One -- may applicants choose to apply for only one strategy under Component One?

Answer: Applicants may apply for one or both strategies under Component One.

14. Can a private organization from a LMIC apply for this?

Answer: Please refer to the “Eligibility” section of the NOFO to see if your organization meets the eligibility requirements for this opportunity.

15. Do we apply for all three components as three separate applications and submit separately onto grants.gov or as one proposal with three components separately within the same application?

Answer: Applicants are advised to develop separate proposals for Components One, Two, and Three and submit as one combined application in grants.gov.

16. A University not within state control, but which is a non-profit organization may apply (be involved)?

Answer: Please refer to the “Eligibility” section of the NOFO to see if your organization meets the eligibility requirements for this opportunity.

17. May higher education institutions/Universities outside of the US apply? Does this require Ministry of Health endorsement?

Answer: Please refer to the “Eligibility” section of the NOFO to see if your organization meets the eligibility requirements for this opportunity. Educational Institutions and Universities outside of the US do not require Ministry of Health endorsement.

18. Can a large for-profit company with offices in the US and Europe apply and be eligible for funding?

Answer: Please refer to the “Eligibility” section of the NOFO to see if your organization meets the eligibility requirements for this opportunity.

19. Should we budget for $800,000 even when applying for only one component?

Answer: It is not possible to approximate the amount of each award without knowing the actual number of applicants. The average of $800K provided is more of a guide as there may be applicants who propose work in multiple countries vs. one country.

20. If an entity is applying to Component One and Two and across multiple countries, will the ~ grant award be $800K/component/country/year or $800K across all countries and components/year?

Answer: It is not possible to approximate the amount of each award without knowing the actual number of applicants. The average of $800K provided is more of a guide as there may be applicants who propose work in multiple countries vs. one country for Year One. Also, these amounts (and amounts in subsequent years) are subject to the availability of funds.

21. Any budget range for Component Three for each application?

Answer: We do not have a budget range for component three.

22. Does Component Three require a separate detailed budget?

Answer: Yes, component three requires a separate work plan and budget.

23. What are the criteria for second year (and the rest) funding? if a workplan is developed will have in principle activities that needs long term and looking for sustainability?

Answer: CDC will continue the award in subsequent years based on the availability of funds, the evidence of satisfactory progress by the recipient, and the determination that continued funding is in the best interest of the federal government. Components and strategies not outlined in the initial application cannot be added to work plans in subsequent years.

24. Can we submit a proposal which contains no laboratory work as such, but is about disclosing and sharing information only?

Answer: Applicants should include activities supporting the strategies and activities described in the NOFO.

25. Is an average award of $800k/year assuming that there are separate awards for each component? What is the expected range of budget expected to go to a single awardee over the life of the 5-year implementation period?

Answer: It is not possible to approximate the amount of each award without knowing the actual number of applicants. The average of $800K provided is more of a guide as there may be applicants who propose work in multiple countries vs. one country. Since these amounts (and amounts in subsequent years) are subject to the availability of funds, we cannot provide an expected budget range over the five-year period.

26. What is the benefit of submitting a letter of intent?

Answer: The Letter of Intent is a notice to CDC that the applicant intends to apply for the NOFO. Replies will not be provided.

27. If we want to submit application for all three components, do we need to submit one LOI for each or one LOI is enough for all three components?

Answer: One LOI for all three components is enough.

28. Is an international hospital partner required?

Answer: This is an international funding opportunity. Hospitals in networks proposed as part of Component 1 must be located in a country or countries outside of the U.S.

29. What would be the relationship with regional CDC in terms of activities in a given country?

Answer: CDC staff will be substantially involved in program activities beyond routine grant monitoring. Project Officers and Subject Matter Experts (SMEs) from CDC’s Division of Healthcare Quality Promotion (DHQP) will work with SMEs from other CDC Divisions to serve as technical monitors for specific activities, segments, or aspects of awards made through this NOFO.

30. Do we submit one application for each region?

Answer: Applicants may submit one application for each region. However, if the regions you are proposing to implement work in fall under different components, please make sure only one application is submitted via grants.gov (all proposals addressing each component will need to be submitted as one application).

31. Can CDC confirm if the newly added Capacity Statement Annex would be 1 page per component or 1-page total?

Answer: One page in total.

32. Page 20 of the NOFO states, “a separate application must be submitted for each component”. Will applicants be able to submit three separate applications on the grants.gov portal? Or is it the intention that “separate” applications will be submitted together in one package?

Answer: The intention is that the “separate” applications will be submitted together in one package.

33. Similarly, would LOS be 15 pages per Component or 15 pages total?

Answer: Letters of Support are required for Component One with a total of 15 pages. They are optional for Components Two and Three. If you choose to submit for Components Two and Three, no more than 15 pages for each component.

34. Any page limit for LOI?

Answer: No page limit per se, but it shouldn’t be more than one page.

35. For M&E, is this the Theory of Change & detailed log frame (inputs, activities, outputs, outcomes, impact) with process and output indicators as well as milestones, measures & their associated data sources?

Answer: Outcomes of interest are described in the Outcomes section of the NOFO. Additional information is available in the Evaluation and Performance Management and Applicant Evaluation and Performance Measurement Plan sections of the NOFO.

36. Do applicants upload a single abstract in grants.gov for the three components?

Answer: Yes. The applicants may upload a single abstract that includes all three components.

37. Would an application for Component One, with network hospitals only in the United States, be considered responsive to this NOFO?

Answer: This is an international funding opportunity. Hospitals in networks proposed as part of Component 1 must be located in a country or countries outside of the U.S.

38. Which pathogens are the ones in the CDC and WHO priority pathogens for AMR?

Answer: A few priority pathogens for some strategies within Component Two are described in the text of the NOFO. Please also refer to the 2019 CDC AR Threats Report (https://www.cdc.gov/drugresistance/biggest-threats.html) for the CDC list of top priority bacterial and fungal resistant pathogens of concern to human health (Urgent, Serious, Concerning, and Watch).

39. 8 GLASS pathogens should be included?

Answer: A few priority pathogens for some strategies within Component Two are described in the text of the NOFO. Please also refer to the 2019 CDC AR Threats Report (https://www.cdc.gov/drugresistance/biggest-threats.html) for the CDC list of top priority bacterial and fungal resistant pathogens of concern to human health (Urgent, Serious, Concerning, and Watch).

40. The average budget per year is 800K ...is that per component, per country? Can we increase the budget funding request if we cover multiple countries/regions in one application?

Answer: It is not possible to approximate the amount of each award without knowing the actual number of applicants. The average of $800K provided is more of a guide as there may be applicants who propose work in multiple countries vs. one country.

41. Do you have to apply for all strategies in components II, or can you pick one?

Answer: Applicants may select one strategy to apply for in Component Two.

42. If an applicant is to submit a different application per component, what does that mean for the organizational information since it will be the same organization applying?

Answer: Applicants may include key personnel that are shared across components. Please be sure to include level of effort for personnel that are shared across components. Level of effort must not exceed 100% for each personnel. You may also include the same organization chart for each component.

43. Is there any guidance or recommendation in terms of sub-national level programing?

Answer: No. Applicants may propose activities at the national, sub-national, or facility levels in alignment with the strategies and activities described in the NOFO text.

44. Does CDC have a prioritized regional strategy in Pakistan?

Answer: Applicants may propose activities in any country and/or region, as this is an open competitive funding opportunity. Priority countries for some strategies and activities in Component Two are described in the NOFO text.

45. About N/gonorrhoeae, the EGASP support should be done in collaboration with WHO? or we could support new sites following the EGASP technical recommendations?

Answer: Text in the NOFO for Component Two – Strategy Five includes guidance that allows for expanding EGASP activities and capabilities at sites where this work has already begun and implementing EGASP, per established protocol, in new regions/countries, prioritizing areas with little to no data on gonococcal infection rates and/or AMR levels, with known or suspected high levels of AMR among gonococcal infections, or with existing gonococcal laboratory and/or surveillance capacities, and includes an extensive list of specific regions/countries.

46. Is there any established hospital network in the target countries that CDC recommends or are we expected to establish a new one?

Answer: Applicants may propose to collaborate with an existing network of hospitals outside of the U.S. or propose to create a new network of hospitals outside of the U.S. in Component One. Applicants should review the specifications for network hospitals described in the Organizational Capacity of Recipients to Implement the Approach section in the NOFO when developing their networks.

47. May applicants submit a statement of experience as an Appendix?

Answer: Yes, this should be submitted as the Capacity Statement.

48. As this is a cooperative agreement, what does CDC substantial support mean?

Answer: A cooperative agreement is used when the awarding agency (e.g., CDC) anticipates substantial involvement (beyond normal oversight and monitoring activities) during the period of performance. This involvement may include collaboration or participation by designated CDC staff in specified activities and, as appropriate, at particular points during performance.

49. Component Two, Strategy Five: AMR surveillance in Neisseria gonorrhoeae- does this require WGS or is phenotypic susceptibility testing adequate. And do applicants need to be part of EGASP already?

Answer: Text in the NOFO for Component Two – Strategy Five includes guidance that allows for expanding EGASP activities and capabilities at sites where this work has already begun and implementing EGASP, per established protocol, in new regions/countries, prioritizing areas with little to no data on gonococcal infection rates and/or AMR levels, with known or suspected high levels of AMR among gonococcal infections, or with existing gonococcal laboratory and/or surveillance capacities, and includes an extensive list of specific regions/countries.

50. Are there any updates on prioritization of countries or regions for each component?

Answer: The NOFO includes the most recent information regarding priority countries and regions.

51. Does NOFO cover activities focus antimicrobial resistance in post-acute care (non-hospital) facilities such as nursing homes?

Answer: Strategies and activities in Component One should be implemented in acute care hospitals. Strategies and activities in Component Two reach beyond health facilities and into the community and the environment; in situations where activities are proposed in health facilities, there is no limitation on facility type. Strategies and activities Component 3 should be implemented in acute care health facilities, but applicants may propose to work in a variety of facility types (e.g., hospital, health center, primary health facility).

52. As a non-profit research organization from a LMIC apply for this or only bona fide agents are eligible from LMICs?

Answer: Please refer to the “Eligibility” section of the NOFO to see if your organization meets the eligibility requirements for this opportunity.

53. For Component One, Strategy Two, may the reference laboratory be in the US?

Answer: Networks proposed for Component One, Strategy Two must include at least 3 hospitals and at least one reference laboratory outside of the United States. Additional characterization of isolates received by the reference laboratory may be conducted at laboratories within the United States as warranted.

54. The NOFO talks about collaboration with CDC, can we include CDC personnel that we have worked with in our applications?

Answer: The applicant should closely review the NOFO to ensure that all requested criteria are addressed and included in the submitted application. This may include the collaboration with partners.

55. For Component Three, does this include WASH interventions in healthcare facilities? Is the introduction of appropriate technology and operational research within scope?

Answer: Priority activities for Component Three are described in the NOFO text. WASH interventions should not be the focus on an application to Component Three. If use of technology aligns with priority activities in the NOFO text, it can be included in the application for Component Three.

56. If there are multiple regions, can there be one PI for multiple regions?

Answer: Yes, if an applicant applies to implement work in multiple regions, there can be one PI for multiple regions. Please note that the PI must be staffed under one organization (the organization will be listed as the applicant).

57. Would in-country CDC personnel be allowed as collaborators?

Answer: Yes, CDC in-country personnel could be considered as collaborators.

58. Can the network include a site or two in the US, but have majority of sites (3-4) outside of US?

Answer: Activities in Component One must be implemented in a network of hospitals outside of the U.S. Network coordinators may be located within the U.S., but facility-level activities must occur within non-U.S. hospitals.

59. What are the requirements with respect to submitting private organizations?

Answer: Please refer to the “Eligibility” section of the NOFO to see if your organization meets the eligibility requirements for this opportunity.

60. Can CDC clarify whether countries proposed in this opportunity should/should not overlap with countries participating in other global CDC programs?

Answer: Applicants may propose countries that other global CDC programs conduct work in. However, the activities can not be duplicative of that in other CDC mechanisms.

61. Can proposed networks include just one site in the US with others being outside of the US?

Answer: Activities in Component One must be implemented in a network of hospitals outside of the U.S. Network coordinators may be located within the U.S., but facility-level activities must occur within non-U.S. hospitals.

62. Component One: Does CDC provide guidance around HAI definitions and detection methods (e.g. for HA-BSI)?

Answer: CDC will serve as the overall coordinator of the global “network of networks” created as part of Component One. CDC and recipients will collaborate to develop global network protocols and methods.

63. Is there a limit to the number of participating institutions and key personnel? Is the WGS in Component Two/Strategy Two limited to those within the PulseNet network?

Answer: There is no limit to the number of participating institutions and key personnel. Whole genome sequencing activities in Component Two, Strategy Two are not limited to PulseNet networks; please refer to the NOFO text, particularly the second main bullet of the description of Component Two, Strategy Two, which describes priority activities outside of PulseNet networks, including WGS.

64. What is the max budget per year for each component?

Answer: It is not possible to approximate the amount of each award without knowing the actual number of applicants. The average of $800K provided is more of a guide as there may be applicants who propose work in multiple countries vs. one country. Keep in mind these amounts (and amounts in subsequent years) are subject to the availability of funds.

65. Regarding the Letter of Support from partner hospitals, does CDC encourage LOS from respective govt agencies as well?

Answer: Applicants may submit Letters of Support from government agencies in the country or countries that the propose to work in, but Letters of Support from government agencies are not required.

66. How is "research" defined in the NOFO? Some words in activities in Component II ("assessing risk factors....", "examining potential relationships...") lend themselves to interpretation as research.

Answer: Research is defined at https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf. Guidance on how CDC interprets the definition of research in the context of public health can be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html (See section 45 CFR 46.102(d)).

67. The budget section lists "equipment and supplies" as a required section. However, the NOFO (p.40) states: "Generally, recipients may not use funds to purchase furniture or equipment. Any such proposed spending must be clearly identified in the budget". Could you please clarify/elaborate"?

Answer: Equipment and supplies are part of the budget and should be outlined in the budget narrative. However, purchasing furniture and certain equipment is not allowed. Please be sure to clearly identify the equipment proposed in your budget.

68. Is scaling up encouraged during the first year with raised budget?

Answer: Please propose all activities that you feel can be implemented for each component in your application.

69. Can for example the development of new diagnostics test for gonorrhea suitable for LMICs be considered under the NOFO?

Answer: Priority activities for Component Two, Strategy Five are described in the NOFO text. Development of new diagnostic tests is not included in the list of priority activities in this strategy.

70. Can the technical work (i.e.) sequencing be done in the US for pathogens gathered outside of the US?

Answer: Activities that generate specimens for testing must be conducted outside of the U.S. Testing of isolates that result from these activities may be conducted by partners within the U.S.

71. Can project funds be used to help identified hospitals meet some of the infrastructure and technology criteria to be selected as part of a network?

Answer: Applicants should review the specifications for network hospitals described in the Organizational Capacity of Recipients to Implement the Approach section in the NOFO when developing networks in Component One. Hospitals included in proposed networks should meet these specifications.

72. Can applicants in the US be funded for their effort as long as all the work is being done outside the country?

Answer: Yes, applicants in the US may be funded for efforts outside of the US.

73. Can we spend the project fund to assist hospital infrastructure and equipment for capacity enhancement?

Answer: Depends. Please outline all proposed activities and costs in your application.

74. Many of the strategies relate to either the 'design' or 'evaluation' or AMR interventions. Could the panel please speak to how these activities are compatible with the 'no research' restriction on the NOFO?

Answer: Research is defined at https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf. Guidance on how CDC interprets the definition of research in the context of public health can be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html (See section 45 CFR 46.102(d)).

75. What is the maximum number of health care facilities which could be included as we have six regions in our country?

Answer: There is no maximum number of facilities to be included in an application. In Component One, applicants must include a minimum of three facilities in their proposed networks.

76. What about the institutional requirements in Component Two? What should be the balance between equipment and facilities that are available and new ones that could be proposed to be bought?

Answer: Applicants must demonstrate organizational capacity to successfully execute their proposed project strategies and activities. Guidance on capacities that applicants should have for Components One, Two, and Three is provided in the Organizational Capacity of Recipients to Implement the Approach section of the NOFO text. Component Two has a wide range of focus areas, but across all it intends to identify the strongest from already existing laboratories to strengthen capacities and expand to new capabilities. Therefore, the asks could reflect the need for more, additional, or updated equipment as appropriate to the proposal focus and testing coverage intended.

77. Where is the amended NOFO located?

Answer: The amended NOFO will be located on grants.gov.

78. Will the recording of this webinar be made available or published on the website?

Answer: The recording of the webinar will be made available at the following site: https://www.cdc.gov/ncezid/what-we-do/grants/2021/global-AR-HAI.html.

79. For Component Two, Strategy Three, is C. gattii a priority?

Answer: A few priority pathogens for some strategies within Component 2 are described in the text of the NOFO. Please also refer to the 2019 CDC AR Threats Report (https://www.cdc.gov/drugresistance/biggest-threats.html) for the CDC list of top priority bacterial and fungal resistant pathogens of concern to human health (Urgent, Serious, Concerning, and Watch).

80. How much of sustainability would you be looking in the proposals?

Answer: Details on how applications will be reviewed and evaluated are provided in the Review and Selection Process section of the NOFO text. Applications are not explicitly scored on sustainability beyond the five-year project period, but leveraging relationships, other existing resources, and related ongoing efforts to promote sustainability is strongly encouraged.

81. Is participation of two or more applicable countries under one application preferred?

Answer: Yes, as entities are only allowed to submit one application.

82. For Component Two, Strategy One, can the applicants be university professors based in countries other than the ones where the surveillance will take place?

Answer: Yes.

83. Component Two, Strategy Five: M genitalium is specified. Would other STIs such as C. trachomatis also be considered. Must this be in relation to co-infection with N. gonorrhoeae or monoinfection?

Answer: A few priority pathogens for some strategies within Component 2 are described in the text of the NOFO. Please also refer to the 2019 CDC AR Threats Report (https://www.cdc.gov/drugresistance/biggest-threats.html) for the CDC list of top priority bacterial and fungal resistant pathogens of concern to human health (Urgent, Serious, Concerning, and Watch). Work suggested on N.gonorrhoeae and M. genitalium is separate and so not required to be in relation to co-infection.

84. If applying for multiple countries, is the applicant expected to constitute a network across facilities across each of the countries, or only link facilities in each proposed country to CDC's global network of networks?

Answer: Applicants should propose networks of facilities that collaborate with each other and the network coordinators. The proposed network coordinators will serve as the main point of contact for CDC’s global “network of networks.”

85. Some countries which are very appropriate for this call are dealing with pandemic leading to inability to respond this call. Will there be any considerations for extending the deadline in such situations?

Answer: Unfortunately, we will not be able to extend the deadline for this opportunity.

86. Can we procure IPC supplies for IPC trainings?

Answer: Yes, as long as the costs are outlined in your budget and the costs are allocable and allowable.

87. Could you please clarify submission process for applicants that apply to multiple components? There is only one 4,000-character Abstract text box per Grants.gov Workspace. If an applicant applies to multiple components, do we only submit a single abstract? Additionally, if an applicant submits for multiple components, do we upload separate Project Narratives and Appendix documents per Component?

Answer: The applicant may submit a single abstract that includes multiple components. Yes, separate Project Narratives and Appendix documents may be uploaded per Component. Please note an additional 20 pages will be allowed for each component via the announcement modification. A total of 60 pages is allowed for the Narratives.

88. Does this call also consider looking into pathogens coming from wildlife especially in ecosystems of high interaction between human and wildlife?

Answer: CDC’s focus in this funding opportunity is priority pathogens of concern to human health. But, to fully understand and assess the pressures, drivers, and impacts that affect AMR in human health, the study and evaluation of interactions across the one health spectrum, between humans, animals, and the environment, is often required.

89. We believe this NOFO covers only Human Health and not Animal Health factors. Please clarify?

Answer: CDC’s focus in this funding opportunity is priority pathogens of concern to human health. But, to fully understand and assess the pressures, drivers, and impacts that affect AMR in human health, the study and evaluation of interactions across the one health spectrum, between humans, animals, and the environment, is often required.

90. If applying for Components One and Two, is it possible that only one and not the other could be funded from an application?

Answer: Yes, this is possible.

91. Can you clarify the application requirements for Component Three?

Answer: Please refer to the NOFO for the requirements for Component Three.

92. Are subcontracts allowed to collaborating partners?

Answer: Yes, subcontracts are allowed for collaborating partners.

93. Will the list of organizations expressing interest to respond be publicly available and if so where can that be accessed?

Answer: No, this list will not be available.

94. Will there be an amendment to the NOFO and what is the expected timeline for amendment release and/or written response to questions?

Answer: Yes, an amended NOFO will be published no later than June 4, 2021.

95. Can we still send questions after today?

Answer: Yes

96. You narrated the importance of the company profile, but how about the PI/s profile/experience?

Answer: This information will be captured in the Key Personnel and Capacity Statement sections.

97. If an applicant has 2 substantially different proposals that fall under the same component (different strategies, different key personnel, different countries), can they submit separate proposals?

Answer: No, an applicant can only submit one proposal for each component.

98. Can you please clarify the part of sharing data? Will the network data be shared with the CDC only or with the global networks? and how the shared data is going to be used?

Answer: Applicants must demonstrate and document a willingness to share relevant and agreed-upon data with CDC. Specifications for exact data to be shared will be developed in a collaborative process with CDC. As part of Component One, Strategy One, networks will be asked to share relevant and agreed-upon data pertaining to facility and/or network-level HAI surveillance and prevention activities within their proposed network and with CDC. As part of Component One, Strategy Two, networks will be asked to share relevant and agreed-upon data pertaining to laboratory results and AMR containment responses within their proposed network and with CDC. Shared data will be used to monitor network- and global-network level progress towards project objectives. Applicants should provide a description of any anticipated challenges in sharing data with CDC or storing data on CDC data systems due to local or national guidelines, standards, or regulations.

99. Can CDC please confirm the budget ceiling for Component Two?

Answer: Component Two does not have a budget ceiling.

100. Can CDC please confirm that if one entity submits an application for two components, we are able to include two separate Org Charts.

Answer: Yes, if an entity submits an application for two components they may include two separate org charts.

101. Can a proposal be focused on a single strategy or should it cover all strategies under a component? Same question for activities: can a proposal be focused on a number of activities under a strategy, if not all the activities under that strategy? Is there any requirement of the minimum number of activities under a strategy that should be covered by a proposal?

Answer: A proposal can be submitted with a focus on a single strategy or multiple strategies. Within each strategy, an applicant can propose a single activity or multiple activities. There is no minimum number of activities required to be included in a proposal.

102. Since this NOFO is for "non-research activities," are there specific restrictions on research-related outputs like publications and concurrent or future epidemiological/laboratory studies?

Answer: Even though this is a non-research cooperative agreement, recipients may generate publications and develop ideas for future epidemiological or laboratory studies.

103. General guidelines in the NOFO are not to include research studies but some of the proposed activities are entirely research based (e.g. Page 17 of NOFO under Component Two, Strategy Two asks for clinical trials & evaluation of treatment options). Can you please provide more details on this?

Answer: Research is defined at https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf. Guidance on how CDC interprets the definition of research in the context of public health can be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html (See section 45 CFR 46.102(d)).

104. Can CDC please confirm that applicants that submit budget amounts that exceed $800,000 for Component Two will be in non-compliance and therefore the application will not be considered?

Answer: The average of $800K provided is more of a guide as there may be applicants who propose work in multiple countries vs. one country. If an application and budget are submitted and it exceeds $800K (this applies to all components), it will still be reviewed.

105. Would the outbreaks responded to in Component Three be outbreaks occurring in the facilities supported or identified in the labs supported under Component One and/or Two only or any hospital/lab that identifies an outbreak in the country/ies supported?

Answer: In the event of an outbreak that results in funding of Component Three, a recipient could support health facilities within or outside of the health facilities that they may be funded to support in Components One and/or Two.

106. Is the vision that the policies developed for outbreaks in Component Three are specific to the facility/ies where they occur or developed for the national level?

Answer: In the event of an outbreak that results in funding of Component Three, a recipient may support the development of national policies and/or guidelines to respond to the outbreak. The recipient may also support the adaptation of national policies and/or guidelines at the facility level.

107. Are County PHLs able to apply for this grant, or is this reserved for State PHLs only?

Answer: Please refer to the “Eligibility” section of the NOFO to see if your organization meets the eligibility requirements for this opportunity.

108. Will involving the Veterans Health Administration (VHA) system suffice the national/global involvement in the program? Or is a global component (such as an international hospital involvement) critical to the application?

Answer: Applicants must propose activities outside of the U.S.

109. Would mathematical modeling (theoretical work to project outcomes) be something that could be included in the application?

Answer: Priority activities for Components One, Two, and Three are described in the NOFO text. Mathematical modeling is not included in the list of priority activities.

110. Is it possible to include overhead costs in the budget? And payment to specialized consultants?

Answer: Please review the “Budget Narrative” and “Funding Restrictions” sections of the NOFO for guidance in these areas.

111. Could the application include infrastructure activities for enhancing laboratory capacities?

Answer: Depends on the type of infrastructure activities you are referring to.

112. Can renovations or infrastructure improvements be included in the proposal budget?

Answer: Renovations should not be included. Regarding infrastructure improvements, it depends on what you are referring to.

113. Any advantage on focusing specific country or region?

Answer: No, not from our viewpoint.

114. Can CDC please clarify whether or not organizations can apply their NICRA in the budget?

Answer: Yes, organizations can apply their NICRA in the budget.

115. Does the budget plan need to be detailed for the whole 5-year period? Or only for the first year?

Answer: Budget plans should be detailed for the first year.

116. Are applicants required to submit three different project abstracts in grants.gov?

Answer: Applicants should submit one project abstract per component in grants.gov.

117. Is there an indirect cost limit?

Answer: If the applicant proposes indirect costs, then an approved negotiated indirect cost rate agreement must be included in the applications.

118. For Component Two, Strategy Two “Strategy Two: Assess Antimicrobial Resistance in Enteric Pathogens” is this limited to the Pulse Net International or can be expanded?

Answer: Activities in Component Two, Strategy Two are not limited to PulseNet networks; please refer to the NOFO text, particularly the full list of priority activities in Component Two, Strategy Two. Only the first main bullet under this list of priority activities refers to activities within PulseNet networks; additional priority activities outside of PulseNet networks are described in subsequent bullets.

119. Can State organizations as MoH be co applicants?

Answer: Only one applicant will be included with each application. The applicant may include partners or collaborators.

120. If three separate abstracts are needed when applying to all three components would you attach the abstracts for Components Two and Three in "other mandatory attachments" within grants.gov?

Answer: The applicant may submit one abstract that includes all 3 components.