FOA-CK-16-002.pdf

Centers for Disease Control and Prevention

National Center for Emerging and Zoonotic Infectious Diseases Extramural Research Program Office

Spatially Scalable Integrated Tick Vector/Rodent Reservoir Management to Reduce Human Risk of Exposure to Ixodes scapularis Ticks Infected with Lyme Disease Spirochetes

RFA-CK-16-002

Application Due Date: 02/02/2016

Spatially Scalable Integrated Tick Vector/Rodent Reservoir Management to Reduce Human Risk of Exposure to Ixodes scapularis Ticks Infected with Lyme Disease Spirochetes

RFA-CK-16-002

TABLE OF CONTENTS

Part 1. Overview Information Key Dates Required Application Instructions Executive Summary

Part 2. Full Text Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 1. Overview Information Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations National Center for Emerging and Zoonotic Infectious Diseases Extramural Research Program Office

(NCEZID ERPO)

National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) Funding Opportunity Announcement (FOA) Title Spatially Scalable Integrated Tick Vector/Rodent Reservoir Management to Reduce Human Risk of Exposure to Ixodes scapularis Ticks Infected with Lyme Disease Spirochetes Activity Code U01 Research Project Cooperative Agreements

Funding Opportunity Announcement Type New Funding Opportunity Announcement Number

RFA-CK-16-002

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.942 Category of Funding Activity:

Health FOA Purpose To advance knowledge of the impact of environmentally-based tick/pathogen control conducted on single versus multiple adjacent properties, in relation to human landscape use patterns and tick exposure locations, on the risk of human exposure to ticks infected with Lyme disease spirochetes.

Key Dates Publication Date: To receive notification of any changes to RFA-CK-16-002, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

Letter of Intent Due Date: 01/04/2016

Application Due Date: 02/02/2016

On-time submission requires that electronic applications be error-free and made available to CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM U.S. Eastern Time. Note:

HHS/CDC grant submission procedures do not provide a period of time beyond the application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review: 04/14/2016

Secondary Review: 05/10/2016 http://grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=U01&Search_Type=Activity&Search.x=16&Search.y=3 http://www.grants.gov

Estimated Start Date: 09/01/2016

Expiration Date: 02/03/2016 Due Dates for E.O. 12372: Due no later than 60 days after the application receipt date.

Required Application Instructions It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this FOA. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note: The Research Strategy component of the Research Plan is limited to 25 pages.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Executive Summary Purpose. To advance knowledge of the impact of environmentally-based tick/pathogen control conducted on single versus multiple adjacent properties, in relation to human landscape use patterns and tick exposure locations, on the risk of human exposure to ticks infected with Lyme disease spirochetes.

Mechanism of Support. Cooperative Agreement.

Funds Available and Anticipated Number of Awards. Estimated total funding (direct and indirect) is $1,600,000. A single award is anticipated. Awards issued under this FOA are contingent upon availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of the award may also vary. The total amount awarded and the number of awards will depend upon the number, quality, duration and cost of the applications received.

Budget and Project Period. Total funding (direct and indirect) for the first year (12-month budget period) is $300,000. Estimated total funding (direct and indirect) for the entire 4-year project period is $1,600,000. The project period will run from 9/01/2016 to 8/31/2020.

Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. Application and Submission Information of this announcement.

Eligible Institutions/Organizations. Institutions/organizations listed in Section III.1 are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE: CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

Number of PDs/PIs. There will only be one PD/PI per application. If necessary, Co-PI(s) may be listed in the application but only one PI may be the primary CDC contact for the award and this must be indicated in the application.

Number of Applications. Eligible applicant institutions may submit only one application.

Application Type. New.

Special Date(s). Not applicable.

Application Materials. See Section IV.1 for application materials. Please note that Form C is to be used when downloading the application package. http://grants.nih.gov/grants/funding/424/SF424 _RR_Guide_General_VerC.pdf Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY:

http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

(770) 488-2783.

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority Public Health Service Act, Section 301, 42 U.S.C 241(a).

1. Background and Purpose Background: Lyme disease, caused primarily by the spirochete Borrelia burgdorferi sensu stricto in the United States, is the most commonly reported vector-borne disease in the United States with >30,000 confirmed or probable cases reported annually and a recent estimate suggesting that ten-fold more cases may occur. Primary Lyme disease foci occur in the Northeast and Upper Midwest, where the blacklegged tick, Ixodes scapularis, is the primary enzootic vector of B. burgdorferi and, particularly with respect to the nymphal stage, the primary bridging vector to humans. There is currently no human vaccine against B.

burgdorferi. In contrast to mosquito control, which is implemented at the scale of communities or neighborhoods, the responsibility for tick control rests firmly on individual homeowners. Options for protection of individuals or single residential properties include personal protective measures to reduce the likelihood of tick contact (avoidance of high risk microhabitats, protective clothing, repellents, etc.) or to prevent transmission of B. burgdorferi by an attached tick (prompt tick removal, antibiotic prophylaxis) and various environmentally-based control methods. Environmentally-based control methods include: 1) landscape modification to reduce the risk of tick exposure (brush clearing, leaf litter removal, reduction of tree/forest canopy, deer fencing, placing play structures in microhabitats inhospitable for host-seeking ticks, etc.); 2) application of biological or chemical control agents directly to the ground substrate/vegetation to kill host-seeking ticks; and 3) targeting of rodent reservoirs to suppress enzootic B. burgdorferi transmission and reduce the number of infected ticks. These environmentally-based control approaches are all scalable in that they can be implemented on either single or multiple adjacent residential properties. In contrast, deer reduction or deer-targeted acaricides are community-wide approaches that are not scalable down to single residential properties.

Tick/pathogen control driven by individual homeowners results in complex patchworks of residential properties on which control is undertaken versus not undertaken, intermingled with public use lands lacking tick/pathogen control measures. Consequently, human landscape use patterns are key determinants for risk of exposure to infected ticks based on time spent in protected areas (on properties where control measures are successfully implemented) versus non-protected settings (residential properties or public lands without control measures). The residential property itself, which may be considered the primary risk setting for acquisition of Lyme disease in the Northeast, can be protected as outlined above. However, there may be substantial additional risk of exposure to infected ticks from nearby non-protected areas. Examples of common behaviors that may lead to tick bites, unless personal protection measures are taken, include children living on partly protected residential properties but ranging in their play outside of the protected portion of the property (e.g., across a treated woods/lawn edge into a wooded non-treated area) or people routinely hiking or walking dogs on nearby public access land trails and in natural areas.

Previous studies have demonstrated dramatic reductions of the acarological risk of exposure to Lyme disease spirochetes (i.e., the abundance of host-seeking I. scapularis infected with B. burgdorferi) on single residential properties based on application of chemical control agents to kill host-seeking ticks and/or treatment of rodent reservoirs to reduce their tick loads and suppress enzootic spirochete transmission. These studies have not included assessments of human spatial activity patterns or tick-human encounter locations, nor have they explored potential beneficial effects of treating multiple adjacent versus single properties, particularly for rodent reservoir targeted interventions where the effect can be assumed to span the rodent home range. This raises several important questions including: 1) what is the interplay of adjacent treated and non-treated settings in terms of acting as sinks and sources, respectively, for enzootic B. burgdorferi transmission and production of infected host-seeking ticks?; and 2) to what extent is tick/pathogen control on single or multiple adjacent residential properties counteracted by additional tick exposures in other non-treated settings?

Purpose: To advance knowledge of the impact of environmentally-based tick/pathogen control conducted on single versus multiple adjacent properties, in relation to human landscape use patterns and tick exposure locations, on the risk of human exposure to ticks infected with Lyme disease spirochetes.

Healthy People 2020 and other National Strategic Priorities The proposed research addresses the Healthy People 2020 focus area relating to “Immunization and Infectious Diseases” (focus area 14), specifically to “Reduce Lyme Disease” (section 14-8). The FOA aims to help reduce Lyme disease by improved spatial implementation of existing tick vector and rodent reservoir control methods on residential properties, and by better defining human-tick encounter locations in Lyme disease endemic areas thus increasing awareness of high risk microhabitats that call for increased vigilance in personal protective measures or tick/rodent-targeted control efforts.

Public Health Impact Key expected outcomes include: guidance for homeowners in Lyme disease endemic areas regarding the added value of tick/pathogen control on multiple adjacent properties, which could potentially be implemented by homeowner associations; and improved knowledge of human-tick encounter locations in Lyme disease endemic areas to inform the use of personal protection measures.

Relevant Work Hayes, E. B., and J. Piesman. 2003. How can we prevent Lyme disease? New England Journal of Medicine 348: 2424-2430.

1.

Schulze, T. L., R. A. Jordan, C. J. Schulze, S. P. Healy, M. B. Jahn, and J. Piesman. 2007. Integrated use of 4-poster passive topical treatment devices for deer, targeted acaricide applications, and Maxforce TMS bait boxes to rapidly suppress populations of Ixodes scapularis (Acari: Ixodidae) in a residential landscape. Journal of Medical Entomology 44: 830-839.

2.

Stafford III, K. C. 2007. Tick management handbook. An integrated guide for homeowners, pest control operators, and public health officials for the prevention of tick-associated disease. The Connecticut Agricultural Experiment Station, New Haven, CT, Bulletin No. 1010.

3.

Eisen, R. J., J. Piesman, E. Zielinski-Gutierrez, and L. Eisen. 2012. What do we need to know about disease ecology to prevent Lyme disease in the Northeastern United States? Journal of Medical Entomology 49: 11-22.

4.

2. Approach

Objectives/Outcomes Whenever possible, applications should include objectives written in the SMART format (e.g., Specific, Measurable, Achievable, Realistic and Time-bound).

The proposed research approach is expected to be scientifically sound and statistically robust. Key questions that the proposed research is expected to address include: 1) the extent of added protection for a treated residential property that is bordered by other treated residential properties versus non-treated properties; and

2) to what extent is tick/pathogen control on single or multiple adjacent treated residential properties counteracted by human-tick encounters that occur in non-treated settings (on residential properties and/or public land)?

A key expected outcome of the research is guidance for homeowners regarding the added value of tick/pathogen control on multiple adjacent properties (i.e., whether treatment of multiple adjacent properties provides an added protective effect for an individual property within this group compared to treatment of a single property surrounded by non-treated properties). Should such an added value be demonstrated, there is the possibility for homeowner associations or other similar groups to implement coordinated tick/pathogen control on multiple adjacent properties.

Specific requirements for the approach of research projects funded under this FOA:

The research team is expected to include expertise in medical entomology, small mammal biology, human behavioral science, and statistics/study design.

The research is expected to be conducted within a county or multiple counties that in the last 3 years can be considered to be endemic for Lyme disease, with a combined incidence of reported or probable Lyme disease exceeding 10 per 100,000 population per year.

The research is expected to be conducted within general areas with previously documented dense populations of host-seeking I. scapularis nymphs (≥0.1/m2).

The research is expected to be conducted in residential settings in an area where tick exposures on residential properties are thought to account for the majority of Lyme disease cases.

The project will extend across four (4) spring-summer periods. The first spring-summer period is expected to be devoted to developing baseline data for acarological risk of exposure to I. scapularis and B. burgdorferi, and for human-tick encounters. The second and third spring-summer periods are expected to include implementation of the integrated tick/pathogen management strategy outlined below together with the continued collection of data for acarological risk of exposure to I. scapularis and B. burgdorferi, and for human-tick encounters. The fourth and final spring-summer period is expected to be devoted to collection of follow-up data for acarological risk of exposure to I. scapularis and B. burgdorferi, and for human-tick encounters.

Experimental groups of residential properties must include: 1) non-treated control properties, 2) single treated properties, and 3) multiple adjacent treated properties. Clusters of multiple adjacent treated properties should be designed such that at least one of the treated properties within each cluster is surrounded on all sides by other treated properties.

To facilitate comparison with other CDC-funded studies that evaluated single control methods, the integrated tick/pathogen management strategy used in this research must combine the use of a commercially available synthetic pyrethroid acaricide for application to the ground substrate and vegetation with the use of a commercially available rodent reservoir-targeted acaricide application product with potential for impacting both mice and chipmunks. Pesticide application is expected to be conducted by or under the guidance of a licensed pesticide applicator, and to comply with any pesticide label and use guidelines and existing regulatory terms.

Acaricide application to the ground substrate and vegetation must be performed using hydraulic high-pressure spray equipment; and be done twice per year, just prior to the onset of the nymphal activity season and then repeated 4-6 weeks later.

Rodent-targeted acaricide application must cover the entire period of nymphal and larval seasonal activity, tentatively from early May to late September. Sampling of host-seeking ticks must minimally include nymphal I. scapularis collected during the peak of their seasonal activity period.

As the integrated control approach can be assumed to impact the entire residential property, the design for sampling of host-seeking ticks should reflect acarological risk across the main types of habitats found on the study properties (e.g., open lawn, lawn edge along woods, lawn edge along rock wall, woods edge bordering on lawn, woods, and sturdy ornamental vegetation); and data should be collected as to be traceable back to those habitats.

Detection of Borrelia burgdorferi and other human pathogens in collected host-seeking ticks will be an area of joint responsibility in the research and potentially carried out by CDC staff.

A power analysis is required to justify the proposed sample size for number of properties to be included in the research with regard to assessing reductions in the abundance of host-seeking I.

scapularis nymphs, B. burgdorferi infection rate in host-seeking I. scapularis nymphs and, most importantly, the abundance of B. burgdorferi-infected host-seeking I. scapularis nymphs.

Human activity space must be assessed in sufficient detail to minimally clarify usage of the participant’s own residential property versus other nearby residential properties and other potential tick exposure habitats on public use land during the time of year when nymphs are most active.

Human tick encounter locations – for ticks found crawling on or attached to study participants – must minimally be classified as most likely being on the participant’s own residential property versus other nearby residential properties and other potential tick exposure habitats on public use land. Further consideration must be given to attempt to determine more specific likely tick encounter locations, including in what microhabitat on the participant’s own residential property the tick encounter most likely occurred, and how far distant from the home encounters occurred on other residential properties or on public lands, and what type of activity most likely resulted in the tick exposure.

The majority of ticks encountered by the study participants should be recovered and identified to species and life stage.

If deemed feasible following consultation with the applicants institutional review board for human subjects research, I. scapularis ticks recovered from humans should be examined for the presence of B. burgdorferi to allow for comparison of infection rates in ticks from treatment and control groups (at the experimental group level, not linking back to individual participants).

The number of individuals from the properties falling into each of the three above-mentioned experimental groups that are recruited to participate in the studies on human activity space and tick encounters must be justified statistically to ensure that the results will not be superficial or inconclusive due to low sample sizes.

A project timeline should be included to demonstrate that the proposed work can be completed during the funding period.

As this is a cooperative agreement, CDC staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards – this is further detailed under Section VI.4.

Cooperative Agreement Terms and Conditions of Award of this FOA.

Minimal outcomes that applicants are expected to achieve by the end of the funding period:

Quantification and statistical comparison of acarological risk of exposure to I. scapularis and B.

burgdorferi (minimally abundance of host-seeking I. scapularis nymphs, B. burgdorferi infection rate in host-seeking I. scapularis nymphs, and abundance of B. burgdorferi-infected host-seeking I.

scapularis nymphs) for the three above-mentioned experimental scenarios (non-treated control properties; single treated properties; and multiple adjacent treated properties, including separation of the treated properties that are surrounded by other treated properties on all sides versus treated properties bordering on treated properties on some sides but non-treated areas on other sides).

Determination of whether treatment of multiple adjacent properties provides an added protective effect, with respect to the above-mentioned acarological risk measures, for an individual property within this group (including separation of the treated properties that are surrounded by other treated properties on all sides versus treated properties bordering on treated properties on some sides but non-treated areas on other sides) compared to treatment of a single property surrounded by non-treated properties.

Quantification and statistical comparison of human-tick encounters for the three above-mentioned experimental scenarios (non-treated control properties; single treated properties; and multiple adjacent treated properties, including separation of the treated properties that are surrounded by other treated properties on all sides versus treated properties bordering on treated properties on some sides but non-treated areas on other sides).

Determination of whether treatment of multiple adjacent properties provides an added protective effect, with respect to human-tick encounters, for an individual property within this group (including separation of the treated properties that are surrounded by other treated properties on all sides versus treated properties bordering on treated properties on some sides but non-treated areas on other sides) compared to treatment of a single property surrounded by non-treated ones.

Determination of the extent to which treatment of single or multiple adjacent properties covers the human activity space with respect to exposure to tick risk habitat during the nymphal activity period.

Determination of specific settings (residential properties and public use land) and specific locations (e.g., lawn/woods edge; lawn; garden; ornamental vegetation away from the lawn/woods edge; woods directly outside the lawn/woods edge; and public use trail in wooded land) where human-tick encounters most frequently occur.

Additional work to determine acarological risk measures for other I. scapularis-borne pathogens (e.g., Anaplasma phaagocytophilum and Babesia microti)among the three experimental scenarios is encouraged but not a requirement.

Additional work to determine B. burgdorferi infection rates for rodents among the three experimental scenarios is encouraged but not a requirement.

Target Population The research is expected to be conducted within a county or multiple counties that in the last 3 years can be considered to be endemic for Lyme disease, with a combined incidence of reported or probable Lyme disease exceeding 10 per 100,000 population per year.

The research is expected to be conducted in residential settings in an area where tick exposures on residential properties are thought to account for the majority of Lyme disease cases.

Collaboration/Partnerships The research team is expected to include expertise in medical entomology, small mammal biology, human behavioral science, and statistics/study design.

Pesticide application is expected to be conducted by or under the guidance of a licensed pesticide applicator, and to comply with any pesticide label and use guidelines and existing regulatory terms.

Evaluation/Performance Measurement As part of the application, the PI should include measurable goals and aims based on a four-year research project period. The grantee will collaborate with CDC to: (1) establish specific, measurable, achievable, realistic and time-phased (SMART) project objectives for each activity described in the applicant’s project plan, and (2) develop and implement project performance measures that are based on specific programmatic objectives. Also, funded PIs must submit an annual progress report showing their activities and outcomes based on their overall research goals and timeline. For more information on required Reporting, please see Section VI of this FOA.

Specific Requirements

Evaluation activities must include determination of acarological risk measures (minimally abundance of host-seeking I. scapularis nymphs, B. burgdorferi infection rate in host-seeking I. scapularis nymphs, and abundance of B. burgdorferi-infected host-seeking I. scapularis nymphs) as well as quantification of human-tick encounters and assessment of human activity space with respect to tick encounter locations and exposure to tick risk habitat during the peak nymphal activity period.

The method used for detection of B. burgdorferi sensu stricto in ticks must be adequate to distinguish this spirochete from other known B. burgdorferi sensu lato spirochetes that occur in the eastern U.S.

and the relapsing fever spirochete Borrelia miyamotoi.

The proposed scale of the evaluation, i.e., the number of residential properties and individuals recruited in the experimental groups, must be justified by power analyses or other statistical assessments.

Translation Plan Dissemination of research findings is expected to occur via: 1) publication of research results in

Dissemination of research findings is expected to occur via: 1) publication of research results in peer-reviewed scientific journals, 2) presentation of research results at scientific conferences, and 3) inclusion of key findings on CDC’s webpage for Lyme disease (http://www.cdc.gov/lyme/).

Section II. Award Information

Funding Instrument Type: Cooperative Agreement A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed:

New - An application that is submitted for funding for the first time. Includes multiple submission attempts within the same round.

Estimated Total Funding: $1,600,000 Year 1: $300,000

Year 2: $500,000

Year 3: $500,000

Year 4: $300,000

Anticipated Number of Awards: 1

Awards issued under this FOA are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Award Ceiling: $300,000 Per Budget Period Award Floor: $100,000 Per Budget Period Total Project Period Length: 4 year(s)

Throughout the project period, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://www.hhs.gov/ asfr/ogapa/aboutog/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

County governments City or township governments Special district governments Independent school districts Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal http://www.cdc.gov/lyme/ http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf

Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Others (see text field entitled "Additional Information on Eligibility" for clarification)

Additional Eligibility Category:

The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education:

Nonprofits (Other than Institutions of Higher Education)

Governments:

Eligible Agencies of the Federal Government U.S. Territory or Possession

Other:

Native American tribal organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Bona Fide Agents: a Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms" when submitting via www.grants.gov.

Federally Funded Research and Development Centers (FFRDCs): FFRDCs are operated, managed, and/or administered by a university or consortium of universities, other not-for-profit or nonprofit organization, or an industrial firm, as an autonomous organization or as an identifiable separate operating unit of a parent organization. A FFRDC meets some special long-term research or development need which cannot be met as effectively by an agency's existing in-house or contractor resources. FFRDC's enable agencies to use private sector resources to accomplish tasks that are integral to the mission and operation of the sponsoring agency. For more information on FFRDCs, go to http:// ecfr.gpoaccess.gov /cgi/t/text/ text-idx?c=ecfr& http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=512ff78311f427c00454772dcf21523a&rgn=div8&view=text&node=48:1.0.1.6.34.0.1.18&idno=48 http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=512ff78311f427c00454772dcf21523a&rgn=div8&view=text&node=48:1.0.1.6.34.0.1.18&idno=48 sid=512ff78311f427c00454772dcf21523a&rgn=div8 &view=text&node=48:1.0.1.6.34.0.1.18& idno=48

2. Foreign Organizations Foreign Organizations are not eligible to apply.

Foreign components of U.S. Organizations are not eligible to apply.

For this announcement, applicants may not include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Special Eligibility Requirements Applicant organizations that request funding above the ceiling amount of the award will not be forwarded to peer review or considered for funding.

4. Justification for Less than Maximum Competition N/A

5. Responsiveness Applications submitted under this funding opportunity announcement must not include activities that overlap with simultaneously-funded research already awarded to applicants under other awards.

6. Required Registrations Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https://eportal.nspa.nato. int/AC135Public/Docs/US%20Instructions%2 0for%20NSPA%20NCAGE.pdf System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, https://www.sam.gov/portal/SAM/#1.

Grants.gov eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes.

The “one-time” registration process will take three to five days to complete. However, it is best to start the registration process at least two weeks prior to application submission.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization. All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=512ff78311f427c00454772dcf21523a&rgn=div8&view=text&node=48:1.0.1.6.34.0.1.18&idno=48 http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=512ff78311f427c00454772dcf21523a&rgn=div8&view=text&node=48:1.0.1.6.34.0.1.18&idno=48 http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=512ff78311f427c00454772dcf21523a&rgn=div8&view=text&node=48:1.0.1.6.34.0.1.18&idno=48 https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://www.sam.gov/portal/SAM/%231 http://www.Grants.gov https://public.era.nih.gov/commons/public/login.do?TYPE=33554433&REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-http%3a%2f%2fpublic%2eera%2enih%2egov%2fcommons http://www.Grants.gov

7. Universal Identifier Requirements and System for Award Management (SAM) All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements.

The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An AOR should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Web Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

Additionally, all applicant organizations must register in the System for Award Management (SAM).

Organizations must maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later. SAM is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient. Additional information about registration procedures may be found at the SAM internet site at https://www.sam.gov/index.html.

If an award is granted, the grantee organization must notify potential sub-recipients that no organization may receive a subaward under the grant unless the organization has provided its DUNS number to the grantee organization.

8. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for HHS/CDC support.

9. Cost Sharing This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http:// www.hhs.gov/ asfr/ ogapa/ aboutog/ hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement, (http: //www.hhs.gov /asfr /ogapa /aboutog /hhsgps107.

pdf), applications received in response to the same funding opportunity announcement generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Only one application per institution (normally identified by having a unique DUNS number) is allowed.

Section IV. Application and Submission Information

1. Address to Request Application Package Applicants must download the SF424 (R&R) application package associated with this funding opportunity from www.Grants.gov.

If access to the Internet is not available or if the applicant encounters difficulty accessing the forms on-line, contact the HHS/CDC Procurement and Grants Office Technical Information Management Section (PGO TIMS) staff at (770) 488-2700 or pgotim@cdc.gov for further instructions. Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern Time. CDC Telecommunications for the hearing impaired or disabled is available at:

TTY 1-888-232-6348.

http://fedgov.dnb.com/webform https://www.sam.gov/index.html http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.Grants.gov mailto:pgotim@cdc.gov

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/ 424/SF424_RR_Guide_General_VerC.pdf), except where instructed in this Funding Opportunity Announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

The forms package associated with this FOA includes all applicable components, mandatory and optional.

Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF 424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

In conjunction with the SF424 (R&R) components, CDC grants applicants should also complete and submit additional components titled “PHS398.” Note the PHS398 should include assurances and certifications, additional data required by the agency for a complete application. While these are not identical to the PHS398 application form pages, the PHS398 reference is used to distinguish these additional data requirements from the data collected in the SF424 (R&R) components. A complete application to CDC will include SF424 (R&R) and PHS398 components.

3. Letter of Intent Due Date for Letter of Intent: 01/04/2016

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CIO staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. “Overview Information”, prospective applicants are asked to submit a letter of intent that includes the following information:

Name of the Applicant

Descriptive title of proposed research

Name, address, and telephone number of the PD(s)/PI(s)

Names of other key personnel

Participating institutions

Number and title of this funding opportunity

The letter of intent should be sent to:

Gregory Anderson, MPH, MS

Extramural Research Program Office

Office of the Associate Director of Science

National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention

Centers for Disease Control and Prevention

U.S. Department of Health and Human Services

1600 Clifton Road, MS E-60

Atlanta, GA 30333

Telephone: 404-718-8833

Fax: 404-718-8822

Email: GAnderson@cdc.gov

4. Required and Optional Components A complete application has many components, both required and optional. The forms package associated with this FOA in Grants.gov includes all applicable components for this FOA, required and optional.

5. PHS 398 Research Plan Component The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of 16 components. Not all 16 components of the Research Plan apply to all Funding Opportunity Announcements (FOAs). Specifically, some of the following 16 components are for Resubmissions or Revisions only. See Part I, Section 5.5 of the SF 424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf) for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Funding Opportunity Announcement Description).

Follow the page limits stated in the SF 424 unless otherwise specified in the FOA. As applicable to and specified in the FOA, the application should include the bolded headers in this section and should address activities to be conducted over the course of the entire project, including but not limited to:

1. Introduction to Application (for Resubmission and Revision ONLY) - provide a clear description about the purpose of the proposed research and how it addresses the specific requirements of the FOA.

2. Specific Aims – state the problem the proposed research addresses and how it will result in public health impact and improvements in population health.

3. Research Strategy – the research strategy should be organized under 3 headings: Significance, Innovation and Approach. Describe the proposed research plan, including staffing and timeline.

4. Inclusion Enrollment Report (Renewal and Revision applications ONLY)

5. Progress Report Publication List (for Continuation ONLY)

Human Subjects Section

6. Protection of Human Subjects

7. Inclusion of Women and Minorities

8. Targeted/Planned Enrollment Table (for New Application ONLY)

9. Inclusion of Children

Other Research Plan Sections

10. Vertebrate Animals

11. Select Agent Research

12. Multiple PD/PI Leadership Plan.

13. Consortium/Contractual Arrangements

14. Letters of Support

15. Resource Sharing Plan(s)

16. Appendix

Component 4 (Inclusion Enrollment Report) applies only to Renewal and Revision applications for clinical research. Clinical research is that which is conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies). Follow the page limits in the SF 424 unless otherwise specified in the FOA.

All instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf) must be followed along with any additional instructions provided in the FOA.

mailto:GAnderson@cdc.gov

6. Appendix Do not use the appendix to circumvent page limits. A maximum of 10 PDF documents are allowed in the appendix. Additionally, up to 3 publications may be included that are not publically available. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

7. Page Limitations All page limitations described in this individual FOA must be followed. For this specific FOA, the Research Strategy component of the Research Plan narrative is limited to 25 pages. Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 50 pages for all appendices.

8. Format for Attachments Designed to maximize system-conducted validations, multiple separate attachments are required for a complete application. When the application is received by the agency, all submitted forms and all separate attachments are combined into a single document that is used by peer reviewers and agency staff. Applicants should ensure that all attachments are uploaded to the system.

CDC requires all text attachments to the Adobe application forms be submitted as PDFs and that all text attachments conform to the agency-specific formatting requirements noted in the SF424 (R&R) Application Guide (Part I, Section 2) (http://grants.nih.gov/ grants/funding/424/ SF424_RR_Guide_General_VerC.pdf).

9. Submission Dates & Times Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov (http://www.grants.gov), the online portal to find and apply for grants across all Federal agencies. The eRA Commons systems retrieve the application from Grants.gov and check the application against CDC business rules. If no errors are found, the application will be assembled in the eRA Commons for viewing by the applicant before moving on for further CDC processing.

If errors are found, the applicant will be notified in the eRA Commons. They must make required changes to the local copy of their application and submit again through Grants.gov.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Once you can see your application in the Commons, be sure to review it carefully as this is what the reviewer will see. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons (http:// grants.nih. gov/grants /guide/url_redirect .htm? id=11123).

Information on the submission process is provided in the SF424 (R&R) Application Guide.

Note: HHS/CDC grant submission procedures do not provide a period of time beyond the grant application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e. error correction window).

The application package is not complete until it has passed the Grants.gov/eRA Commons validation http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://grants.nih.gov/grants/guide/url_redirect.htm?id=11128 http://www.grants.gov/ http://grants.nih.gov/grants/guide/url_redirect.htm?id=11123 process. This process and email notifications of receipt, validation or rejection may take two (2) business days.

Applicants are strongly encouraged to allocate additional time prior to the submission deadline to submit their applications and to correct errors identified in the validation process. Applicants are encouraged also to check the status of their application submission to determine if the application packages are complete and error-free. Applicants who encounter system errors when submitting their applications must attempt to resolve them by contacting the Grants.gov Contact Center ( 1-800-518-4726; support@grants.gov). If the system errors cannot be resolved, applicants must contact CDC PGO TIMS at 770-488-2700; pgotim@cdc.gov for guidance at least 3 calendar days before the deadline date.

After submission of your application package, applicants will receive a “submission receipt” email generated by Grants.gov. Grants.gov will then generate a second e-mail message to applicants which will either validate or reject their submitted application package. This validation process may take as long as two (2) business days. A third and final e-mail message is generated once the applicant’s application package has passed validation and the grantor has confirmed receipt of the application.

Unsuccessful Submissions:

If an application submission was…