RFA-CK-16-006 11 04 15.pdf

Centers for Disease Control and Prevention

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

Research on Technical Improvement of Personal Protective Equipment (PPE) to be used in Healthcare

Settings for Infection Control, including Ebola and other Emerging Pathogens

RFA-CK-16-006

Application Due Date: 01/19/2016

Research on Technical Improvement of Personal Protective Equipment (PPE) to be used in Healthcare Settings for Infection Control, including Ebola and other Emerging Pathogens

RFA-CK-16-006

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 Research on Technical Improvement of Personal Protective Equipment (PPE) to be used in Healthcare Settings for Infection Control, including Ebola and other Emerging Pathogens Activity Code U01 Research Project Cooperative Agreements

Funding Opportunity Announcement Type New Funding Opportunity Announcement Number

RFA-CK-16-006

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.823 Category of Funding Activity:

Health FOA Purpose The purpose of this announcement is to fund research to improve personal protective equipment (PPE) to be used in healthcare settings for infection control. Specifically, it will focus on improving the design of and the material used in isolation gowns and respirators to address challenges related to comfort, ease of communication, reprocessing for re-use, fluid penetration through materials, fit and sizing, and ease of safe donning and doffing. The applicant must also develop the capability to produce these two products in the United States.

Key Dates Publication Date: To receive notification of any changes to RFA-CK-16-006, 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: 12/14/2015

Application Due Date: 01/19/2016

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).

http://www.grants.gov

Scientific Merit Review: 03/17/2016

Secondary Review: 04/19/2016

Estimated Start Date: 07/30/2016

Expiration Date: 01/20/2016 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

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. The purpose of this announcement is to fund research to improve personal protective equipment (PPE) to be used in healthcare settings for infection control. Specifically, it will focus on improving the design of and the material used in isolation gowns and respirators to address challenges related to comfort, ease of communication, reprocessing for re-use, fluid penetration through materials, fit and sizing, and ease of safe donning and doffing.

Mechanism of Support. Cooperative Agreement Funds Available and Anticipated Number of Awards. Estimated total funding available, to include direct and indirect costs for the entire project period, is $3,000,000. The project period will be three years. There will be one award. The award issued under this FOA is contingent upon availability of funds and the total number of meritorious applications received.

Budget and Project Period. The estimated total funding (direct and indirect) for the first budget period (36 months) will be $3,000,000. Please note that there is only one budget period which is the same length as the project period (36 months). The project period will run from 07/30/2016 to 07/29/2019.

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

Eligible Institutions/Organizations. Institutions/organizations listed in Section III.1 of this announcement 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 for each application. If necessary, Co-PI(s) may be listed in the application, but only one PI may be the primary CDC contact for the application and the award and this must be indicated in the application.

Number of Applications. Each eligible applicant institution may submit only one application.

Application Type. New – Type 1 – Applications are being submitted for the first time.

Special Date(s). Not applicable.

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

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:

(770) 488-2783.

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority Public Health Service Act Sections 301(a)[42 U.S.C. 241(a)] and 317(k)(2)[42 U.S.C. 247b(k)(2)], as amended.

1. Background and Purpose Background:

Protection of healthcare workers potentially exposed to infectious material, including during care of Ebola patients, is a national and international imperative of which personal protective equipment (PPE) is an important component.

The healthcare response to Ebola has shown that current PPE used for infection control in healthcare settings is not ideal. Design and technical limitations reflect the changing demands on healthcare PPE and ongoing evolution of intent for its use. Improvements are needed to make PPE more uniform within healthcare, with assurance of wearer protection and less interference with healthcare delivery, while making errors in use less probable. Specific elements limiting the effectiveness of currently available designs and technologies include challenges related to comfort, ease of communication, reprocessing for re-use, fluid penetration through materials, fit and sizing, and ease of safe donning and doffing.

Whereas CDC recommends that PPE worn by healthcare providers working with Ebola patients, at a minimum, include isolation gown, gloves, face shield, respirator, and shoe covers, this FOA will focus only on the design of isolation gowns and respirators.

Purpose:

The purpose of this announcement is to fund research to improve personal protective equipment (PPE) to be used in healthcare settings for infection control. Specifically, it will focus on improving the design of and the material used in isolation gowns and respirators to address challenges related to comfort, ease of communication, reprocessing for re-use, fluid penetration through materials, fit and sizing, and ease of safe donning and doffing.

The objectives of the proposed research are:

1) Design and develop an innovative, cost-effective, wearer-friendly, impermeable isolation gown with demonstrated protection against infectious bodily fluids and microorganisms in a healthcare setting.

2) Design and develop an innovative, cost-effective, user-friendly, reusable, textile facepiece-filtering respirator with demonstrated protection against infectious aerosols in a healthcare setting.

3) Develop, in conjunction with an industrial partner(s), the capability to produce these two products within U.S. industry.

Healthy People 2020 and other National Strategic Priorities The objectives of this research align with CDC’s Winnable Battle on healthcare-associated infections (http http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://www.cdc.gov/winnablebattles/healthcareassociatedinfections/index.html

The objectives of this research align with CDC’s Winnable Battle on healthcare-associated infections (http ://www.cdc.gov/winnablebattles/healthcareassociatedinfections/index.html). With additional effort and support for evidence-based, cost-effective strategies that can be implemented now, a significant impact on our nation’s health can be achieved.

Public Health Impact The healthcare response to Ebola has shown that improvements in PPE can improve healthcare worker safety and patient care delivery. The design limitations in current PPE provide challenges for healthcare workers (HCWs), especially while doffing certain components of PPE. The improvement in gowns and respirators could have a substantial impact on public health, both domestically and internationally.

Relevant Work http://www.fda.gov/medicaldevices/productsandmedicalprocedures/generalhospitaldevicesandsupplies/perso nalprotectiveequipment/default.htm

2. Approach This research will focus on improving the material and design of isolation gowns and respirators to address current design and technical challenges and considerations. Protection of healthcare workers potentially exposed to infectious material, including during care of Ebola patients, is a national and international imperative of which personal protective equipment (PPE) is an important component.

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

The first objective of this research is to design of an impermeable isolation gown that allows for easy doffing, provides freedom of movement while maintaining accurate sizing, includes integrated thumbhooks, and incorporates impermeable and breathable material. The design must meet the Association for the Advancement of Medical Instrumentation (AAMI) Level 4 standards.

Isolation gowns are defined by the Association for the Advancement of Medical Instrumentation (AAMI) as “the protective apparel used to protect healthcare workers and patients from the transfer of microorganisms and body fluids in patient isolation situations”. In addition to being easy to wear and remove, these garments must not permit the movement of microorganisms through isolation gown fabric during normal use. This depends on several factors, including the physical and chemical properties of the fabric, the size, shape and surface properties of the microorganism, and the characteristics of carriers, and other physical and chemical stressors. Isolation gowns have varying performance based upon a number of fabric and design characteristics, which include fabric and seam strength, pore size, repellency, size, fit, thermal comfort and mobility.

AAMI Level 4 surgical and isolation gowns have the ability to resist liquid and viral penetration as demonstrated in a laboratory test, referred to as ASTM F1671. ASTM F1671 is the standard test method for resistance of materials used in protective clothing to penetration by blood-borne pathogens using Phi-X174 bacteriophage penetration as a test system. The Phi-X174 bacteriophage is similar in size to the Ebola virus.

Applicants should describe how the design parameters of their isolation gown (easy doffing, freedom of movement, impermeable yet breathable, etc.) will be evaluated and ranked.

The second objective of this research is to design a facepiece-filtering respirator that meets or exceeds National Institute for Occupational Safety and Health (NIOSH)-certification for N95 respirators. This design http://www.cdc.gov/winnablebattles/healthcareassociatedinfections/index.html http://www.cdc.gov/winnablebattles/healthcareassociatedinfections/index.html http://www.fda.gov/medicaldevices/productsandmedicalprocedures/generalhospitaldevicesandsupplies/personalprotectiveequipment/default.htm http://www.fda.gov/medicaldevices/productsandmedicalprocedures/generalhospitaldevicesandsupplies/personalprotectiveequipment/default.htm should include an external layer of fluid-resistance material allowing its use for surgical applications where there is a risk of splashes of blood and exposure to bloodborne pathogens during procedures. The respirator design should eliminate the necessity for fit testing. Thus, the facepiece seal would be such that if tested, the wearer would pass a NIOSH-certified fit test for N95 respirators.

Respirators used for medical care should be designed to protect both the patient and the healthcare workers from transmission of microorganisms, body fluids, and particulate material. However, successful use and acceptance by healthcare workers depends on several factors including efficacy, comfort, usability, wearability, and durability.

Additionally, the respirator should be designed to be reusable. The possibility of reuse of respirators will increase availability in the event of a pandemic and could reduce the reliance on single-use disposable masks.

Applicants should describe how the design parameters of their facepiece filtering respirator (fit, comfort, usability, wearability, durability, etc.) will be evaluated and ranked.

The third objective of this research will focus on the ability of the applicant to develop, in conjunction with an industry partner(s), the capability to manufacture these two products (isolation gowns and respirator) in the United States. The applicant must work with one or more US manufacturers to demonstrate the ability to produce prototypes as well as the ability to produce products on a large scale.

Applicants should describe how manufacturing capability and scalability will be evaluated.

Target Population The proposed research focuses on protecting healthcare workers and patients in healthcare settings in the U.S. and internationally.

Collaboration/Partnerships The nature of this research requires experience in the design of personal protective equipment, specifically isolation gowns and respirators. Knowledge of material science and textile engineering, as well as previous or ongoing collaboration with appropriate industry partner(s), including manufacturer(s) of related devices is also required.

In the application, the investigators must define their working relationships with each organization that will participate in the research and detail the nature of their involvement.

Evaluation/Performance Measurement As part of the application, the PI should include measurable goals and aims based on a three 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 application’s project plan, and (2) develop and implement project performance measures that are based on specific programmatic objectives. Also, funded PIs must submit progress reports 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.

Applicants must provide an overall evaluation and performance measurement plan. Data collected must be used for ongoing monitoring of the award to evaluate its effectiveness, and for continuous program improvement. This plan should include the following:

Measuring progress toward completion of the proposed research project within the project period and milestones to evaluate progress at six-month intervals, including interactions with potential industry partners.

Description of the processes for development of production capability and scalability.

Description of how evaluation findings will be used for continuous program quality improvement.

Description of the type of evaluation(s) (i.e., process, outcome, or both) to be conducted.

Description of the type of evaluation(s) (i.e., process, outcome, or both) to be conducted.

Description of key evaluation questions to be addressed by these evaluations.

Description of other information relevant to the evaluation (e.g., measures, data sources).

Development of peer-reviewed articles that report on the proposed research project.

Presentation of findings as a result of the proposed research project.

Translation Plan When relevant to the goals of the research project, the PI should describe in the application how the significant findings of the research may be used to inform the translation of research to production and deployment of innovative products. This section should address which research findings may be translated, how these findings can guide future research or related activities, and any additional recommendations for translation.

Questions to consider in preparing this section include:

How will the scientific findings inform clinical and public health practices?

How will the project improve or effect the translation of research findings into practice or inform policy?

How will the research findings help promote or accelerate the dissemination, implementation, or diffusion of improvements in personal protective equipment use?

How will the findings advance or guide future research efforts or related activities?

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: $3,000,000

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: $3,000,000 Per Project Period Award Floor: $2,000,000 Per Project Period Total Project Period Length: 3 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.

http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf

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 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 For profit organizations other than small businesses Small businesses

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 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& 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

To be eligible to apply to this Funding Opportunity Announcement (FOA), an applicant must meet the following criteria:

Demonstrated success in producing prototype devices for respiratory protection and barrier protection.

Demonstrated experience working with NIOSH on device assessment.

Demonstrated access to industry counterparts for device production.

Published peer-reviewed articles reflecting expertise and innovation in textile design.

Demonstrated access to materials engineering research laboratories.

Applicants must provide a letter, no more than two typewritten pages—12-point font, and double-spaced—documenting how they meet the stated special eligibility requirements. This letter must be entitled “Special Eligibility Requirements” and placed in the Other Attachment section of the application.

Applications submitted under this funding opportunity announcement must not include activities that overlap with simultaneously-funded research under other awards.

4. Justification for Less than Maximum Competition N/A

5. Responsiveness Applications that request funds above the ceiling of the award be considered nonresponsive will not move forward to peer review or be eligible for funding.

Applications that do not focus on the design and development of both an isolation gown and a facepiece-filtering respirator will be considered nonresponsive will not move forward to peer review or be eligible for funding.

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

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.

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.

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 http://fedgov.dnb.com/webform https://www.sam.gov/index.html

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 Standard Time. CDC Telecommunications for the hearing impaired or disabled is available at: TTY 1-888-232-6348.

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: 12/14/2015

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:

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

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 announcement

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) mailto:GAnderson@cdc.gov

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.

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 25 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).

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 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 unsuccessful, the applicant must:

1. Track his/her submission and verify the submission status (tracking should be done initially regardless of rejection or success).

a. If the status states “rejected,” do #2a or #2b.

2. Check his/her emails from both Grants.gov and eRA Commons for rejection notices.

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 mailto:support@grants.gov mailto:www.pgotim@cdc.gov

2. Check his/her emails from both Grants.gov and eRA Commons for rejection notices.

a. If the deadline has passed, he/she should email the Grant Management Specialist listed in the FOA (pgotim@cdc.gov) explaining why the submission failed.

b. If there is time before the deadline, he/she should correct the problem(s) and resubmit as soon as possible.

Due Date for Applications: 01/19/2016

Electronically submitted applications must be submitted no later than 5:00 p.m., ET, on the listed application due date.

10. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review (http:// www. whitehouse.gov/ omb/ grants_spoc).

11. Funding Restrictions All HHS/CDC awards are subject to the terms and conditions, cost principles, and other requirements described in the HHS Grants Policy Statement. Pre-award costs may be allowable as an expanded authority, but only if authorized by CDC.

For more information on expanded authority and pre-award costs, go to: http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf.

Funds related to the conduct of research involving human subjects will be restricted until the appropriate assurances and Institutional Review Board (IRB) approvals are in place. Copies of all current local IRB approval letters and local IRB approved protocols (and CDC IRB approval letters, if applicable) will be required to lift restrictions.

Projects that involve the collection of information, identical record keeping or reporting from 10 or more individuals and are funded by a cooperative agreement and constitute a burden of time, effort, and/or resources expended to collect and/or disclose the information will be subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA).

On September 24, 2014, the Federal government issued a policy for the oversight of life sciences “Dual Use Research of Concern” (DURC) and required this policy to be implemented by September 24, 2015. This policy applies to all New and Renewal awards issued on applications submitted on or after September 24, 2015, and to all non-competing continuation awards issued on or after that date. CDC grantee institutions and their investigators conducting life sciences research subject to the Policy have a number of responsibilities that they must fulfill. Institutions should reference the policy, available at http://www.phe .gov/s3/dualuse, for a comprehensive listing of those requirements.

Non-compliance with this Policy may result in suspension, limitation, or termination of United States Government (USG) funding, or loss of future USG funding opportunities for the non-compliant USG-funded research project and of USG funds for other life sciences research at the institution, consistent with existing regulations and policies governing USG funded research, and may subject the institution to other potential penalties under applicable laws and regulations.

12. Other Submission Requirements and Information http://www.whitehouse.gov/omb/grants_spoc http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.phe.gov/s3/dualuse http://www.phe.gov/s3/dualuse

Application Submission Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

Applicants must complete all required registrations before the application due date. Section III.6 "Required Registrations" contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically (http://grants.nih.gov/grants/guide /url_ redirect.htm? id=11144).

Important reminders:

All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to CDC.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

If the applicant has an FWA number, enter the 8-digit number. Do not enter the letters “FWA” before the number. If a Project/Performance Site is engaged in research involving human subjects, the applicant organization is responsible for ensuring that the Project/Performance Site operates under and appropriate Federal Wide Assurance for the protection of human subjects and complies with 45 CFR Part 46 and other CDC human subject related policies described in Part II of the SF 424 (R&R) Application Guide and in the HHS Grants Policy Statement.

See more resources to avoid common errors and submitting, tracking, and viewing applications: http:// grants.nih. gov/grants/ Electronic Receipt /avoiding _errors.htm or http:// grants. nih.gov/grants/ Electronic Receipt/submit _app.htm Upon receipt, applications will be evaluated for completeness by the CDC Procurement and Grants Office (PGO) and responsiveness by PGO and the Center, Institute or Office of the CDC. Applications that are incomplete and/or nonresponsive will not be reviewed.

Section V. Application Review Information

1. Criteria Only the review criteria described below will be considered in the review process. As part of the CDC mission (http:// www.cdc.gov/ about/ organization/ mission.htm), all applications submitted to the CDC in support of public health research are evaluated for scientific and technical merit through the CDC peer review system.

Overall Impact Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance http://grants.nih.gov/grants/guide/url_redirect.htm?id=11144 http://grants.nih.gov/grants/ElectronicReceipt/avoiding_errors.htm http://grants.nih.gov/grants/ElectronicReceipt/avoiding_errors.htm http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm http://www.cdc.gov/about/organization/mission.htm

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? Have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Does the application include sufficient information on the research team’s experience and expertise in producing prototype devices for respiratory protection and barrier protection? How well does this experience and expertise match that needed to conduct the proposed research?

Do the investigators have experience working with NIOSH on device assessment? Is this experience adequate to conduct the proposed research?

Do the investigators have access to industry counterparts for device production? Is this access sufficient to produce the proposed gown and respirator?

Is the research team’s access to materials…