eh-13-001 final amendment i 01-31-13.doc

Amendment I (01.16.13):

This amendment reflects changes to the FOA noted in red text, or crossed-through text, on the following pages: 1, 2, 5, 16, 26 and 39.

Table of Contents

3Part 1. Overview Information

4Key Dates

5Required Application Instructions

5Executive Summary

6Part 2. Full Text

6Section I. Funding Opportunity Announcement Description

6Statutory Authority

10Section II. Award Information

11Section III. Eligibility Information

111.

Eligible Applicants

2.

Foreign Organizations……………………………………………………………….12

3. Special Eligibility Requirements:

In addition, the Principal Investigator must have:

13Established relationships with low-income multifamily households located in a metropolitan area with a population greater than 1 million located in the Western region of the continental U.S (i.e., Arizona, California, Colorado, Idaho, Montana, Nevada, New Mexico, Oregon, Utah, Washington, or Wyoming).

134.

Responsiveness: Applicant must demonstrate experience and expertise in the areas of indoor air quality, environmental sampling, and biological sampling related to asthma as well as strong, well-established relationships with low-income communities.

5. Required Registrations……..….…………………………………………………..…13

6. Universal Identifier Requirements and Central Contractor Registration....………….14

7. Eligible Individuals (Project Director/Principal Investigator) in Organizations/

Institutions.……………………………………………………………………..……...…...14 158.

Cost Sharing

9. Number of Applications………………………………………………………….….15

16Section IV. Application and Submission Information

1. Address to Request Application Package……………………………………………16

2. Content and Form of Application Submission

163.

Letter of Intent

174.

Required and Optional Components

175.

PHS 398 Research Plan Component

186.

Appendix

207.

Page Limitations

208.

Format for Attachments

209.

Submission Dates and Times

2110.

Intergovernmental Review (E.O. 12372)

2211.

Funding Restrictions

2212.

Other Submission Requirements and Information

23Section V. Application Review Information

231.

Criteria

2. Additional Review Criteria…………………………………………………………..25

3. Additional Review Considerations……………………………………………….….26 4.26 Review and Selection Process

275.

Anticipated Announcement and Award Dates

27Section VI. Award Administration Information

271.

Award Notices

272.

CDC Administrative Requirements

3. Additional Policy Requirements……………………………………………………..28

4. Cooperative Agreement Terms and Conditions of Award……………………….….30

335.

Reporting

38Section VII. Agency Contacts

40Section VIII. Other Information

Part 1. Overview Information

Funding Opportunity Announcement Type

New

Key Dates

Publication Date

To receive notification of any changes to EH13-001 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.

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).

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 _15__ 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 the program is to evaluate housing factors that are energy efficient and have the potential to mitigate the negative health outcomes of low income children with asthma.

· Mechanism of Support. Cooperative Agreement

· Funds Available and Anticipated Number of Awards. The award for the first year of funding will not exceed $200,000. The second year of funding will not exceed $300,000. These funding amounts include both direct and indirect costs. 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 each 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. The award for the first year of funding will not exceed $200,000. The second year of funding will not exceed $300,000. These funding amounts include both direct and indirect costs. The estimated total funding (direct and indirect) for the entire project period will be $500,000. The project period will run from 07/01/2013 to 06/31/2015.

· 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. State the authoritative structure you expect to see in submitted applications.

· Number of Applications. Eligible applicant institutions may submit more than one application, provided that each application is scientifically distinct.

· Application Type. New

· Special Date(s). N/A

· Application Materials. See Section IV.1 for application materials.

· Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: (770) 488-2783.

Part 2. Full Text

Section I. Funding Opportunity Announcement Description

Statutory Authority Awards are made under the authorization of Sections of the Public Health Service Act as amended and under the Code Federal Regulations. Awards are made under the authorization of Section 301 of the Public Health Service Act [42 U.S.C. Section 241], as amended.

1. Background and Purpose The efficacy of green building design features in reducing allergens and toxic substances within the home has been assumed based on conventional wisdom. A better understanding is needed of the extent to which green-built, low-income housing actually reduces exposures to these compounds when compared to standard-built, low-income housing. A research study undertaken to investigate relationships between green housing and certain environmental exposures may provide insight into how specific green building practices (e.g., use of low chemical-emitting paints and carpets) may influence levels of substances in the home (such as volatile organic compounds [VOCs]). A study investigating these topics would provide a solid foundation upon which to explore green affordable housing’s potential to promote healthy homes principles. This investigation is consistent with the Centers for Disease Control and Prevention’s (CDC) health protection research agenda, which calls for research to identify the major environmental causes of disease and disability and related risk factors. In addition, this study directly supports several of the United States Health and Human Services’ (HHS) Healthy People 2020 objectives and the proposed 2020 objectives (proposed objectives available at www.healthypeople.gov/HP2020/Objectives/TopicAreas.aspx).

Few studies have explored how green building practices affect indoor air quality (IAQ) and even fewer have examined how the health of occupants changed as a result of these practices. In Finland, IAQ and resident health were assessed in two buildings situated next to each other. One building had improved ventilation and policies against smoking and furred pets; the other had no intervention and served as the comparison. After one year, total VOCs were lower in the intervention vs. the comparison homes, and asthmatics in the intervention building reported improvements in respiratory symptoms (Tuomainen, Tuomainen, Liesivuori, & Pasanen, 2003). In a more recent study in the US, children who moved into asthma-friendly homes (e.g., improved ventilation, low VOC paint and cabinetry, improved insulation) and received asthma education were compared to those who received asthma education alone (Takaro et al., 2011). Exposures to mold, rodents, and moisture were reduced significantly in the intervention group and night-time awakening due to asthma was significantly different between the intervention and comparison group.

Eligible households will include children with doctor-diagnosed asthma (ages 7-12 years) and their mothers who live in HUD-subsidized housing that either will receive a green renovation (i.e., green intervention) or a renovation comprised of only Energy Star appliances or low-flow-toilets, or no renovation at all (i.e., control). The total would be n=64 children (half in control apartments and half in renovated apartments). Only one child with asthma (ages 7-12 years) is eligible per household. Additional children from other age groups may be added in Year 2. Details of the eligibility criteria are listed in Table 1.

In Figure 1, we describe a scenario of how measurements collected in green-renovated homes would be compared to: 1) those of the baseline measurement and 2) those of homes without any renovation at all. Residents will participate for 1 month prior to rehabilitation, the time required for rehabilitation of their home (usually just a few days), and 12 months after completion of the rehabilitation. The duration of the participation for the residents of comparison homes is the same except no renovation will occur.

Figure 1. Diagram of renovation schedule (green intervention vs. comparison)

Details of the eligibility criteria are listed in Table 1.

Table 1. The Green Housing Study’s inclusion and exclusion criteria

1. Children (age 7-12 years with asthma)

- Child has been told at some time by a physician that they have asthma and has experienced asthma-related symptoms (wheezing, slow play or night awakening) during the past 6 months. Additional children from other age groups may be added in Year 2.

2. Mothers of the children listed above.

- No clinical markers will be collected, but we will ask questions regarding their home environment that might be related to health outcomes of interest. Green homes will be renovated using low VOC materials and integrated pest management (IPM) principles.

3. Households that had baseline environmental and biological measurements taken within 4 months of the cessation of renovation activities.

1. Health condition (e.g. Cystic Fibrosis or Diabetes Mellitus) that would make it difficult to participate.

2. Does not live in housing complex on average 7 days per week.

3. Mother does not speak English, Spanish, or Chinese.

Purpose

The purpose of the program is to evaluate housing factors that are energy efficient and have the potential to mitigate the negative health outcomes of low income children with asthma. This program addresses the “Healthy People 2020” focus areas of homes and communities and respiratory diseases by:

1) Comparing the levels of certain environmental chemical and biological agents in green vs. comparison, multi-family, and low-income housing

2) Documenting the differences in the health of the residents in these homes

3) Assessing the economic impacts of the “greening” of housing -- particularly those related to health

This objective and related program actions will be accomplished in ongoing building renovation programs, including but not limited to, public housing and the “Mark-to-Market” (M2M) program, both of which are sponsored by United States Department of Housing and Urban Development (HUD). The M2M program is a nationwide initiative that encourages landlords of multi-family properties to use green building principles. In partnership with HUD, CDC will leverage this opportunity to collect survey and biomarker data from residents and to take environmental measurements in their homes. Prior to this proposed study, there have been no multi-site studies of how green housing factors are associated with health effects such as asthma.

Through this announcement, the CDC intends to fund research applications that have the potential to yield high impact results by reducing the level of public health burden and by improving population health.

The specific aims of this study are as follows:

1. To conduct an exposure assessment of chemical and biological contaminants, pesticides, volatile organic compounds (VOCs), fungi, and indoor allergens (in terms of variety and concentration) in green vs. comparison housing.

a. Measure interior levels of pesticides in surface wipe samples; fungi and indoor allergens in dust samples; and VOCs in air samples.

b. Compare levels of biomarkers of VOCs and pesticides (in terms of variety and concentration) from the participating residents of green and comparison housing.

2. To examine the relationship between living in green vs. comparison housing and asthma morbidity (e.g., symptoms, emergency department visits, use of medications, lost school days) of children with doctor-diagnosed asthma (ages 7-12 years). Any analysis will adjust for allergic sensitization and environmental tobacco smoke (ETS).

In summary, the applicant should collect environmental and biological data from homes and from enrolled residents at four (4) time points: 1) baseline; 2) soon after renovation; 3) 6 months post-renovation; and 4) 12 months post-renovation as described by the study protocol (questionnaires, consent forms, etc) that will be provided by CDC Green Housing Study staff. There is an existing OMB/PRA approval for 'The Green Housing Study' (No. 0920-0906; expiration date 11/30/2014). Any change to the existing data collection will be subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act.

Section II. Award Information

Application Types Allowed

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

Funds Available and Anticipated Number of Awards

$500,000 on one award for a two year project. The award for the first year of funding will not exceed $200,000. The second year of funding will not exceed $300,000. These funding amounts include both direct and indirect costs.

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

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://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html) will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions:

· Public/State Controlled Institutions of Higher Education

· Private Institutions of Higher Education

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)

For- Profit Organizations

· Small Businesses

· For-Profit Organizations (Other than Small Businesses)

Governments

· State Governments

· County Governments

· City or Township Governments

· Special District Governments

· Indian/Native American Tribal Governments (Federally Recognized)

· Indian/Native American Tribal Governments (Other than Federally Recognized)

· Eligible Agencies of the Federal Government

· U.S. Territory or Possession

Other

· Independent School Districts

· Public Housing Authorities/Indian Housing Authorities

· 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.

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

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

3. Special Eligibility Requirements:

In addition, the Principal Investigator must have:

Established relationships with low-income multifamily households located in a metropolitan area with a population greater than 1 million located in the Western region of the continental U.S (i.e., Arizona, California, Colorado, Idaho, Montana, Nevada, New Mexico, Oregon, Utah, Washington, or Wyoming).

Furthermore, there is currently a scientific gap on how green housing located in the Western part of the United States affects indoor exposures and respiratory health. The housing stock, profiles of outdoor air pollution and climate can vary across the US. With limited funding at this time, this FOA is limited in its ability to fund more than one more study site. Therefore this FOA will seek applicants that have the following: established relationships with low-income multifamily households located in a metropolitan area with a population greater than 1 million located in the Western region of the continental U.S (inclusive of: Arizona, California, Colorado, Idaho, Montana, Nevada, New Mexico, Oregon, Utah, Washington, or Wyoming).

4. Responsiveness: Applicant must demonstrate experience and expertise in the areas of indoor air quality, environmental sampling, and biological sampling related to asthma as well as strong, well-established relationships with low-income communities.

5. 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.

· (http://www.dlis.dla.mil/Forms/Form_AC135.asp

· System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, http://www.grants.gov/applicants/org_step2.jsp.

· 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.

6. Universal Identifier Requirements and Central Contractor Registration 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), the replacement system for the Central Contractor Registration (CCR) database. 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 sub-award under the grant unless the organization has provided its DUNS number to the grantee organization.

7. 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.

In addition, the Principal Investigator must have:

1) Established relationships with low-income multifamily households located in a metropolitan area with a population greater than 1 million located in the Western region of the continental U.S (i.e., Arizona, California, Colorado, Idaho, Montana, Nevada, New Mexico, Oregon, Utah, Washington, or Wyoming);

2) Relationships with key stakeholders (e.g., housing authority management, landlords, tenant organizations) at housing complex(es) that could contribute to a pool of study participants outlined in this FOA;

3) Partnerships with local community groups and will be able to partner with them for a required element of this program, namely to report study results back to the study participants and to the general communities of their respective metropolitan areas. These capabilities are necessary to collect data and maintain follow-up of the study participants.

4) Assemble a team that has demonstrated academic and professional expertise in the areas of indoor air quality, environmental sampling, and biological sampling related to asthma as well as strong, well-established relationships with low-income communities where: 1) childhood asthma prevalence is high and 2) multifamily housing is common. In addition, a suitable low-income multifamily housing complex (or collection of housing complexes) must already be scheduled for green renovation (per description in Section I.) in order to accomplish all of the activities required within the time period of this FOA. Please note that the renovation themselves are not part of this research study. They would take place whether the research is conducted or not. The green-renovated apartments should already be funded through a separate source other than this cooperative agreement. Public housing units and other HUD-subsidized apartments that are scheduled for green renovations are examples of apartments that would be appropriate for this research study. Specifically, applicant should demonstrate that: 1) the low-income multifamily housing complex (or collection of housing complexes) has a sufficient number of children (ages 7-12) and 2) the asthma prevalence for children in this city/metropolitan area is high enough that the pool of participants would be large enough to reach the sample size requirements of this FOA (i.e., n= 32 green-renovated and n=32 control homes).

8. Cost Sharing This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html).

9. Number of Applications Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

As defined in the HHS Grants Policy Statement, (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html), 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.

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/guide/url_redirect.htm?id=12000), 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. These forms can be downloaded and uploaded as Attachment A from the following link: http://www.cdc.gov/od/pgo/funding/grants/foamain.shtm

3. Letter of Intent (revised) 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:

J Felix Rogers, PhD, MPH

Scientific Review Officer

National Center for Injury Prevention and Control

National Center for Environmental Health/Agency for Toxic Substances and Disease Registry

Extramural Research Program Office

The Centers for Disease for Disease Control and Prevention

4470 Buford Highway

Mail Stop F63

Atlanta, GA 30341

Email: fxr3@cdc.gov

Telephone: 770 488 4334

FAX: 404-929-2741

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/guide/url_redirect.htm?id=12000) 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. Multiple PD/PI Leadership Plan.

11. Consortium/Contractual Arrangements

12. Letters of Support

13. Resource Sharing Plan(s)

14. 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_Adobe_VerB.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.

Need to address the following hypotheses of this study:

1. Green housing utilizes different strategies to reduce environmental contaminants. We hypothesize that these strategies will lead to: 1) lower levels of environmental contaminants compared with those of comparison housing, and 2) lower levels of related biomarkers in the residents of green vs. comparison housing.

2. Integrated pest management (IPM) is a method to reduce pests such as cockroaches and mice by eliminating entry points in the home and harborage areas. We hypothesize that IPM will result in lower cockroach and mouse allergen levels while at the same time lowering the concentrations and array of pesticides in the green vs. comparison homes, and that concentrations of pesticide metabolites in urine of children living in green housing will be lower than those living in comparison homes.

3. The use of low VOC paints, carpeting, and other building materials contain lower concentrations of aldehydes, ketones, and alcohols. We hypothesize that the levels of VOCs will be lower at baseline in green-renovated vs. comparison homes, and that the concentrations of VOCs in urine of children with asthma (ages 7-12 years) living in green housing will be lower than those living in comparison housing.

4. Insulation can reduce sources of moisture, specifically condensation. We hypothesize that green housing will have more and possibly better insulation (e.g., higher R-value) than comparison housing. We hypothesize that insulation (e.g., dual-paned windows, insulated cold water pipes, and rigid insulation above concrete floors and in exterior walls) will result in lower concentrations of dust mites (and therefore their allergens) and fungi.

5. Another aspect of green housing is improved ventilation which can reduce moisture and decrease indoor concentration of VOCs. For example, improved exterior wall insulation can reduce condensation and a properly-sized and maintained central heating, ventilating, and air-conditioning unit (HVAC) can help buildings keep dry and, at the same time, exhaust environmental contaminants to the outside. We hypothesize that green housing will have a higher percentage of units with the recommended air exchange rates than comparison housing, will have lower VOCs than comparison homes, and will have lower levels of fungi and dust mite allergen than comparison homes.

6. If irritants and allergens are lower in green vs. comparison housing, residents of green housing should experience decreased asthma morbidity. Specifically, we hypothesize those children with asthma (ages 7-12 years) in green housing will have lower asthma morbidity, adjusting for allergy status and environmental tobacco smoke (ETS) exposure.

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 _15___ pages.

Supporting materials for the Research Plan narrative included as appendices may not exceed __15__ 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/guide/url_redirect.htm?id=12000).

9. Submission Dates and 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; www.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.

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.

10. Intergovernmental Review (E.O. 12372)

Your application is subject to Intergovernmental Review of Federal Programs, as governed by Executive Order 12372 (http://www.archives.gov/federal-register/codification/executive-order/12372.html). This order sets up a system for state and local review of proposed federal assistance applications. You should contact your state single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications, and to receive instructions on your state’s process. Click on the following link to get the current SPOC list: 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.

Pre-award costs are allowable only as described in the HHS Grants Policy Statement.

12. Other Submission Requirements and Information

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. Eligibility Information 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.

Applicants are reminded to enter the approved Federal Wide Assurance (FWA) that the applicant has on file with the Office for Human Research Protections, if available. If the applicant has a FWA number, enter the 8-digit number. Do not enter the 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 this 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/ElectronicReceipt/avoiding_errors.htm or http://grants.nih.gov/grants/ElectronicReceipt/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

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 are improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the application address the comparison of environmental chemical and biological agents in green vs. comparison, multi-family and low-income housing? Does the application document differences in the health of the residents of these homes? Does the application assess the economic impacts of “greening” as it relates to health?

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 applicant demonstrate established relationships with study participants and partnerships with local community groups? Will this applicant have access to a sufficient pool of study participants in control and green-renovated housing? Specifically, can the applicant demonstrate that: 1) the low-income multifamily housing complex (or collection of housing complexes) has a sufficient number of children (ages 7-12) and 2) the asthma prevalence for children in this city/metropolitan area is high enough that the pool of participants would be large enough to reach the sample size requirements of this FOA (i.e., n= 32 green-renovated and n=32 control homes)? Does that applicant have a proven track record of research in low-income multi-family housing? Can the applicant demonstrate established relationships with: 1) key stakeholders (e.g., housing authority management, landlords, tenants organizations) at the housing complex(es) that could contribute to a pool of study participants outlined in this FOA and 2) local community groups in order to report study results back to the study participants and to the general communities of their respective metropolitan areas.

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are there plans for 1)…