eh12-001 foa final 12.19.11.doc

Table of Contents

Part 1. Overview Information Part 2. Full Text of the Announcement 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

Announcement Type

New

Key Dates Publication Date

December 19, 2011TBDDed

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 or in a Notice from the NIH Guide for Grants and Contracts). 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 Part 2. Full Text

Section I. Funding Opportunity Description Statutory Authority

Awards are made under the authorization of Sections 317(k)(2) of the Public Health Service Act (42 U.S.C. Section 247b(k)(2)), as amended.

Background

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. In addition, this study 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 2010 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 asthma education were compared to those who had 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.

The proposed study will address several of the research gaps that were mentioned above. The study participants are children with asthma (age 7-12 years).

Eligible households will include children with doctor-diagnosed asthma (ages 7-12 years) (n=32) and their mothers living in HUD-subsidized housing that either received a green renovation (i.e., green intervention) or living in HUD-subsidized housing that received a renovation comprised of only Energy Star appliances or low-flow-toilets, or no renovation at all (i.e., control). Only one child with asthma (ages 7-12 years) is eligible per household. All eligible households must have had environmental and biological measurements taken within four months of renovation (or a be a control home linked to a renovated home). This is referred to as the “Baseline measurement” 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 ever told by a physician that they have asthma and has experienced asthma-related symptoms (wheezing, slow play or night awakening) during the past 6 months.

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 and also regarding their health.

3. Green homes will be renovated using low VOC materials and integrated pest management (IPM) principles.

4. 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 primary objective of this study is to collect and evaluate the data that will allow CDC and Housing and Urban Development (HUD) to identify housing factors that are energy efficient and have the potential to improve and prevent the negative health outcomes of low income children with asthma, 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 “Mark-to-Market” (M2M), 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, 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/work days) of children with doctor-diagnosed asthma (ages 7-12 years). CDC/applicant 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 intervals of 6 and 12 months after baseline measurements as described by the study protocol that is provided by CDC Green Housing Study staff. The baseline measurement will have already been obtained, so the only new data collection is the 6 and 12-month post renovation measurements. 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

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

$375,000 for two awards

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 be conditional on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the 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 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:

· University of Cincinnati (Public Higher Education)

· Harvard University, School of Public Health (Private Higher Education) Academic institutions, specifically, The University of Cincinnati (public higher education) and Harvard University, School of Public Health (private higher education) located in the Cincinnati, Ohio and Boston, Massachusetts metropolitan areas, respectively have already collected baseline measurements of the exposures and respiratory outcomes from the children recruited for The Green Housing Study (GHS). In addition, these two universities have established relationships with study participants, 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 Cincinnati and Boston. Both of these institutions were recipients of a contract/task order, titled Green Housing Study that was a precursor to this FOA development. The contract number and task order are as follows: Contract #200-2010-37369; Task Order #0003. These institutions have 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 communities living in communities where the GHS has collected baseline data. These institutions are uniquely qualified to undertake the research based upon data previously collected and knowledge of and confirmed access to the study populations in Cincinnati, OH and Boston, MA.

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.

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are not allowed.

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.

· Central Contractor Registration (CCR) – must maintain current registration in CCR.

· Grants.gov

· eRA Commons

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.

Central Contractor Registration and Universal Identifier Requirements

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 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 Central Contractor Registry (CCR) and 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. CCR 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 CCR internet site at www.ccr.gov.

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.

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 established relationships with Green Housing study participants located in the Cincinnati, Ohio and Boston, Massachusetts metropolitan areas, 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 Cincinnati and Boston. These capabilities are necessary to collect data and maintain follow-up of the study participants.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

2. Cost Sharing This FOA does not require cost sharing as defined in the HHS Grants Policy Statement.

3. Other Additional Information on Eligibility Number of Applications

Applicant organizations may not submit more than one application.

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. HHS/CDC will not accept any application that is essentially the same as one already reviewed.

Academic institutions located in the Cincinnati, Ohio and Boston, Massachusetts metropolitan areas must have 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 communities living in communities where the Green Housing Study has collected baseline data.

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 for further instruction. CDC Telecommunications for the hearing impaired or disable is available at: TTY 1-888-232-6348.

If the applicant encounters technical difficulties with Grants.gov, the applicant should contact Grants.gov Customer Service. The Grants.gov Contact Center is available 24 hours a day, 7 days a week, with the exception of all Federal Holidays. The Contact Center provides customer service to the applicant community. The extended hours will provide applicants support around the clock, ensuring the best possible customer service is received any time it is needed. You can reach the Grants.gov Support Center at 1-800-518-4726 or by email at support@grants.gov. Submissions sent by email, fax, CD’s or thumb drives of applications will not be accepted.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, 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.

Letter of Intent Not applicable 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.

Page Limitations

All page limitations described in this individual FOA must be followed. For this FOA, the Research Strategy section is limited to 15 pages.

Research Plan Components All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

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.

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 mite (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 that children with asthma (ages 7-12 years) in green housing will have lower asthma morbidity, adjusting for environmental tobacco smoke (ETS) exposure.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide, with the following modifications:

Up to 3 publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to the proposed project. Do not include manuscripts submitted for publication. Applicants should refer to instruction guides and specific Funding Opportunity Announcements (FOAs) to determine the appropriate limit on the number of publications that may be submitted for a particular program. Note that not all grant activity codes allow the inclusion of publications.

· Publications in press: Include only a publication list with a link to the publicly available on-line journal article or the NIH Pub Med Central (PMC) submission identification number. Do not include the entire article.

· Manuscripts accepted for publication but not yet published: The entire article may be submitted electronically as a PDF attachment.

· Manuscripts published but a publicly available online journal link is not available: The entire article may be submitted electronically as a PDF attachment.

· Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents..

3. 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, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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

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 and 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 PGO TIMS for guidance at least 3 calendar days before the deadline date.

4. Intergovernmental Review (E.O. 12372) This initiative is not subject to intergovernmental review.

5. Funding Restrictions All HHS/CDC awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Pre-award costs are not allowable.

6. Other Submission Requirements

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.

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 Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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, 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 be 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 in either Cincinnati, OH or Boston, MA?

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? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area in order to expand to other areas?

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 the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Does the applicant demonstrate use of the data previously collected (by the applicant) and has knowledge of and confirmed access to the study populations in either Cincinnati, OH or Boston, MA?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

· The relevance and balance of proposed research relative to the HHS/CDC/NCEH programs and priorities.

· Consideration for funding to achieve geographic specificity, specifically in the cities of Cincinnati, OH and Boston, MA

· Availability of funds.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the HHS/CDC Requirements under AR-1 Human Subjects Requirements.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Inclusion of Women and Racial and Ethnic Minorities in Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Renewals For Renewals (formerly called competing continuation applications), the committee will consider the progress made in the last funding period.

Revisions Revisions (formerly called competing supplement applications), are a request for an increase in support in a current budget period for expansion of the scope of the approved project or program or to meet an unforeseen increase in costs. The request may specify budgetary changes required for the remainder of the project period as well as for the current budget period. Supplemental applications requesting a programmatic expansion (change in scope) must undergo objective review and generally are required to compete for support; requests for administrative supplements may be awarded without objective review or competition.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Resource Sharing Plans

HHS/CDC policy requires that recipients of grant awards make unique research resources and data readily available for research purposes to qualified individuals within the scientific community after publication. Please see:

http://www.cdc.gov/od/foia/policies/sharing.htm. Investigators responding to this funding opportunity should include a plan on sharing research resources and data.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process Applications will be evaluated for scientific and technical merit by an appropriate peer review group, in accordance with CDC peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications will all applications will be discussed (no streamlining of applications):

· Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review), will be discussed and assigned an overall impact/priority score.

· Receive a written critique.

Applications will be assigned to the appropriate HHS/CDC Center, Institute, or Office. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review. The following will be considered in making funding decisions:

· Scientific and technical merit of the proposed project as determined by scientific peer review.

· Availability of funds.

· Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the HHS Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices Any applications awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements. If the application is under consideration for funding, HHS/CDC will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. Pre-award costs are not allowable. Expanded authority will be granted to successful applicant.

2. Administrative and National Policy Requirements All HHS/CDC grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA. For these terms of award, see the HHS Grants Policy Statement Part II: Terms and Conditions of Award, Overview of Terms and Conditions of Award and Requirements for Specific Types of Grants. Additional requirements are available at the following internet address: http://www.cdc.gov/od/pgo/funding/Addtl_Reqmnts.htm.

Federal Citations

Human Subjects Protection:

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar1 SF424: Part III, Section 2.1 Data and Safety Monitoring Plan:

http://grants.nih.gov/grants/guide/notice-files/not98-084.html

SF424: Part II, Section 4.1.5 Sharing Research Data:

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar25 SF424: Part III, Section 4.5 Inclusion of Women and Racial and Ethnic Minorities in Research: http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar2 SF424: Part II, Section 4.2 Inclusion of Persons Under the Age of 21 in Research: http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar28 SF424: Part II, Section 4.4 Publications:

HHS Grants Policy Statement (Intellectual Property-Rights in Data & Publications) Health Insurance Portability and Accountability Act Requirements:

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar24 SF424: Part III, Section 4.2 URLs in HHS/CDC Grant Applications or Appendices:

SF424: Part I, Section 4.2 Healthy People 2020:

http://www.healthypeople.gov

Authority and Regulations:

HHS Grants Policy Statement (AR-11)

Smoke-Free Workplace:

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar10 Public Law 103-227

Pro-Children Act of 1994.

SF424: Part III, Section 2.11

HIV/AIDS Confidentiality Provisions http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar4 HIV Program Review Panel http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar5 Patient Care http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar6 Executive Order 12372 Review http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar7 Public Health System Reporting http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar8 Paperwork Reduction Act http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar9 Lobbying Restrictions http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar12 Prohibition of Use of CDC Funds for Certain Gun Control Activities http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar13 Accounting System Requirements http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar14 Proof of Non-profit Status http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar15 Security Clearance http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar16 Peer and Technical Reviews of Final Reports of Health Studies – HHS/ATSDR http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar17 Cost Recovery – HHS/ATSDR http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar18 Third Party Agreements – HHS/ATSDR http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar19 Small, Minority and Women-owned Business http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar21 Research Integrity http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar22 Compliance with Executive Order 13279 http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar23 National Historic Preservation Act of 1966 (Public Law 89-665, 80 Stat. 915) http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar26 Conference Disclaimer and Use of Logos http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar27 Compliance with Section 508 of the Rehabilitation Act of 1973 http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar30 Research Definition http://aops-mas-iis.cdc.gov/Policy/Doc/policy557.pdf (AR-31) Compliance with EO13513, “Federal Leadership on Reducing Text Messaging while Driving”, October 1, 2009 http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar29 Conference Support http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar20 Other

For additional information on this reporting requirement, visit the CDC website at: http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm Cooperative Agreement Terms and Conditions of Award The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and CDC grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial CDC programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the HHS/CDC purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and HHS/CDC as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

· Identify and employ/assign at a minimum for each site: 0.4 full-time equivalent (FTE) study coordinator (e.g., this does not necessarily need to be one person), 1 FTE study technicians, and 0.1 FTE senior scientist to perform activities identified in the protocol.

· Study technicians must have some college background or have experience in research studies that required home visits, must have access to campus and laboratory buildings on the campus of selected institution, and must be available during evenings and weekends. Field teams that have contact with study participants should have at least one member with fluency in the predominant languages of potential study participants. In Boston, these languages are Chinese and Spanish; in Cincinnati, this is to be determined.

· Follow up with 64 households (32 interventions, 32 controls) that have had baseline environmental and biological measurements taken according to the Green Housing Study Protocol from each study site.

· Collect environmental and biological data outlined in tables 2 and 3 below from homes and from enrolled residents at intervals of 6 and 12 months after baseline measurements as described by the study protocol that is provided by CDC Green Housing Study staff (see attached). This item requires local travel within each study site. The baseline measurement will have already been obtained, so the only new data collection is the 6- and 12-month post renovation measurements.

· Collect throat and nasal swabs performed by a participating parent, collect an additional nasal and throat swab performed by a study technician and related information from children with doctor-diagnosed asthma that have had symptoms of flu.

· Follow up with participating household with phone calls at intervals of 3 and 9 months after baseline measurements have been taken

· Send samples to designated laboratories (CDC will provide list) for testing

· Organize a community meeting at the end of the study to disseminate results to community members, stakeholders and participants

· Maintain up-to-date approval from study-site’s Institutional Review Board (IRB) or ensure that the Reliance upon CDC’s IRB is up-to-date.

Table 2. Summary of clinical measurements

(Age 7-12)

Urine

Baseline*

6 months Post-renovation

12 months Post-renovation

Pulmonary Function Test

Baseline)*

Exhaled Nitric Oxide

Baseline*

Respiratory Symptoms Questionnaire

Baseline*

* The baseline measurement will have already been obtained by the applicant, so the only new data collection is the 6- and 12-month post renovation measurements.

· Grantee will be required to collect the following environmental assessments from each participating household at each indicated time point:

Table 3. Summary of environmental measurements in homes*

12 months Post-renovation

* The baseline measurement will have already been obtained by the applicant, so the only new data collection is the 6- and 12-month post renovation measurements.

· Grantee will investigate the availability, and collect when available, information on the heating, cooling and maintaining the households participating in the study

· Required data elements to be collected by local study site researchers include:

· Questionnaires (including those with study ID #s and address, but not name and phone numbers)

· Environmental sampling log sheets, measurements (raw and cleaned datasets, requisite internal calculations such as VOC concentrations in µg/m3 and…