dd-13-002 foa final 12.11.12.docx

Table of Contents

Part 1. Overview Information

Division of Human Development and Disability (DHDD)

Funding Opportunity Announcement Type

New

Key Dates Publication Date

To receive notification of any changes to RFA-DD-13-002, return to the synopsis page of this announcement at www.grants.gov and click on the “Send Me Change Notification Emails” link An email address is needed for this service.

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 25 pages.

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

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

“Apply Electronically” at www.grants.gov.

Executive Summary

· The purpose of this project is to systematically evaluate agreement between the treatments and services currently provided to people who have Duchenne muscular dystrophy (DMD) and the recommendations documented in the DMD Care Considerations. The evaluation will focus on a limited geographic area but the design and results of the study should apply to other geographic areas.

· Mechanism of Support. This funding opportunity will use the cooperative agreement funding mechanism (CDC U-01).

· Funds Available and Anticipated Number of Awards. Total funding available for this cooperative agreement is expected to be $550,000 over the three year project period. It is anticipated that one award will be made to a single recipient for up to $150,000 in FY 2013. The award issued under this FOA is contingent upon availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of the award may also vary. The total amount awarded will depend upon the number, quality, duration and cost of the applications received.

· Budget and Project Period. The estimated total funding (direct and indirect) for the first year (12 month budget period) is $150,000 and the estimated total funding (direct and indirect) for the entire project period will be $550,000. The project period will run from September 30, 2013 to September 29, 2016.

· 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. Applications may contain more than one PI, however, the first PI listed will be the “contact PI” for all correspondence.

· Number of Applications. Only one application per institution (normally identified by having a unique DUNS Number) is allowed.

· Application Type. New (Type 1)

· 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 This program is authorized under Section 301(a) and 317C of the Public Health Service Act, [42 U.S.C. Section 241(a)).and 247-4], as amended.

1. Background and Purpose Duchenne muscular dystrophy (DMD) is a rare disorder with early childhood onset that results in progressive, irreversible muscle weakness which eventually affects other systems and organs. It is the most common form of muscular dystrophy in children with an estimated 1 in 3,500 to 1 in 6,000 affected, most of them male. The recommended optimal health care management for DMD consists of a multidisciplinary team approach designed to improve, maintain, and support muscle strength and function, and to prevent or treat spinal deformity, respiratory complications and cardiomyopathy. Additional specialty care is needed in genetics, gastroenterology, nutrition, physical, occupational, and speech therapy, and psychology.

In 2001, Congress authorized funds to support research and education on muscular dystrophy through the Muscular Dystrophy Community Assistance Research and Education Amendments of 2001, (MD-CARE Act). In response to this Act and the 2008 reauthorization, the Centers for Disease Control and Prevention (CDC), National Center on Birth Defects and Developmental Disabilities (NCBDDD) supported the development of comprehensive care considerations to help guide clinical management of DMD (Lancet Neurology 2010;9(1):77-93 and 9(2):177-189). These recommendations set as priorities the standardization of health care and the improvement of health outcomes for individuals with DMD. The DMD Care Considerations provide a framework for a coordinated multisystem approach for treating primary manifestations and secondary complications of the disorder. The next step is to evaluate whether the current delivery of treatment and services to people affected by DMD is occurring according to the recommendations outlined in the DMD Care Considerations. Such evaluation will serve to highlight potential gaps between actual and recommended standards of care and to identify barriers with the delivery of treatments and services. A project that brings together a network of leading care centers to evaluate these DMD Care Considerations is under way in Europe (http://en.care-nmd.eu/). The Lancet’s articles previously cited are available in this website.

The purpose of this project is therefore to systematically evaluate agreement between treatments and services actually provided to people who have Duchenne muscular dystrophy (DMD) and the recommendations documented in the DMD Care Considerations. The evaluation will focus on a limited geographic area (such as one or more states or a large health system) but the design and results of the study are expected to apply, at least partially, to other geographic areas.

Healthy People 2020 and other National strategic priorities

1. Improve access to comprehensive, quality health care services.

AHS-6: Reduce the proportion of individuals who are unable to obtain or delay in obtaining necessary medical care, dental care, or prescription medicines

2. Promote the health and well-being of people with disabilities.

DH-4: (Developmental) Reduce the proportion of people with disabilities who report delays in receiving primary and periodic preventive care due to specific barriers

3. Priorities of the Division of Human Development and Disability

· Improve developmental outcomes of children.

· Reduce disparities in health care access for people with disabilities.

Public Health Impact The range of treatments and health care services available to people with DMD has been greatly expanded in recent years. These treatments and services are aimed at preserving muscle function and preventing or delaying major complications of the disease, which has no cure. The recently issued DMD Care Considerations have summarized this range of treatments and services and have proposed a strategy for their delivery. However, the extent of the adoption of these recommendations by specialized health care providers is unknown. This project has the potential of having a major public health impact by evaluating the uptake of these care considerations and identifying barriers that may prevent the delivery of recommended health care to people with DMD. This project will be restricted to a specific region of the USA but the findings may be applicable to other areas of the country. The dissemination of the results of this project will inform health care providers dedicated to DMD of the potential disagreement between actual and recommended care and of potential solutions for reducing it.

2. Approach Research Objectives/Outcomes

1. To assemble a tool or questionnaire to collect data on the delivery of health care services and treatments to people with DMD. The objective is to know if the care provided by muscular dystrophy clinics in the USA follows (intentionally or not) current recommendations. The applicant should be familiar with a similar effort from Europe (http://en.care-nmd.eu/) and should aim at using a methodology that, although specific to the needs of this project, can be compared to the European study. The articles are available here: http://www.treat-nmd.eu/care/dmd/diagnosis-management-DMD/. This is an evaluation; so, the methods could be semi-quantitative. The applicant will have to identify the geographic area and the clinics available in this area to develop the specific methodology.

Target population: clinics that provide health care services to children, adolescents and young adults affected with DMD within a large defined geographic area (one or more states) or as part of a large but well-defined health care system.

Collaboration/Partnerships: the applicant is expected to utilize existing or establish new partnerships and collaborate with clinics caring for people with DMD. Letters of support are required.

Evaluation/Performance measurement: the applicant is expected to perform an evaluation on the agreement between current recommendations and actual treatment provided by clinics caring for DMD patients. This evaluation should include: 1) A complete list of the elements of DMD care that will be evaluated; 2) which performance indicators will be applied to the clinics; 3) criteria to determine agreement between the actual treatment provided by the clinics and current recommendations; 4) a definition of what is considered best practice for DMD clinics; 5) a list of barriers preventing clinics from following current recommendations; 6) recommendations to improve quality of care to DMD patients in clinics in poor agreement with current standards; 7) how the effectiveness in the application of current recommendations by DMD clinics will be assessed.

Translation plan: the applicant is expected to write a final report to CDC documenting the methodology, results, conclusions and recommendations emanating from this project. The applicant is also expected to prepare and publish at least two reports with the methodology and major findings of this study in peer-reviewed journals.

Section II. Award Information

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

Application Types Allowed

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

Funds Available and Anticipated Number of Awards

Total estimated funding (direct and indirect costs) for the first year (12 month budget period) up to $150,000. Estimated total funding for the entire project $550,000.

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

Applications with budget requests greater than the ceiling will be considered non-responsive and will not be reviewed.

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.

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

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

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

3. Responsiveness: If your application is incomplete, it will not enter into the review process.

Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.

4. 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.

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.

5. 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 subaward under the grant unless the organization has provided its DUNS number to the grantee organization.

6. 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.

7. 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).

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

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 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:

Natalie J. Darling, MPH National Center for Chronic Disease and Health Promotion Extramural Research Program Office Centers for Disease Control and Prevention 4770 Buford Highway, NE M/S F-46 Atlanta, GA 30341 Telephone: (770) 488-5740 Email: ndarling@cdc.gov

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

5. PHS 398 Research Plan Component The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of 16 components. Not all 16 components of the Research Plan apply to all Funding Opportunity Announcements (FOAs). Specifically, some of the following 16 components are for Resubmissions or Revisions only. See Part I, Section 5.5 of the SF 424 (R&R) Application Guide (http://grants.nih.gov/grants/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. Vertebrate Animals

11. Select Agent Research

12. Multiple PD/PI Leadership Plan.

13. Consortium/Contractual Arrangements

14. Letters of Support

15. Resource Sharing Plan(s)

16. Appendix

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

All instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerB.pdf) must be followed along with any additional instructions provided in the FOA.

Research Plan The applicant’s research plan should address activities that will be conducted over the entire 3 year project period and should include the following items:

· Describe the clinics specializing in DMD care that will be involved in this project and the set of services they provide to DMD patients.

· Describe the chosen geographic area where the study will be performed and provide an explanation on why the results from this area may be generalizable or applicable to other geographic areas within the USA.

· Describe approach that’s being used or planned to identify and contact appropriate partners such as university medical centers, non-profit organizations including patient advocacy groups, health systems, professional organizations and other agencies or organizations relevant to the study to request their cooperation for this project. Include any letters of support from participating clinics and other study partners which outline their participation, role, and any commitment to access to clinic sites or data in the appendix.

· Describe strategy for case finding and case definition.

· Describe the health outcomes that will be considered to evaluate the implementation of current recommendations.

· Describe the planned approach to develop the data collection instrument(s) that will be used to evaluate health care treatments and services.

· Describe the approach to the collection, management, protection, quality control, and analysis of the data.

· Describe plan to evaluate the agreement between treatment provided by the participating clinics and care recommended in the DMD Care Considerations; for each clinic, assess the adoption of these recommendations and highlight gaps between actual and recommended care; identify barriers interfering with the delivery of recommended care and suggest strategies to overcome these barriers; identify health outcomes that might be affected by the lack of agreement between actual and recommended care; discuss potential weaknesses of the proposed research approach and discuss how these weaknesses will be addressed.

· Describe plan to compare results with similar results being carried out in Europe (http://en.care-nmd.eu/). The European project is conducting an evaluation of the same care considerations and the comparison will be informative for both projects.

· Provide distinguishable benchmarks for monitoring the progress of the project.

· Describe the experience and expertise of the project team, outlining key roles and time commitments.

· Provide detailed timeframe and the execution of the project.

· Provide plan to report and publish the results of this project and to issue recommendations applicable to DMD clinics from other regions.

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

7.Page Limitations All page limitations described in this individual FOA must be followed. For this specific FOA, the Research Strategy component of the Research Plan narrative is limited to 25 pages.

Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 35 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).

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

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

1. 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.

1. 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) This initiative is not subject to intergovernmental review (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11142).

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.

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 Central Contractor Registration (CCR). 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 be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

What is the potential or actual impact of this research on the health of the population living with DMD?

If successful, do the research results have the potential to be scalable to a larger proportion of the clinics caring for the population affected by this condition?

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?

Do they have a track record of working with clinics specialized in rare disorders, DMD in particular?

Do they have ample expertise and experience in conducting evaluations? Does it show in their publication record?

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 have the potential to improve the clinical care of people affected with DMD?

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) 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?

Is the geographic area selected well delimited? Does this area include a sufficient number of MD clinics as required by the methodology? Have these MD clinics offered their support for the study?

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?

Does the project utilize critical partnerships or collaborations? Does the project support key stakeholder involvement throughout the research process?

2. 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.

Protections for Human Subjects If the research 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 (http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar1).

If your proposed research involves the use of human data and/or biological specimens, you must provide a justification for your claim that no human subjects are involved in the Protection of Human Subjects section of the Research Plan.

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 policy on the Inclusion of Women and Racial and Ethnic Minorities in Research (http://www.cdc.gov/OD/foia/policies/inclusio.htm) and the policy on the Inclusion of Persons Under21 in Research (http://aops-mas-iis.cdc.gov/Policy/Doc/policy496.pdf).

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 (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11150).

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.

3. Additional Review Considerations As applicable for the project proposed, reviewers will…