dd11-006 foa final 12.16.10.doc

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Department of Health and Human Services

Part 1. Overview Information

For other OpDivs add the relevant components (centers/offices) at the end of the list, following the same format.

National Center on Birth Defects and Developmental Disabilities (NCBDDD)

U01 Research Project Cooperative Agreements

Some activity codes may need prior approval or may have limited use, and CIO may or may not have authority for each activity code. Add the relevant activity code, if not listed above. Please see the Activity Codes, Organizational Codes, and Definitions Used in Extramural Programs for more information.

Announcement Type

New Keep relevant text; enter previous FOA Number if a reissuance

Delete the non-relevant choices (RFA/PA. Fill in Fiscal Year (FY). For a CIO RFA, insert the RFA number for NNN. Leave the FOA number as NNN and it will be assigned by PGO staff.

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Health

Key Dates Publication Date

December 16, 2010 PGO will add this information when posted. This field is not available for CIO edit.

The Letter of Intent due date must be at least one month (assume 30 days in one month) before application due date, and generally at least one month after posting date. If not applicable, replace “Month Day, Year” with “Not Applicable”

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 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).

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Rarely applicable See THIS IS ONLY USED WHEN STATE HEALTH DEPARTMENTS ARE INVOLVED for details.

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.

Insert as applicable and include the page limits:

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.

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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 2. Full Text of Announcement Section I. Funding Opportunity Description

Recommended length: 1-5 pages. Present the purpose of the funding opportunity in paragraph form, addressing all of the items below. Please keep in mind that readers will appreciate clarity and brevity. The following headers may be useful in preparing this section:

Purpose/Research objectives (describe the nature and need of the research opportunity)

Specific Areas of Research Interest (include examples of research topics. In such cases, add a statement indicating that appropriate topics “include but are not limited to those listed below.”

This section may also address scientific knowledge to be achieved through research supported by the special program and types of research and experimental approaches that are being sought to achieve the objectives.

In this section Use the following headings and add text below The CDC and NCBDDD are committed to achieving the health promotion and disease prevention objectives of "Healthy People 2020". This RFA addresses a “Healthy People 2020” priority area of Disability and Secondary Conditions. This FOA particularly addresses objectives 6-6 (accessibility of health and wellness programs) and 6-12 (surveillance and health promotion programs) www.healthypeople.gov/hp2020 .

The goals and objectives of this funding opportunity announcement (FOA) are consistent with the missions of NCBDDD and DHDD to prevent morbidity and mortality caused by birth defects, genetic diseases, and developmental disabilities and to promote optimal development, health, and well-being of children and people of all ages with disabilities. Add Priority Area(s) Here.

Nature of the Research Opportunity This is the purpose of the FOA The Muscular Dystrophy Surveillance, Tracking, and Research Network (MD STARnet) identifies and tracks the health of patients with Duchenne/Becker muscular dystrophy (DBMD) in six sites (Arizona, Colorado, Georgia, Hawaii, Iowa, and Western New York State). This FOA is soliciting applications to characterize the population of individuals who have a variety of types of muscular dystrophies through modification and expansion of MD STARnet. This FOA will assess the feasibility of utilizing the existing infrastructure for collecting data for DBMD to expand to population-based surveillance for other types of muscular dystrophy (Myotonic, Congenital, Limb-Girdle, Emery-Dreifuss, Facioscapulohumeral, Distal, and Oculopharyngeal).

Background This is the story so far Duchenne muscular dystrophy (DMD) is an X-linked disease of progressive muscle weakness that becomes symptomatic in childhood and affects approximately 1/3,500 males. Becker muscular dystrophy (BMD) is milder than DMD. Both DMD and BMD are caused by mutations within the same gene and are thus collectively referred to as DBMD. DBMD has been studied in clinic-based populations. However, population-based studies were needed to more accurately describe the prevalence, natural history, and the type of care received by individuals with DBMD. The MD Care Act of 2001 authorized CDC to award grants and cooperative agreements to public or nonprofit private entities for the collection, analysis, and reporting of data on Duchenne and other forms of muscular dystrophy. In 2002, a surveillance system called the Muscular Dystrophy Surveillance, Tracking, and Research Network (MD STARnet) was established in Arizona, Colorado, Iowa, and Western New York State (program announcement 02172) to identify and track the healthcare of all cases of DBMD residing in these areas. In 2006, MD STARnet was continued through a subsequent announcement (RFA DD-06-002); expanded to include Georgia in 2005 (conducted by NCBDDD and the Georgia Division of Public Health); and expanded to include Hawaii in 2008 (RFA DD-08-002). Surveillance data were primarily collected through medical records of patients and through vital records. These data were supplemented through interviews and surveys of caregivers and adult individuals with DBMD. The original objectives of MD STARnet were to determine: 1) prevalence, 2) early signs and symptoms, 3) types of care received, 4) factors that affect outcome, and 5) needs of patients and families with DBMD. Achieving a better understanding of these issues through population-based surveillance and research informs public health activities designed to improve the lives of individuals affected by DBMD.

Scientific Knowledge to be Achieved through this Funding Opportunity

1) Big goals/vision

1) Based on the longitudinal surveillance and research dataset of DBMD, scientific knowledge will include factors that affect:

a. Outcome and survival,

b. Needs,

c. Quality of life, and

d. Adolescent to adult transition in health care and other life stage issues of individuals with DBMD and their families.

2) For patients with any of the seven additional muscular dystrophies, knowledge will be enhanced on preliminarily assessments of:

a. Prevalence,

b. Demographics,

c. Healthcare coverage and

d. Locations of care.

3) A summary report collaboratively developed across sites will describe and assess methods for conducting population-based surveillance for muscular dystrophies. This report will include:

a. Strengths,

b. Challenges,

c. Costs, and

d. Recommend methods for muscular dystrophy and other rare disease surveillance programs.

Research Objectives and Approach Key steps to achieve purpose - details/framework of what we want them to explain to us in Other Submission Requirements/how they will accomplish this This FOA will provide support to conduct population-based surveillance of nine MDs (Duchenne, Becker, Myotonic, Congenital, Limb-Girdle, Emery-Dreifuss, Facioscapulohumeral, Distal, and Oculopharyngeal) to determine prevalence, demographics, healthcare coverage, and types of clinics where patients receive care. A reduced number of clinical variables will continue to be collected for DBMD. Surveillance efforts for this activity will use MD STARnet as an infrastructure with modified case ascertainment and data collection methods. Sites will collaborate to provide a summary report on the methods used to conduct surveillance for the nine muscular dystrophies. This cooperative agreement will support research efforts to better understand healthcare transition and other life stage issues for people who have DBMD, and ongoing analysis and dissemination of DBMD data collected previously.

The FOA has two components. Component A consists of the core activities - on designing and collecting data on nine muscular dystrophies. Component B consists of four enhanced activities that support ongoing MD STARnet data collection. In addition to applying for Component A, applicants can also submit a separate application for one or more of the four enhanced activities: (1. Data Coordinating Center [DCC]; 2. Abstractor training and quality assurance/control activities; 3. National Coordinating Center; and 4. Georgia healthcare transitions interview).

Component A: Core:

Objective 1: Conduct population-based surveillance and research of Duchenne/Becker muscular dystrophy

1) Examine data utility and quality of the existing DBMD data set for public health practice. Participate with the other MD STARnet sites through a new or existing committee (e.g. Surveillance and Research) to examine data quality issues associated with data collection, management and analysis of current MD STARnet data for DBMD.

2) Provide information to CDC regarding site experiences with surveillance for DBMD as part of a CDC assessment of MD STARnet.

3) Refine the number of clinical data variables collected on individuals who have DBMD to include a maximum of 75-100 variables that yield reliable, relevant information that informs public health practice.

4) Conduct medical record abstraction of new and follow-up DBMD cases using the reduced number of variables during year 1 of the funding period.

5) Design and conduct an interview to determine healthcare transition and other life stage issues affecting individuals with DBMD and their families.

Objective 2: Design and implement population-based surveillance on seven additional muscular dystrophies (Myotonic, Congenital, Limb-Girdle, Emery-Dreifuss, Facioscapulohumeral, Distal, and Oculopharyngeal)

1) Through assessment of the existing MD STARnet system, modify or develop:

a) Protocols for ascertaining cases,

b) Case definitions,

c) Data collection instruments to collect information on prevalence, demographics, healthcare coverage, and locations of care.

d) Comprehensive quality control procedures to address data quality issues associated with data collection, management and analysis.

2) Develop or maintain partnerships with local clinics and stakeholders

3) Conduct medical record abstraction for the seven additional muscular dystrophies once during years 2 and 3 of the funding period.

Objective 3: Assess the methodology for conducting population-based surveillance for the nine muscular dystrophies (2011-2014)

1) Under the leadership of the national coordinating center, collaborate with other sites to produce a summary report assessing the expansion of surveillance to other muscular dystrophies. The summary should include:

a) Methods used,

b) Lessons learned,

c) Strengths,

d) Challenges,

e) Costs,

f) Barriers, and

g) Recommendations for conducting muscular dystrophy and rare disease surveillance programs.

Objective 4: Analyze data, publish articles, and disseminate reports using information collected on MD STARnet from 2002-2011

1) Each site will propose and lead a minimum of three manuscripts; extensively collaborate on three other manuscripts.

2) Participate in at least one PI meeting per year in Atlanta, Georgia for the opportunity for investigators to present study findings.

Timeline

1) Consider the following timeline for the proposed project:

a) Year 1:

i) Assess data utility and quality of current MD STARnet database for DBMD

ii) Reduce data collection on DBMD to a maximum of 75-100 variables that yield reliable, relevant information that informs public health practice

iii) Abstract records of cases of DBMD using the reduced number of variables

iv) Modify MD STARnet methods to prepare for conducting surveillance on seven additional muscular dystrophies

v) Build and maintain partnerships with clinics and other local and state stakeholders

vi) Train abstractors and other staff on modified methods

vii) Develop and pilot interview to assess healthcare transitions and other life stage issues for DBMD

b) Year 2:

i) Start data collection for 7 other MDs

ii) Stop data collection for DBMD

iii) Conduct ongoing assessment of expanded surveillance and revise methods accordingly

iv) Conduct healthcare transitions interview

c) Year 3:

i) Continue data collection for 7 other MDs (cases will only be abstracted once during years 2 and 3)

ii) Finalize data collection and produce a pooled data set for the 7 other MDs

iii) Collaborate with other sites on report describing surveillance for MDs and rare disorders Component B: Enhanced Activities:

In addition to the above core activities, sites can apply and receive funding to conduct one or more of the following activities for MD STARnet:

1) Data Coordinating Center (DCC): The responsibilities of this site will include managing the data collected and pooled from each site, developing and maintaining databases, and providing technical assistance to sites.

2) Abstractor training and quality assurance/control activities: The responsibilities of this site will include planning, implementing, and overseeing new and follow-up abstractor training and quality activities for all sites.

3) National coordinating center: The responsibilities of this site will be to employ a national coordinator who will plan and organize conference calls and in-person meetings, take meeting minutes, lead the production of the MD surveillance summary report, and coordinate other activities among sites.

4) Georgia healthcare transitions interview: The responsibilities of this site will be to conduct the healthcare transitions interview for the Georgia site.

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

Choose one of the following:.

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

Indicate the total funds available for the entire program. Sometimes this area is complicated if multiple types of awards are awarded Component A – Up to 5 sites will be awarded approximately $450,000 for the first 12 month period.

Component B: Sites applying for Component A can submit a separate application for one or more of the following 4 enhanced activities:

1) One site will be awarded approximately $250,000 to fund the Data coordinating center (DCC);

2) One site will be awarded approximately $75,000 to fund the Abstractor training and quality assurance/control activities;

3) One site will be awarded approximately $100,000 to fund the National coordinating center ; and

4) One site will be awarded approximately $50,000 to fund the Georgia healthcare transitions interview.

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

INSERT maximum $ amount; amount that you will not exceed OR INSERT "None." This ceiling is for the first 12-month budget period. Indicate if this is direct cost only or total cost, which would include indirect costs. The ceiling of the award for Component A will be $450,000 (including direct and indirect costs) for the first year.

The ceiling of the award (including direct and indirect costs) for Component B:

1) Data coordinating center (DCC) will be $250,000will be $550,000 (including direct and indirect costs) for the first year will be $550,000 (including direct and indirect costs) for the first year will be $550,000 (including direct and indirect costs) for the first year;

2) Abstractor training and quality assurance/control activities will be $75,000;

3) National coordinating center will be $100,000; and

4) Georgia healthcare transitions interview will be $50,000.

INSERT any minimum $ amount, if you will not make an award smaller than a floor amount OR INSERT "None."

Component B:

1) Data coordinating center (DCC) will be for 3 yearswill be $550,000 (including direct and indirect costs) for the first year will be $550,000 (including direct and indirect costs) for the first year will be $550,000 (including direct and indirect costs) for the first year;

2) Abstractor training and quality assurance/control activities will be for 3 years;

3) National coordinating center will be for 3 years; and

4) Georgia healthcare transitions interview will be for 3 years.

If project period is more than five years, approval is required.

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

Are you doing open or limited competition? Justification letter is required if limited competition. Delete organizations that are not eligible to apply.

Only organizations operating as established MD STARnet sites under RFA DD-06-002 or DD-08-002 are eligible to submit an application under this FOA. These eligible sites include:

1. University of Arizona, College of Medicine,

2. Colorado Department of Public Health and Environment,

3. University of Iowa, College of Medicine,

4. New York State Department of Health, and

5. Hawaii Department of Health.

Existing MD STARnet sites have an established population-based Duchenne/Becker muscular dystrophy surveillance system utilizing a unique protocol and methods to collect longitudinal data on individuals with DBMD, and provide the basis for this expansion demonstration effort. Limiting eligibility to these sites enables the continuation of longitudinal data collection on over 700 individuals with DBMD and for efficient expansion of data collection to other muscular dystrophies.

If foreign organizations are eligible to apply, then delete the following sentence if foreign components are not allowed, delete “not” Add additional eligibility requirements here for institutions THIS WAS SECTION III, 1.A - WHERE WE COULD LIMIT ELIGIBILITY 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 be renewed annually

· 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.

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.

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.

Add additional eligibility requirements here for individuals.

2. Cost Sharing

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

THIS WAS SECTION III, 2

3. Additional Information on Eligibility Number of Applications

Applicants can submit only one application per institution (normally identified by having a unique DUNS Number) for Component A - core. Applicants can submit only one application each for each of the four enhanced activities under Component B.Applicant organization may submit more than one application, provided that each application is scientifically distinct. I AM CHANGING THE DEFAULT TO ONE APPLICATION ONLY. IF MULTIPE AWARDS (ENHANCED ACTIVITIES) THIS WILL NEED FURTHER MODIFICATION.

If the sentence above is not true, , CIO must insert a comment to change the sentence above to “Only one application per institution (normally identified by having a unique DUNS number) is allowed.”

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.

Add Information Here related to eligibility and number of applications.

THIS WAS PREVIOUSLY “Other-Special Eligibility cRITERIA”

For an applicant to even get considered they must be responsive to the information here. Our FOA responsiveness document is developed from these criteria.

Use words like: evidence of, access to, etc.

THIS LINE MUST BE INCLUDED IF YOU HAVE SPECIAL ELIGIBILITY REQUIREMENTS HERE

If your application is incomplete or non-responsive to the special requirements listed in this section, it will not enter into the review process.

Section IV. Application and Submission Information

1. Obtaining an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity from Grants.gov.

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 The only acceptable modifications to this section are those related to the staff contact information. Current policy does not allow any changes to the type of information requested in the Letter of Intent. If Letter of Intent is not applicable for this FOA, delete the heading above and the section below.

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 IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants for Component A Core - are asked to submit a letter of intent that includes the following information:

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

By the date listed in Part 1. Overview Information, prospective applicants for a Component B enhanced activity - should include the title of the activity (1. Data coordinating center (DCC); 2 Abstractor training and quality assurance/control activities; 3. National coordinating center, or 4. Georgia healthcare transitions interview) and the following information:

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:

Michael A. Brown ADD YOUR NAME Extramural Research Program Office

National Center for Chronic Disease Prevention and Health Promotion

Centers for Disease Control and Prevention

U.S. Department of Health and Human Services

4770 Buford Hwy, N.E., M/S K-92

Atlanta, GA 30341

Telephone: (770) 488-5118 ADD YOUR PHONE INFO Fax: (770) 488-8046

Email: mab5@cdc.gov

YOUR E-MAIL ADDRESS

FedEx address

Koger Center-Davidson Building

2858 Woodcock Blvd.

Atlanta, GA 30341 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 25 pages.

, insert text for page limits for the Research Strategy section of the application.

Use additional text to describe other exceptions to the page limits described in the Application Guide.

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

Add text in the space below (before Appendix) to supply any additional instructions related to the Research Plan, but only include information that is different from application guide.

Identify any special programmatic, performance or reporting requirements [e.g., ability to enroll a specified number of patients, special expertise or facilities required, requirements for coordination among investigators (e.g., annual meetings), etc.]. Applicants should be advised to include the cost for such items in the budget. Note: guidelines must be cleared by PGO.

THIS WAS PREVIOUSLY “OTHER SUBMISSION REQUIREMENTS.”

This is where you identify special programmatic, performance, or reporting requirements, etc. This is really where you tell them what you want them to do, and for them to respond to in their application.

Use action words like: a description of, demonstrate, describe, document, experience, identify, information on, plans, procedures, provide, report, etc.

The applicants’ research plan(s) should address activities they will conduct over the entire project period and must include the following core activity items:

Component A: Core:

Background:

1) Describe accomplishments of your program to date including a list of;

a) Publications and abstracts/presentations your site has led;

b) Another list of publications and abstracts/presentations in which your site has participated;

c) Other ways your site has contributed to improving MD STARnet.

2) Describe the existing cohort for DBMD in your site and provide a table which classifies cases found through each source of information (e. g. MDA clinic, hospital discharge data, children’s hospital etc.) stratified by case status (definite, probable, possible, asymptomatic, female). Some cases will be found in multiple sources. In your table, please show two rows for each source. The first row will show the total number of cases identified by the source. The second row will show the patients identified solely by that source. The columns will show cases classifications of case status. For an example, see Table 1 on page 259 in van Essen AJ et al Birth and population prevalence of Duchenne muscular dystrophy in the Netherlands Human Genetics 1992; 8:258-266.

3) Describe facilitators, deterrents, and barriers to using all the likely sources in your site for identifying cases.

4) Describe steps your site takes to locate cases that are lost to follow-up and facilitators and barriers to locating these cases.

5) Describe the methods you use to ascertain deaths among the cohort and facilitators and barriers to ascertaining deaths.

6) Describe existing collaborative relationships in your site that have helped to identify cases of DBMD and/or help disseminate findings to patients, families, and other stakeholders.

7) Describe the population of your site and estimate the number of expected cases for each type of MD based on prevalence estimates in published literature.

Description of Proposed Project:

1) Describe plans to collaborate with other sites and CDC in a committee assessing and reducing data variables collected for DBMD and modifying methods to expand surveillance to seven other MDs.

2) For children and adults with 7 other types of MD: develop a case definition for each muscular dystrophy that accepts a diagnosis as presented in the medical record; identify essential information to collect that enables determination of prevalence, healthcare coverage, locations of care, and additional data that will inform public health practice; define methods for case ascertainment and data gathering, including the likely sources to identify cases; describe anticipated deterrents or barriers to using these sources and strategies for overcoming these potential deterrents or barriers.

3) Describe plans to collect data and examine data quality issues for all 9 MDs (DBMD in year 1 and the 7 other MDs in year 2 and 3). These plans should describe participation in a new or existing committee comprised of representatives from all sites to modify or develop comprehensive data quality control procedures for the new muscular dystrophies. These procedures need to address data quality issues associated with data collection, management and analysis which will include a description of possible methods for handling missing data and for monitoring the system’s output. Plans should include a description of a cross-sectional data collection for the 7 additional MDs in which data is abstracted once during the 2nd and 3rd years of the funding period. Medical record abstraction will likely occur on records with patient visits after 2005.

4) Describe a plan to collaborate with stakeholders and appropriate partners (i.e. health care providers, community-based organizations, patient advocacy groups, academic medical centers and/or treatment centers specializing in neuromuscular diseases, and other organizations) to ensure complete case ascertainment for your site and to assist in disseminating findings to affected persons and their families. Describe the anticipated content and frequency of communication with each of these partners. Include letters of support from partners.

Staffing:

1) Demonstrate research capacity by describing staff expertise, including senior staff with a track record of conducting surveillance and research activities and authoring publications and junior staff being mentored.

2) Provide evidence of a clear management and staffing plan for both ongoing data collection and analysis of collected data.

3) Describe how project staff will participate in cross-site committees to support:

a) Coordination of MD STARnet activities,

b) Analysis and dissemination of data,

c) Assessment and modification of current methods for reduction of variables for DBMD and expansion to collecting data on other MDs. Ongoing data quality assessment

d) Transition issues interview development

4) Describe how staff will collaborate with the national coordinating center and other sites to write a report on conducting surveillance for all nine MDs during the FY11 – FY14 funding period. This report should describe lessons learned, including the strengths and weaknesses of MD STARnet and address how the MD STARnet model might be used for surveillance and tracking of other rare disorders. The national coordinating center will be responsible for leading the effort to produce this report. The report should:

a) Describe methods used to conduct surveillance and the associated costs,

b) Explain the challenges of conducting population-based surveillance a rare disorders, such as the muscular dystrophies, and how the sites overcame these barriers,

c) Consider how results from such surveillance can be used at the state level to improve the lives of people with MDs and their families,

d) Identify project enhancements that could make the MD STARnet model more effective in the future, and

e) Address the feasibility of linking MD STARnet data with Medicaid data or other administrative databases to better understand use of health care services by people with muscular dystrophy.

Dissemination of findings:

1) Propose and lead the development of a minimum of three manuscripts using existing MD STARnet data and include a description of the topic, analytic approach, and timeline toward submission to peer-reviewed journals. Extensively collaborate on 3 other manuscripts.

2) Communicate information on project activities and results to partners and other state programs. Provide an oral presentation to one or more stakeholder groups at each site.

Component B: Enhanced Activities:

The applicants should submit a separate application for each enhanced activity and should include the title of the enhanced activity in the application- MD STARnet: (1. Data coordinating center (DCC); 2 Abstractor training and quality assurance/control activities; 3. National coordinating center, or 4. Georgia healthcare transitions interview).

Data coordinating center:

1) Describe staff roles and responsibilities including experience hosting a data coordinating center (DCC).

2) Describe how the DCC will provide support to all sites for the applications, databases, and software for the abstraction, clinical review, and interview data collection instrument. This should include a plan for modifying existing software, applications, and database for reduced collection of DBMD variables and expansion for data collection to other MDs.

3) Describe a plan for:

a) Conducting quality control/assurance, cleaning, and pooling of abstraction and interview data,

b) Compiling monthly abstraction and interview reports,

c) Securing and protecting abstraction and interview data,

d) Making yearly data sets available to all sites,

e) Writing/revision of data managers’ manual,

f) Providing technical support to data managers,

g) Leading the data manager monthly conference call,

h) Hosting the internal MD STARnet website and FTP site, and

4) Describe timelines.

Abstractor training and quality assurance/quality control (QA/QC) activities:

1) Describe staff roles and responsibilities including any previous experience conducting abstractor training and QA/QC,

2) Describe a plan to oversee abstractor training and QA/QC activities for all sites. In the application include plans for:

a) Training and certifying new abstractors

b) Planning and conducting ongoing training and QA/QC exercises for experienced abstractors, particularly in light of the reduction of variables collected for DBMD and addition of variables for other MDs

c) Assessing abstractor reliability by reviewing 5% of records,

d) Maintaining and updating abstractor training and user manuals,

e) Leading and recording monthly abstractor conference calls,

f) Participating on other committees as needed to provide expertise regarding abstraction data,

g) Preparing an annual report for the coordinating committee on QA/QC activities conducted and recommended, and

3) Describe timelines.

National coordinator site:

1) Describe staff roles and responsibilities including any previous experience providing national coordination for a mult-site project,

2) Describe qualifications of and plans to employ a national coordinator who will be responsible for coordinating communication and facilitating publication submissions between all sites,

3) Describe a plan to lead a multi-site collaborative effort to produce a summary report on the experience of conducting surveillance for muscular dystrophies. Include a description of the staff member(s) who will be responsible for communicating among sites, writing the report, and other activities necessary to completing the report.

4) Include a description of national coordinator responsibilities:

a) Plan all conference calls and in-person meetings,

b) Develop agendas and provide meeting minutes,

c) Facilitate communication between committees and sites,

d) Maintain and update committee documents,

e) Develop a newsletter for DBMD families, and

f) Provide assistance to investigators that expedites publication of MD STARnet data, and

5) Describe timelines.

Georgia healthcare transitions interview:

1) Describe staff roles and responsibilities and any previous experience conducting telephone interviews

2) Describe a plan to conduct approximately 200 healthcare transitions interviews for the Georgia site including:

a) Coordinating and communicating with CDC staff,

b) Providing study materials and communicating with potential participants,

c) Consenting participants and conducting interviews in English and Spanish,

d) Using available techniques to trace potential subjects without current contact information,

e) Proposing methods to increase response rate

f) Conducting interview QA/QC,

g) Cleaning and maintaining interview data,

h) Communicating with CDC about progress of interviews and issues encountered, and

3) Describe a timelines.

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.

If applicable, add Information in the bullet above about requirements for other content and form that is in addition to and different from that described in SF424. Use Style Heading 4 for the names of application sections. DELETE THE LAST BULLET IF NOT NEEDED.

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.

Or:

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

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 allowable only as described in the HHS Grants Policy Statement.

Add additional information about funding restrictions. If any of these restrictions become part of the terms of award, that must be stated in Section VI.1. Delete this block if there is no additional information.

6. Other Submission Requirements and Information

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.

When submitting an application for Component A - include in the title MD STARnet: Feasibility of Expansion to Other Muscular Dystrophies.

To receive funding for an enhanced activity, an applicant must apply for and receive funding for Component A -core activities under this FOA. If you are submitting an application for one or more enhanced activity components in Component B – include in the title the enhanced activity you are applying for - MD STARnet: (1. Data coordinating center (DCC); 2 Abstractor training and quality assurance/control activities; 3. National coordinating center, or 4. Georgia healthcare transitions interview). Applications for each enhanced activity will be grouped accordingly and evaluated separately by activity.

Add information here related to responsiveness if applicable.

Add any other Submission Requirements and Information; include heading (and description. Do not include information about the CONTENT and FORM of the application, which should instead be placed above in Section IV.2. Content and Form.

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).

Overall Impact is not editable.

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.

Here is what the peer reviewers are going to be evaluating the application on. Add more here if the generic are not adequate. These would come from other submission requirements.

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?