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Developing a Plan to Evaluate Delivery of Health Care Treatments and Services for Duchenne Muscular Dystrophy (DMD)

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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 1. OVERVIEW INFORMATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Agency Name: Federal Centers for Disease Control and Prevention (CDC)

Funding Opportunity Title: Developing a Plan to Evaluate Delivery of Health Care Treatments and Services for Duchenne Muscular Dystrophy (DMD) Announcement Type: New- Type 1 Agency Funding Opportunity Number: CDC-RFA-DD12-1208 Catalog of Federal Domestic Assistance Number: 93.184 Key Dates: To receive notification of any changes to CDC-RFA-DD12-1208, 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.

Application Deadline Date: June 4, 2012, 11:59pm U.S. Eastern Standard Time Executive Summary:

The purpose of this program is to provide support through a CDC cooperative agreement for non-research activities to develop a plan for evaluating whether health care treatments and services for people who have Duchenne muscular dystrophy are currently being delivered according to recommendations outlined in the DMD Care Considerations1,2. The evaluation plan should include strategies for: 1) assembling a data collection tool that operationalizes the care considerations 2) collecting data to assess whether health care treatments and services specified in the care considerations are currently being delivered and highlight gaps and disparities in care and 3) identifying barriers that interfere with the delivery of these treatments and services. The plan should be adaptable for similar evaluations of delivery of care and treatment for other rare neuromuscular conditions.

Measurable outcomes of the program will be in alignment with one (or more) of the following performance goal(s) for the National Center on Birth Defects and Developmental Disabilities

· Improve the health and quality of life of American with disabilities This announcement is only for non-research activities supported by CDC.

If research is proposed, the application will not be reviewed. For the definition of research, please see the CDC Web site at the following Internet address:

http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf.

PART 2. FULL TEXT

I. FUNDING OPPORTUNITY 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.

Background Duchenne muscular dystrophy (DMD) is a rare disorder with early childhood onset in males that results in progressive muscle weakness leading to multisystem involvement. It is the most common form of muscular dystrophy in children with an estimated 1 in 3,500 to 1 in 6,000 males affected. Optimal health care management consists of a multidisciplinary team approach to improve, maintain, and support muscle strength and function, prevent and manage spinal deformity, manage respiratory complications and prevent and treat cardiomyopathy. Additional specialty care is needed in genetics, gastroenterology, nutrition, occupational therapy, and psychology.

In 2001, Congress authorized funding 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 reauthorization in 2008, the Centers for Disease Control and Prevention (CDC), National Center on Birth Defects and Developmental Disabilities supported development of comprehensive care considerations to help guide clinical management of DMD. Development of recommendations to guide the health care management of DMD was determined to be a priority to help reduce disparities in care and improve health outcomes for individuals impacted by the disorder. The DMD Care Considerations provide a framework for recognizing the multisystem primary manifestations and secondary complications of the disorder and providing coordinated multidisciplinary care. The next step in the process of improving health outcomes is to develop a method for evaluating whether health care treatment and services are currently being delivered according to recommendations outlined in the DMD Care Considerations. Evaluation of current health care treatments and services will highlight potential gaps and disparities in care and identify barriers that interfere with the delivery of these treatments and services.

Purpose

The purpose of this program is to provide support through a CDC cooperative agreement for non-research activities to develop a plan for evaluating whether health care treatments and services for people who have Duchenne muscular dystrophy are currently being delivered according to recommendations outlined in the DMD Care Considerations. The evaluation plan should include strategies for: 1) assembling a data collection tool that operationalizes the care considerations; 2) collecting data to assess whether health care treatments and services specified in the care considerations are currently being delivered and highlight gaps and disparities in care; and 3) identifying barriers that interfere with the delivery of these treatments and services. This evaluation plan will enable the program to develop potential strategies for providing improved care to the DMD population.

The plan should be adaptable for similar evaluations of delivery of care and treatment for other rare neuromuscular conditions.

This program addresses the following “Healthy People 2020” focus area(s):

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

Recipient Activities are as follows:

· Identify 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 development of a plan to evaluate whether health care treatment and services are being delivered according to the DMD Care Considerations. These experts can assist with assuring cooperation from all the sectors involved in the planned evaluation.

· With guidance from the partnership, create a comprehensive plan for evaluating whether health care treatments and services for people who have Duchenne muscular dystrophy are currently being delivered according to recommendations outlined in the DMD Care Considerations

· Evaluation should focus on a defined geographic area, although the methods used should be transferrable to other geographic areas.

· Assemble a data collection instrument(s) that will be used to evaluate health care treatments and services. Describe the approach to pilot testing the instrument.

· Describe the population of people with DMD in a defined geographic area suitable for a study to evaluate current health care treatments and services that will enable identification of potential gaps and disparities in care.

· Describe a strategy for case finding and case definition, description of infrastructure for data acquisition, management, analysis, and security and methods to evaluate data completeness and data quality.

· Propose a timeframe and estimated costs for implementing and evaluating the plan.

· Study population. Recipient must confirm the availability of and access to a defined population of people with DMD.

· Develop a plan to identify barriers that interfere with the delivery of recommended treatments and services.

· Address methods for assessing physician awareness and use of the DMD Care Considerations

· Identify barriers and rationale for identified gaps in adherence to the recommendations

· Describe potential processes to eliminate identified barriers.

In a cooperative agreement, CDC staff is substantially involved in the program activities, above and beyond routine grant monitoring.

CDC Activities

· Collaborate with the recipient in the development of a plan for evaluating delivery of health care treatments and services for Duchenne muscular dystrophy (DMD).

· Facilitate collaboration between recipient and families, caregivers, and the health care professionals to support activities outlined in this award

· Collaborate on methodological issues such as strategies for case findings and case definitions, data management and security, data quality, and analysis.

II. AWARD INFORMATION

Type of Award: Cooperative Agreement. CDC substantial involvement in this program appears in the Activities Section above.

Award Mechanism: U38 (Cooperative Agreements to Develop or Improve Facets for the Public Health Information)

Fiscal Year Funds: 2012 Approximate Current Fiscal Year Funding: $ 150,000 Approximate Total Project Period Funding: $ 150,000 including direct and indirect costs. This amount is an estimate, and is subject to availability of funds.

Approximate Number of Awards: 1 to 3 awards.

Approximate Average Award: $ 50,000 (This amount is for the first 12-month budget period, and includes both direct and indirect costs.)

Floor of Individual Award Range: None Ceiling of Individual Award Range: $150,000 total cost, including direct and non-direct costs. This ceiling is for the first 12-month budget period.

Anticipated Award Date: August 31, 2012 Budget Period Length: 12 months Project Period Length: 12 months Throughout the project period, CDC’s commitment to continuation of awards will be conditioned 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.

III. ELIGIBILITY INFORMATION

Eligible Applicants Eligible applicants that can apply for this funding opportunity are listed below:

· Nonprofit with 501C3 IRS status (other than institution of higher education)

· Nonprofit without 501C3 IRS status (other than institution of higher education)

· For-profit organizations (other than small business)

· Small, minority, and women-owned businesses

· Universities

· Colleges

· Research institutions

· Hospitals

· Community-based organizations

· Faith-based organizations

· Federally recognized or state-recognized American Indian/Alaska Native tribal governments

· American Indian/Alaska native tribally designated organizations

· Alaska Native health corporations

· Urban Indian health organizations

· Tribal epidemiology centers

· State and local governments (this includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau)

· Political subdivisions of States (in consultation with States)

· Other (specify) 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.

Required Registrations

Registering your organization through www.Grants.gov, the official agency-wide E-grant website, is the first step in submitting an application online. Registration information is located on the “Get Registered” screen of www.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, the Grants.gov registration process also requires that you register your organization with the Central Contractor Registry (CCR) and DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) which will require at least 4 weeks to complete in its entirety. The CCR registration can require an additional two weeks to complete. You are required to maintain a current registration in CCR. CCR registration must be renewed annually.

Central Contractor Registration and Universal Identifier Requirements All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An Authorized Organization Representative (AOR) should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

Additionally, all applicant organizations must register in the Central Contractor Registry (CCR) and maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later. CCR is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient. Additional information about registration procedures may be found at the CCR internet site at www.ccr.gov.

If an award is granted, the grantee organization must notify potential sub-recipients that no organization may receive a subaward under the grant unless the organization has provided its DUNS number to the grantee organization.

Cost Sharing or Matching

Cost sharing or matching funds are not required for this program.

Other If a funding amount greater than the ceiling of the award range is requested, the application will be considered non-responsive and will not be entered into the review process. The applicant will be notified that the application did not meet the eligibility requirements.

Special Requirements:

Moved to Recipient activities and is part of evaluation criteria 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 a grant, loan, or an award.

Maintenance of Effort Maintenance of Effort is not required for this program IV. Application and Submission Information Submission Dates and Times This announcement is the definitive guide on LOI and application content, submission, and deadline. It supersedes information provided in the application instructions. If the application submission does not meet the deadline published herein, it will not be eligible for review and the applicant will be notified the application did not meet the submission requirements.

Letter of Intent (LOI) Deadline Date: A letter of intent is not applicable to this funding opportunity announcement.

Application Deadline Date: June 4, 2012, 11:59 pm U.S. Eastern Standard Time Applicants must download the SF424 application package associated with this funding opportunity from Grants.gov. If access to the Internet is not available or if the applicant encounters difficulty in accessing the forms on-line, contact the HHS/CDC Procurement and Grant Office Technical Information Management Section (PGO TIMS) staff at (770) 488-2700 email:pgotim@cdc.gov Monday-Friday 7:00am – 4:30pm U.S. Eastern Standard Time for further instruction. CDC Telecommunications for the hearing impaired or disabled is available at: TTY 1-888-232-6348.

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

Content and Form of Application Submission

All applicants are required to sign and submit CDC Assurances and Certifications that can be found on the CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/grants/foamain.shtm Print, scan and upload as an additional attachment into the application package.

Letter of Intent (LOI): A letter of intent is not applicable to this funding opportunity announcement.

A Project Abstract must be completed in the Grants.gov application forms. The Project Abstract must contain a summary of the proposed activity suitable for dissemination to the public. It should be a self-contained description of the project and should contain a statement of objectives and methods to be employed. It should be informative to other persons working in the same or related fields and insofar as possible understandable to a technically literate lay reader. This abstract must not include any proprietary/confidential information.

A Project Narrative must be submitted with the application forms. The project narrative must be uploaded in a PDF file format when submitting via Grants.gov. The narrative must be submitted in the following format:

· Maximum number of pages 15. If your narrative exceeds the page limit, only the first pages which are within the page limit will be reviewed.

· Font size: 12 point unreduced, Times New Roman

· Double spaced

· Page margin size: One inch

· Number all narrative pages; not to exceed the maximum number of pages.

The narrative should outline a plan to evaluate delivery of health care treatments and services for Duchenne muscular dystrophy (DMD). The outline should address the following items in the order listed:

· Background

· Need for evaluation of treatment and services

· Awareness of the DMD Care Considerations Approach

· Identify partners to develop a plan to evaluate whether health care treatment and services are being delivered according to the DMD Care considerations.

· Assemble a data collection instrument(s).

· Identify steps for how to access a population of people who have DMD

· Identify steps for data collection

· Describe steps needed to identify barriers that interfere with the delivery of recommended treatments and services.

· Previous experience with evaluating health care treatments and services.

Additional information may be included in the application appendices. The appendices will not be counted toward the narrative page limit. This additional information submitted via Grants.gov should be uploaded in a PDF file format, and named as appropriate:

· Curriculum Vitas, Resumes, Organizational Charts, Letters of Support, Indirect Cost Rate Agreements, etc.

No more than 10 electronic attachments should be uploaded per application.

Funding Restrictions Restrictions, which must be taken into account while writing the budget, are as follows:

· Recipients may not use funds for research.

· Recipients may not use funds for clinical care.

· Recipients may only expend funds for reasonable program purposes, including personnel, travel, supplies, and services, such as contractual.

· Awardees may not generally use HHS/CDC/ATSDR funding for the purchase of furniture or equipment. Any such proposed spending must be identified in the budget.

· The direct and primary recipient in a cooperative agreement program must perform a substantial role in carrying out project objectives and not merely serve as a conduit for an award to another party or provider who is ineligible.

· Reimbursement of pre-award costs is not allowed.

Additional Submission Requirements Electronic Submission Submit the application electronically by using the forms and instructions posted for this funding opportunity on www.Grants.gov. If access to the Internet is not available or if the applicant encounters difficulty in accessing the forms on-line, contact the HHS/CDC, Procurement and Grant Office, Technical Information Management Section (PGO TIMS) staff at (770) 488-2700 Email:pgotim@cdc.gov Monday-Friday 7:30am -4:30pm for further instruction.

Note: Application submission is not concluded until successful completion of the validation process. 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. Applicants are strongly encouraged to check the status of their application to ensure submission of their application package is complete and no submission errors exists. To guarantee that you comply with the application deadline published in the Funding Opportunity Announcement, applicants are also strongly encouraged to allocate additional days prior to the published deadline to file their application. Non-validated applications will not be accepted after the published application deadline date.

In the event that you do not receive a “validation” email within two (2) business days of application submission, please contact Grants.gov. Refer to the email message generated at the time of application submission for instructions on how to track your application or the Application User Guide, Version 3.0 page 57.

Applications must be submitted electronically at www.Grants.gov. Electronic applications will be considered as having met the deadline if the application has been successfully made available to CDC for processing from Grants.gov on the deadline date. The application package can be downloaded from www.Grants.gov. Applicants can complete the application package off-line, and then upload and submit the application via the Grants.gov Web site. The applicant must submit all application attachments using a PDF file format when submitting via Grants.gov. Directions for creating PDF files can be found on the Grants.gov Web site. Use of file formats other than PDF may result in the file being unreadable by staff.

Applications submitted through Grants.gov (http://www.grants.gov), are electronically time/date stamped and assigned a tracking number. The AOR will receive an e-mail notice of receipt when Grants.gov receives the application. The tracking number serves to document submission and initiate the electronic validation process before the application is made available to CDC for processing.

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

Organizations that encounter technical difficulties in using www.Grants.gov to submit their application must attempt to overcome those difficulties by contacting the Grants.gov Support Center (1-800-518-4726, support@grants.gov). After consulting with the Grants.gov Support Center, if the technical difficulties remain unresolved and electronic submission is not possible to meet the established deadline, organizations may submit a request prior to the application deadline by email to the GMO/GMS [See Section VII “Agency Contacts”], for permission to submit a paper application. An organization's request for permission must: (a) include the Grants.gov case number assigned to the inquiry, (b) describe the difficulties that prevented electronic submission and the efforts taken with the Grants.gov Support Center (c) be submitted to the GMO/GMS at least 3 calendar days prior to the application deadline.

Intergovernmental Review Executive Order 12372 does not apply to this program.

V. Application Review Information Eligible applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the Funding Opportunity Announcement DD12-1208. Measures of effectiveness must relate to the performance goals stated in the “Purpose” section of this announcement. Measures of effectiveness must be objective, quantitative and measure the intended outcome of the proposed program. The measures of effectiveness must be included in the application and will be an element of the evaluation of the submitted application.

Criteria Eligible applications will be evaluated against the following criteria:

1. Organizational Profile, Background and Need (10 Points)

a. Are the applicant’s existing organizational structure, expertise, mission, and functions consistent with the purpose of this Funding Opportunity Announcement?

b. Has the applicant provided evidence of a commitment to addressing the health care treatment and services of individuals with Duchenne muscular dystrophy, as evidenced by past work or documented interest in this area?

c. Did the applicant demonstrate familiarity with the delivery of clinical care and services to people with Duchenne muscular dystrophy?

2. Narrative Plan (40 Points)

a. Does the applicant’s narrative clearly outline the steps needed to develop a plan for evaluating delivery of health care treatments and services for Duchenne muscular dystrophy (DMD)?

b. Does the assembling of the data collection instrument(s) follow a logical plan?

c. Do the steps for how to access people who have DMD accurately reach this population?

d. Do the steps for data collection follow current best practices?

e. Will the steps needed to identify barriers that interfere with the delivery of recommended treatments and services capture the challenges of working with this population?

f. Does the evaluation focus on a well-defined geographic area?

3. Partnerships and Letters of Support (20 Points)

a. Does the applicant identify appropriate partners, such as university medical centers, non-profit organizations, professional organizations, health systems, and other agencies, who are relevant to the project?

b. Has the applicant provided letters of support which identify the role of the organization in the project?

4. Previous Experience (15 Points)

a. Has the applicant documented their experience in evaluating the delivery of treatment and services to a population with a low prevalence condition?

5. Performance Monitoring Plan (15)

a. To what extent does the applicant describe the establishment of milestones to monitor program progress?

b. Does the performance monitoring plan include timelines for the proposed activities?

c. Are the proposed performance monitoring methods feasible?

6. Budget (SF424A) and Budget Narrative – (Reviewed but not scored) Although the budget is not scored, applicants should consider the following in development of their budget:

a. Is the itemized budget and justification for conducting the project reasonable and consistent with stated objectives and planned program activities? If the applicant requests indirect costs in the budget, a copy of the indirect cost rate agreement is required. If the indirect cost rate is a provisional rate, the agreement should be less than 12 months of age. The indirect cost rate agreement should be uploaded as a PDF file with “Other Attachment Forms” when submitting via Grants.gov.

The applicant can obtain guidance for completing a detailed justified budget on the CDC website, at the following Internet address:

http://www.cdc.gov/od/pgo/funding/budgetguide.htm.

Review and Selection Process

Review

All eligible applications will be initially reviewed for completeness by the Procurement and Grants Office (PGO) staff. In addition, eligible applications will be jointly reviewed for responsiveness by the National Center on Birth Defects and Developmental Disabilities and PGO. Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance through the review process. Applicants will be notified that the application did not meet eligibility and/or published submission requirements.

An objective review panel will evaluate complete and responsive applications according to the criteria listed in Section V. Application Review Information, subsection entitled “Criteria”. The objective review process will be performed by CDC employees, both from inside and outside the funding center. Applications will be reviewed objectively by a minimum of three qualified independent reviewers. A primary, secondary, and tertiary objective reviewer will assess each full application using only the criteria published in this announcement. One consistent voting panel will vote on all applications, presided over by a non-voting chairperson.

Selection

Applications will be funded in order by score and rank determined by the review panel. In addition, applicants that demonstrate the ability to collaborate with relevant partners needed to execute the full scale project will be given preference for funding decisions. CDC will provide justification for any decision to fund out of rank order.

VI. Award Administration Information Award Notices

Successful applicants will receive a Notice of Award (NoA) from the CDC Procurement and Grants Office. The NoA shall be the only binding, authorizing document between the recipient and CDC. The NoA will be signed by an authorized Grants Management Officer and e-mailed to the program director. A hard copy of the NoA will be mailed to the recipient fiscal officer identified in the application.

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration and Transparency Act requirements.

Unsuccessful applicants will receive notification of the results of the application review by mail.

Administrative and National Policy Requirements

Successful applicants must comply with the administrative requirements outlined in 45 Code of Federal Regulations (CFR) Part 74 or Part 92, as appropriate. The following additional requirements apply to this project:

· AR-8

Public Health System Reporting Requirements

· AR-9

Paperwork Reduction Act Requirements

· AR-10

Smoke-Free Workplace Requirements

· AR-11

Healthy People 2020

· AR-12

Lobbying Restrictions

· AR-14

Accounting System Requirements

· AR-15

Proof of Non-Profit Status

· AR-16

· AR-21

Small, Minority, and Women-Owned Business

· AR-23

States and Faith-Based Organizations

· AR-24

Health Insurance Portability and Accountability Act Requirements

· AR-25

Release and Sharing of Data

· AR-27

Conference Disclaimer and Use of Logos

· AR-29

Compliance with E.O. 13513 Federal Leadership on Reducing

Text Messaging While Driving, October 1, 2009.

· AR-30

Information Letter 10-006. – Compliance with Section 508 of the

Rehabilitation Act of 1973

· Additional information on the requirements can be found on the CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/Addtl_Reqmnts.htm.

For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html Reporting

Federal Funding Accountability And Transparency Act Of 2006 (FFATA): Public Law 109-282, the Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), requires full disclosure of all entities and organizations receiving Federal funds including grants, contracts, loans and other assistance and payments through a single publicly accessible Web site, www.USASpending.gov. The Web site includes information on each Federal financial assistance award and contract over $25,000, including such information as:

1. The name of the entity receiving the award

2. The amount of the award

3. Information on the award including transaction type, funding agency, etc.

4. The location of the entity receiving the award

5. A unique identifier of the entity receiving the award; and

6. Names and compensation of highly-compensated officers (as applicable)

Compliance with this law is primarily the responsibility of the Federal agency. However, two elements of the law require information to be collected and reported by recipients: 1) information on executive compensation when not already reported through the Central Contractor Registry; and 2) similar information on all sub-awards/subcontracts/consortiums over $25,000.

For the full text of the requirements under the Federal Funding Accountability and Transparency Act of 2006, please review the following website:

http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=109_cong_bills&docid=f:s2590enr.txt.pdf .

Content required in the progress report includes a brief report addressing the following elements of each objective or activity described by status, as met, ongoing, or unmet:

· Major findings, significance of those findings (a description of how the findings impact or contribute to the CDC public health goals)

· Barriers encountered, and how the barriers were addressed.

· If applicable, include the reasons that goals were not met and a discussion of assistance needed to resolve the situation.

Additionally, funded applicants must provide CDC with an original, plus two hard copies of the following reports:

1. Federal Financial Report SF 425 and annual progress report, no more than 90 days after the end of the budget period.

2. Final performance and Federal Financial Report SF 425 no more than 90 days after the end of the project period.

These reports must be submitted to the attention of the Grants Management Specialist listed in the Section VII below entitled “Agency Contacts”.

VII. Agency Contacts CDC encourages inquiries concerning this announcement.

For programmatic technical assistance, contact:

Tiffany Neal, Project Officer

Department of Health and Human Services

Centers for Disease Control and Prevention

1600 Clifton Road NE, MS E88

Atlanta, Georgia 30333

Telephone: 404-498- 3042

E-mail: tneal@cdc.gov For financial, grants management, or budget assistance, contact:

Stephanie Lankford, Grants Management Specialist

CDC Procurement and Grants Office

2920 Brandywine Road, MS E09

Atlanta, GA 30341

Telephone: 770-488-2936

E-mail: FZI8@cdc.gov For assistance with submission difficulties, contact:

Grants.gov Contact Center Phone: 1-800-518-4726 Email: support@grants.gov Hours of Operation: 24 hours a day, 7 days a week. Closed on Federal holidays.

For submission questions, contact:

Technical Information Management Section

CDC Procurement and Grants Office

2920 Brandywine Road, MS E-14

Atlanta, GA 30341

Telephone: 770-488-2700

Email:

pgotim@cdc.gov CDC Telecommunications for the hearing impaired or disabled is available at:

TTY 1-888-232-6348

VIII. Other Information References:

1. Bushby, K. Finkel, R., Birnkrant, D, Case, L.E, .Clemens, P. R., Cripe, L., Kaul, A., Kinnett, K., McDonald, C., Pandya, S., Poysky, J., Shapiro, F., Tomezsko, J., Constantin, C., DMD Care Considerations Working Group. (2010). The Diagnosis and Management of Duchenne Muscular Dystrophy- Part 1. Diagnosis, Pharmacological and Psychosocial Management. Lancet Neurology. 9(1), p 77-93.

2. Bushby, K. Finkel, R., Birnkrant, D, Case, L.E, .Clemens, P. R., Cripe, L., Kaul, A., Kinnett, K., McDonald, C., Pandya, S., Poysky, J., Shapiro, F., Tomezsko, J., Constantin, C., DMD Care Considerations Working Group. (2010). The Diagnosis and Management of Duchenne Muscular Dystrophy- Part 2. Implementation of Multidisciplinary Care. Lancet Neurology. 9(2), p 177- 189

For additional information on reporting requirements, visit the CDC website at: http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm.

Other CDC funding opportunity announcements can be found at www.grants.gov.

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