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State Based Surveillance for Hemoglobinopathies

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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: State Based Surveillance for Hemoglobinopathies Announcement Type:

· Revision – Type 3 Agency Funding Opportunity Number: CDC-RFA DD10-10170201SUPP12 Catalog of Federal Domestic Assistance Number: 93.184 Key Dates:

Application Deadline Date: June 13, 2012, 11:59pm U.S. Eastern Standard Time.

Additional Overview Content: Eligible applicants are restricted to programs currently funded under program announcement number CDC-RFA-DD10-1017. Applicants can only apply for funding to continue activities for the core components of the original FOA.

Executive Summary:

The Centers for Disease Control and Prevention (CDC), National Center on Birth Defects and Developmental Disabilities (NCBDDD), Division of Blood Disorders (DBD), announces the opportunity to apply for funds to complete objectives for CDC-RFA DD10-1017.

This cooperative agreement provides financial assistance to: (1) determine prevalence of hemoglobinopathies across the lifespan; (2) determine annual incidence of hemoglobinopathies utilizing newborn screening data as well as identifying new cases due to immigration; (3) describe the demographics of the various hemoglobinopathies patient populations; (4) describe the distribution of disease severity, co-morbidities, and chronic disease complications among people with hemoglobinopathies; (5) describe the reproductive and pregnancy outcomes of the hemoglobinopathy patient populations; (6) calculate mortality rates, including case fatality rates for hemoglobinopathies and complications; (7) track health care utilization and the availability of specific services; and (8) assist with public health planning.

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 (NCBDDD), Division of Blood Disorders (DBD). (1) Prevent and Reduce Complications Experienced by Persons with Certain Blood Disorders, and (2) Improve the Health and Development of All People with Disabilities or Potentially Disabling Conditions.

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 Sections 311, 317 (k)(2) and 317 (C) of the Public Health Service Act [42 U.S.C. Sections 243, 247b(k)(2) and 247b-4] as amended.

Purpose

The purpose of the program is to provide financial assistance to allow completion of objectives related to improving the health and quality of life for people with hemoglobinopathies. This program addresses the “Healthy People 2020” focus area(s) of BDBS-1 (Developmental) Increase the proportion of persons with hemoglobinopathies who receive recommended vaccinations

BDBS-4 (Developmental) Increase the proportion of persons with a diagnosis of hemoglobinopathies who receive early and continuous screening for complications

BDBS-5 (Developmental) Increase the proportion of persons with hemoglobinopathies who receive disease-modifying therapies

Program Implementation

Recipient Activities Awardees should use this extension period to effectively close out the cooperative agreement by finalizing data analysis and dissemination of the project results. Activities may include the completion of those activities described in the FOA and an orderly close-out of the cooperative agreement:

· Disseminate data on enhanced population-based surveillance for hemoglobinopathies.

· Communicate information on project activities and results to partners and other state programs.

· Assess the challenges and opportunities of the pilot project including a description of the problems encountered, lessons learned, potential improvements, etc.

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

CDC Activities

· Assist in performing data analysis and/or quality assurance verification.

· Maintain the centralized database and assist with data dissemination.

· Facilitate the communication/coordination among awardees.

II. AWARD INFORMATION

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

Award Mechanism: U50 Fiscal Year Funds: 2012 Approximate Total Supplemental Funding: $20,000 (This amount is subject to availability of funds.) This includes direct and/or indirect costs.

Approximate Number of Awards: 1 Approximate Average Award: $ 20,000 Anticipated Award Date: July 1, 2012 Budget Period Length: up to 12 months Project Period Length: up to 12 months

III. ELIGIBILITY INFORMATION

Eligible Applicants

The following recipients may submit an application: Only awardees that are currently funded under CDC-RFA DD10-1017, State Based Surveillance for Hemoglobinopathies: Health Research Inc/New York State Department of Health.

Required Registrations 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.

The recipient is required to have the original DUNS identifier to apply for additional funds.

An AOR should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

Additionally, all applicant organizations must register in the Central Contractor Registry (CCR) and maintain their CCR 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 sub-award 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

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 Address to Request Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity from Grants.gov. If access to the Internet is not available or if the applicant encounters difficulty accessing the forms on-line, contact the HHS/CDC Procurement and Grants Office Technical Information Management Section (PGO TIMS) staff at (770) 488-2700 for further instruction. CDC Telecommunications for the hearing impaired or disable is available at: TTY 1-888-232-6348.

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

Content and Form of Application Submission Unless specifically indicated, this announcement requires submission of the following information:

Checklist of required contents of application packet:

A. Application for Federal Domestic Assistance-Short Organizational Form B. Project Abstract

C. Project Narrative

D. SF-424A Budget Information-Non-Construction Programs E. Budget Justification F. Indirect Cost Rate Agreement

Instructions for completing required contents of the application package:

A. 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.

B. 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: 10, 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 address activities to be conducted over the entire project period and must include the following items in the order listed:

1) Plan

a) Description of the data analyses that will be completed during the time period

b) Description of the plan for dissemination of the analyses

2) Methods

a) Description of the methods that will be used for data analysis

b) Description of the methods that will be used for analyses dissemination

3) Timeline

a) Reasonable and achievable timeline to complete the activities in the specified project period

4) Staff

a) Description of the staff members needed to effectively complete the data analyses and dissemination in the time specified in the timeline

Additional information may be included in the application appendices. The appendices must be uploaded to the “Other Attachments Form” of application package in Grants.gov. Note: appendices will not be counted toward the narrative page limit. This additional information includes:

C. SF 424A Budget Information and Justification:

1) Download the form from www.grants.gov.

2) Complete all applicable sections.

3) Estimated Un-obligated

a) Provide an estimate of anticipated un-obligated funds at the end of the current budget period.

b) If use of estimated un-obligated funds is requested in addition to funding for the next year, complete all columns in Section A of 424A and submit an interim Federal Financial Report (FSR), Standard Form-SF 425. The estimated un-obligated balance should be realistic in order to be consistent with the annual FFR to be submitted following the end of the budget period.

c) Based on the current rate of obligation, if it appears there will be un-obligated funds at the end of the current budget period, provide detailed actions that will be taken to obligate this amount.

d) If it appears there will be insufficient funds, (1) provide detailed justification of the shortfall; and (2) list the actions taken to bring the obligations in line with the authorized funding level.

e) The proposed budget should be based on the federal funding level stated in the letter from CDC.

f) In a separate narrative, provide a detailed, line-item budget justification of the funding amount requested to support the activities to be carried out with those funds. Attach in the “Mandatory Documents” box under “Budget Narrative Attachment Form.” Document needs to be in the PDF format.

g) The budget justification must be prepared in the general form, format, and to the level of detail as described in the CDC Budget Guidance. The sample budget guidance is provided on CDC’s internet at: http://www.cdc.gov/od/pgo/funding/grantmain.htm.

D. Indirect Cost Rate Agreement

a) If indirect costs are requested, include a copy of the current negotiated Federal indirect cost rate agreement or a cost allocation plan approval letter for those Grantees under such a plan.

b) Clearly describe the method used to calculate indirect costs. Make sure the method is consistent with the Indirect Cost Rate Agreement.

c) To be entitled to use indirect cost rates, a rate agreement must be in effect at the start of the budget period.

d) If an Indirect Cost Rate Agreement is not in effect, indirect costs may be charged as direct if (1) this practice is consist with the grantee’s/applicant’s approved accounting practices; and (2) if the costs are adequately supported and justified. Please see the Budget Guidelines (http://www.cdc.gov/od/pgo/funding/grantmain.htm) for additional information.

1. If applicable, attach in the “Mandatory Documents” box under “Other Attachments Form.” Name document “Indirect Cost Rate.”

E. Additional Program Requirements Additional information submitted via Grants.gov must be uploaded in a PDF file format, and should be named:

1) Appendix 1: Budget

2) Appendix 2: Indirect Cost Rate Agreement

CDC Assurances and Certifications can be found on the CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/grants/foamain.shtm and is required for competing continuations.

Additional requirements for additional documentation with the application are listed in Section VI. Award Administration Information, subsection entitled “Administrative and National Policy Requirements.”

Submission Dates and Times

This announcement is the definitive guide on 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 recipient will be notified the application did not meet the submission requirements.

Application Deadline Date: June 13, 2012, 11:59 pm U.S. Eastern Standard Time.

Explanation of Deadlines: Application must be successfully submitted to Grants.gov by 11:59 pm Eastern Standard Time on the deadline date.

Intergovernmental Review

Executive Order 12372 does not apply to this program.

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.

· Funds may not be used for new activities or for new personnel.

The recipient 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.

Other Submission Requirements Application 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 recipient 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 for further instruction.

Note: Application submission is not concluded until successful completion of the validation process. After submission of your application package, recipients will receive a “submission receipt” email generated by Grants.gov. Grants.gov will then generate a second e-mail message to recipients which will either validate or reject their submitted application package. This validation process may take as long as two (2) business days. Recipients are strongly encouraged 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, recipients 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.

Electronic Submission of Application:

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. Recipients can complete the application package off-line, and then upload and submit the application via the Grants.gov website. The recipient 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 website. 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 HHS/CDC 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 recipient encounters technical difficulties with Grants.gov, the recipient should contact Grants.gov Customer Service. The Grants.gov Contact Center is available 24 hours a day, 7 days a week. The Contact Center provides customer service to the recipient community. The extended hours will provide recipients 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 Grants Management Specialist/Officer 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 prevent electronic submission and the efforts taken with the Grants.gov Support Center (c) be submitted to the Grants Management Specialist/Officer at least 3 calendar days prior to the application deadline. Paper applications submitted without prior approval will not be considered. 98

If a paper application is authorized, the recipient will receive instructions from PGO TIMS to submit the original and two hard copies of the application by mail or express delivery service.

V. Application Review Information

Eligible recipients are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the CDC-RFA DD09-909. 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.

Recipients will be evaluated on how well the awardee proposes to use this extension period to strengthen their plans for analysis and dissemination of information on people with hemoglobinopathies as well as the progress towards the achievement of the performance measures in DD10-1017 and priority areas of work. Activities should include the completion of those activities described in the FOA and an orderly close-out of the cooperative agreement.

VI. Award Administration Information Award Notices

Successful recipients 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.

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

Administrative and National Policy Requirements

Successful recipients must comply with the administrative requirements outlined in 45 Code of Federal Regulations (CFR) Part 74 or Part 92, as appropriate. For competing supplements, ARs remain in effect as published in the original announcement.

· AR-7

Executive Order 12372

· 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-13

Prohibition on Use of CDC Funds for Certain Gun Control

Activities

· AR-14

Accounting System Requirements

· AR-15

Proof of Non-Profit Status

· 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-26

National Historic Preservation Act of 1966

(Public Law 89-665, 80 Stat. 915)

· AR-27

Conference Disclaimer and Use of Logos

· 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

Funded recipients must provide CDC with an original, plus two hard copies of the following reports:

1. Financial Status Report* (SF 269) no more than 90 days after the end of the budget period.

2. Final Performance and Financial Status Reports*, 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”.

Disclaimer: As of February 1, 2011, current Financial Status Report (FSR) requirements will be obsolete. Existing practices will be updated to reflect changes for implementation of the new Federal Financial Reporting (FFR) requirements.

VII. Agency Contacts

CDC encourages inquiries concerning this announcement.

For programmatic technical assistance and general inquiries, contact:

Mary Hulihan, Project Officer

Department of Health and Human Services

Centers for Disease Control and Prevention

Telephone: 404-498-6724

E-mail: ibx5@cdc.gov For financial, grants management, budget assistance and general inquiries, contact:

Christine Bennett, Grants Management Specialist

CDC Procurement and Grants Office

2920 Brandywine Road, MS E-09

Atlanta, GA 30341

Telephone: 770-488-2066

E-mail: vhk8@cdc.gov For application 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

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

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