dd14-1409 final foa 03.26.14 amendment i.pdf

Amendment: Has been made to the following Sections of this FOA:

Part I: Application Deadline has been changed to April 18, 2014 and under Submission Dates and Time

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

PART 1. OVERVIEW INFORMATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

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

Funding Opportunity Title: Public Health Surveillance for the Prevention of Complications of Bleeding and Clotting Disorders

Announcement Type: Type 2 – Competing Continuation

Agency Funding Opportunity Number: CDC-RFA-DD14-1409: Public Health Surveillance for the Prevention of Complications of Bleeding and Clotting Disorders-CDC RFA-DD11-1103

Catalog of Federal Domestic Assistance Number: 93.184

Key Dates:

Closing Date: April 18, 2014, 5:00pm Eastern Standard Time

Only applicants funded under DD11-1103 are eligible to apply.

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 Sections 301(a) [42 USC 241(a)] and 317 (C) of the Public Health Service Act [42 U.S.C.

Section 247b-4] as amended.

Background Hemophilia and other bleeding disorders, characterized by a permanent tendency towards spontaneous or traumatic hemorrhages, are responsible for significant disease burden and negative impact on the quality of life. Hemophilia, an X-linked recessive condition resulting in a decrease or lack of clotting factor VIII or IX, is marked by bleeding into joints and muscle, but may also lead to bleeding that causes neurologic damage, damage to other organ systems, or death. Hemophilia occurs in about 1/5000 male births and affects all racial and ethnic groups; it is estimated there are about 20,000 males with hemophilia in the United States at this time. Von

Willebrand disease (VWD) results from a deficiency or defect in the body's ability to make von

Willebrand factor, a protein that helps blood clot. Although VWD occurs in men and women equally, women are more likely to notice the symptoms because of heavy or abnormal bleeding during their menstrual periods and after childbirth. Joint bleeds and muscle hematomas may occur in severe forms of the disease, but mucocutaneous bleeding is more common. VWD is http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf thought to occur in up to 1% of the population. Deficiencies of other clotting factor proteins and platelet function defects may cause rarer bleeding disorders.

The complications of hemophilia, von Willebrand disease and other bleeding disorders have been monitored by CDC since 1998 through the Universal Data Collection (UDC) project, a nation-wide effort carried out in federally funded hemophilia treatment centers (HTCs) that longitudinally collects medical records information, joint range of motion measurements and blood specimens for monitoring complications of bleeding disorders, including transmission of blood-borne pathogens. Since 1975, Congress has provided support for these centers through the

Maternal and Child Health Bureau and the Centers for Disease Control and Prevention (CDC).

In the United States, hemophilia treatment centers (HTCs) have developed a model of care delivery called comprehensive care which includes specialized prevention, diagnostic, and treatment programs designed to provide family-centered education, state-of-the-art treatment, research, and support services for individuals and families living with bleeding disorders. Some

HTCs also care for persons with clotting disorders. A six-state population-based hemophilia surveillance project conducted by CDC in the mid-1990s found that 67% of identified cases attended an HTC for preventive care and management. Persons who had received care in HTCs during the study period were 40% less likely to die and 40% less likely to be hospitalized for a bleeding complication than those who had not. Little is known about the characteristics and outcomes of patients receiving care outside of HTCs today.

Clotting disorders, including venous thromboembolism (VTE) and thrombophilia, are responsible for significant morbidity and mortality. VTE is a continuum encompassing both deep vein thrombosis (DVT), clots in the deep veins of the body, and pulmonary embolism (PE), which occurs when a clot breaks free and enters the arteries of the lungs. PE is serious, often resulting in sudden death, and is a leading cause of preventable hospital death and maternal mortality in the United States. Currently there is no national surveillance for clotting disorders and so the precise number of people affected by these conditions is unknown. Based on analyses of clinical administrative databases, and hospital and community based studies, the overall annual incidence of DVT and PE collectively in the U.S is estimated to be between 1-2 per thousand of the population, or 300,000 to 600,000 cases. Thrombophilias are inherited and acquired biological states that place a person at higher risk for DVT/PE. In addition, they may also be associated with increased risk for adverse pregnancy outcomes, and other conditions such as cerebral palsy, and perhaps arterial thrombosis. Several thrombophilias have been identified and include factor V Leiden, prothrombin G20210A mutation, antiphospholipid syndrome, and deficiencies of the natural anticoagulants protein C, protein S, and antithrombin. Patients with clotting disorders are seen in many settings, including HTCs, however care within the HTCs has yet to be explored.

Purpose The purpose of the program is to provide support and assistance through CDC cooperative agreements for non-research activities for the collection, aggregation and use of data describing the epidemiologic characteristics of people with bleeding and clotting disorders and the complications of these disorders, in order to monitor health indicators for these populations.

The program consists of two modules, one for collection of information on patients who do not receive care in HTCs (Module A) and one for collection of information on patients who are cared for in HTCs (Module B); to the extent an applicant for Module B is not an HTC, it will collaborate and coordinate with HTCs to ensure that the activities can be undertaken. The target populations are people of all ages with bleeding disorders, primarily those due to congenital factor deficiencies such as hemophilia, von Willebrand disease and other clotting factor deficiencies. However, women and girls with certain platelet disorders may also be included. In addition, minimal information will be collected on patients with DVT/PE or thrombophilia receiving treatment in HTCs.

The primary objectives of this project are to continue the longitudinal collection of routine clinical data within HTCs as established in the UDC project; to characterize the population of persons with clotting disorders receiving services at HTCs and ascertain the potential of this population for future surveillance and research on DVT/PE and thrombophilia; and to characterize populations with bleeding disorders receiving treatment outside of HTCs. This data will be used by recipients and CDC to monitor health indicators of importance to the bleeding disorders population; measure rates of complications of bleeding disorders (including those related to blood and treatment product safety) and monitor trends over time; identify high risk populations for prevention programs; and identify issues that require further study. Outcomes for this surveillance project include:

1. Knowledge of the demographics of populations with bleeding disorders receiving treatment inside and outside of HTCs;

2. Knowledge of the health service utilization of populations with bleeding disorders receiving treatment inside and outside of HTCs.

3. Knowledge of the demographics and health service utilization of populations with clotting disorders receiving treatment inside HTCs.

Among persons with bleeding disorders receiving care at HTCs:

4. Knowledge of the rates of complications of bleeding disorders including joint disease, reproductive complications among women with bleeding disorders, intracranial hemorrhage and other bleeding episodes, development of inhibitors (including serologic testing), and trends in these rates over time;

5. Better understanding of risk factors contributing to complications of bleeding disorders;

6. Knowledge of the health status of the bleeding disorders population as measured by health indicators including obesity, immunization, quality of life, chronic diseases of aging, co-morbid conditions and mortality;

7. Knowledge of treatment practices and patterns and their association with clinical outcomes;

8. Identification of seroconversions of emerging, as well as known, pathogens among persons receiving blood products for the purpose of halting transmission;

9. Identification of inhibitor development and other markers of treatment complications for the purpose of identifying risk factors and comparing outcomes;

10. A repository of blood samples maintained by CDC for future testing for blood-borne pathogens; other treatment product safety issues; and markers (or potential markers) of either the body’s response to the bleeding disorder or complications of the bleeding disorder, or to substances to treat or ameliorate the bleeding disorder or its complications.

This program addresses the “Healthy People 2020” focus area(s) of Blood Disorders and Blood

Safety.

Program Implementation

Recipient Activities

This announcement is comprised of two funding Modules:

(1) Module A: Public Health Surveillance for the Prevention of Complications of Bleeding

Disorders outside of HTCs; and

(2) Module B: Public Health Surveillance for the Prevention of Complications of Bleeding and

Clotting Disorders in HTCs.

An HTC is a center that provides care for persons with bleeding disorders under a model called comprehensive care, which includes specialized prevention, diagnostic, and treatment programs designed to provide family-centered education, state-of-the-art treatment, research, and support services for individuals and families living with bleeding disorders. Applicants applying for

Module B must document that the patients upon whom they will report and who they will enroll in the registry will be recruited from either a) treatment centers that are receiving funding (as an awardee or subcontractor) under CDC-RFA- DD06-005, or b) centers that are not receiving funding under CDC-RFA-DD06-005 but which fulfill the qualifications of an HTC as described by the Medical and Scientific Advisory Committee of the National Hemophilia Foundation in

MASAC Recommendation # 132- Standards and Criteria for the Care of Persons with

Congenital Bleeding Disorders (Revised April 2002), which may be found at:

http://www.hemophilia.org/NHFWeb/MainPgs/MainNHF.aspx?menuid=57&contentid=220.

Applicants may apply for one module only. If an applicant applies for more than one module, only the first application received will advance through the review process. Applicants will be http://www.hemophilia.org/NHFWeb/MainPgs/MainNHF.aspx?menuid=57&contentid=220 notified that more than one application was received and will be informed which application will advance.

Module A: Public Health Surveillance for the Prevention of Complications of Bleeding

Disorders outside of HTCs

1. For all patients with an eligible bleeding disorder diagnosis, collect patient-level data about unique individuals on certain characteristics including: demographics, insurance coverage, socio-economic status, health services utilization, education and employment status, diagnosis, number and location of bleeds, treatment type, treatment products used, vaccination status, infectious disease status, inhibitor status, joint function and disease, invasive orthopedic procedures and mortality;

2. Contribute data collected in activity #1 to a central data repository at CDC;

3. Maintain the confidentiality of the study data in accordance with all applicable laws and regulations;

4. Participate in conference calls and an annual face-to-face meeting with CDC; and

5. Work with CDC to disseminate findings.

Module B: Public Health Surveillance for the Prevention of Complications of Bleeding and

Clotting Disorders in HTCs

Recipients under Module B shall coordinate and collaborate with HTCs (including establishing and managing subcontracts or other necessary agreements) to:

1. Collect, for each patient of the participating HTCs with an eligible bleeding or clotting diagnosis seen during the calendar year, minimal data on certain characteristics including: demographics, diagnosis, and health services utilization;

2. Collect patient-level mortality data from each participating HTC;

3. Enroll patients of the participating HTCs with an eligible bleeding diagnosis into a registry for repeated, longitudinal collection of patient-level data on certain characteristics including: demographics, insurance coverage, socio-economic status, health services utilization, education and employment status, diagnosis, number and location of bleeds, treatment type, treatment products used, vaccination status, infectious disease status, inhibitor status, joint function and disease, invasive orthopedic procedures, conditions of aging and mortality;

4. Contribute data collected in activities #1, 2 and 3 to a central data repository at CDC;

5. For each patient enrolled in the registry, periodically collect and send to CDC a blood specimen for screening for treatment complications including inhibitors and blood-borne pathogens, and for storage in a repository for screening for complications (as described in

Outcome #10 under Purpose above) and pathogens identified in the future;

Recipients under Module B shall monitor and ensure that their collaborating HTCs:

6. Obtain authorization from patients to enroll them in the registry and collect and use their information and blood specimens;

7. Maintain the confidentiality of the study data in accordance with all applicable laws and regulations;

Recipients under Module B shall also:

8. Coordinate and assist the activities of their subcontractors;

9. Participate in conference calls and an annual face-to-face meeting with CDC;

10. Work with CDC to disseminate findings.

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

CDC Activities

For Modules A and B:

1. Specify minimal data elements to be collected;

2. Provide technical support for collection of data including data collection instruments, data cleaning and a secure interface for data submission;

3. Work with awardees to assess training needs and provide training for data collection;

4. Obtain OMB clearance if necessary;

5. Serve as host and steward of data aggregated from recipients;

6. Prepare surveillance reports and other public health practice reports of data aggregated from recipients;

7. Provide technical assistance to recipients for analysis of their data as requested;

8. Participate in project site visits and scheduled conference calls as appropriate;

9. Work with awardees to disseminate findings.

CDC may contract with a central logistics support center for data standardization, receipt, cleaning and aggregation as well as to manage other project details such as development and dissemination of project guidelines and training materials as specified by CDC (the logistics support center will not be an applicant for or awardee of this FOA).

For Module B only:

10. Provide guidance for ethical conduct of non-research data collection and patient authorization;

11. Provide guidance on appropriate collection, processing and shipping of blood specimens;

12. Perform, or arrange for, laboratory tests called for by the project;

13. Report clinically-relevant test results to the contributing HTC; and

14. Serve as host and steward of specimen repository for future use.

II. AWARD INFORMATION

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

Award Mechanism: U27 Surveillance of the Complications of Hemophilia -- Cooperative

Agreements

Fiscal Year Funds: 2014

Approximate Current Fiscal Year Funding: $4,200,000- based on availability

Approximate Total Project Period Funding: $4,200,000

(This amount is an estimate, and is subject to availability of funds.)

Approximate Number of Awards: Module A: 2; Module B: 1

Approximate Average Award: Module A: $225,000; Module B: $4,150,000 (This amount is for the first 12-month budget period, and includes both direct and indirect costs.)

Anticipated Award Date: September 30, 2014

Budget Period Length: 12 months

Project Period Length: 1 year

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 or their Bona Fide Agents (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)

• Non-domestic (non-U.S.) entity

• 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). The CCR registration can require an additional one to two days to complete. You are required to maintain a current registration in

CCR.

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

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

http://www.grants.gov/ http://www.grants.gov/ http://www.grants.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

Special Requirements:

Modules A and B:

• Applicants may apply for one module only. If an applicant applies for more than one module, only the first application received will advance through the review process.

Applicants will be notified that more than one application was received and will be informed which application will advance.

• Applicants must submit letters of support from any subcontracting sites or partners indicating that those sites are able and willing to participate in the recipient activities.

Upload letters of support in Grants.gov under “Other Attachment Forms” and label them

“Letters of Support.”

Module A only:

Applicants for Module A must have access to patient-level data on a pool of at least 300

(three hundred) patients with eligible bleeding disorder diagnoses who are not receiving care in an HTC (refer to the description of an HTC under the Purpose section of this

FOA, and the criteria described by the Medical and Scientific Advisory Committee of the

National Hemophilia Foundation in MASAC Recommendation # 132- Standards and

Criteria for the Care of Persons with Congenital Bleeding Disorders (Revised April

2002), which may be found at:

http://www.hemophilia.org/NHFWeb/MainPgs/MainNHF.aspx?menuid=57&contentid=2

20). Eligible bleeding disorder diagnoses include hemophilia A or B, von Willebrand disease and rarer clotting factor deficiencies. For women and girls, certain platelet disorders are also eligible. This may be documented in the Project Narrative.

Module B only:

• Applicants applying for Module B must document that the patients upon whom they will report and who will be enrolled in the registry will be recruited from either a) treatment centers that are receiving funding (as an awardee or subcontractor) under CDC-RFA-

DD06-005, or b) centers that are not receiving funding under CDC-RFA-DD06-005 but which fulfill the qualifications of an HTC as described by the Medical and Scientific

Advisory Committee of the National Hemophilia Foundation in MASAC

Recommendation # 132- Standards and Criteria for the Care of Persons with Congenital

Bleeding Disorders (Revised April 2002), which may be found at:

http://www.hemophilia.org/NHFWeb/MainPgs/MainNHF.aspx?menuid=57&contentid=2

20.

Receipt of funding under CDC-RFA-DD06-005 may be documented by listing those centers by name. Centers that are not receiving funding under CDC-RFA-DD06-005 must document their qualifications to be an HTC by addressing each of the criteria in

MASAC Recommendation # 132- Standards and Criteria for the Care of Persons with http://www.hemophilia.org/NHFWeb/MainPgs/MainNHF.aspx?menuid=57&contentid=220 http://www.hemophilia.org/NHFWeb/MainPgs/MainNHF.aspx?menuid=57&contentid=220

Congenital Bleeding Disorders (Revised April 2002). Upload documentation of HTC status in Grants.gov under “Other Attachment Forms” and label it “Documentation of

HTC Status.”

• Applicants for Module B must demonstrate that they have access to a pool of at least

5000 (five thousand) patients with eligible bleeding disorder diagnoses (there is no minimum requirement for clotting disorder patients). Eligible bleeding disorder diagnoses include hemophilia A or B, von Willebrand disease and rarer clotting factor deficiencies.

For women and girls, certain platelet disorders are also eligible. Eligible clotting disorder diagnoses include DVT/PE and thrombophilia. This may be documented in the Project

Narrative.

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. 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

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

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: 25. 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. Understanding of the Public Health Need and Impact

Modules A and B:

• State the module for which application is being made, including the title of the module;

• Demonstrate understanding of the need for this program and the planned activities for the targeted populations;

mailto:support@grants.gov?subject=Support http://www.cdc.gov/od/pgo/funding/grants/foamain.shtm

• Demonstrate comprehension of the requirements, objectives, and purpose of this FOA by describing them clearly and concisely.

2. Methods

Module A:

• Describe the characteristics of the available patient population: number of patients with eligible bleeding disorder diagnoses, gender, age, diagnoses, severity, geographic distribution, race/ethnicity, urban/rural;

• Describe the source(s) of the population and method(s) for case finding; describe how it will be determined that patients do not receive care in an HTC;

• Describe the source(s) of data and the method(s) by which the data will be obtained:

broadly, what data elements does each source contain; is the data available electronically or will abstraction be necessary; is all information available within a single source or will linkage of multiple sources be required; capacity to link to other appropriate data sources (e.g. vital records, medical records, radiology reports, hospital discharge records, pharmacy records, administrative databases, etc.); for what years are the data available;

• Describe the applicant’s legal authority to access data sources needed to accomplish activities and goals;

• If collaborating or partnering with other entities, provide evidence of intent to collaborate such as letters of support, memoranda of understanding, etc.;

• Describe the applicant’s legal authority to share data with CDC; describe any limitations to sharing data with CDC or other awardees of this Cooperative agreement.

Module B:

• Describe the characteristics of the available patient population: number of patients with eligible bleeding disorder diagnoses, gender, age, diagnoses, severity, geographic distribution, race/ethnicity, urban/rural; what is the estimated number of patients with eligible bleeding disorders seen in clinic each year; what is the estimated number of patients with eligible clotting disorders seen in clinic each year;

• Describe the source(s) of the patients and document their eligibility as HTCs;

• Describe how data will be collected for the both the eligible annual clinic population

(see Recipient activities, Module B, #1) and the patients enrolled in the registry (see

Recipient activities, Module B, #3);

• Describe plans to obtain patient authorization for registry data and specimens;

• If collaborating or partnering with other entities, provide evidence of intent to collaborate such as letters of support, memoranda of understanding, etc.;

• Describe applicant’s legal authority to share data with CDC; describe any limitations to sharing data with CDC or other awardees of this cooperative agreement.

3. Objectives

• Present clear and measurable objectives to address the need and activities of this

FOA;

• Submit measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of this FOA. Measures of effectiveness must relate to the performance goals stated in the “Purpose” section of this announcement and must be objective, quantitative and measure the intended outcome of the proposed program.

• Provide yearly enrollment targets for registry.

4. Plan and Timeline

• Provide a complete and comprehensive plan to carry out the proposed objectives for the entire project period with a timeline for activities.

5. Organizational and Personnel Capability

• Define the roles of project staff;

• Describe the expertise and skills of project personnel as it relates to project activities, including previous experience with similar data collection efforts;

• Describe the personnel available for data collection, entry and management;

• If applicable, describe how quickly staff and consultants can be identified and hired;

• Describe the resources (personnel and equipment) available for blood specimen collection, processing and shipping.

Additional information may be included in the application appendices. The appendices will not be counted toward the narrative page limit. This additional information includes:

• Documentation of HTC Status (Module B only)

• Budget (SF 424A) and Budget Narrative: provide a detailed budget which identifies and describes the basis for the anticipated costs for personnel, fringe benefits, travel, supplies, equipment, contractual, consultants, indirect, and other items.

• Bona fide agent letter from state, if applicable

• Memorandum of Understanding (MOU) for subawards, consultants, partnering agreements, etc., if applicable

• Curricula Vitae/Resumes

• Letters of Support, if applicable

• Organizational Charts

• Indirect Cost Rate Agreement

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

• Appendix 1: Documentation of HTC Status

• Appendix 2: Budget (SF 424A) and Budget Narrative

• Appendix 3: Bona fide agent letter from state

• Appendix 4: Memorandum of Understanding (MOU) for subawards, consultants, partnering agreements, etc.

• Appendix 5: Curricula Vitae/Resumes

• Appendix 6: Letters of Support

• Appendix 7: Organizational Charts

• Appendix 8: Indirect Cost Rate Agreement

• Appendix 9: Other

No more than 30 electronic attachments should be uploaded per application.

Additional requirements for additional documentation with the application are listed in Section VII. 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 applicant will be notified the application did not meet the submission requirements.

Application Deadline Date: April 18, 2014, 5:00pm Eastern Standard Time.

Intergovernmental Review

The application is subject to Intergovernmental Review of Federal Programs, as governed by Executive Order (EO) 12372. This order sets up a system for state and local governmental review of proposed federal assistance applications. Contact the state single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications and to receive instructions on the State’s process. Visit the following Web address to get the current SPOC list:

http://www.whitehouse.gov/omb/grants_spoc/.

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.

http://www.whitehouse.gov/omb/grants_spoc/

• 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.

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 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 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 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.

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. 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 http://www.grants.gov/

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).

V. Application Review Information

Eligible applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of CDC-RFA-DD11-1103. 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. Methods (40 Points)

Module A:

• Does the applicant fully describe the characteristics of the available population?

• Does the applicant have access to at least 300 patients with a bleeding disorder?

• Does the applicant describe how they will determine that patients do not receive care in an HTC?

• Does the applicant describe the source(s) of patients and demonstrate their authority to access the patients’ data?

mailto:support@grants.gov?subject=Support mailto:support@grants.gov

• Does the applicant describe the source(s) of data- their format (electronic or other);

whether and how linkage will be established; the elements each contains; the years for which data is available?

• Does the applicant describe their legal authority to share data with CDC and other awardees of this Cooperative agreement and discuss any limitations to data sharing?

• If applicable, are letters of support or memoranda of understanding, etc. provided?

• Are the proposed methods feasible? To what extent will they accomplish the program goals?

Module B:

• Does the applicant fully describe the characteristics of the available population?

• Does the applicant have access to at least 5000 patients with a bleeding disorder?

Does the applicant give estimates of the number of patients with bleeding disorders and the number with clotting disorders seen each year?

• Does the applicant provide evidence that each of the participating centers fulfills the criteria to be an HTC?

• Does the applicant describe how data will be collected for the both the eligible annual clinic population (Recipient activities, Module B, #1) and the patients enrolled in the registry (Recipient activities, Module B, #3)?

• Does the applicant describe plans to obtain patient authorization for registry data and specimens?

• Does the applicant describe its legal authority to share data with CDC and other awardees of this cooperative agreement and discuss any limitations to data sharing?

• If applicable, are letters of support or memoranda of understanding, etc. provided?

• Are the proposed methods feasible? To what extent will they accomplish the program goals?

2. Plan and Timeline (20 Points)

• Does the applicant provide a plan to carry out all of the proposed objectives?

• Is the plan adequate to carry out the proposed objectives?

• Does the plan cover the entire project period?

• Is a timeline provided for activities that will accomplish the objectives?

• Is the timeline reasonable?

• Will the applicant be able to implement project activities immediately?

• Will the timeline allow the applicant to accomplish the goals of the program?

3. Organizational and Personnel Capability (20 Points)

• Are the roles of project staff well-defined?

• Are the expertise and skills of project personnel appropriate to their roles on the project?

• Are the personnel available for data collection, entry and management sufficient, given the nature and volume of the data?

• If applicable, can staff and consultants be identified and hired in a timely manner?

• For Module B applicants only, are personnel and equipment available for blood specimen collection, processing and shipping?

4. Objectives (10 Points)

• Does the applicant present objectives to address the need and activities of this FOA?

Are they clear? Are they measureable?

• Does the applicant suggest measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of this FOA? Are they objective?

Are they quantitative? Do they measure the intended outcome of the program?

• For Module B applicants only, are yearly enrollment targets for the registry provided?

Are they reasonable?

5. Understanding of the Public Health Burden and Impact (10 Points)

• Is clear to which module the applicant is applying?

• To what extent does the applicant demonstrate understanding of the need for this program and the planned activities for the targeted populations?

• Did the applicant describe concisely a clear understanding of the requirements, objectives, and purpose of this FOA?

6. Budget (SF 424A) and Budget Narrative (Reviewed, but not scored)

Although the budget is not scored applicants should consider the following in development of their budget. Is the itemized budget for conducting the project, and justification reasonable and consistent with stated objectives and planned program activities?

If the applicants 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 National Center on Births 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 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 VI. Application Review Information, subsection entitled “Evaluation Criteria”. The objective review panel will be composed of CDC employees who do not work in the Division of Blood Disorders. The objective review process will follow the policy requirements as stated in the GPD 2.04 at http://198.102.218.46/doc/gpd204.doc.

Selection In addition, the following factors may affect the funding decision:

Maintaining diversity of diagnosis and/or geography and/or race/ethnicity.

CDC will provide justification for any decision to fund out of rank order.

VII. 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 http://www.cdc.gov/od/pgo/funding/budgetguide.htm http://198.102.218.46/doc/gpd204.doc

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-4 HIV/AIDS Confidentiality Provisions

• AR-5 HIV Program Review Panel Requirements

• AR-6 Patient Care

• 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-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-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, 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 http://www.cdc.gov/od/pgo/funding/Addtl_Reqmnts.htm http://www.access.gpo.gov/nara/cfr/cfr-table-search.html

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

Each funded applicant must provide CDC with an annual Interim Progress Report submitted via www.grants.gov:

1. The…