Submission Checklist to Accompany First Submission of Rfa/Pa Non-Research Announcement s5

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: Sudden Unexpected Infant Death Case Registry: Building

Capacity (Module A) and Pilot Program (Module B)

Announcement Type: New – Type 1

Agency Funding Opportunity Number: CDC-RFA-DP12-1202

1 Catalog of Federal Domestic Assistance Number: 93.946 Cooperative Agreements to

Support State-Based Safe Motherhood and Infant Health Initiative Programs

Key Dates:

Application Deadline Date: May 29, 2012, 11:59pm U.S. Eastern Standard Time

To receive notification of any changes to DP12-1202 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.

Executive Summary:

The Sudden Unexpected Infant Death Case Registry (SUID-CR) is a surveillance system that compiles information on unexpected infant deaths from various data sources. States use the SUID-CR for surveillance, program planning, modifying public health practice and policy for state maternal and child health programs, public health and medicolegal evaluation and reporting on Title V Performance Objectives.

Module A will continue to support the work of the 7 states that have successfully implemented the SUID-CR pilot program through an existing FOA that ends July 31,

2012. Module B will fund new states to implement the necessary components of a state- based SUID Case Registry and surveillance system including timely and complete review, data entry, quality control procedures, and reporting.

2 Measurable outcomes of the program will be in alignment with one (or more) of the following performance goal(s) for the Division of Reproductive Health within the

National Center for Chronic Disease prevention and Health Promotion. This program addresses the Division of Reproductive Health Priority Area of ‘Infant Health: Improve fetal, newborn and infant health’ by reducing SUID through improved surveillance, and reduction of disparities. This program also addresses the Division’s Strategic Area of

Focus: Sudden Infant Death Syndrome/Sudden Unexpected Infant Death Prevention. In addition, this program is in alignment with the Division’s QPR to increase the number of evidence-based findings available to inform the delivery of effective maternal/child health and reproductive health interventions.

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

3 Statutory Authority

Public Health Service Act, as amended, Section 301(a) and Section 317K, 42 U.S.C.

241(a); 42 U.S.C. 247b-12

Background

Each year in the United States approximately 4,200 infants die suddenly of no immediately obvious cause prior to investigation. These sudden unexpected infant deaths

(SUID) account for about 16% of all infant deaths and Sudden Infant Death Syndrome

(SIDS) account for about half of all SUID. When SUID are investigated, data related to the events leading to the death are not collected and reported consistently. This is a concern because by definition, SIDS should be assigned as the cause of death only if a thorough investigation (including a complete autopsy, examination of the death scene, and review of the clinical history) is conducted and no findings were present. Because

SIDS is nonspecific and the term SIDS is prone to inconsistencies in reporting and classification, the ability to accurately monitor national trends or evaluate prevention programs is limited.

The SUID-CR builds on existing state-based child death review programs. The registry provides comprehensive information about the circumstances associated with an infant death, as well as information about whether a case investigation was conducted and, if so, the components of that investigation. Most importantly, the SUID-CR monitors risk factors associated with these infant deaths, which allows for development of targeted prevention messages. States use the SUID-CR surveillance data for monitoring SUID trends, program planning and evaluation, modifying public health practice and policy for

4 state maternal and child health programs, and reporting on Title V Performance

Objectives.

Module A will support the continued work of the 7 states that receive funding under

CDC-RFA- DP09-904 that ends July 31, 2012. These states have successfully increased data completeness, and have established new and improved relationships with local partners. These states will continue to implement the necessary components of a state- based SUID Case Registry including timely and complete review, data entry, quality control procedures, and reporting. In addition, Module A awardees will be expected to achieve improved data completeness as measured by less than 10% missing and unknown data.

Module B will fund new states to implement the necessary components of a state-based, population-based SUID Case Registry and surveillance system for all SUID cases, including timely and complete review, data entry, quality control procedures, and reporting. Currently, unfunded states review and enter data on select cases only.

Purpose

The purpose of the SUID-CR is to monitor category-specific trends in SUID, including racial and ethnic disparities and characteristics associated with SUID. Objectives include: 1) identifying and reviewing all SUID cases in the awardee state (population- based surveillance); 2) collecting and reporting standardized information from a variety of sources; 3) creating actionable recommendations aimed at improving death scene

5 investigations and autopsy procedures, as well as developing health and safety SUID prevention messages; and 4) generating reports and disseminating findings.

Performance goals and process evaluation measures will be aimed at improving the data collected and will specifically address: 1) timeliness of case identification, review, data entry and quality assurance measures; and 2) improving data completeness (i.e. no missing or blank data fields for key SUID variables in the Case Report and reducing

‘unknown’ responses for key SUID variables from required data sources to less than 10% for Module A awardees and less than 20% for Module B awardees).

This program addresses the Division of Reproductive Health Priority Area of Infant

Health: Improve fetal, newborn and infant health by reducing SUID through improved surveillance, and reduction of disparities. This program also addresses the Division’s

Strategic Areas of Focus:

Sudden Infant Death Syndrome/Sudden Unexpected Infant Death Prevention –

Improve the investigation and monitoring of SIDS/SUID and identify

opportunities for prevention

Healthy People 2020 Focus Area(s):

The Sudden Unexpected Infant Death (SUID) Case Registry (SUID-CR) addresses

Healthy People 2020 objectives relating to Maternal, Infant, and Child Health, including:

 MICH-1.8 Reduce infant deaths from sudden infant death syndrome (SIDS)

6  MICH-1.9 Reduce infant deaths from sudden unexpected infant deaths

(includes SIDS, Unknown Cause, Accidental Suffocation, and Strangulation

in Bed)

 IVP-5 Increase the number of States and the District of Columbia where 90

percent of sudden and unexpected deaths to infants are reviewed by a child

fatality review team

 IVP-24.2 Reduce unintentional suffocation deaths to infants 0-12 months

Program Implementation

Recipient Activities

Awardees will identify all SUID cases in their state. For purposes of the SUID-CR, we define SUID as any infant death investigated by the medical examiner or coroner office, except homicides, and other obvious causes of death (e.g. hospital deaths to prematurely born infants). For each case, awardees will access, review and abstract records from a variety of local sources (e.g., medical examiner and coroner reports, law enforcement reports, social services, medical records), convene a multidisciplinary team to review

SUID cases and enter data into the National Center for Child Death Review (NCCDR)

Case Reporting System.

Module A awardees will build upon their work accomplished over the three years they have participated in the pilot SUID-CR. It is expected that they will monitor yearly trends in detailed surveillance reports, improve data completeness, implement targeted quality assurance activities and work with CDC to identify measures of practice and 7 policy changes that occur as a result of the SUID-CR process. It is anticipated that

Module A awardees will improve data completeness from a baseline of <20% missing and unknown data to <10% missing and unknown data. Module B awardees will focus efforts on establishing the SUID-CR processes in their state and creating a baseline assessment of missing and unknown data fields with a goal to attain <20% missing and unknown data.

General Activities (applicable to both Module A and Module B)

Successful awardees will be responsible for carrying out the following activities:

 Identifying all SUID cases in the state, ideally within 30 days of death. Cases

may be identified by regular communication with medical examiner/coroner

offices or through death certificate notifications from vital statistics.

 Securing and maintaining authority to access death scene information, medical

examiner/coroner records, birth certificates (the long form for public health

purposes), death certificates, law enforcement records, social service records, and

pediatric and obstetric medical records.

 Accessing and abstracting data from the following required data sources: (1)

death certificates, (2) death scene investigation information from Sudden

Unexplained Infant Death Investigation Reporting Form or jurisdictional

equivalent including doll reenactment photos, sleep environment and infant

medical history, (3) autopsy and/or pathology reports and other medical examiner

and/or coroner records (4) law enforcement reports, (5) public health record birth

certificates and (6) any social service records that pertain to the case. It is

8 preferable to also have access to: (1) infant medical records since birth (including

newborn screening results), (2) mother’s prenatal and obstetric records.

 Convening multidisciplinary child death review teams to review and discuss every

SUID case and make recommendations aimed at preventing similar deaths and

improving local systems of infant death investigation.

 Maintaining active membership in the multidisciplinary review team to include

agencies that represent medical examiners/coroners, law enforcement, death scene

investigators, public health, pediatrician or other health care providers, child

protective services and preferably emergency services.

 Reviewing and discussing all SUID cases, and their corresponding case

investigations within 3 months of case identification. Include scene photos and

scene reenactment information where available.

 Discussing and recording information on: infant health, maternal health during

pregnancy, caregiver history of involvement with social services or law

enforcement, official cause of death statement from the infant’s death certificate,

information from the death scene investigation, autopsy results. If the death

occurred in a sleep environment, the following information must be discussed and

recorded: incident sleep place, sleep position, any obstruction of the infant’s nose

and mouth, shared sleep surface and/or soft bedding in the sleep environment.

Teams must have access to a doll reenactment photo of the position the infant was

found.

 Documenting discussion of factors that the team feels directly contributed to each

death, which factors were modifiable and recommendations to prevent similar

9 deaths. In addition, the team must also discuss and document any identified areas

for improvements to the death investigation and autopsy procedures for each case,

which will demonstrate a local need for increased resources to support these

activities.

 Entering data within 30 days of review into a centralized and secure web-based

data collection system with an off-site backup storage system, specifically the

NCCDR Case Reporting System.

 Tracking the number of days it takes each case to move: from death to

identification; from identification to review; from review to data entry; from data

entry until quality assurance measures are completed.

 Implementing written manual of procedures for the multidisciplinary team (such

as those endorsed by the NCCDR and currently in place for state or local CDR

programs). These should include policies on confidentiality, HIPAA compliance,

and member participation.

 Implementing a quality assurance plan that includes methods to identify and

resolve case identification, case review and data entry issues as well as data

collection problems, including strategies for reducing missing, unknown or

inaccurate data. All quality assurance measures should be complete within 90

days of data entry.

 Communicating information on project activities and results to CDC, partners and

other state programs, including preparing descriptive reports with state aggregated

data and distribute them widely.

10  Sharing information learned from the project through presentations, reports and

media events.

 Participating in collaborative grantee meetings, recommended trainings, site visits

at your institution and yearly “reverse site visits”.

 Participating in evaluation of collaborative surveillance methods and make

adjustments to the methodology to improve the quality of data, increase

timeliness, and/or respond to changing case registry methodologies.

 Collaborating with the CDC and NCCDR to implement data sharing policies For

CDC’s policies on releasing and sharing data see

http://www.cdc.gov/od/foia/policies/sharing.htm

Module A Activities:

 Maintaining data collection efforts from previously funded SUID-CR Pilot

Program.

days of data entry.

 Maintaining quality assurance efforts so that there are no missing variables in the

Case Report and unknown responses are kept below 10% for all SUID-specific

variables.

11 Module B Activities:

 Participating in SUID-CR training and train Child Death Review teams in the

grantee state by January 2013.

 Beginning data collection January 2013.

 Securing authority to access death scene information, medical examiner/coroner

records, birth certificates (the long form for public health purposes), death

certificates, law enforcement records, social service records, and pediatric and

obstetric medical records.

days of data entry.

 Maintaining quality assurance efforts so that there are no missing variables in the

Case Report and unknown responses are kept below 20% for all SUID-specific

variables.

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

 Providing case definition, variable definitions and data dictionary.

12  Ensuring that the NCCDR Case Reporting System is functioning for awardees.

 Providing training in data standards and coding, data entry, data editing and other

quality assurance functions, and transmission of data to CDC for surveillance,

quality assurance and evaluation purposes.

 Reviewing submitted data for quality and completeness and provides feedback to

awardees. Work with the awardee to systematically resolve problems of missing

or unknown data.

 Providing technical assistance to include, but not limited to site visits and

conference calls to assist awardees in solving problems related to data collection,

case review, data entry, data analysis, quality assurance and evaluation.

 Conducting a reverse site visit yearly with all awardees and partners to assist

awardees in achieving their goals and objectives.

 Reviewing descriptive reports submitted by awardees and provide general

assistance to awardees in developing these reports.

 Disseminating project findings through presentations, reports, publications and

media events.

13 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 of the

Public Health Information.

Fiscal Year Funds: 2012

Approximate Current Fiscal Year Funding: $ 362,584

Approximate Total Project Period Funding: $ 1,087,752 (This amount is an estimate, and is subject to availability of funds and includes direct costs.)

Approximate Number of Awards:

Module A: 5-7

Module B: 1-3

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

Floor of Individual Award Range: $ 15,000

Ceiling of Individual Award Range: $110,000 (This ceiling is for the first 12-month budget period.)

Anticipated Award Date: 09/30/2012

Budget Period Length: 09/30/2012-09/29/2013 in 12 month increments

Project Period Length: 09/30/2012-09/29/2015 for a 3 year total

14 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.

15 III. ELIGIBILITY INFORMATION

Eligible Applicants

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

 State Health Departments 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).

A Bona Fide Agent is an agency/organization identified by the state as eligible to

submit an application under the state eligibility. If applying as a bona fide agent

of a state or local government, a letter from the state or local government as

documentation of the status is required. Attach with “Other Attachment Forms”

when submitting via www.grants.gov.

 A state can submit only one application.

Reasons to Justify Limited Competition, where eligibility is not limited by statute or regulation and the circumstances are not urgent.

Assistance will be provided only to state health departments or their bona fide agents.

State health departments are designated as registration areas for vital statistics are uniquely qualified to perform the programmatic activities for the SUID-CR. Moreover, they have the ability and authority to obtain population-based information from core data

16 sets (such as birth and death files), which is crucial for the successful implementation of the SUID-CR.

For Module A, eligibility is limited to existing Sudden Unexpected Infant Death Case

Registry (SUID-CR) grantee states funded under CDC-RFA- DP09-904. Applicants eligible to apply for this module are: Colorado Department of Public Health and

Environment, Georgia Department of Human Resources, Michigan Public Health

Institute (acting as a bona fide agent of the Michigan Department to f Health), Minnesota

Department of Health, New Hampshire Department of Health and Human Services, New

Jersey Department of Health and Senior Service and New Mexico Department of Health.

These states are uniquely qualified to build upon their two to three years of experience implementing the SUID-CR. During the next three years, these eligible states will begin activities that will build their capacity to improve data quality and data collection, conduct SUID surveillance and move their data into actionable prevention strategies whose outcomes may be measured. It is anticipated that Module A awardees will improve data completeness from a baseline of <20% missing and unknown data to <10% missing and unknown data.

For Module B, funding will be provided only to the state health departments or their bona fide agents that are not currently funded to participate in the SUID-CR. These states have no experience implementing a SUID-CR and, if awarded, will begin activities to train teams to collect, review, and enter data and to perform quality assurance measures at the state program office. While they have no formal experience with a

17 SUID-CR, potential awardees have experience in collecting, reviewing and entering data in the Child Death Review program. This funding ensures that they are performing these functions for all infant cases in their state (rather than reviewing only some cases).

Therefore, currently non-funded states will be competitive and have the capacity to demonstrate they have experience similar to what is required in the FOA.

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 up to at least 4 weeks to complete registration 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

18 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-awardees 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.

19 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:

If the application is incomplete or non-responsive to the special requirements listed in this section, it will not be entered into the review process. The applicant will be notified the application did not meet submission requirements.

 If applying as a bona fide agent of a state health department, applicant must

include a letter stating this relationship. Only one proposal will be accepted per

state.

 Late applications will be considered non-responsive. See section “IV.3.

Submission Dates and Times” for more information on deadlines.

 Proposal must demonstrate collaboration between state health office, child death

review program, medical examiner/coroner office, death scene investigators, law

enforcement, and medical community. This may be demonstrated by letters of

support from the applicant’s state health office, child death review program,

medical examiner/coroner office, death scene investigators, law enforcement, and

medical community.

 Proposal must demonstrate access to death certificate, autopsy report, Sudden

Unexplained Infant Death Investigation Reporting Form (SUIDIRF) or

jurisdictional equivalent of a comprehensive death investigation, medical

20 examiner/coroner report, law enforcement records and pediatric records. This

may be demonstrated with memorandums of agreements from the applicant’s

state health office, child death review program, medical examiner/coroner office,

death scene investigators, law enforcement, and medical community.

 Applicants must upload all additional documentation in Grants.gov under “Other

Attachment Forms” and each document should be labeled with a title clearly

identifies it as evidence of eligibility.

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.

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)

21 488-2700 email: [email protected] 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 [email protected]. Submissions sent by e-mail, 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:

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.

22 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.

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: 30. If your narrative exceeds the page limit, only the

first 30 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

 Paper size: 8.5 by 11 inches

 Printed only on one side of page.

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

23 The narrative should address activities to be conducted over the entire project period and must include the following items in the order listed:

 Background and Understanding of Public Health Impact

 Goal(s) and Objectives

 Methods

 Experience and Capacity

 Evaluation

 Collaborations

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

 Memorandums of Agreement (or Understanding)

 Letters of Support

 Organizational Charts

 Resumes or curriculum vitae

 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.

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

 State name_document name_ page # _____ of _____.

No more than ten (10) should be uploaded per application.

24 Additional requirements for additional documentation with the application are listed in

Section VII. Award Administration Information, subsection entitled “Administrative and

National Policy Requirements.”

Funding Restrictions

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

 Awardees may not use funds for research.

 Awardees may not use funds for clinical care.

 Awardees 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

25 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: [email protected] 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.

26 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-

27 518-4726 or by email at [email protected]. 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, [email protected]). 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. Paper applications submitted without prior approval will not be considered.

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/.

28 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 CDC-RFA-

DP12-1202. 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

Each eligible application will be evaluated individually against the following criteria, which are listed in order of points awarded and not in the order of the proposal.

1. Methods (50 points)

 The extent that the applicant describes the methods used for case identification.

(6 points)

o Applicants demonstrating methods for case identification that include

direct notification from medical examiner/coroner offices within 3 days of

an infant arriving for autopsy or electronic notification from vital statistics

within 3 days of the infant death will be assigned maximum points.

o Applicants demonstrating methods that would take greater than 3 months

to identify cases from the time of death to notification will be assigned no

29 points.

 The extent that the applicant describes the methods used to access data sources

necessary for case review. This should include a discussion of methods used in

motivating reporting sources, ensuring high quality data and resolving data issues.

(7 points)

o Applicants will receive maximum points if they include a signed MOA

from each agency that demonstrates access to the required data sources (1)

death certificates, (2) death scene investigation information from Sudden

Unexplained Infant Death Investigation Reporting Form or jurisdictional

equivalent including sleep environment and infant medical history 72

hours prior to death, (3) autopsy and/or pathology reports and other

medical examiner and/or coroner records (4) law enforcement reports, (5)

birth certificates and (6) any social service records that pertain to the

case).

 The extent that the applicant describes the process for the collection of death

scene investigation and autopsy information and the sharing of this information at

the review meeting. (6 points)

o Applicants will receive maximum points if they demonstrate that the

SUIDIRF or an approximate facsimile is used in the majority of areas in

the state and that they have continuous and open communication with

medical examiner/coroner and law enforcement offices.

 The extent that the applicant fully describes a realistic plan to review and discuss

all sudden unexpected infant deaths in their state and their corresponding case

30 investigations within 3 months of case identification (except for those cases

pending legal proceedings). The review team should discuss information

collected on the most recent version of the Child Death Review Case Reporting

System’s Case Report with expanded questions for SUID. (7 points)

o Applicants will receive maximum points if they demonstrate that team

reviews include scene photos and scene reenactment information where

available.

 The extent that the applicant describes the case review process and the level it

occurs (state versus local), as well as core team members and the organizations

they represent. (6 points)

o Applicants will receive maximum points if they demonstrate adherence to

the manual of procedures endorsed by NCCDR and submit Memorandums

of Understanding (MOU) or other evidence that medical

examiners/coroners, law enforcement, death scene investigators, public

health, pediatrician or other health care providers, child protective services

and preferably emergency services are present at every review meeting.

 The extent that the applicant can demonstrate that review teams discuss

information about: infant health, maternal health during pregnancy, caregiver

history of involvement with social services or law enforcement, official cause of

death statement from the infant’s death certificate, information from the death

scene investigation, autopsy results. If the death occurred in a sleep environment,

the following information must also be discussed and recorded: incident sleep

place, sleep position, presence of other people, animals and/or soft bedding in the

31 sleep environment. The review team should discuss information collected on the

most recent version of the Child Death Review Case Reporting System’s Case

Report with expanded questions for SUID. (6 points)

 The extent that the applicant describes how data will be entered in the NCCDR

web-based Case Reporting System within 30 days of review. (5 points)

 The extent that the applicant describes a quality assurance plan to check and clean

data entered as well as efforts to improve the completeness and timeliness of data.

(5 points)

 The extent that the applicant provides a detailed plan for assuring confidentiality

where required by state law or regulation. (2 points)

2. Experience and Capacity (17 points)

 The extent that the applicant documents experience in accessing, collecting,

editing, managing and analyzing information, from multiple data sources,

especially experience with infant mortality surveillance. (2 points)

o Applicants will receive maximum points if they demonstrate that staff

have extensive experience with child death review (or another infant

mortality review program); extensive experience in project or program

management; a knowledge and understanding of medical terminology

(such as a clinical background relevant to infant death); and extensive

experience in collaborative efforts.

 The extent that the applicant provides evidence of experience in infant mortality

surveillance, conducting data quality assurance activities and generating data

32 reports. (3 points)

o Applicants will receive maximum points if they demonstrate that staff is

masters prepared and has at least 5 years’ experience with data analysis to

include writing programs for statistical analysis software such as SAS,

SPSS or STATA.

 The extent that the applicant demonstrates readiness to collect, review and enter

SUID case information for infant deaths. For new awardees, it is understood that

the first three months of the award will be considered a training period. This

training period will be used to orient awardees to the enhanced NCCDR’s Case

Reporting System and the process of inputting data into the web-based system. (2

points)

 The extent that the applicant provides evidence of existing staff with skills in

child death review or other infant mortality review. Skills include convening and

maintaining multidisciplinary review teams, data management, and quality

assurance. (3 points)

 The extent the applicant demonstrates that staff members have appropriate

expertise and skills necessary to complete the planned activities. If additional

staff or consultants are needed, the applicant demonstrates the capacity to identify

additional staff and consultants in a timely manner. (2 points)

 The extent in which staff roles are clearly defined. (2 points)

 The extent that the applicant provides a time table showing when information

regarding the occurrence of a SUID death is available to the applicant from 1) the

medical examiner or coroner’s office, 2) vital statistics death certificate, 3) other

33 means of case identification. (2 points)

 The extent that the applicant describes existing or needed computer equipment for

entering and managing data in a secured web based data collection system. (1

points)

3. Collaboration (15 points)

 The extent that the applicant provides evidence of involvement by key

stakeholders in the current system or a plan for including key stakeholders in the

development of a SUID-CR. Key stakeholders include representatives from the

following agencies: death scene investigation, medical examiner/coroner, public

health, vital statistics, law enforcement, child protection services, social services,

medical offices including obstetrics and pediatrics, and others as appropriate. (6

points)

o Applicants will receive maximum points if they submit signed MOUs

from stakeholders.

 The extent that the applicant documents the limitations of data source access, the

most recent month and year data are available, the duration of access, the

expedience and availability of data from all data sources. (4 points)

o Applicants will receive maximum points if they demonstrate they can

identify and review cases within 3 months. Information from the letters of

support will be considered in this context and should be included in the

appendix.

 The extent that the letters of support document specific contributions of the

34 partner, including but not limited to a description of the precise nature of past and

proposed collaborations, products, services, and other activities that will be

provided by and to the applicant through the proposed collaboration. (3 points)

 The extent that the applicant provides additional letters of support from potential

partners in the project. (2 points)

4. Goal(s) and Objectives (8 points)

 The extent that the applicant has included goals which are relevant and consistent

with the purpose of this funding announcement. Goals and objectives should

match the methods and activities as outlined in this document. For example,

activities include: identifying all cases within 30 days of infant death; gathering

credible data from all required data sources and convening a multidisciplinary

review within 90 days of case identification; entering data within 30 days or

review and completing quality assurance measures within 30 days of data entry.

(5 points)

 The extent that the objectives are specific, measurable, assigned, realistic, and

time-phased to address the activities listed in this funding announcement. For

example, activities include: identifying all cases within 30 days of infant death;

gathering credible data from all required data sources and convening a

multidisciplinary review within 90 days of case identification; entering data

within 30 days or review and completing quality assurance measures within 30

days of data entry. (3 points)

35 5. Evaluation (5 points)

 The extent that the applicant provides a detailed plan for process evaluation that

reflects a method to measure each of the proposal’s objectives. This may be

integrated into the objective statements. (5 points)

6. Background and Understanding of Public Health Need (5 points)

 The extent that the applicant documents the magnitude of the infant mortality,

SIDS and SUID problem in the applicant’s state. (2 points)

 The extent that the applicant demonstrates understanding of the need for this

program and the planned activities within the target community. (1 point)

 The extent that the applicant adequately describes a clear, concise understanding

of the requirements and purpose of this funding announcement. (1 point)

 The extent the applicant describes the demonstrated geographic and racial/ethnic

diversity in the state’s population. (1 point)

7. Budget (Not Scored)

 The extent that the budget request is clearly explained, adequately justified,

reasonable, sufficient and consistent with the stated objectives and planned

activities. The Budget should include funds for at least one trip per year to CDC

in Atlanta and one trip per year to a grantee meeting for program related meetings

and training for two program-related staff with direct experience with the

program.

36 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 NCCDPHP 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 panel will be comprised of CDC employees from both inside and outside the funding center. A primary, secondary, and tertiary reviewer will score the applications and document their strengths and weaknesses. The applications will be scored against the criteria not against one another. These comments will be presented to the entire panel and a vote will take place by the panel to determine if the application is approved, disapproved, or deferred.

Selection

Applications will be funded in order by score and rank determined by the review panel.

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

 Number of annual SUID cases in the state

 Geographic and racial/ethnic diversity of the state

37  Experience with the NCCDR web-based Case Reporting System

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

Anticipated Announcement and Award Dates

Anticipated award notification date: July 15- July 30, 2012

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

38 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-7 Executive Order 12372 Review  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-23 States and Faith-Based Organizations

 AR 24 Health Insurance Portability and Accountability Act Requirements

 AR-25 Release and Sharing of Data

 AR 29 Compliance with EO13513, “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

39 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 awardees: 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.

40 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 interim progress report is due no less than 120 days before the end of the

budget period. The Interim Progress Report will serve as the non-competing

continuation application, and must contain the following elements:

a. Standard Form (“SF”) 424S Form.

b. SF-424A Budget Information-Non-Construction Programs.

c. Budget Narrative.

d. Indirect Cost Rate Agreement.

e. Project Narrative.

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

Additionally, funded applicants must provide CDC with the following reports:

2. Semi-annual progress report, due April 15 and October 15. The semi-annual

progress report will include:

a. Status update on objectives outlined in the proposal

b. Personnel changes since last report

41 c. Grant activities since last report

d. Quality improvements efforts and their outcomes

e. Planned activities

3. Federal Financial Report (SF 425) and annual progress report, no more than 90

days after the end of the budget period.

4. 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 Programmatic contact listed in the

Section VII below entitled “Agency Contacts”.

VII. Agency Contacts

CDC encourages inquiries concerning this announcement.

For programmatic technical assistance, contact:

Lena Camperlengo, Project Officer

Department of Health and Human Services

Centers for Disease Control and Prevention

4770 Buford Highway NE, MS K-23

Telephone: 770-488-6322

E-mail: [email protected]

For financial, grants management, or budget assistance, contact:

Veronica Davis, Grants Management Specialist

42 Department of Health and Human Services

CDC Procurement and Grants Office

2920 Brandywine Road,

Atlanta, GA 30341

Telephone: 770-488-2743

E-mail: [email protected]

For assistance with submission difficulties, contact:

Grants.gov Contact Center Phone: 1-800-518-4726 Email: [email protected]

Hours of Operation: 24 hours a day, 7 days a week. Closed on Federal holidays.

For submission questions, contact:

Technical Information Management Section

Department of Health and Human Services

CDC Procurement and Grants Office

2920 Brandywine Road, MS E-14

Atlanta, GA 30341

Telephone: 770-488-2700

Email: [email protected]

CDC Telecommunications for the hearing impaired or disabled is available at:

TTY 1-888-232-6348

43 VIII. Other Information

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.