cdc-rfa-dd10-1007 final 06 07 10.doc

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention (CDC) Utilizing Existing Birth Defects Surveillance Programs to Include Surveillance Data on Stillbirths

I. AUTHORIZATION AND INTENT

Announcement Type: New – Type 1 Funding Opportunity Number: CDC-RFA-DD10-1007 Catalog of Federal Domestic Assistance Number: 93.073; Birth Defects and Developmental Disabilities – Prevention and Surveillance Key Dates:

Letter of Intent Deadline Date: June 28, 2010, AFTER DATE OF PUBLICATION on Grants.gov]

Application Deadline Date: July 19, 2010, AFTER DATE OF PUBLICATION on grants.gov] 11:59pm Eastern Standard Time Authority:

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

Background:

In 2005, CDC was encouraged by Congress to develop pilot projects to assess the feasibility of expanding existing active, population-based birth defects surveillance systems to include data on stillbirths. For the purposes of this announcement, CDC defines stillbirth as follows: an intrauterine fetal death occurring at 20 or more weeks of gestation or weight of 350 or more grams if the age of the fetus is unknown. The pilot projects have identified a core list of variables and methods for conducting population-based surveillance of stillbirths with active case finding. Refer to Attachment I for the referenced publication on methodology and a list of variables.

Purpose:

The purpose of this program is to support: (1) the expansion of existing state population-based birth defects surveillance programs to incorporate surveillance data of stillbirths; (2) the monitoring and reporting on the occurrence of stillbirths in the study population; and (3) the evaluation of the stillbirth surveillance activities assessing completeness of case ascertainment and the improvement and enhancement of data available from fetal death reports/certificates.

This program addresses the “Healthy People 2010” focus area(s) of Maternal, Infant and Child Health, specifically Objective 16-1. Reduce fetal and infant deaths including those related to birth defects and sudden infant death syndrome.

Measurable outcomes of the program will be in alignment with the following performance goal for the National Center on Birth Defects and Developmental Disabilities (NCBDDD): Increase the number of American births covered by birth defects monitoring programs, which use these data to plan services for children and evaluate prevention strategies. (Government Performance and Result Act of 1993, GPRA) 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/regs/hrpp/researchDefinition.htm

II. PROGRAM IMPLEMENTATION

Recipient Activities:

a) Broaden birth defect surveillance methodologies to improve and expand the capacity of their existing population-based birth defects surveillance system to ascertain cases of stillbirths and generate timely population-based data.

b) Revise their current birth defects data collection system to incorporate additional information on stillbirths including maternal risk factors, health conditions, obstetric history, pregnancy complications and any information related to stillbirth postmortem evaluation (autopsy, placental pathology, laboratory blood work-up, etc.) The core variables recommended by CDC are listed in Attachment I.

c) Implement a standardized data collection tool for surveillance of stillbirths as part of a birth defects surveillance program. The awardee should provide initial and periodic training in the use of the data collection tool and forms.

d) Develop a strategy for expanding and utilizing data linkages to include fetal death records within the state to enhance the quality and utility of the stillbirth surveillance data.

e) Evaluate and report on the value of linking stillbirth surveillance data with fetal death records to enhance case ascertainment and quality of data collected.

f) Conduct ongoing assessment of stillbirth surveillance methods and make revisions in both case ascertainment sources and data collection tools to improve case finding and quality of data collected as well as timeliness.

g) Develop and describe a framework for case processing of stillbirths to include clinical review of information to assess and record reported and likely causes (underlying and contributory causes) of death.

h) Develop a framework for ongoing reporting of surveillance data on stillbirths that includes data processing, analytical methods, and dissemination of data.

i) Publish an annual report on rates and descriptive epidemiology of stillbirths among the surveillance population, including description by maternal age, race/ethnicity, plurality, and underlying medical risk factors.

j) Conduct an evaluation of these stillbirth expansion activities describing and assessing such areas as: the benefits of and challenges/barriers of expanding an existing state-based birth defects registry, resources needed for implementation, ongoing maintenance, and other areas. Summarize the results and prepare a manuscript for publication in a peer-reviewed journal.

k) Identify and provide a plan to engage partners and potential stakeholders in the state with an interest in the epidemiology and prevention of stillbirths.

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

CDC Activities:

a) Arrange and coordinate at least quarterly conference calls between the grantee and Atlanta project staff to allow for progress updates and discussion of technical issues and programmatic needs.

b) Provide the stillbirth surveillance methodology and a list of data collection core variables. Coordinate changes to the methodology or data collection variables. Coordinate activities to ensure that surveillance methods and data collection procedures are consistent for both stillbirth surveillance projects.

c) Assist with the training materials and coordination of the training of the abstractor staff.

d) Assist in the development of guidelines and procedures for the analysis of stillbirth surveillance data for reporting purposes.

e) Assist in identifying potential collaborative studies between the two projects investigating risk factors and/or causes of stillbirth.

f) Participate in planning an annual meeting on stillbirth surveillance activities.

g) Assist in the development of an annual stillbirth surveillance report template for use by both sites and analysis of report data.

h) If needed, assist in dissemination of stillbirth surveillance methodology and annual reports to interested partners.

III. AWARD INFORMATION AND REQUIREMENTS

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

Award Mechanism: U50 – Special Cooperative Health Investigations and Assessments of Control and Prevention Methods Fiscal Year Funds: 2010 Approximate Current Fiscal Year Funding: Up to $300,000

Approximate Total Project Period Funding: Up to $1,500,000 (includes both direct and indirect costs)

Approximate Number of Awards: 1 Approximate Average Award: Up to $300,000 (This amount is for the first 12-month budget period and includes both direct and indirect costs.)

Floor of Individual Award Range: Up to $250,000 Ceiling of Individual Award Range: Up to $300,000 (This ceiling is for the first 12-month budget period and includes direct and indirect costs.)

Anticipated Award Date: September 30, 2010 Budget Period Length: 1 year; 9/30/2010 – 9/29/2011 Project Period Length: 5 years; 9/30/2010 – 9/29/2015 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.

IV. ELIGIBILITY

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

· 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 Boards

· 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)

A Bona Fide Agent is an agency/organization identified by the state Department of Health 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, a letter from the state Department of Health as documentation of the status is required. Attach with “Other Attachment Forms” when submitting via www.grants.gov.

Eligibility is limited to the state, district, or territory’s Department of Health and American Indian/Alaska Native organizations or their bona fide agents due to the public health authority and/or legislative mandate to conduct birth defects surveillance activities. This authority provides unique and specific access to datasets from multiple data sources required to implement the activities outlined in the FOA #CDC-RFA-DD10-1007. They also have the experience, capacity, expertise, and resources to conduct a population-based surveillance program.

SPECIAL ELIGIBILITY CRITERIA:

Cost Sharing or Matching

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

Maintenance of Effort

Maintenance of Effort is not required for this program.

Birth Coverage Area

Population-based birth defects surveillance coverage area for the defined geographic area of the city, region, or state should have a minimum of 30,000 annual live births.

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 government, a letter must be provided from the state as documentation of your status. Upload this documentation into www.Grants.gov. Applications that fail to submit the evidence requested above will be considered non-responsive.

· Late applications will be considered non-responsive. See section “IV.3. Submission Dates and Times” for more information on deadlines.

· 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.

Intergovernmental Review of Applications

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. The current SPOC list can be accessed at the following web address: http://www.whitehouse.gov/omb/grants/spoc.html V. Application Content

Unless specifically indicated, this announcement requires submission of the following information 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

· Single spaced

· Paper size: 8.5 by 11 inches

· Page margin size: One inch

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

· Printed only on one side of page.

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

1. Methods and Plan Are the proposed methods feasible? To what extent are the proposed methods likely to lead to the accomplishment of the proposed objectives? Does the applicant provide clear explanations of appropriate methods to conduct and/or evaluate fetal death activities? Does the plan identify and summarize the planned activities? To what extent does the plan for confidentiality and data security meet the needs required for a study of this type? Is the plan adequate to carry out the proposed activities? How complete and comprehensive is the plan for the entire project period? Does the plan include quantitative process and outcome measures?

2. Performance Measures

Do the performance measures enable the applicant to determine the appropriateness and effectiveness of the project? Did the applicant provide performance measures addressing the Recipient Activities? Are the performance measures realistic and achievable? Measures of effectiveness must relate to the performance goals stated in the “Purpose” section of this announcement. Measures must be objective and quantitative and must measure the intended outcome. The measures of effectiveness must be submitted with the application and will be an element of evaluation. Some examples of measures are: improve the timeliness, accuracy, and completeness of stillbirths case ascertainment; monitor current trends in stillbirths, and evaluate the stillbirth surveillance methodology and activities.

3. Objectives

The adequacy of the applicant’s description that the proposed project objectives are relevant, specific, achievable, measurable, time-phased, and can be addressed through the proposed methods.

4. Applicant’s Understanding of the Public Health Impact of stillbirths:

The adequacy of the applicant’s description should convey a clear and concise understanding of the requirements, objectives, and purpose. The applicant should clearly describe their understanding of the public health impact of birth defects and stillbirths surveillance in their State and the purpose and complexities of the birth defects program as it relates to the State. The applicant should describe any specific characteristics of the state population that underscore the need for the enhanced population-based stillbirth surveillance.

5. Organizational and Program Personnel Capability

a) Whether the applicant has the appropriate experience, skills, and ability to implement stillbirth surveillance into their birth defects surveillance program.

b) The adequacy of the present staff and/or the capability to assemble competent staff to either implement or improve upon a birth defects surveillance program. If it is necessary to hire staff to conduct program activities, the applicant should provide plans for identifying and hiring qualified applicants on a timely basis. The applicant should provide plans for how program activities will be conducted prior to hiring necessary staff.

c) The applicant shall identify all current and potential personnel who will work on this cooperative agreement including qualifications and specific experience as it relates to the requirements set forth in this announcement. The applicant should provide curriculum vitae for key personnel.

6. Budget (SF 424A) and Budget Narrative Provide a detailed budget narrative and line-item justification of all operating expenses for Year 01. The budget should be consistent with the stated objectives and planned activities of the project. The guidance for completing a detailed budget can be found on the CDC Web site at the following Internet address:

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

Additional information may be included in the application appendices. The appendices will not be counted toward the narrative page limit. Additional information submitted via Grants.gov should be uploaded in a PDF file format, and should be named ATTACHMENT I, ATTACHMENT II, and so forth and could include such information as:

· Bona fide agent letter from state

· Most recent calendar year birth and birth defects surveillance data, stratified by race/ethnicity

· International Classification of Diseases codes covered by surveillance system

· Timeline clearly identifying all key milestones

· Memorandums of Understanding/Agreement with neighboring states describing existing and proposed collaborations, and the data and activities to be shared.

· Curriculum Vitae/Resumes

· Organizational Charts

· Letters of Support

· Subcontractor/Subawardee budget justification and detail budget

· Scientific articles and publications

· Indirect Cost Rate Agreement or memorandum with current and future year Cost Allocation Plan indirect rates.

No more than 20 attachments should be uploaded per application.

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

APPLICATION SUBMISSION

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) annually. The CCR registration can require an additional one to two days to complete.

Submit the application electronically by using the forms and instructions posted for this funding opportunity on www.Grants.gov. 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.

Other Submission Requirements

Letter of Intent (LOI):

Prospective applicants are asked to submit a LOI. Although a LOI is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CDC Program staff to estimate the potential review workload and plan the review. Requested LOIs should be provided no later than by the date indicated in Section I entitled “Authorization and Intent”. The LOI does not need to be signed and should include the following information:

· The FOA title and number.

· The applicant’s name and address; project director’s name, phone number, and e-mail.

· A brief description of the planned project narrative. The narrative should be no more than two, double-spaced pages, printed on one side, with one-inch margins and 12-point unreduced, Times New Roman font.

Letter of Intent (LOI) Submission Address: Submit the LOI by fax or e-mail to:

William Paradies

CDC, NCBDDD

Telephone Number: 404.498.3919

Fax: 404.498.3040

E-mail address: Wparadies@cdc.gov Dun and Bradstreet Universal Number (DUNS)

The applicant is required to have a Dun and Bradstreet Data Universal Numbering System (DUNS) identifier to apply for grants or cooperative agreements from the Federal government. The DUNS is a nine-digit number which uniquely identifies business entities. There is no charge associated with obtaining a DUNS number. Applicants may obtain a DUNS number by accessing the Dun and Bradstreet website or by calling 1-866-705-5711.

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 submitted electronically by the applicant organization’s Authorized Organizational representative (AOR) to Grants.gov on or before the deadline date and time.

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 HHS/CDC receives the application. The tracking number serves as a receipt of submission.

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. 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.

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. The application face page will be returned by HHS/CDC with a written explanation of the reason for non-acceptance.

Letter of Intent Deadline Date: June 28, 2010, AFTER DATE OF PUBLICATION on Grants.gov]

Application Deadline Date: July 19, 2010, AFTER DATE OF PUBLICATION on grants.gov] 11:59pm Eastern Standard Time VI. Application Review Information

Eligible applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the FOA #CDC-RFA-DD10-1007. 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.

Evaluation Criteria Eligible applications will be evaluated against the following criteria:

1. Methods and Plan (35 points)

Are the proposed methods feasible? To what extent are the proposed methods necessary to lead to the accomplishment of the proposed objectives? Does the applicant provide clear explanations of appropriate methods to conduct and/or evaluate fetal death activities? Does the plan identify and summarize the planned activities? To what extent does the plan for confidentiality and data security meet the needs required for a study of this type? Is the plan adequate to carry out the proposed activities? How complete and comprehensive is the plan for the entire project period? Does the plan include quantitative process and outcome measures?

2. Performance Measures (30 points)

Do the performance measures enable the applicant to determine the appropriateness and effectiveness of the project? Did the applicant provide performance measures addressing the Recipient Activities? Are the performance measures realistic and achievable? Measures of effectiveness must relate to the performance goals stated in the “Purpose” section of this announcement. Measures must be objective and quantitative and must measure the intended outcome. The measures of effectiveness must be submitted with the application and will be an element of evaluation. Some examples of measures are: improve the timeliness, accuracy, and completeness of stillbirths case ascertainment; monitor current trends in stillbirths, and evaluate the stillbirth surveillance methodology and activities.

3. Objectives (15 points)

The adequacy of the applicant’s description on the proposed project objectives are relevant, specific, achievable, measurable, time-phased, and can be addressed through the proposed methods.

4. Applicant’s Understanding of the Public Health Impact of stillbirths (10 points):

The adequacy of the applicant’s description of a clear and concise understanding of the requirements, objectives, and purpose of the cooperative agreement. The applicant should clearly describe their understanding of the public health impact of birth defects and stillbirths surveillance in their State and the purpose and complexities of their birth defects program as it relates to their State. The applicant should describe any specific characteristics of the state population that underscore the need for the enhanced population-based stillbirth surveillance.

5. Organizational and Program Personnel Capability (10 points)

d) Whether the applicant has the appropriate experience, skills, and ability to implement stillbirth surveillance into their birth defects surveillance program.

e) The adequacy of the present staff and/or the capability to assemble competent staff to either implement or improve upon a birth defects surveillance program. If it is necessary to hire staff to conduct program activities, the applicant should provide plans for identifying and hiring qualified applicants on a timely basis. The applicant should provide plans for how program activities will be conducted prior to hiring necessary staff.

f) The applicant shall identify all current and potential personnel who will work on this cooperative agreement including qualifications and specific experience as it relates to the requirements set forth in this announcement. The applicant should provide curriculum vitas for key personnel.

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. The indirect cost rate agreement should be uploaded as a PDF file with “Other Attachment Forms” when submitting via Grants.gov.

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 only expend funds for reasonable program purposes, including personnel, fringe benefits, travel, supplies, services (such as contractual), and indirect.

· 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.

· Project funds may not be used to supplant State funds available for birth defects surveillance or prevention, health care services, patient care, nor construction.

· Award recipients agree to use cooperative agreement funds for travel by project staff agreed-upon by CDC to participate in CDC-sponsored workshops, or other called meetings such as regional or annual meetings.

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.

Application Review Process

All eligible applications will be initially reviewed for completeness by the Procurement and Grants Office (PGO) staff. In addition, eligible applications will be jointly reviewed for responsiveness by the National Center on Birth Defects and Developmental Disabilities and PGO. Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance through the review process. Applicants will be notified 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”. An objective review panel will evaluate complete and responsive applications according to the criteria listed above. The objective review process will follow the policy requirements as stated in GPD 2.04 at the following website: http://198.102.218.46/doc/gpd204.doc.

Applications Selection Process

The following factors may affect the funding decision: number of annual births, race/ethnic populations, geographical coverage, existing birth defects surveillance systems. 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.

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

Administrative and National Policy Requirements

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

· AR-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 2010

· AR-12

Lobbying Restrictions

· AR-13

Prohibition on Use of CDC Funds for Certain Gun Control Activities

· AR-14

Accounting System Requirements

· AR-24

Health Insurance Portability and Accountability Act Requirements

· AR-25

Release and Sharing of Data

· AR-27

Conference Disclaimer and Use of Logos

· AR-29

Text message requirement 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 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 Reporting Requirements

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 90 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

f. Current Budget Period Activities Objectives

g. Current Budget Period Financial Progress

h. Identify Estimated Unobligated Funds in the current budget period by component separately on the 424A Forms and provide detail actions to be taken to obligate the funds.

i. New Budget Period Program Proposed Activity Objectives

j. Budget

k. Measures of Effectiveness

l. Additional Requested Information

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

2. Financial Status Report (SF 269) and annual progress report, due no more than 90 days after the end of the budget period. The annual progress report must contain all activities that have been conducted within the 12 month budget period.

3. Final performance report and final Financial Status Report, no more than 90 days after the end of the project period.

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

VIII. Agency Contacts For programmatic technical assistance, contact:

William Paradies, Project Officer Department of Health and Human Services

Centers for Disease Control and Prevention

National Center on Birth Defects and Developmental Disabilities Division of Birth Defects and Developmental Disabilities

1600 Clifton Road NE, MS E-86

Atlanta, GA 30333

Telephone: (404) 498-3919

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

Tracey Sims, Grants Management Specialist

CDC Procurement and Grants Office

2920 Brandywine Road, MS E-14

Atlanta, GA 30341

Telephone: (770) 488-2739

E-mail: ATU9@cdc.gov For general questions, contact:

Technical Information Management Section

CDC Procurement and Grants Office

2920 Brandywine Road, MS E-14

Atlanta, GA 30341

Telephone: 770-488-2700

Email:

pgotim@cdc.gov CDC Telecommunications for the hearing impaired or disabled is available at: TTY 770-488-2783.

Other Information

Other CDC funding opportunity announcements can be found on the CDC Web site, Internet address: http://www.cdc.gov/od/pgo/funding/FOAs.htm.

ATTACHMENT I

Stillbirth Surveillance Methodology and Variables

Methodology References:

Duke CW, Correa A, Romitti PA, Martin JA, Kirby R. Challenges and Priorities for Surveillance of Stillbirths: A Report on Two Workshops. Public Health Reports 2009; 124 (5):652 – 59.

Duke W, Williams L, Correa A. Using active birth defects surveillance programs to supplement data on fetal death reports: improving surveillance data on stillbirths. Birth Defects Res A Clin Mol Teratol 2008; 82 (11):799-804.

Recommended Variables for Surveillance of Stillbirths:

Demographic Information

Baby Information

Current Pregnancy Information

Obstetric History

Maternal Conditions

Baby Conditions

Admission Information

Procedure Information

Defect Information

Medications

Physician Information

Family History

Co-twin or Other Multiple Information

Placental Exam and Histopathology

Autopsy Information

Laboratory Information

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